|
Sweden
(State or other jurisdiction of incorporation or organization) |
| |
2834
(Primary Standard Industrial Classification Code Number) |
| |
Not applicable
(I.R.S. Employer Identification Number) |
|
|
Kristopher D. Brown
James Xu Michael J. Rosenberg Goodwin Procter LLP 620 Eighth Avenue New York, NY 02109 (212) 813-8800 |
| |
Dain Hard Nevonen
Linnéa Sellstrom Advokatfirman Vinge KB Stureplan 8, Box 1703 SE-111 87 Stockholm, Sweden +46(0) 10 614 30 00 |
| |
Joshua A. Kaufman
Divakar Gupta Marc A. Recht Madison A. Jones Cooley LLP 55 Hudson Yards New York, New York 10001 (212) 479-6000 |
| |
Joakim Falkner
Henric Roth Baker & McKenzie Advokatbyrå KB Vasagatan 7, Box 180 SE-101 23 Stockholm, Sweden +46 8 566 177 00 |
|
| | |
Per Common
Share |
| |
Per ADS
|
| |
Total(1)
|
| |||||||||
Public offering price | | | | | SEK | | | | | $ | | | | | | $ | | | |
Underwriting discounts and commissions(2) | | | | | SEK | | | | | $ | | | | | | $ | | | |
Proceeds to Calliditas Therapeutics AB (before expenses) | | | | | SEK | | | | | $ | | | | | | $ | | | |
| | |
Page
|
| |||
| | | | iii | | | |
| | | | iii | | | |
| | | | 1 | | | |
| | | | 12 | | | |
| | | | 14 | | | |
| | | | 16 | | | |
| | | | 79 | | | |
| | | | 81 | | | |
| | | | 82 | | | |
| | | | 84 | | | |
| | | | 85 | | | |
| | | | 87 | | | |
| | | | 98 | | | |
| | | | 115 | | | |
| | | | 155 | | | |
| | | | 163 | | | |
| | | | 164 | | | |
| | | | 166 | | | |
| | | | 174 | | | |
| | | | 185 | | | |
| | | | 187 | | | |
| | | | 193 | | | |
| | | | 200 | | | |
| | | | 201 | | | |
| | | | 201 | | | |
| | | | 202 | | | |
| | | | 203 | | | |
| | | | F-1 | | |
| | |
Years Ended
December 31, |
| |
Nine Months Ended
September 30, |
| ||||||||||||||||||
| | |
2019
|
| |
2018
|
| |
2020
|
| |
2019
|
| ||||||||||||
| | |
(SEK in thousands, except per share amounts)
|
| |||||||||||||||||||||
Consolidated Statement of Income Data: | | | | | | | | | | | | | | | | | | | | | | | | | |
Net sales
|
| | | | 184,829 | | | | | | — | | | | | | 474 | | | | | | 138,243 | | |
Operating expenses | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | (149,826) | | | | | | (99,260) | | | | | | (167,379) | | | | | | (108,117) | | |
Administrative and selling
|
| | | | (62,882) | | | | | | (31,132) | | | | | | (77,843) | | | | | | (39,092) | | |
Other operating income
|
| | | | 4,385 | | | | | | — | | | | | | 969 | | | | | | 3,515 | | |
Other operating expenses
|
| | | | (4,525) | | | | | | (2,090) | | | | | | — | | | | | | (4,525) | | |
Operating loss
|
| | | | (28,019) | | | | | | (132,482) | | | | | | (243,779) | | | | | | (9,976) | | |
Financial income
|
| | | | 926 | | | | | | 441 | | | | | | 504 | | | | | | 2,158 | | |
Financial expenses
|
| | | | (5,408) | | | | | | (8) | | | | | | (19,603) | | | | | | (1,710) | | |
Loss before income tax
|
| | | | (32,501) | | | | | | (132,049) | | | | | | (262,878) | | | | | | (9,528) | | |
Income tax expense
|
| | | | (77) | | | | | | — | | | | | | (185) | | | | | | — | | |
Loss for the period attributable to shareholders
|
| | | | (32,578) | | | | | | (132,049) | | | | | | (263,063) | | | | | | (9,528) | | |
Loss per share before and after dilution
|
| | | | (0.88) | | | | | | (5.09) | | | | | | (6.09) | | | | | | (0.26) | | |
| | |
As of December 31,
|
| |
As of
September 30, 2020 |
| |
As of
September 30, 2020 |
| |||||||||||||||
| | |
2019
|
| |
2018
|
| ||||||||||||||||||
| | | | | | | | | | | | | | |
Actual
|
| |
As Adjusted(2)
|
| ||||||
| | |
(SEK in thousands)
|
| |||||||||||||||||||||
Consolidated Statement of Financial Position Data: | | | | | | | | | | | | | | | | | | | | | |||||
Cash
|
| | | | 753,540 | | | | | | 646,175 | | | | | | 1,396,869 | | | | | | 1,964,604 | | |
Working capital(1)
|
| | | | 767,762 | | | | | | 617,727 | | | | | | 1,357,343 | | | | | | 1,925,078 | | |
Total assets
|
| | | | 845,200 | | | | | | 648,417 | | | | | | 1,440,183 | | | | | | 2,007,918 | | |
Total liabilities
|
| | | | 57,129 | | | | | | 30,242 | | | | | | 63,395 | | | | | | 63,395 | | |
Total equity
|
| | | | 788,071 | | | | | | 618,175 | | | | | | 1,376,788 | | | | | | 1,944,523 | | |
| | |
As of September 30, 2020
|
| |||||||||||||||||||||
| | |
Actual
|
| |
As Adjusted
|
| ||||||||||||||||||
| | |
$
|
| |
SEK
|
| |
$
|
| |
SEK(1)
|
| ||||||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||
Cash
|
| | | | 168,545 | | | | | | 1,396,869 | | | | | | 237,048 | | | | | | 1,964,604 | | |
Shareholders’ equity | | | | | | | | | | | | | | | | | | | | | | | | | |
Share capital
|
| | | | 241 | | | | | | 1,998 | | | | | | 263 | | | | | | 2,178 | | |
Additional paid-in capital
|
| | | | 256,524 | | | | | | 2,126,016 | | | | | | 325,004 | | | | | | 2,693,571 | | |
Reserves
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Retained earnings including net loss for the year
|
| | | | (90,642) | | | | | | (751,159) | | | | | | (90,642) | | | | | | (751,226) | | |
Total equity attributable to shareholders
|
| | | | 166,122 | | | | | | 1,376,788 | | | | | | 234,625 | | | | | | 1,944,523 | | |
Total capitalization
|
| | | | 166,480 | | | | | | 1,379,753 | | | | | | 234,983 | | | | | | 1,947,488 | | |
|
Public offering price per ADS
|
| | | $ | 32.92 | | |
|
Historical net tangible book value per ADS as of September 30, 2020
|
| | | $ | 6.58 | | |
|
Increase in pro forma net tangible book value per ADS attributable to new investors
|
| | | $ | 1.97 | | |
|
Pro forma net tangible book value per ADS after the global offering
|
| | | $ | 8.55 | | |
|
Dilution per ADS to new investors participating in the global offering
|
| | | $ | 24.37 | | |
| | |
Shares or ADSs(1)
Purchased |
| |
Total
Consideration (in thousands) |
| |
Average
Price per Share |
| |
Average
Price per ADS |
| ||||||||||||||||||||||||
|
Number
|
| |
Percent
|
| |
Amount
|
| |
Percent
|
| ||||||||||||||||||||||||||
Existing shareholders
|
| | | | 49,941,584 | | | | | | 91.7% | | | | | $ | 276,418,470 | | | | | | 78.9% | | | | | $ | 5.53 | | | | | $ | 11.07 | | |
New investors
|
| | | | 4,500,000 | | | | | | 8.3% | | | | | $ | 74,070,000 | | | | | | 21.1% | | | | | $ | 16.46 | | | | | $ | 32.92 | | |
Total
|
| | | | 54,441,584 | | | | | | 100% | | | | | $ | 350,488,470 | | | | | | 100% | | | | | $ | 6.44 | | | | | $ | 12.88 | | |
| | |
Years Ended December 31,
|
| |
Nine Months Ended September 30,
|
| ||||||||||||||||||
| | |
2019
|
| |
2018
|
| |
2020
|
| |
2019
|
| ||||||||||||
| | |
(SEK in thousands, except per share amounts)
|
| |||||||||||||||||||||
Consolidated Statement of Income Data: | | | | | | | | | | | | | | | | | | | | | | | | | |
Net sales
|
| | | | 184,829 | | | | | | — | | | | | | 474 | | | | | | 138,243 | | |
Operating expenses
|
| | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | (149,826) | | | | | | (99,260) | | | | | | (167,379) | | | | | | (108,117) | | |
Administrative and selling
|
| | | | (62,882) | | | | | | (31,132) | | | | | | (77,843) | | | | | | (39,092) | | |
Other operating income
|
| | | | 4,385 | | | | | | — | | | | | | 969 | | | | | | 3,515 | | |
Other operating expenses
|
| | | | (4,525) | | | | | | (2,090) | | | | | | — | | | | | | (4,525) | | |
Operating loss
|
| | | | (28,019) | | | | | | (132,482) | | | | | | (243,779) | | | | | | (9,976) | | |
Financial income
|
| | | | 926 | | | | | | 441 | | | | | | 504 | | | | | | 2,158 | | |
Financial expenses
|
| | | | (5,408) | | | | | | (8) | | | | | | (19,603) | | | | | | (1,710) | | |
Loss before income tax
|
| | | | (32,501) | | | | | | (132,049) | | | | | | (262,878) | | | | | | (9,528) | | |
Income tax expense
|
| | | | (77) | | | | | | — | | | | | | (185) | | | | | | — | | |
Loss for the period attributable to shareholders
|
| | | | (32,578) | | | | | | (132,049) | | | | | | (263,063) | | | | | | (9,528) | | |
Loss per share before and after dilution
|
| | | | (0.88) | | | | | | (5.09) | | | | | | (6.09) | | | | | | (0.26) | | |
|
| | |
As of December 31,
|
| |
As of September 30,
|
| ||||||||||||
| | |
2019
|
| |
2018
|
| |
2020
|
| |||||||||
| | |
(SEK in thousands)
|
| |||||||||||||||
Consolidated Statement of Financial Position Data: | | | | | | | | | | | | | | | | | | | |
Cash
|
| | | | 753,540 | | | | | | 646,175 | | | | | | 1,396,869 | | |
Working capital(1)
|
| | | | 767,762 | | | | | | 617,727 | | | | | | 1,357,343 | | |
Total assets
|
| | | | 845,200 | | | | | | 648,417 | | | | | | 1,440,183 | | |
Total liabilities
|
| | | | 57,129 | | | | | | 30,242 | | | | | | 63,395 | | |
Total equity
|
| | | | 788,071 | | | | | | 618,175 | | | | | | 1,376,788 | | |
| | |
CALLIDITAS
THERAPEUTICS AB (Historical) |
| |
GENKYOTEX S.A.
(Historical) |
| |
Pro Forma
Adjustments |
| |
Note 4
|
| |
Pro Forma
Combined |
| ||||||||||||||||||
| | |
(in SEK)
|
| |
(in EUR)
|
| |
(in SEK)
|
| |
(in SEK)
|
| | | | |
(in SEK)
|
| |||||||||||||||
ASSETS | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Non-current assets | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Intangible assets
|
| | | | 16,066 | | | | | | 2,801 | | | | | | 29,393 | | | | | | 386,927 | | | |
(a)
|
| | | | 432,386 | | |
Goodwill
|
| | | | — | | | | | | — | | | | | | — | | | | | | 47,595 | | | |
(a)
|
| | | | 47,595 | | |
Equipment
|
| | | | 89 | | | | | | 10 | | | | | | 105 | | | | | | — | | | | | | | | | 194 | | |
Right-of-use assets
|
| | | | 4,144 | | | | | | 208 | | | | | | 2,183 | | | | | | — | | | | | | | | | 6,327 | | |
Non-current financial assets
|
| | | | 2,111 | | | | | | 36 | | | | | | 378 | | | | | | — | | | | | | | | | 2,489 | | |
Total non-current assets
|
| | | | 22,410 | | | | | | 3,055 | | | | | | 32,059 | | | | | | 434,522 | | | | | | | | | 488,991 | | |
Current assets
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Other current assets
|
| | | | 4,106 | | | | | | 668 | | | | | | 7,010 | | | | | | — | | | | | | | | | 11,116 | | |
Prepaid expenses
|
| | | | 16,798 | | | | | | 179 | | | | | | 1,878 | | | | | | — | | | | | | | | | 18,676 | | |
Cash and cash equivalents
|
| | | | 1,396,869 | | | | | | 3,590 | | | | | | 37,674 | | | | | | (287,568) | | | |
(a)
|
| | | | 1,146,975 | | |
Total current assets
|
| | | | 1,417,773 | | | | | | 4,437 | | | | | | 46,562 | | | | | | (287,568) | | | | | | | | | 1,767,767 | | |
TOTAL ASSETS
|
| | | | 1,440,183 | | | | | | 7,492 | | | | | | 78,621 | | | | | | 146,954 | | | | | | | | | 1,665,758 | | |
SHAREHOLDERS’ EQUITY AND LIABILITIES
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Share capital
|
| | | | 1,998 | | | | | | 11,549 | | | | | | 121,196 | | | | | | (121,196) | | | |
(a)
|
| | | | 1,998 | | |
Additional paid-in capital
|
| | | | 2,126,016 | | | | | | 4,747 | | | | | | 49,815 | | | | | | (44,576) | | | |
(a)
|
| | | | 2,131,255 | | |
Reserves
|
| | | | (66) | | | | | | (2,752) | | | | | | (28,880) | | | | | | 28,880 | | | |
(a)
|
| | | | (66) | | |
Accumulated other comprehensive loss
|
| | | | — | | | | | | (647) | | | | | | (6,790) | | | | | | 6,790 | | | |
(a)
|
| | | | — | | |
Retained earnings, including net loss for
the period |
| | | | (751,160) | | | | | | (8,350) | | | | | | (87,625) | | | | | | 69,248 | | | |
(a), (e)
|
| | | | (769,537) | | |
Noncontrolling interest
|
| | | | — | | | | | | — | | | | | | — | | | | | | 51,171 | | | |
(a)
|
| | | | 51,171 | | |
Total equity attributable to shareholders
of the Parent Company |
| | | | 1,376,788 | | | | | | 4,547 | | | | | | 47,716 | | | | | | (9,683) | | | | | | | | | 1,414,821 | | |
Non-current liabilities
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Employee benefit obligations
|
| | | | — | | | | | | 960 | | | | | | 10,074 | | | | | | — | | | | | | | | | 10,074 | | |
Acquisition liability
|
| | | | — | | | | | | — | | | | | | — | | | | | | 51,200 | | | |
(a)
|
| | | | 51,200 | | |
Deferred tax liability
|
| | | | — | | | | | | — | | | | | | — | | | | | | 87,060 | | | |
(a)
|
| | | | 87,060 | | |
Provisions
|
| | | | 1,931 | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | 1,931 | | |
Other non-current liabilities
|
| | | | 1,034 | | | | | | 63 | | | | | | 661 | | | | | | — | | | | | | | | | 1,695 | | |
Total non-current liabilities
|
| | | | 2,965 | | | | | | 1,023 | | | | | | 10,735 | | | | | | 138,260 | | | | | | | | | 151,960 | | |
Current liabilities
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Accounts payable
|
| | | | 19,872 | | | | | | 656 | | | | | | 6,884 | | | | | | — | | | | | | | | | 26,756 | | |
Current tax liabilities
|
| | | | 15 | | | | | | 258 | | | | | | 2,708 | | | | | | — | | | | | | | | | 2,723 | | |
Current financial liabilities
|
| | | | — | | | | | | 146 | | | | | | 1,532 | | | | | | — | | | | | | | | | 1,532 | | |
Other current liabilities
|
| | | | 3,907 | | | | | | 54 | | | | | | 567 | | | | | | — | | | | | | | | | 4,474 | | |
Accrued expenses and deferred revenue
|
| | | | 36,636 | | | | | | 808 | | | | | | 8,479 | | | | | | 18,377 | | | |
(e)
|
| | | | 63,492 | | |
Total current liabilities
|
| | | | 60,430 | | | | | | 1,922 | | | | | | 20,170 | | | | | | 18,377 | | | | | | | | | 98,977 | | |
TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES
|
| | | | 1,440,183 | | | | | | 7,492 | | | | | | 78,621 | | | | | | 146,954 | | | | | | | | | 1,665,758 | | |
| | |
CALLIDITAS
THERAPEUTICS AB (Historical) |
| |
GENKYOTEX S.A.
(Historical) |
| |
Pro Forma
Adjustments |
| |
Note 4
|
| |
Pro Forma
Combined |
| ||||||||||||||||||
| | |
(in SEK)
|
| |
(in EUR)
|
| |
(in SEK)
|
| |
(in SEK)
|
| | | | |
(in SEK)
|
| |||||||||||||||
Net sales
|
| | | | 474 | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | 474 | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | (167,379) | | | | | | (9,271) | | | | | | (97,978) | | | | | | 65,124 | | | |
(b)
|
| | | | (200,233) | | |
Administrative and selling
|
| | | | (77,843) | | | | | | (1,757) | | | | | | (18,568) | | | | | | 4,162 | | | |
(c), (d)
|
| | | | (92,249) | | |
Other operating income
|
| | | | 969 | | | | | | 35 | | | | | | 370 | | | | | | — | | | | | | | | | 1,339 | | |
Operating loss
|
| | | | (243,779) | | | | | | (10,993) | | | | | | (116,176) | | | | | | 69,286 | | | | | | | | | (290,669) | | |
Financial income
|
| | | | 504 | | | | | | 12 | | | | | | 127 | | | | | | — | | | | | | | | | 631 | | |
Financial expenses
|
| | | | (19,603) | | | | | | (101) | | | | | | (1,067) | | | | | | — | | | | | | | | | (20,670) | | |
Change in fair value of derivative instruments
|
| | | | — | | | | | | 64 | | | | | | 676 | | | | | | — | | | | | | | | | 676 | | |
Loss before income tax
|
| | | | (262,878) | | | | | | (11,018) | | | | | | (116,440) | | | | | | 69,286 | | | | | | | | | (310,032) | | |
Income tax expense
|
| | | | (185) | | | | | | — | | | | | | — | | | | | | — | | | |
(f)
|
| | | | (185) | | |
Loss for the year attributable to
shareholders of the Parent Company and noncontrolling interest |
| | | | (263,063) | | | | | | (11,018) | | | | | | (116,440) | | | | | | 69,286 | | | | | | | | | (310,217) | | |
Whereof: | | | | | | | | |||||||||||||||||||||||||||
Loss for the year attributable to noncontrolling interest
|
| | | | — | | | | | | — | | | | | | — | | | | | | (6,660) | | | |
(g)
|
| | | | (6,660) | | |
Loss for the year attributable to shareholders of the Parent
Company |
| | | | (263,063) | | | | | | (11,018) | | | | | | (116,440) | | | | | | 75,946 | | | | | | | | | (303,557) | | |
Loss per share before and after dilution attributable to Parent Company
|
| | | | (6.09) | | | | | | | | | | | | | | | | | | | | | | | | | | | (7.03) | | |
Weighted average shares
outstanding |
| | | | 43,165,505 | | | | | | | | | | | | | | | | | | | | | | | | | | | 43,165,505 | | |
| | |
CALLIDITAS
THERAPEUTICS AB (Historical) |
| |
GENKYOTEX S.A.
(Historical) |
| |
Pro Forma
Adjustments |
| |
Note 4
|
| |
Pro Forma
Combined |
| ||||||||||||||||||
| | |
(in SEK)
|
| |
(in EUR)
|
| |
(in SEK)
|
| |
(in SEK)
|
| | | | |
(in SEK)
|
| |||||||||||||||
Net sales
|
| | | | 184,829 | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | 184,829 | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | (149,826) | | | | | | (5,406) | | | | | | (57,248) | | | | | | 4,276 | | | |
(b)
|
| | | | (202,798) | | |
Administrative and selling
|
| | | | (62,882) | | | | | | (2,160) | | | | | | (22,874) | | | | | | 64 | | | |
(c)
|
| | | | (85,692) | | |
Other operating income
|
| | | | 4,385 | | | | | | 142 | | | | | | 1,504 | | | | | | — | | | | | | | | | 5,889 | | |
Other operating expenses
|
| | | | (4,525) | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | (4,525) | | |
Operating loss
|
| | | | (28,019) | | | | | | (7,424) | | | | | | (78,618) | | | | | | 4,340 | | | | | | | | | (102,297) | | |
Financial income
|
| | | | 926 | | | | | | 348 | | | | | | 3,685 | | | | | | — | | | | | | | | | 4,611 | | |
Financial expenses
|
| | | | (5,408) | | | | | | (190) | | | | | | (2,012) | | | | | | — | | | | | | | | | (7,420) | | |
Change in fair value of derivative instruments
|
| | | | — | | | | | | 64 | | | | | | 678 | | | | | | — | | | | | | | | | 678 | | |
Loss before income tax
|
| | | | (32,501) | | | | | | (7,202) | | | | | | (76,267) | | | | | | 4,340 | | | | | | | | | (104,428) | | |
Income tax expense
|
| | | | (77) | | | | | | — | | | | | | — | | | | | | — | | | |
(f)
|
| | | | (77) | | |
Loss for the year attributable to shareholders of the Parent Company and noncontrolling interests
|
| | | | (32,578) | | | | | | (7,202) | | | | | | (76,267) | | | | | | 4,340 | | | | | | | | | (104,505) | | |
Whereof: | | | | | | | | |||||||||||||||||||||||||||
Loss for the year attributable to noncontrolling interest
|
| | | | — | | | | | | — | | | | | | — | | | | | | (9,926) | | | |
(g)
|
| | | | (9,926) | | |
Loss for the year attributable to shareholders of the Parent
Company |
| | | | (32,578) | | | | | | (7,202) | | | | | | (76,267) | | | | | | 14,266 | | | | | | | | | (94,579) | | |
Loss per share before and after dilution attributable to Parent Company
|
| | | | (0.88) | | | | | | | | | | | | | | | | | | | | | | | | | | | (2.56) | | |
Weighted average shares outstanding
|
| | | | 36,940,587 | | | | | | | | | | | | | | | | | | | | | | | | | | | 36,940,587 | | |
| | |
Exchange
Rate |
| |||
Period end exchange rate as of September 30, 2020 (statement of financial position)
|
| | | | 10.494052 | | |
Average exchange rate for the nine months ended September 30, 2020 (statement of operations)
|
| | | | 10.568175 | | |
Average exchange rate for the year ended December 31, 2019 (statement of operations)
|
| | | | 10.589781 | | |
(in thousands)
|
| |
EUR
|
| |
SEK
|
| ||||||
Cash and cash equivalents
|
| | | | 3,590 | | | | | | 37,674 | | |
Other current assets
|
| | | | 668 | | | | | | 7,010 | | |
Prepaid expenses
|
| | | | 179 | | | | | | 1,878 | | |
Equipment
|
| | | | 10 | | | | | | 105 | | |
Right of use assets
|
| | | | 208 | | | | | | 2,183 | | |
Other non-current assets
|
| | | | 36 | | | | | | 378 | | |
Intangible assets
|
| | | | 2,801 | | | | | | 29,393 | | |
Acquired identifiable intangible assets (see Note 4)
|
| | | | 36,871 | | | | | | 386,927 | | |
Noncontrolling interest (see Note 4)
|
| | | | (13,022) | | | | | | (136,658) | | |
Accounts payable
|
| | | | (656) | | | | | | (6,884) | | |
Accrued expenses
|
| | | | (808) | | | | | | (8,479) | | |
Current tax liabilities
|
| | | | (258) | | | | | | (2,708) | | |
Current financial liabilities
|
| | | | (146) | | | | | | (1,532) | | |
(in thousands)
|
| |
EUR
|
| |
SEK
|
| ||||||
Other current liabilities
|
| | | | (54) | | | | | | (567) | | |
Deferred tax liabilities
|
| | | | (8,296) | | | | | | (87,060) | | |
Employee benefit obligations
|
| | | | (960) | | | | | | (10,074) | | |
Other non-current liabilities
|
| | | | (63) | | | | | | (661) | | |
Net assets acquired (a)
|
| | | | 20,100 | | | | | | 210,925 | | |
Estimated consideration transferred (b)
|
| | | | 24,635 | | | | | | 258,520 | | |
Estimated goodwill (b) - (a)
|
| | | | 4,535 | | | | | | 47,595 | | |
|
(in thousands)
|
| |
EUR
|
| |
SEK
|
| ||||||
Total consideration transferred
|
| | | | 24,635 | | | | | | 258,520(i) | | |
Fair value of noncontrolling interest
|
| | | | 13,022 | | | | | | 136,658(ii) | | |
Less: | | | | | | | | | | | | | |
Share capital
|
| | | | 11,549 | | | | | | 121,196 | | |
Additional paid-in capital
|
| | | | 4,747 | | | | | | 49,815 | | |
Accumulated other comprehensive income
|
| | | | (647) | | | | | | (6,790) | | |
Reserves
|
| | | | (2,752) | | | | | | (28,880) | | |
Retained earnings, including net loss for the period
|
| | | | (8,350) | | | | | | (87,625) | | |
Acquired identifiable intangible assets
|
| | | | 36,871 | | | | | | 386,927 | | |
Deferred tax liability
|
| | | | (8,296) | | | | | | (87,060) | | |
Goodwill–related to the Acquisition
|
| | | | 4,535 | | | | | | 47,595 | | |
|
(in thousands, except shares and per share amounts)
|
| | | | | | |
Shares tendered
|
| | | | 2,885,161 | | |
Price per share (EUR)
|
| | | | 2.80 | | |
Total cash paid for Tender Offer (EUR)
|
| | | | 8,078 | | |
Total cash paid for Tender Offer (SEK)
|
| | | | 84,776(i) | | |
Fair value of noncontrolling interest from Initial Acquisition (SEK)
|
| | | | 136,658 | | |
Noncontrolling interest in connection with exercise of warrants (SEK)
|
| | | | 4,528 | | |
Noncontrolling interest before Tender Offer (SEK)
|
| | | | 141,186 | | |
Less: adjustment to carrying value of noncontrolling interest in connection with Tender
Offer |
| | | | (90,015)(i) | | |
Carrying value of noncontrolling interest subsequent to Tender Offer (SEK)
|
| | | | 51,171 | | |
| | | | | | | | | | | | | | |
Amortization Expenses
|
| |||||||||
(Amounts in thousands SEK)
|
| |
Estimated
Fair Value |
| |
Estimated
Useful Life in Years |
| |
Nine Months
Ended September 30, 2020 |
| |
Year Ended
December 31, 2019 |
| ||||||||||||
Technology – NOX 1 & 4 Platform
|
| | | | 386,927 | | | | | | 15 | | | | | | — | | | | | | — | | |
Technology – SIL Vaxiclase Platform
|
| | | | 29,394 | | | | | | 17 | | | | | | 1,297 | | | | | | 1,729 | | |
Historical impairment charges
|
| | | | | | | | | | | | | | | | (61,919) | | | | | | — | | |
Historical amortization expense
|
| | | | | | | | | | | | | | | | (4,502) | | | | | | (6,005) | | |
Pro forma adjustments to amortization expense
|
| | | | | | | | | | | | | | | | (65,124) | | | | | | (4,276) | | |
| | |
Depreciation Expenses
|
| |||||||||
(Amounts in thousands SEK)
|
| |
Nine Months
Ended September 30, 2020 |
| |
Year Ended
December 31, 2019 |
| ||||||
Estimated depreciation expense
|
| | | | — | | | | | | (105) | | |
Historical depreciation expense
|
| | | | 85 | | | | | | 169 | | |
Pro forma adjustments to depreciation expense
|
| | | | 85 | | | | | | 64 | | |
| | |
Net loss attributable to noncontrolling
interest |
| |||||||||
(Amounts in thousands SEK)
|
| |
Nine Months
Ended September 30, 2020 |
| |
Year Ended
December 31, 2019 |
| ||||||
Net loss for Genkyotex
|
| | | | (116,440) | | | | | | (76,267) | | |
Pro forma adjustments(1)
|
| | | | 68,178 | | | | | | 4,340 | | |
Adjusted net loss for Genkyotex
|
| | | | (48,262) | | | | | | (71,927) | | |
Noncontrolling interest percentage(2)
|
| | | | 13.8% | | | | | | 13.8% | | |
Net loss attributable to noncontrolling interest
|
| | | | (6,660) | | | | | | (9,926) | | |
| | |
Years Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
| | |
(SEK in thousands,
except per share amounts) |
| |||||||||
Consolidated Statement of Income Data: | | | | | | | | | | | | | |
Net sales
|
| | | | 184,829 | | | | | | — | | |
Operating expenses
|
| | | | | | | | | | | | |
Research and development
|
| | | | (149,826) | | | | | | (99,260) | | |
Administrative and selling
|
| | | | (62,882) | | | | | | (31,132) | | |
Other operating income
|
| | | | 4,385 | | | | | | — | | |
Other operating expenses
|
| | | | (4,525) | | | | | | (2,090) | | |
Operating loss
|
| | | | (28,019) | | | | | | (132,482) | | |
Financial income
|
| | | | 926 | | | | | | 441 | | |
Financial expenses
|
| | | | (5,408) | | | | | | (8) | | |
Loss before income tax
|
| | | | (32,501) | | | | | | (132,049) | | |
Income taxes
|
| | | | (77) | | | | | | — | | |
Net loss for the year attributable to shareholders
|
| | | | (32,578) | | | | | | (132,049) | | |
Loss per share before and after dilution
|
| | | | (0.88) | | | | | | (5.09) | | |
| | |
Nine Months Ended September,
|
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
| | |
(SEK in thousands,
except per share amounts) |
| |||||||||
Consolidated Statement of Income Data: | | | | | | | | | | | | | |
Net sales
|
| | | | 474 | | | | | | 138,243 | | |
Operating expenses
|
| | | | | | | | | | | | |
Research and development
|
| | | | (167,379) | | | | | | (108,117) | | |
Administrative and selling
|
| | | | (77,843) | | | | | | (39,092) | | |
Other operating income
|
| | | | 969 | | | | | | 3,515 | | |
Other operating expenses
|
| | | | — | | | | | | (4,525) | | |
Operating loss
|
| | | | (243,779) | | | | | | (9,976) | | |
Financial income
|
| | | | 504 | | | | | | 2,158 | | |
Financial expenses
|
| | | | (19,603) | | | | | | (1,710) | | |
Loss before income tax
|
| | | | (262,878) | | | | | | (9,528) | | |
Income taxes
|
| | | | (185) | | | | | | — | | |
Net loss for the period attributable to shareholders
|
| | | | (263,063) | | | | | | (9,528) | | |
Loss per share before and after dilution
|
| | | | (6.09) | | | | | | (0.26) | | |
| | |
Years Ended
December 31, |
| |
Nine Months Ended
September 30, |
| ||||||||||||||||||
| | |
2019
|
| |
2018
|
| |
2020
|
| |
2019
|
| ||||||||||||
| | |
(SEK in thousands)
|
| |||||||||||||||||||||
Cash used in operating activities
|
| | | | (71,011) | | | | | | (128,191) | | | | | | (189,107) | | | | | | (25,576) | | |
Cash used in investing activities
|
| | | | (18,072) | | | | | | — | | | | | | (2) | | | | | | (17,781) | | |
Cash used in/provided by financing activities
|
| | | | 198,835 | | | | | | 716,572 | | | | | | 847,882 | | | | | | 200,088 | | |
Net increase (decrease) in cash
|
| | | | 109,752 | | | | | | 588,381 | | | | | | 658,773 | | | | | | 156,731 | | |
| | |
Payments due by Period
|
| |||||||||||||||||||||||||||
| | |
Total
|
| |
Less than
1 Year |
| |
1-3 years
|
| |
4-5 Years
|
| |
More
than 5 years |
| |||||||||||||||
| | |
(in thousands)
|
| |||||||||||||||||||||||||||
Operating lease obligations(1)
|
| | | | 6,655 | | | | | | 3,816 | | | | | | 2,839 | | | | | | — | | | | | | — | | |
Total
|
| | | | 6,655 | | | | | | 3,816 | | | | | | 2,839 | | | | | | — | | | | | | — | | |
Currency Exposure 2019 (%)
|
| |
Revenue
|
| |
Operating
expenses |
| ||||||
USD | | | | | 100% | | | | | | 22% | | |
EUR | | | | | — | | | | | | 54% | | |
GBP | | | | | — | | | | | | 3% | | |
SEK | | | | | — | | | | | | 21% | | |
Currency Exposure 2018 (%)
|
| |
Revenue
|
| |
Operating
expenses |
| ||||||
USD | | | | | 100% | | | | | | 10% | | |
EUR | | | | | — | | | | | | 52% | | |
Currency Exposure 2018 (%)
|
| |
Revenue
|
| |
Operating
expenses |
| ||||||
GBP | | | | | — | | | | | | 2% | | |
SEK | | | | | — | | | | | | 36% | | |
Currency Exposure for the nine months ended September 30, 2020 (%)
|
| |
Revenue
|
| |
Operating
expenses |
| ||||||
USD
|
| | | | — | | | | | | 32% | | |
EUR
|
| | | | — | | | | | | 40% | | |
GBP | | | | | — | | | | | | 5% | | |
SEK | | | | | — | | | | | | 23% | | |
Currency Exposure for the nine months ended September 30, 2019 (%)
|
| |
Revenue
|
| |
Operating
expenses |
| ||||||
USD | | | | | — | | | | | | 17% | | |
EUR | | | | | — | | | | | | 62% | | |
GBP | | | | | — | | | | | | 3% | | |
SEK | | | | | — | | | | | | 19% | | |
Name
|
| |
Age
|
| |
Position(s)
|
|
Executive Officers: | | | | | | | |
Renée Aguiar-Lucander
|
| |
58
|
| | Chief Executive Officer | |
Fredrik Johansson
|
| |
43
|
| | Chief Financial Officer | |
Richard Philipson, M.D.
|
| |
56
|
| | Chief Medical Officer | |
Andrew Udell
|
| |
50
|
| | Vice President, North America Commercial | |
Frank Bringstrup, M.D.
|
| |
61
|
| | Vice President Regulatory Affairs | |
Katayoun Welin-Berger, Ph.D.
|
| |
52
|
| | Vice President Operations | |
Directors: | | | | | | | |
Elmar Schnee(2)
|
| |
61
|
| | Chairman of the Board of Directors | |
Hilde Furberg(1)
|
| |
62
|
| | Director | |
Lennart Hansson, Ph.D.(1)(2)
|
| |
64
|
| | Director | |
Diane Parks(2)
|
| |
68
|
| | Director | |
Molly Henderson(1)
|
| |
50
|
| | Director | |
| | |
Number of
Shares Beneficially Owned Before Global Offering |
| |
Percentage of Shares
Beneficially Owned |
| ||||||||||||
Name of beneficial owner
|
| |
Before
Offering* |
| |
After
Offering* |
| ||||||||||||
5% or Greater Shareholders: | | | | | | | | | | | | | | | | | | | |
BVF Partners LP(1)
|
| | | | 6,331,562 | | | | | | 12.68% | | | | | | 11.91% | | |
Stiftelsen Industrifonden(2)
|
| | | | 5,772,995 | | | | | | 11.56% | | | | | | 10.86% | | |
Linc AB(3)
|
| | | | 4,836,108 | | | | | | 9.68% | | | | | | 9.10% | | |
Handelsbanken Fonder AB(4)
|
| | | | 2,634,684 | | | | | | 5.28% | | | | | | 4.96% | | |
Executive Officers and Directors: | | | | | | | | | | | | | | | | | | | |
Renée Aguiar-Lucander(5)
|
| | | | 412,000 | | | | | | 0.86% | | | | | | 0.77% | | |
Fredrik Johansson(6)
|
| | | | 18,250 | | | | | | 0.04% | | | | | | 0.03% | | |
Richard Philipson, M.D.
|
| | | | — | | | | | | * | | | | | | * | | |
Andrew Udell
|
| | | | — | | | | | | * | | | | | | * | | |
Frank Bringstrup, M.D.
|
| | | | — | | | | | | * | | | | | | * | | |
Katayoun Welin-Berger
|
| | | | — | | | | | | * | | | | | | * | | |
Elmar Schnee
|
| | | | — | | | | | | * | | | | | | * | | |
|
Year
|
| |
Transaction
|
| |
Nominal
Value |
| |
Subscription
Price per Share (SEK) |
| |
Increase in
Number of Shares |
| |
Increase in
Share Capital (SEK) |
| |
Total
Number of Shares |
| |
Total Share
Capital (SEK) |
| ||||||||||||||||||
|
2004
|
| | Foundation | | | | | 100 | | | | | | — | | | | | | 1,000 | | | | | | 100,000 | | | | | | 1,000 | | | | | | 100,000 | | |
|
2004
|
| | New share issue | | | | | 100 | | | | | | 25,000 | | | | | | 12 | | | | | | 1,200 | | | | | | 1,012 | | | | | | 101,200 | | |
|
2005
|
| | New share issue | | | | | 100 | | | | | | 50,562 | | | | | | 178 | | | | | | 17,800 | | | | | | 1,190 | | | | | | 119,000 | | |
|
2009
|
| | New share issue | | | | | 100 | | | | | | 60,000 | | | | | | 132 | | | | | | 13,200 | | | | | | 1,322 | | | | | | 132,000 | | |
|
2012
|
| | New share issue | | | | | 100 | | | | | | 52,950 | | | | | | 664 | | | | | | 66,400 | | | | | | 1,986 | | | | | | 198,600 | | |
|
2013
|
| | New share issue | | | | | 100 | | | | | | 52,950 | | | | | | 813 | | | | | | 81,300 | | | | | | 2,799 | | | | | | 279,900 | | |
|
2014
|
| | New share issue | | | | | 100 | | | | | | 52,950 | | | | | | 189 | | | | | | 18,900 | | | | | | 2,988 | | | | | | 298,800 | | |
|
2014
|
| | New share issue | | | | | 100 | | | | | | 52,950 | | | | | | 809 | | | | | | 80,900 | | | | | | 3,797 | | | | | | 379,700 | | |
|
2015
|
| | New share issue | | | | | 100 | | | | | | 52,950 | | | | | | 756 | | | | | | 75,600 | | | | | | 4,553 | | | | | | 455,300 | | |
|
2016
|
| | New share issue | | | | | 100 | | | | | | 52,950 | | | | | | 752 | | | | | | 75,200 | | | | | | 5,305 | | | | | | 530,500 | | |
|
2017
|
| | New share issue | | | | | 100 | | | | | | 52,950 | | | | | | 605 | | | | | | 60,500 | | | | | | 5,910 | | | | | | 591,000 | | |
|
2017
|
| | Share split (1:10) | | | | | 10 | | | | | | — | | | | | | 53,190 | | | | | | — | | | | | | 59,100 | | | | | | 591,000 | | |
|
2017
|
| | New share issue | | | | | 10 | | | | | | 5,295 | | | | | | 7,026 | | | | | | 70,260 | | | | | | 66,126 | | | | | | 661,260 | | |
|
2017
|
| | New share issue | | | | | 10 | | | | | | 5,295 | | | | | | 566 | | | | | | 5,660 | | | | | | 66,692 | | | | | | 666,920 | | |
|
2017
|
| | Share split (1:250) | | | | | 0.04 | | | | | | | | | | | | 16,606,308 | | | | | | — | | | | | | 16,673,000 | | | | | | 666,920 | | |
|
2018
|
| | Conversion of bridge loans in connection with offering | | | | | 0.04 | | | | | | 45.00 | | | | | | 2,114,903 | | | | | | 84,596.12 | | | | | | 18,787,903 | | | | | | 751,516.12 | | |
|
2018
|
| | New share issue in connection with listing | | | | | 0.04 | | | | | | 45.00 | | | | | | 16,414,444 | | | | | | 656,577.76 | | | | | | 35,202,347 | | | | | | 1,408,093.88 | | |
|
2019
|
| | New share issue | | | | | 0.04 | | | | | | 60.00 | | | | | | 3,505,291 | | | | | | 140,211.64 | | | | | | 38,707,638 | | | | | | 1,548,305.52 | | |
|
2020
|
| | New share issue in connection with listing | | | | | 0.04 | | | | | | 89.70 | | | | | | 9,937,446 | | | | | | 397,497.80 | | | | | | 48,645,084 | | | | | | 1,945,803.40 | | |
|
2020
|
| | Exercise of Warrant program | | | | | 0.04 | | | | | | 42.36 | | | | | | 1,296,500 | | | | | | 52,860.00 | | | | | | 49,941,584 | | | | | | 1,997,663.40 | | |
| Number of Directors | | | | |
|
Sweden. Under the Swedish Companies Act, a public company shall have a board of directors consisting of at least three directors. More than half of the directors shall be resident within the European Economic Area (unless otherwise approved by the Swedish Companies Registration Office). The actual number of board members shall be determined by a shareholders’ meeting, within the limits set out in the company’s articles of association. Under the Swedish Code of Corporate Governance, only one director may also be a senior executive of the relevant company or a subsidiary. The Swedish Code of Corporate Governance includes certain independence requirements for the directors, and requires a majority of the directors to be independent of the company and at least two directors to also be independent of major shareholders.
|
| | Delaware. Under the Delaware General Corporation Law, a corporation must have at least one director and the number of directors shall be fixed by or in the manner provided in the bylaws. The Delaware General Corporation Law does not address director independence, though Delaware courts have provided general guidance as to determining independence, including that the determination must be both an objective and a subjective assessment. | |
| Removal of Directors | | | ||
|
Sweden. Under the Swedish Companies Act, directors appointed at a general meeting may be removed by a resolution adopted at a general meeting, upon the affirmative vote of a simple majority of the votes cast.
|
| | Delaware. Under the Delaware General Corporation Law, unless otherwise provided in the certificate of incorporation, directors may be removed from office, with or without cause, by a majority stockholder vote, though in the case of a | |
| | | | corporation whose board is classified, stockholders may effect such removal only for cause. | |
| Vacancies on the Board of Directors | | | | |
|
Sweden. Under the Swedish Companies Act, if a director’s tenure should terminate prematurely, the election of a new director may be deferred until the time of the next annual general meeting, providing there are enough remaining directors to constitute a quorum.
|
| | Delaware. Under the Delaware General Corporation Law, vacancies on a corporation’s board of directors, including those caused by an increase in the number of directors, may be filled by a majority of the remaining directors. | |
| Annual General Meeting | | | | |
|
Sweden. Under the Swedish Companies Act, within six months of the end of each fiscal year, the shareholders shall hold an annual general meeting at which the board of directors shall present the annual report and auditor’s report and, for a parent company which is obliged to prepare group accounts, the group accounts and the auditor’s report for the group. Shareholder meetings shall be held in the city stated in the articles of association. The minutes of a shareholders’ meeting must be made available on the company’s website no later than two weeks after the meeting.
|
| | Delaware. Under the Delaware General Corporation Law, the annual meeting of stockholders shall be held at such place, on such date and at such time as may be designated from time to time by the board of directors or as provided in the certificate of incorporation or by the bylaws. If a company fails to hold an annual meeting or fails to take action by written consent to elect directors in lieu of an annual meeting for a period of 30 days after the date designated for the annual meeting, or if no date was designated, 13 months after either the last annual meeting or the last action by written consent to elect directors in lieu of an annual meeting, whichever is later, the Delaware Court of Chancery may summarily order a meeting to be held upon the application of any stockholder or director. The Delaware General Corporation Law does not require minutes of stockholders’ meetings to be made public. | |
| Special Meeting | | | | |
|
Sweden. Under the Swedish Companies Act, the board of directors shall convene an extraordinary general meeting if a shareholder minority representing at least ten per cent of the company’s shares or the auditor of the company so demands, and the board of directors may convene an extraordinary general meetings whenever it believes reason exists to hold an extraordinary general meeting prior to the next annual general meeting.
|
| | Delaware. Under the Delaware General Corporation Law, special meetings of the stockholders may be called by the board of directors or by such person or persons as may be authorized by the certificate of incorporation or by the bylaws. | |
| Notices | | | | |
|
Sweden. Under the Swedish Companies Act, a shareholders’ meeting must be preceded by a notice. The notice of the annual general meeting of shareholders must be issued no sooner than six weeks and no later than four weeks before the date of an annual general meeting. In general, notice of other extraordinary general meetings must be issued no sooner than six weeks and no later than three weeks before the meeting. Publicly listed companies must always notify shareholders of a general meeting by
|
| | Delaware. Under the Delaware General Corporation Law, unless otherwise provided in the certificate of incorporation or bylaws, written notice of any meeting of the stockholders must be given to each stockholder entitled to vote at the meeting not less than ten nor more than 60 days before the date of the meeting and shall specify the place, date, hour, and purpose or purposes of the meeting. | |
|
advertisement in a Swedish newspaper, the Swedish Official Gazette, by press release, and on the company’s website.
|
| | | |
| Preemptive Rights | | | | |
|
Sweden. Under the Swedish Companies Act, shareholders of any class of shares have a preemptive right (Sw. företrädesrätt) to subscribe for shares issued of any class in proportion to their shareholdings. The preemptive right to subscribe does not apply in respect of shares issued for consideration other than cash or of shares issued pursuant to convertible debentures or warrants previously granted by the company. The preemptive right to subscribe for new shares may also be set aside by a resolution passed by two thirds of the votes cast and shares represented at the shareholders’ meeting resolving upon the issue.
|
| | Delaware. Under the Delaware General Corporation Law, unless otherwise provided in a corporation’s certificate of incorporation, a stockholder does not, by operation of law, possess preemptive rights to subscribe to additional issuances of the corporation’s stock. | |
| Shareholder Vote on Certain Transactions | | | | |
|
Sweden. In matters which do not relate to elections and are not otherwise governed by the Swedish Companies Act or the articles of association, resolutions shall be adopted at the general meeting by a simple majority of the votes cast. In the event of a tied vote, the chairman shall have the casting vote. For matters concerning securities of the company, such as new share issuances, and other transactions such as private placements, mergers, and a change from a public to a private company (or vice-versa), the articles of association may only prescribe thresholds which are higher than those provided in the Swedish Companies Act.
|
| | Delaware. Generally, under Delaware law, unless the certificate of incorporation provides for the vote of a larger portion of the stock, completion of a merger, consolidation, sale, lease or exchange of all or substantially all of a corporation’s assets or dissolution requires: (i) the approval of the board of directors; and (ii) approval by the vote of the holders of a majority of the outstanding stock or, if the certificate of incorporation provides for more or less than one vote per share, a majority of the votes of the outstanding stock of a corporation entitled to vote on the matter. | |
|
Unless otherwise prescribed in the articles of association, the person who receives the most votes in an election shall be deemed elected. In general, a resolution involving the alteration of the articles of association shall be valid only when supported by shareholders holding not less than two-thirds of both the votes cast and the shares represented at the general meeting. The Swedish Companies Act lays out numerous exceptions for which a higher threshold applies, including restrictions on certain rights of shareholders, limits on the number of shares shareholders may vote at the general meeting, directed share issues to directors, employees and other closely related parties, and changes in the legal relationship between shares.
|
| | | |
|
Service
|
| |
Fees
|
|
|
•
Issuance of ADSs (e.g., an issuance of ADS upon a deposit of common shares, upon a change in the ADS-to-share ratio, or for any other reason), excluding ADS issuances as a result of distributions of common shares
|
| | Up to $0.05 per ADS issued | |
|
•
Cancellation of ADSs (e.g., a cancellation of ADSs for delivery of deposited property, upon a change in the ADS-to-share ratio, or for any other reason)
|
| | Up to $0.05 per ADS cancelled | |
|
•
Distribution of cash dividends or other cash distributions (e.g., upon a sale of rights and other entitlements)
|
| | Up to $0.05 per ADS held | |
|
•
Distribution of ADSs pursuant to (i) stock dividends or other free stock distributions, or (ii) exercise of rights to purchase additional ADSs
|
| | Up to $0.05 per ADS held | |
|
•
Distribution of securities other than ADSs or rights to purchase additional ADSs (e.g., upon a spin-off)
|
| | Up to $0.05 per ADS held | |
|
•
ADS Services
|
| | Up to $0.05 per ADS held on the applicable record date(s) established by the depositary bank | |
|
•
Registration of ADS transfers (e.g., upon a registration of the transfer of registered ownership of ADSs, upon a transfer of ADSs into DTC and vice versa, or for any other reason)
|
| | Up to $0.05 per ADS (or fraction thereof) transferred | |
|
•
Conversion of ADSs of one series for ADSs of another series (e.g., upon conversion of Partial Entitlement ADSs for Full Entitlement ADSs, or upon conversion of Restricted ADSs (each as defined in the Deposit Agreement) into freely transferable ADSs, and vice versa)
|
| |
Up to $0.05 per ADS (or fraction thereof) converted
|
|
Underwriters
|
| |
Number of ADSs
|
| | ||
Citigroup Global Markets Inc.
|
| |
|
| | ||
Jefferies LLC
|
| | | | | ||
Stifel, Nicolaus & Company, Incorporated
|
| | | | | ||
Kempen & Co U.S.A., Inc.
|
| | | ||||
LifeSci Capital, LLC
|
| | | | | | |
| | | | | | ||
Total
|
| | | | |
Underwriters
|
| |
Number of
Common Shares |
| | ||
Citigroup Global Markets Limited
|
| |
|
| | ||
Jefferies International Limited/Jefferies GmbH*
|
| | | | | ||
Stifel, Nicolaus & Company, Incorporated
|
| | | | | ||
Kempen & Co U.S.A., Inc.
|
| | | ||||
LifeSci Capital, LLC
|
| | | | | | |
Carnegie Investment Bank AB (publ)
|
| | | | | ||
| | | | | | ||
Total
|
| | | | |
| | |
Per ADS
|
| |
Per Common Share
|
| |
Total (in thousands)
|
| |||||||||||||||||||||||||||
| | |
Without
Option to Purchase Additional ADSs |
| |
With
Option to Purchase Additional ADSs |
| |
Without
Option to Purchase Additional Common Shares |
| |
With
Option to Purchase Additional Common Shares |
| |
Without
Option to Purchase Additional ADSs and/or Common Shares |
| |
With
Option to Purchase Additional ADSs and/or Common Shares |
| ||||||||||||||||||
Offering price
|
| | | $ | | | | | $ | | | | | $ | | | | | $ | | | | | $ | | | | | $ | | | ||||||
Underwriting discounts to be paid by
us |
| | | $ | | | | | $ | | | | | $ | | | | | $ | | | | | $ | | | | | $ | | | ||||||
Proceeds, before expenses, to us
|
| | | $ | | | | | $ | | | | | $ | | | | | $ | | | | | $ | | | | | $ | | | |
| | |
Amount to
be Paid |
| |||
SEC registration fee
|
| | | $ | 9,294 | | |
FINRA filing fee
|
| | | | 13,278 | | |
Printing expenses
|
| | | | 70,000 | | |
Legal fees and expenses
|
| | | | 417,646 | | |
Accounting fees and expenses
|
| | | | 591,692 | | |
Miscellaneous costs
|
| | | | 23,384 | | |
Total | | | | $ | 1,125,294 | | |
| | |
Page
|
| |||
Audited Consolidated Financial Statements: | | | | | | | |
| | | | F-2 | | | |
Financial Statements: | | | | | | | |
| | | | F-3 | | | |
| | | | F-4 | | | |
| | | | F-5 | | | |
| | | | F-6 | | | |
| | | | F-7 | | | |
| | | | F-8 | | | |
Unaudited Interim Condensed Consolidated Financial Statements: | | | | | | | |
Financial Statements: | | | | | | | |
| | | | F-40 | | | |
| | | | F-41 | | | |
| | | | F-42 | | | |
| | | | F-43 | | | |
| | | | F-44 | | | |
| | | | F-45 | | |
| | | | | |
Year Ended December 31,
|
| |||||||||
| | |
Note
|
| |
2019
|
| |
2018
|
| ||||||
Net sales
|
| |
3
|
| | | | 184,829 | | | | | | — | | |
Operating expenses: | | | | | | | | | | | | | | | | |
Research and development
|
| |
9,10
|
| | | | (149,826) | | | | | | (99,260) | | |
Administrative and selling
|
| |
6,8,9,10
|
| | | | (62,882) | | | | | | (31,132) | | |
Other operating income
|
| |
4
|
| | | | 4,385 | | | | | | — | | |
Other operating expenses
|
| |
5
|
| | | | (4,525) | | | | | | (2,090) | | |
Operating loss
|
| |
7
|
| | |
|
(28,019)
|
| | | |
|
(132,482)
|
| |
Financial income
|
| |
11
|
| | | | 926 | | | | | | 441 | | |
Financial expenses
|
| |
12
|
| | | | (5,408) | | | | | | (8) | | |
Loss before income tax
|
| | | | | | | (32,501) | | | | | | (132,049) | | |
Income tax expense
|
| |
13
|
| | | | (77) | | | | | | — | | |
Loss for the year attributable to shareholders of the Parent Company
|
| | | | | | | (32,578) | | | | | | (132,049) | | |
Loss per share before and after dilution
|
| |
14
|
| | | | (0.88) | | | | | | (5.09) | | |
| | | | | |
Year Ended December 31,
|
| |||||||||
| | |
Note
|
| |
2019
|
| |
2018
|
| ||||||
Loss for the year
|
| | | | | | | (32,578) | | | | | | (132,049) | | |
Other comprehensive income/(loss) that may be reclassified to profit or loss
in subsequent periods: |
| | | | | | | | | | | | | | | |
Exchange differences on translation of foreign operations
|
| |
19,23
|
| | | | (11) | | | | | | 6 | | |
Total other comprehensive income/(loss)
|
| | | | | | | (11) | | | | | | 6 | | |
Total comprehensive loss attributable to shareholders of the Parent Company
|
| | | | | | | (32,589) | | | | | | (132,043) | | |
| | | | | |
December 31,
|
| |||||||||
| | |
Note
|
| |
2019
|
| |
2018
|
| ||||||
ASSETS | | | | | | | | | | | | | | | | |
Non-current assets
|
| | | | | | | | | | | | | | | |
Intangible assets
|
| |
15
|
| | | | 16,066 | | | | | | — | | |
Equipment
|
| |
16
|
| | | | 104 | | | | | | 107 | | |
Right-of-use assets
|
| |
8
|
| | | | 5,959 | | | | | | — | | |
Non-current financial assets
|
| |
17,18,27
|
| | | | 1,939 | | | | | | 341 | | |
Total non-current assets
|
| | | | | | | 24,068 | | | | | | 448 | | |
Current assets | | | | | | | | | | | | | | | | |
Accounts receivables
|
| |
19
|
| | | | 46,586 | | | | | | — | | |
Other current assets
|
| |
18
|
| | | | 2,719 | | | | | | 1,630 | | |
Prepaid expenses
|
| |
20
|
| | | | 18,287 | | | | | | 164 | | |
Cash
|
| |
21
|
| | | | 753,540 | | | | | | 646,175 | | |
Total current assets
|
| | | | | | | 821,132 | | | | | | 647,969 | | |
TOTAL ASSETS
|
| | | | | | | 845,200 | | | | | | 648,417 | | |
SHAREHOLDERS’ EQUITY AND LIABILITIES | | | | | | | | | | | | | | | | |
Shareholders’ equity
|
| |
23
|
| | | | | | | | | | | | |
Share capital
|
| | | | | | | 1,548 | | | | | | 1,408 | | |
Additional paid-in capital
|
| | | | | | | 1,274,664 | | | | | | 1,072,319 | | |
Reserves
|
| | | | | | | (45) | | | | | | (34) | | |
Retained earnings including net loss for the year
|
| | | | | | | (488,096) | | | | | | (455,518) | | |
Total equity attributable to shareholders of the Parent Company
|
| | | | | | | 788,071 | | | | | | 618,175 | | |
Non-current liabilities | | | | | | | | | | | | | | | | |
Provisions
|
| |
24
|
| | | | 175 | | | | | | — | | |
Other non-current liabilities
|
| |
8,18
|
| | | | 3,584 | | | | | | — | | |
Total non-current liabilities
|
| | | | | | | 3,759 | | | | | | — | | |
Current liabilities | | | | | | | | | | | | | | | | |
Accounts payable
|
| |
18,19
|
| | | | 24,384 | | | | | | 22,643 | | |
Current tax liabilities
|
| | | | | | | 77 | | | | | | — | | |
Other current liabilities
|
| |
8,18
|
| | | | 3,394 | | | | | | 904 | | |
Accrued expenses and deferred revenue
|
| |
25
|
| | | | 25,515 | | | | | | 6,695 | | |
Total current liabilities
|
| | | | | | | 53,370 | | | | | | 30,242 | | |
TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES
|
| | | | | | | 845,200 | | | | | | 648,417 | | |
| | |
Note
|
| |
Share
Capital |
| |
Additional-
Paid-in Capital |
| |
Translation
Reserve |
| |
Retained
Earnings Including Net Loss for the Year |
| |
Total
|
| |||||||||||||||
Opening shareholders’ equity January 1, 2018
|
| | | | | | | 667 | | | | | | 352,959 | | | | | | (40) | | | | | | (320,410) | | | | | | 33,176 | | |
Loss for the year
|
| | | | | | | — | | | | | | — | | | | | | — | | | | | | (132,049) | | | | | | (132,049) | | |
Other comprehensive income/(loss)
|
| | | | | | | — | | | | | | — | | | | | | 6 | | | | | | — | | | | | | 6 | | |
Total comprehensive income/(loss)
|
| | | | | | | — | | | | | | — | | | | | | 6 | | | | | | (132,049) | | | | | | (132,043) | | |
Transactions with owners: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
New share issue
|
| | | | | | | 741 | | | | | | 737,909 | | | | | | — | | | | | | — | | | | | | 738,650 | | |
Cost attributable to new share issue
|
| | | | | | | — | | | | | | (54,433) | | | | | | — | | | | | | — | | | | | | (54,433) | | |
Premiums received from warrants
|
| |
10
|
| | | | — | | | | | | 2,826 | | | | | | — | | | | | | — | | | | | | 2,826 | | |
Contributions from shareholders
|
| |
23
|
| | | | — | | | | | | 29,999 | | | | | | — | | | | | | — | | | | | | 29,999 | | |
Interest from capital contributions from
shareholders |
| |
23
|
| | | | — | | | | | | 3,059 | | | | | | — | | | | | | (3,059) | | | | | | — | | |
Total transactions with owners
|
| | | | | | | 741 | | | | | | 719,360 | | | | | | — | | | | | | (3,059) | | | | | | 717,042 | | |
Closing shareholders’ equity December 31,
2018 |
| | | | | | | 1,408 | | | | | | 1,072,319 | | | | | | (34) | | | | | | (455,518) | | | | | | 618,175 | | |
Opening shareholders’ equity January 1, 2019
|
| | | | | | | 1,408 | | | | | | 1,072,319 | | | | | | (34) | | | | | | (455,518) | | | | | | 618,175 | | |
Loss for the year
|
| | | | | | | — | | | | | | — | | | | | | — | | | | | | (32,578) | | | | | | (32,578) | | |
Other comprehensive income/(loss)
|
| | | | | | | — | | | | | | — | | | | | | (11) | | | | | | — | | | | | | (11) | | |
Total comprehensive income/(loss)
|
| | | | | | | — | | | | | | — | | | | | | (11) | | | | | | (32,578) | | | | | | (32,589) | | |
Transactions with owners: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
New share issue
|
| | | | | | | 140 | | | | | | 210,177 | | | | | | — | | | | | | — | | | | | | 210,317 | | |
Cost attributable to new share issue
|
| | | | | | | — | | | | | | (10,915) | | | | | | — | | | | | | — | | | | | | (10,915) | | |
Premiums received from warrants
|
| |
10
|
| | | | — | | | | | | 2,834 | | | | | | — | | | | | | — | | | | | | 2,834 | | |
Share-based payments
|
| |
10
|
| | | | — | | | | | | 249 | | | | | | — | | | | | | — | | | | | | 249 | | |
Total transactions with owners
|
| | | | | | | 140 | | | | | | 202,345 | | | | | | — | | | | | | — | | | | | | 202,485 | | |
Closing shareholders’ equity December 31,
2019 |
| |
10,23
|
| | | | 1,548 | | | | | | 1,274,664 | | | | | | (45) | | | | | | (488,096) | | | | | | 788,071 | | |
| | | | | |
Year Ended December 31,
|
| |||||||||
| | |
Note
|
| |
2019
|
| |
2018
|
| ||||||
Operating activities: | | | | | | | | | | | | | | | | |
Operating loss
|
| | | | | | | (28,019) | | | | | | (132,482) | | |
Adjustments for non-cash items
|
| |
21
|
| | | | 2,308 | | | | | | 51 | | |
Interest received
|
| | | | | | | 926 | | | | | | 6 | | |
Interest paid
|
| | | | | | | (325) | | | | | | (8) | | |
Cash flow from operating activities before changes in working capital
|
| | | | | | | (25,110) | | | | | | (132,433) | | |
Cash flow from changes in working capital: | | | | | | | | | | | | | | | | |
Changes in operating receivables
|
| | | | | | | (53,546) | | | | | | 2,642 | | |
Changes in operating liabilities
|
| | | | | | | 7,645 | | | | | | 1,600 | | |
Cash flow from operating activities
|
| | | | | | | (71,011) | | | | | | (128,191) | | |
Investing activities: | | | | | | | | | | | | | | | | |
Purchase of equipment
|
| |
16
|
| | | | (118) | | | | | | — | | |
Investments in non-current financial assets
|
| |
17
|
| | | | (1,888) | | | | | | — | | |
Purchase of intangible assets
|
| |
15
|
| | | | (16,066) | | | | | | — | | |
Cash flow from investing activities
|
| | | | | | | (18,072) | | | | | | — | | |
Financing activities: | | | | | | | | | | | | | | | | |
New share issue
|
| | | | | | | 210,317 | | | | | | 738,650 | | |
Cost attributable to new share issue
|
| | | | | | | (10,915) | | | | | | (54,433) | | |
Repayment of loans
|
| | | | | | | (1,652) | | | | | | (470) | | |
Premiums received from warrants
|
| | | | | | | 2,834 | | | | | | 2,826 | | |
Transaction costs, paid
|
| | | | | | | (1,748) | | | | | | — | | |
Contributions from shareholders
|
| | | | | | | — | | | | | | 29,999 | | |
Cash flow from financing activities
|
| | | | | | | 198,835 | | | | | | 716,572 | | |
Net increase (decrease) in cash
|
| | | | | | | 109,752 | | | | | | 588,381 | | |
Cash at beginning of the year
|
| | | | | | | 646,175 | | | | | | 57,352 | | |
Exchange-rate difference in cash
|
| | | | | | | (2,387) | | | | | | 442 | | |
Cash at the end of the year
|
| |
21
|
| | | | 753,540 | | | | | | 646,175 | | |
| | |
December 31,
2018 |
| |
Adjustments
|
| |
January 1,
2019 |
| |||||||||
Assets | | | | | | | | | | | | | | | | | | | |
Non-current assets | | | | | | | | | | | | | | | | | | | |
Equipment
|
| | | | 107 | | | | | | — | | | | | | 107 | | |
Right-of-use assets
|
| | | | — | | | | | | 1,819 | | | | | | 1,819 | | |
Non-current financial assets
|
| | | | 341 | | | | | | — | | | | | | 341 | | |
Total non-current assets
|
| | | | 448 | | | | | | 1,819 | | | | | | 2,267 | | |
Current assets
|
| | | | 647,969 | | | | | | — | | | | | | 647,969 | | |
Total assets
|
| | | | 648,417 | | | | | | 1,819 | | | | | | 650,236 | | |
Shareholders’ equity and liabilities | | | | | | | | | | | | | | | | | | | |
Shareholders’ equity
|
| | | | 618,175 | | | | | | — | | | | | | 618,175 | | |
Other non-current liabilities
|
| | | | — | | | | | | 1,290 | | | | | | 1,290 | | |
Current liabilities | | | | | | | | | | | | | | | | | | | |
Accounts payable
|
| | | | 22,643 | | | | | | — | | | | | | 22,643 | | |
Other current liabilities
|
| | | | 904 | | | | | | 529 | | | | | | 1,433 | | |
| | |
December 31,
2018 |
| |
Adjustments
|
| |
January 1,
2019 |
| |||||||||
Accrued expenses
|
| | | | 6,695 | | | | | | — | | | | | | 6,695 | | |
Total current liabilities
|
| | | | 30,242 | | | | | | 529 | | | | | | 30,771 | | |
Total shareholders’ equity and liabilities
|
| | | | 648,417 | | | | | | 1,819 | | | | | | 650,236 | | |
|
| Reconciliation of operational lease commitments: | | | | | | | |
|
Commitments for operating leases as of December 31, 2018
|
| | | | 1,983 | | |
|
Discounting effects
|
| | | | (164) | | |
|
Recorded leasing liabilities as per January 1, 2019
|
| | | | 1,819 | | |
| | |
Year Ended December 31, 2018
|
| |||||||||||||||
| | |
Before adjustments
|
| |
Adjustments
|
| |
After adjustments
|
| |||||||||
Research and development expenses
|
| | | | — | | | | | | (99,260) | | | | | | (99,260) | | |
Administrative and selling expenses
|
| | | | — | | | | | | (31,132) | | | | | | (31,132) | | |
Other operating income
|
| | | | 715 | | | | | | (715) | | | | | | — | | |
Other operating expenses
|
| | | | — | | | | | | (2,090) | | | | | | (2,090) | | |
Other external expenses
|
| | | | (114,056) | | | | | | 114,056 | | | | | | — | | |
Personnel cost
|
| | | | (19,090) | | | | | | 19,090 | | | | | | — | | |
Depreciation
|
| | | | (51) | | | | | | 51 | | | | | | — | | |
Total operating expenses
|
| | | | (132,482) | | | | | | — | | | | | | (132,482) | | |
|
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Type of goods or service | | | | | | | | | | | | | |
Out-licensing
|
| | | | 184,829 | | | | | | — | | |
Total
|
| | | | 184,829 | | | | | | — | | |
|
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Geographical markets | | | | | | | | | | | | | |
China, Hong Kong, Macau, Taiwan and Singapore
|
| | | | 184,829 | | | | | | — | | |
Total
|
| | | | 184,829 | | | | | | — | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Exchange rate differences
|
| | | | 4,385 | | | | | | — | | |
|
| | |
Year Ended
December 31, |
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Total
|
| | | | 4,385 | | | | | | — | | |
|
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Exchange rate differences
|
| | | | 4,464 | | | | | | 2,090 | | |
Net loss on disposal of equipment
|
| | | | 61 | | | | | | — | | |
Total
|
| | | | 4,525 | | | | | | 2,090 | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Ernst & Young | | | | | | | | | | | | | |
Audit services
|
| | | | 645 | | | | | | 509 | | |
Other audit activities
|
| | | | 3,343 | | | | | | 1,861 | | |
Other services
|
| | | | 98 | | | | | | — | | |
Total
|
| | | | 4,086 | | | | | | 2,370 | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Other external operating expenses
|
| | | | 176,729 | | | | | | 111,251 | | |
Personnel costs
|
| | | | 34,157 | | | | | | 19,090 | | |
Depreciation on equipment and right-of-use assets
|
| | | | 1,822 | | | | | | 51 | | |
Other operating expenses
|
| | | | 4,525 | | | | | | 2,090 | | |
Total
|
| | | | 217,233 | | | | | | 132,482 | | |
| | |
According to
Prior Principles |
| |
Effect of
IFRS 16 |
| |
Year Ended
December 31, 2019 |
| |||||||||
Net sales
|
| | | | 184,829 | | | | | | — | | | | | | 184,829 | | |
Research and development expenses
|
| | | | (149,826) | | | | | | — | | | | | | (149,826) | | |
Administrative and selling expenses
|
| | | | (63,078) | | | | | | 196 | | | | | | (62,882) | | |
Other operating income
|
| | | | 4,385 | | | | | | — | | | | | | 4,385 | | |
Other operating expenses
|
| | | | (4,525) | | | | | | — | | | | | | (4,525) | | |
Operating loss
|
| | | | (28,215) | | | | | | 196 | | | | | | (28,019) | | |
Financial income
|
| | | | 926 | | | | | | — | | | | | | 926 | | |
Financial expenses
|
| | | | (5,101) | | | | | | (307) | | | | | | (5,408) | | |
Income tax expense
|
| | | | (77) | | | | | | — | | | | | | (77) | | |
Loss for the year
|
| | | | (32,467) | | | | | | (111) | | | | | | (32,578) | | |
| | |
According to
Prior Principles |
| |
Effect of
IFRS 16 |
| |
December 31,
2019 |
| |||||||||
Assets | | | | | | | | | | | | | | | | | | | |
Non-current assets | | | | | | | | | | | | | | | | | | | |
Intangible assets
|
| | | | 16,066 | | | | | | — | | | | | | 16,066 | | |
Equipment
|
| | | | 104 | | | | | | — | | | | | | 104 | | |
Right-of-use assets
|
| | | | — | | | | | | 5,959 | | | | | | 5,959 | | |
Non-current financial assets
|
| | | | 1,939 | | | | | | — | | | | | | 1,939 | | |
Total non-current assets
|
| | | | 18,109 | | | | | | 5,959 | | | | | | 24,068 | | |
Current assets
|
| | | | 821,132 | | | | | | — | | | | | | 821,132 | | |
Total Assets
|
| | | | 839,241 | | | | | | 5,959 | | | | | | 845,200 | | |
Total Shareholders’ Equity & Liabilities | | | | | | | | | | | | | | | | | | | |
Shareholders’ equity
|
| | | | 788,182 | | | | | | (111) | | | | | | 788,071 | | |
Non-current liabilities | | | | | | | | | | | | | | | | | | | |
Provisions
|
| | | | 175 | | | | | | — | | | | | | 175 | | |
Other non-current liabilities
|
| | | | — | | | | | | 3,584 | | | | | | 3,584 | | |
Total non-current liabilities
|
| | | | 175 | | | | | | 3,584 | | | | | | 3,759 | | |
Current liabilities | | | | | | | | | | | | | | | | | | | |
Accounts payable
|
| | | | 24,384 | | | | | | — | | | | | | 24,384 | | |
Current tax liabilities
|
| | | | 77 | | | | | | — | | | | | | 77 | | |
Other current liabilities
|
| | | | 908 | | | | | | 2,486 | | | | | | 3,394 | | |
Accrued expenses and deferred revenue
|
| | | | 25,515 | | | | | | — | | | | | | 25,515 | | |
Total current liabilities
|
| | | | 50,884 | | | | | | 2,486 | | | | | | 53,370 | | |
|
| | |
According to
Prior Principles |
| |
Effect of
IFRS 16 |
| |
December 31,
2019 |
| |||||||||
Total Shareholders’ Equity & Liabilities
|
| | | | 839,241 | | | | | | 5,959 | | | | | | 845,200 | | |
|
| | |
December 31,
2019 |
| |||
Cost | | | | | | | |
At January 1, 2019
|
| | | | 1,819 | | |
Additional agreement
|
| | | | 7,527 | | |
Termination of agreement
|
| | | | (1,819) | | |
At December 31, 2019
|
| | | | 7,527 | | |
Depreciation | | | | | | | |
At January 1, 2019
|
| | | | — | | |
Depreciation
|
| | | | (1,778) | | |
Termination of agreement
|
| | | | 210 | | |
At December 31, 2019
|
| | | | (1,568) | | |
Net book value
|
| | | | 5,959 | | |
| | |
December 31,
2019 |
| |||
At January 1, 2019
|
| | | | 1,819 | | |
Additional agreement
|
| | | | 7,527 | | |
Termination of agreement
|
| | | | (1,624) | | |
Amortization
|
| | | | (1,652) | | |
At December 31, 2019
|
| | | | 6,070 | | |
| | |
December 31,
2019 |
| |||
<12 months
|
| | | | 3,816 | | |
1–2 years
|
| | | | 2,306 | | |
>2 year
|
| | | | 533 | | |
| | | | | 6,655 | | |
| | |
Year Ended
December 31, 2019 |
| |||
Interest expenses attributable to lease liabilities
|
| | | | 307 | | |
Expenses attributable to short-term lease
|
| | | | 265 | | |
Expenses attributable to leasing agreements with low value
|
| | | | 96 | | |
Expenses attributable to variable lease payments that are not included in lease liabilities
|
| | | | 187 | | |
This year’s lease payments in the Group
|
| | | | 2,343 | | |
| | |
Year Ended December 31,
|
| |||||||||||||||||||||
| | |
2019
|
| |
2018
|
| ||||||||||||||||||
| | |
Number of
Employees |
| |
Percentage
of Male Employees |
| |
Number of
Employees |
| |
Percentage
of Male Employees |
| ||||||||||||
Parent Company | | | | | | | | | | | | | | | | | | | | | | | | | |
Sweden
|
| | | | 13 | | | | | | 38% | | | | | | 10 | | | | | | 30% | | |
| | | | | 13 | | | | | | 38% | | | | | | 10 | | | | | | 30% | | |
Subsidiaries | | | | | | | | | | | | | | | | | | | | | | | | | |
United States
|
| | | | 1 | | | | | | 100% | | | | | | — | | | | | | — | | |
| | | | | 1 | | | | | | 100% | | | | | | — | | | | | | — | | |
Group, total
|
| | | | 14 | | | | | | 43% | | | | | | 10 | | | | | | 30% | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Parent Company | | | | | | | | | | | | | |
Board and senior executives(1)
|
| | | | 13,109 | | | | | | 9,875 | | |
Other employees
|
| | | | 6,091 | | | | | | 3,789 | | |
Subsidiaries | | | | | | | | | | | | | |
Board and senior executives
|
| | | | 2,973 | | | | | | — | | |
Total
|
| | | | 22,173 | | | | | | 13,664 | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Parent Company | | | | | | | | | | | | | |
Pension costs for the Board and senior executives
|
| | | | 1,644 | | | | | | 1,429 | | |
Pension costs to other employees
|
| | | | 1,180 | | | | | | 699 | | |
Social security costs
|
| | | | 3,008 | | | | | | 2,843 | | |
Subsidiaries | | | | | | | | | | | | | |
Social security costs
|
| | | | 299 | | | | | | — | | |
Total
|
| | | | 6,131 | | | | | | 4,971 | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Percentage of women on the Board
|
| | | | 33% | | | | | | 33% | | |
Percentage of men on the Board
|
| | | | 67% | | | | | | 67% | | |
Percentage of women among other senior executives
|
| | | | 33% | | | | | | 43% | | |
Percentage of men among other senior executives
|
| | | | 67% | | | | | | 57% | | |
| | |
Base
Salary, Board Fee |
| |
Pension
Costs |
| |
Variable
Remuneration |
| |
Other
Remuneration |
| |
Share-
Based Payments |
| |
Total
|
| ||||||||||||||||||
Year Ended December 31, 2019 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Board Chairman Elmar Schnee
|
| | | | 402 | | | | | | — | | | | | | — | | | | | | — | | | | | | 101 | | | | | | 503 | | |
Board members | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Thomas Eklund
|
| | | | 280 | | | | | | — | | | | | | — | | | | | | — | | | | | | 37 | | | | | | 317 | | |
Hilde Furberg
|
| | | | 180 | | | | | | — | | | | | | — | | | | | | — | | | | | | 37 | | | | | | 217 | | |
Lennart Hansson
|
| | | | 102 | | | | | | — | | | | | | — | | | | | | — | | | | | | 37 | | | | | | 139 | | |
Bengt Julander
|
| | | | 102 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 102 | | |
Diane Parks
|
| | | | 201 | | | | | | — | | | | | | — | | | | | | — | | | | | | 37 | | | | | | 238 | | |
Olav Hellebo (until May 2019)
|
| | | | 58 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 58 | | |
Senior executives | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
CEO
|
| | | | 2,634 | | | | | | 510 | | | | | | 956 | | | | | | — | | | | | | — | | | | | | 4,100 | | |
Other senior executives (8 people)
|
| | | | 8,927 | | | | | | 1,134 | | | | | | 1,991 | | | | | | 4,701 | | | | | | — | | | | | | 16,753 | | |
of which relates to subsidiaries
|
| | |
|
2,382
|
| | | |
|
—
|
| | | |
|
591
|
| | | | | — | | | | | | — | | | | |
|
2,973
|
| |
Total | | | | | 12,886 | | | | | | 1,644 | | | | | | 2,947 | | | | | | 4,701 | | | | | | 249 | | | | | | 22,427 | | |
Year Ended December 31, 2018 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Board Chairman Thomas Eklund
|
| | | | 413 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 413 | | |
Board members(1) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Olav Hellebø
|
| | | | 160 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 160 | | |
Hilde Furberg
|
| | | | 173 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 173 | | |
| | |
Base
Salary, Board Fee |
| |
Pension
Costs |
| |
Variable
Remuneration |
| |
Other
Remuneration |
| |
Share-
Based Payments |
| |
Total
|
| ||||||||||||||||||
Senior executives
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
CEO
|
| | | | 2,462 | | | | | | 456 | | | | | | 692 | | | | | | — | | | | | | — | | | | | | 3,610 | | |
Other senior executives (7 people)
|
| | | | 5,301 | | | | | | 973 | | | | | | 674 | | | | | | 6,001 | | | | | | — | | | | | | 12,949 | | |
Total | | | | | 8,509 | | | | | | 1,429 | | | | | | 1,366 | | | | | | 6,001 | | | | | | — | | | | | | 17,305 | | |
|
Allotted Warrants
|
| |
Accumulated
No. of Outstanding |
| |
Weighted-
Average Exercise Price, SEK |
| ||||||
On December 31, 2018
|
| | | | 2,518,086 | | | | | | 56 | | |
On December 31, 2019
|
| | | | 2,575,586 | | | | | | 58 | | |
Outstanding Warrants per Year
|
| |
Warrants
Outstanding as of December 31, 2018 |
| |
Warrants
Outstanding as of December 31, 2019 |
| |
Inputs used for the Black & Scholes valuation
|
| ||||||||||||||||||||||||||||||||||||
|
Exercise Price
in SEK |
| |
Price per
warrant in SEK |
| |
Value per
share in SEK |
| |
Risk-Free
Rate |
| |
Volatility
|
| |
Expiration date
|
| |||||||||||||||||||||||||||||
Warrant program 2015/2019(1)
|
| | | | 365,000 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Apr 30, 2019
|
|
Warrant program 2017/2020
|
| | | | 1,296,500 | | | | | | 1,296,500 | | | | | | 42.36 | | | | | | 0.28 | | | | | | 21.18 | | | | | | (0.42)% | | | | | | 27% | | | |
Jun 30/Aug 30, 2020
|
|
Warrant program 2018/2022
|
| | | | 856,586 | | | | | | 856,586 | | | | | | 74.30 | | | | | | 3.29 | | | | | | 46.50 | | | | | | (0.28)% | | | | | | 33% | | | |
Mar 31, 2022
|
|
Warrant program 2019/2022
|
| | | | — | | | | | | 422,500 | | | | | | 74.50 | | | | | | 6.69* | | | | | | 54.39* | | | | | | (0.55)%* | | | | | | 36%* | | | |
Dec 31, 2022
|
|
Total | | | | | 2,518,086 | | | | | | 2,575,586 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Holder
|
| |
Warrants
Outstanding as of January 1, 2018 |
| |
Change
|
| |
Warrants
Outstanding as of December 31, 2018 |
| |
Change
|
| |
Warrants
Outstanding as of December 31, 2019 |
| |||||||||||||||
CEO Renée Aguiar-Lucander
|
| | | | 369,500 | | | | | | 350,000 | | | | | | 719,500 | | | | | | 195,000 | | | | | | 914,500 | | |
Board member Thomas Eklund
|
| | | | 111,250 | | | | | | — | | | | | | 111,250 | | | | | | — | | | | | | 111,250 | | |
Board member Hilde Furberg
|
| | | | 29,500 | | | | | | — | | | | | | 29,500 | | | | | | — | | | | | | 29,500 | | |
Other senior executives
|
| | | | 538,500 | | | | | | 188,586 | | | | | | 727,086 | | | | | | 107,500 | | | | | | 834,586 | | |
Other employees, consultants and external parties
|
| | | | 612,750 | | | | | | 318,000 | | | | | | 930,750 | | | | | | (245,000) | | | | | | 685,750 | | |
Total | | | | | 1,661,500 | | | | | | 856,586 | | | | | | 2,518,086 | | | | | | 57,500 | | | | | | 2,575,586 | | |
Holder
|
| |
Share
Awards Outstanding as of January 1, 2018 |
| |
Change
|
| |
Share
Awards Outstanding as of December 31, 2018 |
| |
Change
|
| |
Share
Awards Outstanding as of December 31, 2019 |
| |||||||||||||||
Elmar Schnee, Chairman of the Board
|
| | | | — | | | | | | — | | | | | | — | | | | | | 23,236 | | | | | | 23,236 | | |
Thomas Eklund, Board member
|
| | | | — | | | | | | — | | | | | | — | | | | | | 8,449 | | | | | | 8,449 | | |
Hilde Furberg, Board member
|
| | | | — | | | | | | — | | | | | | — | | | | | | 8,449 | | | | | | 8,449 | | |
Lennart Hansson, Board member
|
| | | | — | | | | | | — | | | | | | — | | | | | | 8,449 | | | | | | 8,449 | | |
Diane Parks, Board member
|
| | |
|
—
|
| | | |
|
—
|
| | | |
|
—
|
| | | |
|
8,449
|
| | | |
|
8,449
|
| |
Total | | | | | — | | | | | | — | | | | | | — | | | | | | 57,032 | | | | | | 57,032 | | |
| | |
Grant Date
|
| |
Exercise Date
|
| |
Fair Value at
Grant Date |
| |
Number of
Share Awards |
| ||||||||||||
Board LTIP 2019
|
| | | | May 10,2019 | | | | | | June 1,2022 | | | | | | 22.49 | | | | | | 57,032 | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Personnel cost, IFRS 2 Share-based payments
|
| | | | 249 | | | | | | — | | |
Provisions attributable to social security costs, IFRS 2 Share-based payments
|
| | | | 175 | | | | | | — | | |
| | | | | 424 | | | | | | — | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Interest income
|
| | | | 926 | | | | | | 6 | | |
Exchange rate differences
|
| | | | — | | | | | | 435 | | |
Total | | | | | 926 | | | | | | 441 | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Interest on lease liabilities
|
| | | | (307) | | | | | | — | | |
Other interest expenses
|
| | | | (18) | | | | | | (8) | | |
| | |
Year Ended
December 31, |
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Exchange rate differences
|
| | | | (2,383) | | | | | | — | | |
Changes in FX options measured at fair value
|
| | | | (2,700) | | | | | | — | | |
Total
|
| | |
|
(5,408)
|
| | | | | (8) | | |
|
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Current income taxes
|
| | | | (77) | | | | | | — | | |
Income tax expense recorded in the statement of income
|
| | |
|
(77)
|
| | | | | — | | |
Reconciliation of effective tax rate | | | | | | | | | | | | | |
Accounting loss before income tax
|
| | | | (32,501) | | | | | | (132,049) | | |
Tax in accordance with applicable tax rate in Sweden 21.4% (22.0%)
|
| | | | 6,955 | | | | | | 29,051 | | |
Effect of other tax rates for foreign subsidiaries
|
| | | | 2 | | | | | | — | | |
Tax attributable to non-deductible tax losses carried forward and unrecognized deferred tax assets
|
| | | | (6,316) | | | | | | (29,069) | | |
Non-deductible expenses
|
| | | | (782) | | | | | | (35) | | |
Non-taxable income
|
| | | | 64 | | | | | | 53 | | |
Income tax expense recorded in the statement of income
|
| | | | (77) | | | | | | — | | |
At the effective income tax rate
|
| | | | 0% | | | | | | 0% | | |
| | |
Year Ended December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Loss per share before and after dilution | | | | | | | | | | | | | |
Net loss for the year attributable to shareholders of the Parent Company
|
| | | | (32,578) | | | | | | (132,049) | | |
Weighted-average number of common shares outstanding
|
| | | | 36,940,587 | | | | | | 25,948,037 | | |
Loss per share before and after dilution
|
| | | | (0.88) | | | | | | (5.09) | | |
| | |
December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Licenses and similar rights | | | | | | | | | | | | | |
Cost at opening balance
|
| | | | | | | | | | — | | |
Acquisition for the year
|
| | | | 16,066 | | | | | | — | | |
Cost at closing balance
|
| | | | 16,066 | | | | | | — | | |
Amortization at closing balance
|
| | | | — | | | | | | — | | |
Net book value
|
| | | | 16,066 | | | | | | — | | |
| | |
December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Cost at opening balance
|
| | | | 813 | | | | | | 813 | | |
Acquisition for the year
|
| | | | 118 | | | | | | — | | |
Disposal for the year
|
| | | | (813) | | | | | | — | | |
Cost at closing balance
|
| | | | 118 | | | | | | 813 | | |
Depreciation at opening balance
|
| | | | (706) | | | | | | (655) | | |
Depreciation for the year
|
| | | | (44) | | | | | | (51) | | |
Disposal for the year
|
| | | | 736 | | | | | | — | | |
Depreciation at closing balance
|
| | | | (14) | | | | | | (706) | | |
Net book value
|
| | | | 104 | | | | | | 107 | | |
| | |
December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Opening cost
|
| | | | 341 | | | | | | 341 | | |
Bank guarantees granted
|
| | | | 1,888 | | | | | | — | | |
Reimbursement security deposit
|
| | | | (290) | | | | | | — | | |
Net book value
|
| | | | 1,939 | | | | | | 341 | | |
December 31, 2019
|
| |
Financial
Assets Measured at Fair Value through Profit or Loss |
| |
Financial
Assets Measured at Amortized Cost |
| |
Non-Financial
Assets |
| |
Total
Carrying Amount |
| ||||||||||||
Assets | | | | | | | | | | | | | | | | | | | | | | | | | |
Fixed assets
|
| | | | — | | | | | | — | | | | | | 22,129 | | | | | | 22,129 | | |
Non-current financial assets
|
| | | | — | | | | | | 1,939 | | | | | | — | | | | | | 1,939 | | |
Accounts receivables
|
| | | | — | | | | | | 46,586 | | | | | | — | | | | | | 46,586 | | |
Other current assets
|
| | | | 399 | | | | | | — | | | | | | 2,320 | | | | | | 2,719 | | |
Prepaid expenses
|
| | | | — | | | | | | — | | | | | | 18,287 | | | | | | 18,287 | | |
Cash
|
| | | | — | | | | | | 753,540 | | | | | | — | | | | | | 753,540 | | |
| | | | | 399 | | | | | | 802,065 | | | | | | 42,736 | | | | | | 845,200 | | |
|
| | |
Financial
Liabilities Measured at Amortized Cost |
| |
Non-Financial
Liabilities |
| |
Total
Carrying Amount |
| |||||||||
Liabilities | | | | | | | | | | | | | | | | | | | |
Provisions
|
| | | | — | | | | | | 175 | | | | | | 175 | | |
Non-current lease liabilities
|
| | | | 3,584 | | | | | | — | | | | | | 3,584 | | |
Accounts payable
|
| | | | 24,384 | | | | | | — | | | | | | 24,384 | | |
Current lease liabilities
|
| | | | 2,486 | | | | | | — | | | | | | 2,486 | | |
Other current liabilities
|
| | | | — | | | | | | 985 | | | | | | 985 | | |
Accrued expenses and deferred revenue
|
| | | | 14,837 | | | | | | 10,678 | | | | | | 25,515 | | |
| | | | | 45,291 | | | | | | 11,838 | | | | | | 57,129 | | |
|
December 31, 2018
|
| |
Financial
Assets Measured at Amortized Cost |
| |
Non-Financial
Assets |
| |
Total
Carrying Amount |
| |||||||||
Assets | | | | | | | | | | | | | | | | | | | |
Equipment
|
| | | | — | | | | | | 107 | | | | | | 107 | | |
Non-current financial assets
|
| | | | 341 | | | | | | — | | | | | | 341 | | |
December 31, 2018
|
| |
Financial
Assets Measured at Amortized Cost |
| |
Non-Financial
Assets |
| |
Total
Carrying Amount |
| |||||||||
Other current assets
|
| | | | — | | | | | | 1,630 | | | | | | 1,630 | | |
Prepaid expenses
|
| | | | — | | | | | | 164 | | | | | | 164 | | |
Cash
|
| | | | 646,175 | | | | | | — | | | | | | 646,175 | | |
| | | | | 646,516 | | | | | | 1,901 | | | | | | 648,417 | | |
|
| | |
Financial
Liabilities Measured at Amortized Cost |
| |
Non-Financial
Liabilities |
| |
Total
Carrying Amount |
| |||||||||
Liabilities | | | | | | | | | | | | | | | | | | | |
Accounts payable
|
| | | | 22,643 | | | | | | — | | | | | | 22,643 | | |
Other current liabilities
|
| | | | — | | | | | | 904 | | | | | | 904 | | |
Accrued expenses
|
| | | | 944 | | | | | | 5,751 | | | | | | 6,695 | | |
| | | | | 23,587 | | | | | | 6,655 | | | | | | 30,242 | | |
| | |
December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Days past due account receivables
|
| | | | — | | | | | | — | | |
Not due account receivables
|
| | | | 46,586 | | | | | | — | | |
Total
|
| | |
|
46,586
|
| | | | | — | | |
Currency Exposure 2019
|
| |
Revenue
|
| |
Operating
expenses |
| ||||||
USD
|
| | | | 100% | | | | | | 22% | | |
EUR
|
| | | | — | | | | | | 54% | | |
GBP
|
| | | | — | | | | | | 3% | | |
SEK
|
| | | | — | | | | | | 21% | | |
Currency Exposure 2018
|
| |
Revenue
|
| |
Operating
expenses |
| ||||||
USD
|
| | | | — | | | | | | 10% | | |
EUR
|
| | | | — | | | | | | 52% | | |
GBP
|
| | | | — | | | | | | 2% | | |
SEK
|
| | | | — | | | | | | 36% | | |
| | |
December 31, 2019
|
| |||||||||||||||
| | |
< 6 Months
|
| |
6 – 12 Months
|
| |
>12 months
|
| |||||||||
Accounts payable
|
| | | | 24,384 | | | | | | — | | | | | | — | | |
Other current liabilities
|
| | | | 908 | | | | | | — | | | | | | — | | |
Accrued expenses
|
| | | | 21,982 | | | | | | 2,659 | | | | | | — | | |
| | |
December 31, 2018
|
| |||||||||||||||
| | |
< 6 Months
|
| |
6 – 12 Months
|
| |
>12 month
|
| |||||||||
Accounts payable
|
| | | | 22,643 | | | | | | — | | | | | | — | | |
Other current liabilities
|
| | | | 904 | | | | | | — | | | | | | — | | |
Accrued expenses
|
| | | | 4,409 | | | | | | 2,286 | | | | | | — | | |
| | |
December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Prepaid rental charges
|
| | | | 771 | | | | | | 164 | | |
Prepaid expenses for research and development
|
| | | | 2,854 | | | | | | — | | |
Prepaid transaction costs
|
| | | | 14,662 | | | | | | — | | |
Total
|
| | | | 18,287 | | | | | | 164 | | |
| | |
December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Available balances
|
| | | | 753,540 | | | | | | 646,175 | | |
Total | | | | | 753,540 | | | | | | 646,175 | | |
| | |
Year Ended December 31,
|
| |||||||||
Adjustments for non-cash items
|
| |
2019
|
| |
2018
|
| ||||||
Depreciation and amortization
|
| | | | 1,822 | | | | | | 51 | | |
Change in provisions
|
| | | | 175 | | | | | | — | | |
Share-based payments
|
| | | | 249 | | | | | | — | | |
Other
|
| | | | 62 | | | | | | — | | |
Total
|
| | | | 2,308 | | | | | | 51 | | |
| | |
January 1,
2019 |
| |
Cash
Flow |
| |
Non-Cash Items
|
| |
December 31,
2019 |
| ||||||||||||||||||
|
Additional
Agreement |
| |
Termination of
Agreement |
| ||||||||||||||||||||||||||
Lease liabilities
|
| | | | 1,819 | | | | | | (1,652) | | | | | | 7,527 | | | | | | (1,624) | | | | | | 6,070 | | |
| | | | | 1,819 | | | | | | (1,652) | | | | | | 7,527 | | | | | | (1,624) | | | | | | 6,070 | | |
|
| | |
January 1,
2018 |
| |
Cash
Flow |
| |
Non-Cash Items
|
| |
December 31,
2018 |
| ||||||||||||||||||
|
Interest on
Loan |
| |
Offsetting of
New Shares |
| ||||||||||||||||||||||||||
Shareholder loans
|
| | | | 470 | | | | | | (470) | | | | | | — | | | | | | — | | | | | | — | | |
| | | | | 470 | | | | | | (470) | | | | | | — | | | | | | — | | | | | | — | | |
Name
|
| |
Principal Activities
|
| |
Country of
Incorporation |
| |
% Equity
Interest 2019 |
| |
% Equity
Interest 2018 |
|
Parent Company | | | | | | | | | | | | | |
Calliditas
Therapeutics AB |
| | Research and development of pharmaceuticals | | |
Sweden
|
| | | | | | |
Name
|
| |
Principal Activities
|
| |
Country of
Incorporation |
| |
% Equity
Interest 2019 |
| |
% Equity
Interest 2018 |
| ||||||
Nefecon AB
|
| | Administration of incentive programs issued by | | | | | | | | | | | | | | | | |
| | | the Parent Company | | |
Sweden
|
| | | | 100% | | | | | | 100% | | |
Calliditas
Therapeutics Inc. |
| | Pre-commercialization activities in the United States | | |
USA
|
| | | | 100% | | | | | | — | | |
Pharmalink
Oncology AS |
| |
No activities as of December 31, 2019 and December 31, 2018
|
| |
Norway
|
| | | | 100% | | | | | | 100% | | |
Share capital and other contributed capital
|
| |
Number of
Shares |
| |
Share
Capital |
| |
Additional
Paid-in Capital |
| |||||||||
At January 1, 2018
|
| | | | 16,673,000 | | | | | | 667 | | | | | | 352,959 | | |
Premiums received from warrants
|
| | | | — | | | | | | — | | | | | | 2,826 | | |
Contributions from shareholders
|
| | | | — | | | | | | — | | | | | | 29,999 | | |
Interest from capital contributions from shareholders
|
| | | | — | | | | | | — | | | | | | 3,059 | | |
Offset issue approved in June 2018
|
| | | | 2,114,903 | | | | | | 84 | | | | | | (84) | | |
IPO new share issue June, 2018(1)
|
| | | | 16,414,444 | | | | | | 657 | | | | | | 683,560 | | |
At December 31, 2018
|
| | | | 35,202,347 | | | | | | 1,408 | | | | | | 1,072,319 | | |
Premiums received from warrants
|
| | | | — | | | | | | — | | | | | | 2,834 | | |
Share-based payment
|
| | | | — | | | | | | — | | | | | | 249 | | |
New share issue
|
| | | | 3,505,291 | | | | | | 140 | | | | | | 199,262 | | |
At December 31, 2019
|
| | | | 38,707,638 | | | | | | 1,548 | | | | | | 1,274,664 | | |
| | |
December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Balance at January 1
|
| | | | (34) | | | | | | (40) | | |
Change for the year ended
|
| | | | (11) | | | | | | 6 | | |
Balance at December 31
|
| | | | (45) | | | | | | (34) | | |
| | |
December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Opening balance
|
| | | | — | | | | | | — | | |
Provisions for the year
|
| | | | 175 | | | | | | — | | |
Total
|
| | | | 175 | | | | | | — | | |
| | |
December 31,
|
| |||||||||
| | |
2019
|
| |
2018
|
| ||||||
Accrued salaries and Board fees
|
| | | | 4,726 | | | | | | 2,286 | | |
Vacation pay liability
|
| | | | 1,904 | | | | | | 1,347 | | |
Social security costs
|
| | | | 2,975 | | | | | | 2,098 | | |
Accrued expenses for research and development
|
| | | | 1,176 | | | | | | 944 | | |
Deferred revenue
|
| | | | 874 | | | | | | — | | |
Other accrued expenses
|
| | | | 13,860 | | | | | | 20 | | |
Total
|
| | | | 25,515 | | | | | | 6,695 | | |
| | | | | | | | |
Nine Months Ended September 30,
|
| |||||||||
| | |
Notes
|
| |
2020
|
| |
2019
|
| |||||||||
Net sales
|
| | | | 4 | | | | | | 474 | | | | | | 138,243 | | |
Operating expenses: | | | | | | | | | | | | | | | | | | | |
Research and development
|
| | | | | | | | | | (167,379) | | | | | | (108,117) | | |
Administrative and selling
|
| | | | | | | | | | (77,843) | | | | | | (39,092) | | |
Other operating income
|
| | | | | | | | | | 969 | | | | | | 3,515 | | |
Other operating expenses
|
| | | | | | | | | | — | | | | | | (4,525) | | |
Operating loss
|
| | | | | | | | | | (243,779) | | | | | | (9,976) | | |
Financial income
|
| | | | | | | | | | 504 | | | | | | 2,158 | | |
Financial expenses
|
| | | | | | | | | | (19,603) | | | | | | (1,710) | | |
Loss before income tax
|
| | | | | | | | | | (262,878) | | | | | | (9,528) | | |
Income tax expense
|
| | | | | | | | | | (185) | | | | | | — | | |
Loss for the period attributable to shareholders of the Parent Company
|
| | | | | | | | | | (263,063) | | | | | | (9,528) | | |
Loss per share before and after dilution
|
| | | | | | | | | | (6.09) | | | | | | (0.26) | | |
| | | | | |
Nine Months Ended September 30,
|
| |||||||||
| | |
Notes
|
| |
2020
|
| |
2019
|
| ||||||
Loss for the period
|
| | | | | | | (263,063) | | | | | | (9,528) | | |
Other comprehensive income/(loss) that may be reclassified to profit or loss in subsequent periods:
|
| | | | | | | | | | | | | | | |
Exchange differences on translation of foreign operations
|
| | | | | | | (20) | | | | | | 27 | | |
Total other comprehensive income/(loss)
|
| | | | | | | (20) | | | | | | 27 | | |
Total comprehensive loss attributable to shareholders of the Parent Company
|
| | | | | | | (263,083) | | | | | | (9,501) | | |
| | |
Notes
|
| |
September 30
2020 |
| |
December 31
2019 |
| |||||||||
ASSETS | | | | | | | | | | | | | | | | | | | |
Non-current assets | | | | | | | | | | | | | | | | | | | |
Intangible assets
|
| | | | | | | | | | 16,066 | | | | | | 16,066 | | |
Equipment
|
| | | | | | | | | | 89 | | | | | | 104 | | |
Right-of-use assets
|
| | | | | | | | | | 4,144 | | | | | | 5,959 | | |
Non-current financial assets
|
| | | | | | | | | | 2,111 | | | | | | 1,939 | | |
Total non-current assets
|
| | | | | | | | | | 22,410 | | | | | | 24,068 | | |
Current assets | | | | | | | | | | | | | | | | | | | |
Accounts receivables
|
| | | | | | | | | | — | | | | | | 46,586 | | |
Other current assets
|
| | | | 6 | | | | | | 4,106 | | | | | | 2,719 | | |
Prepaid expenses
|
| | | | | | | | | | 16,798 | | | | | | 18,287 | | |
Cash
|
| | | | | | | | | | 1,396,869 | | | | | | 753,540 | | |
Total current assets
|
| | | | | | | | | | 1,417,773 | | | | | | 821,132 | | |
TOTAL ASSETS
|
| | | | | | | | | | 1,440,183 | | | | | | 845,200 | | |
SHAREHOLDERS’ EQUITY AND LIABILITIES | | | | | | | | | | | | | | | | | | | |
Shareholders’ equity | | | | | | | | | | | | | | | | | | | |
Share capital
|
| | | | | | | | | | 1,998 | | | | | | 1,548 | | |
Additional paid-in capital
|
| | | | | | | | | | 2,126,016 | | | | | | 1,274,664 | | |
Reserves
|
| | | | | | | | | | (66) | | | | | | (45) | | |
Retained earnings including net loss for the year
|
| | | | | | | | | | (751,160) | | | | | | (488,096) | | |
Total equity attributable to shareholders of the Parent Company
|
| | | | 7,8 | | | | | | 1,376,788 | | | | | | 788,071 | | |
Non-current liabilities | | | | | | | | | | | | | | | | | | | |
Provisions
|
| | | | 8 | | | | | | 1,931 | | | | | | 175 | | |
Other non-current liabilities
|
| | | | | | | | | | 1,034 | | | | | | 3,584 | | |
Total non-current liabilities
|
| | | | | | | | | | 2,965 | | | | | | 3,759 | | |
Current liabilities | | | | | | | | | | | | | | | | | | | |
Accounts payable
|
| | | | | | | | | | 19,872 | | | | | | 24,384 | | |
Current tax liabilities
|
| | | | | | | | | | 15 | | | | | | 77 | | |
Other current liabilities
|
| | | | | | | | | | 3,907 | | | | | | 3,394 | | |
Accrued expenses and deferred revenue
|
| | | | | | | | | | 36,636 | | | | | | 25,515 | | |
Total current liabilities
|
| | | | | | | | | | 60,430 | | | | | | 53,370 | | |
TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES
|
| | | | | | | | | | 1,440,183 | | | | | | 845,200 | | |
|
| | |
Notes
|
| |
Share
Capital |
| |
Additional-
Paid-in Capital |
| |
Translation
Reserve |
| |
Retained
Earnings Including Net Loss for the Period |
| |
Total
|
| ||||||||||||||||||
Opening shareholders’ equity January 1, 2019
|
| | | | | | | | | | 1,408 | | | | | | 1,072,319 | | | | | | (34) | | | | | | (455,518) | | | | | | 618,175 | | |
Loss for the period
|
| | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | (9,528) | | | | | | (9,528) | | |
Other comprehensive income/
(loss) |
| | | | | | | | | | — | | | | | | — | | | | | | 27 | | | | | | — | | | | | | 27 | | |
Total comprehensive income/(loss) for the period
|
| | | | | | | | | | — | | | | | | — | | | | | | 27 | | | | | | (9,528) | | | | | | (9,501) | | |
Transactions with owners: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
New share issue
|
| | | | 7 | | | | | | 140 | | | | | | 210,177 | | | | | | — | | | | | | — | | | | | | 210,317 | | |
Cost attributable to new share
issue |
| | | | 7 | | | | | | — | | | | | | (10,915) | | | | | | — | | | | | | — | | | | | | (10,915) | | |
Premiums from warrants issuance
|
| | | | 8 | | | | | | — | | | | | | 1,749 | | | | | | — | | | | | | — | | | | | | 1,749 | | |
Share-based payments
|
| | | | 8 | | | | | | — | | | | | | 142 | | | | | | — | | | | | | — | | | | | | 142 | | |
Total transactions with owners
|
| | | | | | | | | | 140 | | | | | | 201,153 | | | | | | — | | | | | | — | | | | | | 201,293 | | |
Closing shareholders’ equity September 30,
2019 |
| | | | | | | | | | 1,548 | | | | | | 1,273,473 | | | | | | (7) | | | | | | (465,046) | | | | | | 809,967 | | |
Opening shareholders’ equity January 1, 2020
|
| | | | | | | | | | 1,548 | | | | | | 1,274,664 | | | | | | (45) | | | | | | (488,096) | | | | | | 788,071 | | |
Loss for the period
|
| | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | (263,063) | | | | | | (263,063) | | |
Other comprehensive income/(loss)
|
| | | | | | | | | | — | | | | | | — | | | | | | (20) | | | | | | — | | | | | | (20) | | |
Total comprehensive income/(loss) for the period
|
| | | | | | | | | | — | | | | | | — | | | | | | (20) | | | | | | (263,063) | | | | | | (263,083) | | |
Transactions with owners:
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
New share issue
|
| | | | 7 | | | | | | 398 | | | | | | 890,990 | | | | | | — | | | | | | — | | | | | | 891,388 | | |
Cost attributable to new share
issue |
| | | | 7 | | | | | | — | | | | | | (97,686) | | | | | | — | | | | | | — | | | | | | (97,686) | | |
Exercise of warrants
|
| | | | 7 | | | | | | 52 | | | | | | 54,867 | | | | | | — | | | | | | — | | | | | | 54,919 | | |
Premiums from warrants issuance
|
| | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Share based payments
|
| | | | 8 | | | | | | — | | | | | | 3,179 | | | | | | — | | | | | | — | | | | | | 3,179 | | |
Total transactions with owners
|
| | | | | | | | | | 450 | | | | | | 851,350 | | | | | | — | | | | | | — | | | | | | 851,800 | | |
Closing shareholders’ equity September 30,
2020 |
| | | | | | | | | | 1,998 | | | | | | 2,126,016 | | | | | | (65) | | | | | | (751,159) | | | | | | 1,376,788 | | |
| | | | | |
Nine Months Ended September 30,
|
| |||||||||
| | |
Notes
|
| |
2020
|
| |
2019
|
| ||||||
Operating activities: | | | | | | | | | | | | | | | | |
Operating loss
|
| | | | | | | (243,779) | | | | | | (9,976) | | |
Adjustments for non-cash items
|
| | | | | | | 6,866 | | | | | | 1,438 | | |
Interest paid
|
| | | | | | | (321) | | | | | | (219) | | |
Income taxes paid
|
| | | | | | | (427) | | | | | | — | | |
Cash flow used in operating activities before changes in working capital
|
| | | | | | | (237,661) | | | | | | (8,757) | | |
Cash flow (used in)/from changes in working capital: | | | | | | | | | | | | | | | | |
Changes in operating receivables
|
| | | | | | | 28,558 | | | | | | (10,784) | | |
Changes in operating liabilities
|
| | | | | | | 19,996 | | | | | | (6,035) | | |
Cash flow used in operating activities
|
| | | | | | | (189,107) | | | | | | (25,576) | | |
Investing activities: | | | | | | | | | | | | | | | | |
Cash flow used in investing activities
|
| | | | | | | (2) | | | | | | (17,781) | | |
Financing activities: | | | | | | | | | | | | | | | | |
New share issue
|
| | | | | | | 891,388 | | | | | | 210,317 | | |
Cost attributable to new share issue
|
| | | | | | | (95,937) | | | | | | (10,915) | | |
Premiums from warrants issuance
|
| | | | | | | 54,919 | | | | | | 1,749 | | |
Repayment of loans
|
| | | | | | | (2,488) | | | | | | (1,063) | | |
Cash flow from financing activities
|
| | | | | | | 847,882 | | | | | | 200,088 | | |
Net increase/(decrease) in cash
|
| | | | | | | 658,773 | | | | | | 156,731 | | |
Cash at the beginning of the period
|
| | | | | | | 753,540 | | | | | | 646,175 | | |
Net foreign exchange gains/(loss) on cash
|
| | | | | | | (15,444) | | | | | | 2,169 | | |
Cash at the end of the period
|
| | | | | | | 1,396,869 | | | | | | 805,075 | | |
| | |
Nine Months Ended
September 30, |
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Type of good or service | | | | | | | | | | | | | |
Out-licensing
|
| | | | — | | | | | | 138,243 | | |
Provision of drugs
|
| | | | 474 | | | | | | — | | |
Total
|
| | | | 474 | | | | | | 138,243 | | |
|
| | |
Nine Months Ended
September 31, |
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Geographical markets | | | | | | | | | | | | | |
China, Hong Kong, Macau, Taiwan and Singapore
|
| | | | 474 | | | | | | 138,243 | | |
Total
|
| | | | 474 | | | | | | 138,243 | | |
| | |
September 30,
|
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Total registered shares at the beginning of the period
|
| | | | 38,707,638 | | | | | | 35,202,347 | | |
New issue of shares during the period
|
| | | | 11,233,946 | | | | | | 3,505,291 | | |
Total registered shares at the end of period
|
| | | | 49,941,584 | | | | | | 38,707,638 | | |
Share capital at the end of period
|
| | | | 1,998 | | | | | | 1,548 | | |
Shareholders’ equity at the end of period
|
| | | | 1,376,788 | | | | | | 809,967 | | |
| | |
Nine Months Ended
September 30, |
| |||||||||
| | |
2020
|
| |
2019
|
| ||||||
Loss per share before and after dilution
|
| | | | (6.09) | | | | | | (0.26) | | |
Weighted-average number of shares outstanding for the period, before and after
dilution |
| | | | 43,165,505 | | | | | | 36,345,098 | | |
Incentive Programs
|
| |
Warrants
Outstanding |
| |
Options
Outstanding |
| |
Share Awards
Outstanding |
| |
Total
Outstanding |
| ||||||||||||
Warrant program 2018/2022
|
| | | | 856,586 | | | | | | | | | | | | — | | | | | | 856,586 | | |
Warrant program 2019/2022
|
| | | | 422,500 | | | | | | | | | | | | — | | | | | | 422,500 | | |
Board LTIP 2019
|
| | | | — | | | | | | | | | | | | 51,399 | | | | | | 51,399 | | |
Board LTIP 2020
|
| | | | — | | | | | | | | | | | | 31,371 | | | | | | 31,371 | | |
ESOP 2020
|
| | | | — | | | | | | 1,089,000 | | | | | | — | | | | | | 1,089,000 | | |
Total Outstanding as of September 30, 2020
|
| | |
|
1,279,086
|
| | | |
|
1,089,000
|
| | | |
|
82,770
|
| | | |
|
2,450,856
|
| |
|
Incentive Programs
|
| |
Warrants
Outstanding |
| |
Share Awards
Outstanding |
| |
Total
Outstanding |
| |||||||||
Warrant program 2017/2020
|
| | | | 1,296,500 | | | | | | — | | | | | | 1,296,500 | | |
Warrant program 2018/2022
|
| | | | 856,586 | | | | | | — | | | | | | 856,586 | | |
Warrant program 2019/2022
|
| | | | 422,500 | | | | | | — | | | | | | 422,500 | | |
Board LTIP 2019
|
| | | | — | | | | | | 57,032 | | | | | | 57,032 | | |
Total Outstanding as of September 30, 2019
|
| | | | 2,575,586 | | | | | | 57,032 | | | | | | 2,632,618 | | |
(thousands)
|
| |
EUR
|
| |
SEK
|
| ||||||
Acquired identifiable intangible assets
|
| | | | 36,871 | | | | | | 382,521 | | |
Patents and software
|
| | | | 2,785 | | | | | | 28,893 | | |
Fixed assets
|
| | | | 39 | | | | | | 405 | | |
Right of use assets
|
| | | | 196 | | | | | | 2,033 | | |
Other current assets
|
| | | | 966 | | | | | | 10,022 | | |
Cash and cash equivalents
|
| | | | 3,110 | | | | | | 32,265 | | |
Noncontrolling interest
|
| | | | (13,023) | | | | | | (135,111) | | |
Deferred taxes liabilities
|
| | | | (7,970) | | | | | | (82,683) | | |
Interest-bearing provisions
|
| | | | (907) | | | | | | (9,410) | | |
Lease liability
|
| | | | (196) | | | | | | (2,033) | | |
Short term debt
|
| | | | (199) | | | | | | (2,065) | | |
Accounts payables
|
| | | | (810) | | | | | | (8,403) | | |
Other operating liabilities
|
| | | | (788) | | | | | | (8,175) | | |
Net assets acquired (a)
|
| | | | 20,074 | | | | | | 208,259 | | |
Total contingent consideration (b)
|
| | | | 4,941 | | | | | | 51,257 | | |
Total consideration transferred (c)
|
| | | | 19,747 | | | | | | 204,867 | | |
Estimated goodwill (b)+(c)-(a)
|
| | | | 4,614 | | | | | | 47,866 | | |
|
|
Consolidated Financial Statements as of December 31, 2019 and September 30, 2020 and for the
twelve-month period ended December 31, 2019 and the nine-month period ended September 30, 2020 |
| | |||||
| Independent Auditors’ Report | | | |||||
| | | | | F-55 | | | |
| | | | | F-56 | | | |
| | | | | F-57 | | | |
| | | | | F-58 | | | |
| | | | | F-59 | | | |
| | | | | F-60 | | |
| Stéphane Devin | | | Bertrand Roussel | |
| Partner | | | Partner | |
| | | | | | | | |
AS OF
|
| |||||||||
(amounts in thousands of euros)
|
| |
NOTES
|
| |
DECEMBER 31,
2019 |
| |
SEPTEMBER 30,
2020 |
| |||||||||
ASSETS | | | | | | | | | | | | | | | | | | | |
Intangible assets
|
| | | | 3 | | | | | | 9,086 | | | | | | 2,801 | | |
Property, plant and equipment
|
| | | | 4 | | | | | | 154 | | | | | | 218 | | |
Non-current financial assets
|
| | | | 5 | | | | | | 29 | | | | | | 36 | | |
Total non-current assets
|
| | | | | | | | | | 9,270 | | | | | | 3,055 | | |
Other current assets
|
| | | | 6 | | | | | | 1,349 | | | | | | 668 | | |
Prepaid expenses
|
| | | | 6 | | | | | | 151 | | | | | | 179 | | |
Cash and cash equivalents
|
| | | | 7 | | | | | | 2,417 | | | | | | 3,590 | | |
Total current assets
|
| | | | | | | | | | 3,917 | | | | | | 4,437 | | |
TOTAL ASSETS
|
| | | | | | | | | | 13,186 | | | | | | 7,492 | | |
SHAREHOLDER’S EQUITY AND LIABILITIES | | | | | | | | | | | | | | | | | | | |
Shareholders’ equity | | | | | | | | | | | | | | | | | | | |
Share capital
|
| | | | 8 | | | | | | 8,683 | | | | | | 11,549 | | |
Additional paid-in capital
|
| | | | | | | | | | 126,118 | | | | | | 4,747 | | |
Foreign currency transaction adjustment
|
| | | | | | | | | | (2,732) | | | | | | (2,752) | | |
Accumulated other comprehensive loss
|
| | | | | | | | | | (697) | | | | | | (647) | | |
Accumulated deficit–attributable to shareholders of
Genkyotex |
| | | | | | | | | | (114,332) | | | | | | 2,669 | | |
Net loss–attributable to shareholders of Genkyotex
|
| | | | | | | | | | (7,203) | | | | | | (11,017) | | |
Shareholders’ equity–attributable to shareholders of
Genkyotex |
| | | | | | | | | | 9,836 | | | | | | 4,548 | | |
Non-controlling interests
|
| | | | | | | | | | — | | | | | | — | | |
Total shareholders’ equity
|
| | | | | | | | | | 9,836 | | | | | | 4,548 | | |
Liabilities | | | | | | | | | | | | | | | | | | | |
Employee benefit obligations
|
| | | | 11 | | | | | | 1,348 | | | | | | 960 | | |
Non-current financial liabilities
|
| | | | 10 | | | | | | 17 | | | | | | 63 | | |
Total non-current liabilities
|
| | | | | | | | | | 1,364 | | | | | | 1,023 | | |
Current financial liabilities
|
| | | | 10 | | | | | | 848 | | | | | | 146 | | |
Derivative liabilities
|
| | | | 10 | | | | | | 64 | | | | | | — | | |
Provisions
|
| | | | 12 | | | | | | — | | | | | | 258 | | |
Accounts payables
|
| | | | | | | | | | 562 | | | | | | 656 | | |
Tax and social liabilities
|
| | | | 12 | | | | | | 469 | | | | | | 808 | | |
Other creditors and miscellaneous liabilities
|
| | | | | | | | | | 43 | | | | | | 54 | | |
Total current liabilities
|
| | | | | | | | | | 1,986 | | | | | | 1,922 | | |
TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES
|
| | | | | | | | | | 13,186 | | | | | | 7,492 | | |
(amounts in thousands of euros, except share and per share data)
|
| |
NOTES
|
| |
December 31,
2019 12 months |
| |
September 30,
2020 9 months |
| ||||||
Research and development expenses, net | | | | | | | | | | | | | | | | |
Research and development expenses
|
| |
16.1
|
| | | | (6,305) | | | | | | (9,627) | | |
Research tax credit
|
| |
16.1
|
| | | | 899 | | | | | | 356 | | |
General and administrative expenses
|
| |
16.2
|
| | | | (2,160) | | | | | | (1,757) | | |
Other operating income
|
| | | | | | | 142 | | | | | | 35 | | |
Operating loss
|
| | | | | | | (7,425) | | | | | | (10,993) | | |
Financial expenses
|
| |
18
|
| | | | (190) | | | | | | (101) | | |
Financial income
|
| |
18
|
| | | | 348 | | | | | | 12 | | |
Change in fair value of derivative instruments
|
| |
18
|
| | | | 64 | | | | | | 64 | | |
Net financial expense
|
| | | | | | | 222 | | | | | | (25) | | |
Loss before taxes
|
| | | | | | | (7,203) | | | | | | (11,017) | | |
Income taxes benefit
|
| | | | | | | — | | | | | | — | | |
Net loss for the period
|
| | | | | | | (7,203) | | | | | | (11,017) | | |
Attributable to shareholders of Genkyotex
|
| | | | | | | (7,203) | | | | | | (11,017) | | |
Non-controlling interests
|
| | | | | | | — | | | | | | — | | |
Basic and diluted weighted average number of shares outstanding | | | | | | | | 8,146,178 | | | | | | 11,160,072 | | |
Basic loss per share (€/share)
|
| |
20
|
| | |
|
(0.88)
|
| | | |
|
(0.99)
|
| |
Diluted loss per share (€/share)
|
| |
20
|
| | | | (0.88) | | | | | | (0.99) | | |
(amounts in thousands of euros)
|
| |
December 31,
2019 12 months |
| |
September 30,
2020 9 months |
| ||||||
Net loss for the period
|
| | | | (7,203) | | | | | | (11,017) | | |
Items that will not be reclassified to profit or loss | | | | | | | | | | | | | |
Remeasurements of the defined benefit liability (asset)
|
| | | | (183) | | | | | | 50 | | |
Items that will be reclassified to profit or loss | | | | | | | | | | | | | |
Foreign currency translation adjustment
|
| | | | (370) | | | | | | (20) | | |
Other comprehensive income (loss)
|
| | | | (554) | | | | | | 30 | | |
Total comprehensive loss
|
| | | | (7,757) | | | | | | (10,987) | | |
Attributable to shareholders of Genkyotex
|
| | | | (7,757) | | | | | | (10,987) | | |
Non-controlling interests
|
| | | | — | | | | | | — | | |
(amounts in thousands of euros, except share data)
|
| |
Notes
|
| |
Share capital–
number of shares |
| |
Share
capital |
| |
Additional
paid-in capital |
| |
Accumulated
deficit and net loss |
| |
Treasury
Shares |
| |
Foreign
currency translation adjustment |
| |
Other
comprehensive loss |
| |
Shareholders’
equity– Attributable to shareholders of Genkyotex |
| |
Non-
controlling interests |
| |
Shareholders’
equity |
| |||||||||||||||||||||||||||||||||
As of January 1, 2019
|
| | | | | | | | |
|
79,347,621
|
| | | |
|
7,935
|
| | | |
|
124,183
|
| | | |
|
(114,649)
|
| | | |
|
(152)
|
| | | |
|
(2,361)
|
| | | |
|
(514)
|
| | | |
|
14,442
|
| | | |
|
—
|
| | | |
|
14,442
|
| |
Net loss for the twelve-month period
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | (7,203) | | | | | | — | | | | | | — | | | | | | — | | | | | | (7,203) | | | | | | — | | | | | | (7,203) | | |
Other comprehensive income (loss)
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (370) | | | | | | (183) | | | | | | (554) | | | | | | — | | | | | | (554) | | |
Total comprehensive income (loss)
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | (7,203) | | | | | | — | | | | | | (370) | | | | | | (183) | | | | | | (7,757) | | | | | | — | | | | | | (7,757) | | |
Conversion of convertible bonds
|
| | | | | | | | |
|
748,687
|
| | | | | 749 | | | | | | 1,961 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 2,710 | | | | | | — | | | | | | 2,710 | | |
Effect of reverse stock split by 10(2)
|
| | | | | | | | |
|
(71,412,859)
|
| | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Costs incurred in relation to equity transactions(1)
|
| | | | | | | | | | | | | | | | — | | | | | | (27) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (27) | | | | | | — | | | | | | (27) | | |
Treasury shares movements, net
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | 107 | | | | | | — | | | | | | — | | | | | | 107 | | | | | | — | | | | | | 107 | | |
Gains and losses, net related to treasury shares
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | (122) | | | | | | — | | | | | | — | | | | | | — | | | | | | (122) | | | | | | — | | | | | | (122) | | |
Equity settled share-based payments
|
| | | | 9 | | | | | | | | | | | | — | | | | | | — | | | | | | 483 | | | | | | — | | | | | | — | | | | | | — | | | | | | 483 | | | | | | — | | | | | | 483 | | |
As of December 31, 2019
|
| | | | | | | | |
|
8,683,449
|
| | | | | 8,683 | | | | | | 126,118 | | | | | | (121,491) | | | | | | (45) | | | | | | (2,732) | | | | | | (697) | | | | | | 9,836 | | | | | | — | | | | | | 9,836 | | |
Net loss for the nine-month period
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | (11,017) | | | | | | — | | | | | | — | | | | | | — | | | | | | (11,017) | | | | | | — | | | | | | (11,017) | | |
Other comprehensive income (loss)
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (20) | | | | | | 50 | | | | | | 30 | | | | | | — | | | | | | 30 | | |
Total comprehensive income (loss)
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | (11,017) | | | | | | — | | | | | | (20) | | | | | | 50 | | | | | | (10,987) | | | | | | — | | | | | | (10,987) | | |
Conversion of convertible bonds
|
| | |
|
8
|
| | | | | 417,816 | | | | | | 418 | | | | | | 382 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 800 | | | | | | — | | | | | | 800 | | |
Capital increase
|
| | |
|
8
|
| | | | | 2,447,297 | | | | | | 2,447 | | | | | | 2,496 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 4,944 | | | | | | — | | | | | | 4,944 | | |
Costs incurred in relation to equity
transactions(1) |
| | | | | | | | | | | | | | | | — | | | | | | (323) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (323) | | | | | | — | | | | | | (323) | | |
Allocation of premiums to retained earnings
|
| | | | | | | | | | | | | | | | — | | | | | | (123,926) | | | | | | 123,926 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Treasury shares movements, net
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | (1) | | | | | | — | | | | | | — | | | | | | (1) | | | | | | — | | | | | | (1) | | |
Gains and losses, net related to treasury shares
|
| | | | | | | | | | | | | | | | — | | | | | | — | | | | | | 8 | | | | | | — | | | | | | — | | | | | | — | | | | | | 8 | | | | | | — | | | | | | 8 | | |
Equity settled share-based payments
|
| | | | 9 | | | | | | | | | | | | — | | | | | | — | | | | | | 271 | | | | | | — | | | | | | — | | | | | | — | | | | | | 271 | | | | | | — | | | | | | 271 | | |
As of September 30, 2020
|
| | | | | | | | |
|
11,548,562
|
| | | | | 11,549 | | | | | | 4,747 | | | | | | (8,303) | | | | | | (46) | | | | | | (2,752) | | | | | | (647) | | | | | | 4,548 | | | | | | — | | | | | | 4,548 | | |
(amounts in thousands of euros)
|
| |
NOTES
|
| |
December 31,
2019 12 months |
| |
September 30,
2020 9 months |
| ||||||
Cash flows from operating activities | | | | | | | | | | | | | | | | |
Net loss for the period
|
| | | | | | | (7,203) | | | | | | (11,017) | | |
Adjustments to reconcile net loss to cash flows used in operating activities
|
| | | | | | | | | | | | | | | |
Amortization of intangible assets
|
| |
3
|
| | | | (567) | | | | | | (427) | | |
Depreciation of property, plant and equipment
|
| |
4
|
| | | | (147) | | | | | | (109) | | |
Impairment on the SIIL contract
|
| |
3, 17
|
| | | | | | | | | | (5,859) | | |
Unrealized foreign exchange gains or losses
|
| | | | | | | 325 | | | | | | 4 | | |
Provisions for pension commitments
|
| |
11
|
| | | | (123) | | | | | | 349 | | |
Provisions
|
| |
12
|
| | | | — | | | | | | (258) | | |
Costs related to share-based payments
|
| |
9
|
| | | | (483) | | | | | | (271) | | |
Variation of the fair value of derivative
|
| | | | | | | — | | | | | | 64 | | |
Fair value of bond loans
|
| |
10
|
| | | | — | | | | | | (75) | | |
Interest expenses
|
| | | | | | | (6) | | | | | | (3) | | |
Operating cash flows before change in working capital requirements
|
| | | | | | | (6,201) | | | | | | (4,433) | | |
Change in working capital requirements (net of depreciation of trade receivables and inventories)
|
| | | | | | | (1,386) | | | | | | 1,098 | | |
Decrease (increase) in other current assets
|
| | | | | | | 673 | | | | | | 682 | | |
Decrease (increase) in prepaid expenses
|
| | | | | | | (17) | | | | | | (28) | | |
(Decrease) increase in Accounts payables
|
| | | | | | | (1,652) | | | | | | 94 | | |
(Decrease) increase in social security liabilities
|
| | | | | | | (358) | | | | | | 446 | | |
(Decrease) increase in tax liabilities
|
| | | | | | | (16) | | | | | | (107) | | |
(Decrease) increase in other creditors and miscellaneous liabilities
|
| | | | | | | (17) | | | | | | 11 | | |
Cash flows used in operating activities
|
| | | | | | | (7,588) | | | | | | (3,335) | | |
Cash flows used in investing activities
|
| | | | | | | | | | | | | | | |
Acquisition of intangible and tangible assets
|
| |
3, 4
|
| | | | (1) | | | | | | (2) | | |
Cash flows used in investing activities
|
| | | | | | | (1) | | | | | | (2) | | |
Cash flows from financing activities | | | | | | | | | | | | | | | | |
Capital increase
|
| | | | | | | — | | | | | | 4,944 | | |
Reduction of financial debt relating to the right of use (IFRS 16)
|
| |
10.3
|
| | | | (130) | | | | | | (102) | | |
Financial interest paid
|
| | | | | | | (5) | | | | | | (3) | | |
Repayment of conditional advances
|
| |
10.1
|
| | | | (118) | | | | | | — | | |
Costs paid in relation to equity transactions
|
| | | | | | | (27) | | | | | | (323) | | |
Cash flows (used in) from financing activities
|
| | | | | | | (281) | | | | | | 4,516 | | |
Net effect of exchange rate changes on cash and cash equivalents
|
| | | | | | | (11) | | | | | | (5) | | |
Decrease in cash and cash equivalents
|
| | | | | | | (7,881) | | | | | | 1,173 | | |
Cash and cash equivalents at the beginning of the period
|
| |
7
|
| | | | 10,297 | | | | | | 2,416 | | |
Cash and cash equivalents at the end of the period
|
| |
7
|
| | | | 2,416 | | | | | | 3,590 | | |
| | |
AS OF
|
| |||||||||||||||||||||
| | |
DECEMBER 31, 2019
|
| |
SEPTEMBER 30, 2020
|
| ||||||||||||||||||
| | |
Percent interest
|
| |
Percent control
|
| |
Percent interest
|
| |
Percent control
|
| ||||||||||||
GENKYOTEX SA
|
| |
Parent company (from a legal standpoint)
|
| |||||||||||||||||||||
GENKYOTEX SUISSE SA
|
| | | | 100.00% | | | | | | 100.00% | | | | | | 100.00% | | | | | | 100.00% | | |
| | |
Closing rate AS OF
|
| |
Average rate for the periods ended AS OF
|
| ||||||||||||||||||
EXCHANGE RATE
|
| |
DECEMBER 31,
2019 |
| |
SEPTEMBER 30,
2020 |
| |
DECEMBER 31, 2019
12 months |
| |
SEPTEMBER 30, 2020
9 months |
| ||||||||||||
CHF
|
| | | | 1.0854 | | | | | | 1.0804 | | | | | | 1.1124 | | | | | | 1.0680 | | |
Items
|
| |
Amortization period
|
|
Software | | | 1 year–straight line | |
SIIL contract and extensions | | | 19 years–straight line (2017–2035 corresponding to the life of the patent underlying the Vaxiclase technology license sold to SIIL) | |
Items
|
| |
Depreciation period
|
|
Office equipment, furniture and computer equipment | | | 3 to 5 years | |
Laboratory equipment | | | 5 to 8 years | |
Right of use | | | 1 to 3 years | |
(amounts in thousands of euros)
|
| |
Software
|
| |
SIIL Contract
and extensions |
| |
Total
|
| |||||||||
GROSS AMOUNT | | | | | | | | | | | | | | | | | | | |
As of December 31, 2018
|
| | | | 16 | | | | | | 10,697 | | | | | | 10,713 | | |
Addition
|
| | | | 1 | | | | | | — | | | | | | 1 | | |
As of December 31, 2019
|
| | | | 17 | | | | | | 10,697 | | | | | | 10,714 | | |
Addition
|
| | | | 1 | | | | | | — | | | | | | 1 | | |
As of September 30, 2020
|
| | | | 18 | | | | | | 10,697 | | | | | | 10,714 | | |
AMORTIZATION AND IMPAIRMENT | | | | | | | | | | | | | | | | | | | |
As of December 31, 2018
|
| | | | 16 | | | | | | 1,043 | | | | | | 1,060 | | |
Increase
|
| | | | — | | | | | | 567 | | | | | | 567 | | |
Exchange effect
|
| | | | 1 | | | | | | — | | | | | | 1 | | |
As of December 31, 2019
|
| | | | 17 | | | | | | 1,611 | | | | | | 1,628 | | |
Increase
|
| | | | 1 | | | | | | 426 | | | | | | 427 | | |
Impairment
|
| | | | | | | | | | 5,859 | | | | | | 5,859 | | |
As of September 30, 2020
|
| | | | 18 | | | | | | 7,896 | | | | | | 7,914 | | |
NET BOOK VALUE | | | | | | | | | | | | | | | | | | | |
As of December 31, 2019
|
| | | | — | | | | | | 9,086 | | | | | | 9,086 | | |
As of September 30, 2020
|
| | | | — | | | | | | 2,801 | | | | | | 2,801 | | |
| | |
Probability of success of
each phase |
| |
Overall probability of
success |
| ||||||
POC(1) | | | | | 100% | | | | | | 100% | | |
Phase 1
|
| | | | 70% | | | | | | 70% | | |
Phase 2
|
| | | | 43% | | | | | | 30% | | |
Phase 3
|
| | | | 73% | | | | | | 22% | | |
Commercial success
|
| | | | 89% | | | | | | 19% | | |
(amounts in thousands of euros)
|
| |
Laboratory
equipment |
| |
Office equipment,
furniture and computer equipment |
| |
Buildings
(right of use) |
| |
Total
|
| ||||||||||||
GROSS AMOUNT | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 538 | | | | | | 98 | | | | | | — | | | | | | 636 | | |
IFRS 16 first application impact
|
| | | | — | | | | | | — | | | | | | 262 | | | | | | 262 | | |
Disposal
|
| | | | — | | | | | | 1 | | | | | | — | | | | | | 1 | | |
Exchange effect
|
| | | | 15 | | | | | | 3 | | | | | | 10 | | | | | | 29 | | |
As of December 31, 2019
|
| | | | 553 | | | | | | 102 | | | | | | 272 | | | | | | 927 | | |
Addition
|
| | | | — | | | | | | 2 | | | | | | 171 | | | | | | 173 | | |
Disposal
|
| | | | (46) | | | | | | (11) | | | | | | — | | | | | | (57) | | |
Exchange effect
|
| | | | 2 | | | | | | 1 | | | | | | 0 | | | | | | 3 | | |
As of September 30, 2020
|
| | | | 509 | | | | | | 94 | | | | | | 443 | | | | | | 1,046 | | |
|
(amounts in thousands of euros)
|
| |
Laboratory
equipment |
| |
Office equipment,
furniture and computer equipment |
| |
Buildings
(right of use) |
| |
Total
|
| ||||||||||||
DEPRECIATION | | | | | | | | | | | | | | | | | | | | | | | | | |
As of January 1, 2019
|
| | | | 508 | | | | | | 97 | | | | | | — | | | | | | 605 | | |
IFRS 16 first application impact
|
| | | | — | | | | | | — | | | | | | 131 | | | | | | 131 | | |
Increase
|
| | | | 15 | | | | | | 1 | | | | | | — | | | | | | 16 | | |
Decrease
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Exchange effect
|
| | | | 15 | | | | | | 3 | | | | | | 3 | | | | | | 21 | | |
As of December 31, 2019
|
| | | | 538 | | | | | | 101 | | | | | | 134 | | | | | | 772 | | |
Increase
|
| | | | 7 | | | | | | 1 | | | | | | 102 | | | | | | 109 | | |
Decrease
|
| | | | (46) | | | | | | (11) | | | | | | — | | | | | | (57) | | |
Exchange effect
|
| | | | 2 | | | | | | 1 | | | | | | (0) | | | | | | 3 | | |
As of September 30, 2020
|
| | | | 501 | | | | | | 91 | | | | | | 235 | | | | | | 827 | | |
NET BOOK VALUE | | | | | | | | | | | | | | | | | | | | | | | | | |
As of December 31, 2019
|
| | | | 15 | | | | | | 1 | | | | | | 138 | | | | | | 154 | | |
As of September 30, 2020
|
| | | | 8 | | | | | | 2 | | | | | | 208 | | | | | | 218 | | |
|
(amounts in thousands of euros)
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Cash reserve related to the liquidity agreement
|
| | | | 14 | | | | | | 21 | | |
Guarantees
|
| | | | 15 | | | | | | 15 | | |
Total non-current financial assets
|
| | | | 29 | | | | | | 36 | | |
(amounts in thousands of euros)
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Research tax credit(1)
|
| | | | 899 | | | | | | 356 | | |
Value added tax
|
| | | | 229 | | | | | | 206 | | |
Social security receivables
|
| | | | 16 | | | | | | 71 | | |
Suppliers–advances payment and debit balance(2)
|
| | | | 75 | | | | | | — | | |
Miscellaneous
|
| | | | 131 | | | | | | 35 | | |
Total other current assets
|
| | | | 1,349 | | | | | | 668 | | |
(amounts in thousands of euros)
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Prepaid expenses
|
| | | | 151 | | | | | | 179 | | |
(amounts in thousands of euros)
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Bank accounts
|
| | | | 2,417 | | | | | | 3,590 | | |
Short-term deposits
|
| | | | — | | | | | | — | | |
Total cash and cash equivalents
|
| | | | 2,417 | | | | | | 3,590 | | |
| | |
At the end of the financial periods presented
|
| |||||||||
SHARE CAPITAL
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Share capital (in thousands of euros)
|
| | | | 8,683 | | | | | | 11,549 | | |
Number of shares
|
| | | | 8,683,449 | | | | | | 11,548,562 | | |
o/w ordinary shares
|
| | | | 8,863,449 | | | | | | 11,548,562 | | |
Par value of shares (in euro)
|
| | | | 1.00 € | | | | | | 1.00€ | | |
| | | | | |
Plan features
|
| ||||||||||||
Type
|
| |
Grant date
|
| |
Number of
warrants granted(1) |
| |
Maturity date
|
| |
Adjusted
exercise price(2) |
| ||||||
BSA 02/2010
|
| |
02/04/2010
|
| | |
|
155,200
|
| | |
10 years
|
| | | € | 30.00 | | |
BSA 12/2013
|
| |
12/20/2013
|
| | |
|
116,000
|
| | |
10 years
|
| | | € | 40.00 | | |
BSA 09/2014
|
| |
09/12/2014
|
| | |
|
35,000
|
| | |
10 years
|
| | | € | 57.90 | | |
Type
|
| |
Grant date
|
| |
Number of outstanding warrants
|
| |
Number of
shares which can be subscribed(3) |
| ||||||||||||||||||||||||||||||
|
At 12/31/2019
|
| |
Granted
|
| |
Exercised
|
| |
Lapsed
|
| |
At 09/30/2020
|
| ||||||||||||||||||||||||||
BSA 02/2010
|
| |
02/04/2010
|
| | | | 155,200 | | | | | | — | | | | | | — | | | | | | (2,700) | | | | | | 152,500 | | | | | | 15,295 | | |
BSA 12/2013
|
| |
12/20/2013
|
| | | | 116,000 | | | | | | — | | | | | | — | | | | | | — | | | | | | 116,000 | | | | | | 11,631 | | |
BSA 09/2014
|
| |
09/12/2014
|
| | | | 35,000 | | | | | | — | | | | | | — | | | | | | — | | | | | | 35,000 | | | | | | 3,509 | | |
Total | | | | | | | | 306,200 | | | | | | — | | | | | | — | | | | | | (2,700) | | | | | | 303,500 | | | | | | 30,435 | | |
| | | | | |
Plan features
|
| |
Assumptions
|
| |||||||||||||||||||||||||||
Type
|
| |
Grant date
|
| |
Number of
options granted(1) |
| |
Exercise
period |
| |
Adjusted
exercise price(2) |
| |
Volatility
|
| |
Risk-free rate
|
| |
Total initial IFRS 2
valuation (€ thousands) (Black&Scholes) |
| |||||||||||||||
Stock option 01/2018
|
| |
01/09/2018
|
| | |
|
1,159,934
|
| | |
10 years
|
| | | € | 16.70 | | | | | | 60.68% | | | | | | 0.00% | | | | |
|
1,096
|
| |
Stock option 10/2018
|
| |
10/11/2018
|
| | |
|
20,000
|
| | |
10 years
|
| | | € | 14.90 | | | | | | 56.86% | | | | | | 0.11% | | | | |
|
13
|
| |
Stock option 03/2019
|
| |
03/21/2019
|
| | |
|
1,336,380
|
| | |
10 years
|
| | | € | 9.10 | | | | | | 56.80% | | | | | | -0.27% | | | | |
|
604
|
| |
Stock option 06/2020
|
| |
06/04/2020
|
| | |
|
187,612
|
| | |
10 years
|
| | | € | 2.30 | | | | | | 59,33% | | | | | | -0.49% | | | | |
|
241
|
| |
Type
|
| |
Grant date
|
| |
Number of warrants outstanding
|
| |
Number of
shares which can be subscribed(3) |
| ||||||||||||||||||||||||||||||
|
At
12/31/2019 |
| |
Granted
|
| |
Exercised
|
| |
Lapsed
|
| |
At
09/30/2020 |
| ||||||||||||||||||||||||||
Stock option 01/2018
|
| |
01/09/2018
|
| | | | 1,130,153 | | | | | | — | | | | | | — | | | | | | (28,294) | | | | | | 1,101,859 | | | | | | 110,513 | | |
Stock option 10/2018
|
| |
10/11/2018
|
| | | | 20,000 | | | | | | — | | | | | | — | | | | | | — | | | | | | 20,000 | | | | | | 2,006 | | |
Stock option 03/2019
|
| |
03/21/2019
|
| | | | 1,336,380 | | | | | | — | | | | | | — | | | | | | (61,750) | | | | | | 1,274,630 | | | | | | 127,882 | | |
Stock option 06/2020
|
| |
06/04/2020
|
| | | | — | | | | | | 187,612 | | | | | | — | | | | | | — | | | | | | 187,612 | | | | | | 187,612 | | |
TOTAL | | | | | | | | 2,486,533 | | | | | | 187,612 | | | | | | — | | | | | | (90,044) | | | | | | 2,584,101 | | | | | | 428,013 | | |
| | |
TWELVE-MONTH PERIOD ENDED
DECEMBER 31, 2019 |
| |
NINE-MONTH PERIOD ENDED
SEPTEMBER 30, 2020 |
| ||||||||||||||||||||||||||||||||||||||||||
Type
|
| |
Probable
cost of the plan |
| |
Cumulative
expenses– beginning of period |
| |
Expense for
the period |
| |
Cumulative
expense to date |
| |
Probable
cost of the plan |
| |
Cumulative
expenses– beginning of period |
| |
Expense for
the period |
| |
Cumulative
expense to date |
| ||||||||||||||||||||||||
Stock option 01/2018
|
| | | | 1,068 | | | | | | 511 | | | | | | 250 | | | | | | 761 | | | | | | 1,041 | | | | | | 761 | | | | | | 108 | | | | | | 869 | | |
Stock option 10/2018
|
| | | | 13 | | | | | | 1 | | | | | | 6 | | | | | | 7 | | | | | | 13 | | | | | | 7 | | | | | | 2 | | | | | | 10 | | |
Stock option 03/2019
|
| | | | 604 | | | | | | — | | | | | | 228 | | | | | | 228 | | | | | | 577 | | | | | | 228 | | | | | | 123 | | | | | | 351 | | |
Stock option 06/2020
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 241 | | | | | | — | | | | | | 38 | | | | | | 38 | | |
Total | | | | | 1,685 | | | | | | 512 | | | | | | 483 | | | | | | 996 | | | | | | 1,872 | | | | | | 996 | | | | | | 271 | | | | | | 1,268 | | |
(amounts in thousands of euros)
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Conditional advances
|
| | | | — | | | | | | — | | |
Lease obligations (IFRS 16)
|
| | | | 17 | | | | | | 63 | | |
Non-current financial liabilities
|
| | | | 17 | | | | | | 63 | | |
Conditional advances
|
| | | | — | | | | | | — | | |
Lease obligations (IFRS 16)
|
| | | | 122 | | | | | | 145 | | |
Convertible bonds (refer to note 10.2)
|
| | | | 725 | | | | | | — | | |
Derivative liabilities
|
| | | | 64 | | | | | | — | | |
Bank overdrafts
|
| | | | 0 | | | | | | 0 | | |
Current financial liabilities
|
| | | | 912 | | | | | | 146 | | |
Total financial liabilities
|
| | | | 928 | | | | | | 209 | | |
(amounts in thousands of euros)
|
| |
AS OF
SEPTEMBER 30, 2020 |
| |
Current
|
| |
Non-current
|
| |||||||||||||||
|
< 1 year
|
| |
1 to 5 years
|
| |
> 5 years
|
| |||||||||||||||||
Conditional advances
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Lease obligations
|
| | | | 208 | | | | | | 145 | | | | | | 63 | | | | | | — | | |
Convertible bonds
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Derivative liabilities
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Bank overdrafts
|
| | | | 0 | | | | | | 0 | | | | | | — | | | | | | — | | |
Total financial liabilities
|
| | | | 209 | | | | | | 145 | | | | | | 63 | | | | | | — | | |
CHANGE IN CONDITIONAL ADVANCES AND SUBSIDIES
(amounts in thousands of euros) |
| |
OSEO 3–
ProCervix (GTL001) |
| |
TOTAL
|
| ||||||
As of January 1, 2019
|
| | | | 118 | | | | | | 118 | | |
Proceeds from conditional advances
|
| | | | — | | | | | | — | | |
Repayment
|
| | | | (118) | | | | | | (118) | | |
Subsidies
|
| | | | — | | | | | | — | | |
Financial expenses
|
| | | | 1 | | | | | | 1 | | |
As of December 31, 2019
|
| | | | — | | | | | | — | | |
Proceeds from conditional advances
|
| | | | — | | | | | | — | | |
Repayment
|
| | | | — | | | | | | — | | |
Subsidies
|
| | | | — | | | | | | — | | |
Financial expenses
|
| | | | — | | | | | | — | | |
As of September 30, 2020
|
| | | | — | | | | | | — | | |
CHANGE IN CONVERTIBLE BONDS
(amounts in thousands of euros) |
| |
2019
YORKVILLE OCABSA |
| |
2018
YORKVILLE OCABSA |
| |
TOTAL
|
| |||||||||
As of January 1, 2019
|
| | | | — | | | | | | 3,510 | | | | | | 3,510 | | |
Issuance | | | | | 1,600 | | | | | | — | | | | | | 1,600 | | |
Derivative liabilities
|
| | | | (128) | | | | | | — | | | | | | (128) | | |
Amortized cost of debt
|
| | | | 53 | | | | | | (260) | | | | | | (207) | | |
Debt extinction
|
| | | | — | | | | | | (1,600) | | | | | | (1,600) | | |
Conversion
|
| | | | (800) | | | | | | (1,650) | | | | | | (2,710) | | |
As of December 31, 2019
|
| | | | 725 | | | | | | — | | | | | | 725 | | |
Cash inflow
|
| | | | — | | | | | | — | | | | | | — | | |
Derivative liabilities
|
| | | | — | | | | | | — | | | | | | — | | |
Amortized cost of debt
|
| | | | 75 | | | | | | — | | | | | | 75 | | |
Debt extinction
|
| | | | — | | | | | | — | | | | | | — | | |
Conversion
|
| | | | (800) | | | | | | — | | | | | | (800) | | |
As of September 30, 2020
|
| | | | — | | | | | | — | | | | | | — | | |
Conversion date
|
| |
Number of
bonds |
| |
Amounts (in €)
|
| |
Conversion price
|
| |
Number of shares
issued |
| |
Issuance
premium |
| |||||||||||||||
01/14/2020
|
| | | | 30 | | | | | € | 300,000 | | | | | € | 1.874 | | | | | | 160,085 | | | | | | 139,914 | | |
01/15/2020
|
| | | | 50 | | | | | € | 500,000 | | | | | € | 1.940 | | | | | | 257,731 | | | | | | 242,267 | | |
|
Conversion date
|
| |
Number of
bonds |
| |
Amounts (in €)
|
| |
Conversion price
|
| |
Number of shares
issued |
| |
Issuance
premium |
| ||||||||||||
Total converted in 2020
|
| | | | 80 | | | | | € | 800,000 | | | | | | | | | 417,816 | | | | | | 382,181 | | |
|
CHANGES IN FINANCIAL DEBT—LEASE OBLIGATIONS
(amounts in thousands of euros) |
| |
Financial debt
(lease liabilities) |
| |||
As of January 1, 2019
|
| | | | — | | |
IFRS 16 first application impact
|
| | | | 263 | | |
(+) Newlease liabilities
|
| | | | — | | |
(-) Repayments (IFRS 16)
|
| | | | (121) | | |
(-) Advance payment
|
| | | | (9) | | |
Exchange rate
|
| | | | 6 | | |
As of December 31, 2019
|
| | | | 139 | | |
(+) New lease liabilities
|
| | | | 171 | | |
(-) Repayments (IFRS 16)
|
| | | | (102) | | |
(-) Advance payment
|
| | | | — | | |
Exchange rate
|
| | | | 1 | | |
As of September 30, 2020
|
| | | | 208 | | |
EMPLOYEE BENEFIT OBLIGATIONS
(amounts in thousands of euros) |
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Swiss employees
|
| | | | 1,335 | | | | | | 874 | | |
French employees
|
| | | | 13 | | | | | | 86 | | |
Employee benefit obligations
|
| | | | 1,348 | | | | | | 960 | | |
|
ACTUARIAL ASSUMPTIONS
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
|
Age at retirement
|
| |
Voluntary retirement
64 years of age for women/ 65 years of age for men |
| |||
Discount rate
|
| |
0.20%
|
| |
0.20%
|
|
Mortality table
|
| |
LPP 2015 generation
|
| |
LPP 2015 generation
|
|
Salary revaluation rate
|
| |
1.00%
|
| |
1.00%
|
|
Retirement pension inflation rate
|
| |
0.50%
|
| |
0.50%
|
|
Deposit rate on savings accounts
|
| |
1.00%
|
| |
1.00%
|
|
Turnover rate
|
| |
10.00%
|
| |
10.00%
|
|
| | |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
The weighted average duration of the retirement obligation
|
| | | | 26.00 | | | | | | 25.90 | | |
(amounts in thousands of euros)
|
| |
Defined
benefit plan obligation |
| |
Fair value of
plan assets |
| |
Employee
benefit obligations |
| |||||||||
January 1, 2019
|
| | | | 2,228 | | | | | | (1,237) | | | | | | 991 | | |
Service costs
|
| | | | 328 | | | | | | — | | | | | | 328 | | |
Interest expense
|
| | | | 19 | | | | | | (11) | | | | | | 8 | | |
Employee contribution
|
| | | | — | | | | | | (109) | | | | | | (109) | | |
Subtotal included in the statement of consolidated operations
|
| | | | 347 | | | | | | (120) | | | | | | 227 | | |
Amounts paid/received
|
| | |
|
(22)
|
| | | |
|
22
|
| | | | | — | | |
Return on assets (excluding interest expenses)
|
| | | | — | | | | | | (2) | | | | | | (2) | | |
Actuarial gains and losses related to changes in demographic assumptions
|
| | | | — | | | | | | — | | | | | | — | | |
Actuarial gains and losses related to changes in financial
assumptions |
| | | | 172 | | | | | | — | | | | | | 172 | | |
Other actuarial gains (losses)
|
| | | | 11 | | | | | | — | | | | | | 11 | | |
Experience effect
|
| | | | — | | | | | | — | | | | |
|
—
|
| |
Subtotal included in other items of comprehensive income
|
| | | | 182 | | | | | | (2) | | | | | | 180 | | |
Employer contributions
|
| | | | — | | | | |
|
(109)
|
| | | |
|
(109)
|
| |
Currency translation effect
|
| | | | 98 | | | | | | (52) | | | | | | 45 | | |
December 31, 2019
|
| | | | 2,833 | | | | | | (1,498) | | | | | | 1,335 | | |
|
(amounts in thousands of euros)
|
| |
Defined
benefit plan obligation |
| |
Fair value of
plan assets |
| |
Employee
benefit obligations |
| |||||||||
Service costs
|
| | | | 257 | | | | | | — | | | | | | 257 | | |
Interest expense
|
| | | | 4 | | | | | | (2) | | | | | | 2 | | |
Curtailment
|
| | | | (1,114) | | | | | | 564 | | | | | | (550) | | |
Employee contribution
|
| | | | — | | | | | | (66) | | | | | | (66) | | |
Subtotal included in the statement of the consolidated operations
|
| | | | (852) | | | | | | 496 | | | | | | (357) | | |
Amounts paid/received
|
| | |
|
(46)
|
| | | |
|
46
|
| | | | | — | | |
Return on assets (excluding interest expenses)
|
| | | | — | | | | | | (9) | | | | | | (9) | | |
Actuarial gains and losses related to changes in demographic assumptions
|
| | | | — | | | | | | — | | | | | | — | | |
Actuarial gains and losses related to changes in financial
assumptions |
| | | | — | | | | | | — | | | | | | — | | |
Other actuarial gains (losses)
|
| | | | (41) | | | | | | — | | | | | | (41) | | |
Experience effect
|
| | | | — | | | | | | — | | | | |
|
—
|
| |
Subtotal included in other items of comprehensive income
|
| | | | (41) | | | | | | (9) | | | | | | (50) | | |
Employer contributions
|
| | | | — | | | | |
|
(66)
|
| | | |
|
(66)
|
| |
Currency translation effect
|
| | | | 24 | | | | | | (12) | | | | | | 12 | | |
September 30, 2020
|
| | | | 1,918 | | | | | | (1,044) | | | | | | 874 | | |
|
(Amounts in € thousands)
|
| | | | | | | |
Salary revaluation rate
|
| | | | | | |
Sensitivity analysis
|
| | | | 0.50% | | | |
Assumptions: 1.00%
|
| | | | 1.50% | | |
Retirement obligation
|
| | | | 1,879 | | | |
1,918
|
| | | | 1,958 | | |
| | | | | | | | |
Discount rate
|
| | | | | | |
Sensitivity analysis
|
| | | | -0.30% | | | |
Assumptions: 0.20%
|
| | | | 0.70% | | |
Retirement obligation
|
| | | | 2,190 | | | |
1,918
|
| | | | 1,691 | | |
| | | | | | | | |
Pension inflation rate
|
| | | | | | |
Sensitivity analysis
|
| | | | 0.00% | | | |
Assumptions: 0.50%
|
| | | | 1.00% | | |
Retirement obligation
|
| | | | 1,803 | | | |
1,918
|
| | | | 2,045 | | |
Allocation (in € thousands)
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Cash and cash equivalent
|
| | | | 37 | | | | | | 23 | | |
Bonds
|
| | | | 840 | | | | | | 599 | | |
Mortgage loans
|
| | | | 228 | | | | | | 143 | | |
Shares
|
| | | | 259 | | | | | | 34 | | |
Real estate
|
| | | | — | | | | | | 155 | | |
Allocation (in € thousands)
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Other investments
|
| | | | 133 | | | | | | 90 | | |
Total | | | | | 1,498 | | | | | | 1,044 | | |
|
|
2021
|
| |
€105 thousand
|
|
|
2022
|
| |
€93 thousand
|
|
|
2023
|
| |
€82 thousand
|
|
|
2024
|
| |
€69 thousand
|
|
|
2025–2029
|
| |
€197 thousand
|
|
ACTUARIAL ASSUMPTIONS
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
|
Age at retirement
|
| |
Voluntary retirement age between 65 and 67
|
| |||
Collective bargaining agreement
|
| |
Pharmaceutical industry
|
| |||
Discount rate | | | | | | | |
(IBOXX Corporates AA)
|
| |
0.77%
|
| |
0.59%
|
|
Mortality table
|
| |
INSEE 2018
|
| |
INSEE 2018
|
|
Salary revaluation rate
|
| |
2.00%
|
| |
2.00%
|
|
Turnover rate
|
| |
20 years to 30 years old from 18.3% to 10.90%
31 years old to 40 years old from 10.4% to 6.3% 41 years old to 50 years old from 6% to 4.2% 51 years old to 60 years old from 3.9% to 1% 61 years old to 64 years old 1% Above 65 years nil |
| |||
Social security expense ratio | | | | ||||
Managers | | |
47%
|
| |
45%
|
|
Non-managers
|
| |
47%
|
| |
45%
|
|
(amounts in thousands of euros)
|
| |
Retirement
obligation |
| |||
As of January 1, 2019
|
| | | | 5 | | |
Service costs
|
| | | | 5 | | |
Interest expense
|
| | | | 0 | | |
Actuarial gains and losses
|
| | |
|
3
|
| |
As of December 31, 2019
|
| | | | 13 | | |
Service costs
|
| | | | 73 | | |
Interest expense
|
| | | | 0 | | |
(amounts in thousands of euros)
|
| |
Retirement
obligation |
| |||
Actuarial gains and losses
|
| | | | (0) | | |
As of September 30, 2020
|
| | | | 86 | | |
|
(amounts in thousands of euros)
|
| |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||
Bonus (including social security contributions)
|
| | | | 17 | | | | | | 417 | | |
Payroll & related accounts
|
| | | | 190 | | | | | | 309 | | |
Social security expenses
|
| | | | 134 | | | | | | 61 | | |
Other taxes and similar
|
| | | | 128 | | | | | | 21 | | |
Total tax and social liabilities
|
| | | | 469 | | | | | | 808 | | |
| | |
AS OF DECEMBER 31, 2019
|
| |||||||||||||||||||||
(amounts in thousands of euros)
|
| |
Value–
Statement of financial position |
| | | | | | | |
Value–Statement of financial
position (IFRS 9) |
| ||||||||||||
|
Fair
value |
| |
Fair value
through profit or loss |
| |
Amortized
cost |
| |||||||||||||||||
Non-current financial assets Level 1
|
| | | | 29 | | | | | | 29 | | | | | | — | | | | | | 29 | | |
Other current assets Level 1
|
| | | | 1,349 | | | | | | 1,349 | | | | | | — | | | | | | 1,349 | | |
Prepaid expenses Level 1
|
| | | | 151 | | | | | | 151 | | | | | | | | | | | | 151 | | |
Cash and cash equivalents Level 1
|
| | | | 2,417 | | | | | | 2,417 | | | | | | 2,417 | | | | | | — | | |
Total assets
|
| | | | 3,946 | | | | | | 3,946 | | | | | | 2,417 | | | | | | 1,529 | | |
Non-current financial liabilities Level 1
|
| | | | 17 | | | | | | 17 | | | | | | — | | | | | | 17 | | |
Current financial liabilities Level 3 & level 1
|
| | | | 912 | | | | | | 912 | | | | | | 725 | | | | | | 186 | | |
Accounts payables Level 1
|
| | | | 562 | | | | | | 562 | | | | | | — | | | | | | 562 | | |
Other payables Level 1
|
| | | | 512 | | | | | | 512 | | | | | | — | | | | | | 512 | | |
Total liabilities
|
| | | | 2,002 | | | | | | 2,002 | | | | | | 725 | | | | | | 1,277 | | |
| | |
AS OF SEPTEMBER 30, 2020
|
| |||||||||||||||||||||
(amounts in thousands of euros)
|
| |
Value–
Statement of financial position |
| | | | | | | |
Value–Statement of financial position (IFRS 9)
|
| ||||||||||||
|
Fair
value |
| |
Fair value
through profit or loss |
| |
Amortized
cost |
| |||||||||||||||||
Non-current financial assets Level 1
|
| | | | 36 | | | | | | 36 | | | | | | — | | | | | | 36 | | |
Other current assets Level 1
|
| | | | 668 | | | | | | 668 | | | | | | — | | | | | | 668 | | |
Prepaid expenses Level 1
|
| | | | 179 | | | | | | 179 | | | | | | | | | | | | 179 | | |
Cash and cash equivalents Level 1
|
| | | | 3,590 | | | | | | 3,590 | | | | | | 3,590 | | | | | | — | | |
Total assets
|
| | | | 4,473 | | | | | | 4,473 | | | | | | 3,590 | | | | | | 883 | | |
Non-current financial liabilities Level 1
|
| | | | 63 | | | | | | 63 | | | | | | — | | | | | | 63 | | |
Current financial liabilities Level 1
|
| | | | 146 | | | | | | 146 | | | | | | — | | | | | | 146 | | |
Accounts payables Level 1
|
| | | | 656 | | | | | | 656 | | | | | | — | | | | | | 656 | | |
Other payables Level 1
|
| | | | 862 | | | | | | 862 | | | | | | — | | | | | | 862 | | |
Total liabilities
|
| | | | 1,727 | | | | | | 1,727 | | | | | | — | | | | | | 1,727 | | |
| | |
AS OF DECEMBER 31,
2019 |
| |
AS OF SEPTEMBER 30,
2020 |
| ||||||||||||||||||
(amounts in thousands of euros)
|
| |
Interest
|
| |
Change in
fair value |
| |
Interest
|
| |
Change in
fair value |
| ||||||||||||
Profit or loss impact of assets | | | | | | | | | | | | | | | | | | | | | | | | | |
Fair value through income/(loss)
|
| | |
|
—
|
| | | | | — | | | | | | — | | | | | | — | | |
Cash and cash equivalents
|
| | |
|
—
|
| | | | | — | | | | | | — | | | | | | — | | |
Profit or loss impact of liabilities | | | | | | | | | | | | | | | | | | | | | | | | | |
Financial debt at amortized cost (conditional advances)
|
| | | | 1 | | | | | | — | | | | | | — | | | | | | — | | |
Financial debt at amortized cost (lease liabilities)
|
| | | | 5 | | | | | | — | | | | | | 3 | | | | | | — | | |
Convertible bond at amortized cost
|
| | | | 156 | | | | | | — | | | | | | — | | | | | | 75 | | |
Derivative liability at fair value through profit or loss
|
| | | | — | | | | | | (64) | | | | | | — | | | | | | (64) | | |
Bonds at fair value through profit or loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | |
(amounts in thousands of euros)
|
| |
DECEMBER 31, 2019
12 months |
| |
SEPTEMBER 30, 2020
9 months |
| ||||||
Raw materials and consumables
|
| | | | (83) | | | | | | (19) | | |
Research and studies
|
| | | | (3,158) | | | | | | (1,281) | | |
Personnel expenses
|
| | | | (1,277) | | | | | | (1,315) | | |
Expenses related to retirement obligations
|
| | | | (84) | | | | | | 147 | | |
Licenses and intellectual property costs
|
| | | | (722) | | | | | | (388) | | |
Depreciation and amortization
|
| | | | (581) | | | | | | (690) | | |
Share-based payments
|
| | | | (258) | | | | | | (129) | | |
Miscellaneous
|
| | | | (44) | | | | | | (22) | | |
Amortization of rights of use
|
| | | | (98) | | | | | | (71) | | |
Impairment of SIIL contract
|
| | | | — | | | | | | (5,859) | | |
Research and development expenses
|
| | | | (6,305) | | | | | | (9,627) | | |
Research tax credit
|
| | | | 899 | | | | | | 356 | | |
Subsidies
|
| | | | — | | | | | | — | | |
Research tax credit and subsidies
|
| | | | 899 | | | | | | 356 | | |
Research and development expenses, net
|
| | | | (5,406) | | | | | | (9,271) | | |
(amounts in thousands of euros)
|
| |
DECEMBER 31, 2019
12 months |
| |
SEPTEMBER 30, 2020
9 months |
| ||||||
Travel and incidental expenses
|
| | | | (208) | | | | | | (56) | | |
Fees
|
| | | | (889) | | | | | | (874) | | |
Insurance
|
| | | | (35) | | | | | | (44) | | |
Marketing and sales expenditure
|
| | | | (89) | | | | | | (130) | | |
Taxes and duties
|
| | | | (29) | | | | | | (18) | | |
Personnel expenses
|
| | | | (411) | | | | | | (504) | | |
Expenses related to retirement obligations
|
| | | | (39) | | | | | | 203 | | |
Attendance fees
|
| | | | (49) | | | | | | (60) | | |
Depreciation and amortization
|
| | | | (3) | | | | | | (1) | | |
Share-based payments
|
| | | | (226) | | | | | | (142) | | |
Miscellaneous
|
| | | | (150) | | | | | | (99) | | |
Amortization of rights of use
|
| | | | (33) | | | | | | (32) | | |
General and administrative expenses
|
| | | | (2,160) | | | | | | (1,757) | | |
(amounts in thousands of euros)
|
| |
DECEMBER 31, 2019
12 months |
| |
SEPTEMBER 30, 2020
9 months |
| ||||||
Convertible bonds effective interest expenses
|
| | | | (156) | | | | | | (75) | | |
Other financial expenses
|
| | | | (7) | | | | | | (3) | | |
Currency losses
|
| | | | (27) | | | | | | (23) | | |
Financial expenses
|
| | | | (190) | | | | | | (101) | | |
Currency gains
|
| | | | 348 | | | | | | 12 | | |
Derivative liabilities (change in fair value)
|
| | | | 64 | | | | | | 64 | | |
Total net financial expense
|
| | | | 222 | | | | | | (25) | | |
(amounts in thousands of euros)
|
| |
AS OF
DECEMBER 31, 2019 |
| |
AS OF
SEPTEMBER 30, 2020 |
| ||||||
Retirement
|
| | | | 297 | | | | | | 218 | | |
Other
|
| | | | 4 | | | | | | 5 | | |
Total items with a deferred tax asset nature
|
| | |
|
301
|
| | | |
|
223
|
| |
Unrecognized deferred tax assets
|
| | | | (301) | | | | | | (223) | | |
Deferred taxes, net
|
| | | | — | | | | | | — | | |
| | |
DECEMBER 31, 2019
12 months |
| |
SEPTEMBER 30, 2020
9 months |
| ||||||
Weighted average number of outstanding shares
|
| | | | 8,146,178 | | | | | | 11,160,072 | | |
Net loss (in thousands of euros)
|
| | | | (7,203) | | | | | | (11,017) | | |
Basic loss per share (€/share)
|
| | | | (0.88) | | | | | | (0.99) | | |
Diluted loss per share (€/share)
|
| | | | (0.88) | | | | | | (0.99) | | |
(amounts in thousands of euros)
|
| |
DECEMBER 31, 2019
12 months |
| |
SEPTEMBER 30, 2020
9 months |
| ||||||
Fixed compensation
|
| | | | 221 | | | | | | 177 | | |
Variable compensation
|
| | | | — | | | | | | 150 | | |
Benefits in kind
|
| | | | 20 | | | | | | 10 | | |
Employer contributions to the retirement plan
|
| | | | 29 | | | | | | 17 | | |
Share-based payments
|
| | | | 232 | | | | | | 130 | | |
Attendance fees
|
| | | | 49 | | | | | | 60 | | |
Total compensation of executive officers
|
| | | | 551 | | | | | | 543 | | |
(amounts in thousands of euros)
|
| |
Value–
Statement of financial position |
| | | | | | | |
Non current
|
| ||||||||||||
|
Current
< 1 year |
| |
1 to 5 years
|
| |
>5 years
|
| |||||||||||||||||
Non-current financial liabilities
|
| | | | 63 | | | | | | — | | | | | | 63 | | | | | | — | | |
Current financial liabilities
|
| | | | 146 | | | | | | 146 | | | | | | — | | | | | | — | | |
Accounts payables
|
| | | | 656 | | | | | | 656 | | | | | | — | | | | | | — | | |
Other payables
|
| | | | 862 | | | | | | 862 | | | | | | — | | | | | | — | | |
Total liabilities
|
| | | | 1,727 | | | | | | 1,664 | | | | | | 63 | | | | | | — | | |
|
Signature
|
| |
Title
|
| |
Date
|
|
|
/s/ Renée Aguiar-Lucander
Renée Aguiar-Lucander
|
| |
Chief Executive Officer
(Principal Executive Officer) |
| |
January 26, 2021
|
|
|
/s/ Fredrik Johansson
Fredrik Johansson
|
| |
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer) |
| |
January 26, 2021
|
|
|
/s/ Elmar Schnee
Elmar Schnee
|
| | Chairman of the Board of Directors | | |
January 26, 2021
|
|
|
/s/ Hilde Furberg
Hilde Furberg
|
| | Director | | |
January 26, 2021
|
|
|
/s/ Lennart Hansson, Ph.D.
Lennart Hansson, Ph.D.
|
| | Director | | |
January 26, 2021
|
|
|
Signature
|
| |
Title
|
| |
Date
|
|
|
/s/ Diane Parks
Diane Parks
|
| | Director | | |
January 26, 2021
|
|
|
/s/ Molly Henderson
Molly Henderson
|
| | Director | | |
January 26, 2021
|
|
| By: | | |
/s/ Renée Aguiar-Lucander
Calliditas Therapeutics Inc.
By: Renée Aguiar-Lucander Title: President |
| | Authorized Representative in the United States | |
Exhibit 1.1
CALLIDITAS THERAPEUTICS AB
[●] Common Shares (Quota Value SEK
0.04 Per Share)
(including [●] American Depositary Shares, each Representing Two Common Shares)
Underwriting Agreement
January [●], 2021
Citigroup Global Markets Inc.
Jefferies LLC
Citigroup Global Markets Limited
Jefferies International Limited
Jefferies GmbH
As Representatives of the several Underwriters,
c/o Citigroup Global Markets Inc.
388 Greenwich Street
New York, New York 10013
c/o Jefferies LLC
520 Madison Avenue
New York, New York 10022
c/o Citigroup Global Markets Limited
Citigroup Centre
Canada Square
Canary Wharf
London E14 5LB
United Kingdom
c/o Jefferies International Limited
100 Bishopsgate
London EC2N 4JL
United Kingdom
c/o Jefferies GmbH
Bockenheimer Landstrasse 24
60323 Frankfurt am Main
Germany
Ladies and Gentlemen:
Calliditas Therapeutics AB, a Swedish public limited liability company (the “Company”), proposes to issue and sell to the Underwriters (as defined below) an aggregate of (i) [●] common shares, quota value SEK 0.04 per share (“Common Shares”), of the Company to be delivered in the form of [●] American Depositary Shares (“ADSs”), each representing two Common Shares in a public offering in the United States (the “Public Offering”) and (ii) [●] Common Shares of the Company in a private placement in Europe and countries outside the United States (the “Private Placement”). The aggregate of [●] ADSs so proposed to be issued and sold in the Public Offering are hereinafter referred to as the “Firm ADSs”, the aggregate of [●] Common Shares to be issued and sold in the Private Placement are hereinafter referred to as the “Firm Shares”, and the Firm ADSs and Firm Shares are hereinafter collectively referred to as the “Firm Securities”. The Company also proposes to grant to the Underwriters an option to purchase up to [●] additional Common Shares, which may be in the form of (i) ADSs (the “Option ADSs”) and/or (ii) Common Shares (the “Option Shares” and, together with the Option ADSs, the “Option Securities”) in the Private Placement. The Firm Shares and the Option Shares are hereinafter collectively referred to as the “Offered Shares” and the Firm ADSs and the Option ADSs are hereinafter collectively referred to as the “Offered ADSs.” The Option Securities and the Firm Securities are hereinafter called the “Offered Securities”. The new Common Shares underlying the Offered ADSs are herein called the “Underlying Shares.”
The Offered ADSs will be evidenced by American Depositary Receipts (“ADRs”) and issued pursuant to that certain Deposit Agreement dated as of June 9, 2020 (the “Deposit Agreement”), by and among the Company, Citibank, N.A. as depositary (the “Depositary”) and all holders and beneficial owners of ADSs issued thereunder. The Company shall, following subscription by the Underwriters of the Offered Securities pursuant to this Agreement, deposit, on behalf of the Underwriters, the Underlying Shares being delivered in the form of ADSs with Citibank Europe plc as custodian (the “Custodian”) for the Depositary, which shall deliver the Offered ADSs to the Representatives for the account of the several Underwriters for subsequent delivery to the other several Underwriters or the investors, as the case may be.
The term “Representatives” or “you” as used herein shall mean, with respect to the Public Offering and sale of the Offered ADSs, Citigroup Global Markets Inc. and Jefferies LLC, as representatives of the several underwriters named in the first table in Schedule I hereto (the “U.S. Underwriters”), and, with respect to the Private Placement and sale of the Offered Shares, Citigroup Global Markets Limited, Jefferies International Limited and Jefferies GmbH, as representatives of the several underwriters named in the second table in Schedule I hereto (the “EU Underwriters” and, together with the U.S. Underwriters, the “Underwriters”). The division of services between Jefferies International Limited and Jefferies GmbH shall be determined at Jefferies' absolute discretion, whereby regulated services with respect to EU 27 countries and EU 27 investors shall be undertaken by Jefferies GmbH only. References herein to the “Underwriters” shall mean, with respect to the Public Offering and sale of the Offered ADSs, the U.S. Underwriters, and, with respect to the Private Placement and sale the Offered Shares, the EU Underwriters. The Offered Shares offered in the Private Placement will be offered in the context of a private placement to institutional investors including (i) in Sweden and other member states of the European Economic Area (the “EEA”) to “qualified investors” within the meaning of article 2(e) of the Prospectus Regulation (as defined below) and (ii) in the United Kingdom to “qualified investors” as defined in Article 2 of the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 who are persons who (a) have professional experience in matters relating to investments falling within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") and/or (b) are high net worth bodies corporate, unincorporated associations or partnerships or trustees of high value trusts as described in Article 49(2)(a) to (d) of the Order. To the extent there are no additional Underwriters listed on Schedule I other than you, the term Representatives as used in this Agreement shall mean you, as Underwriters, and the terms Representatives and Underwriters shall mean either the singular or plural as the context requires.
2
Unless the context otherwise requires, each reference to the Offered Securities or Offered ADSs herein also includes the Underlying Shares and the ADRs evidencing such ADSs. Unless the context otherwise requires, each reference to the Offered Securities, the Offered Shares or the Offered ADSs, as the case may be, refers to the Firm Securities, the Firm Shares or the Firm ADSs, respectively, and, to the extent the Underwriters’ option referred to in Section 2(b) of this Agreement is exercised, any Option Securities, Option Shares or Option ADSs, respectively, purchased pursuant to such option. The use of the neuter in this Agreement shall include the feminine and masculine wherever appropriate.
As used in this Agreement, the “Registration Statement” means the registration statement referred to in Section 1(a) hereof, including the exhibits, schedules and financial statements and any prospectus supplement relating to the Offered Securities that is filed with the Securities and Exchange Commission (the “SEC”) pursuant to Rule 424(b) under the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder (the “Securities Act”) and deemed part of such registration statement pursuant to Rule 430A under the Securities Act (“Rule 430A”), as amended at the date and time that this Agreement is executed and delivered by the parties hereto (the “Execution Time”), and, in the event any post-effective amendment thereto or any registration statement and any amendments thereto filed pursuant to Rule 462(b) under the Securities Act (a “Rule 462(b) Registration Statement”) becomes effective prior to the Closing Date (as defined in Section 3 hereof), shall also mean such registration statement as so amended or such Rule 462(b) Registration Statement, as the case may be; the “Effective Date” means each date and time that the Registration Statement and the ADR Registration Statement (as defined below), any post-effective amendment or amendments thereto or any Rule 462(b) Registration Statement became or becomes effective, as applicable; the “Preliminary Prospectus” means any preliminary prospectus with respect to the offering of the Offered Securities included in the Registration Statement at the Effective Date that omits information with respect to the Offered Securities and the offering thereof permitted to be omitted from the Registration Statement when it becomes effective pursuant to Rule 430A (“Rule 430A Information”); and the “Prospectus” means the prospectus relating to the Offered Securities that is first filed pursuant to Rule 424(b) under the Securities Act (“Rule 424(b)”) after the Execution Time.
The Public Offering and the Private Placement will be completed on basis of an available prospectus exemption set out in Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, which, jointly with the Commission Delegated Regulation (EU) 2019/979 of 14 March 2019 and the Commission Delegated Regulation (EU) 2019/980 of 14 March 2019, is referred to as the “Prospectus Regulation”, and, accordingly, no offer prospectus or other offering documents will be required to be prepared under the Prospectus Regulation in connection with the Offering Public Offering and the Private Placement.
As used in this Agreement, the “Disclosure Package” shall mean (i) the Preliminary Prospectus, as generally distributed to investors and used to offer the Offered Securities, (ii) any issuer free writing prospectus, as defined in Rule 433 under the Securities Act (“Rule 433” and, any such issuer free writing prospectus, an “Issuer Free Writing Prospectus”), identified in Schedule II hereto, and (iii) any other free writing prospectus, as defined in Rule 405 under the Securities Act (“Rule 405” and, any such free writing prospectus, a “Free Writing Prospectus”), that the parties hereto shall hereafter expressly agree in writing to treat as part of the Disclosure Package.
3
1. | Representations and Warranties. |
The Company represents and warrants to, and agrees with, each Underwriter as set forth below in this Section 1.
(a) The Company has prepared and filed with the SEC a registration statement (File No. 333-[●]) on Form F-1, including a related Preliminary Prospectus, for the registration of the offering and sale of the Offered Securities under the Securities Act. Such Registration Statement, including any amendments thereto filed prior to the Execution Time, has become effective. The Company may have filed one or more amendments thereto, including the related Preliminary Prospectus, each of which has previously been furnished to you. The Company will file with the SEC a final Prospectus relating to the Offered Securities in accordance with Rule 424(b) after the Execution Time. As filed, such final Prospectus shall contain all information with respect to the Offered Securities and the offering thereof required by the Securities Act and the rules thereunder and, except to the extent the Representatives shall agree in writing to a modification, shall be in all substantive respects in the form furnished to you prior to the Execution Time or, to the extent not completed at the Execution Time, shall contain only such specific additional information and other changes (beyond that contained in the latest Preliminary Prospectus) as the Company has advised you, prior to the Execution Time, will be included or made therein.
(b) When the Prospectus is first filed in accordance with Rule 424(b), on the Closing Date and on any date on which Option Securities are purchased, if such date is not the Closing Date (a “settlement date”), the Prospectus (and any supplement thereto) will comply in all material respects with the applicable requirements of the Securities Act and the rules thereunder; on the Effective Date, at the Execution Time and on the Closing Date, the Registration Statement complied and will comply in all material respects with the applicable requirements of the Securities Act and the rules thereunder, and did not and will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements therein not misleading; and on the date of any filing pursuant to Rule 424(b) and on the Closing Date and any settlement date, each Prospectus (together with any supplement thereto) will not include any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that the Company makes no representations or warranties as to the information contained in or omitted from the Registration Statement or the Prospectus (or any supplement thereto) in reliance upon and in conformity with information furnished in writing to the Company by or on behalf of any Underwriter through the Representatives specifically for inclusion in the Registration Statement or the Prospectus (or any supplement thereto), it being understood and agreed that the only such information furnished by or on behalf of any Underwriter consists of the information described as such in Section 8 hereof.
4
(c) The Company has filed with the SEC a registration statement (File No. 333-238726) on Form F-6 for the registration under the Securities Act of the offering and sale of the Offered ADSs (such registration statement, including all exhibits thereto, at the time it became effective, being hereinafter referred to as the “ADR Registration Statement”), and the ADR Registration Statement has become effective under the Securities Act. The Company may have filed one or more amendments thereto, each of which has previously been furnished to you. Such ADR Registration Statement at the time of its effectiveness did comply and on the Closing Date, will comply, in all material respects with the applicable requirements of the Securities Act and the rules thereunder and at the time of its Effective Date and at the Execution Time, did not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary in order to make the statements therein not misleading.
(d) A registration statement on Form 8-A (File No. 001-39308), and any amendments thereto, in respect of the registration of the Offered Securities under the Securities Exchange Act of 1934, as amended, and the rules and regulations of the SEC thereunder (collectively, the “Exchange Act”) has been filed with the SEC; such registration statement in the form heretofore delivered to the Representatives and, excluding exhibits, to the Representatives for each of the other Underwriters, has been declared effective by the SEC; no other document with respect to such registration statement has heretofore been filed with the SEC; no stop order suspending the effectiveness of such registration statement has been issued and, to the knowledge of the Company, no proceeding for that purpose has been initiated or threatened by the SEC (the various parts of such registration statement, including all exhibits thereto, each as amended at the time such part of the registration statement became effective, being hereinafter called the “Form 8-A Registration Statement”); and the Form 8-A Registration Statement when it became effective complied, and any further amendments thereto will comply, in all material respects with the Exchange Act, and did not, as of the applicable effective date, and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order to make the statements therein not misleading.
(e) The Public Offering and the Private Placement will be completed on the basis of an available prospectus exemption set out in the Prospectus Regulation and, accordingly, the Company will not be required to prepared any prospectus under the Prospectus Regulation in connection with the Public Offering or the Private Placement.
5
(f) The issuance of the Offered Shares and the Underlying Shares has been duly authorized and the Offered Shares and the Underlying Shares will, in each case, upon payment, issuance and registration with the Swedish Companies Registration Office (Bolagsverket), constitute valid, fully paid and non-assessable shares that are freely transferable, without the need to obtain any approval or authorization in connection therewith, under the Company’s Articles of Association and there are vis-à-vis the Company no other restrictions on subsequent transfers of the Offered Securities or on the voting rights of the Offered Securities by the Underwriters; and the issuance of the Offered Securities is not subject to the preemptive or other similar rights of any security holder of the Company. The Offered Shares and the Underlying Shares will, once registered with Swedish Companies Registration Office and upon admission to trading on Nasdaq Stockholm, conform to all statements relating thereto contained in the Registration Statement, the Disclosure Package and the Prospectus and such descriptions conform to the rights set forth in the instruments defining the same. No holder of the Offered Securities will be subject to personal liability by reason of being such a holder. Upon the delivery to the Custodian of the Underlying Shares, the Depositary will, subject to the terms of the Deposit Agreement, acquire good, marketable and valid title to such Underlying Shares, free and clear of all pledges, liens, security interests, charges, claims or encumbrances of any kind.
(g) Except as described in each of the Disclosure Package and the Prospectus, all dividends and other distributions declared and payable on the Common Shares may under current Swedish law and regulations be paid to the Depositary and to the holders of the Offered Securities, as the case may be, in Swedish Krona and may be converted into foreign currency that may be transferred out of the Kingdom of Sweden in accordance with the Deposit Agreement.
(h) The Company is not currently a Passive Foreign Investment Company (“PFIC”) within the meaning of Section 1296 of the U.S. Internal Revenue Code of 1986, as amended (the “Code”), and does not expect to become a PFIC in the future.
(i) The Company is not currently a Controlled Foreign Corporation (“CFC”) within the meaning of Section 957 of the Code, and does not expect to become a CFC in the future.
(j) The Company is not currently a “foreign personal holding company” within the meaning of the Code.
(k) (i) The Disclosure Package and the price to the public, the number of Firm Securities and the number of Option Securities to be included on the cover page of the Prospectus, when taken together as a whole, (ii) each electronic road show, when taken together as a whole with the Disclosure Package and the price to the public, the number of Firm Securities and the number of Option Securities to be included on the cover page of the Prospectus, and (iii) any individual Written Testing-the-Waters Communication, when taken together as a whole with the Disclosure Package and the price to the public, the number of Firm Securities and the number of Option Securities to be included on the cover page of the Prospectus, does not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The preceding sentence does not apply to statements in or omissions from the Disclosure Package based upon and in conformity with written information furnished to the Company by or on behalf of any Underwriter through the Representatives specifically for use therein, it being understood and agreed that the only such information furnished by or on behalf of any Underwriter consists of the information described as such in Section 8 hereof.
(l) (i) At the time of filing the Registration Statement and (ii) as of the Execution Time (with such date being used as the determination date for purposes of this clause (ii)), the Company was not and is not an Ineligible Issuer (as defined in Rule 405), without taking account of any determination by the SEC pursuant to Rule 405 that it is not necessary that the Company be considered an Ineligible Issuer.
6
(m) From the time of initial confidential submission of the Registration Statement to the SEC (or, if earlier, the first date on which the Company engaged directly or through any Person authorized to act on its behalf in any Testing-the-Waters Communication) through the Execution Time, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the Securities Act (an “Emerging Growth Company”). “Testing-the-Waters Communication” means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the Securities Act.
(n) The Company (i) has not alone engaged in any Testing-the-Waters Communication other than Testing-the-Waters Communications with the consent of the Representatives with entities that are qualified institutional buyers within the meaning of Rule 144A under the Securities Act or institutions that are accredited investors within the meaning of Rule 501 under the Securities Act and (ii) has not authorized anyone other than Citigroup Global Markets Inc. and Jefferies LLC to engage in Testing-the-Waters Communications. The Company reconfirms that each of Citigroup Global Markets Inc. and Jefferies LLC have been authorized to act on its behalf in undertaking Testing-the-Waters Communications. The Company has not distributed any Written Testing-the-Waters Communications other than those listed on Schedule III hereto. “Written Testing-the-Waters Communication” means any Testing-the-Waters Communication that is a written communication within the meaning of Rule 405.
(o) Each Issuer Free Writing Prospectus does not include any information that conflicts with the information contained in the Registration Statement. The foregoing sentence does not apply to statements in or omissions from any Issuer Free Writing Prospectus based upon and in conformity with written information furnished to the Company by or on behalf of any Underwriter through the Representatives specifically for use therein, it being understood and agreed that the only such information furnished by or on behalf of any Underwriter consists of the information described as such in Section 8 hereof.
(p) Each of the Company and its subsidiaries has been duly incorporated or organized and is validly existing as a corporation or other organization in good standing under the laws of the jurisdiction in which it is chartered or organized with full corporate power and authority to own or lease, as the case may be, and to operate its properties and conduct its business as described in the Disclosure Package and the Prospectus, and is duly qualified to do business as a foreign corporation and is in good standing under the laws of each jurisdiction which requires such qualification, except when the failure to be qualified or in good standing would not reasonably be expected, individually or in the aggregate, to have a material adverse effect on the condition (financial or otherwise), prospects, earnings, business or properties of the Company and its subsidiaries, taken as a whole (a “Material Adverse Effect”).
7
(q) The Company’s issued share capital is as set forth in the Disclosure Package and the Prospectus under the heading “Capitalization”; the share capital of the Company conforms to the description thereof contained in the Disclosure Package and the Prospectus; and, except as set forth in the Disclosure Package and the Prospectus, no options, warrants or other rights to purchase, agreements or other obligations to issue, or rights to convert any obligations into or exchange any securities for shares or ownership interests in the Company are outstanding.
(r) All the outstanding share capital of each subsidiary have been duly and validly authorized and issued and are fully paid and non-assessable, and, except as otherwise set forth in the Disclosure Package and the Prospectus, all outstanding share capital of the subsidiaries are owned by the Company either directly or through wholly owned subsidiaries free and clear of any perfected security interest or any other security interests, claims, liens or encumbrances.
(s) There is no franchise, contract or other document of a character required to be described in the Registration Statement, the ADR Registration Statement or the Prospectus, or to be filed as an exhibit thereto, which is not described or filed as required (and the Preliminary Prospectus contains in all material respects the same description of the foregoing matters contained in the Prospectus); and the statements in the Preliminary Prospectus and the Prospectus under the headings “Material Income Tax Considerations,” “Risk Factors—Risks Related to Intellectual Property,” “Risk Factors—Risks Related to the Discovery, Development and Commercialization of Our Product Candidates,” “Business—Intellectual Property,” “Business—Government Regulation” and “Description of Share Capital and Articles of Association,” insofar as such statements summarize legal matters, agreements, documents or proceedings discussed therein, are accurate and fair summaries of such legal matters, agreements, documents or proceedings.
(t) This Agreement has been duly authorized, executed and delivered by the Company.
(u) The Deposit Agreement has been duly authorized, executed and delivered by the Company. Assuming due authorization, execution and delivery by the Depositary, the Deposit Agreement constitutes a valid and legally binding agreement of the Company enforceable against the Company in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by equitable principles relating to enforceability. Upon (i) issuance by the Depositary of the Offered ADSs against the deposit of the Underlying Shares in respect thereof and/or (ii) due execution and delivery by the Depositary of ADRs evidencing the Offered ADSs against the deposit of the Underlying Shares in respect thereof, in accordance with the provisions of the Deposit Agreement, such ADSs and/or ADRs will be duly and validly issued and the persons in whose names the ADSs and/or the ADRs are registered will be entitled to the rights specified therein and in the Deposit Agreement; the deposit of the Underlying Shares with the Depositary and the issuance of the Offered ADSs in respect thereof and the ADRs evidencing the same as contemplated by this Agreement and the Deposit Agreement is not subject to the preemptive or other similar rights of any securityholder of the Company; and the Deposit Agreement and the ADSs and ADRs conform to the descriptions thereof contained in the Registration Statement, the Disclosure Package and the Prospectus.
8
(v) The Company is not and, after giving effect to the offering and sale of the Offered Securities and the application of the proceeds thereof as described in the Disclosure Package and the Prospectus, will not be an “investment company” as defined in the Investment Company Act of 1940, as amended.
(w) No consent, approval, authorization, filing with or order of any court or governmental agency or body is required in connection with the transactions contemplated herein or in the Deposit Agreement, except such as have been obtained under the Securities Act and such as may be required under the listing rules of the Nasdaq Stock Market, applicable rules of the Financial Industry Regulatory Authority, Inc. (“FINRA”) and the blue sky laws of any jurisdiction or the Swedish Companies Act (Aktiebolagslagen (2005:551)), as amended, in connection with the purchase and distribution of the Offered Securities by the Underwriters in the manner contemplated herein and in the Disclosure Package and the Prospectus. Without limitation, the Company has not, directly or indirectly, without giving effect to activities by the Underwriters, caused the Offered Securities to be, and will not cause them to be, the subject of an offer to the public in the Kingdom of Sweden (or in any other EU Member State) for the purposes of Swedish law (or any laws of any other EU Member State) or in the United Kingdom for the purposes of law in the United Kingdom, and no invitation or inducement to acquire them has been or will be made by the Company, directly or indirectly, without giving effect to activities of the Underwriters, which would be prohibited by Swedish law (or any laws of any other EU Member State) or law in the United Kingdom.
(x) Neither the issue and sale of the Offered Securities nor the consummation of any other of the transactions herein contemplated nor the fulfillment of the terms of this Agreement or of the Deposit Agreement or the execution or delivery of this Agreement or the Deposit Agreement will conflict with, result in a breach or violation of, or imposition of any lien, charge or encumbrance upon any property or assets of the Company or any of its subsidiaries pursuant to, (i) the articles of association or bylaws of the Company or any of its subsidiaries, (ii) the terms of any indenture, contract, lease, mortgage, deed of trust, note agreement, loan agreement or other agreement, obligation, condition, covenant or instrument to which the Company or any of its subsidiaries is a party or bound or to which its or their property is subject, or (iii) any statute, law, rule, regulation, judgment, order or decree applicable to the Company or any of its subsidiaries of any court, regulatory body, administrative agency, governmental body, arbitrator or other authority having jurisdiction over the Company or any of its subsidiaries or any of its or their properties (including, without limitation, the rules and regulations of Nasdaq Stockholm), except in the case of clause (ii) and (iii) for any such breach, violation or imposition as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect and as would not have a material adverse effect on the ability of the Underwriters to execute the transactions contemplated by this agreement.
(y) No holders of securities of the Company have rights to the registration of such securities under the Registration Statement.
9
(z) The consolidated historical financial statements, together with the related notes and schedules, of the Company and its consolidated subsidiaries included in the Preliminary Prospectus, the Prospectus and the Registration Statement present fairly in all material respects the financial condition, results of operations and cash flows of the Company and its consolidated subsidiaries as of the dates and for the periods indicated, comply as to form in all material respects with the applicable accounting requirements of the Securities Act. Such statements and related notes and schedules have been prepared in accordance with International Financial Reporting Standards, as adopted by the International Accounting Standards Board (“IFRS”), and in compliance with the financial reporting requirements of Swedish law, in each case applied on a consistent basis throughout the periods involved except as may be set forth in the related notes included in the Prospectus. The consolidated historical financial statements, together with the related notes, of Genkyotex S.A. and its consolidated subsidiary included in the Preliminary Prospectus, the Prospectus and the Registration Statement present fairly in all material respects the financial condition, results of operations and cash flows of Genkyotex S.A. and its consolidated subsidiary as of the dates and for the periods indicated, comply as to form in all material respects with the applicable accounting requirements of the Securities Act. Such statements and related notes have been prepared in accordance with IFRS, as adopted by the International Accounting Standards Board, and, with respect to the nine month period ended September 30, 2020, in accordance with IAS 34 “Interim financial reporting”, applied on a consistent basis throughout the periods involved except as may be set forth in the related notes included in the Prospectus, except that they do not include comparative financial information as of and for the year ended December 31, 2018 and for the nine-month period ended September 30, 2019 as required by IAS 1 “Presentation of Financial Statements”. The financial statements, together with the related notes and schedules, included in the Preliminary Prospectus, the Prospectus and the Registration Statement comply in all material respects with Regulation S-X. No other financial statements or supporting schedules or exhibits are required by Regulation S-X to be described or included in the Preliminary Prospectus, the Prospectus and the Registration Statement. The selected financial data set forth under the caption “Selected Consolidated Financial Data” in the Preliminary Prospectus, the Prospectus and Registration Statement fairly present in all material respects, on the basis stated in the Preliminary Prospectus, the Prospectus and the Registration Statement, the information included therein. The pro forma financial statements included in the Preliminary Prospectus, the Prospectus and the Registration Statement include assumptions that provide a reasonable basis for presenting the significant effects directly attributable to the transactions and events described therein, the related pro forma adjustments give appropriate effect to those assumptions, and the pro forma adjustments reflect the proper application of those adjustments to the historical financial statement amounts in the pro forma financial statements included in the Preliminary Prospectuses, the Prospectuses and the Registration Statement. The pro forma financial statements included in the Preliminary Prospectuses, the Prospectuses and the Registration Statement comply as to form in all material respects with the applicable accounting requirements of Regulation S-X and the pro forma adjustments have been properly applied to the historical amounts in the compilation of those statements
(aa) No action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its subsidiaries or its or their property is pending or, to the knowledge of the Company, threatened that (i) would reasonably be expected to have a material adverse effect on the performance of this Agreement or the consummation of any of the transactions contemplated hereby or (ii) could reasonably be expected to have a Material Adverse Effect, except as set forth in or contemplated in the Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto).
(bb) Each of the Company and each of its subsidiaries owns or leases all such properties as are necessary to the conduct of its operations as presently conducted, and except as would not reasonably be expected to have a Material Adverse Effect.
10
(cc) Neither the Company nor any subsidiary is in violation or default of: (i) any provision of its articles of association or bylaws, (ii) the terms of any indenture, contract, lease, mortgage, deed of trust, note agreement, loan agreement or other agreement, obligation, condition, covenant or instrument to which it is a party or bound or to which its property is subject, or (iii) any statute, law, rule, regulation, judgment, order or decree of any court, regulatory body, administrative agency, governmental body, arbitrator or other authority having jurisdiction over the Company or such subsidiary or any of its properties, as applicable, except in case of clauses (ii) and (iii), for any such violation or default as would not reasonably expected, individually or in the aggregate, to have a Material Adverse Effect.
(dd) (i) Ernst & Young AB, who have audited the consolidated financial statements of the Company and its consolidated subsidiaries and delivered their report with respect to the audited consolidated financial statements and schedules included in the Disclosure Package and the Prospectus, are independent public accountants with respect to the Company within the meaning of the Securities Act and the applicable published rules and regulations thereunder. (ii) KPMG S.A., who have audited the consolidated financial statements of Genkyotex S.A. and its subsidiary included in the Disclosure Package and the Prospectus and who have delivered their report with respect thereto, are independent certified public accountants with respect to Genkyotex S.A. under Rule 101 of the AICPA Code of Professional Conduct, and its interpretations and rulings, which is accepted by the SEC for audits of acquiree financial statements pursuant to Rule 3-05 of Regulation S-X
(ee) No stamp, documentary, issuance, registration, transfer or other similar taxes or duties are payable by or on behalf of the Underwriters, the Company or any of its subsidiaries in the Kingdom of Sweden, the United States, any state or political subdivision thereof or to any taxing authority thereof or therein in connection with (i) the execution, delivery or consummation of this Agreement, (ii) the creation, allotment and issuance of the Offered Securities by the Company, (iii) the sale and delivery of the Offered Securities by the Company to the Underwriters or purchasers procured by the Underwriters, or (iv) the resale and delivery of the Offered Securities by the Underwriters in the manner contemplated herein.
(ff) The Company and each of its subsidiaries have filed all tax returns that are required to be filed or have requested extensions thereof (except in any case in which the failure to so file would not have a Material Adverse Effect or except as set forth in or contemplated in the Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto)) and have paid all taxes required to be paid by it and any other assessment, fine or penalty levied against it, to the extent that any of the foregoing is due and payable, except for any such assessment, fine or penalty that is currently being contested in good faith or as would not have a Material Adverse Effect or except as set forth in or contemplated in the Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto). No tax deficiency has been determined adversely to the Company or any of its subsidiaries which has had (nor does the Company nor any of its subsidiaries have any notice or knowledge of any tax deficiency which would reasonably be expected to be determined adversely to the Company or any of its subsidiaries and which would reasonably be expected to have) a Material Adverse Effect on the Company and its subsidiaries, taken as a whole.
11
(gg) No labor problem or dispute with the employees of the Company or any of its subsidiaries exists or is threatened in writing or, to the Company’s knowledge, imminent, and the Company is not aware of any existing or imminent labor disturbance by the employees of any of its or its subsidiaries’ principal suppliers, contractors or customers, that would be reasonably expected to have a Material Adverse Effect, except as set forth in or contemplated in the Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto).
(hh) The Company and each of its subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as the Company reasonably believes are prudent and customary in the businesses in which they are engaged; all policies of insurance and fidelity or surety bonds insuring the Company or any of its subsidiaries or their respective businesses, assets, employees, officers and directors are in full force and effect; the Company and its subsidiaries are in compliance with the terms of such policies and instruments in all material respects; and there are no material claims by the Company or any of its subsidiaries under any such policy or instrument as to which any insurance company is denying liability or defending under a reservation of rights clause; neither the Company nor any such subsidiary has been refused any insurance coverage sought or applied for; and neither the Company nor any such subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not reasonably be expected to have a Material Adverse Effect.
(ii) No subsidiary of the Company is currently prohibited, directly or indirectly, from paying any dividends to the Company, from making any other distribution on such subsidiary’s share capital, from repaying to the Company any loans or advances to such subsidiary from the Company or from transferring any of such subsidiary’s property or assets to the Company or any other subsidiary of the Company, except as described in or contemplated by the Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto).
(jj) The Company and its subsidiaries possess all licenses, certificates, permits and other authorizations issued by all applicable authorities necessary to conduct their respective businesses, except where the failure to possess such license, certificate, permit and other authorization would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any such subsidiary has received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably be expected to have a Material Adverse Effect, except as set forth in or contemplated in the Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto).
12
(kk) The Company and each of its subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with IFRS and to maintain asset accountability; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. Except as otherwise set forth in the Prospectus, the Company and its subsidiaries’ internal controls over financial reporting are effective and the Company and its subsidiaries are not aware of any material weakness in their internal controls over financial reporting. Neither the Company nor any of its subsidiaries has any material off-balance sheet financing arrangement as defined in accordance with IFRS.
(ll) The Company and its subsidiaries maintain “disclosure controls and procedures” (as such term is defined in Rule 13a-15(e) under the Exchange Act; such disclosure controls and procedures are effective.
(mm) The Company has not taken, directly or indirectly (without giving effect to the activities of the Underwriters), any action designed to or that would constitute or that might reasonably be expected to cause or result in, under the Exchange Act or otherwise, stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Offered Securities.
(nn) The Company and its subsidiaries are (i) in compliance with any and all applicable foreign, federal, state and local laws and regulations relating to the protection of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (collectively, the “Environmental Laws”), (ii) have received and are in compliance with all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses and (iii) have not received notice of any actual or potential liability under any environmental law, except where such non-compliance with Environmental Laws, failure to receive required permits, licenses or other approvals, or liability would not, individually or in the aggregate, have a Material Adverse Effect. Except as set forth in the Disclosure Package and the Prospectus, neither the Company nor any of the subsidiaries has been named as a “potentially responsible party” under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended.
13
(oo) None of the following events has occurred or exists, except where the occurrence of any such event would not reasonably be expected to result in a Material Adverse Effect: (i) a failure to fulfill the obligations, if any, under the minimum funding standards of Section 302 of the U.S. Employee Retirement Income Security Act of 1974, as amended (“ERISA”), or any foreign equivalent, and the regulations and published interpretations thereunder with respect to a Plan, determined without regard to any waiver of such obligations or extension of any amortization period; (ii) an audit or investigation by the Internal Revenue Service, the U.S. Department of Labor, the Pension Benefit Guaranty Corporation or any other federal or state governmental agency or any foreign regulatory agency with respect to the employment or compensation of employees by any of the Company or any of its subsidiaries; (iii) any breach of any contractual obligation, or any violation of law or applicable qualification standards, with respect to the employment or compensation of employees by the Company or any of its subsidiaries . None of the following events has occurred or is reasonably likely to occur, except where the occurrence of any such event would not reasonably be expected to result in a Material Adverse Effect: (i) an increase in the aggregate amount of contributions required to be made to all Plans in the current fiscal year of the Company and its subsidiaries compared to the amount of such contributions made in the most recently completed fiscal year of the Company and its subsidiaries; (ii) an increase in the “accumulated post-retirement benefit obligations” (within the meaning of Statement of Financial Accounting Standards 106) of the Company and its subsidiaries compared to the amount of such obligations in the most recently completed fiscal year of the Company and its subsidiaries; (iii) any event or condition giving rise to a liability under Title IV of ERISA (or any foreign equivalent); or (iv) the filing of a claim by one or more employees or former employees of the Company or any of its subsidiaries related to their employment. For purposes of this paragraph, the term “Plan” means a plan (within the meaning of Section 3(3) of ERISA) subject to Title IV of ERISA with respect to which the Company or any of its subsidiaries may have any liability.
(pp) There is and has been no failure on the part of the Company and any of the Company’s directors or officers, in their capacities as such, to comply with any provision of the Sarbanes-Oxley Act of 2002, as amended, and the rules and regulations promulgated in connection thereunder (the “Sarbanes-Oxley Act”), that are in effect and with which the Company is required to comply as of the effectiveness of the Registration Statement, including Section 402 relating to loans.
(qq) Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director, officer, agent, employee or affiliate or other person acting on behalf of the Company or any of its subsidiaries is aware of or has (i) taken any action, directly or indirectly, that could result in a violation or a sanction for violation by such persons of the U.S. Foreign Corrupt Practices Act of 1977 or the U.K. Bribery Act 2010, each as may be amended, or any similar law of any other relevant jurisdiction, or the rules or regulations thereunder (collectively, “Anti-Corruption Laws”); (ii) promised, offered, provided, attempted to provide, or authorized the provision of money or anything of value, directly or indirectly, to any person for the purpose of obtaining or retaining business, influencing any act or decision of the recipient, or securing any improper advantage; or (iii) made, offered, agreed, or requested any unlawful bribe or unlawful benefit including, without limitation, any rebate, payoff, influence payment, kickback, or other unlawful or improper payment or benefit. The Company and its subsidiaries have instituted and maintain policies and procedures to ensure compliance with Anti-Corruption Laws. No part of the proceeds of the offering will be used, directly or indirectly, in violation of Anti-Corruption Laws.
(rr) The operations of the Company and its subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements and the money laundering statutes and the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Money Laundering Laws is pending or, to the best knowledge of the Company, threatened.
14
(ss) Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director, officer, agent, employee or affiliate or other person acting on behalf of the Company or any of its subsidiaries (i) is, or is controlled or 50% or more owned in the aggregate by or is acting on behalf of, one or more individuals or entities that are currently the subject of any sanctions administered or enforced by the United States (including any administered or enforced by the Office of Foreign Assets Control of the U.S. Department of the Treasury, the U.S. Department of State or the Bureau of Industry and Security of the U.S. Department of Commerce), the United Nations Security Council, the European Union, a member state of the European Union (including sanctions administered or enforced by Her Majesty’s Treasury of the United Kingdom) or other relevant sanctions authority (collectively, “Sanctions” and such persons, “Sanctioned Persons” and each such person, a “Sanctioned Person”), (ii) is located, organized or resident in a country or territory that is, or whose government is, the subject of Sanctions that broadly prohibit dealings with that country or territory (collectively, “Sanctioned Countries” and each, a “Sanctioned Country”) or (iii) will, directly or indirectly, use the proceeds of this offering, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other individual or entity in any manner that would result in a violation of any Sanctions by, or could result in the imposition of Sanctions against, any individual or entity (including any individual or entity participating in the offering, whether as underwriter, advisor, investor or otherwise).
(tt) Neither the Company nor any of its subsidiaries has engaged in any dealings or transactions with or for the benefit of a Sanctioned Person, or with or in a Sanctioned Country, in the preceding three years, nor does the Company or any of its subsidiaries have any plans to engage in dealings or transactions with or for the benefit of a Sanctioned Person, or with or in a Sanctioned Country.
(uu) The subsidiaries listed on Exhibit 21.1 to the Registration Statement are the only “significant subsidiaries” of the Company as defined by Rule 1-02 of Regulation S-X.
(vv) The Company and its subsidiaries own, possess, license or have other rights to use, on reasonable terms, all patents, patent applications, trade and service marks, trade and service mark registrations, trade names, copyrights, licenses, inventions, trade secrets, technology, know-how and other intellectual property (collectively, the “Intellectual Property”) necessary for the conduct of the Company’s business as now conducted or as proposed in the Disclosure Package and Prospectus to be conducted. Except as set forth in the Disclosure Package and the Prospectus under the caption “Business—Intellectual Property,” (a) there are no rights of third parties to any such Intellectual Property; (b) to the knowledge of the Company, there is no material infringement by third parties of any such Intellectual Property; (c) there is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others challenging the Company’s rights in or to any such Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; (d) the Intellectual Property has not been adjudged by a court of competent jurisdiction invalid or unenforceable, in whole or in part, (e) there is no pending or, to the Company’s knowledge, threatened action, suit, proceeding or claim by others challenging the validity or scope of any such Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such claim; (f) there is no pending or, to the knowledge of the Company, threatened action, suit, proceeding or claim by others that the Company infringes, misappropriates or otherwise violates any patent, trademark, copyright, trade secret or other proprietary rights of others, and the Company is unaware of any other fact which would form a reasonable basis for any such claim; and (g) there is no prior art of which the Company is aware that may render any patent held by the Company invalid or any patent application held by the Company un-patentable which has not been disclosed to the U.S. Patent and Trademark Office.
15
(ww) Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, the Company (i) does not have any material lending or other relationship with any bank or lending affiliate of any of the Underwriters; and (ii) does not intend to use any of the proceeds from the sale of the Offered Securities hereunder to repay any outstanding debt owed to any affiliate of any of the Underwriters.
(xx) The Company (i) is, and at all relevant times has been, in compliance with all applicable Health Care Laws (as defined below) related to the regulation of the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company, except where the failure to comply would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect. For the purposes of this Agreement, Health Care Laws means: (1) Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.); (2) all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuse, including but not limited to the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), criminal false statements (42 U.S.C. §1320a-7b(a)), the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusions law (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), and the civil monetary penalties law (42 U.S.C. §1320a-7a); (3) Medicare (Title XVIII of the Social Security Act); (4) Medicaid (Title XIX of the Social Security Act); (5) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. §§ 17921 et seq.); (6) the Patient Protection and Affordable Care Act (Pub. Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws; (7) regulations relating to Good Clinical Practices and Good Laboratory Practices; and (8) all other local, state, federal, national and foreign health care laws applicable to the regulation of the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company; (ii) has not received any written notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting noncompliance with any Health Care Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Health Care Laws (“Authorizations”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws or Authorizations nor, to the knowledge of the Company, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) has not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to materially limit, suspend, materially modify or revoke any Authorizations nor, to the knowledge of the Company, is any such limitation, suspension, modification or revocation threatened; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, nor have any of its officers or directors, nor, to the knowledge of the Company, have any of its employees, been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or subject to a governmental inquiry, investigation, proceeding, or other any other Action that could reasonably be expected to result in debarment, suspension, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.
16
(yy) The clinical trials and pre-clinical studies conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, the Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States to which they are subject including but not limited to the European Medicines Agency (collectively, the “Regulatory Authorities”) and current Good Clinical Practices and Good Laboratory Practices, as applicable; the descriptions in the Registration Statement, the Disclosure Package or the Prospectus of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived from such studies and trials; the Company has no knowledge of any other studies or trials the results of which are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Disclosure Package and the Prospectus; the Company is in compliance in all material respects with all applicable statutes, rules and regulations of the Regulatory Authorities and has not received any written notices, correspondence or other communication from the Regulatory Authorities or any other governmental agency which could lead to the termination or suspension of any clinical trials or pre-clinical studies that are described in the Registration Statement, the Disclosure Package and the Prospectus or the results of which are referred to in the Registration Statement, Disclosure Package or the Prospectus, and, to the Company’s knowledge, there are no reasonable grounds for same.
17
(zz) The Company (i) possesses all licenses, certificates, permits and other authorizations (collectively, “Permits”) issued by, and has made all declarations and filings with, the applicable federal, state, local or foreign governmental or regulatory authorities that are necessary for the ownership or lease of its properties or the conduct of its businesses as described in the Registration Statement, the Disclosure Package and the Prospectus, or to permit all clinical trials and nonclinical studies conducted by or on behalf of the Company, including, without limitation, all necessary FDA and applicable foreign regulatory agency approvals; (ii) the Company is not in violation of, or in default under, any such Permit; and (iii) the Company has not received notice of any revocation, suspension or modification of any such Permit in each case, except where failure to do so would reasonably be expected to result in a Material Adverse Effect. The Company (i) is, and at all times has been, in material compliance with all such Permits; and (ii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with (A) any Health Care Laws or (B) any Permits required by any such Health Care Laws.
(aaa) To the knowledge of the Company, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities.
(bbb) None of the Company’s product candidates have received marketing approval from any Regulatory Authority.
(ccc) The Company is a “foreign private issuer” within the meaning of Rule 405.
(ddd) Except pursuant to this Agreement, there is no broker, finder or other party that is entitled to receive from the Company any brokerage or finder’s fee or other fee or commission as a result of any transactions contemplated by this Agreement.
(eee) The statistical and market-related data included in the Registration Statement, the Disclosure Package and the Prospectus are based on or derived from sources which the Company reasonably and in good faith believes are reliable and accurate in all material respects.
(fff) Each financial or operational projection or other “forward-looking statement” (as defined by Section 27A of the Securities Act or Section 21E of the Exchange Act) contained in the Registration Statement, the Disclosure Package or the Prospectus (i) was so included by the Company in good faith and with reasonable basis after due consideration by the Company of the underlying assumptions, estimates and other applicable facts and circumstances and (ii) is accompanied by meaningful cautionary statements identifying those factors that could cause actual results to differ materially from those in such forward-looking statement.
18
(ggg) Neither the Company nor any of its subsidiaries nor any of its or their properties or assets has any immunity from the jurisdiction of any court or from any legal process (whether through service or notice, attachment prior to judgment, attachment in aid of execution or otherwise), including under the laws of the Kingdom of Sweden and the European Union. The irrevocable and unconditional waiver and agreement of the Company contained in Section 14 of this Agreement not to plead or claim any such immunity in any legal action, suit or proceeding based on this Agreement is valid and binding under the laws of the Kingdom of Sweden.
(hhh) Except as disclosed in the Registration Statement, the Disclosure Package and the Prospectus, neither the Company nor any of its subsidiaries have been notified of, or have any knowledge of (i)(x) a security breach or incident, unauthorized access or disclosure, violations, outages or other compromise of or relating to any of the Company’s or any of its subsidiaries’ information technology and computer systems, networks, hardware, software, data (including the data of their respective customers, employees, suppliers, vendors and any third party data maintained by or on behalf of them and all Personal Data (defined below), sensitive, confidential or regulated data), equipment or technology (collectively, “IT Systems and Data”) or (y) of any event or condition that would reasonably be expected to result in, any security breach or incident, unauthorized access or disclosure or other compromise to its IT Systems and Data, except as would not, in the case of this clause (i), individually or in the aggregate, be reasonably expected to have a Material Adverse Effect; (ii) the Company and each of its subsidiaries have at all times been in compliance with all applicable laws or statutes and all judgments, orders, rules and regulations of any court or arbitrator or governmental or regulatory authority, internal policies and contractual obligations relating to the privacy and security of IT Systems and Data and to the protection of such IT Systems and Data from unauthorized use, access, misappropriation or modification, except as would not, in the case of this clause (ii), individually or in the aggregate, be reasonably expected to have a Material Adverse Effect; and (iii) the Company and its subsidiaries have implemented information system backup and disaster recovery procedures.
(iii) The outstanding Common Shares of the Company have been duly listed and are freely tradable on Nasdaq Stockholm; the Company is in compliance with all listing and admission requirements and continuing obligations pursuant to applicable laws and the rules of Nasdaq Stockholm.
(jjj) The sale or issuance of the Offered Securities by the Company will not violate the rules and regulations of Nasdaq Stockholm, the Swedish Penalties for Market Abuse in Financial Instruments Trading Act (SFS 2016:1307) (Lag (2016:1307) om straff för marknadsmissbruk på värdepappersmarknaden), as amended or the Market Abuse Regulation (EU) No 596/2014.
19
(kkk) The Company has no debt securities that has been rated by any “nationally recognized statistical rating organization” (as defined for purposes of Rule 3(a)(62) under the Exchange Act).
Any certificate signed by any officer of the Company and delivered to the Representatives or counsel for the Underwriters in connection with the offering of the Offered Securities shall be deemed a representation and warranty by the Company, as to matters covered thereby, to each Underwriter.
2. | Purchase and Sale. |
(a) Subject to the terms and conditions and in reliance upon the representations and warranties herein set forth, (i) the Company agrees to issue to each U.S. Underwriter, and each U.S. Underwriter agrees, severally and not jointly, to subscribe for from the Company, the respective numbers of Firm ADSs set forth opposite such Underwriter’s name in the first table in Schedule I hereto and (ii) the Company agrees to issue to each EU Underwriter, and each EU Underwriter agrees, severally and not jointly, to subscribe for from the Company, the respective numbers of Firm Shares set forth opposite such Underwriter’s name in the second table in Schedule I hereto. The Firm Shares (and, as the case may be, the Option Shares) and the Firm ADSs (and, as the case may be, the Option ADSs) are being offered as part of a single capital increase at an identical purchase price of $[●] per ADS (the “ADS Purchase Price”), corresponding to SEK [●] per Common Share (the “Share Purchase Price” and, together with the ADS Purchase Price, the “Purchase Price”).
(b) Subject to the terms and conditions and in reliance upon the representations and warranties herein set forth, the Company hereby grants an option to the several Underwriters to purchase, severally and not jointly, up to [●] Option Securities, which may be in the form of (i) Option ADSs, less an amount per ADS equal to any dividends or distributions declared by the Company and payable on the Firm ADSs or the Firm ADSs’ Underlying Shares but not payable on the Option ADSs or the Option ADSs’ Underlying Shares; and/or (ii) Option Shares, less an amount per Common Share equal to any dividends or distributions declared by the Company and payable on the Firm Shares but not payable on the Option Shares. The number of Option Shares and Option ADSs, respectively, may be reallocated provided that the total number of Common Shares, including Common Shares represented by ADSs, issued as Option Securities shall not exceed 15% of the total number of Common Shares, including Common Shares represented by ADSs, issued as Firm Securities. Said option may be exercised in whole or in part at any time on or before the 30th day after the date of the Prospectus upon written, electronic or telegraphic notice by the Representatives to the Company setting forth the number of shares of the Option Securities as to which the several Underwriters are exercising the option and the settlement date. The number of Option ADSs or Option Shares, as the case may be, to be purchased by each Underwriter shall be the same percentage of the total number of shares of the Option ADSs or Option Shares, as the case may be, to be purchased by the several Underwriters as such Underwriter is purchasing of the Firm ADSs or Firm Shares, as the case may be, subject to such adjustments as you in your absolute discretion shall make to eliminate any fractional shares.
20
3. Delivery and Payment. Timing of payment and delivery of the Offered Securities shall be made in accordance with Schedule IV hereto. Delivery of and payment for (i) the Firm ADSs and the Option ADSs and (ii) the Firm Shares and the Option Shares (in each case if the option provided for in Section 2(b) hereof shall have been exercised on or before the second Business Day immediately preceding the Closing Date) shall be made at 10:00 AM, New York City time, on [●], 2021, or at such time on such later date not more than two Business Days after the foregoing date as the Representatives shall designate, which date and time may be postponed by agreement among the Representatives and the Company or as provided in Section 9 hereof (such date and time of delivery and payment for the Offered Securities being called in this Agreement the “Closing Date”). As used herein, “Business Day” shall mean any day other than a Saturday, a Sunday or a legal holiday or a day on which banking institutions or trust companies are authorized or obligated by law to close in New York City. Delivery of the Offered ADSs shall be made to the U.S. Representatives for the designated accounts of the several U.S. Underwriters against payment by the several U.S. Underwriters through the U.S. Representatives of the ADS Purchase Price to or upon the order of the Company by wire transfer payable in same-day funds to an account specified by the Company. Delivery of the Offered ADSs shall be made through the facilities of The Depository Trust Company unless the U.S. Representatives shall otherwise instruct. Delivery of the Offered Shares shall be made to the EU Representatives for the designated accounts of the several EU Underwriters against payment by the several EU Underwriters through the EU Representatives of the Share Purchase Price to or upon the order of the Company by wire transfer payable in same-day funds to an account specified by the Company. Delivery of the Offered Shares shall be made through the facilities of Euroclear Sweden AB unless the EU Representatives shall otherwise instruct.
If the option provided for in Section 2(b) hereof is exercised with respect to the Option ADSs or Option Shares after the second Business Day immediately preceding the Closing Date, the Company will deliver the Option ADSs or Option Shares (at the expense of the Company), as the case may be, to the Representatives on the date specified by the Representatives (which shall be within two Business Days after exercise of said option) for the designated accounts of the several Underwriters, against payment by the several Underwriters through the Representatives of the ADS Purchase Price or the Share Purchase Price, as the case may be, to or upon the order of the Company by wire transfer payable in same-day funds to an account specified by the Company. If settlement for the Option ADSs or Option Shares occurs after the Closing Date, the Company will deliver to the Representatives on the settlement date for the Option ADSs or Option Shares, as the case may be, and the obligation of the Underwriters to purchase the Option ADSs or Option Shares, as the case may be, shall be conditioned upon receipt of, supplemental opinions, certificates and letters confirming as of such date the opinions, certificates and letters delivered on the Closing Date pursuant to Section 6 hereof.
The ADR certificates, if any, evidencing the Firm ADSs and Option ADSs shall be registered in such names and in such denominations as the Representatives may request not less than one full Business Day prior to the Closing Date or the settlement date for the Option Securities, as the case may be.
4. Offering by Underwriters. It is understood that the several Underwriters propose to offer the Offered Securities for sale to the public as set forth in the Prospectus.
21
5. Agreements. The Company agrees with the several Underwriters that:
(a) Prior to the termination of the offering of the Offered Securities, the Company will not file any amendment of the Registration Statement or the ADR Registration Statement or supplement to the Prospectus or any Rule 462(b) Registration Statement unless the Company has furnished you a copy for your review prior to filing and will not file any such proposed amendment or supplement to which you reasonably object. The Company will cause the Prospectus, properly completed, and any supplement thereto to be filed in a form approved by the Representatives with the SEC pursuant to the applicable paragraph of Rule 424(b) within the time period prescribed and will provide evidence satisfactory to the Representatives of such timely filing. The Company will promptly advise the Representatives (i) when the Prospectus, and any supplement thereto, shall have been filed (if required) with the SEC pursuant to Rule 424(b) or when any Rule 462(b) Registration Statement or the ADR Registration Statement shall have been filed with the SEC, (ii) when, prior to termination of the offering of the Offered Securities, any amendment to the Registration Statement or the ADR Registration Statement shall have been filed or become effective, (iii) of any request by the SEC or its staff for any amendment of the Registration Statement, the ADR Registration Statement or any Rule 462(b) Registration Statement, or for any supplement to the Prospectus or for any additional information, (iv) of the issuance by the SEC of any stop order suspending the effectiveness of the Registration Statement or the ADR Registration Statement or of any notice objecting to their use or the institution or threatening of any proceeding for that purpose and (v) of the receipt by the Company of any notification with respect to the suspension of the qualification of the Offered Securities for sale in any jurisdiction or the institution or threatening of any proceeding for such purpose. The Company will use its best efforts to prevent the issuance of any such stop order or the occurrence of any such suspension or objection to the use of the Registration Statement or the ADR Registration Statement and, upon such issuance, occurrence or notice of objection, to obtain as soon as possible the withdrawal of such stop order or relief from such occurrence or objection, including, if necessary, by filing an amendment to the Registration Statement or the ADR Registration Statement or a new registration statement and using its best efforts to have such amendment or new registration statement declared effective as soon as practicable.
(b) If, at any time prior to the filing of the Prospectus pursuant to Rule 424(b) , any event occurs as a result of which the Disclosure Package would include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein in the light of the circumstances under which they were made or the circumstances then prevailing not misleading, the Company will (i) notify promptly the Representatives so that any use of the Disclosure Package may cease until it is amended or supplemented; (ii) amend or supplement the Disclosure Package to correct such statement or omission; and (iii) supply any amendment or supplement to you in such quantities as you may reasonably request.
22
(c) If, at any time when a prospectus relating to the Offered Securities is required to be delivered under the Securities Act (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act (“Rule 172”)), any event occurs as a result of which the Prospectus as then supplemented would include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein in the light of the circumstances under which they were made or the circumstances then prevailing not misleading, or if it shall be necessary to amend the Registration Statement or supplement the Prospectus to comply with the Securities Act or the rules thereunder, the Company promptly will (i) notify the Representatives of any such event; (ii) prepare and file with the SEC, subject to the second sentence of paragraph (a) of this Section 5, an amendment or supplement which will correct such statement or omission or effect such compliance; and (iii) supply any supplemented Prospectus to you in such quantities as you may reasonably request.
(d) As soon as practicable, the Company will make generally available to its security holders and to the Representatives an earnings statement or statements of the Company and its subsidiaries which will satisfy the provisions of Section 11(a) of the Securities Act and Rule 158 under the Securities Act.
(e) Upon request, the Company will furnish to the Representatives and counsel for the Underwriters, without charge, signed copies of the Registration Statement and the ADR Registration Statement (including exhibits thereto) and to each other Underwriter a copy of the Registration Statement and the ADR Registration Statement (without exhibits thereto) and, so long as delivery of a prospectus by an Underwriter or dealer may be required (including in circumstances where such requirement may be satisfied pursuant to Rule 172) by the Securities Act, as many copies of each Preliminary Prospectus, the Prospectus and each Issuer Free Writing Prospectus and any supplement thereto as the Representatives may reasonably request. The Company will pay the expenses of printing or other production of all documents relating to the offering.
(f) The Company will arrange, if necessary, for the qualification of the Offered Securities for sale under the laws of such jurisdictions as the Representatives may designate and will maintain such qualifications in effect so long as required for the distribution of the Offered Securities; provided that in no event shall the Company be obligated to qualify to do business in any jurisdiction where it is not now so qualified or to take any action that would subject it to service of process in suits, other than those arising out of the offering or sale of the Offered Securities, in any jurisdiction where it is not now so subject.
23
(g) The Company will not, without the prior written consent of Citigroup Global Markets, Inc. and Jefferies LLC, offer, sell, contract to sell, pledge, or otherwise dispose of, (or enter into any transaction which is designed to, or might reasonably be expected to, result in the disposition (whether by actual disposition or effective economic disposition due to cash settlement or otherwise) by the Company or any affiliate of the Company or any person in privity with the Company or any affiliate of the Company) directly or indirectly, including the filing (or participation in the filing) of a registration statement with the SEC in respect of, or establish or increase a put equivalent position or liquidate or decrease a call equivalent position within the meaning of Section 16 of the Exchange Act, any Common Shares or ADSs or any other securities convertible into, or exercisable, or exchangeable for, Common Shares or ADSs; or publicly announce an intention to effect any such transaction, for a period of 90 days after the date of this Agreement; provided, however, that the Company may: (i) effect the transactions contemplated hereby; (ii) issue and sell Common Shares pursuant to any employee stock option plan, incentive plan, employee stock purchase plan, stock bonus plan, stock option ownership plan, dividend reinvestment plan or warrant program of the Company in effect at the Execution Time or adopted in connection with the offering contemplated by this Agreement and described in the Disclosure Package, and the Company may issue Common Shares issuable upon the conversion of securities or the exercise of warrants outstanding at the Execution Time; (iii) file one or more registration statements on Form S-8 relating to stock options or employee benefit plans of the Company described in the Disclosure Package and Prospectus; (iv) offer, issue and sell Common Shares in connection with any merger, acquisition or strategic investment (including any joint venture, strategic alliance, partnership, the acquisition or license of the business, property, technology or other assets of another individual or entity, or the assumption of an employee benefit plan in connection with such a merger or acquisition); (v) offer, issue and sell Common Shares, on an arm’s length basis to, to any unaffiliated collaborators, manufacturers, distributors, or any other similar parties pursuant to a collaboration, licensing agreement, strategic alliance, manufacturing or distribution agreement or similar transaction; or (vi) offer, issue and sell Common Shares, on an arm’s length basis to, to unaffiliated financial institutions or lessors pursuant to a commercial agreement, equipment financing transaction or commercial property lease transaction, provided, however, that the aggregate number of Common Shares that the Company may issue or agree to issue pursuant to clauses (iv), (v) and (vi) shall not exceed 5 % of the number of Common Shares outstanding immediately after the issuance and sale of securities, and provided, further, that each recipient of such securities agrees to restrictions on the resale of securities that are consistent with the provisions set forth in the lock-up letter described in Section 6(r) hereof .
(h) If Citigroup Global Markets, Inc. and Jefferies LLC, in their sole discretion, agree to release or waive the restrictions set forth in a lock-up letter described in Section 6(r) hereof for an officer or director of the Company and provides the Company with notice of the impending release or waiver substantially in the form of Exhibit B-1 at least three Business Days before the effective date of the release or waiver, the Company agrees to announce the impending release or waiver by a press release substantially in the form of Exhibit B-2 hereto through a major news service at least two Business Days before the effective date of the release or waiver.
(i) The Company will use the net proceeds received by it from the sale of the Offered Securities in all material respects in the manner specified in the Disclosure Package under the heading “Use of Proceeds.”
(j) The Company will use its reasonable best efforts to maintain the listing for both the ADSs listed by the Company on the Nasdaq Global Select Market and the Common Shares listed by the Company on Nasdaq Stockholm.
(k) The Company will file with the SEC such reports as may be required by Rule 463 under the Securities Act.
24
(l) The Company will not take, directly or indirectly, without giving effect to activities by the Underwriters, any action designed to or that would constitute or that might reasonably be expected to cause or result in, under the Exchange Act or otherwise, stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Offered Securities.
(m) The Company agrees to pay the costs and expenses relating to the following matters: (i) the preparation, printing or reproduction and filing with the SEC of the Registration Statement (including financial statements and exhibits thereto), each Preliminary Prospectus, the Prospectus, each Issuer Free Writing Prospectus, the ADR Registration Statement, and each amendment or supplement to any of them; (ii) the preparation of the Deposit Agreement, the deposit of the Underlying Shares under the Deposit Agreement, the issuance thereunder of ADSs representing such deposited Underlying Shares, the issuance of ADRs evidencing such ADSs and the fees of the Depositary; (iii) the printing (or reproduction) and delivery (including postage, air freight charges and charges for counting and packaging) of such copies of the Registration Statement, each Preliminary Prospectus, the Prospectus, the ADR Registration Statement, and each Issuer Free Writing Prospectus, and all amendments or supplements to any of them, as may, in each case, be reasonably requested for use in connection with the offering and sale of the Offered Securities; (iv) the preparation, printing, authentication, issuance and delivery of certificates for the Offered Securities, including any stamp or transfer taxes in connection with the issuance and sale of the Offered Securities; (v) the printing (or reproduction) and delivery of this Agreement, any blue sky memorandum and all other agreements or documents printed (or reproduced) and delivered in connection with the offering of the Offered Securities; (vi) the registration of the Offered Securities under the Exchange Act and the listing of the Offered Securities on the Nasdaq Global Select Market; (vii) the listing of each of the Offered Shares and the Underlying Shares on Nasdaq Stockholm; (viii) any registration or qualification of the Offered Securities for offer and sale under the securities or blue sky laws of the several states (including filing fees and the reasonable fees and expenses of counsel for the Underwriters relating to such registration and qualification); (ix) any filings required to be made with FINRA (including filing fees and the reasonable fees and expenses of counsel for the Underwriters relating to such filings, with such fees and expenses of counsel contained in clauses (viii) and (ix) not to exceed $35,000 in the aggregate); (x) the transportation and other expenses incurred by or on behalf of Company representatives in connection with presentations to prospective purchasers of the Offered Securities, provided, however, that if the Representatives and the Company mutually agree that an aircraft shall be chartered in connection with any road show, the Company shall be responsible for 50% of the cost and expenses of such chartered aircraft and the Underwriters shall be responsible for the remaining 50% of such costs and expenses; (xi) the fees and expenses of the Company’s accountants and the fees and expenses of counsel (including local and special counsel) for the Company; and (xii) all other costs and expenses incident to the performance by the Company of its obligations hereunder.
25
(n) The Company agrees that, unless it has or shall have obtained the prior written consent of the Representatives, and each Underwriter, severally and not jointly, agrees with the Company that, unless it has or shall have obtained, as the case may be, the prior written consent of the Company, it has not made and will not make any offer relating to the Offered Securities that would constitute an Issuer Free Writing Prospectus or that would otherwise constitute a “free writing prospectus” (as defined in Rule 405) required to be filed by the Company with the SEC or retained by the Company under Rule 433; provided that the prior written consent of the parties hereto shall be deemed to have been given in respect of the Free Writing Prospectuses included in Schedule II hereto and any electronic road show. Any such free writing prospectus consented to by the Representatives or the Company is hereinafter referred to as a “Permitted Free Writing Prospectus.” The Company agrees that (x) it has treated and will treat, as the case may be, each Permitted Free Writing Prospectus as an Issuer Free Writing Prospectus and (y) it has complied and will comply, as the case may be, with the requirements of Rule 164 under the Securities Act (“Rule 164”) and Rule 433 applicable to any Permitted Free Writing Prospectus, including in respect of timely filing with the SEC, legending and record keeping.
(o) The Company will promptly notify the Representatives if the Company ceases to be an Emerging Growth Company at any time prior to the later of (a) completion of the distribution of the Offered Securities within the meaning of the Securities Act and (b) completion of the 90-day restricted period referred to in Section 5(g) hereof.
(p) If at any time following the distribution of any Written Testing-the-Waters Communication, any event occurs as a result of which such Written Testing-the-Waters Communication would include any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements therein in the light of the circumstances under which they were made or the circumstances then prevailing not misleading, the Company will (i) notify promptly the Representatives so that use of the Written Testing-the-Waters Communication may cease until it is amended or supplemented; (ii) amend or supplement the Written Testing-the-Waters Communication to correct such statement or omission; and (iii) supply any amendment or supplement to the Representatives in such quantities as may be reasonably requested.
(q) The Company agrees, at or prior to the Closing Date, to facilitate the issue of the Underlying Shares to the Custodian in accordance with the provisions of the Deposit Agreement and otherwise to comply with the Deposit Agreement so that the Offered ADSs will be issued by the Depositary against receipt of such Underlying Shares and delivered to the Underwriters on the Closing Date.
(r) The Company will make the appropriate filings with the Swedish Companies Registration Office in relation to allotment of each of the Offered Shares and the Underlying Shares.
6. Conditions to the Obligations of the Underwriters. The obligations of the Underwriters to subscribe for the Firm Securities and the Option Securities, as the case may be, shall be subject to the accuracy of the representations and warranties on the part of the Company contained in this Agreement as of the Execution Time, the Closing Date and any settlement date pursuant to Section 3 hereof, to the accuracy of the statements of the Company made in any certificates pursuant to the provisions hereof, to the performance by the Company of its obligations under this Agreement and to the following additional conditions:
26
(a) The Prospectus, and any supplement thereto, have been filed in the manner and within the time period required by Rule 424(b); any material required to be filed by the Company pursuant to Rule 433(d) shall have been filed with the SEC within the applicable time periods prescribed for such filings by Rule 433; and no stop order suspending the effectiveness of the Registration Statement or the ADR Registration Statement or any notice objecting to their use shall have been issued and no proceedings for that purpose shall have been instituted or threatened.
(b) The Company shall have requested and caused Goodwin Procter LLP, U.S. counsel for the Company, to have furnished to the Representatives their opinion and negative assurance letter, dated the Closing Date and addressed to the Representatives, in form and substance as previously agreed to with the Representatives.
(c) The Company shall have requested and caused Advokatfirman Vinge KB, Swedish counsel for the Company, to have furnished to the Representatives their opinion, dated the Closing Date and addressed to the Representatives, in form and substance as previously agreed to with the Representatives.
(d) The Company shall have requested and caused each of Potter Clarkson LLP and Panitch Schwarze Belisario & Nadel, LLP, special counsel for the Company with respect to certain intellectual property matters, to have furnished to the Representatives their opinions, in form and substance as previously agreed to with the Representatives.
(e) The Depositary shall have requested and caused Patterson Belknap Webb & Tyler LLP, counsel for the Depositary, to have furnished to the Representatives their opinion dated the Closing Date and addressed to the Representatives, in form and substance as previously agreed to with the Representatives.
(f) The Representatives shall have received from Cooley LLP, U.S. counsel for the Underwriters, their opinion, dated the Closing Date and addressed to the Representatives, in form and substance as the Representatives may reasonably require, and the Company shall have furnished to such counsel such documents as they request for the purpose of enabling them to pass upon such matters.
(g) The Representatives shall have received from Baker & McKenzie Advokatbyrå KB, Swedish counsel for the Underwriters, such opinions, dated the Closing Date and addressed to the Representatives, in form and substance as the Representatives may reasonably require, and the Company shall have furnished to such counsel such documents as they request for the purpose of enabling them to pass upon such matters.
(h) The Company shall have furnished to the Representatives a certificate of the Company, signed by the Chief Executive Officer and the principal financial or accounting officer of the Company, dated the Closing Date, to the effect that the signers of such certificate have carefully examined the Registration Statement, the ADR Registration Statement, the Disclosure Package, the Prospectus and any amendment or supplement thereto, as well as each electronic road show used in connection with the offering of the Offered Securities, and this Agreement and that:
27
(i) the representations and warranties of the Company in this Agreement are true and correct on and as of the Closing Date with the same effect as if made on the Closing Date and the Company has complied with all the agreements and satisfied all the conditions on its part to be performed or satisfied at or prior to the Closing Date;
(ii) no stop order suspending the effectiveness of the Registration Statement or the ADR Registration Statement, or any notice objecting to their use, has been issued and no proceedings for that purpose have been instituted or, to the Company’s knowledge, threatened; and
(iii) since the date of the most recent financial statements included in the Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto), there has been no material adverse change in the condition (financial or otherwise), prospects, earnings, business or properties of the Company and its subsidiaries, taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated in the Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto).
(i) The Company shall have requested and caused Ernst & Young AB to have furnished to the Representatives, at the Execution Time and at the Closing Date, letters, dated respectively as of the Execution Time and as of the Closing Date, in form and substance satisfactory to the Representatives, confirming that they are an independent registered public accounting firm within the meaning of the Securities Act and the applicable rules and regulations adopted by the SEC thereunder and by the Public Company Accounting Oversight Board and under applicable Swedish law, containing statements and information of the type ordinarily included in accountants’ “comfort letters” to underwriters with respect to the financial statements and certain financial information contained in the Registration Statement, the Disclosure Package and the Prospectus (including, for the avoidance of doubt, as to compliance with Article 11 of Regulation S-X). The Company shall have requested and caused KPMG S.A. to have furnished to the Representatives, at the Execution Time and at the Closing Date, letters, dated respectively as of the Execution Time and as of the Closing Date, in form and substance satisfactory to the Representatives, confirming that they are independent certified public accountants with respect to Genkyotex S.A. under Rule 101 of the AICPA Code of Professional Conduct, containing statements and information of the type ordinarily included in accountants’ “comfort letters” to underwriters with respect to the financial statements and certain financial information contained in the Registration Statement, the Disclosure Package and the Prospectus.
28
(j) Subsequent to the Execution Time or, if earlier, the dates as of which information is given in the Registration Statement (exclusive of any amendment or supplement thereto) and the Prospectus (exclusive of any amendment or supplement thereto), there shall not have been (i) any change or decrease specified in the letter or letters referred to in paragraph (i) of this Section 6 or (ii) any change, or any development involving a prospective change, in or affecting the condition (financial or otherwise), earnings, business or properties of the Company and its subsidiaries taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated in the Disclosure Package and the Prospectus the effect of which, in any case referred to in clause (i) or (ii) above, is, in the sole judgment of the Representatives, so material and adverse as to make it impractical or inadvisable to proceed with the offering or delivery of the Offered Securities as contemplated by the Registration Statement (exclusive of any amendment or supplement thereto), the Disclosure Package and the Prospectus (exclusive of any amendment or supplement thereto).
(k) The Deposit Agreement is and remains in full force and effect; the Company and the Depositary shall have taken all action necessary to permit the deposit of the Underlying Shares and the issuance of the Offered ADSs in accordance with the Deposit Agreement.
(l) The Depositary shall have furnished or caused to be furnished to the Representatives a certificate of one of its authorized officers, satisfactory to the Representatives, evidencing the deposit with the Custodian of the Underlying Shares against the issuance of the Offered ADSs to be delivered by the Company on the Closing Date, the execution, issuance, countersignature (if applicable) and delivery of the Offered ADSs pursuant to the Deposit Agreement and such other matters related thereto as the Representatives reasonably request.
(m) At or prior to the Closing Date, the Company shall have furnished to the Representatives such further information, certificates and documents as the Representatives may reasonably request.
(n) The Offered ADSs shall have been listed and admitted and authorized for trading on the Nasdaq Global Select Market, and satisfactory evidence of such actions shall have been provided to the Representatives.
(o) Each of the Offered Shares and the Underlying Shares have been registered by the Swedish Companies Registration Office.
(p) Each of the Offered Shares and the Underlying Shares shall have been listed and admitted and authorized for trading on Nasdaq Stockholm, and satisfactory evidence of such actions shall have been provided to the Representatives.
(q) At or before the Execution Time, the Company shall have furnished to the Representatives a lock-up letter substantially in the form of Exhibit A hereto from each officer and director of the Company listed on Annex A, addressed to the Representatives.
(r) At the Execution Time and as of each Closing Date, the Representatives shall have received from the principal financial officer of the Company a certificate, in form and substance satisfactory to the Representatives.
If any of the conditions specified in this Section 6 shall not have been fulfilled when and as provided in this Agreement, or if any of the opinions and certificates mentioned above or elsewhere in this Agreement shall not be reasonably satisfactory in form and substance to the Representatives and counsel for the Underwriters, this Agreement and all obligations of the Underwriters hereunder may be canceled at, or at any time prior to, the Closing Date by the Representatives. Notice of such cancellation shall be given to the Company in writing or by telephone or facsimile confirmed in writing.
29
The documents required to be delivered by this Section 6 shall be delivered at the office of Cooley LLP, counsel for the Underwriters, at 55 Hudson Yards, New York, New York 10001, on the Closing Date.
7. Reimbursement of Underwriters’ Expenses. If the sale of the Offered Securities provided for in this Agreement is not consummated because any condition to the obligations of the Underwriters set forth in Section 6 hereof is not satisfied, because of any termination pursuant to Section 10 hereof or because of any refusal, inability or failure on the part of the Company to perform any agreement herein or comply with any provision hereof other than by reason of a default by any of the Underwriters, the Company will reimburse the Underwriters severally through Citigroup Global Markets Inc. on demand for all documented expenses (including reasonable fees and disbursements of counsel) that shall have been reasonably incurred by them in connection with the proposed purchase and sale of the Offered Securities.
8. Indemnification and Contribution.
(a) The Company agrees to indemnify and hold harmless each Underwriter, the directors, officers, employees, affiliates and agents of each Underwriter and each person who controls any Underwriter within the meaning of either the Securities Act or the Exchange Act against any and all losses, claims, damages or liabilities, joint or several, to which they or any of them may become subject under the Securities Act, the Exchange Act or other Federal or state statutory law or regulation, at common law or otherwise, insofar as such losses, claims, damages or liabilities (or actions in respect thereof) arise out of or are based upon any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement for the registration of the Offered Securities as originally filed or in any amendment thereof, or in the ADR Registration Statement as originally filed or in any amendment thereof, or in any Preliminary Prospectus, or in the Prospectus, any Issuer Free Writing Prospectus, any Written Testing-the-Waters Communication or in any amendment thereof or supplement thereto, or arise out of or are based upon the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, and agrees to reimburse each such indemnified party, as incurred, for any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability or action; provided, however, that the Company will not be liable in any such case to the extent that any such loss, claim, damage or liability arises out of or is based upon any such untrue statement or alleged untrue statement or omission or alleged omission made therein in reliance upon and in conformity with written information furnished to the Company by or on behalf of any Underwriter through the Representatives specifically for inclusion therein. This indemnity agreement will be in addition to any liability which the Company may otherwise have.
30
(b) Each Underwriter severally and not jointly agrees to indemnify and hold harmless the Company, each of its directors, each of its officers who signs the Registration Statement or the ADR Registration Statement, and each person who controls the Company within the meaning of either the Securities Act or the Exchange Act, to the same extent as the foregoing indemnity from the Company to each Underwriter, but only with reference to written information relating to such Underwriter furnished to the Company by or on behalf of such Underwriter through the Representatives specifically for inclusion in the documents referred to in the foregoing indemnity. This indemnity agreement will be in addition to any liability which any Underwriter may otherwise have. The Company acknowledges that the only information furnished in writing by or on behalf of the several Underwriters for inclusion in the Preliminary Prospectus, the Prospectus or any Issuer Free Writing Prospectus consists of the following statements set forth in the Preliminary Prospectus and the Prospectus: [the third sentence of the fifth paragraph, the second and third sentences of the sixth paragraph, the first sentence of the thirteenth paragraph, the third and fourth sentences of the fourteenth paragraph and the sixteenth paragraph] under the heading “Underwriting.”
(c) Promptly after receipt by an indemnified party under this Section 8 of notice of the commencement of any action, such indemnified party will, if a claim in respect thereof is to be made against the indemnifying party under this Section 8, notify the indemnifying party in writing of the commencement thereof; but the failure so to notify the indemnifying party (i) will not relieve it from liability under paragraph (a) or (b) above unless and to the extent it did not otherwise learn of such action and such failure results in the forfeiture by the indemnifying party of substantial rights and defenses and (ii) will not, in any event, relieve the indemnifying party from any obligations to any indemnified party other than the indemnification obligation provided in paragraph (a) or (b) above. The indemnifying party shall be entitled to appoint counsel of the indemnifying party’s choice at the indemnifying party’s expense to represent the indemnified party in any action for which indemnification is sought (in which case the indemnifying party shall not thereafter be responsible for the fees and expenses of any separate counsel retained by the indemnified party or parties except as set forth below); provided, however, that such counsel shall be reasonably satisfactory to the indemnified party. Notwithstanding the indemnifying party’s election to appoint counsel to represent the indemnified party in an action, the indemnified party shall have the right to employ separate counsel (including local counsel), and the indemnifying party shall bear the reasonable fees, costs and expenses of such separate counsel if (i) the use of counsel chosen by the indemnifying party to represent the indemnified party would present such counsel with a conflict of interest, (ii) the actual or potential defendants in, or targets of, any such action include both the indemnified party and the indemnifying party and the indemnified party shall have reasonably concluded that there may be legal defenses available to it and/or other indemnified parties which are different from or additional to those available to the indemnifying party, (iii) the indemnifying party shall not have employed counsel reasonably satisfactory to the indemnified party to represent the indemnified party within a reasonable time after notice of the institution of such action or (iv) the indemnifying party shall authorize the indemnified party to employ separate counsel at the expense of the indemnifying party. An indemnifying party will not, without the prior written consent of the indemnified parties, settle or compromise or consent to the entry of any judgment with respect to any pending or threatened claim, action, suit or proceeding in respect of which indemnification or contribution may be sought hereunder (whether or not the indemnified parties are actual or potential parties to such claim or action) unless such settlement, compromise or consent (i) includes an unconditional release of each indemnified party from all liability arising out of such claim, action, suit or proceeding and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act, by or on behalf of any indemnified party.
31
(d) In the event that the indemnity provided in paragraph (a), (b) or (c) of this Section 8 is unavailable to or insufficient to hold harmless an indemnified party for any reason, the Company and the Underwriters severally agree to contribute to the aggregate losses, claims, damages and liabilities (including legal or other expenses reasonably incurred in connection with investigating or defending the same) (collectively, “Losses”) to which the Company and one or more of the Underwriters may be subject in such proportion as is appropriate to reflect the relative benefits received by the Company on the one hand and by the Underwriters on the other from the offering of the Offered Securities. If the allocation provided by the immediately preceding sentence is unavailable for any reason, the Company and the Underwriters severally shall contribute in such proportion as is appropriate to reflect not only such relative benefits but also the relative fault of the Company on the one hand and of the Underwriters on the other in connection with the statements or omissions which resulted in such Losses as well as any other relevant equitable considerations. Benefits received by the Company shall be deemed to be equal to the total net proceeds from the offering (before deducting expenses) received by it, and benefits received by the Underwriters shall be deemed to be equal to the total underwriting discounts and commissions, in each case as set forth on the cover page of the Prospectus. Relative fault shall be determined by reference to, among other things, whether any untrue or any alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information provided by the Company on the one hand or the Underwriters on the other, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such untrue statement or omission. The Company and the Underwriters agree that it would not be just and equitable if contribution were determined by pro rata allocation or any other method of allocation which does not take account of the equitable considerations referred to above. Notwithstanding the provisions of this paragraph (d), in no event shall any Underwriter be required to contribute any amount in excess of the amount by which the total underwriting discounts and commissions received by such Underwriter with respect to the offering of the Offered Securities exceeds the amount of any damages that such Underwriter has otherwise been required to pay by reason of such untrue or alleged untrue statement or omission or alleged omission. Notwithstanding the provisions of this paragraph (d), no person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of this Section 8, each person who controls an Underwriter within the meaning of either the Securities Act or the Exchange Act and each director, officer, employee, affiliate and agent of an Underwriter shall have the same rights to contribution as such Underwriter, and each person who controls the Company within the meaning of either the Securities Act or the Exchange Act, each officer of the Company who shall have signed the Registration Statement and the ADR Registration Statement and each director of the Company shall have the same rights to contribution as the Company, subject in each case to the applicable terms and conditions of this paragraph (d).
32
9. Default by an Underwriter. If any one or more Underwriters shall fail to purchase and pay for any of the Offered Securities agreed to be purchased by such Underwriter or Underwriters under this Agreement and such failure to purchase shall constitute a default in the performance of its or their obligations under this Agreement, the remaining Underwriters shall be obligated severally to take up and pay for (in the respective proportions which the amount of Offered Securities set forth opposite their names in Schedule I hereto bears to the aggregate amount of Firm Securities set forth opposite the names of all the remaining Underwriters) the Offered Securities which the defaulting Underwriter or Underwriters agreed but failed to purchase; provided, however, that in the event that the aggregate amount of Offered Securities which the defaulting Underwriter or Underwriters agreed but failed to purchase shall exceed 10% of the aggregate amount of Firm Securities set forth in Schedule I hereto, the remaining Underwriters shall have the right to purchase all, but shall not be under any obligation to purchase any, of the Offered Securities, and if such nondefaulting Underwriters do not purchase all the Offered Securities, this Agreement will terminate without liability to any nondefaulting Underwriter or the Company. In the event of a default by any Underwriter as set forth in this Section 9, the Closing Date shall be postponed for such period, not exceeding five Business Days, as the Representatives shall determine in order that the required changes in the Registration Statement, the ADR Registration Statement and the Prospectus or in any other documents or arrangements may be effected. Nothing contained in this Agreement shall relieve any defaulting Underwriter of its liability, if any, to the Company and any nondefaulting Underwriter for damages occasioned by its default under this Agreement.
10. Termination. This Agreement shall be subject to termination in the absolute discretion of the Representatives, by notice given to the Company prior to delivery of and payment for the Offered Securities, if at any time prior to such delivery and payment (i) trading in the Company’s Common Shares or ADSs shall have been suspended by the SEC, Nasdaq Stockholm or the Nasdaq Global Select Market or trading in securities generally on the New York Stock Exchange, the Nasdaq Stock Market or Nasdaq Stockholm shall have been suspended or limited or minimum prices shall have been established on any of such exchanges, (ii) a banking moratorium shall have been declared by U.S. Federal, New York State authorities or authorities in the Kingdom of Sweden, the United Kingdom or the European Union, (iii) there shall have occurred a material disruption in commercial banking or securities settlement or clearance services or (iv) there shall have occurred any outbreak or escalation of hostilities, declaration by the United States or the Kingdom of Sweden of a national emergency or war, or other calamity or crisis the effect of which on financial markets is such as to make it, in the sole judgment of the Representatives, impractical or inadvisable to proceed with the offering or delivery of the Offered Securities as contemplated by the Preliminary Prospectus and the Prospectus (exclusive of any amendment or supplement thereto).
11. Representations and Indemnities to Survive. The respective agreements, representations, warranties, indemnities and other statements of the Company or its officers or directors and of the Underwriters set forth in or made pursuant to this Agreement will remain in full force and effect, regardless of any investigation made by or on behalf of any Underwriter or the Company or any of the officers, directors, employees, agents, affiliates or controlling persons referred to in Section 8 hereof, and will survive delivery of and payment for the Offered Securities. The provisions of Sections 7 and 8 hereof shall survive the termination or cancellation of this Agreement.
33
12. Notices. All communications hereunder will be in writing and effective only on receipt, and, if sent to the Representatives, will be mailed, delivered or telefaxed to (i) Citigroup Global Markets Inc., at 388 Greenwich Street, New York, New York 10013, Attention: General Counsel, facsimile number: +1 (646) 291-1469; (ii) Citigroup Global Markets Limited, at Citigroup Centre, Canada Square, Canary Wharf, London E14 5LB, United Kingdom, Attention: General Counsel; and (iii) Jefferies LLC, Jefferies International Limited and Jefferies GmbH, at 520 Madison Avenue, New York, New York 10022, Attention: General Counsel, facsimile number: +1 646 619 4437 with a copy (which shall not constitute notice) to Cooley LLP, 55 Hudson Yards, New York, New York 10001, Attention: Joshua A. Kaufman and Divakar Gupta; or, if sent to the Company, will be mailed, delivered or telefaxed to Calliditas Therapeutics AB at Kungsbron 1, C8, SE-111 22 Stockholm, Sweden, 46-0-8-611-3303., Attention: Chief Financial Officer, with a copy (which shall not constitute notice) to Goodwin Procter LLP, 620 Eighth Avenue, New York, New York 10018, Attention: Kristopher Brown and James Xu.
13. Successors. This Agreement will inure to the benefit of and be binding upon the parties hereto and their respective successors and the officers, directors, employees, agents and controlling persons referred to in Section 8 hereof, and no other person will have any right or obligation hereunder.
14. Jurisdiction. The Company agrees that any suit, action or proceeding against the Company brought by any Underwriter, the directors, officers, employees, affiliates and agents of any Underwriter, or by any person who controls any Underwriter, arising out of or based upon this Agreement or the transactions contemplated hereby may be instituted in any State or U.S. federal court in The City of New York and County of New York, and waives any objection which it may now or hereafter have to the laying of venue of any such proceeding, and irrevocably submits to the non-exclusive jurisdiction of such courts in any suit, action or proceeding. The Company has appointed Calliditas Therapeutics Inc. as its authorized agent (the “Authorized Agent”) upon whom process may be served in any suit, action or proceeding arising out of or based upon this Agreement or the transactions contemplated herein that may be instituted in any State or U.S. federal court in The City of New York and County of New York, by any Underwriter, the directors, officers, employees, affiliates and agents of any Underwriter, or by any person who controls any Underwriter, and expressly accepts the non-exclusive jurisdiction of any such court in respect of any such suit, action or proceeding. The Company hereby represents and warrants that the Authorized Agent has accepted such appointment and has agreed to act as said agent for service of process, and the Company agrees to take any and all action, including the filing of any and all documents that may be necessary to continue such appointment in full force and effect as aforesaid. Service of process upon the Authorized Agent shall be deemed, in every respect, effective service of process upon the Company. Notwithstanding the foregoing, any action arising out of or based upon this Agreement may be instituted by any Underwriter, the directors, officers, employees and agents of any Underwriter, or by any person who controls any Underwriter, in any court of competent jurisdiction in the Kingdom of Sweden.
34
15. Recognition of the U.S. Special Resolution Regimes.
(a) In the event that any Underwriter that is a Covered Entity becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer from such Underwriter of this Agreement, and any interest and obligation in or under this Agreement, will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement, and any such interest and obligation, were governed by the laws of the United States or a state of the United States.
(b) In the event that any Underwriter that is a Covered Entity or a BHC Act Affiliate of such Underwriter becomes subject to a proceeding under a U.S. Special Resolution Regime, Default Rights under this Agreement that may be exercised against such Underwriter are permitted to be exercised to no greater extent than such Default Rights could be exercised under the U.S. Special Resolution Regime if this Agreement were governed by the laws of the United States or a state of the United States.
As used in this Section 15, “BHC Act Affiliate” has the meaning assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12 U.S.C. § 1841(k); “Covered Entity” means any of the following: (i) a “covered entity” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 252.82(b), (ii) a “covered bank” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 47.3(b) or (iii) a “covered FSI” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 382.2(b); “Default Right” has the meaning assigned to that term in, and shall be interpreted in accordance with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as applicable; and “U.S. Special Resolution Regime” means each of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder and (ii) Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
16. No Fiduciary Duty. The Company hereby acknowledges that (a) the purchase and sale of the Offered Securities pursuant to this Agreement is an arm’s-length commercial transaction between the Company, on the one hand, and the Underwriters and any affiliate through which it may be acting, on the other, (b) the Underwriters are acting as principal and not as an agent or fiduciary of the Company and (c) the Company’s engagement of the Underwriters in connection with the offering and the process leading up to the offering is as independent contractors and not in any other capacity. Furthermore, the Company agrees that it is solely responsible for making its own judgments in connection with the offering (irrespective of whether any of the Underwriters has advised or is currently advising the Company on related or other matters). The Company agrees that it will not claim that the Underwriters have rendered advisory services of any nature or respect, or owe an agency, fiduciary or similar duty to the Company, in connection with such transaction or the process leading thereto.
17. Integration. This Agreement supersedes all prior agreements and understandings (whether written or oral) between the Company and the Underwriters, or any of them, with respect to the subject matter hereof.
18. Applicable Law. This Agreement will be governed by and construed in accordance with the laws of the State of New York applicable to contracts made and to be performed within the State of New York.
35
19. Currency. Each reference in this Agreement to U.S. Dollars (the “relevant currency”) is of the essence. To the fullest extent permitted by law, the obligations of each of the Company in respect of any amount due under this Agreement will, notwithstanding any payment in any other currency (whether pursuant to a judgment or otherwise), be discharged only to the extent of the amount in the relevant currency that the party entitled to receive such payment may, in accordance with its normal procedures, purchase with the sum paid in such other currency (after any premium and costs of exchange) on the Business Day immediately following the day on which such party receives such payment. If the amount in the relevant currency that may be so purchased for any reason falls short of the amount originally due, the Company making such payment will pay such additional amounts, in the relevant currency, as may be necessary to compensate for the shortfall. Any obligation of any of the Company not discharged by such payment will, to the fullest extent permitted by applicable law, be due as a separate and independent obligation and, until discharged as provided herein, will continue in full force and effect.
20. EEA Product Governance. Solely for the purposes of Article 9(8) of the Commission Delegated Directive 2017/593 (the “Delegated Directive”) regarding the responsibilities of “manufacturers” under the Product Governance requirements contained within: (a) Directive 2014/65/EU on markets in financial instruments, as amended (“MIFID II”); (b) Articles 9 and 10 of the Delegated Directive; and (c) local implementing measures (the “EU MIFID II Product Governance Requirements”), each Underwriter, to whom such rules apply, acknowledges to each other Underwriter that it understands the responsibilities conferred upon it under the EU MIFID II Product Governance Requirements relating to: (i) the target market for the Private Placement; (ii) the eligible distribution channels for dissemination of the Offered Shares; and (iii) the requirement to carry out a product approval process.
21. UK Product Governance. Solely for the purposes of PROD 3.2.7 of the FCA Handbook Product Intervention and Product Governance Sourcebook (“PROD”) regarding the responsibilities of “manufacturers” under the Product Governance requirements contained within PROD (the “UK MiFIR Product Governance Rules”), each Underwriter, to whom such rules apply, acknowledges to each other Underwriter that it understands the responsibilities conferred upon it under the UK MiFIR Product Governance Rules relating to: (i) the target market for the Private Placement; (ii) the eligible distribution channels for dissemination of the Offered Shares; and (iii) the requirement to carry out a product approval process.
22. Taxes. All payments to be made by the Company to the Underwriters under this Agreement shall be made gross, without withholding or deduction for or on account of any present or future Swedish taxes, duties or governmental shares whatsoever unless the Company is compelled by law to deduct or withhold such taxes, duties or charges. In that event, except for any net income, capital gains, dividends or franchise taxes imposed on the Underwriters by the Kingdom of Sweden or the United States or the United Kingdom or any political subdivision or any taxing authority thereof or therein as a result of any present or former connection (other than any connection resulting from the transactions contemplated by this Agreement) between the Underwriters and the jurisdiction imposing such withholding or deductions, the Company shall pay such additional amounts as may be necessary in order to ensure that the net amounts received after such withholding or deductions shall equal the amounts that would have been received if no withholding or deduction has been made.
23. Waiver of Immunity. To the extent that the Company has or hereafter may acquire any immunity (sovereign or otherwise) from any legal action, suit or proceeding, from jurisdiction of any court or from set-off or any legal process (whether service or notice, attachment in aid or otherwise) with respect to itself or any of its property, the Company hereby irrevocably waives and agrees not to plead or claim such immunity in respect of its obligations under this Agreement
36
24. Waiver of Jury Trial. The Company hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions contemplated hereby.
25. Counterparts. This Agreement may be signed in one or more counterparts, each of which shall constitute an original and all of which together shall constitute one and the same agreement. This Agreement may be delivered via facsimile, electronic mail (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, including www.docusign.com or www.echosign.com) or other transmission method of any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
26. Headings. The section headings used herein are for convenience only and shall not affect the construction hereof.
37
If the foregoing is in accordance with your understanding of our agreement, please sign and return to us the enclosed duplicate hereof, whereupon this letter and your acceptance shall represent a binding agreement among the Company and the several Underwriters.
Very truly yours, | ||
CALLIDITAS THERAPEUTICS AB | ||
By: | ||
Name: | ||
Title: |
[Signature Page to Underwriting Agreement]
The foregoing Agreement is hereby
confirmed and accepted as of the date
first above written.
Citigroup Global Markets Inc.
Jefferies LLC
Citigroup Global Markets Limited
Jefferies International Limited
Jefferies GmbH
By: | Citigroup Global Markets Inc. | |
By: | ||
Name: | ||
Title: | ||
By: | Jefferies LLC | |
By: | ||
Name: | ||
Title: | ||
By: Citigroup Global Markets Limited | ||
By: | ||
Name: | ||
Title: | ||
By: Jefferies International Limited | ||
By: | ||
Name: | ||
Title: | ||
By: JEFFERIES GMBH | ||
By: | ||
Name: | ||
Title: | ||
By: | ||
Name: | ||
Title: |
For themselves and the other several
Underwriters named in Schedule I to
the foregoing Agreement.
[Signature Page to Underwriting Agreement]
SCHEDULE I
Underwriters |
Number of Firm
ADSs to be Purchased |
|||
Citigroup Global Markets Inc. | [●] | |||
Jefferies LLC | [●] | |||
Stifel, Nicolaus & Company, Incorporated | [●] | |||
Kempen & Co U.S.A., Inc. | [●] | |||
LifeSci Capital, LLC | [●] | |||
Total | [●] |
Underwriters |
Number of Firm
Shares to be Purchased |
|||
Citigroup Global Markets Limited | [●] | |||
Jefferies International Limited/Jefferies GmbH(1) | [●] | |||
Stifel, Nicolaus & Company, Incorporated | [●] | |||
Kempen & Co U.S.A., Inc. | [●] | |||
LifeSci Capital, LLC | [●] | |||
Carnegie Investment Bank AB (publ) | [●] | |||
Total | [●] |
(1) The division of services between Jefferies International Limited and Jefferies GmbH shall be determined at Jefferies’ absolute discretion, whereby regulated services with respect to EU 27 countries and EU 27 investors shall be undertaken by Jefferies GmbH only.
I-1
SCHEDULE II
Schedule of Free Writing Prospectuses included in the Disclosure Package
[None]
II-1
SCHEDULE III
Schedule of Written Testing-the-Waters Communications
[Testing-the-Waters Presentation dated January 2020]
III-1
SCHEDULE IV
IV-1
[Form of Lock Up Agreement] | EXHIBIT A |
Lock-Up Agreement
Calliditas
Therapeutics AB
Public Offering of Securities
________, 2021
Citigroup Global Markets Inc.
Jefferies LLC
As Representatives of the several Underwriters,
c/o Citigroup Global Markets Inc.
388 Greenwich Street
New York, New York 10013
c/o Jefferies LLC
520 Madison Avenue
New York, New York 10022
Ladies and Gentlemen:
This letter agreement (this “Agreement”) is being delivered to you in connection with the proposed Underwriting Agreement (the “Underwriting Agreement”), between Calliditas Therapeutics AB, a Swedish public limited liability company (the “Company”), and each of you as representatives (the “Representatives”) of a group of underwriters named therein (the “Underwriters”), relating to an underwritten public offering of ordinary shares (the “Offering”), quotient value SEK 0.04 per share (the “Ordinary Shares”), and/or American Depository Shares representing a certain number of Ordinary Shares to be determined (the “ADSs” and, together with the Ordinary Shares, the “Securities”), of the Company (the “Offering”).
In order to induce you and the other Underwriters to enter into the Underwriting Agreement, the undersigned will not, without the prior written consent of the Representatives, offer, sell, contract to sell, pledge or otherwise dispose of, (or enter into any transaction which is designed to, or might reasonably be expected to, result in the disposition (whether by actual disposition or effective economic disposition due to cash settlement or otherwise) by the undersigned or any affiliate of the undersigned or any person in privity with the undersigned or any affiliate of the undersigned), directly or indirectly, including the filing (or participation in the filing) of a registration statement with the Securities and Exchange Commission in respect of, or establish or increase a put equivalent position or liquidate or decrease a call equivalent position within the meaning of Section 16 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the rules and regulations of the Securities and Exchange Commission promulgated thereunder with respect to, any Securities or any other securities convertible into, or exercisable or exchangeable for Securities, or publicly announce an intention to effect any such transaction, for a period from the date hereof until 90 days after the date of the Underwriting Agreement (the “Lock-Up Period”). If the undersigned is an officer or director of the Company, the undersigned further agrees that the foregoing restrictions shall be equally applicable to any issuer-directed Securities the undersigned may purchase in the Offering.
The foregoing restrictions shall not apply to:
(i) sales of Securities by the undersigned to the underwriters pursuant to the Underwriting Agreement;
(ii) transactions relating to Securities or any other security acquired in the Offering (other than any issuer-directed Securities purchased in the Offering by an officer or director of the Company) or in open market transactions after the completion of the Offering;
(iii) transfers of shares of Securities or any security convertible into Securities as a bona fide gift or charitable contribution;
(iv) exercises of share options or warrants to purchase Securities or the vesting of awards of Securities and any related transfer of Securities to the Company in connection therewith (x) deemed to occur upon the “cashless” or “net” exercise of such options or warrants or (y) for the purpose of paying the exercise price, or debt obtained to pay the exercise price, of such options or warrants or for paying taxes due as a result of the exercise of such options or warrants, the vesting of such options, warrants or awards, or as a result of the vesting of such shares of Securities, it being understood that all shares of Securities received upon such exercise, vesting or transfer will remain subject to the restrictions of this agreement during the Lock-Up Period;
(v) transfers of Securities or any security convertible into or exercisable or exchangeable for Securities to the Company in connection with the termination of the undersigned’s employment with the Company or pursuant to contractual arrangements under which the Company has the option to repurchase such shares;
(vi) transfers to the spouse, domestic partner, parent, child or grandchild or first cousin of the undersigned (each, an “Immediate Family Member”) or to a trust formed for the direct or indirect benefit of the undersigned or an Immediate Family Member;
(vii) transfers by will, other testamentary document or intestate succession to the legal representative, heir, beneficiary, trustee or Immediate Family Member of the undersigned;
(viii) transfers pursuant to a divorce settlement agreement or decree or a qualified domestic relations order;
(ix) transfers of Securities or any security convertible into or exchangeable for Securities to any affiliate (as such term is defined in Rule 405 of the Securities Act of 1933, as amended), limited partners, general partners, limited liability company members or stockholders of the undersigned, or if the undersigned is a corporation to any wholly owned subsidiary of such corporation;
(x) the establishment of a trading plan pursuant to Rule 10b5-1 under the Exchange Act for the transfer of shares of Securities or any security convertible into or exchangeable for Securities, provided that such plan does not provide for the transfer of shares of Securities during the Lock- Up Period and no filing under the Exchange Act or other public announcement shall be required or voluntarily made during the Lock-Up Period;
A-2
(xi) transfers of Securities to a bona fide third party pursuant to a merger, consolidation, tender offer or other similar transaction made to all holders of Securities and involving a “Change of Control” of the Company after the Public Offering and approved by the Company’s Board of Directors (with “Change of Control” meaning the transfer of the Company’s voting securities in one transaction or a series of related transactions to any “person” (as defined in Section 13(d)(3) of the Exchange Act) or group of affiliated persons if, after such transfer, such person or group of affiliated persons would hold more than 75% of the outstanding voting securities of the Company (or the surviving entity)), provided that in the event that such transaction is not completed, the Securities held by the undersigned shall remain subject to the restrictions contained in this Agreement, and provided further that in the event any Securities not transferred in the Change of Control shall remain subject to the restrictions contained in this Agreement; or
(xii) transfers of Securities to a capital insurance (Sw. kapitalförsäkring) or to an Investment Savings Account (Sw. investeringssparkonton), provided that no transactions in any such Securities shall be permitted during the Lock-Up Period;
provided, that, in the case of clauses (ii), (iv), (v) and (xii), (a) no filing under the Exchange Act or other public announcement reporting a reduction in beneficial ownership of Securities shall be required or voluntarily made during the Lock-Up Period, other than a filing required by Schedule 13F; provided further, that, in the case of any transfer or distribution pursuant to clauses (iii), (vi), (vii), (viii) and (ix), (a) the recipient agrees to be bound in writing by the same restrictions set forth herein for the duration of the Lock-Up Period and (b) no filing under the Exchange Act reporting a reduction in beneficial ownership of Securities shall be required or voluntarily made during the Lock-Up Period, other than a filing required by Schedule 13F, which shall state the nature of such transfer or distribution and (c) any such transfer shall not involve a disposition for value.
This lock-up agreement shall automatically terminate, and the undersigned shall be released from its obligations hereunder, upon the earliest to occur, if any, of (1) the execution of the Underwriting Agreement in connection with the Offering shall not have occurred on or before March 31, 2021 (provided that the Company may by written notice to the undersigned prior to March 31, 2021 extend such date for a period of up to three additional months), (2) the Company files an application to withdraw the registration statement relating to the Offering, (3) the Underwriting Agreement (other than the provisions thereof which survive termination) shall terminate or be terminated prior to payment for and delivery of the Securities to be sold thereunder or (4) the Representatives, on behalf of the underwriters, advise the Company, or the Company advises the Representatives, in writing, prior to the execution of the Underwriting Agreement, that they have determined not to proceed with the Offering.
A-3
If the undersigned is an officer or director of the Company, (i) the Representatives agree that, at least three business days before the effective date of any release or waiver of the foregoing restrictions in connection with a transfer of Securities, the Representatives will notify the Company of the impending release or waiver, and (ii) the Company has agreed in the Underwriting Agreement to announce the impending release or waiver by press release through a major news service at least two business days before the effective date of the release or waiver. Any release or waiver granted by the Representatives hereunder to any such officer or director shall only be effective two business days after the publication date of such press release. The provisions of this paragraph will not apply if (a) the release or waiver is effected solely to permit a transfer not for consideration and (b) the transferee has agreed in writing to be bound by the same terms described in this letter to the extent and for the duration that such terms remain in effect at the time of the transfer.
This lock-up agreement shall be governed by, and construed in accordance with, the laws of the State of New York.
Yours very truly, | ||
By: | ||
Name: | ||
Title: |
A-4
EXHIBIT B-1
[Form of Waiver of Lock-up]
Calliditas Therapeutics AB
Public Offering of Securities
, 2021
[name and address of officer or director requesting waiver]
Dear Mr./Ms. [Name]:
This letter is being delivered to you in connection with the offering by Calliditas Therapeutics AB (the “Company”) of (i) common shares, quota value SEK 0.04 per share (the “Common Shares”), and (ii) Common Shares to be delivered in the form of American Depositary Shares (“ADSs”), of the Company, and the lock-up letter dated ______, 2021 (the “Lock-up Letter”), executed by you in connection with such offering, and your request for a [waiver] [release] dated [insert date], 2021, with respect to [__ Common Shares (the “Lock-Up Shares”)] [__ ADSs (the “Lock-Up ADSs”)].
Citigroup Global Markets Inc. and Jefferies LLC hereby agree to [waive] [release] the transfer restrictions set forth in the Lock-up Letter, but only with respect to the [Lock-Up Shares][Lock-Up ADSs], effective ______, 2021; provided, however, that such [waiver] [release] is conditioned on the Company announcing the impending [waiver] [release] by press release through a major news service at least two business days before effectiveness of such [waiver] [release]. This letter will serve as notice to the Company of the impending [waiver] [release].
Except as expressly [waived] [released] hereby, the Lock-up Letter shall remain in full force and effect.
Yours very truly, | ||
Citigroup Global Markets Inc. | ||
By: | ||
Name: | ||
Title: | ||
Jefferies LLC | ||
By: | ||
Name: | ||
Title: |
cc: Calliditas Therapeutics AB
EXHIBIT B-2
[Form of Press Release]
Calliditas Therapeutics AB
[Date]
Calliditas Therapeutics AB (the “Company”) announced today that Citigroup Global Markets Inc. and Jefferies LLC, the joint book-running managers in the Company’s recent public sale of [●] common shares (“Common Shares”), including [●] common shares to be delivered in the form of [●] American Depositary Shares (“ADSs”), are [waiving] [releasing] a lock-up restriction with respect to ______ [Common Shares][ADSs] of the Company held by [certain officers or directors] [an officer or director] of the Company. The [waiver] [release] will take effect on ______, 2021, and the [Common Shares][ADSs] may be sold on or after such date.
This press release is not an offer for sale of the securities in the United States or in any other jurisdiction where such offer is prohibited, and such securities may not be offered or sold in the United States absent registration or an exemption from registration under the United States Securities Act of 1933, as amended.
ANNEX A
Lock-up Securityholders
Executive Officers:
· | Renée Aguiar-Lucander |
· | Fredrik Johansson |
· | Richard Philipson, M.D. |
· | Andrew Udell |
· | Frank Bringstrup, M.D. |
· | Katayoum Welin-Berger, Ph.D. |
Directors: |
· | Elmar Schnee |
· | Hilde Furberg |
· | Lennart Hansson, Ph.D. |
· | Diane Parks |
· | Molly Henderson |
Exhibit 2.1
SHARE PURCHASE AGREEMENT
BIODISCOVERY 2
BIODISCOVERY 3
ECLOSION2 & CIE SCPC
VESALIUS BIOCAPITAL II SA, SICAR
NEOMED INNOVATION V L.P.
N5 INVESTMENTS AS
WELLINGTON PARTNERS NOMINEE LTD
MR. ELIAS PAPATHEODOROU
MR. PHILIPPE WIESEL
MR. ALEXANDRE GRASSIN
as Sellers
and
CALLIDITAS THERAPEUTICS AB (PUBL)
as Buyer
13 August 2020
TABLE OF CONTENTS | |||
CLAUSE | PAGE | ||
1. | DEFINITIONS | 2 | |
1.1 | DEFINITIONS | 2 | |
1.2 | INTERPRETATION | 6 | |
2. | SALE AND PURCHASE OF THE TRANSFERRED SHARES | 6 | |
3. | PURCHASE PRICE | 7 | |
3.1 | CONSIDERATION TO BE PAID AT CLOSING | 7 | |
3.2 | CONTINGENT CONSIDERATIONS | 7 | |
4. | CONDITIONS PRECEDENT | 9 | |
4.2 | FOREIGN INVESTMENT CLEARANCE | 9 | |
4.3 | NO IMPAIRMENT oF MATERIAL COMPANY IP RIGHTS | 10 | |
5. | SELLERS’ COVENANTS | 10 | |
6. | CLOSING AND POST-CLOSING | 11 | |
6.1 | CLOSING DATE | 11 | |
6.2 | ACTIONS TO BE TAKEN FOR CLOSING | 11 | |
7. | REPRESENTATIONS AND WARRANTIES OF THE SELLERS | 12 | |
7.1 | EXISTENCE - AUTHORIZATION | 13 | |
7.2 | TITLE TO THE TRANSFERRED SHARES | 13 | |
7.3 | ACCURACY OF PUBLICLY AVAILABLE INFORMATION | 14 | |
7.4 | BROKERS’ FEES | 14 | |
8. | REPRESENTATIONS AND WARRANTIES OF THE BUYER | 14 | |
9. | POST-CLOSING UNDERTAKINGS | 15 | |
10. | COMMUNICATION – PUBLIC STATEMENTS | 15 | |
11. | SELLERS’ AGENT | 15 | |
12. | NOTICES | 16 | |
13. | ASSIGNMENT | 17 | |
14. | TAXES - OTHER EXPENSES | 17 | |
15. | TERMINATION | 17 | |
16. | MISCELLANEOUS | 18 | |
16.1 | AMENDMENT – WAIVER | 18 | |
16.2 | INVALIDITY – ENTIRE AGREEMENT | 18 | |
17. | GOVERNING LAW - DISPUTES | 18 | |
SCHEDULE 1 | 2 | ||
ALLOCATION OF THE TRANSFERRED SHARES AND PURCHASE PRICE AMONG THE SELLERS | 2 | ||
SCHEDULE 2 | 3 | ||
FORM OF RESIGNATION LETTER | 3 |
THIS AGREEMENT is made on 13 August 2020
AMONG
(1) | BioDiscovery 2, a Fonds Professionnel de Capital Investissement organized under the laws of France, represented by Andera Partners, a Société en commandite par actions whose registered office is at whose registered office is at 374 rue Saint Honoré, 75001 Paris, registered with the Trade and Companies Register of Paris under number 444 071 989; |
(2) | BioDiscovery 3, a Fonds Professionnel de Capital Investissement organized under the laws of France, represented by Andera Partners, a Société en commandite par actions whose registered office is at whose registered office is at 374 rue Saint Honoré, 75001 Paris, registered with the Trade and Companies Register of Paris under number 444 071 989; |
(3) | Eclosion2 & Cie SCPC, a partnership for collective investments (société en commandite de placements collectifs) organized under the laws of Switzerland, whose registered office is at rue du Nant 8, c/o Duchosal Berney SA, 1207 Geneva, Switzerland and registered under number CHE-116.231.008, represented by Eclosion2 SA, whose registered office is at rue du Nant 8, c/o Duchosal Berney SA, 1207 Geneva, Switzerland and registered under number CHE-116.043.501; |
(4) | Vesalius Biocapital II SA, SICAR, a Société anonyme Société d'investissement en capital à risque organized under the laws of Luxemburg, whose registered office is at 8, rue Lou Hemmer, L-1748 Senningerberg, Luxembourg, registered with the Trade and Companies Register of Luxemburg under number B-158, represented by SGV MANAGEMENT SERVICES BVBA, a société de personnes à responsabilité limitée organized under the laws of Belgium, whose registered office is at 1B, Liskenstraat, B-3080 Tervuren, Belgium, registered with the Banque-Carrefour des Entreprises under number BE 0472.774.139, represented by Stephane Verdood and ORRIX MANAGEMENT BVBA, a société de personnes à responsabilité limitée organized under the laws of Belgium, whose registered office is at 27, Hoevestraat, B-1640 Sint-Genesius-Rode, Belgium, registered with the Banque-Carrefour des Entreprises under number BE 0476 019 184; |
(5) | Neomed Innovation V L.P., a Limited Partnership organized under the laws of Jersey, whose registered office is at IFC 5 ST Helier Jersey, JE1 1ST, Jersey, represented by its General Partner Neomed Innovation V Limited; |
(6) | N5 Investments AS, a company organized under the laws of Norway, whose registered office is at Parkveien 55, N-0256 Oslo, Norway, registered under number 998406730; |
(7) | Wellington Partners Nominee Ltd, a limited company organized under the laws of Jersey, whose registered office is at 11-15 Seaton Place, St. Helier, Jersey JE4 0QH, British Channel Islands, registered with the Jersey Financial Services Commission under number RC112326; |
(8) | Mr. Elias Papatheodorou, a Greek citizen, born on 30 May 1969 at Athens (Greece) and residing at Engelfriedshalde 27, 72076 Tubingen, Germany; |
(9) | Mr. Philippe Wiesel, a Swiss citizen, born on 7 November 1966 in Uccle (Belgium) and residing at 11 Rue Juliette Lamber, 75017 Paris, France; |
(10) | Mr. Alexandre Grassin, a French and Swiss citizen, born on 3 February 1978 at Reims, France and residing at rue Micheli-du-Crest 20, 1205 Geneva, Switzerland; |
(individually a “Seller” and collectively, the “Sellers”)
(11) | Calliditas Therapeutics AB (publ), a public limited liability company (aktiebolag) organized under the laws of Sweden, whose registered office is at Kungsbron 1, C8, SE-111 22, Stockholm, Sweden, registered under the corporate registration number 556659-9766 and which common shares are admitted to trading on Nasdaq Stockholm under ISIN code SE0010441584 and, in the form of American depositary shares on the Nasdaq Global Select Market under ISIN code US13124Q1067; |
(the “Buyer”)
The Sellers and the Buyer are hereinafter referred to individually as a “Party” and collectively as the “Parties”.
PREAMBLE
(a) | GENKYOTEX is a limited liability company (société anonyme) organized under the laws of France with a share capital of €11,548,562, whose registered office is at 218 avenue Marie Curie – Forum 2 Archamps Technopole, 74166 Saint-Julien-en-Genevois Cedex, France and registered with the Commerce and Companies Registry under number 439 489 022 RCS Thonon-les-Bains (the “Company”). As of the date hereof, the Company has issued 11,548,562 ordinary shares with a nominal value of €1.00 which are admitted to trading on Euronext Paris and Euronext Brussels under ISIN code FR0013399474 (the “Company Shares”) including 9,243 ordinary shares held in treasury. |
(b) | The Sellers own 7,236,515 Company Shares (the “Transferred Shares”) representing, as of the date hereof, 62,66% of the issued share capital and of 62,71% the theoretical voting rights of the Company. The details of the Transferred Shares are set out in Schedule 1. |
(c) | The Buyer is seeking to acquire all the Transferred Shares and, as soon as reasonably practicable after the completion of such acquisition and in compliance with French and Belgian securities laws, the Buyer intends to file with the French Financial Market Authority (Autorité des Marchés Financiers – the “AMF”) a mandatory cash simplified tender offer (offre publique obligatoire d’achat simplifiée) on the remaining Company Shares (the “Tender Offer”) on the terms and subject to the conditions set forth in the Tender Offer Agreement. |
(d) | In connection with the foregoing, the Buyer is prepared to acquire the Transferred Shares from the Sellers and the Sellers are prepared to sell the Transferred Shares to the Buyer under the terms and conditions of this agreement (the “Transaction”). |
THE PARTIES HEREBY AGREE AS FOLLOWS:
1. | DEFINITIONS |
1.1 | DEFINITIONS |
For the purpose of this agreement, the following capitalized terms shall have the following meanings, which shall be equally applicable to the singular and plural forms of such terms:
“Affiliate” means, in relation to any Person, any other Person who/which, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such first Person. The term “control” as used in this definition (including its correlative meanings “controlled by” and “under common control with”) shall have the meaning ascribed to it in Article L. 233-3 of the French Commercial Code, it being agreed that the managing company or the general partner of an investment fund shall be deemed to have control over such investment fund.
2
“Agreement” means this share purchase agreement and each of its schedules.
“AMF” has the meaning given to such term in the Preamble hereof.
“Andera Sellers” means the persons listed in paragraphs (1) and (2) of the Parties hereto.
“Board Represented Sellers” means the Andera Sellers, Eclosion2 & Cie SCPC, Vesalius Biocapital II SA, SICAR and Neomed Innovation V L.P.
“Business Day” means any day other than (i) a Saturday or Sunday, (ii) a day that is not a trading day (jour de négociation) on the Euronext Paris and Euronext Bruxelles stock exchanges or (iii) a day on which banks in Belgium, France or Sweden are closed.
“Buyer” means the person described in paragraph (1) of the Parties hereto or the Substituted Subsidiary, as the case may be.
“Closing” means the consummation of the Transaction by delivery of the documents and completion of the transactions referred to in Clause 6.2 and in particular the payment of the Purchase Price.
“Closing Date” means the date referred to in Clause 6.1 on which the Closing shall occur.
“Company” has the meaning given to such term in the Preamble hereof.
“Company Shares” has the meaning given to such term in the Preamble hereof.
“Conditions Precedent” has the meaning given to such term in Clause 4.
“Contingent Consideration 1” has the meaning given to such term in Clause 3.2.
“Contingent Consideration 2” has the meaning given to such term in Clause 3.2.
“Contingent Consideration 3” has the meaning given to such term in Clause 3.2.
“Contingent Considerations” has the meaning given to such term in Clause 3.2.
“Contingent Consideration Portion” has the meaning given to such term in Clause 3.2.
“Encumbrance” means any security interest, mortgage, charge, pledge, lien, assignment or fiducie by way of security, hypothecation, title retention, easement, burden, or other restriction or limitation of any kind to the rights of disposal, ownership or assignment of an asset (including any right to acquire, call option, tag along, drag along, preference or pre-emption right) whether created by applicable Laws, by contract or otherwise.
“FDA” shall mean the U.S. Food and Drug Administration, and any successor agency thereto.
“Foreign Investment Authority” means the French Ministry of Economy and Finance or any other competent French Governmental Authority for the purposes of authorizing the Transaction pursuant to articles L. 151-3, R. 151-1 et seq. of the French Monetary and Financial Code.
“Foreign Investment Clearance” means (i) a decision from the Foreign Investment Authority which, pursuant to articles L. 151-3, R. 151-1 et seq. of the French Monetary and Financial Code, authorizes in accordance with the relevant applicable Laws and regulations or does not prevent the acquisition of the Company by the Buyer or (ii) a written confirmation from the Foreign Investment Authority that the Transaction does not fall within the scope of articles L. 151-3, R. 151-1 et seq. of the French Monetary and Financial Code.
3
“Governmental Authority” means any international, European, national, state, regional, departmental, municipal or local body with executive, legislative, judicial, regulatory, or administrative authority including any ministry, department, agency, office, organization or other subdivision thereof and any Person having received delegated authority from any of the above, as well as any judicial authority of competent jurisdiction.
“Group” means the Company and its Subsidiary taken as a whole.
“Investment Services Provider” means Bryan, Garnier & Co, appointed to act as investment services provider (prestataire de services d’investissement) in connection with the Transaction.
“Law” means, in respect of any person, any mandatory law or regulation of any Governmental Authority, which is in force and binding upon such person and capable of enforcement, from time to time.
“Longstop Date” means 1 November 2020 at 23:59 pm CET.
“Manager Sellers” means Mr. Elias Papatheodorou, Mr. Philippe Wiesel and Mr. Alexandre Grassin.
“Material Company IP Rights” means intellectual property, patent, patent application, documentation or know-how, and any rights thereto, held by the Group, relating to setanaxib.
“Milestones” means the setanaxib Milestone 1, setanaxib Milestone 2 and the setanaxib Milestone 3.
“Parties” means either the Buyer or any of the Sellers and together, the Buyer and the Sellers.
“Permitted Transfer” means a transfer or disposal of one or more Contingent Considerations
(i) | in the case of a Seller who is an individual, upon death or by gift (donation); |
(ii) | made pursuant to a court order of a court of competent jurisdiction (such as in connection with divorce, bankruptcy or liquidation), |
(iii) | made by operation of law (including a consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability company, partnership or other entity; |
(iv) | if the Contingent Consideration holder is a partnership, a distribution from the transferring partnership to its partners or former partners in accordance with their partnership interests; or |
(v) | by a venture capital company or fund, private equity company or fund or other similarly-situated type of institutional investor to any Affiliate of such entity; provided, that |
(1) | such transfer can be effected without subjecting the Contingent Considerations to registration or filing requirements under applicable European, French, Belgian, Swedish or U.S. securities rules and regulations and |
(2) | to the extent any items above result in the portion of the Contingent Considerations offered in the context of the Tender Offer being subject to registration or filing requirements under applicable European, French, Belgian, Swedish or U.S. securities rules and regulations, such items shall be deemed removed from this definition of Permitted Transfers. |
“Person” means any present or future individual or any corporation, association, partnership, joint venture, limited liability, joint stock or other company, business trust, trust, organization, business or government or any governmental agency or political subdivision thereof.
“Purchase Price” means the total purchase price for the Transferred Shares, to be paid on the Closing Date, as set forth in Clause 3.
“Rules” has the meaning given to such term in Clause 17(b).
“Schedule(s)” means the Schedule(s) attached hereto and any attachment(s) thereto.
4
“Sellers” means the persons listed in paragraphs (1) to (10) of the Parties hereto.
“Sellers’ Agent” has the meaning given to such term in Clause 11.
“setanaxib” means a NADPH Oxidase 1 (NOX1) and NADPH Oxidase 4 (NOX4) inhibitor, as used in the currently pending clinical trial sponsored by the Company, or an Affiliate or licensee thereof.
“setanaxib Milestone 1” means the first approval by the FDA of a new drug application (NDA) that grants the Company or any of its Affiliates (or their respective successors and assigns) the right to commercially manufacture, market and sell setanaxib in the United States in accordance with applicable Laws.
“setanaxib Milestone 2” means a marketing authorization by the European Commission that grants the Company or any of its Affiliates (or their respective successors and assigns) the right to commercially manufacture, market and sell setanaxib in the European Union in accordance with applicable Laws.
“setanaxib Milestone 3” means the first approval by the FDA of a new drug application (NDA) or a marketing authorization by the European Commission that grants the Company or any of its Affiliates (or their respective successors and assigns) the right to commercially manufacture, market and sell setanaxib in the United States or in the European Union respectively in accordance with applicable Laws for the treatment of Idiopathic Pulmonary Fibrosis (IPF) or Type 1 Diabetes.
“Stifel” means Stifel, Nicolaus & Company, Incorporated.
“Stifel Engagement Letter” means the engagement letter entered into between Stifel and the Company on 17 June 2019, as amended from time to time.
“Subsidiary” means Genkyotex Suisse SA, a limited liability company (société anonyme) organized under the Laws of Switzerland, whose registered office is at Chemin des Aulx 16, 1228 Plan-les-Ouates, Switzerland and registered number CHE-112.747.508.
“Substituted Subsidiary” has the meaning given to such term in Clause 13.
“Tender Offer” has the meaning given to such term in the Preamble hereof.
“Tender Offer Agreement” means the tender offer agreement entered into on the date hereof between the Buyer and the Company, a copy of which the Sellers have been provided with.
“Tender Offer Closing Date” means the date of closing (clôture de l’offre) of the Tender Offer.
“Transaction” has the meaning given to such term in the Preamble hereof.
“Transferred Shares” has the meaning given to such term in the Preamble hereof.
“Universal Registration Document” means the universal registration document, including the annual financial report, filed by the Company with the AMF on 30 April 2020 for the financial year ending on 31 December 2019.
“Yorkville Warrants” means the 666,312 share subscription warrants (bons de souscription d'action) subscribed on 20 August 2018 by YA II PN, Ltd. allowing for the subscription of 66,845 Company Shares at a price of €18.70 per Company Share and expiring on 20 August 2023.
5
1.2 | INTERPRETATION |
(a) | In the Agreement, unless the context otherwise requires: |
(i) | except if otherwise specified, references to clauses and schedules are references to Clauses of and Schedules to the Agreement, references to paragraphs are references to paragraphs of the Clause and the Schedule in which the reference appears and references to the Agreement include the Schedules; |
(ii) | references to the singular shall include the plural and vice versa and references to one gender include any other gender; |
(iii) | references to “EUR”, “euros”, or “€” are references to the lawful currency from time to time of France and references to “dollars”, or “$” are references to the lawful currency from time to time of the United States of America; |
(iv) | any amount to be converted from one currency into another currency for the purposes of this Agreement, if it shall be converted into an equivalent amount, shall be at the Conversion Rate prevailing at the Relevant Date. For the purpose of the foregoing: “Conversion Rate” means the close spot mid-trade composite (London) rate for a transaction between the two currencies in question as quoted on Bloomberg on the date immediately preceding the Relevant Date or, if no such rate is quoted on that date, on the preceding date on which such rates are quoted; and “Relevant Date” means the date on which a payment or an assessment is to be made; |
(v) | references to times of the day are to Paris time unless otherwise stated; and |
(vi) | general words shall not be given a restrictive meaning because they are followed by words which are particular examples of the acts, matters or things covered by the general words and the words “includes” and “including” shall be construed without limitation. |
(b) | The headings and sub-headings in the Agreement are inserted for convenience only and shall have no legal effect. |
(c) | Each of the schedules to the Agreement shall form part of the Agreement. |
(d) | References to the Agreement include the Agreement as amended or varied in accordance with its terms. |
(e) | Any French term in this Agreement shall supersede its English translation. |
(f) | The provisions of Articles 640 to 642 of the French Code of Civil Procedure shall be applied to calculate any period of time under the Agreement, provided that the references in Article 642 to “un jour férié ou chômé” and “premier jour ouvrable” shall be interpreted by reference to the definition of “Business Day” provided herein. |
2. | SALE AND PURCHASE OF THE TRANSFERRED SHARES |
(a) | Upon the terms and subject to the conditions of this Agreement, the Buyer shall purchase from each of the Sellers, and each Seller shall sell to the Buyer, on the Closing Date, all of its Transferred Shares as listed in Schedule 1 and representing in the aggregate 7,236,515 Company Shares, free and clear of any Encumbrance, for the Purchase Price specified in Clause 3. |
(b) | The Transaction shall be completed on the Closing Date by the Investment Services Provider, acting pursuant to the joint instructions of the Sellers and the Buyer. |
6
(c) | The transfer of ownership of the Transferred Shares to the Buyer shall occur on the Closing Date by means of off-market block trades (cessions de bloc hors marché) and in accordance with the relevant Euroclear procedure. |
(d) | As of the Closing Date, the Buyer shall have the full ownership of the Transferred Shares together with all the rights attached thereto, including the right to all dividends declared and paid on and after the Closing Date, with respect to the Transferred Shares. |
(e) | The Buyer shall not be required to purchase the Transferred Shares unless all the Transferred Shares are transferred simultaneously on the Closing Date to an account opened by the Buyer with the Investment Services Provider, free of any Encumbrance. Under any other circumstances, the Buyer shall have the right to terminate this Agreement without incurring any liability vis à vis the Sellers in connection with such termination. |
(f) | The Buyer undertakes (i) unless otherwise agreed with the Sellers' Agent, not to acquire any Company Shares until the filing of the Tender Offer except for the transactions provided in this Agreement and (ii) between the filing of the Tender Offer and the settlement and delivery (règlement-livraison) of the Tender Offer, not to acquire any Company Shares at a price higher than the price of the Tender Offer. |
3. | PURCHASE PRICE |
3.1 | CONSIDERATION TO BE PAID AT CLOSING |
(a) | The consideration for the Transferred Shares (the “Purchase Price”) shall be a total amount of €20,262,242 (as reduced, as the case may be, pursuant to Clause 3.1(c)), representing a price per Transferred Share of €2.8. |
(b) | The allocation of the Purchase Price among the Sellers is set forth in Schedule 1. |
(c) | The Purchase Price to be paid on Closing by the Buyer as indicated in Clause 6.2 shall be reduced by any amount (including taxes if any) in excess of (and in excess only) US$400,000 paid or payable by any entity of the Group to Stifel (or any of its Affiliates) pursuant to the Stifel Engagement Letter. |
(d) | The Purchase Price (as reduced, as the case may be, pursuant to Clause 3.1(c)) shall be paid by the Buyer to the Sellers, on the Closing Date, as indicated in Clause 6.2. |
3.2 | CONTINGENT CONSIDERATIONS |
(a) | As an additional consideration for the Transferred Shares and subject to the satisfaction of the conditions set forth below, the Buyer agrees to pay to the Sellers after the Tender Offer Closing Date, additional amounts to the Purchase Price based on the following sums expressed in relation to 100% of the Company Shares on a fully diluted basis on the day preceding the settlement and delivery (règlement-livraison) of the Tender Offer (but excluding dilution resulting from any Yorkville Warrants that have not been waived or exercised by such date) apportioned to the Sellers and other security holders of the Company pursuant to the provisions of Clause 3.2(c): |
(i) | €30,000,000 in cash if the setanaxib Milestone 1 is achieved at the latest on the date falling ten years as from the Tender Offer Closing Date (the “Contingent Consideration 1”); |
7
(ii) | €15,000,000 in cash if the setanaxib Milestone 2 is achieved at the latest on the date falling ten years as from the Tender Offer Closing Date (the “Contingent Consideration 2”); |
(iii) | €10,000,000 in cash if the setanaxib Milestone 3 is achieved at the latest on the date falling ten years as from the Tender Offer Closing Date (the “Contingent Consideration 3” and, together with the Contingent Consideration 1 and the Contingent Consideration 2, the “Contingent Considerations”), provided, however, that if setanaxib Milestone 1 or setanaxib Milestone 2 is achieved for the treatment of Idiopathic Pulmonary Fibrosis (IPF) or Type 1 Diabetes then the Contingent Consideration 3 shall be equal to 0 for the same indication. |
(b) | The Sellers hereby acknowledge and agree that: |
(i) | the Buyer (including as the controlling shareholder of the Company after the Closing Date) shall retain sole discretion and decision making authority over any continued operation of, development or investment in setanaxib after the Closing Date, including any decision to cease developing any drug candidate; and |
(ii) | the Buyer shall not be required to take or pursue any action to ensure the achievement of the Milestones and shall not have any responsibility with respect to the achievement of the Milestones. |
(c) | The sums to be paid by the Buyer to each Seller under the Contingent Considerations will be equal to (i) the global sum due under the relevant Contingent Consideration (i.e. €30,000,000 for the Contingent Consideration 1, €15,000,000 for the Contingent Consideration 2 or €10,000,000 for the Contingent Consideration 3) multiplied by (ii) a percentage equal to (a) the number of Transferred Shares by the relevant Seller as set forth in Schedule 1 divided by (b) the number of Company Shares on a fully diluted basis on the day preceding the settlement and delivery (règlement-livraison) of the Tender Offer (the “Contingent Consideration Portion”). |
(d) | The Contingent Consideration Portion to be paid to each Seller by the Buyer as indicated in Clause 3.2(g) shall be reduced by an amount in euros equal to 60% of any amount (including taxes if any) paid or payable by any entity of the Group to Stifel (or any of its Affiliates) as a result of the Contingent Considerations being due, such reduction being allocated to each Seller pro rata the number of Transferred Shares sold by such Seller (as set forth in Schedule 1) divided by the total number of Transferred Shares. |
(e) | The contractual right of each Seller to be paid a Contingent Consideration Portion may not be transferred or disposed of, in whole or in part, other than in relation to a Permitted Transfer. |
(f) | The Buyer, upon becoming aware that any of the Milestones has been achieved, shall promptly notify the Sellers of the achievement of such Milestone, such notification including a copy of any document evidencing such achievement. |
(g) | The payment of the Contingent Consideration Portion will be made by the Buyer to each Seller within 30 Business Days following the relevant notification sent pursuant to Clause 3.2(f), by transferring immediately available funds to the bank accounts of the relevant Seller as shall be notified by each Seller to the Buyer in writing by no later than 20 Business Days following receipt of the notification referred in Clause 3.2(f). |
(h) | In the event that prior to the tenth anniversary of the Tender Offer Closing Date the Buyer desires to consummate a transaction with a third party relating to the transfer or licensing of part or all of Material Company IP Rights necessary for setanaxib to attain either of the setanaxib Milestone 1, the setanaxib Milestone 2, the setanaxib Milestone 3, while any such milestone has not been attained but remains eligible to be attained, the Buyer will, at its discretion, (i) either retain its obligations in respect of the Contingent Considerations or (ii) cause the person acquiring any such Material Company IP Rights relating to setanaxib to assume the Buyer’s obligations in respect of the Contingent Considerations. No later than the consummation of any such transaction, the Buyer shall disclose to the Sellers’ Agent information relating to such transaction so that the Sellers are informed that such transaction complies with this Clause 3.2(h). |
8
4. | CONDITIONS PRECEDENT |
The obligation of the Buyer to consummate the Transaction shall be subject to the satisfaction (or waiver by the Buyer in writing) of the following conditions (the “Conditions Precedent”):
(i) | the Buyer shall have received the Foreign Invest Clearance as provided for in Section 4.2 below; and |
(ii) | no material impairment of Material Company IP Rights shall have occurred, as provided for in Section 4.3 below. |
If at any time either Party becomes aware of any event, circumstance or condition that would be reasonably likely to prevent any Conditions Precedent being satisfied it shall forthwith inform the other Parties.
4.2 | FOREIGN INVESTMENT CLEARANCE |
(a) | The Buyer agrees, as soon as practicable after the date of this Agreement, to make the compulsory filing with the Foreign Investment Authority in order to obtain the Foreign Investment Clearance. |
(b) | The Buyer shall keep the Sellers’ Agent regularly informed of the status of the Foreign Investment Clearance process and the expected timing of obtaining the Foreign Investment Clearance. |
(c) | The Buyer shall undertake its reasonable best efforts to obtain the Foreign Investment Clearance without undue delay on or before the Longstop Date provided, for the avoidance of doubt, that nothing in this Agreement shall require the Buyer to (i) offer (and not withdraw) any commitments, undertakings and other remedies that the Foreign Investment Authority may impose as a condition to clearance or (ii) divest, dispose of, or hold separate (or otherwise take or commit to take any action that limits the Buyer’s freedom of action with respect to, or its ability to retain, operate or control of) any of its businesses or assets or the businesses or assets of the entities of the Group. |
(d) | The Sellers shall, and (to the extent of their respective available powers as shareholders, directors and corporate officers of the Company or the Subsidiary), shall cause the Company and its management to promptly co-operate with and provide all such assistance as the Buyer may request in order to obtain the Foreign Investment Clearance and shall provide at the request of the Buyer in a timely fashion all information requested by the Buyer for the preparation of the filings with the Foreign Investment Authority and responses to questions raised by the Foreign Investment Authority. |
9
4.3 | NO IMPAIRMENT OF MATERIAL COMPANY IP RIGHTS |
An impairment of Material Company IP Rights shall be deemed to have occurred if any of the following is untrue as of the Closing Date:
(a) | All of the Material Company IP Rights are validly owned by the Company or the Subsidiary (or, in the case of the assay enabling technology, validly licensed to the Company). |
(b) | No Material Company IP Rights are challenged or, to the knowledge of the Sellers, threatened to be challenged by third parties. |
(c) | All necessary fees and taxes have been paid, and all necessary and material documents have been filed, in connection with each Material Company IP Right that needs to be registered. In connection with the registered Material Company IP Right, all registrations are in force and all applications for the same are pending (required fees paid) and without any adverse action or proceedings pending or, to the knowledge of the Sellers, threatened by or before the Governmental Authority in which the registrations or applications are issued or filed. |
(d) | No facts or circumstances exist that, to the knowledge of the Sellers, could render any of the Material Company IP Rights invalid or unenforceable. |
5. | SELLERS’ COVENANTS |
(a) | From the date hereof up to the Closing Date, to the extent of their respective and available powers as shareholders, directors and corporate officers of the Company or the Subsidiary, the Sellers shall cause the Group to operate and carry on their activity in the ordinary course of business and in substantially the same manner as previously conducted and take all reasonable steps to preserve and protect their assets and goodwill, including their existing relationships with customers and suppliers and including the timely filing of all documents and the timely payment of fees and taxes required to maintain the Material Company IP Rights. |
(b) | In particular, from the date hereof, in no event will any Seller propose, encourage, otherwise support or approve in their respective capacities as shareholders and/or members of the board of directors of the Company: (i) any plan of complete or partial liquidation, dissolution, merger, consolidation, business combination, restructuring, recapitalization or other reorganization, (ii) any material acquisition by merger or consolidation with, or by purchase of an equity interest in or portion of the assets of, or by any other manner, any business or any corporation, partnership, joint venture, association or other business organization or division thereof, or (iii) any issuance, repurchase, redemption, cancellation, sale, pledge, disposition of, grant, transfer, encumbrance or authorize the issuance, sale, pledge, disposition, grant, transfer or encumbrance of any share capital or other equity or voting interests of the Company, or securities convertible or exchangeable into or exercisable for any share capital or other equity or voting interests of the Company, or any options, warrants or other rights of any kind to acquire any share capital or other equity or voting interests of the Company or such convertible, exchangeable or exercisable securities and (iv) any distribution of profits, dividends (including interim dividends), reserve or assets of the Company, in all cases above except as expressly permitted by the Tender Offer Agreement, provided that, for avoidance of doubt, this covenant in (b) will not restrict the ability of the Board to decide to modify partially or totally the vesting period or other terms of existing stock options in accordance with the Tender Offer Agreement. |
(c) | From the date hereof up to the Closing Date, the Sellers shall, and to the extent of their respective powers as shareholders and corporate officers of the Company, shall cause the Company to comply with, the provisions of the Tender Offer Agreement. |
(d) | The Sellers acknowledge that the Purchase Price offers significant value and premium to the shareholders of the Company, and that the Transaction is in the best interest of the Company, its employees and other stakeholders. Consequently, the Sellers hereby agree to support and recommend the Tender Offer, as the case may be, in their respective capacities as shareholders and/or members of the board of directors of the Company. |
10
6. CLOSING AND POST-CLOSING
6.1 CLOSING DATE
The Closing shall take place at the offices of Latham & Watkins, 45 rue Saint-Dominique, 75007 Paris as soon as practicable and no later than ten Business Days following the satisfaction of the Conditions Precedent or on any other date or location as mutually agreed upon by the Parties.
6.2 ACTIONS TO BE TAKEN FOR CLOSING
6.2.1 Transfer of the Transferred Shares
(a) | At the latest three Business Days prior to the Closing Date: |
(i) | The Sellers’ Agent shall notify to the Buyer the amount due or to be paid, on or around the Closing Date or the Tender Offer Closing Date, by any entity of the Group pursuant to the Stifel Engagement Letter and the final amount of the Purchase Price to be paid by the Buyer to the Sellers for the Transferred Shares; |
(ii) | The Sellers’ Agent shall (i) instruct the Investment Services Provider to open securities trading accounts (capable of receiving and holding Company Shares) and bank accounts in its books under the name of each Seller and (ii) notify to the Buyer the relevant details of such accounts; |
(iii) | Each Seller shall transfer all of its Transferred Shares to the securities trading account opened in its respective name in the books of the Investment Services Provider; |
(iv) | The Buyer shall (i) instruct the Investment Services Provider to open a securities’ trading account (capable of receiving and holding Company Shares) and a bank account in its books under its name and (ii) notify to the Sellers’ Agent the relevant details of such accounts; and |
(v) | The Buyer shall notify to the Sellers' Agent the identity of the individuals or entities to be appointed to the board of directors of the Company on the Closing Date. |
(b) | On the Closing Date, the following should occur: |
(i) | The Sellers and the Buyer shall deliver prior to 9:00 a.m. Paris time to the Investment Services Provider a joint transfer instruction, in a form to be provided by the Investment Services Provider, giving it irrevocable instructions to complete the Transaction on the Closing Date consisting in an off-market sale and purchase order for the acquisition by the Buyer from the Sellers of the Transferred Shares (with a trade date corresponding to the settlement date). |
(ii) | The Investment Services Provider shall complete the transactions set forth in the joint transfer instruction and in particular, it shall: |
(A) | transfer the Transferred Shares to such securities’ trading account opened in its books under the name of the Buyer; |
(B) | deliver to the Buyer a duly executed certificate of registration of shares (certificat d’inscription en compte) registering the Buyer as owner of the Transferred Shares as from the Closing Date; and |
11
(C) | pay the Purchase Price attributed to the Transferred Shares in immediately available funds by wire transfer to such bank accounts of the Sellers opened in its books. |
(iii) | The Sellers shall: |
(A) | cause Eclosion 2 SA, Andera Partners, Claudio Nessi and, if requested by the Buyer, Elias Papatheodorou, to execute and deliver to the Company written resignation letters from their position as directors of the Company with effect from the Closing Date substantially in the form attached as Schedule 2 and provide copies of such resignation letters to the Buyer; |
(B) | cause Stéphane Verdood to execute and deliver to the Company a written resignation letter from his position as observer of the board of directors of the Company with effect from the Closing Date substantially in the form attached as Schedule 2 and provide a copy of such resignation letter to the Buyer; and |
(C) | deliver to the Buyer a certified true copy of the extract of the minutes of the board of the Company held on the Closing Date (i) acknowledging the resignation of Eclosion 2 SA, Andera Partners, Claudio Nessi and Stéphane Verdood and (ii) appointing in replacement (cooptation) the individuals or entities designated by the Buyer in accordance with Clause 6.2.1(a)(v). |
6.2.2 Other Closing considerations
(a) | The Parties shall execute all instruments and documents and otherwise take all actions as shall be necessary or required by Law and this Agreement to consummate the Transaction on the Closing Date. |
(b) | All matters described in this Clause 6.2 will be deemed to take place simultaneously and all documents and items delivered and payments made in connection with Closing shall be held by the recipient to the order of the person delivering them until such time as Closing takes place. Each of such actions, deliveries and payments shall be deemed to have occurred as at the Closing Date. |
(c) | All of the actions required for Closing described in this Clause 6.2 are conditional upon the occurrence of all other such actions. Therefore: |
(i) | in the event that any Seller fails to complete any of the actions and deliveries set forth in this Clause 6.2 on the Closing Date, then the Buyer shall be entitled to refuse to proceed with the Closing with respect to that Seller or all Sellers at its discretion; and |
(ii) | in the event that the Buyer fails to complete any of the actions and deliveries set forth in this Clause 6.2 on the Closing Date, then each Seller shall be entitled to refuse to proceed with the Closing. |
(d) | Such right to refuse to proceed with Closing is in addition and without prejudice to all other rights and remedies available to the non-defaulting Parties, including the right to claim damages and/or the right to require the specific performance (exécution forcée) of the Transaction in accordance with Articles 1221 and 1222 of the French Civil Code. |
7. REPRESENTATIONS AND WARRANTIES OF THE SELLERS
The Sellers represent and warrant to the Buyer that the following representations and warranties are true and accurate as of the date hereof, and shall remain true and accurate up to the Closing Date. The Buyer acknowledges that the representations and warranties contained in this Clause 7 are the only representations and warranties on behalf of the Sellers on which the Buyer may rely, or has relied, in entering into this Agreement.
12
7.1 EXISTENCE - AUTHORIZATION
(a) | Each Seller that is not an individual is duly organized and validly incorporated under the Laws of its jurisdiction, and has all requisite corporate power and authority to own its assets and conduct its business as now being conducted. |
(b) | Each Seller has all requisite capacity and right to enter into this Agreement, to perform its obligations hereunder and to consummate the Transaction contemplated hereby. |
(c) | This Agreement has been duly authorized by all relevant corporate bodies of each Seller that is not an individual (and, to the extent required, of Affiliates of each Seller), and duly executed and delivered by each Seller and constitutes the legal, valid and binding obligation of such Seller, enforceable against such Seller in accordance with its terms. |
(d) | Except as otherwise specifically mentioned in this Agreement, no authorization is required to be obtained by any Seller or any of its Affiliates in connection with the signing of this Agreement or the consummation of any of the transactions contemplated by this Agreement. |
(e) | The execution of the Agreement by each Seller and the performance of its obligations thereunder do not conflict with, or constitute a breach of any Laws, agreement or other obligation to which such Seller is subject. |
(f) | Each Seller represents that it is not insolvent (en état de cessation de paiements). Such Seller is not subject to any safeguard, bankruptcy or insolvency proceedings under any applicable Laws, nor to any other proceedings with regard to the prevention or resolution of business difficulties. |
7.2 TITLE TO THE TRANSFERRED SHARES
(a) | Each Seller represents that it is the sole holder of all of the Transferred Shares that are mentioned in front of its name in Schedule 1. |
(b) | The Transferred Shares owned by such Seller are free and clear of any Encumbrance. |
(c) | The Sellers do not own any Company Shares, securities giving deferred access to Company Shares or rights to acquire Company Shares other than (i) the Transferred Shares and (ii) stock options in the case of the Manager Sellers as further detailed in the Tender Offer Agreement. |
(d) | No Seller is a party to any option, warrant, purchase right or other contract or commitment that requires such Seller to sell, transfer or otherwise dispose of any capital stock of the Company, except as indicated in this Agreement or as provided for in the Tender Offer Agreement. |
(e) | To the best of the Sellers’ knowledge, (i) all the Company Shares are fully paid up and validly issued and (ii) all the Company Shares have equal voting rights and each such Company Share entitles its holder to dividends in proportion to the percentage of share capital it represents. |
(f) | To the best of the Sellers’ knowledge, the Company Shares represent all of the issued share capital of the Company. |
13
7.3 ACCURACY OF PUBLICLY AVAILABLE INFORMATION
(a) | Elias Papatheodorou, Alexandre Grassin (for the information for which he is responsible in his capacity as employee of the Group) and Philippe Wiesel (for the information for which he is responsible in his capacity as employee of the Group) respectively represents that the information in relation to the Group which was made or is publicly available in accordance with the Company’s disclosure obligations (and in particular but not limited to the Universal Registration Document) did not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. |
(b) | Each Manager Seller represents that there are no material fact or circumstance (including any suit, action or proceeding pending or, to the knowledge of each Manager Seller, threatened against the Company or its Subsidiary) that, individually or in aggregate is adversely affecting (or reasonably likely to adversely affect) the affairs of the Group which has not been disclosed publicly and which, if disclosed, might have a noticeable (sensible) influence on the traded market price of the Company Shares. |
7.4 | BROKERS’ FEES |
Each Manager Seller and each Board Represented Seller represents that none of the entities of the Group has any liability or obligation to pay any fees, costs, charges or commissions to any broker, finder, agent or financial advisor with respect to the Transaction or the Tender Offer other than pursuant to the Stifel Engagement Letter and the engagement letter to be entered into with the independent expert in connection with the Tender Offer.
8. REPRESENTATIONS AND WARRANTIES OF THE BUYER
The Buyer represents and warrants to the Sellers that the following representations and warranties are true and accurate as of the date hereof, and shall remain true and accurate up to the Closing Date. The Sellers acknowledge that the representations and warranties contained in this Clause 8 are the only representations and warranties on behalf of the Buyer on which the Sellers may rely, or have relied, in entering into this Agreement.
(a) | The Buyer is duly organized and validly incorporated under the Laws of its jurisdiction, and has all requisite corporate power and authority to own its assets and conduct its business as now being conducted. |
(b) | The Buyer has all requisite corporate capacity and right to enter into this Agreement, to perform its obligations hereunder and to consummate the Transaction contemplated hereby. |
(c) | This Agreement has been duly authorized by any and all relevant corporate bodies of the Buyer and duly executed and delivered by the Buyer and constitutes and shall constitute the legal, valid and binding obligation of the Buyer, enforceable against the Buyer in accordance with its terms. |
(d) | The execution of this Agreement by the Buyer and the performance of its obligations thereunder do not, and will not, conflict with, or constitute a breach of any Laws, agreement or other obligation to which the Buyer is subject. |
(e) | The Buyer is not insolvent (en état de cessation de paiements). The Buyer is not subject to any safeguard, bankruptcy or insolvency proceedings under any applicable Laws, nor to any other proceedings with regard to the prevention or resolution of business difficulties. |
14
(f) | As of the date hereof, the Buyer does not own any Company Shares, nor has entered into any agreement relating to the acquisition by the Buyer of any Company Shares other than the Transferred Shares under this Agreement or the Tender Offer Agreement. |
9. POST-CLOSING UNDERTAKINGS
(a) | The Buyer hereby undertakes to file the Tender Offer as soon as reasonably practicable further to Closing in compliance with applicable Laws. |
(b) | The Sellers shall cooperate with and provide to, and shall cause (to the extent of their respective powers as shareholders, directors and corporate officers of the Company or the Subsidiary) the Group to cooperate with and provide to, the Buyer all necessary information reasonably required for the drafting of the offer documentation prior to the filing of the Tender Offer in compliance with applicable Laws. |
(c) | The Sellers undertake not to implement, directly or indirectly, any transaction which may disturb the proper implementation of the Tender Offer and/or squeeze-out regarding the Company Shares and in particular shall not, from the date of announcement of such Tender Offer and/or squeeze-out until its final settlement and delivery, directly or indirectly, acquire, transfer (other than to the Buyer or one of its Affiliates), or take an economic exposure on, Company Shares other than in accordance with the Tender Offer Agreement. |
(d) | For a period of two (2) year from the Closing Date, the Sellers will not, and procure that their Affiliates do not, approach, solicit or employ directly or indirectly any of the managers, directors or employees that is currently or that will remain in the Group following the Transaction, provided that this restriction will not apply (i) if such Sellers or their Affiliate do not control (with the meaning ascribed in Article L. 233-3 of the French Commercial Code) the entity hiring the person that approaches, solicits or employs directly or indirectly any of the managers, directors or employees that is currently or that will remain in the Group following the Transaction, or (ii) if the employment of such employees is terminated by any Group Companies. |
10. COMMUNICATION – PUBLIC STATEMENTS
(a) | No publicity, public announcement, press release, or disclosure regarding this Agreement or the transactions contemplated herein shall be made by the Sellers without the prior written consent of the Buyer on the time, form and content of such public announcement, release or disclosure, which consent shall not be unreasonably withheld or delayed. In the event any Seller is required by applicable Law to make any public announcement related to this Agreement or the Transaction, such Seller will give the Buyer a reasonable opportunity to review and comment upon such communication before it is disseminated. |
(b) | Notwithstanding the foregoing, certain Sellers and the Buyer are required to notify the AMF and the Company of the crossing of share ownership thresholds as a consequence of the Transaction, and they are free to do so to the extent required by applicable Laws or the articles of association of the Company. |
11. SELLERS’ AGENT
(a) | For the purposes of this Agreement, each Seller shall hereby appoint Alexandre Grassin (the “Sellers’ Agent”), who accepts, as its representative, in its name and on its behalf, under the circumstances provided in this Agreement, to sign and negotiate all documents required for the completion of the Transaction as well as any amendment to this Agreement, to make and receive all notices, to make all communications or declarations and to receive all payments which are to be made pursuant to this Agreement or as a consequence thereof, to, or on behalf of, the Sellers. In view of the mutual interest it represents for the Sellers, such power of attorney is irrevocable. |
15
(b) | Any notification to the Sellers’ Agent shall thus be deemed to have been made to each of the Sellers. |
(c) | Should Alexandre Grassin, acting as Sellers’ Agent, be unable to perform his duties to act as the Sellers’ Agent, for any reason whatsoever, the Sellers’ Agent will be appointed among the Sellers by the Sellers. If the Sellers do not reach an agreement within 15 Business Days of the date Alexandre Grassin has ceased to perform his duties as Sellers’ Agent, then the Sellers’ Agent shall be appointed among the Sellers by the President of the Commercial Court of Paris ruling in summary form (statuant en référé), such ruling being unchallengeable in appeal. |
12. NOTICES
(a) | Any notice or other communication given under the Agreement or in connection with the matters contemplated herein shall, except where otherwise specifically provided, be in writing in the English language, addressed as provided in Clause (b) and served: |
(i) | by hand delivery in which case it shall be deemed to have been given upon delivery to the recipient (as evidenced by the acknowledgement of receipt); |
(ii) | by registered letter with acknowledgment of receipt or by an internationally recognized express overnight delivery service in which case it shall be deemed to have been given on the date of first presentation; or |
(iii) | by e-mail, in which case it shall be deemed to have been given when dispatched subject to confirmation of delivery by a delivery receipt, |
provided that any notice dispatched after 6:00 p.m. CET on a Business Day shall be deemed given at the start of the next Business Day.
(b) | Notices under the Agreement shall be sent for the attention of the person and to the address, or e-mail address, as set out below: |
(i) | If to the Buyer, to: |
Calliditas Therapeutics AB (publ) | |
Address: | Kungsbron 1, C8, SE-111 22, Stockholm, Sweden |
Email: | Fredrik.johansson@calliditas.com |
Attn: | Fredrik Johansson |
with a copy to: | |
Latham & Watkins AARPI | |
Address: | 45, rue Saint-Dominique,75007, Paris, France |
Email: | alexander.crosthwaite@lw.com |
Attn: | Alexander Crosthwaite |
(ii) | If to the Sellers, to: |
with a copy to: | |
Mc Dermott Will & Emery AARPI | |
Address: | 23 rue de l’Université |
Email: | drevcolevschi@mwe.com |
Attn: | David Revcolevschi |
or to such other addresses as a Party may provide to the other Parties in accordance with this Clause 12.
16
(c) | Any notice to be given to or by all of the Sellers under the Agreement shall be deemed to have been properly given if it is given to or by the Sellers’ Agent. |
13. ASSIGNMENT
The Buyer shall be authorized, at any time prior to the Closing Date, to substitute for itself, in all the rights and obligations provided herein, one or several of its Affiliates (the “Substituted Subsidiary”), subject only to the condition that the Buyer notifies the Sellers’ Agent of such substitution at least five Business Days prior to the Closing Date and confirms in such notice that it will remain jointly and severally (solidairement) liable, with effect from the substitution date, with the Substituted Subsidiary for the performance by the latter of all the Buyer’s obligations under this Agreement. The Buyer may not assign, directly or indirectly, the benefit of any provision of this Agreement to any other Person without the prior written consent of the Sellers’ Agent.
14. TAXES - OTHER EXPENSES
(a) | Any transfer or stamp duty or similar levies that may become payable as a result of the signing of this Agreement or the transfer of the Transferred Shares to the Buyer shall be borne by the Buyer exclusively. |
(b) | Whether or not the transactions contemplated by this Agreement are consummated and except as may otherwise be specifically provided herein, each Party shall bear its own costs and expenses, including fees of legal and other counsel, incurred in connection with the negotiation, preparation, execution and implementation of this Agreement and the consummation of the transactions contemplated hereby. |
15. TERMINATION
(a) | This Agreement may be terminated at any time prior to the Closing Date as follows: |
(i) | by mutual consent of the Buyer and the Sellers’ Agent; |
(ii) | by the Buyer if the Foreign Investment Authority issues, prior to the Longstop Date, a decision in writing denying the Foreign Investment Clearance; |
(iii) | by the Buyer or the Sellers’ Agent if the Conditions Precedent are not satisfied (or waived by the Buyer) at the latest at the Longstop Date, provided that the Buyer shall be entitled to postpone the Longstop Date (not more than once) by up to 30 Business Days by notice to the Sellers’ Agent; |
17
(iv) | by the Buyer if the Closing does not occur by the Longstop Date as a result of Clause 6.2.2(c)(i); or |
(v) | by the Sellers’ Agent if the Closing does not occur by the Longstop Date as a result of Clause 6.2.2(c)(ii). |
(b) | If the Agreement is terminated, whatever the reason, the obligations hereunder shall automatically cease to be binding on the Parties and, except as otherwise specifically agreed in this Agreement, no Party shall have any claim hereunder of any nature whatsoever against the other, provided that the foregoing will be without prejudice to the rights of any Party in the event of a prior breach hereof by another Party. |
(c) | In case of termination of this Agreement, whatever the reason, the obligations set forth in Clauses 10, 11, 12, 14 and 17 shall survive such termination. |
16. MISCELLANEOUS
16.1 AMENDMENT – WAIVER
(a) | No terms of this Agreement may be altered, modified, amended or supplemented or terminated except by an instrument in writing duly signed by all Parties. |
(b) | A waiver of any term, provision or condition of, or consent granted under this Agreement shall be effective only if given in writing and signed by the waiving or consenting Party, and then only in the instance and for the purpose for which it is given. |
(c) | No failure or delay on the part of any Party in exercising any right under this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise of any such right preclude any other or further exercise thereof or the exercise of any other right except as specifically set forth herein. |
(d) | No breach by any Party of any provision of this Agreement shall be waived or discharged except with the express written consent of the other Parties. |
16.2 INVALIDITY – ENTIRE AGREEMENT
(a) | If any term or provision herein is held to be void, unenforceable, invalid, illegal or inapplicable, the legality, enforceability, validity and applicability of the other provisions of this Agreement shall not be affected or impaired thereby. In such case the Parties shall negotiate in good faith a lawful substitute provision to replace the void, unenforceability, invalid, illegal or inapplicable provision or term that shall be consistent with the intent and object of the original provision. |
(b) | This Agreement (including the Schedules hereto and the documents referred to herein) constitutes the entire agreement among the Parties and supersedes all prior understandings, agreements or representations by or among the Parties, written or oral, to the extent they have related in any way to the subject matter hereof. |
17. GOVERNING LAW - DISPUTES
(a) | This Agreement and any contractual or non-contractual obligation arising out of or in connection with this Agreement shall be governed by, and construed in accordance with, French law. |
18
(b) | Any dispute, controversy, or claim arising out of or in relation to this Agreement, including in relation to the validity, invalidity, breach, enforcement or termination of this Agreement shall be finally settled in accordance with the Rules of Arbitration of the International Chamber of Commerce (the “Rules”) in force on the date when the notice of arbitration is submitted. The tribunal shall be composed of three arbitrators appointed as set forth below. Any such arbitration shall be held in Paris. The language in such arbitration proceedings shall be English. The decision and award of the arbitral tribunal shall be final and binding without being subject to further judicial review. The Parties shall jointly appoint two arbitrators and the third arbitrator shall be appointed by the two arbitrators jointly appointed by the Parties. Failing such appointment or in case of disagreement between the Parties on the appointment of the arbitrators, the arbitrators shall be appointed by the Court of the International Chamber of Commerce in accordance with the Rules. |
Signed on below on the date specified above, in 11 originals.
[Signature pages to follow]
19
The Sellers
BioDiscovery 2
By: Andera Partners SCA
Represented by |
[Share Purchase Agreement – Signature page – 12 August 2020]
BioDiscovery 3
By: Andera Partners SCA
Represented by |
[Share Purchase Agreement – Signature page – 12 August 2020]
Eclosion2 & Cie SCPC
By: Eclosion2 SA
Represented by |
[Share Purchase Agreement – Signature page – 12 August 2020]
Vesalius Biocapital II SA, SICAR
By: |
Represented by |
[Share Purchase Agreement – Signature page – 12 August 2020]
Neomed Innovation V L.P.
By: Neomed Innovation V Limited
Represented by | Ashley Vardon & Christina Kembery |
[Share Purchase Agreement – Signature page – 12 August 2020]
N5 Investments AS
By: |
Represented by |
[Share Purchase Agreement – Signature page – 12 August 2020]
Wellington Partners Nominee Ltd
By: |
[Share Purchase Agreemenl – Signature page – 12 August 2020]
Mr. Elias Papatheodorou
[Share Purchase Agreement – Signature page – 13 August 2020]
Mr. Philippe Wiesel
[Share Purchase Agreement – Signature page – 12 August 2020]
Mr. Alexandre Grassin
[Share Purchase Agreement – Signature page – 12 August 2020]
The Buyer | |
Calliditas Therapeutics AB (publ) | |
By: Calliditas Therapeutics AB | |
Represented by Elmar Schnee and Lennart Hansson |
[Share Purchase Agreement – Signature page – 13 August 2020]
SCHEDULE 1
Allocation of the Transferred Shares and Purchase Price among the Sellers
Seller |
|
Number
of
Transferred Shares |
|
|
Percentage
of Company
Shares (based on total shares on the date hereof) |
Percentage
of allocation
of the Purchase Price |
Estimated
Contingent
Consideration Portion (1) (in % of Contingent Consideration) |
|||||||||
BioDiscovery 2 | 209 752 | 1.82 | % | 2.90 | % | 1.79 | % | |||||||||
BioDiscovery 3 | 2 717 174 | 23.53 | % | 37.55 | % | 23.15 | % | |||||||||
Eclosion2 & Cie SCPC | 1 393 285 | 12.06 | % | 19.25 | % | 11.87 | % | |||||||||
Vesalius Biocapital II SA, SICAR | 1 087 568 | 9.42 | % | 15.03 | % | 9.27 | % | |||||||||
Neomed Innovation V L.P. | 940 589 | 8.14 | % | 13.00 | % | 8.01 | % | |||||||||
N5 Investments AS | 67 633 | 0.59 | % | 0.93 | % | 0.58 | % | |||||||||
Wellington Partners Nominee Ltd | 482 967 | 4.18 | % | 6.67 | % | 4.12 | % | |||||||||
Mr. Philippe Wiesel | 115 231 | 1.00 | % | 1.59 | % | 0.98 | % | |||||||||
Mr. Elias Papatheodorou | 148 689 | 1.29 | % | 2.05 | % | 1.27 | % | |||||||||
Mr. Alexandre Grassin | 73 627 | 0.64 | % | 1.02 | % | 0.63 | % | |||||||||
TOTAL | 7 236 515 | 62.66 | % | 100.00 | % | 61.66 | % |
(1) Assuming that the total number of Company Shares on a fully diluted basis on the day preceding the settlement and delivery of the Tender Offer is equal to 11,736,174 (i.e. expected situation if all dilutive instruments other than the 2020 stock options have been waived or have lapsed)
2
SCHEDULE 2
Form of resignation letter
Genkyotex
218 avenue Marie Curie – Forum 2 Archamps Technopole
74166 Saint-Julien-en-Genevois Cedex, France
To: The Board of Directors
Paris, on [ · ],
Dear Sirs and Madams,
I do hereby resign as a [chairman of the Board of Directors/director/observer] of Genkyotex, a limited liability company (société anonyme) organized under the laws of France with a share capital of €11,548,562, whose registered office is at 218 avenue Marie Curie – Forum 2 Archamps Technopole, 74166 Saint-Julien-en-Genevois Cedex, France and registered with the Commerce and Companies Registry under number 439 489 022 RCS Thonon-les-Bains.
This resignation will be effective as of [ · ] [following the meeting of the Board of Directors of Genkyotex acknowledging my resignation and appointing my successor].
Please proceed with the appropriate formalities required in connection with my resignation.
I hereby confirm that my decision to resign has been made freely. I also confirm that I have, and will have, no claim against Genkyotex or any of its subsidiaries of whatsoever nature (whether statutory, contractual or otherwise) in connection with the exercise or termination of my office as [chairman of the Board of Directors/director/observer] and that Genkyotex or any of its subsidiaries does not owe me any compensation or any other sum in connection therewith or for any reason whatsoever (other than any compensation that may be due under separate existing employment agreements or arrangements with Genkyotex).
Yours sincerely,
*[Director/Observer]
___________________________
3
Exhibit 3.1
Articles of Association of Calliditas Therapeutics AB. Reg. no. 556659-9766.
Adopted at the annual general meeting held on 25 June 2020.
1 § Name of company
The name of the company is Calliditas Therapeutics AB. The Company is a public company (publ).
2 § Registered office of the company
The registered office of the company is situated in Stockholm, Sweden.
3 § Objects of the company
The company shall, directly or through subsidiaries, conduct research and development as well as the manufacture and sale of pharmaceuticals and medical devices, own and manage shares and other securities as well as other movable and immovable property, as well as business associated therewith.
4 § Share capital and number of shares
The share capital shall be not less than SEK 710,000 and not more than SEK 2,840,000. The number of shares shall be not less than 17,750,000 and not more than 71,000,000.
5 § Board of directors
The board of directors elected by the shareholders’ meeting shall comprise not less than three (3) and not more than ten (10) members.
6 § Auditors
The company shall have one or two (1–2) auditors and not more than two (2) alternate auditors or a registered accounting firm.
7 § Notice to attend shareholders’ meetings
Notice of shareholders’ meetings shall be published in the Swedish Official Gazette and on the company’s website, within such time as set forth in the Swedish Companies Act (2005:551). It shall be announced in Svenska Dagbladet that a notice has been issued.
8 § Participation at shareholders’ meetings
Shareholders who wish to participate at a shareholders’ meeting shall be registered as shareholders on a transcript of the entire share register as stipulated in Chapter 7, Section 28, third paragraph of the Swedish Companies Act (2005:551) that relates to the conditions prevailing five workdays prior to the meeting and shall also provide notification of their intention to attend the meeting no later than on the date stipulated in the notice convening the shareholders’ meeting. The latter mentioned day must not be a Sunday, any other public holiday, Saturday, Midsummer’s Eve, Christmas Eve or New Year’s Eve and must not be more than the fifth weekday prior to the meeting. If a shareholder wishes to be joined by proxy (not more than two proxies) at the shareholders’ meeting, the number of proxies must be stated in the notice of participation.
9 § Matters at annual shareholders’ meetings
The annual shareholders’ meeting is held each year within six months of the end of the financial year.
The following matters shall be addressed at annual shareholders’ meetings:
1. | Election of a chairman of the meeting; |
2. | Preparation and approval of the voting register; |
3. | Approval of the agenda; |
4. | Election of one or two persons to attest the minutes; |
5. | Determination of whether the meeting was duly convened; |
6. | Presentation of the annual report and auditor’s report and, where applicable, the consolidated financial statements and auditor’s report for the group; |
7. |
Resolutions
regarding
(a) adoption of the income statement and balance sheet and, where applicable, the consolidated income statement and consolidated balance sheet; (b) allocation of the company’s profit or loss according to the adopted balance sheet; (c) discharge from liability for board members and the managing director; |
8. | Determination of fees for the board of directors and the auditors; |
9. | Election of the board of directors and accounting firm or auditors; |
10. | Any other business incumbent on the meeting according to the Companies Act or the articles of association. |
10 § Financial year
The company’s financial year shall be the calendar year.
11 § Euroclear company
The company’s shares shall be registered in a securities register in accordance with the Swedish Securities Register and Financial Instruments Accounts Act (1998:1479).
12 § US forum
Without any infringement on Swedish forum provisions and without applying Chapter 7, Section 54 of the Swedish Companies Act (2005:551), the United States District Court for the Southern District of New York shall be the sole and exclusive forum for resolving any complaint filed in the United States asserting a cause of action arising under the U.S. Securities Act of 1933, as amended, unless the Company consents in writing to the selection of an alternative forum.
Exhibit 5.1
Stockholm, 25 January 2021
Calliditas Therapeutics AB (publ), Company Reg. No. (CVR) 556659-9766 – F-1 registration
We, Swedish law firm Advokatfirman Vinge KB, have acted as Swedish law legal advisers to Calliditas Therapeutics AB (publ) (the “Company”) with respect to certain matters of Swedish law in connection with, inter alia, the registration statement on Form F-1 (File No. ) initially filed with the United States Securities and Exchange Commission (the “SEC”) on 25 January 2021 as amended, (the “Registration Statement”), for the registration of up to 5,175,000 new ordinary shares in the capital of the Company each with a quota value of SEK 0.04 (the “New Shares”), under the United States Securities Act of 1933, as amended, and the issue of the American Depositary Shares (the “ADSs”), each representing two New Shares, on Nasdaq Global Select Market, and the concurrent placement of New Shares to certain investors outside of the United States (together the “Transaction”). The ordinary shares with quota value of SEK 0.04 each in the capital of the Company shall hereinafter be defined as the “Ordinary Shares”. This legal opinion is delivered to you pursuant to the Company’s request.
Basis of the Opinion.—For the purpose of this Opinion we have examined the following documents:
(i) | a copy of the Registration Statement; |
(ii) | the articles of association (Sw. bolagsordning) of the Company, adopted on 25 June 2020 (the “Articles of Association”); |
(iii) | the certificate of incorporation (Sw. registreringsbevis) for the Company, issued by the Swedish Companies Registration Office (Sw. Bolagsverket) (the “SCRO”), on [7:32] p.m. CEST on [25] January 2021, showing relevant entries in the Swedish Company Registry (Sw. bolagsregistret) as per such date; |
(iv) | the minutes of the annual general meeting of the Company held on 25 June 2020; and |
(v) | the minutes of the meetings of the board of directors of the Company, held on [●], inter alia, approving the Registration Statements and the registration hereof with the SEC. |
The documents mentioned in Sections (i) – (v) above are referred to as the “Corporate Documents” and individually a “Corporate Document”.
Reliance.—With respect to various questions of fact, we have relied upon certificates of public officials and upon certificates issued by the SCRO. For the purposes of this opinion, we have examined such other agreements, documents and records as we have deemed necessary or appropriate for the purpose of rendering this opinion.
Assumptions.—This opinion is subject to the following nature of opinion and observations:
a) | the accuracy and completeness of: the facts set out in any other documents reviewed by us; and any other information set out in public registers, e.g. certificates from the SCRO, or that has otherwise been supplied or disclosed to us; and as we have not made any independent investigation thereof you are advised to seek verification of such matters or information from other parties or seek comfort in respect thereof in other ways; |
b) | that the Company and its board of directors have acted in accordance with the general clause (Sw. generalklausulen) in the Swedish Companies Act and provisions regarding good market practice (including recommendations issued by the Swedish Corporate Governance Board) in connection with resolving to issue the New Shares; |
c) | that all signatures on all documents supplied to us as originals or as copies of originals are genuine and that all documents submitted to us are true, authentic and complete; |
d) | that all documents, authorizations, powers and authorities produced to us remain in full force and effect and have not been amended or affected by any subsequent action not disclosed to us; |
e) | that where a document has been examined by us in draft form, it will be or has been executed in the form of that draft, and where a number of drafts of a document have been examined by us all changes to them have been marked or otherwise drawn to our attention; |
f) | all documents retrieved by us or supplied to us electronically (whether in portable document format (PDF) or as scanned copies), as photocopies, facsimile copies or e-mail conformed copies are in conformity with the originals; |
g) | that there has been no mutual or relevant unilateral mistake of fact and that there exists no fraud or duress; and |
h) | at or prior to the time of the delivery of the New Shares, the payment for such New Shares will have been received by the Company. |
Opinions.—Based upon and subject to the foregoing and subject to the qualifications set out below, we are of the opinion that:
a) | The Company is a public limited liability company (Sw. publikt aktiebolag) registered and validly existing under the laws of the Kingdom of Sweden; |
b) | The existing Ordinary Shares have been validly authorized and constitute valid and fully paid shares; |
c) | Each New Share has been duly authorized, and will, upon registration with the SCRO, be validly issued and fully paid and will be non-assessable. |
Qualifications.—The qualifications to which this opinion is subject are as follows:
1) | we express no opinion as to the exact interpretation of any particular wording in the Corporate Documents by any court; |
2) | provisions in the Corporate Documents providing that certain facts, determinations or calculations will be conclusive and binding (or prima facie evidence) may not be effective if they are incorrect and such provisions will not necessarily prevent judicial inquiry into the merits of such facts, determinations or calculations; |
3) | this Opinion is given only with respect to the laws of the Kingdom of Sweden as in force today and as such laws are currently applied by Swedish courts and we express no opinion with respect to the laws of any other jurisdiction nor have we made any investigations as to any law other than the laws of the Kingdom of Sweden; |
4) | in rendering this Opinion we have relied on certain matters of information obtained from the Company and other sources reasonably believed by us to be credible; |
5) | the underwriting agreement, to be entered into between the Company and the underwriters of the Transaction, and this opinion are expressed in the English language whilst addressing and explaining institutions and concepts of the laws of the Kingdom of Sweden; and such institutions and concepts may be reflected in or described by the English language only imperfectly; and we express no opinion on how the courts of the Kingdom of Sweden would construe contractual language expressed in English where the contract would be subject to the laws of the Kingdom of Sweden. However, we believe that such courts may pay attention to the meaning and import of such expressions in the laws of any pertinent jurisdiction in which the English language is normally or habitually employed, in construing, for the purposes of the laws of the Kingdom of Sweden, what the parties intended to put in writing. |
Governing Law.—This opinion is given in the Kingdom of Sweden and shall be governed by and construed in accordance with the laws of the Kingdom of Sweden.
Benefit of opinion.—
This Opinion is strictly limited to the matters stated herein and is not to be read as extending by implication to any other matter.
We are not assuming any obligation to notify you of any changes to this Opinion as a result of any facts or circumstances that may come to our attention in the future or as a result of any change in the laws of the Kingdom of Sweden which may hereafter occur.
We hereby consent to the filing of this opinion as an exhibit to the Registration Statement and the references to this firm in the sections of the Registration Statement entitled “Legal Matters”. This consent is not to be construed as an admission that we are a party whose consent is required to be filed as part of the Registration Statement under the provisions of the Securities Act.
This opinion is addressed to you solely for your benefit in connection with the Registration Statement.
Yours faithfully,
/s/ Advokatfirman Vinge KB
Advokatfirman Vinge KB
Exhibit 10.6
Board LTIP 2020 in Calliditas Therapeutics AB (publ)
GRANT NOTICE & AGREEMENT
On 25 June 2020, the annual general meeting in Calliditas Therapeutics AB (publ) (the “Company”) resolved to introduce a long-term performance-based incentive program for certain members of the Board of Directors (“Board LTIP 2020”).
In summary, the resolution entails that the main owner independent members of the Board of Directors (each a “Participant”) are granted share awards (the “Share Awards”) which entitle the Participant to receive a corresponding number of shares in the Company over a three-year vesting period (1/3 vesting at the end of each term), provided that the Participant is still a member of the Board of Directors on such date and to the extent that certain performance vesting requirements, based on the Company’s share price development, are met. The Share Awards are granted free of charge and each vested Share Award entitles the Participant to one share in the Company without any compensation being payable.
The Share Awards may not be transferred or pledged.
On this day, ______________ 2020, you have, under Board LTIP 2020, been allocated ______________ Share Awards, entitling you to a corresponding number of shares in the Company, subject to the above and the detailed terms set out in “Terms for Board LTIP 2020 in Calliditas Therapeutics AB (publ)”.
Your vested Share Awards will be exercised automatically on the day falling immediately after the date of, whichever is earliest, (i) the annual general meeting 2023 or (ii) 1 July 2023 (the “Vesting Date”), and the vesting result will be confirmed and communicated to you by the Company as soon as practically possible after the Vesting Date.
By signing this Grant Notice & Agreement, you hereby confirm
i) | that you have read, understood and accepted the above information, |
ii) | that you have read, understood and accepted the “Terms for Board LTIP 2020 in Calliditas Therapeutics AB (publ)”, |
iii) | that you have read, understood and accepted the information under “Personal data” on the next page of this Grant Notice & Agreement, |
iv) | that you accept the receipt of the above said number of Share Awards (in accordance with the above said terms and conditions), and |
v) | that you understand and accept that all tax and currency risks and effects for you related to your participation in Board LTIP 2020 are your responsibility. |
___________________________________
Place and date
___________________________________
Signature
___________________________________
Clarification of signature
Please complete, sign and return this Grant Notice & Agreement by scanned copy to Fredrik.Johansson@calliditas.com by no later than ______________ 2020.
Personal data
Personal data submitted to the Company, e.g. contact details and personal identity number, or otherwise registered in connection with the administration of Board LTIP 2020, is processed by the Company, as data controller, for the administration of the program. The processing of personal data is necessary for the Company in order to fulfill the agreement concerning Board LTIP 2020 and to enable the Company to fulfill its statutory obligations. If you do not provide the requested personal data to the Company, you may not participate in the program.
Personal data may, for specified purposes, sometimes be disclosed to other companies within the Company’s group, to banks or to companies with which the Company cooperates, within and outside the EU/EEA. Should personal data be transferred outside the EU/EEA, it will be conducted in accordance with suitable safeguards approved by the EU. You may, at any time, request further information regarding such transfer and request copies of agreements or other safeguards used by the Company for such transfer. In certain situations the Company is also obligated by law to disclose data, e.g. to the Swedish Tax Agency.
Requests for information on the personal data being processed by the Company, erasure of personal data, limitations to the processing of personal data, data portability, or rectification of personal data may be directed to the Company’s CFO, who you may also contact if you desire any further information regarding the Company’s processing of personal data. Should you wish to register a complaint regarding the Company’s processing of personal data you may contact the Swedish Data Protection Authority in its capacity of supervisory authority.
Personal data is only kept for as long as it is necessary for the administration of Board LTIP 2020 or as long as it is required for the Company to fulfill its statutory obligations.
Address to the Company’s CFO: Fredrik.Johansson@calliditas.com
TERMS FOR BOARD LTIP 2020 IN CALLIDITAS THERAPEUTICS AB (PUBL)
1. | Background and scope of Board LTIP 2020 |
At the annual general meeting in Calliditas Therapeutics AB (publ), Reg. No 556659-9766 (the ”Company” or “Calliditas”), held on 25 June 2020 (the “Annual General Meeting”), it was resolved to introduce a performance-based, long-term incentive program for certain board members in the Company (“Board LTIP 2020”). As part of Board LTIP 2020, the Company will therefore grant share awards subject to performance vesting (“Share Awards”) that entitle to not more than 40,000 shares in Calliditas in total, in accordance with these terms and conditions (the “T&C’s”). |
2. | Entitlement to Share Awards |
The number of Share Awards that shall be granted to each participant shall equal the below amount for the respective participant divided by the volume-weighted average price of the Calliditas Therapeutics share on Nasdaq Stockholm for the 10 trading days preceding the date the Share Awards are allocated. |
The Share Awards under Board LTIP 2020 shall be awarded in accordance with the following: |
• | [●] Share Awards to the chairman of the board of directors; and |
• | [●] Share Awards to each of Diane Parks, Hilde Furberg, Lennart Hansson and Molly Henderson. |
A board member that is entitled to or is a holder of Share Awards shall be referred to as the “Participant”. |
3. | Performance Vesting |
3.1 | The Share Awards are subject to performance vesting based on the development of the Calliditas share price over a certain period, as set out in the following. The development of the share price will be measured based on the volume-weighted average price of the Company’s share on Nasdaq Stockholm for the 10 trading days immediately following the date the Share Awards are allocated (the “First Reference Price”) and the 10 trading days immediately preceding the Vesting Date, as defined below (the “Second Reference Price”). In the event the price of the Company’s share has thereby increased by more than 60 percent, 100 percent of the Share Awards will vest and 33 percent of such Share Awards will vest should the share price increase by 20 percent. In the event of an increase of the share price of between 20 and 60 percent, vesting of the Share Awards will occur linearly. Should the increase be less than 20 percent, no vesting will occur. |
Example of performance conditions:
Share price increase, percent (Second Reference Price compared to First Reference Price) | Percentage of Share Awards Vested |
20.0% | 33.0% |
40.0%* | 66.5%* |
>60.0% | 100.0% |
*In the event of an increase of the share price of between 20 and 60 percent, vesting of the Share Awards will occur linearly.
3.2 | The terms under the heading “Vesting in exceptional cases and in case of transactions” provides that Share Awards will vest in their entirety in certain cases. |
4. | Exercise of Share Awards |
4.1 | Vested Share Awards will be exercised automatically on the date of, whichever is earliest, (i) the annual general meeting 2023 or (ii) 1 July 2023 (the “Vesting Date”), subject to that Share Awards which have vested pursuant to Clause 7.3 may instead be exercised from and including the day of vesting. |
4.2 | Each vested Share Award entitles the Participant to receive one share in Calliditas without any compensation being payable provided that the Participant is still a board member of Calliditas at the relevant time of vesting. The Share Awards shall vest gradually over approximately three years, corresponding to three terms up to the Vesting Date, where each term equals the period from one annual general meeting up until the day falling immediately prior to the next annual general meeting or the Vesting Date, as applicable (each such period a “Term”). The Share Awards shall vest by 1/3 at the end of each Term. The requirement that the Participant shall be a Board member of Calliditas at the relevant time of vesting shall not apply if the Share Awards have vested in accordance with what is stated in items 7.2– 7.3 below. For clarity, if the Participant is not a board member and was not a board member of Calliditas on the relevant time of vesting, and if the aforementioned exceptions do not apply, the Share Awards will not be exercisable. |
5. | Automatic exercise and lapse |
Vested Share Awards will be exercised automatically on the day set out in Clause 4.1, and on the same day all unvested Share Awards will lapse. |
6. | Transferability |
The Share Awards may not be transferred and vested Share Awards may only be exercised by the Participant or, in the event of the death of the Participant, by the Participant’s estate (Sw. dödsbo), heirs (Sw. arvtagare) or beneficiaries (Sw. testamentstagare). For the avoidance of doubt, in each case exercise of the Share Awards will be automatic in accordance with these T&C’s and neither the Participant nor its estate, heirs or beneficiaries need to take any action. |
7. | General clause on leaving the Board |
7.1 | A Share Award which has not vested will lapse automatically on the date on which a Participant is no longer a Board member of Calliditas, whether or not such resignation is voluntary, unless the reason for resignation is one listed in item 7.2(i)–(ii) below. |
Leaving in exceptional cases and in case of transactions
7.2 | Notwithstanding the above, if a Participant ceases to be a Board member of Calliditas (also if this occurs during the first Term (i.e. up until the day of the annual general meeting 2021)) for any of the following reasons: |
(i) | death; |
(ii) | permanent illness or incapacity or disability; |
allocated Share Awards will not lapse. Instead, the number of Share Awards allocated to the Participant will in such situation be reduced on a monthly pro rata basis for the period from the date when the application for the Board member’s resignation is filed with the Swedish Companies Registration Office (the “Resignation Date”) up until the day falling immediately prior to the Vesting Date. Further, all remaining Share Awards after such reduction will vest in accordance with what is stated in item 3.1 above, except that the allocated Share Awards will vest based on the development of the Calliditas share price over the period from the date the Share Awards are allocated up to and including the Resignation Date. The development of the share price will in such case be measured based on the volume-weighted average share price 10 trading days immediately following the date the Share Awards are allocated and 10 trading days immediately preceding the Resignation Date. |
7.3 | In the event any party (an “Overtaking Entity”), alone or together with subsidiaries, has become the owner of more than 90 percent of all outstanding shares in the Company (“Take-Over”), a sale of substantially all assets (“Asset Sale”) or a merger where the Company is not the surviving entity (“Merger”) has been completed, all Share Awards will vest in their entirety upon the day of completion of such transaction. |
8. | Re-purchase |
Following a Take-Over, Asset Sale or Merger, the Company, or the surviving entity in case of a Merger, shall have the right by a written communication to that effect, to re-purchase all Share Awards from the Participants for market value. The right to re-purchase Share Awards shall in such cases encompass all Share Awards. |
9. | Merger |
9.1 | In the event that the general meeting, in accordance with Chapter 23 Section 15 of the Swedish Companies Act, approve – or all shareholders, in accordance with paragraph four of aforementioned provision, signs – a merger plan, whereby the Company shall be absorbed by another company, whereby the Company shall be absorbed by a parent company, exercise of Share Awards may not thereafter be made. |
9.2 | Not later than in the immediate adjacent to the Board of Directors’ resolution to convene a general meeting that shall resolve upon merger pursuant to what is stated above, or if the merger plan shall be signed by all shareholders, not later than six weeks prior to such signing, notice shall be given to the Participant in respect of the intent to execute a merger of the Company. The notice shall be given by the Board of Directors in the manner set out in item 14 below. The notice shall state the principal terms of the merger plan and remind the Participant that exercise of Share Awards may not be made after a final decision regarding a merger has been made or a merger plan has been signed, in accordance with what is stated in 9.1 above. |
9.3 | In the event that a merger has been effectuated in pursuance of such decisions as referred to in item 9.1 above, the Participant shall, in exchange for the Participant’s Share Awards and unless the Share Awards have been re-purchased in accordance with item 8 above, have a right to receive shares in the absorbing company upon exercise of Share Awards. The right to receive shares in the absorbing company in the event of a merger shall however not prevail if the Participant has a right to have his or her Share Awards re-purchased by the absorbing company for cash consideration pursuant to the terms set out in the merger plan. |
10. | Partition |
10.1 | In the event that the general meeting, in accordance with Chapter 24 Section 17 of the Swedish Companies Act, approves – or all shareholders, in accordance with paragraph four of aforementioned provision, signs – a partition plan, whereby the Company shall be dissolved without liquidation, exercise of Share Awards may not thereafter be made. |
10.2 | Not later than in the immediate adjacent to the Board of Directors’ resolution to convene a general meeting that shall resolve upon partition pursuant to what is stated above, or if the partition plan shall be signed by all shareholders, not later than six weeks prior to such signing, notice shall be given to Participants in respect of the intent to execute a partition of the Company. The notice shall be given by the Board of Directors in the manner set out in section 14 below. The notice shall state the principal terms of the partition plan and remind the Participant that exercise of Share Awards may not be made after a final decision regarding partition has been made or a partition plan has been signed, in accordance with what is stated above. |
10.3 | In the event of a forthcoming partition, the value of the Participant’s Share Awards shall be unaffected. |
11. | Liquidation |
11.1 | In the event it is resolved that the Company shall enter into liquidation in accordance with Chapter 25 of the Swedish Companies Act, regardless of the grounds for such liquidation, exercise of Share Awards may not thereafter be made. The right to exercise the Share Awards shall also terminate if the Company is declared bankrupt. The right to exercise the Share Awards shall terminate in conjunction with the resolution to liquidate the Company, regardless of whether such resolution has entered into effect (Sw. vunnit laga kraft), or in conjunction with the declaration of bankruptcy. |
11.2 | Not later than in the immediate adjacent to the Board of Directors’ resolution to convene a general meeting that shall resolve whether the Company shall be placed into liquidation in accordance with what is stated in 11.1 above, notice shall be given to the Participant in respect of the intended liquidation. The notice shall be given by the Board of Directors of the Company in the manner set out in section 14 below. The notice shall state that exercise of Share Awards may not be made following the adoption of a resolution by the general meeting that the Company shall enter into liquidation. |
11.3 | Should a liquidation be effected, all Share Awards shall lapse. |
12. | Discontinued merger or partition or terminated liquidation |
Notwithstanding the provisions set forth in items 9.1, 10.1 and 11.1 above, stating that exercise of Share Awards may not be made following the approval of a Merger, partition or resolution of entering into liquidation or declaration of bankruptcy, the right to exercise Share Awards shall be re-instated in circumstances where the merger or partition, respectively, is discontinued or the liquidation or declaration of bankruptcy has been terminated. |
13. | Recalculation terms |
The provisions in item 8 (a)–(j) in the terms and conditions for the warrants issued to ensure the delivery of shares upon exercise of Share Awards, Appendix 1, shall constitute an integral part of the T&C’s and what is stated in regards to warrants in item 8 (a)–(j) in Appendix 1 shall prevail mutatis mutandis to Share Awards. Items 8 (a)–(j) in Appendix 1 inter alia states that the number of shares to which each warrant entitles may be recalculated. In case of a conflict between the terms of the T&C’s and Appendix 1, the terms of the T&C’s shall prevail. |
14. | Notices |
Notices to be given to a Participant pursuant to the T&C’s shall be sent via registered letter, courier or e-mail to the Participant’s address or e-mail address that is known to the Company. The notice shall be deemed received by the Participant at the earlier of |
i) | the date when the Participant signs a certificate of receipt, |
ii) | the date when the Participant otherwise confirms receipt, and |
iii) | in case of a notice sent by registered letter, on the date occurring five days after the date when the notice was sent by the Company. |
15. | Force Majeure |
15.1 | In respect to actions by the Company, the Company cannot be made liable for loss resulting from Swedish or foreign legislation, Swedish or foreign governmental actions, acts of war, terrorism, strikes, blockades, boycotts, lockouts or other similar circumstances. The reservation in respect to strikes, blockades, boycotts and lockouts shall apply even if the Company is itself the subject of such action. |
15.2 | In the event the Company, fully or partially, is prevented from taking actions due to circumstances mentioned in item 15.1 above, the actions may be postponed until the obstacle is removed. If the Company due to such circumstance is prevented from making or receiving payments, the Company or the Participant shall not be required to pay interest. |
16. | Applicable law and dispute |
16.1 | Swedish law shall apply on the T&C’s. Any dispute shall be finally settled by arbitration in accordance with the rules for expedited arbitration of the Arbitration Institute of Stockholm Chamber Commerce. The seat of arbitration shall be Stockholm, Sweden. The language of the arbitration shall be English. Written evidence may however be provided in the Swedish or English language. |
16.2 | All arbitral proceedings conducted pursuant to Clause 16.1, all information disclosed and all documents submitted or issued by or on behalf of any of the disputing Parties or the arbitrators in any such proceedings as well as all decisions and awards made or declared in the course of any such proceedings shall be kept strictly confidential and may not be used for any other purpose than these proceedings or the enforcement of any such decision or award nor be disclosed to any third party without the prior written consent of the party to which the information relates or, as regards to a decision or award, the prior written consent of all the other disputing parties. |
Exhibit 10.13
ANSTALLNINGSAVTAL Mcllan Calliditas Therapeutics AB, 556659-9766, f'Bolaget"), Kungsgatan 1, 111 22 Stockholm och Katayoun Welin-Berger (Welin-Berger), personnummer 19680321-0803, Nybergagatan 18, 152 43 Sodertlilje, har triiffat fOljande anstallningsavtal. 1. Atbetsuppgifter, anstiiDningsform m.m. 1.1 Welin-Berger anstalls som VP Operations. Welin-Berger skall arbeta heltid iBolaget och rapporterar till VD. Normal arbetstid ar 40 timmar per vecka. 1.2 Anstallningen galler fran och med den 13 januari, 2020 cller tidigare om overenskommits mellan parterna. 1.3 Welin-Berger skall utfora alla delar av sitt arbete med den skicklighet, snabbhet och omsorg som Bolaget har anledning att forviinta sig av en vah:enommerad VP Operations. Arbetet skall utforas pa bolagets kontor i Stockholm. 2.Lon, overtid m.m. 2.1 Welin-Berger erhiiller en Ion om 105 000 kr per manad. Lonen utbetalas den 25:e i intjanandemanaden. Infallcr den 25:e pa en helgdag utbetalas lonen narmast efterfOljande vardag. Forutom Ion erhaller Welin-Berger 16,3% av manadslonen per mlinad ipensions och forslikringsforman, utover lagstiftad pension och fOrsakringar. Arbetet kan medfora saval ovcrtid som resor i tjanstcn. Welin-Berger har inte ratt till ovcrtids-cller restidsersattning vilket skall anses inga och vara fullt betalda genom ordinarie Ion. Sjuk1on betalas ienlighet med gallande lagstiftning. 2.2 Oversyn och eventucll justering av Ion sker arligen per den 1 maj. 2.3 Ratt till bonus for Welin-Berger avtalas iforekommande fall i scparat skriftligt avtal mcllan partema och utgor inte en del av anstallningsavtalet. 3.SeEOester Welin-Berger har ratt till30 dagars betald semester. per ar. Betald semester intjanas pa sedvanligt vis och skall uttas i overenskommelse med bolagets VD. 4. Atbetsverktyg m.m. 4.1Fi:ir. utforande av Welin-Bergers arbetsuppgifter tillhandahaller Bolaget sadan utr.ustning som ar vasentlig fOr arbetets utforande. For narvarande innebar detta bar.bar dator och mobiltelefon. 4.2Welin-Berger har ratt till ersattning fi:ir skliliga kostnader for representation efter godklinnande av VD. 4.3 Welin-Berger skall folja Bolagets policy vad galler utlagg och skall redovisa samtliga kvitton senast manaden efter att utlaggcn gjordes. Welin-Berger har inte riitt till ersattning for utlagg om inte Welin Berger kan redovisa kvitto for utlagget. 5. Lojalitet m.m. Welin-Berger har att vid alla tillfallen noga bevaka och tillvarata Bolagets intressen. Welin-Berger har inte rlitt att utfora arbete eller, direkt eller. indirek:t, bedriva eller. ha ekonomiskt intresse i verksamhet som konkurrerar med den verksatnhet som Bolaget bedriver fran tid till annan. Vidare skall Welin-Berger inte !ita sig nagot uppdrag som till sin omfattning eller natur negativt kan pavcrka anstallningens utovande.
6. Sekretess Welin-Berger forbinder sig utan begransning itiden att inte for utomstliende yppa eller for egen del utnyttja konfidentiell information rorande Bolaget, dess verksamhet, kunder eller samarbetspartner. Med "konfidentiell information" fi:irstlis idetta avtal varje uppgift - teknisk, kommersiell eller av annan art - oavsett om uppgiften dokumenterats ellcr intc, med undantag for uppgiftcr som iir eller blir allmant kanda eller som kommit eller kommer till allman kiinnedom pli annat satt an genom Welin-Bergers brott mot denna bestammelse. 7,Konkurrensrorbud 7.1 Partema ar overens om att Welin-Berger genom sin stallning iBolaget kommer att ta del av fOretagshemligheter som inte kan skyddas genom patent eller liknande registreringsforfarande, och vars anvandning ikonkurrerande verksamhet skulle medfora patagligt men for Bolaget. Partema ar ocksa overens om att det ar en forutsattning for att Bolaget ifortrocnde ska kwma overliillltla sadana uppgifter till Welin-Berget att Bolaget kan forsiikta sig om att Wclin-Berger inte anviinder de kunskaper och de kontakter som erhiillits genom anstiillningen till att bygga upp eller verka i verksamhet som konkurrera.r med Bolaget eller dess niirstaende bolag. Det aligger darfOr Welin-Berger att under .r\nstiillningsavtalets glltighetstid och under nio (9) manader fran anstallningens upphorande vare sig sjiilv eller i egenskap av agate, deliigare, styrelseledamot, radgivare eller anstiilld i annat bolag, vare sig direkt eller indirekt bedriva med Bolaget, eller med dess niirstaende bolag, konkurrerande verksamhet. 7.2 Bolaget ska-utom ide fall som niillltls nedan-som ersiittning for den olli.genhet som giillande konkurrensforbud innebiir for Welin-Berger efter anstiillningens upph6rande, till Welin-Berger per mlinad iefterskott utbetala skillnaden mellan Welin-Bergers genomsnittliga manatliga ersattning fran Bolaget (innefattande saviil fast lon som rorlig ersiittning) under de sista 12 manaderna innan anstallningens upphorande och den iigre) inkomst, som Welin-Berger diirefter intjiinar, ellet rimligen kunde ha intjiinat i ny anstiillning eller annan forviirvsverksamhet. Ersiittningen fran Bolaget ska dock per manad aldrig overstiga sextio (60) procent av Welin-Bergers genomsnittliga manatliga ersattning enligt ovan under den period da konkurrensforbudet giiller. For det fall Welin-Berger trots skiiliga atgiirder for att begrlinsa sin inkomstfOrlust inte erhaller ny anstiillning eller bedtiver annan forviirvsverksamhet efter anstiillningens upphorande, utgar kompensation per manad med sextio (60) procent av Welin-Bergers genomsnittliga manatliga ersiittning enligt ovan under den period da konkurrensforbudet giiller. Riitt till ersiittningen frlin Bolaget enligt denna punk.t forutsiitter att det foreligger ett orsakssamband mellan Welin-Ber:gers atagande om konkurrensforbud och den inkomstfOrlust som uppstlir till fOijd av dess tilliimpning. Ersiittning utgar inte om Welin-Berger bryter mot konkurrensforbudet. 7.3 Welin-Berger ska efter anstiillningens upphorande fortlopande hiilla Bolaget underriittat om storleken av sina inkomster fran ny arbetsgivare eller annan fOrviirvsverksamhet. Sadan underriittelse ska liillltlas skriftligen till Bolaget senast den 15:e i varje manad. Om sainte sker forutsatts att Welin-Berger inte har drabbats av nagon inkomstforlust fOr den miinaden, utan att konkurrensbegriinsningen enligt punkten 7.1 for den skull bortfaller. 7.4 Ersiittning enligt denna punkt ska inte utga fOr period under vilken Welin-Berger kan komma att erhalla avgangsvederlag fran Bolaget eller om anstiillningen upphOr pa grund av: (i) Wclin-Bergers pensionering eller (ii) hiivning av Anstiillningsavtalet eller att Bolaget har avskedat Welin-Berger. 7.5 Saval under anstiillningen som efter endera partens uppsiigning av anstiillningen och sa llinge konkurrensforbudet iir giillande kan Bolaget ensidigt genom meddelande till Welin-Berger begriinsa tilliimpningsomtadet for konkurrensforbudet altemativt helt befria Welin-Berger fran skyldigheten att iaktta konkurrensforbudet. For det fall Bolaget helt befriar Welin-Berger fran skyldigheten att iaktta konkurrensforbudet upphor Bolagets ersiittningsskyldighet enligt pwlkten 7.2 ovan upphOr att galla. Bolagets eventuella befrielse fran konkurrensforhudet ska bTCS med en miinads uppsiigningstid 8.Anstiillnings-och kundforbud 8.1Parterna iir overens om, att Welin-Berger w1der Anstallningsavtalets giltighetstid och under tolv (12) manader fran anstiillningens upphorande inte f"ar, vare sig personligen eller genom nagon annan, ha affarsmassiga kontakter med nagon person eller nagot bolag, som under de sista tolv manaderna fore anstallningens upphorande har varit kund till eller som aktivt bearbetats av Bolaget eller dess niirstaende bolag, isyfte att formli sadan kund/potentiell.kund att forandra, upphora eller inte inleda en kommersiell
relation med Bolaget eller dess niirstaende bolag. Efter forfdgan fran Welin;Berger. kan dock Bolaget genom sk.riftlig bekraftelse ienskilda fall befria Welin-Berger. fran detta atagande. 8.2 Parterna ar vidare overens om, att Welin-Berger under Anstlillningsavtalets giltighetstid och under tolv {12) mM1ader frM1 anstiillningens upphOrande inte far, vare sig personligen eller genom nagon annan, anstiilla eller forsoka anstalla nagon som iir anstalld av Bolaget eller dess narstaende bolag eller utnyttja deras anster pa annat satt an genom Bolaget. Efter forfdgan fran Welin-Berger kan dock Bolaget genom skriftlig bekriiftelse i enskilda fall befria Welin-Berger frM1 detta litagande. 9.Tidrapportering m. fl. policies Welin-Berger forbinder sig att folja Bolagets vid var tid gallande policy for tidredovisning, IT-sakerhet, anvandning ave-post och mternet, resor m.m. 10.Resultat Alit resultat, inklusive all information, data, know-how, uppfinningar eller motsvarande och samtliga dii.rtill horande immateriella riittigheter som ligget mom Bolagets verksamhetsomraden och som uppkommer genom Welin-Bergers forsor.g eller medverkan under anstiillningstiden (''Resultat'') skall omgaende tillhora Bolaget med full och oinsk.rankt iiganderiitt utan annan ersiittning till Welin-Berget iin ordinarie Ion enligt detta ..Avtal. Pa Bolagets begiiran skall Welin--Berger bektiifta overliitelse av Resultat i separat skriftlig handling diir sa iir liimpligt eller behOvligt for tex sokande av immaterialriittsligt skydd eller genomforande av transaktion. 11.Personuppgifter. I syfte att administr.era detta anstlillningsavtal och for att kunna utova arbetsledning och bedriva verksamheten pa ett andamlilsenligt satt kommer Bolaget att behandla Welin-Bergers personuppgifter med hjiilp av bl.a. datorer. Personuppgifterna utgors av Welin-Berger, personnummer, telefonnummer, hemadress, ovriga kontaktdetaljer, uppgifter om bankkonto, m.m. Bolaget kan iiven komma att publicera Welin-Bergers namn, befattning, telefonnummer, e-postadress samt ett foto pa Welin-Berger pa Bolagets hemsida. Welin-Berger lamnar harmed sitt godkiinnande till Bolagets behandling av Wclin-Bcrgers personuppgifter enligt ovan. 12. Uppsagning 12.1 Omsesidig uppsiigningstid om 3 manader tillampas. 12.2 Vid anstallningens upphOrande skall Welin-Berger till Bolaget overliimna alit Bolaget tillhorigt material och egendom som Welin-Berger hat i sin besittning eller aonars ansvarar for. Detta giiller bland annat nycklar, handlingat och dokument (saviil ipappersform som digitala), dator, mobiltelefon, mjukvara etc. 13.Vite Skulle Welin-Bcrgcr bryta mot bestiimmelserna iartik.elS, 6, 8 och 10 skall bolagct utover skadestiind for faktisk skada liven vara beriittigat att for varje overtriidelse erballa vite om m.inst tr.e manadsloner. 14. Lag Svensk lag skall tilliimpas pa detta avtal.
Detta avtal har uppriittats itva likalydandc exemplar, av vilka partcrna tagit vat sitt. Stockholm den 17/9 2019Stockholm den 17/9 2019 Calliditas lberapeutics .c'ill
Exhibit 10.14
CONTRACT OF EMPLOYMENT
PRIVATE AND CONFIDENTIAL
CHIEF MEDICAL OFFICER
To: Richard Philipson ("the Employee")
Of: 18 Ridley Avenue, London W13 9XW
D.O.B: 6th January 1964
N.I No: NB 78 09 63 A
From: Calliditas Therapeutics AB, 556659-9766 ("the Company")
Of: |
Kungsborn 1, C8
SE-111 22 Stockholm |
Date: March 26, 2020
Welcome to Calliditas Therapeutics AB.
This contract sets out your main terms and conditions of employment with the Company unless otherwise agreed in writing. This contract supersedes any previous agreements (including any custom and practice) and shall prevail in the event of any inconsistency of terms.
In respect of new employees, employment is conditional upon the receipt of written references satisfactory to the Company and, if considered appropriate after appointment, a medical assessment satisfactory to the Company. It may also be subject to the provision of proof of academic and/or professional qualifications, work status and identity.
Given the nature and seniority of your position, you will be expected to strictly comply with your express and implied terms and conditions of employment. In particular, you must ensure that you do not breach the implied duties of trust and confidence, fidelity, transparency and integrity or conduct yourself in a manner which is inconsistent or prejudicial to the interests of the Company. This is a condition of your employment.
By signing this Contract of Employment, or in the alternative continuing to work after these terms and conditions have been issued to you, (under protest or otherwise) you agree to the terms and conditions stated below and shall be bound by these terms.
Your terms and conditions of employment include the following:
1. | COMMENCEMENT OF EMPLOYMENT |
1.1. | This employment contract shall commence on September 20, 2020, or earlier if mutually agreed upon, and shall continue until it is terminated in accordance with clause 12 of this contract. |
1.2. | Your continuous employment began on September 20, 2020, or earlier if mutually agreed upon, and it is agreed that there is no period of previous continuous employment with the Company. |
2. | JOB TITLE AND DUTIES |
2.1. | Your job title is Chief Medical Officer and you report to the Company's CEO. |
2.2. | Your normal duties will be outlined by the CEO and confirmed in a job description which will be provided to you. Flexibility is a condition of your employment. Accordingly, in addition to your normal duties, you may be expected to carry out additional or alternative duties for the Company as the Company may from time to time reasonably require. Your job content and duties may change from time to time according to the requirements of the Company, our business and the sectors in which the Company operates. The Company, therefore, reserves the right, upon giving as much notice as is reasonably practicable to require you to undertake alternative duties upon either a temporary or a permanent basis which, in the Company's reasonable opinion, fall within your capabilities. |
1
2.3. | You shall during your employment devote during your working hours the whole of your time, attention, ability and skills to your duties of employment and at all times comply with the reasonable directions and requests of the Company. |
2.4. | It is a condition of your employment that, apart from your work within the Company, you do not engage in any other employment or engage in any profession, trade or business, directly or indirectly (including any preparatory activity), without the Company's prior consent. |
3. | PLACE OF WORK |
3.1. | Your principal place of employment shall be your home address, 18 Ridley Avenue, London W13 9XW. |
3.2. | You will be required to travel to the Company's headquarters in Sweden on a regular basis. |
3.3. | You agree to travel upon the Company's business as may be required for the proper performance of your duties. |
4. | NORMAL HOURS OF WORK |
4.1. | Your normal hours of work are 40 hours per week, working Monday — Friday. |
4.2. | It is expected that you will be able to perform your duties in your normal working hours, however you will be required to work any additional hours to ensure the proper performance of your duties. |
4.3. | If you are unable to work, you must inform the CEO prior to commencing work and make up the time during the day. If you fail to follow this procedure, you may be subject to disciplinary action, and the Company reserves the right to make deductions from your pay. |
4.4. | The Company may temporarily or permanently alter the above working hours to take account of business needs and service requirements. You agree to vary your hours and/or working pattern in response to the operational needs of the business and accept that this requirement is a condition of your employment. No variation to working hours will be made without prior consultation and wherever possible consideration of individual circumstances. |
4.5. | By your signature to this statement, you: |
4.5.1. | acknowledge that you may be required to work in excess of an average of 48 hours per week in any one period of 17 calendar weeks and consent to do so if so requested by the Company or otherwise necessary for the fulfilment of your duties. You may withdraw such consent by giving no less than 3 months prior notice in writing to the Company of such withdrawal; and |
4.5.2. | confirm that you do not undertake any other work for any other Company and undertake to seek the consent of the Company before undertaking work for any other Company. |
5. | SALARY |
5.1. | Your basic rate of pay will be £240,000 per annum payable by monthly payments in arrears by bank transfer on 25th of each month. If the 25th falls on a weekend or a bank holiday, you will be paid on the following week day. Salary shall be deemed to accrue from day to day. |
5.2. | You shall receive a net salary after deduction of National Insurance Contributions and Income Tax. Any deductions will be notified to you. |
5.3. | Your salary shall be reviewed from time to time, usually annually on 1 May, however there is no obligation to award an increase. Where an increase is awarded, this will be entirely at the Company's discretion. |
2
5.4. | There will be no review of salary after notice has been given by either party to terminate the employment. |
5.5. | The Company reserves the right to alter its pay frequency, or the date when payment is made, or the method of payment upon giving reasonable notice. |
5.6. | In exceptional circumstances it may be necessary to make deductions from your salary or other benefits due to you. By your signature to this contract, you authorise the Company to make deductions from any salary or other payment due to you, (including any payment upon termination of your employment) in respect of any sums the Company considers due from you to the Company, including repayment of any loans, advances, repayable expenses, excess holiday pay, course fees, overpayment of salary, unauthorised expenditure (including Company credit or fuel cards), expenses or other benefits due to you or any direct loss caused to the Company or the Company's clients' property or vehicles which in the Company's reasonable opinion is malicious, intentional, negligent or reckless, breach of authority or Company operating rules. The Company will generally not make deductions without notifying you in writing as to the amounts deducted and reasons for deduction. |
6. | EXPENSES |
6.1. | The Company shall reimburse (or procure the reimbursement of) all reasonable expenses wholly, properly and necessarily incurred by you in the course of your appointment, subject to production of receipts or other appropriate evidence of payment. |
6.2. | Expenses such as international travel, conference attendance and significant expenses must be authorised by the CEO, in advance of these being incurred. |
6.3. | You shall abide by the Company's policies on expenses as contained within the Personnel Handbook or communicated to you by general staff notice. |
7. | BENEFITS |
7.1. | Bonus |
7.1.1. | The Company may, in its absolute discretion, pay the Employee a bonus of such amount, at such intervals and subject to such conditions as the Company may in its absolute discretion determine from time to time. Any bonus will be agreed in a separate written agreement between the parties. |
7.1.2. | Any bonus payment to the Employee shall be entirely discretionary and shall not form part of the Employee's contractual remuneration under this contract. If the Company makes a bonus payment to the Employee it shall not be obliged to make subsequent bonus payments and shall not constitute a custom or practice. |
7.1.3. | Notwithstanding clause 7.1, the Employee shall in any event have no right to a bonus or a time-apportioned bonus if their employment terminates for any reason or the Employee is under notice of termination (whether given by the Employee or the Company) at or prior to the date when a bonus might otherwise have been payable. |
7.1.4. | Any bonus payment shall not be pensionable. |
7.2. | Mobile Telephone |
7.2.1. | You may be provided with a mobile telephone to assist you to perform your duties. The Company will pay the line rental and the costs of business telephone calls. |
7.2.2. | You are permitted reasonable use of the mobile telephone for personal purposes. Where the Company reasonably considers the level of personal calls to be unreasonable, you will be notified of this and you will be responsible for paying the excess costs, normally by deduction from your pay unless you agree an alternative method with the CEO. |
3
7.3. | Laptop |
7.3.1. | You may be provided with a laptop to assist you to perform your duties only. This remains the property of the Company at all times and upon termination of this contract for whatsoever reason it must be returned. immediately. |
7.4. | Professional Registrations & Subscriptions |
7.4.1. | The Company will pay the costs for the following: |
7.4.1.1. | General Medical Council Annual Registration |
7.4.1.2. | Medical Defence Union Annual Subscription |
7.4.1.3. | Annual Appraisal for Revalidation Fee |
7.4.1.4. | Faculty of Pharmaceutical Medicine Fellowship |
7.4.1.5. | Royal College of Physicians Membership |
8. | HOLIDAY ENTITLEMENT |
8.1. | The Company's holiday year runs from January — December ("the Holiday Year"). The Company adheres to the Working Time Regulations in respect of annual leave. |
8.2. | Full-time employees are entitled to 25 days holiday per year calculated at the rate of 1/52nd of the annual entitlement for each complete week of service ("Basic Leave"). |
8.3. | In addition to Basic Leave full time employees are also entitled to eight public holidays each year, and will be advised of the relevant dates as early as possible. The public holidays that are recognised are as follows: |
New Years Day | Good Friday | Easter Monday |
May Day | Spring Bank Holiday Monday | Late Summer Bank Holiday |
Christmas Day | Boxing Day |
8.4. | Where you are expected to work a public holiday, you will be permitted to take that day's annual leave at another point within the current holiday year. |
8.5. | Where a recognised public holiday falls on a Saturday or a Sunday, alternative dates will be substituted for these. Employees will be advised of these as early as possible. |
8.6. | All holiday pay will be calculated at your basic rate of pay only and will be subject to normal deductions. Any variations in your basic rate of pay will also be inclusive in calculating your holiday pay including bonus payments. |
8.7. | Any holiday not taken during the Holiday Year cannot be carried forward to the following Holiday Year and no payment in lieu of untaken holiday or increase in your holiday entitlement in any subsequent year will be made except at the absolute discretion of the Company. |
8.8. | If, on termination of employment, you have taken more annual holiday entitlement than you have accrued in that holiday year, an appropriate deduction will be made from your final payment. |
8.9. | Where several employees require the same holiday period, which if granted would impair Company efficiency, the Company will grant holidays upon a 'first come first served' basis. |
8.10. | During periods of incapacity, you will continue to accrue holiday leave at the normal rate. If there is not enough time left in the current holiday year to make it practicable to take your holiday entitlement which you have been prevented from taking due to sickness, you can carry over up to four weeks' unused holiday entitlement to the following leave year to be used within three months of your return to work. Any annual leave not taken within 18 months of the end of the holiday year in which it accrues (whether or not you have returned to work) will be lost. |
8.11. | If you fall ill either before or during a period of pre-booked annual leave, you may reschedule that period of holiday for a later date within the current holiday year. If you wish to rearrange a period of annual leave due to sickness or incapacity, you should notify the CEO as soon as possible but no later than one week after the first day of sickness absence. |
4
8.12. | Further rules relating to the Company holiday rules can be found in the Personnel Handbook. You are advised to familiarise yourself with these before making an annual leave request. |
9. | SICKNESS AND SICKPAY |
9.1. | If you are going to be absent from work due to incapacity or illness, you should ensure that you have notified the CEO no later than 10am UK time. You should inform the CEO of details of the nature of your illness or injury, the expected length of your absence from work, any contact details and any outstanding or urgent work that requires attention. |
9.2. | For sickness absence of up to seven calendar days, you must telephone the CEO each day to keep them updated. You must complete a self-certification form and return this. |
9.3. | Failure to report your absence and provide the requisite evidence as set out above, will be considered unauthorised absence and will be unpaid. In addition, unauthorised absence is a disciplinary offence warranting disciplinary action up to and including dismissal without notice. |
9.4. | For sickness absence of more than a week you must obtain a certificate from your doctor stating that you are not fit for work and the reasons why. This should be forwarded on to the CEO as soon as possible. If your absence continues, further medical certificates must be provided to cover the whole period of absence. |
9.5. | During authorised absence due to sickness or injury, you will be entitled to receive Statutory Sick Pay (SSP) from the Company. Rules relating to SSP are outlined in the Company Sickness Absence Policy within the Personnel Handbook. |
9.6. | In addition to SSP, you are entitled to receive the following enhancement of sick pay: |
1 month full pay
1 month 50% of pay
9.7. | Any payment made in excess of Statutory Sick Pay will be inclusive of the current SSP rate. |
9.8. | If the incapacity is or appears to be occasioned by actionable negligence, nuisance or breach of any statutory duty on the part of a third party in respect of which damages are or may be recoverable, the Employee shall immediately notify the Company of that fact and of any claim, compromise, settlement or judgment made or awarded in connection with it. The Employee shall, if required, refund to the Company that part of any damages or compensation recovered by him/her relating to the loss of earnings for the period of the incapacity, less any costs borne by him/her in connection with the recovery of such damages or compensation, provided that the amount to be refunded shall not exceed the total amount paid to the Employee by the Company in respect of the period of Incapacity. |
9.9. | Further rules relating to sickness, sick pay and the Company absence policies and procedures can be found in the Personnel Handbook. |
10. | PENSION |
10.1. | The Company will comply with the employer pension duties in respect of the Employee in accordance with Part 1 of the Pensions Act 2008. |
10.2. | You will become an active member of our occupational pension scheme (Scheme) (or such other registered pension scheme as we may establish to replace the Scheme) subject to the rules of the Scheme and the tax reliefs and exemptions available from HM Revenue & Customs, in both cases as amended from time to time. The Company will contribute £10,000 per year to this Scheme. |
5
11. | RETIREMENT |
11.1. | There is no fixed retirement age associated with your position. Your retirement age shall solely be determined by you at any point during your employment. If you wish to retire, you should advise the CEO as soon as possible, providing the minimum notice as required by this contract. |
12. | TERMINATION OF EMPLOYMENT |
12.1. | Both parties are required to give 6 months written notice of termination. |
12.2. | The Company reserves the right to make payment in lieu of notice. Any payment In lieu of notice shall be limited to your basic rate of pay only. |
12.3. | Should you leave without notice or during the notice period without the Company's consent, the Company reserves the right to deduct pay for time not worked during the notice period. This clause is taken to be authority given by you that the Company shall have such contractual right to deduct such sums from your final payment of salary. |
13. | GARDEN LEAVE |
13.1. | After you have given or received notice to terminate your employment: |
13.1.1. | The Company will be under no obligation to give you any powers or duties, or provide work for you. The Company may, in its discretion vary, or suspend you from, the performance of your duties, exclude from its premises, or require you to perform your duties at home for a period not exceeding 6 months, in which case all other provisions of this contract shall continue in force. |
13.1.2. | The Company may require you to return all Company property in your possession or control including any Company vehicle (without compensation) and to resign from any positions held by you as part of your duties. |
13.1.3. | The Company may require you to not, either directly or indirectly, contact the Company's clients, customers, suppliers or employees until your employment ends. |
14. | COLLECTIVE AGREEMENTS |
14.1. | There are no collective agreements which affect your terms and conditions of employment |
15. | RESTRICTIVE COVENANTS |
15.1. | The parties agree that through your position in the Company, you may disclose corporate secrets that cannot be protected by patents or similar registration procedures, and whose use in competing activities would result in significant loss for the Company. The parties also agree that it is a prerequisite for the Company, in confidence, to submit such information to you in order that the Company can ensure that you do not use the knowledge and contacts obtained through the employment to build or operate in operations that compete with the Company or its affiliates. It is therefore incumbent upon you to, during the term of the Employment Agreement and for nine (9) months from termination of employment, either yourself or as owner, partner, board member, adviser or employee of another company, either directly or indirectly with the Company, or with its affiliates, in competing operations. |
15.2. | Except in the cases mentioned below, the Company shall pay you a monthly payment in arrears, as compensation for the inconvenience of the competitive prohibition on competition. The compensation shall be calculated as the difference of the income that you subsequently earn, or could reasonably have eamt in a new employment or other employment, and the average compensation received (including both fixed salary and variable remuneration) in the last 12 months before termination of employment. However, the remuneration from the Company shall never exceed sixty (60) percent per month of your average monthly remuneration per month during the period when the prohibition on competition applies. In the event that you, despite reasonable measures to limit its loss of income, do not receive new employment or engage in other employment activities after termination of employment, compensation is paid monthly by sixty (60) percent of your average monthly compensation as set out above during the period of the competitive ban. The right to compensation from the Company in accordance with this paragraph assumes that there is a causal link between your commitment to prohibit competition and the loss of income arising from its application. Compensation is not paid if you violate the prohibition on competition. |
6
15.3. | After the termination of employment, you shall keep the Company informed of the size of its income from new employers or other business activities. Such notification shall be made in writing to the Company no later than the 15th of each month. If this does not happen, it is assumed that you have not suffered any loss of income for that month, without the restriction of competition according to point 15.1, for that reason. |
15.4. | Compensation under this paragraph shall not be paid for the period during which you may receive severance pay from the Company or if the employment terminates due to: (i) your retirement or (ii) cancellation of the Employment Agreement or the Company has terminated you. |
15.5. | Both during the employment and after either party's termination of employment and as long as the prohibition on competition is in force, the Company can unilaterally, through notification to you, limit the scope of the prohibition on competition or completely free you from the obligation to comply with the prohibition on competition. In the event that the Company completely exempts you from the obligation to comply with the prohibition on competition, the Company's liability under paragraph 15.2 above shall cease to apply. The company's possible exemption from the competition ban must be given with one month's notice period. |
15.6. | The parties agree that during the term of employment of the Employment Agreement and for twelve (12) months from termination of employment, you must not have, in person or through any other, business contacts with any person or company, which during the last twelve months prior to the employment cessation has been a customer of, or actively processed by, the Company or its affiliated companies, with the aim of causing such customer / potential customer to change, terminate or not enter into a commercial relationship with the Company or its affiliates. However, upon request from you, the Company may, in written confirmation, in individual cases release you from this undertaking. |
15.7. | The parties further agree that during the term of the Employment Agreement and for twelve (12) months from termination of employment, you may not employ, either personally or through any other person, any person employed or employed by the Company or its affiliates or utilize their services other than through the Company. However, upon request from you, the Company may, in written confirmation, in individual cases release you from this undertaking. |
16. | CONFIDENTIALITY |
16.1. | Without prejudice to their common law duties, the employee shall not (except in the proper course of his duties, as authorised or required by law or as authorised by the Board, either during Employment or at any time after Termination (however arising): |
16.1.1. | Use any Confidential Information; or |
16.1.2. | Make or use any Copies; or |
16.1.3. | Disclose any Confidential Information to any person, company or other organisation whatsoever. |
16.2. | The restriction in clause 16 does not apply to any Confidential information which is in or comes into the public domain other than through the Employee's unauthorised disclosure. |
16.3. | The Employee shall be responsible for protecting the confidentiality of the Confidential Information and shall: |
16.3.1. | Use their best endeavours to prevent the use or communication of any Confidential Information by any person, company or organisation (except in the proper course of their duties, as required by law or as authorised by the Board; and |
16.3.2. | Inform the Board immediately on becoming aware, or suspecting, that any such person, company or organisation knows or has used any Confidential Information. |
16.4. | Any Confidential Information and copies, including all material belonging to the Company and that which you have produced during the course of your Employment, shall be the property of the Company on Termination, or at the request of the Board at any time during Employment with the Company, the Employee shall: |
16.4.1. | Hand over all Confidential Information or copies to the Company; |
7
16.4.2. | Irretrievably delete any Confidential Information (including any copies) stored on any magnetic or optical disk or memory, including personal computer networks, personal e-mail accounts or personal accounts on websites and all matter derived from such sources which is in their possession or under their control outside the Company's premises; and |
16.4.3. | Provide a signed statement that they have complied fully with their obligations under this clause. |
16.5. | You agree to return all confidential information immediately upon termination, including material belonging to the Company, and that which you have produced during the course of your employment. |
16.6. | Nothing in this clause 16 shall prevent the Employee from making a protected disclosure within the meaning of section 43A of the Employment Rights Act 1996. |
17. | INTELLECTUAL PROPERTY |
17.1. | The definitions in this clause apply in this agreement. |
Appointment: the employment of you by the Company on the terms of this contract.
Intellectual Property Rights: patents, rights to inventions, copyright and related rights, trademarks, trade names and domain names, rights in get-up, goodwill and the right to sue for passing off or unfair competition, rights in designs, rights in computer software, database rights, rights to preserve the confidentiality of information (including know-hoe and trade secrets) and any other intellectual property rights, in each case whether registered or unregisters and including all applications (or rights to apply) for and be granted, renewals or extensions of, and rights to claim priority from, such rights and all similar or equivalent rights and forms of protection which may now or in the future subsist in any part of the world.
Inventions: inventions, ideas and improvements, whether or not patentable, and whether or not recorded in any medium.
17.2. | You shall give the Company full written details of all inventions and of all works embodying Intellectual Property Rights made wholly or partially by you at any time during the course of the Appointment which relate to, or are reasonably capable of being used in, the business of the Company. You acknowledge that all Intellectual Property Rights subsisting (or which may in the future subsist) in all such Inventions and works shall automatically, on creation, vest in the Company absolutely. To the extent that they do not vest automatically, you hold them on trust for the Company. You agree promptly to execute all documents and do all acts as may, in the opinion of the Company, be necessary to give effect to this clause. |
17.3. | You hereby irrevocably waive all moral rights under the Copyright, Designs and Patents Act 1988 (and all similar rights in other jurisdictions) which you have or will have in any existing or future works referred to in this clause. |
17.4. | You irrevocably appoint the Company to be your attorney in your name and on your behalf to execute documents, use your name and do all things which are necessary or desirable for the Company to obtain for itself or its nominee the full benefit of this clause. |
18. | DISCIPLINARY & GRIEVANCE |
18.1. | Your attention is drawn to the disciplinary and grievance procedures applicable to your employment, which are available from the CEO and stated in the Personnel Handbook. These procedures do not form part of your contract of employment and are intended for guidance only. The Company disciplinary rules are however terms and conditions of your employment. |
18.2. | We reserve the right to suspend you with pay for a reasonable period for the purposes of investigating any allegation of misconduct or neglect against you. Suspension under these circumstances is a neutral act and does not infer any assumption of guilt. |
18.3. | In exceptional circumstances, suspension from work without pay for an appropriate period of time may be considered at the conclusion of any disciplinary process as an alternative to dismissal. |
18.4. | In some cases as an alternative to issuing a formal written warning or as an alternative to dismissal, the Company reserves the right to demote you for such period as is necessary to enable you to reach the desired standards. This will be done by notice in writing to you. The Company also reserves the right to impose a reduction in your pay for the period of demotion and the written notice will detail any changes to your terms and conditions of employment arising from such demotion. In particular, the notice will give details of any reduction to your salary and / or loss of benefits arising from the demotion. |
8
19. | HEALTH & SAFETY |
19.1. | You have a duty whilst at work to take reasonable care for the health and safety of yourself and of other persons who may be affected by your acts or omissions. You also have a duty to co-operate with the Company in complying with any statutory duty or requirements concerning health and safety at work. |
19.2. | As regards to any duty or requirement imposed on the Company or any other person by or under any of the relevant statutory provisions, you must co-operate with the Company so far as is necessary to enable that duty or requirement to be performed or complied with. |
19.3. | You must at all times use any safety equipment provided by the Company and must adopt a safe and correct practice to all work done by you. You must comply with the Company's Health and Safety Policy from time to time In force. You should note that it may be a criminal offence for you not to wear or use safety equipment that has been provided for your safety. |
19.4. | You are responsible for acquainting yourself with all the health and safety and fire procedures. In the event you are unclear or unsure or have any genuine safety concerns or observations then you must report these to the CEO immediately. |
19.5. | Any failure to comply with any of these health and safety requirements may lead to disciplinary action being taken against you. |
20. | DATA PROTECTION (GDPR) |
20.1. | Employee's personal data - The Company will collect and process information relating to you in accordance with the privacy notice. You required to sign and date the privacy notice provided to you, and return the same to the CEO with a signed copy of this contract. |
20.2. | Employee's responsibilities when handling personal data — You shall comply with the GDPR Data Protection policy when handling personal data in the course of employment including personal data relating to any employee, customer, client, supplier or agent of the Company. You will also comply with the Company's IT and Communications Systems Policy and Social Media Policy. |
20.3. | Failure to comply with the GDPR Data Protection Policy or any of the policies listed above in clause 20.2 may be dealt with under our disciplinary procedure and, in serious cases, may be treated as gross misconduct leading to summary dismissal. |
21. | MONITORING |
21.1. | The Company's systems enable the Company to monitor telephone, email, voicemail, intemet and other communications. In order to carry out its legal obligations as an employer (such as ensuring the Employee's compliance with the Company's IT related policies), and for other business reasons, the Company may monitor use of systems including the telephone and computer systems, and any personal use of them, by automated software or otherwise. Monitoring is only carried out to the extent permitted or as required by law and as necessary and justifiable for business purposes. |
22. | WARRANTY |
22.1. | You warrant that you have the right to work in the UK and further agree to immediately notify the Company should there be any change in your circumstances which may affect your right to work in the UK. The Company reserves the right to terminate your employment (with or without notice, as appropriate) should your right to work in the UK be withdrawn. Any misrepresentation of your employment status is a serious disciplinary offence which may result in your summary dismissal. |
22.2. | You represent and warrant to us that, by entering into this agreement or performing any of their obligations under it, you will not be in breach of any court order or any express or implied terms of any contract or other obligation binding on them and undertake to indemnify us against any claims, costs, damages, liabilities or expenses which we may incur as a result if you are in breach of any such obligations. |
9
23. | TERMINATION WITHOUT PREJUDICE |
23.1. | Any termination of the employment of the Employee will be without prejudice to your continuing obligations under this contract. |
24. | DUTIES ON TERMINATION |
24.1. | Promptly deliver up to the Company all Company property, including but not limited to any mobile phone, laptop, documents, records, manuals, computer files or software, visual or audio tapes or other materials containing information (including, without limitation, confidential information) relating to the Company's business created by, in the possession of, or under the control of you. |
25. | ALTERATION OF TERMS AND CONDITIONS |
25.1. | The Company reserves the right to make any reasonable changes to the terms and conditions of employment set out in this document from time to time if this shall be deemed necessary for the Company's business and/or efficiency. This will normally be undertaken through consultation and providing employees with as much notice as possible. |
25.2. | Whilst the Company will only alter such terms out of necessity in order to safeguard, promote, maintain or operate more efficiently in response to business needs, it shall consult and consider all reasonable objections by the employees. |
25.3. | You will be notified of minor changes of detail by way of a general notice to all employees and any such changes take effect from the date of such notice. |
26. | ENTIRE UNDERSTANDING |
26.1. | Except as otherwise expressly provided by its terms, this contract represents the entire understanding and supersedes any previous agreement between the parties in relation to the employment of you by the Company. |
26.2. | This contract should be read in conjunction with the Personnel Handbook which gives further details on the rules, regulations and guidelines of the Company. |
27. | JURISDICTION |
27.1. | This contract and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the law of England and Wales. |
28. | ACCEPTANCE |
28.1. | I acknowledge that I have carefully considered the above terms and conditions and acknowledge that I fully understand the stated terms and in particular the stated conditions and agree to be contractually bound by them. |
Signed by the Employee | Signed on behalf of the Company | |
Richard Philipson | Renee Aguir-Lucander, CEO | |
R S Philipson | ||
Date: 26 MAR 2020 | Date | |
10
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the reference to our firm under the caption “Experts” and to the use of our report dated February 28, 2020, in the Registration Statement (Form F-1) and related Prospectus of Calliditas Therapeutics AB dated January 26, 2021.
/s/ Ernst & Young AB
Stockholm, Sweden
January 26, 2021
Exhibit 23.2
Consent of Independent Auditors
We consent to the use of our report dated January 25, 2021, with respect to the consolidated statements of financial position of Genkyotex S.A and its subsidiary as of September 30, 2020 and December 31, 2019 and the related consolidated income statements, consolidated statements of comprehensive income (loss), statements of changes in consolidated shareholders’ equity and consolidated statements of cash flows for the nine month period ended September 30, 2020 and the year ended December 31, 2019, and the related notes to the consolidated financial statements, included in Calliditas Therapeutics AB’s Registration Statement on Form F-1 and to the reference to our firm under the heading "Experts" in the prospectus.
Our report dated January 25, 2021 expresses a qualified opinion and includes a Basis for Qualified Opinion paragraph stating that as disclosed in Note 2.1 to the consolidated financial statements, the consolidated financial statements have been prepared to meet the reporting requirements of Rule 3-05 of Regulation S-X for purposes of a filing with the U.S. Securities and Exchange Commission and do not include comparative financial information as required by IAS 1 “Presentation of Financial Statements”.
Lyon, France
January 26, 2021
KPMG Audit
Division of KPMG S.A.
Stephane Devin | Bertrand Roussel |
Partner | Partner |