UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2019
Commission File Number: 001-38064
Aeterna Zentaris Inc.
(Translation of registrant’s name into English)
315 Sigma Drive, Summerville, South Carolina, USA 29486
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [X] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
This report on Form 6-K, including the exhibits hereto, shall be deemed incorporated by reference into the Registrant’s Registration Statements on Form F-3 (Files No. 333-232935) and Forms S-8 (File Nos. 333-224737, 333-210561, 333-200834) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
DOCUMENTS INDEX
Exhibit | Description | |
99.1 | Aeterna Zentaris’ Condensed Interim Consolidated Financial Statements - Second Quarter 2019 (Q2) | |
99.2 | Aeterna Zentaris’ Management’s Discussion and Analysis of Financial Condition and Results of Operations - Second Quarter 2019 (Q2) | |
99.3 | Certification of the Chief Executive Officer pursuant to National Instrument 52-109 | |
99.4 | Certification of the Principal Financial Officer pursuant to National Instrument 52-109 | |
101 | IV XBRL | |
101. | SCH XBRL | |
101. | CAL XBRL | |
101. | DEF XBRL | |
101. | LAB XBRL | |
101. | PRE XBRL |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
AETERNA ZENTARIS INC. | |||
Date: August 13, 2019 | By: | /s/ Michael V. Ward | |
Michael V. Ward | |||
Chief Executive Officer |
Exhibit 99.1
Condensed Interim Consolidated Financial Statements
( Unaudited )
Aeterna Zentaris Inc.
As at June 30, 2019 and for the three-month and six-month periods ended June 30, 2019 and 2018
(presented in thousands of US dollars)
Aeterna Zentaris Inc. |
As at June 30, 2019 and for the three-month and six-month period ended June 30, 2019 and 2018 |
Condensed Interim Consolidated Financial Statements |
(Unaudited) |
( 2 ) |
Aeterna Zentaris Inc. |
Condensed Interim Consolidated Statements of Financial Position |
(in thousands of US dollars) | ||||||||
( Unaudited ) | June 30, 2019 | December 31, 2018 | ||||||
$ | $ | |||||||
ASSETS | ||||||||
Current Assets | ||||||||
Cash and cash equivalents | 9,683 | 14,512 | ||||||
Trade and other receivables (note 6) | 494 | 294 | ||||||
Inventory | 562 | 240 | ||||||
Prepaid expenses and other current assets | 1,030 | 1,210 | ||||||
Total current assets | 11,769 | 16,256 | ||||||
Restricted cash | 367 | 418 | ||||||
Right of use assets (note 4) | 340 | — | ||||||
Property, plant and equipment | 48 | 65 | ||||||
Identifiable intangible assets | 50 | 62 | ||||||
Goodwill | 8,177 | 8,210 | ||||||
Total assets | 20,751 | 25,011 | ||||||
LIABILITIES | ||||||||
Current liabilities | ||||||||
Payables and accrued liabilities (note 7) | 3,200 | 2,966 | ||||||
Provision for restructuring and other costs (note 8) | 1,004 | 887 | ||||||
Income taxes payable | 1,662 | 1,669 | ||||||
Current portion of deferred revenues | 74 | 74 | ||||||
Current portion of lease liabilities (note 4) | 635 | — | ||||||
Current portion of warrant liability (note 9) | 447 | — | ||||||
Total current liabilities | 7,022 | 5,596 | ||||||
Deferred revenues | 222 | 258 | ||||||
Lease liabilities (note 4) | 570 | — | ||||||
Warrant liability (note 9) | 1,004 | 3,634 | ||||||
Employee future benefits (note 10) | 14,561 | 13,205 | ||||||
Non-current portion of provision for restructuring and other costs (note 8) | 400 | 411 | ||||||
Total liabilities | 23,779 | 23,104 | ||||||
SHAREHOLDERS’ (DEFICIENCY) EQUITY | ||||||||
Share capital | 223,140 | 222,335 | ||||||
Other capital | 89,824 | 89,342 | ||||||
Deficit | (315,977 | ) | (309,781 | ) | ||||
Accumulated other comprehensive (loss) income | (15 | ) | 11 | |||||
Total shareholders’ (deficiency) equity | (3,028 | ) | 1,907 | |||||
Total liabilities and shareholders’ (deficiency) equity | 20,751 | 25,011 |
Going concern (note 1)
Commitments and contingencies (note 18)
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
( 3 ) |
Aeterna Zentaris Inc. |
Condensed Interim Consolidated Statements of Financial Position |
(in thousands of US dollars) |
Approved by the Board of Directors
/s/ Carolyn Egbert | /s/ Gérard Limoges | |
Carolyn Egbert
Chair of the Board |
Gérard Limoges
Director |
( 4 ) |
Aeterna Zentaris Inc. |
Condensed Interim Consolidated Statements of Changes in Shareholders’ (Deficiency) Equity |
For the three and six months ended June 30, 2019 and 2018 |
(in thousands of US dollars, except share data) | ||||||||||||||||||||||||
(Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive (loss) income | Total | ||||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||||||
Balance - April 1, 2019 | 16,440,760 | 222,335 | 89,437 | (315,427 | ) | 95 | (3,560 | ) | ||||||||||||||||
Net income | — | — | — | 206 | — | 206 | ||||||||||||||||||
Other comprehensive loss: | ||||||||||||||||||||||||
Foreign currency translation adjustments | — | — | — | — | (110 | ) | (110 | ) | ||||||||||||||||
Actuarial loss on defined benefit plan (note 10) | — | — | — | (756 | ) | — | (756 | ) | ||||||||||||||||
Comprehensive (loss) | — | — | — | (550 | ) | (110 | ) | (660 | ) | |||||||||||||||
Issuance of common shares | 191,650 | 805 | — | — | — | 805 | ||||||||||||||||||
Share-based compensation costs | — | — | 387 | — | — | 387 | ||||||||||||||||||
Balance - June 30, 2019 | 16,632,410 | 223,140 | 89,824 | (315,977 | ) | (15 | ) | (3,028 | ) |
(Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive (loss) income | Total | ||||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||||||
Balance - April 1, 2018 | 16,440,760 | 222,335 | 88,895 | (299,737 | ) | 49 | 11,542 | |||||||||||||||||
Net income | — | — | — | (2,602 | ) | — | (2,602 | ) | ||||||||||||||||
Other comprehensive loss: | ||||||||||||||||||||||||
Foreign currency translation adjustments | — | — | — | — | (28 | ) | (28 | ) | ||||||||||||||||
Actuarial gain on defined benefit plan (note 10) | — | — | — | 205 | — | 205 | ||||||||||||||||||
Comprehensive income (loss) | — | — | — | (2,397 | ) | (28 | ) | (2,425 | ) | |||||||||||||||
Share-based compensation costs | — | — | 393 | — | — | 393 | ||||||||||||||||||
Balance - June 30, 2018 | 16,440,760 | 222,335 | 89,288 | (302,134 | ) | 21 | 9,510 |
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
( 5 ) |
Aeterna Zentaris Inc. |
Condensed Interim Consolidated Statements of Changes in Shareholders’ (Deficiency) Equity |
For the three and six months ended June 30, 2019 and 2018 |
(in thousands of US dollars, except share data) | ||||||||||||||||||||||||
(Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive (loss) income | Total | ||||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||||||
Balance - January 1, 2019 | 16,440,760 | 222,335 | 89,342 | (309,781 | ) | 11 | 1,907 | |||||||||||||||||
Net (loss) | — | — | — | (4,705 | ) | — | (4,705 | ) | ||||||||||||||||
Other comprehensive loss: | ||||||||||||||||||||||||
Foreign currency translation adjustments | — | — | — | — | (26 | ) | (26 | ) | ||||||||||||||||
Actuarial loss on defined benefit plan (note 10) | — | — | — | (1,491 | ) | — | (1,491 | ) | ||||||||||||||||
Comprehensive (loss) | — | — | — | (6,196 | ) | (26 | ) | (6,222 | ) | |||||||||||||||
Issuance of common shares | 191,650 | 805 | — | — | — | 805 | ||||||||||||||||||
Share-based compensation costs | — | — | 482 | — | — | 482 | ||||||||||||||||||
Balance - June 30, 2019 | 16,632,410 | 223,140 | 89,824 | (315,977 | ) | (15 | ) | (3,028 | ) |
(Unaudited) | Common shares (number of) | Share capital | Other capital | Deficit | Accumulated other comprehensive (loss) income | Total | ||||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||||||
Balance - January 1, 2018 | 16,440,760 | 222,335 | 88,772 | (314,161 | ) | 271 | (2,783 | ) | ||||||||||||||||
Net income | — | — | — | 11,822 | — | 11,822 | ||||||||||||||||||
Other comprehensive loss: | ||||||||||||||||||||||||
Foreign currency translation adjustments | — | — | — | — | (250 | ) | (250 | ) | ||||||||||||||||
Actuarial gain on defined benefit plan (note 10) | — | — | — | 205 | — | 205 | ||||||||||||||||||
Comprehensive income (loss) | — | — | — | 12,027 | (250 | ) | 11,777 | |||||||||||||||||
Share-based compensation costs | — | — | 516 | — | — | 516 | ||||||||||||||||||
Balance - June 30, 2018 | 16,440,760 | 222,335 | 89,288 | (302,134 | ) | 21 | 9,510 |
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
( 6 ) |
Aeterna Zentaris Inc. |
Condensed Interim Consolidated Statements of Comprehensive Income (Loss) |
For the three and six months ended June 30, 2019 and 2018 |
(in thousands of US dollars, except share and per share data) | ||||||||||||||||
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||||
(Unaudited) | 2019 | 2018 | 2019 | 2018 | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Revenues | ||||||||||||||||
Royalty income (note 5) | 8 | — | 21 | — | ||||||||||||
Product sales (note 5) | 129 | — | 129 | — | ||||||||||||
Sales commission and other | 39 | 79 | 45 | 169 | ||||||||||||
Licensing revenue (note 5) | 18 | 89 | 36 | 24,657 | ||||||||||||
Total revenues | 194 | 168 | 231 | 24,826 | ||||||||||||
Cost of goods sold | 101 | 197 | 101 | 197 | ||||||||||||
Gross income (loss) | 93 | (29 | ) | 130 | 24,629 | |||||||||||
Research and development costs | 571 | 974 | 1,099 | 1,807 | ||||||||||||
General and administrative expenses | 1,923 | 2,004 | 3,560 | 4,790 | ||||||||||||
Selling expenses | 495 | 497 | 799 | 2,138 | ||||||||||||
Restructuring costs (note 8) | 773 | — | 773 | — | ||||||||||||
Impairment of right of use asset (note 4) | 64 | — | 401 | — | ||||||||||||
Write-off of other current assets | — | — | 169 | — | ||||||||||||
Total operating expenses | 3,826 | 3,475 | 6,801 | 8,735 | ||||||||||||
(Loss) income from operations | (3,733 | ) | (3,504 | ) | (6,671 | ) | 15,894 | |||||||||
(Loss) gain due to changes in foreign currency exchange rates | (6 | ) | 677 | 58 | 725 | |||||||||||
Change in fair value of warrant liability (note 9) | 3,926 | (134 | ) | 1,865 | 1,694 | |||||||||||
Other finance income | 19 | 126 | 43 | 144 | ||||||||||||
Net finance income | 3,939 | 669 | 1,966 | 2,563 | ||||||||||||
Income (loss) before income taxes | 206 | (2,835 | ) | (4,705 | ) | 18,457 | ||||||||||
Income tax recovery (expense) | — | 233 | — | (6,635 | ) | |||||||||||
Net income (loss) | 206 | (2,602 | ) | (4,705 | ) | 11,822 | ||||||||||
Other comprehensive (loss) income: | ||||||||||||||||
Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||
Foreign currency translation adjustments | (110 | ) | (28 | ) | (26 | ) | (250 | ) | ||||||||
Items that will not be reclassified to profit or loss: | ||||||||||||||||
Actuarial loss (gain) on defined benefit plans | (756 | ) | 205 | (1,491 | ) | 205 | ||||||||||
Comprehensive (loss) income | (660 | ) | (2,425 | ) | (6,222 | ) | 11,777 | |||||||||
Net (loss) income per share [basic] | 0.01 | (0.16 | ) | (0.28 | ) | 0.72 | ||||||||||
Net (loss) income per share [diluted] | 0.01 | (0.16 | ) | (0.28 | ) | 0.70 | ||||||||||
Weighted average number of shares outstanding (note 17): | ||||||||||||||||
Basic | 16,622,415 | 16,440,760 | 16,532,090 | 16,440,760 | ||||||||||||
Diluted | 17,260,016 | 16,440,760 | 16,532,090 | 16,489,364 |
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
( 7 ) |
Aeterna Zentaris Inc. |
Condensed Interim Consolidated Statements of Cash Flow |
For the three and six months ended June 30, 2019 and 2018 |
(in thousands of US dollars, except share and per share data) | ||||||||||||||||
Three months ended June 30, |
Six months ended
June 30, |
|||||||||||||||
(Unaudited) | 2019 | 2018 | 2019 | 2018 | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Cash flows from operating activities | ||||||||||||||||
Net income (loss) for the period | 206 | (2,602 | ) | (4,705 | ) | 11,822 | ||||||||||
Items not affecting cash and cash equivalents: | ||||||||||||||||
Change in fair value of warrant liability (note 9) | (3,926 | ) | 134 | (1,865 | ) | (1,694 | ) | |||||||||
Provision for restructuring costs (note 8) | 790 | — | 773 | (214 | ) | |||||||||||
Depreciation and amortization | 70 | 21 | 136 | 35 | ||||||||||||
Impairment of right of use asset (note 4) | 64 | — | 401 | — | ||||||||||||
Write-off of current assets | — | — | 169 | — | ||||||||||||
Deferred income taxes | — | — | — | 3,479 | ||||||||||||
Share-based compensation costs | 595 | 392 | 690 | 515 | ||||||||||||
Employee future benefits (note 10) | 2 | (311 | ) | 136 | (233 | ) | ||||||||||
Amortization of deferred revenues | (18 | ) | — | (36 | ) | (541 | ) | |||||||||
Foreign exchange loss on items denominated in foreign currencies | (4 | ) | (629 | ) | (49 | ) | (729 | ) | ||||||||
Gain on disposal of property, plant and equipment | — | — | (3 | ) | 9 | |||||||||||
Other non-cash items | — | 8 | — | 24 | ||||||||||||
Changes in operating assets and liabilities (note 13) | 51 | (1,790 | ) | (823 | ) | (533 | ) | |||||||||
Net cash (used in) provided by operating activities | (2,170 | ) | (4,777 | ) | (5,176 | ) | 11,940 | |||||||||
Cash flows from financing activities | ||||||||||||||||
Proceeds from issuance of common shares | 314 | — | 314 | — | ||||||||||||
Payments on lease liability | (159 | ) | — | (310 | ) | — | ||||||||||
Net cash from financing activities | 155 | — | 4 | — | ||||||||||||
Cash flows from investing activities | ||||||||||||||||
Disposal of property, plant and equipment | — | — | — | 11 | ||||||||||||
Change in restricted cash | — | — | 50 | — | ||||||||||||
Net cash from investing activities | — | — | 50 | 11 | ||||||||||||
Effect of exchange rate changes on cash and cash equivalents | 341 | 175 | 293 | 215 | ||||||||||||
Net change in cash and cash equivalents | (1,674 | ) | (4,602 | ) | (4,829 | ) | 12,166 | |||||||||
Cash and cash equivalents – Beginning of period | 11,357 | 24,548 | 14,512 | 7,780 | ||||||||||||
Cash and cash equivalents – End of period | 9,683 | 19,946 | 9,683 | 19,946 |
The accompanying notes are an integral part of these condensed interim consolidated financial statements.
( 8 ) |
1 | Going Concern |
The Company has incurred significant expenses in its efforts to develop and co-promote products. Consequently, the Company has incurred operating losses and negative cash flow from operations historically and in each of the last several years except for the year ended December 31, 2018 when the Company earned revenue from the sale of a license for the adult indication of Macrilen™ (macimorelin) in the United States and Canada (note 5). As at June 30, 2019, the Company had an accumulated deficit of $316 million. The Company also had a net loss of $4,705 for the six months ended June 30, 2019, and negative cash flow from operations of $5,176.
The Company’s principal focus is on the licensing and development of Macrilen™ (macimorelin) and it currently does not have any other approved products. Under the terms of License and Assignment Agreement, Novo is funding 70% of the pediatric clinical trial submitted to the EMA and FDA, the Company’s sole development activity.
On March 12, 2019, the Company announced that its board of directors formed a special committee of independent directors (the “Special Committee”) to review strategic options available to the Company. The Special Committee has approved the engagement by the Company of a financial advisor that is working with management to assist the Special Committee and the board of directors in considering a wide range of transactions (including opportunities for the license of Macrilen™ (macimorelin) outside of the United States and Canada, or other monetization transactions relating to Macrilen™ (macimorelin).
Management has evaluated whether material uncertainties exist relating to events or conditions and has considered the following in making that critical judgment.
The ability of the Company to realize its assets and meet its obligations as they come due is dependent on earning sufficient revenues under the License and Assignment Agreement, developing opportunities for Macrilen™ (macimorelin) in the rest of the world, realizing other monetizing transactions, and raising additional sources of funding, the outcome of which cannot be predicted at this time. The revenue provided under the License and Assignment Agreement was $21 for the six months ended June 30, 2019 and as at June 30, 2019, the Company had cash of $9,683.
Furthermore, nearly all of the Company’s cash is held in AEZS Germany, our wholly owned German subsidiary. AEZS Germany is also the counter-party for any and all cash received from revenue earned under the License and Assignment Agreement. At the present time, the Company’s North American operations are financed through the repayment of intercompany liabilities by AEZS Germany to the Canadian parent company and its U.S. subsidiary. However, if and when current and medium term liabilities of AEZS Germany exceed the values ascribed to AEZS Germany’s assets, it may no longer be possible under applicable German solvency laws for such cash transfers to take place. Although the Company currently expects AEZS Germany to continue to transfer cash to the Company’s North American operations to finance operations in the Canadian parent company and its U.S. subsidiary, in an amount sufficient for the Company (absent other funding sources) to finance most of its North American obligations, through at least the remainder of 2019, there is significant risk that AEZS Germany’s ability to make these transfers will become restricted. The Company expects to have secured additional financing prior to the end of 2019 from third party sources; however, there is no certainty that the Company will be successful in raising additional sources of cash.
The Company has some discretion to manage research and development costs, administrative expenses and capital expenditures in order to maintain its cash liquidity, however the Company will need to obtain equity or debt financing in 2019 in order to fund its ongoing operations. The outcome of these efforts is uncertain.
Management has assessed the Company’s ability to continue as a going concern and concluded that additional capital will be required. There can be no assurance that the Company will be able to obtain equity or debt financing, or on terms acceptable to it. Factors within and outside the Company’s control could have a significant bearing on its ability to obtain additional financing. As a result, management has determined that there are material uncertainties that may cast significant doubt upon the Company’s ability to continue as a going concern.
These financial statements have been prepared on a going concern basis, which asserts the Company has the ability in the near term to continue to realize its assets and discharge its liabilities and commitments in a planned manner giving consideration to the above and expected possible outcomes. Conversely, if the going concern assumption is not appropriate, adjustments to the carrying amounts of the Company’s assets, liabilities, revenues, expenses and balance sheet classifications may be necessary, and these adjustments could be material.
( 9 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
2 | Summary of business and basis of preparation |
Summary of business
Aeterna Zentaris Inc. (“Aeterna Zentaris” or the “Company”) is a specialty biopharmaceutical company which is commercializing novel pharmaceutical therapies. On December 20, 2017, the United States Food and Drug Administration (“FDA”) granted marketing approval for Macrilen™ (macimorelin) to be used in the diagnosis of patients with adult growth hormone deficiency (“AGHD”). On January 16, 2018, the Company, through Aeterna Zentaris GmbH (“AEZS Germany”), entered into a license and assignment agreement with Strongbridge Ireland Limited (“Strongbridge”) to carry out development, manufacturing, registration, regulatory and supply chain services for the commercialization of Macrilen™ (macimorelin) in the United States and Canada (the “License and Assignment Agreement”). Effective December 19, 2018, Strongbridge sold the United States and Canadian rights to Macrilen™ (macimorelin) under the License and Assignment Agreement to Novo Nordisk A/S (“Novo”).
Basis of presentation
These unaudited condensed interim consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) applicable to the preparation of interim financial statements, including IAS 34, Interim Financial Reporting . These unaudited condensed interim consolidated financial statements should be read in conjunction with the Company’s annual consolidated financial statements as at and for the year ended December 31, 2018.
The accounting policies in these condensed interim consolidated financial statements are consistent with those presented in the Company’s annual consolidated financial statements, except for the adoption, of IFRS 16, Leases, effective January 1, 2019. See note 4 for the impact of the adoption of IFRS 16.
These unaudited condensed interim consolidated financial statements were approved by the Company’s Board of Directors on August 12, 2019.
These unaudited condensed interim consolidated financial statements were prepared on a going concern basis.
3 | Critical accounting estimates and judgments |
The preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures. Judgments, estimates and assumptions are based on historical experience, expectations, current trends and other factors that management believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements are prepared.
Management reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgments in order to ensure that the condensed interim consolidated financial statements are presented fairly and in accordance with IFRS. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Critical accounting estimates and assumptions, as well as critical judgments used in applying accounting policies in the preparation of the Company’s condensed interim consolidated financial statements, were the same as those found in note 4 to the Company’s annual consolidated financial statements as of December 31, 2018 and 2017 and for the years ended December 31, 2018, and 2017 except for those related to the adoption of IFRS 16, as follows:
( 10 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
Critical judgments in determining the lease term and discount rate
In determining the lease term, management considers all facts and circumstances that create an economic incentive to exercise an extension option, or not exercise a termination option. Extension options (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated).
In determining the appropriate discount rate, management identified the rate for the building based on the type and location of the Company’s office, laboratory and storage facility in Frankfurt and, for vehicle and equipment leases, used the risk-free rate, credit spread and lease specific adjustment for similar assets.
4 | Recent accounting pronouncements |
Impact of adoption significant new IFRS standards in 2019
The following new IFRS standards have been adopted by the Company effective January 1, 2019:
A) IFRS 16, Leases
The Company has adopted IFRS 16 on a modified retrospective basis from January 1, 2019 with no restatement of comparatives, as permitted under the specific transitional provisions in the standard.
(i) Adjustments recognized on adoption of IFRS 16
Lease liabilities
The Company has operating leases for building, cars and equipment leases at its location in Frankfurt. Upon adoption of IFRS 16, the Company recognized lease liabilities in relation to leases which had previously been classified as ‘operating leases’ under the principles of IAS 17 Leases. Under IFRS 16, these liabilities were measured at the present value of the remaining lease payments excluding renewal options as they are not expected to be exercised, discounted using the Company’s incremental borrowing rate as of January 1, 2019. The Company’s incremental annual borrowing rate applied to the lease liabilities on January 1, 2019 were:
● | Building lease 5.5% | |
● | Car leases ranging from 4.84% to 5.32% | |
● | Equipment leases 3.88% |
The weighted average incremental borrowing rate applied to lease liabilities recognized in the statement of financial position at January 1, 2019 was 5.45%.
( 11 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
2019 | ||||
Operating lease commitments disclosed as at December 31, 2018 | 1,620 | |||
Discounted using the lessee’s incremental borrowing rate of at the date of initial application: | ||||
Lease liability recognized as at January 1, 2019 | 1,522 | |||
Current lease liabilities | 629 | |||
Non-current lease liabilities | 893 | |||
During the six-month period ended June 30, 2019 | ||||
Cash lease payments made | 348 | |||
Interest paid as charged to comprehensive profit and loss as other finance income | 38 | |||
Payment against lease liabilities | 310 | |||
Foreign exchange | 7 | |||
Lease liability recognized as at June 30, 2019 | 1,205 | |||
Current lease liabilities | 635 | |||
Non-current lease liabilities | 570 |
The Company’s lease liabilities come due, as at June 30, 2019, as follows:
$ | ||||
Less than 1 year | 635 | |||
1 - 3 years | 560 | |||
4 - 5 years | 10 | |||
More than 5 years | — | |||
Total | 1,205 |
Right of use assets
The Company’s related right of use assets were measured at the amount equal to the lease liability at the date of initial application. Only the building right of use asset was further adjusted by the application of $663 in related onerous lease provision to the value at inception.
Building | Cars and equipment | Total | ||||||||||
$ | $ | $ | ||||||||||
Cost | ||||||||||||
At January 1, 2019 | 735 | 124 | 859 | |||||||||
Additions | — | 26 | 26 | |||||||||
Disposals | — | (25 | ) | (25 | ) | |||||||
Impact of foreign exchange rate changes | (4 | ) | (5 | ) | (9 | ) | ||||||
At June 30, 2019 | 731 | 120 | 851 |
( 12 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
Building | Cars and equipment | Total | ||||||||||
$ | $ | $ | ||||||||||
Accumulated Amortization | ||||||||||||
At January 1, 2019 | — | — | — | |||||||||
Disposals | — | (3 | ) | (3 | ) | |||||||
Amortization | 87 | 30 | 117 | |||||||||
Impairment | 401 | — | 401 | |||||||||
Impact of foreign exchange rate changes | (2 | ) | (2 | ) | (4 | ) | ||||||
At June 30, 2019 | 486 | 25 | 511 |
Building | Cars and equipment | Total | ||||||||||
$ | $ | $ | ||||||||||
Carrying amount | ||||||||||||
At June 30, 2019 | 245 | 95 | 340 |
During the three-month period ended March 31, 2019, management continued its search for a sub-lessee. However, there have been delays which led to a reassessment of its onerous lease provision as the Company has determined that its plan to exit its building lease, in full, as at December 31, 2019 was not probable. As such, the Company recognized an impairment of its right of use building asset of $337 in the statement of comprehensive income and loss. In light of the June 2019 restructuring of the German operations (note 8), management recognized an additional impairment of $64 as office and lab space will become vacant or underutilized.
Overall impact from adoption
The change in accounting policy affected the following items in the balance sheet on January 1, 2019:
● | Right of use assets - increase by $859 | |
● | Onerous lease contracts - decrease by $663 | |
● | Lease liabilities - increase by $1,522 |
Income (loss) per share for the three and six months to June 30, 2019 was not affected as a result of the adoption of IFRS 16.
(ii) Practical expedients applied
In applying IFRS 16 for the first time, the Company has used the following practical expedients permitted by the standard:
● | the use of a single discount rate to a portfolio of leases with reasonably similar characteristics | |
● | reliance on previous assessments on whether leases are onerous | |
● | the exclusion of initial direct costs for the measurement of the right of use asset at the date of initial application; and | |
● | the use of hindsight in determining the lease term where the contract contains options to extend or terminate the lease. |
The Company has also elected not to reassess whether a contract is or contains a lease at the date of initial application. Instead, for contracts entered into before the transition date, the Company relied on its assessment made applying IAS 17 and IFRIC 4 Determining whether an Arrangement contains a Lease.
( 13 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
(iii) The Company’s leasing activities and how these are accounted for
The Company leases various office and lab premises (building), cars and equipment. The building lease was originally for 10 years with one five-year extension, such extension is ending on April 30, 2021. Car lease contracts are typically made for fixed periods of three to four years while the equipment lease is for five years ending April 30, 2020. Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. and the lease agreements do not impose any covenants, but leased assets may not be used as security for borrowing purposes.
Until the 2018 financial year, leases of property, plant and equipment were classified as operating leases. Payments made under operating leases (net of any incentives received from the lessor) were charged to profit or loss on a straight-line basis over the period of the lease.
From January 1, 2019, leases are recognized as a right of use asset and a corresponding liability at the date at which the leased asset is available for use by the Company. Each lease payment is allocated between the liability and finance cost. The finance cost is charged to comprehensive profit or loss over the lease period so as to produce a constant periodic rate of interest on the remaining balance of the liability for each period. The right of use assets are measured at cost and are depreciated over the shorter of the assets’ useful life and the lease terms on a straight-line basis, less any accumulated impairment losses and adjusted for any remeasurement of the lease liability.
Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities include the net present value of its fixed payments (including in-substance fixed payments), less any lease incentives receivable
The lease payments are discounted using the interest rate implicit in the lease. If that rate cannot be determined, the lessee’s incremental borrowing rate is used, being the rate that the lessee would have to pay to borrow the funds necessary to obtain an asset of similar value in a similar economic environment with similar terms and conditions.
Right of use assets are measured at cost comprising the following:
● | the amount of the initial measurement of lease liability; | |
● | any lease payments made at or before the commencement date less any lease incentives received; | |
● | any initial direct costs; | |
● | onerous lease provisions as previously determined (note 8); and | |
● | any restoration costs. |
Payments associated with short-term leases and leases of low-value assets are recognized on a straight-line basis as an expense in the statement of comprehensive profit or loss.
B) IFRIC 23, “ Uncertainty over Income Tax Treatment ” (“IFRIC 23”)
In June 2017, IFRIC 23, was issued and it provides guidance on how to value uncertain income tax positions based on the probability of whether the relevant tax authorities will accept the company’s tax treatments. A company is to assume that a taxation authority with the right to examine any amounts reported to it will examine those amounts and will have full knowledge of all relevant information when doing so. IFRIC 23 is effective for annual periods beginning on or after January 1, 2019. The adoption of this interpretation did not have a significant impact on the Company’s condensed interim consolidated financial statements.
C) Amendments in Plan Amendment, Curtailment or Settlement (Amendments to IAS 19)
In June 2015, the IASB published ED/2015/5 Remeasurement on a Plan Amendment, Curtailment or Settlement/Availability of a Refund from a Defined Benefit Plan (Proposed amendments to IAS 19 and IFRIC 14) combining two issues submitted separately to the IFRS Interpretations Committee into a single package of narrow-scope amendments to IAS 19 Employee Benefits and IFRIC 14 IAS 19 - The Limit on a Defined Benefit Asset, Minimum Funding Requirements and their Interaction . However, in April 2017 the IASB decided to pursue the amendments to IAS 19 and in September 2017 confirmed it would do so despite putting off the amendments to IFRIC 14. The amendments in Plan Amendment, Curtailment or Settlement (Amendments to IAS 19) are: (i) if a plan amendment, curtailment or settlement occurs, it is now mandatory that the current service cost and the net interest for the period after the remeasurement are determined using the assumptions used for the remeasurement and (ii) amendments have been included to clarify the effect of a plan amendment, curtailment or settlement on the requirements regarding the asset ceiling. An entity applies the amendments to plan amendments, curtailments or settlements occurring on or after the beginning of the first annual reporting period that begins on or after January 1, 2019. The adoption of these amendments did not have a significant impact on the Company’s condensed interim consolidated financial statements.
( 14 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
5 | Licensing arrangement |
On January 16, 2018, the Company, through AEZS Germany, entered into the License and Assignment Agreement with Strongbridge to carry out development, manufacturing, registration, regulatory and supply chain services for the commercialization of Macrilen™ (macimorelin) in the United States and Canada, which provides for (i) the “right to use” license relating to the Adult Indication; (ii) the sale of the right to acquire a license of a future FDA-approved Pediatric Indication; (iii) the agreement by Strongbridge to fund 70% of the costs of a pediatric clinical trial submitted for approval to the EMA and FDA to be run by the Company with customary oversight from a joint steering committee; and (iv) an Interim Supply Arrangement. Effective December 19, 2018, Strongbridge sold the entity which is the licensee under the License and Assignment Agreement to Novo.
Royalty income earned under the License and Assignment Agreement for the six-month period ending June 30, 2019 was $21 (2018- $nil). During the six-month period ended June 30, 2019, the Company invoiced Novo $621 for its share of PIP study costs and $839 for supply chain costs.
6 | Trade and other receivables |
June 30, 2019 | December 31, 2018 | |||||||
$ | $ | |||||||
Trade accounts receivable (net of allowance for doubtful accounts of $55 (December 31, 2018 - $55) | 217 | 142 | ||||||
Value added tax | 247 | 49 | ||||||
Other | 30 | 103 | ||||||
494 | 294 |
( 15 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
7 | Payables and accrued liabilities |
June 30, 2019 | December 31, 2018 | |||||||
$ | $ | |||||||
Trade accounts payable | 1,197 | 1,282 | ||||||
Accrued research and development costs | — | 26 | ||||||
Salaries, employment taxes and benefits | 258 | 183 | ||||||
Financing of insurance premiums (a) | 210 | 738 | ||||||
Other accrued liabilities | 1,535 | 737 | ||||||
3,200 | 2,966 |
(a) Represents financing of the Company’s 2019 insurance premiums, carrying interest at 6.5% and repayable in eight equal monthly installments commencing January 31, 2019.
8 | Provision for restructuring costs |
In the third quarter of 2017, AEZS Germany, and its Works Council approved a restructuring program (the “2017 German Restructuring”), which was rolled out as a part of the continued strategy to transition into a commercially operating specialty biopharmaceutical organization focused on the commercialization of Macrilen™ (macimorelin). On June 6, 2019, the Company announced that it was further reducing the size of its German workforce to more closely reflect the Company’s ongoing commercial activities in Frankfurt. AEZS Germany and its Works Council approved a restructuring that affects 8 employees and resulted in $773 of severance costs that is expected to be paid by January 31, 2020.
The changes in the Company’s provision for restructuring and other costs can be summarized as follows:
Cetrotide(R) onerous contracts | German Restructuring: onerous lease | German Restructuring: severance | Total | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Balance – January 1, 2019 | 547 | 663 | 88 | 1,298 | ||||||||||||
Adoption of IFRS 16 (note 4) | — | (663 | ) | — | (663 | ) | ||||||||||
Utilization of provision | (59 | ) | — | — | (59 | ) | ||||||||||
Change in provision | 59 | — | 773 | 832 | ||||||||||||
Impact of foreign exchange rate changes | (2 | ) | — | (2 | ) | (4 | ) | |||||||||
Balance – June 30, 2019 | 545 | — | 859 | 1,404 | ||||||||||||
Less current portion | (145 | ) | — | (859 | ) | (1,004 | ) | |||||||||
Non-current portion | 400 | — | — | 400 |
( 16 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
9 | Warrant liability |
The change in the Company’s warrant liability can be summarized as follows:
Six months ended June 30, 2019 |
||||
$ | ||||
Balance – January 1, 2019 | 3,634 | |||
Exercise of warrants | (318 | ) | ||
Change in fair value of warrant liability | (1,865 | ) | ||
Balance – June 30, 2019 | 1,451 | |||
Current portion of warrant liability | 447 | |||
Long-term portion of warrant liability | 1,004 |
A summary of the activity related to the Company’s share purchase warrants that are classified as a liability is provided below.
Six months ended June 30, 2019 |
Year ended December 31, 2018 |
|||||||||||||||
Number | Weighted average exercise price | Number |
Weighted average exercise price |
|||||||||||||
$ | $ | |||||||||||||||
Balance – Beginning of period | 3,391,844 | 6.23 | 3,417,840 | 7.59 | ||||||||||||
Exercised | (87,700 | ) | 1.07 | — | — | |||||||||||
Expired | — | — | (25,996 | ) | 185.00 | |||||||||||
Balance – End of period | 3,304,144 | 6.36 | 3,391,844 | 6.23 |
The table presented below shows the inputs and assumptions applied to the Black-Scholes option pricing model in order to determine the fair value of all warrants outstanding as at June 30, 2019. The Black-Scholes option pricing model uses “Level 2” inputs, as defined by IFRS 13, Fair value measurement (“IFRS 13”) and as discussed in note 15 - Financial instruments and financial risk management.
Number of equivalent shares | Market value per share price | Weighted average exercise price | Risk-free annual interest rate | Expected volatility | Expected life (years) | Expected dividend yield | ||||||||||||||||||||||
($) | ($) | (a) | (b) | (c) | (d) | |||||||||||||||||||||||
March 2015 Series A Warrants (e) | 28,144 | 2.95 | 1.07 | 1.91 | % | 100.09 | % | 0.70 | 0.00 | % | ||||||||||||||||||
December 2015 Warrants | 2,331,000 | 2.95 | 7.10 | 1.83 | % | 80.62 | % | 1.46 | 0.00 | % | ||||||||||||||||||
November 2016 Warrants (f) | 945,000 | 2.95 | 4.70 | 1.91 | % | 92.73 | % | 0.84 | 0.00 | % |
(a) | Based on United States Treasury Government Bond interest rates with a term that is consistent with the expected life of the warrants. | |
(b) | Based on the historical volatility of the Company’s stock price over the most recent period consistent with the expected life of the warrants, as well as on future expectations. | |
(c) | Based upon time to expiry from the reporting period date. | |
(d) | The Company has not paid dividends and it does not intend to pay dividends in the foreseeable future. | |
(e) | For the March 2015 Series A Warrants, the inputs and assumptions applied to the Black-Scholes option pricing model have been further adjusted to take into consideration the value attributed to certain anti-dilution provisions. Specifically, the weighted average exercise price is subject to adjustment (see note 11 - Share and other capital). | |
(f) | For the November 2016 Warrants, the Company reduced the fair value of these warrants to take into consideration the fair value of the $10.00 call option, which was also calculated using the Black-Scholes pricing model. |
( 17 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
10 | Employee future benefits |
The Company sponsors a pension plan in Germany (The Aeterna Zentaris GmbH Pension Plan). The change in the Company’s accrued benefit obligations is summarized as follows:
Six months ended June 30, 2019 |
Year ended December 31, 2018 |
|||||||||||||||
Pension benefit plans | Other benefit plans | Total | Total | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Balances – Beginning of the period | 13,100 | 105 | 13,205 | 14,229 | ||||||||||||
Current service cost | 21 | 3 | 24 | 72 | ||||||||||||
Interest cost | 111 | 1 | 112 | 225 | ||||||||||||
Actuarial loss (gain) arising from changes in financial assumptions | 1,491 | — | 1,491 | (174 | ) | |||||||||||
Benefits paid | (217 | ) | — | (217 | ) | (494 | ) | |||||||||
Impact of foreign exchange rate changes | (53 | ) | (1 | ) | (54 | ) | (653 | ) | ||||||||
Balances – End of the period | 14,453 | 108 | 14,561 | 13,205 | ||||||||||||
Amounts recognized: | ||||||||||||||||
In net loss | (132 | ) | (4 | ) | (136 | ) | (316 | ) | ||||||||
In other comprehensive loss | 1,491 | — | 1,491 | 846 |
The calculation of the pension benefit obligation is sensitive to the discount rate assumption. For the first quarter of 2019, management determined that the discount rate assumption should be adjusted from 1.9% to 1.4% and, for the second quarter of 2019, this was adjusted from 1.4% to 1.1%.
11 | Share and other capital |
The Company has an unlimited number of authorized common shares (being voting and participating shares) with no par value, as well as an unlimited number of preferred, first and second ranking shares, issuable in series, with rights and privileges specific to each class, with no par value.
( 18 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
Shareholder rights plan
Effective May 8, 2019, the shareholders re-approved the Company’s shareholder rights plan (the “Rights Plan”) that provides the board of directors and the Company’s shareholders with additional time to assess any unsolicited take-over bid for the Company and, where appropriate, to pursue other alternatives for maximizing shareholder value. Under the Rights Plan, one right has been issued for each currently issued common share, and one right will be issued with each additional common share that may be issued from time to time.
Other capital
The Company accounts for costs associated with share-based compensation from security grants under its long-term incentive plan and stock option plans as other capital in its consolidated statements of changes in shareholders’ equity (deficiency) and as general and administrative expenses in its consolidated statements of comprehensive income (loss).
Long-term incentive plan
During 2019, the Company has only granted Deferred Share Units (DSU) to the members of the board of directors. The following tables summarizes the activity under the LTIP and the Stock Option Plan:
Six months ended | Year ended | |||||||||||||||
June 30, 2019 | December 31, 2018 | |||||||||||||||
US dollar-denominated stock options and DSU | Number |
Weighted average exercise price
(US$) |
Number |
Weighted average exercise price
(US$) |
||||||||||||
Balance – Beginning of the period | 888,816 | 3.66 | 712,415 | 4.66 | ||||||||||||
Granted | 150,000 | 3.15 | 426,000 | 1.74 | ||||||||||||
Exercised | (110,850 | ) | 2.35 | — | — | |||||||||||
Forfeited | — | — | (249,599 | ) | 3.23 | |||||||||||
Balance – End of period | 927,966 | 3.76 | 888,816 | 3.66 |
Six months ended | Year ended | |||||||||||||||
June 30, 2019 | December 31, 2018 | |||||||||||||||
Canadian dollar-denominated options | Number |
Weighted average exercise price
(CAN$) |
Number |
Weighted average exercise price
(CAN$) |
||||||||||||
Balance – Beginning of the period | 869 | 743.56 | 1,503 | 605.84 | ||||||||||||
Forfeited | — | — | (104 | ) | 668.65 | |||||||||||
Expired | — | — | (530 | ) | 367.70 | |||||||||||
Balance – End of the period | 869 | 743.56 | 869 | 743.56 |
Mr. Ernst did not stand for re-election at the Company’s May 8, 2019 annual and special meeting of shareholders and at such time his 23,000 DSUs granted in May 2018 became exercisable. As of the date hereof, the underlying common shares have not been issued.
( 19 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
12 | Operating expenses |
The nature of the Company’s operating expenses from continuing operations include the following:
Six months ended June 30, | ||||||||
2019 | 2018 | |||||||
$ | $ | |||||||
Key management personnel: | ||||||||
Salaries and short-term employee benefits | 594 | 1,229 | ||||||
Consultant fees | 118 | — | ||||||
Share-based compensation costs | 681 | 39 | ||||||
Post-employment benefits | 18 | 23 | ||||||
1,411 | 1,291 | |||||||
Other employees: | ||||||||
Salaries and short-term employee benefits | 1,042 | 543 | ||||||
Share-based compensation costs | 9 | 25 | ||||||
Post-employment benefits | 158 | 25 | ||||||
Termination benefits | — | 331 | ||||||
1,209 | 814 | |||||||
Professional fees | 1,474 | 150 | ||||||
Restructuring costs | 773 | — | ||||||
Consulting fees | 76 | — | ||||||
Insurance | 446 | 38 | ||||||
Third-party R&D | 307 | 4,796 | ||||||
Contracted sales force | — | 155 | ||||||
Travel | 84 | 31 | ||||||
Marketing services | 2 | 576 | ||||||
Laboratory supplies | 28 | 303 | ||||||
Other goods and services | 64 | 231 | ||||||
Leasing costs, net of sublease receipts of $58 (2018 - $62) | 176 | 264 | ||||||
Impairment of right of use asset (note 4) | 401 | — | ||||||
Write-off of other current assets | 197 | — | ||||||
Depreciation and amortization | 136 | 35 | ||||||
Operating foreign exchange losses | 17 | 51 | ||||||
6,801 | 8,735 |
( 20 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
13 | Supplemental disclosure of cash flow information |
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Changes in operating assets and liabilities: | ||||||||||||||||
Trade and other receivables | 133 | (189 | ) | (196 | ) | (269 | ) | |||||||||
Inventory | (191 | ) | (379 | ) | (496 | ) | (816 | ) | ||||||||
Prepaid expenses and other current assets | (267 | ) | 20 | (123 | ) | (151 | ) | |||||||||
Other non-current assets | — | 151 | — | 151 | ||||||||||||
Payables and accrued liabilities | 502 | (1,040 | ) | 247 | (864 | ) | ||||||||||
Provision for restructuring costs | — | — | — | (1,352 | ) | |||||||||||
Income taxes payable | — | (396 | ) | — | 2,904 | |||||||||||
Employee future benefits (note 10) | (108 | ) | 260 | (217 | ) | 144 | ||||||||||
Lease liabilities | (18 | ) | — | (38 | ) | — | ||||||||||
Provisions and other non-current liabilities | — | (217 | ) | — | (280 | ) | ||||||||||
51 | (1,790 | ) | (823 | ) | (533 | ) |
14 | Capital disclosures |
The Company’s objective in managing capital, consisting of shareholders’ equity, with cash and cash equivalents and restricted cash being its primary components, is to ensure sufficient liquidity to fund R&D costs, selling expenses, G&A expenses and working capital requirements (see note 1 – Going Concern). Over the past several years, the Company has raised capital via public equity offerings and issuances under various ATM sales programs as its primary source of liquidity. The policy on dividends is to retain cash to keep funds available to finance the activities required to advance the Company’s product development portfolio and to pursue appropriate commercial opportunities as they may arise. The Company is not subject to any capital requirements imposed by any regulators or by any other external source.
( 21 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
15 | Financial instruments and financial risk management |
Financial assets (liabilities) as at June 30, 2019 and December 31, 2018 are presented below.
June 30, 2019 | Financial assets at amortized cost |
Financial
liabilities at FVTPL |
Financial
liabilities at amortized cost |
Total | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Cash and cash equivalents * | 9,683 | — | — | 9,683 | ||||||||||||
Trade and other receivables | 494 | — | — | 494 | ||||||||||||
Restricted cash | 367 | — | — | 367 | ||||||||||||
Payables and accrued liabilities | — | — | (3,200 | ) | (3,200 | ) | ||||||||||
Provision for restructuring and other costs | — | — | (1,404 | ) | (1,404 | ) | ||||||||||
Warrant liability | — | (1,451 | ) | — | (1,451 | ) | ||||||||||
10,544 | (1,451 | ) | (4,604 | ) | 4,489 |
December 31, 2018 | Financial assets at amortized cost |
Financial
liabilities at FVTPL |
Financial
liabilities at amortized cost |
Total | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Cash and cash equivalents * | 14,512 | — | — | 14,512 | ||||||||||||
Trade and other receivables | 245 | — | — | 245 | ||||||||||||
Restricted cash | 418 | — | — | 418 | ||||||||||||
Payables and accrued liabilities | — | — | (2,940 | ) | (2,940 | ) | ||||||||||
Provision for restructuring and other costs | — | — | (1,298 | ) | (1,298 | ) | ||||||||||
Warrant liability | — | (3,634 | ) | — | (3,634 | ) | ||||||||||
15,175 | (3,634 | ) | (4,238 | ) | 7,303 |
* As of June 30, 2019 and December 31, 2018, cash and cash equivalents consisted only of balances with banks.
( 22 ) |
Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
Fair value
IFRS 13, establishes a hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The input levels discussed in IFRS 13 are:
Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2 – Inputs other than quoted prices included within Level 1 that are observable for an asset or liability, either directly (i.e. prices) or indirectly (i.e. derived from prices).
Level 3 – Inputs for an asset or liability that are not based on observable market data (unobservable inputs).
As discussed above in note 9 - Warrant liability, the Black-Scholes valuation methodology uses “Level 2” inputs in calculating fair value.
The carrying values of the Company’s cash and cash equivalents, trade and other receivables, restricted cash, payables and accrued liabilities and provision for restructuring and other costs approximate their fair values due to their short-term maturities or to the prevailing interest rates of the related instruments, which are comparable to those of the market.
Financial risk factors
The following provides disclosures relating to the nature and extent of the Company’s exposure to risks arising from financial instruments, including credit risk, liquidity risk and market risk (share price risk) and how the Company manages those risks.
(a) | Credit risk |
Credit risk is the risk of an unexpected loss if a customer or counterparty to a financial instrument fails to meet its contractual obligations. The Company regularly monitors credit risk exposure and takes steps to mitigate the likelihood of this exposure resulting in losses. The Company’s exposure to credit risk currently relates to the financial assets at amortized cost in the table above. The Company holds its available cash in amounts that are readily convertible to known amounts of cash and deposits its cash balances with financial institutions that have an investment grade rating of at least “P-2” or the equivalent. This information is supplied by independent rating agencies where available and, if not available, the Company uses publicly available financial information to ensure that it invests its cash in creditworthy and reputable financial institutions. Once there are indicators that there is no reasonable expectation of recovery, such financial assets are written off but are still subject to enforcement activity.
As at June 30, 2019, trade accounts receivable for an amount of approximately $272 were with three counterparties of which $55 was past due and impaired and fully provided for (December 31, 2018 - $197 with four counterparties and $55 past due and impaired and fully provided for). The licensee is obligated to pay its quarterly royalties, 60 days after quarter-end.
Generally, the Company does not require collateral or other security from customers for trade accounts receivable; however, credit is extended following an evaluation of creditworthiness. In addition, the Company performs ongoing credit reviews of all of its customers and establishes an allowance for doubtful accounts. On this basis, as at June 30, 2019, the Company has provided for all outstanding and unpaid amounts relating to its operations before its licensing of Macrilen TM (macimorelin). The licensee has paid all amounts owing within 90 days of invoicing.
The maximum exposure to credit risk approximates the amount recognized in the Company’s consolidated statement of financial position.
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Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
(b) | Liquidity risk |
Liquidity risk is the risk that the Company will not be able to meet its financial obligations as they become due. As indicated in note 14 - Capital risk management, the Company manages this risk through the management of its capital structure. It also manages liquidity risk by continuously monitoring actual and projected cash flows as further discussed in note 1 – Going Concern. The Board of Directors reviews and approves the Company’s operating and capital budgets, as well as any material transactions occurring outside of the ordinary course of business. The Company has adopted an investment policy in respect of the safety and preservation of its capital to ensure the Company’s liquidity needs are met. The instruments are selected with regard to the expected timing of expenditures and prevailing interest rates.
(c) | Market risk |
Share price risk
The change in fair value of the Company’s warrant liability, which is measured at FVTPL, results from the periodic “mark-to-market” revaluation, via the application of option pricing models, of currently outstanding share purchase warrants. These valuation models are impacted, among other inputs, by the market price of the Company’s common shares. As a result, the change in fair value of the warrant liability, which is reported in the consolidated statements of comprehensive loss, has been and may continue in future periods to be materially affected most notably by changes in the Company’s common share closing price, which on the NASDAQ ranged from $2.04 to $5.43 during the six-months ended June 30, 2019.
If variations in the market price of our common shares of -30% and +30% were to occur, the impact on the Company’s net loss related to the warrant liability held at June 30, 2019 would be as follows:
Carrying amount | -30% | +30% | ||||||||||
$ | $ | $ | ||||||||||
Warrant liability | 1,451 | 1,122 | (839 | ) | ||||||||
Total impact on net loss – decrease /(increase) | 1,122 | (839 | ) |
(d) | Foreign exchange risk |
Entities using the Euro as their functional currency
The Company is exposed to foreign exchange risk due to its investments in foreign operations whose functional currency is the Euro. As at June 30, 2019, if the US dollar had increased or decreased by 10% against the Euro, with all variables held constant, net income for the six-month period ended June 30, 2019 would have been lower or higher by approximately $546 (2018 - $1,180).
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Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
16 | Segment information |
The Company operates in a single operating segment, being the biopharmaceutical segment.
17 | Net (loss) income per share |
The following table sets forth pertinent data relating to the computation of basic and diluted net loss per share attributable to common shareholders.
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Net (loss) income | 206 | (2,602 | ) | (4,705 | ) | 11,822 | ||||||||||
Basic weighted average number of shares outstanding | 16,622,415 | 16,440,760 | 16,532,090 | 16,440,760 | ||||||||||||
Net (loss) income per share (basic) | 0.01 | (0.16 | ) | (0.28 | ) | 0.72 | ||||||||||
Dilutive effect of share purchase warrants | — | — | — | 48,604 | ||||||||||||
Diluted weighted average number of shares outstanding | 17,260,016 | 16,440,760 | 16,532,090 | 16,489,364 | ||||||||||||
Net income (loss) per share (diluted) | 0.01 | (0.16 | ) | (0.28 | ) | 0.70 | ||||||||||
Items excluded from the calculation of diluted net loss per share because the exercise price was greater than the average market price of the common shares or due to their anti-dilutive effect | ||||||||||||||||
Stock options | 161,021 | 975,196 | 641,021 | 975,196 | ||||||||||||
Deferred stock units | 150,000 | 161,000 | 288,000 | 161,000 | ||||||||||||
Warrants (number of equivalent shares) | 3,276,000 | 3,417,840 | 3,296,008 | 3,301,996 |
Net (loss) income per share is calculated by dividing net (loss) income by the weighted average number of shares outstanding during the relevant period. Diluted weighted average number of shares reflects the dilutive effect of equity instruments, such as any “in the money” stock options and share purchase warrants. In periods with reported net losses, all stock options and share purchase warrants are deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal, and thus “in the money” stock options and share purchase warrants have not been included in the computation of net loss per share because to do so would be anti-dilutive.
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Aeterna Zentaris Inc. |
Notes to Condensed Interim Consolidated Financial Statements (Unaudited) |
As at June 30, 2019 and for the three and six months ended June 30, 2019 and 2018 |
(amounts in thousands of US dollars, except share/option/warrant and per share/option/warrant data and as otherwise noted) |
18 | Commitments and contingencies |
Service and manufacturing | ||||
$ | ||||
Less than 1 year | 2,528 | |||
1 - 3 years | 13 | |||
4 - 5 years | 13 | |||
More than 5 years | 24 | |||
Total | 2,578 |
Contingencies
In the normal course of operations, the Company may become involved in various claims and legal proceedings related to, for example, contract terminations and employee-related and other matters.
Securities class action lawsuit
The Company’s securities class action lawsuit pending in the U.S. District Court for the District of New Jersey, brought on behalf of shareholders of the Company alleges violations of the Securities Exchange Act of 1934 in connection with allegedly false and misleading statements made by the defendants between August 30, 2011 and November 6, 2014 regarding the safety and efficacy of Macrilen™ (macimorelin) and the prospects for the approval of the Company’s New Drug Application for the product by the FDA. In February 2018, the U.S. court granted a motion for class certification in the case, and on May 30, 2019 the U.S Third Circuit Court of Appeals dismissed an appeal of that certification motion that had been brought by the Company. The Company considers the claims that have been asserted in the lawsuit to be without merit and is vigorously defending against them. The Company cannot, however, predict at this time the outcome or potential losses, if any, with respect to this lawsuit. The Company continues to believe that substantially all of the costs for its defense and indemnity will be borne by the insurers who provide directors’ and officers’ liability insurance to the Company, subject to policy limits.
Other lawsuits
On December 21, 2018, the Company settled a dispute with its former President and Chief Executive Officer and with its former Senior Vice President, Chief Administrative Officer, General Counsel and Corporate Secretary with the Company agreeing to make a payment in the amount of $775.
On November 5, 2018, the Company settled a dispute with Cogas Consulting, LLC with the Company agreeing to make a payment of $625.
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Exhibit 99.2
Second Quarter MD&A - 2019
Management’s Discussion and Analysis
of Financial Condition and Results of Operations
Introduction
This Management’s Discussion and Analysis (“MD&A”) provides a review of the results of operations, financial condition and cash flows of Aeterna Zentaris Inc. as at June 30, 2019 and for the three-months and six-months ended June 30, 2019 and 2018. In this MD&A, “Aeterna Zentaris”, the “Company”, “we”, “us” and “our” mean Aeterna Zentaris Inc. and its subsidiaries. This discussion should be read in conjunction with the information contained in our unaudited condensed interim consolidated financial statements and the accompanying notes thereto as at June 30, 2019 and for the three-months and six-months ended June 30, 2019 and 2018, and the audited consolidated financial statements and MD&A for the years ended December 31, 2018 and 2017, which were prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”). All amounts in this MD&A are presented in US dollars, except as otherwise noted.
We have three wholly-owned direct and indirect subsidiaries, Aeterna Zentaris GmbH (“AEZS Germany”), based in Frankfurt, Germany; Zentaris IVF GmbH, a direct wholly-owned subsidiary of AEZS Zentaris GmbH, based in Frankfurt, Germany; and Aeterna Zentaris, Inc., an entity incorporated in the State of Delaware with an office in Summerville, South Carolina in the United States. Our common shares are listed on both the NASDAQ Capital Market and on the Toronto Stock Exchange under the symbol “AEZS”.
This MD&A was approved by our Board of Directors on August 12, 2019.
About Forward-Looking Statements
This document contains forward-looking statements (as defined by applicable securities legislation) made pursuant to the safe-harbor provision of the U.S. Securities Litigation Reform Act of 1995, which reflect our current expectations regarding future events. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “will,” “expects,” “believes,” “intends,” “would,” “could,” “may,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties, including those discussed in this MD&A and in our Annual Report on Form 20-F, under the caption “Key Information - Risk Factors” filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form and with the U.S. Securities and Exchange Commission (“SEC”). Known and unknown risks and uncertainties could cause our actual results to differ materially from those in forward-looking statements. Such risks and uncertainties include, among others, our ability to continue as a going concern dependent, in part, on the Company’s ability to transfer cash from AEZS Germany to the Canadian parent and U.S. subsidiary and secure additional financing, our heavy dependence on the success of Macrilen™ (macimorelin) and related out-licensing arrangements and the continued availability of funds and resources to successfully commercialize the product, our strategic review process, the ability of the Special Committee to carry out its mandate, the ability of the Company to enter into out-licensing, development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect, reliance on third parties for the manufacturing and commercialization of our product candidates, potential disputes with third parties, leading to delays in or termination of the manufacturing, development, out-licensing or commercialization of our product candidates, or resulting in significant litigation or arbitration, and, more generally, uncertainties related to the regulatory process, our ability to efficiently commercialize or out-license Macrilen™ (macimorelin), the degree of market acceptance and resulting sales of Macrilen™ (macimorelin), our ability to obtain necessary approvals from the relevant regulatory authorities to enable us to use the desired brand names for our product, the impact of securities class action litigation on our cash flow, results of operations and financial position, any evaluation of potential strategic alternatives to maximize potential future growth and stakeholder value may not result in any such alternative being pursued, and even if pursued, may not result in the anticipated benefits, our ability to take advantage of business opportunities in the pharmaceutical industry, our ability to protect our intellectual property, and the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult our quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties. Given these uncertainties and risk factors, readers are cautioned not to place undue reliance on these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or applicable law.
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Second Quarter MD&A - 2019
About Material Information
This MD&A includes information that we believe to be material to investors after considering all circumstances. We consider information and disclosures to be material if they result in, or would reasonably be expected to result in, a significant change in the market price or value of our securities, or where it is likely that a reasonable investor would consider the information and disclosures to be important in making an investment decision.
We are a reporting issuer under the securities legislation of all of the provinces of Canada, and our securities are registered with the SEC. We are therefore required to file or furnish continuous disclosure information, such as interim and annual financial statements, MD&A, proxy or information circulars, annual reports on Form 20-F, material change reports and press releases with the appropriate securities regulatory authorities. Copies of these documents may be obtained free of charge upon request from our Corporate Secretary or on the Internet at the following addresses: www.aezsinc.com , www.sedar.com and www.sec.gov .
Company Overview
Aeterna Zentaris Inc. is a specialty biopharmaceutical company engaged in commercializing novel pharmaceutical therapies, principally through out-licensing arrangements. We are a party to a license and assignment agreement with Novo Nordisk A/S (“Novo”) to carry out development, manufacturing, registration, regulatory, supply chain for the commercialization of Macrilen™ (macimorelin), which is to be used in the diagnosis of patients with adult growth hormone deficiency (“AGHD”), in the United States and Canada (the “License and Assignment Agreement”). In addition, we are actively pursuing business development opportunities for macimorelin in the rest of the world and to monetize the value of our non-strategic assets.
Key Developments
On January 16, 2018, the Company through AEZS Germany entered into the “License and Assignment Agreement with Strongbridge Ireland Limited (“Strongbridge”) to carry out development, manufacturing, registration, regulatory and supply chain services for the commercialization of Macrilen™ (macimorelin) in the United States and Canada, which provides for (i) the “right to use” license relating to the Adult Indication; (ii) the sale of the right to acquire a license of a future pediatric indication approved by the United States Food and Drug Administration (“FDA”); (iii) the licensee to fund 70% of the costs of a pediatric clinical trial submitted for approval to the EMA and FDA to be run by the Company with customary oversight from a joint steering committee (the “JSC”); and (iv) an Interim Supply Arrangement. Product sales of Macrilen™ (macimorelin) began on July 23, 2018 by Strongbridge; effective December 19, 2018, Strongbridge was sold to Novo. The Company has earned $21,000 in royalty income, sold $129,000 in product supply, invoiced $621,000 relating to the Pediatric Investigation Plan (“PIP”) study and $839,000 for supply chain costs to Novo in the six-month period ended June 30, 2019 (2018 - $nil).
In the first six months of 2019, the Company has earned $21,000 from the license of Macrilen™ (macimorelin) as gross sales in the U.S. continue to disappoint. Novo Nordisk has advised that Macrilen™ (macimorelin) has been successfully integrated into their patient and provider support hub as they work to gain broader product coverage with payers and specialty pharmacies. We continue to work with Novo Nordisk on addressing the disappointing U.S. commercial execution and results to date.
Also, in the first six months of 2019, the initial phase of the macimorelin PIP study (the dose ranging study) continued to progress with the first one-third of subjects having completed the protocol, all in accordance with our expected timeline.
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Second Quarter MD&A - 2019
On March 12, 2019, the Company announced that its board of directors formed a special committee of independent directors (the “Special Committee”) to review strategic options available to the Company. The Special Committee has approved the engagement by the Company of a financial advisor that is working with management to assist the Special Committee and the board of directors in considering a wide range of transactions, including opportunities for the license of Macrilen TM (macimorelin) outside of the United States and Canada, or other monetization transactions relating to Macrilen TM (macimorelin).
On January 16, 2019, we announced that the European Medicines Agency (“EMA”) granted marketing authorization for macimorelin for the diagnosis of AGHD. We believe that this marks an important development in our European commercialization strategy based on research evaluating the prevalence of AGHD in adults in Europe. We are in discussions with a variety of companies regarding licensing and/or distribution opportunities in the rest of the world (“ROW”).
On June 6, 2019, the Company announced that it was reducing the size of its German workforce and operations to more closely reflect the Company’s ongoing commercial activities in Frankfurt. This restructuring affects 8 employees in Frankfurt, Germany and resulted in $773,000 of severance costs that are expected to be paid by January 31, 2020.
Management has evaluated whether material uncertainties exist relating to events or conditions and believes that the commercial success of Macrilen™ (macimorelin) will depend on several factors, including, but not limited to, the receipt of approvals from foreign regulatory authorities; Novo developing appropriate distribution and marketing infrastructure and arrangements and launching and growing commercial sales of Macrilen™ (macimorelin); and acceptance of Macrilen™ (macimorelin) in the medical community, among patients and with third party payers.
Monetization of non-strategic assets
Opportunities for the Company to monetize non-strategic assets include preclinical work done on AEZS-120, a prostate cancer vaccine and discovery research for ERK-inhibitors for Oncology indication.
Outlook for 2019
The following represents forward-looking information and users are cautioned that actual results may vary.
Following Novo’s acquisition of the U.S. and Canadian rights to Macrilen™ (macimorelin), the JSC met in January and May 2019 to discuss Novo’s commercialization plan for the United States, their supply chain needs and the enrollment of patients and protocols of the PIP study. The Company expects that quarterly meetings will continue to occur as forecasts for sales, inventory build and needs for the PIP study continue to occur.
The Special Committee has approved the engagement of Torreya, a global investment bank specializing in life sciences, as its financial advisor. Torreya is working with management to assist the Special Committee and the board of directors in considering a wide range of transactions, including opportunities for the license of macimorelin outside of the United States and Canada, other monetization transactions relating to macimorelin or the potential sale of the Company, which may create value for our shareholders and other stakeholders. The Company believes that the EMA’s January 2019 announcement of marketing authorization for macimorelin for the diagnosis of AGHS has further validated the clinical profile and commercial value of macimorelin. As of the date hereof, the Special Committee continues to evaluate strategic options but has not recommended that the Company enter into any particular transaction at this time.
Our priority is in the commercialization of macimorelin; however, we continue to pursue out-licensing opportunities of our non-strategic assets, as they arise.
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Second Quarter MD&A - 2019
Summary of key expectations for revenues, operating expenditures and cash flows
The further development and commercialization of Macrilen™ (macimorelin) in 2019 is the Company’s primary focus. As such, we expect that research and development costs will be up to $2.0 million for the year ending December 31, 2019 and will comprise termination benefits, commercial service, consultant, employee and patent costs relating to the PIP study and for follow-up studies agreed with the EMA. We expect our general and administrative expenses to range between $6.5 million and $7.5 million for the year ending December 31, 2019 and to consist primarily of employee, insurance, rent, legal and public company costs.
The recently announced restructuring to the German operations has increased the Company’s operating expenses by $773,000 and led to an additional impairment in the building right of use asset of $64,000 as office and lab space will become vacant or underutilized.
In addition, the Company has incurred $354,000 in operating expenses relating to its work with Torreya which have been classified as follows:
● | $279,000 as Selling expenses; and | |
● | $75,000 as General and administrative expenses. |
We are working with Torreya on European and ROW business development activities to support the commercialization of macimorelin outside of Canada and the United States and expect our selling expenses to be up to $2.0 million for the year ending December 31, 2019.
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Second Quarter MD&A - 2019
Condensed Interim Consolidated Statements of Comprehensive Income (Loss)
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
( in thousands, except share and per share data ) | 2019 | 2018 | 2019 | 2018 | ||||||||||||
$ | $ | $ | $ | |||||||||||||
Revenues | ||||||||||||||||
Royalty income | 8 | — | 21 | — | ||||||||||||
Product sales | 129 | — | 129 | — | ||||||||||||
Sales commission and other | 39 | 79 | 45 | 169 | ||||||||||||
Licensing revenue | 18 | 89 | 36 | 24,657 | ||||||||||||
Total revenues | 194 | 168 | 231 | 24,826 | ||||||||||||
Cost of goods sold | 101 | 197 | 101 | 197 | ||||||||||||
Gross income (loss) | 93 | (29 | ) | 130 | 24,629 | |||||||||||
Research and development costs | 571 | 974 | 1,099 | 1,807 | ||||||||||||
General and administrative expenses | 1,923 | 2,004 | 3,560 | 4,790 | ||||||||||||
Selling expenses | 495 | 497 | 799 | 2,138 | ||||||||||||
Restructuring costs | 773 | — | 773 | — | ||||||||||||
Impairment of right of use asset | 64 | — | 401 | — | ||||||||||||
Write-off of other current assets | — | — | 169 | — | ||||||||||||
Total operating expenses | 3,826 | 3,475 | 6,801 | 8,735 | ||||||||||||
(Loss) income from operations | (3,733 | ) | (3,504 | ) | (6,671 | ) | 15,894 | |||||||||
(Loss) gain due to changes in foreign currency exchange rates | (6 | ) | 677 | 58 | 725 | |||||||||||
Change in fair value of warrant liability | 3,926 | (134 | ) | 1,865 | 1,694 | |||||||||||
Other finance income | 19 | 126 | 43 | 144 | ||||||||||||
Net finance income | 3,939 | 669 | 1,966 | 2,563 | ||||||||||||
Income (loss) before income taxes | 206 | (2,835 | ) | (4,705 | ) | 18,457 | ||||||||||
Income tax recovery (expense) | — | 233 | — | (6,635 | ) | |||||||||||
Net income (loss) | 206 | (2,602 | ) | (4,705 | ) | 11,822 | ||||||||||
Other comprehensive (loss) income: | ||||||||||||||||
Foreign currency translation adjustments | (110 | ) | (28 | ) | (26 | ) | (250 | ) | ||||||||
Actuarial loss (gain) on defined benefit plans | (756 | ) | 205 | (1,491 | ) | 205 | ||||||||||
Comprehensive (loss) income | (660 | ) | (2,425 | ) | (6,222 | ) | 11,777 | |||||||||
Net (loss) income per share [basic] | 0.01 | (0.16 | ) | (0.28 | ) | 0.72 | ||||||||||
Net (loss) income per share [diluted] | 0.01 | (0.16 | ) | (0.28 | ) | 0.70 | ||||||||||
Weighted average number of shares outstanding: | ||||||||||||||||
Basic | 16,622,415 | 16,440,760 | 16,532,090 | 16,440,760 | ||||||||||||
Diluted | 17,260,016 | 16,440,760 | 16,532,090 | 16,489,364 |
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Second Quarter MD&A - 2019
Condensed Interim Consolidated Statement of Financial Position
(in thousands) | As at June 30, | As at December 31, | ||||||
2019 | 2018 | |||||||
$ | $ | |||||||
Cash and cash equivalents | 9,683 | 14,512 | ||||||
Trade and other receivables and other current assets | 1,524 | 1,504 | ||||||
Inventory | 562 | 240 | ||||||
Restricted cash equivalents | 367 | 418 | ||||||
Property, plant and equipment | 48 | 65 | ||||||
Right of use asset | 340 | — | ||||||
Other non-current assets | 8,227 | 8,272 | ||||||
Total assets | 20,751 | 25,011 | ||||||
Payables and other current liabilities | 3,200 | 2,966 | ||||||
Current portion of deferred revenues | 74 | 74 | ||||||
Warrant liability | 1,451 | 3,634 | ||||||
Current provision for restructuring costs and other costs | 1,004 | 887 | ||||||
Taxes payable | 1,662 | 1,669 | ||||||
Employee future benefits | 14,561 | 13,205 | ||||||
Lease liabilities | 1,205 | — | ||||||
Non-current portion of restructuring and other costs and deferred revenues | 622 | 669 | ||||||
Total liabilities | 23,779 | 23,104 | ||||||
Shareholders’ (deficiency) equity | (3,028 | ) | 1,907 | |||||
Total liabilities and shareholders’ equity (deficiency) | 20,751 | 25,011 |
Critical Accounting Policies, Estimates and Judgments
The preparation of condensed interim consolidated financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions that affect the reported amounts of the Company’s assets, liabilities, revenues, expenses and related disclosures. Judgments, estimates and assumptions are based on historical experience, expectations, current trends and other factors that management believes to be relevant at the time at which the Company’s condensed interim consolidated financial statements are prepared.
Management reviews, on a regular basis, the Company’s accounting policies, assumptions, estimates and judgments in order to ensure that the condensed interim consolidated financial statements are presented fairly and in accordance with IFRS. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
Critical accounting estimates and assumptions, as well as critical judgments used in applying accounting policies in the preparation of our interim condensed consolidated financial statements were the same as those found in note 4 to our annual consolidated financial statements as of December 31, 2018 and 2017 and for the years ended December 31, 2018, and 2017 except for those related to the adoption of IFRS 16, as follows:
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Second Quarter MD&A - 2019
Critical judgments in determining the lease term and discount rate
In determining the lease term, management considers all facts and circumstances that create an economic incentive to exercise an extension option, or not exercise a termination option. Extension options (or periods after termination options) are only included in the lease term if the lease is reasonably certain to be extended (or not terminated).
In determining the appropriate discount rate, management identified the rate for the building based on the type and location of the Company’s office, laboratory and storage facility in Frankfurt and, for vehicle and equipment leases, used the risk-free rate, credit spread and lease specific adjustment for similar assets.
Results of operations for the three-month period ended June 30, 2019
For the three-month period ended June 30, 2019, we reported a consolidated net income of $0.2 million, or $0.01 income per common share (basic), as compared with a consolidated net loss of $2.6 million, or $0.16 loss per common share, for the three-month period ended June 30, 2018. The $2.8 million improvement in net results is primarily from a gain in fair value of warrant liability of $4.1 million, offset by a loss in exchange rates of $0.7 million, an increase in operating expenses of $0.3 million and $0.2 million movement in tax recovery.
Revenues
Our total revenue for the three-month period ended June 30, 2019 was $194,000 as compared with $168,000 for the same period in 2018, representing an increase of $26,000. The 2019 revenue was comprised of $8,000 in royalty revenue (2018 - $nil), $129,000 in product sales (2018 - $nil), $39,000 in sales commission and other (2018 - $79,000) and $18,000 in licensing revenue (2018 - $89,000). The increase in total revenue in 2019 relates to the launch of product sales Macrilen™ (macimorelin) on July 23, 2018 in the US.
Operating expenses
Our total operating expense for the three-month period ended June 30, 2019 was $3.8 million as compared with $3.5 million for the same period in 2018, representing an increase of $0.3 million. This increase arises primarily from a $0.8 million increase in restructuring costs offset by a decline of $0.4 million in research and development costs and $0.1 million decline in general and administrative expenses. As discussed on page 4 of this Management’s Discussion and Analysis, the June 2019 restructuring in Germany and the costs associated with efforts undertaken with Torreya in the second quarter of 2019 have led to increased costs which have mitigated the gains experience from cost controls instituted in late 2018.
Net finance income
Our net finance income for the three-month period ended June 30, 2019 was $3.9 million as compared with a net finance income of $0.7 million for the same period in 2018, representing an increase of $3.2 million. This is primarily due to a $4.1 million change in fair value of warrant liability. Such a non-cash change in fair value results from the periodic “mark-to-market” revaluation, which occurs through the application of our pricing model, to our outstanding share purchase warrants.
Results of operations for the six-month period ended June 30, 2019
For the six-month period ended June 30, 2019, we reported a consolidated net loss of $4.7 million, or $0.28 loss per common share, as compared with a consolidated net income of $11.8 million, or $0.72 income per common share (basic), for the six-month period ended June 30, 2018. The $16.5 million decline in net results is primarily from a reduction of $24.5 million in gross income and $0.6 million decrease in net finance income, offset by a reduction of tax expense of $6.6 million and operating expenses of $1.9 million.
Revenues
Our total revenue for the six-month period ended June 30, 2019 was $0.2 million as compared with $24.8 million for the same period in 2018, representing a decline of $24.6 million. The 2019 revenue was comprised of $21,000 in royalty income (2018 - $nil), $129,000 in product sales (2018 – nil), $45,000 in sales commission and other (2018 - $169,000) and $36,000 in licensing revenue (2018 - $24.7 million). The decline in total revenue in 2019 relates to $24.0 million cash payment received from executing the Macrilen™ (macimorelin) License and Assignment Agreement in January 2018.
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Second Quarter MD&A - 2019
Operating expenses
Our total operating expense for the six-month period ended June 30, 2019 was $6.8 million as compared with $8.7 million for the same period in 2018, representing a decrease of $1.9 million. This net decline arises primarily from a $1.3 million reduction in selling costs, a $1.2 million reduction in general and administration expenses, and a $0.7 million reduction in research and development costs, offset by $0.8 million increase in restructuring costs, $0.4 million impairment in right to use asset and $0.2 million write-off of other current assets.
While total operating costs incurred in the second quarter of 2019 increased by $0.3 million (as discussed on page 7 of this Management’s Discussion and Analysis) over the same period in 2018, our total operating expenses declined, in total, in the first quarter of 2019 by $2.3 million, which was in-line with the expected impact of our cost control initiatives that were implemented in late 2018.
Net finance income
Our net finance income for the six-month period ended June 30, 2019 was $2.0 million as compared with $2.6 million for the same period in 2018, representing a decrease of $0.6 million. This is primarily due to a $0.7 million decline in gain due to foreign currency exchange rates and a $0.1 million decline in other finance income, offset by $0.2 million change in fair value of warrant liability.
Quarterly Consolidated Results of Operation
(in thousands, except for per share data) | Three months ended | |||||||||||||||
June 30, 2019 | March 31, 2019 | December 31, 2018 | September 30, 2018 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Revenues | 194 | 37 | 1,392 | 663 | ||||||||||||
Net income (loss) | 206 | (4,911 | ) | (5,126 | ) | (2,509 | ) | |||||||||
Net income (loss) per share [basic]* | 0.01 | (0.30 | ) | (0.31 | ) | (0.15 | ) | |||||||||
Net income (loss) per share [diluted]* | 0.01 | (0.30 | ) | (0.31 | ) | (0.15 | ) |
(in thousands, except for per share data) | Three months ended | |||||||||||||||
June 30, 2018 | March 31, 2018 | December 31, 2017 | September 30, 2017 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Revenues | 168 | 24,658 | 178 | 241 | ||||||||||||
Net loss | (2,602 | ) | 14,424 | (484 | ) | (9,631 | ) | |||||||||
Net (loss) per share [basic]* | (0.16 | ) | 0.88 | (0.03 | ) | (0.61 | ) | |||||||||
Net (loss) per share [diluted]* | (0.16 | ) | 0.87 | (0.03 | ) | (0.61 | ) |
* | Net (loss) income per share is based on the weighted average number of shares outstanding during each reporting period, which may differ on a quarter-to-quarter basis. As such, the sum of the quarterly net loss per share amounts may not equal full-year net loss per share. |
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Second Quarter MD&A - 2019
Historical quarterly results of operations and net (loss) income cannot be taken as reflective of recurring revenue or expenditure patterns of predictable trends, largely given the non-recurring nature of certain components of our historical revenues, due most notably to unpredictable quarterly variations in net finance income, which are impacted by periodic “mark-to-market” revaluations of our warrant liability and of foreign exchange gains and losses. In addition, we cannot predict what the revenues from royalties will be from the Macrilen™ (macimorelin) License and Assignment Agreement.
Use of Proceeds
We began 2019 with $14.5 million in cash and cash equivalents. During the six-month period ended June 30, 2019, our operating activities consumed $5.2 million, foreign exchange contributed $0.3 million, and our investing activities provided $0.1 million. As at June 30, 2019 we had $9.7 million of cash and cash equivalents.
Liquidity and capital resources
Summary of cash flows:
(in thousands) | Six months ended June 30, | |||||||
2019 | 2018 | |||||||
Cash and cash equivalents - Beginning of period | 14,512 | 7,780 | ||||||
Cash flows from operating activities: | ||||||||
Net cash (used in) provided by operating activities | (5,176 | ) | 11,940 | |||||
Cash flows from financing activities: | ||||||||
Net cash provided by financing activities | 4 | — | ||||||
Cash flows from investing activities: | ||||||||
Net cash provided by investing activities | 50 | 11 | ||||||
Effect of exchange rate changes on cash and cash equivalents | 293 | 215 | ||||||
Cash and cash equivalents - End of period | 9,683 | 19,946 |
Operating Activities
Cash (used by) operating activities totaled ($5.2) million for the six months ended June 30, 2019, as compared to $11.9 million provided by operating activities in the same period in 2018. In the six-month period ended June 30, 2019, the Company had net loss of $4.7 million as compared with net income of $11.8 million in the same period in 2018. In the first half of 2019, the Company did not have significant revenues, while, in the same period in 2018, the Company received a $24.0 million cash payment from executing the Macrilen™ (macimorelin) License and Assignment Agreement in January 2018.
Financing Activities
Cash (used by) financing activities totaled $4,000 for the six months ended June 30, 2019, as compared with $nil in the same period in 2018. In 2019, the Company received $314,000 from the exercise of warrants, options and deferred share units and paid $310,000 in lease liabilities subsequent to adoption of IFRS 16 in January 2019.
Investing Activities
Cash provided by investing activities totaled $50,000 for the six months ended June 30, 2019, as compared with $11,000 provided by investing activities in the same period in 2018. In 2019, the Company received $50,000 in restricted cash when it closed out certain banking arrangements, while in 2018, the Company sold certain property, plant and equipment for $11,000.
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Second Quarter MD&A - 2019
Common shares
As at June 30, 2019, the Company had 16,632,410 issued and outstanding common shares.
Warrants as June 30, 2019
Warrants | Exercise Price | |||||||||
# | $ | Expiry date | ||||||||
March 2015 registered direct offering - Series A | 28,144 | 1.07 | March 10, 2020 | |||||||
December 2015 registered direct offering | 2,331,000 | 7.10 | December 13, 2020 | |||||||
November 2016 registered direct offering | 945,000 | 4.70 | May 1, 2020 | |||||||
3,304,144 |
Long-term incentive plan
There were 928,835 stock options and deferred share units (“DSUs”) outstanding at June 30, 2019; with exercise prices denominated in U.S. dollars (December 31, 2018 - 889,685). During the six-month period ended June 30, 2019, 110,859 of these securities were exercised, 150,000 DSUs were granted, no such securities were forfeited or expired (twelve-month period ended December 31, 2018 - none, 426,000 securities and 249,599, respectively).
Liquidity and capital resources
The Company has incurred significant expenses in its efforts to develop and co-promote products. Consequently, the Company has incurred operating losses and negative cash flow from operations historically and in each of the last several years except for the year ended December 31, 2018 when the Company earned revenue from the sale of a license for the adult indication of Macrilen™ (macimorelin) in the United States and Canada. As at June 30, 2019, the Company had an accumulated deficit of $316 million. The Company also had a net loss of $4.7 million for the six months ended June 30, 2019, and negative cash flow from operations of $5.2 million.
The Company’s principal focus is on the licensing and development of Macrilen™ (macimorelin) and it currently does not have any other approved products. Under the terms of License and Assignment Agreement, Novo is funding 70% of the pediatric clinical trial submitted to the EMA and FDA, the Company’s sole development activity.
On March 12, 2019, the Company announced that its board of directors formed a special committee of independent directors (the “Special Committee”) to review strategic options available to the Company. The Special Committee has approved the engagement by the Company of a financial advisor that is working with management to assist the Special Committee and the board of directors in considering a wide range of transactions (including opportunities for the license of Macrilen™ (macimorelin) outside of the United States and Canada, or other monetization transactions relating to Macrilen™ (macimorelin).
Management has evaluated whether material uncertainties exist relating to events or conditions and has considered the following in making that critical judgment.
The ability of the Company to realize its assets and meet its obligations as they come due is dependent on earning sufficient revenues under the License and Assignment Agreement, developing opportunities for Macrilen™ (macimorelin) in the rest of the world, realizing other monetizing transactions, and raising additional sources of funding, the outcome of which cannot be predicted at this time. The revenue provided under the License and Assignment Agreement was $21,000 for the six months ended June 30, 2019 and as at June 30, 2019, the Company had cash of $9.7 million.
Furthermore, nearly all of the Company’s cash is held in AEZS Germany, our wholly owned German subsidiary. AEZS Germany is also the counter-party for any and all cash received from revenue earned under the License and Assignment Agreement. At the present time, the Company’s North American operations are financed through the repayment of intercompany liabilities by AEZS Germany to the Canadian parent company and its U.S. subsidiary. However, if and when current and medium term liabilities of AEZS Germany exceed the values ascribed to AEZS Germany’s assets, it may no longer be possible under applicable German solvency laws for such cash transfers to take place. Although the Company currently expects AEZS Germany to continue to transfer cash to the Company’s North American operations to finance operations in the Canadian parent company and its U.S. subsidiary, in an amount sufficient for the Company (absent other funding sources) to finance most of its North American obligations, through at least the remainder of 2019, there is significant risk that AEZS Germany’s ability to make these transfers will become restricted. The Company expects to have secured additional financing prior to the end of 2019 from third party sources; however, there is no certainty that the Company will be successful in raising additional sources of cash. The Company has some discretion to manage research and development costs, administrative expenses and capital expenditures in order to maintain its cash liquidity, however the Company will need to obtain equity or debt financing in 2019 in order to fund its ongoing operations. The outcome of these efforts is uncertain.
Management has assessed the Company’s ability to continue as a going concern and concluded that additional capital will be required. There can be no assurance that the Company will be able to obtain equity or debt financing, or on terms acceptable to it. Factors within and outside the Company’s control could have a significant bearing on its ability to obtain additional financing. As a result, management has determined that there are material uncertainties that may cast significant doubt upon the Company’s ability to continue as a going concern.
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Second Quarter MD&A - 2019
Contractual obligations and contingencies
The Company is committed to various operating leases for its premises which are now accounted with the implementation of IFRS 16. Future payments in connection with service and manufacturing agreements, as at June 30, 2019, are as follows:
(in thousands) | Service and manufacturing | |||
$ | ||||
Less than 1 year | 2,528 | |||
1 - 3 years | 13 | |||
4 - 5 years | 13 | |||
More than 5 years | 24 | |||
Total | 2,578 |
Contingencies
In the normal course of operations, the Company may become involved in various claims and legal proceedings related to, for example, contract terminations and employee-related and other matters.
Securities class action lawsuit
The Company’s securities class action lawsuit pending in the U.S. District Court for the District of New Jersey, brought on behalf of shareholders of the Company alleges violations of the Securities Exchange Act of 1934 in connection with allegedly false and misleading statements made by the defendants between August 30, 2011 and November 6, 2014 regarding the safety and efficacy of Macrilen™ (macimorelin) and the prospects for the approval of the Company’s New Drug Application for the product by the FDA. In February 2018, the U.S. court granted a motion for class certification in the case, and on May 30, 2019 the U.S Third Circuit Court of Appeals dismissed an appeal of that certification motion that had been brought by the Company. The Company considers the claims that have been asserted in the lawsuit to be without merit and is vigorously defending against them. The Company cannot, however, predict at this time the outcome or potential losses, if any, with respect to this lawsuit. The Company continues to believe that substantially all of the costs for its defense will be borne by the insurers who provide directors’ and officers’ liability insurance to the Company, subject to policy limits.
Other lawsuits
On December 21, 2018, the Company settled a dispute with its former President and Chief Executive Officer and with its former Senior Vice President, Chief Administrative Officer, General Counsel and Corporate Secretary with the Company agreeing to make a payment in the amount of $775,000.
On November 5, 2018, the Company settled a dispute with Cogas Consulting, LLC with the Company agreeing to make a payment of $625,000.
Financial Risk Factors and Other Instruments
The nature and extent of our exposure to risks arising from financial instruments, including credit risk, liquidity risk and market risk (share price risk) and how we manage those risks are described in note 15 to our condensed interim consolidated financial statements as at June 30, 2019 and for the three-month and six-month periods ended June 30, 2019 and 2018.
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Second Quarter MD&A - 2019
Related Party Transactions and Off-Balance Sheet Arrangements
As at June 30, 2019, other than employment agreements and indemnification agreements with management, there are no related party transactions, except those eliminated upon consolidation. As at June 30, 2019, we did not have any interests in special purpose entities or any other off-balance sheet arrangements.
Recent accounting pronouncements
The IASB continues to issue new and revised IFRS. A listing of the recent accounting pronouncements promulgated by the IASB and not yet adopted is included in note 5 to our audited annual consolidated financial statements for the year ended December 31, 2018 and in note 4 to our condensed interim consolidated financial statements as at June 30, 2019 and for the three months and six months ended June 30, 2019 and 2018.
Changes in Internal Controls over Financial Reporting
There have been no changes in our internal control over financial reporting during the three-month or six-month period ended June 30, 2019 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
The design of any system of controls and procedures is based in part upon certain assumptions about the likelihood of certain events. There can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, including conditions that are remote.
Risk Factors and Uncertainties
An investment in our securities involves a high degree of risk. In addition to the other information included in this MD&A and in the related unaudited condensed interim consolidated financial statements, investors are urged to carefully consider the risks described below and under the caption “Risk Factors and Uncertainties” in our most recent Annual Report on Form 20-F for the year ended December 31, 2018, for a discussion of the various risks that may materially affect our business. The risks and uncertainties not presently known to us or that we currently deem immaterial may also materially harm our business, operating results and financial condition and could result in a complete loss of your investment.
The following updates and supplements the risk factors previously disclosed in the Annual Report on Form 20-F.
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We may not be able to continue as a going concern if we do not obtain cash from AEZS Germany to fund our North American operations and we do not obtain additional financing.
The Company has incurred significant expenses in its efforts to develop and co-promote products. Consequently, the Company has incurred operating losses and negative cash flow from operations historically and in each of the last several years except for the year ended December 31, 2018 when the Company earned revenue from the sale of a license for the adult indication of Macrilen™ (macimorelin) in the United States and Canada.
The ability of the Company to realize its assets and meet its obligations as they come due is dependent on earning sufficient revenues under the License and Assignment Agreement, developing opportunities for Macrilen™ (macimorelin) in the rest of the world, realizing other monetizing transactions, and raising additional sources of funding, the outcome of which cannot be predicted at this time.
Furthermore, nearly all of the Company’s cash is held in AEZS Germany, our wholly owned German subsidiary. AEZS Germany is also the counter-party for any and all cash received from revenue earned under the License and Assignment Agreement. At the present time, the Company’s North American operations are financed through the repayment of intercompany liabilities by AEZS Germany to the Canadian parent company and its U.S. subsidiary. However, if and when current and medium term liabilities of AEZS Germany exceed the values ascribed to AEZS Germany’s assets, it may no longer be possible under applicable German solvency laws for such cash transfers to take place. Although the Company currently expects AEZS Germany to continue to transfer cash to the Company’s North American operations to finance operations in the Canadian parent company and its U.S. subsidiary, in an amount sufficient for the Company (absent other funding sources) to finance most of its North American obligations through at least the remainder of 2019, there is significant risk that AEZS Germany’s ability to make these transfers will become restricted. The Company expects to have secured additional financing prior to the end of 2019 from third party sources; however, there is no certainty that the Company will be successful in raising additional sources of cash.
Second Quarter MD&A - 2019
The Company has some discretion to manage research and development costs, administrative expenses and capital expenditures in order to maintain its cash liquidity, however the Company will need to obtain equity or debt financing in 2019 in order to fund its ongoing operations. The outcome of these efforts is uncertain. Management has assessed the Company’s ability to continue as a going concern and concluded that additional capital will be required. There can be no assurance that the Company will be able to obtain equity or debt financing, or on terms acceptable to it. Factors within and outside the Company’s control could have a significant bearing on its ability to obtain additional financing. As a result, management has determined that there are material uncertainties that may cast significant doubt upon the Company’s ability to continue as a going concern.
In the event that we are not able to transfer cash from AEZS Germany to fund our North American operations and/or secure additional funding, we may be forced to curtail operations, cease operations altogether or file for bankruptcy.
Our most recent Annual Report on Form 20-F was filed with the relevant Canadian securities regulatory authorities in lieu of an annual information form at www.sedar.com and with the SEC at www.sec.gov, and investors are urged to consult such risk factors.
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Exhibit 99.3
Form 52-109F2
Certification of interim filings
Full certificate
I, Michael V. Ward, President and Chief Executive Officer of Aeterna Zentaris Inc., certify the following:
1. Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of Aeterna Zentaris Inc. (the “issuer”) for the interim period ended June 30, 2019.
2. No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.
3. Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.
4. Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in Regulation 52-109 respecting Certification of Disclosure in Issuers’ Annual and Interim Filings (c. V-1.1, r. 27), for the issuer.
5. Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings
A. | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that |
I. | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and | |
II. | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
B. | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP. |
5.1 Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is Internal Control – Integrated Framework , issued by the Committee of Sponsoring Organizations of the Treadway Commission.
5.2 N/A
5.3 N/A
6. Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on April 1, 2019 and ended on June 30, 2019 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.
Date: August 13, 2019
/s/ Michael V. Ward | |
Michael V. Ward | |
President and Chief Executive Officer |
M.O. 2008-16, Sch. 52-109F2; M.O. 2010-17, s. 5.
Exhibit 99.4
Form 52-109F2
Certification of interim filings
Full certificate
I, Leslie Auld, Chief Financial Officer of Aeterna Zentaris Inc., certify the following:
1. Review: I have reviewed the interim financial report and interim MD&A (together, the “interim filings”) of Aeterna Zentaris Inc. (the “issuer”) for the interim period ended June 30, 2019.
2. No misrepresentations: Based on my knowledge, having exercised reasonable diligence, the interim filings do not contain any untrue statement of a material fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances under which it was made, with respect to the period covered by the interim filings.
3. Fair presentation: Based on my knowledge, having exercised reasonable diligence, the interim financial report together with the other financial information included in the interim filings fairly present in all material respects the financial condition, financial performance and cash flows of the issuer, as of the date of and for the periods presented in the interim filings.
4. Responsibility: The issuer’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (DC&P) and internal control over financial reporting (ICFR), as those terms are defined in Regulation 52-109 respecting Certification of Disclosure in Issuers’ Annual and Interim Filings (c. V-1.1, r. 27), for the issuer.
5. Design: Subject to the limitations, if any, described in paragraphs 5.2 and 5.3, the issuer’s other certifying officer(s) and I have, as at the end of the period covered by the interim filings
A. | designed DC&P, or caused it to be designed under our supervision, to provide reasonable assurance that |
I. | material information relating to the issuer is made known to us by others, particularly during the period in which the interim filings are being prepared; and | |
II. | information required to be disclosed by the issuer in its annual filings, interim filings or other reports filed or submitted by it under securities legislation is recorded, processed, summarized and reported within the time periods specified in securities legislation; and |
B. | designed ICFR, or caused it to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with the issuer’s GAAP. |
5.1 Control framework: The control framework the issuer’s other certifying officer(s) and I used to design the issuer’s ICFR is Internal Control – Integrated Framework , issued by the Committee of Sponsoring Organizations of the Treadway Commission.
5.2 N/A
5.3 N/A
6. Reporting changes in ICFR: The issuer has disclosed in its interim MD&A any change in the issuer’s ICFR that occurred during the period beginning on April 1, 2019 and ended on June 30, 2019 that has materially affected, or is reasonably likely to materially affect, the issuer’s ICFR.
Date: August 13, 2019
/s/ Leslie Auld | |
Leslie Auld | |
Chief Financial Officer |
M.O. 2008-16, Sch. 52-109F2; M.O. 2010-17, s. 5.