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Delaware
|
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46-1385614
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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520 Newport Center Drive Suite 1200
Newport Beach, California
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92660
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(Address of Principal Executive Offices)
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(Zip Code)
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(949) 284-4555
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||
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(Registrant’s Telephone Number, Including Area Code)
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Title of Class
|
Trading Symbol(s)
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Name of each exchange on which registered
|
Common Stock, par value $0.00001 per share
|
EOLS
|
Nasdaq Global Market
|
Large accelerated filer
|
☐
|
Accelerated filer
|
☐
|
Non-accelerated filer
|
☒
|
Smaller reporting company
|
☒
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Emerging growth company
|
☒
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TABLE OF CONTENTS
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Page
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PART I - FINANCIAL INFORMATION
|
|
Item 1.
|
||
|
||
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||
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||
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||
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||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
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PART II - OTHER INFORMATION
|
|
Item 1.
|
||
Item 1A.
|
||
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
Item 5.
|
||
Item 6.
|
||
|
•
|
our ability to successfully commercialize our sole product Jeuveau
®
, including our ability to successfully market and sell Jeuveau
®
to our customers;
|
•
|
our ability to maintain regulatory approval of Jeuveau
®
, and any related restrictions, limitations and warnings in the label of Jeuveau
®
in a timely manner;
|
•
|
the potential market size, opportunity and growth potential for Jeuveau
®
;
|
•
|
the attractiveness of the product characteristics of Jeuveau
®
(including the benefits of a 900 kilodalton, or kDa, botulinum toxin type A complex) and the rate and degree of physician and patient acceptance of Jeuveau
®
;
|
•
|
the pricing of Jeuveau
®
, and the flexibility of our pricing and marketing strategy compared to our competitors;
|
•
|
the performance of our third-party licensors, suppliers, manufacturers and distributors;
|
•
|
our expectations regarding our future development of Jeuveau
®
for other indications and approval in other jurisdictions;
|
•
|
the accuracy of our estimates regarding the amount and timing of expenses, revenue, capital requirements and needs for additional financing;
|
•
|
regulatory and legislative developments in the United States, European Union, or EU, Canada and other countries;
|
•
|
developments and projections relating to our competitors and our industry, including competing products and procedures;
|
•
|
the loss of key management personnel;
|
•
|
our future financial performance and our ability to continue as a going concern; and
|
•
|
the results of current and any future legal proceedings.
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
|
(unaudited)
|
|
(Note 2)
|
||||
ASSETS
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
30,289
|
|
|
$
|
93,162
|
|
Short-term investments
|
69,640
|
|
|
—
|
|
||
Accounts receivable, net
|
1,410
|
|
|
—
|
|
||
Inventories
|
11,522
|
|
|
—
|
|
||
Prepaid expenses and other current assets
|
2,965
|
|
|
1,177
|
|
||
Total current assets
|
115,826
|
|
|
94,339
|
|
||
Property and equipment, net
|
290
|
|
|
—
|
|
||
Operating lease right-of-use assets
|
5,040
|
|
|
—
|
|
||
Intangible assets, net
|
59,211
|
|
|
56,076
|
|
||
Goodwill
|
21,208
|
|
|
21,208
|
|
||
Other assets
|
1,206
|
|
|
221
|
|
||
Total assets
|
$
|
202,781
|
|
|
$
|
171,844
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current Liabilities
|
|
|
|
||||
Accounts payable and accrued expenses
|
$
|
22,074
|
|
|
$
|
5,276
|
|
Current portion of operating lease liabilities
|
1,031
|
|
|
—
|
|
||
Total current liabilities
|
23,105
|
|
|
5,276
|
|
||
Operating lease liabilities
|
4,147
|
|
|
25
|
|
||
Contingent royalty obligation payable to Evolus Founders
|
43,773
|
|
|
50,200
|
|
||
Contingent promissory note payable to Evolus Founders
|
17,408
|
|
|
16,904
|
|
||
Long-term debt, net of discounts and issuance costs
|
72,862
|
|
|
—
|
|
||
Deferred tax liability
|
305
|
|
|
15,055
|
|
||
Total liabilities
|
161,600
|
|
|
87,460
|
|
||
Commitments and contingencies (Note 8)
|
|
|
|
|
|
||
Stockholders’ equity
|
|
|
|
||||
Preferred Stock, $0.00001 par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively
|
—
|
|
|
—
|
|
||
Common Stock, $0.00001 par value; 100,000,000 shares authorized; 27,393,004 and 27,274,991 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively
|
1
|
|
|
1
|
|
||
Additional paid-in capital
|
212,704
|
|
|
207,408
|
|
||
Accumulated other comprehensive gain
|
43
|
|
|
—
|
|
||
Accumulated deficit
|
(171,567
|
)
|
|
(123,025
|
)
|
||
Total stockholders’ equity
|
41,181
|
|
|
84,384
|
|
||
Total liabilities and stockholders’ equity
|
$
|
202,781
|
|
|
$
|
171,844
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net revenues
|
$
|
2,311
|
|
|
$
|
—
|
|
|
$
|
2,311
|
|
|
$
|
—
|
|
Cost of sales (excludes amortization of intangible assets)
|
660
|
|
|
—
|
|
|
660
|
|
|
—
|
|
||||
Gross profit
|
1,651
|
|
|
—
|
|
|
1,651
|
|
|
—
|
|
||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative
|
34,892
|
|
|
6,248
|
|
|
52,411
|
|
|
9,715
|
|
||||
Research and development
|
509
|
|
|
1,648
|
|
|
2,862
|
|
|
3,326
|
|
||||
Revaluation of contingent royalty obligation payable to Evolus Founders
|
1,269
|
|
|
8,200
|
|
|
6,182
|
|
|
9,100
|
|
||||
Depreciation and amortization
|
978
|
|
|
4
|
|
|
1,462
|
|
|
4
|
|
||||
Total operating expenses
|
37,648
|
|
|
16,100
|
|
|
62,917
|
|
|
22,145
|
|
||||
Loss from operations
|
(35,997
|
)
|
|
(16,100
|
)
|
|
(61,266
|
)
|
|
(22,145
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Interest income
|
615
|
|
|
—
|
|
|
1,004
|
|
|
—
|
|
||||
Interest expense
|
(2,412
|
)
|
|
(321
|
)
|
|
(3,030
|
)
|
|
(428
|
)
|
||||
Loss before income taxes:
|
(37,794
|
)
|
|
(16,421
|
)
|
|
(63,292
|
)
|
|
(22,573
|
)
|
||||
Income tax (benefit) expense
|
(227
|
)
|
|
12
|
|
|
(14,750
|
)
|
|
22
|
|
||||
Net loss
|
$
|
(37,567
|
)
|
|
$
|
(16,433
|
)
|
|
$
|
(48,542
|
)
|
|
$
|
(22,595
|
)
|
Other comprehensive gain:
|
|
|
|
|
|
|
|
||||||||
Unrealized gain on available-for-sale securities, net of tax
|
52
|
|
|
—
|
|
|
43
|
|
|
—
|
|
||||
Comprehensive loss
|
$
|
(37,515
|
)
|
|
$
|
(16,433
|
)
|
|
$
|
(48,499
|
)
|
|
$
|
(22,595
|
)
|
Net loss per share, basic and diluted
|
$
|
(1.37
|
)
|
|
$
|
(0.69
|
)
|
|
$
|
(1.77
|
)
|
|
$
|
(1.03
|
)
|
Weighted-average shares outstanding used to compute basic and diluted net loss per share
|
27,408,774
|
|
|
23,687,866
|
|
|
27,369,691
|
|
|
21,961,576
|
|
|
Series A Preferred Stock
|
|
Common Stock
|
|
Additional
Paid In
Capital
|
|
Accumulated
Other Comprehensive (Loss) Gain
|
|
Accumulated Deficit
|
|
Total Stockholders’ (Deficit) Equity
|
||||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
||||||||||||||||||
Balance at December 31, 2017
|
1,250,000
|
|
|
$
|
—
|
|
|
16,527,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(75,543
|
)
|
|
$
|
(75,543
|
)
|
Deemed contribution from Parent, increase of related-party receivable
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,051
|
|
|
—
|
|
|
—
|
|
|
1,051
|
|
||||||
Deemed distribution to Parent, increase of convertible note obligation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,387
|
)
|
|
—
|
|
|
(615
|
)
|
|
(2,002
|
)
|
||||||
Capital contribution from Parent, convertible note write-off
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
66,998
|
|
|
—
|
|
|
—
|
|
|
66,998
|
|
||||||
Capital contribution from Parent, forgiveness of related party borrowings
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13,188
|
|
|
—
|
|
|
—
|
|
|
13,188
|
|
||||||
Preferred stock conversion upon initial public offering
|
(1,250,000
|
)
|
|
—
|
|
|
2,065,875
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of common stock upon initial public offering, net of issuance costs
|
—
|
|
|
—
|
|
|
5,047,514
|
|
|
1
|
|
|
53,445
|
|
|
—
|
|
|
—
|
|
|
53,446
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,006
|
|
|
—
|
|
|
—
|
|
|
1,006
|
|
||||||
Net loss and comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,162
|
)
|
|
(6,162
|
)
|
||||||
Balance at March 31, 2018
|
—
|
|
|
$
|
—
|
|
|
23,640,389
|
|
|
$
|
1
|
|
|
$
|
134,301
|
|
|
$
|
—
|
|
|
$
|
(82,320
|
)
|
|
$
|
51,982
|
|
Issuance of common stock in connection with the incentive equity plan
|
—
|
|
|
—
|
|
|
34,602
|
|
|
—
|
|
|
(238
|
)
|
|
—
|
|
|
—
|
|
|
(238
|
)
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,623
|
|
|
—
|
|
|
—
|
|
|
2,623
|
|
||||||
Net loss and comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,433
|
)
|
|
(16,433
|
)
|
||||||
Balance at June 30, 2018
|
—
|
|
|
$
|
—
|
|
|
23,674,991
|
|
|
$
|
1
|
|
|
$
|
136,686
|
|
|
$
|
—
|
|
|
$
|
(98,753
|
)
|
|
$
|
37,934
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at December 31, 2018
|
—
|
|
|
$
|
—
|
|
|
27,274,991
|
|
|
$
|
1
|
|
|
$
|
207,408
|
|
|
$
|
—
|
|
|
$
|
(123,025
|
)
|
|
$
|
84,384
|
|
Issuance of common stock in connection with the incentive equity plan
|
—
|
|
|
—
|
|
|
10,372
|
|
|
—
|
|
|
(58
|
)
|
|
—
|
|
|
—
|
|
|
(58
|
)
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,015
|
|
|
—
|
|
|
—
|
|
|
2,015
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,975
|
)
|
|
(10,975
|
)
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(9
|
)
|
|
—
|
|
|
(9
|
)
|
||||||
Balance at March 31, 2019
|
—
|
|
|
$
|
—
|
|
|
27,285,363
|
|
|
$
|
1
|
|
|
$
|
209,365
|
|
|
$
|
(9
|
)
|
|
$
|
(134,000
|
)
|
|
$
|
75,357
|
|
Issuance of common stock in connection with the incentive equity plan
|
—
|
|
|
—
|
|
|
107,641
|
|
|
—
|
|
|
853
|
|
|
—
|
|
|
—
|
|
|
853
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,486
|
|
|
—
|
|
|
—
|
|
|
2,486
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(37,567
|
)
|
|
(37,567
|
)
|
||||||
Other comprehensive gain
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
52
|
|
|
—
|
|
|
52
|
|
||||||
Balance at June 30, 2019
|
—
|
|
|
$
|
—
|
|
|
27,393,004
|
|
|
$
|
1
|
|
|
$
|
212,704
|
|
|
$
|
43
|
|
|
$
|
(171,567
|
)
|
|
$
|
41,181
|
|
|
Six Months Ended
June 30, |
||||||
|
2019
|
|
2018
|
||||
Cash flows from operating activities
|
|
|
|
||||
Net loss
|
$
|
(48,542
|
)
|
|
$
|
(22,595
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
1,462
|
|
|
4
|
|
||
Amortization of discount on short-term investments
|
(586
|
)
|
|
—
|
|
||
Stock-based compensation
|
4,455
|
|
|
3,630
|
|
||
Amortization of operating lease right-of-use assets
|
523
|
|
|
—
|
|
||
Amortization of debt discount and issuance costs
|
889
|
|
|
428
|
|
||
Deferred income taxes
|
(14,750
|
)
|
|
22
|
|
||
Revaluation of contingent royalty obligation payable to Evolus Founders
|
6,182
|
|
|
9,100
|
|
||
Changes in assets and liabilities:
|
|
|
|
||||
Inventories
|
(11,522
|
)
|
|
—
|
|
||
Accounts receivable, net
|
(1,410
|
)
|
|
—
|
|
||
Prepaid expenses and other current assets
|
(1,997
|
)
|
|
(854
|
)
|
||
Accounts payable and accrued expenses
|
13,347
|
|
|
2,405
|
|
||
Operating lease liabilities
|
(409
|
)
|
|
(5
|
)
|
||
Net cash used in operating activities
|
(52,358
|
)
|
|
(7,865
|
)
|
||
Cash flows from investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(346
|
)
|
|
(9
|
)
|
||
Additions to capitalized software
|
(2,441
|
)
|
|
—
|
|
||
Purchases of short-term investments
|
(94,011
|
)
|
|
—
|
|
||
Maturities of short-term investments
|
25,000
|
|
|
—
|
|
||
Net cash used in investing activities
|
(71,798
|
)
|
|
(9
|
)
|
||
Cash flows from financing activities
|
|
|
|
||||
Payment of contingent royalty obligation to Evolus Founders
|
(9,213
|
)
|
|
—
|
|
||
Milestone payment for intangible assets
|
(2,000
|
)
|
|
—
|
|
||
Proceeds from issuance of long-term debt, net of discounts
|
73,906
|
|
|
—
|
|
||
Payments for debt issuance costs
|
(2,205
|
)
|
|
—
|
|
||
Proceeds from initial public offering, net of underwriters fees
|
—
|
|
|
56,330
|
|
||
Payments for offering costs
|
—
|
|
|
(760
|
)
|
||
Related party borrowings
|
—
|
|
|
1,127
|
|
||
Payments on related party borrowings
|
—
|
|
|
(5,000
|
)
|
||
Issuance of common stock in connection with incentive equity plan
|
795
|
|
|
(238
|
)
|
||
Net cash provided by financing activities
|
61,283
|
|
|
51,459
|
|
||
Change in cash and cash equivalents
|
(62,873
|
)
|
|
43,585
|
|
||
Cash and cash equivalents, beginning of period
|
93,162
|
|
|
—
|
|
||
Cash and cash equivalents, end of period
|
$
|
30,289
|
|
|
$
|
43,585
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Cash paid for interest
|
$
|
1,544
|
|
|
$
|
—
|
|
Cash paid for amounts included in the measurement of operating lease liabilities
|
$
|
468
|
|
|
$
|
—
|
|
Non-cash investing and financing information:
|
|
|
|
||||
Related party receivable
|
$
|
—
|
|
|
$
|
73,690
|
|
Related party borrowings
|
$
|
—
|
|
|
$
|
(68,767
|
)
|
Note obligation
|
$
|
—
|
|
|
$
|
(140,688
|
)
|
Contingent royalty obligation payable to Evolus Founders
|
$
|
—
|
|
|
$
|
39,700
|
|
Contingent promissory note payable to Evolus Founders
|
$
|
—
|
|
|
$
|
16,042
|
|
Capital contribution from Parent, convertible note write-off
|
$
|
—
|
|
|
$
|
66,998
|
|
Capital contribution from Parent, forgiveness of related party borrowings
|
$
|
—
|
|
|
$
|
13,188
|
|
Deferred offering costs
|
$
|
—
|
|
|
$
|
(2,885
|
)
|
Deferred offering costs, unpaid
|
$
|
—
|
|
|
$
|
(22
|
)
|
Accounts payable, paid by Parent
|
$
|
—
|
|
|
$
|
(163
|
)
|
Operating lease right-of-use assets obtained in exchange for operating lease liabilities
|
$
|
5,566
|
|
|
$
|
—
|
|
Capitalized software recorded in accounts payable and accrued expenses
|
$
|
55
|
|
|
$
|
—
|
|
•
|
Level 1—Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
|
•
|
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities in active markets; quoted prices in markets that are not active; or other inputs that are observable, either directly or indirectly, or can be corroborated by observable market data for substantially the full term of the asset or liability; and
|
•
|
Level 3—Prices or valuation techniques that require inputs that are unobservable that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
•
|
Rebates -
Volume rebates are contractually offered to certain customers. Generally, the rebates payable to each customer are determined objectively based on the contract and quarterly purchase volumes.
|
•
|
Coupons -
The Company implemented a program by which customers receive coupons redeemable into gift cards funded by the Company for the benefit of patients. The coupons are accounted for as variable consideration. The Company currently does not have sufficient historical data to estimate the coupon redemption rates. Accordingly, the coupons are fully accrued based on contract terms and the volume of products purchased and recorded as a reduction to revenues on product delivery.
|
|
June 30,
|
|
December 31,
|
||||
|
2019
|
|
2018
|
||||
Accounts payable
|
$
|
7,708
|
|
|
$
|
1,558
|
|
Accrued professional services
|
4,653
|
|
|
931
|
|
||
Contingent royalty obligation payable to Evolus Founders
|
3,396
|
|
|
—
|
|
||
Accrued payroll and related benefits
|
3,365
|
|
|
2,577
|
|
||
Directors’ and officers’ insurance
|
1,387
|
|
|
—
|
|
||
Other accrued expenses
|
1,565
|
|
|
210
|
|
||
|
$
|
22,074
|
|
|
$
|
5,276
|
|
|
Weighted-Average Life (Years)
|
|
Original Cost
|
|
Accumulated Amortization
|
|
Net Book Value
|
||||||
Definite-lived intangible assets
|
|
|
|
|
|
|
|
||||||
Distribution right
|
20
|
|
$
|
58,076
|
|
|
$
|
(1,210
|
)
|
|
$
|
56,866
|
|
Capitalized software
|
2
|
|
2,542
|
|
|
(197
|
)
|
|
2,345
|
|
|||
Intangible assets, net
|
|
|
60,618
|
|
|
(1,407
|
)
|
|
59,211
|
|
|||
Indefinite-lived intangible asset
|
|
|
|
|
|
|
|
||||||
Goodwill
|
*
|
|
21,208
|
|
|
—
|
|
|
21,208
|
|
|||
Total as of June 30, 2019
|
|
|
$
|
81,826
|
|
|
$
|
(1,407
|
)
|
|
$
|
80,419
|
|
|
Weighted-Average Life (Years)
|
|
Original Cost
|
|
Accumulated Amortization
|
|
Net Book Value
|
||||||
Indefinite-lived intangible assets
|
|
|
|
|
|
|
|
||||||
IPR&D**
|
*
|
|
$
|
56,076
|
|
|
$
|
—
|
|
|
$
|
56,076
|
|
Goodwill
|
*
|
|
21,208
|
|
|
—
|
|
|
21,208
|
|
|||
Total as of December 31, 2018
|
|
|
$
|
77,284
|
|
|
$
|
—
|
|
|
$
|
77,284
|
|
Fiscal year
|
(in thousands)
|
|
|
Remaining in 2019
|
$
|
2,092
|
|
2020
|
4,183
|
|
|
2021
|
3,330
|
|
|
2022
|
2,904
|
|
|
2023
|
2,904
|
|
|
Thereafter
|
43,798
|
|
|
|
$
|
59,211
|
|
|
Principal
|
|
Final Payment
|
|
Total
|
||||||
2022
|
$
|
26,087
|
|
|
$
|
—
|
|
|
$
|
26,087
|
|
2023
|
39,130
|
|
|
—
|
|
|
39,130
|
|
|||
2024
|
9,783
|
|
|
4,125
|
|
|
13,908
|
|
|||
|
$
|
75,000
|
|
|
$
|
4,125
|
|
|
$
|
79,125
|
|
|
Amortized
|
|
Gross Unrealized
|
|
Estimated
|
||||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
||||||||
Available-for-sale securities
|
|
|
|
|
|
|
|
||||||||
U.S treasury securities
|
$
|
69,596
|
|
|
$
|
52
|
|
|
$
|
(8
|
)
|
|
$
|
69,640
|
|
|
As of June 30, 2019
|
||||||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Available-for-sale securities
|
|
|
|
|
|
|
|
||||||||
U.S treasury securities
|
$
|
69,640
|
|
|
$
|
69,640
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||||
Contingent royalty obligation payable to Evolus Founders
|
$
|
47,169
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
47,169
|
|
|
As of December 31, 2018
|
||||||||||||||
|
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Contingent royalty obligation payable to Evolus Founders
|
$
|
50,200
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
50,200
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Fair value, beginning of period
|
$
|
45,900
|
|
|
$
|
40,600
|
|
|
$
|
50,200
|
|
|
$
|
39,700
|
|
FDA milestone payment
|
—
|
|
|
—
|
|
|
(9,213
|
)
|
|
—
|
|
||||
Change in fair value recorded in operating expenses
|
1,269
|
|
|
8,200
|
|
|
6,182
|
|
|
9,100
|
|
||||
Fair value, end of period
|
$
|
47,169
|
|
|
$
|
48,800
|
|
|
$
|
47,169
|
|
|
$
|
48,800
|
|
Contingent royalty obligation payable to Evolus Founders
|
$
|
47,169
|
|
|
$
|
48,800
|
|
|
$
|
47,169
|
|
|
$
|
48,800
|
|
|
Three Months Ended
June 30, 2019 |
|
Six Months Ended
June 30, 2019 |
||||
Fixed operating lease expense
|
$
|
267
|
|
|
$
|
501
|
|
Variable operating lease expense
|
32
|
|
|
61
|
|
||
Short-term operating lease expense
|
28
|
|
|
49
|
|
||
|
$
|
327
|
|
|
$
|
611
|
|
|
|
|
|
||||
Weighted-average remaining lease term in years - operating leases
|
|
|
5.5
|
||||
Weighted-average discount rate
|
|
|
9.4%
|
Remainder of 2019
|
$
|
479
|
|
2020
|
1,167
|
|
|
2021
|
1,168
|
|
|
2022
|
1,221
|
|
|
2023
|
1,275
|
|
|
Thereafter
|
1,444
|
|
|
Total operating lease payments
|
6,754
|
|
|
Less: Imputed interest
|
(1,576
|
)
|
|
Present value of operating lease liabilities
|
$
|
5,178
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Volatility
|
59.7%
|
|
59.2%
|
|
59.3%
|
|
57.6%
|
Risk-free interest rate
|
2.40%
|
|
2.84%
|
|
2.57%
|
|
2.62%
|
Expected life in years
|
6.25
|
|
6.23
|
|
6.18
|
|
6.23
|
Dividend yield rate
|
—%
|
|
—%
|
|
—%
|
|
—%
|
|
|
|
|
|
Weighted
|
|
|
||||
|
|
|
Weighted
|
|
Average
|
|
Aggregate
|
||||
|
|
|
Average
|
|
Remaining
|
|
Intrinsic
|
||||
|
Stock
|
|
Exercise
|
|
Contractual
|
|
Value
|
||||
|
Options
|
|
Per Share
|
|
Terms (Years)
|
|
(in thousands)
|
||||
Outstanding, December 31, 2018
|
3,257,801
|
|
$
|
11.99
|
|
|
9.26
|
|
$
|
7,119
|
|
Granted
|
1,086,585
|
|
19.51
|
|
|
|
|
|
|
||
Exercised
|
(107,373)
|
|
9.98
|
|
|
|
|
|
|
||
Cancelled/forfeited
|
(217,672)
|
|
12.58
|
|
|
|
|
|
|
||
Outstanding, June 30, 2019
|
4,019,341
|
|
$
|
14.04
|
|
|
8.61
|
|
$
|
12,724
|
|
Exercisable, June 30, 2019
|
762,993
|
|
$
|
10.85
|
|
|
7.23
|
|
$
|
3,779
|
|
|
|
|
Weighted-Average
|
||
|
Stock
|
|
Grant Date
|
||
|
Options
|
|
Fair Value
|
||
Outstanding, December 31, 2018
|
3,257,801
|
|
$
|
7.32
|
|
Granted
|
1,086,585
|
|
11.22
|
|
|
Vested
|
(870,366)
|
|
6.80
|
|
|
Cancelled/forfeited
|
(217,672)
|
|
8.24
|
|
|
Outstanding, June 30, 2019
|
3,256,348
|
|
$
|
8.70
|
|
|
|
|
Weighted
|
||
|
Restricted
|
|
Average
|
||
|
Stock
|
|
Grant Date
|
||
|
Units
|
|
Fair Value
|
||
Outstanding, December 31, 2018
|
271,404
|
|
$
|
16.53
|
|
Granted
|
3,000
|
|
18.33
|
|
|
Vested
|
(21,375)
|
|
25.69
|
|
|
Forfeited
|
(17,534)
|
|
13.08
|
|
|
Outstanding, June 30, 2019
|
235,495
|
|
$
|
15.98
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Selling, general and administrative
|
$
|
2,282
|
|
|
$
|
2,246
|
|
|
$
|
4,026
|
|
|
$
|
2,924
|
|
Research and development
|
175
|
|
|
377
|
|
|
429
|
|
|
706
|
|
||||
|
$
|
2,457
|
|
|
$
|
2,623
|
|
|
$
|
4,455
|
|
|
$
|
3,630
|
|
|
Three Months Ended
June 30, |
|
|
||||||||
|
2019
|
|
2018
|
|
Change
|
||||||
Net revenues
|
$
|
2,311
|
|
|
$
|
—
|
|
|
$
|
2,311
|
|
Cost of sales (excludes amortization of intangible assets)
|
660
|
|
|
—
|
|
|
660
|
|
|||
Gross profit
|
1,651
|
|
|
—
|
|
|
1,651
|
|
|||
As a percentage of net revenues
|
71.4
|
%
|
|
—
|
%
|
|
|
||||
Operating expenses:
|
|
|
|
|
|
||||||
Selling, general and administrative
|
34,892
|
|
|
6,248
|
|
|
28,644
|
|
|||
Research and development
|
509
|
|
|
1,648
|
|
|
(1,139
|
)
|
|||
Revaluation of contingent royalty obligation payable to Evolus Founders
|
1,269
|
|
|
8,200
|
|
|
(6,931
|
)
|
|||
Depreciation and amortization
|
978
|
|
|
4
|
|
|
974
|
|
|||
Total operating expenses
|
37,648
|
|
|
16,100
|
|
|
21,548
|
|
|||
Loss from operations
|
(35,997
|
)
|
|
(16,100
|
)
|
|
(19,897
|
)
|
|||
Non operating income (expense), net
|
(1,797
|
)
|
|
(321
|
)
|
|
(1,476
|
)
|
|||
Loss before income taxes:
|
(37,794
|
)
|
|
(16,421
|
)
|
|
(21,373
|
)
|
|||
Income tax (benefit) expense
|
(227
|
)
|
|
12
|
|
|
(239
|
)
|
|||
Net loss
|
$
|
(37,567
|
)
|
|
$
|
(16,433
|
)
|
|
$
|
(21,134
|
)
|
|
Six Months Ended
June 30, |
|
|
||||||||
|
2019
|
|
2018
|
|
Change
|
||||||
Net revenues
|
$
|
2,311
|
|
|
$
|
—
|
|
|
$
|
2,311
|
|
Cost of sales (excludes amortization of intangible assets)
|
660
|
|
|
—
|
|
|
660
|
|
|||
Gross profit
|
1,651
|
|
|
—
|
|
|
1,651
|
|
|||
As a percentage of net revenues
|
71.4
|
%
|
|
—
|
%
|
|
|
||||
Operating expenses:
|
|
|
|
|
|
||||||
Selling, general and administrative
|
52,411
|
|
|
9,715
|
|
|
42,696
|
|
|||
Research and development
|
2,862
|
|
|
3,326
|
|
|
(464
|
)
|
|||
Revaluation of contingent royalty obligation payable to Evolus Founders
|
6,182
|
|
|
9,100
|
|
|
(2,918
|
)
|
|||
Depreciation and amortization
|
1,462
|
|
|
4
|
|
|
1,458
|
|
|||
Total operating expenses
|
62,917
|
|
|
22,145
|
|
|
40,772
|
|
|||
Loss from operations
|
(61,266
|
)
|
|
(22,145
|
)
|
|
(39,121
|
)
|
|||
Non operating income (expense), net
|
(2,026
|
)
|
|
(428
|
)
|
|
(1,598
|
)
|
|||
Loss before income taxes:
|
(63,292
|
)
|
|
(22,573
|
)
|
|
(40,719
|
)
|
|||
Income tax (benefit) expense
|
(14,750
|
)
|
|
22
|
|
|
(14,772
|
)
|
|||
Net loss
|
$
|
(48,542
|
)
|
|
$
|
(22,595
|
)
|
|
$
|
(25,947
|
)
|
•
|
the number and characteristics of any future product candidates we develop or acquire;
|
•
|
the timing of any cash milestone payments to Daewoong if we successfully achieve certain predetermined milestones;
|
•
|
our ability to forecast demand for our products, scale our supply to meet that demand and manage working capital effectively
|
•
|
the cost of manufacturing our product or any future product candidates and any products we successfully commercialize, including costs associated with building our supply chain;
|
•
|
the cost of commercialization activities for Jeuveau
®
or any future product candidates are approved or cleared for sale, including marketing, sales and distribution costs;
|
•
|
the cost of maintaining a sales force, the productivity of that sales force, and the market acceptance of our products;
|
•
|
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of any such agreements that we may enter into;
|
•
|
any product liability or other lawsuits related to our products;
|
•
|
the expenses needed to attract and retain skilled personnel;
|
•
|
the costs associated with being a public company;
|
•
|
the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including ongoing litigation costs related to Jeuveau
®
and the outcome of this and any other future patent litigation we may be involved in; and
|
•
|
the timing, receipt and amount of sales of any future approved or cleared products, if any.
|
|
Six Months Ended
June 30, |
||||||
|
2019
|
|
2018
|
||||
Net cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(52,358
|
)
|
|
$
|
(7,865
|
)
|
Investing activities
|
(71,798
|
)
|
|
(9
|
)
|
||
Financing activities
|
61,283
|
|
|
51,459
|
|
||
Change in cash and cash equivalents
|
(62,873
|
)
|
|
43,585
|
|
||
Cash and cash equivalents, beginning of period
|
93,162
|
|
|
—
|
|
||
Cash and cash equivalents, end of period
|
$
|
30,289
|
|
|
$
|
43,585
|
|
•
|
our success in educating physicians and consumers about the benefits, administration and use of Jeuveau
®
;
|
•
|
the prevalence, duration and severity of potential side effects experienced with Jeuveau
®
;
|
•
|
achieving and maintaining compliance with all regulatory requirements applicable to Jeuveau
®
;
|
•
|
the ability to raise additional capital on acceptable terms, or at all, if needed, to support the commercial launch of Jeuveau
®
;
|
•
|
the acceptance by physicians and consumers of the safety and efficacy of Jeuveau
®
;
|
•
|
our ability to successfully commercialize Jeuveau
®
, whether alone or in collaboration with others, including our ability to hire, retain and train sales representatives in the United States;
|
•
|
the ability of our current manufacturer and any third parties with whom we may contract to manufacture Jeuveau
®
to remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with current Good Manufacturing Practice, or cGMP, requirements; and
|
•
|
the availability, perceived advantages, relative cost, relative safety and relative efficacy of competing products, the timing of new product introductions by our competitors, and the sales and marketing tactics of our competitors, including bundling of multiple products, in response to our launch of Jeuveau
®
.
|
•
|
limiting our ability to obtain additional financing on satisfactory terms to fund our working capital requirements, capital expenditures, potential acquisitions, debt obligations and other general corporate requirements, and making it more difficult for us to satisfy our obligations with respect to any such additional financing;
|
•
|
increasing our vulnerability to general economic downturns, competition and industry conditions, which could place us at a competitive disadvantage compared to our competitors with no debt obligations or with debt obligations on more favorable terms.
|
•
|
limiting our ability to pursue acquisition opportunities and to license intellectual property outside specified exceptions.
|
•
|
dispose of assets;
|
•
|
undergo certain business, management, ownership, business and other fundamental changes;
|
•
|
engage in certain merger, acquisition and consolidation transactions;
|
•
|
incur additional indebtedness and create liens and other encumbrances;
|
•
|
make restricted payments, including dividends and other distributions; and
|
•
|
engage in certain transactions with affiliates.
|
•
|
the cost of commercialization activities for Jeuveau
®
or if any other future product candidates are approved for sale, including marketing, sales and distribution costs;
|
•
|
the scope, progress, results and costs of researching and developing any future product candidates, and conducting preclinical and clinical trials;
|
•
|
our ability to accurately forecast demand for our products, the ability of our third-party manufacturers to scale production to meet that demand, and our ability to effectively manage our working capital requirements including the purchase of inventory and collection of receivables;
|
•
|
costs under our third-party manufacturing and supply arrangements for our current and any future product candidates and any products we commercialize;
|
•
|
our ability to establish and maintain strategic collaborations, licensing or other arrangements and the terms of and timing of such arrangements;
|
•
|
the timing of, and the costs involved in, obtaining and maintaining regulatory approvals for any future product candidates;
|
•
|
the degree and rate of market acceptance of Jeuveau
®
or any future approved products;
|
•
|
the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products, the timing of new product introductions by competitors and other actions by competitors in the marketplace;
|
•
|
costs of operating as a public company; and
|
•
|
costs associated with any acquisition or in-license of products and product candidates, technologies or businesses.
|
•
|
the effectiveness, ease of use, and safety of Jeuveau
®
and any future product candidates as compared to existing products or treatments;
|
•
|
physician and consumer willingness to adopt Jeuveau
®
to treat glabellar lines or other aesthetic indications we may pursue over products and brands with which consumers and physicians may have more familiarity or recognition
or additional approved uses
;
|
•
|
overcoming any biases physicians or consumers may have toward the use, safety and efficacy of existing products or treatments
and successful marketing of the benefits of a 900 kDa botulinum toxin type A complex
;
|
•
|
the cost of Jeuveau
®
and any future product candidates in relation to alternative products or treatments and willingness to pay for the product or treatment on the part of consumers;
|
•
|
proper training and administration of Jeuveau
®
and any future product candidates by physicians and medical staff;
|
•
|
consumer satisfaction with the results and administration of Jeuveau
®
and any future product candidates and overall treatment experience;
|
•
|
changes in pricing,
promotional, negative sales tactics, promotion of longer-term purchase agreements
and bundling efforts by competitors;
|
•
|
the filing of various lawsuits by competitors with the intent of preventing or delaying our product launches, to distract management’s attention from operating our business and to devote significant financial resources to defend such litigation attempts;
|
•
|
consumer demand for the treatment of glabellar lines or other aesthetic indications that may be approved in the future;
|
•
|
the willingness of consumers to pay for Jeuveau
®
and any future product candidates relative to other discretionary items, especially during economically challenging times;
|
•
|
the revenue and profitability that Jeuveau
®
and any future product candidates may offer a physician as compared to alternative products or treatments;
|
•
|
the effectiveness of our sales, marketing and distribution efforts and our ability to develop our brand awareness;
|
•
|
any adverse impact on our brand resulting from key opinion leader relationships with ALPHAEON or SCH, whether or not related to us;
|
•
|
our ability to compete with our competitors’ product bundling offerings as we initially launch Jeuveau
®
as a stand-alone product; and
|
•
|
adverse
publicity
about our product candidates, competitive products, or the industry as a whole, or favorable publicity about competitive products.
|
•
|
the success of any sales and marketing programs that we, or any third parties we engage, undertake, and as to which we have limited experience;
|
•
|
the extent to which physicians recommend Jeuveau
®
to their patients;
|
•
|
the extent to which Jeuveau
®
satisfies consumer expectations
and overcoming consumer loyalty with existing products and brands
;
|
•
|
our ability to properly train physicians in the use of Jeuveau
®
such that their consumers do not experience excessive discomfort during treatment or adverse side effects;
|
•
|
the cost, safety and effectiveness of Jeuveau
®
versus other aesthetic treatments;
|
•
|
the development
and
availability of alternative products and treatments that seek to address similar goals;
|
•
|
consumer sentiment about the benefits and risks of aesthetic procedures generally and Jeuveau
®
in particular;
|
•
|
the success of any direct-to-consumer marketing efforts that we may initiate;
|
•
|
the ability and ease with which physicians are able to incorporate Jeuveau
®
into their practices;
|
•
|
changes in demographic and social trends; and
|
•
|
general consumer
confidence
, which may be impacted by economic and political conditions.
|
•
|
regulatory authorities may withdraw their approval of the product;
|
•
|
regulatory authorities may require a recall of the product or we may voluntarily recall a product;
|
•
|
regulatory authorities may require the addition of warnings or contraindications in the product labeling, narrowing of the indication in the product label or issuance of field alerts to physicians and pharmacies;
|
•
|
regulatory authorities may require us to create a medication guide outlining the risks of such side effects for distribution to patients or institute a
Risk Evaluation and Mitigation Strategies, or
REMS;
|
•
|
we may be subject to limitations as to how we market or promote the product;
|
•
|
we may be required to change the way the product is administered or modify the product in some other way;
|
•
|
regulatory authorities may require additional clinical trials or costly post-marketing testing and surveillance to monitor the safety or efficacy of the product;
|
•
|
sales of the product may decrease significantly;
|
•
|
we could be sued and held liable for harm caused to patients; and
|
•
|
our brand
and
reputation may suffer.
|
•
|
manage any of our future clinical trials effectively;
|
•
|
identify, recruit, retain, incentivize and integrate any additional employees;
|
•
|
manage our internal development efforts effectively while carrying out our contractual obligations to third parties; and
|
•
|
continue
to improve our operational, financial and management controls, reporting systems and procedures.
|
•
|
requirements or preferences for domestic products or solutions, which could reduce demand for our products;
|
•
|
differing existing or future regulatory and certification requirements;
|
•
|
management communication and integration problems resulting from cultural and geographic dispersion;
|
•
|
greater difficulty in collecting accounts receivable and longer collection periods;
|
•
|
difficulties in enforcing contracts;
|
•
|
difficulties and costs of staffing and managing non-U.S. operations;
|
•
|
the uncertainty of protection for intellectual property rights in some countries;
|
•
|
tariffs and trade barriers, export regulations and other regulatory and contractual limitations on our ability to sell our products;
|
•
|
multiple, conflicting and changing laws and regulations such as privacy regulations, including General Data Protection Regulation, or GDPR, tax laws, export and import restrictions, employment laws, immigration laws, labor laws, regulatory requirements and other governmental approvals, permits and licenses;
|
•
|
more stringent data protection standards in some countries;
|
•
|
greater risk of a failure of foreign employees to comply with both U.S. and foreign laws, including export and antitrust regulations, the U.S. Foreign Corrupt Practices Act, or FCPA, quality assurance and other healthcare regulatory requirements and any trade regulations ensuring fair trade practices;
|
•
|
heightened risk of unfair or corrupt business practices in certain geographies and of improper or fraudulent sales arrangements that may impact financial results and result in restatements of, or irregularities in, financial statements;
|
•
|
foreign currency exchange rates and the generally lower average sales prices available in most international markets compared to those in the United States;
|
•
|
potentially adverse tax consequences, including multiple and possibly overlapping tax structures and difficulties relating to repatriation of cash; and
|
•
|
political and
economic
instability, political unrest and terrorism.
|
•
|
decreased demand for Jeuveau
®
or any future product candidates or products we develop;
|
•
|
termination of clinical trial sites or entire trial programs;
|
•
|
injury to our reputation and significant negative media attention;
|
•
|
withdrawal of clinical trial participants or cancellation of clinical trials;
|
•
|
significant costs to defend the related litigation;
|
•
|
a diversion of management’s time and our resources;
|
•
|
substantial monetary awards to trial participants or patients;
|
•
|
regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
•
|
loss of revenue;
|
•
|
the inability to commercialize any products we develop; and
|
•
|
a decline in our share price.
|
•
|
impose restrictions on the marketing or manufacturing of the product, suspend or withdraw product approvals or revoke necessary licenses;
|
•
|
issue warning letters, show cause notices or untitled letters describing alleged violations, which may be publicly available;
|
•
|
mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners;
|
•
|
require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;
|
•
|
commence criminal investigations and prosecutions;
|
•
|
impose injunctions;
|
•
|
impose other civil or criminal penalties;
|
•
|
suspend any ongoing clinical trials;
|
•
|
delay or refuse to approve pending applications or supplements to approved applications filed by us;
|
•
|
refuse to permit drugs or active ingredients to be imported or exported;
|
•
|
suspend or impose restrictions on operations, including costly new manufacturing requirements; or
|
•
|
seize or detain products or require us to initiate a product recall.
|
•
|
a product candidate may not be deemed safe, effective, pure or potent;
|
•
|
the data from preclinical studies and clinical trials may not be deemed sufficient;
|
•
|
the FDA or other regulatory authorities might not approve our third-party manufacturers’ processes or facilities;
|
•
|
deficiencies in the formulation, quality control, labeling, or specifications of a product candidate
or in response to citizen petitions or similar documents filed in connection with the product candidate
;
|
•
|
general requirements intended to address risks associated with a class of drugs, such as a new REMS requirement for neurotoxins;
|
•
|
the enactment of new laws or promulgation of new regulations that change the approval requirements; or
|
•
|
the FDA or other regulatory authorities may change their approval policies or adopt new regulations.
|
•
|
restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
|
•
|
fines, warning letters or holds on clinical trials;
|
•
|
refusal by the FDA, EMA or other similar regulatory authorities to approve pending applications or supplements to approved applications filed by us or our strategic collaborators or suspension or revocation of product license approvals;
|
•
|
product seizure or detention or refusal to permit the import or export of products; and
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
•
|
changes to manufacturing or marketing methods;
|
•
|
changes to product labeling or promotional materials;
|
•
|
recall, replacement, or discontinuance of one or more of our products; and
|
•
|
additional recordkeeping.
|
•
|
corporate opportunities;
|
•
|
the impact that operating decisions for our business may have on ALPHAEON’s consolidated financial statements;
|
•
|
the impact that operating or capital decisions (including the incurrence of indebtedness) for our business may have on ALPHAEON’s current or future indebtedness or the covenants under that indebtedness;
|
•
|
the timing and amount of financing efforts, whether they are debt or equity, and the amount of resulting dilution to existing shareholders;
|
•
|
business combinations involving us;
|
•
|
our dividend policy;
|
•
|
management stock ownership; and
|
•
|
the related party services and agreements between ALPHAEON and us.
|
•
|
indemnification and other matters arising from our initial public offering;
|
•
|
the nature, quality and pricing of services ALPHAEON agrees to provide to us;
|
•
|
sales or other disposal by ALPHAEON of all or a portion of its ownership interest in us; and
|
•
|
business combinations involving us.
|
•
|
engaging in the same or similar business activities or lines of business as we do;
|
•
|
doing business with any of our clients or consumers; or
|
•
|
employing or otherwise engaging any of our officers or employees.
|
•
|
announcements of regulatory approval or disapproval of product candidates;
|
•
|
adverse results from or delays in clinical trials of any of our future product candidates;
|
•
|
unanticipated safety concerns related to the use of Jeuveau
®
or any of our future products;
|
•
|
any termination or loss of rights under the Daewoong Agreement;
|
•
|
FDA or other U.S. or foreign regulatory or legal actions or changes affecting us or our industry;
|
•
|
adverse developments concerning our manufacturer or any future strategic partnerships;
|
•
|
introductions and announcements of new technologies and products by us, any commercialization partners or our competitors, and the timing of these introductions and announcements;
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
•
|
success or failure of competitive products or medical aesthetic products generally;
|
•
|
changes in the structure of healthcare payment systems;
|
•
|
announcements by us or our competitors of significant acquisitions, licenses, strategic partnerships, new product approvals and introductions, joint ventures or capital commitments;
|
•
|
overall financial market conditions for the pharmaceutical and biopharmaceutical sectors and issuance of securities analysts’ reports or recommendations;
|
•
|
quarterly variations in our results of operations or those of our competitors
;
|
•
|
changes in financial estimates or guidance, including our ability to meet our future revenue and operating profit or loss estimates or guidance;
|
•
|
the public’s reaction to our earnings releases, other public announcements and filings with the SEC;
|
•
|
rumors and market speculation involving us or other companies in our industry;
|
•
|
short selling of our common stock or the publication of opinions regarding our business prospects in a manner that is designed to create negative market momentum;
|
•
|
sales of substantial amounts of our stock by ALPHAEON or other significant stockholders or our insiders, or the expectation that such sales might occur;
|
•
|
general economic, industry and market conditions, including the size and growth, if any, of the medical aesthetics market;
|
•
|
news reports relating to trends, concerns and other issues in medical aesthetics market or the pharmaceutical or biopharmaceutical industry;
|
•
|
operating and stock performance of other companies that investors deem comparable to us and overall performance of the equity markets;
|
•
|
additions or departures of key personnel, including our Chief Executive Officer, Chief Financial Officer,
Chief Medical Officer and Chief Marketing Officer;
|
•
|
intellectual property, product liability or other litigation against us, our manufacturer or other parties on which we rely or litigation against our general industry;
|
•
|
announcements or actions taken by ALPHAEON as our controlling stockholder, including sales of substantial amounts of our common stock by ALPHAEON;
|
•
|
changes in our capital structure, such as future issuances of securities and the incurrence of additional debt;
|
•
|
changes in accounting standards, policies, guidelines, interpretations or principles; and
|
•
|
other factors
described
in this “Risk Factors” section.
|
•
|
the requirement that a majority of our board of directors consist of independent directors;
|
•
|
the requirement that our nominating and corporate governance committee be comprised entirely of independent directors with a written charter addressing the committee's purpose and responsibilities;
|
•
|
the requirement that our compensation committee be comprised entirely of independent directors with a written charter addressing the committee's purpose and responsibilities; and
|
•
|
the requirement for an annual performance evaluation of our nominating and corporate governance and compensation committees;
|
•
|
our historical financial data reflects expense allocations for certain support functions that are provided on a centralized basis within ALPHAEON, such as expenses for business technology, facilities, legal, finance, human resources and business development, that may be higher or lower than the comparable expenses that we would have actually incurred, or will incur in the future, as a stand-alone company;
|
•
|
significant
increases have and will continue to occur in our cost structure as a result of our being a public company, including costs related to public company reporting, investor relations and compliance with the Sarbanes-Oxley Act; and
|
•
|
our becoming a commercial company in 2019.
|
•
|
permit our board of directors to issue shares of preferred stock, with any rights, preferences and privileges as they may designate, without stockholder approval, which could be used to dilute the ownership of a hostile bidder significantly;
|
•
|
provide that the authorized number of directors may be changed only by resolution of our board of directors
and that, f
rom and after the date on which ALPHAEON no longer beneficially owns
a majority of the voting power of all
|
•
|
provide that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;
|
•
|
divide our board of directors into three classes, with each class serving staggered three-year terms, which may delay the ability of stockholders to change the membership of a majority of our board of directors;
|
•
|
f
rom and after the date on which ALPHAEON no longer beneficially owns
a majority of the voting power of all of the then-outstanding shares of our capital stock
,
require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent;
|
•
|
provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner and also specify requirements as to the form and content of a stockholder’s notice, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror’s own slate of directors or otherwise attempting to obtain control of our company;
|
•
|
prohibit cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates; and
|
•
|
provide that special meetings of our stockholders may be called only by the chairman of the board, our Chief Executive Officer or by
our
board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors, which may delay the ability of our stockholders to force consideration by our company of a take-over proposal or to take certain corporate actions, including the removal of directors.
|
•
|
We have indemnified our directors and officers for serving us in those capacities, or for serving as a director, officer, employee or agent of other business enterprises at our request, to the fullest extent permitted by Delaware law. Delaware law provides that we may indemnify such person if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to our best interest and, with respect to any criminal proceeding, had no reasonable cause to believe such person’s conduct was unlawful.
|
•
|
We will be required to advance expenses, as incurred, to our directors and officers in connection with defending a proceeding, except that such directors or officers shall undertake to repay such advances if it is ultimately determined that such person is not entitled to indemnification.
|
•
|
The rights conferred in our bylaws will not be exclusive. W
e may not retroactively amend our bylaw provisions to reduce our indemnification obligations to directors, officers, employees and agents.
|
•
|
being permitted to have only two years of audited financial statements and only two years of related selected financial data and management’s discussion and analysis of financial condition and results of operations disclosure;
|
•
|
an exemption from compliance with the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act;
|
•
|
reduced disclosure about executive compensation arrangements in our periodic reports, registration statements and proxy statements; and
|
•
|
exemptions from the requirements to seek non-binding advisory votes on executive compensation or golden parachute arrangements.
|
|
|
|
|
Incorporated by Reference
|
|
|
||||||
Exhibit Number
|
|
Exhibit Title
|
|
Form
|
|
File No.
|
|
Exhibit
|
|
Filing Date
|
|
Filed Herewith
(x)
|
|
|
|
|
|
|
|
|
|
|
X
|
||
|
|
|
|
|
|
|
|
|
|
X
|
||
|
|
|
|
|
|
|
|
|
|
X
|
||
|
|
|
|
|
|
|
|
|
|
X
|
||
101.INS
|
|
XBRL Instance Document.
|
|
|
|
|
|
|
|
|
|
X
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document.
|
|
|
|
|
|
|
|
|
|
X
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
|
|
|
|
|
|
X
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
|
|
|
|
|
|
X
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
|
|
|
|
|
|
X
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
|
|
|
|
|
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X
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The information in Exhibit 32.1 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act (including this Quarterly Report on Form 10-Q), unless the Registrant specifically incorporates the foregoing information into those documents by reference.
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Evolus, Inc.
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Date:
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August 12, 2019
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By:
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/s/ David Moatazedi
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David Moatazedi
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President and Chief Executive Officer
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(Principal Executive Officer )
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Date:
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August 12, 2019
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By:
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/s/ Lauren Silvernail
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Lauren Silvernail
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Chief Financial Officer and Executive Vice President, Corporate Development
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(Principal Financial Officer )
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BORROWER:
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EVOLUS, INC.
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By
/s/ David Moatazedi
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Name:
David Moatazedi
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Title:
President and Chief Executive Officer
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COLLATERAL AGENT AND LENDER:
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OXFORD FINANCE LLC
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By
/s/ Colette H. Featherly
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Name:
Colette H. Featherly
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Title:
Senior Vice President
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1.
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I have reviewed this Quarterly Report on Form 10-Q of Evolus, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting 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 generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: August 12, 2019
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/s/ David Moatazedi
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David Moatazedi
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President, Chief Executive Officer and Director
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(Principal Executive Officer)
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1.
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I have reviewed this Quarterly Report on Form 10-Q of Evolus, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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(b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting 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 generally accepted accounting principles;
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(c)
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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(d)
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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(b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: August 12, 2019
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/s/ Lauren Silvernail
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Lauren Silvernail
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Chief Financial Officer and Executive Vice President, Corporate Development
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(Principal Financial Officer)
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Date: August 12, 2019
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By:
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/s/ David Moatazedi
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David Moatazedi
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President and Chief Executive Officer
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(Principal Executive Officer)
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Date: August 12, 2019
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By:
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/s/ Lauren Silvernail
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Lauren Silvernail
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Chief Financial Officer and Executive Vice President, Corporate Development
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(Principal Financial Officer)
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