UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
| |
(Mark one) | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, | |
OR | |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 001-37581
Aclaris Therapeutics, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware | 46-0571712 |
640 Lee Road, Suite 200 | 19087 |
Registrant’s telephone number, including area code: (484) 324‑7933324-7933
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| | |||||
Title of Each Class: |
| Trading Symbol(s) | | Name of Each Exchange on which Registered | ||
Common Stock, $0.00001 par value |
| ACRS | | The Nasdaq Stock Market, LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒⌧ No ☐◻
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S‑TS-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒⌧ No ☐◻
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non‑acceleratednon-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b‑212b-2 of the Securities Exchange Act of 1934:
| | |
Large accelerated filer | | Accelerated filer |
| | |
Non-accelerated filer | | Smaller reporting company ☒ |
| | |
| | Emerging growth company ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934). Yes ☐ No ☒
The number of outstanding shares of the registrant’s common stock, par value $0.00001 per share, as of the close of business on August 5, 20196, 2020 was 41,368,224.42,722,780.
ACLARIS THERAPEUTICS, INC.
INDEX TO FORM 10-Q
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| PAGE | |||
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| 2 | |||
| | | ||
Unaudited Condensed Consolidated Balance Sheets as of June 30, | | 2 | ||
| | | ||
| 3 | |||
| | | ||
| 4 | |||
| | | ||
| 5 | |||
| | | ||
Notes to Unaudited Condensed Consolidated Financial Statements | | 6 | ||
| | | ||
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 24 | ||
| | | ||
Item 3. Quantitative and Qualitative Disclosures about Market Risk | | 41 | ||
| | | ||
| 41 | |||
| | | ||
| | |||
| | | ||
| 42 | |||
| | | ||
| 43 | |||
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | | 45 | ||
| | | ||
| 45 | |||
| | | ||
| 47 | |||
| ||||
Part I. FINANCIAL INFORMATION
Item 1. Financial Statements
ACLARIS THERAPEUTICS, INC.INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
| June 30, |
| December 31, |
| ||
|
| 2019 |
| 2018 |
| ||
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
| $ | 31,654 |
| $ | 57,019 |
|
Marketable securities |
|
| 83,863 |
|
| 110,953 |
|
Accounts receivable, net |
|
| 19,370 |
|
| 4,861 |
|
Inventory |
|
| 185 |
|
| 791 |
|
Prepaid expenses and other current assets |
|
| 2,822 |
|
| 5,875 |
|
Total current assets |
|
| 137,894 |
|
| 179,499 |
|
Property and equipment, net |
|
| 4,241 |
|
| 4,280 |
|
Intangible assets |
|
| 69,781 |
|
| 72,951 |
|
Goodwill |
|
| — |
|
| 18,504 |
|
Other assets |
|
| 5,323 |
|
| 332 |
|
Total assets |
| $ | 217,239 |
| $ | 275,566 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
| $ | 14,160 |
| $ | 14,755 |
|
Accrued expenses |
|
| 27,597 |
|
| 11,986 |
|
Current portion of lease liabilities |
|
| 991 |
|
| 601 |
|
Total current liabilities |
|
| 42,748 |
|
| 27,342 |
|
Other liabilities |
|
| 5,120 |
|
| 1,703 |
|
Long-term debt |
|
| 29,924 |
|
| 29,914 |
|
Contingent consideration |
|
| 1,668 |
|
| 934 |
|
Deferred tax liability |
|
| 549 |
|
| 549 |
|
Total liabilities |
|
| 80,009 |
|
| 60,442 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued or outstanding at June 30, 2019 and December 31, 2018 |
|
| — |
|
| — |
|
Common stock, $0.00001 par value; 100,000,000 shares authorized at June 30, 2019 and December 31, 2018; 41,278,570 and 41,210,725 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively |
|
| — |
|
| — |
|
Additional paid‑in capital |
|
| 516,836 |
|
| 507,366 |
|
Accumulated other comprehensive loss |
|
| 8 |
|
| (69) |
|
Accumulated deficit |
|
| (379,614) |
|
| (292,173) |
|
Total stockholders’ equity |
|
| 137,230 |
|
| 215,124 |
|
Total liabilities and stockholders’ equity |
| $ | 217,239 |
| $ | 275,566 |
|
| | | | | | | |
|
| June 30, | | December 31, |
| ||
|
| 2020 |
| 2019 |
| ||
| | | | | |
| |
Assets | | | | | | | |
Current assets: | | | | | | | |
Cash and cash equivalents | | $ | 32,587 | | $ | 35,937 | |
Marketable securities | |
| 35,528 | |
| 39,078 | |
Accounts receivable, net | | | 775 | | | 704 | |
Prepaid expenses and other current assets | |
| 2,065 | |
| 3,118 | |
Discontinued operations - current assets | | | — | | | 4,966 | |
Total current assets | |
| 70,955 | |
| 83,803 | |
Property and equipment, net | |
| 2,230 | |
| 2,470 | |
Intangible assets | | | 7,161 | | | 7,199 | |
Other assets | |
| 4,653 | |
| 4,825 | |
Total assets | | $ | 84,999 | | $ | 98,297 | |
Liabilities and Stockholders’ Equity | | | | | | | |
Current liabilities: | | | | | | | |
Accounts payable | | $ | 5,502 | | $ | 9,917 | |
Accrued expenses | |
| 9,344 | |
| 7,721 | |
Current portion of lease liabilities | | | 610 | | | 637 | |
Discontinued operations - current liabilities | | | 2,289 | | | 4,157 | |
Total current liabilities | |
| 17,745 | |
| 22,432 | |
Other liabilities | | | 3,331 | |
| 3,736 | |
Long-term debt, net | | | 10,573 | | | — | |
Contingent consideration | | | 3,435 | | | 1,668 | |
Deferred tax liability | |
| 549 | |
| 549 | |
Total liabilities | |
| 35,633 | |
| 28,385 | |
Stockholders’ Equity: | | | | | | | |
Preferred stock, $0.00001 par value; 10,000,000 shares authorized and 0 shares issued or outstanding at June 30, 2020 and December 31, 2019 | | | — | | | — | |
Common stock, $0.00001 par value; 100,000,000 shares authorized at June 30, 2020 and December 31, 2019; 42,691,114 and 41,485,638 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | |
| — | |
| — | |
Additional paid‑in capital | |
| 530,061 | |
| 523,505 | |
Accumulated other comprehensive income (loss) | |
| 15 | |
| (66) | |
Accumulated deficit | |
| (480,710) | |
| (453,527) | |
Total stockholders’ equity | |
| 49,366 | |
| 69,912 | |
Total liabilities and stockholders’ equity | | $ | 84,999 | | $ | 98,297 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share data)
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
| Six Months Ended |
| ||||||||
|
| June 30, |
| June 30, |
| ||||||||
|
| 2019 |
| 2018 |
| 2019 |
| 2018 |
| ||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
| $ | 4,979 |
| $ | 1,533 |
| $ | 8,757 |
| $ | 1,533 |
|
Contract research |
|
| 886 |
|
| 1,143 |
|
| 2,149 |
|
| 2,261 |
|
Other revenue |
|
| — |
|
| 1,000 |
|
| — |
|
| 1,000 |
|
Total revenue, net |
|
| 5,865 |
|
| 3,676 |
|
| 10,906 |
|
| 4,794 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (excludes amortization) |
|
| 2,703 |
|
| 1,181 |
|
| 5,480 |
|
| 2,148 |
|
Research and development |
|
| 17,622 |
|
| 13,984 |
|
| 37,541 |
|
| 27,590 |
|
Sales and marketing |
|
| 7,177 |
|
| 12,368 |
|
| 17,008 |
|
| 23,601 |
|
General and administrative |
|
| 7,990 |
|
| 8,121 |
|
| 16,180 |
|
| 14,381 |
|
Goodwill impairment |
|
| 18,504 |
|
| — |
|
| 18,504 |
|
| — |
|
Amortization of definite-lived intangible |
|
| 1,660 |
|
| — |
|
| 3,319 |
|
| — |
|
Total costs and expenses |
|
| 55,656 |
|
| 35,654 |
|
| 98,032 |
|
| 67,720 |
|
Loss from operations |
|
| (49,791) |
|
| (31,978) |
|
| (87,126) |
|
| (62,926) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
| (85) |
|
| 760 |
|
| (315) |
|
| 1,479 |
|
Net loss |
| $ | (49,876) |
| $ | (31,218) |
| $ | (87,441) |
| $ | (61,447) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
| $ | (1.21) |
| $ | (1.01) |
| $ | (2.12) |
| $ | (1.99) |
|
Weighted average common shares outstanding, basic and diluted |
|
| 41,274,808 |
|
| 30,944,899 |
|
| 41,261,808 |
|
| 30,915,577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on marketable securities, net of tax of $0 |
| $ | 30 |
| $ | 111 |
| $ | 64 |
| $ | 46 |
|
Foreign currency translation adjustments |
|
| 27 |
|
| 28 |
|
| 13 |
|
| 12 |
|
Total other comprehensive income |
|
| 57 |
|
| 139 |
|
| 77 |
|
| 58 |
|
Comprehensive loss |
| $ | (49,819) |
| $ | (31,079) |
| $ | (87,364) |
| $ | (61,389) |
|
| | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended | | ||||||||
| | June 30, | | June 30, | | ||||||||
|
| 2020 |
| 2019 |
| 2020 |
| 2019 | | ||||
Revenues: | | | | | | | | | | | | | |
Contract research | | $ | 1,853 | | $ | 886 | | $ | 3,042 | | $ | 2,149 | |
Other revenue | | | 193 | | | — | | | 411 | | | — | |
Total revenue | | | 2,046 | | | 886 | | | 3,453 | | | 2,149 | |
| | | | | | | | | | | | | |
Costs and expenses: | | | | | | | | | | | | | |
Cost of revenue | | | 1,389 | | | 994 | | | 2,658 | | | 2,201 | |
Research and development |
| | 6,466 | | | 17,519 | |
| 15,909 | |
| 37,161 | |
General and administrative |
| | 5,572 | | | 7,469 | |
| 11,773 | |
| 14,926 | |
Goodwill impairment | | | — | | | 18,504 | | | — | | | 18,504 | |
Total costs and expenses |
| | 13,427 | |
| 44,486 | |
| 30,340 | |
| 72,792 | |
Loss from operations |
| | (11,381) | |
| (43,600) | |
| (26,887) | |
| (70,643) | |
| | | | | | | | | | | | | |
Other income (expense), net |
| | (189) | |
| (85) | |
| (11) | |
| (315) | |
Loss from continuing operations | | | (11,570) | | | (43,685) | | | (26,898) | | | (70,958) | |
Loss from discontinued operations | | | (27) | | | (6,191) | | | (285) | | | (16,483) | |
Net loss | | $ | (11,597) | | $ | (49,876) | | $ | (27,183) | | $ | (87,441) | |
| | | | | | | | | | | | | |
Net loss per share, basic and diluted | | $ | (0.28) | | $ | (1.21) | | $ | (0.65) | | $ | (2.12) | |
Weighted average common shares outstanding, basic and diluted | |
| 42,133,646 | |
| 41,274,808 | |
| 41,876,037 | |
| 41,261,808 | |
| | | | | | | | | | | | | |
Other comprehensive income (loss): | | | | | | | | | | | | | |
Unrealized gain (loss) on marketable securities, net of tax of $0 | | $ | (37) | | $ | 30 | | $ | 23 | | $ | 64 | |
Foreign currency translation adjustments | | | 5 | | | 27 | | | 58 | | | 13 | |
Total other comprehensive income (loss) | |
| (32) | |
| 57 | |
| 81 | |
| 77 | |
Comprehensive loss | | $ | (11,629) | | $ | (49,819) | | $ | (27,102) | | $ | (87,364) | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
(Unaudited)
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Accumulated |
|
|
|
|
|
|
| |
|
| Common Stock |
| Additional |
| Other |
|
|
| Total |
| |||||||
|
|
|
| Par |
| Paid‑in |
| Comprehensive |
| Accumulated |
| Stockholders’ |
| |||||
|
| Shares |
| Value |
| Capital |
| Loss |
| Deficit |
| Equity |
| |||||
Balance at December 31, 2018 |
| 41,210,725 |
| $ | — |
| $ | 507,366 |
| $ | (69) |
| $ | (292,173) |
| $ | 215,124 |
|
Vesting of RSUs |
| 58,918 |
|
| — |
|
| (188) |
|
| — |
|
| — |
|
| (188) |
|
Unrealized gain on marketable securities |
| — |
|
| — |
|
| — |
|
| 34 |
|
| — |
|
| 34 |
|
Foreign currency translation adjustment |
| — |
|
| — |
|
| — |
|
| (14) |
|
| — |
|
| (14) |
|
Stock-based compensation expense |
| — |
|
| — |
|
| 4,862 |
|
| — |
|
| — |
|
| 4,862 |
|
Net loss |
| — |
|
| — |
|
| — |
|
| — |
|
| (37,565) |
|
| (37,565) |
|
Balance at March 31, 2019 |
| 41,269,643 |
|
| — |
|
| 512,040 |
|
| (49) |
|
| (329,738) |
|
| 182,253 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options and vesting of RSUs |
| 8,927 |
|
| — |
|
| (18) |
|
| — |
|
| — |
|
| (18) |
|
Unrealized gain on marketable securities |
| — |
|
| — |
|
| — |
|
| 30 |
|
| — |
|
| 30 |
|
Foreign currency translation adjustment |
| — |
|
| — |
|
| — |
|
| 27 |
|
| — |
|
| 27 |
|
Stock-based compensation expense |
| — |
|
| — |
|
| 4,814 |
|
| — |
|
| — |
|
| 4,814 |
|
Net loss |
| — |
|
| — |
|
| — |
|
| — |
|
| (49,876) |
|
| (49,876) |
|
Balance at June 30, 2019 |
| 41,278,570 |
| $ | — |
| $ | 516,836 |
| $ | 8 |
| $ | (379,614) |
| $ | 137,230 |
|
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | Accumulated | | | | | | |
| |
| | Common Stock | | Additional | | Other | | | | Total |
| |||||||
| | | | Par | | Paid‑in | | Comprehensive | | Accumulated | | Stockholders’ |
| |||||
|
| Shares |
| Value |
| Capital |
| Income (Loss) |
| Deficit |
| Equity |
| |||||
Balance at December 31, 2019 | | 41,485,638 | | $ | — | | $ | 523,505 | | $ | (66) | | $ | (453,527) | | $ | 69,912 | |
Vesting of restricted stock units | | 346,582 | | | — | | | (121) | | | — | | | — | | | (121) | |
Fair value of warrants issued | | — | | | — | | | 378 | | | — | | | — | | | 378 | |
Unrealized gain on marketable securities | | — | | | — | | | — | | | 60 | | | — | | | 60 | |
Foreign currency translation adjustment | | — | | | — | | | — | | | 53 | | | — | | | 53 | |
Stock-based compensation expense | | — | | | — | | | 3,453 | | | — | | | — | | | 3,453 | |
Net loss | | — | | | — | | | — | | | — | | | (15,586) | | | (15,586) | |
Balance at March 31, 2020 | | 41,832,220 | | $ | — | | $ | 527,215 | | $ | 47 | | $ | (469,113) | | $ | 58,149 | |
| | | | | | | | | | | | | | | | | | |
Vesting of restricted stock units | | 858,894 | | | — | | | (463) | | | — | | | — | | | (463) | |
Unrealized loss on marketable securities | | — | | | — | | | — | | | (37) | | | — | | | (37) | |
Foreign currency translation adjustment | | — | | | — | | | — | | | 5 | | | — | | | 5 | |
Stock-based compensation expense | | — | | | — | | | 3,309 | | | — | | | — | | | 3,309 | |
Net loss | | — | | | — | | | — | | | — | | | (11,597) | | | (11,597) | |
Balance at June 30, 2020 | | 42,691,114 | | $ | — | | $ | 530,061 | | $ | 15 | | $ | (480,710) | | $ | 49,366 | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | Accumulated | | | | | | | |
| | Common Stock | | Additional | | Other | | | | Total | |||||||
| | | | Par | | Paid‑in | | Comprehensive | | Accumulated | | Stockholders’ | |||||
|
| Shares |
| Value |
| Capital |
| Income (Loss) |
| Deficit |
| Equity | |||||
Balance at December 31, 2018 | | 41,210,725 | | $ | — | | $ | 507,366 | | $ | (69) | | $ | (292,173) | | $ | 215,124 |
Vesting of restricted stock units | | 58,918 | | | — | | | (188) | | | — | | | — | | | (188) |
Unrealized gain on marketable securities | | — | | | — | | | — | | | 34 | | | — | | | 34 |
Foreign currency translation adjustment | | — | | | — | | | — | | | (14) | | | — | | | (14) |
Stock-based compensation expense | | — | | | — | | | 4,862 | | | — | | | — | | | 4,862 |
Net loss | | — | | | — | | | — | | | — | | | (37,565) | | | (37,565) |
Balance at March 31, 2019 | | 41,269,643 | | $ | — | | $ | 512,040 | | $ | (49) | | $ | (329,738) | | $ | 182,253 |
| | | | | | | | | | | | | | | | | |
Exercise of stock options and vesting of restricted stock units | | 8,927 | | | — | | | (18) | | | — | | | — | | | (18) |
Unrealized gain on marketable securities | | — | | | — | | | — | | | 30 | | | — | | | 30 |
Foreign currency translation adjustment | | — | | | — | | | — | | | 27 | | | — | | | 27 |
Stock-based compensation expense | | — | | | — | | | 4,814 | | | — | | | — | | | 4,814 |
Net loss | | — | | | — | | | — | | | — | | | (49,876) | | | (49,876) |
Balance at June 30, 2019 | | 41,278,570 | | $ | — | | $ | 516,836 | | $ | 8 | | $ | (379,614) | | $ | 137,230 |
| | | | | | | | | | | | | | | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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| Accumulated |
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| Common Stock |
| Additional |
| Other |
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| Total | |||||||
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| Par |
| Paid‑in |
| Comprehensive |
| Accumulated |
| Stockholders’ | |||||
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| Shares |
| Value |
| Capital |
| Loss |
| Deficit |
| Equity | |||||
Balance at December 31, 2017 |
| 30,856,505 |
| $ | — |
| $ | 384,943 |
| $ | (246) |
| $ | (159,435) |
| $ | 225,262 |
Exercise of stock options and vesting of RSUs |
| 49,124 |
|
| — |
|
| 378 |
|
| — |
|
| — |
|
| 378 |
Unrealized loss on marketable securities |
| — |
|
| — |
|
| — |
|
| (65) |
|
| — |
|
| (65) |
Foreign currency translation adjustment |
| — |
|
| — |
|
| — |
|
| (17) |
|
| — |
|
| (17) |
Stock-based compensation expense |
| — |
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| — |
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| 5,143 |
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| — |
|
| — |
|
| 5,143 |
Net loss |
| — |
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| — |
|
| — |
|
| — |
|
| (30,229) |
|
| (30,229) |
Balance at March 31, 2018 |
| 30,905,629 |
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| — |
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| 390,464 |
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| (328) |
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| (189,664) |
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| 200,472 |
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Exercise of stock options and vesting of RSUs |
| 59,667 |
|
| — |
|
| (440) |
|
| — |
|
| — |
|
| (440) |
Unrealized gain on marketable securities |
| — |
|
| — |
|
| — |
|
| 111 |
|
| — |
|
| 111 |
Foreign currency translation adjustment |
| — |
|
| — |
|
| — |
|
| 29 |
|
| — |
|
| 29 |
Stock-based compensation expense |
| — |
|
| — |
|
| 5,249 |
|
| — |
|
| — |
|
| 5,249 |
Net loss |
| — |
|
| — |
|
| — |
|
| — |
|
| (31,218) |
|
| (31,218) |
Balance at June 30, 2018 |
| 30,965,296 |
| $ | — |
| $ | 395,273 |
| $ | (188) |
| $ | (220,882) |
| $ | 174,203 |
(In thousands)
| | | | | | | |
| | Six Months Ended |
| ||||
| | June 30, | | ||||
|
| 2020 |
| 2019 |
| ||
Cash flows from operating activities: |
| |
|
| |
| |
Net loss | | $ | (27,183) | | $ | (87,441) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | |
Depreciation and amortization | |
| 1,182 | |
| 4,457 | |
Stock-based compensation expense | |
| 6,762 | |
| 9,676 | |
Change in fair value of contingent consideration | | | 1,767 | | | 734 | |
Goodwill impairment charge | | | — | | | 18,504 | |
Changes in operating assets and liabilities: | | | | | | | |
Accounts receivable | | | 4,895 | | | (14,509) | |
Prepaid expenses and other assets | |
| 890 | |
| 2,579 | |
Accounts payable | |
| (6,026) | |
| (583) | |
Accrued expenses | |
| 87 | |
| 13,887 | |
Net cash used in operating activities | |
| (17,626) | |
| (52,696) | |
Cash flows from investing activities: | | | | | | | |
Purchases of property and equipment | |
| (141) | |
| (525) | |
Purchases of marketable securities | |
| (27,139) | |
| (89,407) | |
Proceeds from sales and maturities of marketable securities | |
| 30,735 | |
| 117,500 | |
Net cash provided by (used in) investing activities | |
| 3,455 | |
| 27,568 | |
Cash flows from financing activities: | | | | | | | |
Proceeds from debt financing (including warrants), net of issuance costs | | | 10,913 | | | — | |
Finance lease payments | | | (92) | | | (240) | |
Proceeds from exercise of employee stock options and the issuance of stock | | | — | | | 3 | |
Net cash provided by (used in) financing activities | |
| 10,821 | |
| (237) | |
Net decrease in cash and cash equivalents | |
| (3,350) | |
| (25,365) | |
Cash, cash equivalents and restricted cash at beginning of period | |
| 35,937 | |
| 57,019 | |
Cash, cash equivalents and restricted cash at end of period | | $ | 32,587 | | $ | 31,654 | |
Supplemental disclosure of non-cash investing and financing activities: | | | | | | | |
Additions to property and equipment included in accounts payable | | $ | 339 | | $ | 392 | |
Operating lease asset recorded as a result of new accounting standard | | $ | — | | $ | 2,132 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
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| Six Months Ended |
| ||||
|
| June 30, |
| ||||
|
| 2019 |
| 2018 |
| ||
Cash flows from operating activities: |
|
|
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|
|
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Net loss |
| $ | (87,441) |
| $ | (61,447) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Depreciation and amortization |
|
| 4,457 |
|
| 537 |
|
Stock-based compensation expense |
|
| 9,676 |
|
| 10,392 |
|
Change in fair value of contingent consideration |
|
| 734 |
|
| 866 |
|
Goodwill impairment charge |
|
| 18,504 |
|
| — |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Accounts receivable |
|
| (14,509) |
|
| (1,701) |
|
Inventory |
|
| 606 |
|
| (1,026) |
|
Prepaid expenses and other assets |
|
| 1,973 |
|
| 2,345 |
|
Accounts payable |
|
| (583) |
|
| 4,693 |
|
Accrued expenses |
|
| 13,887 |
|
| 1,636 |
|
Net cash used in operating activities |
|
| (52,696) |
|
| (43,705) |
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
Purchases of property and equipment |
|
| (525) |
|
| (650) |
|
Purchases of marketable securities |
|
| (89,407) |
|
| (74,246) |
|
Proceeds from sales and maturities of marketable securities |
|
| 117,500 |
|
| 144,375 |
|
Net cash provided by investing activities |
|
| 27,568 |
|
| 69,479 |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
Finance lease payments |
|
| (240) |
|
| (335) |
|
Proceeds from the exercise of employee stock options |
|
| 3 |
|
| 394 |
|
Net cash (used in) provided by financing activities |
|
| (237) |
|
| 59 |
|
Net increase (decrease) in cash and cash equivalents |
|
| (25,365) |
|
| 25,833 |
|
Cash and cash equivalents at beginning of period |
|
| 57,019 |
|
| 20,202 |
|
Cash and cash equivalents at end of period |
| $ | 31,654 |
| $ | 46,035 |
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
|
Additions to property and equipment included in accounts payable |
| $ | 392 |
| $ | 442 |
|
Property and equipment obtained pursuant to capital lease financing arrangements |
| $ | — |
| $ | 1,896 |
|
Offering costs included in accounts payable |
| $ | — |
| $ | 20 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
ACLARIS THERAPEUTICS, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share data)
1. Organization and Nature of Business
Overview
Aclaris Therapeutics, Inc. was incorporated under the laws of the State of Delaware in 2012. In July 2015, Aclaris Therapeutics International Limited (“ATIL”) was established under the laws of the United Kingdom as a wholly-owned subsidiary of Aclaris Therapeutics, Inc. In March 2016, Vixen Pharmaceuticals, Inc. (“Vixen”) became a wholly-owned subsidiary of Aclaris Therapeutics, Inc., and in September 2018, Vixen was dissolved. In August 2017, Confluence Life Sciences, Inc. (now known as Aclaris Life Sciences, Inc.) (“Confluence”) was acquired by Aclaris Therapeutics, Inc. and became a wholly-owned subsidiary thereof. Aclaris Therapeutics, Inc., ATIL Vixen and Confluence are referred to collectively as the “Company.” The Company is a physician-ledclinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory and dermatological diseases. The Company currently has two commercial products and a diverse pipeline of drug candidates. RHOFADE (oxymetazoline hydrochloride) cream, 1% (“RHOFADE”) wascandidates focused on immuno-inflammatory diseases, as well as one product approved by the U.S. Food and Drug Administration (“FDA”) in January 2017that it is not currently distributing, marketing or selling, and other investigational drug candidates. In September 2019, the Company announced the completion of a strategic review of its business, as a result of which it refocused its resources on its immuno-inflammatory development programs. The Company is pursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. The Company’s other commercial product, and/or commercialize its drug candidates and ESKATA (hydrogen peroxide) topical solution, 40% (w/w) (“ESKATA”), is a proprietary formulation of high-concentration hydrogen peroxide which was approved by the FDA in December 2017 as an office-based prescription treatment for raised seborrheic keratosis (“SK”), a common non-malignant skin tumor. The Company launched ESKATA in the United States in May 2018. In August 2019, the Company voluntarily discontinued the commercialization of ESKATA in the United States. The Company continues to maintain the New Drug Application (“NDA”) for ESKATA in the United States. The Company is currently seeking a strategic partner to commercialize ESKATA, both in the United States and worldwide (excluding Canada).Company’s non-marketed FDA-approved product.
Liquidity
The Company’s condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. AtAs of June 30, 2019,2020, the Company had cash, cash equivalents and restricted cash and marketable securities of $115,517$68,115 and an accumulated deficit of $379,614.$480,710. Since inception, the Company has incurred net losses and negative cash flows from its operations. Prior to the acquisition of Confluence in August 2017, the Company had never generated any revenue. There can be no assurance that profitable operations will ever be achieved, and, if achieved, will be sustained on a continuing basis. In addition, development activities, including clinical and preclinical testing of the Company’s drug candidates, and commercialization of the Company’s marketed product(s) will require significant additional financing. The future viability of the Company is dependent on its ability to successfully develop its drug candidates and to generate cashrevenue from operating activitiesidentifying and consummating transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize its development assets or to raise additional capital to finance its operations. The Company will require additional capital to complete the clinical development of ATI-450 and ATI-1777, to develop its preclinical compounds, and to support its discovery efforts. Additional funds may not be available on a timely basis, on commercially acceptable terms, or at all, and such funds, if raised, may not be sufficient to enable the Company to continue to implement its long-term business strategy. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. If the Company is unable to raise sufficient additional capital or generate revenue from transactions with third-party partners for the development and/or commercialization of its drug candidates, it may need to substantially curtail planned operations. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.
In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that its consolidated financial statements are issued. As of the report date, the Company believes the actions described below are probable of being implemented effectively and of alleviating the conditions or events that exist which raise substantial doubt about its ability to continue as a going concern within one year after the date of the issuance of these condensed consolidated financial statements. The Company believes its existing
6
cash, cash equivalents and marketable securities are sufficient to fund its operating and capital expenditure requirements for a period greater than 12 months from the date of issuance of these condensed consolidated financial statements.
The Company has taken a number of actions to support its operations and meet its liquidity needs. In September 2019, the Company announced the completion of a strategic review and its decision to refocus its resources on its immuno-inflammatory development programs and to pursue strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for and/or commercialize its drug candidates and ESKATA. As a result of this decision, the Company restructured its operations and terminated employees, which lowered operating costs. In October 2019, the Company sold the worldwide rights to RHOFADE (oxymetazoline hydrochloride) cream, 1% (“RHOFADE”) to further its focus on its development programs and improve cash flow. In March 2020, the Company borrowed $11,000 under a term loan facility with Silicon Valley Bank.
The Company’s plans to further alleviate the substantial doubt about its going concern, which are probable of effectively being implemented and mitigating these conditions, primarily include its ability to control the timing and spending on its research and development programs. The Company may also consider other plans to fund its operations including: (1) raising additional capital through debt or equity financings; (2) identifying third-party partners to further develop, obtain marketing approval for and/or commercialize its drug candidates and ESKATA, which may generate revenue and/or milestone payments; (3) reducing spending on one or more research and development programs by delaying or discontinuing development; and/or (4) further restructuring its operations to change its overhead structure. Finally, additional funds may not be available on a timely basis, on commercially acceptable terms, or at all, and such funds, if raised, may not be sufficient to enable the Company to continue to implement its long-term business strategy.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The condensed consolidated financial statements of the Company include the accounts of the operating parent company, Aclaris Therapeutics, Inc., and its wholly-owned subsidiaries, ATIL Confluence and Vixen.Confluence. All significant intercompany transactions have been eliminated. Based upon the combination of revenue from product sales and contract research services, the Company
6
believes that gross profit does not provide a meaningful measure of profitability and, therefore, has not included a line item for gross profit on the condensed consolidated statement of operations.
Discontinued Operations
In September 2019, the Company announced the completion of a strategic review and its decision to refocus its resources on its immuno-inflammatory development programs and to actively seek partners for its commercial products.
The accompanying condensed consolidated financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to the Company’s commercial products as discontinued operations (see Note 15).
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, variable consideration included in product sales, net, research and development expenses, contingent consideration and the valuation of stock-based awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. The COVID-19 pandemic has resulted in a global slowdown of economic activity. As of the date of issuance of these financial statements, the Company is not aware of any specific event
7
or circumstance that would require an update to its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. Actual results could differ from the Company’s estimates.
Unaudited Interim Financial Information
The accompanying condensed consolidated balance sheet as of June 30, 2019,2020, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 20192020 and 2018,2019, the condensed consolidated statement of stockholders’ equity for the three and six months ended June 30, 20192020 and 2018,2019, and the condensed consolidated statements of cash flows for the six months ended June 30, 20192020 and 20182019 are unaudited. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements contained in the Company’s annual report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 18, 2019February 25, 2020 and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the Company’s financial position as of June 30, 2019,2020, the results of its operations and comprehensive loss for the three and six months ended June 30, 20192020 and 2018,2019, its changes in stockholders’ equity for the three and six months ended June 30, 20192020 and 20182019 and its cash flows for the six months ended June 30, 20192020 and 2018.2019. The condensed consolidated balance sheet data as of December 31, 20182019 was derived from audited financial statements but does not include all disclosures required by GAAP. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 20192020 and 20182019 are unaudited. The results for the three and six months ended June 30, 20192020 are not necessarily indicative of results to be expected for the year ending December 31, 2019,2020, any other interim periods, or any future year or period. The unaudited interim financial statements of the Company included herein have been prepared, pursuant to the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 20182019 included in the Company’s annual report on Form 10-K filed with the SEC on March 18, 2019.February 25, 2020.
Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 20182019 included in the Company’s annual report on Form 10-K filed with the SEC on March 18, 2019. Since theFebruary 25, 2020.
Cash, Cash Equivalents and Restricted Cash
The Company considers all short-term, highly liquid investments with original maturities of 90 days or less at acquisition date to be cash equivalents. Cash equivalents, which have consisted of such financial statements, there have been no changesmoney market accounts, commercial paper and corporate debt securities with original maturities of less than three months, are stated at fair value. Restricted cash as of June 30, 2020 consisted of $1,753 placed in escrow pursuant to the Company’s significant accounting policies other than those noted below. asset purchase agreement with EPI Health, LLC (“EPI Health”) (see Note 13 for additional information).
Revenue Recognition
The Company accounts for revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services.
7
To determine revenue recognition in accordance with ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) performance obligations are satisfied. At contract inception, the Company assesses the goods or services promised within a contract with a customer to identify the performance obligations, and to determine if they are distinct. The Company recognizes the revenue that is allocated to each distinct performance obligation when (or as) that
8
performance obligation is satisfied. The Company only recognizes revenue when collection of the consideration it is entitled to under a contract with a customer is probable.
Product Sales, net
The Company sells RHOFADE, and during the three and six months ended June 30, 2019 and 2018 sold ESKATA, to a limited number of wholesalers in the United States (collectively, its “Customers”). These Customers subsequently resell the Company’s products to pharmacies and health care providers. In addition to distribution agreements with Customers, the Company has entered and may continue to enter into arrangements with health care providers, third-party payors, pharmacy benefit managers, and/or group purchasing organizations (“GPOs”) which provide for government mandated or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s marketed product(s). The Company discontinued selling ESKATA in August 2019.
The Company recognizes revenue from product sales at the point the Customer obtains control of the product, which generally occurs upon delivery, and includes estimates of variable consideration in the same period revenue is recognized. Components of variable consideration include trade discounts and allowances, product returns, government rebates, discounts and rebates, other incentives such as patient co-pay assistance, and other fee for service amounts. Variable consideration is recorded on the condensed consolidated balance sheet as either a reduction of accounts receivable, if payable to a Customer, or as a current liability, if payable to a third party other than a Customer. The Company considers all relevant information when estimating variable consideration such as current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount of net revenue the Company can recognize is constrained by estimates of variable consideration which are included in the transaction price. Payment terms with Customers do not exceed one year and, therefore, the Company does not account for a financing component in its arrangements. The Company expenses incremental costs of obtaining a contract with a Customer, including sales commissions, when incurred as the period of benefit is less than one year. Shipping and handling costs for product shipments to Customers are recorded as sales and marketing expenses in the condensed consolidated statement of operations.
Trade Discounts and Allowances - The Company may provide Customers with trade discounts, rebates, allowances or other incentives. The Company records an estimate for these items as a reduction of revenue in the same period the revenue is recognized.
Government and Payor Rebates - The Company has contracted and may continue to contract with certain third-party payors, primarily health insurance companies, pharmacy benefit managers and/or government programs, for the payment of rebates with respect to utilization of its marketed product(s). The Company also has agreements with GPOs that provide for administrative fees and discounted pricing in the form of volume-based rebates. The Company is also subject to discount obligations under state Medicaid programs and Medicare. The Company records an estimate for these rebates as a reduction of revenue in the same period the revenue is recognized.
Other Incentives - Other incentives includes the Company’s co-pay assistance program which is intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The Company estimates and records an accrual for these incentives as a reduction of revenue in the period the revenue is recognized. The Company estimates amounts for co-pay assistance based upon the number of claims and the cost per claim that the Company expects to receive associated with product that has been sold to Customers but remains in the distribution channel at the end of each reporting period.
8
Product Returns - Consistent with industry practice, the Company has a product returns policy that provides Customers a right of return for product purchased within a specified period prior to and subsequent to the product’s expiration date. The right of return lapses upon shipment of the goods to a patient. The Company records an estimate for the amount of its products which may be returned as a reduction of revenue in the period the related revenue is recognized. The Company’s estimates for product returns are based upon available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. There is no returns liability associated with sales of ESKATA as the Company has a no returns policy for this product.
Product sales, net consisted of the following:
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| Three Months Ended |
| Six Months Ended | ||||||||
|
| June 30, |
| June 30, | ||||||||
|
| 2019 |
| 2018 |
| 2019 |
| 2018 | ||||
ESKATA |
| $ | 272 |
| $ | 1,533 |
| $ | 344 |
| $ | 1,533 |
RHOFADE |
|
| 4,707 |
|
| — |
|
| 8,413 |
|
| — |
Total product sales, net |
| $ | 4,979 |
| $ | 1,533 |
| $ | 8,757 |
| $ | 1,533 |
Contract Research
The Company earns contract research revenue from the provision of laboratory services to clients through Confluence, its wholly-owned subsidiary. Contract research revenue is generally evidenced by contracts with clients which are on an agreed upon fixed-price, fee-for-service basis and are generally billed on a monthly basis in arrears for services rendered. Revenue related to these contracts is generally recognized as the laboratory services are performed, based upon the rates specified in the contracts. Under ASC Topic 606, the Company elected to apply the “right to invoice” practical expedient when recognizing contract research revenue. The Company recognizes contract research revenue in the amount to which it has the right to invoice.
The Company has also received revenue from grants under the Small Business Innovation Research program of the National Institutes of Health (“NIH”). During the six months ended June 30, 2018, the Company had two active grants from NIH which were related to early-stage research. There are no remaining funds available to the Company under the grants. The Company recognizes revenue related to grants as amounts become reimbursable under each grant, which is generally when research is performed, and the related costs are incurred.
Other Revenue
Licenses of Intellectual Property – The Company recognizes revenue received from non-refundable, upfront fees related to the licensing of intellectual property when the intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the license has been transferred to the customer, and the customer is able to use and benefit from the license.
Milestone Payments - – At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the amount allocated to the license of intellectual property. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received.
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Inventory
Inventory includes the third-party cost of manufacturing and assembly of finished product, quality control and other overhead costs. Inventory is stated at the lower of cost or net realizable value. Inventory is adjusted for short-dated, unmarketable inventory equal to the difference between the cost of inventory and the estimated value based upon assumptions about future demand and market conditions. The Company had $185 and $791 of inventory as of June 30, 2019 and December 31, 2018, respectively, which was comprised primarily of finished goods.
Intangible Assets
Intangible assets include both finite-liveddefinite-lived and indefinite-lived assets. Finite-livedDefinite-lived intangible assets are amortized over their estimated useful life based on the pattern over which the intangible assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the straight-line method of amortization is used. Finite-livedDefinite-lived intangible assets consist of a research technology platform the Company acquired through the acquisition of Confluence and the intellectual property rights related to RHOFADE.Confluence. Indefinite-lived intangible assets consist of an in-process research and development (“IPR&D”) drug candidate acquired through the acquisition of Confluence. IPR&D assets are considered indefinite-lived until the completion or abandonment of the associated research and development efforts. The cost of IPR&D assets is either amortized over theirits estimated useful life beginning when the underlying drug candidate is approved and launched commercially, or expensed immediately if development of the drug candidate is abandoned.
Finite-livedDefinite-lived intangible assets are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Indefinite-lived intangible assets are tested for impairment at least annually, which the Company performs during the fourth quarter, or when indicators of an impairment are present. The Company recognizes impairment losses when and to the extent that the estimated fair value of an indefinite-lived intangible asset is less than its carrying value.
Leases
Goodwill
Goodwill is not amortized, but rather is subject to testing for impairment at least annually, which the Company performs during the fourth quarter, or when indicators of an impairment are present. The Company considers each of its operating segments, dermatology therapeutics and contract research, to be a reporting unit since this is the lowest level for which discrete financial information is available. The Company attributed the full amount of the goodwill acquired with Confluence, or $18,504, to the dermatology therapeutics segment. The annual impairment test performed by the Company is a qualitative assessment based upon current facts and circumstances related to operations of the dermatology therapeutics segment. If the qualitative assessment indicates an impairment may be present, the Company would perform the required quantitative analysis and an impairment charge would be recognized to the extent that the estimated fair value of the reporting unit is less than its carrying amount. However, any loss recognized would not exceed the total amount of goodwill allocated to that reporting unit.
During the three months ended June 30, 2019, the Company performed an interim impairment analysis due to the decline in its stock price, which was considered a triggering event to evaluate goodwill for impairment. The Company’s impairment analysis, using a market approach, noted that its stock price, including a reasonable control premium, resulted in a fair value for the dermatology therapeutics reporting unit which was less than its carrying value. As a result, the Company recorded an impairment charge of $18,504, the full balance of goodwill, in the three months ended June 30, 2019.
10
Leases
Leases represent a company’s right to use an underlying asset and a corresponding obligation to make payments to a lessor for the right to use those assets. The Company evaluates leases at their inception to determine if they are an operating lease or a finance lease. A lease is accounted for as a finance lease if it meets one of the following five criteria: the lease has a purchase option that is reasonably certain of being exercised, the present value of the future cash flows are substantially all of the fair market value of the underlying asset, the lease term is for a significant portion of the remaining economic life of the underlying asset, the title to the underlying asset transfers at the end of the lease term, or if the
9
underlying asset is of such a specialized nature that it is expected to have no alternative uses to the lessor at the end of the term. Leases that do not meet the finance lease criteria are accounted for as an operating lease.
The Company recognizes assets and liabilities for leases at their inception based upon the present value of all payments due under the lease. The Company uses an implicit interest rate to determine the present value of finance leases, and its incremental borrowing rate to determine the present value of operating leases. The Company determines incremental borrowing rates by referencing collateralized borrowing rates for debt instruments with terms similar to the respective lease. The Company recognizes expense for operating and finance leases on a straight-line basis over the term of each lease, and interest expense related to finance leases is recognized over the lease term based on the effective interest method. The Company includes estimates for any residual value guarantee obligations under its leases in lease liabilities recorded on its condensed consolidated balance sheet.
Right-of-use assets are included in other assets and property and equipment, net on the Company’s condensed consolidated balance sheet for operating and finance leases, respectively. Obligations for lease payments are included in current portion of lease liabilities and other liabilities on the Company’s condensed consolidated balance sheet for both operating and finance leases.
Contingent Consideration
The Company initially recorded thea contingent consideration liability related to future potential payments based upon the achievement of certain development, regulatory and commercial milestones, as well as future projected sales performance, resulting from the acquisition of Confluence, at its estimated fair value on the date of acquisition. ChangesThe ultimate amount of future payments, if any, is based on criteria such as sales performance and the achievement of certain regulatory and sales milestones. The Company estimates the fair value of the contingent consideration liability related to the achievement of regulatory milestones by assigning an achievement probability to each potential milestone and discounting the associated cash payment to its present value using a risk-adjusted rate of return. The Company estimates the fair value of the contingent consideration liability associated with sales milestones and royalties by estimating future sales levels, assigning an achievement probability and discounting the associated cash payment amounts to their present values using a credit-risk-adjusted interest rate. Significant assumptions used in the Company’s estimates include the probability of success of achieving regulatory and sales milestones, which are based upon an asset’s current stage of development and ranged between 4% and 15%. The Company evaluates fair value estimates of contingent consideration liabilities on a periodic basis. Any change in fair value reflectreflects new information about the likelihood of the payment of the contingent consideration and the passage of time. For example, if the timing of the development of an acquired drug candidate, or the size of potential commercial opportunities related to an acquired drug, differ from the Company’s assumptions, then the fair value of contingent consideration would be adjusted accordingly. Future changes in the fair value of the contingent consideration, if any, will be recorded as income or expense in the Company’s condensed consolidated statement of operations.
Concentration of Credit Risk and of Significant Customers and Suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company holds all cash, cash equivalents and marketable securities balances at one1 accredited financial institution, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
The Company’s top five customers represented 94% of aggregate gross revenues from product sales and contract research revenue for the six months ended June 30, 2019. The Company’s top five customers represented 87% of aggregate gross revenues from product sales and contract research revenue for the six months ended June 30, 2018. The Company currently relies on Allergan Sales, LLC (“Allergan”) to distribute RHOFADE on its behalf pursuant to the terms of a transition services agreement. Accounts receivable, net as of June 30, 2019 and December 31, 2018 included $18,532 and $4,298, respectively, related to amounts invoiced by Allergan for sales of RHOFADE pursuant to the terms of the transition services agreement.
11
The Company is dependent on third-party manufacturers to supply productsdrug product, including all underlying components, for commercial distribution, as well as forits research and development activities, including preclinical and clinical testing. These activities could be adversely affected by a significant interruption in the supply of active pharmaceutical ingredients andor other components.
10
Recently Issued Accounting Pronouncements
In November 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606, which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions should be accounted for under Topic 606. The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted.2019. The Company is evaluatingadopted this standard as of January 1, 2020, the impact of ASU 2018-18which on its consolidated financial statements.statements was not significant.
In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40). ASU 2018-15 requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. The standard will beis effective for fiscal years beginning after December 15, 2019, including interim periods within such fiscal years, with early adoption permitted.years. The Company is evaluatingadopted this standard as of January 1, 2020, the impact of ASU 2018-15which on its consolidated financial statements.statements was not significant.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820). The FASB developed the amendments to ASC 820 as part of its broader disclosure framework project, which aims to improve the effectiveness of disclosures in the notes to financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. This update eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some of the existing disclosure requirements. The standard will beis effective for fiscal years beginning after December 15, 2019, including interim periods within such fiscal years, with early adoption permitted. The Company is evaluating the impact of ASU 2018-13 on its consolidated financial statements.
In June 2018, the FASB issued ASU 2018-07, Compensation—Stock Compensation (Topic 718). The amendments in this ASU expand the scope of Topic 718 to include stock-based compensation arrangements with nonemployees except for specific guidance on option pricing model inputs and cost attribution. ASU 2018-07 is effective for annual reporting periods beginning after December 31, 2018, including interim periods within that year.years. The Company adopted the provisions of this standard onas of January 1, 2019,2020, the impact of which on its consolidated financial statements was not significant.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842, Leases, and 2018-11, Targeted Improvements, which included a number of technical corrections and improvements, including additional options for transition. The new standard establishes a right-of-use model that requires a lessee to record a right-of-use asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, including interim periods within those annual periods. The amendments in ASU 2016-02 must be applied to all leases existing at the date a company initially applies the standard.
The Company adopted the new standard on January 1, 2019, using the effective date as the date of its initial application, and used the modified retrospective approach. In addition, the Company elected the practical expedients permitted under the transition guidance within the new standard which, among other things, allowed the Company to carry forward the historical lease identification and classification. The Company also elected the practical expedient to not separate lease and non-lease components, as well as the short-term lease practical expedient which allowed the Company to not capitalize leases with terms less than 12 months that do not contain a reasonably certain purchase option. The
Company’s consolidated financial statements have not been restated, and disclosures required by the new standard have not been provided, for periods before January 1, 2019.
The adoption of ASU 2016-02 resulted in recording additional assets and liabilities of $2,132 and $2,317, respectively upon adoption on January 1, 2019. The adoption of ASU 2016-02 did not have a material impact on the Company’s consolidated statement of operations or cash flows.
3. Fair Value of Financial Assets and Liabilities
The following tables present information about the fair value measurements of the Company’s financial assets and liabilities thatwhich are measured at fair value on a recurring and non-recurring basis, and indicate the level of the fair value hierarchy utilized to determine such fair values:
| | | | | | | | | | | | | |
| | June 30, 2020 |
| ||||||||||
|
| Level 1 |
| Level 2 |
| Level 3 |
| Total |
| ||||
Assets: |
| |
|
| |
|
| |
|
| |
| |
Cash equivalents | | $ | 16,754 | | $ | — | | $ | — | | $ | 16,754 | |
Marketable securities | |
| — | | | 35,528 | | | — | | | 35,528 | |
Total assets | | $ | 16,754 | | $ | 35,528 | | $ | — | | $ | 52,282 | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
Liabilities: | | | | | | | | | | | | | |
Acquisition-related contingent consideration | | $ | — | | $ | — | | $ | 3,435 | | $ | 3,435 | |
Total liabilities | | $ | — | | $ | — | | $ | 3,435 | | $ | 3,435 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| June 30, 2019 |
| ||||||||||
|
| Level 1 |
| Level 2 |
| Level 3 |
| Total |
| ||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
| $ | 20,226 |
| $ | — |
| $ | — |
| $ | 20,226 |
|
Marketable securities |
|
| — |
|
| 83,863 |
|
| — |
|
| 83,863 |
|
Total assets |
| $ | 20,226 |
| $ | 83,863 |
| $ | — |
| $ | 104,089 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration |
| $ | — |
| $ | — |
| $ | 1,668 |
| $ | 1,668 |
|
Total liabilities |
| $ | — |
| $ | — |
| $ | 1,668 |
| $ | 1,668 |
|
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| December 31, 2018 |
| ||||||||||
|
| Level 1 |
| Level 2 |
| Level 3 |
| Total |
| ||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
| $ | 49,766 |
| $ | 4,992 |
| $ | — |
| $ | 54,758 |
|
Marketable securities |
|
| — |
|
| 110,953 |
|
| — |
|
| 110,953 |
|
Total assets |
| $ | 49,766 |
| $ | 115,945 |
| $ | — |
| $ | 165,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration |
| $ | — |
| $ | — |
| $ | 934 |
| $ | 934 |
|
Total liabilities |
| $ | — |
| $ | — |
| $ | 934 |
| $ | 934 |
|
| | | | | | | | | | | | | |
| | December 31, 2019 |
| ||||||||||
|
| Level 1 |
| Level 2 |
| Level 3 |
| Total |
| ||||
Assets: |
| |
|
| |
|
| |
|
| |
| |
Cash equivalents | | $ | 21,277 | | $ | — | | $ | — | | $ | 21,277 | |
Marketable securities | |
| — | | | 39,078 | | | — | | | 39,078 | |
Total assets | | $ | 21,277 | | $ | 39,078 | | $ | — | | $ | 60,355 | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
Liabilities: | | | | | | | | | | | | | |
Acquisition-related contingent consideration | | $ | — | | $ | — | | $ | 1,668 | | $ | 1,668 | |
Total liabilities | | $ | — | | $ | — | | $ | 1,668 | | $ | 1,668 | |
As of June 30, 20192020 and December 31, 2018,2019, the Company’s cash equivalents consisted of investments with maturities of less than three months and included a money market fund, and commercial paper, which werewas valued based upon Level 1 inputs. Theinputs, and the Company’s marketable securities consisted of investments with maturities of more than three months and included commercial paper, corporate debt, asset-backed securities and government obligations, which were valued based upon Level 2 inputs. In determining the fair value of its Level 2 investments, the Company relied on quoted prices for identical securities in markets that are not active. These quoted prices were obtained by the Company with the assistance of a third-party pricing service based on available trade, bid and other observable market data for identical securities. On a quarterly basis,Quarterly, the Company compares the quoted prices obtained from the third-party pricing service to other available independent pricing information to validate the reasonableness of thosethe quoted prices.prices provided. The Company evaluates whether adjustments to third-party pricing is necessary and, historically, the Company has not made adjustments to the quoted prices obtained from the third-party pricing service. During the six months ended June 30, 20192020 and the year ended December 31, 2018,2019, there were no transfers between Level 1, Level 2 and Level 3. The changeincrease in acquisition-related contingent consideration
13
related to Confluence of $734$1,767 during the six months ended June 30, 2020 was the result of updates to the Company’s assumptions as a result of the filingsuccessful completion of an Investigational New Drug Application (“IND”)a Phase 1 clinical trial for ATI-450 during the six months endedATI-450.
As of June 30, 2019.
The following tables present2020 and December 31, 2019, the fair value of the Company’s available for sale marketable securities by type of security:security was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||||||||
|
| June 30, 2019 |
| |||||||||||||||||||||||
|
|
|
|
| Gross |
| Gross |
|
|
|
| |||||||||||||||
|
| Amortized |
| Unrealized |
| Unrealized |
| Fair |
| |||||||||||||||||
|
| Cost |
| Gain |
| Loss |
| Value |
| |||||||||||||||||
| | | | | | | | | | | | | | |||||||||||||
| | June 30, 2020 |
| |||||||||||||||||||||||
| | | | | Gross | | Gross | | | |
| |||||||||||||||
| | Amortized | | Unrealized | | Unrealized | | Fair |
| |||||||||||||||||
| | Cost | | Gain | | Loss | | Value |
| |||||||||||||||||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
| | | | | | | | | | | | | |
Corporate debt securities |
| $ | 16,872 |
| $ | 20 |
| $ | — |
| $ | 16,892 |
| | $ | 5,688 | | $ | 2 | | $ | — | | $ | 5,690 | |
Commercial paper |
|
| 25,834 |
|
| — |
|
| — |
|
| 25,834 |
| | | 15,768 | | | — | | | — | | | 15,768 | |
Asset-backed securities |
|
| 18,646 |
|
| 9 |
|
| — |
|
| 18,655 |
| | | 1,408 | | | — | | | (1) | | | 1,407 | |
U.S. government agency debt securities |
|
| 22,472 |
|
| 10 |
|
| — |
|
| 22,482 |
| | | 12,637 | | | 26 | | | — | | | 12,663 | |
Total marketable securities |
| $ | 83,824 |
| $ | 39 |
| $ | — |
| $ | 83,863 |
| | $ | 35,501 | | $ | 28 | | $ | (1) | | $ | 35,528 | |
| | | | | | | | | | | | | |
| | December 31, 2019 |
| ||||||||||
| | | | | Gross | | Gross | | | |
| ||
| | Amortized | | Unrealized | | Unrealized | | Fair |
| ||||
| | Cost | | Gain | | Loss | | Value |
| ||||
Marketable securities: |
| |
|
| |
|
| |
|
| |
| |
Corporate debt securities | | $ | 7,815 | | $ | 2 | | $ | — | | $ | 7,817 | |
Commercial paper | | | 15,129 | | | — | | | — | | | 15,129 | |
Asset-backed securities | | | 8,004 | | | 4 | | | — | | | 8,008 | |
U.S. government agency debt securities | |
| 8,126 | | | 1 | | | (3) | |
| 8,124 | |
Total marketable securities | | $ | 39,074 | | $ | 7 | | $ | (3) | | $ | 39,078 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| December 31, 2018 |
| ||||||||||
|
|
|
|
| Gross |
| Gross |
|
|
|
| ||
|
| Amortized |
| Unrealized |
| Unrealized |
| Fair |
| ||||
|
| Cost |
| Gain |
| Loss |
| Value |
| ||||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
| $ | 5,030 |
| $ | — |
| $ | (14) |
| $ | 5,016 |
|
Commercial paper |
|
| 67,159 |
|
| — |
|
| — |
|
| 67,159 |
|
Asset-backed securities |
|
| 21,745 |
|
| — |
|
| (8) |
|
| 21,737 |
|
U.S. government agency debt securities |
|
| 17,044 |
|
| — |
|
| (3) |
|
| 17,041 |
|
Total marketable securities |
| $ | 110,978 |
| $ | — |
| $ | (25) |
| $ | 110,953 |
|
12
4. Property and Equipment, Net
Property and equipment, net consisted of the following:
|
|
|
|
|
|
|
| |||||||
|
|
| June 30, |
|
| December 31, |
| |||||||
|
| 2019 |
| 2018 |
| |||||||||
| | | | | | | | |||||||
| | | June 30, | | | December 31, | | |||||||
| | 2020 | | 2019 |
| |||||||||
Computer equipment |
| $ | 1,360 |
| $ | 1,292 |
|
| $ | 1,317 |
| $ | 1,315 | |
Fleet vehicles |
|
| — |
|
| 2,131 |
| |||||||
Finance lease right-of-use assets |
|
| 2,557 |
|
| — |
| | | 435 | | | 435 | |
Manufacturing equipment |
|
| 607 |
|
| 604 |
| |||||||
Lab equipment |
|
| 994 |
|
| 1,068 |
| | | 1,292 | | | 1,250 | |
Furniture and fixtures |
|
| 852 |
|
| 524 |
| | | 647 | | | 647 | |
Leasehold improvements |
|
| 336 |
|
| 332 |
| | | 1,200 | | | 889 | |
Property and equipment, gross |
|
| 6,706 |
|
| 5,951 |
| |
| 4,891 | |
| 4,536 | |
Accumulated depreciation |
|
| (2,465) |
|
| (1,671) |
| |
| (2,661) | |
| (2,066) | |
Property and equipment, net |
| $ | 4,241 |
| $ | 4,280 |
| | $ | 2,230 | | $ | 2,470 | |
Depreciation expense was $394$297 and $296$393 for the three months ended June 30, 20192020 and 2018,2019, respectively, and was$595 and $795 and $499 for the six months ended June 30, 20192020 and 2018,2019, respectively.
14
5. Intangible Assets
Intangible assets consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||||||||||
|
|
|
|
| Gross Cost |
| Accumulated Amortization | |||||||||||||||||||||||
|
|
| Remaining |
|
| June 30, |
|
| December 31, |
|
| June 30, |
|
| December 31, | |||||||||||||||
|
|
| Life (years) |
| 2019 |
| 2018 |
| 2019 |
| 2018 | |||||||||||||||||||
RHOFADE product rights |
|
| 9.4 |
| $ | 66,415 |
| $ | 66,229 |
| $ | 3,871 |
| $ | 552 | |||||||||||||||
| | | | | | | | | | | | | | | ||||||||||||||||
| | | | Gross Cost | | Accumulated Amortization | ||||||||||||||||||||||||
| | Remaining | | | June 30, | | | December 31, | | | June 30, | | | December 31, | ||||||||||||||||
| | Life (years) | | 2020 | | 2019 |
| 2020 | | 2019 | ||||||||||||||||||||
Other intangible assets |
|
| 8.1 |
|
| 751 |
|
| 751 |
|
| 143 |
|
| 106 | | 7.1 | | | 751 | | | 751 | | | 219 | | | 181 | |
Total definite-lived intangible assets |
|
|
|
|
| 67,166 |
|
| 66,980 |
|
| 4,014 |
|
| 658 | | | | | 751 | | | 751 | | | 219 | | | 181 | |
IPR&D |
|
| na |
|
| 6,629 |
|
| 6,629 |
|
| — |
|
| — | | na | | | 6,629 | | | 6,629 | | | — | | | — | |
Total intangible assets, net |
|
|
|
| $ | 73,795 |
| $ | 73,609 |
| $ | 4,014 |
| $ | 658 | |||||||||||||||
Total intangible assets | | | | $ | 7,380 | | $ | 7,380 | | $ | 219 | | $ | 181 | ||||||||||||||||
Amortization expense was $1,679 and $0 for the three months ended June 30, 2019 and 2018, respectively, and was $3,356 and $0 for the six months ended June 30, 2019 and 2018, respectively.
As of June 30, 2019,2020, estimated future amortization expenses areexpense is as follows:
|
|
|
|
| ||||
| | | | | ||||
Year Ending December 31, |
|
|
|
|
| |
| |
2019 |
| $ | 3,360 |
| ||||
2020 |
|
| 6,717 |
| | $ | 37 | |
2021 |
|
| 6,718 |
| |
| 75 | |
2022 |
|
| 6,717 |
| |
| 75 | |
2023 |
|
| 6,718 |
| | | 75 | |
2024 | | | 75 | | ||||
Thereafter |
|
| 32,922 |
| | | 195 | |
Total |
| $ | 63,152 |
| | $ | 532 | |
6. Accrued Expenses
Accrued expenses consisted of the following:
|
|
|
|
|
|
|
| |||||||
|
|
| June 30, |
|
| December 31, |
| |||||||
|
| 2019 |
| 2018 |
| |||||||||
| | | | | | | | |||||||
| | | June 30, | | | December 31, | | |||||||
| | 2020 | | 2019 |
| |||||||||
Employee compensation expenses |
| $ | 3,660 |
| $ | 5,293 |
| | $ | 2,489 | | $ | 3,321 | |
Sales discounts and allowances |
|
| 18,415 |
|
| 2,650 |
| |||||||
Selling and marketing expenses |
|
| 741 |
|
| 453 |
| |||||||
Research and development expenses |
|
| 2,036 |
|
| 1,437 |
| | | 1,134 | | | 2,857 | |
Professional fees |
|
| 407 |
|
| 1,123 |
| | | 112 | | | 168 | |
Payable to EPI Health | | | 4,950 | | | — | | |||||||
Other |
|
| 2,338 |
|
| 1,030 |
| |
| 659 | |
| 1,375 | |
Total accrued expenses |
| $ | 27,597 |
| $ | 11,986 |
| | $ | 9,344 | | $ | 7,721 | |
1513
Payable to EPI Health
As of June 30, 2020, the Company had $4,950 payable to EPI Health (see Note 15 for additional information).
7. Debt
Loan and Security Agreement – Oxford Finance LLCSilicon Valley Bank
In October 2018,March 2020, the Company entered into a Loan and Security Agreement (“Loan Agreement”) with Oxford Finance LLC, a Delaware limited liability companySilicon Valley Bank (“Oxford”SVB”). The Loan and Security Agreement providedprovides for up to $65,000$11,000 in term loans, (the “Term Loan Facility”). Of the $65,000,of which the Company borrowed $30,000 in October 2018,the entire amount on March 30, 2020. The Loan and Security Agreement is secured by substantially all of which was outstanding asthe assets of June 30, 2019, and did not draw the remaining $35,000 that was available until March 31, 2019 underCompany other than intellectual property. In connection with the Loan Agreement.and Security Agreement, the Company issued to SVB a warrant to purchase up to 460,251 shares of common stock (the “Warrant”). The proceeds of the Loan and Security Agreement were allocated to the term loan and Warrant using a relative fair value approach.
The Loan Agreementterm loan repayment schedule provides for interest only payments beginning April 1, 2020 and continuing through November 2021,March 1, 2022, followed by 24 consecutive equal monthly installments of principal, plus monthly payments of principal andaccrued interest, in arrears starting on November 2021April 1, 2022 and continuing through the maturity date of October 2023.March 1, 2024. All unpaidoutstanding principal and accrued and unpaid interest will be due and payable on the maturity date. The Loan and Security Agreement provides for an annual interest rate equal to the greater of (i) 8.35%the prime rate then in effect as reported in The Wall Street Journal plus 2% and (ii) the 30-day U.S. LIBOR rate plus 6.25%6.75%.
The Loan and Security Agreement also provides forincludes a final payment fee equal to 5.75%5% of the original principal amount of the term loans drawn under the Term Loan Facility, which final payment is due on October 1, 2023 or upon the prepayment of the facility or the acceleration of amounts due under the facility as a result of an event of default.
borrowed. The Company has the option to prepay the outstanding balance of the term loans in full, subject to a prepayment feepremium of (i) 3% of the original principal amount of the aggregate term loans drawnborrowed for any prepayment on or prior to the first anniversary of the date such term loan was funded,March 30, 2020, (ii) 2% of the original principal amount of the aggregate term loans drawnborrowed for any prepayment betweenafter the first anniversary and on or before the second anniversariesanniversary of the date such term loan was fundedMarch 30, 2020 or (iii) 1% of the original principal amount of the aggregate term loans drawnborrowed for any prepayment after the second anniversary of the funding dateMarch 30, 2020 but before OctoberMarch 1, 2023. The Company also has the option to prepay the term loans in part, once in a three-month period, of an amount of $2,000 or greater, subject to the same prepayment fees and other specified limitations.2024.
The Term Loan Facility is collateralized by substantially all of the Company’s assets, except that the collateral does not include the Company’s intellectual property, and the Company has agreed not to encumber any of its intellectual property. The Loan Agreement contains customary representations, warranties and covenants by the Company. The Loan Agreement also contains specified financial covenants related to minimum consolidated future revenues of the Company.
The carrying value of the Loan Agreement approximates fair value because the interest is a floating rate based on the 30-day U.S. LIBOR rate, and is therefore reflective of market rates.
8. Stockholders’ Equity
Preferred Stock
As of June 30, 20192020 and December 31, 2018,2019, the Company’s amended and restated certificate of incorporation authorized the Company to issue 10,000,000 shares of undesignated preferred stock. NoThere were 0 shares of preferred stock were outstanding as of June 30, 20192020 or December 31, 2018.2019.
Common Stock
As of June 30, 20192020 and December 31, 2018,2019, the Company’s amended and restated certificate of incorporation authorized the Company to issue 100,000,000 shares of $0.00001 par value common stock.
Each share of common stock entitles the holder to one1 vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any,
16
subject to any preferential dividend rights of any series of preferred stock that may be outstanding. The Company did not declare anyNaN dividends have been declared through June 30, 2019.2020.
Warrants
9. Stock‑Based Awards
2017 Inducement Plan
In July 2017,connection with the Company’s boardLoan and Security Agreement with SVB, the Company issued the Warrant to SVB. The Warrant has an initial exercise price of directors adopted$0.956 per share, subject to adjustment as provided in the 2017 Inducement Plan (the “2017 Inducement Plan”).Warrant. The 2017 Inducement PlanWarrant became immediately exercisable in full upon the funding of the term loan facility. The Warrant will terminate, if not earlier exercised, on the earlier of March 29, 2030 and the closing of certain merger or other transactions in which the consideration is cash, stock of a non-shareholder approved stock plan adopted pursuantpublicly-traded acquirer or a combination thereof. The Company assigned a fair value of
14
$378 to the “inducement exception” provided under Nasdaq listing rules. The only employees eligibleWarrant using a Black-Scholes valuation methodology, and also concluded that the Warrant was indexed to receive grants of awards underits own stock and therefore classified the 2017 Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq listing rules, generally including individuals who were not previouslyWarrant as an employee or director of the Company. Under the terms of the 2017 Inducement Plan, up to 1,000,000 shares of common stock were available for issuance pursuant to nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit (“RSU”) awards, and other stock awards. All shares of common stock that were eligible for issuance under the 2017 Inducement Plan after October 1, 2018, including any shares underlying any awards that expire or are otherwise terminated, reacquired to satisfy tax withholding obligations, settled in cash or repurchased by the Company in the future that would have been eligible for re-issuance under the 2017 Inducement Plan, were retired.equity instrument.
9. Stock-Based Awards
2015 Equity Incentive Plan
In September 2015, the Company’s board of directors adopted the 2015 Equity Incentive Plan (the “2015 Plan”), and the Company’s stockholders approved the 2015 Plan. The 2015 Plan became effective in connection with the Company’s initial public offering in October 2015. Beginning at the time the 2015 Plan became effective, no further grants may be made under the Company’s 2012 Equity Compensation Plan, as amended and restated (the “2012 Plan”). The 2015 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, RSUrestricted stock unit (“RSU”) awards, performance stock awards, cash-based awards and other stock-based awards. The number of shares initially reserved for issuance under the 2015 Plan was 1,643,872 shares of common stock. The number of shares of common stock that may be issued under the 2015 Plan will automatically increase on January 1 of each year ending on January 1, 2025, in an amount equal to the lesser of (i) 4.0% of the shares of the Company’s common stock outstanding on December 31 of the preceding calendar year or (ii) an amount determined by the Company’s board of directors. The shares of common stock underlying any awards that expire, are otherwise terminated, settled in cash or repurchased by the Company under the 2015 Plan and the 2012 Plan will be added back to the shares of common stock available for issuance under the 2015 Plan. As of January 1, 2019,2020, the number of shares of common stock that may be issued under the 2015 Plan was automatically increased by 1,648,4291,451,997 shares. As of June 30, 2019, 1,975,8202020, 1,922,147 shares remained available for grant under the 2015 Plan.
2017 Inducement Plan
In July 2017, the Company’s board of directors adopted the 2017 Inducement Plan (the “2017 Inducement Plan”). The 2017 Inducement Plan is a non-stockholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules. The Company had 443,000 stock options and 44,390 RSUs outstanding as of June 30, 2020 under the 2017 Inducement Plan. All shares of common stock that were eligible for issuance under the 2017 Inducement Plan after October 1, 2018, including any shares underlying any awards that expire or are otherwise terminated, reacquired to satisfy tax withholding obligations, settled in cash or repurchased by the Company in the future that would have been eligible for re-issuance under the 2017 Inducement Plan, were retired.
2012 Equity Compensation Plan
Upon the 2015 Plan becoming effective, no0 further grants can be made under the 2012 Plan. The Company granted stock options to purchase a total of 1,140,524 shares under the 2012 Plan, of which 945,200609,628 and 948,761745,735 were outstanding as of June 30, 20192020 and December 31, 2018,2019, respectively. Stock options granted under the 2012 Plan vestvested over four years and expire after ten years. As required, the exercise price for the stock options granted under the 2012 Plan was not less than the fair value of the shares of common stock underlying the awards as determined by the Company as of the date of grant.
17
Stock Option Valuation
The weighted average assumptions the Company used to estimate the fair value of stock options granted during the six months ended June 30, 2020 and 2019 were as follows:
| | | | | | | |
|
| Six Months Ended | | | |||
| | June 30, | | | |||
| | 2020 | | | 2019 | |
|
Risk-free interest rate |
| 0.87 | % | | 2.53 | % | |
Expected term (in years) |
| 6.1 | | | 6.3 | | |
Expected volatility |
| 85.19 | % | | 101.70 | % | |
Expected dividend yield |
| 0 | % | | 0 | % | |
|
|
|
|
|
|
|
|
|
| Six Months Ended |
| ||||
|
| June 30, |
| ||||
|
| 2019 |
|
| 2018 |
|
|
Risk-free interest rate |
| 2.53 | % |
| 2.63 | % |
|
Expected term (in years) |
| 6.3 |
|
| 6.3 |
|
|
Expected volatility |
| 101.70 | % |
| 95.78 | % |
|
Expected dividend yield |
| 0 | % |
| 0 | % |
|
15
The Company recognizes compensation expense for awards over their vesting period. Compensation expense for awards includes the impact of forfeitures in the period when they occur.
Stock Options
The following table summarizes stock option activity from January 1, 2019 throughfor the six months ended June 30, 2019:2020:
| | | | | | | | | | | |
|
| |
| | |
| Weighted |
| | |
|
| | | | Weighted | | Average | | | |
| |
| | | | Average | | Remaining | | Aggregate |
| ||
| | Number | | Exercise | | Contractual | | Intrinsic |
| ||
| | of Shares | | Price | | Term | | Value |
| ||
| | | | | | | (in years) | | | |
|
Outstanding as of December 31, 2019 |
| 3,102,221 | | $ | 20.33 |
| 6.55 | | $ | 148 | |
Granted |
| 734,800 | | | 1.30 | | | | | | |
Exercised |
| — | | | — | | | | | | |
Forfeited and cancelled |
| (557,222) | | | 21.33 | | | | | | |
Outstanding as of June 30, 2020 |
| 3,279,799 | | $ | 15.90 |
| 6.99 | | $ | 316 | |
Options vested and expected to vest as of June 30, 2020 |
| 3,279,799 | | $ | 15.90 |
| 6.99 | | $ | 316 | |
Options exercisable as of June 30, 2020 |
| 1,897,671 | | $ | 19.16 |
| 5.79 | | $ | 79 | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted |
|
|
|
|
|
|
|
| Weighted |
| Average |
|
|
|
| |
|
|
|
| Average |
| Remaining |
| Aggregate |
| ||
|
| Number |
| Exercise |
| Contractual |
| Intrinsic |
| ||
|
| of Shares |
| Price |
| Term |
| Value |
| ||
|
|
|
|
|
|
| (in years) |
|
|
|
|
Outstanding as of December 31, 2018 |
| 4,282,081 |
| $ | 20.53 |
| 7.91 |
| $ | 2,404 |
|
Granted |
| 28,500 |
|
| 7.66 |
|
|
|
|
|
|
Exercised |
| (1,800) |
|
| 1.52 |
|
|
|
|
|
|
Forfeited and cancelled |
| (298,358) |
|
| 24.08 |
|
|
|
|
|
|
Outstanding as of June 30, 2019 |
| 4,010,423 |
| $ | 20.18 |
| 7.23 |
| $ | 345 |
|
Options vested and expected to vest as of June 30, 2019 |
| 4,010,423 |
| $ | 20.18 |
| 7.23 |
| $ | 345 |
|
Options exercisable as of June 30, 2019 |
| 2,207,189 | (1) | $ | 17.54 |
| 6.46 |
| $ | 345 |
|
|
|
The weighted average grant date fair value of stock options granted during the six months ended June 30, 20192020 was $6.22$0.93 per share.
The intrinsic value of a stock option is calculated as the difference between the exercise price of the stock option and the fair value of the underlying common stock, and cannot be less than zero.
18
Restricted Stock Units
The following table summarizes RSU activity from January 1, 2019 throughfor the six months ended June 30, 2019:2020:
| | | | | | |
| | | | Weighted | | |
| | | | Average | | |
| | | | Grant Date | | |
| | Number | | Fair Value | | |
| | of Shares | | Per Share | | |
| | | | | | |
Outstanding as of December 31, 2019 | | 3,592,915 | | $ | 4.62 | |
Granted | | 998,385 | | | 1.26 | |
Vested | | (1,618,634) | | | 3.09 | |
Forfeited and cancelled | | (444,265) | | | 4.12 | |
Outstanding as of June 30, 2020 | | 2,528,401 | | $ | 4.36 | |
|
|
|
|
|
|
|
|
|
|
| Weighted |
| |
|
|
|
| Average |
| |
|
|
|
| Grant Date |
| |
|
| Number |
| Fair Value |
| |
|
| of Shares |
| Per Share |
| |
|
|
|
|
|
|
|
Outstanding as of December 31, 2018 |
| 626,407 |
| $ | 20.30 |
|
Granted |
| 1,517,042 |
|
| 6.27 |
|
Vested |
| (96,252) |
|
| 22.02 |
|
Forfeited and cancelled |
| (87,610) |
|
| 13.37 |
|
Outstanding as of June 30, 2019 |
| 1,959,587 |
| $ | 9.67 |
|
16
Stock-Based Compensation
Stock‑Based Compensation
The following table summarizes stock‑basedStock-based compensation expense recorded byincluded in total costs and expenses on the Company:condensed consolidated statement of operations included the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||||||||
|
| Three Months Ended |
| Six Months Ended |
| |||||||||||||||||||||
|
| June 30, |
| June 30, |
| |||||||||||||||||||||
|
| 2019 |
| 2018 |
| 2019 |
| 2018 |
| |||||||||||||||||
| | | | | | | | | | | | | | |||||||||||||
| | Three Months Ended | | Six Months Ended |
| |||||||||||||||||||||
| | June 30, | | June 30, |
| |||||||||||||||||||||
|
| 2020 |
| 2019 |
| 2020 |
| 2019 |
| |||||||||||||||||
Cost of revenue |
| $ | 223 |
| $ | 190 |
| $ | 429 |
| $ | 366 |
|
| $ | 252 |
| $ | 223 |
| $ | 512 |
| $ | 429 | |
Research and development |
|
| 1,721 |
|
| 1,756 |
|
| 3,315 |
|
| 3,483 |
| | | 939 | | | 1,721 | | | 1,755 | | | 3,315 | |
Sales and marketing |
|
| 216 |
|
| 1,020 |
|
| 806 |
|
| 1,927 |
| |||||||||||||
General and administrative |
|
| 2,654 |
|
| 2,283 |
|
| 5,126 |
|
| 4,616 |
| |
| 2,118 | |
| 2,654 | |
| 4,495 | |
| 5,126 | |
Total stock-based compensation expense |
| $ | 4,814 |
| $ | 5,249 |
| $ | 9,676 |
| $ | 10,392 |
| | $ | 3,309 | | $ | 4,598 | | $ | 6,762 | | $ | 8,870 | |
As of June 30, 2019,2020, the Company had unrecognized stock‑basedstock-based compensation expense for stock options and RSUs of $24,719$8,195 and $15,151,$8,604, respectively, which is expected to be recognized over weighted average periods of 2.151.52 years and 3.102.13 years, respectively.
19
10. Net Loss per Share
Basic and diluted net loss per share is summarized in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
| |||||||||||||
|
| Three Months Ended |
| Six Months Ended |
| |||||||||||||||||||||
|
| June 30, |
| June 30, |
| |||||||||||||||||||||
|
| 2019 |
| 2018 |
| 2019 |
| 2018 |
| |||||||||||||||||
| | | | | | | | | | | | | | |||||||||||||
| | Three Months Ended | | Six Months Ended |
| |||||||||||||||||||||
| | June 30, | | June 30, |
| |||||||||||||||||||||
| | 2020 | | 2019 |
| 2020 |
| 2019 | | |||||||||||||||||
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
| |
| | |
|
| |
| |
Net loss |
| $ | (49,876) |
| $ | (31,218) |
| $ | (87,441) |
| $ | (61,447) |
| | $ | (11,597) | | $ | (49,876) | | $ | (27,183) | | $ | (87,441) | |
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
| | | | | | | | | | | | | |
Weighted average shares of common stock outstanding |
|
| 41,274,808 |
|
| 30,944,899 |
|
| 41,261,808 |
|
| 30,915,577 |
| |
| 42,133,646 | |
| 41,274,808 | |
| 41,876,037 | |
| 41,261,808 | |
Net loss per share, basic and diluted |
| $ | (1.21) |
| $ | (1.01) |
| $ | (2.12) |
| $ | (1.99) |
| | $ | (0.28) | | $ | (1.21) | | $ | (0.65) | | $ | (2.12) | |
The Company’s potentially dilutive securities, which included stock options, RSUs and RSUs,warrants, have been excluded from the computation of diluted net loss per share since the effect would be to reduce the net loss per share. Therefore, the weighted average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The following table presents potential shares of common stock excluded from the calculation of diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 20192020 and 2018.2019. All share amounts presented in the table below represent the total number outstanding as of June 30, 20192020 and 2018.2019.
|
|
|
|
|
| |||||
|
|
|
| |||||||
|
| June 30, |
| |||||||
|
| 2019 |
| 2018 |
| |||||
| | | | | | |||||
| | |
| |||||||
| | June 30, | | |||||||
| | 2020 | | 2019 |
| |||||
Options to purchase common stock |
| 4,010,423 |
| 4,315,942 |
| | 3,279,799 | | 4,010,423 | |
Restricted stock unit awards |
| 1,959,587 |
| 532,756 |
| | 2,528,401 | | 1,959,587 | |
Warrants issued to SVB | | 460,251 | | — | | |||||
Total potential shares of common stock |
| 5,970,010 |
| 4,848,698 |
| | 6,268,451 | | 5,970,010 | |
11. Leases
The Company has operating leases for office space and laboratory facilities, and finance leases for fleet vehicles leased for its sales force and laboratory equipment. The components of lease expense were as follows:
|
|
|
|
|
|
| Six Months Ended |
| |
|
| June 30, |
| |
|
| 2019 |
| |
Operating lease expense |
| $ | 302 |
|
|
|
|
|
|
Finance Leases: |
|
|
|
|
Amortization of right-to-use assets |
| $ | 313 |
|
Interest expense |
|
| 67 |
|
Total finance lease expenses |
| $ | 380 |
|
During the three and six months ended June 30, 2018 the Company recorded $201 and $478, respectively, of rent expense which was recognized on a straight-line basis over the term of the lease.
2017
11. Leases
Operating Leases
Agreements for Office Space
In November 2017, the Company entered into a sublease agreement with Auxilium Pharmaceuticals, LLC (the “Sublandlord”) pursuant to which it subleases 33,019 square feet of office space for its headquarters in Wayne, Pennsylvania. Subject to the consent of Chesterbrook Partners, LP (“Landlord”) as set forth in the lease by and between them and Sublandlord, theThe sublease has a term that runs through October 2023. If for any reason the lease between Chesterbrook Partners, LP (“the LandlordLandlord”) and Sublandlord is terminated or expires prior to October 2023, the Company’s sublease will automatically terminate.
In February 2019, the Company entered into a sublease agreement with a third party for 21,056 square feet of office and laboratory space in St. Louis, Missouri with total future total rent payments of $3,538. The Company has also agreed to pay $1,472 of the total renovation and improvement costs incurred by the landlord, which is collateralized by a standby letter of credit held by the Company.Missouri. The lease commenced in June 2019 and has a term that runs through June 2029.
Supplemental balance sheet information related to operating leases is as follows:
|
|
|
|
| ||||||
|
|
| June 30, |
| ||||||
| | | | | | | ||||
| | | June 30, | | | December 31, | ||||
Operating Leases: |
| 2019 |
| | 2020 | | 2019 | |||
Gross cost |
| $ | 5,207 |
| | $ | 5,213 | | $ | 5,213 |
Accumulated amortization |
|
| (177) |
| | | (789) | | | (480) |
Operating lease right-of-use assets |
| $ | 5,030 |
| ||||||
|
|
|
|
| ||||||
Other assets | | $ | 4,424 | | $ | 4,733 | ||||
| | | | | | | ||||
Other current liabilities |
| $ | 488 |
| | $ | 567 | | $ | 526 |
Other liabilities |
|
| 3,794 |
| | | 3,253 | | | 3,548 |
Total operating lease liabilities |
| $ | 4,282 |
| | $ | 3,820 | | $ | 4,074 |
Amortization expense related to operating lease right-of-use assets and liabilities was $253 and $143 for the three months ended June 30, 2020 and 2019, respectively, and $510 and $286 for the six months ended June 30, 2020 and 2019, respectively.
Finance Leases
Laboratory Equipment
The Company leases laboratory equipment which is used in its laboratory space in St. Louis, Missouri under two2 finance lease financing arrangements which the Company entered into in August 2017 and October 2017, respectively.2017. The leases have terms which end in October 2020 and December 2020, respectively.
Fleet Vehicles
The Company leases automobiles for its sales force and other field-based employees under the terms of a master lease agreement with a third party. The lease term for each automobile begins on the date the Company takes delivery and continues for a period of four years.
21
Supplemental balance sheet information related to finance leases is as follows:
|
|
|
|
|
|
|
| June 30, |
|
Finance Leases: |
| 2019 |
| |
Property and equipment, gross |
| $ | 2,557 |
|
Accumulated depreciation |
|
| (763) |
|
Property and equipment, net |
| $ | 1,794 |
|
|
|
|
|
|
Other current liabilities |
| $ | 503 |
|
Other liabilities |
|
| 1,173 |
|
Total finance lease liabilities |
| $ | 1,676 |
|
Supplemental information related to operating and finance leases is as follows:
|
|
|
|
|
|
| Six Months Ended |
| |
|
| June 30, |
| |
Supplemental Cash Flow Lease Information: |
| 2019 |
| |
Operating cash flows from operating leases |
| $ | 309 |
|
Operating cash flows from finance leases |
|
| 61 |
|
Financing cash flows from finance leases |
|
| 240 |
|
|
|
|
|
|
Leased assets obtained in exchange for new operating lease liabilities |
| $ | 3,060 |
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Remaining Lease Term (in years): |
|
|
|
|
Operating leases |
|
| 7.19 |
|
Finance leases |
|
| 2.74 |
|
|
|
|
|
|
Weighted-Average Discount Rate: |
|
|
|
|
Operating leases |
|
| 10.10 | % |
Finance leases |
|
| 6.94 | % |
Future maturities of lease liabilities under operating and finance leases as of June 30, 2019 are as follows:
|
|
|
|
|
|
|
|
|
| Operating |
|
| Finance |
Year Ending December 31, | �� |
| Leases |
|
| Leases |
2019 |
| $ | 419 |
| $ | 295 |
2020 |
|
| 909 |
|
| 567 |
2021 |
|
| 934 |
|
| 448 |
2022 |
|
| 959 |
|
| 180 |
2023 |
|
| 877 |
|
| — |
Thereafter |
|
| 2,024 |
|
| — |
Total undiscounted lease payments |
|
| 6,122 |
|
| 1,490 |
Less: unrecognized interest |
|
| (1,840) |
|
| (187) |
Plus: residual value guarantees |
|
| — |
|
| 373 |
Total lease liability |
| $ | 4,282 |
| $ | 1,676 |
22
The undiscounted lease payments presented in the table above are consistent with the future minimum lease payments disclosed in the Company’s Annual Report on Form 10-K filed with the SEC on March 18, 2019 under the prior lease guidance.
12. Related Party Transactions
SubleaseMallinckrodt plc
In August 2013,April 2018, Bryan Reasons was appointed to the Company’s board of directors. Subsequently, in March 2019, Mr. Reasons became the Chief Financial Officer of Mallinckrodt plc. Prior to Mr. Reasons joining Mallinckrodt plc, the Company entered into a subleasemaster services agreement with NeXeption, Inc. ("NeXeption"a subsidiary (“Mallinckrodt”), of Mallinckrodt plc in November 2018, pursuant to which Confluence provides laboratory services to Mallinckrodt in the ordinary course of business. Mr. Reasons was subsequently assigned to NST Consulting, LLC, a wholly-owned subsidiary of NST, LLC. In November 2017,not involved in the Company terminated the sublease with NST Consulting, LLC effective March 31, 2018. The Company paid $590 to NST Consulting, LLC, which amount represented accelerated rent payments. Total payments made under the sublease during the six months ended June 30, 2019 and 2018 were $0 and $570, respectively.
Mr. Stephen Tullman, the former chairmannegotiation or execution of the Company’s board of directors, wasagreement, but may be deemed to have an interest in the ongoing transactions based on his employment as an executive officer of NeXeption and is also the manager of NST Consulting, LLC and NST, LLC, and three of the Company’s executive officers are and have been members of entities affiliated with NST, LLC.
The Company had no amounts payable to NST Consulting, LLC asMallinckrodt plc. As of June 30, 20192020 and December 31, 2018.
Asset Purchase Agreement with Allergan
In November 2018, the Company closed the acquisition of RHOFADE, which includes an exclusive license to certain intellectual property for RHOFADE, as well as additional intellectual property, from Allergan pursuant to the terms of the Asset Purchase Agreement dated as of October 15, 2018 (as amended, the “Asset Purchase Agreement”).
Pursuant to the Asset Purchase Agreement, the Company has agreed to assume the obligation to pay specified royalties and milestone payments under agreements with Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc. Members of the Company’s management team, including Neal Walker, Frank Ruffo and Stuart Shanler, as well as Anand Mehra, a member of the Company’s board of directors, are former stockholders of Vicept Therapeutics, Inc., and Dr. Shanler is also a current member of Aspect Pharmaceuticals, LLC. In their capacities as current or former holders of equity interests in these entities, these individuals may be entitled to receive a portion of the potential future payments payable by the Company.
For the six months ended June 30, 2019, the Company incurred an expense of $379had invoiced Mallinckrodt for $292 and $0 related to royalties and milestones earned by Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc.,$57, respectively, under those agreements.the master services agreement. Mr. Reasons had no financial interest in these transactions.
18
13.Agreements Related to Intellectual Property
Asset Purchase Agreement – Allergan Sales, EPI Health, LLC
In November 2018,October 2019, the Company closed the acquisition ofsold RHOFADE from Allerganto EPI Health pursuant to the Asset Purchase Agreement (see Note 12). The Company is obligatedan asset purchase agreement. EPI Health agreed to pay Allergan specified royalties, ranging fromthe Company a mid-single digit percentage tohigh single-digit royalty calculated as a mid-teen percentage of net sales subject to specified reductions, limitations and other adjustments, on a country-by-country basis until the date that the patent rights related to RHOFADE have expired or, if later, November 30, 2028.10 years from the date of the first commercial sale of RHOFADE in such country. The Company incurred royalties earned by Allerganrecorded royalty income under the Asset Purchase Agreementasset purchase agreement of $471 and $0 during the three months ended June 30, 2019 and 2018, respectively, and $842$411 and $0 during the six months
23
ended June 30, 2020 and 2019, respectively. EPI Health has also agreed to pay the Company potential sales milestone payments of up to $20,000 in the aggregate upon the achievement of specified levels of net sales of products covered by the asset purchase agreement, and 25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health in connection with any license or sublicense of the assets transferred in the disposition in any territory outside of the United States, subject to specified exceptions.
Agreement and Plan of Merger – Confluence
In August 2017, the Company entered into an Agreement and Plan of Merger, pursuant to which it acquired Confluence (the “Confluence Agreement”). In November 2018, respectively. Thethe Company achieved a development milestone specified in the Confluence Agreement, as a result of which the Company paid the former Confluence equity holders $2,500 in cash and issued them 253,208 shares of its common stock with a fair value of $2,200. Under the Confluence Agreement, the Company also agreed to pay Allerganthe former Confluence equity holders aggregate remaining contingent consideration of up to $75,000 based upon the achievement of specified regulatory and commercial milestones. In addition, the Company agreed to pay the former Confluence equity holders future royalty payments calculated as a one-timelow single-digit percentage of annual net sales, subject to specified reductions, limitations and other adjustments, until the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or, in specified circumstances, ten years from the first commercial sale of such product. In addition, if the Company sells, licenses or transfers any of the intellectual property acquired from Confluence pursuant to the Confluence Agreement to a third party, the Company will be obligated to pay the former Confluence equity holders a portion of any consideration received from such sale, license or transfer in specified circumstances.
License and Collaboration Agreement – Rigel Pharmaceuticals, Inc.
In August 2015, the Company entered into an exclusive, worldwide license and collaboration agreement with Rigel Pharmaceuticals, Inc. (“Rigel”) for the development and commercialization of products containing two specified JAK inhibitors, which the Company refers to as ATI-501 and ATI-502. Under the agreement, the Company agreed to make aggregate payments of up to $80,000 upon the achievement of specified development milestones. In September 2019, the Company made a milestone payment of $5,000$4,000 to Rigel upon the achievement of a specified development milestone relatedmilestone. With respect to the potential development of an additional dermatology product.
License, Development and Commercialization Agreement – Cipher Pharmaceuticals Inc.
In April 2018,any products the Company entered into an exclusive licensecommercializes under the agreement, with Cipher Pharmaceuticals Inc. (“Cipher”) for the rights to obtain regulatory approval of and commercialize A-101 40% Topical Solution, which the Company markets under the brand name ESKATA in the United States, in Canada for the treatment of SK. Under the agreement, Cipher is responsible for obtaining marketing approval in Canada for A-101 40% Topical Solution. The Company will supply Cipher with finished product under a supply agreement, and, if regulatory approval is obtained, Cipher will be responsible for distribution and commercialization of A-101 40% Topical Solution in Canada. Additionally, Cipher is responsible for all expenses related to regulatory and commercial activities for A-101 40% Topical Solution in Canada. In April 2018, the Company received an upfront payment of $1,000 upon signing of the agreement and in October 2018, the Company received $500 upon the achievement of a specified regulatory milestone. The Company can earn a remaining payment of $500 upon the achievement of a specified regulatory milestone, and aggregate payments of $1,750 upon the achievement of specified commercial milestones under the terms of the agreement with Cipher. Cipher will also be required to pay the Company a low double-digit percentage royaltyRigel quarterly tiered royalties on its annual net sales of A-101 40% Topical Solution in Canada. The termeach product at a high single-digit percentage of annual net sales, subject to specified reductions, until the date that all of the agreement expirespatent rights for that product have expired, as determined on the later of the expiration of applicable patentsa country-by-country and product-by-product basis or, in Canada or the 15th anniversary ofspecified countries under specified circumstances, ten years from the first commercial sale of licensed product in Canada. Cipher submitted a New Drug Submission for A-101 40% Topical Solution for the treatment of raised SKs, which was accepted for review by Health Canada in December 2018. such product.
Assignment Agreement – Estate of Mickey Miller and
Finder’s Services Agreement – KPT Consulting, LLC
In August 2012, the Company entered into an assignment agreement with the Estate of Mickey Miller (the “Miller Estate”), under which the Company acquired some of the intellectual property rights covering ESKATA and A-101 45% Topical Solution. In connection with obtaining the assignmentan amendment of the intellectual property from the Miller Estate,agreement with Rigel in October 2019, the Company also entered into a separate finder’s services agreement with KPT Consulting, LLC. Underpaid Rigel an amendment fee of $1,500 in 3 installments of $500 in each of January 2020, April 2020 and July 2020. In addition, the terms of the finder’s services agreement,parties modified certain other development milestones, and the Company made a milestone payment of $1,000agreed to increase the potential payments payable upon the achievement of a specified regulatory milestone in April 2017 and a milestone payment of $1,500 upon the achievement of a specified commercial milestone in May 2018. The payments were recorded as general and administrative expensessuch milestones from $10,000 to $10,500 in the Company’s condensed consolidated statementaggregate.
19
Under the finder’s services agreement, the Company is obligated to make an additional milestone payment of $3,000 upon the achievement of a specified commercial milestone. Under each of the assignment agreement and the finder’s services agreement, the Company is also obligated to pay royalties on sales of ESKATA and any related products, at low single-digit percentages of net sales, subject to reduction in specified circumstances. During the six months ended June 30, 2019 and 2018, the Company incurred an aggregate expense of $14 and $0, respectively, related to royalty payments under these agreements. Both agreements will terminate upon the expiration of the last pending, viable patent claim of the patents acquired under the assignment agreement, but no sooner than 15 years from the effective date of the agreements.
14. Income Taxes
The Company did not record a federal or state income tax benefit for losses incurred during the six months ended June 30, 20192020 and 20182019 due to the Company’s conclusion that a valuation allowance was required for those periods.
15. Discontinued Operations
The components of loss from discontinued operations as reported in the Company’s condensed consolidated statement of operations were as follows:
| | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended | ||||||||
| | June 30, | | June 30, | ||||||||
|
| 2020 |
| 2019 | | 2020 |
| 2019 | ||||
Revenues: | | | | | | | | | | | | |
Product sales, net |
| $ | — |
| $ | 4,979 |
| $ | — |
| $ | 8,757 |
Total revenue, net | | | — | | | 4,979 | | | — | | | 8,757 |
| | | | | | | | | | | | |
Costs and expenses: | | | | | | | | | | | | |
Cost of revenue | | | — | | | 1,709 | | | — | | | 3,279 |
Research and development |
| | — | | | 103 | | | 1 | | | 380 |
Sales and marketing | | | 27 | | | 6,805 | | | 283 | | | 16,499 |
General and administrative |
| | — | | | 893 | | | 1 | | | 1,763 |
Amortization of definite-lived intangible | | | — | | | 1,660 | | | — | | | 3,319 |
Total costs and expenses |
| | 27 | |
| 11,170 | | | 285 | | | 25,240 |
Loss from discontinued operations |
| $ | (27) | | $ | (6,191) | | $ | (285) | | $ | (16,483) |
| | | | | | | | | | | | |
Net loss from discontinued operations per share, basic and diluted | | $ | (0.00) | | $ | (0.15) | | $ | (0.01) | | $ | (0.40) |
Weighted average common shares outstanding, basic and diluted | |
| 42,133,646 | |
| 41,274,808 | |
| 41,876,037 | |
| 41,261,808 |
The following table presents the details of product sales, net included in discontinued operations:
| | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended | ||||||||
| | June 30, | | June 30, | ||||||||
|
| 2020 |
| 2019 | | 2020 |
| 2019 | ||||
ESKATA |
| $ | — |
| $ | 272 | | $ | — |
| $ | 344 |
RHOFADE | | | — | | | 4,707 | | | — | | | 8,413 |
Total product sales, net | | $ | — | | $ | 4,979 | | $ | — | | $ | 8,757 |
2420
The following table presents information related to assets and liabilities reported as discontinued operations in the Company’s condensed consolidated balance sheet:
15.
| | | | | | | | | | | | |
| | | | | | | | June 30, | | December 31, | ||
| | | | | | |
| 2020 |
| 2019 | ||
Accounts receivable, net | | | | | | |
| $ | — |
| $ | 4,966 |
Discontinued operations - current assets | | | | | | | | $ | — | | $ | 4,966 |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
Accounts payable | | | | | | | | $ | 36 | | $ | 1,705 |
Accrued expenses | | | | | | |
| | 2,253 | | | 2,452 |
Discontinued operations - current liabilities | | | | | | | | $ | 2,289 | | $ | 4,157 |
| | | | | | | | | | | | |
The following table presents certain non-cash items related to discontinued operations, which are included in the Company’s condensed consolidated statement of cash flows:
| | | | | | | | | | | | |
| | | | | | | | Six Months Ended | ||||
| | | | | | | | June 30, | ||||
| | | | | | | | 2020 |
| 2019 | ||
Depreciation and amortization | | | | | | | | $ | — |
| $ | 3,552 |
Stock-based compensation expense | | | | | | | | | — | | | 806 |
Total non-cash items | | | | | | | | $ | — | | $ | 4,358 |
The Company relied on Allergan Sales, LLC (“Allergan”) to distribute RHOFADE on its behalf pursuant to the terms of a transition services agreement. Accounts receivable, net as of June 30, 2020 and December 31, 2019 included $0 and $4,966, respectively, related to amounts invoiced by Allergan for sales of RHOFADE. In addition, during the three months ended June 30, 2020, in accordance with the asset purchase agreement with EPI Health (see Note 13 for additional information), the Company received cash from Allergan related to sales of RHOFADE that occurred after the date the Company sold RHOFADE to EPI Health. Accordingly, the Company had $4,950 payable to EPI Health, which is included in accrued expenses on the Company’s condensed consolidated balance sheet as of June 30, 2020.
16. Segment Information
The Company has two2 reportable segments, dermatology therapeutics and contract research. The dermatology therapeutics segment is focused on identifying developing and commercializingdeveloping innovative therapies to address significant unmet needs for immuno-inflammatory and dermatological diseases. The Company currently markets and sells RHOFADE, which is a topical treatment for persistent facial erythema, or redness, associated with rosacea in adults. The Company sells RHOFADE to a limited number of wholesalers in the United States. These wholesalers subsequently resell RHOFADE to pharmacies and health care providers. The Company sold and marketed ESKATA in the United States during the six months ended June 30, 2019 and 2018 and subsequently discontinued sales and marketing of ESKATA in August 2019. ESKATA is a proprietary formulation of high-concentration hydrogen peroxide topical solution that the Company was marketing as an office-based prescription treatment for raised SKs.
The contract research segment earns revenue from the provision of laboratory services to clients through Confluence, the Company’s wholly-owned subsidiary. Contract research revenue is generally evidenced by contracts with clients which are on an agreed upon fixed-price, fee-for-service basis. Corporate and other includes general and administrative expenses as well as eliminations of intercompany transactions. The Company does not report balance sheet information by segment since it is not reviewed by the chief operating decision maker, and all of the Company’s tangible assets are held in the United States.
21
The Company’s results of operations by segment for the three and six months ended June 30, 20192020 and 20182019 are summarized in the tables below:
| | | | | | | | | | | | |
| | | | Contract | | Corporate | | Total | ||||
Three Months Ended June 30, 2020 | | Therapeutics | | Research | | and Other | | Company | ||||
Total revenue | | $ | 193 | | $ | 3,657 | | $ | (1,804) | | $ | 2,046 |
Cost of revenue | | | — | | | 3,082 | | | (1,693) | | | 1,389 |
Research and development | | | 6,577 | | | — | | | (111) | | | 6,466 |
General and administrative | | | — | | | 688 | | | 4,884 | | | 5,572 |
Loss from operations | | $ | (6,384) | | $ | (113) | | $ | (4,884) | | $ | (11,381) |
Loss from discontinued operations | | $ | (27) | | $ | — | | $ | — | | $ | (27) |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | Contract | | Corporate | | Total | ||||
Three Months Ended June 30, 2019 | | Therapeutics | | Research | | and Other | | Company | ||||
Total revenue | | $ | — | | $ | 3,807 | | $ | (2,921) | | $ | 886 |
Cost of revenue | | | — | | | 3,819 | | | (2,825) | | | 994 |
Research and development | | | 17,615 | | | — | | | (96) | | | 17,519 |
General and administrative | | | 359 | | | 613 | | | 6,497 | | | 7,469 |
Goodwill impairment | | | 18,504 | | | — | | | — | | | 18,504 |
Loss from operations | | $ | (36,478) | | $ | (625) | | $ | (6,497) | | $ | (43,600) |
Loss from discontinued operations | | $ | (5,298) | | $ | — | | $ | (893) | | $ | (6,191) |
| | | | | | | | | | | | |
| | | | Contract | | Corporate | | Total | ||||
Six Months Ended June 30, 2020 | | Therapeutics | | Research | | and Other | | Company | ||||
Total revenue | | $ | 411 | | $ | 7,064 | | $ | (4,022) | | $ | 3,453 |
Cost of revenue | | | — | | | 6,468 | | | (3,810) | | | 2,658 |
Research and development | | | 16,121 | | | — | | | (212) | | | 15,909 |
General and administrative | | | — | | | 1,440 | | | 10,333 | | | 11,773 |
Loss from operations | | $ | (15,710) | | $ | (844) | | $ | (10,333) | | $ | (26,887) |
Loss from discontinued operations | | $ | (284) | | $ | — | | $ | (1) | | $ | (285) |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | Contract | | Corporate | | Total | ||||
Six Months Ended June 30, 2019 | | Therapeutics | | Research | | and Other | | Company | ||||
Total revenue | | $ | — | | $ | 8,995 | | $ | (6,846) | | $ | 2,149 |
Cost of revenue | | | — | | | 8,856 | | | (6,655) | | | 2,201 |
Research and development | | | 37,352 | | | — | | | (191) | | | 37,161 |
General and administrative | | | 477 | | | 1,145 | | | 13,304 | | | 14,926 |
Goodwill impairment | | | 18,504 | | | — | | | — | | | 18,504 |
Loss from operations | | $ | (56,333) | | $ | (1,006) | | $ | (13,304) | | $ | (70,643) |
Loss from discontinued operations | | $ | (14,720) | | $ | — | | $ | (1,763) | | $ | (16,483) |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dermatology |
| Contract |
| Corporate |
| Total | ||||
Three Months Ended June 30, 2019 |
| Therapeutics |
| Research |
| and Other |
| Company | ||||
Revenue, net |
| $ | 4,979 |
| $ | 3,807 |
| $ | (2,921) |
| $ | 5,865 |
Cost of revenue (excludes amortization) |
|
| 1,709 |
|
| 3,819 |
|
| (2,825) |
|
| 2,703 |
Research and development |
|
| 17,718 |
|
| — |
|
| (96) |
|
| 17,622 |
Sales and marketing |
|
| 7,164 |
|
| 13 |
|
| — |
|
| 7,177 |
General and administrative |
|
| — |
|
| 600 |
|
| 7,390 |
|
| 7,990 |
Goodwill impairment |
|
| 18,504 |
|
| — |
|
| — |
|
| 18,504 |
Amortization of definite-lived intangible |
|
| 1,660 |
|
| — |
|
| — |
|
| 1,660 |
Loss from operations |
| $ | (41,776) |
| $ | (625) |
| $ | (7,390) |
| $ | (49,791) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dermatology |
| Contract |
| Corporate |
| Total | ||||
Three Months Ended June 30, 2018 |
| Therapeutics |
| Research |
| and Other |
| Company | ||||
Revenue, net |
| $ | 2,533 |
| $ | 3,053 |
| $ | (1,910) |
| $ | 3,676 |
Cost of revenue |
|
| 152 |
|
| 2,621 |
|
| (1,592) |
|
| 1,181 |
Research and development |
|
| 13,984 |
|
| — |
|
| — |
|
| 13,984 |
Sales and marketing |
|
| 12,360 |
|
| 8 |
|
| — |
|
| 12,368 |
General and administrative |
|
| — |
|
| 521 |
|
| 7,600 |
|
| 8,121 |
Loss from operations |
| $ | (23,963) |
| $ | (97) |
| $ | (7,918) |
| $ | (31,978) |
|
|
|
|
|
|
|
|
|
|
|
|
|
25
|
| Dermatology |
| Contract |
| Corporate |
| Total | ||||
Six Months Ended June 30, 2019 |
| Therapeutics |
| Research |
| and Other |
| Company | ||||
Revenue, net |
| $ | 8,757 |
| $ | 8,995 |
| $ | (6,846) |
| $ | 10,906 |
Cost of revenue (excludes amortization) |
|
| 3,279 |
|
| 8,856 |
|
| (6,655) |
|
| 5,480 |
Research and development |
|
| 37,732 |
|
| — |
|
| (191) |
|
| 37,541 |
Sales and marketing |
|
| 16,976 |
|
| 32 |
|
| — |
|
| 17,008 |
General and administrative |
|
| — |
|
| 1,113 |
|
| 15,067 |
|
| 16,180 |
Goodwill impairment |
|
| 18,504 |
|
| — |
|
| — |
|
| 18,504 |
Amortization of definite-lived intangible |
|
| 3,319 |
|
| — |
|
| — |
|
| 3,319 |
Loss from operations |
| $ | (71,053) |
| $ | (1,006) |
| $ | (15,067) |
| $ | (87,126) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Dermatology |
| Contract |
| Corporate |
| Total | ||||
Six Months Ended June 30, 2018 |
| Therapeutics |
| Research |
| and Other |
| Company | ||||
Revenue, net |
| $ | 2,533 |
| $ | 5,554 |
| $ | (3,293) |
| $ | 4,794 |
Cost of revenue |
|
| 152 |
|
| 4,740 |
|
| (2,744) |
|
| 2,148 |
Research and development |
|
| 27,590 |
|
| — |
|
| — |
|
| 27,590 |
Sales and marketing |
|
| 23,581 |
|
| 20 |
|
| — |
|
| 23,601 |
General and administrative |
|
| — |
|
| 992 |
|
| 13,389 |
|
| 14,381 |
Loss from operations |
| $ | (48,790) |
| $ | (198) |
| $ | (13,938) |
| $ | (62,926) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Intersegment Revenue
Revenue for the contract research segment included $2,921$4,022 and $1,910$6,846 for services performed on behalf of the dermatology therapeutics segment for the three months ended June 30, 2019 and 2018, respectively, and $6,846 and $3,293 for the six months ended June 30, 20192020 and 2018,2019, respectively. All intersegment revenue has been eliminated in the Company’s condensed consolidated statement of operations.
16. Subsequent Events
Linda Rosi v. Aclaris Therapeutics, Inc. et al.
22
17. Legal Proceedings
Securities Class Action
On July 30, 2019, plaintiff Linda Rosi (the “Plaintiff”(“Rosi”) filed a purportedputative class action complaint captioned Rosi v. Aclaris Therapeutics, Inc., et al. in the U.S. District Court for the Southern District of New York against the Company and certain of its executive officers (the “Defendants”), alleging violations by the Defendants of certain federal securities laws. Plaintiffofficers. The complaint alleges that the Defendants made misleading statements to investors about the Company’s business, operations and prospects and faileddefendants violated federal securities laws by, among other things, failing to disclose an alleged likelihood that regulators would scrutinize advertising materials related to ESKATA and find that the materials minimized the risks or overstated the efficacy of the product. Plaintiff is seekingThe complaint seeks unspecified compensatory damages on behalf of herselfRosi and all other persons and entities that purchased or otherwise acquired the Company’s securities between May 8, 2018 and June 20, 2019. Defendants
On September 5, 2019, an additional plaintiff, Robert Fulcher (“Fulcher”), filed a substantially identical putative class action complaint captioned Fulcher v. Aclaris Therapeutics, Inc., et al. in the same court against the same defendants.
On November 6, 2019, the court consolidated the Rosi and Fulcher actions (together, the “Consolidated Securities Action”) and appointed Fulcher “lead plaintiff” for the putative class.
On January 24, 2020, Fulcher filed a consolidated amended complaint in the Consolidated Securities Action, naming 2 additional executive officers as defendants, extending the putative class period to August 12, 2019, and adding allegations concerning, among other things, alleged statements and omissions throughout the putative class period concerning ESKATA’s risks, tolerability and effectiveness. The defendants filed a motion to dismiss the consolidated amended complaint on April 17, 2020. Fulcher filed an opposition to the defendants’ motion on June 15, 2020, and the defendants filed a reply to such opposition on August 4, 2020. The motion remains under judicial consideration.
The Company and the other defendants dispute plaintiffs’ claims in the Plaintiff’s claimsConsolidated Securities Action and intend to defend the matter vigorously.
Stockholder Derivative Action
On November 15, 2019, plaintiff Keith Allred (“Allred”) filed a derivative stockholder complaint captioned Allred v. Walker et al. in the U.S. District Court for the Southern District of New York against certain of the Company’s directors and executive officers. The Company is unablecomplaint alleges that the defendants, among other things, breached their fiduciary duties as directors and/or officers in connection with the claims alleged in the Consolidated Securities Action. The complaint seeks, among other things, unspecified compensatory damages on behalf of the Company.
On November 25, 2019, an additional plaintiff, Bruce Brown (“Brown”), filed a substantially identical complaint captioned Brown v. Walker et al. in the same court against the same defendants.
On December 12, 2019, the court consolidated the Allred and Brown actions under the caption In re Aclaris Therapeutics, Inc. Derivative Litigation (the “Consolidated Derivative Action”) and directed that future derivative cases filed in or transferred to determine any potential liabilitythe court arising out of substantially the same transactions or financial exposure which mayevents be associated with thissimilarly consolidated. Thereafter, on January 11, 2020, the court stayed – subject to certain conditions – all deadlines in the Consolidated Derivative Action pending resolution of the defendants’ anticipated motion to dismiss the Consolidated Securities Action.
The defendants dispute plaintiffs’ claims in the Consolidated Derivative Action and intend to defend the matter at this time. vigorously.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q particularly in Part II – Item 1A, “Risk Factors,”and those in our Annual Report on Form 10-K, in Part I, Item 1A,each case under the caption “Risk Factors,” and in our other filings with the Securities and Exchange Commission, or SEC. Statements made herein are as of the date of the filing of this Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and related notes for the year ended December 31, 2018,2019, which are included in our Annual Report on Form 10-K filed with the SEC on March 18, 2019.February 25, 2020.
Overview
We are a physician-ledclinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory and dermatological diseases. We currently have two commercial products and a diverse pipeline of drug candidates. In August 2019, we announced that we are undertaking a strategic business review of our commercial and research and development portfolio of assets to determine how to optimally deploy capital and maximize shareholder return.
RHOFADE (oxymetazoline hydrochloride) cream, 1%, or RHOFADE, wascandidates focused on immuno-inflammatory diseases, as well as one product approved by the U.S. Food and Drug Administration, or FDA, in January 2017 forthat we are not currently distributing, marketing or selling, and other investigational drug candidates. In September 2019, we announced the topical treatmentcompletion of persistent facial erythema (redness) associated with rosacea in adults. Persistent facial redness is the most common signa strategic review of rosacea in most skin types. We acquired RHOFADE,our business, as a result of which includes an exclusive license to certain intellectual property for RHOFADE, as well as additional intellectual property, from Allergan Sales, LLC, or Allergan, in November 2018. We currently rely on Allergan to distribute RHOFADEwe refocused our resources on our behalf pursuantimmuno-inflammatory development programs. We are pursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to the terms of a transition services agreement.
Our other commercial product,further develop, obtain marketing approval for and/or commercialize our drug candidates and ESKATA (hydrogen peroxide) topical solution, 40% (w/w), or ESKATA, is a proprietary formulation of high-concentration hydrogen peroxide which was approved by the FDA in December 2017 as an office-based prescription treatment for raised seborrheic keratosis, or SK, a common non-malignant skin tumor. We launched ESKATA in the United States in May 2018. We have also received marketing authorizations for this product in select countries outside of the United States.In August 2019, we voluntarily discontinued the commercialization of ESKATA in the United States and withdrew the marketing authorizations we had previously received for the product in all countries outside of the United States. We continue to maintain the New Drug Application, or NDA, for ESKATA in the United States. We are currently seeking a strategic partner to commercialize ESKATA, both in the United States and worldwide (excluding Canada). We made this decision due to the fact that revenues from product sales were insufficient for us to sustain continued commercialization as a result of the product not achieving sufficient market acceptance by physicians and patients, and not for efficacy or safety reasons.
We are developing another high-concentration formulation of hydrogen peroxide, A-101 45% Topical Solution, as a potential prescription treatment for common warts, also known as verruca vulgaris. On an annual basis, approximately 2.0 million people in the United States are diagnosed with common warts. In our Phase 2 clinical trials, subjects treated
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with A-101 45% Topical Solution achieved clinically and statistically significant outcomes for the primary and secondary endpoints of each of the trials. Based on the results from our Phase 2 clinical trials and our end of Phase 2 meeting with the FDA, we are evaluating a twice-weekly dosing regimen in our two Phase 3 pivotal clinical trials, which we refer to as THWART-1 and THWART-2, of A-101 45% Topical Solution as a potential treatment for common warts, which we initiated in September 2018. We completed enrollment of more than 1,000 patients in these two trials. We expect to report data from both of these trials in the second half of 2019. In addition, in February 2019, we commenced an open-label safety extension trial investigating A-101 45% Topical Solution as a potential treatment for common warts, for which we completed enrollment of 425 patients in May 2019.
In 2015, we in-licensed exclusive, worldwide rights from Rigel Pharmaceuticals, Inc., or Rigel, to certain inhibitors of the Janus kinase, or JAK, family of enzymes, which we refer to as ATI-501 and ATI-502, an oral and topical formulation, respectively, for specified dermatological conditions, including alopecia areata, or AA, androgenetic alopecia, or AGA, also known as male or female pattern baldness, vitiligo and atopic dermatitis. The following summarizes the status of our Phase 2 clinical trials of ATI-501 and ATI-502:
AA-201 Topical – This Phase 2 randomized, double-blinded, parallel-group, vehicle-controlled trial evaluated the safety, efficacy and dose response of two concentrations of ATI-502 on the regrowth of hair in 129 patients with AA. In June 2019, we announced that ATI-502 did not achieve statistical superiority at the primary or secondary endpoints in this trial due to high rates of disease resolution in vehicle-treated patients. We currently intend to seek a strategic partner to further develop ATI-502 for this indication.
AGA-201 Topical – This ongoing Phase 2 open-label uncontrolled clinical trial is evaluating the safety and efficacy of ATI-502 on the regrowth of hair in 31 patients with AGA. 6-month data were reported in June 2019 and 12-month data are expected in the fourth quarter of 2019. If the 12-month data from this trial are positive, we currently intend to seek a strategic partner to further develop ATI-502 for this indication.
VITI-201 Topical – This ongoing Phase 2 open-label uncontrolled clinical trial is evaluating the safety and efficacy of ATI-502 on the repigmentation of facial skin in 34 patients with vitiligo. Although an interim analysis at 6 months demonstrated evidence of repigmentation in some patients, the response rate has been slow and not sufficient to be clinically meaningful. ATI-502 has been observed to be generally well-tolerated and no treatment-related serious adverse events, or SAEs, have been reported to date. Based on this interim analysis, we have decided to discontinue the further development of ATI-502 for this indication.
AD-201 Topical – This Phase 2 open-label uncontrolled clinical trial evaluated the safety and efficacy of ATI-502 in 22 adult subjects with moderate-to-severe atopic dermatitis (i.e., subjects who had a Physician’s Global Assessment, or PGA, score of 3 or 4 on a 5 point scale). The primary objective was the assessment of safety and tolerability of ATI-502. In this trial, ATI-502 was observed to be generally well-tolerated and no treatment-related SAEs were reported. 7 of the 17 evaluable subjects, or 41%, met the secondary endpoint of achieving a PGA score of less than or equal to 1, with at least a two point change in the PGA score.
AUAT-201 Oral–This Phase 2 randomized, double-blinded, parallel-group, placebo-controlled trial evaluated the safety, efficacy and dose response of three doses of ATI-501 on the regrowth of hair in 87 subjects with AA. In July 2019, we announced that ATI-501 achieved statistically significant improvement over placebo in several measures of hair growth, including the primary endpoint and certain secondary endpoints of this trial. ATI-501 was observed to be generally well-tolerated at all doses. There were no SAEs reported. All adverse events, or AEs, were mild or moderate in severity and rates of AEs were similar across all groups. No thromboembolic events were observed in the trial. The most common AEs across all groups were: nasopharyngitis, influenza, upper respiratory tract infection, urinary tract infection, acne, increased blood creatine phosphokinase, and sinusitis. Two subjects in each of the placebo and 400 mg groups and one subject in the 600 mg group had AEs leading to discontinuation of study drug, with no such AEs in the 800 mg group. We currently intend to seek a strategic partner to further develop ATI-501 for this indication.
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In 2016, in connection with our acquisition of Vixen Pharmaceuticals, Inc., or Vixen, we acquired additional intellectual property rights for the development and commercialization of certain JAK inhibitors for specified dermatological conditions.
In 2017, we acquired Confluence Life Sciences, Inc. (now known as Aclaris Life Sciences, Inc.), or Confluence. The acquisition of Confluence added small molecule drug discovery and preclinical development capabilities that allowed us to bring early-stage research and development activities in-house that we previously outsourced to third parties. We intend to leverage our proprietary drug discovery platform, called KINect, to identify potential drug candidates that we may develop either independently or in collaboration with third parties. We also earn revenue from Confluence’s provision of contract research services to third parties. We also acquired several preclinical drug candidates, including additional topical JAK inhibitors known as soft-JAK inhibitors, inhibitors of the mitogen-activated protein kinase-activated protein kinase 2, or MK2, signaling pathway and inhibitors of interleukin-2-inducible T cell kinase, or ITK.
non-marketed FDA-approved product.
We submitted an Investigational New Drug Application, or IND, in April 2019 for ATI-450, an investigational compound and oral, novel, small molecule selective mitogen-activated protein kinase-activated protein kinase 2, orMK2, inhibitor compound, for the treatment of rheumatoid arthritis, which was allowed by the FDA in May 2019. MK2 is a key regulator of pro-inflammatory mediators including TNFα, IL-1βIL1β, IL-6, IL-8IL6, IL8 and other essential pathogenic signals in chronic inflammatory and autoimmuneimmuno-inflammatory diseases, as well as in cancer. As an oral drug candidate, we are developing ATI-450 is being developed as a potential alternative to injectable anti-TNF/anti-IL-1IL1/IL6 biologics for treating certain immuno-inflammatory diseases.
We initiated a Phase 1 single and multiple ascending dose clinical trial for ATI-450 in approximately 60 patients77 healthy subjects in August 2019. If we successfully completeFinal data from this trial demonstrated that ATI-450 resulted in marked inhibition of TNFα, IL1β, IL8 and IL6. We also observed that ATI-450 had dose-proportional pharmacokinetics with a terminal half-life of 9-12 hours in the multiple ascending dose cohort, and had no meaningful food effect or drug-drug interaction with methotrexate. ATI-450 was generally well-tolerated at all doses tested in the trial. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, abdominal pain, and nausea.
Following the completion of the Phase 1 clinical trial, in March 2020 we expectinitiated a Phase 2a clinical trial to advanceinvestigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-450 into twoin subjects with moderate to severe rheumatoid arthritis. Due to the COVID-19 pandemic, we temporarily paused enrollment. We resumed enrolling subjects, and the first subject was dosed, in May 2020. At this time, we are actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, we now anticipate reporting data from this trial in the first half of 2021.
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We are also planning to initiate a Phase 22a clinical trials: onetrial of ATI-450 in patients with rheumatoid arthritis and one in an additional inflammatory indication, which may include psoriasis, hidradenitis suppurativa, cryopyrin associatedcryopyrin-associated periodic syndrome (CAPS), or pyoderma gangrenosum. an Ilβ-driven disease, in the second half of 2020.
We are also supporting an investigator-initiated Phase 2a, randomized, double-blind, placebo-controlled clinical trial to investigate the safety and efficacy of ATI-450, when used in addition to standard of care therapy, as a potential treatment for cytokine release syndrome in 36 hospitalized patients with COVID-19. The primary endpoint in this trial is the proportion of subjects who are free from respiratory failure by day 14. We are providing funding and clinical drug supply to the University of Kansas Medical Center, the sponsor of the trial. The first subject was dosed in August 2020.
We expect to submitsubmitted an IND to the FDAin June 2020 for ATI-1777, an investigational topical “soft” Janus kinase, or JAK, 1/3 inhibitor compound, and soft-JAK inhibitor, for the treatment of moderate to severe atopic dermatitis, byand now plan to progress to the endfirst-in-human trial of the first half of 2020. Soft-JAKATI-1777 in subjects with moderate to severe atopic dermatitis. “Soft” JAK inhibitors are designed to be topically applied and active in the skin, but rapidly metabolized and inactivated when they enter the bloodstream, which may result in low systemic exposure. If the IND is allowed by the FDA, weWe expect to initiate a Phase 1/2 clinical2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics and efficacy of topically applied ATI-1777 in subjects with moderate to severe atopic dermatitis in the second half of 2020. We are considering developing ATI-1777 as a potential treatment for moderate-to-severe atopic dermatitis.The primary endpoint will assess efficacy at four weeks.
We are considering developing our ITK inhibitorsATI-2138, an investigational oral ITK/TXK/JAK3, or ITJ, inhibitor compound, as a potential treatment for psoriasis inflammatory dermatoses, and/or inflammatory bowel disease.disease, which are both T-cell mediated autoimmune diseases. The ITJ compound interrupts T cell signaling through the combined inhibition of ITK/TXK/JAK3 pathways in lymphocytes. We expect to file an IND for ATI-2138 in 2021.
We are pursuing strategic alternatives, including seeking a partner, to further develop, obtain regulatory approval and/or commercialize, as applicable, our drug candidate A-101 45% Topical Solution as a potential treatment for common warts, as well as ATI-501 and ATI-502, our other JAK inhibitor candidates, as potential treatments for alopecia, and ESKATA, our non-marketed FDA-approved product.
Since our inception, we have incurred significant operating losses. Our net loss was $87.4$27.2 million for the six months ended June 30, 20192020 and $132.7$161.4 million for the year ended December 31, 2018.2019. As of June 30, 2019,2020, we had an accumulated deficit of $379.6$480.7 million. We expect to incur significant expenses and operating losses related to product manufacturing, marketing, sales and distribution in the near term as we continue to commercialize our marketed product(s). In addition, our marketed product(s), and our drug candidates if approved, may not achieve commercial success. We also expect to incur significant expenses and operating losses for the foreseeable future as we advance our drug candidates from discovery through preclinical development and clinical trials.development. In addition, our drug candidates, even if wethey are approved by regulatory agencies for marketing, may not achieve commercial success. We may also not be successful in pursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for any ofand/or commercialize our drug candidates we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.or ESKATA. Furthermore, we have incurred and expect to continue to incur significant costs associated with operating as a public company, including legal, accounting, investor relations and other expenses. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.operations.
We have historically financed our operations primarily with sales of our convertible preferred stock, as well as net proceedsequity securities and incurring indebtedness in the form of loans from our initial public offering, or IPO, in October 2015, and subsequent public offerings of, and a private placement of, our common stock. Until such time as we can generate significant revenue from product sales, if ever,commercial lenders. In the near term, we expect to finance our operations through the sale of equity, debt financings orthese and other capital sources, including potential collaborationspartnerships with other companies or other strategic transactions. We may be unable to raise additional funds or enter
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into such other agreements or arrangements when needed on commercially acceptable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and/or commercialization of one or more of our marketed product(s) or drug candidates.
Impact of COVID-19 on Our Business
The global outbreak of COVID-19 continues to rapidly evolve. We have implemented a virtual operations strategy, including telecommuting and other alternative work arrangements for our employees, intended to protect the health and safety of our employees while enabling us to continue to develop our pipeline of drug candidates and provide contract research services to our clients. We are focused on ensuring the continuity of our operations. In March 2020, we
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initiated a Phase 2a clinical trial of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis. Due to the COVID-19 pandemic, we temporarily paused enrollment. We resumed enrolling subjects, and the first subject was dosed, in May 2020. At this time, we are actively recruiting for this trial. Given the continuing evolution of the COVID-19 pandemic, we now anticipate reporting data from this trial in the first half of 2021.
If COVID-19 continues to spread, we may experience additional disruptions that could severely impact our business, results of operations and prospects, including the timing of our clinical trials and development programs. The extent to which the COVID-19 pandemic impacts our business, our preclinical and clinical development and our regulatory efforts will depend on future developments that are highly uncertain and cannot be predicted, such as the geographic spread of the disease, the duration of the outbreak, travel restrictions, quarantines, stay-at-home orders, social distancing requirements, business closures and supply chain and other disruptions in the United States and other countries, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. Accordingly, we do not yet know the full extent of the potential impacts on our business, our preclinical and clinical development and regulatory activities.
Components of Our Results of Operations
Revenue
Product Sales, net
We began commercializing RHOFADE in the United States in December 2018. We currently rely on Allergan to distribute RHOFADE on our behalf pursuant to the terms of a transition services agreement. We sell RHOFADE to wholesalers in the United States, which, in turn, distribute it to pharmacies that will ultimately fill patient prescriptions. We may also enter into arrangements with health care providers, pharmacy benefit managers, third-party payors, and/or group purchasing organizations, or GPOs, which provide for government mandated or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of RHOFADE. We have no sales of RHOFADE in countries outside of the United States.
We discontinued sales of ESKATA in the United Stated in August 2019. During the six months ended June 30, 2019 and 2018, we sold ESKATA to one wholesaler, McKesson Specialty Care Distribution, or McKesson, which in turn resold ESKATA to health care providers. We also entered into agreements with two GPOs that provided for administrative fees and discounted pricing in the form of volume-based rebates and chargebacks. We have never sold ESKATA outside of the United States.
Contract Research
We earn revenue from the provision of laboratory services to clients through Confluence Life Sciences, Inc. (now known as Aclaris Life Sciences, Inc.), or Confluence, our wholly-owned subsidiary. Contract research revenue is generally evidenced by contracts with clients which are on an agreed upon fixed-price, fee-for-service basis and are generally billed on a monthly basis in arrears for services rendered.
We have also received revenue from grants under the Small Business Innovation Research program of the National Institutes of Health, or NIH. During the six months ended June 30, 2018, we had two active grants from NIH which were related to early-stage research. There are no remaining funds available to us under the grants.
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Cost of Revenue
Cost of revenue consists of the cost of manufacturing the finished product forms of ESKATA and RHOFADE, as well as costs incurred in connection with the provision of contract research services to our clients through Confluence. Cost of revenue primarily includes:
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| employee-related expenses, which include salaries, benefits and stock-based compensation; |
| outsourced professional scientific services; |
| depreciation of laboratory equipment; |
| facility-related costs; and |
| laboratory materials and supplies used to support the services provided. |
Research and Development Expenses
Research and development expenses consist of expenses incurred in connection with the discovery and development of our drug candidates. These expenses primarily include:
| expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our clinical trials and preclinical studies; |
| manufacturing scale-up expenses and the cost of acquiring and manufacturing active pharmaceutical ingredients and preclinical and clinical trial |
| outsourced professional scientific development services; |
| medical affairs expenses related to our drug candidates, including investigator-initiated studies; |
| employee-related expenses, which include salaries, benefits and stock-based compensation; |
| depreciation of manufacturing equipment; |
| payments made under agreements with third parties under which we have acquired or licensed intellectual property; |
| expenses relating to regulatory activities, including filing fees paid to regulatory agencies; |
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| laboratory materials and supplies used to support our research |
| ● | non-cash charges related to the revaluation of contingent consideration. |
Research and development activities are central to our business model. Drug candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect to continue to incur research and development expenses in the near term as we continue the clinical development of A-101 45% Topical Solution as a potential treatment
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for common warts and ATI-450 as a potential treatment for rheumatoid arthritis and other inflammatory conditions,immuno-inflammatory diseases and ATI-1777 as a potential treatment for moderate to severe atopic dermatitis, continue the development of our preclinical compounds, and continue to identify, research and develop additional drug candidates. We expense research and development costs as incurred. Our direct research and development expenses primarily consist of external costs including fees paid to CROs, consultants, investigator sites, regulatory agencies and third parties that manufacture our preclinical and clinical trial materials, and are tracked on a program-by-program basis. We do not allocate personnel costs, facilities or other indirect expenses, to specific research and development programs.
The successful development of our drug candidates is highly uncertain. At this time, weWe cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from any of our drug candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials, which vary significantly over the life of a project as a result of many factors, including:
| the number of clinical sites included in the trials; |
| the length of time required to enroll suitable subjects; |
| the number of subjects that ultimately participate in the trials; |
| the number of doses subjects receive; |
| the impact on the timing of our clinical trials due to the COVID-19 pandemic; |
● | the duration of subject follow-up; and |
| the results of our clinical trials. |
Our expenditures are subject to additional uncertainties, including the terms and timingpreparation of marketing approvals,regulatory filings for our drug candidates, and the expense of filing, prosecuting, defending and enforcing any patent claims or other intellectual property rights. We may never succeed in achieving marketing approval for any of our drug candidates. We may obtain unexpected results from our clinical trials.trials or other development activities. We may elect to discontinue, delay or modify the development, including clinical trials, of some drug candidates or focus on others. A change in the outcome of any of these variables with respect to the development of a drug candidate could mean a significant change in the costs and timing associated with the development of that drug candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
Sales and Marketing Expenses
Sales and marketing expenses include salaries and related costs for our field sales force, as well as personnel in our marketing and sales operations functions, including stock-based compensation, travel expenses, expenses related to leasing a fleet of vehicles for our field-based sales force, and recruiting expenses. Sales and marketing expenses also include costs of content development, advertising, sponsorships and attendance at dermatology conferences, and costs incurred under the transition services agreement with Allergan.
We anticipate continuing to incur sales and marketing expenses in the near term as we commercialize our marketed product(s) in the United States.
General and Administrative Expenses
General and administrative expenses consist principally of salaries and related costs for personnel in executive, administrative, finance, investor relations and legal functions, including stock-based compensation travel expenses and recruitingtravel expenses. General and administrative expenses also include facility-related costs, patent filing and prosecution costs, professional fees for legal, auditing and tax services, and insurance costs, costs incurred under the transition services agreement with Allergan, medical affairs activity related to marketed products, as well as payments made under a terminated related party sublease agreement and milestone payments under our finder’s services agreement.costs. We anticipate that our general and administrative expenseswe will continue to increase as a result ofincur increased personnel costs, including
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stock-based compensation, expanded infrastructure and higher consulting, legal and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements, accounting and investor relations costs, and director and officer insurance premiums and legal expenses associated with being a public company.defending the current lawsuits described in this report.
Other Income (Expense), Net
Other income (expense), net primarily consists of interest earned on our cash, cash equivalents and marketable securities, interest expense related to our debt obligations and finance leases, and gains and losses on transactions denominated in foreign currencies.
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Critical Accounting Policies and Significant Judgments and Estimates
This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and judgments on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions. Except as described below, we believe there have been no material changes to our significant accounting policies and use of estimates as disclosed in the footnotes to our audited consolidated financial statements for the year ended December 31, 20182019 included in our Annual Report on Form 10-K filed with the SEC on March 18, 2019.February 25, 2020.
Revenue Recognition
We account for revenue in accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers. Under ASC Topic 606, revenue is recognized when a customer obtains control of promised goods or services in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services.
To determine revenue recognition in accordance with ASC Topic 606, we perform the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) performance obligations are satisfied. We recognize revenue when collection of the consideration we are entitled to under a contract with a customer is probable. At contract inception, we assess the goods or services promised within a contract with a customer to identify the performance obligations, and to determine if they are distinct. We recognize revenue that is allocated to each distinct performance obligation when (or as) that performance obligation is satisfied.
Product Sales, net
We recognize revenue from product sales at the point the customer obtains control, which generally occurs upon delivery, and also include estimates of variable consideration in the same period revenue is recognized. Components of variable consideration include trade discounts and allowances, product returns, government rebates, discounts and rebates, other incentives such as patient co-pay assistance, and other fee for service amounts. Variable consideration is recorded on the condensed consolidated balance sheet as either a reduction of accounts receivable, if payable to a customer, or as a current liability, if payable to a third party other than a customer. We consider all relevant information when estimating variable consideration such as current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount of net revenue we can recognize is constrained by estimates of variable consideration which are included in the transaction price. Payment terms with
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customers do not exceed one year and, therefore, we do not account for a financing component in our arrangements. We expense incremental costs of obtaining a contract with a customer, including sales commissions, when incurred as the period of benefit is less than one year. Shipping and handling costs for product shipments to customers are recorded as sales and marketing expenses in the condensed consolidated statement of operations.
Trade Discounts and Allowances - We may provide customers with trade discounts, rebates, allowances or other incentives. We record an estimate for these items as a reduction of revenue in the same period the revenue is recognized.
Government and Payor Rebates – We have contracted and may continue to contract with certain third-party payors, primarily health insurance companies, pharmacy benefit managers and/or government programs, for the payment of rebates with respect to utilization of our products. We also have agreements with GPOs that provide for administrative fees and discounted pricing in the form of volume-based rebates. We are also subject to discount obligations under state Medicaid programs and Medicare. We record an estimate for these rebates as a reduction of revenue in the same period the revenue is recognized.
Other Incentives - Other incentives includes our co-pay assistance program which is intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. We estimate and record an accrual for these incentives as a reduction of revenue in the period the revenue is recognized. Our estimated amounts for co-pay assistance are based upon the number of claims and the cost per claim that we expect to receive associated with product that has been sold to customers but remains in the distribution channel at the end of each reporting period.
Product Returns - Consistent with industry practice, we have a product returns policy which may provide customers a right of return for product purchased within a specified period prior to and subsequent to the product’s expiration date. The right of return lapses upon shipment of the goods to a patient. We record an estimate for the amount of product which may be returned as a reduction of revenue in the period the related revenue is recognized. Our estimates for product returns are based upon available industry data and our own sales information, including visibility into the inventory remaining in the distribution channel. There is no returns liability associated with sales of ESKATA as we have a no returns policy for ESKATA.
Contract Research
Revenue related to laboratory services is generally recognized as the laboratory services are performed, based upon the rates specified in the contracts. Under ASC Topic 606, we elected to apply the “right to invoice” practical expedient when recognizing contract research revenue. We recognize contract research revenue in the amount to which we have the right to invoice.
We recognize revenue related to grants as amounts become reimbursable under each grant, which is generally when research is performed, and the related costs are incurred.
Inventory
Inventory includes the third-party cost of manufacturing and assembly of the finished product forms of ESKATA and RHOFADE, quality control and other overhead costs. Inventory is stated at the lower of cost or net realizable value. Inventory is adjusted for short-dated, unmarketable inventory equal to the difference between the cost of inventory and the estimated value based upon assumptions about future demand and market conditions. Our inventory is comprised primarily of finished goods.
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Intangible Assets
Our intangible assets include both finite-liveddefinite-lived and indefinite-lived assets. Finite-livedDefinite-lived intangible assets are amortized over their estimated useful life based on the pattern over which the intangible assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the straight-line method of amortization is used. Our finite-liveddefinite-lived intangible assets consist of a research technology platform acquired through the acquisition of Confluence and the intellectual property rights related to RHOFADE.Confluence. Our indefinite-lived intangible assets consist of an in-process research and development, or IPR&D, drug candidate also acquired through the acquisition of Confluence. IPR&D assets are considered indefinite-lived until the completion or abandonment of the associated research and development efforts. The cost of IPR&D assets is either amortized over their estimated useful life beginning when the underlying drug candidate is approved and launched commercially, or expensed immediately if development of the drug candidate is abandoned.
Finite-livedDefinite-lived intangible assets are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Indefinite-lived intangible assets are tested for impairment at least
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annually, which we perform during the fourth quarter, or when indicators of an impairment are present. We recognize an impairment losslosses when and to the extent that the estimated fair value of an indefinite-lived intangible asset is less than its carrying value.
Goodwill
Leases
Goodwill is not amortized, but rather is subject to testing for impairment at least annually, which we perform during the fourth quarter, or when indicators of an impairment are present. We consider each of our operating segments, dermatology therapeutics and contract research, to be a reporting unit since this is the lowest level for which discrete financial information is available. We attributed the full amount of the goodwill in connection with the acquisition of Confluence, or $18.5 million, to our dermatology therapeutics segment. We perform an impairment test annually which is a qualitative assessment based upon current facts and circumstances related to operations of the dermatology therapeutics segment. If our qualitative assessment indicates an impairment may be present, we would perform the required quantitative analysis and an impairment charge would be recognized to the extent that the estimated fair value of the reporting unit is less than its carrying amount. However, any loss recognized would not exceed the total amount of goodwill allocated to that reporting unit.
During the three months ended June 30, 2019, we performed an interim impairment analysis due to the decline in our stock price, which was considered a triggering event to evaluate goodwill for impairment. Our impairment analysis, using a market approach, noted that our stock price, including a reasonable control premium, resulted in a fair value for the dermatology therapeutics reporting unit which was less than its carrying value. As a result, we recorded an impairment charge of $18.5 million, the full balance of goodwill, in the three months ended June 30, 2019.
Leases
Leases represent a company’s right to use an underlying asset and a corresponding obligation to make payments to a lessor for the right to use those assets. We evaluate leases at their inception to determine if they are an operating lease or a finance lease. A lease is accounted for as a finance lease if it meets one of the following five criteria: the lease has a purchase option that is reasonably certain of being exercised, the present value of the future cash flows are substantially all of the fair market value of the underlying asset, the lease term is for a significant portion of the remaining economic life of the underlying asset, the title to the underlying asset transfers at the end of the lease term, or if the underlying asset is of such a specialized nature that it is expected to have no alternative uses to the lessor at the end of the term. Leases that do not meet the finance lease criteria are accounted for as an operating lease.
We recognize assets and liabilities for leases at their inception based upon the present value of all payments due under the lease. We use an implicit interest rate to determine the present value of finance leases, and our incremental borrowing rate to determine the present value of operating leases. We determine incremental borrowing rates by
35
referencing collateralized borrowing rates for debt instruments with terms similar to the respective lease. We recognize expense for operating and finance leases on a straight-line basis over the term of each lease, and interest expense related to finance leases is recognized over the lease term based on the effective interest method. We include estimates for any residual value guarantee obligations under our leases in lease liabilities recorded on our condensed consolidated balance sheet.
Right-of-use assets are included in other assets and property and equipment, net on our condensed consolidated balance sheet for operating and finance leases, respectively. Obligations for lease payments are included in current portion of lease liabilities and other liabilities on our condensed consolidated balance sheet for both operating and finance leases.
Contingent Consideration
We initially recorded thea contingent consideration liability related to future potential payments based upon the achievement of specifiedcertain development, regulatory and commercial milestones, as well as future projected sales performance, resulting from the acquisition of Confluence, at its estimated fair value on the date of acquisition. ChangesThe ultimate amount of future payments, if any, is based on criteria such as sales performance and the achievement of certain regulatory and sales milestones. We estimate the fair value of the contingent consideration liability related to the achievement of regulatory milestones by assigning an achievement probability to each potential milestone and discounting the associated cash payment to its present value using a risk-adjusted rate of return. We estimate the fair value of the contingent consideration liability associated with sales milestones and royalties by estimating future sales levels, assigning an achievement probability and discounting the associated cash payment amounts to their present values using a credit-risk-adjusted interest rate. Significant assumptions used in our estimates include the probability of success of achieving regulatory and sales milestones, which are based upon an asset’s current stage of development and ranged between 4% and 15%. We evaluate fair value estimates of contingent consideration liabilities on a periodic basis. Any change in fair value reflectreflects new information about the likelihood of the payment of the contingent consideration and the passage of time. For example, if the timing of the development of an acquired drug candidate, or the size of potential commercial opportunities related to an acquired drug, differ from our assumptions, then the fair value of contingent consideration would be adjusted accordingly. Future changes in the fair value of the contingent consideration, if any, will be recorded as income or expense in our condensed consolidated statement of operations.
During the six months ended June 30, 2019, we updated our assumptions for contingent consideration related to the acquisition of Confluence as a result of the filing of an IND for ATI-450, which resulted in a charge of $0.7 million.
Recently Issued Accounting Pronouncements
In November 2018, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction Between Topic 808 and Topic 606,
29
which, among other things, provides guidance on how to assess whether certain collaborative arrangement transactions should be accounted for under Topic 606. The amendments in this ASU are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted.2019. We are evaluatingadopted this standard as of January 1, 2020, the impact of ASU 2018-18which on our consolidated financial statements.statements was not significant.
In August 2018, the FASB issued ASU 2018-15, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40). ASU 2018-15 requires a customer in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in Accounting Standards Codification, or ASC, 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. The standard will beis effective for fiscal years beginning after December 15, 2019, including interim periods within such fiscal years, with early adoption permitted.years. We are evaluatingadopted this standard as of January 1, 2020, the impact of ASU 2018-15which on our consolidated financial statements.statements was not significant.
In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820). The FASB developed the amendments to ASC 820 as part of its broader disclosure framework project, which aims to improve the effectiveness of disclosures in the notes to financial statements by focusing on requirements that clearly communicate the most important information to users of the financial statements. This update eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some of the existing disclosure requirements. The standard will beis effective for fiscal years beginning after December 15, 2019, including interim periods within such fiscal years, with early adoption permitted. We are evaluating the impact of ASU 2018-13 on our consolidated financial statements.
In June 2018, the FASB, issued ASU 2018-07, Compensation-Stock Compensation (Topic 718). The amendments in this ASU expand the scope of Topic 718 to include stock-based compensation arrangements with non-employees except for specific guidance on option pricing model inputs and cost attribution. ASU 2018-07 was effective
36
for annual reporting periods beginning after December 31, 2018, including interim periods within that year.years. We adopted this standard as of January 1, 2019,2020, the impact of which on our consolidated financial statements was not significant.
In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). In July 2018, the FASB issued ASU 2018-10, Codification Improvements to Topic 842, Leases, and ASU 2018-11, Targeted Improvements, both of which included a number of technical corrections and improvements, including additional options for transition. The new standard establishes a right-of-use model that requires a lessee to record a right-of-use asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, including interim periods within those annual periods. The amendments in ASU 2016-02 must be applied to all leases existing at the date a company initially applies the standard.
We adopted the new standard on January 1, 2019, using the effective date as the date of initial application, and we used the modified retrospective approach. In addition, we elected the practical expedients permitted under the transition guidance within the new standard, which, among other things, allowed us to carry forward the historical lease identification and classification. We also elected the practical expedient to not separate lease and non-lease components, as well as the short-term lease exemption which allowed us to not capitalize leases with terms less than 12 months that do not contain a reasonably certain purchase option. Our consolidated financial statements have not been updated, and disclosures required by the new standard have not been provided, for periods before January 1, 2019.
The adoption of ASU 2016-02 resulted in recording additional assets and liabilities of $2,132 and $2,317, respectively upon adoption on January 1, 2019. The adoption of ASU 2016-02 did not have a material impact on our consolidated statement of operations or cash flows.
3730
Results of Operations
Comparison of Three Months Ended June 30, 20192020 and 20182019
| | | | | | | | | | | ||||||||||
| | Three Months Ended June 30, | | | |
| ||||||||||||||
|
| 2020 |
| 2019 |
| Change |
| |||||||||||||
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
| Three Months Ended June 30, |
|
|
|
| ||||||||||||||
|
| 2019 |
| 2018 |
| Change |
| |||||||||||||
|
| (In thousands) |
| |||||||||||||||||
| | (In thousands) |
| |||||||||||||||||
Revenues: |
|
|
|
|
|
|
|
|
|
| | | | | | | | | | |
Product sales, net |
| $ | 4,979 |
| $ | 1,533 |
| $ | 3,446 |
| ||||||||||
Contract research |
|
| 886 |
|
| 1,143 |
|
| (257) |
| | $ | 1,853 | | $ | 886 | | $ | 967 | |
Other revenue |
|
| — |
|
| 1,000 |
|
| (1,000) |
| | | 193 | | | — | | | 193 | |
Total revenue, net |
|
| 5,865 |
|
| 3,676 |
|
| 2,189 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
| ||||||||||
Total revenue | | | 2,046 | | | 886 | | | 1,160 | | ||||||||||
| | | | | | | | | | | ||||||||||
Costs and expenses: |
|
|
|
|
|
|
|
|
|
| | | | | | | | | | |
Cost of revenue (excludes amortization) |
|
| 2,703 |
|
| 1,181 |
|
| 1,522 |
| ||||||||||
Cost of revenue | | | 1,389 | | | 994 | | | 395 | | ||||||||||
Research and development |
|
| 17,622 |
|
| 13,984 |
|
| 3,638 |
| |
| 6,466 | |
| 17,519 | |
| (11,053) | |
Sales and marketing |
|
| 7,177 |
|
| 12,368 |
|
| (5,191) |
| ||||||||||
General and administrative |
|
| 7,990 |
|
| 8,121 |
|
| (131) |
| |
| 5,572 | |
| 7,469 | |
| (1,897) | |
Goodwill impairment |
|
| 18,504 |
|
| — |
|
| 18,504 |
| | | — | | | 18,504 | | | (18,504) | |
Amortization of definite-lived intangible |
|
| 1,660 |
|
| — |
|
| 1,660 |
| ||||||||||
Total costs and expenses |
|
| 55,656 |
|
| 35,654 |
|
| 20,002 |
| |
| 13,427 | |
| 44,486 | |
| (31,059) | |
Loss from operations |
|
| (49,791) |
|
| (31,978) |
|
| (17,813) |
| |
| (11,381) | |
| (43,600) | |
| 32,219 | |
|
|
|
|
|
|
|
|
|
|
| ||||||||||
| | | | | | | | | | | ||||||||||
Other income (expense), net |
|
| (85) |
|
| 760 |
|
| (845) |
| |
| (189) | |
| (85) | |
| (104) | |
Loss from continuing operations | | | (11,570) | | | (43,685) | | | 32,115 | | ||||||||||
Loss from discontinued operations | | | (27) | | | (6,191) | | | 6,164 | | ||||||||||
Net loss |
| $ | (49,876) |
| $ | (31,218) |
| $ | (18,658) |
| | $ | (11,597) | | $ | (49,876) | | $ | 38,279 | |
Revenue
RevenueContract research revenue was $5.9$1.9 million and $0.9 million for the three months ended June 30, 2019, compared to $3.7 million for the three months ended June 30, 2018. Product sales, net included $4.7 million2020 and $0.3 million from sales of RHOFADE and ESKATA, respectively, during the three months ended June 30, 2019. Product sales, net included $1.5 million from sales of ESKATA during the three months ended June 30, 2018. We acquired RHOFADE in November 2018. Contract research revenue was $0.9 million and $1.1 million for the three months ended June 30, 2019, and 2018, respectively, and was comprised primarily of fees earned from the provision of laboratory services to clients through Confluence. Other revenue consisted of an up-front payment$0.2 million of $1.0 million we received upon signingroyalties earned on net sales of a licenseRHOFADE (oxymetazoline hydrochloride) cream, 1%, or RHOFADE, pursuant to the asset purchase agreement with Cipher in April 2018.EPI Health, LLC, or EPI Health.
Cost of Revenue
Cost of revenue was $2.7$1.4 million and $1.0 million for the three months ended June 30, 2020 and 2019, included $1.0 millionrespectively, and $0.7 million of costs related to RHOFADE and ESKATA product sales, net, respectively, of which $0.7 million represented royalties on sales of RHOFADE, and $0.4 million related to a non-cash charge for the write-down of ESKATA finished inventory. We also incurred $1.0 million of costs related to providing laboratory services to our clients through Confluence. Cost of revenue was $1.2 million for the three months ended June 30, 2018 and was comprised of $0.2 million of costs related to ESKATA product sales, net, and $1.0 million of costs incurred to provide laboratory services to our clients through Confluence.
3831
Research and Development Expenses
The following table summarizes our research and development expenses:
| | | | | | | | | ||||||||||
| | Three Months Ended | | | | |||||||||||||
| | June 30, | | | | |||||||||||||
| | 2020 |
| 2019 | | Change | ||||||||||||
|
|
|
|
|
|
|
|
| ||||||||||
|
| Three Months Ended |
|
|
| |||||||||||||
|
| June 30, |
|
|
| |||||||||||||
|
| 2019 |
| 2018 |
| Change | ||||||||||||
|
| (In thousands) | ||||||||||||||||
| | (In thousands) | ||||||||||||||||
ATI-450 |
| $ | 740 |
| $ | 1,184 |
| $ | (444) | |||||||||
ATI-1777 | | | 1,102 | | 653 | | | 449 | ||||||||||
ATI-2138 | | | 1,102 | | 781 | | | 321 | ||||||||||
Other JAK inhibitors | | | 186 | | 4,765 | | | (4,579) | ||||||||||
A-101 45% Topical Solution |
| $ | 4,403 |
| $ | 507 |
| $ | 3,896 | | | 52 | | 4,403 | | | (4,351) | |
JAK inhibitors |
|
| 5,418 |
| 6,434 |
|
| (1,016) | ||||||||||
MK2 inhibitors |
|
| 1,184 |
| 798 |
|
| 386 | ||||||||||
ESKATA |
|
| 102 |
| 563 |
|
| (461) | ||||||||||
Other research and development expenses | | | 601 | | 686 | | | (85) | ||||||||||
Personnel expenses |
|
| 2,363 |
| 2,378 |
|
| (15) | | | 1,744 | | 2,592 | | | (848) | ||
Stock-based compensation | | | 939 | | 1,721 | | | (782) | ||||||||||
Change in contingent consideration |
|
| 734 |
| — |
|
| 734 | | | — | | | 734 | | | (734) | |
Other research and development expenses |
|
| 1,697 |
| 1,548 |
|
| 149 | ||||||||||
Stock-based compensation |
|
| 1,721 |
|
| 1,756 |
|
| (35) | |||||||||
Total research and development expenses |
| $ | 17,622 |
| $ | 13,984 |
| $ | 3,638 | | $ | 6,466 | | $ | 17,519 | | $ | (11,053) |
Research and development expenses for ATI-450 primarily consisted of preclinical development activities during the three months ended June 30, 2019 and initial activities for a Phase 2a clinical trial during the three months ended June 30, 2020. Expenses for ATI-1777 were higher during the three months ended June 30, 2020 primarily due to initial activities related to a Phase 1/2a clinical trial which we expect to initiate in the second half of 2020. Expenses for ATI-2138 were higher primarily due to preclinical development activities during the three months ended June 30, 2020. Expenses related to A-101 45% Topical Solution increased primarily due to our ongoing Phase 3 clinical trials for the treatment of common warts which we initiated during the third quarter of 2018. Development expenses related to ourother JAK inhibitors decreased primarily as a result of the completion of several Phase 2 clinical trials of ATI-501 and ATI-502 during 2019. Expenses related to A-101 45% Topical Solution decreased primarily due to the completion of our Phase 3 clinical trials during 2019. Other research and development expenses, which primarily included expenses for medical affairs activities as well as drug discovery, were at or near completionlower primarily as a result of lower medical affairs related activities during the three months ended June 30, 2019. The increase2020 primarily resulting from our clinical trials that were completed during 2019 for A-101 45% Topical Solution, ATI-501 and ATI-502. Personnel expenses and stock-based compensation decreased due to lower headcount primarily as a result of the restructuring we announced in expenses for our MK2 inhibitors resulted primarily from preclinical development activities as we prepared to file an IND for ATI-450 and initiate a Phase 1 clinical trial. Other research and development expenses primarily included expenses for medical affairs activities related to RHOFADE and ESKATA as well as drug discovery.September 2019. The change in contingent consideration during the three months ended June 30, 2019 was the result of updates to our assumptions as a result of the filing of an IND for ATI-450. The increase in other research and development expenses was primarily driven by drug discovery research related to our ITK inhibitors.
Sales and Marketing Expenses
The following table summarizes our sales and marketing expenses:
|
|
|
|
|
|
|
|
|
|
|
|
| Three Months Ended |
|
|
|
| ||||
|
| June 30, |
|
|
|
| ||||
|
| 2019 |
| 2018 |
| Change |
| |||
|
| (In thousands) |
| |||||||
Direct marketing and professional fees |
| $ | 1,604 |
| $ | 4,651 |
| $ | (3,047) |
|
Personnel expenses |
|
| 3,000 |
|
| 3,786 |
|
| (786) |
|
Other sales and marketing expenses |
|
| 2,357 |
|
| 2,911 |
|
| (554) |
|
Stock-based compensation |
|
| 216 |
|
| 1,020 |
|
| (804) |
|
Total sales and marketing expenses |
| $ | 7,177 |
| $ | 12,368 |
| $ | (5,191) |
|
Direct marketing and professional fees decreased primarily due to expenses we incurred in the three months ended June 30, 2018 preparing for and commercially launching ESKATA which were not present in the current year period. Personnel expenses decreased primarily due to higher recruiting and incentive compensation costs included in the three months ended June 30, 2018 which resulted from the hiring of our field sales force, as well as turnover in our sales force during the three months ended June 30, 2019. Other sales and marketing expenses included sales operations, travel costs, depreciation and other miscellaneous expenses. The decrease in other sales and marketing expenses was primarily the result of costs related to our national sales meeting, employee training and samples fulfillment resulting from our launch
39
of ESKATA in 2018. The decrease in stock-based compensation was primarily driven by forfeitures of equity awards as the result of turnover in our sales force.
General and Administrative Expenses
The following table summarizes our general and administrative expenses:
| | | | | | | | | ||||||||||
| | Three Months Ended | | | | |||||||||||||
| | June 30, | | | | |||||||||||||
| | 2020 |
| 2019 | | Change | ||||||||||||
|
|
|
|
|
|
|
|
| ||||||||||
|
| Three Months Ended |
|
|
| |||||||||||||
|
| June 30, |
|
|
| |||||||||||||
|
| 2019 |
| 2018 |
| Change | ||||||||||||
|
| (In thousands) | ||||||||||||||||
| | (In thousands) | ||||||||||||||||
Personnel expenses |
| $ | 2,136 |
| $ | 1,756 |
| $ | 380 |
| $ | 1,671 |
| $ | 2,136 |
| $ | (465) |
Professional and legal fees |
|
| 2,077 |
| 1,566 |
|
| 511 | | | 831 | | 1,184 | | | (353) | ||
Facility and support services |
|
| 652 |
|
| 571 |
|
| 81 | |
| 422 | |
| 652 | |
| (230) |
Milestone payment |
|
| — |
|
| 1,500 |
|
| (1,500) | |||||||||
Other general and administrative expenses |
|
| 471 |
|
| 445 |
|
| 26 | | | 530 | | | 843 | | | (313) |
Stock-based compensation |
|
| 2,654 |
|
| 2,283 |
|
| 371 | | | 2,118 | | | 2,654 | | | (536) |
Total general and administrative expenses |
| $ | 7,990 |
| $ | 8,121 |
| $ | (131) | | $ | 5,572 | | $ | 7,469 | | $ | (1,897) |
Personnel and stock-based compensation expenses increaseddecreased primarily due to increasedlower headcount. Professional and legal fees included accounting, legal, medical affairs, costs incurred under the transition services agreement with Allergan, investor relations and corporate communication costs, as well as legal fees related to patents. The increasepatents and current lawsuits described in professionalthis report, and were lower year-over-year primarily as a result of lower legal fees was primarily related to costs incurred under the transition services agreement with Allergan related to RHOFADE, which we acquired in November 2018, as well as medical affairs activities.fees. Facility and support services included general office expenses, and information technology costs whichand other expenses, and have risendecreased primarily due to our increasedlower information technology costs resulting from lower headcount. We incurred a one-time milestone paymentOther general and
32
administrative expenses included travel, insurance and marketing costs, and were lower primarily due to reduced travel-related activities in light of the three months ended June 30, 2018 upon the achievement of a milestone as specified in the finder’s services agreement with KPT Consulting, LLC.COVID-19 pandemic.
Goodwill Impairment
During the three months ended June 30, 2019, we performed an interim impairment analysis due to thea decline in our stock price. Our impairment analysis noted that our stock price, including a reasonable control premium, resulted in a fair value for the dermatology therapeutics reporting unit which was less than its carrying value. As a result, we recorded ana goodwill impairment charge of $18.5 million writing off the full balance of goodwill.
Amortization of Definite-Lived IntangibleOther Income (Expense), net
DuringOther expense, net for the three months ended June 30, 2020 was $0.2 million and primarily included interest expense related to our term loan facility with Silicon Valley Bank, or SVB, which we borrowed in March 2020, as well as interest on our finance leases, partially offset by interest income earned on our cash and investments. Other expense, net for the three months ended June 30, 2019 we incurred $1.7was $0.1 million of non-cash amortization expense related to the intangible asset for RHOFADE intellectual property we acquired in November 2018.
Other Income (Expense), net
The $0.8 million decrease in other income (expense), net wasand primarily due toincluded interest expense incurred on our debt with Oxford Finance LLC, which we borrowed in October 2018.2018 and repaid in full in October 2019, partially offset by interest income earned on our cash and investments.
Loss from Discontinued Operations
In September 2019, we announced the completion of a strategic review and our decision to refocus on our immuno-inflammatory development programs and to actively seek partners for our commercial products. The condensed consolidated financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to our commercial products as discontinued operations (see Note 15 to the condensed consolidated financial statements included in this report for additional information).
4033
Comparison of Six Months Ended June 30, 20192020 and 20182019
| | | | | | | | | | | ||||||||||
| | Six Months Ended June 30, | | | |
| ||||||||||||||
|
| 2020 |
| 2019 |
| Change |
| |||||||||||||
|
|
|
|
|
|
|
|
|
|
| ||||||||||
|
| Six Months Ended June 30, |
|
|
|
| ||||||||||||||
|
| 2019 |
| 2018 |
| Change |
| |||||||||||||
|
| (In thousands) |
| |||||||||||||||||
| | (In thousands) |
| |||||||||||||||||
Revenues: |
|
|
|
|
|
|
|
|
|
| | | | | | | | | | |
Product sales, net |
| $ | 8,757 |
| $ | 1,533 |
| $ | 7,224 |
| ||||||||||
Contract research |
|
| 2,149 |
|
| 2,261 |
|
| (112) |
| | $ | 3,042 | | $ | 2,149 | | $ | 893 | |
Other revenue |
|
| — |
|
| 1,000 |
|
| (1,000) |
| | | 411 | | | — | | | 411 | |
Total revenue, net |
|
| 10,906 |
|
| 4,794 |
|
| 6,112 |
| ||||||||||
|
|
|
|
|
|
|
|
|
|
| ||||||||||
Total revenue | | | 3,453 | | | 2,149 | | | 1,304 | | ||||||||||
| | | | | | | | | | | ||||||||||
Costs and expenses: |
|
|
|
|
|
|
|
|
|
| | | | | | | | | | |
Cost of revenue (excludes amortization) |
|
| 5,480 |
|
| 2,148 |
|
| 3,332 |
| ||||||||||
Cost of revenue | | | 2,658 | | | 2,201 | | | 457 | | ||||||||||
Research and development |
|
| 37,541 |
|
| 27,590 |
|
| 9,951 |
| |
| 15,909 | |
| 37,161 | |
| (21,252) | |
Sales and marketing |
|
| 17,008 |
|
| 23,601 |
|
| (6,593) |
| ||||||||||
General and administrative |
|
| 16,180 |
|
| 14,381 |
|
| 1,799 |
| |
| 11,773 | |
| 14,926 | |
| (3,153) | |
Goodwill impairment |
|
| 18,504 |
|
| — |
|
| 18,504 |
| | | — | | | 18,504 | | | (18,504) | |
Amortization of definite-lived intangible |
|
| 3,319 |
|
| — |
|
| 3,319 |
| ||||||||||
Total costs and expenses |
|
| 98,032 |
|
| 67,720 |
|
| 30,312 |
| |
| 30,340 | |
| 72,792 | |
| (42,452) | |
Loss from operations |
|
| (87,126) |
|
| (62,926) |
|
| (24,200) |
| |
| (26,887) | |
| (70,643) | |
| 43,756 | |
|
|
|
|
|
|
|
|
|
|
| ||||||||||
| | | | | | | | | | | ||||||||||
Other income (expense), net |
|
| (315) |
|
| 1,479 |
|
| (1,794) |
| |
| (11) | |
| (315) | |
| 304 | |
Loss from continuing operations | | | (26,898) | | | (70,958) | | | 44,060 | | ||||||||||
Loss from discontinued operations | | | (285) | | | (16,483) | | | 16,198 | | ||||||||||
Net loss |
| $ | (87,441) |
| $ | (61,447) |
| $ | (25,994) |
| | $ | (27,183) | | $ | (87,441) | | $ | 60,258 | |
Revenue
Revenue
RevenueContract research revenue was $10.9$3.0 million and $2.1 million for the six months ended June 30, 2019, compared to $4.8 million for the six months ended June 30, 2018. Product sales, net included $8.5 million2020 and $0.3 million of net revenue from sales of RHOFADE and ESKATA, respectively, during the six months ended June 30, 2019. Product sales, net included $1.5 million from sales of ESKATA during the six months ended June 30, 2018. We acquired RHOFADE in November 2018. Contract research revenue was $2.1 million and $2.3 million for the six months ended June 30, 2019, and 2018, respectively, and was comprised primarily of fees earned from the provision of laboratory services to clients through Confluence. Other revenue consisted of an up-front payment$0.4 million of $1.0 million we received upon signingroyalties earned on net sales of a licenseRHOFADE pursuant to the asset purchase agreement with Cipher in April 2018.EPI Health.
Cost of Revenue
Cost of revenue was $5.5$2.7 million and $2.2 million for the six months ended June 30, 2020 and 2019, and included $2.3 million and $1.0 million of costs related to RHOFADE and ESKATA product sales, net, respectively, of which $1.2 million represented royalties on sales of RHOFADE, and $0.4 million related to a non-cash charge for the write-down of ESKATA finished inventory. We also incurred $2.2 million of costs related to providing laboratory services to our clients through Confluence. Cost of revenue was $2.1 million for the six months ended June 30, 2018 and was comprised of $0.2 million of costs related to ESKATA product sales, net, and $1.9 million of costs incurred to provide laboratory services to our clients through Confluence.
41
Research and Development Expenses
The following table summarizes our research and development expenses:
| | | | | | | | | |
| | Six Months Ended | | | | ||||
| | June 30, | | | | ||||
| | 2020 |
| 2019 | | Change | |||
| | (In thousands) | |||||||
ATI-450 |
| $ | 2,734 |
| $ | 3,419 |
| $ | (685) |
ATI-1777 | | | 1,859 | | | 2,372 | | | (513) |
ATI-2138 | | | 1,603 | | | 1,683 | | | (80) |
Other JAK inhibitors | | | 635 | | | 8,691 | | | (8,056) |
A-101 45% Topical Solution | | | 532 | | | 9,863 | | | (9,331) |
Other research and development expenses | | | 1,356 | | | 1,826 | | | (470) |
Personnel expenses | | | 3,668 | | | 5,258 | | | (1,590) |
Stock-based compensation | | | 1,755 | | | 3,315 | | | (1,560) |
Change in contingent consideration | | | 1,767 | | | 734 | | | 1,033 |
Total research and development expenses | | $ | 15,909 | | $ | 37,161 | | $ | (21,252) |
|
|
|
|
|
|
|
|
|
|
|
| Six Months Ended |
|
|
| ||||
|
| June 30, |
|
|
| ||||
|
| 2019 |
| 2018 |
| Change | |||
|
| (In thousands) | |||||||
A-101 45% Topical Solution |
| $ | 9,863 |
| $ | 1,526 |
| $ | 8,337 |
JAK inhibitors |
|
| 11,063 |
|
| 11,715 |
|
| (652) |
MK2 inhibitors |
|
| 3,419 |
|
| 1,435 |
|
| 1,984 |
ESKATA |
|
| 390 |
|
| 1,248 |
|
| (858) |
Personnel expenses |
|
| 4,874 |
|
| 4,345 |
|
| 529 |
Change in contingent consideration |
|
| 734 |
|
| 866 |
|
| (132) |
Other research and development expenses |
|
| 3,883 |
|
| 2,972 |
|
| 911 |
Stock-based compensation |
|
| 3,315 |
|
| 3,483 |
|
| (168) |
Total research and development expenses |
| $ | 37,541 |
| $ | 27,590 |
| $ | 9,951 |
34
Research and development expenses for ATI-450 during the six months ended June 30, 2019 primarily consisted of preclinical development activities and activities related to a Phase 1 clinical trial that was completed in January 2020. Research and development expenses for ATI-450 during the six months ended June 30, 2020 primarily consisted of initial activities for a Phase 2a clinical trial. Expenses for ATI-1777 were lower primarily due to the completion of preclinical development activities. Expenses for ATI-2138 were comparable period over period as we completed early stage development work on candidate selection in 2019 and began preclinical development activities during the six months ended June 30, 2020. Expenses related to A-101 45% Topical Solution increased primarily due to our ongoing Phase 3 clinical trials for the treatment of common warts which we initiated during the third quarter of 2018. Development expenses related to ourother JAK inhibitors decreased primarily as a result of the completion of several Phase 2 clinical trials of ATI-501 and ATI-502 during 2019. Expenses related to A-101 45% Topical Solution decreased primarily due to the completion of our Phase 3 clinical trials during 2019. Other research and development expenses, which primarily included expenses for medical affairs activities as well as drug discovery, were at or near completionlower primarily as a result of lower medical affairs related activities during the six months ended June 30, 2020 primarily resulting from our clinical trials that were completed during 2019 for A-101 45% Topical Solution, ATI-501 and ATI-502. Personnel expenses and stock-based compensation decreased due to lower headcount primarily as a result of the restructuring we announced in September 2019. The increasechange in expenses forcontingent consideration during the six months ended June 30, 2020 was the result of updates to our MK2 inhibitors resulted primarily from preclinical development activitiesassumptions as we prepared to file an IND for ATI-450 and initiate a result of the completion of a successful Phase 1 clinical trial. Personnel expenses increased due to increased headcount. Other research and development expenses primarily included expensestrial for medical affairs activities related to RHOFADE and ESKATA as well as drug discovery. The increase in other research and development expenses was primarily driven by drug discovery research related to our ITK inhibitors. TheATI-450, while the change in contingent consideration during the six months ended June 30, 2019 was the result of updates to our assumptions as a result of the filing of an IND for ATI-450. The change in contingent consideration during the six months ended June 30, 2018 was the result of updates to our assumptions related to drug discovery research on our soft-JAK inhibitors, which progressed more quickly than we had originally planned. The decrease in stock-based compensation was primarily driven by the timing of the issuance of the equity awards during the twelve months preceding June 30, 2019, as well as the relatively lower fair value of those awards.
Sales and Marketing Expenses
The following table summarizes our sales and marketing expenses:
|
|
|
|
|
|
|
|
|
|
|
|
| Six Months Ended |
|
|
|
| ||||
|
| June 30, |
|
|
|
| ||||
|
| 2019 |
| 2018 |
| Change |
| |||
|
| (In thousands) |
| |||||||
Direct marketing and professional fees |
| $ | 4,797 |
| $ | 9,010 |
| $ | (4,213) |
|
Personnel expenses |
|
| 6,549 |
|
| 7,658 |
|
| (1,109) |
|
Other sales and marketing expenses |
|
| 4,856 |
|
| 5,006 |
|
| (150) |
|
Stock-based compensation |
|
| 806 |
|
| 1,927 |
|
| (1,121) |
|
Total sales and marketing expenses |
| $ | 17,008 |
| $ | 23,601 |
| $ | (6,593) |
|
Direct marketing and professional fees decreased primarily due to expenses we incurred in the six months ended June 30, 2018 preparing for and commercially launching ESKATA which were not present in the current year period. Personnel expenses decreased primarily due to higher recruiting and incentive compensation costs included in the six months ended June 30, 2018 which resulted from the hiring of our field sales force, as well as turnover in our sales force
42
during the six months ended June 30, 2019. Other sales and marketing expenses included sales operations, travel costs, depreciation and other miscellaneous expenses. The decrease in stock-based compensation was primarily driven by forfeitures of equity awards as the result of turnover in our sales force.
General and Administrative Expenses
The following table summarizes our general and administrative expenses:
| | | | | | | | | ||||||||||
| | Six Months Ended | | | | |||||||||||||
| | June 30, | | | | |||||||||||||
| | 2020 |
| 2019 | | Change | ||||||||||||
|
|
|
|
|
|
|
|
| ||||||||||
|
| Six Months Ended |
|
|
| |||||||||||||
|
| June 30, |
|
|
| |||||||||||||
|
| 2019 |
| 2018 |
| Change | ||||||||||||
|
| (In thousands) | ||||||||||||||||
| | (In thousands) | ||||||||||||||||
Personnel expenses |
| $ | 4,590 |
| $ | 3,553 |
| $ | 1,037 |
| $ | 3,268 |
| $ | 4,590 |
| $ | (1,322) |
Professional and legal fees |
|
| 4,179 |
| 2,685 |
|
| 1,494 | | | 1,949 | | 2,417 | | | (468) | ||
Facility and support services |
|
| 1,356 |
|
| 1,208 |
|
| 148 | |
| 933 | |
| 1,356 | |
| (423) |
Milestone payment |
|
| — |
|
| 1,500 |
|
| (1,500) | |||||||||
Other general and administrative expenses |
|
| 928 |
|
| 819 |
|
| 109 | | | 1,128 | | | 1,437 | | | (309) |
Stock-based compensation |
|
| 5,127 |
|
| 4,616 |
|
| 511 | | | 4,495 | | | 5,126 | | | (631) |
Total general and administrative expenses |
| $ | 16,180 |
| $ | 14,381 |
| $ | 1,799 | | $ | 11,773 | | $ | 14,926 | | $ | (3,153) |
Personnel and stock-based compensation expenses increaseddecreased primarily due to increasedlower headcount. Professional and legal fees included accounting, legal, medical affairs, costs incurred under the transition services agreement with Allergan, investor relations and corporate communication costs, as well as legal fees related to patents. The increasepatents and current lawsuits described in professionalthis report, and were lower year-over-year primarily as a result of lower legal fees was primarily related to costs incurred under the transition services agreement with Allergan related to RHOFADE, which we acquired in November 2018, as well as medical affairs activities.fees. Facility and support services included general office expenses, and information technology costs whichand other expenses, and have risendecreased primarily due to our increasedlower information technology costs resulting from lower headcount. We incurred a one-time milestone paymentOther general and administrative expenses included travel, insurance and marketing costs, and were lower primarily due to reduced travel-related activities in light of $1.5 million in the six months ended June 30, 2018 upon the achievement of a milestone as specified in the finder’s services Agreement with KPT Consulting, LLC.COVID-19 pandemic.
Goodwill Impairment
During the six months ended June 30, 2019, we performed an interim impairment analysis due to thea decline in our stock price. Our impairment analysis noted that our stock price, including a reasonable control premium, resulted in a fair value for the dermatology therapeutics reporting unit which was less than its carrying value. As a result, we recorded ana goodwill impairment charge of $18.5 million writing off the full balance of goodwill.
Amortization of Definite-Lived IntangibleOther Income (Expense), net
DuringOther expense, net for the six months ended June 30, 2020 was $11,000 and primarily included interest expense related to our term loan facility with SVB which we borrowed in March 2020, as well as interest on our finance leases, substantially offset by interest income earned on our cash and investments. Other expense, net for the six months ended June 30, 2019 we incurred $3.3was $0.3 million of non-cash amortization expense related to the intangible asset for RHOFADE intellectual property we acquired in November 2018.
Other Income (Expense), net
The $1.8 million decrease in other income (expense), net wasand primarily due toincluded interest expense incurred on our debt with Oxford Finance LLC,
35
which we borrowed in October 2018.2018 and repaid in full in October 2019, partially offset by interest income earned on our cash and investments.
Loss from Discontinued Operations
43
a strategic review and our decision to refocus on our immuno-inflammatory development programs and to actively seek partners for our commercial products. The condensed consolidated financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to our commercial products as discontinued operations (see Note 15 to the condensed consolidated financial statements included in this report for additional information).
Liquidity and Capital Resources
Since our inception, we have incurred net losses and negative cash flows from our operations. Prior to our acquisition of Confluence in August 2017, we did not generate any revenue. We have financed our operations over the last several years primarily through sales of our equity securities in public offerings and a private placement transaction. As described below, in October 2018In March 2020, we also entered into a loan facilitythe Loan and Security Agreement with an institutional lender.SVB.
As of June 30, 2019,2020, we had cash, cash equivalents and restricted cash and marketable securities of $115.5$68.1 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view towards liquidity and capital preservation.
We currently have no ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity, over the next five years, other than our debt financing obligation, sublease obligations, capitalterm loan facility, lease obligations, and contingent obligations under acquisition and intellectual property licensing agreements, which are summarized below under “Contractual Obligations and Commitments.”
Loan and Security Agreement with Oxford Silicon Valley Bank
In October 2018,March 2020 we entered into a loan and security agreement, or the Loan and Security Agreement with Oxford Finance LLC, or Oxford. The agreement provided for up to $65.0 million in term loans. Of the $65.0 million, we borrowed $30.0 million in October 2018, and did not draw the remaining $35.0 million that was available until March 31, 2019 under the agreement.SVB. The Loan and Security Agreement provides for $11.0 million in term loans, of which we borrowed the entire amount on March 30, 2020. The Loan and Security Agreement is secured by substantially all of our assets other than intellectual property.
The term loan repayment schedule provides for interest only payments beginning April 1, 2020 and continuing through the payment date immediately prior to NovemberMarch 1, 2021,2022, followed by 24 consecutive equal monthly installments of principal, plus monthly payments of principal andaccrued interest, in arrears starting on NovemberApril 1, 20212022 and continuing through the maturity date of OctoberMarch 1, 2023.2024. All unpaidoutstanding principal and accrued and unpaid interest will be due and payable on the maturity date. The Loan and Security Agreement provides for an annual interest rate equal to the greater of (i) 8.35% and (ii) the 30-day U.S. LIBORprime rate then in effect as reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue plus 6.25%2% and (ii) 6.75%.
The Loan and Security Agreement also provides forincludes a final payment fee equal to 5.75%5% of the original principal amount of the term loans drawn, which final payment is due on October 1, 2023 or upon the prepayment of the facility or the acceleration of amounts due under the facility as a result of an event of default.
borrowed. We have the option to prepay the outstanding balance of the term loans in full, subject to a prepayment feepremium of (i) 3% of the original principal amount of the aggregate term loans drawnborrowed for any prepayment on or prior to the first anniversary of the applicable funding date,March 30, 2020, (ii) 2% of the original principal amount of the aggregate term loans drawnborrowed for any prepayment betweenafter the first anniversary and on or before the second anniversariesanniversary of the applicable funding dateMarch 30, 2020 or (iii) 1% of the original principal amount of the aggregate term loans drawnborrowed for any prepayment after the second anniversary of the applicable funding dateMarch 30, 2020 but before OctoberMarch 1, 2023. We also have the option to prepay the term loans in part, once in2024.
The Loan and Security Agreement contains a three-month period, of an amount of $2.0 million or greater,customary covenant that limits our ability, subject to specified exceptions, to incur additional indebtedness without the same prepayment fees and other specified limitations. prior consent of SVB.
4436
Cash Flows
The following table summarizes our cash flows for each of the periods presented:
| | | | | | | ||||||
| | Six Months Ended June 30, | ||||||||||
|
| 2020 |
| 2019 | ||||||||
|
|
|
|
|
|
| ||||||
|
| Six Months Ended June 30, | ||||||||||
|
| 2019 |
| 2018 | ||||||||
|
| (In thousands) | ||||||||||
| | (In thousands) | ||||||||||
Net cash used in operating activities |
| $ | (52,696) |
| $ | (43,705) | | $ | (17,626) | | $ | (52,696) |
Net cash provided by investing activities |
|
| 27,568 |
|
| 69,479 | ||||||
Net cash provided by (used in) investing activities | |
| 3,455 | |
| 27,568 | ||||||
Net cash provided by (used in) financing activities |
|
| (237) |
|
| 59 | |
| 10,821 | |
| (237) |
Net increase (decrease) in cash and cash equivalents |
| $ | (25,365) |
| $ | 25,833 | ||||||
Net decrease in cash and cash equivalents | | $ | (3,350) | | $ | (25,365) | ||||||
Operating Activities
During the six months ended June 30, 2020, operating activities used $17.6 million of cash primarily resulting from our net loss of $27.2 million, partially offset by non-cash adjustments of $9.7 million. Net cash used by changes in our operating assets and liabilities during the six months ended June 30, 2020 consisted of a $5.9 million net decrease in accounts payable and accrued expenses, which were partially offset by a $4.9 million decrease in accounts receivable and a $0.9 million decrease in prepaid expenses and other assets. The decrease in accounts receivable was primarily the result of cash received from Allergan Sales, LLC, or Allergan, related to sales of RHOFADE made during the year ended December 31, 2019. The decrease in prepaid expenses and other assets was primarily due to amortization of the premiums for our corporate insurance policies, which we expense equally over the policy term. The net decrease in accounts payable and accrued expenses was primarily driven by expenses incurred, but not yet paid, as of December 31, 2019, which were partially offset by cash received from Allergan which related to sales of RHOFADE that occurred after the date we sold RHOFADE to EPI Health. Accordingly, we had $4.9 million payable to EPI Health as of June 30, 2020, which is included in accrued expenses on our condensed consolidated balance sheet. Expenses incurred, as of December 31, 2019, and paid during the six months ended June 30, 2020, primarily included employee annual merit bonuses, as well as expenses related to preclinical development and Phase 1 clinical trial activities for ATI-450, and preclinical development activities for ATI-1777 and ATI-2138. Non-cash expenses of $9.7 million were composed of stock-based compensation expense of $6.8 million, a charge of $1.7 million related to the change in contingent consideration and depreciation and amortization expense of $1.2 million.
During the six months ended June 30, 2019, operating activities used $52.7 million of cash primarily resulting from our net loss of $87.4 million, partially offset by non-cash adjustments of $33.4 million. Net cash provided by changes in our operating assets and liabilities during the six months ended June 30, 2019 consisted of a $13.3 million increase in accounts payable and accrued expenses and a $2.9 million decrease in prepaid expenses and other current assets, which were partially offset by a $14.5 million increase in accounts receivable. The increase in accounts payable and accrued expenses was primarily driven by expenses incurred, but not yet paid, as of June 30, 2019, as well as the timing of vendor invoicing and payments. Expenses incurred, but not yet paid, as of June 30, 2019 primarily included sales discounts and allowances related to sales of RHOFADE, as well as expenses related to our Phase 3 clinical trials for A-101 45% Topical Solution, our Phase 2 clinical trials for ATI-501 and ATI-502 and pre-clinicalpreclinical development activities for ATI-450. The decrease in prepaid expenses and other current assets was due to research and development activities primarily related to pre-clinicalpreclinical development activities for ATI-450 and ATI-502 which concluded during the six months ended June 30, 2019 and sales and marketing expenses related to our national sales meeting which was held during the six months ended June 30, 2019. The increase in accounts receivable was primarily the result of sales of RHOFADE. Non-cash expenses of $33.4 million were composed of a goodwill impairment charge of $18.5 million, stock-based compensation expense of $9.7 million, a charge of $0.7 million related to the change in contingent consideration and depreciation and amortization expense of $4.5 million.
Investing Activities
During the six months ended June 30, 2018, operating2020, investing activities used $43.7provided $3.5 million of cash, primarily resultingconsisting of proceeds from our net losssales and maturities of $61.4marketable securities of $30.7 million, partially offset by changes in our operating assets and liabilitiespurchases of $5.9marketable securities of $27.1 million, and non-cash adjustmentspurchases of $11.8equipment of $0.1 million. Net cash provided by changes in our operating assets and liabilities during the six months ended June 30, 2018 consisted of a $2.3 million decrease in prepaid expenses and other current assets and a $6.3 million increase in accounts payable and accrued expenses, which were partially offset by a $1.7 million increase in accounts receivable and a $1.0 million increase in inventory. The decrease in prepaid expenses and other current assets was primarily due to a $2.0 million PDUFA fee paid to the FDA in conjunction with the filing of the NDA for ESKATA, for which we received a refund during the six months ended June 30, 2018. The increase in accounts payable and accrued expenses was primarily driven by expenses incurred, but not yet paid, as of June 30, 2018, as well as the timing of vendor invoicing and payments. Expenses incurred, but not yet paid, as of June 30, 2018 primarily included sales and marketing expenses related to the commercial launch of ESKATA in May 2018, as well as expenses related to our Phase 2 clinical trials for A-101 45% Topical Solution, ATI-501 and ATI-502. The increases in accounts receivable and inventory were the result of the commercial launch of ESKATA in May 2018. Non-cash expenses of $11.8 million were primarily composed of stock-based compensation expense.
4537
Investing Activities
During the six months ended June 30, 2019, investing activities provided $27.6 million of cash, consisting of proceeds from sales and maturities of marketable securities of $117.5 million, partially offset by purchases of marketable securities of $89.4 million, and purchases of equipment of $0.5 million.
Financing Activities
During the six months ended June 30, 2018, investing2020, financing activities provided $69.5$10.8 million of cash consistingand consisted of proceeds from sales$10.9 million of net borrowings pursuant to the Loan and maturities of marketable securities of $144.4 million, partiallySecurity Agreement with SVB offset by purchases$0.1 million of marketable securities of $74.2 million, and purchases of equipment of $0.7 million.finance lease payments.
Financing Activities
During the six months ended June 30, 2019, financing activities used $0.2 million of cash primarily related to finance lease payments.
During the six months ended June 30, 2018, financing activities provided $0.1 million of cash and included $0.4 million from the exercise of employee stock options, partially offset by $0.3 million of capital lease payments.
Funding Requirements
We anticipate we will incur net losses in the near term as we continue to commercialize our marketed product(s), continue the clinical development of A-101 45% Topical Solution as a potential treatment for common warts and ATI-450 as a potential treatment for rheumatoid arthritis, other immuno-inflammatory diseases and other inflammatory conditions,COVID-19 and ATI-1777 as a potential treatment for moderate to severe atopic dermatitis, continue the development of our preclinical compounds, and continue to identify, research and develop additional drug candidates. We may not be able to complete the development and initiate commercialization ofgenerate revenue from these programs if, among other things, our clinical trials are not successful, or if the FDA does not approve our drug candidates currently in clinical trials when we expect, or at all.all, or we are not able to identify and consummate transactions with third-party partners to further develop, obtain marketing approval for and/or commercialize our drug candidates.
Our primary uses of capital are, and we expect will continue in the near term to be, compensation and related expenses, clinical costs, external research and development services, laboratory and related supplies, sales, marketing and advertising costs, legal and other regulatory expenses, and administrative and overhead costs. In addition, we are investing in a new research facility for our drug discovery operations. Our future funding requirements will be heavily determined by the resources needed to support the commercialization of our marketed product(s), as well as the development of our drug candidates.
As a publicly traded company, we have incurredincur and will continue to incur significant legal, accounting and other expenses that we were not required to incur as a private company.expenses. In addition, the Sarbanes-Oxley Act of 2002, as well as rules adopted by the SEC and the Nasdaq Stock Market LLC, requires public companies to implement specified corporate governance practices that were not applicable to us prior to our IPO. We expect ongoing compliance with these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly, in particular after we cease to be an “emerging growth company” under the Jumpstart Our Business Startups Act of 2012, or JOBS Act.practices.
We believe our existing cash, cash equivalents and marketable securities are sufficient to fund our operating and capital expenditure requirements for a period greater than 12 months from the date of issuance of our condensed consolidated financial statements that appear in Item 1 of this Quarterly Report on Form 10-Q based on our current operating assumptions. These assumptions may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We expect that we will require additional capital to commercialize A-101 45% Topical Solution for the treatment of common warts, if approved, to complete the clinical development of ATI-450 and ATI-1777, to develop our preclinical compounds, and to support our discovery efforts. Additional funds may not be available on a timely basis, on commercially acceptable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy.
46
Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. If we are unable to raise sufficient additional capital or generate revenue from transactions with third-party partners for the development and/or commercialization of our drug candidates, we may need to substantially curtail our planned operations and the pursuit of our growth strategy.operations.
We may raise additional capital through the sale of equity or debt securities. In such an event, yourour stockholders’ ownership will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of a holder of our common stock.
38
Because of the numerous risks and uncertainties associated with research development and commercializationdevelopment of pharmaceutical drugs, we are unable to estimate the exact amount of our working capital requirements. Our funding requirements in the near term will depend on many factors, including:
| the number and development requirements of the drug candidates that we may pursue; |
| the scope, progress, results and costs of preclinical development, laboratory testing and conducting |
| the costs, timing and outcome of regulatory review of our drug candidates; |
| the |
|
|
|
|
| the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; |
| the impact on the timing |
| ● | our ability to identify and consummate transactions with third-party partners to further develop, obtain marketing approval for and/or |
| ● | the revenue earned from our commercial products as a result of licenses to, or |
Contractual Obligations and Commitments
We occupy space for our headquarters in Wayne, Pennsylvania under a sublease agreement which has a term through October 2023. We terminated our lease for office space in Malvern, Pennsylvania in June 2019. We occupy office and laboratory space in St. Louis, Missouri under an operating leasea sublease agreement which has a term through June 2029.
We lease laboratory equipment used in our laboratory space in St. Louis, Missouri under two capital lease financing arrangements which have terms through October 2020 and December 2020, respectively.2020.
We lease a fleet of automobiles for our sales force and other field-based employees under the terms of a master lease agreement. The lease term for each automobile begins on the date we take delivery and continues for a period of four years.
In October 2018,March 2020, we borrowed $30.0$11.0 million under the Loan and Security Agreement with Oxford.SVB. Amounts borrowed under the Loan and Security Agreement are subject to interest only through October 2021,March 2022, after which we will be required to make principal and interest payments through the maturity date of October 2023.March 2024.
Under various agreements, we may be required to make milestone payments and pay royalties and other amounts to third parties.
Under the assignment agreement with the Estate of Mickey Miller pursuant to which we acquired intellectual property, we have agreed to pay royalties on sales of ESKATA or otherand related products at rates ranging in low single-digit percentages of net sales, as defined in the agreement. Under the related finder’s services agreement with KPT Consulting, LLC, we have agreed to make a remaining payment of $3.0 million upon the achievement of a specified
47
commercial milestone. In addition, we have agreed to pay royalties on sales of ESKATA or otherand related products at a low single-digit percentage of net sales, as defined in the agreement. In August 2019, we voluntarily discontinued the commercialization of ESKATA in the United States and withdrew the marketing authorizations we had previously received for the product in all countries outside of the United States.
Under a license agreement with Rigel Pharmaceuticals, Inc., or Rigel, we have agreed to make remaining aggregate payments of up to $80.0$76.0 million upon the achievement of specified pre-commercializationdevelopment milestones, such as clinical trials and regulatory approvals. Further, we have agreed to pay up to an additional $10.0$10.5 million to Rigel upon the achievement of a second set of development milestones. In addition, in connection with the amendment of the agreement in October 2019, we paid Rigel an amendment fee of $1.5 million in three installments of $500,000 in each of January 2020, April 2020 and July 2020. With respect to any products we commercialize under the agreement, we will pay Rigel quarterly tiered royalties on our annual net sales of each product developed using the licensed JAK inhibitors at a high single digit percentage of annual net sales, subject to specified reductions.
Under a stock purchase agreement with the selling stockholders of Vixen, weone of our former subsidiaries, we are obligated to make aggregate payments of up to $18.0 million upon the achievement of specified pre-commercialization milestones for three products covered by the Vixenacquired patent rights in the United States, the European Union and Japan, and aggregate payments of up to $22.5 million upon the achievement of specified commercial milestones for products covered by the Vixenacquired patent rights. We are also obligated to make an annual payment of $0.1 million through March 2022, which
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amounts are creditable against any specified future payments that may be paid under the agreement. With respect to any covered products that we commercialize under the agreement,, we are obligated to pay a low single-digit percentage of annual net sales, subject to specified reductions, limitations and other adjustments, until the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or, in specified circumstances, ten years from the first commercial sale of such product. If we sublicense any of the patent rights and know-how acquired pursuant to the agreement,, we will be obligated to pay a portion of any consideration we receive from such sublicenses in specified circumstances.
Under a license agreement with The Trustees of Columbia University in the City of New York, or Columbia, we are obligated to pay an annual license fee of $10,000, subject to specified adjustments for patent expenses incurred by Columbia and creditable against any royalties that may be paid under the license agreement. We are also obligated to pay up to an aggregate of $11.6 million upon the achievement of specified commercial milestones, including specified levels of net sales of products covered by Columbia patent rights and/or know-how, and royalties at a sub-single-digit percentage of annual net sales of products covered by Columbia patent rights and/or know-how, subject to specified adjustments. If we sublicense any of Columbia’s patent rights and know-how acquired pursuant to the agreement, we will be obligated to pay Columbia a portion of any consideration we receive from such sublicensessublicense in specified circumstances.
Under a merger agreement with Confluence, we we are obligated to make remaining aggregate payments of up to $75.0 million upon the achievement of specified regulatory and commercialization milestones. With respect to any covered products we commercialize, we are obligated to pay a low single-digit percentage of annual net sales, subject to specified reductions, limitations and other adjustments, until the date that all of the patent rights for that product have expired, as determined on a country-by-country and product-by-product basis or, in specified circumstances, ten years from the first commercial sale of such product. If we sublicensesell, license or transfer any of the patent rights and know-howintellectual property acquired pursuant to the agreement, we will be obligated to pay a portion of any consideration we receive from such sublicensessale, license or transfer in specified circumstances.
Under the Asset Purchase Agreement with Allergan pursuant to which we acquired intellectual property, we have agreed to pay Allergan royalties on net sales of RHOFADE ranging from a mid-single digit percentage to a mid-teen percentage of net sales, subject to specified reductions, limitations and other adjustments, on a country-by-country basis until the date that the patent rights related to a particular product, such as RHOFADE, have expired or, if later, November 30, 2028. In addition, we have agreed to assume the obligation to pay specified royalties and milestone payments under agreements with Aspect Pharmaceuticals, LLC and Vicept Therapeutics, Inc. We have also agreed to pay Allergan a one-time payment of $5.0 million upon the achievement of a specified development milestone related to the potential development of an additional dermatology product.
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We enter into contracts in the normal course of business with CROs for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. These contracts generally provide for termination upon notice, and therefore we believe that our non-cancelable obligations under these agreements are not material.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Emerging Growth Company Status
The JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have irrevocably elected to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies. We will cease to be an emerging growth company as of December 31, 2020.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are exposed to market risk related to changes in interest rates. Our cash equivalents and marketable securities consist of money market funds, asset-backed securities, commercial paper, corporate debt securities and government agency debt. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Our marketable securities are subject to interest rate risk and will fall in value if market interest rates increase. However, due to the short-term nature and risklow-risk profile of our investment portfolio, we do not expect that an immediate 10% change in market interest rates would have a material effect on the fair market value of our investment portfolio. We have the ability to hold our marketable securities until maturity, and therefore we dowould not expect our operating results or cash flows to be affected significantlyto any significant degree by the effect of a change in market interest rates on our investments.
The Loan and Security Agreement with OxfordSVB provides for an annual interest rate equal to the greater of (i) 8.35%the prime rate then in effect as reported in The Wall Street Journal plus 2% and (ii) the 30-day U.S. LIBOR rate plus 6.25%6.75%. To the extent that any present or future credit facilities that we enter into are based on a floating interest rate, we will be subject to risks relating to changes in market interest rates. In periods of rising interest rates when we have such debt outstanding, our interest expense would increase. Based upon our debt outstanding under the Loan and Security Agreement of $30.0$11.0 million as of June 30, 2019,2020, a 100 basis-point increase in the interest rate on our loan with OxfordSVB would result in approximately $304,000$0.1 million of additional interest expense on an annualized basis.
The uncertainty that exists with respect to the economic impact of the global COVID-19 pandemic has introduced significant volatility in the financial markets during and subsequent to our quarter ended June 30, 2020.
Item 4. Controls and Procedures
(a)Evaluation of Disclosure Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
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In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2019,2020, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon such evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of such date at the reasonable assurance level.
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(b) Changes in Internal Control Over Financial Reporting
There have not been any changes in our internal control over financial reporting during our fiscal quarter ended June 30, 20192020 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. In connection with the acquisition of RHOFADE, management is in the process of analyzing and evaluating our internal control over financial reporting.
PART II. OTHER INFORMATION
Linda Rosi v. Aclaris Therapeutics, Inc. et al. Securities Class Action
On July 30, 2019, plaintiff Linda Rosi, (the “Plaintiff”)or Rosi, filed a purportedputative class action complaint captioned Rosi v. Aclaris Therapeutics, Inc., et al. in the U.S. District Court for the Southern District of New York against us and certain of our executive officers (the “Defendants”), alleging violations by the Defendants of certain federal securities laws. Plaintiffofficers. The complaint alleges that the Defendants made misleading statements to investors about our business, operations and prospects and faileddefendants violated federal securities laws by, among other things, failing to disclose an alleged likelihood that regulators would scrutinize advertising materials related to ESKATA and find that the materials minimized the risks or overstated the efficacy of the product. Plaintiff is seekingThe complaint seeks unspecified compensatory damages on behalf of herselfRosi and all other persons and entities that purchased or otherwise acquired our securities between May 8, 2018 and June 20, 2019. Defendants
On September 5, 2019, an additional plaintiff, Robert Fulcher, or Fulcher, filed a substantially identical putative class action complaint captioned Fulcher v. Aclaris Therapeutics, Inc., et al. in the same court against the same defendants.
On November 6, 2019, the court consolidated the Rosi and Fulcher actions, or together, the Consolidated Securities Action, and appointed Fulcher “lead plaintiff” for the putative class.
On January 24, 2020, Fulcher filed a consolidated amended complaint in the Consolidated Securities Action, naming two additional executive officers as defendants, extending the putative class period to August 12, 2019, and adding allegations concerning, among other things, alleged statements and omissions throughout the putative class period concerning ESKATA’s risks, tolerability and effectiveness. The defendants filed a motion to dismiss the consolidated amended complaint on April 17, 2020. Fulcher filed an opposition to the defendants’ motion on June 15, 2020, and the defendants filed a reply to such opposition on August 4, 2020. The motion remains under judicial consideration.
We and the other defendants dispute plaintiffs’ claims in the Plaintiff’s claimsConsolidated Securities Action and intend to defend the matter vigorously.
Stockholder Derivative Action
On November 15, 2019, plaintiff Keith Allred, or Allred, filed a derivative stockholder complaint captioned Allred v. Walker et al. in the U.S. District Court for the Southern District of New York against certain of our directors and executive officers. The complaint alleges that the defendants, among other things, breached their fiduciary duties as directors and/or officers in connection with the claims alleged in the Consolidated Securities Action. The complaint seeks, among other things, unspecified compensatory damages on behalf of our company.
On November 25, 2019, an additional plaintiff, Bruce Brown, or Brown, filed a substantially identical complaint captioned Brown v. Walker et al. in the same court against the same defendants.
On December 12, 2019, the court consolidated the Allred and Brown actions under the caption In re Aclaris Therapeutics, Inc. Derivative Litigation, or the Consolidated Derivative Action, and directed that future derivative cases filed in or transferred to the court arising out of substantially the same transactions or events be similarly consolidated. Thereafter, on January 11, 2020, the court stayed – subject to certain conditions – all deadlines in the
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Consolidated Derivative Action pending resolution of the defendants’ anticipated motion to dismiss the Consolidated Securities Action.
The defendants dispute plaintiffs’ claims in the Consolidated Derivative Action and intend to defend the matter vigorously.
In addition, from time to time, we are subject to litigation and claims arising in the ordinary course of business but, except as stated above, we are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.
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Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. Except as noted below, our risk factors have not changed materially from those described in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2018,2019, filed with the SEC on March 18, 2019.February 25, 2020.
If
Risks Related to Our Business, Our Financial Position and Capital Needs
Our business has been adversely impacted and could continue to be adversely affected by the evolving and ongoing COVID-19 global pandemic in regions where we failor third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations. The COVID-19 pandemic could adversely affect our operations, including at our headquarters, which is currently subject to maintain compliancea stay-at-home order, and at our clinical trial sites, as well as the business or operations of our manufacturers, CROs or other third parties with whom we conduct business.
Our business has been adversely affected by the listing requirementseffects of the recent and evolving COVID-19 pandemic, which was declared by the World Health Organization as a global pandemic. The Nasdaq Global Market,COVID-19 pandemic has resulted in travel and other restrictions in order to reduce the spread of the disease, which, among other things, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, and order cessation of non-essential travel. In response to these public health directives and orders, we have implemented a virtual operations strategy, including telecommuting and other alternative work arrangements for all employees. The effects of our alternative work arrangement policies may negatively impact productivity, disrupt our business and delay our preclinical and clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition.
Quarantines, executive and similar government orders, and business shutdowns, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, related to COVID-19 or other infectious diseases could impact personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials, which would disrupt our supply chain. Some of our third-party manufacturers which we use for the supply of materials for our drug candidates or other materials necessary to manufacture drug product to conduct preclinical studies and clinical trials are located in countries affected by COVID-19, and should they experience disruptions, such as temporary closures or suspension of services, we would likely experience delays in advancing these studies and trials.
In addition, our clinical trials have been and may continue to be affected by the COVID-19 pandemic. Clinical site initiation and patient enrollment may be delisteddelayed due to prioritization of hospital resources toward the COVID-19 pandemic. Some subjects may not be able to comply with clinical trial protocols if quarantines impede patient movement
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or interrupt healthcare services. Similarly, our ability to recruit and retain subjects and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, may adversely impact our clinical trial operations. For example, in March 2020, we initiated a Phase 2a clinical trial of ATI-450 as a potential treatment for moderate to severe rheumatoid arthritis. Due to the COVID-19 pandemic, we temporarily paused enrollment. We resumed enrolling subjects, and the pricefirst subject was dosed, in May 2020. At this time, we are actively recruiting for this trial. Given the continuing evolution of our common stockthe COVID-19 pandemic, we now anticipate reporting data from this trial in the first half of 2021.
The spread of COVID-19, which has caused a broad impact globally, may materially affect us economically. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a widespread pandemic could result in significant disruption of global financial markets, reducing our ability to access capital, which could in the capital marketsfuture negatively affect our liquidity and impact our ability to make scheduled payments pursuant to our Loan and Security Agreement with SVB. In addition, a recession or market correction resulting from the further spread of COVID-19 could be negatively impacted.
Our common stock is currently listed on The Nasdaq Global Market. To maintainmaterially affect our business and the listingvalue of our common stockstock.
The global pandemic of COVID-19 continues to rapidly evolve. The extent to which the COVID-19 pandemic impacts our business, our preclinical and clinical development and our regulatory efforts will depend on The Nasdaq Global Market, wefuture developments that are required to meet certain listinghighly uncertain and cannot be predicted, such as the geographic spread of the disease, the duration of the outbreak, travel restrictions, quarantines, stay-at-home orders, social distancing requirements including, among others, either: (i) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors and 10% or more stockholders) of at least $5 millionbusiness closures and stockholders’ equity of at least $10 million; or (ii) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors, affiliatessupply chain and 10% or more stockholders) of at least $15 million and a total market value of listed securities of at least $50.0 million.
We may fail to satisfy one or more Nasdaq Global Market requirements for continued listing of our common stockother disruptions in the future. There can be no assurance thatUnited States and other countries, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. Accordingly, we will be successful in maintainingdo not yet know the listingfull extent of our common stock on the Nasdaq Global Market, or, if transferred, on the Nasdaq Capital Market. This could impair the liquidity and market price of our common stock. In addition, the delisting of our common stock from a national exchange could have a material adverse effectimpacts on our access to capital markets,business, our preclinical and any limitation on market liquidityclinical development and regulatory activities, healthcare systems or reduction in the price of our common stockglobal economy as a result of that delistingwhole. However, these impacts could adversely affect our abilitybusiness, financial condition, results of operations and growth prospects.
In addition, to raise capitalthe extent the ongoing COVID-19 pandemic adversely affects our business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties described in “Part I, Item 1A. Risk Factors” of our Annual Report on terms acceptableForm 10-K for the fiscal year ended December 31, 2019, filed with the SEC on February 25, 2020.
We may not be able to us, or at all. Further, ourgenerate sufficient cash to service our indebtedness, including the Loan and Security Agreement with SVB.
In March 2020, we entered into the Loan and Security Agreement with SVB, pursuant to which we borrowed $11.0 million. Our obligations under the Loan and Security Agreement are secured by substantially all of our assets except for our intellectual property, and we may not encumber our intellectual property without SVB’s prior written consent. The Loan and Security Agreement contains customary representations, warranties and covenants by us, which covenants, among other things, limit our ability, subject to specified exceptions, to convey, sell, lease, transfer, assign or otherwise dispose of our assets; engage in any business other than the businesses currently engaged in by us or reasonably related thereto; liquidate or dissolve; undergo specified change of control events; create, incur, assume or be liable for indebtedness; create, incur, allow or suffer any liens on our property; pay dividends and make other restricted payments; make investments; or enter into any material transactions with Oxfordour affiliates. Our obligations under the Loan and Security Agreement are subject to acceleration upon the occurrence of specified events of default, including a material adverse change in our business, operations or financial condition. We may also enter into other debt agreements in the delistingfuture which may contain similar or more restrictive terms.
Our ability to make scheduled monthly payments or to refinance our debt obligations depends on numerous factors, including the amount of our common stock on The Nasdaq Global Market.
The trading pricecash reserves and our actual and projected financial and operating performance. These amounts and our performance are subject to certain financial and business factors, as well as prevailing economic and competitive conditions, including the impact of the COVID-19 pandemic, some of which may be beyond our control. We cannot assure you that we will maintain a level of cash reserves or cash flows from operating activities sufficient to permit us to pay the principal, premium, if any, and interest on our existing or future indebtedness. If our cash flows and capital resources are insufficient to fund our debt service obligations, we may be forced to reduce or delay capital expenditures, sell assets or operations, seek additional capital or restructure or refinance our indebtedness. We cannot assure you that we
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would be able to take any of these actions, or that these actions would permit us to meet our scheduled debt service obligations. Failure to comply with the covenants and conditions of the Loan and Security Agreement could result in an event of default, which could result in an acceleration of amounts due under the Loan and Security Agreement. We may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness or to make any accelerated payments, and SVB could seek to enforce security interests in the collateral securing such indebtedness, which would harm our business.
Risks Related to Ownership of Our Common Stock
Exclusive forum provisions in our amended and restated certificate of incorporation and amended and restated bylaws could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim for breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, our amended and restated certificate of incorporation or our amended and restated bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine. This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated bylaws provide the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation and our amended and restated bylaws. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.
Our amended and restated certificate of incorporation and amended and restated bylaws further provide any person or entity purchasing or otherwise acquiring any interest in shares of our common stock has beenis deemed to have notice of and is likely to continue to be volatile.
Since our initial public offering, our stock price has been and is likely to continue to be volatile. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelatedconsented to the operating performance of particular companies. Asforegoing provisions. These exclusive forum provisions may limit a result of this volatility, investorsstockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees, which may not be able to sell their common stock at or above the price paid for the shares. The market price for our common stock may be influenced by many factors, including:
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In addition, in the past, stockholders have initiated class action lawsuits against pharmaceutical companies following periods of volatility in the market prices of these companies’ stock. On July 30, 2019, one purported class action complaint was filed against us and certainour directors, officers and other employees. If a court were to find either exclusive-forum provision to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of our executive officers alleging violations of certain federal securities laws. Defendants dispute the plaintiff’s claims and intend to defend the matter vigorously. This case, and additional litigation, if instituted against us,which could cause us to incur substantial costs and divert management’s attention and resources fromseriously harm our business.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
None.
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Exhibit | Document | |
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3.1 | | |
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3.2 | | |
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10.1 | | |
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10.2*# | | |
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31.1* | | Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act. |
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31.2* | | Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act. |
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32.1** | | |
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101.INS | | XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) |
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101.SCH | | Inline XBRL Taxonomy Extension Schema Document |
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101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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104 | | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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* | Filed herewith. |
** | These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Exchange Act and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
# | Pursuant to Item 601(b)(10)(iv) of Regulation S-K promulgated by the SEC, certain portions of this exhibit have been redacted because such portions, indicated by asterisks, are both not material and would likely cause competitive harm to the Registrant if publicly disclosed. The Registrant hereby agrees to furnish supplementally to the SEC, upon its request, an unredacted copy of this exhibit. |
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SIGNATURES
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.
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| ACLARIS THERAPEUTICS, INC. | |
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Date: August | By: | /s/ Neal Walker |
| | Neal Walker |
| | President and Chief Executive Officer |
| | (On behalf of the Registrant) |
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Date: August | By: | /s/ Frank Ruffo |
| | Frank Ruffo |
| | Chief Financial Officer |
| | (Principal Financial Officer) |
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