Item 1. Financial Statements
Item 1. Financial Statements
ACLARIS THERAPEUTICS, IN C.
CONDENSED CONSOLIDATED BALANCE SHEET S
(Unaudited)
(In thousands, except share and per share data)
March 31,
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
36,342
$
27,349
Short-term marketable securities
143,280
164,065
Accounts receivable, net
633
623
Prepaid expenses and other current assets
10,626
12,995
Total current assets
190,881
205,032
Marketable securities
23,955
34,242
Property and equipment, net
1,277
1,335
Intangible assets
7,030
7,048
Other assets
3,384
3,554
Total assets
$
226,527
$
251,211
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
8,121
$
9,985
Accrued expenses
5,687
10,051
Current portion of lease liabilities
716
693
Discontinued operations
2,202
2,202
Total current liabilities
16,726
22,931
Other liabilities
2,035
2,172
Contingent consideration
27,200
28,400
Deferred tax liability
367
367
Total liabilities
46,328
53,870
Commitments and contingencies (Note 16)
Stockholders’ Equity:
Preferred stock, $ 0.00001 par value; 10,000,000 shares authorized and no shares issued or outstanding at March 31, 2022 and December 31, 2021
—
—
Common stock, $ 0.00001 par value; 100,000,000 shares authorized at March 31, 2022 and December 31, 2021; 61,737,483 and 61,228,446 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively
1
1
Additional paid‑in capital
795,366
792,971
Accumulated other comprehensive loss
( 972 )
( 224 )
Accumulated deficit
( 614,196 )
( 595,407 )
Total stockholders’ equity
180,199
197,341
Total liabilities and stockholders’ equity
$
226,527
$
251,211
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share data)
Three Months Ended
March 31,
2022
2021
Revenues:
Contract research
$
1,221
$
1,535
Other revenue
232
242
Total revenue
1,453
1,777
Costs and expenses:
Cost of revenue
1,155
1,202
Research and development
14,306
7,838
General and administrative
6,099
4,827
Revaluation of contingent consideration
( 1,200 )
16,439
Total costs and expenses
20,360
30,306
Loss from operations
( 18,907 )
( 28,529 )
Other income (expense), net
118
( 225 )
Net loss
$
( 18,789 )
$
( 28,754 )
Net loss per share, basic and diluted
$
( 0.31 )
$
( 0.57 )
Weighted average common shares outstanding, basic and diluted
61,431,026
50,337,807
Other comprehensive loss:
Unrealized loss on marketable securities, net of tax of $ 0
$
( 748 )
$
( 35 )
Foreign currency translation adjustment
—
( 11 )
Total other comprehensive loss
( 748 )
( 46 )
Comprehensive loss
$
( 19,537 )
$
( 28,800 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
STOCKHOLDERS’ EQUITY
(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, 2021
61,228,446
$
1
$
792,971
$
( 224 )
$
( 595,407 )
$
197,341
Issuance of common stock in connection with exercise of stock options and vesting of restricted stock units
509,037
—
49
—
—
49
Unrealized loss on marketable securities
—
—
—
( 748 )
—
( 748 )
Stock-based compensation expense
—
—
2,346
—
—
2,346
Net loss
—
—
—
—
( 18,789 )
( 18,789 )
Balance at March 31, 2022
61,737,483
$
1
$
795,366
$
( 972 )
$
( 614,196 )
$
180,199
Accumulated
Common Stock
Additional
Other
Total
Par
Paid ‑ in
Comprehensive
Accumulated
Stockholders’
Shares
Value
Capital
Income (Loss)
Deficit
Equity
Balance at December 31, 2020
45,109,314
$
—
$
542,286
$
( 94 )
$
( 504,542 )
$
37,650
Issuance of common stock in connection with exercise of stock options and warrants and vesting of restricted stock units
666,144
—
( 2,579 )
—
—
( 2,579 )
Issuance of common stock in connection with public offering, net of offering costs of $ 7,011
6,306,271
—
103,348
—
—
103,348
Unrealized loss on marketable securities
—
—
—
( 35 )
—
( 35 )
Foreign currency translation adjustment
—
—
—
( 11 )
—
( 11 )
Stock-based compensation expense
—
—
2,675
—
—
2,675
Net loss
—
—
—
—
( 28,754 )
( 28,754 )
Balance at March 31, 2021
52,081,729
$
—
$
645,730
$
( 140 )
$
( 533,296 )
$
112,294
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
Three Months Ended
March 31,
2022
2021
Cash flows from operating activities :
Net loss
$
( 18,789 )
$
( 28,754 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
208
288
Stock-based compensation expense
2,346
2,675
Revaluation of contingent consideration
( 1,200 )
16,439
Changes in operating assets and liabilities:
Accounts receivable
( 10 )
( 45 )
Prepaid expenses and other assets
188
( 2,250 )
Accounts payable
( 1,865 )
1,842
Accrued expenses
( 1,847 )
( 2,427 )
Net cash used in operating activities
( 20,969 )
( 12,232 )
Cash flows from investing activities:
Purchases of property and equipment
( 164 )
—
Purchases of marketable securities
( 14,558 )
( 85,814 )
Proceeds from sales and maturities of marketable securities
44,654
10,500
Net cash provided by (used in) investing activities
29,932
( 75,314 )
Cash flows from financing activities:
Proceeds from issuance of common stock in connection with public offerings, net of issuance costs
—
103,348
Restricted stock unit employee tax withholdings
( 7 )
( 3,014 )
Proceeds from exercise of employee stock options and the issuance of stock
37
416
Net cash provided by financing activities
30
100,750
Net increase in cash and cash equivalents
8,993
13,204
Cash and cash equivalents at beginning of period
27,349
22,063
Cash and cash equivalents at end of period
$
36,342
$
35,267
Supplemental disclosure of non-cash investing and financing activities:
Additions to property and equipment included in accounts payable
$
111
$
—
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ACLARIS THERAPEUTICS, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 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 and Confluence are referred to collectively as the “Company.” The Company is a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases. In addition to developing its novel drug candidates, the Company is pursuing strategic alternatives, including identifying and consummating transactions with third-party partners, to further develop, obtain marketing approval for and/or commercialize its novel drug candidates.
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. As of March 31, 2022, the Company had cash, cash equivalents and marketable securities of $ 203.6 million and an accumulated deficit of $ 614.2 million. 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 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, 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 revenue from identifying 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 zunsemetinib (ATI-450), ATI-1777 and ATI-2138, 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 potential 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 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 condensed consolidated financial statements are issued. As of the report date, the Company does not believe that substantial doubt exists about its ability to continue as a going concern. The Company believes its existing 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.
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2. Summary of Significant Accounting Policies
Unaudited Interim Financial Information
The accompanying condensed consolidated balance sheet as of March 31, 2022, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2022 and 2021, the condensed consolidated statement of stockholders’ equity for the three months ended March 31, 2022 and 2021, and the condensed consolidated statements of cash flows for the three months ended March 31, 2022 and 2021 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 February 24, 2022 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 March 31, 2022, the results of its operations and comprehensive loss for the three months ended March 31, 2022 and 2021, its changes in stockholders’ equity for the three months ended March 31, 2022 and 2021 and its cash flows for the three months ended March 31, 2022 and 2021. The condensed consolidated balance sheet data as of December 31, 2021 was derived from audited financial statements but does not include all disclosures required by generally accepted accounting principles in the United States (“GAAP”). The financial data and other information disclosed in these notes related to the three months ended March 31, 2022 and 2021 are unaudited. The results for the three months ended March 31, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, 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, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 24, 2022.
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in conformity with 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 and Confluence. All intercompany transactions have been eliminated. Based upon the Company’s revenue, the Company 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.
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, 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 in economic activity. As of the date of issuance of these financial statements, the Company is not aware of any specific event 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.
Reclassifications
Certain prior year amounts have been reclassified to conform to the current year financial statement presentation.
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Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 24, 2022. Except as set forth below, there have been no changes to the Company’s significant accounting policies from those disclosed in the annual report.
Contingent Consideration
The Company initially recorded a contingent consideration liability at fair value on the date of acquisition related to future potential payments resulting from the acquisition of Confluence based upon significant unobservable inputs including the achievement of development, regulatory and commercial milestones, as well as estimated future sales levels and the discount rates applied to calculate the present value of the potential payments. Significant judgement was involved in determining the appropriateness of these assumptions. These assumptions are considered Level 3 inputs. Revaluation of the contingent consideration liability can result from changes to one or more of these assumptions. The Company evaluates the fair value estimate of the contingent consideration liability on a quarterly basis with changes, if any, recorded as income or expense in the condensed consolidated statement of operations.
The fair value of contingent consideration is estimated using a probability-weighted expected payment model for regulatory milestone payments and a Monte Carlo simulation model for commercial milestone and royalty payments and then applying a risk-adjusted discount rate to calculate the present value of the potential payments. Significant assumptions used in the Company’s estimates include the probability of achieving regulatory milestones and commencing commercialization, which are based on an asset’s current stage of development and a review of existing clinical data. Probability of success assumptions ranged between 10 % and 40 % at March 31, 2022. Additionally, estimated future sales levels and the risk-adjusted discount rate applied to the potential payments are also significant assumptions used in calculating the fair value. The discount rate ranged between 7.7 % and 9.0 % depending on the year of each potential payment .
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 which 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:
March 31, 2022
(In thousands)
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents
$
29,590
$
—
$
—
$
29,590
Marketable securities
—
167,235
—
167,235
Total assets
$
29,590
$
167,235
$
—
$
196,825
Liabilities:
Contingent consideration
$
—
$
—
$
27,200
$
27,200
Total liabilities
$
—
$
—
$
27,200
$
27,200
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December 31, 2021
(In thousands)
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents
$
21,678
$
—
$
—
$
21,678
Marketable securities
—
198,307
—
198,307
Total assets
$
21,678
$
198,307
$
—
$
219,985
Liabilities:
Contingent consideration
$
—
$
—
$
28,400
$
28,400
Total liabilities
$
—
$
—
$
28,400
$
28,400
As of March 31, 2022 and December 31, 2021, the Company’s cash equivalents consisted of a money market fund, which was valued based upon Level 1 inputs. The Company’s marketable securities as of March 31, 2022 and December 31, 2021 consisted of commercial paper and corporate, asset-backed, foreign government agency and U.S. government agency debt securities, which were all 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. 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 the quoted prices provided. The Company evaluates whether adjustments to third-party pricing are necessary and, historically, the Company has not made adjustments to quoted prices obtained from the third-party pricing service. During the three months ended March 31, 2022 and 2021, there were no transfers into or out of Level 3.
The decrease in contingent consideration of $ 1.2 million during the three months ended March 31, 2022 was mainly due to higher discount rates, resulting from higher risk-free rates and wider credit spreads, being applied to potential payments relative to prior periods. The overall decrease in contingent consideration was partially offset by the impact of the passage of time.
As of March 31, 2022 and December 31, 2021, the fair value of the Company’s available-for-sale marketable securities by type of security was as follows:
March 31, 2022
Gross
Gross
Amortized
Unrealized
Unrealized
Fair
(In thousands)
Cost
Gain
Loss
Value
Marketable securities:
Corporate debt securities (1)
$
37,550
$
—
$
( 269 )
$
37,281
Commercial paper
60,919
—
—
60,919
Asset-backed debt securities
20,262
—
( 116 )
20,146
Foreign government agency debt securities
4,075
—
( 38 )
4,037
U.S. government agency debt securities (2)
45,404
—
( 552 )
44,852
Total marketable securities
$
168,210
$
—
$
( 975 )
$
167,235
(1) Included in Corporate debt securities is $ 9.1 million with maturity dates between one and five years.
(2) Included in US government agency debt securities is $ 14.9 million with maturity dates between one and five years.
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December 31, 2021
Gross
Gross
Amortized
Unrealized
Unrealized
Fair
(In thousands)
Cost
Gain
Loss
Value
Marketable securities:
Corporate debt securities (1)
$
40,993
$
6
$
( 50 )
$
40,949
Commercial paper
71,837
—
—
71,837
Asset-backed debt securities
36,166
—
( 43 )
36,123
Foreign government agency debt securities
4,073
—
( 13 )
4,060
U.S. government agency debt securities (2)
45,465
—
( 127 )
45,338
Total marketable securities
$
198,534
$
6
$
( 233 )
$
198,307
(1) Included in Corporate debt securities is $ 9.2 million with maturity dates between one and five years.
(2) Included in US government agency debt securities is $ 25.0 million with maturity dates between one and five years.
4. Property and Equipment, Net
Property and equipment, net consisted of the following:
March 31,
December 31,
(In thousands)
2022
2021
Computer equipment
$
1,373
$
1,380
Lab equipment
1,700
1,605
Furniture and fixtures
620
620
Leasehold improvements
1,123
1,123
Property and equipment, gross
4,816
4,728
Accumulated depreciation
( 3,539 )
( 3,393 )
Property and equipment, net
$
1,277
$
1,335
Depreciation expense was $ 0.2 million for each of the three months ended March 31, 2022 and 2021.
5. Intangible Assets
Intangible assets consisted of the following:
Gross Cost
Accumulated Amortization
Remaining
March 31,
December 31,
March 31,
December 31,
(In thousands, except years)
Life (years)
2022
2021
2022
2021
Other intangible assets
5.3
$
751
$
751
$
350
$
332
In-process research and development
n/a
6,629
6,629
—
—
Total intangible assets
$
7,380
$
7,380
$
350
$
332
Amortization expense was $ 19 thousand for each of the three months ended March 31, 2022 and 2021.
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As of March 31, 2022, estimated future amortization expense was as follows:
Year Ending
(In thousands)
December 31,
2022
$
57
2023
75
2024
75
2025
75
2026
75
Thereafter
44
Total
$
401
6. Accrued Expenses
Accrued expenses consisted of the following:
March 31,
December 31,
(In thousands)
2022
2021
Employee compensation expenses
$
2,184
$
4,389
Research and development expenses
1,824
1,278
Litigation settlements (see Note 16)
—
2,650
Other
1,679
1,734
Total accrued expenses
$
5,687
$
10,051
7. Debt
Loan and Security Agreement – Silicon Valley Bank
In March 2020, the Company entered into a Loan and Security Agreement with Silicon Valley Bank (“SVB”). The Loan and Security Agreement provided for $ 11.0 million in term loans, of which the Company borrowed the entire amount on March 30, 2020. In connection with the Loan and Security Agreement, the Company issued to SVB a warrant to purchase up to 460,251 shares of common stock (the “Warrant”) (see Note 8). The proceeds of the Loan and Security Agreement were allocated to the term loan and Warrant using a relative fair value approach.
In July 2021, the Company repaid in full the $ 11.0 million that was outstanding under the Loan and Security Agreement, together with all accrued and unpaid interest and fees as of the payoff date, for a total payment of $ 11.7 million. Following this repayment, all of the Company’s obligations under the Loan and Security Agreement are deemed to be terminated, except as set forth in the agreement.
8. Stockholders’ Equity
Preferred Stock
As of March 31, 2022 and December 31, 2021, the Company’s amended and restated certificate of incorporation authorized the Company to issue 10,000,000 shares of undesignated preferred stock. There were no shares of preferred stock outstanding as of March 31, 2022 or December 31, 2021.
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Common Stock
As of March 31, 2022 and December 31, 2021, 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. There were 61,737,483 and 61,228,446 shares of common stock issued and outstanding as of March 31, 2022 and December 31, 2021, respectively.
Each share of common stock entitles the holder to one 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, subject to any preferential dividend rights of any series of preferred stock that may be outstanding. No dividends have been declared through March 31, 2022.
Warrants
The Warrant issued to SVB in March 2020 had an initial exercise price of $ 0.956 per share, subject to adjustment as provided in the Warrant. The Warrant became immediately exercisable in full upon the funding of the term loan facility. The Company assigned a fair value of $ 0.4 million to the Warrant using a Black-Scholes valuation methodology, and also concluded that the Warrant was indexed to its own stock and therefore classified the Warrant as an equity instrument. In January 2021, SVB net exercised the Warrant in full, and the Company issued to SVB 388,119 shares of common stock.
January 2021 Public Offering
In January 2021, the Company closed a public offering in which it sold 6,306,271 shares of common stock at a price to the public of $ 17.50 per share, for aggregate gross proceeds of $ 110.4 million. The Company paid underwriting discounts and commissions of $ 6.6 million, and also incurred expenses of $ 0.4 million in connection with the offering. As a result, the net offering proceeds received by the Company, after deducting underwriting discounts, commissions and offering expenses, were $ 103.3 million.
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, restricted 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 31st 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, 2022, the number of shares of common stock that may be issued under the 2015 Plan was automatically increased by 2,449,137 shares. As of March 31, 2022, 3,685,011 shares remained available for grant under the 2015 Plan. The Company had 3,957,556 stock options and 1,394,476 RSUs outstanding as of March 31, 2022 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 410,600 stock options and 5,575 RSUs outstanding as of March
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31, 2022 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, no 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 484,145 were outstanding as of March 31, 2022. Stock options granted under the 2012 Plan expire after ten years .
Stock Option Valuation
The weighted average assumptions the Company used to estimate the fair value of stock options granted during the three months ended March 31, 2022 and 2021 were as follows:
Three Months Ended
March 31,
2022
2021
Risk-free interest rate
1.60
%
0.90
%
Expected term (in years)
6.3
6.3
Expected volatility
77.95
%
76.60
%
Expected dividend yield
0
%
0
%
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 for the three months ended March 31, 2022:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Number
Exercise
Contractual
Intrinsic
(In thousands, except share and per share data and years)
of Shares
Price
Term
Value
(in years)
Outstanding as of December 31, 2021
3,792,450
$
17.50
6.8
$
13,710
Granted
1,459,600
14.53
Exercised
( 29,040 )
1.26
476
Forfeited and cancelled
( 370,709 )
14.41
Outstanding as of March 31, 2022
4,852,301
$
16.94
7.0
$
18,355
Options vested and expected to vest as of March 31, 2022
4,852,301
$
16.94
7.0
$
18,355
Options exercisable as of March 31, 2022
2,600,651
$
17.92
4.9
$
11,400
The weighted average grant date fair value of stock options granted during the three months ended March 31, 2022 was $ 9.97 per share.
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Restricted Stock Units
The following table summarizes RSU activity for the three months ended March 31, 2022:
Weighted
Average
Grant Date
Aggregate
Number
Fair Value
Intrinsic
(In thousands, except share and per share data)
of Shares
Per Share
Value
Outstanding as of December 31, 2021
1,496,946
$
12.75
Granted
552,900
14.56
Vested
( 479,232 )
10.84
$
7,128
Forfeited and cancelled
( 170,563 )
12.10
Outstanding as of March 31, 2022
1,400,051
$
14.20
Stock-Based Compensation
Stock-based compensation expense included in total costs and expenses on the condensed consolidated statement of operations included the following:
Three Months Ended
March 31,
(In thousands)
2022
2021
Cost of revenue
$
228
$
247
Research and development
( 113 )
876
General and administrative
2,231
1,552
Total stock-based compensation expense
$
2,346
$
2,675
As of March 31, 2022, the Company had unrecognized stock-based compensation expense for stock options and RSUs of $ 23.2 million and $ 18.6 million, respectively, which is expected to be recognized over weighted average periods of 3.5 years and 3.2 years, respectively.
10. Net Loss per Share
Basic and diluted net loss per share is summarized in the following table:
Three Months Ended
March 31,
(In thousands, except for share and per share data)
2022
2021
Numerator:
Net loss
$
( 18,789 )
$
( 28,754 )
Denominator:
Weighted average shares of common stock outstanding, basic and diluted
61,431,026
50,337,807
Net loss per share, basic and diluted
$
( 0.31 )
$
( 0.57 )
The Company’s potentially dilutive securities, which included stock options and RSUs, 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 is the same. The following table presents potential shares of common stock excluded from the calculation of diluted
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net loss per share for the three months ended March 31, 2022 and 2021. All share amounts presented in the table below represent the total number outstanding as of March 31, 2022 and 2021.
March 31,
2022
2021
Options to purchase common stock
4,852,301
3,714,466
Restricted stock unit awards
1,400,051
2,411,611
Total potential shares of common stock
6,252,352
6,126,077
11. Leases
Operating Leases
Agreements for Office and Laboratory Space
The Company has 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. The sublease has a term that runs through October 2023. If for any reason the lease between Chesterbrook Partners, LP (“Landlord”) and Sublandlord is terminated or expires prior to October 2023, the Company’s sublease will automatically terminate. In December 2020, the Company entered into a sub-sublease agreement under which it sub-subleased 8,115 square feet to a third party. The sub-sublease term runs concurrently with the original sublease agreement.
In February 2019, the Company entered into a sublease agreement with a third party for 20,433 square feet of office and laboratory space in St. Louis, 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:
March 31,
December 31,
(In thousands)
2022
2021
Operating Leases:
Gross cost
$
5,240
$
5,240
Accumulated amortization
( 1,986 )
( 1,803 )
Other assets
$
3,254
$
3,437
Current portion of lease liabilities
$
716
$
693
Other liabilities
2,015
2,201
Total operating lease liabilities
$
2,731
$
2,894
Amortization expense related to operating lease right-of-use assets and accretion of operating lease liabilities totaled $ 0.3 million for each of the three months ended March 31, 2022 and 2021.
12. Agreements Related to Intellectual Property
Asset Purchase Agreement – EPI Health, LLC
In October 2019, the Company sold RHOFADE (oxymetazoline hydrochloride) cream, 1 % (“RHOFADE”) to EPI Health, LLC (“EPI Health”) pursuant to an asset purchase agreement. EPI Health agreed to pay the Company a high single-digit royalty calculated as a percentage of net sales on a country-by-country basis until the date that the patent rights related to RHOFADE have expired or, if later, ten years from the date of the first commercial sale of RHOFADE in such country. The Company recorded royalty income under the asset purchase agreement of $ 0.2 million during each of the
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three months ended March 31, 2022 and 2021. Royalty income is included in other revenue on the condensed consolidated statements of operations and comprehensive loss. EPI Health has also agreed to pay the Company potential sales milestone payments of up to $ 20.0 million 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”). Under the Confluence Agreement, the Company agreed to pay the former Confluence equity holders aggregate remaining contingent consideration of up to $ 75.0 million based upon the achievement of specified regulatory and commercial milestones set forth in the Confluence Agreement. In addition, the Company agreed to pay the former Confluence equity holders future royalty payments calculated as 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. In addition to the payments described above, 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.
As of March 31, 2022 and December 31, 2021, the balance of the Company’s contingent consideration liability was $ 27.2 million and $ 28.4 million, respectively (see Note 3).
13. Income Taxes
The Company did not record a federal or state income tax benefit for losses incurred during the three months ended March 31, 2022 and 2021. The Company concluded that it is more likely than not that its deferred tax assets will not be realized which resulted in recording a full valuation allowance during those periods.
14. Discontinued Operations
The following table presents information related to liabilities reported as discontinued operations in the Company’s condensed consolidated balance sheet:
March 31,
December 31,
(In thousands)
2022
2021
Accrued expenses
$
2,202
$
2,202
Discontinued operations - current liabilities
$
2,202
$
2,202
15. Segment Information
The Company has two reportable segments, therapeutics and contract research. The therapeutics segment is focused on identifying and developing innovative therapies to address significant unmet needs for immuno-inflammatory diseases. The contract research segment earns revenue from the provision of laboratory services. 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.
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The Company’s results of operations by segment for the three months ended March 31, 2022 and 2021 are summarized in the tables below:
(In thousands)
Contract
Corporate
Total
Three Months Ended March 31, 2022
Therapeutics
Research
and Other
Company
Total revenue
$
231
$
4,096
$
( 2,874 )
$
1,453
Cost of revenue
—
3,854
( 2,699 )
1,155
Research and development
14,481
—
( 175 )
14,306
General and administrative
—
840
5,259
6,099
Revaluation of contingent consideration
( 1,200 )
—
—
( 1,200 )
Loss from operations
$
( 13,050 )
$
( 598 )
$
( 5,259 )
$
( 18,907 )
(In thousands)
Contract
Corporate
Total
Three Months Ended March 31, 2021
Therapeutics
Research
and Other
Company
Total revenue
$
242
$
3,200
$
( 1,665 )
$
1,777
Cost of revenue
—
2,769
( 1,567 )
1,202
Research and development
7,936
—
( 98 )
7,838
General and administrative
—
629
4,198
4,827
Revaluation of contingent consideration
16,439
—
—
16,439
Loss from operations
$
( 24,133 )
$
( 198 )
$
( 4,198 )
$
( 28,529 )
Intersegment Revenue
Revenue for the contract research segment included $ 2.9 million and $ 1.7 million for services performed on behalf of the therapeutics segment for the three months ended March 31, 2022 and 2021, respectively. All intersegment revenue has been eliminated in the Company’s condensed consolidated statement of operations.
16. Legal Proceedings
Securities Class Action
On July 30, 2019, plaintiff Linda Rosi (“Rosi”) filed a putative 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 complaint alleged that the defendants violated federal securities laws by, among other things, failing to disclose an alleged likelihood that regulators would scrutinize advertising materials related to ESKATA (hydrogen peroxide) topical solution, 40% (w/w) (“ESKATA”) and find that the materials minimized the risks or overstated the efficacy of the product. The complaint sought unspecified compensatory damages on behalf of Rosi and all other persons and entities that purchased or otherwise acquired the Company’s securities between May 8, 2018 and June 20, 2019.
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 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. Following briefing and oral argument on February 25, 2021, the motion was granted in part and denied in part on March 29, 2021, and the issues in dispute significantly narrowed. The defendants filed an answer to the remaining aspects of the consolidated amended complaint on April 19, 2021.
In June 2021, the defendants and the plaintiffs agreed to settle the Consolidated Securities Action. The parties signed and filed a settlement agreement in July 2021. On August 18, 2021, the court preliminarily approved the proposed
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settlement, directed that notice be given to the putative class and scheduled the final approval settlement hearing for November 30, 2021. Notice was subsequently given to the putative class. The court granted final approval of the settlement on December 9, 2021.
The Company’s financial obligation under the settlement was $ 2.7 million which was within the limits of its insurance coverage.
17. Subsequent Event
Sales of Common Stock Pursuant to At-The-Market Facility
In April 2022, the Company sold 4,838,709 shares of its common stock at a weighted average price per share of $ 15.50 , for aggregate gross proceeds of $ 75.0 million, pursuant to a sales agreement with SVB Securities LLC and Cantor Fitzgerald & Co., as sales agents, dated May 20, 2021. The Company paid selling commissions of $ 2.2 million in connection with the sale.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.