UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10‑Q
(Mark one) |
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☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2018 |
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OR |
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☐ |
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) 324‑7933
N/A
(Former name, former address and former fiscal year, if changed since last report)
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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S‑T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non‑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‑2 of the Securities Exchange Act of 1934:
Large accelerated filer ☐ |
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Accelerated filer ☒ |
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Non-accelerated filer ☐ |
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Smaller reporting company ☐ |
(Do not check if a smaller reporting company) |
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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 $0.00001 per share, as of the close of business on August 2, 2018 was 30,980,663.
ACLARIS THERAPEUTICS, INC.
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEET
(Unaudited)
(In thousands, except share and per share data)
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June 30, |
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December 31, |
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2018 |
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2017 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
46,035 |
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$ |
20,202 |
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Marketable securities |
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118,569 |
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173,655 |
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Accounts receivable, net |
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2,182 |
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481 |
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Inventory |
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1,026 |
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— |
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Prepaid expenses and other current assets |
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3,360 |
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5,883 |
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Total current assets |
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171,172 |
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200,221 |
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Marketable securities |
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— |
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14,997 |
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Property and equipment, net |
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4,375 |
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2,159 |
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Intangible assets |
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7,311 |
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7,349 |
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Goodwill |
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18,504 |
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18,504 |
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Other assets |
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457 |
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279 |
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Total assets |
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$ |
201,819 |
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$ |
243,509 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
12,504 |
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$ |
7,822 |
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Accrued expenses |
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7,565 |
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4,940 |
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Total current liabilities |
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20,069 |
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12,762 |
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Contingent consideration |
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5,244 |
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4,378 |
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Other liabilities |
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1,754 |
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558 |
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Deferred tax liability |
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549 |
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549 |
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Total liabilities |
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27,616 |
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18,247 |
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Stockholders’ Equity: |
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Preferred stock, $0.00001 par value; 10,000,000 shares authorized and no shares issued or outstanding at June 30, 2018 and December 31, 2017 |
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— |
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— |
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Common stock, $0.00001 par value; 100,000,000 shares authorized at June 30, 2018 and December 31, 2017; 30,965,296 and 30,856,505 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively |
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— |
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— |
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Additional paid‑in capital |
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395,273 |
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384,943 |
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Accumulated other comprehensive loss |
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(188) |
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(246) |
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Accumulated deficit |
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(220,882) |
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(159,435) |
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Total stockholders’ equity |
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174,203 |
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225,262 |
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Total liabilities and stockholders’ equity |
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$ |
201,819 |
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$ |
243,509 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share data)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2018 |
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2017 |
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2018 |
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2017 |
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Revenues: |
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ESKATA product sales, net |
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$ |
1,533 |
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$ |
— |
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$ |
1,533 |
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$ |
— |
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Contract research |
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1,143 |
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— |
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2,261 |
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— |
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Other revenue |
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1,000 |
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— |
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1,000 |
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— |
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Total revenue, net |
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3,676 |
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— |
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4,794 |
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— |
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Cost of revenue |
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1,181 |
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— |
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2,148 |
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— |
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Gross profit |
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2,495 |
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— |
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2,646 |
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— |
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Operating expenses: |
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Research and development |
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13,984 |
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7,965 |
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27,590 |
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15,737 |
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Sales and marketing |
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12,368 |
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2,188 |
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23,601 |
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3,626 |
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General and administrative |
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8,121 |
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5,142 |
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14,381 |
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8,862 |
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Total operating expenses |
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34,473 |
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15,295 |
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65,572 |
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28,225 |
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Loss from operations |
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(31,978) |
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(15,295) |
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(62,926) |
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(28,225) |
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Other income, net |
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760 |
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457 |
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1,479 |
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828 |
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Net loss |
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$ |
(31,218) |
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$ |
(14,838) |
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$ |
(61,447) |
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$ |
(27,397) |
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Net loss per share, basic and diluted |
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$ |
(1.01) |
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$ |
(0.56) |
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$ |
(1.99) |
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$ |
(1.04) |
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Weighted average common shares outstanding, basic and diluted |
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30,944,899 |
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26,594,854 |
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30,915,577 |
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26,339,250 |
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Other comprehensive income: |
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Unrealized gain (loss) on marketable securities, net of tax of $0 |
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$ |
111 |
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$ |
(4) |
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$ |
46 |
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$ |
(56) |
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Foreign currency translation adjustments |
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28 |
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87 |
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12 |
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159 |
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Total other comprehensive income |
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139 |
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83 |
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58 |
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103 |
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Comprehensive loss |
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$ |
(31,079) |
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$ |
(14,755) |
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$ |
(61,389) |
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$ |
(27,294) |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENT OF
(Unaudited)
(In thousands, except share data)
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Accumulated |
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Common Stock |
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Additional |
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Other |
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Total |
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Par |
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Paid‑in |
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Comprehensive |
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Accumulated |
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Stockholders’ |
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Shares |
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Value |
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Capital |
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Loss |
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Deficit |
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Equity |
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Balance at December 31, 2017 |
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30,856,505 |
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$ |
— |
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$ |
384,943 |
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$ |
(246) |
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$ |
(159,435) |
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$ |
225,262 |
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Exercise of stock options and vesting of RSUs |
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108,791 |
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— |
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(62) |
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— |
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— |
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(62) |
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Unrealized gain on marketable securities |
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— |
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— |
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— |
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46 |
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— |
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46 |
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Foreign currency translation adjustment |
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— |
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— |
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— |
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12 |
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— |
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12 |
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Stock-based compensation expense |
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— |
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— |
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10,392 |
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— |
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— |
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10,392 |
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Net loss |
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— |
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— |
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— |
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— |
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(61,447) |
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(61,447) |
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Balance at June 30, 2018 |
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30,965,296 |
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$ |
— |
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$ |
395,273 |
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$ |
(188) |
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$ |
(220,882) |
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$ |
174,203 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
(In thousands)
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Six Months Ended |
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June 30, |
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2018 |
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2017 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(61,447) |
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$ |
(27,397) |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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537 |
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105 |
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Stock-based compensation expense |
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10,392 |
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6,457 |
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Change in fair value of contingent consideration |
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866 |
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— |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(1,701) |
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— |
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Inventory |
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(1,026) |
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— |
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Prepaid expenses and other assets |
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2,345 |
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(3,897) |
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Accounts payable |
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4,693 |
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3,161 |
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Accrued expenses |
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1,636 |
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(1,168) |
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Net cash used in operating activities |
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(43,705) |
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(22,739) |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(650) |
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(388) |
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Purchases of marketable securities |
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(74,246) |
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(41,534) |
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Proceeds from sales and maturities of marketable securities |
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144,375 |
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47,652 |
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Net cash provided by investing activities |
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69,479 |
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5,730 |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock under the at-the-market sales agreement, net of issuance costs |
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— |
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19,311 |
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Capital lease payments |
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(335) |
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— |
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Proceeds from the exercise of employee stock options |
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394 |
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235 |
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Net cash provided by financing activities |
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59 |
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19,546 |
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Net increase in cash and cash equivalents |
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|
25,833 |
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2,537 |
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Cash and cash equivalents at beginning of period |
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|
20,202 |
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30,171 |
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Cash and cash equivalents at end of period |
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$ |
46,035 |
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$ |
32,708 |
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Supplemental disclosure of non-cash investing and financing activities: |
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Additions to property and equipment included in accounts payable |
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$ |
442 |
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$ |
190 |
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Property and equipment obtained pursuant to capital lease financing arrangements |
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$ |
1,896 |
|
$ |
— |
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Offering costs included in accounts payable |
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$ |
20 |
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$ |
— |
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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
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. In August 2017, Aclaris Life Sciences Inc. (formerly known as Confluence Life Sciences Inc.) (“Confluence”) was acquired by Aclaris Therapeutics, Inc. and became a wholly-owned subsidiary thereof (see Note 3). Aclaris Therapeutics, Inc., ATIL, Vixen and Confluence are referred to collectively as the “Company”. The Company is a dermatologist-led biopharmaceutical company focused on identifying, developing and commercializing innovative therapies to address significant unmet needs in medical and aesthetic dermatology and immunology. The Company’s lead drug, ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w) (“ESKATA”), is a proprietary high‑concentration formulation of hydrogen peroxide that the Company is commercializing as an office-based prescription treatment for raised seborrheic keratosis (“SK”), a common non‑malignant skin tumor. The Company submitted a New Drug Application (“NDA”) for ESKATA to the U.S. Food and Drug Administration (“FDA”) in February 2017, and it was approved in December 2017. The Company launched ESKATA in May 2018.
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. At June 30, 2018, the Company had cash, cash equivalents and marketable securities of $164,604 and an accumulated deficit of $220,882. Since inception, the Company has incurred net losses and negative cash flows from its operations. Prior to the acquisition of Confluence in August 2017, and the commercial launch of ESKATA in May 2018, 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, clinical and preclinical testing of the Company’s drug candidates, and commercialization of the Company’s products will require significant additional financing. The future viability of the Company is dependent on its ability to generate cash from operating activities or to raise additional capital to finance its 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.
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. All significant intercompany transactions have been eliminated.
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
6
estimates and assumptions reflected in these financial statements include, but are not limited to, 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. Actual results could differ from the Company’s estimates.
Unaudited Interim Financial Information
The accompanying condensed consolidated balance sheet as of June 30, 2018, the condensed consolidated statement of operations and comprehensive loss for the three and six months ended June 30, 2018 and 2017, the condensed consolidated statement of stockholders’ equity for the six months ended June 30, 2018, and the condensed consolidated statement of cash flows for the six months ended June 30, 2018 and 2017 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 12, 2018 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, 2018, the results of its operations and comprehensive loss for the three and six months ended June 30, 2018 and 2017 and its cash flows for the six months ended June 30, 2018 and 2017. The condensed consolidated balance sheet data as of December 31, 2017 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, 2018 and 2017 are unaudited. The results for the three and six months ended June 30, 2018 are not necessarily indicative of results to be expected for the year ending December 31, 2018, 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, 2017 included in the Company’s annual report on Form 10-K filed with the SEC on March 12, 2018.
Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2017 included in the Company’s annual report on Form 10-K filed with the SEC on March 12, 2018. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies other than those noted below.
In February 2017, the Company paid a $2.0 million Prescription Drug User Fee Act (“PDUFA”) fee to the FDA in conjunction with the filing of its NDA for ESKATA. The Company requested a waiver and refund of this PDUFA fee, which was approved by the FDA in December 2017, and was received by the Company in January 2018.
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.
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
7
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.
ESKATA Product Sales
The Company sells ESKATA to McKesson Specialty Care Distribution (“McKesson”) which resells ESKATA to healthcare providers, group purchasing organizations (“GPOs”) and hospitals. The Company has entered into an agreement directly with one GPO, and may enter into additional agreements directly with other GPOs and corporate accounts, that provide for discounted pricing in the form of volume-based rebates and chargebacks, and administrative fees. The Company does not accept product returns.
The Company recognizes revenue from sales of ESKATA at the point when control has transferred to the customer, which generally occurs when McKesson takes delivery of the product. The Company includes estimates for variable consideration, including rebates, chargebacks and administrative fees, as a reduction of revenue when it is recognized. Estimates of variable consideration include reserves for rebates, chargebacks and administrative fees related to units remaining in the distribution channel at McKesson. The Company considers all relevant factors when estimating variable consideration including the terms of current contracts, market trends, industry data and forecasted buying patterns as available and appropriate.
The Company has determined that its arrangement with McKesson, its only direct customer, does not include a financing component since payment terms under the agreement do not exceed one year. The Company expenses incremental costs of contracts with direct and indirect customers, which generally include sales commissions, in the period they are incurred.
Contract Research
The Company earns revenue from the provision of laboratory services to clients through Confluence, its wholly-owned subsidiary. Laboratory service 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 laboratory service revenue. The Company recognizes laboratory service revenue in the amount to which it has the right to invoice.
The Company also receives 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, through Confluence, its wholly-owned subsidiary, had two active grants from NIH which were related to early-stage research. 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.
Inventory
Inventory includes the third-party cost of manufacturing and assembly of the finished product form of ESKATA, quality control and other overhead costs. Inventory is stated at the lower of cost or market. 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 $1,026 and $0 of inventory as of June 30, 2018 and December 31, 2017, respectively, which was comprised solely of finished goods.
8
Contingent Consideration
The Company initially recorded the contingent consideration related to future potential payments based upon the achievement of certain development, regulatory and commercial milestones, resulting from the acquisition of Confluence, at its estimated fair value on the date of acquisition. Changes in fair value reflect 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.
Recently Issued Accounting Pronouncements
In June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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, and early adoption is permitted. The Company is evaluating the impact of ASU 2018-07 on its consolidated financial statements.
In January 2017, the FASB issued ASU 2017-01, Business Combinations-Clarifying the Definition of a Business (Topic 805). The amendments in this ASU provide a screen to determine when a set of acquired assets and/or activities is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired, or disposed of, is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. The amendments in this ASU will reduce the number of transactions that meet the definition of a business. ASU 2017-01 is effective for annual reporting periods beginning after December 15, 2017, including interim periods within those years, and early adoption will be permitted. The Company adopted the provisions of this standard on January 1, 2018, the impact of which on its consolidated financial statements was not significant.
In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). Under this ASU, entities should recognize revenue in an amount that reflects the consideration to which they expect to be entitled to in exchange for goods and services provided. ASU 2014-09 is effective for annual reporting periods beginning after December 15, 2017. The Company adopted the provisions of this standard on January 1, 2018, using the modified retrospective transition method. The Company did not recognize any transition adjustments as a result of adopting ASU 2014-09 and, accordingly, comparative information has not been restated for the periods reported.
3. Acquisition of Confluence
In August 2017, the Company acquired Confluence, at which time, Confluence became a wholly-owned subsidiary of the Company. The Company gave aggregate consideration with a fair value of $24,322 to the equity holders of Confluence. The Company also agreed to pay the Confluence equity holders contingent consideration of up to $80,000, based upon the achievement of certain development, regulatory and commercial milestones, including $2,500 of which may be paid in shares of the Company’s common stock upon the achievement of a specified development milestone. In addition, the Company has agreed to pay the Confluence equity holders specified 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.
9
The following table summarizes the fair value of total consideration given to the Confluence equity holders in connection with the acquisition:
Cash consideration paid |
|
$ |
10,269 |
Aclaris common stock issued |
|
|
9,675 |
Contingent consideration |
|
|
4,378 |
Total fair value of consideration to Confluence equity holders |
|
$ |
24,322 |
The Company accounted for the acquisition of Confluence as a business combination using the acquisition method of accounting. Under the acquisition method of accounting, the assets acquired and liabilities assumed in this transaction were recorded at their respective fair values on the date of acquisition using assumptions that are subject to change. The Company finalized the purchase price allocation for the acquisition of Confluence in the second quarter of 2018.
The following supplemental unaudited pro forma information presents the Company’s financial results, for the periods presented, as if the acquisition of Confluence had occurred on January 1, 2017. This supplemental unaudited pro forma financial information has been prepared for comparative purposes only, and is not necessarily indicative of what actual results would have been had the acquisition of Confluence occurred on January 1, 2017, nor is this information indicative of future results.
|
|
Three Months Ended |
|
Six Months Ended |
||||||||
|
|
June 30, |
|
June 30, |
||||||||
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
||||
Revenue |
|
$ |
3,676 |
|
$ |
1,067 |
|
$ |
4,794 |
|
$ |
2,303 |
Gross profit |
|
|
995 |
|
|
243 |
|
|
1,146 |
|
|
805 |
Total operating expenses |
|
|
32,973 |
|
|
16,133 |
|
|
64,072 |
|
|
29,449 |
Net loss |
|
|
(31,218) |
|
|
(15,432) |
|
|
(61,447) |
|
|
(28,106) |
The supplemental unaudited pro forma financial results for the three and six months ended June 30, 2017 include adjustments to exclude $370 and $670, respectively, of revenue billed to the Company by Confluence. The supplemental unaudited pro forma financial results for the three and six months ended June 30, 2017 also include an adjustment for amortization expense related to the other intangible asset acquired.
4. Fair Value of Financial Assets and Liabilities
The following tables present information about the Company’s assets and liabilities, which are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values:
|
|
June 30, 2018 |
|
||||||||||
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
33,722 |
|
$ |
11,182 |
|
$ |
— |
|
$ |
44,904 |
|
Marketable securities |
|
|
— |
|
|
118,569 |
|
|
— |
|
|
118,569 |
|
Total Assets |
|
$ |
33,722 |
|
$ |
129,751 |
|
$ |
— |
|
$ |
163,473 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration |
|
$ |
— |
|
$ |
— |
|
$ |
5,244 |
|
$ |
5,244 |
|
Total liabilities |
|
$ |
— |
|
$ |
— |
|
$ |
5,244 |
|
$ |
5,244 |
|
10
|
|
December 31, 2017 |
|
||||||||||
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
19,339 |
|
$ |
— |
|
$ |
— |
|
$ |
19,339 |
|
Marketable securities |
|
|
— |
|
|
188,652 |
|
|
— |
|
|
188,652 |
|
Total Assets |
|
$ |
19,339 |
|
$ |
188,652 |
|
$ |
— |
|
$ |
207,991 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related contingent consideration |
|
$ |
— |
|
$ |
— |
|
$ |
4,378 |
|
$ |
4,378 |
|
Total liabilities |
|
$ |
— |
|
$ |
— |
|
$ |
4,378 |
|
$ |
4,378 |
|
As of June 30, 2018 and December 31, 2017, the Company’s cash equivalents consisted of investments with maturities of less than three months and included a money market fund, which was valued based upon Level 1 inputs, and commercial paper which was 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, the Company compares the quoted prices obtained from the third-party pricing service to other available independent pricing information to validate the reasonableness of those quoted prices. 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 three and six months ended June 30, 2018 and the year ended December 31, 2017, there were no transfers between Level 1, Level 2 and Level 3. The change in contingent consideration related to acquisition of Confluence of $866 during the six months ended June 30, 2018 was the result of updates to the Company’s assumptions related to drug discovery research on the soft-JAK inhibitors, which progressed more quickly than originally planned.
The following tables present the fair value of the Company’s available for sale marketable securities by type of security:
|
|
June 30, 2018 |
|
||||||||||
|
|
|
|
|
Gross |
|
Gross |
|
|
|
|
||
|
|
Amortized |
|
Unrealized |
|
Unrealized |
|
Fair |
|
||||
|
|
Cost |
|
Gain |
|
Loss |
|
Value |
|
||||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
$ |
18,084 |
|
$ |
— |
|
$ |
(59) |
|
$ |
18,025 |
|
Commercial paper |
|
|
53,626 |
|
|
— |
|
|
— |
|
|
53,626 |
|
Asset-backed securities |
|
|
22,021 |
|
|
— |
|
|
(16) |
|
|
22,005 |
|
U.S. government agency debt securities |
|
|
24,962 |
|
|
1 |
|
|
(50) |
|
|
24,913 |
|
Total marketable securities |
|
$ |
118,693 |
|
$ |
1 |
|
$ |
(125) |
|
$ |
118,569 |
|
|
|
December 31, 2017 |
|
||||||||||
|
|
|
|
|
Gross |
|
Gross |
|
|
|
|
||
|
|
Amortized |
|
Unrealized |
|
Unrealized |
|
Fair |
|
||||
|
|
Cost |
|
Gain |
|
Loss |
|
Value |
|
||||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
$ |
37,401 |
|
$ |
— |
|
$ |
(68) |
|
$ |
37,333 |
|
Commercial paper |
|
|
85,202 |
|
|
— |
|
|
— |
|
|
85,202 |
|
Asset-backed securities |
|
|
16,708 |
|
|
— |
|
|
(13) |
|
|
16,695 |
|
U.S. government agency debt securities |
|
|
49,511 |
|
|
— |
|
|
(89) |
|
|
49,422 |
|
Total marketable securities |
|
$ |
188,822 |
|
$ |
— |
|
$ |
(170) |
|
$ |
188,652 |
|
11
5. Property and Equipment, Net
Property and equipment, net consisted of the following:
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2018 |
|
2017 |
|
||
Computer equipment |
|
$ |
1,276 |
|
$ |
650 |
|
Fleet vehicles |
|
|
1,896 |
|
|
— |
|
Manufacturing equipment |
|
|
562 |
|
|
511 |
|
Lab equipment |
|
|
838 |
|
|
721 |
|
Furniture and fixtures |
|
|
523 |
|
|
327 |
|
Leasehold improvements |
|
|
259 |
|
|
430 |
|
Property and equipment, gross |
|
|
5,354 |
|
|
2,639 |
|
Accumulated depreciation |
|
|
(979) |
|
|
(480) |
|
Property and equipment, net |
|
$ |
4,375 |
|
$ |
2,159 |
|
Depreciation expense was $296 and $55 for the three months ended June 30, 2018 and 2017, respectively, and $499 and $105 for the six months ended June 30, 2018 and 2017, respectively.
6. Accrued Expenses
Accrued expenses consisted of the following:
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2018 |
|
2017 |
|
||
Employee compensation expenses |
|
$ |
3,922 |
|
$ |
3,010 |
|
Sales and marketing expenses |
|
|
1,237 |
|
|
39 |
|
Research and development expenses |
|
|
938 |
|
|
627 |
|
Capital leases, current portion |
|
|
552 |
|
|
142 |
|
Professional fees |
|
|
389 |
|
|
108 |
|
Payable to NST |
|
|
— |
|
|
590 |
|
Other |
|
|
527 |
|
|
424 |
|
Total accrued expenses |
|
$ |
7,565 |
|
$ |
4,940 |
|
7. Stockholders’ Equity
Preferred Stock
As of June 30, 2018 and December 31, 2017, the Company’s amended and restated certificate of incorporation authorized the Company to issue 10,000,000 shares of undesignated preferred stock. No shares of preferred stock were outstanding as of June 30, 2018 or December 31, 2017.
Common Stock
As of June 30, 2018 and December 31, 2017, 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 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. The Company did not declare any dividends through June 30, 2018.
12
At-The-Market Equity Offering
In November 2016, the Company entered into an at-the-market sales agreement with Cowen and Company, LLC to sell the Company’s securities under a shelf registration statement filed in November 2016. During the six months ended June 30, 2018, the Company did not issue any shares of common stock under the at-the-market sales agreement. As of June 30, 2018, the Company had issued and sold an aggregate of 635,000 shares of common stock under the at-the-market sales agreement at a weighted average price per share of $31.50, for aggregate gross proceeds of $20,003. The Company has incurred expenses of $691 in connection with the shares issued under the at-the-market sales agreement.
Public Offering of Common Stock
In August 2017, the Company entered into an underwriting agreement pursuant to which the Company issued and sold 3,747,602 shares of common stock under a registration statement on Form S-3 (the “Public Offering”), including the underwriters’ partial exercise of their option to purchase additional shares. The shares of common stock were sold to the public at a price of $23.02 per share, for gross proceeds of $86,270.
The Company paid underwriting discounts and commissions of $5,176 to the underwriters in connection with the Public Offering. In addition, the Company incurred expenses of $176 in connection with the Public Offering. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and offering expenses, were $80,918.
8. Stock‑Based Awards
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-shareholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules. The only employees eligible to receive grants of awards under the 2017 Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq listing rules, generally including individuals who were not previously an employee or director of the Company. Under the terms of the 2017 Inducement Plan upon adoption, the Company may grant up to 1,000,000 shares of common stock pursuant to nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit (“RSU”) awards, and other stock awards. The shares of common stock underlying any awards that expire, or are otherwise terminated, settled in cash or repurchased by the Company under the 2017 Inducement Plan will be added back to the shares of common stock available for issuance under the 2017 Inducement Plan. As of June 30, 2018, 112,224 shares of common stock were available for grant under the 2017 Inducement Plan.
2015 Equity Incentive Plan
In September 2015, the Company’s board of directors adopted the 2015 Equity Incentive Plan (the “2015 Plan”), and on September 16, 2015, 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, 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, beginning on January 1, 2016 and 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
13
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, 2018, the number of shares of common stock that may be issued under the 2015 Plan was automatically increased by 1,234,260 shares. As of June 30, 2018, 1,671,239 shares remained available for grant under the 2015 Plan.
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 957,013 and 984,720 were outstanding as of June 30, 2018 and December 31, 2017, respectively. Stock options granted under the 2012 Plan vest 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.
Stock Option Valuation
The weighted average assumptions the Company used to estimate the fair value of stock options granted were as follows:
|
|
Six Months Ended |
|
||||
|
|
June 30, |
|
||||
|
|
2018 |
|
|
2017 |
|
|
Risk-free interest rate |
|
2.63 |
% |
|
1.93 |
% |
|
Expected term (in years) |
|
6.3 |
|
|
6.0 |
|
|
Expected volatility |
|
95.78 |
% |
|
94.09 |
% |
|
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 from January 1, 2018 through June 30, 2018:
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
||
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
||
|
|
of Shares |
|
Price |
|
Term |
|
Value |
|
||
|
|
|
|
|
|
|
(in years) |
|
|
|
|
Outstanding as of December 31, 2017 |
|
3,328,757 |
|
$ |
20.69 |
|
8.28 |
|
$ |
19,812 |
|
Granted |
|
1,215,000 |
|
|
21.70 |
|
|
|
|
|
|
Exercised |
|
(46,700) |
|
|
8.43 |
|
|
|
|
|
|
Forfeited and cancelled |
|
(181,115) |
|
|
24.79 |
|
|
|
|
|
|
Outstanding as of June 30, 2018 |
|
4,315,942 |
|
$ |
20.93 |
|
8.34 |
|
$ |
13,650 |
|
Options vested and expected to vest as of June 30, 2018 |
|
4,315,942 |
|
$ |
20.93 |
|
8.34 |
|
$ |
13,650 |
|
Options exercisable as of June 30, 2018 |
|
1,377,080 |
(1) |
$ |
15.25 |
|
7.21 |
|
$ |
10,725 |
|
(1) |
All options granted under the 2012 Plan are exercisable immediately, subject to a repurchase right in the Company’s favor that lapses as the option vests. This amount reflects the number of shares under options that were vested, as opposed to exercisable, as of June 30, 2018. |
14
The weighted average grant date fair value of stock options granted during the six months ended June 30, 2018 was $17.04 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.
Restricted Stock Units
The following table summarizes RSU activity from January 1, 2018 through June 30, 2018:
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Grant Date |
|
|
|
|
Number |
|
Fair Value |
|
|
|
|
of Shares |
|
Per Share |
|
|
Outstanding as of December 31, 2017 |
|
283,553 |
|
$ |
27.02 |
|
Granted |
|
357,360 |
|
|
21.62 |
|
Vested |
|
(87,357) |
|
|
27.13 |
|
Forfeited and cancelled |
|
(20,800) |
|
|
23.70 |
|
Outstanding as of June 30, 2018 |
|
532,756 |
|
$ |
23.51 |
|
Stock‑Based Compensation
The following table summarizes stock‑based compensation expense recorded by the Company:
|
|
Three Months Ended |
|
Six Months Ended |
|
||||||||
|
|
June 30, |
|
June 30, |
|
||||||||
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
||||
Cost of revenue |
|
$ |
190 |
|
$ |
— |
|