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 March 31, 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 $0.00001 per share, as of the close of business on May 7, 2018 was 30,906,003.
ACLARIS THERAPEUTICS, INC.
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share data)
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March 31, |
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December 31, |
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2018 |
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2017 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
54,881 |
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$ |
20,202 |
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Marketable securities |
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132,096 |
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173,655 |
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Accounts receivable, net |
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529 |
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481 |
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Prepaid expenses and other current assets |
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4,750 |
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5,883 |
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Total current assets |
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192,256 |
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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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2,191 |
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2,159 |
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Intangible assets |
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7,330 |
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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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341 |
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279 |
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Total assets |
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$ |
220,622 |
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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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$ |
8,155 |
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$ |
7,822 |
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Accrued expenses |
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5,668 |
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4,940 |
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Total current liabilities |
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13,823 |
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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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534 |
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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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20,150 |
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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 March 31, 2018 and December 31, 2017 |
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— |
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— |
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Common stock, $0.00001 par value; 100,000,000 shares authorized at March 31, 2018 and December 31, 2017; 30,905,629 and 30,856,505 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively |
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— |
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— |
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Additional paid‑in capital |
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390,464 |
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384,943 |
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Accumulated other comprehensive loss |
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(328) |
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(246) |
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Accumulated deficit |
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(189,664) |
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(159,435) |
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Total stockholders’ equity |
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200,472 |
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225,262 |
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Total liabilities and stockholders’ equity |
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$ |
220,622 |
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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 STATEMENTS 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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March 31, |
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2018 |
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2017 |
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Revenue |
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$ |
1,118 |
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$ |
— |
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Cost of revenue |
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967 |
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— |
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Gross profit |
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151 |
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— |
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Operating expenses: |
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Research and development |
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13,606 |
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7,772 |
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Sales and marketing |
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11,233 |
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1,438 |
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General and administrative |
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6,260 |
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3,720 |
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Total operating expenses |
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31,099 |
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12,930 |
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Loss from operations |
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(30,948) |
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(12,930) |
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Other income, net |
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719 |
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371 |
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Net loss |
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$ |
(30,229) |
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$ |
(12,559) |
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Net loss per share, basic and diluted |
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$ |
(0.98) |
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$ |
(0.48) |
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Weighted average common shares outstanding, basic and diluted |
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30,885,928 |
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26,080,806 |
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Other comprehensive loss: |
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Unrealized loss on marketable securities, net of tax of $0 |
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$ |
(65) |
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$ |
(52) |
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Foreign currency translation adjustments |
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(17) |
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72 |
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Total other comprehensive (loss) income |
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(82) |
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20 |
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Comprehensive loss |
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$ |
(30,311) |
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$ |
(12,539) |
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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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49,124 |
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— |
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378 |
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— |
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— |
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378 |
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Unrealized loss on marketable securities |
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— |
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— |
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— |
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(65) |
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— |
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(65) |
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Foreign currency translation adjustment |
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— |
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— |
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— |
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(17) |
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— |
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(17) |
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Stock-based compensation expense |
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— |
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— |
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5,143 |
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— |
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— |
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5,143 |
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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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(30,229) |
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(30,229) |
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Balance at March 31, 2018 |
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30,905,629 |
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$ |
— |
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$ |
390,464 |
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$ |
(328) |
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$ |
(189,664) |
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$ |
200,472 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ACLARIS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
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Three Months Ended |
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March 31, |
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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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$ |
(30,229) |
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$ |
(12,559) |
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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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222 |
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50 |
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Stock-based compensation expense |
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5,143 |
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3,153 |
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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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Prepaid expenses and other assets |
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1,022 |
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(2,597) |
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Accounts payable |
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316 |
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|
831 |
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Accrued expenses |
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|
788 |
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(1,537) |
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Net cash used in operating activities |
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(21,872) |
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(12,659) |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(298) |
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(195) |
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Purchases of marketable securities |
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(35,614) |
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(17,158) |
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Proceeds from sales and maturities of marketable securities |
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92,105 |
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23,309 |
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Net cash provided by investing activities |
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56,193 |
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5,956 |
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Cash flows from financing activities: |
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Capital lease payments |
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(36) |
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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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209 |
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Net cash provided by financing activities |
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358 |
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209 |
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Net increase (decrease) in cash and cash equivalents |
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34,679 |
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(6,494) |
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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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$ |
54,881 |
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$ |
23,677 |
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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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$ |
210 |
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$ |
91 |
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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. (see Note 12). 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 and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology. 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 commercial product sales of 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 March 31, 2018, the Company had cash, cash equivalents and marketable securities of $186,977 and an accumulated deficit of $189,664. Since inception, the Company has incurred net losses and negative cash flows from its operations. Prior to the acquisition of Confluence in August 2017, the Company had never generated any revenue. There can be no assurance that profitable operations will ever be achieved, and, if achieved, will be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, 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 financial statements include the consolidated accounts of the Company 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 estimates and assumptions reflected in these financial statements include, but are not limited to, research and development
6
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 March 31, 2018, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2018 and 2017, the condensed consolidated statement of stockholders’ equity for the three months ended March 31, 2018, and the condensed consolidated statements of cash flows for the three months ended March 31, 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 March 31, 2018, the results of its operations and comprehensive loss for the three months ended March 31, 2018 and 2017 and its cash flows for the three months ended March 31, 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 months ended March 31, 2018 and 2017 are unaudited. The results for the three months ended March 31, 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 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 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 performance obligation is satisfied. The Company only recognizes revenue when collection of the consideration it is
7
entitled to under a contract with a customer is probable.
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”). The Company, through its Confluence subsidiary, currently has two active grants from NIH which are related to early-stage research. The Company recognizes revenue related to these grants as amounts become reimbursable under each grant, which is generally when research is performed and the related costs are incurred.
Intangible Assets
Intangible assets include both finite-lived and indefinite-lived assets. Finite-lived intangible assets are amortized over their estimated useful life based on the pattern over which the intangible assets are consumed or otherwise used up. If that pattern cannot be reliably determined, the straight-line method of amortization is used. Finite-lived intangible assets consist of a research technology platform the Company acquired through the acquisition of Confluence. Indefinite-lived intangible assets consist of an in-process research and development (“IPR&D”) drug candidate acquired through the acquisition of Confluence. IPR&D assets are considered indefinite-lived until the completion or abandonment of the associated research and development efforts. The cost of IPR&D assets is either amortized over their estimated useful life beginning when the underlying drug candidate is approved and launched commercially, or expensed immediately if development of the drug candidate is abandoned.
Finite-lived intangible assets are tested for impairment when events or changes in circumstances indicate that the carrying value of the asset may not be recoverable. Indefinite-lived intangible assets are tested for impairment at least annually, which the Company performs during the fourth quarter, or when indicators of an impairment are present. The Company recognizes impairment losses when and to the extent that the estimated fair value of an indefinite-lived intangible asset is less than its carrying value.
Goodwill
Goodwill is not amortized, but rather is subject to testing for impairment at least annually, which the Company performs during the fourth quarter, or when indicators of an impairment are present. The Company considers each of its operating segments, dermatology therapeutics and contract research, to be a reporting unit since this is the lowest level for which discrete financial information is available. The Company has attributed the full amount of the goodwill acquired with Confluence, or $18,504, to the dermatology therapeutics segment. The annual impairment test performed by the Company is a qualitative assessment based upon current facts and circumstances related to operations of the dermatology therapeutics segment. If the qualitative assessment indicates an impairment may be present, the Company would perform the required quantitative analysis and an impairment charge would be recognized to the extent that the estimated fair value of the reporting unit is less than its carrying amount. However, any loss recognized would not exceed the total amount of goodwill allocated to that reporting unit.
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
8
the payment of the contingent consideration and the passage of time. Future changes in the fair value of the contingent consideration, if any, will be recorded as income or expense in the Company’s consolidated statement of operations.
Segment Data
The Company operates in two segments, dermatology therapeutics and contract research, for the purposes of assessing performance and making operating decisions. The Company’s dermatology therapeutics segment, which did not generate any revenue through March 31, 2018, is focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology and immunology. The Company’s contract research segment is focused on providing laboratory services under contract research arrangements to pharmaceutical and biotech companies looking to supplement their research and development efforts with difficult-to-execute specialty skills and programs.
Recently Issued Accounting Pronouncements
In January 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 expects to finalize its allocation of the purchase price upon the finalization of valuations for the identified intangible assets, final resolution of the post-closing working capital adjustment and certain tax accounts that are based on the best estimates of management. The completion and filing of federal and state tax returns for the acquired entity may result in adjustments to the carrying value of assets and liabilities.
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.
|
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Three Months Ended |
|
||||
|
|
March 31, |
|
||||
|
|
2018 |
|
2017 |
|
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Revenue |
|
$ |
1,118 |
|
$ |
1,236 |
|
Gross profit |
|
|
151 |
|
|
563 |
|
Total operating expenses |
|
|
31,099 |
|
|
13,607 |
|
Net loss |
|
|
(30,229) |
|
|
(12,673) |
|
The supplemental unaudited pro forma financial results for the three months ended March 31, 2017 include adjustments to exclude $301 of revenue billed to the Company by Confluence. The supplemental unaudited pro forma financial results for the three months ended March 31, 2017 also includes an adjustment for amortization expense related to the other intangible assets 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:
|
|
March 31, 2018 |
|
||||||||||
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
36,035 |
|
$ |
17,471 |
|
$ |
— |
|
$ |
53,506 |
|
Marketable securities |
|
|
— |
|
|
132,096 |
|
|
— |
|
|
132,096 |
|
Total Assets |
|
$ |
36,035 |
|
$ |
149,567 |
|
$ |
— |
|
$ |
185,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 March 31, 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 and asset-backed securities, which were valued based upon Level 2 inputs. In determining the fair value of its Level 2 investments the Company relied on quoted prices for identical securities in markets that are not active. These quoted prices were obtained by the Company with the assistance of a third-party pricing service based on available trade, bid and other observable market data for identical securities. On a quarterly basis, 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 months ended March 31, 2018 and the year ended December 31, 2017, there were no transfers between Level 1, Level 2 and Level 3.
As of March 31, 2018 and December 31, 2017, the fair value of the Company’s available for sale marketable securities by type of security was as follows:
|
|
March 31, 2018 |
|
||||||||||
|
|
|
|
|
Gross |
|
Gross |
|
|
|
|
||
|
|
Amortized |
|
Unrealized |
|
Unrealized |
|
Fair |
|
||||
|
|
Cost |
|
Gain |
|
Loss |
|
Value |
|
||||
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
$ |
36,733 |
|
$ |
— |
|
$ |
(115) |
|
$ |
36,618 |
|
Commercial paper |
|
|
48,610 |
|
|
— |
|
|
(3) |
|
|
48,607 |
|
Asset-backed securities |
|
|
21,003 |
|
|
— |
|
|
(35) |
|
|
20,968 |
|
U.S. government agency debt securities |
|
|
25,985 |
|
|
— |
|
|
(82) |
|
|
25,903 |
|
Total marketable securities |
|
$ |
132,331 |
|
$ |
— |
|
$ |
(235) |
|
$ |
132,096 |
|
|
|
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:
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2018 |
|
2017 |
|
||
Computer equipment |
|
$ |
817 |
|
$ |
650 |
|
Manufacturing equipment |
|
|
562 |
|
|
511 |
|
Lab equipment |
|
|
721 |
|
|
721 |
|
Furniture and fixtures |
|
|
524 |
|
|
327 |
|
Leasehold improvements |
|
|
250 |
|
|
430 |
|
Property and equipment, gross |
|
|
2,874 |
|
|
2,639 |
|
Accumulated depreciation |
|
|
(683) |
|
|
(480) |
|
Property and equipment, net |
|
$ |
2,191 |
|
$ |
2,159 |
|
Depreciation expense was $203 and $50 for the three months ended March 31, 2018 and 2017, respectively.
6. Accrued Expenses
Accrued expenses consisted of the following:
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2018 |
|
2017 |
|
||
Employee compensation expenses |
|
$ |
2,999 |
|
$ |
3,010 |
|
Research and development expenses |
|
|
1,362 |
|
|
627 |
|
Sales and marketing expenses |
|
|
521 |
|
|
39 |
|
Payable to NST |
|
|
— |
|
|
590 |
|
Vixen contract payable |
|
|
100 |
|
|
100 |
|
Capital leases, current portion |
|
|
142 |
|
|
142 |
|
Other |
|
|
544 |
|
|
432 |
|
Total accrued expenses |
|
$ |
5,668 |
|
$ |
4,940 |
|
7. Stockholders’ Equity
Preferred Stock
As of March 31, 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 March 31, 2018 or December 31, 2017.
Common Stock
As of March 31, 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. No dividends have been declared through March 31, 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 three months ended March 31, 2018, the Company did not issue any shares of common stock under the at-the-market sales agreement. As of March 31, 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 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 March 31, 2018, 150,624 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 expire, are otherwise terminated, settled in cash or repurchased by the Company under the 2015 Plan and the 2012 Plan
13
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 March 31, 2018, 1,599,031 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 March 31, 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:
|
|
Three Months Ended |
|
||||
|
|
March 31, |
|
||||
|
|
2018 |
|
|
2017 |
|
|
Risk-free interest rate |
|
2.61 |
% |
|
2.10 |
% |
|
Expected term (in years) |
|
6.3 |
|
|
6.0 |
|
|
Expected volatility |
|
95.60 |
% |
|
95.20 |
% |
|
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 March 31, 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 |
|
1,090,000 |
|
|
22.17 |
|
|
|
|
|
|
Exercised |
|
(46,700) |
|
|
8.43 |
|
|
|
|
|
|
Forfeited and cancelled |
|
(25,147) |
|
|
28.40 |
|
|
|
|
|
|
Outstanding as of March 31, 2018 |
|
4,346,910 |
|
$ |
21.15 |
|
8.60 |
|
$ |
10,779 |
|
Options vested and expected to vest as of March 31, 2018 |
|
4,346,910 |
|
$ |
21.15 |
|
8.60 |
|
$ |
10,779 |
|
Options exercisable as of March 31, 2018 |
|
1,265,616 |
(1) |
$ |
15.33 |
|
7.55 |
|
$ |
8,066 |
|
(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 March 31, 2018. |
14
The weighted average grant date fair value of stock options granted during the three months ended March 31, 2018 was $17.43 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 March 31, 2018:
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Grant Date |
|
|
|
|
Number |
|
Fair Value |
|
|
|
|
of Shares |
|
Per Share |
|
|
Outstanding as of December 31, 2017 |
|
283,553 |
|
$ |
27.02 |
|
Granted |
|
317,360 |
|
|
22.14 |
|
Vested |
|
(3,150) |
|
|
20.39 |
|
Forfeited and cancelled |
|
(2,500) |
|
|
23.62 |
|
Outstanding as of March 31, 2018 |
|
595,263 |
|
$ |
24.46 |
|
Stock‑Based Compensation
The following table summarizes stock‑based compensation expense recorded by the Company:
|
|
Three Months Ended |
|
||||
|
|
March 31, |
|
||||
|
|
2018 |
|
2017 |
|
||
Cost of revenue |
|
$ |
176 |
|
$ |
— |
|
Research and development |
|
|
1,727 |
|
|
1,217 |
|
Sales and marketing |
|
|
907 |
|
|
380 |
|
General and administrative |
|
|
2,333 |
|
|
1,556 |
|
Total stock-based compensation expense |
|
$ |
5,143 |
|
$ |
3,153 |
|
As of March 31, 2018, the Company had unrecognized stock‑based compensation expense for stock options and RSUs of $50,862 and $11,752, respectively, which is expected to be recognized over weighted average periods of 3.12 years and 3.41 years, respectively.
15
9. Net Loss per Share
Basic and diluted net loss per share is summarized in the following table:
|
|
Three Months Ended |
|
||||
|
|
March 31, |
|
||||
|
|
2018 |
|
2017 |
|
||
Numerator: |
|
|
|
|
|
|
|
Net loss |
|
$ |
(30,229) |
|
$ |
(12,559) |
|
Denominator: |
|
|
|
|
|
|
|
Weighted average shares of common stock outstanding |
|
|
30,885,928 |
|
|
26,080,806 |
|
Net loss per share, basic and diluted |
|
$ |
(0.98) |
|
$ |
(0.48) |
|
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 net loss per share for the three months ended March 31, 2018 and 2017. All share amounts presented in the table below represent the total number outstanding as of March 31, 2018 and 2017.
|
|
Three Months Ended |
|
||
|
|
March 31, |
|
||
|
|
2018 |
|
2017 |
|
Options to purchase common stock |
|
4,346,910 |
|
2,656,941 |
|
Restricted stock unit awards |
|
595,263 |
|
214,343 |
|
Total potential shares of common stock |
|
4,942,173 |
|
2,871,284 |
|
10. Commitments and Contingencies
Agreements for Office Space
In November 2017, the Company entered into a sublease agreement with Auxilium Pharmaceuticals, LLC (the “Sublandlord”) pursuant to which it subleases 33,019 square feet of office space for its headquarters in Wayne, Pennsylvania. Subject to the consent of Chesterbrook Partners, LP (“Landlord”) as set forth in the lease by and between them and Sublandlord, the sublease has a term that runs through October 2023. If for any reason the lease between the Landlord and Sublandlord is terminated or expires prior to October 2023, the Company’s sublease will automatically terminate.
In November 2016, the Company entered into a lease agreement with a third party for additional office space in Malvern, Pennsylvania with a term ending in November 2019. The Company also occupies office and laboratory space in St. Louis, Missouri under the terms of an agreement which it entered into in January 2018 and which expires in December 2018.
Rent expense was $276 and $84 for the three months ended March 31, 2018 and 2017, respectively. The Company recognizes rent expense on a straight-line basis over the term of the lease and has accrued for rent expense incurred but not yet paid.
16
As of March 31, 2018, future minimum lease payments under these agreements were as follows:
Year Ending December 31, |
|
|
|
|
2018 |
|
$ |
568 |
|
2019 |
|
|
627 |
|
2020 |
|
|
589 |
|
2021 |
|
|
605 |
|
2022 |
|
|
622 |
|
Thereafter |
|
|
532 |
|
Total |
|
$ |
3,543 |
|
Capital Leases for Laboratory Equipment
The Company leases laboratory equipment which is used in its laboratory space in St. Louis, Missouri under two capital lease financing arrangements which the Company entered into in August 2017 and October 2017, respectively. The capital leases have terms which end in October 2020 and December 2020, respectively.
11. Related Party Transactions
In August 2013, the Company entered into a sublease agreement with NeXeption, Inc. ("NeXeption"), which was subsequently assigned to NST Consulting, LLC, a wholly-owned subsidiary of NST, LLC. In November 2017, the Company terminated the sublease with NST Consulting, LLC effective March 31, 2018. The Company agreed to pay $590 to NST Consulting, LLC, which amount represents accelerated rent payments. Total payments made under the sublease during the three months ended March 31, 2018 and 2017 were $570 and $75, respectively.
In February 2014, the Company entered into a services agreement with NST, LLC (the “NST Services Agreement”), pursuant to which NST, LLC provided certain pharmaceutical development, management and other administrative services to the Company. Under the same agreement, the Company also provided services to another company under common control with the Company and NST, LLC and was reimbursed by NST, LLC for those services. In November 2017, the Company terminated the NST Services Agreement effective December 31, 2017.
Mr. Stephen Tullman, the chairman of the Company’s board of directors, was an executive officer of NeXeption and is also the manager of NST Consulting, LLC and NST, LLC, and three of the Company’s executive officers are and have been members of entities affiliated with NST, LLC.
During the three months ended March 31, 2018 and 2017, amounts included in the condensed consolidated statement of operations and comprehensive loss for the NST Services Agreement are summarized in the following table:
|
|
Three Months Ended |
|
|
||||
|
|
March 31, |
|
|
||||
|
|
2018 |
|
2017 |
|
|
||
Services provided by NST Consulting, LLC |
|
$ |
— |
|
$ |
56 |
|
|
Services provided to NST Consulting, LLC |
|
|
— |
|
|
(11) |
|
|
General and administrative expense, net |
|
$ |
— |
|
$ |
45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net payments made to NST Consulting, LLC |
|
$ |
— |
|
$ |
135 |
|
|
The Company had a net amount payable of $0 and $570 to NST Consulting, LLC under the NST Services Agreement as of March 31, 2018 and December 31, 2017, respectively.
17
12. Agreements Related to Intellectual Property
Assignment Agreement and Finder’s Services Agreement
In August 2012, the Company entered into an assignment agreement with the Estate of Mickey Miller, or the Miller Estate, under which the Company acquired some of the intellectual property rights covering A-101. In connection with obtaining the assignment of the intellectual property from the Miller Estate, the Company also entered into a separate finder’s services agreement with KPT Consulting, LLC. In February 2016, under the terms of the assignment agreement and the finder’s services agreement, the Company made a milestone payment of $300 upon the dosing of the first human subject with ESKATA in the Company’s Phase 3 clinical trial. In April 2017, the Company made an additional milestone payment of $1,000 upon the achievement of specified regulatory milestones. The payments were recorded as general and administrative expenses in the Company’s condensed consolidated statement of operations.
Under the finder’s services agreement, the Company is obligated to make additional milestone payments of up to $4,500 upon the achievement of specified commercial milestones. Under each of the assignment agreement and the finder’s services agreement, the Company is also obligated to pay royalties on sales of A-101 or related products, at low single-digit percentages of net sales, subject to reduction in specified circumstances. The Company has not made any royalty payments to date under either agreement. Both agreements will terminate upon the expiration of the last pending, viable patent claim of the patents acquired under the assignment