Full Press Release Details
Aclaris Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Highlights and an Update on R&D Programs
| Completed Strategic Review and Announced Refocusing of Resources on Immuno-inflammatory Development Pipeline | |||
| Divested RHOFADE (oxymetazoline hydrochloride) cream, 1% | |||
| Repaid $30 Million Term Loan | |||
| Successful Pivotal Phase 3 Clinical Trials of A-101 45% Topical Solution as a Potential Treatment for Common Warts (THWART-1 and THWART-2) | |||
| Management to Host Conference Call at 5:00 PM ET today |
Wayne, PA November 7, 2019 (GLOBE NEWSWIRE) Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced its financial results for the third quarter of 2019 and provided business highlights and an update on its research and development programs.
Business Highlights:
R&D Program Updates:
We are excited with the progress we have made toward executing on our new business strategy, with our first step being the divestiture of RHOFADE, said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. With the success of our two pivotal Phase 3 trials for A-101 45% Topical Solution, which has the potential to be the first FDA-approved prescription treatment for common warts, we believe this program will be of interest to potential commercial partners. In September, we presented our new focus on immuno-inflammatory diseases at our R&D day. We look forward to reporting the results of our Phase 1 trial for ATI-450 by the end of the first quarter of 2020 and providing further updates on the execution of our new strategy, said Dr. Walker.
Clinical Pipeline Update:
Financial Highlights:
Liquidity and Capital Resources
As of September 30, 2019, Aclaris had aggregate cash, cash equivalents and marketable securities of $91.4 million compared to $168.0 million as of December 31, 2018. For the quarter and nine months ended September 30, 2019, net cash used in operating activities was $23.4 million and $76.1 million, respectively. As of September 30, 2019, Aclaris had approximately 41.4 million shares of common stock outstanding.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2019, after giving effect to both the upfront payment from the sale of RHOFADE and the full repayment of the loan facility with Oxford Finance LLC, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential new business development transactions or financing activities.
Third Quarter 2019 and Year-to-Date Financial Results
2019 Financial Outlook and Cash Runway
Company to Host Conference Call
Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris' financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the Investors page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.
To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 2698128 prior to the start of the call.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes one late-stage investigational drug candidate and a pipeline powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn or Twitter @aclaristx.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as believe, expect, intend, may, plan, potential, will, and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding seeking a third-party partner to commercialize A-101 45% Topical Solution, further develop and commercialize ATI-501 and ATI-502 and commercialize ESKATA, the clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials, timing for initiation or completion of clinical trials and timing for regulatory filings, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the third quarter of 2021. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and the commercialization of products, Aclaris' reliance on third parties over which it may not always have full control, Aclaris' ability to enter into strategic partnerships on commercially reasonable terms and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K for the year ended December 31, 2018, the Form
10-Q for the quarter ended September 30, 2019 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "SEC filings section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Aclaris Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||
| Revenues: | ||||||||||||
| Product sales, net | $ | $ | $ | $ | ||||||||
| Contract research | 983 | 1,118 | 3,132 | 3,379 | ||||||||
| Other revenue | 1,000 | |||||||||||
| Total revenues, net | 983 | 1,118 | 3,132 | 4,379 | ||||||||
| Costs and expenses: | ||||||||||||
| Cost of revenue (1) | 826 | 1,067 | 3,028 | 3,063 | ||||||||
| Research and development (1) | 16,183 | 15,189 | 53,334 | 41,482 | ||||||||
| Sales and marketing (1) | 112 | 63 | 629 | 89 | ||||||||
| General and administrative (1) | 6,726 | 6,141 | 21,142 | 20,481 | ||||||||
| Goodwill impairment | 18,504 | |||||||||||
| Amortization of definite-lived intangible | ||||||||||||
| Total costs and expenses | 23,847 | 22,460 | 96,637 | 65,115 | ||||||||
| Loss from operations | (22,864) | (21,342) | (93,505) | (60,736) | ||||||||
| Other (expense) income, net | (274) | 710 | (589) | 2,189 | ||||||||
| Loss from continuing operations | (23,138) | (20,632) | (94,094) | (58,547) | ||||||||
| Loss from discontinued operations (1) | (32,181) | (12,108) | (48,666) | (35,640) | ||||||||
| Net loss | $ | (55,319) | $ | (32,740) | $ | (142,760) | $ | (94,187) | ||||
| Net loss per share, basic and diluted | $ | (1.34) | $ | (1.06) | $ | (3.46) | $ | (3.04) | ||||
| Weighted average common shares outstanding, basic and diluted | 41,364,387 | 30,982,192 | 41,296,377 | 30,938,026 | ||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||
| Cost of revenue | $ | 25 | $ | 194 | $ | 454 | $ | 560 | ||||
| Research and development | 1,418 | 1,433 | 4,733 | 4,916 | ||||||||
| Sales and marketing | ||||||||||||
| General and administrative | 2,581 | 2,320 | 7,707 | 6,936 | ||||||||
| Loss from discontinued operations | (704) | 760 | 102 | 2,687 | ||||||||
| Total stock-based compensation expense | $ | 3,320 | $ | 4,707 | $ | 12,996 | $ | 15,099 |
Aclaris Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(unaudited, in thousands)
| September 30, 2019 | December 31, 2018 | ||||||
| Cash, cash equivalents and marketable securities | $ | 91,428 | $ | 167,972 | |||
| Total assets | 160,416 | 275,566 | |||||
| Total current liabilities | 38,989 | 27,342 | |||||
| Total liabilities | 75,141 | 60,442 | |||||
| Total stockholders' equity | 85,275 | 215,124 |
Corporate Strategy / Investor Relations