Full Press Release Details
Aclaris Therapeutics Reports First Quarter 2019 Financial Results and Provides Update on Clinical and Commercial Developments
| Submitted IND for ATI-450, an oral MK2 inhibitor | |||
| RHOFADE net sales of $3.7 million for the first quarter of 2019 | |||
| Management to Host Conference Call at 5:00 PM ET today |
Wayne, PA May 8, 2019 (GLOBE NEWSWIRE) Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced its financial results for the first quarter of 2019, and provided an update on its clinical development and commercial programs.
Our development stage pipeline continues to advance with multiple data read outs expected during the course of the year across both our Phase 2 and Phase 3 clinical programs. Additionally, we are excited to move ATI-450, our first internally generated asset, into the clinic in the second half of this year. Our drug discovery engine continues to be productive and we look forward to developing small molecule therapeutics for many inflammatory conditions that need new treatment approaches. Finally, we are pleased with the reception to the relaunch and continued growth of RHOFADE through the first quarter, said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.
Clinical Pipeline Update:
Financial Highlights:
Liquidity and Capital Resources
As of March 31, 2019, Aclaris had aggregate cash, cash equivalents and marketable securities of $136.8 million compared to $168.0 million as of December 31, 2018. The $31.2 million decrease during the quarter ended March 31, 2019 included:
Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2019 will be sufficient to fund its operations into the fourth quarter of 2020, without giving effect to any potential new business development transactions or financing activities.
First Quarter 2019 Financial Results
2019 Financial Outlook
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 5737199 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 people with immuno-inflammatory and dermatological diseases who lack satisfactory treatment options. The company's diverse and multi-stage portfolio includes two FDA-approved medicines, one late-stage investigational medicine, and a pipeline powered by a robust R&D engine exploring protein kinase regulation. Aclaris Therapeutics' active development programs focus on areas where significant treatment gaps exist, such as common warts, alopecia areata, and vitiligo. 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", "may", "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the commercialization of Aclaris' marketed products, the clinical development of Aclaris' drug candidates, including the availability of data from its ongoing and planned clinical
trials, timing for initiation of planned clinical trials and timing for regulatory submissions, estimated research and development, sales and marketing and general and administrative expenses for 2019 and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the fourth quarter of 2020. 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 in commercialization of products, Aclaris' reliance on third parties over which it may not always have full control, 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 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.
Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended | ||||||
| March 31, | ||||||
| 2019 | 2018 | |||||
| Revenues: | ||||||
| Product sales, net | $ | 3,778 | $ | - | ||
| Contract research | 1,263 | 1,118 | ||||
| Total revenues, net | 5,041 | 1,118 | ||||
| Costs and expenses: | ||||||
| Cost of revenues (excludes amortization) (1) | 2,777 | 967 | ||||
| Research and development (1) | 19,919 | 13,606 | ||||
| Sales and marketing (1) | 9,828 | 11,233 | ||||
| General and administrative (1) | 8,193 | 6,260 | ||||
| Amortization of definite-lived intangible assets | 1,659 | - | ||||
| Total costs and expenses | 42,376 | 32,066 | ||||
| Loss from operations | (37,335) | (30,948) | ||||
| Other income (expense), net | (230) | 719 | ||||
| Net loss | $ | (37,565) | $ | (30,229) | ||
| Net loss per share, basic and diluted | $ | (0.91) | $ | (0.98) | ||
| Weighted average common shares outstanding, basic and diluted | 41,248,663 | 30,885,928 | ||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||
| Cost of revenue | $ | 206 | $ | 176 | ||
| Research and development | 1,594 | 1,727 | ||||
| Sales and marketing | 590 | 907 | ||||
| General and administrative | 2,472 | 2,333 | ||||
| Total stock-based compensation expense | $ | 4,862 | $ | 5,143 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
| March 31, 2019 | December 31, 2018 | |||||
| Cash, cash equivalents and marketable securities | $ | 136,755 | $ | 167,972 | ||
| Total assets | 253,183 | 275,566 | ||||
| Total current liabilities | 36,228 | 27,342 | ||||
| Total liabilities | 70,930 | 60,442 | ||||
| Total stockholders' equity | 182,253 | 215,124 |
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