Full Press Release Details
Aclaris Therapeutics Reports First Quarter 2018 Financial Results and Provides Update on Clinical and Commercial Developments
Wayne, PA May 8, 2018 (GLOBE NEWSWIRE) Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology, and immunology, today announced financial results for the first quarter 2018 and provided an update on its clinical development and commercial programs.
The first quarter of 2018 was a busy one as we prepared for the launch of ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w), the first and only FDA-approved topical treatment for raised seborrheic keratosis (SK). We held the ESKATA Launch Meeting last week, and ESKATA is now officially available for physicians and their patients, said Brett Fair, Chief Commercial Officer of Aclaris.
In March, we announced positive results from the 3-month follow-up portion of the WART-203 Phase 2 clinical trial of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts (verruca vulgaris). We are also advancing our topical Janus kinase (JAK) inhibitor programs, with results from multiple Phase 2 trials expected this year. As our early-stage pipeline compounds advance towards the clinic, we continue to progress towards our goal of becoming a vertically integrated, commercial-stage biopharmaceutical company with a robust clinical-stage pipeline and drug discovery engine, said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.
Clinical Pipeline Update:
Recent Corporate Highlights
Financial Highlights
Liquidity and Capital Resources
As of March 31, 2018, Aclaris had aggregate cash, cash equivalents and marketable securities of $187.0 million compared to $208.9 million as of December 31, 2017. The $21.9 million decrease during the quarter ended March 31, 2018 included:
Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2018 will be sufficient to fund its operations into the second half of 2019, without giving effect to any potential new business development transactions or financing activities.
First Quarter 2018 Financial Results
2018 Financial Outlook
Company to Host Conference Call
Management will conduct a conference call at 5:00 P.M. ET today to discuss Aclaris' financial results and provide a general business update. The conference 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 7386579 prior to the start of the call.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology, and immunology. Aclaris is focused on market segments with no FDA-approved medications or where treatment gaps exist. Aclaris is based in Wayne, Pennsylvania and more information about the company can be found by visiting the Aclaris website at www.aclaristx.com.
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 Aclaris' commercial launch of ESKATA, the clinical development of its drug candidates, including the availability of data from its ongoing and planned clinical trials and timing for initiation of planned clinical trials, estimated research and development and selling, general and administrative expenses for 2018 and its belief that its existing capital resources will be sufficient to fund its operations into the second half of 2019. 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, 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, 2017, Aclaris' Quarterly Report on Form 10-Q for the quarter ended March 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 "Financial Information" 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.
Senior Vice President
Corporate Strategy/Investor Relations
Aclaris Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenue | $ | 1,118 | $ | - | ||||
| Cost of revenue | 967 | |||||||
| Gross profit | 151 | |||||||
| Operating expenses: | ||||||||
| Research and development (1) | 13,606 | 7,772 | ||||||
| Sales and marketing (1) | 11,233 | 1,438 | ||||||
| General and administrative (1) | 6,260 | 3,720 | ||||||
| Total operating expenses | 31,099 | 12,930 | ||||||
| Loss from operations | (30,948) | (12,930) | ||||||
| Other income, net | 719 | 371 | ||||||
| Net loss | $ | (30,229) | $ | (12,559) | ||||
| Net loss per share, basic and diluted | $ | (0.98) | $ | (0.48) | ||||
| Weighted average common shares outstanding, basic and diluted | 30,885,928 | 26,080,806 | ||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||
| 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 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
| March 31, 2018 | December 31, 2017 | ||||||
| Cash, cash equivalents and marketable securities | $ | 186,977 | $ | 208,854 | |||
| Total assets | 220,622 | 243,509 | |||||
| Total current liabilities | 13,823 | 12,762 | |||||
| Total liabilities | 20,150 | 18,247 | |||||
| Total stockholders' equity | 200,472 | 225,262 |