Full Press Release Details
Aclaris Therapeutics Reports Third Quarter 2018 Financial Results and Provides Update on Clinical and Commercial Developments
Management to Host Conference Call at 5:00 PM ET today
Wayne, PA November 6, 2018 (GLOBE NEWSWIRE) Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, today announced financial results for the third quarter of 2018 and provided an update on its clinical development and commercial programs.
This is an exciting time for Aclaris. With the anticipated closing of the acquisition of RHOFADE in the fourth quarter, we will take another major step toward establishing ourselves as a fully integrated biopharmaceutical company with multiple commercial products, 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:
Third Quarter 2018 Financial Results
Liquidity and Capital Resources
As of September 30, 2018, Aclaris had aggregate cash, cash equivalents and marketable securities of $134.3 million compared to $208.9 million as of December 31, 2017.
Aclaris anticipates that its cash, cash equivalents and marketable securities balances, including the proceeds from the public offering of common stock in October and the initial drawdown from the loan facility with Oxford, will be sufficient to fund its operations into the second half of 2020, without giving effect to any potential new business development transactions or financing activities.
2018 Financial Outlook
| Current | Previous | |||||
| GAAP R&D Expense | $62 $64 million | $67 $75 million | ||||
| GAAP R&D Stock-based Compensation | $7 million | $9 million | ||||
| GAAP SG&A Expense | $77 $79 million | $80 $86 million | ||||
| GAAP SG&A Stock-based Compensation | $14 million | $14 million |
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 7694929 prior to the start of the call.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology. Aclaris' focus on market segments with no FDA-approved medications or where treatment gaps exist has resulted in the first FDA-approved treatment for raised SKs and several clinical programs to develop medications for the potential treatment of common warts, alopecia areata and vitiligo. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.
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' expectations with respect to the closing of the RHOFADE transaction, 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, timing for initiation of planned clinical trials and timing for regulatory submissions, estimated research and development and selling, general and administrative expenses for 2018 and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half 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, 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 September 30, 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.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||
| September 30, | September 30, | |||||||
| 2018 | 2017 | 2018 | 2017 | |||||
| Revenues: | ||||||||
| ESKATA product sales, net | $ 510 | $ - | $ 2,043 | $ - | ||||
| Contract research | 1,118 | 684 | 3,379 | 684 | ||||
| Other revenue | - | - | 1,000 | - | ||||
| Total revenues, net | 1,628 | 684 | 6,422 | 684 | ||||
| Cost of revenue (1) | 1,193 | 453 | 3,341 | 453 | ||||
| Gross profit | 435 | 231 | 3,081 | 231 | ||||
| Operating expenses: | ||||||||
| Research and development (1) | 15,931 | 10,864 | 43,472 | 26,601 | ||||
| Sales and marketing (1) | 11,380 | 3,557 | 35,030 | 7,183 | ||||
| General and administrative (1) | 6,574 | 4,566 | 20,955 | 13,428 | ||||
| Total operating expenses | 33,885 | 18,987 | 99,457 | 47,212 | ||||
| Loss from operations | (33,450) | (18,756) | (96,376) | (46,981) | ||||
| Other income, net | 710 | 564 | 2,189 | 1,392 | ||||
| Net loss | $ (32,740) | $ (18,192) | $ (94,187) | $ (45,589) | ||||
| Net loss per share, basic and diluted | $ (1.06) | $ (0.63) | $ (3.04) | $ (1.68) | ||||
| Weighted average common shares outstanding, basic and diluted | 30,982,192 | 28,834,808 | 30,938,026 | 27,180,244 | ||||
| (1) Amounts include stock-based compensation expense as follows: |
| Cost of revenue | $ 194 | $ 130 | $ 560 | $ 130 | |||
| Research and development | 1,433 | 1,332 | 4,916 | 3,853 | |||
| Sales and marketing | 760 | 480 | 2,687 | 1,260 | |||
| General and administrative | 2,320 | 1,731 | 6,936 | 4,887 | |||
| Total stock-based compensation expense | $ 4,707 | $ 3,673 | $ 15,099 | $ 10,130 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
| September 30, 2018 | December 31, 2017 | ||||||
| Cash, cash equivalents and marketable securities | $ | 134,271 | $ | 208,854 | |||
| Total assets | 176,176 | 243,509 | |||||
| Total current liabilities | 22,280 | 12,762 | |||||
| Total liabilities | 29,848 | 18,247 | |||||
| Total stockholders' equity | 146,328 | 225,262 |
Senior Vice President
Corporate Strategy/Investor Relations
Vice President, Corporate Communications