Full Press Release Details
Aclaris Therapeutics Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Update on Clinical and Commercial Developments
Wayne, PA March 12, 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 fourth quarter and year ended December 31, 2017 and provided an update on its clinical development and commercial programs.
2017 was a defining year in Aclaris' history, with the FDA approval of ESKATA (hydrogen peroxide) Topical Solution, 40% (w/w), the first and only FDA-approved topical, non-invasive treatment of raised seborrheic keratosis (SK). We have generated a high level of excitement around ESKATA in the dermatology community, and look forward to our official launch in the second quarter of 2018, said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. In January 2018, we announced positive topline results from two Phase 2 clinical trials (WART-202 and WART-203) of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts (verruca vulgaris). We also advanced our topical Janus kinase (JAK) inhibitor programs in alopecia, with results from multiple Phase 2 trials expected later 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.
Clinical Pipeline Update
Recent Corporate Highlights
Financial Highlights
Liquidity and Capital Resources
As of December 31, 2017, Aclaris had aggregate cash, cash equivalents and marketable securities of $208.9 million compared to $174.1 million as of December 31, 2016. The $34.8 million increase during the year ended December 31, 2017 included:
Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2017 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.
Fourth Quarter 2017 Financial Results
Full Year 2017 Financial Results
2018 Financial Outlook
Company to Host Conference Call
Management will conduct a conference call at 8:00 a.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 1495576 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, research and development and selling, general and administrative expenses during 2018 and 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, 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 to be filed for the year ended December 31, 2017 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.
Use of Non-GAAP Financial Measures
Aclaris has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included herein include total non-GAAP R&D expense and non-GAAP SG&A expense, both of which exclude stock-based compensation. Aclaris excludes stock-based compensation expense because management believes the exclusion of this item is helpful to investors to evaluate Aclaris' recurring operational performance. Aclaris management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for or superior to GAAP results.
Aclaris Therapeutics, Inc.
Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended | Year Ended | |||||||
| December 31, | December 31, | |||||||
| 2017 | 2016 | 2017 | 2016 | |||||
| Revenue | $ 999 | $ - | $ 1,683 | $ - | ||||
| Cost of revenue | 754 | 1,207 | ||||||
| Gross profit | 245 | 476 | ||||||
| Operating expenses: | ||||||||
| Research and development (1) | 13,189 | 6,943 | 39,790 | 33,476 | ||||
| General and administrative (1) | 12,498 | 4,684 | 33,109 | 15,091 | ||||
| Total operating expenses | 25,687 | 11,627 | 72,899 | 48,567 | ||||
| Loss from operations | (25,442) | (11,627) | (72,423) | (48,567) | ||||
| Other income, net | 678 | 152 | 2,070 | 488 | ||||
| Loss before income taxes | (24,764) | (11,475) | (70,353) | (48,079) | ||||
| Provision for income taxes | (1,830) | (1,830) | ||||||
| Net loss | $ (22,934) | $ (11,475) | $ (68,523) | $ (48,079) | ||||
| Net loss per share, basic and diluted | $ (0.74) | $ (0.49) | $ (2.44) | $ (2.25) | ||||
| Weighted average common shares outstanding, basic and diluted | 30,838,741 | 23,390,746 | 28,102,386 | 21,415,733 | ||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||
| Cost of revenue | $ 81 | $ | $ 211 | $ | ||||
| Research and development | 1,618 | 714 | 5,471 | 2,291 | ||||
| General and administrative | 2,601 | 1,196 | 8,748 | 3,813 | ||||
| Total stock-based compensation expense | $ 4,300 | $ 1,910 | $ 14,430 | $ 6,104 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
| December 31, 2017 | December 31, 2016 | ||||||
| Cash, cash equivalents and marketable securities | $ | 208,854 | $ | 174,134 | |||
| Total assets | 243,509 | 176,085 | |||||
| Total current liabilities | 12,762 | 6,223 | |||||
| Total liabilities | 18,247 | 6,595 | |||||
| Total stockholders' equity | 225,262 | 169,490 |
Aclaris Therapeutics, Inc.
2018 Financial Guidance
Reconciliation of GAAP R&D Expense to Non-GAAP R&D Expense
| 2018 | |||||||
| Low | High | ||||||
| R&D expense: | |||||||
| GAAP R&D expense | $ | 67,000 | $ | 75,000 | |||
| Adjustments: | |||||||
| Stock-based compensation | (9,000) | (9,000) | |||||
| Non-GAAP R&D expense | $ | 58,000 | $ | 66,000 |
Reconciliation of GAAP SG&A to Non-GAAP SG&A Expense
| 2018 | |||||||
| Low | High | ||||||
| SG&A expense: | |||||||
| GAAP SG&A expense | $ | 80,000 | $ | 86,000 | |||
| Adjustments: | |||||||
| Stock-based compensation | (14,000) | (14,000) | |||||
| Non-GAAP SG&A expense | $ | 66,000 | $ | 72,000 |
Senior Vice President
Corporate Strategy/Investor Relations