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-- Planned submission of NDA for glycopyrronium tosylate (formerly DRM04) in 2H17 on schedule after pre-NDA meeting with FDA --
-- Management to host webcast and conference call today 4:30 p.m. ET / 1:30 p.m. PT --
MENLO PARK, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today reported financial results for the quarter and year ended December 31, 2016 and provided an update on its clinical development programs and financial guidance for 2017.
“I am extremely pleased with the progress Dermira made in 2016, which was a transformational year for our company,” said Tom Wiggans, chairman and chief executive officer of Dermira. “We finished the year on a high note and are off to a strong start in 2017, having started the olumacostat glasaretil Phase 3 program in acne, announced positive data from the final Phase 3 CIMZIA trial in moderate-to-severe chronic plaque psoriasis and held our pre-NDA meeting with the FDA for our glycopyrronium tosylate program in primary axillary hyperhidrosis. These milestones have set the stage for what we hope is another productive year for Dermira. We anticipate submitting marketing applications for CIMZIA and an NDA for glycopyrronium tosylate, continuing enrollment for the olumacostat glasaretil Phase 3 program and establishing an experienced commercial organization that will eventually bring our products, if approved, to the people who need them.”
Clinical Pipeline Update
Fourth Quarter 2016 Financial Results
Full Year 2016 Financial Results
Key Milestones and Expectations
Conference Call and Webcast
Dermira management will host a webcast and conference call regarding this announcement at 1:30 p.m. PT / 4:30 a.m. ET today. The live call may be accessed by dialing 877-359-9508 for domestic callers and 224-357-2393 for international callers and using the conference code: 77463468. A live webcast and archive of the call will be available from the investor relations sections of the company website at www.dermira.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 77463468.
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s product pipeline includes three Phase 3 product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate, in development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), in development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil, in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit www.dermira.com.
In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.Dermira is a biopharmaceutical company dedicated to bringing unique scientific insights to medical dermatology to identify and develop leading-edge clinical programs. The Company’s goal is to help transform the way skin conditions are treated by serving as the bridge between unmet patient needs and the significant scientific advances being made in understanding skin biology. Dermira is focused on delivering important new treatments to the millions of patients living with chronic skin conditions. Its unique portfolio of three Phase 3 product candidates includes glycopyrronium tosylate (formerly DRM04), a topical anticholinergic in development for primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), an injectable Tumor Necrosis Factor (TNF) inhibitor, in development in collaboration with UCB S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil (formerly DRM01), a topical sebum inhibitor in development for acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit www.dermira.com.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to patient enrollment in Dermira’s CLAREOS-1, CLAREOS-2 and CLARITUDE trials and the successful completion of, and timing expectations for the receipt and announcement of topline results from, such trials; the anticipated safety and tolerability profile for glycopyrronium tosylate based on a preliminary review of data from the ARIDO trial; the timing and submission of an NDA to the FDA for glycopyrronium tosylate; the timing and submission of marketing applications in the United States, Europe and Canada for CIMZIA; the establishment of an experienced commercial organization in 2017 that will eventually bring Dermira products, if approved, to patients; the potential receipt of regulatory approval for Dermira’s product candidates and the commercial launch of such products; estimates of 2017 collaboration and license revenue, operating expenses, stock-based compensation expense and 2017 year-end cash and investments; anticipated investments in 2017 related to regulatory submissions in 2017, potential product launches in 2018 and the olumacostat glasaretil Phase 3 clinical program; expectations regarding two potential product launches in 2018; and expectations regarding receipt of the $10.7 million final development milestone payment under Dermira’s agreement with UCB. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcome of Dermira’s clinical trials, including related to further analysis of the results of Dermira’s studies; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; the outcomes of future meetings with regulatory agencies; Dermira’s ability to obtain regulatory approval for its product candidates; Dermira’s ability to attract and retain key employees; Dermira’s ability to obtain necessary additional capital; and Dermira’s ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
|Selected Consolidated Statements of Operations Data|
|(in thousands, except share and per share amounts)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Collaboration revenue from a related party||$||21,400||$||-||$||21,400||$||7,300|
|Collaboration and license revenue||1,066||-||1,185||-|
|Research and development (1)||20,860||24,358||83,166||66,831|
|General and administrative (1)||9,493||5,043||30,043||17,721|
|Impairment of intangible assets||-||2,394||-||2,394|
|Total operating expenses||30,353||31,795||113,209||86,946|
|Loss from operations||(7,887||)||(31,795||)||(90,624||)||(79,646||)|
|Interest and other income, net||504||178||1,540||896|
|Loss on extinguishment of debt||-||(124||)||-||(124||)|
|Loss before taxes||(7,383||)||(31,773||)||(89,084||)||(79,021||)|
|(Benefit) provision for income taxes||-||(622||)||-||(622||)|
|Net loss per share, basic and diluted||$||(0.21||)||$||(1.04||)||$||(2.70||)||$||(2.93||)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||35,625,856||29,938,543||33,044,849||26,727,392|
|(1||)||Amounts include stock-based compensation expense as follows:|
|Research and development||$||1,075||$||583||$||4,039||$||1,984|
|General and administrative||2,008||881||6,964||3,148|
|Total stock-based compensation expense||$||3,083||$||1,464||$||11,003||$||5,132|
|Selected Consolidated Balance Sheets Data|
|December 31,||December 31,|
|Cash and cash equivalents and investments||$||276,493||$||215,712|
|Additional paid-in capital||497,718||346,590|
|Total stockholders' equity||247,370||185,475|
Contacts INVESTORS Andrew Guggenhime Chief Operating Officer & Chief Financial Officer 650-421-7200 email@example.com Robert H. Uhl Westwicke Partners, Managing Director 858-356-5932 firstname.lastname@example.org MEDIA Erica Jefferson Senior Director, Head of Corporate Communications 650-421-7216 email@example.comNEXT ARTICLE
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