-- Planned submission of NDA for glycopyrronium tosylate (formerly DRM04) in 2H17 on schedule after pre-NDA meeting with
-- Management to host webcast and conference call today
“I am extremely pleased with the progress
Clinical Pipeline Update
- Completed glycopyrronium tosylate (formerly DRM04) Pre-NDA Meeting with
FDA– In February 2017, Dermiraheld a meeting with the U.S. Food and Drug Administration( FDA) to discuss Dermira’s planned submission of a New Drug Application (NDA) for glycopyrronium tosylate.
- Announced positive topline results from CIMZIA Phase 3 clinical program – In
January 2017, December 2016and October 2016, Dermiraand UCB Pharma S.A.announced positive topline results from the CIMPACT, CIMPASI-1 and CIMPASI-2 Phase 3 clinical trials, respectively, evaluating the efficacy and safety of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. In all three CIMZIA Phase 3 clinical trials, CIMZIA demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at both treatment doses. The safety profile across all three trials appears consistent with the safety profiles observed with CIMZIA for currently approved indications. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
- Initiated Phase 3 clinical program in acne – In
December 2016, Dermiradosed the first patients in a Phase 3 program evaluating the safety and efficacy of olumacostat glasaretil (formerly DRM01), a novel, small molecule designed to target sebum production following topical application, in patients with acne vulgaris. The program consists of two Phase 3 trials to assess the safety and efficacy of olumacostat glasaretil and an additional open-label trial to evaluate long-term safety. The two pivotal trials, CLAREOS-1 and CLAREOS-2, are expected to enroll approximately 1,400 patients. The long-term safety trial, CLARITUDE, is expected to enroll approximately 700 patients from the CLAREOS-1 and CLAREOS-2 trials.
- Completed treatment period for ARIDO trial – In
December 2016, the open-label ARIDO Phase 3 trial assessing the long-term safety of glycopyrronium tosylate was completed. Based on a preliminary review of the trial data, the safety and tolerability profile for glycopyrronium tosylate appears consistent with what was observed in the ATMOS-1 and ATMOS-2 Phase 3 clinical trials.
Fourth Quarter 2016 Financial Results
- For the quarter ended
December 31, 2016, Dermirareported a net loss of $7.4 million, compared with a net loss of $31.2 millionfor the same period in 2015.
- Total revenue for the fourth quarter of 2016 was
$22.5 million. During the quarter, Dermiraearned and recognized $21.4 millionin collaboration revenue from a related party due to the achievement of the final two development milestones pursuant to its agreement with UCB. In addition, the company recognized $1.1 millionof the $25.0 millioninitial license payment received from Maruho Co., Ltdas collaboration and license revenue in connection with the exclusive license agreement for glycopyrronium tosylate in Japanentered into in September 2016. Dermiradid not recognize any revenue for the quarter ended December 31, 2015.
- Total operating expenses for the quarter ended
December 31, 2016were $30.4 million, compared to $31.8 millionfor the fourth quarter of 2015.
-- Research and development expenses for the fourth quarter of 2016 were
$20.9 million, compared to $24.4 millionfor the comparable prior-year period. This decrease was primarily due to lower development costs for the company’s product candidates as a result of a reduction in clinical trial activities, partially offset by an increase in personnel-related expenses.
-- General and administrative expenses for the fourth quarter of 2016 were
$9.5 million, compared to $5.0 millionfor the comparable prior-year period. This increase was primarily related to higher personnel-related and market research and planning expenses.
- As of
December 31, 2016, Dermirahad cash and investments of $276.5 million, no debt and 35.7 million common shares outstanding. The cash and investments balances do not include the $21.4 millionin milestones payments earned by Dermirain the fourth quarter of 2016. Dermirareceived half of this amount in January 2017and expects to receive the remaining half in the second quarter of 2017.
Full Year 2016 Financial Results
- For the year ended
December 31, 2016, Dermirareported a net loss of $89.1 million, compared to a net loss of $78.4 millionfor 2015.
- In 2016,
Dermirarecognized total revenue of $22.6 million, which included the $21.4 millionin collaboration revenue from a related party related to the final two development milestones earned pursuant to the company’s agreement with UCB and $1.2 millionin collaboration and license revenue representing the portion of the $25.0 millioninitial license payment from Maruho recognized during the period. In 2015, Dermirarecognized collaboration revenue from a related party of $7.3 millionfor the achievement of a milestone, completion of patient enrollment in the first CIMZIA Phase 3 clinical trial, pursuant to its agreement with UCB.
- Total operating expenses for 2016 were
$113.2 millioncompared to $86.9 millionfor 2015.
-- Research and development expenses for 2016 were
$83.2 million, compared to $66.8 millionfor the prior year. This increase was primarily due to higher personnel-related expenses and an increase in external costs related to the company’s CIMZIA and glycopyrronium tosylate programs.
-- General and administrative expenses for 2016 were
$30.0 million, compared to $17.7 millionfor 2015. This increase was primarily due to higher personnel-related and market planning and research expenses.
Key Milestones and Expectations
- Submit an NDA to the
FDAfor glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis in the second half of 2017, subject to the completion of registration-enabling activities.
- Submission of marketing applications by UCB in
the United States, Europeand Canadafor CIMZIA for the treatment of moderate-to-severe chronic plaque psoriasis in the third quarter of 2017. If approved, Dermirawould have marketing responsibilities in the United Statesand Canada.
- Announce topline results from the olumacostat glasaretil CLAREOS-1 and CLAREOS-2 Phase 3 clinical trials in patients with acne vulgaris in the first half of 2018.
- Management estimates collaboration and license revenue for 2017 of approximately
$4.3 million. Management estimates operating expenses for 2017 of $165.0 - $175.0 million, including estimated stock-based compensation expense of approximately $20.0 million. The estimated increase in 2017 expenses is primarily due to anticipated investments related to planned regulatory submissions for glycopyrronium tosylate and CIMZIA; preparations for potential commercial launches of these two product candidates in 2018, including commercial planning and organizational readiness efforts; and activities related to the ongoing olumacostat glasaretil Phase 3 clinical program.
- Management expects a balance of over
$145.0 millionin cash and investments at December 31, 2017.
Conference Call and Webcast
In addition to filings with the
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to patient enrollment in Dermira’s CLAREOS-1, CLAREOS-2 and CLARITUDE trials and the successful completion of, and timing expectations for the receipt and announcement of topline results from, such trials; the anticipated safety and tolerability profile for glycopyrronium tosylate based on a preliminary review of data from the ARIDO trial; the timing and submission of an NDA to the
|Selected Consolidated Statements of Operations Data|
|(in thousands, except share and per share amounts)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Collaboration revenue from a related party||$||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|
Andrew GuggenhimeChief Operating Officer & Chief Financial Officer 650-421-7200 firstname.lastname@example.org Robert H. Uhl Westwicke Partners, Managing Director 858-356-5932 email@example.com MEDIA Erica JeffersonSenior Director, Head of Corporate Communications 650-421-7216 firstname.lastname@example.org