DRM01 Phase 2b Trial in Acne to Start
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"Entering 2015 with a strengthened capital position and having added a number of key executives and directors, we are focused on developing our pipeline of late-stage, innovative and differentiated dermatology products," said
Operational Highlights and Clinical Pipeline Update
Presented Phase 2a clinical results for DRM01 in patients with acne at AAD. Data were recently presented from
Dermira's108-patient, randomized, multi-center, double-blind, vehicle-controlled Phase 2a clinical trial, demonstrating statistical significance for DRM01 vs. vehicle in all primary efficacy endpoints widely accepted by clinicians and recommended by the U.S. Food and Drug Administration( FDA). These data were presented as part of the Late-Breaking Researchin Dermatology Forums during the American Academy of Dermatology(AAD) Annual Meeting held March 20-24in San Francisco. Dermiraintends to commence a Phase 2b dose-finding trial in April 2015.
Achieved positive Phase 2b results for DRM04 in hyperhidrosis. In
February 2015, Dermiraannounced positive Phase 2b study results for DRM04, its proprietary topical anticholinergic product, in patients with axillary hyperhidrosis. Based on the results of this study (DRM04-HH02) and its first Phase 2b study (DRM04-HH01), Dermiraintends to initiate a Phase 3 program for DRM04 in axillary hyperhidrosis in the second half of 2015, subject to an end-of-phase 2 meeting with the FDA.
Initiated Phase 3 program for CIMZIA®, with UCB, in psoriasis. In
January 2015, Dermiraand UCB announced that the first patients had been dosed in the Phase 3 clinical program designed to evaluate the efficacy and safety of CIMZIA (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide. Dermiraexpects topline results from this program in 2017.
Completed initial public offering. In
October 2014, Dermiraannounced the pricing of its initial public offering (IPO) of 7,812,500 shares of common stock at a price to the public of $16.00per share. Concurrent with the offering, Dermiraalso sold 468,750 shares of its common stock to UCB S.A.through a private placement at the IPO price. Proceeds from the IPO and private placement totaled $120.3 million, net of underwriting discounts and offering-related transaction costs.
Fourth Quarter 2014 Financial Results
For both the quarter ended
December 31, 2014and the quarter ended December 31, 2013, Dermirareported a net loss of $6.7 million.
Revenue for the quarter ended
December 31, 2014was $7.3 million. In December 2014, the first patient in the Phase 3 clinical program for CIMZIA was dosed. As a result, Dermiraearned the first development milestone payment of $7.3 millionin connection with its development and commercialization agreement with UCB. Dermiradid not recognize any revenue for the quarter ended December 31, 2013.
Total operating expenses for the quarter ended
December 31, 2014were $14.1 millionas compared to $6.7 millionfor the fourth quarter of 2013.
Research and development expenses for the fourth quarter of 2014 were
$11.0 millioncompared to $5.5 millionfor the comparable prior-year period. This increase was primarily due to higher development costs for CIMZIA and increased headcount.
General and administrative expenses for the fourth quarter of 2014 were
$3.0 millioncompared to $1.2 millionfor the comparable prior-year period. This increase was primarily related to increased headcount and the costs associated with being a publicly traded company.
- Research and development expenses for the fourth quarter of 2014 were
December 31, 2014, Dermirahad cash and cash equivalents and investments of $163.6 million, debt of $1.9 million, and 24.6 million common shares outstanding.
Full Year 2014 Financial Results
For the year ended
December 31, 2014, Dermirareported a net loss of $31.9 millioncompared to a net loss of $22.4 millionfor 2013.
Revenue for the year ended
December 31, 2014was $7.3 million. Dermiradid not record any revenue for the year ended December 31, 2013.
Total operating expenses for 2014 were
$39.0 millionas compared to $22.3 millionfor 2013.
Research and development expenses for 2014 were
$30.7 millioncompared to $17.9 millionfor the prior year.
General and administrative expenses for 2014 were
$8.3 millioncompared to $4.4 millionfor the prior year.
- Research and development expenses for 2014 were
2015 Key Milestones and Expectations
Initiate DRM01 Phase 2b dose-finding trial in
Initiate DRM04 Phase 3 clinical program in the second half of 2015, pending the outcome of an end-of-phase 2 meeting with the
- Continue to enroll patients in all three trials, CIMPASI-1, CIMPASI-2 and CIMPACT, of the CIMZIA Phase 3 program.
Management expects non-GAAP operating expenses for 2015, excluding the impact of stock-based compensation expense, to be in the range of
$80-85 millionand to have approximately $90 millionin cash and cash equivalents and investments as of year-end 2015.
Conference Call and Webcast
Use of Non-GAAP Measures
This non-GAAP measure may be different from non-GAAP measures used by other companies. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles.
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, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, 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 with respect to timing and planned next steps in the clinical development of our product candidates, enrollment of the clinical trials, when the results of those trials will be available and management expectations for operating expenses and cash and cash equivalents and investments balances in 2015. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause our 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 outcomes of our clinical trials, our dependence on third-party clinical research organizations, manufacturers and suppliers, regulatory compliance with respect to the design and implementation of our clinical trials, our ability to obtain regulatory approval for our product candidates, the costs of our development programs and other operations, our ability to obtain necessary additional capital, market acceptance of our potential products, our ability to develop and maintain collaborations and license products and intellectual property, the impact of competitive products and therapies including generics and biosimilars, our ability to manage the growth and complexity of our organization, our ability to maintain, protect and enhance our intellectual property, and our ability to continue to stay in compliance with applicable laws and regulations. You should refer to the risks set forth in Part I, Item 1A, "Risk Factors" in the Company's Annual Report on Form 10-K and other filings the Company makes with the
|Selected Consolidated Statements of Operations Data|
|(in thousands, except share and per share amounts)|
Three Months Ended
|Collaboration revenue from a related party||$ 7,300||$ --||$ 7,300||$ --|
|Research and development (1)||11,034||5,540||30,710||17,937|
|General and administrative (1)||3,048||1,152||8,288||4,366|
|Total operating expenses||14,082||6,692||38,998||22,303|
|Loss from operations||(6,782)||(6,692)||(31,698)||(22,303)|
|Interest and other income (expense), net||125||(13)||7||(38)|
|Loss before taxes||(6,696)||(6,714)||(31,844)||(22,350)|
|Provision for income taxes||31||--||31||--|
|Net loss||$ (6,727)||$ (6,714)||$ (31,875)||$ (22,350)|
|Net loss per share, basic and diluted||$ (0.29)||$ (7.56)||$ (4.96)||$ (27.03)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||22,822,844||887,946||6,426,022||826,757|
|(1) Amounts include stock-based compensation expense as follows:|
|Research and development||$ 400||$ 58||$ 836||$ 196|
|General and administrative||609||29||807||96|
|Total stock-based compensation expense||$ 1,009||$ 87||$ 1,643||$ 292|
|Selected Consolidated Balance Sheet Data|
|Cash and cash equivalents and investments||$ 163,634||$ 22,144|
|Bank term loan, current and non-current||1,936||1,919|
|Convertible preferred stock||--||59,588|
|Additional paid-in capital||236,414||970|
|Total stockholders' equity (deficit)||153,579||(49,803)|
CONTACT: Dermira Contact
Andrew GuggenhimeChief Operating Officer and Chief Financial Officer 650.421.7200 Investors@dermira.com Investor Contact Westwicke Partners Robert H. UhlManaging Director 858.356.5932 firstname.lastname@example.org