Operational Highlights and Clinical Pipeline Update
Initiated Phase 2b trial for DRM01 in acne. In April,
Dermiraannounced the dosing of the first patient in a Phase 2b dose-ranging trial for DRM01, a novel, topical sebum inhibitor, in patients with acne vulgaris. The randomized, multi-center, double-blind, parallel-group, vehicle-controlled study is designed to assess the safety and efficacy of DRM01 compared to vehicle. The goal of the study is to establish the optimal dose for a potential Phase 3 program. Based on current enrollment projections, topline data from this Phase 2b study are expected in the first half of 2016. Data from Dermira'sDRM01 Phase 2a clinical trial, which demonstrated clinically meaningful and statistically significant improvements in patients with moderate-to-severe acne across the study's primary efficacy endpoints, were presented at the American Academy of Dermatology(AAD) Annual Meeting in March.
On track to initiate Phase 3 program for DRM04 in hyperhidrosis in the second half of 2015. In February,
Dermiraannounced positive Phase 2b study results for DRM04, its topical anticholinergic product candidate, in patients with axillary hyperhidrosis. In April, Dermiraheld an end-of-phase 2 meeting with the U.S. Food and Drug Administration(FDA). Based on feedback from the FDAand the results of the Phase 2 program comprising three randomized, double-blind, vehicle-controlled clinical trials in 341 patients, Dermirais finalizing the design of a Phase 3 program for DRM04 in axillary hyperhidrosis and plans to initiate the program in the second half of 2015.
Initiated Phase 3 program for CIMZIA®, with UCB, in psoriasis; all three trials enrolling patients. In
January 2015, Dermiraand UCB jointly announced the dosing of the first patients in their Phase 3 clinical program designed to evaluate the efficacy and safety of CIMZIA (certolizumab pegol), a TNF inhibitor, in adult patients with moderate-to-severe chronic plaque psoriasis. All three trials in the Phase 3 program, CIMPASI-1, CIMPASI-2 and CIMPACT, are now enrolling patients. Currently, CIMZIA is not approved for the treatment of psoriasis by any regulatory authority worldwide. Based on current enrollment projections, topline results from this Phase 3 program are expected in 2017.
First Quarter 2015 Financial Results
For the quarter ended
March 31, 2015, Dermirareported a net loss of $14.0 million, compared with a net loss of $8.5 millionfor the same period in 2014.
Total operating expenses for the quarter ended
March 31, 2015were $14.2 millionas compared to $8.5 millionfor the first quarter of 2014.
Research and development expenses for the first quarter of 2015 were
$10.1 millioncompared to $6.7 millionfor the comparable prior-year period. This increase was primarily due to increased development costs for CIMZIA and DRM01 and headcount growth.
General and administrative expenses for the first quarter of 2015 were
$4.1 millioncompared to $1.8 millionfor the comparable prior-year period. This increase was primarily related to headcount growth and the costs associated with being a publicly traded company following the company's initial public offering in October 2014.
- Research and development expenses for the first quarter of 2015 were
March 31, 2015, Dermirahad cash and cash equivalents and investments of $158.1 million, debt of $1.9 million, and 24.7 million common shares outstanding.
2015 Key Milestones and Expectations
- Initiate DRM04 Phase 3 clinical program in the second half of 2015.
- Continue to enroll patients in all three CIMZIA Phase 3 trials, CIMPASI-1, CIMPASI-2 and CIMPACT.
- Continue to enroll patients in the DRM01 Phase 2b dose-finding trial.
Management reiterates its expectations for 2015, including non-GAAP operating expenses, excluding the impact of stock-based compensation expense, of
$80-85 millionand to have approximately $90 millionin cash and cash equivalents and investments as of year-end 2015.
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 initiation of a Phase 3 clinical program for DRM04 and the timing of such initiation, enrollment of the CIMZIA and DRM01 clinical trials and when the results of those trials will be available, impact of our product candidates on patients, commercial opportunity of our product candidates and management expectations for operating expenses and cash and cash equivalents and investments balance 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 II, Item 1A, "Risk Factors" in the Company's Quarterly Report on Form 10-Q 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|
|Research and development (1)||$ 10,088||$ 6,685|
|General and administrative (1)||4,146||1,812|
|Total operating expenses||14,234||8,497|
|Loss from operations||(14,234)||(8,497)|
|Interest and other income (expense), net||237||(9)|
|Net loss||$ (14,035)||$ (8,539)|
|Net loss per share, basic and diluted||$ (0.57)||$ (9.56)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||24,655,011||893,542|
|(1) Amounts include stock-based compensation expense as follows:|
|Research and development||$ 455||$ 106|
|General and administrative||639||30|
|Total stock-based compensation expense||$ 1,094||$ 136|
|Selected Consolidated Balance Sheet Data|
|March 31,||December 31,|
|Cash and cash equivalents and investments||$ 158,144||$ 163,634|
|Bank term loan, current and non-current||1,940||1,936|
|Additional paid-in capital||237,550||236,414|
|Total stockholders' equity||140,859||153,579|
CONTACT: Dermira Contact
Andrew GuggenhimeChief Operating Officer and Chief Financial Officer 650.421.7200 Investor@dermira.com Investor Contact Westwicke Partners Robert H. UhlManaging Director 858.356.5932 email@example.com