Two Product Candidates Now in Phase 3 Development
"I am very pleased with the major strides
Operational Highlights and Clinical Pipeline Update
Closed follow-on public offering. On
August 11, Dermiraclosed a follow-on public offering of 5,175,000 shares of common stock, including 675,000 shares sold upon full exercise of the underwriters' option to purchase additional shares of common stock, at a price to the public of $21.50per share, all of which were sold by Dermira. Dermiraestimates net proceeds from the offering to be approximately $104.0 million, after deducting underwriting discounts and commissions and estimated offering expenses.
Initiated Phase 3 program for DRM04 in hyperhidrosis. In July,
Dermiradosed the first patients in a Phase 3 program for DRM04 in patients with axillary hyperhidrosis. The DRM04 Phase 3 program consists of two identical, randomized, double-blind, vehicle-controlled studies, ATMOS-1 and ATMOS-2, each enrolling approximately 330 patients. The program is designed to assess the safety and efficacy of DRM04 compared to vehicle over a period of four weeks to support a potential New Drug Application submission to the U.S. Food and Drug Administration. The Phase 3 program also will include an open-label study, ARIDO, assessing the long-term safety of DRM04, in which patients from either of the Phase 3 studies will be permitted to continue to receive treatment for up to an additional 44 weeks. Topline results from this Phase 3 program are expected in the second half of 2016.
Initiated Phase 2b trial for DRM01 in acne; trial enrolling patients. In April,
Dermiradosed the first patient in a Phase 2b dose-ranging trial for DRM01, a novel, topical sebum inhibitor, in patients with acne vulgaris. The goal of the study is to establish the optimal dose for a potential Phase 3 program. Topline results from this Phase 2b study are expected in the first half of 2016. Data from Dermira'sDRM01 Phase 2a 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 World Congress of Dermatology Meetingin June 2015.
Enrollment continuing in Phase 3 program for CIMZIA® in psoriasis.
Dermira'sPhase 3 program for moderate-to-severe chronic plaque psoriasis, which consists of the CIMPASI-1, CIMPASI-2 and CIMPACT trials, continues to enroll patients. Currently, CIMZIA is not approved for the treatment of psoriasis by any regulatory authority worldwide. Topline results from this Phase 3 program are expected in 2017.
Second Quarter 2015 Financial Results
Dermirareported a net loss of $17.2 millionfor the quarter ended June 30, 2015, compared with a net loss of $8.8 millionfor the same period in 2014.
Total operating expenses for the quarter ended
June 30, 2015were $17.3 millionas compared to $8.7 millionfor the second quarter of 2014.
Research and development expenses for the second quarter of 2015 were
$13.5 millionas compared to $7.0 millionfor the comparable prior-year period. This increase was primarily due to increased development costs for CIMZIA, DRM04, and DRM01 and headcount growth.
General and administrative expenses in the second quarter of 2015 were
$3.8 millionas compared to $1.7 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 Dermira'sinitial public offering in October 2014.
- Research and development expenses for the second quarter of 2015 were
June 30, 2015, Dermirahad cash and cash equivalents and investments of $143.8 million, debt of $1.9 millionand 24.7 million shares of common stock outstanding. The June 30, 2015, cash and cash equivalents and investments balance and common stock outstanding totals do not include the impact of the approximately $104.0 millionin estimated net proceeds received and approximately 5.2 million shares of common stock issued by Dermirain connection with its follow-on public offering.
2015 Key Milestones and Expectations
- Continue to enroll patients in the CIMZIA Phase 3 program.
- Continue to enroll patients in the DRM04 Phase 3 program.
- Continue to enroll patients in the DRM01 Phase 2b dose‐finding trial.
Management reiterates its operating expense guidance for 2015, including GAAP operating expenses of
$86-$91 millionand non-GAAP operating expenses of $80-$85 million, which excludes the impact of stock-based compensation expense of approximately $6 million. In addition, management is updating its guidance for cash and cash equivalents and investments and total shares of common stock outstanding as of December 31, 2015to reflect the impact of the follow-on public offering completed in August. As a result of this follow-on offering, management now expects to have approximately $194 millionin cash and cash equivalents and investments and approximately 30 million total shares of common stock outstanding as of December 31, 2015.
Use of Non-GAAP Measures
This non-GAAP measure may be different from non-GAAP measures used by other companies. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the "safe harbor" created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including with respect to: enrollment of the CIMZIA, DRM04 and DRM01 clinical trials and when the results of those trials will be available; timing of a Phase 3 program for DRM01; timing of establishment of commercial operations; impact of our product candidates on patients; commercial opportunity for our product candidates; management expectations for operating expenses, including on a non-GAAP basis, and stock-based compensation expenses for 2015; management expectations for cash and cash equivalents and investments, and total shares of common stock outstanding balances as of
|Selected Consolidated Statements of Operations Data|
|(in thousands, except share and per share amounts)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development (1)||$ 13,495||$ 6,963||$ 23,583||$ 13,648|
|General and administrative (1)||3,848||1,740||7,994||3,552|
|Total operating expenses||17,343||8,703||31,577||17,200|
|Loss from operations||(17,343)||(8,703)||(31,577)||(17,200)|
|Interest and other income (expense), net||222||(25)||459||(34)|
|Net loss||$ (17,159)||$ (8,762)||$ (31,194)||$ (17,301)|
|Net loss per share, basic and diluted||$ (0.69)||$ (9.72)||$ (1.26)||$ (19.28)|
|Weighted-average common shares used to compute net loss per share, basic and diluted|
|(1) Amounts include stock-based compensation expense as follows:|
|Research and development||$ 404||$ 121||$ 859||$ 227|
|General and administrative||709||53||1,348||83|
|Total stock-based compensation expense||$ 1,113||$ 174||$ 2,207||$ 310|
|Selected Consolidated Balance Sheet Data|
|June 30,||December 31,|
|Cash and cash equivalents and investments||$ 143,805||$ 163,634|
|Bank term loan, current and non-current||1,944||1,936|
|Additional paid-in capital||239,118||236,414|
|Total stockholders' equity||125,201||153,579|
|Note: The balance sheet data exclude the impact of the Company's follow-on public offering that closed on August 11, 2015, in connection with which the Company issued a total of 5,175,000 shares of common stock and raised total estimated net proceeds of $104.0 million.|
CONTACT: Dermira Contact
Andrew GuggenhimeChief Operating Officer and Chief Financial Officer 650.421.7200 firstname.lastname@example.org Investor Contact Robert H. Uhl Westwicke PartnersManaging Director 858.356.5932 email@example.com