"With the clinical advancement of our three late-stage product candidates, the addition of key executives, and the successful completion of our initial public offering, 2014 has been a pivotal year for
Operational Highlights and Clinical Pipeline Update
Completed initial public offering and Series C financing. In
October 2014, Dermiracompleted its initial public offering (IPO) of 7,812,500 shares of common stock at an offering price of $16per share. Concurrent with the offering, Dermiraalso sold through a private placement 468,750 shares of its common stock to UCB S.A., an existing stockholder, at the IPO price. Proceeds from the IPO and concurrent private placement totaled approximately $120.3 million, net of underwriting discounts, commissions and offering-related transaction costs. Prior to the IPO, in August 2014, Dermiracompleted a Series C financing for net proceeds of $48.8 million. In aggregate, Dermiraraised net proceeds of $169.1 millionpursuant to these financings.
Cimzia® (certolizumab pegol) for psoriasis. In
September 2014, Dermiraand its partner, UCB, filed an investigational new drug (IND) application for Cimzia for the treatment of moderate-to-severe plaque psoriasis with the FDA. Dermiraanticipates the initiation of patient enrollment in its Phase 3 program of Cimzia in psoriasis during the first half of 2015.
DRM04 (topical anticholinergic) for hyperhidrosis. In
August 2014, Dermirasuccessfully completed a 198-patient, randomized, double-blind, vehicle-controlled Phase 2b dose-ranging study in primary axillary hyperhidrosis of a topical formulation of an anticholinergic agent that has been approved for systemic administration in other indications (referred to as the topical formulation of the reference agent). In the study, significant reductions in sweat production and improvements in other efficacy endpoints were observed in patients treated with select doses of the reference agent compared to vehicle. Also during the third quarter, Dermiracompleted enrollment in its ongoing, second Phase 2b study assessing the efficacy, safety and pharmacokinetics of DRM04, the topical formulation of the reference agent and vehicle. Data from this study, which enrolled approximately 100 patients with primary axillary hyperhidrosis, are expected during the first half of 2015. If successful, Dermiraplans to initiate a Phase 3 program for DRM04 during the second half of 2015.
DRM01 (topical sebum inhibitor) for acne. In
June 2014, Dermiracompleted a 108-patient, randomized, double-blind, vehicle-controlled Phase 2a study with DRM01 conducted in Canadathat demonstrated significant reductions in the signs and symptoms of acne. Dermiraremains on track to file an IND application with the FDAand initiate Phase 2b clinical development for DRM01 during the first half of 2015.
Third Quarter 2014 Financial Results
For the quarter ended
September 30, 2014, Dermirareported a net loss of $7.8 millioncompared to a net loss for the quarter ended September 30, 2013of $4.7 million.
Total operating expenses for the quarter ended
September 30, 2014were $7.7 millionas compared to $4.6 millionfor the third quarter of 2013.
Research and development expenses for the third quarter of 2014 were
$6.0 millionversus $3.6 millionfor the third quarter of 2013. This increase was primarily due to higher development costs for DRM04 and Cimzia and increased headcount.
General and administrative expenses during the quarter ended
September 30, 2014were $1.7 millioncompared to $1.0 millionfor the same period in 2013. This increase was primarily related to increased headcount.
- Research and development expenses for the third quarter of 2014 were
September 30, 2014, Dermirahad cash and cash equivalents of $50.8 million, debt of $1.9 million, and 16.3 million common and preferred shares outstanding. The September 30, 2014, cash and cash equivalents balance and shares outstanding totals do not include the impact of the $120.3 millionin net proceeds received and 8.3 million shares issued in connection with the Company's October 2014IPO and concurrent private placement.
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 planned next steps in the clinical development of our product candidates. 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, our ability to obtain regulatory approval for our product candidates, the costs of our development programs, 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||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$ 6,028||$ 3,619||$ 19,676||$ 12,397|
|General and administrative||1,688||1,009||5,240||3,214|
|Total operating expenses||7,716||4,628||24,916||15,611|
|Loss from operations||(7,716)||(4,628)||(24,916)||(15,611)|
|Interest and other income (expense), net||(84)||(37)||(118)||(25)|
|Net loss||$ (7,847)||$ (4,665)||$ (25,148)||$ (15,636)|
|Net loss per share, basic and diluted||$ (8.66)||$ (5.57)||$ (27.93)||$ (19.40)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||906,239||836,876||900,350||806,137|
|Selected Consolidated Balance Sheet Data|
|September 30,||December 31,|
|Cash and cash equivalents||$ 50,845||$ 22,144|
|Bank term loan, current and non-current||1,937||1,919|
|Convertible preferred stock||113,414||59,588|
|Total stockholders' deficit||(74,310)||(49,803)|
|Note: The balance sheet data exclude the impact of the Company's initial public offering (IPO) and concurrent private placement that were completed in October 2014, in connection with which the Company issued a total of 8,281,250 shares and raised total estimated net proceeds of $120.3 million.|
CONTACT: Dermira Contact
Andrew GuggenhimeChief Operating Officer and Chief Financial Officer 650.421.7200 Investor Contact Westwicke Partners Robert H. UhlManaging Director 858.356.5932 firstname.lastname@example.org