"Our clinical development programs continue to move forward, and I am pleased to report another quarter of solid progress for
Operational Highlights and Clinical Pipeline Update
Presented data from DRM01 Phase 2a Trial – In October, data were presented from the company's DRM01 Phase 2a study in acne, which showed that DRM01 met all of the primary efficacy endpoints. In addition, newly presented data suggested that a treatment difference in these endpoints was observed as early as the first efficacy assessment, which occurred at week four of the 12-week treatment period. These data were presented at the
European Academy of Dermatologyand Venereology (EADV) Congress2015 in Copenhagen, Denmark.
Completed patient enrollment for CIMPASI-2 Phase 3 study of CIMZIA® – In September,
Dermiracompleted patient enrollment for the global CIMPASI-2 Phase 3 clinical trial of CIMZIA (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. Completion of enrollment triggered a milestone payment of $7.3 million, which was recognized as collaboration revenue from a related party in Dermira'sthird quarter 2015 financial results and is payable by UCB Pharma S.A.to Dermirain the fourth quarter of 2015. Patient enrollment continues for two additional CIMZIA Phase 3 trials in patients with moderate-to-severe psoriasis. 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.
Kathleen Sebeliusto Board of Directors – In September, Dermira'sboard of directors welcomed Kathleen Sebelius, the 21st U.S. Secretary of Health and Human Services, as a director. Ms. Sebelius was Secretary of Health and Human Servicesfrom 2009 to 2014. Previously, she served for two terms as Governor of Kansas.
Presented DRM01 skin disposition study results – In September,
Dermirapresented new data from a study in Yorkshire pigs, which demonstrated that DRM01 penetrates the skin in a dose- and formulation-dependent manner and accumulates in the sebaceous glands. These results were presented at the 45th Annual Meeting of the European Society for Dermatological Research(ESDR) in Rotterdam, Netherlands.
Closed follow-on public offering. In August,
Dermiraclosed an underwritten follow-on public offering of 5,175,000 shares of common stock sold by the company, including 675,000 shares sold upon full exercise of the underwriters' option to purchase additional shares of common stock, at a price of $21.50per share. Net proceeds from the offering were approximately $104.1 million, after deducting underwriting discounts and commissions and offering expenses.
Initiated Phase 3 program for DRM04 in hyperhidrosis. In July,
Dermiradosed the first patients in a Phase 3 program for DRM04 in axillary hyperhidrosis, consisting of two identical studies totaling approximately 660 patients. The program is designed to assess the safety and efficacy of DRM04 compared to vehicle to support a potential New Drug Application submission to the U.S. Food and Drug Administration. Topline results from this Phase 3 program are expected in the second half of 2016.
Enrollment continuing in Phase 2b program for DRM01 in acne.
Dermira'sPhase 2b dose-ranging trial for DRM01, a novel, topical sebum inhibitor, in patients with acne vulgaris continues to enroll patients. 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.
Third Quarter 2015 Financial Results
Dermirareported a net loss of $16.1 millionfor the quarter ended September 30, 2015, compared with a net loss of $7.8 millionfor the same period in 2014.
Total operating expenses for the quarter ended
September 30, 2015were $23.6 millionas compared to $7.7 millionfor the third quarter of 2014.
- Research and development expenses for the third quarter of 2015 were
$18.9 millionas compared to $6.0 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 third quarter of 2015 were
$4.7 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.
September 30, 2015, Dermirahad cash and cash equivalents and investments of $232.5 million, debt of $1.9 millionand 29.9 million shares of common stock outstanding.
2015 Key Milestones and Expectations
- Continue to enroll patients in CIMPASI-1 and CIMPACT Phase 3 studies for CIMZIA.
- Continue to enroll patients in the DRM04 Phase 3 program.
- Continue to enroll patients in the DRM01 Phase 2b dose‐finding trial.
As a result of completion of patient enrollment for the global CIMPASI-2 Phase 3 clinical trial of CIMZIA, management expects collaboration revenue from a related party for 2015 of
$7.3 million. In addition, management expects operating expenses for 2015 to be at the low end of its previously stated ranges. Its prior guidance reflected 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. Management expects to have over $200 millionin cash and cash equivalents and investments and approximately 30 million total shares of common stock outstanding as of December 31, 2015.
Use of Non-GAAP Measures
This non-GAAP measure may be different from non-GAAP measures used by other companies. In addition, this non-GAAP measure is not based on any comprehensive set of accounting rules or principles.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the "safe harbor" created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including with respect to: enrollment in the Phase 2b program for DRM01, CIMPASI-1 and CIMPACT Phase 3 studies for CIMZIA, and Phase 3 program for DRM04; when the results of the DRM01, DRM04 and CIMZIA clinical trials will be available; management expectations for the timing of the
|Selected Consolidated Statements of Operations Data|
|(in thousands, except share and per share amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Collaboration revenue from a related party||$ 7,300||$ --||$ 7,300||$ --|
|Research and development (1)||18,890||6,028||42,473||19,676|
|General and administrative (1)||4,684||1,688||12,678||5,240|
|Total operating expenses||23,574||7,716||55,151||24,916|
|Loss from operations||(16,274)||(7,716)||(47,851)||(24,916)|
|Interest and other income (expense), net||259||(84)||718||(118)|
|Net loss||$ (16,054)||$ (7,847)||$ (47,248)||$ (25,148)|
|Net loss per share, basic and diluted||$ (0.58)||$ (8.66)||$ (1.84)||$ (27.93)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||27,553,952||906,239||25,645,246||900,350|
|(1) Amounts include stock-based compensation expense as follows:|
|Research and development||$ 541||$ 210||$ 1,401||$ 436|
|General and administrative||920||114||2,267||198|
|Total stock-based compensation expense||$ 1,461||$ 324||$ 3,668||$ 634|
|Selected Consolidated Balance Sheet Data|
|September 30,||December 31,|
|Cash and cash equivalents and investments||$ 232,457||$ 163,634|
|Bank term loan, current and non-current||1,948||1,936|
|Additional paid-in capital||344,645||236,414|
|Total stockholders' equity||214,756||153,579|
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