- Reported Topline Results for Two Late-Stage Clinical Programs
- Raised Approximately
$136 Millionin Net Proceeds from Follow-on Public Offering
- Updates Guidance for Topline Phase 3 CIMZIA® (certolizumab pegol) Clinical Program Results
“Our progress continued in the second quarter with the announcement of favorable results for our DRM01 Phase 2b and DRM04 Phase 3 clinical programs and a successful financing in which we raised net proceeds of approximately
Operational Highlights and Clinical Pipeline Update
- Closed follow-on public offering – In
June 2016, 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, at a price to the public of $28.00per share. All of the shares were sold by Dermira. Net proceeds from the offering were $135.6 million, after deducting the underwriting discounts and commissions and offering expenses.
- Announced topline results for DRM04 Phase 3 pivotal trials in patients with hyperhidrosis – In
June 2016, Dermiraannounced topline results from its ATMOS-1 and ATMOS-2 Phase 3 pivotal trials for DRM04, a topical anticholinergic product candidate in development for patients with primary axillary hyperhidrosis (excessive underarm sweating).
- Announced topline results for DRM01 Phase 2b trial in patients with acne – In
May 2016, Dermiraannounced topline results from its Phase 2b dose-ranging study evaluating the safety and efficacy of DRM01 in patients with facial acne vulgaris.
Second Quarter 2016 Financial Results
- For the quarter ended
June 30, 2016, Dermirareported a net loss of $27.8 million, compared with a net loss of $17.2 millionfor the same period in 2015.
- Total operating expenses for the quarter ended
June 30, 2016were $28.0 million, compared to $17.3 millionfor the second quarter of 2015.
- Research and development expenses for the second quarter of 2016 were
$21.7 million, compared to $13.5 millionfor the comparable prior-year period. This increase was primarily due to increased development costs for the company’s CIMZIA and DRM04 programs and higher personnel-related expenses.
- General and administrative expenses for the second quarter of 2016 were
$6.4 million, compared to $3.8 millionfor the comparable prior-year period. This increase was primarily related to higher personnel-related and market research and planning expenses.
- Research and development expenses for the second quarter of 2016 were
- As of
June 30, 2016, Dermirahad cash and cash equivalents and investments of $297.9 million, no debt and 35.3 million common shares outstanding.
Key Milestones and Expectations
- Announce topline results for the three trials of the CIMZIA Phase 3 program on a sequential basis beginning in the fourth quarter of 2016 through the first quarter of 2017. The trials are evaluating the efficacy and safety of CIMZIA in adult patients with moderate-to-severe chronic plaque psoriasis. Positive results from the Phase 3 clinical trial program are expected to allow for regulatory submissions in the
United States (U.S.) and European Union(EU).
- Complete the treatment period of ARIDO, an open-label Phase 3 trial assessing the long-term safety of DRM04, by the end of 2016.
- Initiate a Phase 3 program for DRM01 in the first half of 2017, subject to an end-of-Phase 2 meeting with the
U.S. Food and Drug Administration( FDA).
- Submit a New Drug Application (NDA) to the
FDAfor DRM04 in the second half of 2017, subject to the completion of the Phase 3 ARIDO trial, other registration-enabling activities and a pre-NDA meeting with the FDA.
- Management continues to estimate GAAP operating expenses of
$110-120 millionfor 2016 (including estimated stock-based compensation expense of $10-12 million), but now expects expenses will be at the upper end of the range. Management is also updating its guidance for 2016 year-end cash and cash equivalents and investments to over $235 millionto reflect the second quarter follow-on stock offering.
About CIMZIA Phase 3 Program
The Phase 3 clinical development program, which is led by
Two of the studies, CIMPASI-1 and CIMPASI-2, are randomized, blinded, parallel group, placebo-controlled, multi-center trials designed to evaluate the efficacy and safety of CIMZIA in the treatment of patients with moderate-to-severe chronic plaque psoriasis. CIMPASI-1 and CIMPASI-2 enrolled 234 and 227 patients, respectively. A third study, CIMPACT, enrolled 559 patients and is a randomized, blinded, parallel group, placebo- and active-controlled, multi-center study designed to evaluate the efficacy and safety of CIMZIA in patients with moderate-to-severe chronic plaque psoriasis. A secondary objective of the CIMPACT trial is to compare the efficacy of CIMZIA to ENBREL®* (etanercept).
The primary endpoint in CIMPACT, the placebo- and active-controlled study, is the percentage of patients on CIMZIA achieving 75% or greater disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75), compared with placebo, at week 12. CIMPASI-1 and CIMPASI-2 have co-primary endpoints comprising both PASI 75 and the percentage of patients achieving at least a two-point improvement to a final score representing clear or almost clear skin on a five-point Physician’s Global Assessment (
Under the terms of the agreement announced in
CIMZIA® is a registered trademark of the UCB Group of Companies.
*ENBREL® (etanercept) is a registered trademark of Amgen Inc.
In addition to our filings with the
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, and Section 21E of the Securities Exchange Act of 1934, as amended, 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 statements with respect to the successful completion of, and timing expectations for the receipt and announcement of topline results from, the CIMZIA clinical trials; the guidelines for interpreting the topline efficacy and safety results from the CIMZIA Phase 3 studies, including expectations regarding necessary achievements to enable registrations in the U.S. and EU; the expected timing and completion of the treatment period for the open-label ARIDO Phase 3 trial; the prospective end-of-Phase 2 meeting with the
|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)||$||21,668||$||13,495||$||44,522||$||23,583|
|General and administrative (1)||6,373||3,848||12,274||7,994|
|Total operating expenses||28,041||17,343||56,796||31,577|
|Loss from operations||(28,041||)||(17,343||)||(56,796||)||(31,577||)|
|Interest and other income, net||286||222||605||459|
|Net loss per share, basic and diluted||$||(0.89||)||$||(0.69||)||$||(1.84||)||$||(1.26||)|
|Weighted-average common shares used to compute net loss per share, basic and diluted|
|(1||)||Amounts include stock-based compensation expense as follows:|
|Research and development||$||990||$||404||$||1,944||$||859|
|General and administrative||1,471||709||3,111||1,348|
|Total stock-based compensation expense||$||2,461||$||1,113||$||5,055||$||2,207|
|Selected Consolidated Balance Sheets Data|
|June 30,||December 31,|
|Cash and cash equivalents and investments||$||297,861||$||215,712|
|Additional paid-in capital||488,083||346,590|
|Total stockholders' equity||270,922||185,475|
Erica JeffersonSenior Director, Head of Corporate Communications 650-421-7216 firstname.lastname@example.org Investors: Andrew GuggenhimeChief Operating Officer and Chief Financial Officer 650.421.7200 Investor@dermira.com Robert H. Uhl Westwicke PartnersManaging Director 858.356.5932 email@example.com