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August 31, 2015 10:35 AM ET

Pharmaceuticals

Company Overview of Dermira, Inc.

Company Overview

Dermira, Inc., a specialty biopharmaceutical company, focuses on the development and commercialization of medical dermatology products to dermatologists and their patients primarily in the United States. The company’s late-stage product candidates comprise Cimzia, an injectable biologic tumor necrosis factor-alpha inhibitor, which is in Phase III clinical trial for the treatment of moderate-to-severe plaque psoriasis; DRM04, a small-molecule anticholinergic product that has completed a Phase IIb clinical trial for the treatment of hyperhidrosis or excessive sweating; and DRM01, a sebum inhibitor, which has completed a Phase IIa clinical trial for the treatment of acne. Its early-stage progra...

275 Middlefield Road

Suite 150

Menlo Park, CA 94025

United States

Founded in 2010

34 Employees

Phone:

650-421-7200

Key Executives for Dermira, Inc.

Chairman of The Board, Chief Executive Officer and Co-Founder
Age: 63
Total Annual Compensation: $371.3K
Co-Founder and Executive Vice President of Product Development
Age: 53
Total Annual Compensation: $300.0K
Chief Financial Officer and Chief Operating Officer
Age: 47
Total Annual Compensation: $224.7K
Compensation as of Fiscal Year 2014.

Dermira, Inc. Key Developments

Dermira, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015

Dermira, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, loss from operations was $17,343,000 against $8,703,000 last year. Net loss was $17,159,000 compared to $8,762,000 a year ago. Net loss per basic and diluted share was $0.69 against $9.72 last year. For the six months, loss from operations was $31,577,000 against $17,200,000 last year. Net loss was $31,194,000 compared to net loss of $17,301,000 last year. Net loss per basic and diluted share was $1.26 against $19.28 last year.

Dermira Doses First Patients in DRM04 Phase 3 Program in Axillary Hyperhidrosis

Dermira, Inc. announced the initial dosing of the first patients in a Phase 3 program for DRM04 in patients with axillary hyperhidrosis (excessive underarm sweating). 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 to support a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). A total of 660 adult and adolescent (9+ years) patients with primary axillary hyperhidrosis will be enrolled in two identical Phase 3 trials, ATMOS-1 and ATMOS-2, being conducted at approximately 60 sites in the United States and Germany. Subjects will be randomized into two separate arms evaluating DRM04 compared to vehicle. In each trial, 220 patients will receive DRM04 and 110 patients will receive vehicle. Patients are instructed to apply the study product to each axilla (underarm) once daily for four weeks using topical wipes containing either DRM04 or vehicle only. The co-primary endpoints will be the average absolute change from baseline in gravimetrically-measured sweat production and the proportion of patients who achieve at least a four-point improvement from baseline in disease severity as measured by the Axillary Sweating Daily Diary (ASDD), the company's proprietary patient-reported outcome (PRO) instrument. Each of these endpoints will be measured at the end of the four-week treatment period. Based on discussions with the FDA, Dermira developed and validated the ASDD instrument in accordance with the 2009 FDA guidance document for PRO measures. The ASDD endpoint, a 4-point change on an 11-point scale, was selected based on analyses of data generated in the second Phase 2b Study, DRM04-HH02, and feedback from the FDA. Secondary efficacy endpoints will measure the proportion of subjects who have at least a two-grade improvement from baseline as measured by the Hyperhidrosis Disease Severity Scale (HDSS), wherein patients rate the severity of their disease on a four-point scale, and the proportion of subjects with at least a 50% reduction from baseline in gravimetrically-measured sweat production, each as measured at the end of the four-week treatment period. Topline results from ATMOS-1 and ATMOS-2 are expected during the second half of 2016. 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. DRM04 is a topical formulation of a novel form of an anticholinergic agent, which is referred to as the reference agent, that has been approved for systemic administration in other indications. The DRM04 dose being evaluated in the Phase 3 program is a 3.75% concentration of Dermira's novel form of the reference agent, which was evaluated in Study DRM04-HH02 and corresponds to the 3% dosage formulation of the reference agent evaluated in both Study DRM04-HH02 and the first Phase 2b study (DRM04-HH01).

Dermira Seeks Acquisitions

Dermira, Inc. (NasdaqGS:DERM) will use the proceeds of the follow-on equity offering, among other things, for expanding the current business by in-licensing or acquiring, as the case may be, commercial products, product candidates, technologies, compounds, other assets or complementary businesses, using cash or shares of Dermira's common stock.

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