FDAdecision on glycopyrronium tosylate New Drug Application expected by June 30, 2018
- Lebrikizumab Phase 2b study enrolling patients, data expected in first half of 2019
“For the past eight years,
Operational Highlights and Clinical Pipeline Update
- In April 2018,
Dermiraannounced the appointment of Christopher Horan as Chief Technical Operations Officer. In this newly created role, Chris will oversee pharmaceutical sciences, procurement, supply chain, including contract manufacturing, and quality as Dermira prepares to commercialize glycopyrronium tosylate (formerly DRM04).
- In March 2018,
Dermiraannounced that the investigational treatment olumacostat glasaretil (formerly DRM01) did not meet the co-primary endpoints in its two Phase 3 pivotal trials (CLAREOS-1 and CLAREOS-2) in patients ages nine years and older with moderate-to-severe acne vulgaris, and the company expects to discontinue the program.
- In February 2018,
Dermirapresented new findings from its glycopyrronium tosylate Phase 3 clinical program. The data showed that when applied topically, the investigational therapy improved disease severity, reduced sweat production and was associated with improved quality of life outcomes for pediatric patients (ages 9 to 16) with primary axillary hyperhidrosis (excessive underarm sweating), compared to vehicle-treated patients.
- In January 2018, Dermira announced the initiation of a Phase 2b dose-ranging study evaluating lebrikizumab in adult patients with moderate-to-severe atopic dermatitis, the most common form of eczema. The randomized, double-blind, placebo-controlled, parallel-group Phase 2b study is designed to evaluate the safety and efficacy of lebrikizumab as a monotherapy compared with placebo and to establish the dosing regimen for a potential Phase 3 program. Lebrikizumab is a novel, humanized monoclonal antibody designed to bind to IL-13 with high affinity, specifically preventing formation of the IL-13 receptor/IL-4 receptor complex and subsequent signaling. IL-13 plays a central role in type 2 inflammation and is an important pathogenic mediator in atopic dermatitis. The study is expected to enroll approximately 275 patients. Topline results are expected in the first half of 2019.
First Quarter 2018 Financial Results
- For the quarter ended
March 31, 2018, Dermirareported a net loss of $59.3 million, compared with a net loss of $29.5 millionfor the same period in 2017.
- Total operating expenses for the quarter ended
March 31, 2018were $57.2 million, compared to $31.2 millionfor the first quarter of 2017. This increase was primarily driven by higher personnel-related and commercial readiness expenses.
- Research and development expenses for the first quarter of 2018 were
$25.6 million, compared to $19.9 millionfor the comparable prior-year period. This increase was primarily driven by clinical trial activities for the lebrikizumab and olumacostat glasaretil product candidates and higher personnel-related expenses, offset by a decrease in clinical trial activities for the Cimzia program.
- General and administrative expenses for the first quarter of 2018 were
$30.5 million, compared to $11.3 millionfor the comparable prior-year period. This increase was primarily driven by higher personnel-related and commercial readiness expenses.
- Research and development expenses for the first quarter of 2018 were
- As of
March 31, 2018, Dermirahad cash and investments of $495.8 million, and 41.8 million common shares outstanding.
Key Milestones and Expectations
- Hold the company’s inaugural analyst and investor day on
May 24, 2018to review the company’s commercial activities for glycopyrronium tosylate and its pipeline and issue financial guidance.
- Initiate the second phase of the hyperhidrosis disease state awareness campaign in the second quarter of 2018.
- If approved by the
U.S. Food and Drug Administration( FDA), launch glycopyrronium tosylate for the treatment of axillary hyperhidrosis in the second half of 2018.
Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s pipeline includes two late-stage product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate (formerly DRM04), for which a New Drug Application is under review by the U.S. Food and Drug Administration for the treatment of primary axillary hyperhidrosis (excessive underarm sweating beyond what is needed for normal body temperature regulation), and lebrikizumab, in Phase 2b development for the treatment of moderate-to-severe atopic dermatitis. Dermira is headquartered in Menlo Park, Calif. For more information, please visit http://www.dermira.com. Follow
In addition to filings with the Securities and Exchange Commission (
Forward-Looking Statements (update)
The information in this news 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 news release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to: Dermira’s goal of bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions; potential FDA approval of glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis and the anticipated timing of such approval; the description of and enrollment expectations for Dermira’s Phase 2b dose-ranging study of lebrikizumab for moderate-to-severe atopic dermatitis; the successful completion of, and timing expectations for the receipt and announcement of topline data from the Phase 2b dose-ranging study of lebrikizumab for moderate-to-severe atopic dermatitis; expectations that
Vice President, Corporate Communications
Vice President, Investor Relations
|Selected Consolidated Statements of Operations Data|
|(in thousands, except per share amounts)|
|Three Months Ended|
|Collaboration and license revenue||$||299||$||1,066|
|Research and development (1)||25,591||19,860|
|General and administrative (1)||30,510||11,326|
|Impairment of intangible assets||1,126||-|
|Total operating expenses||57,227||31,186|
|Loss from operations||(56,928||)||(30,120||)|
|Interest and other income, net||1,734||611|
|Loss before taxes||(59,448||)||(29,509||)|
|Benefit for income taxes||(194||)||-|
|Net loss per share, basic and diluted||$||(1.42||)||$||(0.79||)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||41,827||37,290|
|(1||)||Amounts include stock-based compensation expense as follows:|
|Research and development||$||2,853||$||1,796|
|General and administrative||4,661||2,819|
|Total stock-based compensation expense||$||7,514||$||4,615|
|Selected Consolidated Balance Sheets Data|
|March 31,||December 31,|
|Cash and investments||$||495,793||$||550,993|
|Accrued payments related to acquired in-process research and development||51,802||50,161|
|Convertible notes, net||279,847||279,389|
|Total stockholders' equity||127,873||149,649|
Source: Dermira, Inc.