-Submissions for CIMZIA® (certolizumab pegol) and glycopyrronium tosylate remain on schedule for later this year
“We are off to a great start in 2017, including the successful completion of our third Phase 3 clinical trial for CIMZIA, a pre-NDA meeting with the
Operational Highlights and Clinical Pipeline Update
March 2017, Dermirapresented new information about the Axillary Sweating Daily Diary, a proprietary patient-reported outcome instrument designed to measure the severity of sweating in patients with axillary hyperhidrosis, how bothersome the sweating is and how the sweating impacts daily activities.
March 2017, Dermirapresented 16-week trial results from the CIMPASI-1 and CIMPASI-2 Phase 3 trials for CIMZIA® at the 75th Annual Meeting of the American Academy of Dermatologyin Orlando, Florida. Results from the trials showed that CIMZIA demonstrated significant improvements in patients with moderate-to-severe chronic plaque psoriasis versus placebo. Additionally, data from a key secondary endpoint found that patients who received CIMZIA reported significant improvements in their quality of life compared to patients who received placebo only.
March 2017, Dermiraclosed a follow-on public offering of 5,750,000 shares of common stock, which included full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $33.70per share. All of the shares were sold by Dermira. Net proceeds from the offering were approximately $181.5 million, after deducting the underwriting discounts and commissions and offering expenses.
February 2017, Dermiraheld a meeting with the U.S. Food and Drug Administration( FDA) to discuss Dermira’s planned submission of a New Drug Application (NDA) for glycopyrronium tosylate (formerly DRM04) for the treatment of axillary hyperhidrosis.
January 2017, December 2016and October 2016, Dermiraand UCB Pharma S.A.(UCB) reported positive topline results from the CIMPACT, CIMPASI-1 and CIMPASI-2 Phase 3 clinical trials, respectively, which evaluated the efficacy and safety of CIMZIA in adult patients with moderate-to-severe chronic plaque psoriasis. In all three CIMZIA Phase 3 clinical trials, CIMZIA demonstrated statistically significant improvements for all primary or co-primary endpoints compared to placebo at both treatment doses. The safety profile across all three trials appears consistent with the safety profiles observed with CIMZIA for currently approved indications. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
- In January 2017, Dermira announced the initiation of a Phase 3 program evaluating the safety and efficacy of olumacostat glasaretil (formerly DRM01), a novel, small molecule designed to reduce sebum production following topical application, in patients with acne vulgaris.
First Quarter 2017 Financial Results
- For the quarter ended
March 31, 2017, Dermirareported a net loss of $29.5 million, compared with a net loss of $28.4 millionfor the same period in 2016.
- Total operating expenses for the quarter ended
March 31, 2017were $31.2 million, compared to $28.8 millionfor the first quarter of 2016.
- Research and development expenses for the first quarter of 2017 were
$19.9 million, compared to $22.9 millionfor the comparable prior-year period. This decrease was primarily due to a reduction in clinical trial activities for the company’s CIMZIA and glycopyrronium tosylate product candidates, partially offset by growth in clinical trial activities for the olumacostat glasaretil product candidate and an increase in personnel-related expenses.
- General and administrative expenses for the first quarter of 2017 were
$11.3 million, compared to $5.9 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 2017 were
- As of
March 31, 2017, Dermirahad cash, cash equivalents and short- and long-term investments of $433.1 million, no debt and 41.5 million common shares outstanding.
Key Milestones and Expectations
- Submission of marketing applications by UCB in
the United States, Europeand Canadafor CIMZIA for the treatment of moderate-to-severe chronic plaque psoriasis in the third quarter of 2017. If approved, Dermirawould have marketing responsibilities in the United Statesand Canada.
- Submit an NDA to the
FDAfor glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis in the second half of 2017, subject to the completion of registration-enabling activities.
- Announce topline results in the first half of 2018 from the olumacostat glasaretil Phase 3 clinical trials, CLAREOS-1 and CLAREOS-2, in patients with acne vulgaris.
- Management reiterates its previously issued financial guidance for full year 2017, including expected collaboration and license revenue of approximately
$4.3 millionand operating expenses of $165.0-175.0 million, which includes estimated stock-based compensation expense of approximately $20.0 million.
- Management expects a balance of over
$325.0 millionin cash, cash equivalents and short- and long-term investments at December 31, 2017, updated to reflect the net proceeds received in the March 2017follow-on public offering.
In addition to filings with the
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to: the completion of, and timing expectations for the receipt and announcement of topline results from, Dermira’s CLAREOS-1 and CLAREOS-2 trials; the timing and submission of marketing applications in
|Selected Consolidated Statements of Operations Data|
|(in thousands, except share and per share amounts)|
|Three Months Ended|
|Collaboration and license revenue||$||1,066||$||-|
|Research and development (1)||19,860||22,854|
|General and administrative (1)||11,326||5,901|
|Total operating expenses||31,186||28,755|
|Loss from operations||(30,120||)||(28,755||)|
|Interest and other income, net||611||319|
|Net loss per share, basic and diluted||$||(0.79||)||$||(0.95||)|
|Weighted-average common shares used to
compute net loss per share, basic and diluted
|(1)||Amounts include stock-based compensation expense as follows:|
|Research and development||$||1,796||$||954|
|General and administrative||2,819||1,640|
|Total stock-based compensation expense||$||4,615||$||2,594|
|Selected Consolidated Balance Sheets Data|
|March 31,||December 31,|
|Cash and cash equivalents and investments||$||433,057||$||276,493|
|Additional paid-in capital||684,870||497,718|
|Total stockholders' equity||405,096||247,370|
Erica JeffersonSenior Director, Head of Corporate Communications 650-421-7216 email@example.com Investors: Ian Clements, Ph.D. Vice President, Investor Relations 650-422-7753 firstname.lastname@example.org Robert H. Uhl Westwicke PartnersManaging Director 858-356-5932 email@example.com