- DRM01 Phase 2b and DRM04 Phase 3 data presented at Fall Clinical Dermatology Conference - In October 2016, data were presented from Dermira's DRM01 Phase 2b dose-ranging study in patients with facial acne vulgaris and DRM04 Phase 3 clinical program in patients with primary axillary hyperhidrosis at the 35 th Annual Fall Clinical Dermatology Conference in Las Vegas.
- Announced topline results for CIMZIA from the first of three Phase 3 trials in patients with moderate-to-severe chronic plaque psoriasis - In October 2016, Dermira announced topline results from CIMPASI-2, a Phase 3, multi-center, placebo-controlled clinical trial evaluating the efficacy and safety of CIMZIA in adult patients with moderate-to-severe chronic plaque psoriasis. In the CIMPASI-2 trial, CIMZIA demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses. The CIMPASI-2 trial results are the first of three Phase 3 clinical trials to be reported evaluating CIMZIA in this patient population. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
- DRM04 Phase 3 data presented in late-breaking news session at EADV Congress - In October 2016, data from Dermira's DRM04 Phase 3 clinical program, including new disease-related quality of life data, were presented in a late-breaking news session at the 25 th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria.
- Licensed DRM04 for hyperhidrosis to Maruho in Japan - In September 2016, Dermira entered into an exclusive license agreement with Maruho Co., Ltd., a Japanese company specializing in dermatology. Pursuant to the terms of the agreement, Dermira granted Maruho an exclusive license to develop and commercialize DRM04 for hyperhidrosis in Japan. Terms of the agreement included an initial $25 million license payment to Dermira by Maruho.
- Acquired option to license exclusive rights to early-stage programs from Takeda - In September 2016, Dermira entered into an exclusive option and license agreement with Takeda Pharmaceutical Company Limited. Pursuant to the terms of the agreement, Dermira acquired an option to license exclusive worldwide rights for up to three early-stage, small-molecule programs as potential topical treatment options for dermatologic diseases. Terms of the agreement included an upfront fee of $1.5 million paid by Dermira to Takeda in the form of shares of Dermira common stock.
- Completed end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) for DRM01 - In September 2016, Dermira held an end-of-Phase 2 meeting with the FDA to discuss the DRM01 program. Based on the results of the meeting and the Phase 2b dose-ranging study, Dermira plans to initiate a Phase 3 program to evaluate the safety and efficacy of DRM01 as a potential treatment for acne in adult and adolescent patients in the first half of 2017.
- For the quarter ended September 30, 2016, Dermira reported a net loss of $25.5 million, compared with a net loss of $16.1 million for the same period in 2015.
- Collaboration and license revenue for the third quarter of 2016 was $119,000, representing the portion of the $25.0 million initial license payment from Maruho recognized during the period. Collaboration and license revenue for the third quarter of 2015 was $7.3 million, representing the achievement of a milestone, the completion of patient enrollment in the first CIMZIA Phase 3 clinical trial, pursuant to the company's agreement with UCB Pharma S.A.
- Total operating expenses for the quarter ended September 30, 2016 were $26.1 million, compared to $23.6 million for the third quarter of 2015.
- Research and development expenses for the third quarter of 2016 were $17.8 million, compared to $18.9 million for the comparable prior-year period. This decrease was primarily due to lower development costs for the company's product candidates as a result of a reduction in clinical trial activities, partially offset by an increase in personnel-related expenses and $1.5 million in costs related to the acquisition of license rights from Takeda.
- General and administrative expenses for the third quarter of 2016 were $8.3 million, compared to $4.7 million for the comparable prior-year period. This increase was primarily related to higher personnel-related expenses and a transaction advisory fee paid in connection with the Maruho DRM04 exclusive license agreement.
- As of September 30, 2016, Dermira had cash and investments of $276.6 million, no debt and 35.6 million common shares outstanding. The cash and investments balances do not include the $25 million payment to Dermira by Maruho in October 2016 related to the DRM04 exclusive license agreement.
- Complete the treatment period of ARIDO, an open-label Phase 3 trial assessing the long-term safety of DRM04, by the end of 2016.
- Announce topline results for CIMPASI-1 and CIMPACT, the remaining two trials of the three-study CIMZIA Phase 3 program, on a sequential basis by the end of the first quarter of 2017.
- Initiate a Phase 3 program for DRM01 for the potential treatment of acne vulgaris in adult and adolescent patients in the first half of 2017.
- Submit a New Drug Application (NDA) to the FDA for 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 full-year GAAP operating expenses of $110-120 million for 2016 (including estimated stock-based compensation expense of $10-12 million). Management is also updating its guidance for 2016 year-end cash and investments to over $260 million to reflect the receipt of the $25 million upfront payment in connection with the DRM04 exclusive license agreement with Maruho. Dermira currently expects to recognize this upfront payment as collaboration and license revenue on a straight-line basis over a period of approximately eight years from the execution of the agreement, or approximately $0.8 million per quarter.
|Selected Consolidated Statements of Operations Data|
|(in thousands, except share and per share amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Collaboration and license revenue||$||119||$||7,300||$||119||$||7,300|
|Research and development (1)||17,784||18,890||62,306||42,473|
|General and administrative (1)||8,276||4,684||20,550||12,678|
|Total operating expenses||26,060||23,574||82,856||55,151|
|Loss from operations||(25,941||)||(16,274||)||(82,737||)||(47,851||)|
|Interest and other income, net||431||259||1,036||718|
|Net loss per share, basic and diluted||$||(0.72||)||$||(0.58||)||$||(2.54||)||$||(1.84||)|
|Weighted-average common shares used to compute net loss per share, basic and diluted|
|(1) Amounts include stock-based compensation expense as follows:|
|Research and development||$||1,020||$||541||$||2,964||$||1,401|
|General and administrative||1,845||920||4,956||2,267|
|Total stock-based compensation expense||$||2,865||$||1,461||$||7,920||$||3,668|
|Selected Consolidated Balance Sheets Data|
|September 30,||December 31,|
|Cash and investments||$||276,644||$||215,712|
|Additional paid-in capital||493,681||346,590|
|Total stockholders' equity||250,869||185,475|
Contacts:Media: Erica JeffersonSenior Director, Head of Corporate Communications650email@example.com Investors:Andrew GuggenhimeChief Operating Officer and Chief Financial Officer650.421.7200Investor@dermira.com Robert H. UhlWestwicke PartnersManaging Director858.firstname.lastname@example.org