- Licensed exclusive, worldwide rights to lebrikizumab from
- Completed patient enrollment in two Phase 3 trials for the treatment of acne vulgaris
- Agreed to end collaboration agreement with UCB for CIMZIA
“We continue to make great strides across all aspects of our business. The FDA’s acceptance of our application for glycopyrronium tosylate is an important achievement for
Operational Highlights and Clinical Pipeline Update
- Earlier today,
Dermiraannounced that following its expressed intent to exercise its right to terminate its collaboration agreement with UCB Pharma S.A.(UCB), Dermiraand UCB entered into a transition agreement to terminate the collaboration agreement and to effect an orderly transition of the development and commercialization activities related to CIMZIA® (certolizumab pegol) in psoriasis, pursuant to which UCB will regain U.S. and Canadian development and commercialization rights for CIMZIA for the treatment of psoriasis. In consideration for the repurchase of all product rights, licenses and intellectual property relating to CIMZIA, UCB will pay to Dermira $11.0 millionby November 13, 2017and, upon approval of CIMZIA in psoriasis in the United States, an additional $39.0 millionwithin 30 days of such approval. Dermirais obligated to reimburse UCB for up to $10.0 millionof development costs incurred by UCB in connection with the development of CIMZIA between January 1, 2018and June 30, 2018. If the aggregate development costs reimbursed by Dermirato UCB during this six-month period are less than $10.0 million, Dermirawill pay to UCB the difference between such aggregate costs and $10.0 million. These terms replace the provisions of the original collaboration agreement pursuant to which Dermirawould have been eligible to recoup its external development costs incurred related to the CIMZIA program, net of milestones received, through a royalty on future net sales of CIMZIA.
October 2017, Dermirapresented new long-term safety data for glycopyrronium tosylate in primary axillary hyperhidrosis, showing that daily treatment with glycopyrronium tosylate in the Phase 3, open-label ARIDO trial was generally well-tolerated during the 44-week treatment period.
October 2017, Dermiraannounced the completion of enrollment in two Phase 3 clinical trials investigating the safety and efficacy of olumacostat glasaretil (formerly DRM01) in patients with acne vulgaris. The two pivotal trials, CLAREOS-1 and CLAREOS-2, enrolled a total of 1,503 patients.
September 2017, Dermirapresented new data that suggest, if approved, glycopyrronium tosylate would have the potential to reduce the burden of disease for patients with excessive underarm sweating.
September 2017, Dermiraclosed its transaction with F. Hoffmann-La Roche Ltdand Genentech, Inc., a member of the Roche Group(together Roche). Pursuant to the licensing agreement, Dermiraobtained exclusive, worldwide rights to develop and commercialize lebrikizumab, a monoclonal antibody targeting interleukin 13, for atopic dermatitis and all other indications, except Rocheretained certain rights, including exclusive rights to develop and promote lebrikizumab for interstitial lung disease.
Third Quarter 2017 Financial Results
- For the quarter ended
September 30, 2017, Dermirareported a net loss of $179.2 millioncompared with a net loss of $25.5 millionfor the same period in 2016. The net loss for the quarter ended September 30, 2017included $128.6 millionin acquired in-process research and development expenses related to the licensing agreement with Rocheas detailed below.
- Total operating expenses for the quarter ended
September 30, 2017were $179.1 million, compared to $26.1 millionfor the third quarter of 2016.
- Research and development expenses for the third quarter of 2017 were
$30.8 million, compared to $17.8 millionfor the comparable prior-year period. This increase was primarily due to an increase in clinical trial activities related to the olumacostat glasaretil Phase 3 program, an increase in personnel-related expenses and growth in regulatory and manufacturing activities for the glycopyrronium tosylate program. Dermirarecognized acquired in-process research and development expenses of $128.6 millionfor the third quarter of 2017 related to its licensing agreement with Roche. These expenses reflect the initial $80.0 millionpayment made to Rochein October 2017and the present value of the two additional payments totaling $55.0 milliondue to Rochein 2018.
- General and administrative expenses for the third quarter of 2017 were
$19.8 million, compared to $8.3 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 third quarter of 2017 were
- As of
September 30, 2017, Dermirahad cash, cash equivalents and short- and long-term investments of $662.9 millionand 41.7 million common shares outstanding.
Key Milestones and Expectations
- Initiate a Phase 2b dose-ranging study evaluating lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2018.
- Announce topline results from the CLAREOS-1 and CLAREOS-2 Phase 3 pivotal trials evaluating the safety and efficacy of olumacostat glasaretil in patients with acne vulgaris in the first quarter of 2018.
- If approved by the
FDA, launch glycopyrronium tosylate for the treatment of axillary hyperhidrosis in the second half of 2018.
- Management is updating its financial guidance for full year 2017 primarily to reflect the impact of the licensing agreement with
Roche, including the acquired in-process research and development expenses associated with the payments to Roche. Management now expects collaboration and license revenue of approximately $4.3 million, research and development and general and administrative expenses totaling $170.0 to 180.0 million, which includes estimated stock-based compensation expense of approximately $20.0 million, and acquired in-process research and development expenses of $128.6 million.
- Management expects a balance of over
$540.0 millionin cash, cash equivalents and short- and long-term investments at December 31, 2017, updated to reflect the net proceeds received from the convertible senior notes offering in May 2017, the $80.0 millioninitial payment to Rocherelated to the licensing agreement and the $11.0 millionpayment to be received from UCB in connection with the transition agreement related to CIMZIA.
Webcast and Conference Call Information
Hyperhidrosis is a condition of sweating beyond what is physiologically required for normal thermal regulation and affects an estimated 4.8% of the U.S. population, or approximately 15.3 million people.1 Of these, 65 percent, or nearly 10 million people, suffer from sweating localized to the underarms (axillary disease). Studies have further demonstrated that excessive sweating often impedes normal daily activities and can also result in occupational, emotional, psychological, social and physical impairment.2,3
About Glycopyrronium Tosylate and the Phase 3 Studies
Glycopyrronium tosylate is a once-daily anticholinergic agent, administered as a topical wipe, designed to block sweat production by inhibiting the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation.
The NDA is based on results from ATMOS-1 and ATMOS-2, two identically designed Phase 3 clinical trials designed to assess the safety and efficacy of glycopyrronium tosylate compared to vehicle in adolescent and adult patients (ages nine and older) with primary axillary hyperhidrosis. In addition to these two trials, an open-label trial, ARIDO, assessed the long-term safety of glycopyrronium tosylate. Results from ATMOS-1 and ATMOS-2 were reported in
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 three 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
In addition to filings with the Securities and Exchange Commission (
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: Dermira’s goal of delivering differentiated, new therapies to the millions of patients living with chronic skin conditions; the expected date by which the
1. Doolittle et. al., Hyperhidrosis: An Update on Prevalence and Severity in
2. Bahar et. al., The prevalence of anxiety and depression in patients with or without hyperhidrosis (HH). J Am Acad Dermatol. 75(6): 1126-1133, 2016.
3. Augustin et. al., Prevalence and disease burden of hyperhidrosis in the adult population. Dermatology. 227: 10-13, 2013.
Vice President, Corporate Communications
Vice President, Investor Relations
|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||$||1,066||$||119||$||3,198||$||119|
|Research and development (1)||30,788||17,784||76,626||62,306|
|Acquired in-process research and development||128,555||-||128,555||-|
|General and administrative (1)||19,754||8,276||44,667||20,550|
|Total operating expenses||179,097||26,060||249,848||82,856|
|Loss from operations||(178,031||)||(25,941||)||(246,650||)||(82,737||)|
|Interest and other income, net||1,721||431||3,585||1,036|
|Net loss per share, basic and diluted||$||(4.30||)||$||(0.72||)||$||(6.15||)||$||(2.54||)|
|Weighted-average common shares used to compute net loss per share, basic and diluted|
|(1||)||Amounts include stock-based compensation expense as follows:|
|Research and development||$||2,104||$||1,020||$||5,918||$||2,964|
|General and administrative||3,397||1,845||9,302||4,956|
|Total stock-based compensation expense||$||5,501||$||2,865||$||15,220||$||7,920|
|Selected Consolidated Balance Sheets Data|
|September 30,||December 31,|
|Cash and cash equivalents and investments||$||662,883||$||276,493|
|Accrued payments related to acquired in-process research and development, current and non-current||128,807||-|
|Convertible notes, net||278,938||-|
|Additional paid-in capital||696,152||497,718|
|Total stockholders' equity||198,727||247,370|
Source: Dermira, Inc.