- QBREXZA™ (glycopyrronium) cloth 2018 net product sales of
- Over 14,500 prescriptions for QBREXZA written in first three months of launch
- Secured QBREXZA coverage for approximately 76% of total U.S. commercial lives
- Entered into option and license agreement with
Almirallfor rights to lebrikizumab in Europe
- Lebrikizumab topline Phase 2b data expected in second half of March
“We’re very pleased by the progress of the QBREXZA launch and will continue our efforts to raise awareness of primary axillary hyperhidrosis as a medical condition and ensure seamless access to the therapy for patients,” said
Fourth Quarter 2018 Financial Results
- Total revenue for the fourth quarter was
$2.2 million, comprised exclusively of QBREXZA product sales, compared with $1.3 millionof collaboration and license revenue for the comparable quarter in 2017. QBREXZA revenue is recognized upon delivery of product to wholesalers or a preferred dispensing partner, net of estimated rebates and other reserves.
- Total costs and operating expenses for the quarter ended
December 31, 2018were $72.7 millioncompared to $55.0 millionfor the fourth quarter of 2017.
- Cost of sales for the fourth quarter of 2018 was
$0.9 millionrelated to QBREXZA sales.
- Research and development expenses for the fourth quarter of 2018 were
$19.1 millioncompared to $27.8 millionfor the comparable prior-year period. This decrease was primarily due to a reduction in clinical trial activities associated with the company’s acne, psoriasis and hyperhidrosis programs, which were partially offset by an increase in activities related to the atopic dermatitis clinical program.
- Selling, general and administrative expenses for the fourth quarter of 2018 were
$51.8 millioncompared to $27.2 millionfor the comparable prior-year period. This increase was primarily driven by the execution of the QBREXZA commercial launch, including higher personnel-related costs associated with the addition of a sales force and other positions within the commercial organization, and patient awareness and physician education marketing activities.
- Cost of sales for the fourth quarter of 2018 was
- For the quarter ended
December 31, 2018, Dermirareported a net loss of $71.8 millioncompared with a net loss of $56.0 millionfor the same period in 2017.
Full Year 2018 Financial Results
- Total revenue for the year ended
December 31, 2018was $42.3, compared with $4.5 millionin 2017. Revenue for 2018 was comprised of $3.0 millionin QBREXZA product sales and $39.4 millionin collaboration and license revenue, which was primarily driven by a $39.0 millionmilestone payment from UCB Pharma S.A.
- Total costs and operating expenses for 2018 were
$256.3 millioncompared to $304.9 millionfor 2017.
- Cost of sales for 2018 was
$1.2 millionrelated to QBREXZA sales.
- Research and development expenses for 2018 were
$80.5 millioncompared to $104.4 millionfor the prior year. Dermira also recognized acquired in-process research and development expenses of $128.6 million in 2017 related to its licensing agreement with F. Hoffmann-La Roche Ltdand Genentech, Inc., a member of the Roche Group(together Roche), pursuant to which Dermiraobtained exclusive, worldwide rights to develop and commercialize lebrikizumab for atopic dermatitis and all other indications.
- Selling, general and administrative expenses for 2018 were
$172.6 million, compared to $71.9 millionfor the prior year.
- Cost of sales for 2018 was
- For the year ended
December 31, 2018, Dermirareported a net loss of $221.5 millioncompared with a net loss of $303.3 millionfor the same period in 2017.
Cash, Cash Equivalents and Investments
- As of
December 31, 2018, Dermirahad cash and investments of $316.0 millionand 42.3 million common shares outstanding. In the fourth quarter of 2018, Dermirareceived initial net proceeds of approximately $33.2 millionin connection with a credit facility it entered into with funds managed by Athyrium Capital Management(Athyrium), and made a $30.0 millionmilestone payment for completion of enrollment of the lebrikizumab Phase 2b clinical study in connection with the license agreement with Roche. Dermiraanticipates that its cash and investments on hand are sufficient to meet the company’s anticipated cash requirements, excluding costs to conduct a potential Phase 3 program for lebrikizumab, to at least mid-2020.
Recent Operational Highlights and Clinical Pipeline Update
- Launched QBREXZA in the United States on October 1, 2018 for the treatment of adult and pediatric patients (9 years of age and older) living with primary axillary hyperhidrosis, also commonly known as excessive underarm sweating.
- Generated 14,786 prescriptions for QBREXZA as reported by Symphony PHAST monthly data for the fourth quarter of 2018, which represents the first three months of the QBREXZA launch.
- Secured QBREXZA coverage for approximately 76% of the total U.S. commercial lives (calculated based on
Dermiradata on file).
- Completed patient enrollment in the Phase 2b dose-ranging study evaluating lebrikizumab, an anti-IL13 monoclonal antibody, in patients with moderate-to-severe atopic dermatitis in October 2018. The study enrolled 280 patients ages 18 years and older in
the United States. The study is evaluating three different lebrikizumab treatment dosing arms compared to a placebo arm.
- Bolstered the balance sheet by entering into a credit facility with Athyrium. The financing agreement provides up to
$125 millionof borrowing capacity available in three tranches. An initial tranche of $35 millionwas funded at the December 2018closing and an additional $90 millionis available at Dermira’s option, subject to certain conditions.
- Entered into an option and license agreement with
Almirallin February 2019, under which Almirallacquired an option to exclusively license rights to develop lebrikizumab for the treatment or prevention of dermatology indications, including but not limited to atopic dermatitis, and commercialize lebrikizumab for the treatment or prevention of all indications in Europe. In exchange, Dermirawill receive an upfront option fee of $30 million. If Almirallexercises its option to obtain the license following the results of the ongoing Phase 2b study, Dermirawill receive a $50 millionoption exercise fee and will be eligible to receive additional development, regulatory and sales milestone payments, including $30 millionin connection with the initiation of certain Phase 3 clinical studies, as well as double-digit royalties.
- Initiated a proof-of-concept study to evaluate the efficacy and safety of QBREXZA in people living with primary palmar hyperhidrosis, or excessive sweating of the hands. The study is expected to enroll approximately 60 patients ages 9 years and older at eight sites in
the United States. Findings from the study are expected in the second half of 2019 and will inform next steps for a potential primary palmar hyperhidrosis development program.
Key Milestones and Expectations
- Announce topline results from the Phase 2b study evaluating the safety and efficacy of lebrikizumab in patients with moderate-to-severe atopic dermatitis in the second half of
- If the data from the lebrikizumab Phase 2b study support a differentiated product profile and significant commercial opportunity, initiate a Phase 3 program by the end of 2019.
- Issue 2019 financial guidance after the disclosure of the lebrikizumab Phase 2b trial topline results.
- Launch a branded direct-to-consumer QBREXZA advertising campaign by the end of March.
Conference Call Details
Dermira will host a conference call to discuss the fourth quarter financial results today, February 26, 2019, beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The live call can be accessed by phone by dialing 1-877-359-9508 from the U.S. and Canada or +1-224-357-2393 internationally and using the passcode 2269419. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.dermira.com. It will be archived for 30 days following the call.
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 million people. Of these, 65 percent, or nearly 10 million people, suffer from sweating localized to the underarms (axillary disease). Studies have demonstrated that excessive sweating often impedes normal daily activities and can also result in occupational, emotional, psychological, social and physical impairment.
About QBREXZA™ (glycopyrronium) cloth
QBREXZA (pronounced kew brex’ zah) is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older. QBREXZA is applied directly to the skin and is designed to block sweat production by inhibiting sweat gland activation. For more information visit www.QBREXZA.com.
Important Safety Information
QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA.
WARNINGS AND PRECAUTIONS
Worsening of Urinary Retention: Use with caution in patients with a history or presence of documented urinary retention.
Control of Body Temperature: In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA.
Operating Machinery or an Automobile: Transient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
The most common adverse reactions seen in ≥2% of subjects treated with QBREXZA were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat (2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions of erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.
It is important for patients to understand how to correctly apply QBREXZA (see Patient Product Information). Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
Please see Full Prescribing Information
About Atopic Dermatitis
Atopic dermatitis is the most common and severe form of eczema, a chronic inflammatory condition that can present as early as childhood and continue into adulthood. A moderate-to-severe form of the disease is characterized by rashes on the skin that often cover much of the body and also includes redness, cracking, dryness and intense, persistent itching. The skin condition can have a negative impact on patients’ mental and physical functioning, limiting their daily activities and health-related quality of life. Patients with moderate-to-severe atopic dermatitis have reported a larger impact on quality of life than patients with psoriasis.
Lebrikizumab is a novel, humanized monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.
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, develop and commercialize leading-edge medical dermatology products. The company’s approved treatment, QBREXZA™ (glycopyrronium) cloth, is indicated for pediatric and adult patients (ages nine and older) with primary axillary hyperhidrosis (excessive underarm sweating).
In addition to filings with the Securities and Exchange Commission (
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; Dermira’s plans to generate growth in QBREXZA awareness and use and ensure seamless access to QBREXZA for patients; the belief that lebrikizumab may offer a compelling combination of safety, efficacy and convenience for people living with moderate-to-severe atopic dermatitis; the successful completion of, and timing expectations for the receipt and announcement of topline data from, the Phase 2b study of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis; plans to initiate a Phase 3 program of lebrikizumab for the treatment of moderate-to-severe atopic dermatitis by the end of this year if data from the Phase 2b study support a differentiated product profile and significant commercial opportunity; the anticipation that Dermira’s cash and investments on hand are sufficient to meet the company’s anticipated cash requirements, excluding costs to conduct a potential Phase 3 program for lebrikizumab, to at least mid-2020; the future availability of an additional
Vice President, Corporate Communications
Vice President, Investor Relations
|Selected Consolidated Statement of Operations Data|
|(in thousands, except per share amounts)|
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Collaboration and license revenue||-||1,343||39,379||4,541|
|Costs and operating expenses:|
|Cost of sales (1)||939||-||1,176||-|
|Research and development (1)||19,119||27,783||80,547||104,409|
|Acquired in-process research and development||891||-||891||128,555|
|Selling, general and administrative (1)||51,791||27,236||172,581||71,903|
|Impairment of intangible assets||-||-||1,126||-|
|Total costs and operating expenses||72,740||55,019||256,321||304,867|
|Loss from operations||(70,497)||(53,676)||(213,982)||(300,326)|
|Interest and other income, net||1,918||1,620||7,887||5,205|
|Loss before taxes||(71,810)||(56,012)||(221,734)||(303,261)|
|Benefit for income taxes||-||-||194||-|
|Net loss per share, basic and diluted||$||(1.70)||$||(1.34)||$||(5.27)||$||(7.48)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||42,194||41,720||42,003||40,562|
|(1) Amounts include stock-based compensation expense as follows:|
|Cost of sales||$||-||$||-||$||7||$||-|
|Research and development||2,173||2,088||9,945||8,006|
|Selling, general and administrative||4,766||3,395||19,696||12,697|
|Total stock-based compensation expense||$||6,939||$||5,483||$||29,648||$||20,703|
|Selected Consolidated Balance Sheet Data|
|December 31,||December 31,|
|Cash and investments||$||316,002||$||550,993|
|Accrued payments related to acquired in-process research and development||-||50,161|
|Convertible notes, net||281,223||279,389|
|Total stockholders' equity (deficit)||(9,039)||149,649|
Source: Dermira, Inc.