- QBREXZA™ (glycopyrronium) cloth prescriptions increased more than 50% over fourth quarter 2018
- First quarter net product sales of
- Approximately 80% of commercially insured patients have access to QBREXZA
- End-of-Phase 2
FDAmeeting scheduled following positive lebrikizumab study results
- Balance sheet strengthened through follow-on equity financing
“Positive momentum continued into the first quarter 2019 at
First Quarter 2019 Financial Results
Total revenue for the first quarter was
$2.5 million, comprised exclusively of QBREXZA product sales, compared with $0.3 millionof collaboration and license revenue for the comparable quarter in 2018.
- First quarter 2019 QBREXZA sales were impacted by the company's launch-related patient financial assistance program designed to broaden patient access, a component of which is being phased out beginning in the second quarter of 2019 as a result of the company having achieved specific objectives for commercial coverage of QBREXZA.
Total costs and operating expenses for the quarter ended
March 31, 2019were $65.2 millioncompared to $57.2 millionfor the first quarter of 2018.
Cost of sales for the first quarter of 2019 was
$0.9 millionrelated to QBREXZA sales.
Research and development (R&D) expenses for the first quarter of
$15.6 millioncompared to $25.6 millionfor the comparable prior-year period. This decrease was primarily due to a reduction in activities associated with the company’s previous acne program and, to a lesser degree, in personnel-related costs in research and development functions.
Selling, general and administrative (SG&A) expenses for the first
quarter of 2019 were
$48.7 millioncompared to $30.5 millionfor the comparable prior-year period. This increase was primarily driven by higher costs as a result of the October 2018QBREXZA 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 first quarter of 2019 was
For the quarter ended
March 31, 2019, Dermirareported a net loss of $64.8 millioncompared with a net loss of $59.3 millionfor the same period in 2018.
March 31, 2019, Dermirahad cash and investments of $387.8 millionand 53.6 million common shares outstanding.
Key Operational Highlights
In the first quarter of 2019, generated 23,559 prescriptions for
QBREXZA as reported by Symphony PHAST monthly data and 18,384
prescriptions as reported by
IQVIAmonthly data and the company’s preferred dispensing partner, in each case representing an increase of approximately 59% over the fourth quarter of 2018.
“Life Unfolds,” a new direct-to-consumer campaign designed to drive
consumer awareness of QBREXZA, in
Secured QBREXZA coverage for approximately 80% of the total U.S.
commercial lives (calculated based on
Dermiradata on file) as of May 1, 2019.
positive topline results from a Phase 2b dose-ranging study evaluating
lebrikizumab, an anti-IL-13 monoclonal antibody, in patients with
moderate-to-severe atopic dermatitis in
an underwritten follow-on public offering in
March 2019which generated approximately $140 millionin net proceeds.
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.
- 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.
Upcoming Milestones and Expectations
Following an end-of-Phase 2 meeting with the
U.S. Food and Drug Administration, scheduled for midyear, initiate a Phase 3 clinical development program for lebrikizumab by the end of 2019.
Receive and announce Almirall’s decision regarding the potential
exercise of its option to exclusively license rights to lebrikizumab
Europeat the conclusion of its 45-day evaluation period, which is expected midyear.
For fiscal year 2019:
For QBREXZA, management expects prescriptions and net product
sales to grow quarter-over-quarter over the course of 2019, with
such growth accelerating in the second half of the year; and the
gross-to-net discount to improve from 76% in the first quarter of
2019 to 45-55% in the second quarter and approximately 40% in the
second half of the year based on changes to the company’s patient
financial assistance programs that became effective
April 1, 2019.
Management estimates R&D and SG&A expenses for 2019 to be between
$295 and $315 million, including estimated stock-based compensation expense of approximately $35 million. The estimated increase in 2019 R&D and SG&A expenses compared to 2018 is primarily due to an increase in R&D expenses to prepare for and initiate the lebrikizumab Phase 3 program and the annualization of SG&A expenses incurred in 2018 related to the QBREXZA launch. Management also expects an additional $20 millionacquired in-process research and development expense related to the anticipated milestone payment due to Rocheupon the initiation of the lebrikizumab Phase 3 trials.
- For QBREXZA, management expects prescriptions and net product sales to grow quarter-over-quarter over the course of 2019, with such growth accelerating in the second half of the year; and the gross-to-net discount to improve from 76% in the first quarter of 2019 to 45-55% in the second quarter and approximately 40% in the second half of the year based on changes to the company’s patient financial assistance programs that became effective
Management believes that its existing cash and investments on hand as
March 31, 2019and either (1) the $90.0 millionavailable under its credit agreement with Athyrium or, (2) if Almirallexercises its option to license the rights to lebrikizumab in Europe, the $50 millionit would receive in connection with the option exercise and the $30 millionit would receive upon initiation by Dermiraof the lebrikizumab Phase 3 trials, are sufficient to meet its anticipated cash requirements into the first half of 2021 and to enable the company to fund its planned Phase 3 clinical program for lebrikizumab through receipt of topline results.
Conference Call Details
Dermira will host a conference call to discuss the first quarter
financial results today,
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, injectable, 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 believed to be 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
adult and pediatric patients (ages 9 and older) with primary axillary
hyperhidrosis (excessive underarm sweating). Please see the QBREXZA prescribing
In addition to filings with the Securities and Exchange
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
build awareness of QBREXZA and drive prescription demand and sales
growth, explore lifecycle opportunities for its existing programs and
maintain a strong balance sheet; the anticipated timing of an
end-of-Phase 2 meeting with the
|Selected Consolidated Statement of Operations Data|
|(in thousands, except per share amounts)|
|Three Months Ended|
|Collaboration and license revenue||-||299|
|Costs and operating expenses:|
|Cost of sales (1)||926||-|
|Research and development (1)||15,569||25,591|
|Selling, general and administrative (1)||48,679||30,510|
|Impairment of intangible assets||-||1,126|
|Total costs and operating expenses||65,174||57,227|
|Loss from operations||(62,722||)||(56,928||)|
|Interest and other income, net||1,551||1,734|
|Loss before taxes||(64,832||)||(59,448||)|
|Benefit for income taxes||-||194|
|Net loss per share, basic and diluted||$||(1.49||)||$||(1.42||)|
|Weighted-average common shares used to compute net loss per share, basic and diluted|
|(1)Amounts include stock-based compensation expense as follows:|
|Cost of sales||$||15||$||-|
|Research and development||2,460||2,853|
|Selling, general and administrative||5,506||4,661|
|Total stock-based compensation expense||$||7,981||$||7,514|
|Selected Consolidated Balance Sheet Data|
|March 31,||December 31,|
|Cash and investments||$||387,830||$||316,002|
|Convertible notes, net||281,684||281,223|
|Total stockholders' equity (deficit)||74,594||(9,039||)|
Vice President, Corporate Communications
Chief Financial Officer