- QBREXZA™ (glycopyrronium) cloth
prescriptions increased more than 50% over fourth quarter 2018
- First quarter net product sales of $2.5
million
- Approximately 80% of commercially
insured patients have access to QBREXZA
- End-of-Phase 2 FDA meeting scheduled
following positive lebrikizumab study results
- Balance sheet strengthened through
follow-on equity financing
Dermira, Inc. (NASDAQ: DERM), 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, today reported
financial results for the quarter ended March 31, 2019, provided a
corporate update and issued 2019 financial guidance.
“Positive momentum continued into the first quarter 2019 at
Dermira. Bolstered by significant prescription growth of QBREXZA
and the positive topline efficacy and safety results from our
lebrikizumab Phase 2b study in atopic dermatitis, we’ve never been
in a stronger position,” said Tom Wiggans, chairman and chief
executive officer of Dermira. “As we look ahead to the rest of the
year, we are focused on continuing our efforts to build awareness
of QBREXZA to drive prescription demand and sales growth,
initiating the Phase 3 clinical development program for
lebrikizumab following discussions with the U.S. Food and Drug
Administration, exploring lifecycle opportunities for our existing
programs, and maintaining a strong balance sheet. These efforts
will allow us to continue delivering on our commitment to bring
innovative, new therapies to patients with chronic skin
conditions.”
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 million of 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, 2019 were $65.2 million compared to
$57.2 million for the first quarter of 2018.
- Cost of sales for the first quarter of
2019 was $0.9 million related to QBREXZA sales.
- Research and development (R&D)
expenses for the first quarter of 2019 were $15.6 million compared
to $25.6 million for 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
million compared to $30.5 million for the comparable prior-year
period. This increase was primarily driven by higher costs as a
result of the October 2018 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.
- For the quarter ended March 31, 2019,
Dermira reported a net loss of $64.8 million compared with a net
loss of $59.3 million for the same period in 2018.
- As of March 31, 2019, Dermira had cash
and investments of $387.8 million and 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 IQVIA monthly
data and the company’s preferred dispensing partner, in each case
representing an increase of approximately 59% over the fourth
quarter of 2018.
- Launched “Life Unfolds,” a new
direct-to-consumer campaign designed to drive consumer awareness of
QBREXZA, in March 2019.
- Secured QBREXZA coverage for
approximately 80% of the total U.S. commercial lives (calculated
based on Dermira data on file) as of May 1, 2019.
- Reported 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 March 2019.
- Closed an underwritten follow-on public
offering in March 2019 which generated approximately $140 million
in net proceeds.
- Entered into an option and license
agreement with Almirall in February 2019, under which Almirall
acquired 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 in Europe at 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 million acquired in-process research
and development expense related to the anticipated milestone
payment due to Roche upon the initiation of the lebrikizumab Phase
3 trials.
- Management believes that its existing
cash and investments on hand as of March 31, 2019 and either (1)
the $90.0 million available under its credit agreement with
Athyrium or, (2) if Almirall exercises its option to license the
rights to lebrikizumab in Europe, the $50 million it would receive
in connection with the option exercise and the $30 million it would
receive upon initiation by Dermira of 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, May 7, 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 3485374. 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.
About Hyperhidrosis
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
CONTRAINDICATIONS
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.
ADVERSE REACTIONS
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.
About Lebrikizumab
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.
About Dermira
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 information. Dermira is evaluating lebrikizumab for the
treatment of moderate-to-severe atopic dermatitis (a severe form of
eczema) and plans to initiate a Phase 3 clinical development
program by the end of 2019, subject to an end-of-Phase 2 meeting
with the U.S. Food and Drug Administration. Dermira also has
early-stage research and development programs in other areas of
dermatology. Dermira is headquartered in Menlo Park,
Calif. For more information, please visit
http://www.dermira.com. Follow Dermira on Twitter, LinkedIn
and Instagram.
In addition to filings with the Securities and Exchange
Commission (SEC), press releases, public conference calls and
webcasts, Dermira uses its website (www.dermira.com),
LinkedIn page (https://www.linkedin.com/company/dermira-inc-),
corporate Instagram account
(https://www.instagram.com/dermira_inc/) and corporate Twitter
account (@DermiraInc) as channels of distribution of information
about its company, product candidates, planned financial and other
announcements, attendance at upcoming investor and industry
conferences and other matters. Such information may be deemed
material information and Dermira may use these channels
to comply with its disclosure obligations under Regulation FD.
Therefore, investors should monitor Dermira’s website, LinkedIn
page, Instagram and Twitter accounts in addition to following
its SEC filings, news releases, public conference calls
and webcasts.
Forward-Looking Statements
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 U.S. Food and Drug Administration
and initiation of the Phase 3 clinical development program for
lebrikizumab; the anticipated timing of receipt and announcement of
Almirall’s decision regarding the potential exercise of its option
to exclusively license rights to lebrikizumab in Europe;
expectations regarding the growth in QBREXZA prescriptions and net
product sales and improvement in the gross-to-net discount related
to such sales over the course of 2019; estimated R&D, SG&A
and stock-based compensation expense for 2019 and the anticipated
milestone payment due Roche upon the initiation of the lebrikizumab
Phase 3 trials; the availability to Dermira of $90.0 million under
its credit agreement with Athyrium; the potential receipt of up to
$80 million from Almirall if it exercises its option to license the
rights to lebrikizumab in Europe and in connection with initiation
by Dermira of the lebrikizumab Phase 3 trials; and the belief that
Dermira’s existing cash and investments on hand as of March 31,
2019 and either (1) the $90.0 million available under its credit
agreement with Athyrium or, (2) if Almirall exercises its option to
license the rights to lebrikizumab in Europe, the $50 million it
would receive in connection with the option exercise and the $30
million it would receive upon initiation by Dermira of 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. These statements
deal with future events and involve known and unknown risks,
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from the
information expressed or implied by these forward-looking
statements. Factors that could cause actual results to differ
materially include risks and uncertainties such as those relating
to Dermira’s dependence on third-party clinical research
organizations, manufacturers, suppliers and distributors; the
design and implementation of Dermira’s clinical trials; the
outcomes of future meetings with regulatory agencies; Dermira’s
ability to attract and retain key employees; Dermira’s ability to
manage the growth and complexity of its organization; Dermira’s
ability to maintain, protect and enhance its intellectual property;
and Dermira’s ability to continue to stay in compliance with its
material contractual obligations, applicable laws and regulations.
You should refer to the section entitled “Risk Factors” set forth
in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly
Reports on Form 10-Q and other filings Dermira makes with
the SEC from time to time for a discussion of important
factors that may cause actual results to differ materially from
those expressed or implied by Dermira’s forward-looking statements.
Furthermore, such forward-looking statements speak only as of the
date of this news release. Dermira undertakes no
obligation to publicly update any forward-looking statements or
reasons why actual results might differ, whether as a result of new
information, future events or otherwise, except as required by
law.
Dermira, Inc. Selected Consolidated
Statement of Operations Data (in thousands, except per share
amounts) Three Months Ended March
31, 2019 2018 Product sales $ 2,452 $ -
Collaboration and license revenue - 299
Total revenue 2,452 299 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 Interest expense (3,661 )
(4,254 ) Loss before taxes (64,832 ) (59,448 ) Benefit for income
taxes - 194 Net loss $ (64,832 )
$ (59,254 ) 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 43,585
41,827 (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
Dermira, Inc. Selected Consolidated Balance
Sheet Data (in thousands) March
31, December 31, 2019 2018 Cash and
investments $ 387,830 $ 316,002 Working capital 380,914 296,853
Total assets 461,575 344,321 Term Loan 32,690 32,566 Convertible
notes, net 281,684 281,223 Accumulated deficit (809,870 ) (745,038
) Total stockholders' equity (deficit) 74,594 (9,039 )
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190507005958/en/
Media:Erica JeffersonVice President, Corporate
Communications650-421-7216media@dermira.com
Investors:Andrew GuggenhimeChief Financial
Officer650-421-7200investor@dermira.com
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