- QBREXZA™ (glycopyrronium) cloth net product sales of $8.1M,
more than triple first quarter 2019 sales
- End-of-Phase 2 FDA meeting for lebrikizumab completed, Phase 3
initiation on schedule for later this year
- Company provides revenue guidance for the second half of
2019
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 June 30, 2019 and provided
a corporate update.
“We’ve set ambitious goals for ourselves and continue to
successfully deliver on them. For QBREXZA, our broad payer
coverage, the positive product experience and an improved
gross-to-net discount have established a strong foundation that we
are leveraging to drive patient activation and substantial revenue
growth,” said Tom Wiggans, chairman and chief executive officer of
Dermira. “For lebrikizumab, we completed a very productive
end-of-phase 2 meeting with the FDA and announced plans to move
forward with our partner Almirall to develop lebrikizumab in
Europe. As we look to the second half of the year, we are focused
on continuing to generate demand for QBREXZA and rapidly initiating
the lebrikizumab Phase 3 clinical development program by the end of
the year.”
Second Quarter 2019 Financial Results
- Revenue for the second quarter totaled $66.6 million, comprised
of $8.1 million in QBREXZA product sales and $58.6 million in
collaboration and license revenue associated with the Almirall S.A.
agreement, compared with $39.1 million in collaboration and license
revenue related to a prior collaboration for the comparable quarter
in 2018.
- Total costs and operating expenses for the quarter ended June
30, 2019 were $82.9 million compared to $60.3 million for the
second quarter of 2018.
- Cost of sales for the second quarter of 2019 was $1.3 million
related to QBREXZA.
- Research and development (R&D) expenses for the second
quarter of 2019 were $18.3 million compared to $19.5 million for
the comparable prior-year period. This decrease was primarily due
to reductions in clinical trial activities associated with the
company’s prior acne program and in personnel-related costs, which
were partially offset by increases in activities related to QBREXZA
and other R&D costs.
- Selling, general and administrative (SG&A) expenses for the
second quarter of 2019 were $63.3 million compared to $40.8 million
for the comparable prior-year period. This increase was primarily
driven by costs associated with the QBREXZA commercial launch,
particularly advertising and promotional expenses associated with
patient activation activities as well as higher personnel-related
costs. The second quarter 2019 results were consistent with the
company’s expectations and guidance that the period would represent
the peak SG&A expense quarter for the year.
- For the quarter ended June 30, 2019, Dermira reported a net
loss of $18.0 million compared with a net loss of $23.9 million for
the same period in 2018.
- As of June 30, 2019, Dermira had cash and investments of $327.2
million and 54.4 million common shares outstanding.
Key Operational Highlights
- Generated 28,609 prescriptions for QBREXZA as reported by
Symphony PHAST monthly data for the second quarter of 2019, an
increase of over 20 percent compared to the first quarter of 2019
despite a decrease in April prescriptions related to changes to the
co-pay savings card program.
- Drove a significant improvement in the QBREXZA gross-to-net
discount to 39 percent in the second quarter of 2019 from 76
percent in the first quarter.
- Secured QBREXZA coverage for approximately 85 percent of the
total U.S. commercial lives (calculated based on Dermira data on
file) as of August 1, 2019.
- Completed a successful end-of-Phase 2 meeting for lebrikizumab
with the U.S. Food and Drug Administration (FDA) in June 2019.
Management continues to expect to initiate the lebrikizumab Phase 3
clinical development program by the end of 2019.
- Announced in June 2019 that Almirall exercised its option to
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, pursuant to the option
and license agreement entered into in February 2019. As a result of
this option exercise, Dermira received $50 million in July and will
be eligible to receive additional payments upon the achievement of
certain milestones, including an aggregate of $30 million in
connection with the initiation of clinical studies related to the
lebrikizumab Phase 3 program.
Operational and Financial Expectations
- For QBREXZA, management expects net product sales for the full
year 2019 in the low-$30 million range, and the gross-to-net
discount for the second half of the year to remain at approximately
40 percent.
- Management expects collaboration and license revenue related to
the Almirall agreement of approximately $2 million for each of the
third and fourth quarters of 2019.
- Management maintains its previously issued guidance for cost of
sales and operating expenses. The company previously guided for
2019 R&D and SG&A expenses to be between $295 and $315
million, including estimated stock-based compensation expense of
approximately $35 million, plus 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.
Conference Call Details
Dermira will host a conference call to discuss the second
quarter financial results today, August 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 1-866-211-3117 from the U.S. and
Canada or +1-647-689-6606 internationally and using the passcode
3394726. 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 percent 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 pediatric and adult
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. 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 LinkedIn, Instagram and
Twitter.
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
generate demand for QBREXZA and to drive patient activation and
substantial revenue growth; Dermira’s plans to move forward with
its partner Almirall to develop lebrikizumab in Europe; the
anticipated timing of initiation of the Phase 3 clinical
development program for lebrikizumab by the end of the year;
guidance that the second quarter of 2019 represents the peak
SG&A expense quarter for the year; the anticipated receipt and
timing of payments from Almirall upon the achievement of certain
future milestones; expectations regarding net product sales for the
full year 2019 and the gross-to-net discount and collaboration and
license revenue for the second half of 2019; and estimated R&D,
SG&A, stock-based compensation expense and acquired in-process
research and development expense for 2019. 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 Six Months Ended
June 30, June 30,
2019
2018
2019
2018
Product sales
$
8,060
$
-
$
10,512
$
-
Collaboration and license revenue
58,585
39,080
58,585
39,379
Total revenue
66,645
39,080
69,097
39,379
Costs and operating expenses: Cost of sales (1)
1,335
-
2,261
-
Research and development (1)
18,285
19,545
33,854
45,136
Selling, general and administrative (1)
63,327
40,770
112,006
71,280
Impairment of intangible assets
-
-
-
1,126
Total costs and operating expenses
82,947
60,315
148,121
117,542
Loss from operations
(16,302
)
(21,235
)
(79,024
)
(78,163
)
Interest and other income, net
1,970
2,037
3,521
3,771
Interest expense
(3,630
)
(4,734
)
(7,291
)
(8,988
)
Loss before taxes
(17,962
)
(23,932
)
(82,794
)
(83,380
)
Benefit for income taxes
-
-
-
194
Net loss
$
(17,962
)
$
(23,932
)
$
(82,794
)
$
(83,186
)
Net loss per share, basic and diluted
$
(0.33
)
$
(0.57
)
$
(1.70
)
$
(1.99
)
Weighted-average common shares used to compute net loss per
share, basic and diluted
54,033
41,922
48,838
41,875
(1)
Amounts include stock-based compensation expense as follows:
Cost of sales
$
16
$
-
$
31
$
-
Research and development
2,371
2,408
4,831
5,261
Selling, general and administrative
5,123
4,898
10,629
9,559
Total stock-based compensation expense
$
7,510
$
7,306
$
15,491
$
14,820
Dermira, Inc. Selected Consolidated Balance Sheet
Data (in thousands)
June 30,
December 31,
2019
2018
Cash and investments
$
327,166
$
316,002
Working capital
377,597
296,853
Total assets
447,266
344,321
Term loan
32,731
32,566
Convertible notes, net
282,145
281,223
Accumulated deficit
(827,832
)
(745,038
)
Total stockholders' equity (deficit)
65,556
(9,039
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190807005668/en/
Media: Erica Jefferson Vice President, Corporate Communications
650-421-7216 media@dermira.com
Investors: Andrew Guggenhime Chief Financial Officer
650-421-7200 investor@dermira.com
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