- QBREXZA® (glycopyrronium) cloth net product sales of
$10.2M
- Phase 3 lebrikizumab program initiated in adult and adolescent
patients with moderate-to-severe atopic dermatitis
- Conference call today at 1:30 p.m. PT / 4:30 p.m. ET
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 September 30, 2019 and
provided a corporate update.
“The third quarter was marked by notable progress on key
commercial, clinical and regulatory initiatives as we build a
dynamic medical dermatology company,” said Tom Wiggans, chairman
and chief executive officer at Dermira. “As we look ahead to 2020,
we have a number of attractive investment opportunities, including
two programs of significant value in QBREXZA and lebrikizumab. In
the context of our business and what we anticipate will be an
evolving financial environment, we are evaluating our capital
allocation strategy and overall investment levels. As a result of
this ongoing process, we expect to leverage our progress and
experience with the QBREXZA launch, and the strong foundation we
have established, to target our investment in a manner that
significantly reduces our commercial expenses while continuing to
drive growth for the brand.”
Third Quarter 2019 Financial Results
- Revenue for the third quarter totaled $11.5 million, comprised
of $10.2 million in QBREXZA net product sales and $1.3 million in
collaboration and license revenue associated with the company’s
partnership agreement with Almirall S.A., compared with $0.7
million, comprised exclusively of QBREXZA net product sales, in the
comparable quarter in 2018.
- Total costs and operating expenses for the quarter ended
September 30, 2019 were $66.7 million compared to $66.0 million for
the third quarter of 2018.
- Cost of sales for the third quarter of 2019 was $1.9 million
related to QBREXZA sales compared to $0.2 million for the
comparable prior-year period.
- Research and development (R&D) expenses for the third
quarter of 2019 were $18.4 million compared to $16.3 million for
the comparable prior-year period.
- Selling, general and administrative (SG&A) expenses for the
third quarter of 2019 were $46.4 million compared to $49.5 million
for the comparable prior-year period.
- For the quarter ended September 30, 2019, Dermira reported a
net loss of $57.6 million compared with a net loss of $66.5 million
for the same period in 2018.
- As of September 30, 2019, Dermira had cash and investments of
$360.2 million and 54.5 million common shares outstanding.
Key Operational Highlights
- Announced the initiation of the Phase 3 program evaluating
lebrikizumab in patients with moderate-to-severe atopic dermatitis.
The Phase 3 program includes two identical monotherapy studies
expected to enroll a total of approximately 800 adult and
adolescent patients ages 12 and older with moderate-to-severe
atopic dermatitis at approximately 200 sites in the U.S., Europe
and Asia. Topline results from the 16-week induction period of
these two studies are expected in the first half of 2021.
- Reported detailed primary results from the Phase 2b study of
lebrikizumab in adult patients with moderate-to-severe atopic
dermatitis at the 39th Annual Fall Clinical Dermatology Conference.
The results demonstrated that lebrikizumab produced rapid, robust,
dose-dependent efficacy across endpoints spanning the range of
atopic dermatitis signs and symptoms, including skin lesions and
pruritus, when administered once every two or four weeks, in the
context of a safety profile consistent with the substantial prior
experience with this and other biologics targeting IL-13
signaling.
- Generated 32,646 prescriptions for QBREXZA as reported by
Symphony PHAST monthly data for the third quarter of 2019, an
increase of over 14 percent compared to the second quarter of
2019.
- Grew physician adoption to more than 15,200 unique prescribers
writing for QBREXZA during the first 12 months of the launch.
- Facilitated growth in the hyperhidrosis market, with all
dermatologist-written prescriptions for topical hyperhidrosis
therapies up 53 percent in the 12 months ended September 2019
compared to the 12 months ended September 2018.
Financial Expectations
- For QBREXZA, management expects net product sales for the full
year 2019 in the low-$30 million range, consistent with prior
guidance, and a gross-to-net discount for the fourth quarter in the
high-30 percent range.
- Management expects collaboration and license revenue related to
the Almirall agreement of approximately $2 million for the fourth
quarter of 2019, consistent with prior guidance.
- Management is updating its guidance for operating expenses. The
company expects full year 2019 R&D and SG&A expenses to be
between $275 and $285 million, including estimated stock-based
compensation expense of approximately $30 million. In addition, the
company will recognize a $20 million acquired in-process research
and development expense in the fourth quarter of 2019 related to
the milestone payment due to Roche in connection with the
initiation of the lebrikizumab Phase 3 trials in October.
Conference Call Details
Dermira will host a conference call to discuss the third quarter
financial results today, November 5, 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
3098714. 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 a range of signs and symptoms,
including rashes on the skin that often cover much of the body, as
well as intense, persistent itching. The 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, investigational, 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 underlying the range of signs and symptoms 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 in a Phase 3
clinical development program for the treatment of
moderate-to-severe atopic dermatitis (a severe form of eczema) and
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 belief that
lebrikizumab has the potential to become a best-in-disease
treatment for moderate-to-severe atopic dermatitis; the anticipated
evolving financial environment; Dermira’s plans to leverage its
progress and experience with the QBREXZA launch, and the strong
foundation Dermira has established, to target its capital
investment in a manner that significantly reduces commercial
expenses while continuing to drive growth for the QBREXZA brand;
the design, description of and enrollment expectations for
Dermira’s Phase 3 program evaluating lebrikizumab for
moderate-to-severe atopic dermatitis; the successful completion of,
and timing expectations for the receipt and announcement of topline
data from, the Phase 3 program; and financial guidance regarding
net product sales for the full year 2019, the gross-to-net discount
for the fourth quarter of 2019, collaboration and license revenue
for the fourth quarter of 2019, full year 2019 R&D and SG&A
expenses, including estimated stock-based compensation expense and
acquired in-process research and development expense for the fourth
quarter of 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 the design, implementation and outcomes of
Dermira’s clinical trials; the impact of competitive clinical
trials, products and therapies; Dermira’s dependence on third-party
clinical research organizations, manufacturers, suppliers and
distributors; the outcomes of future meetings with regulatory
agencies; market acceptance of Dermira’s current and potential
products; 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
Nine Months Ended
September 30,
September 30,
2019
2018
2019
2018
Product sales
$
10,228
$
717
$
20,740
$
717
Collaboration and license revenue
1,305
-
59,890
39,379
Total revenue
11,533
717
80,630
40,096
Costs and operating expenses: Cost of sales (1)
1,932
237
4,193
237
Research and development (1)
18,416
16,292
52,270
61,428
Selling, general and administrative (1)
46,356
49,510
158,362
120,790
Impairment of intangible assets
-
-
-
1,126
Total costs and operating expenses
66,704
66,039
214,825
183,581
Loss from operations
(55,171
)
(65,322
)
(134,195
)
(143,485
)
Interest and other income, net
1,948
2,198
5,469
5,969
Interest expense
(4,398
)
(3,420
)
(11,689
)
(12,408
)
Loss before taxes
(57,621
)
(66,544
)
(140,415
)
(149,924
)
Benefit for income taxes
-
-
-
194
Net loss
$
(57,621
)
$
(66,544
)
$
(140,415
)
$
(149,730
)
Net loss per share, basic and diluted
$
(1.06
)
$
(1.58
)
$
(2.77
)
$
(3.57
)
Weighted-average common shares used to compute net loss per
share, basic and diluted
54,460
42,066
50,733
41,939
(1
)
Amounts include stock-based compensation expense as follows:
Cost of sales
$
10
$
-
$
41
$
-
Research and development
1,972
2,511
6,803
7,772
Selling, general and administrative
4,670
5,371
15,299
14,930
Total stock-based compensation expense
$
6,652
$
7,882
$
22,143
$
22,702
Dermira, Inc. Selected Consolidated Balance Sheet
Data (in thousands) September 30,
December 31,
2019
2018
Cash and investments
$ 360,163
$ 316,002
Working capital
353,881
296,853
Total assets
436,241
344,321
Term Loan
71,808
32,566
Convertible notes, net
282,607
281,223
Accumulated deficit
(885,453)
(745,038)
Total stockholders' equity (deficit)
14,480
(9,039)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191105006056/en/
Media: Erica Jefferson Vice President, Corporate Communications
650-421-7216 media@dermira.com Erin Murphy Director, Corporate
Communications 650-422-7746 erin.murphy@dermira.com Investors:
Andrew Guggenhime Chief Financial Officer 650-421-7200
investor@dermira.com
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