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, 2018 and provided an update on the
launch of QBREXZA™ (glycopyrronium) cloth and the lebrikizumab
clinical development program.
Corporate Highlights
- 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.
- Secured QBREXZA coverage for approximately 53% of the total
U.S. commercially-insured lives as of October 1, 2018, including
coverage from Express Scripts, Inc. and OptumRx, two of the largest
pharmacy benefit managers in the U.S.
- In October 2018, partnered with Christian Siriano, a Council of
Fashion Designers of America, Inc. fashion designer, to launch a
new initiative to raise awareness of hyperhidrosis as a medical
condition and inspire people to share stories about the physical
and emotional impact the condition has on their lives.
- Presented results from a new post-hoc analysis from the ARIDO
long-term safety study data during the European Academy of
Dermatology and Venereology Congress in September 2018 showing that
pediatric patients treated with glycopyrronium tosylate for primary
axillary hyperhidrosis experienced similar rates of reduced sweat
production, improvements in disease severity and favorable quality
of life measures compared to adult patients.
- 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,
with topline efficacy and safety results from the study expected by
early April 2019.
- Ended the quarter with cash and investments of $389.7
million.
“The launch of QBREXZA, the first FDA-approved medicated cloth
designed to treat people living with primary axillary
hyperhidrosis, represented an important inflection point for
Dermira. As a commercial-stage company, we are now delivering on
our commitment to provide new therapies to people living with
chronic, underserved skin conditions,” said Tom Wiggans, chairman
and chief executive officer of Dermira. “We are very encouraged by
the response from dermatologists and the promising start to the
launch, with over 2,800 patient starts through only four weeks on
the market. We continue to generate interest in QBREXZA utilization
by educating physicians, obtaining broad, quality payer coverage
and activating patients. Going forward, we intend to maintain the
launch momentum and communicate topline results from our
lebrikizumab Phase 2b data study by early April of next year.”
Third Quarter 2018 Financial Results
- Total revenue for the quarter ended September 30, 2018 was $0.7
million, comprised exclusively of QBREXZA product sales, compared
with $1.1 million of 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. The company
commenced QBREXZA shipments in late September to make QBREXZA
available to patients starting on October 1st.
- Total costs and operating expenses for the quarter ended
September 30, 2018 were $66.0 million, compared to $179.1 million
for the third quarter of 2017. Operating expenses for the quarter
ended September 30, 2017 included $128.6 million in acquired
in-process research and development expenses related to the
licensing agreement with F. Hoffmann-La Roche Ltd and Genentech,
Inc.
- Cost of sales for the third quarter of 2018 was $0.2 million
related to QBREXZA sales.
- Research and development expenses for the third quarter of 2018
were $16.3 million, compared to $30.8 million for 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 third
quarter of 2018 were $49.5 million, compared to $19.8 million for
the comparable prior-year period. This increase was primarily
driven by the preparation for and execution of the QBREXZA
commercial launch, including sales force hiring and readiness,
physician education and patient awareness marketing
activities.
- For the quarter ended September 30, 2018, Dermira reported a
net loss of $66.5 million, or $1.58 per share, compared with a net
loss of $179.2 million, or $4.30 per share, for the same period in
2017.
- As of September 30, 2018, Dermira had cash and investments of
$389.7 million and 42.1 million common shares outstanding.
2018 Financial GuidanceManagement reiterates
its previously issued financial guidance for full year 2018,
consisting of operating expenses of $250.0 to $270.0 million,
including estimated stock-based compensation expense of
approximately $35.0 million. Management is not providing 2018
QBREXZA product sales guidance.
Conference Call DetailsDermira will host a
conference call to discuss third quarter financial results today,
November 7, 2018, 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 1453469. 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 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
CONTRAINDICATIONSQBREXZA is contraindicated in patients with
medical conditions that can be exacerbated by the anticholinergic
effect of QBREXZA.
WARNINGS AND PRECAUTIONSWorsening 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 REACTIONSThe 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 DermiraDermira 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 programs. 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). Dermira is also evaluating
lebrikizumab in a Phase 2b clinical trial for the treatment of
moderate-to-severe atopic dermatitis (a severe form of eczema) and
has early-stage research 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; the successful completion of, and
timing expectations for the receipt and announcement of topline
data from, the Phase 2b dose-ranging study of lebrikizumab for
moderate-to-severe atopic dermatitis; Dermira’s ability to continue
to generate interest in QBREXZA utilization by educating
physicians, obtaining broad, quality coverage and activating
patients; Dermira’s ability to maintain momentum in connection with
its commercial launch of QBREXZA; and financial guidance for full
year 2018, including estimated operating expenses and stock-based
compensation expense. 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;
market acceptance of Dermira’s current and potential products; the
impact of competitive products and therapies; Dermira’s
ability to obtain necessary additional capital; Dermira’s ability
to manage the complexity of its organization; Dermira’s ability to
attract and retain key employees; the design, implementation and
outcomes of Dermira’s clinical trials; the outcomes of Dermira’s
future meetings with regulatory agencies; Dermira’s ability to
maintain, protect and enhance its intellectual property; and
Dermira’s ability to continue to stay in compliance with 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 undertake 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.
Contacts:
Media:Erica JeffersonVice President, Corporate
Communications650-421-7216erica.jefferson@dermira.com
Investors:Ian Clements, Ph.D.Vice President, Investor
Relations650-422-7753investor@dermira.com
|
Dermira, Inc. |
Selected Consolidated Statement of Operations
Data |
(in thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
|
|
|
|
September 30, |
|
September 30, |
|
|
|
|
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
|
$ |
717 |
|
|
$ |
- |
|
|
$ |
717 |
|
|
$ |
- |
|
Collaboration and license revenue |
|
|
- |
|
|
|
1,066 |
|
|
|
39,379 |
|
|
|
3,198 |
|
|
|
Total
revenue |
|
|
|
717 |
|
|
|
1,066 |
|
|
|
40,096 |
|
|
|
3,198 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
|
237 |
|
|
|
- |
|
|
|
237 |
|
|
|
- |
|
|
Research
and development (1) |
|
|
16,292 |
|
|
|
30,788 |
|
|
|
61,428 |
|
|
|
76,626 |
|
|
Acquired
in-process research and development |
|
- |
|
|
|
128,555 |
|
|
|
- |
|
|
|
128,555 |
|
|
Selling,
general and administrative (1) |
|
49,510 |
|
|
|
19,754 |
|
|
|
120,790 |
|
|
|
44,667 |
|
|
Impairment
of intangible assets |
|
- |
|
|
|
- |
|
|
|
1,126 |
|
|
|
- |
|
|
|
Total costs
and operating expenses |
|
66,039 |
|
|
|
179,097 |
|
|
|
183,581 |
|
|
|
249,848 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
|
(65,322 |
) |
|
|
(178,031 |
) |
|
|
(143,485 |
) |
|
|
(246,650 |
) |
Interest
and other income, net |
|
|
2,198 |
|
|
|
1,721 |
|
|
|
5,969 |
|
|
|
3,585 |
|
Interest
expense |
|
|
|
(3,420 |
) |
|
|
(2,864 |
) |
|
|
(12,408 |
) |
|
|
(4,184 |
) |
Loss before
taxes |
|
|
|
(66,544 |
) |
|
|
(179,174 |
) |
|
|
(149,924 |
) |
|
|
(247,249 |
) |
Benefit for
income taxes |
|
|
|
- |
|
|
|
- |
|
|
|
194 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
$ |
(66,544 |
) |
|
$ |
(179,174 |
) |
|
$ |
(149,730 |
) |
|
$ |
(247,249 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share, basic and diluted |
$ |
(1.58 |
) |
|
$ |
(4.30 |
) |
|
$ |
(3.57 |
) |
|
$ |
(6.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares used to compute net loss
per share, basic and diluted |
|
|
42,066 |
|
|
|
41,625 |
|
|
|
41,939 |
|
|
|
40,172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
2,511 |
|
|
$ |
2,104 |
|
|
$ |
7,772 |
|
|
$ |
5,918 |
|
|
Selling,
general and administrative |
|
5,371 |
|
|
|
3,397 |
|
|
|
14,930 |
|
|
|
9,302 |
|
|
Total stock-based compensation expense |
$ |
7,882 |
|
|
$ |
5,501 |
|
|
$ |
22,702 |
|
|
$ |
15,220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermira, Inc. |
Selected Consolidated Balance Sheet
Data |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
|
|
|
|
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
investments |
|
|
|
|
$ |
389,728 |
|
|
$ |
550,993 |
|
|
|
Working
capital |
|
|
|
|
|
318,908 |
|
|
|
451,256 |
|
|
|
Total
assets |
|
|
|
|
|
|
409,922 |
|
|
|
560,794 |
|
|
|
Accrued payments related to acquired in-process research and
development |
|
|
29,727 |
|
|
|
50,161 |
|
|
|
Convertible
notes, net |
|
|
|
|
|
280,764 |
|
|
|
279,389 |
|
|
|
Accumulated
deficit |
|
|
|
|
|
(673,228 |
) |
|
|
(553,393 |
) |
|
|
Total
stockholders' equity |
|
|
|
|
53,847 |
|
|
|
149,649 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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