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 and year ended December 31, 2018.
“We’re very pleased by the progress of the QBREXZA launch and
will continue our efforts to raise awareness of primary axillary
hyperhidrosis as a medical condition and ensure seamless access to
the therapy for patients,” said Tom Wiggans, chairman and chief
executive officer of Dermira. “As we look ahead to 2019, in
addition to generating growth in QBREXZA awareness and use, a key
focus will be on our lebrikizumab clinical development program. We
believe that lebrikizumab may offer a compelling combination of
safety, efficacy and convenience for people living with
moderate-to-severe atopic dermatitis. We look forward to reporting
topline results from our ongoing Phase 2b study in the second half
of March. If the data support a differentiated product profile and
significant commercial opportunity, we plan to initiate a Phase 3
program by the end of this year.”
Financial Highlights
Fourth Quarter 2018 Financial Results
- Total revenue for the fourth quarter was $2.2 million,
comprised exclusively of QBREXZA product sales, compared with $1.3
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.
- Total costs and operating expenses for the quarter ended
December 31, 2018 were $72.7 million compared to $55.0 million for
the fourth quarter of 2017.
- Cost of sales for the fourth quarter of 2018 was $0.9 million
related to QBREXZA sales.
- Research and development expenses for the fourth quarter of
2018 were $19.1 million compared to $27.8 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 fourth
quarter of 2018 were $51.8 million compared to $27.2 million for
the comparable prior-year period. This increase was primarily
driven by the execution of the 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 December 31, 2018, Dermira reported a net
loss of $71.8 million compared with a net loss of $56.0 million for
the same period in 2017.
Full Year 2018 Financial Results
- Total revenue for the year ended December 31, 2018 was $42.3,
compared with $4.5 million in 2017. Revenue for 2018 was comprised
of $3.0 million in QBREXZA product sales and $39.4 million in
collaboration and license revenue, which was primarily driven by a
$39.0 million milestone payment from UCB Pharma S.A.
- Total costs and operating expenses for 2018 were $256.3 million
compared to $304.9 million for 2017.
- Cost of sales for 2018 was $1.2 million related to QBREXZA
sales.
- Research and development expenses for 2018 were $80.5 million
compared to $104.4 million for the prior year. Dermira also
recognized acquired in-process research and development expenses
of $128.6 million in 2017 related to its licensing
agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc., a
member of the Roche Group (together Roche), pursuant to which
Dermira obtained exclusive, worldwide rights to develop and
commercialize lebrikizumab for atopic dermatitis and all other
indications.
- Selling, general and administrative expenses for 2018 were
$172.6 million, compared to $71.9 million for the prior
year.
- For the year ended December 31, 2018, Dermira reported a net
loss of $221.5 million compared with a net loss of $303.3 million
for the same period in 2017.
Cash, Cash Equivalents and Investments
- As of December 31, 2018, Dermira had cash and investments of
$316.0 million and 42.3 million common shares outstanding. In the
fourth quarter of 2018, Dermira received initial net proceeds of
approximately $33.2 million in connection with a credit facility it
entered into with funds managed by Athyrium Capital Management
(Athyrium), and made a $30.0 million milestone payment for
completion of enrollment of the lebrikizumab Phase 2b clinical
study in connection with the license agreement with Roche.
- Dermira anticipates that its cash and investments on hand are
sufficient to meet the company’s anticipated cash requirements,
excluding costs to conduct a potential Phase 3 program for
lebrikizumab, to at least mid-2020.
Recent Operational Highlights and Clinical Pipeline
Update
- 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.
- Generated 14,786 prescriptions for QBREXZA as reported by
Symphony PHAST monthly data for the fourth quarter of 2018, which
represents the first three months of the QBREXZA launch.
- Secured QBREXZA coverage for approximately 76% of the total
U.S. commercial lives (calculated based on Dermira data on
file).
- 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. The study enrolled 280 patients ages 18 years and older in
the United States. The study is evaluating three different
lebrikizumab treatment dosing arms compared to a placebo arm.
- Bolstered the balance sheet by entering into a credit facility
with Athyrium. The financing agreement provides up to $125 million
of borrowing capacity available in three tranches. An initial
tranche of $35 million was funded at the December 2018 closing and
an additional $90 million is available at Dermira’s option, subject
to certain conditions.
- 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. In
exchange, Dermira will receive an upfront option fee of $30
million. If Almirall exercises its option to obtain the license
following the results of the ongoing Phase 2b study, Dermira will
receive a $50 million option exercise fee and will be eligible to
receive additional development, regulatory and sales milestone
payments, including $30 million in connection with the initiation
of certain Phase 3 clinical studies, as well as double-digit
royalties.
- 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. The study is
expected to enroll approximately 60 patients ages 9 years and older
at eight sites in the United States. Findings from the study are
expected in the second half of 2019 and will inform next steps for
a potential primary palmar hyperhidrosis development
program.
Key Milestones and Expectations
- Announce topline results from the Phase 2b study evaluating the
safety and efficacy of lebrikizumab in patients with
moderate-to-severe atopic dermatitis in the second half of March
2019.
- If the data from the lebrikizumab Phase 2b study support a
differentiated product profile and significant commercial
opportunity, initiate a Phase 3 program by the end of
2019.
- Issue 2019 financial guidance after the disclosure of the
lebrikizumab Phase 2b trial topline results.
- Launch a branded direct-to-consumer QBREXZA advertising
campaign by the end of March.
Conference Call Details Dermira will host
a conference call to discuss the fourth quarter financial results
today, February 26, 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 2269419. 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 HyperhidrosisHyperhidrosis 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)
clothQBREXZA (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,
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 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 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 products. The company’s approved treatment, QBREXZA™
(glycopyrronium) cloth, is indicated for pediatric and adult
patients (ages nine 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 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
generate growth in QBREXZA awareness and use and ensure seamless
access to QBREXZA for patients; the belief that lebrikizumab may
offer a compelling combination of safety, efficacy and convenience
for people living with moderate-to-severe atopic dermatitis; the
successful completion of, and timing expectations for the receipt
and announcement of topline data from, the Phase 2b study of
lebrikizumab for the treatment of moderate-to-severe atopic
dermatitis; plans to initiate a Phase 3 program of lebrikizumab for
the treatment of moderate-to-severe atopic dermatitis by the end of
this year if data from the Phase 2b study support a differentiated
product profile and significant commercial opportunity; the
anticipation that Dermira’s cash and investments on hand are
sufficient to meet the company’s anticipated cash requirements,
excluding costs to conduct a potential Phase 3 program for
lebrikizumab, to at least mid-2020; the future availability of an
additional $90 million to Dermira under the credit facility; the
potential exercise of the option by Almirall and the anticipated
fees, payments and royalties associated therewith; the design of,
the successful completion of, and timing expectations for the
receipt and announcement of topline data from, the proof-of-concept
study to evaluate the efficacy and safety of QBREXZA™
(glycopyrronium) cloth in people living with primary palmar
hyperhidrosis; potential development plans for QBREXZA in primary
palmar hyperhidrosis; Dermira’s plan to issue 2019 financial
guidance after the disclosure of the lebrikizumab Phase 2b trial
topline results; and the timing and successful launch of a branded
direct-to-consumer QBREXZA advertising campaign. 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, implementation and outcomes of Dermira’s clinical trials;
the outcomes of future meetings with regulatory agencies; Dermira’s
ability to develop and maintain collaborations and license products
and intellectual property; Dermira’s ability to attract and retain
key employees; Dermira’s ability to obtain necessary additional
capital; market acceptance of Dermira’s current and future
products; the impact of competitive products and therapies;
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.
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 |
|
Year Ended |
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
|
$ |
2,243 |
|
$ |
- |
|
$ |
2,960 |
|
$ |
- |
Collaboration and license revenue |
|
- |
|
1,343 |
|
39,379 |
|
4,541 |
Total revenue |
2,243 |
|
1,343 |
|
42,339 |
|
4,541 |
|
|
|
|
|
|
|
|
Costs and
operating expenses: |
|
|
|
|
|
|
|
|
Cost of sales (1) |
939 |
|
- |
|
1,176 |
|
- |
Research and development (1) |
19,119 |
|
27,783 |
|
80,547 |
|
104,409 |
Acquired in-process research and development |
891 |
|
- |
|
891 |
|
128,555 |
Selling, general and administrative (1) |
51,791 |
|
27,236 |
|
172,581 |
|
71,903 |
Impairment of intangible assets |
- |
|
- |
|
1,126 |
|
- |
Total costs and operating expenses |
72,740 |
|
55,019 |
|
256,321 |
|
304,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(70,497) |
|
(53,676) |
|
(213,982) |
|
(300,326) |
Interest
and other income, net |
|
1,918 |
|
1,620 |
|
7,887 |
|
5,205 |
Interest
expense |
|
|
(3,231) |
|
(3,956) |
|
(15,639) |
|
(8,140) |
Loss before
taxes |
|
|
(71,810) |
|
(56,012) |
|
(221,734) |
|
(303,261) |
Benefit for
income taxes |
|
|
- |
|
- |
|
194 |
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
|
|
|
$ |
(71,810) |
|
$ |
(56,012) |
|
$ |
(221,540) |
|
$ |
(303,261) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share, basic and diluted |
$ |
(1.70) |
|
$ |
(1.34) |
|
$ |
(5.27) |
|
$ |
(7.48) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares used to compute net loss per share,
basic and diluted |
42,194 |
|
41,720 |
|
42,003 |
|
40,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts
include stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
$ |
- |
|
$ |
- |
|
$ |
7 |
|
$ |
- |
Research and development |
2,173 |
|
2,088 |
|
9,945 |
|
8,006 |
Selling, general and administrative |
4,766 |
|
3,395 |
|
19,696 |
|
12,697 |
Total stock-based compensation expense |
$ |
6,939 |
|
$ |
5,483 |
|
$ |
29,648 |
|
$ |
20,703 |
Dermira, Inc. |
Selected Consolidated Balance Sheet
Data |
(in thousands) |
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
Cash and
investments |
|
$ |
316,002 |
|
$ |
550,993 |
|
Working
capital |
|
296,853 |
|
451,256 |
|
Total
assets |
|
344,321 |
|
560,794 |
|
Accrued payments related to acquired in-process research and
development |
|
- |
|
50,161 |
|
Term
Loan |
|
32,566 |
|
- |
|
Convertible
notes, net |
|
281,223 |
|
279,389 |
|
Accumulated
deficit |
|
(745,038) |
|
(553,393) |
|
Total
stockholders' equity (deficit) |
|
(9,039) |
|
149,649 |
|
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