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 announced the closing of a $125
million credit facility with funds managed by Athyrium Capital
Management, LP, a leading healthcare-focused investment firm.
“We are pleased to be partnering with Athyrium,” said Andrew
Guggenhime, chief financial officer of Dermira. “This credit
facility provides us additional financial flexibility to advance
our business with a focus on the ongoing launch of QBREXZA for
primary axillary hyperhidrosis and the lebrikizumab program for
moderate-to-severe atopic dermatitis. In addition to this
transaction and consistent with our strategy, we continue to
actively evaluate other financing alternatives as we plan and
prepare for a potential lebrikizumab phase 3 program following the
topline results of our ongoing phase 2b study which we expect by
early April next year.”
“We are excited to be working with Dermira as they launch
QBREXZA and advance lebrikizumab through the clinic,” said Laurent
D. Hermouet, Partner at Athyrium. “We believe QBREXZA represents an
exciting new treatment option with significant commercial
potential, and we look forward to a rewarding partnership with
Dermira in the years ahead.”
The non-dilutive financing agreement provides Dermira with up to
$125 million of borrowing capacity available in three tranches,
each bearing interest at 10.75% per annum. Under the terms of the
agreement, an initial tranche of $35 million was funded at the
closing and an additional $90 million will be available at
Dermira’s option, subject to certain conditions. Further
information with respect to the credit facility is set forth in a
Form 8-K filed by the Dermira with the Securities and Exchange
Commission on December 4, 2018.
Cowen and Company, LLC acted as Sole Lead Arranger and Financial
Advisor to Dermira on the transaction.
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.
About Athyrium Capital ManagementAthyrium is a
specialized asset management company formed in 2008 to focus on
investment opportunities in the global healthcare sector. Athyrium
advises funds with over $3.7 billion in committed capital. The
Athyrium team has substantial investment experience across a wide
range of asset classes including public equity, private equity,
fixed income, royalties, and other structured securities. Athyrium
invests across all healthcare verticals including biopharma,
medical devices and products, healthcare focused services, and
healthcare information technology. The team partners with
management teams to implement creative financing solutions to
companies’ capital needs. For more information, please
visit www.athyrium.com.
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 advancement of Dermira’s business
with a focus on the ongoing launch of QBREXZA for primary axillary
hyperhidrosis and the lebrikizumab program for moderate-to-severe
atopic dermatitis; 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; a potential lebrikizumab
phase 3 program for moderate-to-severe atopic dermatitis; and the
commercial potential of QBREXZA. 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
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