Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq:
ASRT), a specialty pharmaceutical company offering differentiated
products to patients, today announced a transaction to acquire an
exclusive license for Sympazan® (clobazam) oral film from Aquestive
Therapeutics, Inc. (“Aquestive”) (Nasdaq: AQST), a pharmaceutical
company advancing current standards of care to solve patients’
problems through simplifying complex delivery methods. The
transaction was made through a subsidiary of the Company.
“Sympazan fits perfectly with our non-personal digital platform
and growth plans, further diversifies our portfolio and brings with
it opportunities to significantly extend patent life,” said Dan
Peisert, President and Chief Executive Officer of Assertio.
“Sympazan can offer benefits to its prescribed population, such as
dosing through its oral film technology. For many LGS patients,
severely restricted carbohydrate diets, such as keto, are an
important treatment approach. Unlike other forms of clobazam,
Sympazan has very low carbohydrate content, which aligns to this
important treatment recommendation.”
Under the terms of the definitive agreement, Assertio acquired
an exclusive license for the Sympazan intellectual property from
Aquestive for an upfront payment of $9.0 million. Assertio also
entered into a long-term supply agreement with Aquestive for
Sympazan. Additionally, Aquestive will continue to prosecute an
existing patent application that could extend patent coverage to as
late as 2039. Upon patent allowance, which Assertio believes will
occur in 2023, Assertio will pay a $6.0 million milestone payment
and royalties to Aquestive.
The Company will provide the expected contribution from Sympazan
and an update on its 2022 Guidance on its quarterly earnings call
in early November. On a full year basis, Assertio expects that
Sympazan will add $4.0 - $4.5 million in adjusted EBITDA and $0.05
in adjusted EPS on a fully diluted basis.
“We’re making significant progress towards our business
development goals through the completion of both the Otrexup and
now Sympazan acquisitions in the last 11 months,” said Peisert. “We
believe Sympazan can add approximately 20 percent of the remaining
goal to acquire $40 million in gross profit by 2024. Our business
development pipeline remains robust with a number of additional
opportunities to further deploy our balance sheet capital into new
cash flow generating assets.”
About Sympazan
Trade Name |
Sympazan®(clobazam) oral film formulation |
Indication |
For the adjunctive treatment of seizures associated with
Lennox‐Gastaut Syndrome (LGS) in patients aged 2 years of age or
older |
Last to Expire Orange Book Listed Patent |
April 2024, with potential from filed patent application to extend
intellectual property to as late as 2039 |
Trailing 12 Months Revenue Ended 6/30/22 |
Approximately $9.5 Million |
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL
REACTIONS • Concomitant use of benzodiazepines and opioids
may result in profound sedation, respiratory depression, coma, and
death. Reserve concomitant prescribing of these drugs in patients
for whom alternative treatment options are inadequate. Limit
dosages and durations to the minimum required. Follow patients for
signs and symptoms of respiratory depression and sedation. • The
use of benzodiazepines, including SYMPAZAN, exposes users to risks
of abuse, misuse, and addiction, which can lead to overdose or
death. Before prescribing SYMPAZAN and throughout treatment, assess
each patient’s risk for abuse, misuse, and addiction.• Abrupt
discontinuation or rapid dosage reduction of SYMPAZAN after
continued use may precipitate acute withdrawal reactions, which can
be life-threatening. To reduce the risk of withdrawal reactions,
use a gradual taper to discontinue SYMPAZAN.
Important Safety Information
SYMPAZAN is a benzodiazepine medicine. Taking benzodiazepines
with opioid medicines, alcohol, or other central nervous system
(CNS) depressants (including street drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma, and
death.
Get emergency help right away if any of the following
happens:
- shallow or slowed breathing
- breathing stops (which may lead to the heart stopping)
- excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how
taking SYMPAZAN with opioids affects you.
Please see full Prescribing Information including Boxed Warning
on risks from concomitant use with opioids; abuse, misuse and
addiction; and dependence and withdrawal reactions at
www.sympazan.com/pdfs/pi.pdf.
About Assertio
Assertio is a specialty pharmaceutical company offering
differentiated products to patients utilizing a non-personal
promotional model. We have built and continue to build our
commercial portfolio by identifying new opportunities within our
existing products as well as acquisitions or licensing of
additional approved products. To learn more about Assertio, visit
www.assertiotx.com.
Investor Contact
Matt KrepsManaging DirectorDarrow AssociatesAustin, TX M:
214-597-8200mkreps@darrowir.com
Forward Looking Statements
Statements in this communication that are not historical facts
are forward-looking statements that reflect Assertio's current
expectations, assumptions and estimates of future performance and
economic conditions. These forward-looking statements are made in
reliance on the safe harbor provisions of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. These forward-looking
statements relate to, among other things, future events or the
future performance or operations of Assertio, including our ability
to realize the benefits from our operating model, successfully
acquire and integrate new assets including Sympazan and explore new
business development initiatives, as well as Aquestive’s ability to
successfully prosecute the pending patent application and timing of
allowance by the USPTO. All statements other than historical facts
may be forward-looking statements and can be identified by words
such as "anticipate," "believe," "could," "design," "estimate,"
"expect," "forecast," "goal," "guidance," "imply," "intend," "may",
"objective," "opportunity," "outlook," "plan," "position,"
"potential," "predict," "project," "prospective," "pursue," "seek,"
"should," "strategy," "target," "would," "will," "aim" or other
similar expressions that convey the uncertainty of future events or
outcomes and are used to identify forward-looking statements. Such
forward-looking statements are not guarantees of future performance
and are subject to risks, uncertainties and other factors, some of
which are beyond the control of Assertio, including the risks
described in Assertio's Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q filed with the U.S. Securities and Exchange
Commission ("SEC") and in other filings Assertio makes with the SEC
from time to time. Investors and potential investors are urged not
to place undue reliance on forward-looking statements in this
communication, which speak only as of this date. While Assertio may
elect to update these forward-looking statements at some point in
the future, it specifically disclaims any obligation to update or
revise any forward-looking-statements contained in this press
release whether as a result of new information or future events,
except as may be required by applicable law. Nothing contained
herein constitutes or will be deemed to constitute a forecast,
projection or estimate of the future financial performance or
expected results of Assertio.
Non-GAAP Financial Measures
This release includes estimated non-GAAP adjusted EBITDA and
adjusted earnings per share information, which the Company believes
enables investors to better understand the anticipated performance
of the business, but should be considered a supplement to, and not
as a substitute for or superior to, financial measures calculated
in accordance with GAAP. No reconciliation of estimated non-GAAP
adjusted EBITDA and adjusted earnings per share to estimated net
income and estimated earnings per share, respectively, is provided
in this release because some of the information necessary for
estimated net income such as income taxes, fair value change in
contingent consideration, and stock-based compensation is not yet
ascertainable or accessible and the Company is unable to quantify
these amounts that would be required to be included in estimated
net income without unreasonable efforts.
Specified Items
Non-GAAP measures presented within this release exclude
specified items. The Company considers specified items to be
significant income/expense items not indicative of current
operations. Specified items include adjustments to interest
expense, income tax expense (benefit), depreciation expense,
amortization expense, sales reserves adjustments for products the
Company is no longer selling, stock-based compensation expense,
fair value adjustments to contingent consideration, restructuring
costs, amortization of fair value inventory step-up as result of
purchase accounting, transaction-related costs, gains or losses
from adjustments to long-lived assets and assets not part of
current operations, and gains or losses resulting from debt
refinancing or extinguishment.
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