Assertio Holdings, Inc., (“Assertio” or “the Company”) (Nasdaq:
ASRT), a leading commercial pharmaceutical company bringing
differentiated products to patients, today announced it has
acquired Otrexup (methotrexate), a drug device combination single
dose once weekly auto-injector, from Antares Pharma, Inc.
(“Antares”) in the Company’s first new product acquisition since
2015. The acquisition was made through a subsidiary of the Company.
“The acquisition of Otrexup is a strategic and synergistic fit
with our unique digital platform and a growth driver for Assertio
for years to come,” said Dan Peisert, President and Chief Executive
Officer of Assertio. “With nearly ten years of patent life
remaining, we intend to invest in the further commercialization of
Otrexup and see potential by leveraging our platform and expertise
for growth. This acquisition represents yet another milestone in
our transformation, will be accretive to adjusted EBITDA in 2022,
and is the first step towards our goal of acquiring new products to
deliver at least $50 million in gross profit by 2024.”
Under the terms of the definitive agreements, Assertio acquired
Otrexup from Antares in a partially seller financed transaction for
a total purchase price of $44.0 million inclusive of working
capital investments. Payment terms are as follows:
- $18.0 million in cash on December 15, 2021
- $16.0 million in cash on May 31, 2022
- $10.0 million in cash on December 15, 2022
Updated 2021 Financial Guidance:
Due to strong sales of its existing portfolio of products, the
Company announces it has further raised its full-year net product
sales and non-GAAP adjusted EBITDA guidance:
|
11/4/21 Guidance |
Updated Guidance |
Net Product Sales (GAAP) |
Greater than $103.0 Million |
Greater Than $108.0 Million |
Adjusted EBITDA (Non-GAAP)
(1) |
Greater than $43.0 Million |
Greater Than $48.0 Million |
(1) See “Non-GAAP Financial Measures” below for additional
information.
About Otrexup
Trade Name |
Otrexup (methotrexate) injection for subcutaneous use |
Device |
VIBEX® auto-injector |
Last to Expire Orange Book Listed Patent |
May 2031 |
Trailing 12 Months Revenue Ended 9/30/21 |
$15.5 Million |
Approximate Gross Margin Percent |
Low 70%’s |
Otrexup is a once weekly single dose auto-injector containing a
prescription medicine, methotrexate, which is indicated for:
- Certain adults with
severe, active rheumatoid arthritis, and children with active
polyarticular juvenile idiopathic arthritis (pJIA), after treatment
with other medicines including non-steroidal anti-inflammatory
drugs (NSAIDS) have been used and did not work well.
- Control the symptoms
of severe, resistant, disabling psoriasis in adults when other
types of treatment have been used and did not work well.
Otrexup should not be used for the treatment of cancer. Otrexup
should not be used for the treatment of children with
psoriasis.
Please see full prescribing information including
important safety information at
www.otrexup.com.
About Assertio
Assertio is a leading commercial pharmaceutical company bringing
differentiated products to patients. The Company has a robust
portfolio of branded prescription products in three areas:
neurology, hospital and pain and inflammation. Assertio has grown
through business development including licensing, mergers, and
acquisitions. To learn more about Assertio, visit
www.assertiotx.com.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company
focused primarily on the development and commercialization of
self-administered injectable pharmaceutical products using advanced
drug delivery auto injector technology. The Company has a portfolio
of proprietary and partnered commercial products with several
product candidates in various stages of development, as well as
significant strategic alliances with industry leading
pharmaceutical companies including Teva Pharmaceutical Industries,
Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and
Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s
FDA-approved products include XYOSTED® (testosterone enanthate)
injection and Sumatriptan Injection USP, which is distributed by
Teva. The Company also markets NOCDURNA® (desmopressin acetate) in
the U.S. and expects to commercially launch TLANDO® (testosterone
undecanoate) in the U.S. pending final FDA approval.
Investor Contact
Max NemmersHead, Investor Relations and Administration
investor@assertiotx.com
Non-GAAP Financial Measures To supplement the
Company’s financial results presented on a U.S. generally accepted
accounting principles (GAAP) basis, the Company has included
information about non-GAAP measures of EBITDA and adjusted EBITDA
as useful operating metrics. The Company believes that the
presentation of these non-GAAP financial measures, when viewed with
results under GAAP and the accompanying reconciliation, provides
supplementary information to analysts, investors, lenders, and the
Company’s management in assessing the Company’s performance and
results from period to period. The Company uses these non-GAAP
measures internally to understand, manage and evaluate the
Company’s performance, and in part, in the determination of bonuses
for executive officers and employees. These non-GAAP financial
measures should be considered in addition to, and not a substitute
for, or superior to, net income or other financial measures
calculated in accordance with GAAP. Non-GAAP financial measures
used by us may be calculated differently from, and therefore may
not be comparable to, non-GAAP measures used by other
companies.
This release also includes estimated non-GAAP adjusted EBITDA
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 to
estimated net income 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 effort
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. 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 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. Factors that could cause Assertio's actual
results to differ materially from those implied in the
forward-looking statements include: (1) risks related to the
Company’s commercialization of Otrexup using its non-personal and
digital promotion strategies; (2) the Company’s ability to realize
the anticipated benefits of the acquisition of Otrexup (the
“Transaction”), including the possibility that the expected
benefits from the Transaction will not be realized or will not be
realized within the expected time period; (3) potential liabilities
and/or litigation related to the Transaction, including risks
associated with the supply agreement between the Company and
Antares and/or third-party contracts assumed by the Company in the
Transaction; (4) risks related to disruption of management time
from ongoing business operations due to the Transaction and/or
restructuring of Assertio’s workforce announced on December 15,
2020 (the “Restructuring”) and/or the integration of the merger
with Zyla Life Sciences (the “Merger”); (5) unexpected costs,
charges or expenses resulting from the Transaction, the
Restructuring and/or the Merger; (6) the ability of the Assertio to
retain key personnel; (7) potential adverse changes to business
relationships resulting from the Transaction and/or the Merger; (8)
the Company's ability to achieve the growth prospects and synergies
expected from the Transaction and/or the Merger, as well as delays,
challenges and expenses associated with integrating the Company’s
businesses; (9) negative effects of the Transaction and/or the
Merger on the market price of Assertio's common stock, credit
ratings and operating results; (10) legislative, regulatory and
economic developments, including changing business conditions in
the industries in which Assertio operates; (11) Assertio's ability
to successfully pursue and complete business development, strategic
partnerships, and investment opportunities to build and grow for
the future; (12) the commercial success and market acceptance of
Assertio's products; (13) coverage of Assertio’s products by payors
and pharmacy benefit managers; (14) Assertio’s ability to execute
on its sales, marketing and non-personal and digital promotion
strategies, including developing relationships with customers,
physicians, payors and other constituencies; (15) the entry of any
generic products for any of Assertio’s products; (16) the outcome
of Assertio’s opioid-related investigations, Assertio’s
opioid-related litigation and related claims for insurance
coverage, and Assertio’s securities class action and other disputes
and litigation, and the costs and expenses associated therewith;
(17) the outcome of Assertio’s antitrust litigation relating to the
drug Glumetza®; (18) Assertio's estimates regarding expenses,
future revenues, capital requirements and needs for additional
financing; (19) Assertio's ability to generate sufficient cash flow
from its business to make payments on its indebtedness; (20)
Assertio's ability to restructure or refinance its indebtedness and
Assertio's compliance with the terms and conditions of the
agreements governing its indebtedness; (21) compliance or
non-compliance with legal and regulatory requirements related to
the development or promotion of pharmaceutical products in the
U.S.; (22) Assertio's plans to acquire, in-license or co-promote
other products, and/or acquire companies; (23) Assertio's ability
to raise additional capital, if necessary; (24) variations in
revenues obtained from collaborative agreements; (25) Assertio's
counterparties’ compliance or non-compliance with obligations under
agreements; (26) the ability of Assertio's common stock to maintain
compliance with Nasdaq's minimum closing bid requirement of at
least $1.00 per share; (27) obtaining and maintaining intellectual
property protection for Assertio’s products; (28) Assertio’s
ability to operate its business without infringing the intellectual
property rights of others; (29) the impact of disasters, acts of
terrorism or global pandemics, including COVID-19; (30) general
market conditions; and (31) other risks listed in Assertio's
filings with the United States Securities and Exchange Commission
("SEC"). These risks are more fully described in Assertio's Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q filed with
the 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.
Assertio (NASDAQ:ASRT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Assertio (NASDAQ:ASRT)
Historical Stock Chart
From Sep 2023 to Sep 2024