VTAMA cream is a novel, non-steroidal topical
therapy approved for treatment of plaque psoriasis in adults and is
under FDA review for an additional indication to treat atopic
dermatitis
Proposed acquisition extends Organon’s
international dermatology capabilities to the U.S.
Organon (NYSE: OGN), a global healthcare company with a mission
to improve the health of women throughout their lives, and
Dermavant Sciences Ltd. announced today that they have entered into
a definitive agreement, under which Organon will acquire Dermavant,
a Roivant (NASDAQ: ROIV) company dedicated to developing and
commercializing innovative therapeutics in immuno-dermatology.
Dermavant’s novel product, VTAMA® (tapinarof) cream, 1%, for the
topical treatment of mild, moderate, and severe plaque psoriasis in
adults, was approved by the U.S. Food and Drug Administration (FDA)
in May 2022. VTAMA cream is a once-daily, steroid-free, topical
applied to affected areas with no safety label warnings or
precautions and without restrictions on location and duration of
use or body surface area. The FDA is reviewing a Supplemental New
Drug Application (sNDA) for VTAMA cream as a potential treatment
for atopic dermatitis (AD) in adults and children two years of age
and older, with Prescription Drug User Fee Act (“PDUFA”) action
expected in the fourth quarter of calendar year 2024.
Psoriasis is a common chronic inflammatory skin disease
affecting over 8 million Americans 20 years of age or older1 and
125 million people worldwide2. Atopic dermatitis is one of the most
common inflammatory skin conditions impacting approximately 16.5
million adults and more than 9.6 million children in the U.S.3 In
adults, women are impacted disproportionately4. Psoriasis presents
a significant impact to quality of life5 and atopic dermatitis is
associated with a higher disease burden6 for women compared to
men.
“We look forward to combining Dermavant’s strong dermatology
commercial and field medical organization in the U.S., with
Organon’s market access capabilities, regulatory expertise and
worldwide commercial reach. This will allow us to bring VTAMA
cream, a patient-focused innovation in dermatology, providing an
effective, well-tolerated, non-steroidal treatment option to the
millions of people living with plaque psoriasis and potentially
atopic dermatitis,” said Kevin Ali, Organon Chief Executive
Officer. “The acquisition will deliver on Organon’s objective of
improving the health of women throughout their life stages by
investing in treatments for conditions that affect women
differently.”
“This is another example of Roivant’s ability to offer creative
win-win collaborations. We are able to meet Organon’s structural
objectives and to create a transaction that is very attractive to
both Roivant and Dermavant stakeholders, while still preserving
meaningful economics tied to the potential future success of
VTAMA,” said Matt Gline, Chief Executive Officer of Roivant.
“Additionally, we are excited for VTAMA cream to benefit from
Organon’s commercial scale. We believe they have the capabilities
and reach to ensure patients globally can access this important
medicine.”
“This is an unparalleled opportunity for continued growth and
innovation for Dermavant, preserving our values and vision and
allowing them to thrive in the new structure at Organon. We set out
to revolutionize the standard of care in dermatology, and we
delivered—becoming the #1 branded topical for plaque psoriasis
within just two months after launching VTAMA cream, and providing
over 275,000 patients with the relief they desperately needed,”
said Todd Zavodnick, Chief Executive Officer of Dermavant. “I am
certain that this merger will provide us the scope and global scale
to unleash the potential of VTAMA cream.”
“We structured the deal economics to be heavily weighted towards
success-based milestones and royalties, similar to other
transactions we have executed to date. This is consistent with our
commitment to disciplined capital allocation as we look to continue
to reduce our leverage, but also strategically add growth assets,”
said Matthew Walsh, Organon Chief Financial Officer.
Terms of the Transaction
Organon has agreed to acquire Dermavant for aggregate
consideration of up to approximately $1.2 billion, with an upfront
payment of $175 million and a $75 million milestone payment upon
regulatory approval in AD, as well as payments of up to $950
million for the achievements of certain commercial milestones. In
addition, Organon will pay Dermavant shareholders tiered royalties
on net sales. Dermavant owns the rights to VTAMA cream globally
excluding China and has out licensed Japan rights.
Completion of the transaction is subject to review under the
Hart-Scott-Rodino Antitrust Improvements Act and other customary
conditions. Closing of the transaction is currently expected to
take place in the fourth quarter of 2024. Upon closing of the
transaction, as part of the purchase price consideration, Organon
would assume Dermavant liabilities with an approximate value of
$286 million reported by Roivant as of June 30, 2024, which would
be subject to fair value accounting by Organon. Given the
transaction is expected to close in the fourth quarter 2024,
revenue contribution from VTAMA as well as expenses associated with
onboarding the product are not expected to impact the full year
2024 non-GAAP guidance ranges provided on August 6th, 2024. The
transaction is expected to be modestly dilutive to Adjusted EBITDA
in 2025, turning accretive in 2026. Organon expects net leverage to
be elevated above 4.0x as a result of the transaction. The
transaction is not expected to result in a revision to Organon’s
capital allocation priorities.
Roivant was represented by Freshfields Bruckhaus Deringer LLP as
legal advisor and Goldman Sachs & Co. LLC as financial advisor.
Organon was represented by Covington & Burling LLP as legal
advisor.
About VTAMA® (tapinarof) cream, 1%
VTAMA cream is a non-steroidal once-daily topical treatment that
works by activating aryl hydrocarbon receptors in the skin to
reduce inflammation and normalize the skin barrier. The safety and
effectiveness of VTAMA cream was evaluated via randomized,
double-blind, vehicle-controlled trials, PSOARING-1 and 2 for
psoriasis. The safety and efficacy of VTAMA for the treatment of
atopic dermatitis was also evaluated as part of the ADORING-1 and 2
Phase III clinical studies, and is currently under review with the
FDA.
Important Safety Information
Indication: VTAMA® (tapinarof) cream, 1% is an aryl
hydrocarbon receptor agonist indicated for the topical treatment of
plaque psoriasis in adults. VTAMA cream is for use on the skin
(topical) only. Do not use VTAMA cream in your eyes, mouth, or
vagina. Adverse Events: The most common adverse reactions
(incidence ≥ 1%) in subjects treated with VTAMA cream were
folliculitis (red raised bumps around the hair pores),
nasopharyngitis (pain or swelling in the nose and throat), contact
dermatitis (skin rash or irritation, including itching and redness,
peeling, burning, or stinging), headache, pruritus (itching), and
influenza (flu).
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
See full Prescribing Information and Patient Information.
About Organon
Organon is an independent global healthcare company with a
strategy to help improve the health of women throughout their
lives. Organon’s diverse portfolio offers more than 60 medicines
and products in women’s health, biosimilars, and a large franchise
of established medicines across a range of therapeutic areas. In
addition to Organon’s current products, the company invests in
innovative solutions and research to drive future growth
opportunities in women’s health and biosimilars. In addition,
Organon is pursuing opportunities to collaborate with
biopharmaceutical partners and innovators looking to commercialize
their products by leveraging its scale and agile presence in fast
growing international markets.
Organon has a global footprint with significant scale and
geographic reach, world-class commercial capabilities, and
approximately 10,000 employees with headquarters located in Jersey
City, New Jersey.
For more information, visit http://www.organon.com and connect
with us on LinkedIn, Instagram, X (formerly known as Twitter) and
Facebook.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, this press release includes
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, including, but not limited to, statements about management’s
expectations about Organon’s acquisition of Dermavant (including
statements regarding regulatory approvals and the timing, benefits,
and financial impact of such acquisition), potential regulatory
approvals and other actions relating to VTAMA (including the
expected timeframe thereof), and Organon’s ability to reduce its
leverage and strategically add growth assets. Forward-looking
statements may be identified by words such as "foresees" “expects,”
“intends,” “anticipates,” “plans,” “believes,” “seeks,”
“estimates,” “will” or words of similar meaning. These statements
are based upon the current beliefs and expectations of Organon’s
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Risks and
uncertainties include, but are not limited to, weakening of
economic conditions that could adversely affect the level of demand
for Dermavant’s products; the risk that the business will not be
integrated successfully; risks related to the ability to realize
the anticipated benefits of the acquisition, including the
possibility that the expected benefits from the acquisition will
not be realized or will not be realized within the expected time
period; the ability to retain key personnel; unknown liabilities;
the risk of litigation and/or regulatory actions related to the
proposed acquisition; pricing pressures globally, including rules
and practices of managed care groups, judicial decisions and
governmental laws and regulations related to Medicare, Medicaid and
health care reform, pharmaceutical reimbursement and pricing in
general; an inability to fully execute on Organon’s product
development and commercialization plans in the United States,
Europe, and elsewhere internationally; an inability to adapt to the
industry-wide trend toward highly discounted channels; changes in
tax laws or other tax guidance which could adversely affect
Organon’s cash tax liability, effective tax rates, and results of
operations and lead to greater audit scrutiny; expanded brand and
class competition in the markets in which Organon operates; and
governmental initiatives that adversely impact Organon’s marketing
activities. Organon undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Organon’s filings with
the Securities and Exchange Commission (“SEC”), including Organon’s
most recent Annual Report on Form 10-K and subsequent SEC filings,
available at the SEC’s Internet site www.sec.gov.
References and links to websites have been provided for
convenience, and the information contained on any such website is
not a part of, or incorporated by reference into, this press
release. Organon is not responsible for the contents of third-party
websites.
About Dermavant
Dermavant Sciences, a subsidiary of Roivant Sciences, is a
biopharmaceutical company dedicated to developing and
commercializing innovative therapeutics in immuno-dermatology.
Dermavant’s focus is to develop therapies that have the potential
to address high unmet medical needs while driving greater
efficiency in research and clinical development. The company’s
medical dermatology pipeline includes earlier-development,
late-stage and commercialized, product candidates that target
specific unmet needs in two of the largest growing
immuno-dermatology markets, plaque psoriasis and atopic dermatitis,
as well as other immunological and inflammatory diseases. Dermavant
is marketing VTAMA® (tapinarof) cream, 1%, for the topical
treatment of plaque psoriasis in adults. The FDA approved VTAMA
cream for the topical treatment of mild, moderate, and severe
plaque psoriasis in May 2022. Dermavant has been developing VTAMA
cream for the treatment of atopic dermatitis in adults and children
2 years of age and older and released positive topline results from
its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023.
Dermavant’s pipeline includes DMVT-506, a next generation aryl
hydrocarbon receptor (AhR) agonist under development as a potential
treatment option for immunological and inflammatory diseases with
multiple potential routes of administration. For more information,
please visit http://www.dermavant.com and follow us on Twitter
(@dermavant) and LinkedIn (Dermavant Sciences).
About Roivant
Roivant is a commercial-stage biopharmaceutical company that
aims to improve the lives of patients by accelerating the
development and commercialization of medicines that matter. In
addition to VTAMA, Roivant’s pipeline includes IMVT-1402 and
batoclimab, fully human monoclonal antibodies targeting the
neonatal Fc receptor (“FcRn”) in development across several
IgG-mediated autoimmune indications, and brepocitinib, a potent
small molecule inhibitor of TYK2 and JAK1 for the treatment of
dermatomyositis and non-infectious uveitis, in addition to other
clinical stage molecules. We advance our pipeline by creating
nimble subsidiaries or “Vants” to develop and commercialize our
medicines and technologies. Beyond therapeutics, Roivant also
incubates discovery-stage companies and health technology startups
complementary to its biopharmaceutical business. For more
information, www.roivant.com.
Roivant Forward-Looking Statements
This press release contains forward-looking statements.
Statements in this press release may include statements that are
not historical facts and are considered forward-looking within the
meaning of Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”), and Section 21E of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), which are usually
identified by the use of words such as “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intends,” “may,”
“might,” “plan,” “possible,” “potential,” “predict,” “project,”
“should,” “would” and variations of such words or similar
expressions. The words may identify forward-looking statements, but
the absence of these words does not mean that a statement is not
forward-looking. We intend these forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act and
Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to,
statements regarding our or our management team’s expectations,
hopes, beliefs, intentions or strategies regarding the future, and
statements that are not historical facts, including statements
about the clinical and therapeutic potential of our products and
product candidates, the availability and success of topline results
from our ongoing clinical trials and any commercial potential of
our products and product candidates. In addition, any statements
that refer to projections, forecasts or other characterizations of
future events, results or circumstances, including any underlying
assumptions, are forward-looking statements. Actual results may
differ materially from those contemplated in these statements due
to a variety of risks, uncertainties and other factors, including
(i) the risk that the conditions to the closing of the proposed
transaction may not be satisfied, (ii) the possibility that the
proposed transaction may involve unexpected costs, liabilities or
delays, (iii) the risk that the businesses of the companies may
suffer as a result of uncertainty surrounding the proposed
transaction, (iv) the risk that disruptions from the proposed
transaction will harm relationships with employees, customers and
suppliers and other business partners or (v) the risk that the
achievement of the specified milestones or royalties described in
the definitive agreement may take longer to achieve than expected
or may never be achieved and the resulting contingent milestone
payments or royalties may never be realized.
Although we believe that our plans, intentions, expectations and
strategies as reflected in or suggested by those forward-looking
statements are reasonable, we can give no assurance that the plans,
intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially from
those described in the forward-looking statements and will be
affected by a number of risks, uncertainties and assumptions,
including, but not limited to, those risks set forth in the Risk
Factors section of our filings with the U.S. Securities and
Exchange Commission. Moreover, we operate in a very competitive and
rapidly changing environment in which new risks emerge from time to
time. These forward-looking statements are based upon the current
expectations and beliefs of our management as of the date of this
press release, and are subject to certain risks and uncertainties
that could cause actual results to differ materially from those
described in the forward-looking statements. Except as required by
applicable law, we assume no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
1 Armstrong, A., Mehta, M., Schupp, C., Gondo, C., Bell, S.,
Griffiths, C. Psoriasis Prevalence in Adults in the United States.
JAMA Dermatol. 2021 Aug; 157(8):1-7.
doi:10.1001/jamadermatol.2021.2007
2 Psoriasis Statistics. National Psoriasis Foundation. Get the
Facts About Psoriasis and Psoriatic Arthritis.
3 Eczema Prevalence. National Eczema Foundation. Eczema
Prevalence, Quality of Life and Economic Impact.
4 Valentini, R., Shahriari, M. Atopic Dermatitis in Women:
Special Considerations in the Childbearing Years. Int J Women’s
Dermatol. 2024 Jun; 10(2): e151. doi:
10.1097/JW9.0000000000000151.
5 Carole, G., Corsin, S., Meienberger, N., Valeska Maul, L.,
Maul, J-T. The Impact of Gender and Sex in Psoriasis: What to be
Aware of When Treating Women with Psoriasis. Int J Women’s
Dermatol. 2022 Jun; 8(2): e010. doi: 10.1097/JW9.0000000000000010.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9112394/
6 Urban, K., Chu, S., Giesey, RL., Mehrmal, S., Uppal, P.,
Nedley, N., Delost, GR. The Global, Regional, and National Burden
of Atopic Dermatitis in 195 Countries and Territories: An
ecological study from the Global Burden of Disease Study 2017. 2021
Mar; 2: 12-18. JAAD International. doi:
https://doi.org/10.1016%2Fj.jdin.2020.10.002.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362298/
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Grafico Azioni Organon (NYSE:OGN)
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Da Dic 2024 a Gen 2025
Grafico Azioni Organon (NYSE:OGN)
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Da Gen 2024 a Gen 2025
