September 18, 2024 7:30 am EDT

JERSEY CITY, N.J., September 18, 2024 – 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 older ¹ 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 life ⁵ and
atopic dermatitis is associated with a higher disease burden ⁶
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 6^th, 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/