Brepocitinib

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. JERSEY CITY, NJ, USA I September 18, 2024 I 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 worldwide 2 . 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 disproportionately 4 . 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 . 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 . 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/ SOURCE: Organon

Roivant is once again reaping the benefits of its bespoke business model. This time, it’s selling Dermavant to Organon for up to $1.2 billion. Most of that money — $950 million — is available via commercial milestones, according to Wednesday’s announcement . Organon is paying $175 million upfront plus another $75 million if Dermavant’s skin cream Vtama snags FDA approval to treat atopic dermatitis, a decision that’s expected by the end of the year. It will also pay tiered royalties on sales to Dermavant shareholders. “This is another example of Roivant’s ability to offer creative win-win collaborations,” Roivant CEO Matt Gline said in a statement. In the same release, Organon CFO Matthew Walsh said the milestone-heavy deal structure is meant to reinforce the company’s “commitment to disciplined capital allocation.” Vtama, which was first approved to treat plaque psoriasis in May 2022, brought in $18.4 million in sales in the first quarter , a 10% increase from the same period in 2023. Yet prescriptions have more than doubled, from nearly 200,000 as of August 2023 to over 430,000 by July. An approval in atopic dermatitis would likely provide a significant jolt to revenue potential, with Gline saying that Roivant is “excited for Vtama cream to benefit from Organon’s commercial scale.” In January , Dermavant shared updated data that found more than 80% of patients treated across two studies had a greater than 75% improvement on a skin-clearing endpoint. The deal marks the second acquisition of a Roivant property over the last year after it sold Telavant to Roche for $7.1 billion upfront in late 2023. Other subsidiaries like Priovant and its lead asset, brepocitinib, continue to progress. The company has brepocitinib in two Phase 3 studies for dermatomyositis and non-infectious uveitis, respectively, though recruitment in the NIU trial has yet to begin.