Organon to Acquire Dermavant including its Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1%
Organon (NYSE: OGN) has agreed to acquire Dermavant Sciences , a Roivant company, for up to $1.2 billion. The deal includes Dermavant's VTAMA® (tapinarof) cream, a novel, non-steroidal topical therapy for plaque psoriasis in adults. VTAMA is also under FDA review for atopic dermatitis treatment. The acquisition aims to extend Organon's international dermatology capabilities to the U.S.
Key points:
- Upfront payment of $175 million
- $75 million milestone payment upon regulatory approval for atopic dermatitis
- Up to $950 million for commercial milestones
- Tiered royalties on net sales
- Expected closing in Q4 2024
- Transaction subject to Hart-Scott-Rodino Antitrust Improvements Act review
Organon (NYSE: OGN) ha concordato di acquisire Dermavant Sciences, un'azienda di Roivant, per un massimo di 1,2 miliardi di dollari. L'accordo include la crema VTAMA® (tapinarof) di Dermavant, una nuova terapia topica non steroidea per la psoriasi a placche negli adulti. VTAMA è attualmente in fase di revisione da parte della FDA per il trattamento della dermatite atopica. L'acquisizione mira ad estendere le capacità dermatologiche internazionali di Organon negli Stati Uniti.
Punti chiave:
- Pagamento iniziale di 175 milioni di dollari
- Pagamento di 75 milioni di dollari al raggiungimento dell'approvazione regolatoria per la dermatite atopica
- Fino a 950 milioni di dollari per obiettivi commerciali
- Royalty a scaglioni sulle vendite nette
- Chiusura prevista nel quarto trimestre del 2024
- Transazione soggetta a revisione ai sensi dell'Hart-Scott-Rodino Antitrust Improvements Act
Organon (NYSE: OGN) ha llegado a un acuerdo para adquirir Dermavant Sciences, una empresa de Roivant, por hasta 1.200 millones de dólares. El acuerdo incluye la crema VTAMA® (tapinarof) de Dermavant, una nueva terapia tópica no esteroidea para la psoriasis en placas en adultos. VTAMA también está bajo revisión de la FDA para el tratamiento de la dermatitis atópica. La adquisición tiene como objetivo ampliar las capacidades internacionales de dermatología de Organon en EE. UU.
Puntos clave:
- Pago inicial de 175 millones de dólares
- Pago de 75 millones de dólares al obtener la aprobación regulatoria para la dermatitis atópica
- Hasta 950 millones de dólares por hitos comerciales
- Regalías escalonadas sobre las ventas netas
- Cierre esperado en el cuarto trimestre de 2024
- Transacción sujeta a revisión bajo la Ley de Mejoras Antimonopolio de Hart-Scott-Rodino
Organon (NYSE: OGN)은 Roivant 소속의 Dermavant Sciences를 최대 12억 달러에 인수하기로 합의했습니다. 이 거래에는 성인 플라크 건선을 위한 새로운 비스테로이드성 국소 요법인 Dermavant의 VTAMA® (타피나로프) 크림이 포함됩니다. VTAMA는 아토피 피부염 치료를 위한 FDA 검토를 받고 있습니다. 이번 인수는 Organon의 국제 피부과 역량을 미국으로 확장하는 것을 목표로 하고 있습니다.
핵심 내용:
- 1억 7500만 달러의 선불 지급
- 아토피 피부염에 대한 규제 승인이 이루어지면 7500만 달러의 이정표 지급
- 상업적 이정표에 대해 최대 9억 5000만 달러
- 순매출에 대한 단계적 로열티
- 2024년 4분기 마감 예정
- Hart-Scott-Rodino 반독점 개선법 검토 대상
Organon (NYSE: OGN) a convenu d'acquérir Dermavant Sciences, une entreprise de Roivant, pour un montant allant jusqu'à 1,2 milliard de dollars. L'accord inclut la crème VTAMA® (tapinarof) de Dermavant, une nouvelle thérapie topique non stéroïdienne pour le psoriasis en plaques chez les adultes. VTAMA est également en cours de révision par la FDA pour le traitement de la dermatite atopique. Cette acquisition vise à élargir les capacités dermatologiques internationales d'Organon aux États-Unis.
Points clés :
- Paiement initial de 175 millions de dollars
- Paiement de 75 millions de dollars lors de l'approbation réglementaire pour la dermatite atopique
- Jusqu'à 950 millions de dollars pour les jalons commerciaux
- Redevances échelonnées sur les ventes nettes
- Clôture prévue au quatrième trimestre de 2024
- Transaction soumise à la révision selon la loi Hart-Scott-Rodino sur les améliorations antitrust
Organon (NYSE: OGN) hat zugestimmt, Dermavant Sciences, ein Unternehmen von Roivant, für bis zu 1,2 Milliarden US-Dollar zu übernehmen. Der Deal umfasst die VTAMA® (Tapinarof) Creme von Dermavant, eine neuartige, nicht-steroidale topische Therapie für Plaque-Psoriasis bei Erwachsenen. VTAMA befindet sich auch in der Überprüfung durch die FDA zur Behandlung von atopischer Dermatitis. Die Akquisition zielt darauf ab, die internationalen Dermatologiefähigkeiten von Organon in den USA auszubauen.
Wichtige Punkte:
- Vorauszahlung von 175 Millionen US-Dollar
- 75 Millionen US-Dollar Zahlungen bei regulatorischer Genehmigung für atopische Dermatitis
- Bis zu 950 Millionen US-Dollar für kommerzielle Meilensteine
- Gestaffelte Lizenzgebühren auf Nettoumsätze
- Erwarteter Abschluss im vierten Quartal 2024
- Transaktion unterliegt der Überprüfung nach dem Hart-Scott-Rodino Antitrust Improvements Act
- Acquisition of VTAMA cream, an FDA-approved treatment for plaque psoriasis
- Potential expansion of VTAMA's indication to include atopic dermatitis
- Extension of Organon's dermatology capabilities to the U.S. market
- VTAMA cream became the #1 branded topical for plaque psoriasis within two months of launch
- Over 275,000 patients treated with VTAMA cream
- Deal structure heavily weighted towards success-based milestones and royalties
- Transaction expected to be modestly dilutive to Adjusted EBITDA in 2025
- Net leverage expected to be elevated above 4.0x as a result of the transaction
- Assumption of Dermavant liabilities with an approximate value of $286 million
Insights
The acquisition of Dermavant by Organon for up to
VTAMA cream represents a significant innovation in dermatology as a non-steroidal, once-daily topical treatment for plaque psoriasis. Its potential expansion into atopic dermatitis, with FDA review expected in Q4 2024, could substantially broaden its market reach. The lack of safety label warnings and flexible usage guidelines are notable advantages. With over 8 million Americans affected by psoriasis and 16.5 million adults and 9.6 million children in the U.S. suffering from atopic dermatitis, the market potential is substantial. VTAMA's rapid rise to become the #1 branded topical for plaque psoriasis within two months of launch indicates strong market acceptance and potential for continued growth.
This acquisition aligns with Organon's strategy to improve women's health, as both psoriasis and atopic dermatitis disproportionately affect women in terms of prevalence or disease burden. The deal expands Organon's dermatology portfolio and provides entry into the U.S. market, leveraging Dermavant's established commercial and field medical organization. The combination of Dermavant's innovative product with Organon's global reach and market access capabilities could accelerate VTAMA's growth internationally. However, success will depend on effective integration and execution of commercial strategies. The
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
Dermavant’s novel product, VTAMA® (tapinarof) cream,
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
“We look forward to combining Dermavant’s strong dermatology commercial and field medical organization in the
“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
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
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,
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,
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
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
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,
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
1 Armstrong, A., Mehta, M., Schupp, C., Gondo, C., Bell, S., Griffiths, C. Psoriasis Prevalence in Adults in
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/
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Source: Organon & Co.
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