Gilead and LEO Pharma Enter Into Strategic Partnership to Accelerate Development of Oral STAT6 Program With Potential in Multiple Inflammatory Diseases
Gilead Sciences (NASDAQ: GILD) and LEO Pharma announced a strategic partnership focused on developing LEO Pharma's preclinical oral STAT6 programs for inflammatory diseases. The partnership includes small molecule inhibitors and targeted protein degraders targeting STAT6, a transcription factor important for IL-4 and IL-13 cytokine signaling.
Under the agreement, Gilead will acquire global rights to develop and commercialize the oral STAT6 program, while LEO Pharma retains global rights for topical formulations in dermatology. LEO Pharma has the option to co-commercialize oral programs for dermatology outside the U.S.
The deal includes an upfront payment of $250 million to LEO Pharma, with potential total payments reaching $1.7 billion plus tiered royalties ranging from high single-digit to mid-teens on oral STAT6 product sales. The transaction is expected to reduce Gilead's GAAP and non-GAAP 2025 EPS by approximately $0.15-$0.17.
Gilead Sciences (NASDAQ: GILD) e LEO Pharma hanno annunciato una partnership strategica focalizzata sullo sviluppo dei programmi preclinici orali di STAT6 di LEO Pharma per le malattie infiammatorie. La partnership include inibitori a piccole molecole e degradatori proteici mirati che colpiscono STAT6, un fattore di trascrizione importante per la segnalazione delle citochine IL-4 e IL-13.
In base all'accordo, Gilead acquisirà i diritti globali per sviluppare e commercializzare il programma orale di STAT6, mentre LEO Pharma mantiene i diritti globali per le formulazioni topiche in dermatologia. LEO Pharma ha l'opzione di co-commercializzare programmi orali per la dermatologia al di fuori degli Stati Uniti.
L'accordo prevede un pagamento iniziale di 250 milioni di dollari a LEO Pharma, con potenziali pagamenti totali che potrebbero raggiungere 1,7 miliardi di dollari più royalties variabili che vanno da una cifra bassa a singola cifra alta fino al mid-teens sulle vendite dei prodotti orali di STAT6. Si prevede che la transazione ridurrà l'EPS GAAP e non GAAP di Gilead per il 2025 di circa $0,15-$0,17.
Gilead Sciences (NASDAQ: GILD) y LEO Pharma han anunciado una asociación estratégica centrada en el desarrollo de los programas preclínicos orales de STAT6 de LEO Pharma para enfermedades inflamatorias. La asociación incluye inhibidores de pequeñas moléculas y degradadores proteicos dirigidos que atacan STAT6, un factor de transcripción importante para la señalización de citoquinas IL-4 e IL-13.
Según el acuerdo, Gilead adquirirá los derechos globales para desarrollar y comercializar el programa oral de STAT6, mientras que LEO Pharma retiene los derechos globales para formulaciones tópicas en dermatología. LEO Pharma tiene la opción de co-comercializar programas orales para dermatología fuera de EE. UU.
El acuerdo incluye un pago inicial de 250 millones de dólares a LEO Pharma, con pagos totales potenciales que podrían alcanzar 1,7 mil millones de dólares más regalías escalonadas que van desde cifras de un solo dígito alto hasta la adolescencia media en las ventas de productos orales de STAT6. Se espera que la transacción reduzca el EPS GAAP y no GAAP de Gilead para 2025 en aproximadamente $0,15-$0,17.
길리어드 사이언스(Gilead Sciences, NASDAQ: GILD)와 LEO 제약(LEO Pharma)이 염증성 질환을 위한 LEO 제약의 전임상 경구 STAT6 프로그램 개발에 초점을 맞춘 전략적 파트너십을 발표했습니다. 이 파트너십은 STAT6을 표적으로 하는 소분자 억제제와 선택적 단백질 분해제를 포함하며, STAT6은 IL-4 및 IL-13 사이토카인 신호 전달에 중요한 전사 인자입니다.
계약에 따라, 길리어드는 경구 STAT6 프로그램을 개발하고 상용화할 수 있는 글로벌 권리를 인수하며, LEO 제약은 피부과에서의 국소 제형에 대한 글로벌 권리를 유지합니다. LEO 제약은 미국 외부에서 피부과에 대한 경구 프로그램을 공동 상용화할 수 있는 옵션을 가지고 있습니다.
이번 계약에는 LEO 제약에 대한 2억 5천만 달러의 선불 지급이 포함되어 있으며, 총 지급액은 17억 달러에 이를 수 있으며, 경구 STAT6 제품 판매에 대해 높은 싱글 디지털에서 중간 10대까지 단계별 로열티를 포함합니다. 이 거래는 길리어드의 2025년 GAAP 및 비 GAAP EPS를 약 $0.15-$0.17 정도 감소시킬 것으로 예상됩니다.
Gilead Sciences (NASDAQ: GILD) et LEO Pharma ont annoncé un partenariat stratégique axé sur le développement des programmes STAT6 oraux précliniques de LEO Pharma pour les maladies inflammatoires. Ce partenariat inclut des inhibiteurs de petites molécules et des dégradeurs de protéines ciblés ciblant STAT6, un facteur de transcription important pour la signalisation des cytokines IL-4 et IL-13.
Conformément à l'accord, Gilead acquerra les droits mondiaux de développer et de commercialiser le programme STAT6 oral, tandis que LEO Pharma conserve les droits mondiaux pour les formulations topiques en dermatologie. LEO Pharma a l'option de co-commercialiser des programmes oraux en dermatologie en dehors des États-Unis.
L'accord comprend un paiement initial de 250 millions de dollars à LEO Pharma, avec des paiements totaux potentiels pouvant atteindre 1,7 milliard de dollars plus des redevances échelonnées allant de chiffres à un chiffre élevé à des chiffres moyens dans les ventes de produits ORAUX de STAT6. La transaction devrait réduire le BPA GAAP et non GAAP de Gilead de 0,15 à 0,17 USD environ pour 2025.
Gilead Sciences (NASDAQ: GILD) und LEO Pharma haben eine strategische Partnerschaft angekündigt, die sich auf die Entwicklung von LEO Pharmas präklinischen oralen STAT6-Programmen für entzündliche Erkrankungen konzentriert. Die Partnerschaft umfasst kleinmolekulare Inhibitoren und gezielte Proteinzerstörer, die STAT6 angreifen, einen Transkriptionsfaktor, der wichtig für IL-4- und IL-13-Zytokinsignalisierung ist.
Gemäß der Vereinbarung wird Gilead die globalen Rechte zur Entwicklung und Vermarktung des oralen STAT6-Programms erwerben, während LEO Pharma die globalen Rechte für topische Formulierungen in der Dermatologie behält. LEO Pharma hat die Option, orale Programme für Dermatologie außerhalb der USA gemeinsam zu vermarkten.
Der Deal umfasst eine Vorauszahlung von 250 Millionen Dollar an LEO Pharma, wobei die potenziellen Gesamtzahlungen bis zu 1,7 Milliarden Dollar betragen können, zuzüglich gestaffelter Lizenzgebühren, die von hohen einstelligen bis mittleren Teenagerzahlen bei den Verkaufszahlen der oralen STAT6-Produkte reichen. Die Transaktion wird voraussichtlich das GAAP- und Non-GAAP-EPS von Gilead im Jahr 2025 um etwa 0,15 bis 0,17 USD verringern.
- Strategic acquisition of promising STAT6 program for inflammatory diseases treatment
- Global commercialization rights for oral formulations
- Expansion into new therapeutic areas with potential oral alternatives to injectable biologics
- Expected EPS reduction of $0.15-$0.17 for 2025
- Significant upfront payment of $250 million required
- Program still in preclinical stage, indicating long development timeline
Insights
The strategic partnership between Gilead and LEO Pharma represents a calculated expansion into the inflammatory disease market through the promising STAT6 program. The deal structure, featuring a
The STAT6 inhibitor program targets the IL-4/IL-13 pathway, which has been clinically validated by successful biologics like Dupixent. The key differentiator here is the oral delivery method, which could capture significant market share from injectable competitors in a multi-billion dollar market spanning atopic dermatitis, asthma and COPD.
The
The scientific rationale behind targeting STAT6 is particularly compelling. STAT6 acts as a master regulator in the Th2 inflammatory pathway and its inhibition could potentially provide broader therapeutic effects compared to single cytokine targeting. The inclusion of targeted protein degraders in the program adds an innovative approach that could enhance efficacy and selectivity.
The strategic split between oral and topical formulations maximizes the program's potential - Gilead's expertise in oral therapeutics combined with LEO's dermatology focus creates an optimal development pathway. The preclinical data must be promising to warrant such a substantial deal, though investors should note the long development timeline typical for inflammation programs.
This deal positions Gilead strategically in the high-growth inflammation market, particularly in areas where oral alternatives to biologics could drive significant market penetration. The partnership structure cleverly leverages both companies' strengths - Gilead's development and commercialization capabilities for systemic treatments and LEO's dermatology expertise.
The co-commercialization option for LEO outside the US in dermatology creates aligned incentives while maintaining Gilead's control over the core program. The
-- Strategic Partnership Strengthens Gilead’s Inflammation Research Portfolio with the Addition of LEO Pharma’s Preclinical Oral STAT6 Program, Including Targeted Protein Degraders --
-- Gilead Will Have Exclusive Global Rights to the STAT6 Program, and LEO Pharma Will Have the Option to Co-Commercialize for Dermatology Indications Outside the
-- LEO Pharma to Maintain Global Rights to Topical Formulations of the STAT6 Program in Dermatology --
STAT6 is the specific transcription factor required for IL-4 and IL-13 cytokine signaling, which are clinically validated targets for Th2 mediated inflammatory conditions such as atopic dermatitis, asthma, and COPD, amongst many others. Targeting STAT6 has shown potential preclinically to treat a broad population of patients and provide an oral alternative to those currently treated with injectable biologics.
Under this partnership, Gilead will acquire LEO Pharma’s comprehensive preclinical oral STAT6 small molecule inhibitors and targeted protein degraders. Gilead will lead further development efforts for the oral programs, while LEO Pharma will lead development for potential topical formulations of STAT6 inhibitors.
“As we continue to expand our inflammation portfolio, we're committed to developing next-generation therapies to support long-term remission in patients with inflammatory diseases through mechanisms that block major pathogenic pathways, eliminate pathogenic cells, tolerize the immune system, and restore cell function,” said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. “By partnering with LEO Pharma, we hope to explore the potential of the STAT6 pathway to bring forward an oral option for patients suffering from chronic inflammatory conditions.”
“STAT6 holds potential for treating various inflammatory diseases, including outside dermatology. This strategic partnership with Gilead will enable us to accelerate the development of the STAT6 program and maximize its potential in dermatology and beyond,” said Christophe Bourdon, CEO of LEO Pharma. “This partnership acknowledges LEO Pharma’s scientific capabilities and strengthens our commitment to innovate for people with skin diseases.”
Terms of the Agreement
Gilead will have global rights to develop, manufacture, and commercialize the small molecule oral STAT6 program. LEO Pharma will have the option to potentially co-commercialize oral programs for dermatology outside
LEO Pharma is eligible to receive up to
Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with LEO Pharma is expected to reduce Gilead’s GAAP and non-GAAP 2025 EPS by approximately
Bank of America Securities acted as financial advisors to LEO Pharma in this transaction and Latham Watkins LLP acted as legal advisors.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in
About LEO Pharma
LEO Pharma is a global company dedicated to advancing the standard of care through innovation for the benefit of people with skin conditions. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a broad portfolio of treatments, serving 100 million patients annually. Headquartered in
Gilead Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to realize the anticipated benefits from the partnership; difficulties or unanticipated expenses in connection with the partnership and the potential effects on Gilead’s earnings; the ability of Gilead to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving programs developed pursuant to the partnership; the ability of Gilead to file applications for regulatory approval or receive regulatory approvals in a timely manner or at all for the investigational programs developed pursuant to the partnership, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of any of the investigational programs developed pursuant to the partnership, and therefore these programs may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, as filed with the
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. The LEO Pharma name and logo are trademarks of LEO Pharma.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
View source version on businesswire.com: https://www.businesswire.com/news/home/20250111983856/en/
Gilead Info
Jessica Smith, Media
public_affairs@gilead.com
Jacquie Ross, Investors
investor_relations@gilead.com
LEO Pharma Info
Jeppe Ilkjaer, Media
jeilk@leo-pharma.com
Christian Soerup Ryom, Investors
chsoe@leo-pharma.com
Source: Gilead Sciences, Inc.
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