Gilead and LEO Pharma Enter into Strategic Collaboration to Accelerate Development of Oral STAT6 Program with Potential in Multiple Inflammatory Diseases

– Strategic partnership strengthens Gilead’s inflammation research portfolio with addition of LEO Pharma’s preclinical oral STAT6 program, including targeted protein degraders —

— Gilead Will Have Exclusive Global Rights to STAT6 Program, and LEO Pharma Will Have Option to Co-Market for Dermatology Indications Outside the US —

— LEO Pharma to Retain Global Rights to STAT6 Program Topical Formulations in Dermatology —

FOSTER CITY, Calif. & BALLERUP, Denmark–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and LEO Pharma today announced a strategic collaboration to accelerate the development and commercialization of LEO Pharma’s oral small molecule STAT6 (signal transducer and activator of transcription 6) programs for the potential treatment of patients with inflammatory diseases.

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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, among many others. Targeting STAT6 has shown preclinical potential to treat a wide patient population and provide an oral alternative to those currently treated with injectable biologics.

Under this collaboration, Gilead will acquire LEO Pharma’s complete preclinical oral STAT6 molecule inhibitors and targeted protein degraders. Gilead will lead further development efforts for oral programs, while LEO Pharma will lead the development of potential topical formulations of STAT6 inhibitors.

As we continue to expand our inflammation portfolio, we are committed to developing next-generation therapies to support long-term remission in patients with inflammatory diseases through mechanisms that block key pathogenic pathways, eliminate pathogenic cells, tolerate the immune system and restore the cell. function, said Flavius ​​​​Martin, MD, Executive Vice President, Research, Gilead Sciences. In partnership with LEO Pharma, we hope to explore the potential of the STAT6 pathway to advance an oral option for patients suffering from chronic inflammatory conditions.

STAT6 has potential to treat various inflammatory diseases, including external dermatology. This strategic collaboration with Gilead will allow 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 recognizes LEO Pharma’s scientific capabilities and reinforces 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-market the oral programs for dermatology outside of the United States. LEO Pharma will hold exclusive global rights to STAT6 topical formulations in dermatology.

LEO Pharma is eligible to receive up to $1.7 billion in total payments, including an initial payment of $250 million. In addition, LEO Pharma may also receive royalties at levels ranging from high to mid-teens on sales of STAT6 oral products. Gilead may receive royalties ranging from high to mid-teens on sales of topical STAT6 products.

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 $0.15 – $0.17.

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. (NASDAQ:) is a biopharmaceutical company that has pursued and achieved innovations 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 Foster City, California.

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 the majority shareholder the LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a wide portfolio of treatments, serving 100 million patients a year. Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. In 2023, the company generated net sales of $1.6 billion. Read more at www.leo-pharma.com.

Gilead Statements Forward

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 expected benefits of the partnership; unforeseen difficulties or expenses in connection with the partnership and potential effects on Gilead’s earnings; Gilead’s ability to initiate, progress or complete clinical trials on the currently planned timelines or at all, and the possibility of unfavorable results from ongoing or additional trials, including those involving programs developed pursuant to the partnership; Gilead’s ability to submit applications for regulatory approval or receive regulatory approval on a timely basis or at all for investigational programs developed pursuant to the collaboration, and the risk that such approval may be subject to significant limitations of the use; the possibility that Gilead may make a strategic decision to discontinue the development of any of the investigational programs developed pursuant to the collaboration, and therefore, these programs may never be successfully commercialized; and any assumptions subject to 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 Securities and Exchange Commission of the United States. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that may be considered forward-looking statements. The reader is cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intention to update such forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its affiliated companies. The LEO Pharma name and logo are trademarks of LEO Pharma.

For more information about Gilead, visit the company’s website at www.gilead.comfollow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

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Gilead Info
Jessica Smith, Media
public_affairs@gilead.com

Jacquie Ross, Investors
investor_relations@gilead.com

Information about LEO Pharma
Jeppe Ilkjaer, Media
jeilk@leo-pharma.com

Christian Soerup Ryom, Investors
chsoe@leo-pharma.com

Source: Gilead Sciences, Inc.