— Strategic Partnership Strengthens Gilead’s Inflammation Research Portfolio with Addition of LEO Pharma’s Preclinical Oral STAT6 Program, Including Targeted Protein Degraders —

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

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

FOSTER CITY, Calif. & BALLERUP, Denmark–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and LEO Pharma announced today a strategic partnership to accelerate the development and commercialization of LEO Pharma’s small molecule oral 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, clinically validated targets for Th2 mediated inflammatory conditions such as atopic dermatitis, asthma, and COPD, and so on. 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 additional development efforts for oral programs, while LEO Pharma will lead development for 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 major pathways. of the pathogen, eliminates the pathogen cells, allows the immune system, and restores the cell. function, said Flavius ​​Martin, MD, Executive Vice President, Research, Gilead Sciences. Through collaboration with LEO Pharma, we hope to explore the potential of the STAT6 pathway to bring an oral option for patients suffering from inflammatory conditions.

STAT6 has potential for the treatment of various inflammatory diseases, including external 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 recognizes LEO Pharma’s scientific capabilities and reinforces our commitment to innovate for people with skin diseases.

Terms of Agreement

Gilead has global rights to develop, manufacture, and commercialize the small molecule oral STAT6 program. LEO Pharma has the option to potentially co-commercialize 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 compensation, including an upfront payment of $250 million. In addition, LEO Pharma may also receive tiered royalties ranging from high single-digit to mid-teens on sales of oral STAT6 products. Gilead may receive tiered royalties from the high single-digits to the mid-teens on sales of STAT6 products.

Gilead excludes acquired IPR&D costs from its non-GAAP financial measures. This LEO Pharma transaction 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 been pursuing and achieving breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to developing new 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, Calif.

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 jointly owned by the majority shareholder LEO Foundation and, since 2021, Nordic Capital. LEO Pharma offers a broad portfolio of treatments, serving 100 million patients annually. Headquartered in Denmark, LEO Pharma has a global team of 4,000 people. By 2023, the company will generate net sales of $1.6 billion. Read more at www.leo-pharma.com.

Gilead’s 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 expected benefits from the partnership. ; difficulties or unexpected expenses related to the partnership and the potential effects on Gilead’s earnings; Gilead’s ability to initiate, progress or complete clinical trials within expected timelines now or at all, and the possibility of adverse outcomes from ongoing or additional trials, including those involving programs developed in accordance with the partnership; Gilead’s ability to file applications for regulatory approval or receive regulatory approvals in a timely manner or at all for investigational programs conducted pursuant to the partnership, and the risk that any such approval may be subject to significant use limitations; the possibility that Gilead may make a strategic decision to discontinue the development of any investigational programs developed pursuant to the partnership, and therefore these programs may not 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 US Securities and Exchange Commission. 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 any 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. statement. All forward-looking statements are based on information currently available to Gilead, and Gilead undertakes no obligation and disclaims any intention to update any such forward-looking statements.

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.comfollow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

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Gilead Information
Jessica Smith, Media
[email protected]

Jacquie Ross, investors
[email protected]

Information on LEO Pharma
Jeppe Ilkjaer, Media
[email protected]

Christian Soerup Ryom, Investors
[email protected]

Source: Gilead Sciences, Inc.