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

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

— Gilead will have Exclusive World Rights to the STAT6 Program, and LEO Pharma will have an Option to Participate in Dermatology Shows Outside the US —

— LEO Pharma to Retain World Rights to STAT6 Dermatology Program Content Submissions —

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

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STAT6 is a specific transcription factor required for IL-4 and IL-13 cytokine signaling, which are clinically proven targets for Th2-related inflammatory conditions such as atopic dermatitis, asthma, and COPD, among many others. Targeting STAT6 has shown potential to treat many patients and provide an oral alternative to those currently treated with injectable biologics.

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

As we continue to expand our inflammation platform, we are committed to developing next-generation therapies to support long-term remission in patients with inflammatory diseases through targeted therapies. pathogenic growth, elimination of pathogenic cells, immune tolerance, and cell regeneration. said Flavius ​​Martin, MD, Executive Vice President, Research, Gilead Sciences. In collaboration with LEO Pharma, we hope to explore the potential of the STAT6 pathway to bring about an oral option for patients with chronic inflammatory conditions.

STAT6 has potential in the treatment of various inflammatory diseases, including external dermatology. This strategic partnership with Gilead will help us accelerate the development of the STAT6 program and expand its potential in dermatology even further, said Christophe Bourdon, CEO of LEO Pharma. This collaboration recognizes LEO Pharma’s scientific capabilities and reinforces our commitment to innovation for people with skin diseases.

Terms of Agreement

Gilead will have worldwide rights to develop, manufacture and commercialize the small molecule oral STAT6 program. LEO Pharma will have the option to partner with oral programs for dermatology outside of the United States. LEO Pharma will have exclusive worldwide rights to STAT6 topical formulations in dermatology.

LEO Pharma is eligible for payments of up to $1.7 billion, including an upfront payment of $250 million. In addition, LEO Pharma is likely to earn high single- to mid-teens earnings from sales of STAT6 oral products. Gilead is likely to earn high-single-digit to mid-teens revenue from sales of the STAT6 title product.

Gilead does not include accrued IPR&D costs in its non-GAAP financial statements. 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 Science

Gilead Sciences, Inc. (NASDAQ:) is a biopharmaceutical company that has pursued and achieved medical breakthroughs for more than three decades, with the goal of creating a healthier world for all. The company aims to develop 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 committed to advancing the standard of care through innovative approaches for the benefit of people with skin conditions. LEO Pharma is joined by major shareholders LEO Foundation and, from 2021, Nordic Capital. LEO Pharma offers a wide range of treatments, serving 100 million patients a year. Based in Denmark, LEO Pharma has a global team of 4,000 people. In 2023, the company generated total 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 cooperation; difficulties or unexpected costs in connection with the collaboration and the possible effects on Gilead’s earnings; Gilead’s ability to initiate, progress or complete clinical trials in the current expected time frame or at all, and the possibility of unfavorable results from ongoing or additional trials, including programs developed based on collaboration; Gilead’s ability to submit applications for regulatory approval or obtain regulatory approval in a timely manner or at all for research programs conducted pursuant to the agreement, and the risk that any such approval may be subject to significant limitations of use; the possibility that Gilead may decide to discontinue the development of any research programs developed pursuant to the collaboration, and therefore these programs will not be commercially successful; and any assumptions based on 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. and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed in 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 are cautioned not to place undue reliance on the statements these are expected. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no responsibility 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 (@Gileade Sciences) and LinkedIn (@Gileade-Sciences).

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Gilead News
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.