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

— 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 a co-commercialization option 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 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) program for the potential treatment of patients with inflammatory diseases.

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STAT6 is a specific transcription factor required for cytokine signaling IL-4 and IL-13, 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 broad patient population and provide an oral alternative to those currently treated with injectable biologics.

As part of 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 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 pathogenic pathways, eliminate pathogenic cells, tolerize the immune system, and restore cell function, said Flavius ​​Martin, MD , executive vice president, research, Gilead Sciences. By collaborating with LEO Pharma, we hope to explore the potential of the STAT6 pathway to present an oral option for patients suffering from chronic inflammatory conditions.

STAT6 has the potential to treat a variety of inflammatory diseases, including external dermatology. This strategic partnership 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 validates LEO Pharma’s scientific capabilities and strengthens our commitment to innovation for people with skin diseases.

Terms of the Agreement

Gilead will have global rights to develop, manufacture and commercialize the oral STAT6 small molecule program. LEO Pharma will have the option to potentially co-commercialize oral dermatology programs outside of the United States. LEO Pharma will have exclusive global rights to STAT6 topical formulations in dermatology.

LEO Pharma is eligible to receive up to $1.7 billion in aggregate payments, including an upfront payment of $250 million. In addition, LEO Pharma may also receive multi-level royalties ranging from high single digits to mid-teens on sales of oral STAT6 products. Gilead may receive multiple royalties ranging from the high single digits to the mid-teens on sales of topical STAT6 products.

Gilead does not exclude acquired IPR&D costs 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 advisor to LEO Pharma in this transaction and Latham Watkins LLP acted as legal advisor.

About Gilead Sciences

Gilead Sciences, Inc. (NASDAQ:) 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 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 diseases. LEO Pharma is co-owned by the majority shareholder LEO Foundation, and from 2021 by 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. In 2023, the company achieved 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 anticipated benefits of the partnership; difficulties or unforeseen costs related to the partnership and possible effects on Gilead’s earnings; Gilead’s ability to initiate, progress or complete clinical trials within the currently anticipated timeframes or at all and the possibility of adverse results from ongoing or additional trials, including those involving programs developed pursuant to the partnership; Gilead’s ability to apply for or obtain regulatory approvals in a timely manner or at all for research programs developed pursuant to the partnership, and the risk that any such approvals may be subject to significant use restrictions; the possibility that Gilead will make a strategic decision to discontinue development of any research programs developed pursuant to the partnership, and therefore those programs may never be successfully commercialized; and all assumptions on which any of the foregoing is based. These and other risks, uncertainties and other factors are detailed 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 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 the reader 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 undertakes no obligation and disclaims any intention to update such forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or related 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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Information about Gilead
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.