IL-13 x IL-4

— 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 U.S. — — LEO Pharma to Maintain Global Rights to Topical Formulations of the STAT6 Program in Dermatology — FOSTER CITY, CA, USA & BALLERUP, Denmark I January 11, 2025 I Gilead Sciences, Inc . (Nasdaq: GILD) andLEO Pharmatoday 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) programs for the potential treatment of patients with inflammatory diseases. 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 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 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 ranging from high single-digit 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. 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, 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 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 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 . SOURCE: Gilead Sciences

Gilead has inked a deal to license Leo Pharma’s portfolio of oral STAT6 candidates for inflammatory diseases, less than a month after Johnson & Johnson dipped its toes into the same arena. Gilead is paying $250 million upfront for global rights to develop, manufacture and market Leo’s assets, which include preclinical-stage oral STAT6 inhibitors and protein degraders, according to a Saturday release . The deal could be worth up to $1.7 billion when factoring in milestones, with Leo also eligible for tiered royalties on product sales. The Ballerup, Denmark-based biotech will have the option to co-commercialize some of the oral dermatology programs outside the US. It will also retain the rights to its topical STAT6 programs for various skin diseases, for which Gilead could get tiered royalties. STAT6 is a transcription factor that’s needed for IL-4 and IL-13 cytokine signaling, which play a key role in a variety of inflammatory conditions including eczema, asthma and COPD. On Sunday, Leerink analysts wrote that STAT6 is “strategically important” for companies planning to develop small molecule drugs for immune and inflammatory conditions or “hold a position” in Th2-mediated inflammatory disorders, such as eczema and asthma. “The biology of STAT6 is considered highly compelling as it is a central node in Th2 immunity and is minimally implicated in other biological processes,” the analysts added. The Gilead-Leo partnership marks the fourth major deal to date centered on the target. Just last month, J&J licensed Kaken Pharmaceutical’s lead STAT6 candidate, KP-723, in a deal that featured $30 million upfront. Sanofi has forged two deals in the space so far. In July 2023, the French drugmaker linked up with Recludix on an oral inhibitor candidate, and last year, it expanded a 2019 pact with Nurix Therapeutics for oral STAT6 degraders.

Gilead Sciences and LEO Pharma have entered into a strategic partnership worth $1.7bn to advance LEO’s small molecule oral STAT6 programme for inflammatory diseases. The deal gives Gilead global rights to develop, manufacture and commercialise the oral STAT6 programme. Meanwhile, LEO will hold exclusive global rights to STAT6 topical formulations in dermatology, and will have the option to co-commercialise oral programmes for dermatology indications outside the US. In exchange, LEO will be eligible for up to $1.7bn, including an upfront payment of $250m and approximately $1.5bn in development, regulatory and commercial milestones. LEO may also receive tiered royalties on sales of oral STAT6 products, while Gilead could be in line for tiered royalties on sales of topical STAT6 products. Flavius Martin, executive vice president, research, Gilead, said the company is “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, tolerise the immune system, and restore cell function”. “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,” he added. STAT6 is the specific transcription factor used for interleukin-4 and interleukin-13 cytokine signalling, which has been shown to play a key role in multiple inflammatory conditions, including atopic dermatitis, asthma and chronic obstructive pulmonary disease. The approach has already shown potential pre-clinically to treat a broad population of patients and provide an oral alternative to those currently receiving injectable biologics. “STAT6 holds potential for treating various inflammatory diseases, including outside dermatology,” said LEO’s chief executive officer, Christophe Bourdon. “This strategic partnership with Gilead will enable us to accelerate the development of the STAT6 programme and maximise its potential in dermatology and beyond.” The announcement comes just over a month after LEO’s Anzupgo (delgocitinib) cream was approved by the Medicines and Healthcare Products Regulatory Agency to treat chronic hand eczema in adults with moderate-to-severe cases of the inflammatory skin disease. The company is now working with the National Institute for Health and Care Excellence to make the treatment available on the NHS.