Merck Enters into Exclusive Global License Agreement with Hansoh Pharma for Investigational Oral GLP-1 Receptor Agonist

Rhea-AI Summary

Merck (NYSE: MRK) has entered into an exclusive global license agreement with Hansoh Pharma for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist. Under the agreement, Merck will pay $112 million upfront and up to $1.9 billion in potential milestone payments, plus royalties on sales. Hansoh retains rights to co-promote or solely commercialize the drug in China under certain conditions.

The deal will result in a pre-tax charge of $112 million ($0.04 per share) in Merck's Q4 2024 GAAP and non-GAAP results. The partnership aims to leverage Merck's experience in incretin biology to evaluate HS-10535's potential for cardiometabolic benefits beyond weight reduction.

Positive

• Strategic expansion into oral GLP-1 market, a high-growth therapeutic area
• Potential for additional revenue stream through cardiometabolic treatments
• Secured exclusive global rights for development and commercialization

Negative

• Significant upfront cost of $112 million impacting Q4 2024 earnings
• Additional potential liability of up to $1.9 billion in milestone payments
• Drug still in preclinical stage, indicating long development timeline and uncertain outcome

Insights

Financial Analyst

This licensing deal represents a significant strategic move in the highly competitive GLP-1 market. The $112 million upfront payment and potential $1.9 billion in milestone payments shows Merck's serious commitment to expanding its cardiometabolic portfolio. The oral GLP-1 space is particularly attractive as it offers better patient compliance compared to injectable alternatives. While the $0.04 per share charge is minimal given Merck's size, the long-term potential could be substantial given the explosive growth in the GLP-1 market. The deal structure, including China commercialization rights for Hansoh, demonstrates smart risk-sharing and market access considerations.

Medical Research Analyst

An oral GLP-1 receptor agonist could be a game-changer in the diabetes and obesity treatment landscape. While HS-10535 is still in preclinical stages, suggesting a long development timeline ahead, the oral administration route could provide a significant competitive advantage over current injectable GLP-1 products. Merck's experience with incretin biology and their focus on cardiometabolic benefits beyond weight reduction indicates they may be targeting a differentiated product profile. The development will be closely watched as oral bioavailability has been a historical challenge for GLP-1 drugs.

Market Research Analyst

This deal positions Merck to compete in the rapidly growing GLP-1 market, currently dominated by Novo Nordisk and Eli Lilly. The global GLP-1 market has seen explosive growth, particularly in obesity treatment. An oral formulation could significantly expand the addressable market by appealing to needle-phobic patients and those preferring pill-based treatments. The inclusion of Chinese market rights for Hansoh is strategic, considering China's growing obesity and diabetes epidemic. This deal could help Merck capture a meaningful share of this multi-billion dollar market opportunity.

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Hansoh Pharma, a Chinese biopharmaceutical company, today announced that they have entered into an exclusive global license agreement for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist.

“We continue to leverage science-driven business development to augment and complement our robust pipeline,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “Through this agreement, we aim to build on our experience targeting incretin biology to evaluate HS-10535 and its potential to provide additional cardiometabolic benefits beyond weight reduction.”

Under the agreement, Hansoh Pharma has granted Merck an exclusive global license to develop, manufacture and commercialize HS-10535. Hansoh Pharma will receive an upfront payment of $112 million and is eligible to receive up to $1.9 billion in milestone payments associated with the development, regulatory approval and commercialization of the candidate, as well as royalties on sales. Hansoh Pharma may co-promote or solely commercialize HS-10535 in China subject to certain conditions. Merck will record a pre-tax charge of $112 million, or $0.04 per share, to be included in GAAP and non-GAAP results in the fourth quarter of 2024.

“We are pleased to announce the in-license of our oral GLP-1 by Merck, a company with established leadership in cardiometabolic diseases,” said Ms. Eliza Sun, Executive Director of the Board, Hansoh Pharma. “Hansoh Pharma is becoming an emerging leader in metabolic diseases, and we see Merck’s expertise and capabilities as key to accelerating the development of this promising asset for patients worldwide.”

About Hansoh Pharma

Hansoh Pharma is a leading pharmaceutical company in Greater China driven by innovation. It is committed to the treatment of major diseases in the areas of oncology, anti-infections, CNS diseases, metabolic diseases, as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years and is a national key high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Stock Exchange of Hong Kong in June 2019 (stock code: 03692.HK). For more information, please visit www.hspharm.com.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

View source version on businesswire.com: https://www.businesswire.com/news/home/20241218761534/en/

Merck Media:

Robert Josephson

(203) 914-2372

Justine Moore

(347) 281-3754

Merck Investor:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

Source: Merck & Co., Inc.

FAQ

What is the value of Merck's (MRK) licensing deal with Hansoh Pharma?

Merck will pay $112 million upfront and up to $1.9 billion in potential milestone payments, plus royalties on sales.

How will the Hansoh Pharma deal affect Merck's (MRK) Q4 2024 earnings?

Merck will record a pre-tax charge of $112 million, or $0.04 per share, in both GAAP and non-GAAP results.

What are Hansoh Pharma's commercialization rights for HS-10535 in China under the Merck (MRK) deal?

Hansoh Pharma may co-promote or solely commercialize HS-10535 in China subject to certain conditions.

What type of drug is HS-10535 in Merck's (MRK) new licensing agreement?

HS-10535 is an investigational preclinical oral small molecule GLP-1 receptor agonist.