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Merck Signs Agreement with Dr. Falk Pharma GmbH for Certain Development and Commercialization Rights to MK-8690 (PRA-052) an Investigational Anti-CD30 Ligand Monoclonal Antibody

1. Merck assumes full responsibility for MK-8690 after contract discontinuation. 2. Prometheus BioSciences secures global rights for MK-8690 from Falk. 3. Merck will incur a $150 million pre-tax R&D charge this quarter. 4. MK-8690 is undergoing early-stage clinical trials as a monoclonal antibody.

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Why Neutral?

The R&D expense is significant, but MK-8690's potential is uncertain.

How important is it?

The article reflects on strategic moves in research development impacting Merck’s pipeline.

Why Long Term?

Success in clinical trials will influence future revenue but takes time.

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Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the company, through a subsidiary (Prometheus BioSciences), has reached an agreement with Dr. Falk Pharma GmbH (Falk) to discontinue an existing contract concerning co-development and co-commercialization rights in certain territories for MK-8690 (formerly PRA-052), and for Merck to assume full responsibility for the development program going forward. MK-8690 is an investigational anti-CD30 ligand monoclonal antibody being evaluated by Merck in an early-stage clinical trial.

Under the terms of the agreement, Prometheus BioSciences (Prometheus) and Falk have discontinued their collaboration based on their existing co-development contract resulting in Prometheus having secured global rights to MK-8690. In exchange, Falk will receive a $150 million upfront payment and is eligible to receive a payment associated with a development milestone as well as royalties on sales in certain territories. The original contract between Falk and Prometheus was signed in 2020. Merck subsequently acquired Prometheus in 2023.

As a result of the transaction with Falk, Merck will record a pre-tax charge to research and development expenses of $150 million, or approximately $0.05 per share, in both its GAAP and non-GAAP fourth quarter results.

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, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

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