U.S. drugmaker Merck (MSD) on the 3rd (local time) laid out a growth strategy to prepare for the expiration of its immuno-oncology drug Keytruda's patents during its earnings conference call.
The company said it expects to secure more than $70 billion (about 101 trillion won) in annual revenue over the next 10 years through a new pipeline. In particular, it listed the metabolic dysfunction-associated steatohepatitis (MASH) treatment candidate "efinopegdutide (MK-6024)," to which Hanmi Pharmaceutical transferred technology, among its promising R&D assets.
At the JP Morgan Healthcare Conference (JPM 2026), the world's largest pharma-bio investor event held in the United States in January, MSD did not mention efinopegdutide, sparking rumors in Korea of development setbacks and sending Hanmi Pharmaceutical's share price sharply lower.
But MSD listed efinopegdutide (MK-6024) as a key asset in phase 2 in this earnings release, easing concerns raised by some domestic investors, according to assessments.
Efinopegdutide is a MASH treatment candidate developed using Hanmi Pharmaceutical's long-acting technology "Lapscovery" that simultaneously activates glucagon-like peptide (GLP)-1 and glucagon, and the company out-licensed the technology in 2020. It was designated for the U.S. Food and Drug Administration (FDA) fast track and advanced to a phase 2b trial.
In the presentation, MSD identified potential markets of more than $25 billion in oncology, $20 billion in cardiovascular and metabolic diseases, and $15 billion in infectious diseases, signaling its commitment to developing metabolic disease treatments. Hanmi Pharmaceutical also said, "The partnership with MSD is on track," adding, "We are set to announce phase 2 results in the first half."
The announcement also confirmed the revenue contribution of "Keytruda QLEX," which applies Alteogen's technology to convert the existing intravenous (IV) formulation of the cancer therapy into a subcutaneous (SC) formulation. MSD said cancer drug Keytruda generated $31.7 billion (about 46 trillion won) in revenue, up 7% from a year earlier. Keytruda QLEX, launched in the third quarter last year, posted $40 million (about 58 billion won) in sales. Fourth-quarter sales were $35 million (about 50.7 billion won).
MSD said Keytruda QLEX is expected to receive a permanent J-code in April. In the United States, this is the official code required for hospitals to bill insurer-covered injectables. Once the J-code is set, billing between hospitals and insurers is simplified, which is expected to create a favorable environment for broader prescribing and sales growth in the U.S.
MSD said it has built the broadest and most robust pipeline in recent years, signaling confidence in mid- to long-term growth. Chief Executive Officer Robert Davis said, "As the loss of exclusivity for Keytruda draws closer, we are increasingly confident we can continue to deliver meaningful growth after that."
MSD recently bolstered its growth engines by acquiring Verona Pharma and Cidara Therapeutics. Including these acquisitions, new growth drivers have annual revenue potential of more than $70 billion by the mid-2030s, the company said. That is roughly twice Keytruda's projected peak sales of about $35 billion in 2028.
Keytruda's primary composition patent is set to expire in 2028, and multiple biosimilars are aiming to enter the market. MSD holds two additional patents valid through 2029 and expressed confidence in its ability to defend the franchise.
MSD's annual revenue last year was $65 billion (about 94 trillion won), up 1% from the prior year. Excluding the animal health business, pharmaceutical revenue was $58.1 billion (about 84 trillion won).
Among cancer drugs, new drug Welireg posted fourth-quarter sales of $220 million last year, up 37% from a year earlier. Prescriptions increased as overseas launches gathered pace.
In vaccines, the adult pneumococcal vaccine Capvaxive delivered results. Approved in 2024, the product generated $759 million in sales last year. By contrast, HPV vaccine Gardasil continued to underperform. Gardasil's sales last year were $5.2 billion, down 39% from a year earlier, mainly due to weaker demand in China and Japan.
Pulmonary arterial hypertension (PAH) therapy Winrevair also proved its blockbuster potential. Acquired through Acceleron, which MSD bought for $11.5 billion in 2021, the drug recorded $1.4 billion in sales last year.
MSD guided 2026 revenue of $65.5 billion to $67 billion. It also left the door open to additional mergers and acquisitions (M&A). CEO Davis said, "Deals in the $10 billion to $15 billion range are the most ideal, but we could consider larger ones if the asset is scientifically attractive." However, regarding speculation about acquiring Revolution Medicines, the company avoided specific comment.