Merck Targets $70B Pipeline as It Prepares for KEYTRUDA Exclusivity Loss

Merck raised its estimate of potential human-health revenue to more than $70 billion by the mid-2030s, supported by investments across oncology, cardiometabolic disease, ophthalmology, immunology and HIV, along with acquisitions such as Cidara and Terns. As KEYTRUDA approaches loss of exclusivity, Merck expects a gradual “hill” rather than a revenue cliff. Modest 2027 growth from newer products and Animal Health is expected to offset generic pressure on BRIDION, JANUVIA and Adempas, as well as slowing KEYTRUDA growth. Merck is advancing major growth candidates including the sac-TMT cancer ADC, individualized neoantigen therapy, ophthalmology drugs and the oral PCSK9 therapy LIPFENDRA, while continuing to prioritize business-development deals generally ranging from $1 billion to $15 billion.

Merck & Co., Inc. executives outlined a strategy centered on pipeline investment, new product launches and targeted business development as the company prepares for the eventual loss of exclusivity for KEYTRUDA. Chief Financial Officer Caroline Litchfield said Merck has increased its estimate of non-risk-adjusted revenue potential from its human health product portfolio to more than $70 billion by the mid-2030s, up from an earlier estimate of more than $50 billion. The portfolio spans oncology, cardiometabolic disease, ophthalmology, immunology and HIV, she said.

Litchfield also highlighted the company’s acquisitions of Cidara and Terns during the past year, along with continued growth in its animal health business. “The transformation of Merck’s portfolio is underway,” she said.

Oncology pipeline expands beyond lung and breast cancer Dean Li, head of R&D and president of Merck Research, discussed sac-TMT, a TROP2 antibody-drug conjugate, or ADC, that Merck is advancing across a broad set of tumor types. Li said the company initially emphasized indications beyond breast and lung cancer, noting that 13 of 17 trials were outside those two areas. Merck Just Made a Big Bet on a New Cancer Growth Engine Merck’s endometrial cancer program could make sac-TMT the first TROP2 ADC in that setting, according to Li. He said data from Kelun’s Phase III program in China supported Merck’s confidence in pursuing lung cancer more aggressively, while additional breast cancer data could enable comparisons with other therapies. Li said Merck intends to study sac-TMT broadly across PD-L1-related indications and sees potential combination opportunities with a PD-1/VEGF approach. The company is also exploring PD-1/VEGF combinations with WELIREG, he said.

On individualized neoantigen therapy, or INT, Li said Merck has focused development where KEYTRUDA has already shown activity in earlier-stage disease and across tumors with varying tumor mutation burdens. In melanoma, he said the Phase II data suggested that adding INT to KEYTRUDA “almost double[s]” the number of patients remaining cancer-free compared with KEYTRUDA alone, though he emphasized that investors will look to the Phase III presentation to assess how closely the results align with the earlier study. Li said renal cell carcinoma data could serve as another important reference point for assessing the potential of INT across other immune-sensitive tumors, including non-small cell lung cancer and head and neck cancer.

Litchfield said Merck does not expect a revenue “cliff” during the KEYTRUDA loss-of-exclusivity period. Instead, she said the company expects “more of a hill with a quick return to strong growth” on a risk-adjust...