Merck posts Q2 loss on Terns charge, raises full-year sales outlook

Merck reported second-quarter 2026 sales of $16.6 billion, up 5% year over year, as it disclosed a series of regulatory and clinical updates alongside its earnings. Total worldwide sales grew 5% (4% ex-FX), with KEYTRUDA/KEYTRUDA QLEX sales of $8.4 billion and WINREVAIR sales of $588 million, up 75%.¹

On the regulatory front, the FDA cleared several new uses for Merck's cancer drugs during the quarter. The agency approved KEYTRUDA and KEYTRUDA QLEX, each paired with WELIREG, as adjuvant therapy for certain patients with clear cell renal cell carcinoma based on the Phase 3 LITESPARK-022 trial, marking what the company said was the first approved combination of a PD-1 and HIF-2 alpha inhibitor for this group.¹ In July, the FDA also expanded approval of KEYTRUDA and KEYTRUDA QLEX with Padcev for muscle-invasive bladder cancer to include cisplatin-eligible patients, building on the earlier KEYNOTE-905-based approval.¹ A third approval covered KEYTRUDA and KEYTRUDA QLEX with Trodelvy as first-line treatment for PD-L1 positive advanced triple-negative breast cancer, based on the KEYNOTE-D19/ASCENT-04 trial.¹

Merck also announced positive Phase 3 data outside oncology. Its TroFuse-005 trial of sacituzumab tirumotecan, an antibody-drug conjugate developed with Kelun-Biotech, met its overall survival and progression-free survival endpoints in advanced or recurrent endometrial cancer, the first Phase 3 readout from a program that includes 17 ongoing global trials.¹ With Gilead, Merck reported first Phase 3 results for an investigational once-weekly oral HIV regimen combining islatravir and lenacapavir, which maintained viral suppression in patients who switched therapies; the company said it could become the first approved oral, once-weekly HIV treatment.¹

In cardiometabolic disease, the FDA approved a new once-daily oral cholesterol drug. The agency cleared "LIPFENDRA (enlicitide)," described as the first and only once-daily oral PCSK9 inhibitor, based on the CORALreef Lipids and CORALreef HeFH trials, which showed placebo-adjusted LDL-C reductions of 56% and 59% at week 24.¹

In immunology, results were mixed. Merck reported positive topline results from the Phase 3 ATLAS-UC induction study of tulisokibart in moderate to severe ulcerative colitis.¹ However, a Phase 2 study of the same drug in systemic sclerosis-associated interstitial lung disease missed its primary endpoint and will be discontinued, though no new safety concerns were identified.¹

Financially, both GAAP and non-GAAP loss per share reflected a $2.31 per share charge tied to the acquisition of Terns Pharmaceuticals.¹ Merck completed that $6.8 billion acquisition during the quarter, adding MK-4208, an oral BCR::ABL1 tyrosine kinase inhibitor that recently received FDA Breakthrough Therapy designation for Philadelphia chromosome-positive chronic myeloid leukemia.¹

Looking ahead, Merck raised and narrowed its full-year 2026 sales outlook to a range of $66.3 billion to $67.3 billion.¹ It now expects full-year non-GAAP EPS of $2.66 to $2.76, a range that includes one-time charges of $3.62 per share for the Cidara acquisition and $2.31 per share for Terns.¹