MSD Q2 2026 Financial Results Show KEYTRUDA QLEX, and LIPFENDRA Momentum

MSD Q2 2026 financial results reveal a company navigating a pivotal transition, as Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, reported total worldwide sales of $16.6 billion for the second quarter, a 5% increase over the prior-year period (4% excluding foreign exchange). Even as one-time acquisition charges pushed the pharmaceutical giant to a GAAP loss per share of $0.54, the underlying Merck Q2 2026 financial results point to accelerating demand for newer launches, particularly in oncology and cardiometabolic disease.

Within the Merck Q2 2026 financial results, both GAAP and non-GAAP loss per share included a charge of $2.31 per share tied to Merck’s acquisition of Terns Pharmaceuticals, Inc., which closed during the period for $6.8 billion. Non-GAAP loss per share came in at $0.13, compared with non-GAAP earnings of $2.13 per share a year earlier. The Terns deal added MK-4208, an investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor that has already received Breakthrough Therapy designation from the FDA for certain adults with Philadelphia chromosome-positive chronic myeloid leukemia.

Elsewhere in the release, research and development spending nearly doubled year over year to $9.7 billion, largely reflecting the Terns-related charge and higher clinical trial investment, partially offset by a $200 million reduction tied to a funding arrangement with Blackstone Life Sciences. Selling, general and administrative expenses rose 10% to $2.9 billion on higher IT investment and promotional spending supporting recent launches.

LIPFENDRA Approval Highlights Merck Q2 2026 Financial Results in Cardiovascular Care

Among the developments detailed in the Merck Q2 2026 financial results, the FDA approved LIPFENDRA (enlicitide), described in the release as the first and only once-daily oral PCSK9 inhibitor, as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia. The approval rests on two Phase 3 trials from the CORALreef program, CORALreef Lipids and CORALreef HeFH, in which LIPFENDRA reduced LDL-C by a placebo-adjusted 56% and 59%, respectively, at week 24.

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LIPFENDRA FDA Approval: Merck’s Enlicitide Becomes First Oral PCSK9 Inhibitor to Lower LDL-C

The cardiometabolic and respiratory franchise also benefited from continued uptake of WINREVAIR, which posted sales of $588 million, up 75% both on a reported and currency-neutral basis, reflecting sustained U.S. demand and early international launch traction, particularly in Japan and Europe. OHTUVAYRE, obtained through the October 2025 acquisition of Verona Pharma plc, contributed $204 million in quarterly sales.

Across the broader portfolio, pharmaceutical sales rose 5% to $14.8 billion, driven by oncology as well as cardiometabolic and respiratory growth, partially offset by continued erosion in the diabetes franchise, where JANUVIA and JANUMET sales declined amid generic competition. The table below summarizes the core financial performance disclosed in the Merck Q2 2026 financial results.

Second-Quarter 2026 Financial Performance Snapshot

Merck Q2 2026 Financial Results Highlight KEYTRUDA QLEX and Oncology Pipeline Expansion

KEYTRUDA and its subcutaneous line extension KEYTRUDA QLEX together generated $8.4 billion in the quarter, up 5% (4% ex-exchange), with KEYTRUDA QLEX alone contributing $463 million as global uptake builds across earlier-stage indications including triple-negative breast cancer, cervical cancer, head and neck cancer, and bladder cancer. Growth in metastatic settings, including urothelial cancer, added further momentum.

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Novartis Q2 2026 Results: Kisqali, Kesimpta, and Pluvicto Drive Return to Sales Growth

According to the Merck Q2 2026 financial results, the oncology pipeline advanced on several regulatory fronts during the quarter. The FDA approved KEYTRUDA and KEYTRUDA QLEX, each paired with WELIREG, for the adjuvant treatment of certain patients with clear cell renal cell carcinoma based on the Phase 3 LITESPARK-022 trial, a combination Merck describes as the first approved pairing of a PD-1 inhibitor with a hypoxia-inducible factor-2 alpha inhibitor for this population. In July, the FDA also expanded approval of KEYTRUDA and KEYTRUDA QLEX, each with Padcev, for use before and after surgery in adult patients with muscle-invasive bladder cancer, building on the Phase 3 KEYNOTE-B15 and earlier KEYNOTE-905 data. A separate approval paired KEYTRUDA and KEYTRUDA QLEX with Trodelvy for first-line treatment of PD-L1-positive advanced triple-negative breast cancer, based on the Phase 3 KEYNOTE-D19/ASCENT-04 trial.

Beyond KEYTRUDA, the Merck Q2 2026 financial results reported positive Phase 3 results from the TroFuse-005 trial evaluating sacituzumab tirumotecan (sac-TMT), an investigational anti-TROP2 antibody-drug conjugate developed with Kelun-Biotech, which met its dual primary endpoints of overall survival and progression-free survival in patients with advanced or recurrent endometrial cancer who had progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy. Merck notes this is the first Phase 3 readout from a sac-TMT program that spans 17 ongoing global Phase 3 trials across multiple tumor types. Separately, the FDA granted Breakthrough Therapy designation to calderasib (MK-1084), an investigational oral KRAS G12C inhibitor, for use with KEYTRUDA in first-line KRAS G12C-mutated, PD-L1-expressing non-small cell lung cancer.

HIV and Vaccine Data Add to Merck Q2 2026 Financial Results Momentum

In vaccines and infectious disease, a segment of the Merck Q2 2026 financial results, Merck and partner Gilead presented the first Phase 3 results for islatravir/lenacapavir (ISL/LEN), an investigational once-weekly oral HIV treatment regimen, at the 26th International AIDS Conference in July. The regimen maintained virological suppression in adults with HIV who switched from other antiretroviral therapies, and Merck says it could become the first approved oral, once-weekly HIV treatment if cleared by regulators. A companion Phase 2b study of once-weekly oral islatravir and ulonivirine (ISL/ULO) also reported its first switch-study results during the quarter.

Also during the quarter, Merck secured regulatory approvals in Japan and China for ENFLONSIA, aimed at preventing RSV lower respiratory tract disease in newborns and infants entering their first RSV season. In immunology, the Phase 3 ATLAS-UC induction-only study of tulisokibart (MK-7240), an antibody targeting TL1A, returned positive topline results in moderately to severely active ulcerative colitis, while a Phase 2 hidradenitis suppurativa study met its primary and key secondary endpoints. A separate Phase 2 study of tulisokibart in systemic sclerosis-associated interstitial lung disease did not meet its primary endpoint and will be discontinued, though Merck reported no new safety concerns.

Key Regulatory and Clinical Milestones – Q2 2026