Merck Q2 Net Profit Declines; Upgrades 2026 Guidance

Phase 3 ISLEND-1 results in the New England Journal of Medicine found a once-weekly tablet of islatravir 2 mg plus lenacapavir 300 mg was noninferior to once-daily bictegravir, emtricitabine, and tenofovir alafenamide for maintaining HIV viral suppression at 48 weeks in 607 adults already suppressed for at least 6 months. None on weekly therapy had HIV-1 RNA ≥50 copies/mL vs 0.3% on daily. Serious adverse events were 5.3% vs 4.6%.

Merck reported phase 3 SMART trial results for clesrovimab (Enflonsia) in 276 children entering their second RSV season. The FDA accepted Merck’s application to expand approval to children up to age 2. Second-season medically attended LRTI incidence was 7.3% and RSV hospitalizations 3.0%. Safety was similar to first season.

Merck KGaA reported Q2 results and updated 2026 guidance after its earnings call. It raised group organic net sales growth to 1% to 3% and EBITDA pre to €5.9bn to €6.3bn, with EPS pre at €7.90 to €8.60. Healthcare sales rose 2.4% to €2.2bn but organic fell 3.4%. Merck said it remains on track to acquire Bio-Techne, pending approvals, expected end-2026/early-2027.

Merck & Co (MSD) and Gilead Sciences ended the Phase III KEYNOTE-D46/EVOKE-03 trial in frontline PD-L1-expressing NSCLC after an external data monitoring committee projected the Trodelvy (sacituzumab govitecan) plus Keytruda (pembrolizumab) would not significantly improve overall survival versus Keytruda alone. Trodelvy-Keytruda showed nonsignificant PFS benefit and no new safety issues. Trodelvy Q2 2026 sales rose 26% to $457m.

The FDA approved Merck & Co’s oral cholesterol drug Lipfendra (enlicitide), a PCSK9 inhibitor, to lower LDL-C in patients whose statins do not reduce levels enough. Merck says it is the first oral PCSK9 inhibitor and an alternative to injected PCSK9 antibodies, which include Regeneron’s Praluent and Amgen’s Repatha.

Merck & Co. reported Q2 2026 progress on its strategy to maximize KEYTRUDA and diversify into immunology and cardiometabolic areas, citing earlier-than-expected clinical milestones and 13 earlier-stage KEYTRUDA indications. Full-year revenue guidance was raised and narrowed to $66.3B-$67.3B. GAAP results were hit by a $5.7B non-tax deductible Terns charge; gross margin guidance is ~81%.