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Merck & Co., Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 4 August 2026: press release. Guidance figures: 4 raised, 2 lowered, 1 kept. The quarter’s numbers.

Key takeaways

  • Sales rose 5% to $16.6 billion: Total worldwide sales were $16.6 billion, up 5% (4% ex-FX) from $15.8 billion a year earlier. Pharmaceutical sales were $14.8 billion, up 5%. Source
  • Terns charge drove the quarter's loss: GAAP loss per share was $0.54 and non-GAAP loss per share was $0.13. Both include a $2.31 per share charge for the Terns acquisition. Prior-year GAAP EPS was $1.76. Source
  • Full-year EPS range reset by charges: Full-year non-GAAP EPS range is now $2.66 to $2.76, down from $5.04 to $5.16. The range includes one-time charges for the Cidara and Terns acquisitions. Source
  • LIPFENDRA approved as oral PCSK9 inhibitor: FDA approved LIPFENDRA in July for adults with hypercholesterolemia. Two Phase 3 trials showed placebo-adjusted LDL-C reductions of 56% and 59% at week 24. Source
  • KEYTRUDA with WELIREG approved in kidney cancer: The adjuvant approval for certain clear cell renal cell carcinoma patients is the first approved combination of a PD-1 and a hypoxia-inducible factor-2 alpha inhibitor for these patients. Source
  • Sac-TMT met endpoints in endometrial cancer: TroFuse-005 met overall survival and progression-free survival endpoints in advanced or recurrent endometrial cancer. It is the first Phase 3 result from a program of 17 ongoing trials. Source
  • Tulisokibart SSc-ILD study stopped: The Phase 2 study in systemic sclerosis-associated interstitial lung disease will be discontinued. The hidradenitis suppurativa Phase 2 study met its primary and key secondary endpoints. Source

“The FDA approval of LIPFENDRA is an exciting moment for our company and for patients, marking the latest milestone in our nearly 70-year legacy in cardiovascular disease.”

Robert M. Davis, chairman and chief executive officer

Guidance

AreaPeriodFigureAgainst last quarter
Worldwide sales SourceFull year 2026$66.3 billion to $67.3 billionRaised from $65.8 billion to $67.0 billion
Non-GAAP EPS SourceFull year 2026$2.66 to $2.76Lowered from $5.04 to $5.16
Non-GAAP gross margin SourceFull year 2026Approximately 81%Lowered from Approximately 82%
Non-GAAP operating expenses SourceFull year 2026$42.0 billion to $42.7 billionRaised from $36.0 billion to $36.8 billion
Non-GAAP other (income) expense, net SourceFull year 2026Approximately $1.4 billion expenseRaised from Approximately $1.3 billion expense
Non-GAAP effective income tax rate SourceFull year 202635.0% to 36.0%Raised from 23.5% to 24.5%
Share count (assuming dilution) SourceFull year 2026Approximately 2.48 billionKept

What changed from last quarter

  • Guidance raised: Full-year sales range raised to $66.3 billion to $67.3 billion from $65.8 billion to $67.0 billion. Source
  • Guidance lowered: Full-year non-GAAP EPS range lowered to $2.66 to $2.76 from $5.04 to $5.16. Source
  • Guidance lowered: Full-year non-GAAP gross margin expected at approximately 81%, down from approximately 82%. Source
  • Guidance raised: Full-year non-GAAP operating expense range raised to $42.0 billion to $42.7 billion from $36.0 billion to $36.8 billion. Source
  • Guidance raised: Full-year non-GAAP effective tax rate range raised to 35.0% to 36.0% from 23.5% to 24.5%. Source
  • New: Terns acquisition completed for $6.8 billion, adding MK-4208 to the hematology pipeline. Source
  • New: FDA approved LIPFENDRA (enlicitide) for adults with hypercholesterolemia in July. Source
  • Ended: Tulisokibart Phase 2 study in systemic sclerosis-associated interstitial lung disease will be discontinued. Source

Results and growth drivers

  • Sales rose 5% to $16.6 billion: Total worldwide sales were $16.6 billion, up 5% (4% ex-FX) from $15.8 billion a year earlier. Pharmaceutical sales were $14.8 billion, up 5%. Source
  • Terns charge drove the quarter's loss: GAAP loss per share was $0.54 and non-GAAP loss per share was $0.13. Both include a $2.31 per share charge for the Terns acquisition. Prior-year GAAP EPS was $1.76. Source
  • Full-year EPS range reset by charges: Full-year non-GAAP EPS range is now $2.66 to $2.76, down from $5.04 to $5.16. The range includes one-time charges for the Cidara and Terns acquisitions. Source

Segments and regions

  • Animal Health sales up 8%: Animal Health sales were $1.8 billion, up 8% (5% ex-FX). Livestock rose 8% to $1,041 million and Companion Animal rose 7% to $734 million. BRAVECTO sales were $359 million. Source
  • Oncology and cardiometabolic lifted pharma: Pharmaceutical sales rose 5% to $14.8 billion, driven by oncology, cardiometabolic and respiratory products. Diabetes declined. Source
  • WINREVAIR growth from international launches: WINREVAIR sales were $588 million, up 75%. Growth reflected continued U.S. uptake and early launch uptake in Japan and Europe. Source

“I am confident in the ongoing execution of our strategy as we deliver for patients and further enhance our long-term growth trajectory.”

Robert M. Davis, chairman and chief executive officer

Products and customers

  • KEYTRUDA growth from earlier-stage uses: KEYTRUDA and KEYTRUDA QLEX sales were $8.4 billion, up 5%, including $463 million of KEYTRUDA QLEX. Growth came from earlier-stage indications. Source
  • GARDASIL rose on Asia Pacific and Europe: GARDASIL/GARDASIL 9 sales were $1,169 million, up 4% (3% ex-FX). Lower demand in certain other international markets partly offset the gain. Source
  • JANUVIA fell on competition and generics: JANUVIA/JANUMET sales declined 31%. The company cites U.S. competition and ongoing generic competition in China and other markets. Source
  • VAXNEUVANCE declined on competitive pressure: VAXNEUVANCE sales were $148 million, down 35%. The decline also reflects favorable prior-period U.S. public-sector activity. Source
  • WELIREG up 67% on U.S. demand: WELIREG sales were $271 million, up 67%. Growth included higher U.S. demand, launch uptake in Japan and favorable U.S. wholesaler purchasing. Source
  • OHTUVAYRE sales from Verona acquisition: OHTUVAYRE sales were $204 million. The product came from the October 2025 Verona acquisition. Sales include a benefit from timing of U.S. specialty pharmacy purchases. Source

Pipeline and regulatory milestones

  • LIPFENDRA approved as oral PCSK9 inhibitor: FDA approved LIPFENDRA in July for adults with hypercholesterolemia. Two Phase 3 trials showed placebo-adjusted LDL-C reductions of 56% and 59% at week 24. Source
  • KEYTRUDA with WELIREG approved in kidney cancer: The adjuvant approval for certain clear cell renal cell carcinoma patients is the first approved combination of a PD-1 and a hypoxia-inducible factor-2 alpha inhibitor for these patients. Source
  • Sac-TMT met endpoints in endometrial cancer: TroFuse-005 met overall survival and progression-free survival endpoints in advanced or recurrent endometrial cancer. It is the first Phase 3 result from a program of 17 ongoing trials. Source
  • Tulisokibart SSc-ILD study stopped: The Phase 2 study in systemic sclerosis-associated interstitial lung disease will be discontinued. The hidradenitis suppurativa Phase 2 study met its primary and key secondary endpoints. Source
  • Once-weekly oral HIV regimen Phase 3 data: Phase 3 results for islatravir/lenacapavir, developed with Gilead, maintained virological suppression in adults who switched antiretroviral therapy. Source
  • Calderasib granted breakthrough designation: FDA granted Breakthrough Therapy designation to calderasib (MK-1084) with KEYTRUDA for first-line advanced KRAS G12C-mutated NSCLC with PD-L1 TPS of 1% or more. Source

Costs, margins and EPS

  • Non-GAAP gross margin fell to 81.1%: Non-GAAP gross margin was 81.1%, down from 82.2%. The decline was attributed to higher inventory write-downs. GAAP gross margin was 73.5%. Source
  • R&D rose on Terns charge: R&D expense was $9.7 billion, against $4.0 billion a year earlier. A $200 million reduction from the Blackstone funding agreement offset part of the increase. Source
  • SG&A up 10% on IT and launches: SG&A expense was $2.9 billion, up 10%. The increase reflects higher administrative costs, including IT investment, and higher promotional costs for launches. Source
  • Tax rate shaped by Terns charge: The GAAP effective tax rate was (95.9)%. The non-GAAP rate was 160.3%, and the company notes the Terns charge had no tax benefit recorded. Source
  • Other expense higher on interest: Non-GAAP other expense was $290 million, against $54 million a year earlier. The company attributes the increase mainly to higher net interest expense. Source

Capital and business development

  • MK-4208 added to hematology pipeline: MK-4208 is an oral BCR::ABL1 inhibitor in development for certain adults with Philadelphia chromosome-positive chronic myeloid leukemia. It was recently granted Breakthrough Therapy designation. Source

Vaccines and demand trends

  • CAPVAXIVE up 42% on launches: CAPVAXIVE sales were $184 million, up 42%. Growth came from launches in Asia Pacific and Europe and from U.S. uptake. Source
  • U.S. demand lower for measles vaccines: PROQUAD, M-M-R II and VARIVAX sales were $592 million, down 3%. The company cites lower U.S. demand, partly offset by higher U.S. net pricing. Source
  • LAGEVRIO sales fell 95%: LAGEVRIO sales were $5 million, against $83 million a year earlier. The company cites lower demand in Japan and the U.S. Source

Strategy and access programs

  • Alimatravir access plans announced: The company announced initial access plans for alimatravir (MK-8527), an investigational once-monthly oral PrEP in Phase 3. The strategy covers low- and middle-income countries. Source
  • New HIV access agreement signed: The company announced a new agreement with the AIDS Drug Assistance Program Crisis Task Force to improve access and care for people living with HIV. Source
  • ENFLONSIA approved in Japan and China: Regulatory approvals in Japan and China cover ENFLONSIA for prevention of RSV lower respiratory tract disease in newborns and infants in their first RSV season. Source

Coming up, as management said on 4 August 2026

  • Full tulisokibart HS results to follow: Full results from the hidradenitis suppurativa Phase 2 study will be presented at an upcoming medical meeting. No date is given. Source
  • Alimatravir access strategy if approved: The company's multi-faceted strategy aims to enable access to alimatravir in low- and middle-income countries, subject to approval. Source

Figures management reported

FigureReported
KEYTRUDA/KEYTRUDA QLEX sales Source$8.4 billion, up 5%
WINREVAIR sales Source$588 million, up 75%
GARDASIL/GARDASIL 9 sales Source$1,169 million, up 4%
FDA approval SourceLIPFENDRA (enlicitide)
Phase 3 readout SourceTroFuse-005 met OS and PFS primary endpoints
Phase 2 readout SourceTulisokibart HS met primary endpoint; SSc-ILD did not
R&D spend (non-GAAP) Source$9.7 billion
Generic competition SourceJANUVIA/JANUMET sales down 31%

Risks management discussed

  • Financial: The Terns charge carries no tax benefit, which raised the GAAP and non-GAAP effective tax rates in the quarter. Source
  • Financial: Other expense rose on higher net interest expense, partly offset by investment income. Source
  • External: JANUVIA/JANUMET faces U.S. competition and ongoing generic competition in China and other markets. Source
  • Demand: VAXNEUVANCE demand fell in the U.S. and most international markets due to competitive pressure. Source
  • Operational: Gross margin was reduced by higher amortization of intangible assets and inventory write-downs. A Phase 2 tulisokibart study did not meet its primary endpoint. Source

Earlier plans management reported on

  • Not stated: The second-quarter release reports the acquisition completed but gives no close date. The reported charges were $5.7 billion in R&D and $2.31 per share.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.