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| Period | What was disclosed | |
|---|---|---|
| FY 2024. China sales | 4Q25 earnings presentation | $3.5 billion of Gardasil in China. Worldwide Gardasil in the FY 2025 product table was $8,583 million. Merck did not print an ex-China Gardasil remainder as its own line. |
| Q4 2024. China sales | 4Q25 earnings presentation | $0.4 billion of Gardasil in China. Worldwide Gardasil that quarter was $1,550 million. |
| FY 2025. China sales | 4Q25 earnings presentation | $0.2 billion of Gardasil in China. Worldwide Gardasil was $5,233 million (down 39%). |
| Q4 2025. China sales | 4Q25 earnings presentation | There were no sales of Gardasil in China in 4Q25. Printed as none, not estimated. Worldwide Gardasil that quarter was $1,031 million. |
| Feb 2025. Zhifei shipment pause | FY 2025 Form 10-K MD&A | Above-normal inventory at Zhifei. Merck paused shipments to China beginning February 2025 and, from mid-2025, determined it would make no further 2025 shipments. Will not resume until inventory returns to normal. Timing not predicted. |
| FY 2026 outlook. China | FY 2025 Form 10-K | Sales of Gardasil/Gardasil 9 in China are not expected to increase materially in 2026. Q1 and Q2 2026 decks cite lower China demand but do not reprint a China dollar figure. |
| Period | Program | Printed status |
|---|---|---|
| FY 2025. Phase 3 count | Company-wide late stage | Approximately 80 Phase 3 studies underway. 18 positive Phase 3 trial results announced in 2025. 21 new Phase 3 studies began enrolling. Count is approximate as printed. |
| Q2 2026. LIPFENDRA (enlicitide, MK-0616) | Oral PCSK9 inhibitor. Hypercholesterolemia | FDA approved as the first oral PCSK9 inhibitor (Q2 2026 release). EU remains under review as of the 4 Aug 2026 pipeline chart. 10-K: Phase 3 entry August 2023. CORALreef Outcomes cardiovascular outcomes trial still ongoing per the Q2 deck. |
| Q2 2026. IDVYNSO (doravirine plus islatravir, MK-8591A) | HIV-1, virologically suppressed adults | US FDA approval reported with Q1 2026 results. Q2 2026 deck: access and reimbursement after launches in the US and Japan. EU still under review as of 4 Aug 2026. 10-K PDUFA was 28 Apr 2026. |
| Q2 2026. WINREVAIR HYPERION | PAH label update (US) | sBLA based on Phase 3 HYPERION. 10-K and Q2 2026 deck: FDA PDUFA 21 Sep 2026. Distinct from the already-marketed PAH indication. CADENCE Phase 2 in CpcPH-HFpEF met its primary endpoint; Phase 3 intended, not started as a printed Phase 3 row. |
| Q2 2026. sac-TMT (MK-2870) TroFuse-005 | TROP2 ADC with Kelun-Biotech. Endometrial cancer | Phase 3 TroFuse-005 met primary endpoints of OS and PFS after platinum and anti-PD-1/L1. Q2 deck: first TROP2 ADC to improve OS and PFS versus chemotherapy in that setting, and first positive readout from 17 global Phase 3 TroFuse studies. Other TroFuse indications remain in Phase 3 on the pipeline chart. |
| Q2 2026. tulisokibart (MK-7240) ATLAS-UC | TL1A antibody. Ulcerative colitis | Phase 3 ATLAS-UC induction-only study (Study 2) met primary and key secondary endpoints in moderately to severely active UC. Q2 deck: first anti-TL1A monoclonal antibody with a positive Phase 3 result. Crohn's disease remains Phase 3 on the 10-K chart (entry June 2024). |
| Q2 2026. KEYTRUDA earlier-stage regimens | KEYTRUDA and KEYTRUDA QLEX | Q2 2026 deck: 13 KEYTRUDA-based regimens approved in earlier-stage cancer after LITESPARK-022 (KEYTRUDA or QLEX plus WELIREG, adjuvant ccRCC) and KEYNOTE-B15 (plus Padcev, perioperative MIBC including cisplatin-eligible). KEYNOTE-D19/ASCENT-04: plus Trodelvy, first-line PD-L1-positive advanced TNBC. Not a patients-treated figure. |
| Q2 2026. calderasib (MK-1084) | Oral KRAS G12C inhibitor, with KEYTRUDA | FDA Breakthrough Therapy designation for first-line advanced or metastatic KRAS G12C-mutant NSCLC with PD-L1 TPS at least 1%, in combination with KEYTRUDA. 10-K: Phase 3 NSCLC entry May 2024 and colorectal July 2025. |
| Q2 2026. ifinatamab deruxtecan (MK-2400) | B7-H3 ADC with Daiichi Sankyo. ES-SCLC | Under regulatory review in the US for previously treated extensive-stage SCLC as of 4 Aug 2026. 10-K Phase 3 entries: SCLC July 2024, esophageal March 2025, prostate May 2025. |
| Q2 2026. MK-8527 (alimatravir) PrEP | HIV-1 pre-exposure prophylaxis | Phase 3 as of both the 20 Feb 2026 10-K chart (entry July 2025) and the 4 Aug 2026 presentation. Not approved. Distinct from IDVYNSO treatment. |
| Q2 2026. intismeran autogene (V940) | Individualized mRNA neoantigen therapy with Moderna | ASCO 2026: five-year Phase 2b KEYNOTE-942 follow-up with KEYTRUDA in resected stage III/IV melanoma. 10-K Phase 3: melanoma July 2023, NSCLC December 2023. Not a commercial product. |
George Merck establishes Merck & Co. in the United States. Distinct from German Merck KGaA. Vaccines (Gardasil, pneumococcal, MMR-V) are a US-company franchise.
FDA licenses Gardasil (quadrivalent HPV) on 8 Jun 2006. Gardasil 9 follows. This is the cash cow that China destock later breaks.
FDA approves Enflonsia (clesrovimab), second infant RSV mAb. The June 2025 ACIP vote is later stayed with other post-June ACIP actions.
Vaccines $10.711B. Gardasil $5.233B (-39%) on China destock. Capvaxive $759M in its first full year. Intismeran autogene with Moderna still the oncology option.