Merck & Co (MRK) Investor update summary

Oncology strategy and pipeline progress

• Focus on sustaining leadership in oncology by maximizing KEYTRUDA's impact, especially in earlier disease stages, and diversifying the pipeline with novel mechanisms of action.

• Achieved goal of shifting 25% of KEYTRUDA sales to earlier-stage indications by 2025, with 11 FDA-approved earlier-stage indications and six showing overall survival benefit.

• Pipeline includes approximately 60 phase III oncology trials, with 40 involving novel candidates such as ADCs, T-cell engagers, small molecules, and individualized neoantigen therapies.

• Three pillars guide development: immuno-oncology, precision molecular targeting, and tissue targeting (notably ADCs).

• Emphasis on developing agents with single-agent activity and combinability, supported by a robust biomarker strategy to optimize therapeutic index.

Key clinical data and portfolio highlights

• sac-TMT, a Trop-2 ADC, demonstrated significant PFS improvement in combination with pembrolizumab in non-small cell lung cancer and is the first Trop-2 ADC to show OS benefit in endometrial cancer.

• MK-2010, a PD-1/VEGF bispecific antibody, showed a 55% objective response rate in first-line PD-L1+ NSCLC and is being developed for use as monotherapy and in combinations.

• Multiple positive readouts in breast and lung cancer increase confidence in ongoing global Phase 3 TroFuse studies.

• Acquisition of Terns Pharmaceuticals adds TERN-701, a selective BCR-ABL TKI for CML, to the hematology portfolio, which now includes five assets targeting various hematologic malignancies.

• Upcoming readouts include TroFuse-005 in endometrial cancer and iDXd in small cell lung cancer, with a steady cadence of data expected through 2029.

Commercial outlook and market expansion

• Oncology products have reached over 4.2 million patients globally, with approvals in 58 indications across 25 tumor types.

• KEYTRUDA's revenue from women's cancers and GU is expected to reach about 50% by 2028, driven by new indications and strong adoption of KEYTRUDA QLEX (subcutaneous formulation).

• KEYTRUDA QLEX adoption is accelerating, with 65% of patients preferring it over IV administration; global peak adoption projected at 30%-40% by end of 2027.

• WELIREG is poised for growth with upcoming PDUFA dates for new RCC indications, and ifinatamab deruxtecan (iDXd) is under priority review for small cell lung cancer.

• Late-stage pipeline projected to offer over $25 billion in commercial opportunity by the mid-2030s, with plans to launch 40 new products across 80+ indications and 14 new product approvals targeted.