Merck continues to estimate that its current and potential new growth drivers represent more than $70 billion of non-risk-adjusted annual sales opportunity by the mid-2030s as the pharmaceutical company works to diversify its portfolio and advance a broad group of newer medicines.
The company’s Q2 presentation shows an increasingly clinically derisked pipeline spanning products and programs including enlicitide, remigromig, tulisokibart, islatravir/lenacapavir, MK-1406, sacituzumab tirumotecan and ifinatamab deruxtecan.
Merck reported $16.6 billion of worldwide Q2 sales, up 5% on a reported basis and 4% excluding foreign exchange. Management highlighted strength in Oncology and Animal Health along with increasing contributions from newer launches.
The quarter included several important pipeline and regulatory milestones. Merck received additional approvals involving KEYTRUDA and KEYTRUDA QLEX, announced positive topline results for sacituzumab tirumotecan in certain patients with advanced or recurrent endometrial cancer, and reported positive topline results for tulisokibart from the Phase 3 ATLAS-UC induction study.
Merck also secured FDA approval for LIPFENDRA, which it describes as the first and only approved oral PCSK9 inhibitor. The drug is approved to reduce LDL cholesterol in adults with hypercholesterolemia, while Merck continues evaluating fixed-dose combinations with rosuvastatin and its Lp(a) program, MK-7262.
In HIV, Merck and Gilead reported positive Phase 3 results for islatravir/lenacapavir in adults with virologically suppressed HIV. The companies are developing the regimen as a potential first once-weekly oral treatment option. Merck is also advancing islatravir plus ulonivirine toward Phase 3 development.
The portfolio investment is producing substantial near-term accounting effects. Q2 GAAP operating expenses increased to $12.6 billion from $6.7 billion, largely reflecting a $5.7 billion charge associated with Merck’s acquisition of Terns. GAAP loss per share was $0.54 compared with earnings of $1.76 per share a year earlier.
