NEW YORK — Merck & Co. (MRK) reported second-quarter revenue of $16.607 billion on Monday, up 5 percent from a year earlier, and simultaneously disclosed that the Food and Drug Administration had approved LIPFENDRA, its once-daily oral PCSK9 inhibitor, the first pill of its class cleared for patients with persistently high LDL cholesterol.
The two events converged on the same trading day, offering investors and patients a simultaneous view of the pharmaceutical direction Merck has been building toward through a multibillion-dollar acquisition campaign launched in late 2025. For patients who have relied on injectable alternatives such as Amgen’s Repatha or Sanofi’s Praluent to manage coronary risk, LIPFENDRA represents an oral once-daily option the company says reduces low-density lipoprotein cholesterol by 56 to 59 percent in clinical testing.
The financial results carried a more complicated picture. Merck reported a GAAP net loss of $0.54 per diluted share in the quarter, against earnings of $1.76 in the year-ago period. The reversal was driven principally by a $5.7 billion research and development charge tied to its $6.8 billion acquisition of Terns Pharmaceuticals, completed in the quarter. Terns’s principal asset is MK-4208, an oral BCR-ABL1 inhibitor with FDA Breakthrough Therapy designation for chronic myeloid leukemia, a blood cancer where next-generation oral agents are expected to compete with generic first-generation treatments that currently dominate prescribing.
On a non-GAAP basis, Merck reported a loss of $0.13 per diluted share. For the full year, the company raised its revenue guidance to between $66.3 billion and $67.3 billion but simultaneously cut its non-GAAP earnings forecast to between $2.66 and $2.76 per diluted share, from a prior range of $5.04 to $5.16. The company published full details in its second-quarter earnings disclosure filed Monday with the Securities and Exchange Commission.
Keytruda, the company’s flagship cancer immunotherapy and the world’s best-selling drug, posted $8.366 billion in second-quarter sales, up 5 percent from a year earlier and representing more than half of total company revenue. Winrevair, a pulmonary arterial hypertension treatment approved in 2025, generated $588 million at a 75 percent growth rate. Gardasil, the human papillomavirus vaccine, contributed $1.169 billion, a 4 percent increase. Januvia and Janumet, Merck’s diabetes franchise, continued to decline; combined sales of $429 million reflected a 31 percent drop driven by generics and shrinking physician preference for older-generation glucose-lowering agents.
Chief executive Robert Davis described the quarter as reflecting “strong execution and growing contributions from new product launches.” The framing is calibrated. Keytruda’s dominance remains both the company’s greatest asset and its most pressing long-term constraint; the drug’s patent protections begin to erode after 2028, and Merck’s acquisition strategy has been premised on the need to build parallel revenue streams before that erosion becomes a financial problem. Winrevair’s 75 percent growth and the LIPFENDRA clearance are the most visible early evidence that the strategy is generating results.
A second acquisition completed in the quarter added further charges. Merck’s purchase of Cidara Therapeutics contributed a $3.62 per diluted share hit to reported earnings. Cidara’s pipeline concentrates on antifungal treatments, a therapeutic area where drug-resistant infections have created demand for novel compounds beyond existing standards of care. Taken together, the Terns and Cidara acquisitions reduced Merck’s reported per-share GAAP earnings by roughly six dollars in the quarter, a charge load that management framed as front-loaded investment against a clearer pipeline than the company held a year ago.
Merck’s acquisition campaign sits alongside a broader wave of pharmaceutical consolidation. Goldman Sachs data showed hedge fund healthcare bets reached a five-year high this summer, and GlaxoSmithKline‘s $10.6 billion acquisition of Nuvalent in June underscored that cancer-focused deals have found willing sellers and buyers. Merck KGaA, the German pharmaceuticals group not affiliated with Merck & Co., separately committed $11.3 billion to acquire life sciences tools company Bio-Techne, extending the sector’s pattern of large-scale consolidation into adjacent markets.
For Merck & Co., the second half of 2026 will produce the first commercial evidence on whether LIPFENDRA can penetrate a cholesterol market where injectable PCSK9 inhibitors have been available for years. Convenience is the drug’s principal argument; the clinical LDL-reduction data are competitive, but converting patients and prescribers who have established routines around biweekly or monthly injections requires a different kind of commercial execution than winning a clinical trial. The same question applies to MK-4208 in chronic myeloid leukemia, where generic imatinib and dasatinib have driven per-treatment costs low enough that any novel oral agent needs to demonstrate clear superiority in tolerability or resistance profiles to justify its price. Whether Monday’s FDA clearance and revenue beat represent the beginning of a durable new cycle for Merck or an unusually concentrated quarter of positive news will depend on what those markets look like by December.
