Merck & Co., Inc. (MRK)

Merck, known as MSD outside the United States and Canada, reports its third-quarter 2026 results on 29 October, with a call for analysts at 9:00 in the morning, Eastern time 9. Its last reported quarter, the second, brought sales of $16.6 billion, up 5 percent, with Keytruda, its cancer immunotherapy, at $8.4 billion 1. It still reported a loss of $0.54 a share, because buying Terns Pharmaceuticals, a cancer drug developer, brought a one-time charge of $5.7 billion 1.

This month brought two large trial results at the ESMO cancer congress 78. Merck and Moderna reported that their personalized mRNA vaccine, intismeran, added to Keytruda cut the risk of melanoma returning or death by 42 percent against Keytruda alone 7. Merck's own sac-TMT, a targeted chemotherapy, cut the risk of death by 32 percent in advanced endometrial cancer, and the FDA set a decision date of 15 June 2027 8.

The open question is how much of Keytruda these launches can replace: it made 49 percent of 2025 sales, and the company expects biosimilar copies from December 2028 3. In August it raised its 2026 sales outlook to between $66.3 billion and $67.3 billion 1.

Keytruda, approved for more and more cancers, became the main source of Merck's growth 6. In 2019 worldwide sales rose 11 percent to $46.8 billion, and Keytruda's own sales grew 55 percent to $11.1 billion, with lung cancer leading its U.S. growth 6.

On 2 June 2021 Merck split off its women's health, biosimilars and older established brands into a separate listed company, Organon 5. What stayed grew 17 percent that year to $48.7 billion, helped by molnupiravir, an oral COVID-19 pill later sold as Lagevrio 54. In November it paid $11.5 billion for Acceleron, whose drug sotatercept became the lung blood pressure medicine Winrevair 53.

The pandemic pill lifted sales to $59.3 billion in 2022, when Lagevrio alone sold $5.7 billion 4. As COVID-19 faded, Lagevrio fell to $1.4 billion and total sales grew only 1 percent to $60.1 billion in 2023 4.

That year Merck paid $11.0 billion for Prometheus Biosciences and its bowel disease drug tulisokibart, booking a $10.2 billion research charge because the drug was still in trials 3. The charge cut net income to $365 million for 2023 3. In 2023 Keytruda and Gardasil together made 56 percent of sales, which shows how narrow the base had become 4.

Two launches began to fill gaps: Winrevair sold $419 million in 2024, its first year, and $1.4 billion in 2025, while the adult pneumonia vaccine Capvaxive rose from $97 million to $759 million 3. Older revenue faded as Merck's marketing rights to some immunology products ended in 2024 3.

Sales rose 7 percent to $64.2 billion in 2024, but a problem was building in China 3. From mid-2024 Merck's partner there, Chongqing Zhifei, shipped fewer Gardasil doses to vaccination points, and stock piled up in its warehouses 3.

Merck paused shipments to China in February 2025, and worldwide Gardasil sales fell 39 percent that year to $5.2 billion 3. Sales in China dropped from $5.5 billion to $1.9 billion 3. Keytruda, at $31.7 billion, still carried total sales to $65.0 billion, up 1 percent 3.

To refill its line of medicines, Merck bought Verona Pharma for $10.4 billion in October 2025, gaining the lung medicine Ohtuvayre 3. It then bought Cidara Therapeutics for about $9.2 billion in January 2026, for a long-acting flu preventive 3. Terns followed in May 2026 for $6.8 billion 2.

Profit recovered to $18.3 billion, yet the 2025 annual report stresses how much rests on one medicine whose main U.S. patent runs out in 2028 3. The deals are the company's answer to that clock, bought before the copies arrive 3.

Keytruda and Keytruda Qlex

Keytruda is an antibody that helps the immune system find and attack cancer cells, approved in the U.S. for over 45 uses across 19 tumor types 2. Second-quarter sales grew 5 percent to $8.4 billion, driven by earlier-stage uses in breast, cervical, head and neck and bladder cancer 1. Keytruda Qlex, the same drug given as a shot under the skin, sold $463 million of that 1.

Qlex takes one or two minutes instead of a half-hour infusion, BioPharma Dive reported 13. Alicia Heesen, a consultant at Managed Markets Insight and Technology, told the outlet that Merck expects about 30 to 40 percent of patients to switch 13.

Rivals are closing in: Summit Therapeutics and Akeso's ivonescimab beat Keytruda in a late-stage lung cancer study in China in September 2024, BioSpace reported 14.

Vaccines

Gardasil, which protects against the virus behind cervical and other cancers, sold $1.2 billion in the second quarter, up 4 percent on demand in Asia Pacific and Europe 1. In China, Merck signed a revised contract with Zhifei in April 2026 and began limited shipments, but expects the revenue to be immaterial this year 2.

Capvaxive, a pneumococcal vaccine against pneumonia, sold $184 million, up 42 percent, while the older Vaxneuvance fell 35 percent, partly under competitive pressure 1. Enflonsia, an antibody shot that shields babies from the respiratory virus RSV, has an FDA decision due on 22 March 2027 for a second season in children at higher risk 22.

Heart, lung and cholesterol medicines

Winrevair treats pulmonary arterial hypertension, high blood pressure in the arteries of the lungs, and its second-quarter sales rose 75 percent to $588 million 13. Ohtuvayre, an inhaled maintenance treatment for the chronic lung disease COPD, added $204 million 13.

Lipfendra, approved by the FDA in July, is the first pill among the PCSK9 inhibitors, drugs that lower LDL, the bad cholesterol 11. In two trials it cut LDL by 56 and 59 percent against a placebo at week 24 11. Merck lists a bottle of 30 tablets at $315 before discounts 24.

Writing for Harvard Health, Julie Corliss said it lowers LDL by nearly 60 percent, similar to the injected drugs of its class 12. She put a month's supply at about $300, with insurance coverage still unclear 12.

Other cancer medicines

Welireg, a pill for certain kidney tumors, grew 67 percent to $271 million in the quarter 1. Merck also books its share of profit on two partnered drugs, Lynparza, shared with AstraZeneca, and Lenvima, which together brought $648 million (computed) 13. In September an application for ifinatamab deruxtecan, a lung cancer drug shared with Daiichi Sankyo, was withdrawn after the FDA said the data fell short 21.

Older medicines losing protection

Januvia and Janumet, diabetes pills, lost U.S. market exclusivity in May 2026, and their sales fell 31 percent to $429 million in the quarter 21. Bridion, which reverses muscle relaxants used in surgery, lost U.S. exclusivity in July 2026, and Merck expects to stop selling it in the U.S. in 2027 2.

Animal Health

Merck Animal Health sold $1.8 billion in the second quarter, up 8 percent, from both farm animal and pet products 1. Bravecto, a flea and tick treatment for dogs and cats, made $359 million of it 1. The unit also sells Allflex tags and systems that identify, track and monitor livestock 3.

Plants and people

Merck is based in Rahway, New Jersey, with main research sites in New Jersey, Pennsylvania, Massachusetts, California and Nebraska, and abroad in Britain, Switzerland and China 3. It employed about 75,000 people at the end of 2025, some 30,000 of them in the U.S. 3. In October it opened ADVANCE, a $550 million research lab on its 400-acre West Point campus in Pennsylvania 20.

Robert Davis has been chief executive since July 2021 and chairman since December 2022 3. Caroline Litchfield is finance chief and Dean Li runs Merck Research Laboratories 3. Paul Diaz, a former Myriad Genetics chief executive, joins the board on 1 November, taking it to 14 members 15.

Problems: prices, patents and courts

Since 1 January 2026 the U.S. government sets the Medicare price of Januvia under the Inflation Reduction Act, and Janumet follows on 1 January 2027 2. Under a three-year deal with the administration, Merck sells some pills directly to patients, discounts Medicaid and won a three-year delay of Section 232 tariffs 2.

In Germany a court barred sales of the under-the-skin Keytruda after Halozyme claimed a patent on an ingredient, and Merck's appeal is heard on 19 November 2026 2. Shareholders sued in 2025, saying Merck misled them about Gardasil demand in China, and Merck moved to dismiss the case on 1 May 2026 2.

The umbrella, in words

Merck sells human medicines and vaccines under its own brands, and Merck Animal Health sells veterinary products through subsidiaries such as Intervet and the Allflex companies 316. The subsidiaries exhibit lists companies it bought, among them Acceleron, Prometheus Biosciences, Eyebiotech, Harpoon and Verona Pharma 16. Its human medicines come from production sites at five locations in the U.S. and Puerto Rico, with more plants in Western Europe, Africa and Asia 3.

Merck owns 16.5 percent of the common stock of Personalis, Inc., according to its Schedule 13G of December 2024 18. Its venture arm, Merck Global Health Innovation Fund, held 19.96 percent of Evaxion Biotech's American depositary shares as of January 2025 19.

No owner on file controls Merck: its largest reported holder, Vanguard Capital Management, filed for 7.53 percent of the common stock as of 31 March 2026 17.

Merck reports third-quarter 2026 results on 29 October 9. Those results carry a $400 million charge, about $0.13 a share, for licensing SPR2015, an early KRAS G12D cancer pill from SciBrunch 10. The company expects 2026 sales of $66.3 billion to $67.3 billion, an outlook that assumes no further large deals 1.

Blackstone Life Sciences is due to pay Merck $700 million in the fourth quarter of 2026 toward sac-TMT's development costs 2. The FDA's decision on sac-TMT for endometrial cancer is due by 15 June 2027 8. Merck is testing the drug in 18 ongoing global Phase 3 trials 8.

Merck and Moderna say they are engaging with regulators on intismeran, and the melanoma results were accepted by The New England Journal of Medicine 7. The partners run nine trials of it, including three late-stage studies in lung cancer 7. Gilead and Merck plan to file their once-weekly HIV pill, islatravir with lenacapavir, with regulators worldwide 23.

On the patent clock, Merck expects Keytruda biosimilars in the U.S. as early as December 2028, and loss of exclusivity in Europe in 2031 3. It plans about $20 billion of capital projects from 2025 to 2029, more than $12 billion of it in the U.S. 3. Its 2025 restructuring, costing about $3.0 billion, cuts some sales, office and research jobs, with most steps done by the end of 2027 3.

Merck expects Gardasil sales in China not to increase materially in 2026 3. Enflonsia's FDA decision on 22 March 2027 and Lipfendra's large heart outcomes trial, with over 14,500 people enrolled, are the next tests for two launches 2211.

Two outside dates matter too: the German appeal over Keytruda's injectable form on 19 November, and an FDA decision on the rival ivonescimab expected by 14 November, BioSpace reported 214. Paul Diaz stands for election by shareholders in May 2027 15.

Past

Revenue grew from $40 billion in fiscal 2016 to $65 billion in fiscal 2025, up 5.6% a year over ten filed years, and rose in 8 of 9 years. Net income was positive in all ten of those years. The deepest fall was 8% from fiscal 2018 to fiscal 2019. Over the three fiscal years to 2025, the diluted share count shrank about 0.5% a year. Dividends and buybacks returned about 61% of operating cash flow over those three years. In the year to 2026-10-01, its officers and directors filed 35 sales and 0 purchases of their own stock on the open market. 1

Present

In fiscal 2025 ended 2025-12-31, Merck reported revenue of $65 billion and profit of $18 billion. Return on equity was about 35 cents of profit for every dollar of shareholders' money, and gross profitability was about 36 cents per dollar of everything the company owns. It owed about 62 cents per dollar of assets, and its share count shrank 1.3% over the year. Revenue of $65 billion ranks in the top 1% by size among 315 graded names in its industry family; net margin of 28.1% ranks in the top 10%; revenue growth of 3.1% a year over the last three filed years ranks in the bottom 43%. 21

Robert M Davis is Chairman, CEO and President, filing under that title since 2022-02-28, 4.6 years. The 28 officers and directors filing in the last fifteen months have been on the record a median of 6 years. Four officer or director changes were reported on Form 8-K since 2023-10-21. 1

Future

A quarterly report for the quarter ending 2026-09-30 is due by 2026-11-09. The annual report for the fiscal year ending 2026-12-31 is due by 2027-03-01. Cash of $15 billion against debt of $47 billion leaves -23.5% of assets as net cash, in the bottom 7% of its family. Cash from operations less capital spending is 19% of revenue, in the top 14%. Gross margin is 74.8%, in the top 41%; research spending is 24.3% of revenue, in the bottom 30%. 31

Revenue grew 3.1% a year over the last three filed years against 5.6% over all ten, slowing. The newest year grew 1.3%. Research spending grew 5.2% a year; capital spending declined 2.1% a year. 1

How the company operates

Merck reported two lines of business in fiscal 2025: Pharmaceutical segment at $58 billion and Animal Health segment at $6.4 billion. By geography in fiscal 2025, the United States accounted for 56% of revenue, Europe, Middle East and Africa 22%, Latin America 5%, Asia Pacific 5%, Other 4%, Japan 4%, and China 3%. 12

New moves

On 2026-10-15, a Form 25-NSE delisting notice was filed; the exchange is removing a class of securities. On 2026-10-13, a Form 8-K was filed for an officer or director change. On 2026-08-07, a quarterly report was filed for the quarter ended 2026-06-30. 3