Merck & Co.
The maker of Keytruda, the cancer drug that switches the immune system back on: one medicine brings in half its sales, and its US patent ends in 2028.
Our viewNeutral Medium conviction
The scores
The profile · 1-4
Growth2/4 ↑
Sales grew 1.4%, 6.7% and 1.3% in 2023 to 2025, Keytruda's gains offset by Gardasil's 39% fall; Q2 2026 grew 5%.
Business quality3/4 ↓
A legal moat with a published end: the statutory bar expired September 2026, the patent ends 2028, copies and a challenger are in trials.
Financial position3/4 ↓
Net debt of $46.8B, about 2.2 times profit before deal charges, spread to 2056 and covered by operating cash, but rising to fund acquisitions.
Execution record3/4 →
2026 guidance raised, three late-stage wins, two approvals; but 2025 revenue missed the board's target, Gardasil fell in China, I-DXd was withdrawn.
Per share capture4/4 →
Diluted shares fell from 2,547 million in 2023 to 2,470 million, buybacks exceed stock pay, and the 2026 acquisitions were paid in cash and debt.
Potential2/4 ↑
Replacing half of sales needs several new medicines approved and adopted plus a court win for Qlex, much outside Merck's control.
Risk profile2/4 →
Keytruda is 49% of sales, and inside the horizon its defence turns on single rulings: a German appeal, the US Halozyme case and Medicare's selection.
Valuation3/4 ↓
16.7 times this year's profit before deal charges and 14.6 times 2029's forecast pays for the business plus management's hill working, little beyond it.
Evidence quality3/4 →
The regulator's licence record, the statute, cancer statistics and four rivals' filings; the Halozyme case is the counterparty's account, one biosimilar only reported.
The bet · 2-3 years
Safe, little upside0.9×
If it works 0.9× · if it fails you keep about 80%.
The Verdict
We rate Merck neutral. Keytruda is protected and very profitable, but half of sales rests on it and sales barely grew for three years, so the business is mixed. The price is fair: about 17 times this year's profit before deal charges, a normal drug-maker price if losing Keytruda's patent in 2028 is the hill management promises, not a cliff. What holds us back: the under-the-skin version is in court and most replacements are not on sale. As a bet it is safe, with little upside: if the new medicines work the shares are worth about what they cost, and if they fail shareholders keep about four-fifths.
The long caseCancer care keeps adding immune medicines to Keytruda; if Merck's new ones work, they carry the company past the patent date.
The evidence under this - 9 claims
C01facthigh confidence
Keytruda is half the company: it sold $31,641M of Merck's $65,011M in 2025, and Merck's own risk factors put it at 49% of sales.
C04facthigh confidence
Merck's patent table puts Keytruda's US compound patent at 2028, two related patents at 2029 that it expects to be litigated, Europe 2031, Japan 2032-2033 and China 2028.
C13management claimhigh confidence
Merck expects Medicare to select Keytruda for government price-setting in 2027, with the price effective 1 January 2029, and says US Keytruda sales will then decline materially.
against this
- The set price applies to Medicare, not the whole US market, so the decline depends on how far private payers follow it.
- Biosimilar entry from December 2028 would cut the price first, which could make the Medicare-set price less binding than it looks.
C15facthigh confidence
Gardasil, the cervical-cancer vaccine, fell 39% to $5,233M in 2025 after shipments to China were paused from February 2025.
C25inferencehigh confidence
At $145.95 the shares cost 16.7 times that $8.76 and 15.7 times the $9.28 analysts forecast for 2027.
sourceResearch pack for MRK, frozen beside this thesisprimaryMerck second-quarter 2026 results release, Exhibit 99.1 to…primary
against this
- On reported earnings the trailing price is 115.8 times, the dearest in its cohort, because the acquisition charges sit inside those earnings.
- The 2027 consensus is 13 analysts' average and falls to 5 analysts by 2029, so the later years rest on few forecasts.
C27inferencehigh confidence
So the price already assumes Merck's hill: at 14.6 times 2029's forecast, buyers pay a normal drug-maker price for earnings that do not fall.
sourceResearch pack for MRK, frozen beside this thesisprimaryMerck Q2 2026 earnings call, held 4 August 2026primary
against this
- Fourteen times a flat earnings line is cheap for a company whose new medicines succeed, which is the case management makes.
- Bristol, facing the same 2028 date on its own PD-1 drug, is priced at 13.2 times trailing earnings, so the market pays Merck only a little more.
C10facthigh confidence
On 7 October 2026 a Dutch patent court found Halozyme's EP622 patent valid and infringed by Keytruda SC and barred its sale in eight European countries.
against this
- This is Halozyme's account, the counterparty in the case; Merck's 10-Q says it has filed revocation actions against the same patent in seven countries.
- Halozyme consented to revocation of the same patent in the UK in May 2026, so the patent has already been given up in one market.
C24inferencehigh confidence
Adding those charges back gives about $8.85 a share for 2026 at the middle of the range, roughly $21.9B on 2.48 billion shares (it was $8.76 before the October raise).
sourceMerck Form 8-K Exhibit 99.1: third-quarter 2026 results…primaryMerck Form 10-Q, quarter ended 30 June 2026primary
against this
- Merck buys growth by charging acquired research to profit every year, $14.7B of it in 2026, so a figure before the charges describes a business that does not stop paying them.
- About $0.12 of the Terns figure is financing and development cost that will recur, so the add-back slightly flatters the year.
- 2026-10-29editedre-struck on the raised guide of $2.77-$2.82; the multiples in C25 to C27 are still struck on $8.76 and are off by about a fifth of a turn
C32facthigh confidence
In the cohort Bristol trades at 13.2 times trailing earnings, the lowest of the five peers.
The company
Merck makes prescription medicines and vaccines, and one of them dominates. Keytruda is an antibody, given by drip in hospital, that blocks a protein cancer cells use to switch the immune system off. It is approved for over 45 uses in America, one cancer at a time since 2014.
Hospitals and cancer clinics buy it, paid by insurers and Medicare. Without it a patient would get chemotherapy, a rival drug such as Bristol's Opdivo, or, after surgery, simply wait to see whether the cancer returns.
The evidence under this - 6 claims
C01facthigh confidence
Keytruda is half the company: it sold $31,641M of Merck's $65,011M in 2025, and Merck's own risk factors put it at 49% of sales.
C03facthigh confidence
Keytruda is an antibody that blocks PD-1, a brake cancer cells use to switch the immune system off; it is approved in over 45 US uses across 19 tumour types.
C05facthigh confidence
The FDA first licensed Keytruda under BLA 125514 on 4 September 2014, and has recorded 127 submissions on the application since.
C08facthigh confidence
Keytruda Qlex, the under-the-skin version, was first approved by the FDA in September 2025 and carries a US patent to 2043, against 2031 in Europe.
C38facthigh confidence
Researchers estimated the share of US cancer patients eligible for a checkpoint drug like Keytruda rose from 1.54% in 2011 to 43.63% in 2018, and those who respond from 0.14% to 12.46%.
C40facthigh confidence
US cancer-related medical costs were $208.9 billion in 2020, the National Cancer Institute estimated, as the American Cancer Society reports.
How it makes money
Merck sells each dose to a few large wholesalers, who resell it to hospitals and pharmacies; insurers pay most of the bill after rebates. Keytruda brought in half of all sales in 2025.
The rest is spread out: vaccines such as Gardasil, which fell sharply when sales to China stopped, newer drugs such as Winrevair for blood pressure in the lungs, and medicines for pets and farm animals, about a tenth of sales.
The evidence under this - 6 claims
C01facthigh confidence
Keytruda is half the company: it sold $31,641M of Merck's $65,011M in 2025, and Merck's own risk factors put it at 49% of sales.
C02facthigh confidence
In Q2 2026 the Keytruda family sold $8,366M of $16,607M, 50.4% of sales, up 5%; $463M of it was Keytruda Qlex, the version injected under the skin.
C15facthigh confidence
Gardasil, the cervical-cancer vaccine, fell 39% to $5,233M in 2025 after shipments to China were paused from February 2025.
C17facthigh confidence
Winrevair, a lung blood-pressure drug, sold $588M in Q2 2026, up 75%, after $1,443M in 2025.
C47facthigh confidence
Animal Health, Merck's pet and livestock medicines, sold $6,354M in 2025 and $1,775M in Q2 2026, about a tenth of sales.
C41facthigh confidence
Three wholesalers held most of what Merck is owed at the end of 2025: McKesson 22%, Cencora 21% and Cardinal Health 13% of receivables.
Where the money comes from, stream by stream
| Stream | Share of sales (Q2 2026) | How it earns it |
|---|---|---|
| Keytruda and Keytruda Qlex | 50.4% | The cancer immunotherapy, by drip or under the skin, sold to hospitals and clinics through wholesalers. |
| Gardasil and Gardasil 9 | 7.0% | Vaccines against the virus that causes cervical and other cancers, bought by governments, clinics and pharmacies. |
| Winrevair | 3.5% | An injection for high blood pressure in the lungs, prescribed by specialists. |
| Januvia and Janumet | 2.6% | Diabetes pills that lost US exclusivity in May 2026 and now carry a Medicare-set price. |
| Other medicines and vaccines | 25.8% | Welireg, Lynparza and Lenvima with partners, Bridion, Capvaxive, Ohtuvayre and other products, through the same channel. |
| Animal Health | 10.7% | Medicines and vaccines for pets and farm animals, sold to vets and producers. |
Who runs it
Robert Davis, who came to Merck as finance chief in 2014, has run it since 2021. In 2025 sales fell short of the board's own target, and over three years the shares returned far less than rival drug makers', so that half of the share award paid nothing. The bonus rides on sales, profit and research goals; nothing pays on cash or returns on capital. Insiders each own under 1%.
The evidence under this - 3 claims
C50facthigh confidence
Pay rewards revenue and pre-tax profit, 35% each of the annual bonus, plus pipeline goals; share awards pay half on three-year earnings per share and half on return against peers.
C51facthigh confidence
In 2025 Merck missed its own targets: revenue $63.86B against $65.63B, and its three-year return of 0.3% a year against peers' 12.0% paid nothing on that half of the share award.
C52facthigh confidence
Chief executive Robert Davis beneficially owned 1,226,775 shares in February 2026, 769,873 of them options he could exercise; directors and officers each own under 1%, and pledging is banned.
Why it wins, and who could beat it
Why customers come back
What keeps rivals out is the law, not a secret. American law barred any copy of Keytruda for 12 years after the FDA first approved it, and that bar ended in September 2026. Now only Merck's patents remain, and the main one ends in 2028.
Merck's plan is to move patients to Keytruda Qlex, the same medicine injected under the skin in a few minutes, which carries its own patent to 2043.
The evidence under this - 5 claims
C04facthigh confidence
Merck's patent table puts Keytruda's US compound patent at 2028, two related patents at 2029 that it expects to be litigated, Europe 2031, Japan 2032-2033 and China 2028.
C05facthigh confidence
The FDA first licensed Keytruda under BLA 125514 on 4 September 2014, and has recorded 127 submissions on the application since.
C06facthigh confidence
US law bars the FDA from making a biosimilar approval effective until 12 years after the original medicine was first licensed.
C07inferencehigh confidence
So the statutory bar on a copy of Keytruda ended on 4 September 2026; from now on only Merck's patents stand between Keytruda and a biosimilar.
sourceU.S. Food and Drug Administration, openFDA Drugs@FDA records…primary42 U.S.C. 262, regulation of biological products, subsection…primaryMerck Form 10-K, fiscal year ended 31 December 2025primary
against this
- Merck's patents run to 2028 in the US and to 2029 on two related patents, so the expiry of the statutory bar does not by itself allow a launch.
- A biosimilar applicant may also be held back by patents on the manufacturing process or the formulation that the 10-K's compound table does not list.
C08facthigh confidence
Keytruda Qlex, the under-the-skin version, was first approved by the FDA in September 2025 and carries a US patent to 2043, against 2031 in Europe.
The threat
Three kinds of attack are lined up. Amgen and others are testing cheaper copies of Keytruda for 2028. Summit is testing a new antibody directly against Keytruda in lung cancer. And Halozyme, which owns patents on a similar under-the-skin ingredient, has already had Qlex barred in nine European countries, and is suing in America.
The evidence under this - 6 claims
C10facthigh confidence
On 7 October 2026 a Dutch patent court found Halozyme's EP622 patent valid and infringed by Keytruda SC and barred its sale in eight European countries.
against this
- This is Halozyme's account, the counterparty in the case; Merck's 10-Q says it has filed revocation actions against the same patent in seven countries.
- Halozyme consented to revocation of the same patent in the UK in May 2026, so the patent has already been given up in one market.
C11facthigh confidence
In the US Halozyme is suing over 15 patents, while the patent office's appeal board has found every challenged claim unpatentable in the four reviews it has decided.
C33facthigh confidence
Amgen's own annual report lists ABP 234, a proposed copy of Keytruda, in a Phase 3 study for biosimilarity.
C35factmedium confidence
India's Cipla and China's Qilu have partnered to launch a Keytruda biosimilar in the United States, Reuters reported on 3 September 2026.
against this
- The report reached this repository only through a secondary copy, and neither company's filing was found to confirm it.
- No launch date was reported, and Merck's patents run to 2028 in the US regardless of who holds the rights.
C36facthigh confidence
Summit is testing ivonescimab, a drug that blocks PD-1 and a tumour blood supply at once, head-to-head against Keytruda in first-line lung cancer, with results due from late 2026.
C13management claimhigh confidence
Merck expects Medicare to select Keytruda for government price-setting in 2027, with the price effective 1 January 2029, and says US Keytruda sales will then decline materially.
against this
- The set price applies to Medicare, not the whole US market, so the decline depends on how far private payers follow it.
- Biosimilar entry from December 2028 would cut the price first, which could make the Medicare-set price less binding than it looks.
The rivals: BMY, AMGN, ALVO, RDY, SMMT, HALO, NVS, REGN, SNY, PFE, LLY, ABBV, and 1 more that is private, in-house or listed abroad.
Who else does this, rival by rival
| Ticker | Rival | Where it competes | How far along | Priced against it |
|---|---|---|---|---|
| BMY | Bristol-Myers Squibb (Opdivo and Opdivo Qvantig)Priced against it: Yes | Keytruda, Merck's other marketed medicines and Animal Health | On sale | Yes |
| AMGN | Amgen (ABP 234, a proposed Keytruda biosimilar)Priced against it: Yes | Keytruda, Merck's other marketed medicines and Animal Health | Announced | Yes |
| ALVO · RDY | Alvotech with Dr. Reddy's (AVT33)Priced against it: Different product | Keytruda, Merck's other marketed medicines and Animal Health | In research | Different product |
| Cipla with Qilu (a Keytruda biosimilar with US rights)Priced against it: Listed abroad | Keytruda, Merck's other marketed medicines and Animal Health | In research | Listed abroad | |
| SMMT | Summit Therapeutics and Akeso (ivonescimab)Priced against it: Different product | Keytruda, Merck's other marketed medicines and Animal Health | Announced | Different product |
| HALO | Halozyme Therapeutics (patents, not a product)Priced against it: Different product | Keytruda, Merck's other marketed medicines and Animal Health | On sale | Different product |
| AMGN · NVS · REGN · SNY | Amgen's Repatha, Novartis's Leqvio and Regeneron and Sanofi's Praluent (injected cholesterol drugs)Priced against it: Yes | The next wave: medicines launched in 2026 or still in late trials | On sale | Yes |
| PFE | PfizerPriced against it: Yes | - | On sale | Yes |
| LLY | Eli Lilly and CompanyPriced against it: Yes | - | On sale | Yes |
| ABBV | AbbViePriced against it: Yes | - | On sale | Yes |
How big it could get
How big this could get
About 2.1 million Americans will be told they have cancer in 2026, and researchers estimated that by 2018 nearly half of US cancer patients were eligible for a drug like Keytruda, up from almost none in 2011.
Keytruda's American sales come to about $8,900 for every new case. Nobody has measured eligibility since 2018, and the rest of the world, with 20 million new cases a year, pays far less.
The evidence under this - 3 claims
C37facthigh confidence
The American Cancer Society expects about 2.1 million new US cancer cases in 2026 (2,114,850) and 626,140 deaths, and 20 million cases worldwide in 2022 rising to 35 million by 2050.
C38facthigh confidence
Researchers estimated the share of US cancer patients eligible for a checkpoint drug like Keytruda rose from 1.54% in 2011 to 43.63% in 2018, and those who respond from 0.14% to 12.46%.
C39inferencehigh confidence
Keytruda's 2025 US sales of $18,829M against 2.1 million new US cancer cases are about $8,900 a case.
sourceMerck Form 10-K, fiscal year ended 31 December 2025primaryAmerican Cancer Society, Cancer Facts & Figures 2026primary
against this
- Keytruda treats patients diagnosed in earlier years as well, so the per-case figure mixes new and continuing patients.
- Most cancer cases are not eligible for a checkpoint drug, so the spend per eligible patient is several times higher.
Where the growth is coming from, business by business
Where the growth is coming from
| Business | Share of revenue | Growth: last quarter | Last half-year | Last year | Share in 3 years at its half-year rate |
|---|---|---|---|---|---|
| Keytruda, Merck's other marketed medicines and Animal Health | 100% | +5.1% | +5.0% | +4.6% | 100% |
| Whole company | 100% | +5.1% | +5.0% | +4.6% | 100% |
On the filed split through 2026-06-30, if each business keeps its last half-year's growth, the company grows about 5% next year and 5% in year 3, against 4.6% over the last twelve months. A scenario, not a forecast: no business holds its rate.
The results
The numbers
Is it growing?Slow
Sales grew 4.6% over the twelve months to Jun 2026, about the same pace as the 1.3% in the year to Dec 2025.
Is it profitable?Thin
It keeps 4.8% of sales as profit, up from 0.6% in the year to Dec 2023.
What does it keep on each sale?Rich
It keeps 73¢ of each sales dollar after making what it sells, and spends 46¢ of it on research, its biggest running cost.
Does it earn good returns?Low
Shareholders' money earned 7.0% a year, down from 41% in the year to Dec 2021.
Is it making cash?Strong
It turned 24% of sales into free cash, $16.1B over the last twelve months.
Is the balance sheet safe?Heavy debt
It owes $46.8B more than the cash it holds, about 2.3 years of the cash its operations bring in.
Are shares being diluted?Stable
The share count fell 2.7% in 4.5 years, and pay in shares costs 1.3% of sales.
All the numbers
Filed figures from the company's 10-K and 10-Q, read 2026-10-18. Fiscal years end in December.
| Dec 2021 | Dec 2022 | Dec 2023 | Dec 2024 | Dec 2025 | 12 mo to Jun 2026 | |
|---|---|---|---|---|---|---|
| Size and growth | ||||||
| Sales | $48.7B | $59.3B | $60.1B | $64.2B | $65.0B | $66.6B |
| Sales growth | +17% | +22% | +1.4% | +6.7% | +1.3% | +4.6% |
| Profit | ||||||
| Gross margin | 72% | 71% | 73% | 76% | 75% | 73% |
| Net margin | 27% | 24% | 0.6% | 27% | 28% | 4.8% |
| What growth costs, per sales dollar | ||||||
| Research and development | 25% | 23% | 51% | 28% | 24% | 46% |
| Selling, general and admin | 20% | 17% | 17% | 17% | 17% | 17% |
| Pay in shares | 1.0% | 0.9% | 1.1% | 1.2% | 1.3% | 1.3% |
| Capital spending | 9.1% | 7.4% | 6.4% | 5.3% | 6.3% | 5.9% |
| Cash | ||||||
| Cash from operations | $13.1B | $19.1B | $13.0B | $21.5B | $16.5B | $20.0B |
| Free cash flow | $8.67B | $14.7B | $9.14B | $18.1B | $12.4B | $16.1B |
| Balance sheet | ||||||
| Cash and short-term investments | $8.10B | $13.2B | $7.09B | $13.7B | $14.6B | $7.14B |
| Debt | $33.1B | $30.7B | $35.1B | $37.1B | $49.3B | $53.9B |
| Net cash | −$25.0B | −$17.5B | −$28.0B | −$23.4B | −$34.8B | −$46.8B |
| Returns and shares | ||||||
| Shares (diluted) | 2.54B | 2.54B | 2.55B | 2.54B | 2.51B | 2.47B |
What growth costs
Making and selling each medicine costs less per dollar of sales than four years ago, so growing has made Merck more profitable. Research is the cost that jumps, because Merck charges the companies it buys to research in the year it buys them.
The evidence under this - 2 claims
C53inferencehigh confidence
Merck's cost of sales fell from 28.0 to 25.2 cents per dollar of sales from 2021 to 2025 and selling and administration from 19.8 to 16.5, while sales rose 33%.
against this
- Research was 50.8 cents per dollar in 2023 and 45.7 cents in the year to June 2026, because Merck charges acquired research to profit, so the operating line is far less steady than these two.
- 2021 is restated after the Organon spin-off, so the starting point is a smaller company rather than the same one.
C24inferencehigh confidence
Adding those charges back gives about $8.85 a share for 2026 at the middle of the range, roughly $21.9B on 2.48 billion shares (it was $8.76 before the October raise).
sourceMerck Form 8-K Exhibit 99.1: third-quarter 2026 results…primaryMerck Form 10-Q, quarter ended 30 June 2026primary
against this
- Merck buys growth by charging acquired research to profit every year, $14.7B of it in 2026, so a figure before the charges describes a business that does not stop paying them.
- About $0.12 of the Terns figure is financing and development cost that will recur, so the add-back slightly flatters the year.
- 2026-10-29editedre-struck on the raised guide of $2.77-$2.82; the multiples in C25 to C27 are still struck on $8.76 and are off by about a fifth of a turn
The last report (4 Aug)
Quarter ended June 2026, filed figures.
5%
Sales growth
against the same quarter a year earlier
2.0%
Growth from the quarter before
against -0.7% the quarter before that
In the third quarter of 2026 sales rose 5% to $18.1B. Keytruda grew 6% to $8.6B, and its under-the-skin version sold $830M, up from $463M a quarter earlier. Winrevair, the lung-blood-pressure drug, sold $694M, almost double a year ago. About $550M of the growth was customer buying-timing.
Profit per share before some items was $2.49, down 3%, after a $0.12 charge for a licence. Merck narrowed and raised its sales forecast to $66.8B to $67.3B. The FDA also accepted its sac-TMT cancer drug for priority review.
What it did to the thesisIt met all three tests we set and put the injected version well ahead of our line. It did not touch what holds us at Neutral: the price already pays for success, and the court cases over the injected version are unresolved.
The quarter in detail
Sales growth from the previous quarter, filed figures.
Earnings per share $-0.13 against $-0.27 expected; $-0.54 as filed, the gap being what the company adds back.
The evidence under this - 5 claims
C60facthigh confidence
Q3 2026 sales were $18,085M, up 5% (4% before exchange rates). The Keytruda family sold $8,601M, up 6%, 47.6% of sales, including Qlex at $830M; Winrevair $694M, up 93%; Gardasil $1,995M, up 14%. About $550M of the quarter's growth was timing of customer purchases. Profit per share before some items was $2.49, down 3%, after a $0.12 one-time charge for the SciBrunch licence.
against this
- About $550M of pharmaceutical growth was purchase timing, which flatters the quarter's 5%.
- Keytruda's US wholesaler purchase timing was a drag largely offset by higher channel inventory, so the 6% is not a clean demand reading.
C09facthigh confidence
Qlex, the under-the-skin Keytruda, sold $830M in Q3 2026, up from $463M in Q2, after a permanent billing code arrived in April.
sourceMerck Form 8-K Exhibit 99.1: third-quarter 2026 results…primaryMerck Q2 2026 earnings call, held 4 August 2026primary
against this
- Qlex was $830M of an $8,601M Keytruda family in Q3 2026, 9.6%, so most sales are still the infusion whose patent ends in 2028.
- Halozyme's German injunction and Dutch ruling already bar it in nine European countries, so international adoption is not in Merck's hands.
- 2026-10-29editedthe Q3 2026 release tested the management claim: Qlex sales rose 79% in a quarter
C23facthigh confidence
Merck guides 2026 sales to $66.8B-$67.3B (from $66.3B-$67.3B) and profit per share before some items to $2.77-$2.82 (from $2.66-$2.76), after one-time deal charges of $3.62 for Cidara, $2.31 for Terns and $0.12 for the SciBrunch licence.
sourceMerck Form 8-K Exhibit 99.1: third-quarter 2026 results…primaryMerck second-quarter 2026 results release, Exhibit 99.1 to…primary
- 2026-10-29editedthe Q3 2026 release narrowed and raised the 2026 outlook
C02facthigh confidence
In Q2 2026 the Keytruda family sold $8,366M of $16,607M, 50.4% of sales, up 5%; $463M of it was Keytruda Qlex, the version injected under the skin.
C54facthigh confidence
Q2 2026 reported a loss of $0.54 a share, $0.13 before some items, because Terns' $5.7B purchase was charged to profit with no tax benefit.
What management did with the money
Merck is buying its next medicines: Cidara and Terns cost about $16B in 2026, paid in cash and new debt rather than new shares. The share count keeps falling, so each share keeps its slice; the cost shows up as debt and as charges against profit.
Insiders in 2026Q3: 11 purchases and 21 sales, from their Form 4 filings.
The evidence under this - 3 claims
C22facthigh confidence
Merck bought Cidara for $9.2B in January 2026 for MK-1406, a long-acting flu preventive, and Terns for about $6.8B in May for a leukaemia drug.
C45facthigh confidence
The diluted share count fell from 2,547 million in 2023 to 2,507 million in 2025 and averaged 2,470 million in Q2 2026; Merck bought back $1,631M of stock in the half.
C43facthigh confidence
At 30 June 2026 Merck held $7,141M of cash and short-term investments against $2,825M of short-term debt and $51,081M of long-term debt: net debt of $46,765M.
The price, and where we disagree
In short. Fair. The price pays for Merck as it is plus management's plan to replace Keytruda working, and little beyond that.
Share price
$145.95
close,
Price for each $1 of yearly profit
115.8
rivals' middle 39.1 · its 6-year normal 17.1
The shares have already moved: up 73.5% in a year, from the cheapest price for each dollar of sales in six years, after trial wins and a pricing deal with the government.
The tests come close together. Third-quarter results arrive on 29 October, a German court hears Merck's appeal over the under-the-skin version on 19 November, and Summit's head-to-head lung-cancer result is due by the end of 2026. Medicare is expected to pick Keytruda for price-setting early in 2027.
The evidence under this - 5 claims
C29facthigh confidence
Over the year to 16 October 2026 the shares rose 73.5% while sales per share rose 6.0%: the price paid for each dollar of sales rose 63.8%, from 3.32 to 5.43.
C12facthigh confidence
Germany barred Keytruda SC by preliminary injunction in December 2025; Merck's appeal is set for 19 November 2026.
C36facthigh confidence
Summit is testing ivonescimab, a drug that blocks PD-1 and a tumour blood supply at once, head-to-head against Keytruda in first-line lung cancer, with results due from late 2026.
C13management claimhigh confidence
Merck expects Medicare to select Keytruda for government price-setting in 2027, with the price effective 1 January 2029, and says US Keytruda sales will then decline materially.
against this
- The set price applies to Medicare, not the whole US market, so the decline depends on how far private payers follow it.
- Biosimilar entry from December 2028 would cut the price first, which could make the Medicare-set price less binding than it looks.
C19facthigh confidence
On 19 August 2026 Merck and Moderna said intismeran, a personalised mRNA cancer treatment, added to Keytruda cut melanoma recurrence at a planned interim look. On 22 October they gave the full results: after 24.6 months the risk of recurrence or death fell 42% (hazard ratio 0.58) and of distant spread or death 38% (0.62) against Keytruda alone, level for the first six months, with overall survival not yet mature and the companies engaging with regulators.
sourceMerck and Moderna release: Phase 3 INTerpath-001 trial of…primaryGuruFocus, reproducing the Merck and Moderna release of 22…secondary
- 2026-10-22edited22 October release gave the full INTerpath-001 figures and said the companies are engaging regulators; no filing yet.
The betSafe, little upside
If it works
0.9×
from today's value, at the stated multiple
If it fails
keep 80%
of today's market value: the rest of the company, less its debt
How we read the multiple
Reported profit is no guide this year, because buying companies was charged against it. Before those charges buyers pay about 17 times this year's profit, and about 15 times what analysts expect for 2029, the year Medicare sets Keytruda's price.
That is a normal price for a drug maker whose profit does not fall, and analysts expect it to hold flat. Bristol, whose rival drug loses its patent in 2028 too, costs about 13 times.
Against its own history. Far above its own normal on reported profit, but that is the deal charges; before them it costs about what it usually has.
The evidence under this - 6 claims
C25inferencehigh confidence
At $145.95 the shares cost 16.7 times that $8.76 and 15.7 times the $9.28 analysts forecast for 2027.
sourceResearch pack for MRK, frozen beside this thesisprimaryMerck second-quarter 2026 results release, Exhibit 99.1 to…primary
against this
- On reported earnings the trailing price is 115.8 times, the dearest in its cohort, because the acquisition charges sit inside those earnings.
- The 2027 consensus is 13 analysts' average and falls to 5 analysts by 2029, so the later years rest on few forecasts.
C24inferencehigh confidence
Adding those charges back gives about $8.85 a share for 2026 at the middle of the range, roughly $21.9B on 2.48 billion shares (it was $8.76 before the October raise).
sourceMerck Form 8-K Exhibit 99.1: third-quarter 2026 results…primaryMerck Form 10-Q, quarter ended 30 June 2026primary
against this
- Merck buys growth by charging acquired research to profit every year, $14.7B of it in 2026, so a figure before the charges describes a business that does not stop paying them.
- About $0.12 of the Terns figure is financing and development cost that will recur, so the add-back slightly flatters the year.
- 2026-10-29editedre-struck on the raised guide of $2.77-$2.82; the multiples in C25 to C27 are still struck on $8.76 and are off by about a fifth of a turn
C26facthigh confidence
Analysts' earnings forecasts barely fall through the patent expiry: $10.22 a share for 2028, $9.98 for 2029 and $9.90 for 2030.
C27inferencehigh confidence
So the price already assumes Merck's hill: at 14.6 times 2029's forecast, buyers pay a normal drug-maker price for earnings that do not fall.
sourceResearch pack for MRK, frozen beside this thesisprimaryMerck Q2 2026 earnings call, held 4 August 2026primary
against this
- Fourteen times a flat earnings line is cheap for a company whose new medicines succeed, which is the case management makes.
- Bristol, facing the same 2028 date on its own PD-1 drug, is priced at 13.2 times trailing earnings, so the market pays Merck only a little more.
C32facthigh confidence
In the cohort Bristol trades at 13.2 times trailing earnings, the lowest of the five peers.
C29facthigh confidence
Over the year to 16 October 2026 the shares rose 73.5% while sales per share rose 6.0%: the price paid for each dollar of sales rose 63.8%, from 3.32 to 5.43.
Priced against its rivals
The competitors its own annual report names, each confirmed against the rival's filing. Measured on price for each $1 of yearly profit, cheapest first:
| Ticker | Company | price for each $1 of yearly profit |
|---|---|---|
| BMY | Bristol-Myers Squibb Company | 13.2× |
| AMGN | Amgen | 26.7× |
| PFE | Pfizer | 39.1× |
| LLY | Eli Lilly and Company | 42.1× |
| ABBV | AbbVie | 80.4× |
| MRK | Merck & Co. | 115.8× |
The middle of the other 5 is 39.1. Merck & Co., Inc. is dearest of 6.
Rivals' figures come from a data provider, so read the spread of the group rather than any single pair.
In the middle of its rivals on sales, but well above the one rival facing the same patent date, so the market is giving Merck's replacement plan credit.
Private or foreign rivals that cannot be priced: Proposed pembrolizumab biosimilar developers without a US listing (Samsung Bioepis, Celltrion, Formycon, Qilu), Akeso (with Summit Therapeutics as US licensee).
The bet: what it pays if it works
The bet is on Merck's next wave: a cholesterol pill and an HIV pill just approved, and cancer and bowel-disease drugs that succeeded in late trials but are not yet on sale. The rest of Merck is counted separately, at the price buyers pay Bristol for a drug losing its patent at the same time.
If the new medicines succeed, the shares are worth about what they cost today, because the price already pays for them. If they fail, shareholders keep about four-fifths.
| The next wave: medicines launched in 2026 or still in late trials revenue in two to three years | Medicines selling $1 billion a year needed | At the stated multiple |
|---|---|---|
| $2.00B | about 2 at 100% kept | 0.8× |
| $5.00B (the big win) | about 5 at 100% kept | 0.9× |
| $10.00B | about 10 at 100% kept | 0.9× |
To pay 2× (a Fair bet) it would need about $80.33B of The next wave: medicines launched in 2026 or still in late trials revenue (about 80 medicines selling $1 billion a year); to pay 5× (a Cheap bet), about $280.40B of The next wave: medicines launched in 2026 or still in late trials revenue (about 280 medicines selling $1 billion a year), at the same multiple.
Each row is The next wave: medicines launched in 2026 or still in late trials alone, plus the rest of the company (Keytruda, Merck's other marketed medicines and Animal Health) counted at about $286.44B.
The steps it has to take
- Done Lipfendra approved in the United States
- Done Idvynso approved in the United States
- Done Intismeran's Phase 3 trial meets its main goal
- In progress Sac-TMT, intismeran and tulisokibart filed in the United States due 2027-12
- Not started MK-1406 flu preventive approved due 2029-12
The detail behind the label
Rating
Expensive
the big win's payoff against the 2× and 5× lines
Cheap bet at about
$25.41
83% below the price (close, )
The option
0.4×
what The next wave: medicines launched in 2026 or still in late trials is worth if it works, against what the price pays for it
The evidence under this - 6 claims
C19facthigh confidence
On 19 August 2026 Merck and Moderna said intismeran, a personalised mRNA cancer treatment, added to Keytruda cut melanoma recurrence at a planned interim look. On 22 October they gave the full results: after 24.6 months the risk of recurrence or death fell 42% (hazard ratio 0.58) and of distant spread or death 38% (0.62) against Keytruda alone, level for the first six months, with overall survival not yet mature and the companies engaging with regulators.
sourceMerck and Moderna release: Phase 3 INTerpath-001 trial of…primaryGuruFocus, reproducing the Merck and Moderna release of 22…secondary
- 2026-10-22edited22 October release gave the full INTerpath-001 figures and said the companies are engaging regulators; no filing yet.
C20facthigh confidence
Tulisokibart, a bowel-disease antibody, met its Phase 3 goal in ulcerative colitis, and the FDA approved Idvynso, a two-drug daily HIV pill, in April 2026.
C18facthigh confidence
The FDA approved Lipfendra in July 2026, the first oral PCSK9 cholesterol pill, after trials showed it cut bad cholesterol 56% and 59% against placebo.
C17facthigh confidence
Winrevair, a lung blood-pressure drug, sold $588M in Q2 2026, up 75%, after $1,443M in 2025.
C24inferencehigh confidence
Adding those charges back gives about $8.85 a share for 2026 at the middle of the range, roughly $21.9B on 2.48 billion shares (it was $8.76 before the October raise).
sourceMerck Form 8-K Exhibit 99.1: third-quarter 2026 results…primaryMerck Form 10-Q, quarter ended 30 June 2026primary
against this
- Merck buys growth by charging acquired research to profit every year, $14.7B of it in 2026, so a figure before the charges describes a business that does not stop paying them.
- About $0.12 of the Terns figure is financing and development cost that will recur, so the add-back slightly flatters the year.
- 2026-10-29editedre-struck on the raised guide of $2.77-$2.82; the multiples in C25 to C27 are still struck on $8.76 and are off by about a fifth of a turn
C32facthigh confidence
In the cohort Bristol trades at 13.2 times trailing earnings, the lowest of the five peers.
Where we disagree with the market
The market believes
Merck gets past Keytruda's patent with only a shallow dip, carried by more than 20 new medicines.
We believe
That is possible but not yet earned: the under-the-skin version is in court, and most replacements are not yet on sale.
The market reads the trial wins as the replacement arriving. We read the dates from the regulator and the law, and the threats from rivals' own filings: copies are in trials and a patent holder has already stopped Qlex in part of Europe.
Against us: three late-stage wins this year, a cholesterol pill approved, and Qlex use rising in America since April. If those keep coming, the market is right.
What analysts say, and the evidence
Analysts positive
70%
of 27, 1 Oct
Four months earlier
64%
of 31, 1 Jun
The evidence under this - 7 claims
C26facthigh confidence
Analysts' earnings forecasts barely fall through the patent expiry: $10.22 a share for 2028, $9.98 for 2029 and $9.90 for 2030.
C28management claimhigh confidence
Management says over 20 new products are a $70B-plus commercial opportunity, and calls the expiry period 'more of a hill than a cliff' it aspires to grow through.
against this
- Merck's own 10-K says US Keytruda sales will decline materially after the 2029 Medicare price, and Keytruda is 49% of sales.
- The $70B is a sum of hoped-for peak sales, mostly in the 2030s, and in September 2026 one of those products, I-DXd, had its US filing withdrawn.
C10facthigh confidence
On 7 October 2026 a Dutch patent court found Halozyme's EP622 patent valid and infringed by Keytruda SC and barred its sale in eight European countries.
against this
- This is Halozyme's account, the counterparty in the case; Merck's 10-Q says it has filed revocation actions against the same patent in seven countries.
- Halozyme consented to revocation of the same patent in the UK in May 2026, so the patent has already been given up in one market.
C11facthigh confidence
In the US Halozyme is suing over 15 patents, while the patent office's appeal board has found every challenged claim unpatentable in the four reviews it has decided.
C19facthigh confidence
On 19 August 2026 Merck and Moderna said intismeran, a personalised mRNA cancer treatment, added to Keytruda cut melanoma recurrence at a planned interim look. On 22 October they gave the full results: after 24.6 months the risk of recurrence or death fell 42% (hazard ratio 0.58) and of distant spread or death 38% (0.62) against Keytruda alone, level for the first six months, with overall survival not yet mature and the companies engaging with regulators.
sourceMerck and Moderna release: Phase 3 INTerpath-001 trial of…primaryGuruFocus, reproducing the Merck and Moderna release of 22…secondary
- 2026-10-22edited22 October release gave the full INTerpath-001 figures and said the companies are engaging regulators; no filing yet.
C18facthigh confidence
The FDA approved Lipfendra in July 2026, the first oral PCSK9 cholesterol pill, after trials showed it cut bad cholesterol 56% and 59% against placebo.
C09facthigh confidence
Qlex, the under-the-skin Keytruda, sold $830M in Q3 2026, up from $463M in Q2, after a permanent billing code arrived in April.
sourceMerck Form 8-K Exhibit 99.1: third-quarter 2026 results…primaryMerck Q2 2026 earnings call, held 4 August 2026primary
against this
- Qlex was $830M of an $8,601M Keytruda family in Q3 2026, 9.6%, so most sales are still the infusion whose patent ends in 2028.
- Halozyme's German injunction and Dutch ruling already bar it in nine European countries, so international adoption is not in Merck's hands.
- 2026-10-29editedthe Q3 2026 release tested the management claim: Qlex sales rose 79% in a quarter
What could go wrong, and how we would know
The risks
- One drug, two deadlines. Half of sales loses its patent in 2028 and gets a government price in 2029, and Merck itself expects American Keytruda sales to fall sharply.
- The defence could be blocked. If an American court sides with Halozyme, patients cannot move to the under-the-skin version and the whole franchise meets copies at once.
- A better drug. If ivonescimab beats Keytruda in lung cancer, the largest use, doctors may switch before the patent even ends.
- Buying growth. Merck pays for new medicines by buying companies and charging the cost to profit; if it keeps doing that, shareholders keep much less than the headline profit.
- Trials can fail. One filing was already withdrawn in September 2026 after the FDA said the evidence was not enough.
The evidence under this - 9 claims
C01facthigh confidence
Keytruda is half the company: it sold $31,641M of Merck's $65,011M in 2025, and Merck's own risk factors put it at 49% of sales.
C04facthigh confidence
Merck's patent table puts Keytruda's US compound patent at 2028, two related patents at 2029 that it expects to be litigated, Europe 2031, Japan 2032-2033 and China 2028.
C13management claimhigh confidence
Merck expects Medicare to select Keytruda for government price-setting in 2027, with the price effective 1 January 2029, and says US Keytruda sales will then decline materially.
against this
- The set price applies to Medicare, not the whole US market, so the decline depends on how far private payers follow it.
- Biosimilar entry from December 2028 would cut the price first, which could make the Medicare-set price less binding than it looks.
C11facthigh confidence
In the US Halozyme is suing over 15 patents, while the patent office's appeal board has found every challenged claim unpatentable in the four reviews it has decided.
C10facthigh confidence
On 7 October 2026 a Dutch patent court found Halozyme's EP622 patent valid and infringed by Keytruda SC and barred its sale in eight European countries.
against this
- This is Halozyme's account, the counterparty in the case; Merck's 10-Q says it has filed revocation actions against the same patent in seven countries.
- Halozyme consented to revocation of the same patent in the UK in May 2026, so the patent has already been given up in one market.
C36facthigh confidence
Summit is testing ivonescimab, a drug that blocks PD-1 and a tumour blood supply at once, head-to-head against Keytruda in first-line lung cancer, with results due from late 2026.
C24inferencehigh confidence
Adding those charges back gives about $8.85 a share for 2026 at the middle of the range, roughly $21.9B on 2.48 billion shares (it was $8.76 before the October raise).
sourceMerck Form 8-K Exhibit 99.1: third-quarter 2026 results…primaryMerck Form 10-Q, quarter ended 30 June 2026primary
against this
- Merck buys growth by charging acquired research to profit every year, $14.7B of it in 2026, so a figure before the charges describes a business that does not stop paying them.
- About $0.12 of the Terns figure is financing and development cost that will recur, so the add-back slightly flatters the year.
- 2026-10-29editedre-struck on the raised guide of $2.77-$2.82; the multiples in C25 to C27 are still struck on $8.76 and are off by about a fifth of a turn
C43facthigh confidence
At 30 June 2026 Merck held $7,141M of cash and short-term investments against $2,825M of short-term debt and $51,081M of long-term debt: net debt of $46,765M.
C21facthigh confidence
On 25 September 2026 Merck and Daiichi Sankyo withdrew the US application for I-DXd, a lung-cancer drug, after the FDA said the Phase 2 data were not enough.
What we still do not know
- How fast American Keytruda sales fall once copies launch and Medicare sets the price, since both arrive within weeks of each other.
- What share of Keytruda patients will be on the under-the-skin version by the end of 2028.
- Whether ivonescimab beats Keytruda outside China, where it has so far been tested head-to-head.
The evidence under this - 4 claims
C09facthigh confidence
Qlex, the under-the-skin Keytruda, sold $830M in Q3 2026, up from $463M in Q2, after a permanent billing code arrived in April.
sourceMerck Form 8-K Exhibit 99.1: third-quarter 2026 results…primaryMerck Q2 2026 earnings call, held 4 August 2026primary
against this
- Qlex was $830M of an $8,601M Keytruda family in Q3 2026, 9.6%, so most sales are still the infusion whose patent ends in 2028.
- Halozyme's German injunction and Dutch ruling already bar it in nine European countries, so international adoption is not in Merck's hands.
- 2026-10-29editedthe Q3 2026 release tested the management claim: Qlex sales rose 79% in a quarter
C13management claimhigh confidence
Merck expects Medicare to select Keytruda for government price-setting in 2027, with the price effective 1 January 2029, and says US Keytruda sales will then decline materially.
against this
- The set price applies to Medicare, not the whole US market, so the decline depends on how far private payers follow it.
- Biosimilar entry from December 2028 would cut the price first, which could make the Medicare-set price less binding than it looks.
C36facthigh confidence
Summit is testing ivonescimab, a drug that blocks PD-1 and a tumour blood supply at once, head-to-head against Keytruda in first-line lung cancer, with results due from late 2026.
C38facthigh confidence
Researchers estimated the share of US cancer patients eligible for a checkpoint drug like Keytruda rose from 1.54% in 2011 to 43.63% in 2018, and those who respond from 0.14% to 12.46%.
What would change our view
- Neutral→AttractiveA cheaper price on an unchanged business
It needs all of:
- ○The price falls to 13 times this year's profit before deal charges, about what buyers pay Bristol for the same patent problem.about $113.94 today, 22% below the last close
- ○Keytruda sales keep growing at 3% a year or more.checked at the next results, due by 10 Feb
- Neutral→AttractiveThe defence holds and the replacements file
It needs all of:
- ○The US patent office's review board finishes striking down the Halozyme patents used against the under-the-skin version.watched as it happens
- ○Merck files its three late-stage successes, sac-TMT, intismeran and tulisokibart, in America by the end of 2027.watched as it happens
- Neutral→UnattractiveThe defence fails or a successor wins
It needs any of:
- ○Ivonescimab beats Keytruda in Summit's lung-cancer trial.watched as it happens
- ○An American court bars the under-the-skin version.watched as it happens
- ○Keytruda sales fall from a year earlier before 2028.checked at the next results, due by 10 Feb
We would also be wrong if
- A copy of Keytruda is cleared to launch in America before December 2028.
- Filings for sac-TMT, intismeran or tulisokibart slip past 2027 or are refused.
What is coming
- 29 October 2026 Third quarter 2026 results: Whether the Keytruda family still grows, Qlex keeps gaining from $463M, and the $66.3B-$67.3B sales guide holds.
Every dated event ahead
- 29 October 2026 Third quarter 2026 results: Whether the Keytruda family still grows, Qlex keeps gaining from $463M, and the $66.3B-$67.3B sales guide holds.
- 19 November 2026 German appeal hearing on the Keytruda SC injunction: Whether Qlex can be sold in Germany, and how European courts read Halozyme's patent after the Dutch ruling.
- December 2026 HARMONi-3 squamous lung-cancer result, ivonescimab against Keytruda: Whether a successor antibody beats Keytruda head-to-head in its largest use.
- February 2027 Medicare's next list of drugs selected for price-setting: Whether Keytruda is selected, as Merck expects, for a price from 1 January 2029.
Since we wrote this
Written
18 Oct
Price the thesis read
$145.95
16 Oct
- 29 OctEarningsKeytruda up 6%, Qlex $830M, outlook raised; sac-TMT acceptedAll three pre-registered conditions met and the first next-wave filing was accepted, but the price already holds this and the court cases stand, so the view stays Neutral.
- 22 OctNewsFull melanoma results for intismeran, filing talks begunA 42% cut in recurrence or death firms up one of three late-stage wins. No filing or survival data yet, and the price already pays for it.
- 18 OctThesis writtenNeutral, medium convictionHalf of sales loses protection in 2028; the price already pays for management's plan to replace it.
Also checked 2 times with nothing new to act on.
Sources 26
Where this came from
Sources - 26
Every claim above cites one of these, or states the reasoning that derived it. The quote is frozen at the date it was read: a link can rot, and an agent fetch returns a reading of a page rather than the page. Backs counts the whole claim ledger, so it can name a claim this page does not surface.
- S01primarycompany filing2026-02-24Item 1 on the products and competition stated as classes, the patent expiry table by product and territory, the Inflation Reduction Act selections and Merck's own expectation for Keytruda, the wholesaler receivables, the product sales table and the FY2025 statementsbacksC01C04C07C08C13C14C15C16C17C39C41C46C47
- S02primarycompany filing2026-08-07the balance sheet and cash flows, the Cidara and Terns acquisitions, the Halozyme litigation in the United States and Europe, the most-favoured-nation agreement, the pipeline and approvals, and the diluted share countbacksC03C08C11C12C18C20C22C24C42C43C44C45C46
- S03primarycompany release2026-08-04the product sales table, the 2026 guidance and the one-time acquisition charges inside it, GAAP and non-GAAP earnings per share and gross margin
Total Worldwide Sales Were $16.6 Billion (5% Growth; 4% Growth ex-FX) ... KEYTRUDA/KEYTRUDA QLEX Sales Were $8.4 Billion (5% Growth; 4% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $463 Million
backsC02C17C18C22C23C25C44C47C54C59 - S04primarytranscript2026-08-04Merck Q2 2026 earnings call, held 4 August 2026management's description of the patent-expiry period, the $70 billion opportunity from over 20 new products, Keytruda Qlex adoption since the permanent J-code, and US Keytruda growth moderating at peak penetration
we see that as the LOE period is more of a hill than a cliff. Nothing has changed in our view. I do think you're going to see a shallow dip with a fast return back to growth.
backsC09C27C28C56 - S05primarycompany filing2026-04-08beneficial ownership of directors and officers, the 5% holders, the hedging and pledging ban, the 2025 Company Scorecard and the performance share unit resultsbacksC50C51C52
- S06primaryregulator2026-10-18U.S. Food and Drug Administration, openFDA Drugs@FDA records for BLA 125514 (Keytruda) and BLA 761467 (Keytruda Qlex) U.S. Food and Drug Administrationthe date the regulator first licensed Keytruda, 4 September 2014, and 127 submissions on the application since, independent of the company's own account
"application_number": "BLA125514", "sponsor_name": "MERCK SHARP DOHME" ... "submission_type": "ORIG", "submission_status": "AP", "submission_status_date": "20140904"
backsC03C05C07C08C57 - S07primarygovernment data2026-10-1842 U.S.C. 262, regulation of biological products, subsection (k)(7) (Cornell Legal Information Institute) United States Code (Public Health Service Act section 351)the statutory twelve-year bar on approving a biosimilar, which dates when a copy of Keytruda could first be approved
Approval of an application under this subsection may not be made effective by the Secretary until the date that is 12 years after the date on which the reference product was first licensed under subsection (a).
backsC06C07 - S08primaryindustry data2026-01-13American Cancer Society, Cancer Facts & Figures 2026 American Cancer Societythe number of new US cancer patients a year, 2,114,850 in its table, and what cancer costs the country, from a body that sells no medicine
approximately 2.1 million new cancer cases are expected to be diagnosed in the US in 2026, and more than 626,000 people will die from the disease ... The National Cancer Institute estimated that cancer-related medical costs in the US were $208.9 billion in 2020.
backsC37C39C40 - S09primaryindustry data2019-05-03Haslam and Prasad, 'Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs', JAMA Network Open (PMC6503493) JAMA Network Open (peer-reviewed)how fast the class Keytruda leads spread through cancer care, measured by academics critical of the class rather than by a seller
the estimated percentage of US patients with cancer who are eligible for checkpoint inhibitor drugs increased from 1.54% in 2011 to 43.63% in 2018. The percentage of patients estimated to respond to checkpoint inhibitor drugs was 0.14% in 2011 and increased to 12.46% in 2018.
backsC38 - S10primaryvendor data2026-10-18Research pack for MRK, frozen beside this thesiscontent/MRK/research-pack.jsonprice and the 252-day return and its decomposition, the analyst split and its dated series, consensus estimates, short interest, insider filings, the cohort multiples struck on the confirmed competitor set and the company's own six-year multiple historybacksC25C26C27C29C30C32C49C55
- S11primarycompany release2026-10-07Halozyme Therapeutics release: Halozyme wins injunction stopping manufacture and sale of Merck's Keytruda SC in multiple European markets (PR Newswire copy) Halozyme Therapeutics, Inc.the counterparty's own account of the Dutch ruling and its scope, and of the earlier German injunction
the specialized Dutch patent court of the Hague has found Merck to be infringing one of its MDASE patents, EP 2,797,622 (EP622) ... Keytruda SC in Belgium, Denmark, France, Ireland, Italy, Sweden, Switzerland and the Netherlands.
backsC10C12 - S12primarycompany filing2026-05-06Summit Therapeutics first-quarter 2026 results release, Exhibit 99.1 to Form 8-K Summit Therapeutics Inc.the rival's own design and timetable for the head-to-head trial against Keytruda: squamous final progression-free survival in the second half of 2026, non-squamous in the first half of 2027
HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non- squamous NSCLC
backsC36 - S13primarycompany filing2026-02-11ABP 234, a proposed biosimilar to Keytruda, in a Phase 3 study for biosimilarity, named in a rival's own annual reportbacksC33C58
- S14primarycompany filing2025-08-13AVT33, a proposed biosimilar to Keytruda, and its co-development deal with Dr. Reddy's LaboratoriesbacksC34
- S15primarycompany filing2026-02-11Bristol-Myers Squibb Form 10-K, fiscal year ended 31 December 2025 Bristol-Myers Squibb CompanyOpdivo's 2028 US patent expiry, the same year as Keytruda's, and Opdivo Qvantig, its subcutaneous versionbacksC31
- S16primarygovernment data2025-12-19The White House, fact sheet: most-favoured-nation pricing agreements with nine manufacturers, December 2025 The White Housethe government's own account of what Merck conceded in the pricing agreement
Merck will reduce the price of its diabetes medication, Januvia, from $330 to $100 for patients purchasing directly through TrumpRx.
backsC42 - S17primarycompany release2026-08-19the first Phase 3 readout of a personalised mRNA cancer treatment, run with Keytruda, and that overall survival is still being followed
At a pre-specified interim analysis, intismeran in combination with KEYTRUDA as adjuvant therapy demonstrated statistically significant and clinically meaningful improvements in RFS and DMFS compared to KEYTRUDA alone
backsC19 - S18primarycompany release2026-09-25a next-wave filing withdrawn after the regulator said the Phase 2 data were not enough
The decision to withdraw the BLA is based on discussions with the U.S. Food and Drug Administration (FDA) that data supporting the application, including from the IDeate-Lung01 Phase 2 trial, do not satisfy requirements needed to support an accelerated approval
backsC21 - S19secondarynews2026-09-03a third biosimilar developer with US rights, reported rather than filed
Cipla and Qilu partner for US launch of Merck's Keytruda biosimilar
backsC35 - S20primarycompany filing2026-10-18every open-market trade by an insider in the year, each with the Rule 10b5-1 flag from the filing itselfbacksC48
- S21primarycompany filing2026-10-18six years of filed revenue, cost lines, pretax income, cash flow and diluted sharesbacksC45C53
- S22primarycompany release2026-02-03the first 2026 guidance, against which the August raise is measured
Anticipates Worldwide Sales To Be Between $65.5 Billion and $67.0 Billion | | - | Expects Non-GAAP EPS To Be Between $5.00 and $5.15; Outlook Reflects a One-Time Charge of Approximately $3.65 per Share for the Acquisition of Cidara
backsC59 - S23primarycompany filing2026-02-03the full-year income statement and product sales tables that accompany the releasebacksC16
- S24primarycompany filing2026-08-04the quarter's GAAP to non-GAAP reconciliation and product sales by geographybacksC54
- S25secondarynews2026-10-22the full INTerpath-001 figures and that the companies are engaging regulators; Business Wire refuses this client and no filing carries it
intismeran in combination with KEYTRUDA significantly reduced the risk of recurrence or death by 42% (HR=0.58 [95% CI, 0.45-0.75]; two-sided p<0.001)
backsC19 - S26primarycompany filing2026-10-29Q3 2026 sales and the Keytruda family, Qlex, Winrevair and Gardasil lines, GAAP and non-GAAP profit per share, the one-time charges, the raised 2026 outlook and the sac-TMT filing acceptancebacksC09C23C24C60C61