The American Gardasil Market Held UpNarrow moat

Merck & Co. (MRK) — moat facet

American Gardasil sales grew for three straight years while China collapsed, and the real American risk is a single-dose schedule.

The part of Gardasil that did not break was the American one. American sales were $2,083 million in 2023, $2,425 million in 2024 and $2,641 million in 20251, a rise of about 26.8% in two years2. In the second quarter of 2026 total Gardasil sales were $1,169 million, up 4%3.

Gardasil sales by region, 2025 ($M)2,641United States2,592InternationalMerck Form 10-K FY2025, product sales note
America is now the larger half.

This is the vaccine moat working as designed. Gardasil 9 is the product American doctors use, the schedule recommends it, and a large share of adolescent doses is bought through the Vaccines for Children programme4.

The American business has three dates to respect. Its patent is listed to 20285. A 7% royalty on American sales ends in December 20286. And the CDC's January 2026 announcement reduced the recommended adolescent HPV schedule to a single dose7, a change Merck's quarterly filing describes as part of a "now-stayed" announcement8.

The single-dose question matters more than the patent. Gardasil 9 is indicated in the United States for a two-dose regimen in adolescents aged 9 to 149; halving the doses per adolescent would halve revenue per patient unless more patients are vaccinated. Merck expects the effect not to be material10.

The American number is the steadiest. Gardasil 9 is currently indicated for a two-dose regimen in adolescents aged 9 to 14 and a three-dose regimen for those aged 15 to 4511, and previous CDC recommendations for adolescents followed FDA-approved dosing12. As long as they do again, the American franchise has a stable base.

The American franchise is the one Merck can still rely on. Gardasil's American sales, $2,641 million in 202513, are the figure to track; a fall in 2026 or 2027 would mean the single-dose recommendation, stayed or not, is changing practice.

Moat trajectory: Holding steady

US sales up to $2.6bn in 2025; single-dose schedule announced then stayed.

The number that tests this moat
Reported
Gardasil U.S. sales, full year
$2,641M (2025), against $2,425M in 2024

The dependable part of the franchise; a fall would mean the single-dose recommendation is changing practice.

Source: Merck Form 10-K, FY2025 ↗
⚠ Threats to the moat
⚠ THREAT 01
One Dose Where There Were Two
A single-dose HPV schedule, announced and then stayed, would cut the adolescent doses on which American Gardasil sales rest.
References
  1. ReportedAmerican sales were $2,083 million in 2023, $2,425 million in 2024 and $2,641 million in 2025, a rise of about 26.8% in two years.
    Merck & Co. Form 10-K for fiscal 2025 - Item 7 MD&A and product sales note: sales by product, segment and country. — FY2025 · publ. 24 February 2026 · source ↗
  2. Moat Explorer calcAmerican sales were $2,083 million in 2023, $2,425 million in 2024 and $2,641 million in 2025, a rise of about 26.8% in two years.
    Moat Explorer calculation from Merck's reported sales, segment and financial statement figures ($ millions unless stated). Lines 2025: Keytruda 31,641 + Keytruda Qlex 40 = 31,681; other pharmaceutical 58,142 - 31,681 - 5,233 = 21,228; Animal Health 6,354; other revenue 515; total 31,681 + 5,233 + 21,228 + 6,354 + 515 = 65,011. 2024: 29,482; 57,400 - 29,482 - 8,583 = 19,335. 2023: 53,583 - 25,011 - 8,886 = 19,686. 2022: 52,005 - 20,937 - 6,897 = 24,171. 2021: 42,754 - 17,186 - 5,673 = 19,895. Everything else 2025: 65,011 - 31,681 = 33,330. Keytruda share of sales: 11,084 / 39,121 = 28.3% (2019, continuing basis); 17,186 / 48,704 = 35.3% (2021); 25,011 / 60,115 = 41.6% (2023); 31,681 / 65,011 = 48.7% (2025); Q2 2026 8,366 / 16,607 = 50.4%. Keytruda and Gardasil Q2 2026 (8,366 + 1,169) / 16,607 = 9,535 / 16,607 = 57.4%. Qlex 463 / 8,366 = 5.5%. Keytruda growth: 31,641 / 29,482 - 1 = 7.3% (2025); 29,482 / 25,011 - 1 = 17.9% (2024); 31,641 / 17,186 = 1.84, compound (1.84)^(1/4) - 1 = 16.5% a year; 31,641 / 11,084 = 2.85 (2019-2025). US share of Keytruda 18,829 / 31,641 = 59.5%. International Keytruda 12,812 / 11,610 - 1 = 10.4%; US Keytruda 18,829 / 17,872 - 1 = 5.4%. US Keytruda share of total sales 18,829 / 65,011 = 29.0%. Royalty: 2.5% x 31,681 = 792; 6.5% x 31,681 = 2,059. Gardasil US royalty 7% x 2,641 = 185. Winrevair royalty 22% x 1,443 = 317; 22% x 419 = 92; Winrevair Q2 2026 588 x 4 = 2,352, 22% x 2,352 = 517. Segment margins: Pharmaceutical 45,754 / 58,142 = 78.7% (2025); Q2 2026 11,612 / 14,760 = 78.7% (recast basis). Animal Health 2,131 / 6,354 = 33.5% (2025); 1,938 / 5,877 = 33.0% (2024); 1,737 / 5,625 = 30.9% (2023); 1,963 / 5,550 = 35.4% (2022); 1,950 / 5,568 = 35.0% (2021); Q2 2026 636 / 1,775 = 35.8%. Unallocated research 14,987 / 58,142 = 25.8%; Animal Health research 448 / 6,354 = 7.1%. Animal Health segment profit 2,131 / 45,754 = 4.7% of Pharmaceutical. Gardasil: international 2,592 / 6,158 - 1 = -57.9%; US 2,641 / 2,083 - 1 = 26.8%; share 5,233 / 65,011 = 8.0%; share of sales 2021 5,673 / 48,704 = 11.6%, 2022 6,897 / 59,283 = 11.6%, 2023 8,886 / 60,115 = 14.8%, 2024 8,583 / 64,168 = 13.4%; Q2 2026 1,169 x 4 = 4,676. Vaccines H1 2026 2,314 + 2,361 = 4,675; H1 2025 2,607 + 2,370 = 4,977; 4,675 / 4,977 - 1 = -6.1%. Childhood vaccines growth 2,368 / 2,241 - 1 = 5.7%; 2,485 / 2,368 - 1 = 4.9%; 2,451 / 2,485 - 1 = -1.4%. Pneumococcal: Pneumovax 166 / 893 - 1 = -81%; 825 + 759 + 166 = 1,750; 1,750 / 893 = 2.0; (825 + 759) / 166 = 9.5; Capvaxive + Vaxneuvance 759 + 825 = 1,584; 1,584 / 6,494 = 24.4% of Prevnar. Animal Health: livestock 3,896 / 6,354 = 61.3%; livestock growth 3,300 / 3,295 - 1 = 0.2%, 3,337 / 3,300 - 1 = 1.1%, 3,462 / 3,337 - 1 = 3.7%, 3,896 / 3,462 - 1 = 12.5%; companion 2,458 / 2,415 - 1 = 1.8%, 2,458 / 2,273 - 1 = 8.1%; companion excluding Bravecto 2,458 - 1,100 = 1,358; rest of Animal Health 6,354 - 1,100 = 5,254; Bravecto 359 / 335 - 1 = 7%. Segment 6,354 / 5,877 - 1 = 8.1%; 5,625 / 5,568 - 1 = 1.0%; Q2 2026 1,775 / 1,646 - 1 = 7.8%; compound (6,354 / 5,568)^(1/4) - 1 = 3.4% a year; share 6,354 / 65,011 = 9.8%; 6,354 / 31,681 = 0.20 of Keytruda; 6,354 / 9,467 = 67% of Zoetis; Zoetis 9,467 / 9,256 - 1 = 2.3%. Competitors: Keytruda 31,641 / Opdivo 10,049 = 3.1. Geography: US 36,510 / 65,011 = 56.2%; China 1,939 / 6,802 - 1 = -71%; China share 4,378 / 48,704 = 9.0% (2021), 6,802 / 60,115 = 11.3% (2023), 5,494 / 64,168 = 8.6% (2024), 1,939 / 65,011 = 3.0% (2025); other regions 65,011 - 36,510 - 14,580 - 2,711 - 1,939 = 9,271. Wholesaler receivables 22% + 21% + 13% = 56% (2025); 21 + 21 + 13 = 55 (2024); 21 + 20 + 14 = 55 (2023). Januvia and Janumet: 3,324 + 1,964 = 5,288 (2021); 2,189 + 1,177 = 3,366 (2023); 1,334 + 935 = 2,269 (2024); 1,604 + 940 = 2,544 (2025). Newer products Q2 2026: 588 + 271 + 204 + 184 = 1,247; 1,247 / 8,366 = 14.9%. Bridion 1,841 / 4 = 460 a quarter. Other pharmaceutical Q2 2026 14,760 - 8,366 - 1,169 = 5,225; Q2 2025 14,050 - 7,956 - 1,126 = 4,968; 5,225 / 4,968 - 1 = 5.2%; 2025 share 21,228 / 65,011 = 32.7%. Research: 30,531 / 60,115 = 50.8% of sales (2023). Charges 2026 9.0 + 5.7 = 14.7 bn; per share 3.62 + 2.31 = 5.93. Ohtuvayre 204 x 4 = 816; 12,100 / 816 = 14.8. Tax guidance midpoints (23.5 + 24.5) / 2 = 24.0; (35.0 + 36.0) / 2 = 35.5. Balance sheet: net debt end-2025 2,589 + 46,750 - 14,565 = 34,774; end-2024 2,649 + 34,462 - 13,242 - 447 = 23,422; end-2023 1,372 + 33,683 - 6,841 - 252 = 27,962; 30 June 2026 2,825 + 51,081 - 6,849 - 292 = 46,765, cash and short-term investments 6,849 + 292 = 7,141; net debt to equity 34,774 / 52,606 = 0.66; 46,765 / 41,933 = 1.1. Net income 2023-2025 365 + 17,117 + 18,254 = 35,736. Valuation: year-end 2025 market value 261.26 bn / net income 18.254 bn = 14.3; free cash flow 2025 16,472 - 4,112 = 12,360; 12,360 / 365,090 = 3.4%. Trailing twelve months to June 2026: sales 65,011 - 31,335 + 32,893 = 66,569; net income 18,254 - 9,506 - 5,575 = 3,173. EPS guidance midpoints (5.00 + 5.15) / 2 = 5.075; (5.04 + 5.16) / 2 = 5.10; (2.66 + 2.76) / 2 = 2.71. Protection from 2026: 2043 - 2026 = 17 years; 2028 - 2026 = 2 years. Year-end P/E = market value / net income: 147.55 / 4.442 = 33.2 (2015); 162.31 / 3.920 = 41.4 (2016); 153.30 / 2.394 = 64.0 (2017); 198.69 / 6.220 = 31.9 (2018); 231.56 / 9.843 = 23.5 (2019); 206.96 / 7.067 = 29.3 (2020); 193.59 / 13.049 = 14.8 (2021); 281.30 / 14.519 = 19.4 (2022); 276.26 / 0.365 = 757 (2023); 251.65 / 17.117 = 14.7 (2024); 261.26 / 18.254 = 14.3 (2025); 365.09 / 3.173 = 115.1 (TTM). Return on average equity 2025: 18,254 / ((52,606 + 46,313) / 2) = 18,254 / 49,460 = 36.9%. Gross profit 2025 65,011 - 16,382 = 48,629; 48,629 / 65,011 = 74.8%; royalty 792 / 16,382 = 4.8% of cost of sales. Keytruda increase 2021-2025 31,681 - 17,186 = 14,495; sales increase 65,011 - 48,704 = 16,307. US sales 36,510 / 28,480 - 1 = 28%. Pharmaceutical margin 2021 30,977 / 42,754 = 72.5%. Livestock less companion 3,295 - 2,273 = 1,022 (2021); 3,896 - 2,458 = 1,438 (2025). Prevnar 6,494 / Vaxneuvance 825 = 7.9. Animal Health 2025 6,354 against Keytruda franchise Q2 2026 8,366 - product and segment totals, growth and royalties. — 2015-2026 · publ. September 2026 · source ↗
    Method: Arithmetic on figures reported in Merck's Forms 10-K and 10-Q, results releases, the Bristol Myers Squibb, Pfizer and Zoetis 10-Ks and market data; operands shown in the source line.
  3. ReportedIn the second quarter of 2026 total Gardasil sales were $1,169 million, up 4%.
    Merck second-quarter 2026 results release, Form 8-K exhibit 99.1 - vaccine and Animal Health sales. — Q2 2026 · publ. 4 August 2026 · source ↗
  4. ReportedGardasil 9 is the product American doctors use, the schedule recommends it, and a large share of adolescent doses is bought through the Vaccines for Children programme.
    Merck & Co. Form 10-K for fiscal 2025 - Item 1A risk factors, patents and exclusivity, government pricing, vaccine policy and legal proceedings. — FY2025 · publ. 24 February 2026 · source ↗
  5. ReportedIts patent is listed to 2028.
    Merck & Co. Form 10-K for fiscal 2025 - patents, exclusivity dates, biosimilar competition and royalties. — FY2025 · publ. 24 February 2026 · source ↗
  6. ReportedA 7% royalty on American sales ends in December 2028.
    Merck & Co. Form 10-K for fiscal 2025 - patents, exclusivity dates, biosimilar competition and royalties. — FY2025 · publ. 24 February 2026 · source ↗
  7. ReportedAnd the CDC's January 2026 announcement reduced the recommended adolescent HPV schedule to a single dose, a change Merck's quarterly filing describes as part of a "now-stayed" announcement.
    Merck & Co. Form 10-K for fiscal 2025 - Item 1A risk factors, patents and exclusivity, government pricing, vaccine policy and legal proceedings. — FY2025 · publ. 24 February 2026 · source ↗
  8. ReportedAnd the CDC's January 2026 announcement reduced the recommended adolescent HPV schedule to a single dose, a change Merck's quarterly filing describes as part of a "now-stayed" announcement.
    Merck & Co. Form 10-Q for the quarter ended 30 June 2026 - segment profits on the recast basis, the Cidara and Terns acquisitions, the Halozyme litigation, China shipments, loss of exclusivity events and the balance sheet. — Q2 2026 · publ. 7 August 2026 · source ↗
  9. ReportedGardasil 9 is indicated in the United States for a two-dose regimen in adolescents aged 9 to 14; halving the doses per adolescent would halve revenue per patient unless more patients are vaccinated.
    Merck & Co. Form 10-K for fiscal 2025 - vaccines and China: Gardasil, the childhood and pneumococcal vaccines, and sales in China. — FY2025 · publ. 24 February 2026 · source ↗
  10. ReportedMerck expects the effect not to be material.
    Merck & Co. Form 10-K for fiscal 2025 - Item 1 business: products, customers, segments and people. — FY2025 · publ. 24 February 2026 · source ↗
  11. ReportedGardasil 9 is currently indicated for a two-dose regimen in adolescents aged 9 to 14 and a three-dose regimen for those aged 15 to 45, and previous CDC recommendations for adolescents followed FDA-approved dosing.
    Merck & Co. Form 10-K for fiscal 2025 - Item 1A risk factors, patents and exclusivity, government pricing, vaccine policy and legal proceedings. — FY2025 · publ. 24 February 2026 · source ↗
  12. ReportedGardasil 9 is currently indicated for a two-dose regimen in adolescents aged 9 to 14 and a three-dose regimen for those aged 15 to 45, and previous CDC recommendations for adolescents followed FDA-approved dosing.
    Merck & Co. Form 10-K for fiscal 2025 - Item 1A risk factors, patents and exclusivity, government pricing, vaccine policy and legal proceedings. — FY2025 · publ. 24 February 2026 · source ↗
  13. ReportedGardasil's American sales, $2,641 million in 2025, are the figure to track; a fall in 2026 or 2027 would mean the single-dose recommendation, stayed or not, is changing practice.
    Merck & Co. Form 10-K for fiscal 2025 - Item 1A risk factors, patents and exclusivity, government pricing, vaccine policy and legal proceedings. — FY2025 · publ. 24 February 2026 · source ↗
Sources
Generated September 25, 2026