Novo Nordisk A/S (NVO) FY2025 20-F and Q2 FY2026 6-K Summary

Business

Source: Form 20-F for fiscal 2025, accession 0000353278-26-000012, including the Annual Report 2025 filed as Exhibit 15.1.

Novo Nordisk is a Danish drugmaker that sells medicines for obesity and type 2 diabetes in about 170 countries, most of them built on one molecule, semaglutide. In 2025 it had sales of $46.69 billion (DKK 309,064 million). Ozempic, an injectable semaglutide for type 2 diabetes, was the largest product at $19.20 billion. Wegovy, the same molecule dosed for weight management, was second at $11.95 billion, up 36% in its fifth year on the market. The company says semaglutide now accounts for the vast majority of its revenue. The US is the largest market. US Operations generated $26.16 billion, about 56% of sales, and International Operations generated $20.53 billion.

Novo Nordisk reports two segments:

• Obesity and Diabetes care (more than 90% of sales). Obesity care sales were $12.44 billion in 2025, almost all from Wegovy, plus the older daily injectable Saxenda, whose sales are falling. Wegovy pill, the first oral GLP-1 approved for weight management, launched in the US in January 2026. A 7.2 mg injectable dose is sold in the US as Wegovy HD. GLP-1 diabetes products (Ozempic, the oral Rybelsus and the older Victoza) sold $22.99 billion, and insulins (Tresiba, NovoRapid, NovoMix, Fiasp, Awiqli and human insulin) sold $8.03 billion.
• Rare disease ($2.96 billion). This segment sells haemophilia and other rare blood disorder products (NovoSeven, NovoEight, Esperoct, Alhemo) and growth hormone (Norditropin, Sogroya).

International Operations is split into four regions: EUCAN (Europe and Canada), Emerging Markets, APAC (Japan, Korea, Oceania and Southeast Asia) and Region China. Products are sold through subsidiaries, distributors and agents. The main production sites are in Denmark, the United States, France, China and Brazil. Active pharmaceutical ingredient (API) is made mainly in Kalundborg, Denmark, and in New Hampshire and North Carolina. In 2024 the company bought three former Catalent manufacturing sites, and multi-year API and aseptic-filling expansions are under way in Denmark, the US, France and China.

Competition. In both diabetes and obesity, Novo Nordisk and Eli Lilly are the two largest companies by market share. In 2025 a competing GLP-1 overtook Wegovy as the leading US anti-obesity medicine by weekly prescriptions, and overtook Ozempic in US type 2 diabetes. Novo Nordisk says it lost GLP-1 volume share in both obesity and diabetes, inside and outside the US. Its global diabetes value share fell 3.6 percentage points to 30.1%, although it still held 59.6% of global branded obesity volume in a market whose volume doubled in 2025. US compounding pharmacies sold unapproved copies of its GLP-1s during the 2024-2025 shortage and, according to the company, have continued illicitly since the shortage ended. The US compound patent on semaglutide (Ozempic, Rybelsus, Wegovy) runs to 2032. Outside the US, the compound patent is expiring in certain International Operations markets from 2026. Novo Nordisk has settled US patent litigation with several generic filers for Ozempic on confidential terms.

Ownership and leadership. The Novo Nordisk Foundation controls the company through Novo Holdings A/S. Novo Holdings holds all of the unlisted A shares, which carry 100 votes each against 10 for each B share and cannot be sold while the Foundation exists. The B shares trade in Copenhagen and, as ADRs, on the NYSE. The Foundation's chair, Lars Rebien Sørensen, became chair of Novo Nordisk at an extraordinary general meeting in November 2025, which also elected new board members. Maziar Mike Doustdar succeeded Lars Fruergaard Jørgensen as CEO on 7 August 2025. In September 2025 he launched a company-wide restructuring that cut about 9,000 jobs, and headcount fell from 77,349 to 69,505 by year-end. On 9 December 2025 the company completed its acquisition of Akero Therapeutics, whose lead asset efruxifermin is in phase 3 trials for MASH (metabolic dysfunction-associated steatohepatitis, a fatty-liver disease). The price was USD 54 per share in cash (about USD 4.7 billion in total) plus a contingent value right of USD 6 per share (about USD 0.5 billion), payable if efruxifermin is approved in the US for compensated cirrhosis due to MASH.

Risk factors

Source: Form 20-F for fiscal 2025, accession 0000353278-26-000012, Item 3.D and the 'Risk management' section of the Annual Report 2025 (Exhibit 15.1) that it incorporates.

The company's own risk review starts from its dependence on semaglutide and from the pricing pressure in its largest market:

• Dependence on one molecule. Several brands share semaglutide as their active ingredient, so a competitive, safety, patent or pricing setback for semaglutide hits most of the business at once. The company counters this with internal and in-licensed pipeline investment.
• Competition, generics and compounding. Competition from branded GLP-1s, generics and compounders lowers prices and volumes. The semaglutide compound patent is expiring in certain International Operations markets from 2026. As the market becomes more consumer-driven, the company takes on new risks around direct-to-consumer marketing, telehealth channels and brand reputation.
• US pricing and policy. Pharmacy benefit managers and payer consolidation keep pushing rebates higher, first in insulin and now in GLP-1s. More sales are also moving into high-rebate channels (Medicare, Medicaid) and the cash-pay channel. Medicare Part D prices negotiated under the Inflation Reduction Act for Ozempic, Rybelsus and Wegovy take effect in 2027. A November 2025 "Most Favoured Nations" agreement with the US Administration lowers semaglutide prices in exchange for broader Medicare, Medicaid and self-pay access. The company also flags the risk of US tariffs and reference-pricing measures aimed at pharmaceuticals.
• Pipeline failure. Clinical, regulatory or commercial misjudgements can delay or end pipeline projects. In 2025 the Evoke phase 3 trials in Alzheimer's disease failed to show a statistically significant effect on disease progression. In 2024 an impairment on ocedurenone weighed on R&D costs.
• Supply, quality and product liability. Demand swings, quality problems or geopolitical disruption can cause shortages, and Ozempic itself was periodically supply-constrained in 2025. Capacity expansion is complex and slow. Product-safety failures bring liability and reputational exposure.
• IT security and data privacy. The company depends on a large global IT estate and on third-party vendors that hold personal and health data. A breach could disrupt manufacturing and operations and bring liability under the EU General Data Protection Regulation and other privacy laws. In its Form 20-F for fiscal 2025, the company stated it had not previously experienced material losses from such incidents.
• Currency and tax. The main currency exposures are the US dollar, Chinese yuan and Japanese yen. The company hedges selected currencies for up to 12 months. As of 30 July 2026, it estimated that a 5% move in the US dollar would change adjusted operating profit over the following 12 months by about $763.44 million (DKK 4,970 million), according to the Q2 2026 interim report (Form 6-K furnished 4 August 2026, accession 0000353278-26-000023). Tax disputes and changes in tax law could also raise its tax rate.
• Climate and water. Plants in North Carolina and Indiana face tornado and hurricane risk, the Japanese site in Koriyama faces earthquake risk and the site in Tianjin, China faces storm surges. Some production draws water in water-stressed regions. Missing climate targets could bring regulatory or reputational consequences.

Management's discussion: fiscal 2025

Source: Annual Report 2025, 'Financial performance' and '2026 outlook' (pages 14-17), Exhibit 15.1 to the Form 20-F for fiscal 2025, accession 0000353278-26-000012.

In 2025, growth slowed sharply and profits flattened. Sales rose 6% in Danish kroner and 10% at CER to $46.69 billion, against 25% reported growth in 2024. Sales and operating profit growth at CER landed within the ranges the company gave in November 2025. US Operations grew 8% at CER and International Operations 14%. Obesity care grew 31% at CER and drove most of the gain. Diabetes care grew 4% at CER to $31.29 billion. Within diabetes, Ozempic rose 10% at CER, helped in the US by gross-to-net (rebate) adjustments. Rybelsus fell 2%, Victoza fell 43% as patients moved to once-weekly treatment, and insulin fell 1% to $8.03 billion. Rare disease grew 9% at CER.

Margins fell. Cost of goods sold rose 31% at CER, and the gross margin dropped to 81.0% from 84.7%. The company attributes the decline to depreciation and amortisation at the three former Catalent sites, one-off restructuring costs, capacity build-out and currency, partly offset by a richer GLP-1 mix. Sales and distribution costs rose 7% at CER to $9.71 billion, mainly for Wegovy promotion and launches. R&D rose 10% at CER to $7.86 billion (16.8% of sales) on late-stage obesity trials, early research and cardiovascular programmes. Operating profit fell 1% in Danish kroner and rose 6% at CER to $19.28 billion. The year absorbed one-off restructuring costs of around $1.21 billion (about DKK 8 billion), against which the company expects annualised savings of the same size from 2026. Excluding those costs, operating profit would have grown 13% at CER. Financial items swung to a gain of $435.35 million, mainly from US-dollar hedges. The tax rate was 21.5%. Net profit rose 1% to $15.47 billion, and diluted earnings per share rose 2% to DKK 23.03 ($3.48 per ADR).

Cash generation recovered from 2024 but remained low relative to earnings, with free cash flow equal to 27.6% of net profit. Free cash flow was $4.27 billion, against negative $2.13 billion in 2024, when the Catalent sites were bought for USD 11.7 billion. Capital expenditure on property, plant and equipment rose to $9.08 billion. Spending on intangible assets jumped to $4.53 billion, mainly for Akero. Shareholders received about $7.85 billion, almost all as dividends. The 2025 dividend totals DKK 11.70 per share ($1.77 per ADR), a 50.7% payout. Share buybacks fell 93% from 2024. Net debt rose 37% to $15.03 billion at year-end.

340B provision. For years the company had held back revenue tied to the US 340B Drug Pricing Program while its distribution policy was litigated. At 31 December 2025 it carried a USD 4.2 billion provision for 340B discounts. A favourable administrative dispute ruling became final on 20 January 2026. The company treated this as an event after the balance sheet date that did not change the 2025 accounts, and said it would recognise the full USD 4.2 billion as revenue in the first quarter of 2026.

2026 outlook as first issued (3 February 2026). Management told investors to expect a sales decline in 2026. From 2026 it guides on "adjusted" sales and operating profit, which exclude the 340B reversal and other one-off items. The initial outlook called for adjusted sales growth and adjusted operating profit growth each of -5% to -13% at CER. The drivers were lower US prices under the Most Favoured Nations agreement, reduced Medicaid coverage of obesity drugs, loss of semaglutide exclusivity in some international markets, and no repeat of 2025's favourable US gross-to-net adjustments. International Operations was expected to grow and US Operations to decline. The company also guided to:

• free cash flow of $5.54 billion to $7.12 billion (DKK 35-45 billion)
• capital expenditure of about $8.70 billion (around DKK 55 billion)
• a financial-items gain of about $363.96 million

Current period: second quarter and first half 2026

Source: Form 6-K furnished 4 August 2026, accession 0000353278-26-000023 (Financial report for the period 1 January 2026 to 30 June 2026, Company Announcement No 48/2026; unaudited, IAS 34).

Reported and adjusted results. The quarter's reported figures are distorted by one-off items, so the company leads with adjusted measures. Reported Q2 sales of $12.22 billion rose 2% in Danish kroner and 3% at CER. Growth was held back by a $402.53 million (DKK 2,649 million) 340B provision release that had lifted Q2 2025. Excluding that release, adjusted sales grew 7% at CER. Reported operating profit fell 16% at CER to $4.21 billion. On top of the 340B comparison, it absorbed $984.86 million (DKK 6,328 million) of non-cash impairments on intangible pipeline assets, booked in R&D and including the terminated monlunabant programme. Net profit fell 21% to $3.27 billion, and diluted EPS fell 20% to DKK 4.75 ($0.74 per ADR). Adjusted diluted EPS rose 5% to DKK 6.18 ($0.96). The segment table shows Rare disease swinging to an operating loss of $201.55 million from a profit a year earlier. For the half year, reported sales of $27.37 billion and operating profit of $13.53 billion are inflated by the USD 4.2 billion 340B release in Q1. Adjusted H1 sales were $23.19 billion, up 2% at CER.

Volume up, price down. Growth in the quarter came from volume. In the US, adjusted sales rose 4% at CER to $6.36 billion, but part of that came from rebate adjustments. US sales of injectable Wegovy fell 22% at CER on lower realised prices. The new Wegovy pill ($500.83 million in Q2 sales, nearly all in the US) lifted combined US Wegovy sales 4%. US Ozempic rose 2%, again helped by rebate adjustments, despite lower prices and volumes. US insulin rose 15% at CER on rebate timing, even though the company kept losing share. International Operations grew 10% at CER to $5.85 billion. International obesity care sales rose 37%, and EUCAN grew 17% and Region China 13%. APAC fell 6%, and in Canada the loss of semaglutide exclusivity cut prices while volumes held. Globally, obesity care sales were $3.60 billion (+16% at CER), Ozempic remained the largest product at $4.88 billion (+5%), and Rare disease grew 6%. By the company's count, its obesity medicines reached 4.9 million patients over the 12 months to June 2026, up from 2.9 million a year earlier.

Margins and costs. The adjusted gross margin fell to 78.2% from 82.7%. The company cites lower realised prices, negative currency and about $466.91 million (around DKK 3 billion) of one-time costs to right-size manufacturing capacity agreements, partly offset by productivity gains and GLP-1 mix. Sales and distribution costs fell 13% at CER, reflecting restructuring savings and quarter-to-quarter timing of spend, and adjusted R&D fell 2% on phasing. Adjusted operating profit therefore rose 11% at CER. The company expects R&D and promotional spending to be higher in the second half than in the first.

Cash flow and balance sheet. H1 operating cash flow was $12.38 billion, despite a $3.11 billion working-capital outflow. Q2 free cash flow was $6.62 billion, up 57% in Danish kroner. For the half year, the company attributes the rise to the timing of operating spend, US rebate payments and tax payments, and to lower capital expenditure ($3.75 billion in H1, down 15%). From 2026, free cash flow is defined as operating cash flow less purchases of property, plant and equipment, with prior periods restated. At 30 June 2026, equity was $33.80 billion (37.2% of total assets) and cash at bank was $6.80 billion. Net debt was $13.22 billion, down from $15.03 billion at the end of 2025.

Pipeline in the quarter.

• Monlunabant was terminated.
• In the head-to-head REIMAGINE 4 trial in type 2 diabetes, CagriSema 2.4/2.4 mg was non-inferior to tirzepatide 15 mg on weight loss but not on blood-sugar (HbA1c) reduction. On a treatment-adherent basis, it achieved 15.2% weight loss and a 1.9-point HbA1c reduction, against 15.8% and 2.2 points for tirzepatide.
• The lower-dose REDEFINE 9 trial succeeded, and a high-dose CagriSema phase 3 trial began.
• Zenagamtide (amycretin) entered phase 3 in heart failure with obesity (HF-POLARIS) and in a head-to-head trial against semaglutide (AMAZE 8).
• Etavopivat met both co-primary endpoints in the phase 3 HIBISCUS trial in rare disease.
• Awiqli and the Wegovy FlexTouch 2.4 mg pen were approved in the US.

IT security incident. On 11 June 2026 the company issued a press release about an IT security incident, and the interim report states that it is a defendant in multiple putative class action lawsuits in the US brought on behalf of individuals who allege their personally identifiable information and protected health information were compromised in the incident (accession 0000353278-26-000023).

Raised outlook. With these results the company raised its 2026 outlook. It now expects adjusted sales growth and adjusted operating profit growth each of 0% to -6% at CER, up from -4% to -12% in May, on higher expectations for GLP-1 sales. The outlook still assumes International Operations growth and a US decline, with US prices held down by the Most Favoured Nations agreement and Medicaid coverage cuts. The outlook includes Wegovy pill uptake, cannibalisation of the injectable, the Medicare "Bridge" pilot and possible seasonality, and excludes new business development. Updated modelling items:

• free cash flow of $6.94 billion to $8.48 billion (DKK 45-55 billion, raised from the May range)
• capital expenditure of about $8.48 billion (around DKK 55 billion, unchanged)
• a financial-items loss of about $169.62 million (against the gain expected in February)
• a tax rate of 21-23%

The company also confirmed that from 1 January 2027 it will cut US list prices for all doses of Wegovy (injection and tablets) and of Ozempic injection and Ozempic pill (7 mg and 14 mg) to USD 675. That is a cut of about 50% for Wegovy and 35% for Ozempic, and the company expects it to affect 2027 cash flow.

Milestones the company expected in the second half of 2026 include US decisions on CagriSema and on oral semaglutide 25 mg, US and EU decisions on denecimig (the US decision has since been delayed; see below), and US and EU submissions for etavopivat in sickle cell disease. The US decision on adding MASH data to the Wegovy pill label is expected in Q1 2027. Results for the first nine months of 2026 are scheduled for 4 November 2026.

Subsequent events

Sources: the Form 6-K furnished 4 August 2026 (accession 0000353278-26-000023) for events between 30 June and 4 August 2026, and the company's Form 6-K announcements furnished through 6 October 2026, with accessions noted.

Developments after the 30 June 2026 balance sheet date fall into four groups:

• US market access. On 1 July the Medicare Part D "Bridge" pilot for obesity medicines took effect, covering a majority of beneficiaries, and the company reported encouraging early uptake. From 1 October, CVS Caremark's largest commercial template formularies add other weight-loss medicines alongside Wegovy (accession 0000353278-26-000023).
• Europe. Wegovy pill launched in the UK in early July, following the UAE in June. In July the European Medicines Agency approved Wegovy pill (with the SELECT cardiovascular data in its label) and, on 15 July, the Wegovy 7.2 mg single-dose pen. The company planned EU launches of the 7.2 mg pen from Q3 2026 and a rollout across more than 30 International Operations markets during 2026 (accession 0000353278-26-000023).
• Pipeline setbacks and progress.
  • On 31 July the company announced that the ZEUS phase 3 cardiovascular outcomes trial of ziltivekimab missed its primary endpoint. It said the outcome will result in a non-cash impairment charge in Q3 2026 but will not affect its previously communicated 2026 adjusted operating profit outlook (accession 0001171843-26-005109). The 4 August report says the outcome may result in such a charge (accession 0000353278-26-000023).
  • On 17 September the EU's CHMP recommended approval of FREHEMGO (denecimig) for haemophilia A, with first European launches planned for Q4 2026 (accession 0001171843-26-006088).
  • On 2 October the company disclosed that the FDA's review of denecimig has been extended, with no new action date, because of remediation at the manufacturing facility. No clinical deficiencies were identified. The company now targets a US launch in the first half of 2027 and says the delay does not affect its 2026 outlook (accession 0001171843-26-006374).
• Litigation and capital returns. On 21 July Novo Nordisk sued Eli Lilly in federal court in New Jersey for false advertising over comparative GLP-1 efficacy claims (accession 0000353278-26-000023). The interim dividend declared with the results was scheduled for payment on 18 August (25 August for ADRs). Weekly purchases under the 2026 buyback continued, and treasury holdings reached 50,644,876 B shares (1.1% of share capital) by 2 October (accession 0001171843-26-006440).