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Maziar Mike Doustdar appointed as president and chief executive officer of Novo Nordisk
Maziar Mike Doustdar appointed as president and chief executive officer of Novo Nordisk

Yahoo

time16 hours ago

  • Business
  • Yahoo

Maziar Mike Doustdar appointed as president and chief executive officer of Novo Nordisk

Bagsværd, Denmark, 29 July 2025 – Novo Nordisk today announced that Maziar Mike Doustdar has been appointed as president and chief executive officer, effective 7 August 2025. Mike Doustdar succeeds Lars Fruergaard Jørgensen, who will step down as president and chief executive officer on the same date. The company also announced other executive-level changes, effective 7 August. Mike Doustdar, currently Novo Nordisk's executive vice president of International Operations, has a strong track record of creating value and driving growth. Under his leadership over the past decade, Novo Nordisk's International Operations have more than doubled sales to approximately DKK 112 billion in 2024. The business includes all of Novo Nordisk's affiliates outside of the US and employs nearly 20,000 people. Novo Nordisk Chair, Helge Lund, said: 'Mike is an exceptional leader and has the unanimous support of the Board. We are confident that he is the best person to lead Novo Nordisk through its next growth phase. Mike has consistently demonstrated the ability to drive growth through strong commercial execution and building high-performing teams. This is an important moment for Novo Nordisk. The market is developing rapidly, and the company needs to address recent market challenges with speed and ambition. I believe Novo Nordisk will build on its strengths as a global leader in obesity and diabetes, and Mike has a clear vision of how to unlock the full potential of the opportunities ahead.' Mike Doustdar has been appointed as the result of a comprehensive process that included external and internal candidates. The Novo Nordisk Foundation fully endorses Novo Nordisk Board's decision to appoint Maziar Mike Doustdar as president and chief executive officer. Mike Doustdar said: 'It's an enormous privilege to lead this company at a time of tremendous opportunity and change. I come to this role with a sense of urgency, a laser focus on high performance, and a fierce determination for Novo Nordisk to aim higher than it's ever done, and to deliver to many more patients the innovation they need. From my decades in leadership roles across Novo Nordisk, I know the extraordinary talent and commitment of our people and the excellence of our science. This has enabled us to achieve great things in the past and will ensure we continue to do so in the future.' Novo Nordisk Chair, Helge Lund, added: 'Under Lars's leadership, Novo Nordisk has undergone a profound period of growth and now reaches millions more patients with life-changing medicines. On behalf of Novo Nordisk's Board of Directors and our employees, I want to thank Lars for 34 years of unstinting commitment to the company and wish him all the best in his future endeavours.' Other organisational changes effective 7 August: Research & Early Development and Development EVP areas will be merged into a combined R&D Nordisk has decided to merge the company's Research & Early Development with its Development area into a new, consolidated R&D unit, under the leadership of Martin Holst Lange, MD, PhD. Martin Holst Lange, currently executive vice president, Development, will be appointed chief scientific officer (CSO), effective 7 August. Martin Holst Lange will focus on seamlessly combining the two functions, quickly advancing the innovation of new therapies and ensuring the success of the early and late-stage pipelines, with a significant focus on the diabetes and obesity areas. In addition, Martin Holst Lange will work closely with Mike Doustdar to drive pipeline development and innovation from both within and outside of the company. Marcus Schindler, executive vice president, Research & Early Development and CSO, has decided to retire from the company. Novo Nordisk Chair, Helge Lund, said: 'We thank Marcus for his deep commitment to Novo Nordisk and its pursuit of scientific excellence. We wish him all the best for the future.' Marcus Schindler joined Novo Nordisk in January 2018 as senior vice president of External Innovation and Strategy and has been CSO since 2021. Marcus Schindler has played an integral role in leading the discovery of early scientific innovation. He will remain at Novo Nordisk for a short period to ensure a successful transition. Emil Kongshøj Larsen, currently senior vice president of the Europe and Canada region (EUCAN), will join Executive Management and succeed Mike Doustdar, assuming the responsibility of executive vice president, International Operations. Emil Larsen currently leads a region spanning 40 countries, accounting for about 20% of Novo Nordisk's global sales. He has previously led other significant business areas throughout Europe, Africa and the Middle East, as well as Commercial Affairs and Strategy in International Operations. With these changes, Executive Management will have the following members, effective 7 August: Maziar Mike Doustdar, president and CEO* Thilde Hummel Bøgebjerg, EVP, Quality, IT & Environmental Affairs Emil Kongshøj Larsen, EVP, International Operations Ludovic Helfgott, EVP, Product & Portfolio Strategy Karsten Munk Knudsen, EVP, chief financial officer* Martin Holst Lange, EVP, chief scientific officer, Research & Development David Moore, EVP, US Operations Tania Sabroe, EVP, People, Organisation and Corporate Affairs Henrik Wulff, EVP, CMC & Product Supply * Registered as an executive with the Danish Business Authority. About Maziar Mike DoustdarMike Doustdar became senior vice president of International Operations in 2013, a business that includes 80 affiliates - all of Novo Nordisk's commercial affiliates outside of the US. Novo Nordisk's International Operations had sales of approximately DKK 112 billion in 2024 and serve approximately 35 million patients. Prior to this role, Mike led Novo Nordisk's Southeast Asia and Oceania commercial area out of Malaysia, following on from his leadership of the Middle East business. Prior to this, he was general manager based in Turkey and held leadership roles in finance and IT. Mike Doustdar became executive vice president in 2015. He is a member of the Board of Directors of Orion Corporation. Conference CallNovo Nordisk will host a conference call for investors at 14.30 CEST on 29 July 2025, corresponding to 8.30 am EST. For more information on how to listen, please visit the investor section of There will be a conference call for media at 16.00 CEST, which corresponds to 10.00 am EST. Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ Publication of inside information pursuant to Market Abuse Regulation, Article 17 Company announcement No 19 / 2025 Attachment CA250729-CEO-succession

Novo Nordisk lowers sales and operating profit outlook for 2025
Novo Nordisk lowers sales and operating profit outlook for 2025

Yahoo

time17 hours ago

  • Business
  • Yahoo

Novo Nordisk lowers sales and operating profit outlook for 2025

Bagsværd, Denmark, 29 July 2025 – Novo Nordisk today announced sales and operating profit growth at constant exchange rates (CER) for the first six months of 2025 and updated full-year sales and operating profit outlook at CER. In the first six months of 2025, Novo Nordisk's sales increased by 18% and operating profit increased by 29%, both at CER. Sales growth in the first six months of 2025 was positively impacted by gross-to-net sales adjustments related to prior years, including an adjustment related to the 340B provision of around DKK 3 billion in the second quarter of 2025. Operating profit growth is positively impacted by the ocedurenone impairment in the second quarter of 2024, partially countered by impacts related to the acquisition of the three Catalent manufacturing sites. Profit and loss Second quarter 2025 First six months 2025 Sales growth (CER) 18% 18% Operating profit growth (EBIT) (CER) 40% 29% Diluted earnings per share (in DKK) 5.96 12.49 Novo Nordisk has updated the full-year outlook for 2025, with sales growth now expected to be 8-14% and operating profit growth expected to be 10-16%, both at CER. Sales and operating profit growth reported in Danish kroner is now expected to be 4 and 7 percentage points lower than at CER, respectively, primarily due to depreciation of the USD/DKK exchange rate1. Outlook 2025 (CER) Expectations 29 July Expectations 7 May Sales growth 8-14% 13-21% Operating profit growth (EBIT) 10-16% 16-24% The lowered sales outlook for 2025 is driven by lower growth expectations for the second half of 2025. This is related to lower growth expectations for Wegovy® in the US obesity market, lower growth expectations for Ozempic® in the US GLP-1 diabetes market, as well as lower-than-expected penetration for Wegovy® in select IO markets. For Wegovy® in the US, the sales outlook reflects the persistent use of compounded GLP-1s, slower-than-expected market expansion and competition. Despite the expiry of the FDA grace period for mass compounding on 22 May 2025, Novo Nordisk market research shows that unsafe and unlawful mass compounding has continued, and that multiple entities continue to market and sell compounded GLP-1s under the false guise of 'personalisation'. Novo Nordisk is pursuing multiple strategies, including litigation, to protect patients from knockoff 'semaglutide' drugs. Novo Nordisk is deeply concerned that, without aggressive intervention by federal and state regulators and law enforcement, patients will continue to be exposed to the significant risks posed by knockoff 'semaglutide' drugs made with illicit or inauthentic foreign active pharmaceutical ingredients. As unsafe and unlawful mass compounding continues, the Wegovy® penetration within the cash channel has been lower-than-expected. Within this channel, NovoCare® Pharmacy was launched in March 2025. Wegovy® prescriptions via NovoCare® Pharmacy (including TeleHealth collaborations) amount to around 11,000 total weekly prescriptions, in addition to around 20,000 weekly prescriptions in the retail cash channel. Novo Nordisk will continue to invest in the expansion of direct-to-patient initiatives such as NovoCare® Pharmacy and further collaborations with telehealth organisations. Within the insured channel, despite the initiation of new commercial activities of Wegovy® in the first half of 2025, the sales outlook also reflects lower-than-expected penetration for Wegovy®, mainly due to slower market expansion and competition. Novo Nordisk continues to engage in additional commercial initiatives and expects a regulatory decision around the Wegovy® MASH indication during the second half of 2025. Moreover, Novo Nordisk continues to expect a positive contribution from changes to the CVS national template formulary effective 1 July 2025, where Wegovy® is now the only GLP-1 medicine covered for obesity. For Ozempic®, the updated outlook is negatively impacted by competition in the US. Novo Nordisk continues to invest in commercial activities and label updates towards driving further market penetration of Ozempic®. Finally, while IO Wegovy® sales are growing at high rates and launches are progressing, the sales outlook reflects lower-than-expected penetration for Wegovy® in select IO markets due to slower market expansion and competition. With around 1 billion people living with obesity globally and only a few million on treatment, the outlook reflects a continued global rollout of Wegovy® to more markets. The updated expectation for operating profit growth reflects the lower sales growth outlook, partially countered by reduced spending. A negative mid-single-digit operating profit growth impact related to the acquisition of the three former Catalent manufacturing sites remains included in the guidance. Novo Nordisk now expects financial items (net) for 2025 to amount to a gain of around DKK 3 billion. This is mainly driven by expected gains on hedged currencies, primarily the US dollar, partially offset by interest expenses related to funding of the debt-financed Catalent transaction. Finally, the free cash flow is now expected to be DKK 35-45 billion, reflecting the lower-than-planned expected sales growth, mainly driven by lower volume growth of GLP-1-based treatments in the US and related cash flow implications amplified by the US gross-to-net system. Novo Nordisk's full disclosure of the financial results for the first six months of 2025 will be published on 6 August 2025, where more information will be available. The above expectations are based on additional assumptions, including assumptions described on pages 14 and 15 of the Financial report for the first three months of 2025 (Company Announcement No 14/2025). The forward-looking statements on page 23 in the Financial report for the first three months of 2025 (Company Announcement No 14/2025) also apply to this company announcement. Conference call Novo Nordisk will host a conference call for investors at 14.30 CEST on 29 July 2025, corresponding to 8.30 am EST. For more information on how to listen, please visit the investor section of About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode +45 3075 5956 jrde@ Sina Meyer +45 3079 6656 azey@ Max Ung +45 3077 6414 mxun@ Frederik Taylor Pitter (US)+1 609 613 0568 fptr@ Publication of inside information pursuant to Market Abuse Regulation, Article 17 1 Based on exchange rates of 23 July 2025 with e.g. a USD/DKK spot rate of 635. Full currency overview to be released as part of Novo Nordisk's full disclosure of the financial results on 6 August 2025 Company announcement No 18 / 2025 Attachment CA250729-Q2-Financial-OutlookError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

In Ozempic's home town they fear two things: a new set of tariffs, and a company in Kinsale
In Ozempic's home town they fear two things: a new set of tariffs, and a company in Kinsale

Irish Times

time2 days ago

  • Business
  • Irish Times

In Ozempic's home town they fear two things: a new set of tariffs, and a company in Kinsale

It's an overcast morning in the small town of Bagsværd, Denmark , and the streets are empty. The suburb north of Copenhagen looks like any quiet neighbourhood at first glance. It only takes a few minutes to walk the length of the main street, then you start to pass small red brick houses with well-kept gardens. This isn't the type of place where you would expect to find one of Europe's biggest companies. Turn a corner, though, and you suddenly face a long road with row after row of sleek office buildings. In a few short years Novo Nordisk has morphed from a relatively low-profile Danish manufacturer of diabetes medication, into a pharmaceutical giant , on the back of massive demand for its new weight-loss drugs, Ozempic and Wegovy . READ MORE The market value of the company surpassed the size of Denmark's entire economy last year and, for a period, Novo Nordisk was Europe's most valuable company, eclipsing LVMH, the French luxury brand conglomerate that includes Louis Vuitton, Dior and Tiffany. 'I think every second person works there,' says Dorte Soelmark, a woman who runs a bakery nearby Novo Nordisk's headquarters in Bagsværd. The presence of the pharmaceutical giant in the neighbourhood is good for business, but she says there are downsides as well, from traffic bottlenecks to rising house prices. 'You leave at a certain time during the day, the traffic is just horrendous,' Soelmark says. [ Donald Trump says his tariff plan is working - but he now faces a vital call Opens in new window ] Dorte Soelmark, a worker in a bakery near Novo Nordisk's head offices in Bagsværd, Denmark Jesper Chistiansen, who owns a men's clothes shop in a small outlet in the town, says Novo Nordisk's success has been great for Denmark. 'It's very good for the whole country, for the community in Bagsværd,' he says. 'But also it's very expensive to live here.' The company has had a footprint in the Danish town since 1961, when it opened a laboratory. Its presence expanded significantly over the years. New offices for its headquarters were built a decade ago. The company employs 77,000 people, half of whom work in Denmark between Bagsværd and Kalundborg, where it has plans to massively expand a manufacturing plant and other sites. Novo Nordisk's stratospheric rise has been tied to huge demand for its blockbuster weight-loss drugs, Ozempic and Wegovy. The anti-obesity medication inhibits the appetite and is administered by regular injections. Popularised as a way to lose weight by Hollywood celebrities, there had been a global clamour for Ozempic, either prescribed by a doctor or through rapidly expanding black markets selling the jab online. Production has struggled to keep pace, leading to supply shortages. Jesper Chistiansen says Novo Nordisk's success has been great for Denmark Bumper corporate tax receipts from Novo Nordisk have insulated Denmark economically, but also left the public balance sheet exposed to any big downturn in the company's fortunes. The pharma sector – one of Europe's big industrial beasts – is bracing itself for United States president Donald Trump to follow through on threats to levy huge tariffs on its exports to the US. Trump has repeatedly talked about bringing jobs and manufacturing capacity created by US pharma multinationals in Europe back to the US. To do this, the US president has threatened to put tariffs – which are effectively taxes on imports – of up to 200 per cent on pharma products coming across the Atlantic, in an attempt to force companies to make their medicines in the US. The European Union (EU) and the Trump administration have negotiated a deal that would see tariffs on most EU imports capped at 15 per cent , to avoid a trade war. The EU has pressed hard for any future import levies on pharma products to be capped at that blanket 15 per cent rate. However, EU officials remain concerned that regardless of commitments in a preliminary deal, Trump could decide to put sweeping tariffs on pharma anyway down the line. Novo Nordisk is on high alert waiting to see how things play out, like the rest of the industry. Novo Nordisk's stratospheric rise has been tied to huge demand for its blockbuster weight-loss drugs, Ozempic and Wegovy. Photograph: Sergei Gapon/ AFP via Getty Images Separate to the threats coming from Washington, the Danish company is also concerned about what is going on in Kinsale, Co Cork. That's where US pharma giant Eli Lilly has been producing a rival diabetes and weight-loss drug, Mounjaro. The US multinational has made up ground on Novo Nordisk, in the race for the biggest share of the highly profitable anti-obesity market. Research pointing to its drug offering better results, plus successful trials in the development of new medication that can be taken as a daily pill, rather than a weekly injection, has set Eli Lilly up to potentially overtake Novo Nordisk in that race. Fearful of falling behind, Novo Nordisk recently announced a corporate reshuffle. Chief executive Lars Fruergaard Jørgensen, who had been with the company for more than three decades, was out. In a statement announcing the shake-up this May, Novo Nordisk said its sales and profits had almost tripled during Jørgensen's tenure at the top. However, the decision was taken based on 'recent market challenges' and drops in the firm's share price, it said. [ Pharma companies unprepared for production shift amid US tariffs Opens in new window ] In an industry where so much of the focus is on developing new products, the ousting of Jørgensen is a cautionary tale. 'You can be flying one day and the next day you're down on the ground,' says one source in another pharma company. In Belgium, the pharmaceutical industry is managing the fall off of a different type of recent boom in business. The small country was a big producer of Covid-19 vaccines. A Pfizer factory in the north of the country in Puurs, worked full throttle during the height of the pandemic. One of the company's largest plants, it can produce 500 million vaccine doses a year. Covid-19 vaccines accounted for a third of Belgium's pharma exports in 2022, according to a recent industry report. Pharma is one of Belgium's biggest exports, with the US accounting for about a quarter of that trade. Trump's tariff agenda has caused serious uncertainty, says Liesbet Sommen, a centre-right MEP from Belgium. 'One day he says one thing and the next day he says another,' she adds. Huge numbers of people were employed by Belgium's 'pharma valley', so the stakes are high, she says. Several sources in the industry say companies would likely have to suck up the cost of US tariffs, rather than pass part of them on. This is because they are locked into long-term contracts on pricing in the US. Accepting import taxes of 15 per cent would be a hit. About a dozen of the EU's 27 states host sizeable pharma industries. Photograph: Sergei Gapon/ AFP via Getty Images Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations, says part of the problem is the intertwined nature of supply chains. 'There's no product that is made in one country. Sometimes products cross the Atlantic a couple of times before they are finished, so if you had tariffs on one side, and or the other side, you would end up adding cost to that product,' she says. 'There's really a danger of completely destabilising the supply of medicines for patients, wherever that might be in the world,' she says. This is a point the industry has spent a lot of lobbying capital in Washington trying to drive home to the Trump administration. About a dozen of the EU's 27 states host sizeable pharma industries, though few governments are feeling as exposed as Ireland. Pharmaceuticals account for a huge portion of the Republic's large flow of exports to the US. Several US multinationals, Pfizer, Merck Sharp & Dohme (MSD), Eli Lilly, Johnson & Johnson (J&J) and others, have manufacturing plants in Ireland. The sector employs tens of thousands of people and a handful of those companies alone account for a decent chunk of the State's corporate tax take each year. When talking about pharma, Trump repeatedly singles out Ireland as having 'stolen' those jobs and revenues from the US. [ Irish exports climb to €134.4bn as US pharma sales surge Opens in new window ] Documents obtained by The Irish Times show the pharma industry has kept up that lobbying pressure, in both Dublin and Brussels. Photograph: Sergei Gapon/ AFP via Getty Images Taoiseach Micheál Martin has compared notes with several senior pharma executives about the best way to manage Trump's threats. Martin spoke to Pfizer's global chief executive, Albert Bourla, on the phone the day after Trump announced his 'liberation day' tariffs on nearly all global trading partners in early April. The Taoiseach outlined the thinking in the EU, while Bourla 'updated on discussions and contacts with the US administration,' a note of the call said. Separate calls on the same day with Robert Davis, chief executive of MSD, and Joaquin Duato, the chief executive of J&J, covered much the same ground. Tariffs weren't the only thing on the mind of the pharma executives, Davis also mentioned planned reforms of the EU's regulations governing the sector, according to a note taken of the call. The proposed changes would cut back a current eight-year window pharma companies have to exclusively sell new drugs they produce, before cheaper generic competitors enter the market. The idea is to tie more strings to the number of years of market dominance drugmakers enjoy over new medicines, to push companies to roll out medicines in smaller and poorer EU states more quickly. The industry has been furiously lobbying national capitals to kill that element of the proposed overhaul. A parallel lobbying campaign has been waged in Brussels, targeting MEPs in the European Parliament and the European Commission, the EU's executive arm that proposed the reforms. Documents obtained by The Irish Times show the pharma industry has kept up that lobbying pressure, in Dublin and Brussels. The risk posed by Trump's potential tariffs has strengthened the industry's hand when arguing that now is not the time for such changes. Employees are seen through windows as they work at the Novo Nordisk headquarters in Denmark. Photograph: Sergei Gapon/ AFP via Getty Images In a letter on March 7th to a senior adviser of EU industry commissioner Stéphane Séjourné, Pfizer said there was an 'urgent need' for Europe to do more to be economically competitive, due to 'recent geopolitical developments'. The commission's plan to cut back firms' regulatory protection over new medicines was 'not the right approach,' Michaela Hagenhofer, head of J&J's Irish operation, told Minister for Enterprise Peter Burke . The February 25th letter asked Ireland to join the Coalition of 'pro-innovation' countries opposing the changes at EU-level. Samantha Humphreys, MSD's Irish director, urged the Government to maintain the 'status quo', in a February 11th letter. The correspondence was released to The Irish Times following Freedom of Information Act requests. Further internal records reveal the Department of Health wanted Ireland to stick to its 'more balanced' view that some changes were needed, according to a March 18th briefing paper. [ Looming 'patent cliff' facing Big Pharma adds to sector's woes Opens in new window ] In the end the Taoiseach came down on the side of industry in the debate. Ireland switched positions and joined the camp of countries opposed to diluting the 'protection' firms had over new drugs they developed. National capitals settled on keeping the eight-year window untouched, in an EU vote earlier this year. A pared back version of the new regulations are likely to be signed off in the coming months, in what will be a significant win for the pharma sector. Many of the industry's top executives have probably spent recent months wishing they could command the same level of influence over policy in the White House, given the fight over tariffs that is likely still to come.

Novo Nordisk A/S: Mim8 prophylaxis treatment shown to be well-tolerated when switching from emicizumab in people with haemophilia A in new phase 3 data presented at the ISTH 2025 Congress
Novo Nordisk A/S: Mim8 prophylaxis treatment shown to be well-tolerated when switching from emicizumab in people with haemophilia A in new phase 3 data presented at the ISTH 2025 Congress

Yahoo

time22-06-2025

  • Health
  • Yahoo

Novo Nordisk A/S: Mim8 prophylaxis treatment shown to be well-tolerated when switching from emicizumab in people with haemophilia A in new phase 3 data presented at the ISTH 2025 Congress

New FRONTIER5 data show that a direct switch to investigational Mim8 (denecimig) prophylaxis treatment from emicizumab, without the need for a washout period, was well-tolerated with no safety concerns in adults and adolescents with haemophilia A, with or without inhibitors1. Switching to Mim8 led to a sustained increase in thrombin generation into the normal range, but without causing thrombin levels that might pose a thrombotic risk1. FRONTIER5 Patient-Reported Outcomes (PROs) assessment found the Mim8 pen-injector easy to use, with strong user preference over their emicizumab injection system2. These results add to the overall safety profile of Mim8 based on the FRONTIER clinical trial Denmark, 22 June 2025 – Novo Nordisk today presented results from the phase 3b FRONTIER5 trial showing that a direct switch to investigational Mim8 (denecimig) prophylaxis from emicizumab treatment, without a washout period or Mim8 loading dose, was well-tolerated with no safety concerns in adults and adolescents living with haemophilia A, with or without inhibitors1. Additionally, a FRONTIER5 Patient-Reported Outcomes (PROs) assessment found the Mim8 pen-injector easy to use, with an overall strong user preference for the pen-injector compared to the previous emicizumab injection system2,3. The results were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C. In the study, the first Mim8 maintenance dose was administered on the next planned emicizumab dosing day. Patients were given the option of switching to once-monthly, once every two weeks or once-weekly dosing frequencies of Mim8, regardless of their prior dosing frequency1,3. Steady-state Mim8 concentration was achieved by Week 16, and emicizumab elimination was completed by Week 261. Switching to Mim8 led to a sustained increase in thrombin peak levels without an exaggerated thrombin response1. 'Continuous prophylactic coverage is critical to avoiding breakthrough bleeds in people living with haemophilia; with new non-factor therapeutic options, many people could have hesitations about switching treatment options. These data demonstrate that switching to Mim8 from emicizumab can be done without requiring a washout period,' said Allison P. Wheeler, MD, Washington Center for Bleeding Disorders, Seattle, WA. 'This is critical in ensuring that individuals maintain continuous protection against bleeding events as we seek to help address the ongoing needs of people living with this complex disease.' The open-label phase 3b FRONTIER5 study consisted of 61 adults and adolescents, aged 12 years and older, with haemophilia A. Mim8 was well-tolerated with no safety concerns. No thromboembolic events, hypersensitivity reactions, or treatment-emergent adverse events (TEAEs) leading to discontinuation were observed, and there was no clinical evidence of neutralising anti-Mim8 antibodies1. The PROs data from FRONTIER5 indicated a strong overall preference for the Mim8 pen-injector, with 97% (n=57/59) of patients reporting a 'very strong' or 'fairly strong' preference in comparison to their previous emicizumab injection system2. Of the participants who completed the Haemophilia Device Handling and Preference Assessment (HDHPA) questionnaire at week 26, 98% (n=58/59) found the Mim8 pen-injector 'very easy' or 'easy' to use, and 95% (n=56/59) found it 'much easier' or 'easier' compared with their previous administration method. All participants (100%) were 'extremely confident' or 'very confident' in using the pen-injector correctly, and most participants (83%; n=49/59) found it 'very easy' to inject the dose2. 'The FRONTIER5 safety and patient-reported outcomes data support Mim8 as a potential future treatment option for people living with haemophilia A and demonstrate our continued commitment to developing innovative treatment options for this community', said Stephanie Seremetis, chief medical officer and CVP for Haemophilia at Novo Nordisk. 'These results give valuable insights into haemophilia A management, highlight the feasibility of directly switching to Mim8 from emicizumab, and reveal a strong patient preference for the Mim8 pen-injector device.' Novo Nordisk expects to submit Mim8 for regulatory review during 2025. Data from the ongoing phase 3 FRONTIER programme will be disclosed at upcoming congresses and in publications in 2025 and 2026. About haemophiliaHaemophilia is a rare inherited bleeding disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding4. It is estimated to affect approximately 1,125,000 people worldwide5. There are different types of haemophilia, which are characterised by the type of clotting factor protein that is defective or missing4. Haemophilia A is caused by a missing or defective clotting Factor VIII (FVIII), and haemophilia B is caused by a missing or defective clotting Factor IX4. Inhibitors are an immune system response to the clotting factors in replacement therapy. Currently, it is estimated that up to 30% of people living with severe haemophilia A develop inhibitors6 that can cause replacement therapies to stop working. About Mim8 Mim8 is an investigational FVIIIa mimetic bispecific antibody optimised with the aim to deliver improved potency and sustained efficacy across flexible dosing intervals up to once-monthly prophylaxis for people living with haemophilia A, with or without inhibitors7-10. Administered under the skin, Mim8 bridges Factor IXa and Factor X. This action replaces FVIII function, which helps restore the body's thrombin generation capacity into the normal range, helping blood to clot7,11. The use of Mim8 in people living with haemophilia A is investigational and not approved by regulatory authorities or available anywhere in the world. About the FRONTIER5 trialFRONTIER5 is a single-arm, open-label, 26-week, phase 3b trial evaluating the safety of switching from previous emicizumab prophylaxis treatment directly to Mim8 prophylaxis treatment using the Mim8 pen-injector in adults and adolescents with haemophilia A, with or without inhibitors3. The FRONTIER clinical programme investigates Mim8 as a prophylaxis treatment for people with haemophilia A, with or without inhibitors. This programme includes FRONTIER1, FRONTIER2, FRONTIER3, FRONTIER4 and FRONTIER53,12-15. About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649idmg@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________ References Oldenberg J, Benson G, Chowdaryet P, et al. FRONTIER5 direct switch study: Safety of initiating Mim8 prophylaxis without washout of emicizumab. Oral presentation presented at the Congress of the International Society on Thrombosis and Haemostasis 2025; June 21-25 2025; Walter E. Washington Convention Center, Washington D.C., US. Session code 13686. Mahlangu J, Ahuja S, Cockrell E, et al. FRONTIER5 device handling and patient-reported outcomes. Oral presentation presented at the Congress of the International Society on Thrombosis and Haemostasis 2025; June 21–25 2025; Walter E. Washington Convention Center, Washington D.C., US. Session code 13786. A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER5). Available at: Last accessed: June 2025. MedlinePlus. Hemophilia. Available at: Last accessed: June 2025. Iorio A, Stonebraker JS, Chambost H, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach Using National Registries. Ann Intern Med. 2019;171:540–546. doi: 10.7326/M19-1208. Kim JY, You CW. The prevalence and risk factors of inhibitor development of FVIII in previously treated patients with hemophilia A. Blood Res. 2019;54:204-209. doi: 10.5045/br.2019.54.3.204. Ostergaard H, Lund J, Greisen PJ, et al. A factor VIIIa-mimetic bispecific antibody, Mim8, ameliorates bleeding upon severe vascular challenge in hemophilia A mice. Blood. 2021;138:1258-1268. doi: 10.1182/blood.2020010331. Mancuso EM, et al. Efficacy and safety of Mim8 prophylaxis in adults and adolescents with hemophilia A with or without inhibitors: Phase 3, open-label, randomized, controlled FRONTIER2 study. Abstract presented at the International Society on Thrombosis and Haemostasis (ISTH) 2024 Congress. Kenet G, et al. Patient- and caregiver-reported outcomes with subcutaneous Mim8 prophylaxis in paediatric patients with haemophilia A with or without factor VIII inhibitors: phase 3 FRONTIER3 study. Abstract presented at the European Association for Haemophilia and Allied Disorders (EAHAD) 2025 Annual Congress. Session 6. Chowdary P, Banchev AM, Kavakli K, et al. Safety and Efficacy of Mim8 Prophylaxis Administered Once Every Two Weeks for Patients with Hemophilia A with or without Inhibitors: Interim Analysis of the FRONTIER4 Open-Label Extension Study. Abstract presented at the American Society of Hematology (ASH) 2024 Annual Congress. Session: 322. U.S. National Library of Medicine. F8 gene. MedlinePlus Genetics. Available at Last accessed: June 2025. A Research Study Investigating Mim8 in People With Haemophilia A (FRONTIER1). Available at: Last accessed: June 2025. A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors. Available at: Last accessed: June 2025. A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors. Available at: Last accessed: June 2025. A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A (FRONTIER4). Available at: Last accessed: June 2025. 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Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine
Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine

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time22-06-2025

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Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine

Data presented simultaneously at the American Diabetes Association's® 85th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions1 When adhering to treatment, weight loss of ≥5%, ≥20%, ≥25%, and ≥30% was observed in 97.6%, 60.2%, 40.4% and 23.1% of patients respectively at 68 weeks1* The REDEFINE clinical programme is ongoing to further investigate efficacy and safety of CagriSema, including recently initiated REDEFINE 112 Bagsværd, Denmark, 22 June – Today, The New England Journal of Medicine (NEJM) published results from Novo Nordisk's phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.1 REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.1 These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today during a scientific symposium at the American Diabetes Association's (ADA) 85th Scientific Sessions and published in NEJM. 'In REDEFINE 1, participants saw significant and clinically meaningful weight loss under a protocol that allowed investigators to maintain patients on a submaximal dose if deemed best for the patient. We also witnessed low, single-digit discontinuation rates due to adverse events in both REDEFINE 1 and 2,' said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. 'These results reinforce our confidence in CagriSema, and we continue to study the potential of this combination through the REDEFINE trials.' CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group if all patients adhered to treatment.1* When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group.1** In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI < 30 kg/m2) at the end of treatment, from a mean BMI of 38 kg/m2 at the start of treatment. In the placebo group,10.2% reached that threshold at 68 weeks.1 Select confirmatory secondary endpoints showed that if all participants adhered to treatment 40.4% of those receiving CagriSema achieved a body weight reduction of ≥25%.* Additionally, 23.1% lost ≥30% of their body weight.1* When applying the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ≥25% body-weight reduction and 19.3% achieved ≥30% body-weight reduction.1** In a prespecified analysis of 252 participants, the relative reduction in fat and lean soft-tissue mass from baseline to week 68 was -35.7% (fat mass) and -14.4% (lean soft-tissue mass) for those treated with CagriSema versus –5.7% and –4.3% for the placebo group, respectively.1 "In REDEFINE 1, CagriSema provided weight loss in the highest range of efficacy observed with existing weight loss interventions,' said lead investigator Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. 'Investigators were allowed some flexibility in dose adjustments to balance efficacy and safety, but regardless of dose adjustments participants lost significant weight. These findings are relatable to clinical practice, where dosing is often adjusted based on individual needs and clinical judgement.' Safety data generated in the REDEFINE 1 and 2 trials were comparable with the GLP-1 RA class. Overall, discontinuation rates due to adverse events were low, with 6% for CagriSema versus 3.7% for placebo in REDEFINE 1 and 8.4% with CagriSema versus 3% with placebo in REDEFINE 2.1,3 In REDEFINE 1, adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs. 39.9% with placebo), including nausea (55% vs. 12.6 %), constipation (30.7% vs. 11.6%), vomiting (26.1% vs. 4.1%) and were mostly transient and mild-to-moderate in severity.1 Results from REDEFINE 2, a phase 3 study that evaluated the efficacy and safety of CagriSema plus lifestyle interventions in adults with obesity and type 2 diabetes (T2D), were also simultaneously presented during a scientific symposium at the ADA's Scientific Sessions and published in NEJM.3 In REDEFINE 2, if all participants adhered to treatment, the estimated mean change in body weight from baseline to week 68 was –15.7% with CagriSema versus –3.1% with placebo.3* When applying the treatment policy estimand, the estimated mean change in body weight from baseline to week 68 was –13.7% with CagriSema versus –3.4% with placebo.3** A greater proportion of participants receiving CagriSema, compared with placebo, reduced their body weight by >5% (83.6% vs. 30.8% of participants), ≥10% (65.6% vs. 10.3%), ≥15% (43.9% vs. 2.4%), and ≥20% (22.9% vs. 0.5%;).3 The safety results from CagriSema in REDEFINE 2 were similar to those reported in REDEFINE 1.3 The REDEFINE clinical programme will continue to assess the efficacy and safety of CagriSema. Most recently, Novo Nordisk initiated the REDEFINE 11 trial with the first patient visit occurring in early June 2025. REDEFINE 11 will explore further weight loss potential and safety of CagriSema 2.4 mg / 2.4 mg through a longer trial duration and other protocol changes compared to REDEFINE 1 and 2. * Based on the trial product estimand; this estimand estimates what the effect would be if all participants adhered to treatment ** Based on the treatment policy estimand: treatment effect regardless of treatment adherence About CagriSemaCagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. About the REDEFINE clinical trial programmeREDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. REDEFINE 1 and REDEFINE 2 have enrolled approximately 4,600 adults with overweight or obesity. REDEFINE 1 was a double-blind, placebo-and active-controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. REDEFINE 2 was a double-blind, randomized, placebo- and controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight. Multiple REDEFINE clinical trials are currently underway including: REDEFINE 3, an event-driven cardiovascular outcomes phase 3 trial; REDEFINE 4 an 84-week head-to-head efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide; and REDEFINE 11, a phase 3 trial with longer duration and other protocol changes compared to REDEFINE 1 and 2. About obesity Obesity is a serious chronic, progressive, and complex disease that requires long-term management.4-6 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.4,6 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.7,8 Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289 abmo@ Liz Skrbkova (US) +1 609 917 0632 lzsk@ Investors: Jacob Martin Wiborg Rode +45 3075 5956 jrde@ Ida Schaap Melvold +45 3077 5649 idmg@ Sina Meyer +45 3079 6656 azey@ Max Ung +45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568 fptr@ References: Garvey WT, Blüher MD, Contreras CKO, et al. CagriSema in Adults with Overweight or Obesity. New England Journal of Medicine 2025. doi: 10.1056/NEJMoa2502081 A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term. Last Accessed: June 2025. Available at: Davies MJ, Harpreet S, Bajaj MD, et al. CagriSema in Adults with Overweight or Obesity and Type 2 Diabetes. New England Journal of Medicine 2025. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: Attachment PR250622-ADA-CagriSema

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