Novo Nordisk outgoing CEO blames compounded GLP-1s for decline in 2025 outlook
The maker of GLP-1 drugs Ozempic and Wegovy cut sales grown from 13%-21% down to 8%-14% for the year. That's about half, on the higher end, of the 26% growth seen in 2024. Outgoing CEO Lars Jøregensen told reporters Tuesday that the compounding, or copycat, market in the US is to blame.
That is one of two key issues that appear to have taken the company by surprise. First was the shortage of both its GLP-1 drugs after they unexpectedly zoomed to popularity, creating a new weight-loss drug market.
Jørgensen said that the prevalence of compounded products, which are now restricted after the FDA declared an end to the shortage, is to blame.
"Despite the fact that it is now illegal ... it's still happening. And that's one of the assumptions in the prior guidance, that that would be reduced significantly. And we see, actually, that is actually the same volume as we saw earlier in the year, around a million patients using a compounded product," Jørgensen said.
The compounded products include those from Novo's ex-partner, Hims & Hers (HIMS), which continues to sell the products based on a loophole in FDA rules that allows it to sell "personalized" products for patients who might have negative reactions or side effects to branded drugs — such as common GLP-1 side effects like nausea or dizziness. Novo recently ended its direct-to-consumer sales deal with Hims after the telehealth firm declined to stop selling compounded semaglutide vials.
The result has been a loss in the company's first-to-market position, with competitor Eli Lilly (LLY) taking a harder stance, most recently lobbying Congress to help enforce the FDA rules and rid the market of compounding.
Jørgensen said Tuesday, "Ultimately, compounding will disappear. But it will take some time before it's completely out of the market and we have a fair chance of regaining our fair share (of the market)."
Incoming CEO Mike Doustdar, who has served as Novo's executive vice president of international operations, said the decline of the company's stock, and therefore shareholder value, is disappointing.
"I don't like it as an employee ... as a CEO-elect, and I certainly don't like it as a shareholder myself. But setbacks don't define companies, our response does," Doustdar said, adding that the guidance cut reinforces his mandate to put the company back onto a growth path.
Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, provider services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee as AnjKhem on social media platforms X, LinkedIn, and Bluesky @AnjKhem.
Click here for in-depth analysis of the latest health industry news and events impacting stock prices
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Upturn
13 minutes ago
- Business Upturn
Silexion Therapeutics Announces Exercise of Warrants for $1.8 Million Gross Proceeds
Cayman Islands, July 31, 2025 (GLOBE NEWSWIRE) — Silexion Therapeutics Corp. (NASDAQ: SLXN) ('Silexion Therapeutics' or the 'Company'), a clinical-stage biotech company developing RNA interference (RNAi) therapies for KRAS-driven cancers, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 152,106 of the Company's ordinary shares originally issued in January 2025 at a reduced exercise price of $11.57 per share. The ordinary shares issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-1 (File No. 333-282932) and an effective resale registration statement on Form S-1 (No. 333-284873). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $1.8 million, prior to deducting placement agent fees and estimated offering expenses. The offering is expected to close on or about August 1, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering as working capital for general corporate purposes. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase up to 304,212 of the Company's ordinary shares. The new warrants will have an exercise price of $11.32 per share, will be exercisable upon the effective date of the increase of the Company's authorized ordinary shares following shareholder approval and will have a term of twenty-four months from the effective date of the Resale Registration Statement (as defined below). The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the '1933 Act') and, along with the ordinary shares issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ('SEC') or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the ordinary shares issuable upon exercise of the new warrants (the 'Resale Registration Statement'). This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Silexion Therapeutics Silexion Therapeutics Corp is a pioneering clinical-stage, oncology-focused biotechnology company developing innovative RNA interference (RNAi) therapies to treat solid tumors driven by KRAS mutations, the most common oncogenic driver in human cancers. The Company's first-generation product, LODER™, has shown promising results in a Phase 2 trial for non-resectable pancreatic cancer. Silexion is also advancing its next-generation siRNA candidate, SIL-204, designed to target a broader range of KRAS mutations and showing significant potential in preclinical studies. The company remains committed to pushing the boundaries of therapeutic innovation in oncology, with a focus on improving outcomes for patients with difficult-to-treat cancers. For more information please visit: Notice Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including statements regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of net proceeds from the offering. These forward-looking statements are generally identified by terminology such as 'may', 'should', 'could', 'might', 'plan', 'possible', 'project', 'strive', 'budget', 'forecast', 'expect', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential' or 'continue', or the negatives of these terms or variations of them or similar terminology. For example, the Company is using forward-looking statements when it discusses the timing and completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of proceeds therefrom. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) whether Silexion is able to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion's strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion's future capital requirements and sources and uses of cash, including its ability to obtain additional capital; and (vi) whether Silexion succeeds at maintaining the listing of its securities on the Nasdaq Capital Market. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law. Company Contact: Silexion Therapeutics CorpMs. Mirit Horenshtein Hadar, CFO [email protected]
Yahoo
an hour ago
- Yahoo
Vodka seltzers mislabeled as energy drinks trigger product recall
Americans have been advised that some packages of a brand of vodka seltzers have been mistakenly mislabeled as a non-alcoholic high energy drink, triggering a recall announcement from High Noon, the alcoholic beverage brand, that was posted by the the US Food and Drug Administration. In a statement, High Noon said two lots of High Noon Beach Variety 12-packs contain cans mislabeled as 'CELSIUS® ASTRO VIBE Energy Drink, Sparkling Blue Razz Edition'. 'Consumption of the liquid in these cans will result in unintentional alcohol ingestion,' the brand warned. The recall was declared after High Noon discovered that a shared packaging supplier had mistakenly sent it empty Celsius cans. The recalled packs were shipped to distributors in Florida, Michigan, New York, Ohio, Oklahoma, South Carolina, Virginia and Wisconsin. High Noon said no illnesses or adverse events have so far been reported. • This article was amended on 31 July 2025. A previous version said the FDA recalled the energy drink cans when it was actually High Noon that announced and led the recall on its vodka seltzer products with the FDA's awareness. Solve the daily Crossword
Yahoo
2 hours ago
- Yahoo
European regulatory authority adopts positive opinion for Novo Nordisk's Alhemo® (concizumab), recommending label expansion to treat haemophilia A and B without inhibitors
Pending European Commission (EC) approval, Alhemo® will become available to all adult and paediatric patients 12 years and older living with severe haemophilia A and moderate or severe haemophilia B without inhibitors. This positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is based on results from the explorer8 trial, which showed that Alhemo® reduced spontaneous and traumatic bleeds for patients living with haemophilia A and B without inhibitors compared with no prophylaxis1. If approved by the EC, Alhemo®, with its pen-injector device, has the potential to be an efficacious and easy-to-use option for patients with haemophilia A and B without inhibitors1-3. Bagsværd, Denmark, 25 July 2025 – Novo Nordisk today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an update of the Alhemo® (concizumab) label to include the treatment of severe haemophilia A and moderate or severe haemophilia B without inhibitors. 'If approved by the European Commission, this label update would extend Alhemo®'s convenient once-daily, under-the-skin administration to patients living with haemophilia without inhibitors, providing an efficacious prophylactic choice,' said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. 'Each person living with haemophilia has individual and evolving needs. With its user-friendly, pre-filled, portable pen, we believe that Alhemo® has the potential to offer even more patients an individualised and flexible treatment.' The positive CHMP opinion is based on the results from the phase 3 explorer8 trial, which met its primary endpoint. The results demonstrated that Alhemo® prophylaxis compared with no prophylaxis treatment led to an 86% reduction and 79% reduction in treated spontaneous and traumatic bleeds for patients living with haemophilia A without inhibitors and haemophilia B without inhibitors1, respectively. In this trial, Alhemo® showed a favourable safety profile in patients with haemophilia A and B without inhibitors1. Patient-Reported Outcome (PRO) data from the explorer8 study further indicated an improvement in health-related quality of life and reduction in treatment burden with Alhemo® treatment compared with no prophylaxis3. Specifically, trends favouring Alhemo® over prophylaxis were observed in the short-form health survey (SF-36v2) and Haemophilia Quality of Life Questionnaire for Adults (Haem-A-QoL) results, in patients with haemophilia A and haemophilia B; these included the change in 'bodily pain' and 'physical functioning' from baseline to week 24 in the survey, and the Haem-A-QoL 'total score' and the 'physical health' domain score3. Treatment preference results showed patients were also in favour of Alhemo® over no prophylaxis or previous treatment, with 70.9% of respondents indicating they prefer Alhemo® over their previous haemophilia treatment3. Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission (EC) to approve the label update within approximately two months. About Alhemo® (concizumab)Alhemo® (concizumab) is an anti-tissue factor pathway inhibitor (TFPI), monoclonal antibody designed to block a protein in the body that stops blood from clotting. By blocking TFPI, Alhemo® ensures the production of thrombin, which helps to clot the blood and prevent bleeding4. Alhemo® is currently approved in Europe5, the United States6, India7, Brazil8 and Switzerland9 for the treatment of adolescents and adults (12 years or older) with haemophilia A and B with inhibitors. In Japan10 and Australia11, Alhemo® is currently approved for the treatment of adolescents and adults (12 years or older) with haemophilia A and B with and without inhibitors. In all approved countries, it is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. About the explorer8 studyExplorer8 is a multicentre, open-label, randomised, phase 3a clinical trial aimed to establish the efficacy and safety profile of Alhemo® in adults and paediatric patients 12 years of age and older living with congenital severe haemophilia A or moderate or severe haemophilia B without inhibitors1,12. In explorer8, 148 patients were randomly assigned in a 1:2 ratio to receive no prophylaxis (arm 1, n=21) or Alhemo® prophylaxis (arm 2, n=42), and 85 were nonrandomly assigned to receive Alhemo® prophylaxis (arms 3 and 4). The initial loading dose of Alhemo® was 1 mg per kilogram of body weight, followed by 0.2 mg per kilogram daily, and potentially individualised on the basis of concizumab plasma concentration as measured at Week 41,12. The primary analysis was carried out when all patients in arms 1 and 2 completed at least 24 or 32 weeks, respectively, and compared the number of treated spontaneous and traumatic bleeding episodes, measured as annualised bleeding rate, between arms 1 and 21,12. Supportive secondary endpoints, such as percent of patients experiencing zero bleeds, are reported as descriptive results only1,12. The trial is still ongoing in the extension phase and is expected to complete in 20281,12. About haemophiliaHaemophilia is a rare inherited bleeding disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. It is estimated to affect approximately 1,125,000 people worldwide13. Due to the nature of haemophilia being an x-linked recessive disorder, it often presents differently in males compared with females, with roughly 88% of people diagnosed with haemophilia worldwide being male14,15. There are different types of haemophilia, which are characterised by the type of clotting factor protein that is defective or missing. 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 IX (FIX). About Novo NordiskNovo 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@ _______________________References1. Chowdary P, Angchaisuksiri P, Apte S, et al. Concizumab prophylaxis in people with haemophilia A or haemophilia B without inhibitors (explorer8): a prospective, multicentre, open-label, randomised, phase 3a trial. Lancet Haematol. 2024;11:e891–e904. doi: 10.1016/S2352-3026(24)00307-7.2. Kahr Rasmussen N, Berg B, Christiansen ASL, et al. The Concizumab Pen-Injector is Easy to Use and Preferred by Hemophilia Patients and Caregivers: A Usability Study Assessing Pen-Injector Handling and Preference. Patient Prefer Adherence. 2024;18:1713–1727. doi: 10.2147/PPA.S470091.3. Angchaisuksiri P, von Mackensen S, Apte S, et al. Concizumab prophylaxis in people with hemophilia A or B without inhibitors: patient-reported outcome results from the phase 3 explorer8 study. Res Pract Thromb Haemost. 2025;9:102705. doi: 10.1016/ Matsushita T, Shapiro A, Abraham A, et al. Phase 3 Trial of Concizumab in Hemophilia with Inhibitors. N Engl J Med. 2023;389:783–794. doi: 10.1056/NEJMoa2216455.5. Alhemo® (concizumab): Summary of Product Characteristics. 2024. Available at: Last accessed: July 2025. 6. Alhemo® (concizumab-mtci): Prescribing Information. 2024. Available at: Last accessed: July 2025. 7. CDSCO. List of new drugs (r-DNA origin) approved for import and marketing in India during Jan, 2020 – Apr, 2025 Available at: Last accessed: July 2025. 8. Alhemo® (concizumab): Brazil Product Information. 2025. Available at: Last accessed: July 2025. 9. Alhemo® (concizumab): Switzerland Product Information. 2024. Available at: Last accessed: July 2025. 10. Alhemo® (concizumab): Japanese Product Information. Available at: Latest revision date: July 2025. 11. Alhemo® (concizumab): Therapeutic Goods Administration (TGA) Product Information. 2024. Available at: Last accessed: July 2025. 12. NCT04082429. Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (explorer8). Available at: Last Accessed: July 2025. 13. 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/M19-1208.14. Centers for Disease Control and Prevention. About Hemophilia. Available at: Last accessed: July 2025. 15. Statista. Distribution of people with bleeding disorders worldwide in 2020, by gender. Available at: Last accessed: July 2025. Attachment PR250725-Alhemo-CHMP-Positive-OpinionSign in to access your portfolio
