EU approves higher dose of Novo's Wegovy | ReutersSkip to main content[Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv]Boxes of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy in London, Britain March 8, 2024. REUTERS/Hollie Adams/File Photo [Purchase Licensing Rights, opens new tab]- Companies[Novo Nordisk A/S]FollowFeb 17 (Reuters) - The European Commission has approved a higher dose of Novo Nordisk's [(NOVOb.CO), opens new tab] popular weight- ...

Core Viewpoint - The European Commission has approved a new 7.2 mg once-weekly maintenance dose of Wegovy (semaglutide injection) for adults living with obesity, providing an additional option for weight loss after the 2.4 mg dose [1][6]. Group 1: Approval and Dosage Information - The 7.2 mg dosage can be prescribed as three 2.4 mg injections taken in one sitting, still once a week [2]. - Novo Nordisk has applied for approval of a 7.2 mg single-dose pen in the EU, which could be available this year if approved [2]. - Wegovy 7.2 mg is already approved and available in the UK, with regulatory applications pending with the US FDA and other countries [3]. Group 2: Clinical Study Results - In clinical studies STEP UP and STEP UP T2D, participants taking the 7.2 mg dose lost significantly more weight compared to those on placebo [4]. - On average, participants without diabetes lost about 21% of their body weight with Wegovy 7.2 mg, while placebo participants lost about 2% [7]. - Approximately 1 in 3 participants lost 25% or more of their body weight, with 84% of weight loss coming from fat mass while preserving muscle function [7]. Group 3: Product Information and Indications - Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight loss in adults with a BMI of 30 kg/m or greater, or 27 kg/m or greater with weight-related comorbid conditions [5]. - The injectable semaglutide is available in multiple doses: 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and now 7.2 mg throughout the EU [4][6].

Core Insights - The global weight loss drug market has undergone significant changes in the past five years, with Novo Nordisk's semaglutide gaining approval for weight loss in the U.S. in 2021, marking the entry of GLP-1 weight loss drugs into the pharmaceutical industry [1] - By 2025, Eli Lilly's tirzepatide is projected to achieve $36.5 billion in sales, highlighting the commercial potential of the weight loss sector [1] - The competition has shifted from injectable forms to oral formulations, with Novo Nordisk's oral semaglutide receiving approval in December 2025, becoming the first oral GLP-1 obesity treatment [1][2] Group 1: Market Dynamics - The approval of oral medications signifies a breakthrough beyond the physical limitations of injection pens, enhancing Novo Nordisk's product line defensively [2] - A surge in prescription volume for oral semaglutide has been observed, with approximately 50,000 prescriptions per week by January 23, 2026 [1] - Eli Lilly is also advancing in the oral GLP-1 space with its orforglipron, which has shown positive results in clinical trials and is expected to launch in mid-2026 [2] Group 2: Competitive Landscape - Novo Nordisk's oral semaglutide is a peptide drug, while Eli Lilly's tirzepatide is a small molecule oral drug, showcasing differentiation in their approaches [3] - Small molecule products are expected to have simpler development processes and better cost control, potentially impacting market competition if safety and efficacy are validated [3] - Other pharmaceutical giants, including AstraZeneca and various domestic companies, are also developing oral GLP-1 drugs, indicating a broadening competitive landscape [3][4] Group 3: Clinical Developments - AstraZeneca's oral GLP-1 receptor agonist, elecoglipron, has achieved positive results in key Phase 2 trials and is moving towards Phase 3 development [3] - Domestic companies like HengRui Medicine and others are advancing their oral GLP-1 drug pipelines, with promising clinical trial results [4] - The oral weight loss drug market is expected to grow, but injectable forms will still play a role in the short term, with rising expectations for their effectiveness and safety [4][5] Group 4: Future Outlook - The core patent for semaglutide will expire in 2026 in several markets, paving the way for a wave of generic versions, which may lead to more affordable options for consumers [5] - The penetration of GLP-1 weight loss drugs is anticipated to expand beyond first-tier cities, reaching broader markets [5]

Core Insights - Novo Nordisk is focusing on regaining market share in the GLP-1 space, where it has faced competition from Eli Lilly [1][8] - The company's future growth will depend on the success of its next-generation therapies, particularly CagriSema, as current products are expected to see declining sales [2][6] Product Development - CagriSema is a dual agonist that mimics GLP-1 and amylin, showing promising results in clinical trials [4] - In a phase 3 weight-loss trial, CagriSema achieved a mean weight reduction of 22.7% after 68 weeks, outperforming Wegovy, which had a reduction of 16.1% [4] - Another late-stage study showed CagriSema led to a 1.91% reduction in blood sugar and a 14.2% weight loss in type 2 diabetes patients, surpassing Ozempic's performance [5] Regulatory and Manufacturing Challenges - Novo Nordisk has submitted regulatory applications for CagriSema as a weight loss treatment and plans to seek approval for diabetes treatment after completing additional studies [6] - CagriSema's manufacturing will be more complex and costly compared to semaglutide, which has faced supply constraints [7] Competitive Landscape - Eli Lilly's retatrutide has shown a mean weight loss of up to 28.7%, indicating that Novo Nordisk still faces significant competition [7] - Despite challenges, CagriSema's advantages over Wegovy and Ozempic may enhance Novo Nordisk's market position as the company expands its manufacturing capacity [8] Revenue Potential - Wegovy has received label expansions for treating metabolic dysfunction-associated steatohepatitis (MASH), which could positively impact sales [9] - New approvals and label expansions may help Novo Nordisk's revenue trajectory improve [9]

Core Insights - Novo Nordisk (NVO) shares have dropped 20.5% in the past month due to a weaker-than-expected financial outlook for 2026, despite beating earnings and sales estimates for Q4 2025 [1][11] Financial Performance - The company reported DKK 206.2 billion in sales for 2025, with DKK 53.7 billion generated in Q4 [2] - For 2026, Novo Nordisk expects adjusted sales and operating profit to decline by 5-13% at constant exchange rates (CER), indicating a challenging outlook [4][11] - A one-off $4.2 billion reversal of U.S. 340B rebate provisions will benefit headline sales and operating profit, but this gain is excluded from non-IFRS adjusted metrics, revealing core business weaknesses [4] Market Dynamics - Sales momentum for semaglutide-based drugs has slowed due to increased competition from Eli Lilly (LLY), compounded semaglutide use in the U.S., pricing pressures, and foreign-exchange headwinds [2][5] - In the U.S., slowing prescriptions, reduced Medicaid obesity coverage, and lower realized prices are negatively impacting expectations [5][11] - Eli Lilly's Zepbound has captured significant market share, surpassing Wegovy's sales in 2025, indicating strong competitive pressure [7][14] Growth Challenges - Despite the approval of oral Wegovy, investor optimism has waned due to the disappointing 2026 guidance, raising concerns about its ability to strengthen Novo Nordisk's competitive position [6][11] - The company faces structural growth challenges, with rising costs and limited near-term catalysts further deteriorating its growth outlook [3][8] Strategic Initiatives - Novo Nordisk is expanding its semaglutide reach through new indications and partnerships to mitigate the impact of compounded alternatives [10][12] - The company is also broadening its presence in rare diseases and liver care, with new regulatory filings and approvals for treatments related to hemophilia and metabolic dysfunction-associated steatohepatitis [15][16] Valuation and Estimates - Novo Nordisk shares are trading at a forward price/earnings ratio of 14.76, lower than the industry average of 18.83, indicating a discount in valuation [22] - Earnings estimates for 2026 have decreased from $3.55 to $3.36 per share over the past 60 days, reflecting a negative trend in financial expectations [25]

Core Viewpoint - Novo Nordisk is strategically restructuring its global supply chain for oral weight loss drug Wegovy, focusing on managing production capacity, tariffs, and market timing simultaneously [4][6]. Group 1: Supply Chain Strategy - Novo Nordisk is investing in the Athlone facility in Ireland, acquiring it for approximately $91 million, to serve as a global supply center for non-US markets, allowing for quicker ramp-up of production [4][6]. - The Athlone facility is not a greenfield project but an existing industrial asset, which significantly reduces the time and cost associated with building new production lines [4][6]. - The company is also expanding its Clayton facility in North Carolina with an investment of $4.1 billion, which will double its sterile filling and finished product capacity, creating around 1,000 new jobs [7]. Group 2: Market Demand and Competition - The demand for oral Wegovy is rapidly increasing, with prescriptions climbing from approximately 3,071 in the first four days post-launch to over 240,000 by early February [6]. - Eli Lilly is also ramping up its production capabilities for its oral GLP-1 drug, orforglipron, with a pre-launch inventory of about $1.5 billion and multiple manufacturing sites planned across the U.S. [8][10]. - The competition in the oral weight loss drug market is intensifying, with production capacity becoming a critical factor in determining market share and pricing strategies [10]. Group 3: Trade and Tariff Considerations - Ireland's selection as a manufacturing hub is influenced by the uncertainties surrounding trade and tariffs, prompting companies to stock inventory in target markets to mitigate risks from potential policy changes [9][10]. - In May 2025, Ireland's pharmaceutical exports reached approximately €13.7 billion, a 73.9% increase year-on-year, highlighting the country's growing importance in the global pharmaceutical supply chain [9][10].

Group 1: Healthcare Industry Overview - Healthcare industry stocks serve as effective hedges against technology and growth stocks, performing well when larger stock markets do not [1] - The performance of stocks varies by sub-industry, with some pharmaceutical and biotech stocks behaving more like growth stocks [1] Group 2: Novo Nordisk - Novo Nordisk is a leading global pharmaceutical company specializing in GLP-1 drugs for weight loss and diabetes management, alongside Eli Lilly [6] - In fiscal 2025, sales for diabetes and obesity care drugs increased by 7%, with obesity care drugs seeing a 26% gain; sales growth for 2026 is projected between 5% to 13% [7] - The GLP-1 market is expected to grow to $254 billion by 2034, representing a compound annual growth rate of 17%, positioning Novo Nordisk for long-term benefits [7] - The stock is currently trading at a low valuation of 13 times earnings, priced at $49 per share, making it an attractive investment option [8] Group 3: AbbVie - AbbVie, a spinoff from Abbott Labs, has demonstrated strong defensive characteristics, rising 24% during the 2022 bear market while the S&P 500 fell by 18% [9] - AbbVie has consistently increased its dividend for 13 years since its separation from Abbott, currently offering a high yield of 3.1% [9]

Core Insights - Novo Nordisk's Wegovy pill has seen an explosive launch, with 246,000 patients currently using it, despite facing pricing headwinds that are expected to lead to negative sales growth in 2026 [3][4][2] - The company is optimistic about future growth, citing an increase in patient numbers and production capacity, as well as a growing pipeline for future products [3][4] Market Dynamics - The company anticipates that Medicare coverage for obesity drugs will open access to 67 million people, with an initial target of around 15 million potential patients [6][38] - The Wegovy pill is positioned to attract patients who prefer oral medication over injections, addressing concerns such as needle phobia [7][8] Competitive Landscape - Wegovy's current clinical trial data shows a weight loss efficacy of 16.6%, compared to a competitor's 12.4%, indicating a 40% difference in effectiveness [22] - The company is aware of the need to communicate the efficacy of its products effectively, especially in light of competitors' marketing strategies [20][21] Supply Chain and Regulatory Aspects - Novo Nordisk has filed for registration and approval of the Wegovy pill in the European Union, indicating readiness to expand into other markets [17] - The company emphasizes the importance of maintaining a steady supply of the Wegovy pill to avoid shortages that could frustrate patients [18] Legal and Ethical Considerations - The company has taken legal action against compounding pharmacies that produce knockoff versions of its products, citing concerns over patient safety and the integrity of its intellectual property [27][30] - Novo Nordisk differentiates between mass compounding and individualized compounding, advocating for safe and regulated access to medications [34] Pipeline and Future Strategies - The company is exploring the potential of GLP-1 treatments for conditions like Alzheimer's, although no public decision has been made regarding further investment in this area [41][43] - Novo Nordisk is also working on a new product, Cagrisema, which combines GLP-1 and Amylin technologies, with trials showing promising weight loss results [44][46]

Core Insights - Eli Lilly (LLY.US) is preparing inventory for its experimental oral weight loss drug orforglipron, awaiting a potential FDA approval decision in the coming months [1] - The company reported a pre-market inventory value of $1.5 billion related to orforglipron as of December 31, 2025, up from $548.1 million a year earlier [1] - Orforglipron has received a priority review voucher from the FDA and is expected to gain regulatory approval in Q2 2026 for use in overweight or obese adults [1] Group 1: Clinical Trial Results - In the Phase 3 clinical trial ACHIEVE-1, orforglipron demonstrated a reduction in HbA1c levels by an average of 1.3% to 1.6% in adult patients with type 2 diabetes [2] - Significant weight loss of nearly 8% was observed in the high-dose group by week 40, with the drug administered once daily at doses of 3 mg, 12 mg, and 36 mg [2] - Only the 12 mg and 36 mg dosage groups showed clinically meaningful and statistically significant weight loss compared to placebo [2] Group 2: Competitive Landscape - Novo Nordisk (NVO.US) has established a lead in the oral weight loss drug market with its Wegovy product, which was launched in early January and has over 240,000 patients in the U.S. [3] - The company plans to increase investment in Ireland to produce the oral version of Wegovy for markets outside the U.S. [2] - Despite intensifying price competition in the weight loss drug market, Novo Nordisk aims to leverage its oral medication to regain market dominance and close the gap with Eli Lilly [3]

Core Insights - Novo Nordisk's Wegovy pill achieved 38,220 U.S. prescriptions in the fifth week following its launch, indicating strong initial demand for the product [1] Company Performance - The data from IQVIA suggests that Wegovy is gaining traction in the market shortly after its introduction, reflecting positive reception among healthcare providers and patients [1]