RAFAEL VALVERDE Rafael lives with obesity Mexico Novo Nordisk – a focused healthcare company Novo Nordisk to acquire Akero Therapeutics Inc. 2 Investor presentation 9 October 2025 Forward-looking statements Novo Nordisk's statutory Annual Report 2024, Form 20-F, any quarterly financial reports, investor presentations and written information released, shown, or oral statements made, to the public in the future by or on behalf of Novo Nordisk, may contain certain forward-looking statements relating to the ope ...

Core Insights - Berger Montague PC is investigating claims against Novo Nordisk A/S under federal securities laws following a class action lawsuit filed against the company [1][2]. Company Performance - On July 29, 2025, Novo Nordisk lowered its sales and profit guidance for the second half of fiscal 2025, attributing this to persistent use of compounded GLP-1s, slower-than-expected market expansion, and increased competition for its products Wegovy® and Ozempic® [3]. - Following the announcement, Novo's stock price fell from $69.00 to $53.94 per share, marking a one-day decline of over 21% [3]. Investor Information - Investors who purchased or acquired Novo securities between May 7, 2025, and July 28, 2025, have until September 30, 2025, to seek appointment as lead plaintiff representative of the class [2].

Core Viewpoint - A class action lawsuit has been filed against Novo Nordisk A/S by Berger Montague PC on behalf of investors who acquired Novo's publicly traded securities during the specified class period from May 7, 2025, to July 28, 2025 [1][2] Company Summary - Novo Nordisk A/S is a global pharmaceutical company headquartered in Denmark [3] - The lawsuit alleges that Novo understated the impact of the personalization exception to the compounded GLP-1 exclusion, which has allowed continued use of compounded alternatives to its products [3] - The company is accused of overstating the likelihood that patients using less expensive compounded drugs would switch to its branded products, leading to an overestimation of its long-term growth potential [3] Financial Impact - On July 29, 2025, Novo announced a reduction in its sales and profit outlook for fiscal 2025, citing slower-than-expected growth for its products Wegovy® and Ozempic® due to competition from compounded GLP-1 products [4] - Following this announcement, Novo's stock price fell from $69.00 per share on July 28, 2025, to $53.94 per share on July 29, representing a decline of approximately 21.83% in a single day [4]

Accessibility StatementSkip Navigation 440k+Newsrooms &Influencers 9k+Digital MediaOutlets 270k+JournalistsOpted In GET STARTED PHILADELPHIA, Sept. 22, 2025 /PRNewswire/ -- Berger Montague PC is investigating potential securities fraud claims on behalf of investors of Novo Nordisk A/S. (NYSE: NVO) ("Novo" or the "Company") following the filing of a securities class action lawsuit. The lawsuit was filed on behalf of investors who purchased or otherwise acquired Novo securities from May 7, 2025 through ...

Core Insights - Skye Bioscience, Inc. presented results from a Phase 1b study of nimacimab for metabolic-associated steatotic liver disease (MASLD) at the EASD Annual Meeting, highlighting its safety and tolerability profile [1][2][3] Company Overview - Skye Bioscience is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders [1][5] - The company aims to create first-in-class therapeutics by leveraging biologic targets with substantial human proof of mechanism [5] Study Results - The Phase 1b study demonstrated that nimacimab was safe and well-tolerated, with no serious adverse events or discontinuations due to adverse events [2][3] - Gastrointestinal side effects were infrequent and mild, indicating a differentiated tolerability profile for nimacimab [2] - The study was previously conducted by Bird Rock Bio, Inc., which was acquired by Skye in 2023 [3] Future Focus - Skye's immediate focus is on the upcoming topline readout from the CBeyond™ Phase 2a obesity study, which is assessing nimacimab's efficacy [3][5] - The Phase 2a clinical trial is also evaluating the combination of nimacimab with a GLP-1R agonist (Wegovy®) [5]

Core Insights - The OASIS 4 phase 3 trial demonstrated that oral semaglutide 25 mg (Wegovy® in a pill) achieved an average weight loss of 16.6% over 64 weeks, significantly outperforming the placebo group, which saw only 2.7% weight loss [1][3] - The trial included 307 adults with obesity or overweight and showed that 34.4% of participants on oral semaglutide lost 20% or more of their body weight, compared to 2.9% for placebo [1][3] - Oral semaglutide also improved cardiovascular risk factors and daily activity levels, aligning with previous results from injectable Wegovy® [1][3] Company Insights - Novo Nordisk is preparing for the potential FDA approval of oral semaglutide, with production already underway in the US to meet anticipated demand [2][3] - The company aims to address the low current usage of obesity medications in the US, where less than 2% of individuals with obesity receive treatment [1][3] - Novo Nordisk's chief scientific officer highlighted the importance of patient preference for oral treatments, suggesting that oral semaglutide could increase treatment initiation among those currently untreated [1][3] Industry Insights - The OASIS 4 trial results indicate a significant advancement in obesity treatment options, particularly for oral GLP-1 therapies, which have not been previously approved for weight management [3][6] - Obesity is recognized as a complex disease requiring long-term management, influenced by various factors beyond individual willpower [5][6] - The introduction of oral semaglutide could reshape the landscape of obesity treatment, potentially increasing access and adherence among patients [1][3]

Core Insights - Novo Nordisk is set to present 35 abstracts related to its diabetes and obesity portfolio at the EASD congress 2025, highlighting the health benefits and weight loss effects of semaglutide, along with new obesity pipeline therapies [1][3][4] Company Developments - The company will host an R&D investor event on 17 September to discuss the science and abstracts presented at the congress, which will be available via live webcast [2] - Semaglutide is recognized for having the broadest approved indications for obesity and type 2 diabetes, contributing to weight loss and cardiovascular protection [3] Research Presentations - Key presentations include the SOUL trial on oral semaglutide's cardiovascular outcomes, and various studies on the effectiveness of semaglutide and its impact on eating behaviors and body composition [5][7][8] - The REDEFINE trials will present data on the efficacy of cagrilintide and amycretin as next-generation obesity treatments [11][17] Product Information - Semaglutide is marketed under the brand names Wegovy® (2.4 mg injection), Ozempic® (1.0 mg injection), and Rybelsus® (14 mg oral) [14] - The drug has a well-established safety profile supported by over 33 million patient-years of exposure since its launch in 2018 [13]

Core Viewpoint - Berger Montague PC is investigating potential securities fraud claims against Novo Nordisk A/S following a securities class action lawsuit filed on behalf of investors who acquired Novo securities during the Class Period from May 7, 2025, to July 28, 2025 [1][3] Group 1 - The lawsuit alleges that Novo Nordisk made false and misleading statements regarding the impact of compounded GLP-1 drugs, specifically underestimating the effect of the FDA's personalization exception [3] - The company allegedly overstated the likelihood that patients would switch to its branded drugs, such as Ozempic® and Wegovy®, leading to significant investor losses [3] - Investors who purchased Novo securities during the Class Period have until September 30, 2025, to seek appointment as lead plaintiff representative of the class [2]

Core Insights - Novo Nordisk presented data from the STEER study, showing that Wegovy® (semaglutide 2.4 mg) significantly reduces the risk of major adverse cardiovascular events (MACE) compared to tirzepatide in patients with obesity and established cardiovascular disease (CVD) without diabetes [1][3][4] Group 1: Study Findings - Wegovy® demonstrated a 57% greater risk reduction for heart attack, stroke, and cardiovascular-related death in patients who adhered to treatment compared to tirzepatide, with 0.1% of events recorded for Wegovy® and 0.4% for tirzepatide [1][3] - In all treated individuals, regardless of treatment gaps, Wegovy® showed a 29% risk reduction for heart attack, stroke, and death from any cause compared to tirzepatide [1][3] - The STEER study adds to the evidence that the cardiovascular benefits of Wegovy® are specific to the semaglutide molecule and not applicable to other GLP-1 or GIP/GLP-1-based treatments [3] Group 2: Study Design and Population - The STEER study was a retrospective, observational study evaluating the efficacy of Wegovy® versus tirzepatide for preventing MACE in US adults aged 45 and older with obesity and established CVD without prior diabetes [2][4] - The study included 10,625 participants in each treatment group, with propensity score matching used to ensure comparability between Wegovy® and tirzepatide users [2][4] Group 3: Context of Obesity and CVD - Cardiovascular disease (CVD) is the leading cause of death globally, with nearly 21 million deaths annually, and obesity significantly contributes to cardiovascular morbidity and mortality [2] - Despite a decrease in overall cardiovascular mortality, obesity-related cardiovascular deaths have risen, with two-thirds of such deaths linked to CVD [2]

Core Viewpoint - A class action securities lawsuit has been filed against Hims & Hers Health, Inc. alleging securities fraud that negatively impacted investors between April 29, 2025, and June 23, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that Hims was involved in the deceptive promotion and sale of illegitimate versions of Wegovy®, which posed risks to patient safety [2]. - It is alleged that this situation created a significant risk of termination of the Company's collaboration with Novo Nordisk [2]. - The defendants' positive statements regarding the Company's business and prospects were claimed to be materially misleading and lacked a reasonable basis [2]. Group 2: Investor Information - Investors who suffered losses during the specified timeframe have until August 25, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this role [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].