Core Insights - GoodRx has launched two major initiatives to enhance the availability of FDA-approved GLP-1 medications [1] - The first initiative is GoodRx for Weight Loss, a telemedicine subscription service connecting consumers with licensed healthcare providers for affordable weight management treatment [1] - The second initiative, in partnership with Novo Nordisk, introduces a new cash price of $199 per month for Ozempic® [1]

Core Insights - Novo Nordisk has reached an agreement with the U.S. Administration to lower drug prices for semaglutide medicines starting in 2026, enhancing patient access and affordability in Medicare Part D and Medicaid [1][2] - A pilot program will be initiated to cover anti-obesity medicines under Medicare Part D, benefiting a majority of beneficiaries [1][3] - The company anticipates a direct, negative low single-digit impact on global sales growth in 2026 due to this agreement [3] Company Overview - Novo Nordisk is a leading global healthcare company founded in 1923, headquartered in Denmark, focusing on chronic diseases, particularly diabetes [5] - The company employs approximately 78,500 people across 80 countries and markets its products in around 170 countries [5] - Novo Nordisk's B shares are listed on Nasdaq Copenhagen, and its ADRs are listed on the New York Stock Exchange [5]

RAFAEL VALVERDE Rafael lives with obesity Mexico Novo Nordisk – a focused healthcare company Investor presentation First nine months of 2025 2 Novo Nordisk® Investor presentation First nine months of 2025 Agenda Progress on Strategic Aspirations 2025 Financials Innovation and therapeutic focus Commercial execution Agenda 3 Novo Nordisk® Investor presentation First nine months of 2025 Forward-looking statements Novo Nordisk's statutory Annual Report 2024, Form 20-F, any quarterly financial reports, investor ...

Core Viewpoint - Skye Bioscience, Inc. is set to discuss its Q3 2025 financial results and business updates in a conference call on November 10, 2025, following the release of its financial results after market close [1][2] Company Overview - Skye Bioscience is a clinical-stage biotechnology company focused on developing new therapeutic pathways for obesity and metabolic health disorders through next-generation molecules that modulate G-protein coupled receptors [3] - The company is conducting a Phase 2 clinical trial for nimacimab, an antibody that inhibits CB1, and is also assessing its combination with a GLP-1R agonist (Wegovy®) [3] Upcoming Events - A live webcast of the conference call will be available on the Skye Investor Relations website, along with the earnings press release and financial tables [2] - Skye will present at the Stifel 2025 Healthcare Conference in New York on November 13, 2025, and will be available for one-on-one meetings [2]

Core Insights - The financial report for the first nine months of 2025 shows robust sales growth, but the company has narrowed its guidance due to lower growth expectations for GLP-1 treatments [2][4] Financial Performance - Net sales reached DKK 229.9 billion, a 12% increase compared to DKK 204.7 billion in the same period of 2024, with a 15% growth at constant exchange rates (CER) [2][4] - Operating profit increased by 5% to DKK 95.9 billion, with a 10% growth at CER, impacted by one-off restructuring costs of approximately DKK 9 billion [2][4] - Net profit rose by 4% to DKK 75.5 billion, with diluted earnings per share increasing by 4% to DKK 16.99 [2][4] Sales Breakdown - Sales in US Operations increased by 12% in Danish kroner and 15% at CER, while International Operations saw a 13% increase in Danish kroner and 16% at CER [4] - Sales within Diabetes and Obesity care grew by 12% to DKK 215.7 billion, driven by a 37% increase in Obesity care sales to DKK 59.9 billion and a 7% increase in GLP-1 diabetes sales [4] Research and Development - The US FDA approved Wegovy® for the treatment of MASH, and the company announced the acquisition of Akero Therapeutics, adding a potential first-and-best-in-class asset [4] - The phase 3 development of cagrilintide for weight management has been initiated, with the potential to be the first amylin monotherapy treatment on the market [4] Future Outlook - For the full-year 2025, sales growth is now expected to be between 8-11% at CER, with operating profit growth projected at 4-7% at CER, reflecting a negative impact of around DKK 8 billion from the company-wide transformation [4] - The guidance narrowing is attributed to lowered growth expectations for GLP-1 treatments within diabetes and obesity [4]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company announced the presentation of two abstracts at ObesityWeek 2025, highlighting its drug enobosarm's potential in weight management [1][2] Company Overview - Veru Inc. is developing two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making fat loss more tissue-selective while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass in older patients [4] - The study involved 168 older patients (≥60 years) and showed that while weight loss was similar across treatment groups, the preservation of lean mass is expected to enhance energy expenditure [4] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients initiating GLP-1 RA treatment [5][6] - The primary efficacy endpoint for the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5][7]

Core Viewpoint - A class action securities fraud lawsuit has been filed against Hims & Hers Health, Inc. to recover losses for shareholders affected by alleged fraud between April 29, 2025, and June 22, 2025 [2][3] Group 1: Lawsuit Details - The lawsuit alleges that Hims & Hers Health, Inc. engaged in deceptive practices by promoting and selling illegitimate versions of Wegovy®, which posed risks to patient safety [3] - The complaint suggests that these actions created a substantial risk of termination of the company's collaboration with Novo Nordisk [3] - As a result of these allegations, the positive statements made by the defendants regarding the company's business and prospects were deemed materially misleading [3]

Core Viewpoint - The FDA has approved Rybelsus® as the only oral GLP-1 medication for reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes, regardless of prior cardiovascular events, highlighting the need for treatment options beyond blood sugar control [2][3][5]. Group 1: FDA Approval and Clinical Evidence - Rybelsus® is now recognized as the only oral GLP-1 drug approved for both primary and secondary prevention of MACE in high-risk type 2 diabetes patients [5]. - The SOUL study aimed to evaluate the effectiveness of oral semaglutide 14mg combined with standard treatment in reducing MACE risk, with MACE defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke [5][6]. - In the study, 12.0% of patients receiving semaglutide experienced MACE events compared to 13.8% in the placebo group, demonstrating a hazard ratio of 0.86, indicating a 14% relative risk reduction over four years [6]. Group 2: Safety and Side Effects - The overall safety profile of oral semaglutide 14mg was consistent with previous studies, with serious adverse events (SAEs) occurring in 47.9% of the semaglutide group compared to 50.3% in the placebo group [8]. - The most common SAEs included heart disease and infections, with gastrointestinal issues being slightly more prevalent in the semaglutide group (5.0% vs. 4.4%) [8]. - Discontinuation due to adverse events occurred in 15.5% of the semaglutide group versus 11.6% in the placebo group, primarily due to gastrointestinal disorders and infections [8]. Group 3: Future Developments - The company has submitted a supplemental application to the FDA for a daily oral semaglutide formulation, Wegovy®, aimed at treating obesity, with results expected later this year [9].

Acquisition Overview - Novo Nordisk is set to acquire Akero Therapeutics Inc to enhance its portfolio in diabetes, obesity, and related comorbidities [2, 10] - The acquisition includes Akero's lead asset, Efruxifermin (EFX), for $47 billion USD at closing, plus a contingent value right (CVR) of $05 billion USD [14] - This acquisition aligns with Novo Nordisk's strategy to develop innovative medicines for people living with diabetes, obesity, and associated comorbidities [10, 14] Efruxifermin (EFX) Potential - Efruxifermin is highlighted as a potential first- and best-in-class asset in MASH (metabolic dysfunction-associated steatohepatitis) [14] - EFX is the only asset with demonstrated efficacy for F4 (cirrhosis) in MASH [26] - Phase 2 HARMONY trial results in F2-F3 patients showed 49% improvement in fibrosis with no worsening of MASH, and 37% MASH resolution with no worsening of fibrosis [18] - Phase 2 SYMMETRY trial results in F4 patients showed 29% improvement in fibrosis with no worsening of MASH, and 42% MASH resolution with no worsening of fibrosis [18] MASH Market and Unmet Needs - There is a significant unmet need across MASH stages, particularly for patients living with cirrhosis (F4) [15, 26] - Semaglutide 24 mg (Wegovy) is approved in the US for patients with moderate to advanced liver fibrosis (F2-F3) but not with cirrhosis (F4), creating an opportunity for EFX [17] - MASH affects over 250 million people globally, with prevalence growing [17] Clinical Development - A Phase 3 clinical development program (SYNCHRONY) is ongoing to deliver on the potential of efruxifermin [22, 24] - The SYNCHRONY program includes trials for F1-F4 stages, focusing on safety & tolerability, fibrosis improvement, and disease progression [23]

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].