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Veru (NasdaqCM:VERU) Q4 2025 Earnings Call December 17, 2025 08:00 AM ET Company ParticipantsRohan Mathur - Biopharma Equity Research AssociateMichele Greco - Chief Financial Officer and Chief Administrative OfficerMitchell Steiner - Chairman, CEO and PresidentSam Fisch - Executive Director of Investor Relations and Corporate CommunicationsConference Call ParticipantsNone - AnalystWilliam Wood - Research AnalystOperatorGood morning, ladies and gentlemen, and welcome to Veru Inc.'s Investors Conference Call. ...

Financial Data and Key Metrics Changes - The net loss from continuing operations for fiscal year 2025 was $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year [27] - Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year, primarily due to expenses related to the phase 2b obesity clinical study for Enobosarm [25] - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in the prior year, mainly due to a reduction in share-based compensation expenses [25] Business Line Data and Key Metrics Changes - The company sold the FC2 female condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after selling costs, but incurred a loss of approximately $4.1 million on the sale [22][23] - The gain on the sale of ENTADFI assets was $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year [25] Market Data and Key Metrics Changes - The company reported that as of September 30, 2025, cash, cash equivalents, and restricted cash balance was $15.8 million, down from $24.9 million as of September 30, 2024 [28] - The net working capital was $11.1 million on September 30, 2025, compared to $23.4 million on September 30, 2024 [29] Company Strategy and Development Direction - The company is focusing exclusively on drug development following the sale of the FC2 female condom business, which represents a strategic shift [23] - The planned phase 2b plateau clinical trial will target patients with a BMI greater than or equal to 35 and age greater than or equal to 65, aiming to assess the ability of Enobosarm treatment to break through the weight loss plateau [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regulatory landscape evolving for muscle-preservation drugs for obesity treatment, with at least two possible regulatory pathways for Enobosarm [15] - The company highlighted the importance of addressing the weight loss plateau experienced by many patients on GLP-1 receptor agonists, indicating a significant market opportunity [18][42] Other Important Information - The company completed a public offering on October 31, 2025, resulting in net proceeds of approximately $23.4 million [24] - The company used cash of $30 million for operating activities in fiscal 2025, compared to $21.7 million in the prior year [29] Q&A Session Summary Question: Will any GLP-1 be allowed in your phase 2b, or will it be limited to just tirzepatide? - Management indicated that they will choose one GLP-1 receptor agonist to avoid variability in the study, with tirzepatide currently being the placeholder [32][33] Question: How does the FDA's guidance affect the phase 3 transition? - Management explained that the phase 2b study is designed to mirror phase 3 criteria, allowing for a clear understanding of incremental weight loss and functional endpoints [34][35] Question: What patient population is being targeted in the Plateau study? - The focus is on patients over 65 with physical limitations, as this group is seen as most in need and informative for assessing physical function [37][39]

Core Viewpoint - Novo Nordisk has released positive results from a Phase 2 trial of its GLP-1 receptor agonist, amycretin, for Type 2 diabetes, despite recent disappointing results from a Phase 3 trial of oral semaglutide in early Alzheimer's disease [1][4][8]. Novo Nordisk Trial Results - Novo Nordisk is recognized for its drug semaglutide, which treats Type 2 diabetes (Wegovy) and obesity (Wegovy), part of the GLP-1 receptor agonist class, including Eli Lilly's tirzepatide [2]. - The recent Phase 3 trials of oral semaglutide for Alzheimer's did not show superior efficacy over placebo, which was anticipated as a low probability event [3]. Positive Developments - The Phase 2 trial of amycretin resulted in a significant 14.5% weight loss at 36 weeks, combining a once-weekly subcutaneous dosage with a once-daily oral dosage [4]. - Novo Nordisk is advancing amycretin into Phase 3 trials for obesity and expects FDA approval for oral Wegovy by the end of the year [5]. Market Reaction - Despite the positive news regarding amycretin, the stock of Novo Nordisk has declined over the past two days, indicating market skepticism [6].

Core Insights - The market for obesity and diabetes treatments is experiencing significant growth, with Eli Lilly's drugs Mounjaro and Zepbound generating over $10 billion in sales during Q3, accounting for more than half of the company's total sales of $17.6 billion [1][5] - Novo Nordisk is pursuing the acquisition of Metsera Inc. for up to $9 billion, following Pfizer's nearly $5 billion bid for the same company, which is developing potential treatments but currently has no products on the market [2][6] - The popularity of GLP-1 receptor agonists is driving sales and acquisition interest, as they help regulate appetite and feelings of fullness, although they may not be effective for everyone and can cause side effects [3] Company Performance - Eli Lilly's Zepbound sales nearly tripled to $3.57 billion in Q3, while Mounjaro's revenue doubled to $6.52 billion, largely due to growth outside the U.S. [4] - Combined sales of Mounjaro and Zepbound have reached nearly $25 billion in 2023, surpassing Eli Lilly's total revenue for 2020, and contributing to a Q3 profit of $5.58 billion [5] Market Dynamics - Improved drug supplies and increasing insurance coverage are enhancing access to these treatments, which can cost around $500 per month without insurance [4] - Novo Nordisk's offer for Metsera includes a base payment of $56.50 per share, with potential additional payments based on drug development milestones, significantly increasing the value compared to previous trading prices [6] - Pfizer, known for its COVID-19 vaccine, is re-entering the obesity treatment space after previously halting its own drug development efforts [7]

Core Insights - Orexo AB announced positive pharmacokinetic in-vivo data for a powder-based intranasal semaglutide formulation developed with AmorphOX technology [1][3] - The AmorphOX formulations showed a sevenfold increase in plasma values compared to the oral tablet, although lower than the injectable version [2][7] - The technology allows for needle-free delivery, improved convenience, and potentially better adherence, with extended dosing schedules [3][4] Company Overview - Orexo is a Swedish pharmaceutical company with 30 years of experience in developing improved pharmaceuticals, particularly for opioid use disorder [5] - The company reported total net sales of SEK 590 million in 2024 and has 110 employees [5] - Orexo is listed on Nasdaq Stockholm and available as ADRs on OTCQX market in the US [5] Technology Insights - AmorphOX is a proprietary drug delivery platform that formulates large molecules into powders for intranasal delivery [7][8] - The technology has demonstrated significantly higher plasma concentrations and bioavailability compared to oral formulations [7][8] - AmorphOX aims to prioritize larger molecules like peptides, proteins, and vaccines for more efficient treatment options [4][7] Product Insights - Semaglutide is a GLP-1 receptor agonist used for treating type 2 diabetes and obesity, available in oral and injectable forms [9][10] - Current injectable GLP-1 medications require refrigeration and weekly needle sticks, while oral formulations face bioavailability challenges [10][11] - The AmorphOX intranasal formulation may address these issues by providing a more convenient delivery method [3][4]

Core Insights - Galmed Pharmaceuticals has signed a binding term-sheet with Entomus for a license agreement to develop and commercialize a proprietary Self-Emulsifying Drug Delivery System (SEDDS) for sublingual administration of peptides like GLP-1 [1] - The global GLP-1 market is projected to exceed $120 billion by 2030, with peak sales outside the US expected to reach approximately $20 billion by 2032 [3] - The new sublingual formulation aims to enhance bioavailability, reduce side effects, and improve patient compliance compared to existing injectable and oral forms of semaglutide [6][9] Company Developments - The definitive agreement with Entomus will outline milestone payments and future royalty payments, expected to be finalized within 90 days [1] - The sublingual semaglutide formulation is anticipated to be approved through the expedited 505(b)(2) regulatory pathway [5][6] - Galmed aims to initially target markets with high rates of type 2 diabetes and obesity, such as India, Brazil, and the GCC region, where patent protections for semaglutide are less stringent [4][5] Industry Context - The first-pass effect in oral medications can reduce efficacy, while sublingual administration offers a non-invasive alternative that allows direct entry into the bloodstream [2] - The increasing prevalence of type 2 diabetes and obesity in various global markets creates a favorable environment for GLP-1 therapies [4] - Semaglutide, as a GLP-1 receptor agonist, has shown significant efficacy in managing blood glucose levels and promoting weight loss, positioning it as a transformative treatment option [7]

Core Insights - Novo Nordisk's stock reached an all-time high of $148.15 in June 2024, representing a fivefold increase since 2019, but has since dropped 61% from that peak [1] - The company holds a dominant position in the GLP-1 receptor agonist market, with a 63% market share and a patient base that has nearly tripled to over 12 million in the last three years [6] - Despite strong financial performance, including a 25% year-over-year revenue increase to $42 billion in 2024, Novo Nordisk faces increasing competition from rivals like Eli Lilly and Viking Therapeutics [6][8][9] Company Overview - Novo Nordisk has a long history in diabetes care, with significant advancements such as the development of semaglutide, which has proven effective for managing type 2 diabetes [3] - The company successfully expanded its semaglutide platform with the FDA approval of Ozempic in 2017 and Wegovy in 2021 for obesity treatment [4] Financial Performance - In 2024, Novo Nordisk reported net revenue of $42 billion, a 25% increase from the previous year, and earnings per share (EPS) rose by 22% [6] - The company anticipates annual sales growth between 16% and 24% in 2025, with Wall Street analysts projecting an 18% increase in EPS from 2024 [11] Competitive Landscape - Novo Nordisk faces intensified competition, particularly from Eli Lilly, which is experiencing faster growth with its GLP-1 products [8] - Emerging companies like Viking Therapeutics are developing new platforms that could challenge Novo Nordisk's market share [9] Future Outlook - The GLP-1 market is expected to reach $150 billion by 2030, and Novo Nordisk is expanding its production capacity to capitalize on this growth [10] - The company is advancing a robust pipeline, including new indications for semaglutide and a next-generation weight loss drug, CagriSema [11] Valuation - Novo Nordisk's shares are currently trading at a forward price-to-earnings (P/E) ratio of 14, which is considered attractive compared to Eli Lilly's forward P/E of around 37 [12] - The company offers a 2.7% dividend yield, making it an appealing option for investors seeking value within a diversified portfolio [15]

Core Viewpoint - Eli Lilly's experimental oral drug orforglipron demonstrated significant weight loss in Type 2 diabetes patients, leading to a 15% surge in its stock price, indicating strong market potential for oral GLP-1 receptor agonists [1][5][12]. Company Summary - Eli Lilly's orforglipron trial results showed an average weight loss of 16 pounds (7.9% of body weight) over 26 weeks, outperforming Novo Nordisk's Ozempic, which resulted in a 6% weight loss at its highest dose [1][2][3]. - The drug also achieved a 1.3% average reduction in blood sugar levels, slightly below Ozempic's 2.1% reduction, but overall efficacy in weight loss and diabetes management has been positively received [3][12]. - If approved, orforglipron could provide a convenient oral alternative to injectable medications, addressing a significant barrier to adoption of current GLP-1 therapies [11][12][14]. Industry Summary - The demand for GLP-1 receptor agonists has surged due to rising global obesity rates and a growing preference for pharmaceutical weight management solutions [9]. - Novo Nordisk's shares fell by 3.9% amid concerns that orforglipron could challenge its market dominance with Ozempic and Wegovy, which are currently only available in injectable form [4][14]. - The oral GLP-1 market is becoming increasingly competitive, with Eli Lilly's orforglipron trial being one of several studies aimed at expanding the drug's potential applications, including obesity and sleep apnea [12][14].