Veru (NasdaqCM:VERU) FY Conference February 26, 2026 03:20 PM ET Company ParticipantsMitch S. Steiner - Executive Chairman, President, and CEOConference Call ParticipantsLeland Gershell - Managing Director and Senior Biotechnology AnalystLeland GershellGreat! Thank you. Thanks for joining us here at Oppenheimer's 36th Annual Healthcare Life Sciences Conference. I'm Leland Gershell, one of the analysts with the Biotech Equity Research team at the firm. We're delighted to have with us as our next presenting c ...

iBio Conference Call Summary Company Overview - **Company**: iBio (NYSEAM:IBIO) - **Event**: FY Conference on February 26, 2026 - **Speakers**: Martin Brenner (CEO and CSO), Felipe Duran (CFO) Industry Insights - **Focus Area**: Obesity treatment and related therapies - **Key Drug Class**: GLP-1 (Glucagon-like peptide-1) drugs have shown significant efficacy in obesity treatment, previously achievable only through invasive surgery [3][4] - **Market Need**: There is a growing need for therapies that address the shortcomings of GLP-1 drugs, particularly in preventing lean mass loss and maintaining weight loss [7][9] Core Strategies and Products - **Portfolio Strategy**: iBio is focusing on second-generation drugs that address unmet patient needs beyond GLP-1s, including: - **IBIO-600**: A myostatin molecule aimed at preventing lean mass loss during weight loss [7] - **Activin E**: A long-acting molecule that targets fat-specific weight loss while preserving muscle [14][19] - **Bispecific Molecule**: Targeting myostatin and activin A for conditions like HFpEF (Heart Failure with preserved Ejection Fraction) and obesity [11][30] Clinical Development and Milestones - **Upcoming Data**: Non-human primate data for IBIO-610 expected in the next 30 to 60 days, with presentations planned at ADA ObesityWeek and the European Diabetic Association meeting [10][40] - **IND Filings**: Plans to file for IND equivalent in Australia by the second half of 2026, with first patient dosing anticipated in early 2027 [10][11] - **Clinical Trials**: Emphasis on Phase 1 studies for IBIO-610, leveraging insights from competitors like Arrowhead and Wave [42][44] Market Potential - **Obesity Statistics**: Approximately 1 billion obese individuals worldwide, with a treatable population estimated at 100 to 200 million [19][20] - **Antibody Modality**: iBio's approach to using antibodies for obesity treatment is expected to allow for scalable production and flexibility in market entry [20] Competitive Landscape - **Differentiation**: iBio aims to differentiate its products from existing therapies by focusing on mechanisms that reduce adverse effects associated with GLP-1s and other treatments [8][32] - **Market Position**: The company is positioned as a potential leader in the obesity treatment space, particularly with its unique antibody approaches [52] Financial Overview - **Market Capitalization**: iBio has a market cap of approximately $500 million, with a low float of 34.5 million shares outstanding [36] - **Funding**: The company is well-capitalized, with cash reserves expected to last until the first quarter of 2028, allowing for continued development of its assets [36] Additional Insights - **Patient Journey**: Highlighted the challenges patients face with GLP-1 treatments, including muscle loss and rapid weight regain after discontinuation [5][6] - **Regulatory Considerations**: Acknowledgment of the lack of a regulatory path for weight maintenance drugs, but optimism that high unmet medical needs will drive future decisions [9] Conclusion - iBio is strategically positioned to address significant unmet needs in obesity treatment through innovative drug development and a focus on maintaining muscle mass during weight loss. The upcoming clinical data and regulatory filings will be critical in establishing its market presence and therapeutic efficacy.

Core Viewpoint - Novo Nordisk is a leader in the GLP-1 drug market, but its stock has underperformed recently, and achieving significant returns over the next decade may be unrealistic due to competitive pressures and market dynamics [1][4][5]. Group 1: Market Position and Products - Novo Nordisk's semaglutide, marketed as Wegovy, Ozempic, and Rybelsus, is among the top-selling GLP-1 therapies, positioning the company well for future growth [3]. - The company has a robust pipeline with several candidates expected to receive approval soon, which could enhance its market position [3][7]. Group 2: Competitive Landscape - Novo Nordisk is losing market share to Eli Lilly, its main competitor, particularly with the performance of its next-generation weight loss drug, CagriSema, which did not outperform Eli Lilly's Zepbound in clinical trials [5][7]. - Increased competition is likely to reduce clinical differentiation and pricing power for Novo Nordisk, limiting its potential upside in the market [7]. Group 3: Financial Outlook - Analysts suggest that even with optimal execution, achieving a compound annual growth rate of 25.89% to turn $100,000 into $1 million is highly unlikely for Novo Nordisk [4]. - The company's revenue is projected to decline year-over-year in 2026, indicating potential challenges ahead [5]. Group 4: Investment Considerations - Despite current struggles, Novo Nordisk's long-standing leadership in the diabetes market and its deep pipeline may present investment opportunities for long-term holders [8][9]. - The company's dividend yield of 4.47% could provide additional returns for investors willing to hold the stock over the next decade [7][9].

Core Insights - Ozempic, a drug by Novo Nordisk, is widely recognized for treating type 2 diabetes and aiding weight loss, being part of the GLP-1 drug class [1] - Eli Lilly has overtaken Novo Nordisk in the GLP-1 market, capturing 60% of the market share compared to Novo's 39% [4] Group 1: Company Performance - Eli Lilly's drugs, Mounjaro and Zepbound, generated over $11 billion in revenue, showcasing triple-digit growth in the recent quarter [5] - Novo Nordisk's semaglutide is marketed as Ozempic for diabetes and Wegovy for obesity, but its market share has declined as Lilly's products gained popularity [4][6] Group 2: Competitive Advantage - Eli Lilly's success is attributed to effective manufacturing and availability of its products, addressing previous shortages of GLP-1 drugs [6] - A head-to-head study demonstrated that Zepbound led to greater weight loss compared to Wegovy, influencing patient and doctor preferences [6] Group 3: Future Prospects - Novo recently launched a Wegovy pill, while Lilly is under regulatory review for an oral weight loss candidate that offers a hassle-free option without dietary restrictions [7]

A major pharmaceutical company said it is suing Hims & Hers for allegedly breaching the US patent on semaglutide. Which company filed the lawsuit?Place your bets in the latest edition of Pointed, Bloomberg’s weekly news quiz for risk-takers ⤵️ https://t.co/OTmP234ilm ...

Industry Overview - The biotech industry had a strong performance in 2025, outperforming NVIDIA, with continued enthusiasm into 2026 [5] - There are concerns regarding the FDA's regulatory environment, described as chaotic, which may impact drug approvals [5][9] FDA Regulatory Environment - Richard Pasdur, a former senior FDA executive, expressed concerns about the breach of the firewall between political appointees and drug reviewers, indicating potential risks for the pharma industry [7] - The FDA's current commissioner, Marty Makary, aims to speed up drug approvals, but there are conflicting signals regarding the actual operating reality [9] Company Earnings Predictions Eli Lilly (Ticker: LLY) - Expected earnings per share range from $6.99 to $7.86, with a consensus estimate of $7.48 and revenue of $17.85 billion, indicating over 30% year-over-year earnings growth [15] - Analysts predict a likely earnings beat due to a history of exceeding expectations [15][16] Novo Nordisk (Ticker: NVO) - Earnings per share expectations are between $0.89 and $0.90, with revenue projected at $11.96 billion, showing a flat to slightly down trend [17] - Analysts express a higher possibility of a miss compared to Eli Lilly, citing recent struggles and a new CEO's uncertain direction [17][19] Twist Bioscience (Ticker: TWST) - Reported revenue of $104 million for Q1 2026, consistent with preliminary results, though still unprofitable [20] - The company has shown consistent revenue growth despite industry challenges, reducing cash burn and moving towards profitability [20]

Financial Data and Key Metrics Changes - For the three months ended December 31, 2025, the net loss was $5.3 million or 26 cents per diluted common share, compared to a net loss of $8.9 million or 61 cents per diluted common share in the prior year's quarter [19] - Research and development costs decreased to $1.3 million from $5.7 million in the same period last year, primarily due to the completion of the Phase 2b QUALITY clinical study [17] - General administrative expenses were $4.1 million compared to $5.2 million in the prior quarter, mainly due to a decrease in share-based compensation [17] - Cash, cash equivalents, and restricted cash balance was $33 million as of December 31, 2025, compared to $15.8 million as of September 30, 2025 [19] Business Line Data and Key Metrics Changes - The company is focused on two main drug development programs: enobosarm and sabizabulin, targeting obesity and cardiovascular diseases respectively [3][4] - Enobosarm has shown potential in a Phase 2b clinical trial for obesity, demonstrating selective fat loss while preserving lean mass [6][7] Market Data and Key Metrics Changes - The FDA has provided regulatory clarity for enobosarm in combination with GLP-1 receptor agonists, indicating at least two possible pathways for approval based on weight loss metrics [8][9] Company Strategy and Development Direction - The company aims to develop enobosarm as a next-generation obesity treatment that preserves lean mass and physical function, addressing the limitations of current GLP-1 receptor agonists [4][5] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effects on weight loss and physical function in older patients initiating semaglutide treatment [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's cash position to fund operations through the interim analysis of the Phase 2b PLATEAU study [20] - The company is not currently profitable and has experienced negative cash flow from operations, but the recent public offering has bolstered its financial position [19][22] Other Important Information - The company completed a public offering of 1.4 million shares, generating approximately $23.4 million in net proceeds [16] - The company recorded a gain on the sale of the FC2 Female Condom business in the prior year, which is now classified under discontinued operations [17][18] Q&A Session Summary Question: Why not use the oral semaglutide in this study? - Management explained that the injectable form of semaglutide is preferred to minimize differences in outcomes compared to previous studies [24] Question: Did you discuss the stair climb test with the FDA? - Management confirmed discussions with the FDA regarding the stair climb test as a sensitive measure for assessing physical function in the study [26] Question: Are there any pre-specified decision rules for the interim analysis? - It was clarified that there are no futility analysis or sample size re-estimation associated with the interim analysis [32] Question: What degree of weight loss needs to be seen for functional benefit assessment? - Management indicated that greater than 5% weight loss is a clear criterion, but less than 5% could still be acceptable if accompanied by significant functional benefits [34]

The race to offer cheaper weight loss drugs is running into some legal limits. Tellahalth company Hims and Hers announced a cheaper version of Novo's Waggoi weight loss pill at the beginning of February. Now, it would cost $49 to start, which is far less than the $149 Novo sells the branded pill for, but it pulled the drug after legal and regulatory risks escalated.Now, legally, they're allowed to create a compounded version of a drug if they are saying they're adjusting the formula for quote personalized p ...

Bloomberg News Health Reporter Madison Muller reports on the latest on Novo's lawsuit. - Novo Nordisk said it’s suing Hims & Hers Health Inc. for making knock-offs of its obesity medicines, even as Hims scrapped plans to sell a copycat version of the Wegovy pill. Hims is breaching the US patent on semaglutide, the active ingredient in Novo’s blockbuster obesity treatments, Novo argued Monday. The US lawsuit attacks not only Hims’ new strategy to launch a copycat pill but also goes after shots that mimic Weg ...

Core Viewpoint - Hims & Hers (HIMS) stock has experienced a significant decline of over 25% following a patent-infringement lawsuit filed by Novo Nordisk (NVO) targeting its semaglutide products, compounded by a recent FDA crackdown on unapproved GLP-1 compounding [1][5] Financial Performance - Year-to-date, Hims & Hers stock has lost nearly 45%, with its relative strength index (14-day) indicating it is in deeply oversold territory [2] - Bank of America has lowered its price objective for Hims & Hers to $13, suggesting a potential downside of another 32% from current levels [6] Legal and Regulatory Environment - The lawsuit from Novo Nordisk introduces material risks that the market has not fully accounted for, leading to a recommendation for caution in purchasing HIMS stock [5] - Legal defense costs and the possibility of a permanent injunction on all GLP-1 products necessitate a complete reevaluation of the company's valuation [6] Business Model and Strategy - The transition away from high-margin compounded drugs will require significant investment in talent and supply chain verticalization, which may negatively impact earnings revisions in 2026 [7] - The testing by Novo Nordisk allegedly found impurities of up to 86% in certain compounded samples, which could severely damage the HIMS brand and result in a loss of subscribers [8] Market Sentiment - Other Wall Street firms view the ongoing selloff of HIMS shares as potentially overdone, indicating a divergence in market sentiment regarding the stock's future [10]