PHILADELPHIA, Aug. 22, 2025 (GLOBE NEWSWIRE) -- Berger Montague, a national securities litigation law firm, is investigating potential securities fraud claims against Hims & Hers Health Inc. (“Hims & Hers” or the “Company”) (NYSE: HIMS). Investor Deadline: Investors who purchased or acquired Hims & Hers securities between April 29, 2025 and June 22, 2025 (the “Class Period”) may, no later than August 25, 2025, seek to be appointed as a lead plaintiff representative of the class. To learn your rights, CLICK ...

Core Insights - The company reported positive efficacy and safety data from the Phase 2b QUALITY study, indicating that enobosarm combined with semaglutide led to muscle preservation, increased fat loss, and fewer gastrointestinal side effects compared to semaglutide alone [1][3] - The Phase 2b Maintenance Extension study showed that enobosarm significantly reduced body weight regain and fat regain while preserving lean mass after discontinuation of semaglutide [1][7] - A novel modified release oral formulation of enobosarm has been selected for further clinical studies following a pharmacokinetic clinical study [1][9] Clinical Development - The Phase 2b QUALITY study involved 168 older patients (≥60 years) and demonstrated that the 3mg enobosarm dose preserved 100% of total lean mass compared to placebo + semaglutide at 16 weeks (p<0.001) [4][8] - Enobosarm treatment resulted in a 42% greater relative loss of fat mass with the 6mg dose compared to placebo + semaglutide at 16 weeks (p=0.017) [4][8] - The study found that 44.8% of the placebo + semaglutide group experienced at least a 10% decline in stair climb power, indicating a risk of physical function loss [5][8] Safety and Efficacy - Enobosarm plus semaglutide treatment maintained similar mean body weight loss as semaglutide alone while preserving lean mass [4][7] - The enobosarm 3mg monotherapy significantly reduced body weight regain by 46% after semaglutide discontinuation [8] - The safety profile of enobosarm was positive, with no gastrointestinal side effects or evidence of drug-induced liver injury observed [8][9] Financial Overview - As of June 30, 2025, the company reported cash, cash equivalents, and restricted cash of $15.0 million, down from $24.9 million as of September 30, 2024 [12][19] - Research and development expenses decreased to $3.0 million from $4.8 million year-over-year [15][21] - The net loss from continuing operations decreased to $7.3 million, or $0.50 per share, compared to $10.3 million, or $0.71 per share in the previous year [15][22]

Core Insights - Hims & Hers Health, Inc. (HIMS) is focusing on integrating technology platforms to enhance personalized healthcare delivery, highlighted by its acquisition of ZAVA, a European digital health provider, which facilitates cross-border platform integration [1][7] - The company is investing in personalization technologies, including upgrades to pharmacy infrastructure and lab testing integrations, to improve clinical accuracy in treatments [2][7] - Hims & Hers is transitioning from addressing single health concerns to enabling proactive health management through a fully integrated, tech-powered ecosystem [3] Company Expansion and Strategy - The acquisition of ZAVA allows Hims & Hers to offer 24/7 virtual care and centralized pharmacy fulfillment, expanding its geographic reach and service capabilities [1][7] - The planned expansion into Canada coincides with the market debut of semaglutide, showcasing the company's strategy of leveraging tech integration for timely market entries [2][7] Financial Performance - Hims & Hers shares have increased by 111.4% year to date, significantly outperforming the industry growth of 17.3% [6] - The Zacks Consensus Estimate for HIMS' 2025 earnings per share indicates a projected improvement of 151.9% from 2024 [8] Valuation Metrics - Hims & Hers has a forward 12-month price-to-sales (P/S) ratio of 4.3X, which is lower than the industry average of 5.5X but higher than its three-year median of 2.3X [10]

Core Viewpoint - The development of Alzheimer's drugs is facing significant bottlenecks, with Biogen and Eli Lilly maintaining a leading position in the market. However, due to research setbacks, safety risks, and slow adoption, the market size forecast for 2030 has been drastically reduced to $6 billion from a previous expectation of $13 billion [3][4]. Group 1: Market Forecast and Sales Predictions - The combined sales of Biogen's Leqembi and Eli Lilly's Kisunla are projected to reach $5.91 billion by 2025, with potential growth to $40 billion by 2030, which is 24% lower than the market's general expectation of $50 billion due to slow drug adoption [4]. - By 2030, the total sales of Alzheimer's drugs are expected to reach $6 billion, with nearly $1 billion coming from new mechanism drugs [5]. Group 2: Impact of Research Failures - A series of late-stage clinical trial failures have led to a 54% reduction in sales forecasts for Alzheimer's drugs since June 2024, with risk-adjusted sales expectations shrinking by over $7 billion for 2025-2030, including a $3 billion reduction for 2030 alone [8][11]. - The decline in sales expectations is attributed to the exit of several late-stage candidates from the market due to research failures or lowered priorities [8]. Group 3: Competitive Landscape - The long-term administration of Leqembi shows limited cognitive improvement, particularly in patients with low or no tau pathology, which affects about 40% of the trial population. This has led to skepticism among physicians and patients regarding the drug's efficacy [11]. - New candidates, such as Novo Nordisk's semaglutide and Roche's trontinemab, are expected to increase competitive pressure, potentially limiting the market share of first-generation amyloid-beta antibodies [11][15]. Group 4: Company-Specific Insights - Biogen's Leqembi faces increasing risks due to limited application, with sales forecasts for 2030 being 20% lower than market expectations, driven by safety concerns and access barriers [13]. - Eli Lilly is expected to surpass Biogen in sales by 2029, driven by the approval of Kisunla and subsequent antibody drugs, indicating a shift in market leadership [15].

Core Insights - A leading Chinese drug developer, Jiangsu Hengrui Pharmaceuticals, is advancing in the weight-loss medication market with promising Phase Three trial results for its dual-acting obesity drug, HRS9531, which targets the same peptide receptors as Eli Lilly's tirzepatide [2][3][4] Company Developments - Hengrui Pharmaceuticals recently listed its shares in Hong Kong and has reported positive trial data for HRS9531, a dual-acting obesity drug [3][5] - The company plans to apply for domestic marketing approval for HRS9531 following successful Phase Three trial outcomes [4][6] - The trial involved 567 participants, with those receiving the drug achieving significant weight loss, including a mean weight loss of up to 17.7% and 88% of participants losing at least 5% of their weight [7][8] Market Context - The weight-loss medication market is highly competitive, with major players like Novo Nordisk and Eli Lilly leading the sector [12][17] - Hengrui Pharma's drug is positioned to compete with established products, as it targets GLP-1 and GIP receptors, similar to tirzepatide [10][15] - The market for weight-loss drugs in China is expanding rapidly, with over 200 pipelines currently in development [13] Financial Implications - Hengrui Pharma's stock has traded at a premium of approximately 10% over its Shanghai-listed shares, reflecting investor confidence in its potential [5] - The company has licensed rights to HRS9531 outside Greater China to Kailera Therapeutics, receiving $110 million in upfront payments and potential milestone payments totaling up to $5.725 billion based on sales [11] Competitive Landscape - The success of semaglutide has spurred a race for similar products, with Hengrui Pharma aiming to launch China's first independently developed GLP-1/GIP product [13][17] - Despite the dominance of established players, the high-growth market presents opportunities for new entrants like Hengrui Pharma [16][17]

Financial Performance Overview - The company reported consolidated revenues of $997 million for Q1 FY26, reflecting an 11% year-over-year growth and flat sequentially [8] - EBITDA margin stood at 26.7%, slightly above the target of 25% [7] - Gross profit margin decreased by 350 basis points year-over-year to 56.9%, attributed to price erosion in the generic segment [8] - Profit after tax attributable to equity holders was $166 million, a 2% increase year-over-year but an 11% decline sequentially [12] Business Line Performance - North American business generated $400 million, a 17% year-over-year decline due to price erosion and timing of product procurement [21] - European generic business reported $131 million, a 124% year-over-year increase, driven by new product launches [22] - Emerging markets reported revenue growth of 10% year-over-year, supported by higher volumes and new product introductions [22] - The PSAI business reported $95 million, with a year-over-year growth but a 14% sequential decline [24] Market Performance - The company's India business achieved a revenue of INR 14.71 billion, with a year-over-year growth of 11% and a sequential increase [23] - The Russia business showed a 17% year-over-year growth, indicating resilience despite macroeconomic challenges [22] - The US generic market experienced softness, primarily due to price erosion in selected products [21] Strategic Direction and Industry Competition - The company is focused on scaling its presence in consumer health, innovative therapies, and biosimilars [16] - Strategic collaborations, such as with Albo Tech for pembrolizumab, are aimed at enhancing the biosimilar pipeline [18] - The company is actively exploring partnerships and acquisitions to diversify its portfolio and strengthen its market position [26] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in achieving flat to single-digit growth in the US base business, contingent on successful product launches [32] - The company anticipates a recovery in the US market with the launch of five new products in the upcoming quarters [21] - Management highlighted a commitment to sustainability, achieving an 'A' rating in the climate category from the Carbon Disclosure Project [20] Other Important Information - The company has a net cash surplus of $341 million as of June 30, 2025 [14] - R&D spending for the quarter was $73 million, remaining flat year-over-year, with a focus on complex generics and biosimilars [10] - The company plans to maintain R&D investments at 7-7.5% of sales for the full fiscal year [10] Q&A Session Summary Question: Performance of the US business quarter-on-quarter - Management indicated that the US base business decreased, primarily due to timing issues, and expects flat to single-digit growth for FY26 [32] Question: Outlook for Revlimid - Management expects similar sales levels for Revlimid in the upcoming quarters, with a decline anticipated in Q3 [34] Question: Timeline for semaglutide launches - Management plans to launch semaglutide in Canada and other markets in calendar 2026, with a focus on capacity for the Canadian launch [35][41] Question: Gross margin trends and SG&A costs - Management expects gross margins to remain stable for the year, with SG&A costs projected to be in the 28-29% range [44][45] Question: Update on biosimilar abatacept trials - The readout for the phase two trials is expected on November 25, with plans to submit the BLA following positive results [58] Question: Cost-saving measures and R&D spending - Management indicated potential discretionary cost savings of 500-600 basis points, with flexibility in R&D spending based on business performance [60][98] Question: Capacity for semaglutide and market share - Management expressed confidence in selling the planned 12 million pens, citing strong demand and a strategy to be first to market [66] Question: Status of generic liraglutide filing - Management confirmed plans to launch generic liraglutide in the coming quarters, with some markets expected to be first to market [71]

Financial Data and Key Metrics Changes - The consolidated revenues for Q1 FY26 were $997 million, reflecting an 11% year-over-year growth and remaining flat sequentially [7] - EBITDA margin was reported at 26.7%, slightly above the target of 25% [6] - The net profit after tax attributable to equity holders was $166 million, a 2% increase year-over-year but an 11% decline sequentially [11] - Operating working capital increased to $1.55 billion, up by $84 million from the previous quarter [12] Business Line Data and Key Metrics Changes - North American business revenue declined by 17% year-over-year to $400 million, primarily due to price erosion [21] - European generic business revenue was $131 million, a 124% year-over-year increase, driven by new product launches [21] - Emerging market revenue grew by 10% year-over-year, with 26 new products launched [22] - The PSAI business reported revenue of $95 million, showing year-over-year growth but a 14% sequential decline [24] Market Data and Key Metrics Changes - The Indian market reported a revenue of INR 14.71 billion, with a year-over-year growth of 11% and a sequential increase [23] - The Russia business showed a 17% year-over-year growth, indicating resilience despite macroeconomic challenges [22] Company Strategy and Development Direction - The company is focused on optimizing structural costs and driving operational efficiencies while scaling its presence in consumer health, innovative therapies, and biosimilars [15] - Strategic collaborations are being pursued to enhance capabilities, particularly in biosimilars and complex generics [25] - The company aims to maintain a strong balance sheet with a net cash surplus of $341 million [17] Management's Comments on Operating Environment and Future Outlook - Management acknowledged softness in the US generic market but expressed confidence in recovery through new product launches [16] - The company expects normalized effective tax rates to remain around 25% for the fiscal year [11] - Management highlighted the importance of upcoming product launches, particularly semaglutide, for future growth [40] Other Important Information - The company received a CDP rating of 'A' in the climate category, reflecting its commitment to sustainability [19] - The company is actively exploring strategic partnerships and acquisitions to diversify its portfolio [25] Q&A Session Summary Question: Performance of the US-based business - Management indicated that the US base business decreased, primarily due to timing issues, and expects flat to single-digit growth for FY26 [32] Question: Outlook for Revlimid - Management anticipates a similar trajectory for Revlimid in upcoming quarters, with a potential decline in Q3 [33] Question: Timeline for semaglutide launches - Management expects to launch semaglutide in Canada and other markets in calendar 2026, with a focus on capacity [40] Question: Gross margin trends - Management expects gross margins to remain stable for the year, with SG&A costs projected to be in the 28-29% range [45] Question: Cost-saving measures - Management indicated potential cost savings of 500 to 600 basis points, translating to significant savings, but emphasized that not all savings would be realized [63] Question: Update on biosimilar abatacept trials - Management confirmed that the readout for the phase two trial is expected on November 25, with plans to submit a BLA thereafter [60] Question: Capacity for semaglutide - Management expressed confidence in the ability to sell the planned 12 million pens, citing strong demand [72]

Industry Overview - The GLP-1 weight loss and diabetes control sector is currently the fastest growing pharmaceutical sector globally, with revenue expectations exceeding $100 billion annually [2] - Updated projections indicate that the GLP-1 industry could generate over $156 billion in revenue by 2030, with a significant growth of 31% expected in 2025, reaching $70.1 billion [3] Challenges in the GLP-1 Sector - The GLP-1 industry faces significant challenges due to unwanted adverse effects, particularly gastrointestinal issues such as nausea, vomiting, diarrhea, and constipation [4] - Discontinuation rates among GLP-1 users with type 2 diabetes are high, with studies showing that 47% to 64% of users stop their medication within 1 to 2 years, primarily due to gastrointestinal adverse effects [5][6] Company Innovations - Lexaria Bioscience Corp. has developed DehydraTECH technology, which aims to reduce side effects associated with GLP-1 drugs, potentially improving patient retention and industry growth [8][9] - DehydraTECH has shown promise in clinical testing for reducing gastrointestinal adverse effects in the top GLP-1 drugs, including semaglutide, tirzepatide, and liraglutide [10] Strategic Initiatives - Lexaria is pursuing a multi-faceted strategy to attract pharmaceutical companies to adopt its DehydraTECH technology, evidenced by a material transfer agreement with a pharmaceutical company announced in September 2024 [11]

Core Viewpoint - Hoth Therapeutics, Inc. has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs and the Foundation for Atlanta Veterans Education and Research to evaluate GDNF as a novel metabolic therapy for obesity and hepatic steatosis [1][4]. Study Overview - The study will compare daily GDNF injections against semaglutide in diet-induced obese mice and human liver chimeric mouse models, which are considered a gold-standard translational platform [2]. - The study is titled "Efficacy of Parenteral GDNF Administration in the Induction of Weight Loss and Resolution of Hepatic Steatosis" and has received IRB approval, adhering to VA and federal research ethics standards [3]. Deal Structure & Value - Hoth Therapeutics will fund the study and supply GDNF, while the VA will retain data rights and share de-identified results in compliance with HIPAA [6]. - The agreement represents the first pharmacologic test of GDNF in human liver-engrafted mice, potentially paving the way for first-in-class metabolic applications beyond central nervous system indications [4][6]. Scientific Rationale - GDNF has shown the ability to reduce body weight and hepatic lipid accumulation in previous transgenic models, enhance insulin sensitivity, and promote fatty acid oxidation [6]. - Clinical safety of GDNF has been demonstrated in prior human trials related to Parkinson's disease [6]. Company Background - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative treatments aimed at improving patient quality of life [5][7].

Core Viewpoint - The article discusses the potential of GLP-1 drugs, particularly semaglutide, in treating symptoms of polycystic ovary syndrome (PCOS), highlighting patient experiences and the need for further research and insurance coverage for these treatments. Group 1: Patient Experiences and Outcomes - Grace Hamilton, diagnosed with PCOS, experienced significant improvements in her symptoms after starting semaglutide, including weight loss of 50 pounds and resumption of her menstrual cycle within two weeks [3][4] - Another patient, Haley Sipes, lost over 60 pounds and reported improved emotional health and regular menstrual cycles after taking Zepbound, a GLP-1 drug [28][29] - Nabeelah Karim found relief from her PCOS symptoms and weight loss after using Eli Lilly's Mounjaro, although she faced challenges with insurance coverage [34][35] Group 2: Medical Insights and Research - PCOS affects an estimated 5 to 6 million women in the U.S., often leading to insulin resistance and metabolic issues [4][6] - Current treatments for PCOS are limited, with GLP-1s showing promise in improving insulin sensitivity and weight loss, which may alleviate symptoms [7][14] - Dr. Melanie Cree's ongoing study indicates that GLP-1s may lower testosterone levels and improve ovulation in women with PCOS [19][20] Group 3: Industry and Regulatory Context - Novo Nordisk and Eli Lilly are exploring GLP-1s for various chronic conditions, but not specifically for PCOS due to a lack of established FDA endpoints for clinical trials [10][12] - Insurance coverage remains a significant barrier for many PCOS patients seeking GLP-1 treatments, with only 55% of employers covering these drugs for diabetes [31][32] - The article highlights the ongoing debate regarding compounded versions of GLP-1 drugs, which are not FDA-approved, raising concerns about safety and efficacy [36][38]