Core Insights - Adagene Inc. is participating in the Jefferies Global Healthcare Conference 2025, highlighting its commitment to investor engagement and communication [1][2]. Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [3]. - The company has established strategic collaborations with global partners to enhance its SAFEbody precision masking technology, which is at the forefront of scientific innovation [3]. Technology and Pipeline - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, which are designed to improve the safety and tolerability of antibody therapeutics [4]. - The SAFEbody technology specifically addresses safety challenges by masking the binding domain of biologic therapies, allowing for targeted action in the tumor microenvironment while reducing toxicity to healthy tissues [4]. Clinical Programs - The lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment, currently in phase 1b/2 studies in combination with anti-PD-1 therapy for Metastatic Microsatellite-stable Colorectal Cancer [5]. - The SAFEbody platform is versatile and can be applied to various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [5].

Company Overview - EDAP TMS SA is a global leader in robotic energy-based therapies, focusing on minimally invasive medical devices utilizing ultrasound technology [3] - The company has developed the Focal One®, a leading prostate focal therapy device, which is controlled by urologists and has potential applications beyond prostate cancer [3] Upcoming Event - Ryan Rhodes, the CEO of EDAP TMS, will present and host one-on-one investor meetings at the Jefferies Global Healthcare Conference from June 3-5, 2025, in New York City [1] - The presentation is scheduled for June 5th from 4:20 to 4:50 PM ET, and it will be available via a live and archived webcast [2]

Group 1 - The article discusses the analytical approach of Stephen, who combines clinical insight with valuation methods to analyze healthcare and tech stocks [1] - Stephen specializes in scenario-based DCF modeling, sensitivity analysis, and Monte Carlo simulations to identify asymmetric risk-reward opportunities [1] - The focus is on translating complex scientific and market dynamics into actionable investment theses [1] Group 2 - The article emphasizes the importance of independent verification of information and conducting thorough research before making investment decisions [3] - It highlights that past performance is not indicative of future results and that no specific investment recommendations are provided [4]

Industry Overview - The obesity market is rapidly expanding, driven by the success of GLP-1 therapies Wegovy and Zepbound, and is projected to reach $100 billion by 2030 [1] - There is a growing interest in cannabinoid (CBD)-based therapies as companies seek to innovate beyond GLP-1s for weight management [2] - The cannabis industry is also experiencing significant growth, expected to surpass $200 billion by 2032, although direct investments in cannabis companies have been challenging due to regulatory issues [3] Company Analysis Novo Nordisk - Novo Nordisk is a leader in obesity treatments with its semaglutide products, Wegovy and Ozempic, but faces increasing competition from Eli Lilly [5] - The company entered the CBD space by acquiring Inversago Pharmaceuticals in 2023, adding monlunabant, an investigational oral cannabinoid drug for metabolic diseases [6] - A phase IIa study on monlunabant showed statistically significant weight loss compared to placebo, but higher doses had diminishing returns; a phase IIb study is planned to find an optimal dose [7] - EPS estimates for 2025 have increased from $3.81 to $3.84, while 2026 estimates have slightly decreased from $4.66 to $4.64; the stock has declined about 21% year to date due to competition and regulatory challenges [8] Corbus Pharmaceuticals - Corbus' lead CBD candidate, CRB-913, targets the same CB1 receptor as monlunabant and is currently in phase I studies, with results expected in Q3 2025 [9] - Preclinical data suggest CRB-913 may have advantages over previous therapies, with a significantly lower brain-to-plasma ratio, indicating reduced neuropsychiatric side effects [10] - Corbus is also developing two oncology drugs, CRB-701 and CRB-601, with CRB-701 in phase I/II studies [11] - Loss per share estimates for 2025 have increased from $5.47 to $6.34, and for 2026 from $5.30 to $5.39; the stock has declined 36% year to date, reflecting regulatory volatility [12][13] Skye Bioscience - Skye Bioscience is developing nimacimab, a monoclonal antibody targeting the CB1 pathway, currently in a phase II study evaluating its efficacy as a monotherapy and in combination with Wegovy [14] - Nimacimab is designed to minimize brain penetration while maintaining metabolic effects, with early studies showing no adverse psychiatric events [15] - Loss per share estimates for 2025 have widened from $1.27 to $1.31, and for 2026 from $1.48 to $1.52; the stock has lost 27% year to date due to financial concerns and lack of commercial revenues [16]

Financial Data and Key Metrics Changes - For fiscal year 2025, the company achieved over 12% revenue growth, nearly all organic, with adjusted EBITDA increasing 12% to $1,315 million, yielding an adjusted EBITDA margin of 11% [30][31] - Adjusted diluted earnings per share grew over 15%, driven by increased profitability and a lower share count, with diluted earnings per share at $1.52, a 55% increase year over year [38][39] - Free cash flow for the quarter was $194 million, resulting from $218 million of cash from operations, less $24 million of CapEx [39] Business Line Data and Key Metrics Changes - The defense and intelligence businesses saw significant growth, with revenue up 145% year over year, while the civil business experienced flat revenue in Q4 and is expected to decline in the low double digits in FY 2026 [33][35] - The AI business grew over 30% year over year to approximately $800 million, indicating strong demand and increasing integration into government operations [18][19] Market Data and Key Metrics Changes - The company ended the fiscal year with a record year-end backlog of $37 billion, up 15% year over year, and a qualified pipeline for FY 2026 of $53.4 billion [35][36] - The book-to-bill ratio for the quarter was 0.71 times, in line with historical averages, while the trailing twelve-month book-to-bill ratio was 1.39 times, above the trailing five-year average of 1.28 times [35] Company Strategy and Development Direction - The company is restructuring its civil business to return to growth rapidly after a reset period, while focusing on capturing major outcome-based opportunities [22][23] - The Vault strategy, emphasizing velocity, leadership, and technology, aligns with government changes, particularly in AI and advanced technology [17][24] Management's Comments on Operating Environment and Future Outlook - Management noted a near-term disruption in the civil business due to government spending reductions and procurement slowdowns, but expressed optimism about growth opportunities in defense and intelligence sectors [10][29] - The outlook for FY 2026 anticipates revenue between $12 billion and $12.5 billion, with adjusted EBITDA in the range of $1,315 million to $1,370 million, maintaining an adjusted EBITDA margin of about 11% [42] Other Important Information - The company plans to make targeted cost and headcount reductions to match anticipated demand, with an expected 7% reduction in staff concentrated in the civil business [12][37] - The board of directors approved a quarterly dividend of 55¢ per share, payable on June 27, reflecting a strong balance sheet and commitment to shareholder value [41] Q&A Session Summary Question: How does the company manage the impact of unpredictable descoping and cancellations? - Management highlighted the dual dynamics of a reset in the civil business and continued strength in defense and intelligence, indicating a proactive restructuring to position for growth [47][48] Question: What are the expectations for the multiyear growth environment, particularly in defense and civil? - The company noted a significant increase in defense spending and a focus on technology integration, while the civil business is undergoing a reset with positive reviews of their technology [55][56] Question: How does the company plan to address the low double-digit decline in the civil business? - Management indicated that the civil business has undergone most reviews positively, and they expect growth to resume as new opportunities arise in the second half of the fiscal year [68][73] Question: How does the company view its branding and perception in the market? - Management acknowledged being a market leader attracts attention, and they are working to improve communication about their advanced technology capabilities [88][90] Question: What is the outlook for the AI business and its future programs? - The company remains optimistic about its AI business, emphasizing its integration into various missions and the potential for significant growth in the sector [99][100]

Core Insights - Costco Wholesale's stock has surpassed the $1,000 mark, reflecting its strong operational performance and market presence [1][15] - As of May 22, 2025, Costco's shares were trading around $1,025, with a market capitalization of approximately $455 billion [2] - The membership-based business model is central to Costco's success, fostering customer loyalty and generating high-margin revenue from membership fees [3] Membership and Revenue - In Q2 FY25, membership fees generated $1.193 billion, with over 130 million cardholders as of early 2024 [4] - The renewal rates for memberships were reported at 92.9% in the U.S. and Canada, and 90.5% worldwide, indicating strong customer satisfaction [4] - Costco's net sales for Q2 FY25 increased by 9.1% year-over-year, reaching $62.53 billion, while net sales for the first 35 weeks of FY25 grew by 8.2% to $180.05 billion [5] Brand and Operational Efficiency - The Kirkland Signature private-label brand significantly contributes to member value and sales [6] - Costco's operational efficiency is enhanced by a limited number of SKUs, which streamlines inventory management and leverages high sales volumes for cost advantages [6] Shareholder Returns - Costco has a strong track record of returning value to shareholders, having increased its quarterly dividend for 22 consecutive years, with the latest payout at $1.30 per share [7] E-commerce Growth - The e-commerce channel has become a vital growth driver, with comparable sales in Q2 FY25 showing an adjusted increase of 22.2% [8] Valuation Considerations - As of mid-May 2025, Costco's trailing P/E ratio was approximately 60.21, with a forward P/E around 56.87, indicating a premium valuation compared to market averages [9][11] - Investors justify this premium due to Costco's consistent growth, predictable earnings, and resilience across economic cycles [11] Price Volatility and Market Dynamics - The stock's establishment above $1,000 may lead to increased price volatility as investors reassess growth potential and engage in profit-taking [12][13] - The $1,000 level may serve as a new psychological support or resistance area, indicating a period of price discovery [13]

Group 1 - Alkami Technology, Inc. is a leading provider of cloud-based digital banking solutions for financial institutions in the U.S. [2] - The company will present at the 45th Annual William Blair Growth Stock Conference on June 4, 2025, with CEO Alex Shootman and CFO Bryan Hill participating [1] - A webcast and replay of the conference will be available on the company's investor relations website [1] Group 2 - Alkami's solutions enable clients to grow confidently, adapt quickly, and build thriving digital communities [2] - The company focuses on transforming retail and business banking, onboarding and account opening, payment security, and data and marketing solutions [2]

CTLA-4 inhibitor ADG126 can be dosed at 20 mg/kg Q6W in combination with pembrolizumab with <20% Grade 3 adverse events In combination with pembrolizumab, ADG126 showed a 29% confirmed overall response rate (ORR) in microsatellite stable colorectal cancer All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over forty weeks Median overall survival (OS) for the 10 mg/kg cohorts was 19.4 months, with a median follow-up of 17.8 months and only 1 out of 41 patients was ...

SAN CLEMENTE, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, today announced that Assaf Korner, Chief Financial Officer, will provide a corporate overview and participate in one-on-one investor meetings at the Jefferies Global Healthcare Conference, to be held in New York from June 3-5, 2025. Jefferies Global Healthcare ConferencePresentation Format: Corporate o ...

Core Insights - Ascletis Pharma Inc. has received FDA clearance for the investigational new drug (IND) application for ASC50, an oral small molecule IL-17 inhibitor aimed at treating mild-to-moderate plaque psoriasis [3][6] - ASC50 shows promising preclinical data, including higher oral exposure, longer half-life, and strong efficacy, positioning it as a potential best-in-class treatment for psoriasis [2][4] Company Overview - Ascletis is an innovative R&D driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic and other diseases while addressing unmet medical needs globally [7] - The company utilizes an Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) platform for drug development, with ASC50 being the first oral small molecule candidate in immunology from this platform [6] Clinical Development - The Phase I clinical trial for ASC50 will be a randomized, double-blind, placebo-controlled study conducted at multiple sites in the U.S., with patient dosing expected to start in the third quarter of 2025 [5][6] - Preclinical studies indicate that ASC50 has a lower clearance rate compared to existing oral IL-17 inhibitors currently in clinical development, suggesting a potentially advantageous pharmacokinetic profile [4]