Core Insights - The article discusses the process of identifying potential investment opportunities in the healthcare sector, particularly focusing on biotech and life-saving therapies [2]. Group 1: Investment Strategy - The investment strategy involves creating a high-priority watch list of ten companies within the healthcare sector, emphasizing innovative firms that are developing breakthrough therapies and pharmaceuticals [2]. - The author highlights a target-rich environment for finding candidate tickers to add to investment portfolios, indicating a robust market for healthcare investments [2]. Group 2: Analyst's Position - The analyst has disclosed a beneficial long position in the shares of IBRX and PFE, indicating confidence in these companies' future performance [3]. - There is an intention to potentially enter a long position in CRDF within the next 72 hours, suggesting ongoing evaluation of investment opportunities [3].

Multiple doses of APG808 resulted in rapid suppression of FeNO, a biomarker of Type 2 inflammation associated with exacerbations in asthma, with a robust maximal FeNO decrease from baseline of 53% The Phase 1b double-blind, placebo-controlled, multiple-dose trial evaluated the safety and tolerability of APG808 in 22 adult patients with mild-to-moderate asthma. The trial also evaluated fractional exhaled nitric oxide concentration (FeNO), TARC, and pSTAT6. Participants were randomized 3:1, receiving 600mg of ...

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 reached $114.8 million, a year-over-year increase of $32.9 million, translating to approximately 40% growth [11][20] - Adjusted for voluntary product withdrawals, revenues would have been $118.6 million, representing approximately 45% year-over-year growth [11][20] - Adjusted net income grew by 87% year-over-year to $33.3 million, while adjusted EBITDA increased by 81% to $47.9 million [12][22] Business Line Data and Key Metrics Changes - The increase in total revenue is primarily attributed to higher sales of Ascentive, reflecting increased acceptance and utilization by physicians, payers, and patients [20] - Gross profit for Q1 2025 was $61.1 million, with a gross margin of 53.2%, up from 47.8% in Q1 2024, driven by a favorable mix of higher margin immunoglobulin sales [21] Market Data and Key Metrics Changes - The company has seen robust demand for its commercial products, particularly Ascentive and BIVIGAM, with new patient starts continuing to grow [13][14] - Cash on hand and accounts receivable grew to a combined $171 million at the end of Q1 2025, providing a strong buffer against market volatility [14][24] Company Strategy and Development Direction - The company is focused on advancing its R&D platform and optimizing production capabilities, particularly with the recent FDA approval of the yield enhancement production process, which is expected to increase bulk immunoglobulin output by 20% [8][12] - A stock repurchase program has been authorized, allowing the company to buy back up to $500 million of its common stock, reflecting confidence in its financial position and future growth [15][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve sustainable revenue and earnings growth, driven by a strong balance sheet and capital flexibility [14][26] - The company anticipates significant growth in cash flow and plans to utilize this for debt reduction, funding R&D, and stock repurchases [43][44] Other Important Information - The company has successfully navigated recent geopolitical and trade challenges due to its U.S.-based supply chain and domestic operations [7][8] - The FDA's approval of the yield enhancement process is seen as a pivotal achievement, validating the company's R&D efforts and enhancing its market position [9][10] Q&A Session Summary Question: Guidance increase and yield enhancement process - Management confirmed that three conformance lots were manufactured to secure FDA clearance, and they are conservatively excluding these from 2025 guidance [31][33] Question: Demand generation and backlog for Ascentive - Management indicated that operational expenses are expected to normalize, and demand indicators for all products are strong, supporting revenue growth [41][42] Question: Supply agreements and plasma collection - Management reported that nearly all new centers are contributing to plasma supply, exceeding initial forecasts and supporting increased guidance [49][51] Question: Health economic outcome data for Ascentive - Management is on track to publish health economic outcome data by year-end, which is expected to resonate with payers and support access to the drug [63][64] Question: Voluntary product withdrawals - Management clarified that the withdrawals were due to known adverse events and are considered a one-time occurrence, with no expected ongoing impacts [66][70] Question: Intellectual property extension - Management expressed confidence in extending the IP for Ascentive and highlighted the robust patent protection in place [72][75]

Group 1 - The article discusses the potential for Xeris Biopharma Holdings, Inc. (NASDAQ: XERS) to make significant upward movements in its stock price, indicating a positive outlook for the company [1] - The author has a long position in XERS shares, suggesting confidence in the company's future performance [2] - The author emphasizes a focus on innovative companies in the biotech sector that are developing breakthrough therapies and pharmaceuticals, which aligns with Xeris Biopharma's business model [1]

Market Overview - Wall Street has experienced significant volatility in 2025, with all three major stock indexes (Dow, S&P 500, Nasdaq Composite) in negative territory year to date [1] - Small-cap benchmarks (Russell 2000, S&P 600) and mid-cap-specific S&P 400 Index are also in the red year to date [1] High-Performing Mid-Cap Stocks - Despite market headwinds, five mid-cap stocks have provided over 25% returns year to date: ADMA Biologics Inc. (ADMA), FirstCash Holdings Inc. (FCFS), Stride Inc. (LRN), Life Time Group Holdings Inc. (LTH), and National Fuel Gas Co. (NFG) [2] - These stocks exhibit strong revenue and earnings growth potential for 2025, with positive earnings estimate revisions over the last 60 days [3] ADMA Biologics Inc. - ADMA Biologics specializes in plasma-based biologics for treating and preventing infectious diseases, targeting immune-compromised individuals [7][8] - Expected revenue growth rate is 16.3% and earnings growth rate is 44.9% for the current year, with a 2.9% improvement in earnings estimates over the last 60 days [9] FirstCash Holdings Inc. - FirstCash operates retail pawn stores across the U.S., Mexico, and Latin America, providing loans against personal property and retailing forfeited merchandise [10][11] - Expected revenue growth rate is 0.2% and earnings growth rate is 17.2% for the current year, with a 2.6% improvement in earnings estimates over the last seven days [13] Stride Inc. - Stride is a technology-based education service company offering online curriculum and educational services [14] - Expected revenue growth rate is 14.9% and earnings growth rate is 48.4% for the current year, with a 4.3% improvement in earnings estimates over the last 30 days [16] Life Time Group Holdings Inc. - Life Time provides health, fitness, and wellness experiences, operating various fitness and recreation centers [17][18] - Expected revenue growth rate is 12.9% and earnings growth rate is 37.9% for the current year, with a 6.5% improvement in earnings estimates over the last 60 days [19] National Fuel Gas Co. - National Fuel Gas focuses on systematic investments to strengthen operations and reduce emissions, with significant capital investments planned [20][21] - Expected revenue growth rate is 31.5% and earnings growth rate is 39.1% for the current year, with a 1.9% improvement in earnings estimates over the last 60 days [22][23]

Core Viewpoint - BioStem Technologies Inc. will release its first quarter 2025 financial results on May 12, 2025, and will host a conference call and webcast to discuss the results [1][2]. Company Overview - BioStem Technologies is a MedTech company focused on developing, manufacturing, and commercializing placental-derived biologics for advanced wound care [1][4]. - The company utilizes its proprietary BioREtain processing method to maintain growth factors and preserve tissue structure in its products [4]. - BioStem's quality management system has been accredited by the American Association of Tissue Banks (AATB) and adheres to current Good Tissue Practices (cGTP) and Good Manufacturing Processes (cGMP) [4]. Upcoming Events - The conference call and webcast will feature an overview of the quarter from CEO Jason Matuszewski and CFO Michael Fortunato [2]. - Interested parties can register for the event and follow the company on social media for updates [3]. Contact Information - BioStem Technologies can be contacted via phone at 954-380-8342 or through their website [7]. - Investor relations inquiries can be directed to Adam Holdsworth at adam@holdsworthco.com [7].

MoonLake Immunotherapeutics Capital Markets Update New York April 29th 2025 © 2025 | Proprietary | MoonLake TX W: moonlaketx.com | E: info@moonlaketx.com Welcome to our Capital Markets Update Date: April 29th, 2025 Time: 8.30 am EST Location: New York | Topic | Sub-topics | | Speaker | Timing | | --- | --- | --- | --- | --- | | Introduction | - | Welcome | Jorge | 10 mins | | | - | MLTX & SLK summary | | | | | - | Key points for the session | | | | HS: Clinical & | - | VELA recruitment & baseline | Kristian ...

Core Insights - The report provides a comprehensive analysis of global biologics sales, including various categories such as cancer antibodies, non-TNF inflammatory mAbs, biosimilars, gene therapy, and RNA-based drugs [1][3][5] - It highlights sales data, growth trends, and rankings of top biologics, making it essential for biopharma professionals, investors, and market analysts [1][2] Sales Data Overview - The report compiles and analyzes sales data for originator recombinant therapeutic proteins and antibodies for the year 2024, including publicly available data for biosimilars and new biologic modalities [3][5] - Sales data from 2012 to 2024 are summarized, showing growth rates and the percentage of antibody sales relative to total biologics sales [5] Product Categories - Individual product sales data are categorized into groups such as cancer antibodies, non-TNF anti-inflammatory mAbs, cardiometabolic antibodies, and more [9][10] - Target-specific sales data for cancer antibodies and non-TNF anti-inflammatory antibodies are calculated for 2024, covering various therapeutic areas [7][12] Market Trends - The report emphasizes the commercial success of novel antibody drug modalities, including antibody-drug conjugates and bispecific antibodies, with sales and growth rates presented from 2012 to 2024 [16] - A total of 75 innovator therapeutic antibodies and proteins achieved blockbuster status in 2024, each exceeding sales of US$ 1 billion [16] Company Rankings - A ranking list of the top 30 companies regarding biologics sales in 2024 is provided, along with company-specific sales data for biosimilars from 2020 to 2023 [16] - The report includes detailed sales data for various biologic products, highlighting the competitive landscape within the industry [14][16]

Core Viewpoint - ADMA Biologics has demonstrated strong performance in 2024, with continued growth expected in 2025, driven by its lead product Asceniv and new supply contracts [1][8]. Financial Performance - In Q4 2024, ADMA reported adjusted earnings per share of 14 cents, slightly missing the Zacks Consensus Estimate by one cent, while revenues reached $118 million, surpassing the consensus estimate of $112 million [1]. - The company has revised its financial targets, now expecting revenues of over $490 million in 2025 and $605 million in 2026, with net income projected to exceed $175 million in 2025 and $235 million in 2026 [9]. Product and Market Analysis - ADMA Biologics specializes in plasma-derived biologics for treating immune deficiencies and preventing infectious diseases, with three FDA-approved products: Bivigam, Asceniv, and Nabi-HB [3][4]. - Asceniv, the lead product, is a plasma-derived IVIG designed for treating primary immunodeficiency disease (PIDD) and is manufactured using a patented plasma donor screening methodology [5][6]. - Strong demand for Asceniv is anticipated to continue into 2025, with expectations for increased patient starts and market penetration [7]. Supply Chain and Growth Potential - ADMA has entered into long-term high-titer plasma supply contracts, significantly increasing its access to raw material plasma, with a five-fold increase in total collection capacity from approximately 250 collection centers [8]. - Management projects that these supply agreements could position ADMA to achieve $1 billion in total annual revenues before 2030, indicating substantial growth potential in the 2030s [8]. Competitive Landscape - ADMA Biologics competes with Takeda and Grifols in the U.S. market for plasma-derived products, with a targeted market that shows significant growth potential [10].

Financial Data and Key Metrics Changes - Total revenues for 2024 reached $426.5 million, reflecting a 65% year-over-year increase [9][26] - Adjusted EBITDA grew to $164.6 million, representing a 309% increase from the previous year [10][29] - GAAP net income for Q4 2024 was $111.9 million, compared to a net loss of $17.6 million in Q4 2023 [30] - Adjusted net income for the year was $119.2 million, up from $0.7 million in 2023, marking an increase of $118.5 million [31] Business Line Data and Key Metrics Changes - The increase in total revenue was primarily driven by higher sales of ASCENIV, which saw increased acceptance and utilization [26][27] - Gross profit for 2024 was $219.6 million, with a gross margin of 51.5%, up from 34.4% in 2023, due to a favorable mix of higher-margin immunoglobulin sales [27] Market Data and Key Metrics Changes - ASCENIV's forward-looking demand metrics are at all-time highs, with the company currently penetrating just over 3% of the targeted market for primary immunodeficiency (PI) [13][14] - The company has secured long-term agreements for high-titer plasma supply from approximately 250 US-based collection centers, increasing collection capacity fivefold [14] Company Strategy and Development Direction - The company anticipates regulatory approval for an enhanced yield production process by mid-2025, which could increase production output by approximately 20% [15][16] - The strategic focus includes expanding ASCENIV's market penetration and addressing unmet needs within the PI patient population [13][18] - The company aims to achieve over $1 billion in total annual revenue by 2030, with additional upside potential from the SG-001 program targeting strep pneumonia [19][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to continue generating strong financial results and expanding margins, supported by a solid balance sheet and increasing net cash position [20][36] - The anticipated increase in high-titer plasma supply is expected to meet growing demand and accelerate revenue and earnings growth [17][37] Other Important Information - The company is undergoing an audit process with KPMG, which is expected to enhance the accuracy and quality of financial statements [22][33] - The company has a net cash position exceeding $103 million against $75 million in total debt, providing a strong foundation for strategic initiatives [20][32] Q&A Session Summary Question: Update on third-party supply contracts and expected cadence in 2025 - Management indicated that they are more than 50% of the way to onboarding additional collection centers and are seeing increased plasma collection [42][44] Question: Characterization of the waiting list for new ASCENIV patients - Management confirmed that the queue of prospective patients is growing, and they are onboarding more patients than before [46][48] Question: Long-term guidance and yield enhancement impact - Management clarified that the 2025 guidance does not include yield enhancement, which could provide significant upside in 2026 [59][61] Question: Gross margins expectations for ASCENIV - Management expects ASCENIV's gross margins to remain above 80%, with yield enhancement further improving margins [90][92] Question: FDA review process for enhanced yield - Management expressed confidence that no preapproval inspection is required for the enhanced yield process and anticipates timely approval [94][96] Question: Timeline for SG-001 animal data and clinical entry - Management is optimistic about the rapid progress of SG-001 and expects to have animal data later this year, with potential clinical entry before 2030 [98][100]