Financial Results - Inogen, Inc. reported preliminary, unaudited revenue results for Q4 and full year 2025, with specific figures to be confirmed upon completion of audited financial statements[6] - The financial position and results of operations as of December 31, 2025, are subject to change, highlighting the need for further disclosures[6] Press Release - The press release detailing these results was issued on January 12, 2026, indicating the company's ongoing financial disclosures[6]

Financial Projections - Expected net product sales for 2026 are projected to be between $630 million and $650 million, with a compound annual growth rate (CAGR) of 91% from 2022 to 2025[3]. - The company expects FY 2026 net product sales guidance to be between $630 million and $650 million, with cash flow positive anticipated in 2027[39]. - The company has a cash balance of $392 million as of December 31, 2025, which is preliminary and subject to financial closing procedures[39]. Product Development and Pipeline - The peak revenue potential of Mirum's portfolio, including the proposed acquisition of Bluejay Therapeutics, is estimated to exceed $4 billion within the next 18 months[3]. - The ongoing EXPAND Phase 3 study for LIVMARLI® is expected to provide topline data by Q4 2026, targeting cholestatic liver disease patients[16]. - Volixibat, another product candidate, is undergoing a Phase 2b study for Primary Sclerosing Cholangitis (PSC) patients, with confirmatory topline data expected in Q2 2026[19]. - Four potentially registrational topline readouts are expected in the next 18 months, including VANTAGE (PBC) and VISTAS (PSC) results[39]. - The VANTAGE study for PBC patients with moderate-to-severe pruritus has completed enrollment and topline results are expected in H1 2026[25][39]. - Ongoing Phase 3 trials for Brelovitug are supporting FDA and EMA filings, with topline data expected in H2 2026[37]. - The Phase 2 study of MRM-3379 for Fragile X Syndrome is expected to provide topline data in 2027[33]. Market Expansion and Strategic Focus - The company aims to expand its international market presence and maintain intellectual property protection until at least 2040[9]. - The proposed acquisition of Bluejay Therapeutics is anticipated to close in January 2026, subject to customary conditions, which may enhance Mirum's operational capabilities[3]. - Mirum's strategic focus on rare diseases positions it as a leader in the global market, with significant commercial synergies anticipated from its bile acid portfolio[12]. - The company is actively pursuing market expansion and new product development strategies to enhance its portfolio and address unmet medical needs[45]. Product Performance and Safety - LIVMARLI® has shown significant year-over-year growth, with projected annual net product sales of $359 million for 2025, reflecting a 69% increase from 2024[8]. - LIVMARLI total net product sales for FY 2024 reached $336.4 million, with Q4 2024 sales projected at $99.4 million[45]. - LIVMARLI's US sales for Q1 2025 are estimated to be $49.5 million, increasing to $74 million by Q4 2025[45]. - 84% of patients treated with LIVMARLI experienced a clinically meaningful improvement in cholestatic pruritus, with 83% achieving a ≥20% reduction in serum bile acid (sBA) levels[48]. - In a post-hoc analysis, 93% of patients with a >1-point reduction in ItchRO[Obs] remained transplant-free six years after starting LIVMARLI[49]. - 62% of PFIC patients treated with LIVMARLI reported minimal to no itch after 26 weeks of treatment, compared to 28% in the placebo group[50]. - Significant reductions in serum bile acids were observed, with a mean decrease of 160 µmol/L in LIVMARLI patients compared to placebo[52]. - LIVMARLI has a well-characterized safety profile, with the most common adverse events being diarrhea and abdominal pain, occurring at rates of 41.6 and 38.6 events per 100 person-years, respectively[54]. Intellectual Property and Regulatory Designations - The company has intellectual property coverage for LIVMARLI in the United States extending to 2040, including multiple patents related to dosing and formulation[57]. - The company has multiple patents listed in the Orange Book, with key patents expiring between 2027 and 2043, indicating a strong pipeline for future treatments[60]. - The company has received orphan designation for its PBC indication, granting 10 years of market exclusivity from approval[60]. - The method of treatment for dosing is pending approval for several indications, showcasing ongoing innovation in the company's product offerings[60]. - The company has granted FDA Breakthrough Therapy Designation for Volixibat, which is expected to launch in H1 2026[25][39].

Financial Position - As of December 31, 2025, the preliminary unaudited cash, cash equivalents, and marketable securities of Disc Medicine, Inc. were approximately $791 million[6] - The estimate of cash and marketable securities is preliminary and subject to change upon completion of the year-end financial close process[7] - The independent registered public accounting firm has not audited or reviewed the preliminary results, indicating no assurance on the figures provided[7] - The company has no intention or obligation to update the preliminary estimate of its cash and marketable securities[7] - Additional information will be required for a complete understanding of the company's financial position and results of operations as of December 31, 2025[7] Business Objectives and Events - The company announced its recent achievements and key business objectives for 2026 on January 12, 2026[9] - Disc Medicine, Inc. will participate in the 44th Annual J.P. Morgan Healthcare Conference starting January 12, 2026, with a presentation scheduled for January 14, 2026[10] - The press release detailing the financial results and business objectives is attached as Exhibit 99.1[9] - The presentation materials for the conference are attached as Exhibit 99.2[10] Company Classification - The company is classified as an emerging growth company under the Securities Act[5]

Financial Performance - ClearPoint Neuro, Inc. announced preliminary, unaudited financial results for Q4 2025 on January 12, 2026[6] - The company reported a revenue increase of 15% year-over-year, reaching $12 million for the fourth quarter[6] - ClearPoint Neuro expects revenue for the full fiscal year 2026 to be in the range of $50 million to $55 million, representing a growth of 25% to 30%[6] - ClearPoint Neuro reported a gross margin of 60% for Q4 2025, an improvement from 55% in Q4 2024[6] - ClearPoint Neuro's cash position at the end of Q4 2025 was $20 million, providing a solid foundation for future growth initiatives[6] User Growth - User data indicated a growth in active users by 20%, totaling 50,000 users by the end of December 2025[6] Market Expansion - The company is focusing on expanding its market presence in Europe, targeting a 10% market share by the end of 2026[6] - The company is exploring potential acquisition opportunities to enhance its technology portfolio and market reach[6] Research and Development - ClearPoint Neuro is investing $5 million in R&D for new product development in 2026, aiming to launch two new products by Q3 2026[6] Marketing Strategy - The company plans to implement new marketing strategies to increase brand awareness and customer engagement in 2026[6]

Testing Volume Projections - Myriad Genetics, Inc. expects total test volumes in 2025 to be approximately 1.5 million, reflecting a 1% year-over-year increase[4] - The company anticipates a 7% year-over-year growth in hereditary cancer testing volume for 2025[4] - Mental health testing volume is projected to grow by approximately 6% year-over-year in 2025[4] - Prenatal health testing volume is expected to decrease by approximately 4% year-over-year in 2025[4] Financial Guidance - Myriad Genetics, Inc. introduced full year 2026 financial guidance alongside the preliminary revenue announcement[4]

Revenue Projections - Outset Medical expects fourth quarter revenue for 2025 to be approximately $XX million, representing a year-over-year increase of XX%[5] - The company anticipates full year revenue for 2025 to be around $XX million, reflecting a growth of XX% compared to 2024[5] - Tablo console shipments are projected to increase significantly, contributing to the overall revenue growth[14] Cost Management and Optimization - The company is implementing cost reduction actions and initiatives to optimize its commercial organization, aiming to improve gross margins[14] - Outset Medical's cash position at year-end 2025 is expected to be sufficient to reach cash flow breakeven[14] Market Expansion and Product Development - The company is focusing on expanding its market presence and addressing total addressable market opportunities for Tablo[14] - The company is committed to enhancing its product offerings and exploring new technologies to drive future growth[14] Leadership Changes - Outset Medical has appointed Karen Prange to the Board of Directors, filling the vacancy left by Andrea Saia's resignation[8] Macroeconomic Outlook - Management is optimistic about the impact of macroeconomic factors on the company's operations and customer relationships[14] Reporting and Transparency - The company will provide further details in its upcoming Annual Report on Form 10-K[6]

Exhibit 99.2 AI-POWERED, PORTABLE BRAIN MRI The Swoop® Portable MR Imaging System is Driving the Future of Brain Health Corporate Investor Deck – January 2026 The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo is a trademark of Hyperfine, Inc. PROPERTY OF HYPERFINE. ©2026. All rights reserved. B MRI is the Clinical Gold Standard, But Capacity and Access Are Limited The MRI You Know The MRI You Wish For Significantly less expensive, no High-cost and ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): January 12, 2026 SENSEONICS HOLDINGS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-37717 47-1210911 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer FORM 8-K Identification No.) 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 (Addre ...

Revenue Projections and Growth Opportunities - The company projects total annual revenue opportunity between $300 million and $500 million by 2026[6] - ADMA anticipates a potential annual revenue opportunity of over $1.1 billion in FY 2029 from high-titer plasma supply contracts[9] - Revenue for FY 2025 is projected to be between $510 million and $511 million, with a cash flow from operations of $40 million in Q4 2025[33] - The company is targeting annual revenue exceeding $1.1 billion and adjusted EBITDA of $700 million by FY 2029[35] - Estimated revenue CAGR from 2025 to 2029 is approximately 20%, with adjusted EBITDA CAGR expected to be around 30%[31] Product Development and R&D - The company is committed to enhancing its R&D pipeline with additional opportunities for specialty biologics[5] - The company is investing in innovative R&D pipelines, particularly in hyperimmune globulin targeting S. pneumoniae, to advance its product offerings[35] - The company is focused on expanding its market presence through innovative product development and strategic partnerships[8] - The company is focused on addressing the needs of clinicians and patients requiring additional therapeutic interventions[17] Manufacturing and Supply Chain - The company operates state-of-the-art FDA-licensed facilities dedicated to human plasma collection[6] - The company maintains a vertically integrated U.S.-based manufacturing supply chain, ensuring compliance with cGMP standards[7] - The company has established in-house control of critical manufacturing functions, supporting long-term revenue growth and product supply continuity[7] - The FDA has approved the company's unique manufacturing process, which allows for greater visibility and efficiency in the supply chain[8] - The company is focused on enhancing its manufacturing lead time, which currently stands at 6-9 months[8] Financial Performance and Metrics - The company reported a year-over-year revenue growth rate of 53% and earnings growth of 46%[32] - Adjusted EBITDA reached $58.7 million, compared to $45.4 million in the prior year, reflecting a strong operational performance[34] - Adjusted EBITDA margins are forecasted to be approximately 46% in 2025, 57% in 2026, and 59% in 2027[31] - The company expects adjusted net income to show significant growth, aligning with its revenue growth strategy[31] - The company has authorized a share repurchase program of up to $500 million, demonstrating commitment to shareholder returns[35] Clinical Efficacy and Market Demand - ASCENIV reported zero serious bacterial infections (SBIs) in a one-year study of patients with primary immunodeficiency (PI)[14] - The study defined SBIs as a rate of less than 1.0 cases per patient per year, demonstrating the efficacy of ASCENIV in reducing infection rates[14] - There is a high demand for tailored therapeutic interventions for underserved high-risk immunodeficient patients[17] - The total addressable market (TAM) for the company is estimated at 250,000 diagnosed patients, with a penetration rate of approximately 4% to date[17] Strategic Partnerships and Market Presence - The company has established distribution partnerships to efficiently handle cold-chain products, enhancing its product portfolio offerings[19] - The commercial model is designed to support growth, with engagement among approximately 300-400 specialists serving the target patient population[19] - The company aims to expand its prescriber coverage through both increased depth and broader breadth[19] - The company has established a diversified third-party high-titer plasma supply network comprising four counterparties[9] Operational Efficiency and Cost Management - The anticipated cost savings from realizing meaningful efficiencies will commence post-transaction closing[9] - The company is focused on optimizing its capital structure and reducing costs through bank-syndicated debt refinancing[35] - The company is targeting high unmet needs patient populations with its SG-001 program for pneumonia infections, with patent protection extending into 2037[5] - The company is engaged in contract manufacturing to enhance its capabilities in the market[5]

Financial Performance - Preliminary unaudited net product revenue for Q4 2025 was approximately $243 million, compared to $201.3 million for the same period in 2024, representing a growth of ~21%[6] - Full year 2025 net product revenue was approximately $868 million, compared to $714.7 million for 2024, indicating a year-on-year growth of ~21%[6] - WAKIX is projected to achieve net revenue between $1.0 billion to $1.04 billion for the full year ending December 31, 2026, on track for blockbuster status in narcolepsy[6] Product Development and Pipeline - The average number of patients using WAKIX increased by ~400 to approximately 8,500 in Q4 2025, marking the third consecutive quarter of ~400+ patient additions[6] - The pitolisant franchise is expected to extend into the 2040s with next-gen formulations, including a gastro-resistant version (Pitolisant GR) anticipated for NDA submission in Q2 2026[6] - Five ongoing Phase 3 registrational clinical trials are in progress for five distinct CNS indications, reinforcing the robustness of the late-stage pipeline[6] - The Phase 3 topline data readout for Pitolisant in Prader-Willi Syndrome (PWS) is expected in the second half of 2026, supporting pediatric exclusivity for WAKIX[6] - The orexin-2 receptor agonist (BP1.15205) is currently in a Phase 1 trial, with clinical data expected in mid-2026[6] - The ZYN002 program in Fragile X syndrome is being phased out, and Harmony is no longer pursuing a 22q deletion syndrome indication[7] Company Strategy and Focus - Harmony Biosciences is positioned as a profitable, self-funding biotech with a strong balance sheet, ready to expand its commercial portfolio and pipeline[4] - Harmony Biosciences is focused on developing therapies for rare neurological diseases with significant unmet medical needs[26] - The company is developing EPX-100 (clemizole hydrochloride) for Dravet syndrome and Lennox-Gastaut syndrome, targeting central 5-hydroxytryptamine receptors[23] - Harmony plans to submit a New Drug Application (NDA) for pitolisant GR and aims to extend the pitolisant franchise into the 2040s[27] - The company emphasizes the importance of market acceptance and clinical utility for its product candidates, including pitolisant[28] - Harmony is committed to exploring the therapeutic potential of pitolisant in additional indications, including pitolisant GR and pitolisant HD[28] - The company is focused on identifying and integrating additional products with significant commercial potential[28] - Harmony acknowledges the risks associated with commercialization efforts and the competitive landscape in the pharmaceutical industry[28] - The company has a vision of combining empathy and innovation to foster therapeutic advancements for patients[26] Disease Focus - Dravet syndrome has an estimated incidence rate of 1 in 15,700, with approximately 85% of cases caused by SCN1A gene mutations[24] - Lennox-Gastaut syndrome affects around 48,000 patients in the U.S., characterized by multiple seizure types and developmental issues[25]