Beam Therapeutics(BEAM) - 2025 Q4 - Annual Report
2026-02-24 12:10
Clinical Development - The company is developing risto-cel, an autologous HSC investigational therapy for sickle cell disease, with a Phase 1/2 clinical trial (BEACON) involving approximately 50 patients[657]. - Preliminary data from the BEACON trial showed mean HbF levels above 60% and a mean durable reduction in HbS below 40%[662]. - The company plans to submit a Biologics License Application (BLA) for risto-cel as early as year-end 2026[659]. - The company is conducting a Phase 1/2 clinical trial of BEAM-302 for alpha-1 antitrypsin deficiency (AATD), with updated clinical data expected in Q1 2026[663]. - BEAM-304 is a new liver-targeting LNP formulation for phenylketonuria (PKU), with plans to submit a regulatory application for a Phase 1/2 trial in 2026[665]. - The company is also developing BEAM-301 for glycogen storage disease Ia (GSDIa), with initial data from the trial expected in 2026[667]. - The median time to neutrophil engraftment in the BEACON trial was 17.5 days, with 29% of patients not requiring platelet transfusions post-treatment[662]. - The company has identified multiple targeted LNPs for in vivo delivery of gene editing payloads to HSCs, prioritizing this approach for sickle cell disease[660]. Financial Performance - License and collaboration revenue for the year ended December 31, 2025, was approximately $139.7 million, an increase of $76.2 million from $63.5 million in 2024[687]. - Research and development expenses increased to $409.6 million in 2025 from $367.6 million in 2024, reflecting a rise of $42.1 million[688]. - The accumulated deficit as of December 31, 2025, was $1.6 billion, with net losses of $80.0 million, $376.7 million, and $132.5 million for the years ended December 31, 2025, 2024, and 2023, respectively[675]. - The company expects to continue incurring significant operating losses as it advances its preclinical and clinical development activities[676]. - Total operating expenses for the year ended December 31, 2025, were $523.4 million, compared to $479.1 million in 2024, indicating an increase of $44.4 million[685]. - The company has not generated any revenue from product sales and does not expect to do so in the near future, relying primarily on license and collaboration agreements for revenue[678]. - The company anticipates that general and administrative expenses will increase to support research and development and compliance with public company requirements[683]. - The company recorded a gain of $255.1 million on the sale of an equity method investment during the year ended December 31, 2025[685]. - General and administrative expenses increased to $113.8 million in 2025 from $111.5 million in 2024, with a $27.9 million rise in external research and development expenses[690]. - The company recorded a net cash used in operating activities of $345.1 million for the year ended December 31, 2025, compared to $347.2 million in 2024[707][710]. - Cash used in investing activities for 2025 was $121.4 million, primarily due to net purchases of marketable securities totaling $367.3 million[712]. - Net cash provided by financing activities in 2025 was $478.0 million, largely from the issuance of common stock and pre-funded warrants, generating $470.5 million[714]. - The company had $1.2 billion in cash, cash equivalents, and marketable securities as of December 31, 2025[703]. - The company anticipates significant operating losses and expenses as it advances preclinical and clinical development of product candidates[698]. Financing and Obligations - The financing agreement includes a senior secured term loan facility of up to $500 million, with an initial draw of $100 million on February 24, 2026[668]. - The Credit Facility matures on February 24, 2033, and bears interest at an annual rate equal to the 3-month SOFR plus 6.50%[668]. - The Financing Agreement requires maintaining liquidity of at least $40 million, increasing to $80 million and $125 million upon drawing Delayed Draw A and B, respectively, if market capitalization is below $1.75 billion[671]. - The Financing Agreement includes a Credit Facility with an initial draw of $100 million and additional amounts available upon achieving certain milestones[704]. - The company may owe up to $90.0 million in success payments to Harvard and Broad Institute based on increases in the per share fair market value of its common stock[705]. - The company has potential obligations to pay up to an additional $90.0 million in success payments to Harvard and Broad Institute, payable in cash or shares of common stock[723]. - Future minimum commitments under noncancelable operating leases amount to $210.1 million as of December 31, 2025[722]. - The company may owe up to an additional $89.0 million in development, clinical, and commercial milestones to former stockholders of an acquired life sciences company[726]. Market and Economic Conditions - The company has cash, cash equivalents, and marketable securities totaling $1.2 billion as of December 31, 2025, with primary exposure to interest rate sensitivity[745]. - The company is not currently exposed to significant market risk related to foreign currency exchange rates but may increase exposure through future contracts with international vendors[746]. - Inflation has not materially affected the company's financial statements to date, but future operations may be adversely impacted[747]. - The company is required to make success payments based on increases in the per share fair market value of its common stock, which are accounted for as derivatives[741]. - The company has significant estimates and judgments related to accrued expenses and prepaid research and development costs, impacting financial statements[743]. - Revenue recognition is based on ASC 606, with revenue recognized when control of promised goods or services is obtained by the customer[730]. - The company has not recognized any milestone or royalty revenue from its agreements to date[738].
Fulcrum Therapeutics(FULC) - 2025 Q4 - Annual Report
2026-02-24 12:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38978 FULCRUM THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 47-4839948 (State or other jurisdict ...
Xometry(XMTR) - 2025 Q4 - Annual Results
2026-02-24 12:10
Fourth Quarter 2025 Financial Highlights Exhibit 99.1 Xometry Reports Record Fourth Quarter and Strong Full Year 2025 Results NORTH BETHESDA, MD., February 24, 2026 /Globe Newswire/-- Xometry, Inc. (NASDAQ: XMTR), the global AI-native marketplace connecting buyers and suppliers of custom manufacturing, today announced its financial results for the fourth quarter and full year ended December 31, 2025. "Q4 was another record quarter, capping a transformative year for Xometry as enterprise customers rapidly ad ...
Albany International(AIN) - 2025 Q4 - Annual Results
2026-02-24 12:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934 Date of Report: February 24, 2026 (Date of earliest event reported) ALBANY INTERNATIONAL CORP. (Exact name of registrant as specified in its charter) | Delaware | 1-10026 | 14-0462060 | | --- | --- | --- | | (State or other jurisdiction | (Commission | (I.R.S Employer | | of incorporation) | File Number) | Identification No.) | | 325 Corporate ...
Jumia(JMIA) - 2025 Q4 - Annual Report
2026-02-24 12:08
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _____________________________________________________________________ FORM 20-F o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR o SHELL COMPAN ...
American Tower(AMT) - 2025 Q4 - Annual Results
2026-02-24 12:05
Exhibit 99.1 Contact: Spencer Kurn Senior Vice President, Investor Relations Telephone: (617) 375-7517 CONSOLIDATED HIGHLIGHTS (1)(2) Fourth Quarter 2025 Full Year 2025 Boston, Massachusetts – February 24, 2026: American Tower Corporation (NYSE: AMT) today reported financial results for the quarter and full year ended December 31, 2025. Steven Vondran, American Tower's Chief Executive Officer, stated, "We delivered another strong year, achieving high-single-digit growth in AFFO per Share, as adjusted, while ...
Bowhead Specialty Holdings Inc.(BOW) - 2025 Q4 - Annual Results
2026-02-24 12:04
Bowhead Specialty Holdings Inc. Reports Fourth Quarter and Full Year 2025 Results NEW YORK, New York. (BusinessWire) – February 24, 2026 – Bowhead Specialty Holdings Inc. (NYSE: BOW), a specialty lines insurance group focused on providing casualty, professional liability and healthcare liability insurance products, delivered through complementary "craft" and "digital" underwriting models, today announced financial results for the fourth quarter and year ended December 31, 2025 . (1) Fourth Quarter 2025 High ...
Orthofix(OFIX) - 2025 Q4 - Annual Report
2026-02-24 12:04
Financial Performance - Orthofix's Global Spine segment accounted for 84% of total net sales in 2025, while Global Limb Reconstruction contributed 16%[26]. - The company completed a merger with SeaSpine Holdings Corporation in January 2023, converting each share of SeaSpine common stock into 0.4163 shares of Orthofix common stock[24]. - The company operates in two reporting segments: Global Spine (84% of total net sales) and Global Limb Reconstruction (16% of total net sales) for the year 2025[115]. - In 2025, 2024, and 2023, the company incurred research and development expenses of $65.8 million, $73.6 million, and $80.2 million, respectively[84]. Product Portfolio - The Global Spine segment includes Bone Growth Therapies and Spinal Implants, with significant growth initiatives focused on innovation and partnerships[30]. - Orthofix's Bone Growth Therapies include market-leading devices utilizing PEMF and LIPUS technologies, primarily sold in the U.S.[31]. - The company offers a comprehensive portfolio of spinal implants designed for various surgical procedures, including ALIF, PLIF, and ACDF[36]. - The company’s interbody portfolio includes various material types and integrated fixation options, catering to different surgical approaches and patient needs[50]. - The company’s comprehensive spinal fixation solutions cover the entire spine, offering modular options for various surgical needs[51]. - The company’s biologics portfolio includes bone graft substitutes and is distributed globally through a network of distributors and sales representatives[35]. - The company’s Biologics products are derived from human or bovine tissue, sourced from FDA-registered tissue banks, ensuring safety and compliance[132]. - The company offers a 3D printed Firebird SI system for sacroiliac joint disruptions, differentiating itself from competitors who lack SI fixation options[38]. - Trinity Elite and Virtuos Lyograft are leading products in the cellular allografts portfolio, with Trinity Elite maintaining market leadership for over a decade[58]. Technology and Innovation - The 7D FLASH Navigation System is a key enabling technology that enhances image-guided surgery, providing significant economic value and improved safety[34]. - The 7D FLASH Navigation System utilizes visible light technology for fast, efficient, and radiation-free spine surgery, enhancing surgical workflow[53]. - The 7D FLASH Navigation System's Spine Module will see enhancements and new features launched in 2026, including additional navigation tools and improved user interface[54]. - The STIM onTrack mobile app allows physicians to remotely monitor patient adherence to treatment protocols, enhancing patient engagement and outcomes[44][47]. - The company is exploring opportunities to integrate the 7D FLASH Navigation technology into various orthopedic applications[82]. Market Strategy - The company emphasizes ongoing clinical research to support its product portfolios and aims to attract and retain key talent for growth[33]. - Orthofix's strategy includes regular product launches and global sales channel optimization to enhance market presence[33]. - The company aims to continue the strong pace of new product launches and invest in technologies to support market opportunities[71]. - The company plans to continue investing in additional instrument sets and marketing efforts to support the expansion of its independent sales agent footprint[120]. - The company focuses on enhancing its competitive position through product features, value-added services, and training, rather than competing solely on price[128]. Regulatory Compliance - The company’s Spinal Implants and Global Limb Reconstruction products are primarily classified as Class II devices, while Bone Growth Therapies products are classified as Class III and approved through the PMA process[89]. - The company incurs significant costs to maintain compliance with the E.U. Medical Device Regulation, which imposes strict requirements for marketing and selling medical devices, with transition periods extending until December 2028 for certain products[90]. - The company’s products derived from human tissue must comply with both HCT/P requirements and additional regulations applicable to biologics, devices, or drugs, including 510(k) clearance or PMA approval[96]. - The company is AATB-accredited and licensed for tissue banking in multiple states, ensuring compliance with various state regulations[98]. - The company is subject to various U.S. laws regulating healthcare fraud and abuse, including the Anti-Kickback Statute and the Stark Law, which impact sales and marketing practices[106]. Competition and Market Challenges - The company’s Bone Growth Therapies product category competes with products from companies like EBI, Enovis, and Bioventus, while its Biologics and Spinal Implants markets face competition from major players like Medtronic and DePuy Synthes[127]. - The healthcare industry consolidation has led to increased pricing pressures, with Group Purchasing Organizations (GPOs) negotiating discounts that could adversely affect profitability[147]. - The company faces competition from larger device companies that leverage volume discounts and multi-year arrangements, potentially limiting access to key customers[149]. - The medical device industry is characterized by rapid technological change, with new products regularly introduced that may render existing products non-competitive[151]. - Supply chain disruptions, such as those experienced during the COVID-19 pandemic, have previously impacted operations and could affect future business results[152]. Operational Risks - The company relies on a limited number of suppliers, and interruptions in the supply chain could lead to significant delays and additional costs[153]. - The supply of allograft tissues is unpredictable, and any reclassification by the FDA could increase operational costs and regulatory burdens[157]. - The approval process for human-derived products in the E.U. is lengthy and unpredictable, with non-compliance potentially leading to product bans[159]. - The company faces significant risks in developing and introducing new products, which may not meet market expectations[161]. - Cyber-attacks and data breaches pose risks to the company's information systems, potentially leading to unauthorized access to sensitive data and significant operational disruptions[182]. Human Resources and Talent Management - Attracting and retaining qualified executives and key employees is crucial for the company, as competition for talent in the medical device industry is intense[201]. - The company relies on third parties for clinical studies and pre-clinical development, and any failure in their performance could delay regulatory approvals and commercialization[156]. Community Engagement - The company emphasizes community involvement through its "Orthofix Gives Back" initiative, focusing on health innovation and education to create a lasting impact[144].
Arvinas LLC(ARVN) - 2025 Q4 - Annual Results
2026-02-24 12:02
– ARV-102 (LRRK2) Phase 1 clinical data in patients with Parkinson's disease accepted for oral presentation at AP/PD Conference in March 2026 – – Clinical data from ARV-806 (KRAS G12D) and ARV-393 (BCL6) on track for presentations in 2026 – – Phase 1 trial in healthy volunteers initiated with polyQ-AR degrader ARV-027; first immuno- oncology PROTAC HPK1 degrader, ARV-6723, on track to initiate Phase 1 trial in mid-2026 – – Randy Teel, Ph.D., appointed President, Chief Executive Officer, and Director – – Com ...
Avanos Medical(AVNS) - 2025 Q4 - Annual Results
2026-02-24 12:02
Investor Contact: Scott Galovan Avanos Medical, Inc. 470-562-2692 Investor.Relations@Avanos.com Media Contact: Katrine Kubis Avanos Medical, Inc. CorporateCommunications@Avanos.com Avanos Medical, Inc. Announces Fourth Quarter and Full-Year 2025 Results ALPHARETTA, Ga., February 24, 2026/PRNewswire/ -- Avanos Medical, Inc. (NYSE: AVNS) today reported fourth quarter and full-year 2025 results. "I'm very pleased with our fourth quarter and full-year results, which demonstrate meaningful progress on our strate ...