Financial Data and Key Metrics Changes - Total revenue grew 38% to $1.4 billion, with royalty revenue increasing 52% to $868 million for the full year 2025 [9][17][19] - Net income for the full year was $316.9 million, compared to $444.1 million in 2024, while adjusted EBITDA was $657.6 million, up from $632.2 million in 2024 [19][20] - GAAP diluted EPS was $2.50, down from $3.43 in 2024, while non-GAAP diluted EPS was $4.15, compared to $4.23 in 2024 [19][20] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenue, a 29% year-over-year growth, with total sales reaching $14.4 billion [10][19] - Phesgo's royalty revenue increased 51% year-over-year to $105.6 million, with total sales growing 48% to approximately $3 billion [11][19] - VYVGART and VYVGART Hytrulo saw a 444% year-over-year growth in royalty revenues to $157.2 million, with total sales reaching $4.15 billion [12][19] Market Data and Key Metrics Changes - ENHANZE-enabled products now include 10 global blockbuster opportunities, with significant approvals in multiple markets including the U.S., Japan, and China [8][16] - The subcutaneous formulations of Ocrevus, Opdivo, RYBREVANT, and Tecentriq represent a combined market opportunity of approximately $30 billion by 2028 [13][16] Company Strategy and Development Direction - The company aims to expand its ENHANZE portfolio with six new programs entering phase I in 2026, bringing the total development portfolio to 15 products [24][35] - Hypercon technology is expected to meet the demand for lower volume, auto-injector-ready therapies, with projections of approximately $1 billion in royalty revenue within five years of the first launches [26][27] - The company plans to pursue strategic acquisitions to enhance its drug delivery portfolio while maintaining financial discipline [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, highlighting multiple revenue drivers and the durability of royalty revenue [23][39] - The company anticipates continued strong growth from existing products and new launches, with a focus on expanding into new therapeutic areas [24][35] Other Important Information - The company completed acquisitions of Elektrofi and Surf Bio, enhancing its drug delivery capabilities with long-duration IP [6][27] - The company expects to maintain a strong balance sheet and reduce net debt to below 1x by the end of 2026 [21][22] Q&A Session Summary Question: Regarding the mechanics of DARZALEX collaboration with J&J - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, emphasizing the importance of the partnership [42][43] Question: On the ADC strategy and regulatory paths - Management indicated that the regulatory pathway for converting IV to subcutaneous delivery would likely follow traditional PK non-inferiority studies [49][50] Question: Update on Hypercon products and clinical testing - Management confirmed that two Hypercon products are on track for phase I clinical testing in 2026, with completion of clinical scale-up batches underway [63][64] Question: Expectations for new partnerships in auto-injectors - Management anticipates progress with high-volume auto-injectors and expects to see interest from both current and new partners [75][76]

Financial Data and Key Metrics Changes - Total revenue grew 38% to $1.4 billion, with royalty revenue increasing 52% to $868 million for the full year 2025 [7][15][17] - Net income for the full year was $316.9 million, compared to $444.1 million reported in 2024 [17] - Adjusted EBITDA was $657.6 million, compared to $632.2 million in 2024 [17] - GAAP diluted EPS was $2.50, compared with $3.43 in 2024, while non-GAAP diluted EPS was $4.15, compared with $4.23 in 2024 [17][18] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenues, representing 29% year-over-year growth, with total sales growing 22% to $14.4 billion [8][9] - PHESGO delivered $105.6 million in royalty revenue, reflecting 51% year-over-year growth, with total sales increasing 48% to approximately $3 billion [9][10] - VYVGART and VYVGART Hytrulo generated $157.2 million in royalty revenue, representing 444% year-over-year growth, with total sales growing 90% to $4.15 billion [10][11] Market Data and Key Metrics Changes - The company now has 10 ENHANZE-enabled global blockbuster opportunities, with significant approvals in the U.S., Japan, and China [6][12] - Roche reported that there are now 17,500 patients on Ocrevus Zunovo, a 5,000 patient increase from the third quarter [11] - Analysts project that PHESGO will reach CHF 3.6 billion in 2028, and Ocrevus franchise sales expectations have been increased to CHF 9 billion, or approximately $11.5 billion [10][12] Company Strategy and Development Direction - The company expanded its portfolio from two to four subcutaneous drug delivery technologies through acquisitions, positioning itself as a one-stop shop for biopharma subcutaneous drug delivery [5][6] - The focus is on advancing the ENHANZE pipeline, with projections for 6 new ENHANZE programs entering phase one in 2026 [21][32] - The company aims to continue strategic M&A to enhance its drug delivery portfolio and maintain financial discipline while investing in long-term value creation [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, highlighting multiple revenue drivers that will support durable royalty revenue [20][36] - The company anticipates continued strong growth from its existing blockbusters and new product launches, with a focus on expanding into new therapeutic areas [20][21] - Management expects to enter discussions with Johnson & Johnson to extend the DARZALEX collaboration agreement closer to its expiration in 2032 [39][40] Other Important Information - The company signed three new ENHANZE collaboration and licensing agreements, expanding its reach beyond oncology into obesity and inflammatory bowel disease [6][7] - The acquisition of Surf Bio is expected to enhance the company's hyperconcentration technology capabilities [24] - The company ended the year with a net debt to EBITDA ratio of 2.1x, with expectations to deleverage to below 1x by the end of 2026 [19] Q&A Session Summary Question: Can you elaborate on the mechanics of the DARZALEX collaboration with J&J? - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, as they do not anticipate J&J seeking another source of API [39][40] Question: What are the regulatory paths for ADCs with ENHANZE? - The regulatory pathway for converting from IV to subcutaneous is expected to follow traditional PK non-inferiority studies, while additional benefits would require phase trials [46][47] Question: What is the progress on Hypercon products? - The company is on track to support two partners in advancing to phase 1 clinical testing in 2026, with clinical scale-up batches being completed [61][62] Question: How will sales from auto-injectors be reported? - Sales from auto-injectors will be recognized similarly to API sales, with royalties recognized on commercial sales [76]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving ImmunityBio, Inc. and its officers or directors [1]. Group 1: Company Overview - ImmunityBio, Inc. is listed on NASDAQ under the ticker IBRX [1]. - The company recently announced updated Phase 2 clinical results for a chemotherapy-free combination immunotherapy regimen targeting second-line recurrent or progressive glioblastoma [3]. Group 2: Recent Developments - On January 23, 2026, ImmunityBio reported that the median overall survival, a primary endpoint for its clinical trial, has not yet been reached [3]. - Following the announcement of the clinical results, ImmunityBio's stock price decreased by $0.89 per share, representing a 12.13% decline, closing at $6.45 per share [3]. Group 3: Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a history of recovering significant damages for victims of securities fraud and corporate misconduct [4].

Core Viewpoint - Summit Therapeutics Inc. will announce its fourth quarter and full year 2025 financial results and provide an operational update on February 23, 2026, after market close [1] Group 1 - The earnings call will be hosted via a live webcast at 4:30 PM ET [1] - The webcast will be accessible through the company's website, www.smmttx.com [1] - An archived edition of the session will be made available following the live event [1]

Core Viewpoint - A class action lawsuit has been filed against uniQure N.V. concerning allegations of securities fraud and unlawful business practices [2]. Group 1: Lawsuit Details - The lawsuit involves claims that uniQure and certain officers and/or directors engaged in securities fraud or other unlawful business practices [2]. - Investors have until April 13, 2026, to request to be appointed as Lead Plaintiff if they purchased or acquired uniQure securities during the Class Period [2]. Group 2: Company Developments - On November 3, 2025, uniQure announced feedback from the U.S. FDA regarding its investigational gene therapy AMT-130 for Huntington's disease, indicating a shift in the FDA's stance on the adequacy of data from Phase I/II studies for a Biologics License Application (BLA) submission [4]. - Following this announcement, uniQure's stock price dropped by $33.40 per share, or 49.34%, closing at $34.29 per share on the same day [4].

Core Viewpoint - The company received a complete response letter from the FDA regarding bitopertin, indicating that while there is evidence of its effectiveness in lowering protoporphyrin IX (PPIX), there is uncertainty about whether this reduction can predict clinical benefits [3]. Group 1: Regulatory Update - The FDA's complete response letter highlights sufficient evidence that bitopertin significantly lowers PPIX levels [3]. - However, the FDA expressed uncertainty regarding the correlation between PPIX reduction and actual clinical benefits [3].

Halozyme Therapeutics, Inc. 1 Forward-Looking Statements In addition to historical information, the statements set forth in this presentation include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance and growth rates (including the Company's 2026 financial guidance and longer term financial outlook through 2028 and the assumptions used in deriving such guidance and longer term financial outlook) including expectations for futu ...

Core Viewpoint - A class action lawsuit has been filed against Mereo BioPharma Group plc, alleging securities fraud and unlawful business practices by the company and certain officers and/or directors [2]. Group 1: Lawsuit Details - Investors are encouraged to contact Pomerantz LLP for participation in the class action, with a deadline to apply as Lead Plaintiff by April 6, 2026 [2]. - A copy of the Complaint related to the class action can be accessed at Pomerantz's website [2]. Group 2: Company Performance and Stock Impact - On July 9, 2025, Mereo and Ultragenyx Pharmaceutical Inc. announced that the Phase 3 Orbit study was progressing towards a final analysis, leading to a significant drop in Mereo's ADR price by $1.25, or 42.52%, closing at $1.69 on July 10, 2025 [4]. - On December 29, 2025, Mereo reported that neither the Orbit nor the Cosmic Phase 3 studies achieved statistical significance, resulting in a drastic decline in ADR price by $2.02, or 87.7%, closing at $0.29 [5].

Washington, D.C. 20549 FORM S-1 As filed with the Securities and Exchange Commission on February 17, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Aspire Biopharma Holdings, Inc. (Exact name of registrant as specified in its charter) (State or jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 33-3467744 (I.R.S. Employer Identification No.) 23150 Fashion Dr ...

Core Insights - The conference call was held to discuss the positive topline results from the SOL-1 Phase III clinical trial of AXPAXLI (OTX-TKI) for wet AMD [2][3]. Group 1: Company Overview - Ocular Therapeutix is presenting topline data from its Phase III clinical trial, indicating a significant advancement in its product pipeline [2]. - The call features remarks from key executives and clinical researchers involved in the SOL program, highlighting the collaborative effort in the trial [3]. Group 2: Clinical Trial Details - The SOL-1 trial results are positioned as a pivotal moment for Ocular Therapeutix, potentially impacting the treatment landscape for wet AMD [2]. - The involvement of prominent figures in the ophthalmology field, such as Dr. Arshad Khanani and Dr. Darius Moshfeghi, underscores the credibility and importance of the trial results [3].