A short rebound in stocks fizzled after Monday's drop, as worries about the disruptive impact of artificial intelligence continued to unsettle markets which digested yesterday’s AI scare, and await today’s Claude / Anthropic presentation, while preparing for tonight’s State of the Union address (“SOTU”). Some have suggested that Trump may attack power generation risks during SOTU as he deals with affordability.As of 8:00am ET, S&P 500 futures traded unchanged, erasing an earlier 0.3% gain. The benchmark fel ...

Vir Biotechnology (NasdaqGS:VIR) Q4 2025 Earnings call February 23, 2026 05:30 PM ET Company ParticipantsJason O'Byrne - EVP and Interim CFOJohann de Bono - Regius Professor of Cancer ResearchJosh Schimmer - Senior Managing DirectorKiki Patel - Head of Investor RelationsMarianne De Backer - CEO and DirectorMark Eisner - EVP and Chief Medical OfficerPatrick Trucchio - Managing Director of Equity ResearchSean McCutcheon - VP of Biotechnology Equity ResearchConference Call ParticipantsAlec Stranahan - VP and S ...

Vir Biotechnology (NasdaqGS:VIR) Q4 2025 Earnings call February 23, 2026 05:30 PM ET Company ParticipantsJason O'Byrne - EVP and Interim CFOJohann de Bono - Regius Professor of Cancer ResearchJosh Schimmer - Senior Managing DirectorKiki Patel - Head of Investor RelationsMarianne De Backer - CEO and DirectorMark Eisner - EVP and Chief Medical OfficerPatrick Trucchio - Managing Director of Equity ResearchSean McCutcheon - VP of Biotechnology Equity ResearchConference Call ParticipantsAlec Stranahan - VP and S ...

Financial Data and Key Metrics Changes - R&D expenses for 2025 were $456 million, a decrease of $51 million or 10% from $507 million in 2024 [42] - SG&A expenses decreased to $92 million in 2025 from $119 million in the prior year, representing a 23% reduction [42] - The net loss for 2025 was $438 million, compared to $522 million in 2024 [43] - The company started 2026 with approximately $782 million in cash, cash equivalents, and investments, not including the upfront cash and equity from the Astellas collaboration [43] Business Line Data and Key Metrics Changes - The collaboration with Astellas is focused on the development and commercialization of VIR-5500, a T-cell engager for prostate cancer [6][12] - The total potential in combined upfront and milestone payments from the collaboration is $1.7 billion, with a 50/50 profit-sharing arrangement in the U.S. [13][41] Market Data and Key Metrics Changes - Prostate cancer represents a significant global health burden, with 1 in 8 men diagnosed in their lifetime and a five-year survival rate of only 30% for patients with metastatic castration-resistant prostate cancer (mCRPC) [9] - There are approximately 100,000 mCRPC patients in the U.S. and Europe, indicating a substantial unmet need for novel treatment solutions [9] Company Strategy and Development Direction - The strategic collaboration with Astellas aims to accelerate the development of VIR-5500 across various lines of prostate cancer, unlocking significant market opportunities [7][12] - The company plans to initiate dose expansion cohorts in late-line mCRPC monotherapy and combinations in the second quarter of 2026 [38][61] - The PRO-XTEN platform is expected to enable the development of next-generation T-cell engagers for solid tumors, with plans for further preclinical programs [44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of VIR-5500, highlighting its favorable safety and efficacy profile based on emerging Phase I data [6][18] - The collaboration with Astellas is seen as a key factor in maximizing the potential of VIR-5500 and expanding the company's pipeline [44][45] Other Important Information - The Phase I clinical study of VIR-5500 showed a favorable safety profile with no observed dose-limiting toxicities and limited cytokine release syndrome [30][32] - The company is positioned to transition into expansion cohorts and plans to continue dose optimization to meet FDA requirements [38][39] Q&A Session Summary Question: Can you comment on the range of PSA responses seen by prior line of therapies, particularly with regard to prior radiotherapy? - Management noted strong PSA responses, particularly at higher doses, but specific effects of prior treatments on PSA responses were difficult to determine due to the heavily pretreated population [52][54] Question: What are the next steps before moving to Phase 3 with Astellas? - The company plans to initiate expansion cohorts in Q2 2026, focusing on late-line mCRPC as a monotherapy and combinations with other therapies [60][61] Question: How does the larger cohort of patients evaluated on VIR-5500 evolve the thinking about its positioning within the treatment paradigm? - Management indicated plans to address a broad range of patients, including late-line mCRPC and combinations, highlighting the high unmet need in these populations [66] Question: Can you provide more information on the go-forward dose? - The go-forward dose is expected to be in the range of 3,000 to 3,500 micrograms per kilogram, with compelling dose-response data observed [76][77]

2026 Vir Biotechnology, Inc. 1 VIR-5500 Strategic Collaboration with Astellas and Positive Phase 1 Data February 23, 2026 2026 Vir Biotechnology, Inc. 2 Agenda Legal disclaimer Forward-Looking Statements Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: the therapeutic and commercial potential of VIR-5500 and other assets within its oncology solid tumor portfolio, precl ...

Core Insights - Vir Biotechnology has announced significant partnerships and advancements in its pipeline, including a global collaboration with Astellas and promising Phase 1 data for its oncology program VIR-5500, which targets hard-to-treat cancers [2][4]. Pipeline Programs - The company is advancing several investigational therapies, including VIR-5500 for metastatic castration-resistant prostate cancer (mCRPC), with positive Phase 1 data indicating dose-dependent anti-tumor activity [4][7]. - The Phase 1 study of VIR-5818, targeting HER2, is ongoing, with response data expected in the second half of 2026 [4]. - The Phase 1 study of VIR-5525, targeting EGFR, continues to enroll participants as planned [5]. Chronic Hepatitis Delta (CHD) Program - Vir Biotechnology has licensed to Norgine the combination of tobevibart and elebsiran for treating CHD, aiming to reach patients globally [2][7]. - Phase 2 SOLSTICE data showed that the combination therapy achieved undetectable hepatitis delta virus RNA in 88% of participants at Week 96 [7]. - The ECLIPSE registrational program is designed to evaluate the safety and efficacy of tobevibart and elebsiran, with topline data from ECLIPSE 1 expected in Q4 2026 and from ECLIPSE 2 and 3 in Q1 2027 [21]. Financial Results - As of December 31, 2025, the company reported approximately $781.6 million in cash, cash equivalents, and investments, a decline of $29.1 million in Q4 2025 [9]. - Revenue for Q4 2025 was $64.1 million, a significant increase from $12.4 million in Q4 2024, primarily due to a $64.3 million license revenue from the Norgine agreement [10]. - The net loss for Q4 2025 was $(42.9) million, an improvement from a net loss of $(104.6) million in Q4 2024 [17]. Future Outlook - The company expects its cash reserves to fund operations into the second quarter of 2028, bolstered by the Astellas collaboration and equity investment [18]. - The company plans to initiate pivotal Phase 3 trials for its oncology programs in 2027, following the expansion of dose cohorts for VIR-5500 [7][8].

Japan's Astellas and Vir Biotechnology said on Monday they will together develop and commercialize the U.S. drug developer's prostate cancer experimental drug. ...

Francesca DeMartino Chief Investor Relations Officer, Senior Vice President Fourth Quarter 2025 Earnings 2 Fourth Quarter 2025 Earnings Teleconference February 3, 2026 1 Introduction Forward-Looking Statements and Non-GAAP Financial Information Fourth Quarter 2025 Earnings 3 • Our discussions during this conference call will include forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such s ...

Core Insights - Apellis Pharmaceuticals' stock has decreased by 31% over the past year despite receiving FDA approval for EMPAVELI, indicating a disconnect between regulatory success and commercial performance [2][7] Product Approval and Market Potential - EMPAVELI is the first and only approved treatment for C3 glomerulopathy and IC-MPGN, targeting approximately 5,000 patients in the U.S., with exclusive approval for about two-thirds of this population [3] - The positive opinion from the European CHMP in December 2025 enhances the global expansion potential and pricing power, typically associated with gross margins exceeding 90% [3] Patient Start Forms and Growth Expectations - Management has guided for 225 cumulative patient start forms by the end of 2025, having achieved 152 by the end of September, suggesting a slowdown to 24 forms per month in Q4 [4] - CEO Cedric Francois indicated that the company is moving past the initial wave of early adopters and anticipates steady growth moving into the next year [4] Revenue Challenges and Market Dynamics - SYFOVRE, which constitutes the majority of revenue, reported flat sales of $151 million in Q3 2025, with a mere 4% growth in injections, primarily driven by free goods costing the company $15 million [5] - The share of new patients for SYFOVRE has decreased to 52%, with management noting that retina specialists are adopting a cautious approach despite SYFOVRE's 60% market share [5] External Market Issues - The cessation of new co-pay assistance applications by Good Days Foundation has led to practices halting new patient enrollments, a challenge not unique to Apellis but reflective of broader issues in the geographic atrophy market [6]

Core Perspective - Astellas Pharma expresses strong confidence in its long-term growth trajectory and aims to share its excitement and momentum with stakeholders [1] Group 1: Company Vision and Strategy - Astellas Pharma has a clear vision to transform innovative science into VALUE for patients, defined as outcomes that matter to patients divided by the costs to the entire healthcare system [2] - The company emphasizes the importance of creating better patient outcomes while managing healthcare costs across the system, rather than focusing solely on its own costs [2]