[Management Summary and Outlook](index=1&type=section&id=Management%20Summary%20and%20Outlook) Management highlighted significant progress in their pneumococcal conjugate vaccine (PCV) pipeline, including VAX-24 and VAX-31, aiming to redefine the standard of care, while confirming a strong financial position with approximately $3.0 billion in cash - CEO Grant Pickering emphasized progress towards delivering broader-spectrum PCVs for both adults and infants, with key data readouts and study initiations planned for 2025 and 2026[3](index=3&type=chunk) - CFO Andrew Guggenhime confirmed a strong balance sheet with approximately **$3.0 billion** in cash, cash equivalents, and investments, enabling the company to advance its PCV pipeline[2](index=2&type=chunk)[3](index=3&type=chunk) [Key First Quarter Highlights](index=2&type=section&id=Key%20First%20Quarter%20Highlights) During the first quarter, Vaxcyte reported positive topline results from the VAX-24 infant Phase 2 study, advanced the VAX-31 infant Phase 2 study to its second stage, and announced its next-generation VAX-XL candidate, additionally strengthening its Board of Directors with a key appointment [PCV Franchise Developments](index=2&type=section&id=PCV%20Franchise) The company made significant strides in its PCV franchise, with VAX-24 showing positive safety and immunogenicity in its infant Phase 2 study, VAX-31 progressing to its final stage, and the unveiling of VAX-XL for broader coverage - In March 2025, Vaxcyte announced positive topline results for the VAX-24 infant Phase 2 study, showing it was well-tolerated with a safety profile similar to Prevnar 20®[4](index=4&type=chunk) - The VAX-24 Mid dose met target non-inferiority criteria for **20 of 24 serotypes** and generated robust OPA responses, with full booster data expected by the end of 2025[5](index=5&type=chunk) - The VAX-31 infant Phase 2 dose-finding study advanced to its second and final stage in February 2025, following a positive safety assessment[5](index=5&type=chunk) - Vaxcyte announced VAX-XL in March 2025, its third-generation PCV candidate designed to offer the broadest coverage for infants and adults[5](index=5&type=chunk) [Board of Directors Appointment](index=3&type=section&id=Board%20of%20Directors%20Appointment) In May 2025, Vaxcyte appointed Dr. Olivier Brandicourt, former CEO of Sanofi S.A. and Bayer HealthCare AG, to its Board of Directors, bringing extensive experience in commercial strategy and the global vaccine market - Dr. Olivier Brandicourt was appointed to the Board of Directors, bringing significant biopharmaceutical and global vaccine market expertise[6](index=6&type=chunk) [Anticipated Key Milestones](index=3&type=section&id=Anticipated%20Key%20Milestones) Vaxcyte outlined several key upcoming milestones for its PCV programs, including the VAX-31 Phase 3 study for adults by mid-2025, and further data from the VAX-24 and VAX-31 infant studies by the end of 2025 and mid-2026, respectively [VAX-31 (Adult Indication)](index=3&type=section&id=PCV%20Franchise%20Adult%20Indication) The company plans to initiate a pivotal Phase 3 non-inferiority study for VAX-31 in adults by mid-2025, with topline data expected in 2026, and subsequent Phase 3 studies planned for 2025 and 2026 - A Phase 3 pivotal, non-inferiority study for VAX-31 in adults is expected to start by mid-2025[11](index=11&type=chunk) - Topline safety, tolerability, and immunogenicity data from this study are anticipated in 2026[11](index=11&type=chunk) [VAX-24 & VAX-31 (Infant Indication)](index=3&type=section&id=PCV%20Franchise%20Infant%20Indication) Key data for the infant PCV programs are expected soon, with the balance of the VAX-24 Phase 2 data due by the end of 2025, and initial data from the VAX-31 Phase 2 primary immunization series anticipated in mid-2026 - The balance of the VAX-24 Phase 2 dose-finding study data, including full post-dose 3 and post-dose 4 results, is expected by the end of 2025[8](index=8&type=chunk) - Topline data for the VAX-31 Phase 2 study's primary three-dose series is expected in mid-2026, with complete booster data up to nine months later[9](index=9&type=chunk) [Upcoming Investor Conferences](index=3&type=section&id=Upcoming%20May%20and%20June%20Investor%20Conferences) Vaxcyte management will participate in three investor conferences in May and June 2025: the BofA Securities Health Care Conference, the Jefferies Global Healthcare Conference, and the Goldman Sachs Global Healthcare Conference - Management will participate in fireside chats and meetings at the BofA Securities, Jefferies, and Goldman Sachs healthcare conferences in May and June 2025[10](index=10&type=chunk)[12](index=12&type=chunk)[13](index=13&type=chunk) [First Quarter 2025 Financial Results](index=4&type=section&id=First%20Quarter%202025%20Financial%20Results) For the first quarter of 2025, Vaxcyte reported a net loss of $140.7 million, with cash, cash equivalents, and investments at $2.95 billion as of March 31, 2025, and increased operating expenses driven by higher R&D activities and G&A personnel costs Key Financial Data (Q1 2025 vs Q1 2024) | Financial Metric | Q1 2025 (USD Millions) | Q1 2024 (USD Millions) | Change (%) | | :--- | :--- | :--- | :--- | | R&D Expenses | 148.1 | 94.6 | +56.5 | | G&A Expenses | 32.7 | 19.9 | +64.3 | | Net Loss | (140.7) | (95.0) | +48.1 | Cash Position | Date | Cash, Cash Equivalents and Investments (USD Millions) | | :--- | :--- | | March 31, 2025 | 2,950.8 | | December 31, 2024 | 3,134.7 | - The increase in R&D expenses was primarily due to development and manufacturing activities for the PCV programs and higher personnel costs[16](index=16&type=chunk) - The company incurred an additional **$31.7 million** in capital expenditures for its dedicated manufacturing suite, with total incurred costs reaching **$246.0 million** as of March 31, 2025[16](index=16&type=chunk) [Consolidated Financial Statements](index=7&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements provide detailed financial data for Vaxcyte, showing a net loss of $140.7 million for the three months ended March 31, 2025, and total assets of $3.38 billion with total stockholders' equity of $3.20 billion as of March 31, 2025 [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, Vaxcyte reported total operating expenses of $180.8 million and a net loss of $140.7 million, or $1.04 per share, compared to a net loss of $95.0 million, or $0.85 per share, for the same period in 2024 Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended March 31, (USD Thousands) | | | :--- | :--- | :--- | | | **2025** | **2024** | | **Operating expenses:** | | | | Research and development | 148,134 | 94,587 | | General and administrative | 32,659 | 19,885 | | **Total operating expenses** | **180,793** | **114,472** | | **Loss from operations** | **(180,793)** | **(114,472)** | | Interest income | 32,935 | 21,666 | | **Net loss** | **(140,718)** | **(95,020)** | | **Net loss per share, basic and diluted** | **(1.04)** | **(0.85)** | | Weighted-average shares outstanding | 135,690,949 | 111,690,951 | [Summary Consolidated Balance Sheet Data](index=7&type=section&id=Summary%20Consolidated%20Balance%20Sheet%20Data) As of March 31, 2025, Vaxcyte's balance sheet showed $2.95 billion in cash, cash equivalents, and investments, total assets of $3.38 billion, and total stockholders' equity of $3.20 billion Summary Consolidated Balance Sheet Data (in thousands) | | March 31, 2025 (USD Thousands) | December 31, 2024 (USD Thousands) | | :--- | :--- | :--- | | Cash, cash equivalents and investments | 2,950,762 | 3,134,718 | | Total assets | 3,378,103 | 3,511,318 | | Total stockholders' equity | 3,200,026 | 3,305,819 |

Core Insights - Vaxcyte, Inc. reported positive topline safety, tolerability, and immunogenicity data from the Phase 2 dose-finding study of VAX-24 in healthy infants, with further data expected by the end of 2025 [1][3] - The company has initiated the second and final stage of the VAX-31 infant Phase 2 dose-finding study, with topline data anticipated in mid-2026 [1][5] - Vaxcyte plans to initiate a Phase 3 pivotal, non-inferiority study for VAX-31 in adults by mid-2025, with topline data expected in 2026 [1][8] - The company announced VAX-XL, a third-generation pneumococcal conjugate vaccine candidate aimed at expanding coverage [1][5] - As of March 31, 2025, Vaxcyte had approximately $3.0 billion in cash, cash equivalents, and investments [1][11] PCV Franchise Developments - VAX-24 demonstrated a well-tolerated safety profile similar to Prevnar 20® across all doses studied, with substantial immunoglobulin G (IgG) and opsonophagocytic assay (OPA) immune responses observed [3][4] - The mid-dose of VAX-24 met the target Phase 2 non-inferiority criteria for seroconversion rates and IgG Geometric Mean Ratio (GMR) point estimates [3][7] - VAX-31 has progressed to the second stage of its Phase 2 study, evaluating safety and immunogenicity compared to PCV20 in infants [5][7] Financial Performance - For Q1 2025, Vaxcyte reported a net loss of $140.7 million, compared to a net loss of $95.0 million in Q1 2024 [11][21] - Research and development expenses increased to $148.1 million in Q1 2025 from $94.6 million in Q1 2024, primarily due to development activities for PCV programs [11][21] - General and administrative expenses rose to $32.7 million in Q1 2025 from $19.9 million in Q1 2024, attributed to higher personnel costs [11][21] Key Milestones and Future Plans - The company plans to announce the balance of the VAX-24 Phase 2 study data, including final safety and full post-dose data, by the end of 2025 [6][9] - Vaxcyte anticipates initiating a Phase 3 program with an optimized dose formulation of VAX-24 or VAX-31, pending the VAX-31 topline Phase 2 study results [5][8] - Upcoming investor conferences will feature management participation, providing opportunities for engagement with stakeholders [10][13]

Core Insights - Vaxcyte, Inc. has appointed Dr. Olivier Brandicourt, former CEO of Sanofi S.A., to its Board of Directors, enhancing its leadership with significant biopharmaceutical expertise [1][2] - Dr. Brandicourt's experience in the global vaccine market is expected to be instrumental as Vaxcyte advances its pneumococcal conjugate vaccine (PCV) candidates towards potential commercialization [2] - Vaxcyte is focused on developing high-fidelity vaccines to combat bacterial diseases, with its lead candidates VAX-31 and VAX-24 targeting invasive pneumococcal disease [6][8] Company Overview - Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines aimed at preventing bacterial diseases [6] - The company is developing broad-spectrum conjugate and novel protein vaccines, including VAX-31, a 31-valent PCV candidate, and VAX-24, a 24-valent PCV candidate [6][8] - Vaxcyte utilizes modern synthetic techniques and the XpressCF™ cell-free protein synthesis platform to produce complex vaccines efficiently [7] Leadership Background - Dr. Brandicourt has a distinguished career in the biopharmaceutical industry, previously serving as CEO of Sanofi S.A. and Bayer HealthCare AG, and has extensive experience at Pfizer [3][4] - His leadership roles have included advancing vaccine portfolios and strategic insights in commercial execution within the vaccine market [2][4] Strategic Goals - Vaxcyte aims to set a new standard of care in the prevention of invasive pneumococcal disease and contribute to combating antimicrobial resistance [2][6] - The company is committed to addressing unmet needs in bacterial disease prevention through its innovative vaccine candidates [2][8]

Company Overview - Vaxcyte (PCVX) is a clinical-stage biotech company focused on developing vaccines for bacterial infectious diseases [1] - The company's shares have experienced a significant decline of 56% in the past month due to mixed results from a phase II study on its pneumococcal conjugate vaccine (PCV) [1][3] Stock Performance - Year-to-date, Vaxcyte's shares have plummeted over 62%, significantly underperforming the industry, which has seen an 8% decline [3] - The stock is trading below its 50 and 200-day moving averages, indicating weak market sentiment [3] Vaccine Study Results - Vaxcyte's recent mid-stage study evaluated its 24-valent PCV VAX-24 against Pfizer's Prevnar 20, which is approved for preventing invasive pneumococcal disease caused by 20 serotypes [6] - The mid-dose of VAX-24 met non-inferiority criteria for seroconversion and showed robust immune responses, but did not meet the criteria for four of the 24 serotypes compared to Prevnar 20, contributing to the stock's decline [7] - VAX-24 was well-tolerated and demonstrated a safety profile similar to Prevnar 20, with strong markers for protection against invasive pneumococcal disease [8] Future Development Plans - Based on the study results, Vaxcyte plans to advance the mid-dose formulation of VAX-24 into late-stage development [9] - The company is also conducting a mid-stage study on its investigational 31-valent PCV vaccine VAX-31, with top-line results expected in mid-2026, and plans to start a phase III study in infants with either VAX-24 or VAX-31 [10] Industry Context - The broader biotech and drug sector is facing challenges, including the resignation of a senior FDA official, raising concerns about the agency's ability to maintain innovation and regulatory clarity [2]

Analyst's Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical ...

Core Insights - Vaxcyte, Inc. announced positive topline results from its Phase 2 dose-finding study for VAX-24, a 24-valent pneumococcal conjugate vaccine (PCV) candidate, demonstrating safety and immunogenicity comparable to Prevnar 20® (PCV20) in healthy infants [2][3][4] Group 1: VAX-24 Study Results - VAX-24 was well-tolerated across all evaluated doses, with a safety profile similar to PCV20, and no serious adverse events related to the vaccine were reported [3][4] - Substantial immune responses were elicited post-primary three-dose immunization series, with robust IgG and opsonophagocytic assay (OPA) responses observed across all doses [4][5] - The mid dose of VAX-24 (2.2 mcg) was selected for further development based on its ability to meet non-inferiority criteria and generate robust immune responses [5][6] Group 2: Future Development Plans - The company plans to advance VAX-24 to a potential Phase 3 program, pending topline data from the VAX-31 Phase 2 study expected in mid-2026 [2][6] - Vaxcyte is also introducing VAX-XL, a third-generation PCV candidate aimed at expanding the spectrum of coverage against pneumococcal disease [2][6] - Key milestones include the initiation of a Phase 3 infant program with either VAX-24 or VAX-31 and the announcement of additional data from ongoing studies [8][10][11] Group 3: Study Design and Participant Information - The VAX-24 Phase 2 study is a randomized, observer-blind, dose-finding study involving 802 healthy infants, assessing safety, tolerability, and immunogenicity [7][9] - The study design includes a primary immunization series of three doses followed by a booster dose, with ongoing evaluations of immunogenicity and safety [9][10] Group 4: Industry Context - Pneumococcal disease remains a significant health threat, particularly in children under five, with Streptococcus pneumoniae being a leading cause of vaccine-preventable deaths globally [14][15] - The development of broader-spectrum vaccines like VAX-24 and VAX-31 is critical to addressing the substantial burden of invasive pneumococcal disease [6][14]

Core Insights - Vaxcyte, Inc. is set to present topline results from its VAX-24 infant Phase 2 study, focusing on the safety, tolerability, and immunogenicity of its 24-valent pneumococcal conjugate vaccine compared to Prevnar 20® [1] Company Overview - Vaxcyte is a clinical-stage vaccine innovation company dedicated to developing high-fidelity vaccines to combat bacterial diseases [3] - The company is advancing VAX-31, a 31-valent PCV candidate, into a Phase 3 adult clinical program while VAX-24 is currently in a Phase 2 infant clinical program [3] - VAX-24 aims to cover more serotypes than any existing infant PCV on the market, addressing significant public health concerns related to invasive pneumococcal disease (IPD) [3] Technology and Innovation - Vaxcyte employs modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, to enhance the production of complex vaccines [4] - This innovative approach is designed to improve the efficiency and immunological benefits of vaccine development [4] Pipeline Candidates - Vaxcyte's pipeline includes several vaccine candidates: - VAX-A1 for preventing Group A Strep infections - VAX-PG for slowing or stopping periodontal disease progression - VAX-GI for preventing Shigella infections [4]

Financial Data and Key Metrics Changes - Vaxcyte reported a strong financial position with $3.13 billion in cash, cash equivalents, and investments as of December 31, 2024, which includes $2.2 billion in net proceeds from successful follow-on equity offerings [17][20] - R&D expenses increased in 2024 primarily due to heightened development and manufacturing activities related to adult and infant PCV programs, alongside growth in R&D personnel [18][19] - G&A expenses rose due to higher personnel costs associated with an increase in the number of employees [18] Business Line Data and Key Metrics Changes - The PCV franchise remains a cornerstone for Vaxcyte, with significant clinical progress reported in both adult and infant programs, particularly with the VAX-31 clinical data in adults [11][25] - VAX-31 demonstrated robust opsonophagocytic activity across all 31 serotypes, with strong results in its Phase 1/2 study, leading to FDA granting Breakthrough Therapy Designation [27][28] Market Data and Key Metrics Changes - The global pneumococcal vaccine market is valued at approximately $8 billion annually, with the adult segment expected to grow significantly due to expanded vaccination guidelines [10] - The infant segment remains the largest, estimated at $6 billion in annual sales, highlighting the urgent need for broader spectrum coverage against pneumococcal diseases [10] Company Strategy and Development Direction - Vaxcyte is focused on building a robust pipeline of novel broad-spectrum vaccines targeting significant bacterial threats, including Group A Strep and Shigella, alongside its PCV programs [9][13] - The company is advancing its manufacturing capabilities through a partnership with Lonza, establishing a dedicated large-scale manufacturing suite to support future commercial supply [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their science and the critical role vaccines play in public health, emphasizing the importance of continued investment in vaccine innovation [22][23] - The company anticipates a milestone-rich year ahead, marked by key clinical and regulatory advancements, and is well-positioned for sustainable growth [40] Other Important Information - Vaxcyte incurred an additional $127.8 million in capital and facility expenditures for the dedicated manufacturing suite, with total project costs tracking at about 60% to 70% of the original estimate [18][20] - The establishment of a dedicated public affairs function aims to enhance engagement with policymakers and public health stakeholders [21] Q&A Session Summary Question: Can you provide insight into the timing of the Phase 2 VAX-24 infant primary series data readout? - Management explained that the primary endpoint is based on IgG antibody responses, and safety data will be included up to the booster dose [45][47] Question: How should we interpret the non-inferiority criteria for the Phase 2 study? - Management clarified that while the registrational non-inferiority margin is set at 10%, they will also consider a 15-point delta due to the smaller sample size in Phase 2 studies [91] Question: What is the potential for VAX-31 to advance directly to pediatric use? - Management indicated that both VAX-24 and VAX-31 are being developed in parallel, with decisions to be made based on the data readouts [102] Question: What are the opportunities for conducting efficacy studies in the pediatric setting? - Management acknowledged the potential for efficacy studies related to otitis media, given the high incidence of the condition and the improved coverage expected from VAX-31 [108]

Financial Data and Key Metrics Changes - Vaxcyte reported a strong financial position with $3.13 billion in cash, cash equivalents, and investments as of December 31, 2024, which includes $2.2 billion in net proceeds from two successful follow-on equity offerings last year [17][20] - R&D expenses increased in 2024 primarily due to heightened development and manufacturing activities related to adult and infant PCV programs, alongside growth in R&D personnel [18] - G&A expenses rose due to higher personnel costs from an increase in the number of employees [18] Business Line Data and Key Metrics Changes - The PCV franchise remains a cornerstone for Vaxcyte, with significant clinical progress reported in both adult and infant populations [11][25] - VAX-31 clinical data in adults showed robust opsonophagocytic activity across all 31 serotypes, with the FDA granting Breakthrough Therapy Designation for VAX-31 in adults [28] - The VAX-24 study in infants is fully enrolled, with topline data expected by the end of the current quarter [12][30] Market Data and Key Metrics Changes - The global pneumococcal vaccine market is valued at approximately $8 billion annually, with the adult segment expected to grow significantly due to expanded vaccination guidelines [10] - The infant segment remains the largest, estimated at $6 billion in annual sales, despite ongoing public health challenges related to pneumococcal diseases [10] Company Strategy and Development Direction - Vaxcyte aims to build a robust pipeline of novel broad-spectrum vaccines targeting significant bacterial threats, including Group A Strep and Shigella, alongside its PCV offerings [9][13] - The company is focused on establishing a dedicated large-scale manufacturing suite in partnership with Lonza to support future commercial supply [14][15] - Vaxcyte is committed to financial discipline and strategic investments to maximize long-term impact and sustainable growth [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their science and the critical role vaccines play in global health, emphasizing the importance of continued engagement with policymakers [22][23] - The company anticipates a milestone-rich year ahead, marked by key clinical and regulatory advancements [40] Other Important Information - Vaxcyte's commitment to addressing antimicrobial resistance (AMR) through vaccine innovation is highlighted as a critical public health initiative [13] - The establishment of a dedicated public affairs function aims to enhance engagement with public health stakeholders and policymakers [21] Q&A Session Summary Question: Timing of Phase 2 VAX-24 infant primary series data readout - Management explained that the primary endpoint for the infant indication is split across two co-primary endpoints, focusing on IgG antibody responses [45][46] Question: Non-inferiority criteria and expectations for serotype performance - Management clarified that while the non-inferiority margin is set at 10%, they are also considering a 15-point delta based on historical data from similar studies [88][91] Question: Potential for VAX-31 to advance directly to pediatric use - Management indicated that both VAX-24 and VAX-31 are being developed in parallel, with decisions to be made based on upcoming data readouts [102] Question: Efficacy studies for otitis media - Management acknowledged the potential for conducting an efficacy study in otitis media post-approval, given the high incidence of the condition in infants [108][109]

Corporate Presentation February 25, 2025 Highlights: Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise Positive Phase 1/2 Adult Data for VAX-31 and VAX-24 Validate Potential of Site-Specific, Carrier-Sparing Platform POTENTIAL BEST-IN-CLASS PCV FRANCHISE HIGHLY ATTRACTIVE PCV MARKET Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, ...