Invion (ASX:IVX) is a clinical-stage Australian life sciences company pioneering the next generation of photodynamic therapy (PDT) for the treatment of cancer and infectious diseases. Invion is advancing a transformative approach to disease treatment and diagnosis with a platform grounded in preclinical promise and growing clinical validation.
At the core of Invion’s platform is Photosoft, a proprietary suite of next-generation photosensitizers that selectively accumulate in diseased cells. Upon light activation, these compounds trigger a targeted oxidative stress response, leading to cell death with high precision. Unlike traditional PDT agents, Photosoft compounds are engineered to overcome the limitations of toxicity, off-target damage, and limited immune engagement. They are designed to deliver enhanced safety, selectivity, immune system activation, and theragnostic capabilities.
Invion is strategically expanding its clinical and commercial footprint through non-dilutive global partnerships that accelerate development while preserving shareholder value. In South Korea, Hanlim Pharm is fully funding the preclinical development of Photosoft for two high-need indications: glioblastoma multiforme (GBM) — one of the most aggressive and treatment-resistant brain cancers — and oesophageal cancer. Under the terms of the partnership, Hanlim covers all development costs, while Invion retains full ownership of the underlying intellectual property, positioning the company to benefit from future global opportunities.
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With a strong IP portfolio, deep clinical-stage pipeline, global collaborations and an experienced leadership team, Invion is poised for transformative value creation as it enters the next phase of clinical and commercial growth.
Invion Limited (ASX:IVX) is a clinical-stage Australian life sciences company focused on transforming photodynamic therapy (PDT) into a next-generation solution for treating cancer and infectious diseases. The company’s core value lies not just in preclinical promise, but in real-world clinical validation.
At the heart of Invion’s platform is Photosoft, a proprietary suite of next-generation photosensitizers that selectively target diseased cells and, upon light activation, induce a precise oxidative stress response to destroy them. Unlike conventional PDTs that suffer from toxicity and off-target effects, Photosoft compounds are engineered for enhanced safety, specificity, immune activation, and theragnostic utility. INV043, Invion’s lead cancer drug candidate, has demonstrated up to 80 percent tumor control in combination with immune checkpoint inhibitors, and is now in human trials.The company is actively progressing a broad pipeline across multiple indications, including:
These trials signal a critical shift for Invion from preclinical research to meaningful clinical validation, spanning both systemic and topical formulations. The safety data from the NMSC trial is expected to support accelerated development of the anogenital cancer program, given both use the same topical compound.
The clinical results so far have been consistent with the findings from the preclinical studies – showing INV043 to be very safe with promising efficacy signals. The next set of trials aim to further solidify the potential for the technology, where the one drug can treat multiple cancers, improve patient outcomes when using checkpoint inhibitors in combination with INV043 and demonstrate its diagnostic and theragnostic potential.
Beyond internally funded trials, Invion is strategically expanding its clinical and commercial footprint through non-dilutive, global partnerships. In South Korea, Hanlim Pharm is funding the preclinical development of Photosoft for glioblastoma multiforme — a highly aggressive brain cancer — and oesophageal cancer, both of which present major unmet needs. These programs are fully financed by Hanlim, with Invion retaining all intellectual property
Similarly, Dr. I&B Co. (Dr.inB), another South Korean group, is backing the development of Photosoft for human papillomavirus (HPV) in a new proof-of-concept trial. This collaboration not only funds a novel therapeutic area outside of oncology but underscores the versatility of Photosoft as a multi-indication, platform technology. Invion bears none of the clinical trial costs and maintains all rights to future commercialization.
In parallel, Invion is expanding the Photosoft platform into infectious diseases, where preclinical studies have demonstrated broad-spectrum antimicrobial activity. The compound has proven effective in vitro against:
These results reflect Invion’s long-term vision of developing a scalable, accessible and affordable therapy platform that addresses both high-burden cancers and the growing global threat of antimicrobial resistance. With Photosoft, the company is building a foundation not just for treating disease — but for reshaping therapeutic accessibility and patient outcomes worldwide.
Invion’s leading active trial is a Phase I/II adaptive clinical study targeting non-melanoma skin cancer — a condition that represents 98 percent of all skin cancers and constitutes a substantial public health burden in Australia. Using a topical formulation of INV043, the trial is designed with a 3+3 structure allowing real-time protocol optimization for safety and efficacy. The formulation offers significant cosmetic and pain-reduction benefits over existing approved PDT treatments like Metvix (by Galderma S.A.) and excisional surgery, both of which have limitations related to scarring and pain. Dosing of the first patient commenced in December 2024, with ongoing recruitment and interim data expected in the second half 2025 or early 2026. The skin cancer program not only represents a potentially fast path to market but also supports downstream programs, such as the anogenital cancer study, through shared formulation and safety data.
The anogenital cancer program is a major upcoming milestone for Invion, developed in collaboration with the prestigious Peter MacCallum Cancer Centre in Melbourne, Australia, one of the leading oncology research centres in the world. Utilizing the same topical INV043 formulation as the non-melanoma skin cancer trial, this Phase I/II study will leverage safety data from the trial to accelerate approval timelines. The anogenital trial targets high-risk lesions and cancers with limited therapeutic options, and benefits from the scientific and operational expertise of Peter Mac. Preclinical data showed exceptional synergy when INV043 was used in combination with immune checkpoint inhibitors (anti-PD-1), achieving up to 80 percent tumor-free responses in models of anal squamous cell carcinoma, compared with a circa 12 percent response rate with aniti-PD-1 alone. This program exemplifies Invion’s theragnostic strength, where the compound also enables fluorescent visualization of tumor margins to aid surgical decision-making.
INV043 has completed a Phase II investigator-led clinical trial in prostate cancer, funded by the RMW Cho Group. The trial involved sublingual systemic administration of the compound followed by targeted light therapy. Following COVID-related disruptions, a second cohort of 16 patients was successfully treated and evaluated using PSMA-PET scans and RECIST criteria. Results were compelling: 44 percent of patients showed no detectable cancer via PSMA-PET scan three months post-treatment, while 40 percent demonstrated partial or stable response by MRI. The therapy was extremely well-tolerated, with no serious adverse events and only mild treatment-emergent side effects. These findings serve as clinical proof-of-concept for systemic delivery of INV043, highlighting its potential for deeper-seated cancers and reinforcing its safety and scalability.
Through a strategic partnership with South Korean pharmaceutical company Hanlim Pharma, Invion is advancing preclinical programs for two highly aggressive and deadly cancers: glioblastoma multiforme and oesophageal cancer. Hanlim is funding both programs entirely, allowing Invion to retain all IP and avoid capital outlay. These programs are exploring INV043’s efficacy in some of the most treatment-resistant solid tumors, with early-stage studies underway and updates expected in 2025. If successful, this collaboration could lead to regional licensing or joint ventures in Asia, significantly expanding Invion’s global footprint.
Dr.inB, a leading PDT innovator in South Korea, is partnering with Invion to develop Photosoft-based treatments for HPV-related conditions, including genital warts and potentially HPV-linked cancers. The program, which includes proof-of-concept human trials, is entirely funded by Dr.inB, and Invion retains all IP and commercialization rights. Beyond HPV, Photosoft has demonstrated broad-spectrum antimicrobial potential against antibiotic-resistant bacteria, fungi and viruses, including SARS-CoV-2. This opens the door to applications in periodontal disease, peri-implant mucositis, and other infectious conditions. PDT’s unique mechanism of action — using light to generate oxidative stress — renders it immune to resistance development, making it an ideal candidate for combatting antimicrobial resistance, one of the top 10 threats to humanity identified by the World Health Organization.
Thian Chew brings over two decades of executive and advisory experience in healthcare and finance. He is the co-founder of Chronic Airway Therapeutics and a board advisor at Stanford Medicine’s Center for Asian Health Research and Education (CARE). Formerly an executive director at Goldman Sachs and director at KPMG Consulting, Chew combines strategic vision with operational rigor. He is an adjunct professor at the University College London and associate professor at HKUST, holding dual an MBA from Wharton School (Palmer Scholar) and an MA from the Lauder Institute, University of Pennsylvania.
A world-renowned expert in immunotherapy and translational cancer biology, Robert Ramsay is a senior scientist at Peter MacCallum Cancer Centre and has over 30 years of oncology research experience. He was instrumental in demonstrating the synergy between INV043 and checkpoint inhibitors, leading to his appointment as a key advisor. Ramsay also served as president of the Australian Society for Medical Research.
Scott Carpenter brings cross-functional expertise in regulatory affairs, business development and stakeholder engagement. He previously held leadership roles at Starpharma, AusBiotech and Bayer CropScience and holds an MBA from Melbourne Business School.
The co-inventor of Invion’s PDT patents, Sebastian Marcuccio is the founder of Advanced Molecular Technologies and has a deep background in pharmaceutical R&D, including with CSIRO. He is currently adjunct professor at La Trobe University and holds a PhD in organic chemistry.
With more than 18 years of experience managing global Phase I-IV drug and device trials across 14 countries, Kim Steel has worked with Novotech and Pacific Clinical Research. She is managing director of SAPRO Consulting, leading operational delivery for Invion’s ongoing trials.
A veteran of scientific instrumentation development, Alexander Bennett brings 35+ years of experience designing medical and forensic light systems. He led PDT light source trials at Peter MacCallum Cancer Centre and ensures the clinical precision of INV043’s light activation protocol.
Revolutionizing Photodynamic Therapy (PDT) for cancer and infectious diseases
Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2025 and reaffirmed its 2025 financial guidance (1) .
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and CEO of Pfizer:
"We continued to execute with focus and discipline against our strategic priorities, including strengthening our R&D organization and driving improved productivity. With the underlying strength of our business, we believe we can be agile in navigating an uncertain and volatile external environment."
David Denton, CFO and EVP of Pfizer:
"Our overall solid first-quarter performance demonstrates our continued focus on commercial execution amid U.S. Medicare Part D headwinds. Our focus on operational efficiency and financial discipline is driving strong results to our bottom line. We are currently trending towards the upper end of our 2025 Adjusted diluted EPS guidance range."
OVERALL RESULTS
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates (5) .
Results for the first quarter of 2025 and 2024 (6) are summarized below.
($ in millions, except per share amounts) | First-Quarter | |||||||
2025 | 2024 | % Change | ||||||
Revenues | $ | 13,715 | $ | 14,879 | (8 | %) | ||
Reported (2) Net Income | 2,967 | 3,115 | (5 | %) | ||||
Reported (2) Diluted EPS | 0.52 | 0.55 | (5 | %) | ||||
Adjusted (3) Income | 5,237 | 4,674 | 12 | % | ||||
Adjusted (3) Diluted EPS | 0.92 | 0.82 | 12 | % | ||||
REVENUES
($ in millions) | First-Quarter | |||||||||
2025 | 2024 | % Change | ||||||||
Total | Oper. | |||||||||
Global Biopharmaceuticals Business (Biopharma) | $ | 13,441 | $ | 14,604 | (8 | %) | (6 | %) | ||
Pfizer CentreOne (PC1) | 257 | 258 | — | 2 | % | |||||
Pfizer Ignite | 17 | 17 | (3 | %) | (3 | %) | ||||
TOTAL REVENUES | $ | 13,715 | $ | 14,879 | (8 | %) | (6 | %) | ||
2025 FINANCIAL GUIDANCE (1)
Pfizer's 2025 financial guidance (1) is presented below.
Revenues | $61.0 to $64.0 billion |
Adjusted (3) SI&A Expenses | $13.3 to $14.3 billion |
Adjusted (3) R&D Expenses | $10.7 to $11.7 billion |
Effective Tax Rate on Adjusted (3) Income | Approximately 15.0% |
Adjusted (3) Diluted EPS | $2.80 to $3.00 |
CAPITAL ALLOCATION
During the first three months of 2025, Pfizer deployed its capital in a variety of ways, which primarily included:
No share repurchases have been completed to date in 2025. As of April 29, 2025, Pfizer's remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. Pfizer has actively de-levered and as of March 30, 2025 is below our previously stated gross leverage (7) target. The company expects to continue to de-lever in a prudent manner in order to maintain a balanced capital allocation strategy. This includes maintaining the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases.
Diluted weighted-average shares outstanding of 5,710 million and 5,697 million were used to calculate Reported (2) and Adjusted (3) diluted EPS for first-quarter 2025 and 2024, respectively.
QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2025 vs. First-Quarter 2024)
First-quarter 2025 revenues totaled $13.7 billion, a decrease of $1.2 billion, or 8%, compared to the prior-year quarter, reflecting an operational decrease of $908 million, or 6%, as well as an unfavorable impact of foreign exchange of $256 million, or 2%. The operational decrease was primarily driven by a decline in Paxlovid revenues, partially offset by growth from the Vyndaqel family, Comirnaty (8) , and several other products across categories despite the unfavorable impact of higher manufacturer discounts resulting from the Inflation Reduction Act (IRA) Medicare Part D Redesign.
First-quarter 2025 operational revenue reflected higher revenues primarily for:
more than offset primarily by lower revenues for:
GAAP Reported (2) Statement of Operations Highlights
SELECTED REPORTED (2) COSTS AND EXPENSES
($ in millions) | First-Quarter | |||||||||
2025 | 2024 | % Change | ||||||||
Total | Oper. | |||||||||
Cost of Sales (2) | $ | 2,845 | $ | 3,379 | (16 | %) | (9 | %) | ||
Percent of Revenues | 20.7 | % | 22.7 | % | N/A | N/A | ||||
SI&A Expenses (2) | 3,031 | 3,495 | (13 | %) | (12 | %) | ||||
R&D Expenses (2) | 2,203 | 2,493 | (12 | %) | (11 | %) | ||||
Acquired IPR&D Expenses (2) | 9 | — | * | * | ||||||
Other (Income)/Deductions—net (2) | 953 | 680 | 40 | % | 54 | % | ||||
Effective Tax Rate on Reported (2) Income | (6.8 | %) | 8.6 | % | ||||||
* Indicates calculation not meaningful or results are greater than 100%. | ||||||||||
First-quarter 2025 Cost of Sales (2) as a percentage of revenues decreased by 2.0 percentage points compared to the prior-year quarter, driven primarily by a favorable revision of our estimate of accrued royalties and the favorable impact of foreign exchange, partially offset by the unfavorable impact of changes in sales mix as well as the non-recurrence of the Paxlovid favorable final adjustment (9) recorded in the first quarter of 2024 to the estimated non-cash revenue reversal recorded in the fourth quarter of 2023.
First-quarter 2025 SI&A Expenses (2) decreased 12% operationally compared with the prior-year quarter, primarily reflecting ongoing productivity improvements that drove a decrease in marketing and promotional spend for various products and lower spending in corporate enabling functions, as well as lower spending on COVID-19 products.
First-quarter 2025 R&D Expenses (2) decreased 11% operationally compared with the prior-year quarter, driven primarily by a net decrease in spending due to pipeline focus and optimization, as well as lower compensation-related expenses.
The unfavorable period-over-period change in Other (income)/deductions—net (2) of $273 million for the first quarter of 2025, compared with the prior-year quarter, was driven primarily by (i) net losses on equity securities in the first quarter of 2025 versus net gains on equity securities in the first quarter of 2024, (ii) the non-recurrence of a gain on the partial sale of our investment in Haleon plc in the first quarter of 2024 and (iii) higher intangible asset impairment charges; partially offset by (iv) lower net interest expense.
Pfizer's effective tax rate on Reported (2) income for the first quarter of 2025 is negative, primarily due to favorable global income tax resolutions in multiple tax jurisdictions spanning multiple tax years, as well as a favorable change in the jurisdictional mix of earnings.
Adjusted (3) Statement of Operations Highlights
SELECTED ADJUSTED (3) COSTS AND EXPENSES
($ in millions) | First-Quarter | |||||||||
2025 | 2024 | % Change | ||||||||
Total | Oper. | |||||||||
Adjusted (3) Cost of Sales | $ | 2,593 | $ | 3,036 | (15 | %) | (8 | %) | ||
Percent of Revenues | 18.9 | % | 20.4 | % | N/A | N/A | ||||
Adjusted (3) SI&A Expenses | 3,010 | 3,454 | (13 | %) | (12 | %) | ||||
Adjusted (3) R&D Expenses | 2,173 | 2,477 | (12 | %) | (12 | %) | ||||
Adjusted (3) Other (Income)/Deductions—net | 246 | 296 | (17 | %) | 14 | % | ||||
Effective Tax Rate on Adjusted (3) Income | 7.8 | % | 16.6 | % | ||||||
See the reconciliations of certain Reported (2) to non-GAAP Adjusted (3) financial measures and associated footnotes in the financial tables section of this press release located at the hyperlink below.
RECENT NOTABLE DEVELOPMENTS (Since February 4, 2025)
Product Developments
Product/Project | Milestone | Recent Development | Link |
Abrysvo | Regulatory | April 2025. Announced the European Commission (EC) amended the marketing authorization for Abrysvo to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age. The authorization is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway. | |
ACIP Vote | April 2025. Announced the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of RSV vaccines approved for adults 50-59 years of age at increased risk of RSV-associated LRTD, which includes Abrysvo. The updated ACIP recommendation, which lowers the recommended age for RSV vaccination from 60 to 50 for high-risk adults, is pending final approval by the director of the CDC and the Department of Health and Human Services. | ||
Adcetris (brentuximab vedotin) | Regulatory | February 2025. Announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Adcetris in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma, after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy. | |
Padcev | Phase 3 Results | February 2025. Pfizer and Astellas Pharma Inc. presented additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of Padcev plus Keytruda (10) (pembrolizumab, a PD-1 inhibitor) in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months), with no new safety signals identified. | |
Talzenna (talazoparib) | Phase 3 Results | February 2025. Announced positive OS results from the Phase 3 TALAPRO-2 study of Talzenna, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI), demonstrating a statistically significant and clinically meaningful improvement in OS compared to placebo plus Xtandi in patients with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The safety profile of Talzenna plus Xtandi was generally consistent with the known safety profile of each medicine. |
Pipeline Developments
A comprehensive update of Pfizer's development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline . It includes an overview of Pfizer's research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.
Product/Project | Milestone | Recent Development | Link |
danuglipron | Discontinued | April 2025. Announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management. This decision followed a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators. The company remains committed to evaluating and advancing promising programs for cardiovascular and metabolic diseases, including obesity. | |
sasanlimab | Phase 3 Results | April 2025. Presented results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The findings showed a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression, with the sasanlimab combination regimen as compared with SOC treatment alone. The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors. Pfizer has shared these data with global health authorities to support potential regulatory filings. | |
vepdegestrant | Phase 3 Results | March 2025. Arvinas, Inc. and Pfizer announced topline results from the Phase 3 VERITAC-2 clinical trial (NCT05654623) evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer whose disease progressed following prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy. The trial met its primary endpoint in the estrogen receptor 1-mutant (ESR1m) population, demonstrating a statistically significant and clinically meaningful improvement in PFS compared to fulvestrant. The results exceeded the pre-specified target hazard ratio of 0.60 in the ESR1m population. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat (ITT) population. |
Corporate Developments
Topic | Recent Development | Link |
Cost Realignment Program (4) | Announced at Q1-2025 Earnings. Pfizer announced approximately $1.2 billion of additional anticipated savings associated with its ongoing cost realignment program (4) , expected to be achieved by the end of 2027, designed to further reduce costs primarily in SI&A driven in large part by enhanced digital enablement, including automation and AI, and simplification of business processes. We expect one-time costs to achieve the additional savings to be incurred through 2027 and to total approximately $1.6 billion, primarily representing cash expenditures for severance, digital enablement and implementation. | N/A |
Announced at Q1-2025 Earnings. In connection with our efforts to simplify the structure and sharpen the focus of our R&D organization, in the first quarter of 2025 we expanded this program after having identified additional opportunities to drive improvements in productivity and operational efficiencies through enhanced digital enablement, including automation and AI, and simplification of business processes. Savings associated with the simplification of our R&D organization are anticipated to be realized by the end of 2026 and are expected to total approximately $500 million and be reinvested in R&D programs. We expect one-time costs to implement these initiatives to be incurred through 2026 and to total approximately $600 million, primarily representing cash expenditures for severance, digital enablement and implementation. | N/A | |
Haleon Stock Sale | March 2025. Pfizer sold 618 million ordinary shares of its investment in Haleon to institutional investors and separately Haleon purchased 44 million ordinary shares from Pfizer for a combined total net proceeds of approximately $3.3 billion. This follows the previously announced sale of 700 million Haleon shares in January 2025 which resulted in approximately $3.0 billion in net cash proceeds. Pfizer has fully exited its position in Haleon. | N/A |
R&D Leadership | March 2025. James List, M.D., Ph.D., joined Pfizer as Chief Internal Medicine Officer, overseeing the company's Internal Medicine portfolio, from early discovery to late development, inclusive of Medical Affairs and Business Development strategies. He is responsible for advancing Pfizer's emerging pipeline of cardiovascular, metabolic, and obesity medicines. Dr. List reports to Chris Boshoff, M.D., Ph.D., Chief Scientific Officer and President, Pfizer Research & Development. | |
February 2025. Announced Jeffrey Legos, Ph.D., MBA, will join Pfizer as Chief Oncology Officer and will be responsible for leading the company's Oncology R&D, overseeing all functions from pre-clinical to late-stage clinical development activities. Dr. Legos will report to Chris Boshoff, and will succeed Roger Dansey, M.D., Interim Chief Oncology Officer, who will transition to retirement as previously communicated. | ||
February 2025. Announced Patrizia Cavazzoni, M.D., rejoined Pfizer as Chief Medical Officer, Executive Vice President. In this role, Dr. Cavazzoni leads Pfizer's regulatory, pharmacovigilance, safety, epidemiology, and medical information and evidence generation, among other medical functions, and reports to Chris Boshoff. |
Pfizer TO HOST CONFERENCE CALL
Please find Pfizer's press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink:
https://investors.pfizer.com/Q1-2025-PFE-Earnings-Release
(Note: If clicking on the above link does not open a new webpage, you may need to cut and paste the above URL into your browser's address bar.)
Pfizer will host a live conference call and webcast today at 10:00 AM EDT. To access the live conference call and view the first-quarter 2025 earnings presentation, accompanying prepared remarks from management, and infographic, visit our website at pfizer.com/investors .
You can also listen to the conference call by dialing either 800-456-4352 in the U.S. and Canada or 785-424-1086 outside of the U.S. and Canada. The passcode is "67619".
The transcript and webcast replay of the call will be made available on our website at pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.
For additional details, see the financial schedules and product revenue table within the press release located at the hyperlink above, and the attached disclosure notice.
(1) | Pfizer does not provide guidance for U.S. generally accepted accounting principles (GAAP) Reported financial measures (other than revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of unusual gains and losses, certain acquisition-related expenses, gains and losses from equity securities, actuarial gains and losses from pension and postretirement plan remeasurements, potential future asset impairments and pending litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period. | |
Financial guidance for full-year 2025 reflects the following:
| ||
(2) | Revenues is defined as revenues in accordance with U.S. GAAP. Reported net income and its components are defined as net income attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) is defined as diluted EPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP. | |
(3) | Adjusted income and Adjusted diluted EPS are defined as U.S. GAAP net income attributable to Pfizer Inc. common shareholders and U.S. GAAP diluted EPS attributable to Pfizer Inc. common shareholders before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the first quarter of 2025 and 2024 in the press release at the hyperlink above. Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income and its components and diluted EPS (2) . See the Non-GAAP Financial Measure: Adjusted Income section of Management's Discussion and Analysis of Financial Condition and Results of Operations in Pfizer's 2024 Annual Report on Form 10-K and the accompanying Non-GAAP Financial Measure: Adjusted Income section of the press release located at the hyperlink above for a definition of each component of Adjusted income as well as other relevant information. | |
(4) | Approximately $4.5 billion of overall net cost savings from Pfizer's ongoing cost realignment program are expected to be achieved by the end of 2025. An additional approximately $1.2 billion of anticipated net cost savings is expected to be fully achieved by the end of 2027. The net cost savings are calculated versus the midpoint of Pfizer's 2023 SI&A and R&D expense guidance provided on August 1, 2023. | |
(5) | References to operational variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although foreign exchange rate changes are part of Pfizer's business, they are not within Pfizer's control and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer's results. | |
(6) | Pfizer's fiscal year-end for international subsidiaries is November 30 while Pfizer's fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer's first quarter for U.S. subsidiaries reflects the three months ended on March 30, 2025 and March 31, 2024, while Pfizer's first quarter for subsidiaries operating outside the U.S. reflects the three months ended on February 23, 2025 and February 25, 2024. | |
(7) | Gross leverage (Adjusted Debt to Non-GAAP Adjusted EBITDA ratio) is determined by comparing our total debt (including short-term borrowings, long-term debt, repatriation tax, and lease liabilities (short- and long-term)) as of March 30, 2025 to Non-GAAP Adjusted EBITDA. Non-GAAP Adjusted EBITDA is determined by making the following adjustments to GAAP Income from continuing operations before provision/(benefit) for taxes on income : (i) adding net interest expense, depreciation & amortization, acquisition-related charges, restructuring charges and asset impairment charges; and (ii) adjusting by actuarial valuation and other pension and postretirement plan gains/(losses), gains/(losses) on equity securities, and certain other certain significant items. | |
(8) | As used in this document, "Comirnaty" refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine; Comirnaty (COVID-19 Vaccine, mRNA) original monovalent formula; the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5); the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula); Comirnaty (COVID-19 Vaccine, mRNA) 2023-2024 Formula; Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula); Comirnaty (COVID-19 Vaccine, mRNA) 2024-2025 Formula; Comirnaty Original/Omicron BA.1; Comirnaty Original/Omicron BA.4/BA.5; Comirnaty Omicron XBB.1.5; Comirnaty JN.1 and Comirnaty KP.2. "Comirnaty" includes product revenues and alliance revenues related to sales of the above-mentioned vaccines. | |
(9) | First-quarter 2024 Paxlovid revenue included a $771 million favorable final adjustment to the estimated non-cash revenue reversal of $3.5 billion recorded in fourth-quarter 2023, reflecting 5.1 million EUA-labeled treatment courses returned by the U.S. government through February 29, 2024 versus the estimated 6.5 million treatment courses that were expected to be returned as of December 31, 2023. | |
(10) | Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. |
DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of April 29, 2025. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments.
This earnings release and the related attachments contain forward-looking statements about, among other topics, our anticipated operating and financial performance, including financial guidance and projections; reorganizations; business plans, strategy, goals and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, discontinuations, clinical trial results and other developing data, revenue contribution and projections, potential pricing and reimbursement, potential market dynamics, including demand, market size and utilization rates and growth, performance, timing of exclusivity and potential benefits; strategic reviews; leverage and capital allocation objectives; an enterprise-wide cost realignment program (including anticipated costs, savings and potential benefits); a Manufacturing Optimization Program to reduce our cost of goods sold (including anticipated costs, savings and potential benefits); dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, including our December 2023 acquisition of Seagen, and our ability to successfully capitalize on growth opportunities and prospects; manufacturing and product supply; our ongoing efforts to respond to COVID-19; our expectations regarding the impact of COVID-19 on our business, operations and financial results; and the expected seasonality of demand for certain of our products. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions and we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as "will," "may," "could," "likely," "ongoing," "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," "assume," "target," "forecast," "guidance," "goal," "objective," "aim," "seek," "potential," "hope" and other words and terms of similar meaning. Pfizer's financial guidance is based on estimates and assumptions that are subject to significant uncertainties.
Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following:
Risks Related to Our Business, Industry and Operations, and Business Development:
Risks Related to Government Regulation and Legal Proceedings:
Risks Related to Intellectual Property, Technology and Cybersecurity:
Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned "Forward-Looking Information and Factors That May Affect Future Results" and "Item 1A. Risk Factors," and in our subsequent reports on Form 8-K.
This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.
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Certain of the products and product candidates discussed in this earnings release are being co-researched, co-developed and/or co-promoted in collaboration with other companies for which Pfizer's rights vary by market or are the subject of agreements pursuant to which Pfizer has commercialization rights in certain markets.
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Pfizer Inc. (NYSE: PFE) today announced results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The trial met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance): Hazard Ratio (HR) of 0.68; 95% Confidence Interval (CI), 0.49-0.94; 2-sided p=0.019; median EFS not yet reached. These findings show a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression, with the sasanlimab combination regimen as compared with SOC treatment alone. Pre-specified subgroup analyses for patients harboring higher risk disease showed consistent benefit with EFS HR of 0.63 (0.41, 0.96) for T1 disease, and EFS HR 0.53 (0.29, 0.98) for those with CIS disease.
EFS was a composite endpoint defined as the time from randomization to the earliest of recurrence of high-grade disease, progression of disease, persistence of carcinoma in situ (CIS), or death due to any cause. The probability of being event-free at 36 months was 82.1% (95% CI, 77.4-85.9) with sasanlimab in combination with BCG (induction and maintenance), and 74.8% (95% CI, 69.7-79.2) with BCG alone (induction and maintenance). Results from the CREST trial are being presented today in a plenary oral presentation at the 2025 American Urological Association (AUA) Annual Meeting.
"New bladder cancer treatment options that help reduce rates of disease recurrence or progression are long overdue. Up to 50% of patients with high-risk non-muscle invasive bladder cancer may experience failure of BCG intravesical immunotherapy, yet it has been the standard of care after tumor resection for decades," said Neal Shore, M.D., FACS, Medical Director for START Carolina Research Center, and lead investigator for the CREST trial. "These Phase 3 results show that combining sasanlimab with BCG induction and maintenance therapy earlier in the course of the disease significantly prolonged event-free survival, highlighting the value and potential of sasanlimab in combination with BCG to redefine the treatment paradigm and reduce the burden for patients."
As the ninth most common cancer worldwide, bladder cancer accounts for up to 220,000 deaths annually. 1,2 NMIBC, in particular, represents approximately 75% of all bladder cancer cases. 3 In the U.S., it is estimated that about 38,000 people have high-risk NMIBC. 4 While BCG treatment has been shown to reduce the risk of tumor recurrence, approximately 40-50% of patients with high-risk NMIBC receiving BCG will eventually have disease recurrence or progression despite therapy. 5-7
"Today's pivotal Phase 3 CREST results offer a much-needed therapeutic breakthrough and spotlight sasanlimab as the first immunotherapy combination with BCG to significantly improve outcomes for patients with BCG-naïve, high-risk NMIBC in over three decades," said Megan O'Meara, M.D., Interim Chief Development Officer, Pfizer Oncology. "The CREST findings are especially impactful for these patients with early-stage cancer who may benefit the most from innovative treatment regimens, including a subcutaneous immune checkpoint inhibitor, that delay disease recurrence or progression. These results underscore our long-standing commitment to patients with bladder cancer across all stages of the disease. We look forward to working with global regulatory authorities to potentially bring sasanlimab as an important new treatment option to patients with high-risk NMIBC."
Sasanlimab in combination with BCG (induction only) did not result in prolongation of EFS when compared to BCG alone (induction and maintenance), a key secondary endpoint: HR of 1.16; 95% CI, 0.87-1.55; 2-sided p=0.312, underscoring the need for BCG maintenance not only as a component of SOC treatment but also in combination with sasanlimab. Early interim analysis for the key secondary overall survival (OS) endpoint suggested no difference between treatment arms, with a median follow-up of 40.9 months. The study continues for survival follow-up until the final analysis. Complete response (CR) and duration of CR were additional secondary endpoints for patients with CIS at randomization. The CR rate achieved at any time was 89.8% with sasanlimab in combination with BCG (induction and maintenance) and 85.2% with BCG alone (induction and maintenance). Notably, for those patients with CIS at randomization who achieved a CR, the probability of remaining in CR at 36 months was 91.7% with sasanlimab in combination with BCG (induction and maintenance) compared to 67.7% with BCG alone (induction and maintenance).
The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors. Pfizer has shared these data with global health authorities to support potential regulatory filings.
About CREST
The CREST trial is a Phase 3, multinational, randomized, open-label, three parallel-arm study of sasanlimab, an anti-PD-1 mAb, in combination with BCG (BCG induction with or without BCG maintenance) versus BCG (induction and maintenance) in participants with BCG-naïve, high-risk NMIBC. Patients were randomized to receive sasanlimab 300 mg by subcutaneous (SC) injection every four weeks up to cycle 25 (cycle = four weeks), in combination with BCG once weekly for six consecutive weeks (induction period) followed (Arm A; n=352) or not (Arm B; n=352) by maintenance with BCG, or BCG induction and maintenance up to cycle 25 (Arm C; n=351). The primary endpoint is EFS as assessed by the investigator, between Arm A and C, defined as a composite endpoint that combines time from randomization to the earliest of recurrence of high-grade disease, progression of disease, persistence of CIS, or death. Key secondary endpoints include EFS as assessed by the investigator between Arm B and Arm C, between Arms A/B and Arm C. In patients with CIS, CR and duration of CR were secondary endpoints. For more information on the CREST trial (NCT04165317) , go to www.clinicaltrials.gov .
About Sasanlimab
Sasanlimab is a humanized immunoglobulin G4 (IgG4) mAb that binds to human PD-1 to block its interaction with PD-1 and PD-L1/PD-L2. PD-1 is a protein expressed on T cells, dendritic cells, natural killer cells, macrophages, and B cells, that functions as an immune checkpoint that negatively regulates T-cell activation and effector function when activated by its ligands and may play an important role in tumor evasion from host immunity. It can be administered through a once every four weeks SC injection by prefilled syringe (2mL).
In early-stage clinical studies, sasanlimab administered at 300 mg SC every four weeks showed clinical efficacy in advanced solid tumors and advanced urothelial cancer. In addition to NMIBC, sasanlimab is being evaluated in several ongoing clinical trials in combination with Pfizer's antibody drug conjugate (ADC) portfolio.
About Pfizer Oncology
At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives.
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
Disclosure Notice
The information contained in this release is as of April 26, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer Oncology, sasanlimab, an investigational anti-PD-1 monoclonal antibody, in combination with Bacillus Calmette-Guérin (BCG), as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer, including their potential benefits and the CREST results, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for sasanlimab in combination with BCG may be filed in any jurisdictions for any potential indications; whether and when any such applications for sasanlimab in combination with BCG that may be filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether sasanlimab in combination with BCG will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of sasanlimab in combination with BCG; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.Pfizer.com .
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Board of Directors approves quarterly cash dividend of $0.43 per share
Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.43 second-quarter 2025 dividend on the company's common stock, payable June 13, 2025, to holders of the Common Stock of record at the close of business on May 9, 2025. The second-quarter 2025 cash dividend will be the 346th consecutive quarterly dividend paid by Pfizer.
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
Category: Finance
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Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). This includes ABRYSVO ® (Respiratory Syncytial Virus Vaccine), which in October 2024, the U.S. Food and Drug Administration approved for the prevention of RSV-associated LRTD in adults aged 18 to 59 at increased risk of severe disease.
According to the CDC, between 15,000 - 20,000 RSV-associated hospitalizations occur annually in U.S. adults aged 50 - 59 years. 1 The risk of hospitalization is highest among those adults with one or more underlying medical conditions such as obesity, cardiovascular disease, diabetes, chronic obstructive pulmonary disorder (COPD), asthma, and other chronic or immunocompromising conditions. 1 With respect to ABRYSVO, ACIP stated:
"With its vote to expand adult RSV vaccination recommendations, ACIP has taken an important step toward protecting individuals aged 50 to 59 who have underlying medical conditions that increase their risk for severe RSV illness," said Alejandro Cane, Vice President, Vaccines and Antivirals U.S. Medical Lead, Pfizer. "We are proud that ABRYSVO has the broadest indication among RSV vaccines, covering older adults, adults 18 and older at heightened risk of severe disease, and pregnant women to help protect infants."
The updated ACIP recommendation, which lowers the recommended age for RSV vaccination from 60 to 50 for high-risk adults, is pending final approval by the director of the CDC and the Department of Health and Human Services.
ABOUT RSV
Respiratory syncytial virus (RSV) is a contagious virus and a common cause of respiratory illness. 2 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death. 3,4 Chronic cardiovascular disease, chronic lung disease, moderate or severe immune compromise, diabetes with complications, and severe obesity are among the conditions that increase an individual's risk for severe RSV. 5 There are two major subgroups of RSV: RSV-A and RSV-B. Both subgroups cause disease and can co-circulate or alternate predominance from season to season.
ABOUT ABRYSVO
Pfizer currently is the only company with an RSV vaccine to help protect adults aged 60 and older, and adults 18 and older at increased risk of lower respiratory tract disease caused by RSV (RSV-LRTD), as well as infants through maternal immunization. ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to provide broad protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer's RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies.
In May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. In June 2024, the Advisory Committee on Immunization Practices (ACIP) voted to update its recommendation of RSV vaccines for use in adults aged ≥75 years and adults age 60-74 years who are increased risk for severe RSV disease. In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. This was followed in September 2023 with ACIP's recommendation for maternal immunization to help protect newborns from RSV seasonally where the vaccine should be administered from September through January in most of the continental United States.
Also in August 2023, Pfizer announced that the European Commission granted marketing authorization for ABRYSVO for both older adults and maternal immunization to help protect infants, and in March 2025 announced the amended marketing authorization to extend the indication to include a broader adult population. Additionally, ABRYSVO has received approvals for both indications in multiple countries worldwide.
INDICATIONS FOR ABRYSVO
ABRYSVO ® is a vaccine indicated in the U.S. for:
IMPORTANT SAFETY INFORMATION FOR ABRYSVO
View the full ABRYSVO Prescribing Information .
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
DISCLOSURE NOTICE:
The information contained in this release is as of April 16, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about ABRYSVO, including its potential benefits and a vote by ACIP to expand its recommendation to include adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in particular jurisdictions for ABRYSVO for any potential indications; whether and when any applications that may be pending or filed for ABRYSVO may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ABRYSVO for any such indications will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRYSVO; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.Pfizer.com .
____________________ |
1 U.S. Centers for Disease Control and Prevention. "Evidence to Recommendations Framework (EtR): RSV Vaccination in Adults Aged 50–59 years" https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/06-Melgar-Surie-adult-rsv-508.pdf Presented April 16, 2025. Accessed April 2025.
2 World Health Organization. Respiratory Syncytial Virus (RSV) disease. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/vaccine-standardization/respiratory-syncytial-virus-disease . Accessed February 2025.
3 U.S. Centers for Disease Control and Prevention. How RSV Spreads. https://www.cdc.gov/rsv/causes/index.html . Updated August 30, 2024. Accessed February 2025.
4 U.S. Centers for Disease Control and Prevention. RSV in Older Adults. https://www.cdc.gov/rsv/older-adults/index.html . Updated August 30, 2024. Accessed February 2025.
5 U.S. Centers for Disease Control and Prevention. Clinical Overview of RSV. https://www.cdc.gov/rsv/hcp/clinical-overview/index.html . Updated August 30, 2024. Accessed February 2025.
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Pfizer Inc. (NYSE: PFE) today announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management.
Pfizer's dose-optimization studies of once-daily formulations of danuglipron ( NCT06567327 and NCT06568731 ) met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in Phase 3 testing, based on earlier studies of twice-daily danuglipron. While the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron is in-line with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury which resolved after discontinuation of danuglipron. After a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer has decided to discontinue development of the molecule.
"Cardiovascular and metabolic diseases including obesity remain important areas of unmet medical need, and we plan to continue applying our global capabilities to advance a pipeline of investigational treatments that have the potential to fill critical gaps in patient care, including continued development of our oral GIPR antagonist candidate and other earlier obesity programs," said Chris Boshoff, MD, PhD, Chief Scientific Officer and President, Research and Development at Pfizer. "While we are disappointed to discontinue the development of danuglipron, we remain committed to evaluating and advancing promising programs in an effort to bring innovative new medicines to patients."
Data from the danuglipron clinical development program will be presented at a scientific forum or submitted for publication in a peer-reviewed journal in the future.
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
Disclosure Notice
The information contained in this release is as of April 14, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about, among other topics, Pfizer's plans and pipeline of investigational products, including Pfizer's plans for continued development of its oral GIPR antagonist candidate and other earlier obesity programs and their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; uncertainties regarding the future development of Pfizer's oral GIPR antagonist candidate, other earlier obesity programs or any other product candidates, including whether or when Pfizer's oral GIPR antagonist candidate, other earlier obesity programs or any such other product candidates will advance to future studies or phases of development; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications for any potential indications for Pfizer's oral GIPR antagonist candidate, other earlier obesity programs or any other product candidates may be filed in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications, which will depend on a myriad of factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether Pfizer's oral GIPR antagonist candidate, other earlier obesity programs or any such other product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of Pfizer's oral GIPR antagonist candidate, other earlier obesity programs or any such other product candidates; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .
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Pfizer Inc. (NYSE: PFE) announced today that its shareholders and the general public are invited to access its virtual 2025 Annual Meeting of Shareholders at 9:00 a.m. EDT on Thursday, April 24, 2025. Pfizer has designed the virtual Annual Meeting to ensure that its shareholders who participate will be afforded comparable rights and opportunities to participate as they would at an in-person meeting.
Beginning today, shareholders can find additional information on accessing and registering for the virtual meeting at https://meetnow.global/PFE2025 . On the day of the Annual Meeting, shareholders may begin logging into the virtual meeting platform at 8:45 a.m. EDT using either the control number found on their proxy card, voting instruction form or the notice that was previously received. Only shareholders who log into the meeting using a control number will have the ability to ask questions or vote during the live meeting.
Shareholders also may submit questions in advance of the meeting by following the instructions provided on the "Rules of Conduct and Meeting Procedures" available on the virtual meeting platform. The deadline for submitting questions in advance of the meeting is 5:00 p.m. EDT on April 22. Both registered and most beneficial shareholders will be able to vote their shares during the meeting by following the instructions provided on the virtual meeting platform. Some beneficial owners may be required to obtain a legal proxy and pre-register for the virtual meeting in order to vote or ask questions during the live meeting. Beneficial owners should check with their broker as to whether pre-registration is required. In addition, beneficial owners will be required to obtain a legal proxy and pre-register in order to submit questions in advance of the live meeting.
No control number is required to participate in a listen-only mode. A replay of the webcast will be available for up to one year at: https://investors.pfizer.com/Investors/Events--Presentations .
About Pfizer: Breakthroughs That Change Patients' Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .
Disclosure Notice: The webcast of the meeting may include forward-looking statements about, among other things, our anticipated operating and financial performance, including financial guidance and projections; reorganizations, business plans, strategy, goals and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data, revenue contribution and projections, potential pricing and reimbursement, potential market dynamics, size and utilization rates, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on growth opportunities; manufacturing and product supply; our ongoing efforts to respond to COVID-19, including our COVID-19 products; our expectations regarding the impact of COVID-19 on our business, operations and financial results; and other statements about our business, operations and financial results, that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. A description of these risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .
The forward-looking statements in the webcast speak only as of the original date of the webcast. Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments.
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