PFIZER (PFE) Company Report

On Dec. 14, a patient in Pfizer’s long-term extension trial of hemophilia therapy Hympavzi died due to a stroke and cerebral hemorrhage during perioperative management with recombinant factor VIIa.
Following the trial fatality report, Pfizer’s stock declined about 1%, reflecting market sensitivity to safety issues in blood-disorder treatments.
Pfizer has engaged the trial investigator and an independent Data Monitoring Committee, notified regulators, and is reviewing surgical protocols and potential contributing factors including coexisting conditions and concurrent medications.
Hympavzi, approved in the U.S. in October 2024, remains under ongoing safety monitoring for thrombotic risks, amid Pfizer’s broader strategic shifts in blood-disorder programs such as discontinuation of Beqvez and Oxbryta over safety concerns.

1 day ago

Bloomberg

Pfizer’s subcutaneous Lunsumio approved by FDA

PFE

Product Launch

The FDA granted accelerated approval for subcutaneous mosunetuzumab (Lunsumio VELO) in adult patients with relapsed or refractory follicular lymphoma after ≥2 prior systemic therapies.
In the phase 1/2 GO29781 trial (SC cohort, n=94), the fixed-duration regimen achieved a 75% objective response rate and 59% complete response rate, with a median CR duration of 22.4 months.
The subcutaneous formulation delivers a one-minute injection versus a 2–4 hour IV infusion, enabling outpatient, fixed-duration treatment (as short as six months) and expanding community access.
Approval may require confirmatory trials to verify benefit; clinicians reported a manageable cytokine release syndrome profile.

3 days ago

Morningstar

Pfizer issues 2026 guidance and revises 2025 revenue outlook

PFE

Guidance Update

Reaffirmed FY 2025 adjusted diluted EPS guidance at $3.00–$3.15 and revised FY 2025 revenue guidance to ~$62 billion
COVID-19 revenues expected at ~$6.5 billion in 2025 (–40% YoY) and ~$5 billion in 2026 amid declining infection rates
2026 total revenues guided to $59.5–$62.5 billion and adjusted diluted EPS to $2.80–$3.00 per share
2026 adjusted SI&A and R&D expenses of $23–$25 billion, reflecting $5.7 billion of net savings from cost realignment by end-2026
No share repurchases assumed in 2026; Q1 2026 dividend maintained at $0.43 per share; new hospital and biosimilars organization established for productivity gains

Dec 16, 2025, 1:00 PM

Transcript

Pfizer provides 2026 guidance and cost savings update

PFE

Guidance Update

New Projects/Investments

Updated 2025 guidance: total revenues of approximately $62 billion, COVID product revenues of $6.5 billion, and reaffirmed adjusted diluted EPS of $3.00–$3.15.
2026 outlook: total revenues of $59.5–$62.5 billion (COVID $5 billion); adjusted diluted EPS of $2.80–$3.00; non-COVID/LOE portfolio operational growth ~4%; adjusted SI&A $12.5–$13.5 billion, R&D $10.5–$11.5 billion; effective tax rate ~15%.
Cost realignment program on track to deliver $5.7 billion of net savings by end-2026, a year ahead of plan, including Phase I manufacturing optimization gains.
Capital allocation: declared Q1 2026 dividend at $0.43 per share; no share repurchases planned; year-end leverage ~2.7× and business development capacity of $6 billion.
Strategic investments: FDA approval of PADCEV combo adds ~7,500 U.S. bladder cancer patients; advancing PF-4404 bispecific into Phase III; bolstering obesity pipeline via Metsera; targeting 2029–2030 for return to growth.

Dec 16, 2025, 1:00 PM

Transcript

Pfizer provides full-year 2026 financial guidance

PFE

Guidance Update

Dividends

Share Buyback

2026 revenue guidance of $59.5–$62.5 B (midpoint $61.0 B), implying ~4% operational growth ex-COVID and LOE; COVID-19 product sales ~ $5.0 B; LOE impact ~ $(1.5 B)
Adjusted diluted EPS expected at $2.80–$3.00 (midpoint $2.90), down from the 2025 midpoint of $3.08, driven by LOE headwinds and lower COVID volumes
Adjusted SI&A expenses of $12.5–$13.5 B, Adjusted R&D expenses of $10.5–$11.5 B, and an effective tax rate of approximately 15%
No share repurchases planned in 2026; dividend maintained at $0.43/share, reflecting a balanced capital allocation approach

Dec 16, 2025, 1:00 PM

Presentation

Pfizer provides full-year 2026 guidance and revises 2025 revenue outlook

PFE

Guidance Update

Pfizer revised its full-year 2025 revenue guidance to approximately $62.0 billion, while reaffirming its adjusted diluted EPS guidance of $3.00–3.15 (FY 2025).
The company set full-year 2026 revenue guidance at $59.5–62.5 billion, reflecting a $1.5 billion decline in COVID-19 product sales and $1.5 billion from loss of exclusivity, and expects ~4% operational growth ex-COVID/LOE at the midpoint.
Pfizer forecasted 2026 adjusted diluted EPS of $2.80–3.00, driven by stable margins and a higher expected tax rate.
For 2026, adjusted SI&A expenses are guided to $12.5–13.5 billion and adjusted R&D expenses to $10.5–11.5 billion, supporting ongoing pipeline investment.

Dec 16, 2025, 12:01 PM

8-K

Pfizer reaffirms 2025 EPS outlook and issues 2026 guidance

PFE

Guidance Update

Pfizer reaffirms its full-year 2025 adjusted diluted EPS guidance and revises revenue guidance to approximately $62.0 billion, from a prior range of $61.0–64.0 billion.
Issues full-year 2026 guidance of $59.5–62.5 billion in revenues and $2.80–3.00 in adjusted diluted EPS.
Anticipates a combined ~~$3.0 billion headwind in 2026 revenues—~~$1.5 billion lower COVID-19 product sales and ~1.5 billion from loss-of-exclusivity products—and expects ~4% operational growth excluding these factors.
Guides 2026 adjusted selling, informational & administrative expenses to $12.5–13.5 billion and R&D expenses to $10.5–11.5 billion, totaling $23.0–25.0 billion.
Plans continued investment in its pipeline and recently acquired assets to fuel long-term growth.

Dec 16, 2025, 11:45 AM

Press Release

Pfizer announces TUKYSA first-line maintenance therapy PFS extension

PFE

Phase 3 HER2CLIMB-05 data show TUKYSA plus trastuzumab and pertuzumab reduced risk of progression or death by 35.9% (HR 0.641; 95% CI: 0.514-0.799; p<0.0001) and extended median progression-free survival by 8.6 months (24.9 vs. 16.3 months) in HER2+ metastatic breast cancer.
The TUKYSA combination demonstrated a manageable safety profile consistent with known therapies; most common adverse events were diarrhea, hepatic events, and nausea, with higher rates of asymptomatic Grade ≥3 liver transaminase elevations that were typically reversible.
Pfizer plans to discuss these results with regulatory authorities to potentially expand TUKYSA into a chemotherapy-free, first-line maintenance setting for HER2+ metastatic breast cancer.

Dec 10, 2025, 1:15 PM

Press Release

Pfizer enters exclusive collaboration with YaoPharma

PFE

New Projects/Investments

Pfizer signed an exclusive global collaboration and license agreement with YaoPharma for YP05002, a small-molecule GLP-1 receptor agonist in Phase 1 development for chronic weight management.
Under the deal, YaoPharma will complete the Phase 1 trial, grant Pfizer worldwide rights, receive an upfront payment of $150 million, and is eligible for up to $1.935 billion in milestone payments plus tiered royalties.
Pfizer plans combination studies of YP05002 with its GIPR antagonist PF-07976016 (in Phase 2) and other small molecules in its pipeline.
Cardiometabolic research, including obesity treatments, is a strategic priority and potential key growth driver for Pfizer.

Dec 9, 2025, 11:30 AM

Press Release

Pfizer signs global licensing deal for Fosun's weight-loss drug

PFE

New Projects/Investments

Pfizer entered an exclusive global collaboration and licensing agreement with YaoPharma for YP05002, a GLP-1 receptor agonist in Phase 1 trials for chronic weight management.
The deal includes a $150 million upfront payment and up to $1.935 billion in milestone payments, plus royalties on future sales.
Pfizer will evaluate YP05002 in combination with its glucose-dependent insulinotropic polypeptide receptor antagonist PF-07976016 (currently Phase 2) and other pipeline molecules.
YaoPharma will complete the ongoing Phase 1 trial, after which Pfizer gains exclusive global rights to develop, manufacture, and commercialize the drug.
The agreement bolsters Pfizer’s obesity treatment portfolio alongside top-selling products like Prevnar 13, Ibrance, and Eliquis.

Dec 9, 2025, 11:13 AM

Bloomberg

Earnings Transcripts

Quarterly earnings call transcripts for PFIZER.

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PFIZER (PFE)

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Aamir Malik

Andrew Baum

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James C. Smith

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Trung Huynh

Vamil Divan

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Geoffrey Meacham

Alex Hammond

Carter L. Gould

Chris Shibutani

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Srikripa Devarakonda

Tim Anderson

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