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    PFE
    Earnings call· Dec 2024(Q4 FY24)

    PFIZER INC PFE

    Feb 4, 2025 Source

    Executive summary

    Pfizer Q4 FY24 — Strong Execution and Pipeline Progress

    Pfizer concluded a strong FY24, exceeding financial commitments and advancing strategic priorities, including the Seagen integration and commercial effectiveness improvements. The company is now shifting its emphasis to R&D productivity while maintaining focus on margin expansion and shareholder-friendly capital allocation. Management reaffirmed its FY25 guidance and outlined a clear path to deleveraging and balanced capital deployment, despite anticipated headwinds from the IRA.

    Highlights

    5
    • FY24 operational revenue growth (ex-COVID) was 12%, exceeding expectations of 9-11%.

    • FY24 adjusted diluted EPS reached $3.11, significantly ahead of expectations.

    • Achieved at least $4 billion in net cost savings from cost realignment program in FY24.

    • ELREXFIO generated over $130 million in full year revenue in its first year, with strong momentum.

    • ABRYSVO achieved market leadership in shipped doses at 50% and nearly tripled maternal vaccination rates season-to-date.

    Concerns

    3
    • IRA Medicare Part D redesign is expected to be a net headwind of approximately $1 billion to FY25 revenue, dampening growth by 1.6%.

    • Q4 adjusted gross margin was 68%, primarily due to an unfavorable mix related to COVID-19 products.

    • The total adult RSV market volume decreased, driven by a reduction in vaccination rates in the U.S. for the older adult indication.

    Guidance & targets

    10
    CategoryTargetConfidence
    Full-year 2025 Revenues
    $61 billion to $64 billion
    high materiality
    High
    Full-year 2025 Adjusted Diluted EPS
    $2.80 to $3.00 per share
    high materiality
    High
    Net Cost Savings from Cost Realignment Programs
    $4.5 billion
    medium materiality
    High
    Manufacturing Optimization Program Savings (Phase 1)
    approximately $1.5 billion
    medium materiality
    High
    Gross Leverage Target
    3.25x
    high materiality
    High
    Haleon Investment Monetization
    remaining investment monetized
    medium materiality
    High
    R&D Regulatory Decisions
    at least 4
    medium materiality
    High
    R&D Phase III Readouts
    up to 9 potential
    medium materiality
    High
    R&D Pivotal Program Starts
    13 potential
    medium materiality
    High
    Business Development Capacity
    $10 billion to $15 billion
    high materiality
    Medium

    Segment performance

    6
    SegmentRevenueYoYQoQMargin
    Oncology Portfolio
    Oncology is a key commercial focus. PADCEV plus pembrolizumab is the #1 prescribed first-line treatment for locally advanced metastatic urothelial cancer in the U.S. BRAFTOVI/MEKTOVI expanded leadership in BRAF tumors. LORBRENA saw double-digit share increase in first-line NSCLC after CROWN trial data. ELREXFIO showed strong performance and increasing share in BCMA-directed bispecifics.
    BRAFTOVI/MEKTOVI worldwide operational growth: 27% YoYLORBRENA worldwide operational growth: 37% YoYELREXFIO full year revenue: >$130 million
    COVID-19 Portfolio
    COVID-19 portfolio continues to be a predictable and durable contributor, with utilization correlating to disease burden. Multi-year contracts secured in international markets provide stability. Commercial execution for both PAXLOVID and COMIRNATY has been strong.
    PAXLOVID physician treatment rates: higher in 2024 vs 2023PAXLOVID market share: gains vs 2023COMIRNATY market share: improvement in 2024
    Rare Disease (VYNDAQEL family)
    VYNDAQEL family achieved significant momentum, driven by progress in diagnosing more patients and improving access for transthyretin amyloid cardiomyopathy. Strong growth in both U.S. and international markets.
    VYNDAQEL international operational growth: 32%
    90% YoY (U.S.)
    Cardiovascular (Eliquis)
    Eliquis continues to strengthen its leadership position in the growing oral anticoagulant market, prescribed to millions of patients.
    10% worldwide operational growth
    Migraine (NURTEC)
    NURTEC shows ongoing positive momentum driven by strong commercial execution, maintaining leadership in the oral CGRP class for treating and preventing migraine.
    NURTEC market share (oral CGRP class): ~49%
    36% worldwide operational growth
    Respiratory Vaccines (ABRYSVO & PREVNAR 20)
    ABRYSVO achieved market leadership despite a decrease in the total adult RSV market volume. Strong demand for maternal indication. PREVNAR maintains strong leadership in the U.S. and is making progress internationally, with PCV-25 candidate showing potential for improved immunogenicity.
    ABRYSVO market share (shipped doses): 50% (season-to-date)ABRYSVO market share (shots in arms): 18 percentage points increase vs last yearABRYSVO maternal vaccination rate: nearly tripled vs last seasonPREVNAR market share (U.S. across indications): >87%PREVNAR pediatric market share (U.S.): 12 percentage point improvement (Aug '23 to Dec '24)PREVNAR 20 Japan market share (first dose): 3% (Sept) to 86% (Dec)

    Operational metrics

    33
    Operational Revenue Growth (ex-COVID)
    12%vs 9-11% expectation
    FY24

    Exceeded expectations.

    Adjusted Gross Margin
    74%
    FY24

    Expanded due to cost improvements.

    Adjusted Diluted EPS
    $3.11vs $1.84 LY
    FY24

    Significantly ahead of expectations.

    Non-COVID-19 Products Revenue
    $13.7 billion11% operational YoY growth
    Q4 FY24

    Exhibited robust performance.

    Adjusted Gross Margin
    68%
    Q4 FY24

    Partially offset by cost management.

    Adjusted Operating Expenses
    $7.3 billionflat operationally
    Q4 FY24

    Reflects disciplined expense management.

    Adjusted SI&A Expenses
    decreased 4%operationally
    Q4 FY24

    Part of cost realignment program.

    Adjusted R&D Expenses
    increased 8%operationally
    Q4 FY24

    Reflects focus on high-impact medicines.

    Diluted EPS
    $1.41vs $0.37 LY
    FY24

    Reported GAAP diluted EPS.

    Diluted EPS
    $0.07
    Q4 FY24

    Reported GAAP diluted EPS.

    Adjusted Diluted EPS
    $0.63
    Q4 FY24

    Benefiting from top-line performance and efficient operating structure.

    Intangible Asset Impairments
    $2.9 billion
    Q4 FY24

    Reflects strategic decisions in development plans and updated long-range revenue forecasts.

    Capital Returned to Shareholders (Dividends)
    $9.5 billion
    FY24

    Part of capital allocation strategy.

    Internal R&D Investment
    $10.8 billion
    FY24

    Part of capital allocation strategy.

    Deleveraging
    $7.8 billion
    FY24

    In support of gross leverage target of 3.25x by end of 2025.

    Haleon Net Cash Proceeds
    $3 billion
    Q1 FY25

    Monetization of a tranche of Haleon shares.

    IRA Medicare Part D Redesign Revenue Headwind
    $1 billion1.6% dampening growth
    FY25

    Expected impact on company's revenue.

    IQVIA U.S. Field Force Ranking
    70%
    2024

    Reflects improved commercial capabilities.

    ABRYSVO Market Share (shipped doses)
    50%
    season-to-date

    Achieved market leadership.

    ABRYSVO Market Share (shots in arms)
    18 percentage pointsincrease
    vs last year

    Reflects strong commercial execution.

    ABRYSVO Maternal Vaccination Rate
    nearly tripledvs last season
    season-to-date

    Strong demand for maternal indication.

    PREVNAR Market Share
    >87%
    current

    Well positioned for strong sustained leadership.

    PREVNAR Pediatric Market Revenue Contribution
    2/3
    current

    Globally, pediatric market accounts for significant portion of PREVNAR revenues.

    ABRYSVO Vaccination Rate (France)
    >40%
    Q4

    Administered in a competitive setting.

    ABRYSVO Vaccination Rate (UK)
    44%
    current

    Reached through vaccination campaign.

    Emerging Markets New Babies Cohort
    76 million
    annually

    Represents significant opportunity for pneumococcal vaccine.

    ELREXFIO Revenue
    >$130 million
    FY24

    Strong performance in its first year, in a niche indication.

    PAXLOVID Physician Treatment Rates
    highervs 2023
    2024

    Reflects effective commercial model.

    PAXLOVID Market Share
    gainsvs 2023
    2024

    Reflects effective commercial model.

    R&D Success Rates
    17%vs 10-11% industry
    current

    Higher than industry average.

    Time to Market (R&D)
    5.6 yearsvs 7-8 years industry
    current

    Faster than industry average.

    Muscle Invasive Bladder Cancer Population
    28,000
    current

    Addressable population for PADCEV, could more than double current eligible population.

    PREVNAR Pediatric Market Share
    12 percentage pointimprovement
    August '23 to December '24

    Significant improvement in market share.

    Industry KPIs

    8
    MetricValueDetails
    EPS revenue guidance$61 billion to $64 billionUSD
    Pricing policy impact$1 billionUSD
    Pipeline clinical milestones13programs
    Regulatory approvals filings4decisions
    Therapeutic drug market share49%%
    Geographic regional revenue growth90%%
    Clinical trial efficacy safety data60%%
    Business development capacity deal appetite$10 billion to $15 billionUSD

    Deals & partnerships

    3
    SeagenAcquisition of oncology company

    Successfully integrated, creating one of the best oncology companies in the industry.

    HaleonMonetization of equity investment$3 billion

    Monetized a tranche of Haleon shares in January 2025 (Q1 FY25 event), reducing ownership from approximately 15% to approximately 7%. Remaining investment intended to be monetized in 2025.

    ArvinasCodevelopment of ER degrader

    Codeveloping vepdegestrant, an ER degrader, with Arvinas. Planning a first-line study combining vepdegestrant with atirmociclib.

    Risks & headwinds

    5
    IRA Medicare Part D RedesignFY25

    $1 billion revenue headwind, 1.6% dampening growth

    Mitigation: Focus on operational excellence and cost management. Expect higher gross-to-net impact early in the year, moderating later. Expect positive impact of lower patient out-of-pocket costs to build throughout the year.

    RSV Market Volume Decrease2024

    Decrease in total adult RSV market volume

    Mitigation: Strong commercial execution to retain market position. Midterm growth catalysts include policy updates for year-round vaccination, age expansion (18-59 at-risk), and revaccination recommendations.

    Competitive Pressure in Adult Pneumococcal Market2025

    Competitive pressure from Vaxneuvance

    Mitigation: Confident in maintaining meaningful market share due to commercial execution and preference for single vaccine stocking in non-retail accounts. Growth opportunity in 50-64 age group.

    New Competitors for VYNDAQELNear-term

    Impact on switching patients and new patient starts

    Mitigation: Confident in VYNDAQEL's robust clinical profile, long-term real-world data, strong access, and position as standard of care. Increased diagnosis education and growth in prescriber base.

    RFK Jr. as HHS SecretaryNear-term

    Potential turbulence in the market

    Mitigation: Engaged with Mr. Kennedy to find common ground on chronic diseases and cancer. Believe vaccine liability protections are through Congress. Any attempts to reduce vaccination would face opposition from medical/scientific community and administration.

    What to watch in Q1 FY25

    5

    Danuglipron Dose Optimization Data

    Q1 2025
    CurrentPhase II study ongoing
    TargetData readout and future development decisions

    Why it matters

    This data will determine the future of Pfizer's oral GLP-1 program, a key area in the competitive obesity market.

    we're now targeting first quarter to have data from the ongoing dose optimization and formulation study, the PK study, and we're on track to deliver that in Q1. And we haven't seen the data yet, but obviously, that data will then determine decisions for the future of danuglipron.

    Q&A highlights

    8

    What are the possible outcomes for danuglipron dose optimization data in Q1, including dropping it? What needs to be fixed in Pfizer's R&D portfolio, and is shedding projects a possibility?

    Danuglipron data will determine future decisions; the company has already focused its portfolio into 4 end-to-end therapeutic areas and will prioritize opportunities for biggest value. New R&D leadership is rapidly implementing changes.

    We haven't seen the data yet, but obviously, that data will then determine decisions for the future of danuglipron. ... you will see, during the coming months, how we further focus and execute and accelerate those medicines, we believe, could be potential future blockbusters.

    asked by Steve Scala · answered by Chris Boshoff

    2 min read6 chapters

    Detailed Narrative

    01

    Strategic Transformation and Commercial Excellence

    Pfizer executed significant transformative changes in 2024, including the successful integration of Seagen, establishing one of the industry's leading oncology companies. Commercial operations were split into U.S. and International divisions, leading to enhanced commercial capabilities, precision micro-targeting, and leveraging AI for marketing. These efforts resulted in Pfizer earning the top position in the 2024 IQVIA U.S. Field Force Ranking report and achieving #1 or #2 spots in 70% of specialties.

    02

    R&D Reorganization and Pipeline Focus

    The R&D engine underwent significant changes under new leadership, creating four end-to-end R&D units focused on oncology, vaccines, internal medicine, and inflammation & immunology. This structure aims to empower research units with biotech-like agility while utilizing enterprise-wide capabilities like AI-powered drug discovery. The company expects a strong year of catalysts in 2025, including at least 4 regulatory decisions, up to 9 potential Phase III readouts, and 13 potential pivotal program starts, with a focus on high-impact medicines.

    03

    Financial Discipline and Capital Allocation

    Pfizer demonstrated strong financial discipline in 2024, expanding margins through cost realignment programs that delivered at least $4 billion in net savings. Capital was strategically deployed, with nearly $11 billion invested in internal R&D and $9.5 billion returned to shareholders through dividends. The company deleveraged by approximately $7.8 billion and aims to reach a gross leverage target of 3.25x by the end of 2025, enabling a more balanced capital allocation strategy going forward.

    04

    COVID-19 Portfolio Stability and Predictability

    The COVID-19 portfolio, including PAXLOVID and COMIRNATY, showed stabilizing patterns in 2024, with utilization correlating directly to disease burden. Management expressed confidence in the portfolio's predictable and durable contribution to the business, citing multi-year international contracts and effective commercial models. PAXLOVID saw higher physician treatment rates and market share gains in 2024, while COMIRNATY improved its market share position.

    05

    IRA Medicare Part D Redesign Impact

    The IRA Medicare Part D redesign is expected to create a net headwind of approximately $1 billion to the company's FY25 revenue, dampening growth by 1.6%. The impact of catastrophic coverage is anticipated to exceed potential volume benefits from reduced patient out-of-pocket caps, leading to a higher gross-to-net impact on revenues early in 2025, particularly affecting higher-priced medicines like VYNDAQEL, IBRANCE, XTANDI, and Xeljanz.

    06

    Breast Cancer Franchise Strategy

    Pfizer is pursuing a multi-pronged strategy in breast cancer, leveraging its next-generation CDK4 inhibitor, atirmociclib, and the ER degrader vepdegestrant. Atirmociclib has started a Phase III study in first-line metastatic breast cancer, with plans for an additional study combining it with vepdegestrant. The company also highlighted KAT6, a first-in-category epigenetic molecule, with an ongoing Phase III trial in second-line-plus ER-positive breast cancer, aiming to establish leadership across various treatment lines.

    AI-generated summary of the company’s earnings call. Not investment advice.