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    AMRX
    Earnings call· Dec 2025(Q4 FY25)

    Amneal Pharmaceuticals Q4 FY25 earnings call AMRX

    Feb 27, 2026 Source

    Executive summary

    Amneal Pharmaceuticals Q4 FY25 — Strong Growth and Strategic Portfolio Expansion

    Amneal Pharmaceuticals delivered a strong Q4 and full year 2025, marked by robust financial growth and significant progress in portfolio expansion across complex generics, injectables, and specialty products. The company is strategically focused on vertical integration in biosimilars and advancing its GLP-1 collaboration with Pfizer, while managing near-term headwinds in its Specialty and Health Care segments to position for sustained long-term growth.

    Highlights

    5

    • Full year 2025 revenue grew 8% to $3 billion, adjusted EBITDA increased 10% to $688 million, and adjusted EPS rose 43% to $0.83.

    • Fourth quarter revenues grew 11% to a record $814 million, with adjusted EBITDA up 13% to $175 million and adjusted EPS up 75% to $0.21.

    • Net leverage reduced to 3.5x at the end of 2025, down from 3.9x in 2024, and weighted average cost of debt decreased from 10% in 2024 to approximately 6.8% in 2026.

    • CREXONT uptake reached 23,000 patients, achieving over 3% market share one year post-launch, with interim Phase IV data showing 3.13 hours more 'Good On' time.

    • Launched Brekiya auto-injector for severe migraine/cluster headache and two innovation products (beclomethasone dipropionate and albuterol sulfate) entering the inhalation market.

    Concerns

    2

    • Specialty segment revenues are expected to be flat in 2026 due to the anticipated generic erosion of RYTARY, offsetting growth from CREXONT and other brands.

    • Health Care segment revenues are projected to decline in 2026 to $625 million-$700 million from $745 million in 2025, primarily due to a strategic pivot away from lower-profit distribution business and increased competition for generic Entresto.

    Guidance & targets

    20
    CategoryTargetConfidence
    Total Company Revenue
    $3.05 billion to $3.15 billion
    high materiality
    High
    Total Company Revenue Growth
    1% to 4%
    high materiality
    High
    Adjusted EBITDA
    $720 million and $760 million
    high materiality
    High
    Adjusted EBITDA Growth
    5% to 10%
    high materiality
    High
    Adjusted EPS
    $0.93 and $1.03
    high materiality
    High
    Adjusted EPS Growth
    12% to 24%
    high materiality
    High
    Affordable Medicines Revenue Growth
    7% and 8%
    medium materiality
    High
    Specialty Segment Revenue
    about flat to 2025
    medium materiality
    Medium
    Health Care Revenue
    $625 million to $700 million
    medium materiality
    High
    Adjusted Gross Margins
    over 44%
    medium materiality
    High
    Operating Cash Flow
    $325 million to $375 million
    medium materiality
    High
    Capital Expenditure
    approximately $110 million
    medium materiality
    High
    Biosimilars in U.S. Market
    6 biosimilars
    high materiality
    High
    CREXONT Peak U.S. Sales
    $300 million to $500 million
    high materiality
    High
    Brekiya Peak Sales
    $50 million to $100 million
    medium materiality
    High
    Affordable Medicine New Product Launches
    20 to 30 new products
    medium materiality
    High
    Complex Program Filings
    10 to 15 key complex programs
    medium materiality
    High
    Biosimilar Xolair Market Entry
    among the first biosimilars
    high materiality
    High
    Specialty Business Growth Trajectory
    resume its strong growth trajectory
    medium materiality
    Medium
    Health Care Top and Bottom Line Growth
    resume top line and bottom line growth
    medium materiality
    Medium

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    Affordable Medicines
    Q4 revenue was flat, reflecting timing of key products and new launches. Full year 2025 growth was 4%, with an acceleration to 7-8% expected in 2026 due to robust new product launches, particularly complex generics and injectables.
    FY25 Revenue Growth: 4%2026 Revenue Growth Expectation: 7-8%ANDA pending: 59 (64% complex)Products in development: 52 (94% complex)
    		$437 millionflat——
    Specialty
    Q4 revenue was very strong, up 38% year-over-year, driven by demand for CREXONT, RYTARY, UNITHROID, and initial sales of Brekiya. Full year 2025 growth was 19%. 2026 revenues are expected to be flat due to RYTARY generic erosion offsetting CREXONT and other brand growth, with strong growth resuming in 2027 and beyond.
    FY25 Revenue Growth: 19%2026 Revenue Expectation: about flat to 2025CREXONT patients on therapy (end of 2025): 23,000CREXONT market share (one year post launch): >3%RYTARY patients (10 years post launch): 42,000RYTARY market share (10 years post launch): 6%
    		$167 million38%——
    Health Care
    Q4 revenue grew 24% driven by strong government channel growth. Full year 2025 revenue grew 12% to $745 million, with adjusted gross margin expanding over 400 basis points due to a focus on profitability. 2026 revenues are expected to decline due to a pivot away from low-profit distribution and increased competition for generic Entresto, but profitability is expected to remain flat.
    FY25 Revenue: $745 millionFY25 Revenue Growth: 12%FY25 Adjusted Gross Margin increase: >400 bpsFY25 Gross Margin: $147 million (vs $100 million in 2024)FY25 Operating Income: $94 million (vs $57 million in 2024)2026 Revenue Expectation: $625 million to $700 million2026 Profitability: flat year-over-yearRevenue mix: 40% government channel, 60% distribution channel
    		$211 million24%——

    Operational metrics

    9
    Adjusted Gross Margin
    approximately 43%expanded by 50 bps
    Full Year 2025

    Expanded by 50 basis points year-over-year.

    Weighted Average Cost of Debt
    approximately 6.8%down from 10% in 2024
    2026

    Result of successful refinancing and repricing of term loan B.

    Interest Expense
    $217 millioncompared to $256 million in 2024
    Full Year 2025

    Expected further reduction in 2026.

    Net Leverage
    3.5xreduced from 3.9x at end of 2024
    end of 2025

    Reduced from 7.4x in 2019.

    GLP-1 Manufacturing Facilities
    —
    Ongoing

    Two new facilities are being built and remain on target to support GLP-1 production for Pfizer.

    CREXONT 'Good On' Time Improvement
    >3 hoursmore
    per day

    Patients converted from immediate release (IR) to CREXONT showed over 3 hours more 'Good On' time per day.

    CREXONT Gross-to-Net
    40% to 45%
    Current

    Typical for the category.

    Biosimilar Xolair Private Label Share
    65% to 70%
    Expected

    Expected share of the market to go through private label, leading to immediate market share bump.

    Generic Entresto Revenue Contribution
    $100 million
    Full Year 2025

    Revenue associated with one significant new product line (generic Entresto) for which Amneal was the only one in the market in 2025.

    Industry KPIs

    7
    MetricValueDetails
    Peak sales guidanceCREXONT: $300M-$500M; Brekiya: $50M-$100MUSD
    EPS revenue guidanceRevenue: $3.05B-$3.15B; Adj. EPS: $0.93-$1.03USD
    Pipeline clinical milestones59 ANDA pending; 52 products in developmentcount
    Regulatory approvals filings4th and 5th denosumab biosimilars approved; Biosimilar Xolair in review
    Therapeutic drug market share>3%%
    Clinical trial efficacy safety data3.13 hourshours
    Business development capacity deal appetiteVertical integration in biosimilars; building specialty pipeline

    Product announcements

    6
    ProductTypeDetails
    Brekiya auto-injectorlaunch
    Beclomethasone dipropionate and albuterol sulfatelaunch
    Risperidone extended-releaselaunch
    Sodium oxybate, Bimatoprost, Cyclosporinlaunch
    Iohexol (first generic for Omnipaque)launch
    Epinephrine productslaunch

    Deals & partnerships

    1
    PfizerCollaboration on GLP-1s, including manufacturing support and marketing rights.

    Amneal is assisting Pfizer in the GLP-1 market, with manufacturing build-out of two new facilities (large-scale peptide production and advanced sterile fill-finish) progressing. Amneal retains marketing rights for 18 countries, including India and Southeast Asia.

    Risks & headwinds

    4
    RYTARY generic erosionFull Year 2026

    Expected to offset CREXONT growth, leading to flat Specialty segment revenue in 2026.

    Mitigation: Growth of CREXONT and other branded products expected to overcome this in 2027 and beyond.

    Health Care revenue declineFull Year 2026

    Revenue expected to be $625 million to $700 million in 2026, down from $745 million in 2025.

    Mitigation: Strategic pivot away from low-profit distribution business; focus on more profitable segments and operating expense management to maintain flat profitability year-over-year. Expects to resume top and bottom line growth in 2027 and beyond.

    Increased competition for generic EntrestoFull Year 2026

    Impacted government business revenue in 2026, following $100 million contribution in 2025 when Amneal was the sole provider.

    Mitigation: Focus on other profitable parts of the Health Care business and operating expense management.

    Iohexol (Omnipaque) supply chain complexity2026 and beyond

    Requires ramp-up over time.

    Mitigation: Strengthening supply chain and increasing capacity; additional strengths expected to be approved by end of 2026.

    What to watch in Q1 FY26

    5

    CREXONT Market Share

    next quarter / Full Year 2026
    Current>3%
    Targetabove 6%

    Why it matters

    CREXONT is a key growth driver in the Specialty segment, and its market penetration is critical for offsetting RYTARY erosion and achieving peak sales targets.

    Market share, we would double it in '26, more than double the revenue. And as we march towards the first goal is to reach 100,000 patients and second goalpost would be to reach 200,000 patients, reminding you, total is 700,000 patients on CD-LD treatment.

    Q&A highlights

    7

    Can you elaborate on the market response to CREXONT's Phase IV data and provide insights into revenue or market share targets for 2026?

    Management highlighted positive market reception to the interim Phase IV data showing 3.13 hours of 'Good On' time, with 80% of IR patients converting to CREXONT. They expect to more than double CREXONT's market share in 2026, surpassing RYTARY's historical share, and will release more data in 2026 and 2027.

    “Market share, we would double it in '26, more than double the revenue. And as we march towards the first goal is to reach 100,000 patients and second goalpost would be to reach 200,000 patients, reminding you, total is 700,000 patients on CD-LD treatment.”

    asked by Chris Schott · answered by Chirag Patel

    2 min read5 chapters

    Detailed Narrative

    01

    Affordable Medicines and Complex Generics Strategy

    Amneal's Affordable Medicines segment continues to grow, driven by an expanding portfolio of complex, differentiated products. 2025 was a strong year for approvals and launches, particularly in complex generics and injectables, which are expected to accelerate revenue growth in 2026 and 2027. The company has 59 ANDAs pending, with 64% classified as complex, and 52 more products in development, 94% of which are complex. Amneal plans to file 10 to 15 key complex programs in 2026, including injectables and inhalation products.

    02

    Biosimilars as a Long-Term Growth Engine

    Amneal is building a long-term growth engine in biosimilars, having received approval for its fourth and fifth denosumab biosimilars in December 2025. With biosimilar Xolair under review, the company remains on track to have six biosimilars in the U.S. market by 2027. The strategic goal is vertical integration across development, manufacturing, and commercialization, which is deemed essential for long-term success in this market, given the significant wave of biologic loss of exclusivity expected over the next decade.

    03

    Specialty Portfolio Expansion and Performance

    The Specialty segment saw strong uptake of CREXONT, reaching 23,000 patients and over 3% market share one year post-launch, with peak U.S. sales projected at $300 million to $500 million. Interim Phase IV data reinforced CREXONT's efficacy, showing 3.13 hours more 'Good On' time. The company also launched Brekiya, an auto-injector for severe migraine and cluster headache, with expected peak sales of $50 million to $100 million. Amneal plans to expand its specialty portfolio in CNS and other areas, focusing on differentiated delivery and real-world performance.

    04

    GLP-1 Collaboration and Manufacturing Capabilities

    Amneal's collaboration with Pfizer on GLP-1s is progressing well, with both teams actively working together. The company's manufacturing build-out of two new GLP-1 facilities—one for large-scale peptide production and another for advanced sterile fill-finish—remains on target. These facilities are designed to support all dosage forms, positioning Amneal to play a meaningful long-term role in the GLP-1 market, while retaining marketing rights for 18 countries, including India and Southeast Asia.

    05

    Operational Excellence and Balance Sheet Strength

    Amneal continues to enhance operational efficiency through digitization, automation, and AI across its global manufacturing network. The company has significantly strengthened its balance sheet, reducing net leverage from 7.4x in 2019 to 3.5x at the end of 2025. Successful debt refinancing and repricing of its term loan B have lowered the weighted average cost of debt from 10% in 2024 to approximately 6.8% in 2026, extending maturities to 2032 and reducing interest expense.

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