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    LLY
    Earnings call· Sep 2025(Q3 FY25)

    ELI LILLY & Co LLY

    Oct 30, 2025 Source

    Executive summary

    Eli Lilly Q3 FY25 — Strong Growth Across Key Products and Raised Guidance

    Eli Lilly delivered a robust Q3 FY25, driven by exceptional growth in key products like Mounjaro and Zepbound, leading to a significant revenue and EPS guidance raise. The company continues to advance its pipeline with multiple positive Phase III readouts for orforglipron and other assets, alongside strategic manufacturing expansions to support future launches. Management is focused on expanding market access and addressing unmet medical needs globally, leveraging both traditional and direct-to-consumer channels.

    Highlights

    5

    • Revenue grew 54% compared to Q3 2024, driven by key products.

    • Revenue from key products reached $12 billion in Q3 FY25, more than doubling YoY.

    • Non-GAAP EPS increased to $7.02 in Q3 FY25, up from $1.18 in Q3 FY24.

    • Lilly gained market share in the U.S. incretin analogs market for the fifth consecutive quarter, accounting for nearly 6 out of 10 prescriptions.

    • Full-year 2025 revenue guidance was raised by over $2 billion at the midpoint, now expected to be between $63 billion and $63.5 billion.

    Concerns

    2

    • U.S. price declined by 15% YoY, partially due to a favorable one-time adjustment in Q3 FY24; excluding this, U.S. price declined by high single digits.

    • The CVS formulary change was disruptive to patients and physicians, leading to a modest impact on Zepbound performance and a decline of approximately 2 percentage points in its share of the total U.S. branded anti-obesity market compared to Q2 FY25.

    Guidance & targets

    11
    CategoryTargetConfidence
    Full-year 2025 Revenue
    $63 billion - $63.5 billion
    high materiality
    High
    Full-year 2025 Non-GAAP Performance Margin
    45% - 46% of revenue
    medium materiality
    High
    Full-year 2025 Non-GAAP EPS
    $23 - $23.70
    high materiality
    High
    Orforglipron U.S. Launch for Obesity
    next year
    high materiality
    High
    Orforglipron Submission for Type 2 Diabetes
    first half of 2026
    medium materiality
    High
    Retatrutide Phase III Study Results
    up to 6 studies by the end of 2026
    high materiality
    High
    Retatrutide TRIUMPH-4 Topline Results
    later this year
    high materiality
    High
    Imlunestrant EMBER-4 Full Enrollment
    by early 2026
    medium materiality
    High
    Phase III Trials for Early-Stage Oncology Portfolio
    in 2026, if not sooner
    medium materiality
    High
    TOGETHER Trials First Data Readout
    in the next 6 months
    low materiality
    High
    ATTAIN-MAINTAIN Results
    late this year or early next year
    high materiality
    High

    Segment performance

    15
    SegmentRevenueYoYQoQMargin
    U.S. Revenue
    Driven by strong volume growth of Zepbound and Mounjaro, partially offset by price decline.
    Volume growth: strong (Zepbound and Mounjaro)Price decline: 15% (negatively impacted by favorable onetime adjustment to estimates for rebates and discounts in Q3 2024)Price decline (excluding base period effect): high single digits
    		—45%——
    Europe Revenue
    Reflecting strong uptake of Mounjaro and a one-time $380 million benefit related to a milestone payment and business development.
    Mounjaro uptake: strongMilestone payment and business development benefit: $380 millionGrowth (excluding impact): 81% (constant currency)
    		—over 100% (constant currency)——
    Japan Revenue
    Driven by Mounjaro volume growth.
    Mounjaro volume growth: driving factor
    		—24% (constant currency)——
    China Revenue
    Driven by Mounjaro volume growth.
    Mounjaro volume growth: driving factor
    		—22% (constant currency)——
    Rest of the World Revenue
    Driven by Mounjaro volume growth.
    Mounjaro volume growth: driving factor
    		—51% (constant currency)——
    Key Products (overall)
    Accounted for $12 billion of revenue within the quarter, with sales more than doubling compared to the same period last year.
    		$12 billionmore than doubled——
    Ebglyss (Immunology)
    Delivered strong performance in atopic dermatitis with increased use in the first-line setting.
    U.S. total prescriptions increase: 41% (compared to Q2 2025)First-line setting use: >50% of new patients
    		————
    Omvoh (Immunology)
    Continued a steady uptake with newly published long-term data in ulcerative colitis.
    Uptake: steady4-year data in ulcerative colitis: show long-term safety and efficacy benefits
    		————
    Jaypirca (Oncology)
    Continued to build momentum both in the marketplace and with new data from Phase III trials.
    Momentum: continued to buildNew data: from Phase III trials
    		————
    Verzenio (Oncology)
    Remains the market leader in the U.S. for the node-positive, high-risk early breast cancer population.
    U.S. prescription growth: 3% (compared to Q3 2024)International volume growth: 14%
    		————
    Kisunla (Neuroscience)
    Total prescriptions grew by 50% and continued to increase share of market versus the competition. Recently received EU marketing authorization.
    Total prescription growth: 50% (compared to Q2 2025)Market share: continued to increase
    		————
    Mounjaro (Cardiometabolic Health - OUS)
    Robust performance globally with strong uptake and significant share gains. Approximately 75% of Mounjaro revenue outside the U.S. for obesity is from out-of-pocket payments.
    Launches: 55 countries and all major marketsGlobal reception: strongShare gain: significant in most major marketsObesity revenue (OUS): ~75% from out-of-pocket payments
    		————
    Zepbound (Cardiometabolic Health - U.S.)
    Strong U.S. performance despite CVS formulary changes, with significant growth and high share of new prescriptions, particularly for vials.
    U.S. prescription growth: tripled (compared to Q3 2024)Share of total U.S. branded anti-obesity market: declined ~2 percentage points (compared to Q2 2025)Performance: back to Q2 levelsShare of new prescriptions: 71% (exited Q3)Vials share of total U.S. prescriptions: ~30%Vials share of new prescriptions: >45%
    		————
    Mounjaro (Cardiometabolic Health - U.S.)
    Posted robust Q3 in the U.S. with strong prescription growth and increased market share in the type 2 diabetes incretin analog market.
    Total prescriptions growth: >60%Share of market (type 2 diabetes incretin analog): increased 4 percentage points (compared to Q2 2025)Most widely prescribed incretin for type 2 diabetes in U.S.
    		————
    Lilly Incretins (U.S. combined)
    Combined U.S. market growth was strong, with Lilly medicines capturing approximately two-thirds of new prescriptions in the incretin analog market.
    U.S. incretin analog market growth: 36% (compared to Q3 2024)Share of market: gained (compared to Q2 2025)New prescriptions: ~2 out of every 3 are Lilly medicine
    		————

    Operational metrics

    16
    Non-GAAP EPS
    $7.02$1.18 in Q3 FY24
    Q3 FY25

    Inclusive of acquired IPR&D charges.

    Gross margin
    83.6%increase of 1.4 percentage points vs Q3 FY24
    Q3 FY25

    Improvement driven by favorable product mix, partially offset by lower realized prices.

    Research and development expenses
    27% increase
    Q3 FY25

    Driven by continued investments in the portfolio.

    Marketing, selling and administrative expenses
    31% increase
    Q3 FY25

    As the company continues to increase investment to support ongoing and future launches.

    Non-GAAP performance margin
    48.3%increased by >8 percentage points from Q3 FY24
    Q3 FY25

    Defined as gross margin less R&D, marketing, selling and administrative expenses as a percentage of revenue, driven by revenue growth.

    Dividends distributed
    $1.3 billion
    Q3 FY25

    Part of capital allocation strategy.

    Share repurchases
    $700 million
    Q3 FY25

    Part of capital allocation strategy.

    Semaglutide weight loss (STEP 2, 2.4mg)
    10.6%
    historical

    Weight loss in STEP 2 clinical trial of people with obesity and type 2 diabetes at 2.4 milligrams dose.

    Semaglutide weight loss (STEP 2, 1mg)
    7.6%
    historical

    Weight loss in STEP 2 clinical trial of people with obesity and type 2 diabetes at 1 milligram dose.

    US Incretin users
    8.5 millionout of 170 million who might benefit
    current

    Estimated number of people on incretins in the United States.

    US Incretin addressable market
    170 million
    current

    Estimated number of people in the United States who might benefit from incretins.

    Zepbound vials share (total prescriptions)
    30%
    Q3 FY25

    Vials comprise approximately 30% of total U.S. Zepbound prescriptions.

    Zepbound vials share (new prescriptions)
    45%
    Q3 FY25

    Vials comprise over 45% of new U.S. Zepbound prescriptions.

    LillyDirect price (starting)
    $349
    past 6 months

    Starting price point for LillyDirect.

    LillyDirect price (current)
    $499
    past 6 months

    Current price point for LillyDirect, maintained over the last 6 months.

    Mounjaro OUS obesity revenue
    75%
    Q3 FY25

    Approximately 75% of Mounjaro revenue outside the U.S. is coming from people with obesity, paying out of pocket.

    Industry KPIs

    10
    MetricValueDetails
    Prescription volume41% increase%
    EPS revenue guidance$63 billion - $63.5 billionUSD
    Pricing policy impactgood move
    Pipeline clinical milestones16programs
    Regulatory approvals filingsU.S. FDA approval
    Therapeutic drug market sharenearly 6 out of 10 prescriptionsprescriptions
    Price volume mix decomposition15% decline%
    Glp 1 incretin franchise metrics10.5% weight loss%
    Geographic regional revenue growth45%%
    Clinical trial efficacy safety data10.5% weight loss%

    Risks & headwinds

    4
    U.S. Price DeclineQ3 FY25

    15% YoY (reported), high single digits (ex-base period effect)

    Mitigation: Favorable product mix partially offset; company applauds moves towards transparency in pricing.

    CVS Formulary Change Impact on ZepboundQ3 FY25

    Share of total U.S. branded anti-obesity market declined ~2 percentage points compared to Q2 FY25

    Mitigation: Impact was modest; performance is back to Q2 levels; Zepbound exited Q3 with 71% share of new prescriptions.

    Limited International Obesity ReimbursementOngoing

    Limited

    Mitigation: Encouraged by strong uptake; approximately 75% of Mounjaro revenue outside the U.S. for obesity is from out-of-pocket payments.

    Consumer Pricing Elasticity (OUS)Q3 FY25

    Exists (observed with Mounjaro price increase in UK)

    Mitigation: Orforglipron will meet a slightly different market need; opportunity to scale and reach other patient populations.

    What to watch in Q4 FY25

    5

    Orforglipron Global Submissions

    Later this year
    CurrentEnabled by positive Phase III results
    TargetSubmissions initiated for obesity

    Why it matters

    Marks the formal start of the regulatory process for a key growth driver in the obesity market.

    These submissions are beginning imminently, and we anticipate launching orforglipron in the U.S. for treatment of obesity next year.

    Q&A highlights

    7

    Comment on orforglipron's path to market, specifically regarding the National Priority Review Voucher program, and timelines for launch and 2026 expectations.

    Dave Ricks stated Lilly is pursuing an "all of the above strategy" to get orforglipron to patients quickly, including potentially leveraging the new voucher program, as the drug checks multiple boxes. He emphasized their readiness to launch following imminent global submissions.

    “I think investors can expect us to be pursuing in all of the above strategy to get the medicine out more quickly. Also, I'd point out that if you look at this new voucher program, I think orforglipron checks at least 3 or 4 of the boxes laid out.”

    asked by Terence Flynn · answered by David Ricks

    2 min read5 chapters

    Detailed Narrative

    01

    Cardiometabolic Pipeline Advancements

    Orforglipron demonstrated significant progress with 4 positive Phase III trials, including ATTAIN-2 showing 10.5% weight loss at the 36mg dose, comparable to injectable GLP-1s. ACHIEVE-3 showed superiority over oral semaglutide with a 2.2% A1c reduction and nearly 20 pounds weight loss. Global submissions for obesity are imminent, with type 2 diabetes submissions expected in H1 2026. Retatrutide's TRIUMPH-4 results are expected later this year, with 6 Phase III studies by the end of 2026.

    02

    Manufacturing Expansion

    Lilly announced plans for two new U.S. facilities, one in Virginia to support bioconjugate and monoclonal antibody portfolios, and another in Texas for small molecules. An existing facility in Puerto Rico will also be expanded to support small molecule production, including orforglipron. These expansions are critical for scaling production to meet anticipated demand, with updates on two remaining new U.S. facilities expected in the coming months⏳.

    03

    Oncology Milestones

    The U.S. FDA approved imlunestrant (Inluriyo) as a monotherapy for ER-positive, HER2-negative, ESR1-mutated metastatic breast cancer. Positive Phase III data for Jaypirca in treatment-naive CLL demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival, which will form the basis for global regulatory submissions. Additionally, early-stage oncology assets are progressing towards Phase III trials in 2026 or sooner.

    04

    Neuroscience and Immunology Updates

    The EU granted marketing authorization for Kisunla with modified titration dosing, aligning with U.S. and Japan approvals. Enrollment was completed for TRAILRUNNER-ALZ 3, evaluating subcutaneous remternetug for preclinical Alzheimer's disease. Lilly initiated a Phase III program for brenipatide, a GIP/GLP-1 dual agonist, in alcohol use disorder, with plans to explore its potential in opioid use disorder and asthma, highlighting its broad applicability across CNS and immunology. Lebrikizumab data showed durable disease control in atopic dermatitis with reduced dosing frequency.

    05

    Market Dynamics and Pricing Strategy

    Lilly is actively pursuing strategies to narrow the gap between list and net pricing, applauding moves like Cigna's shift from rebates to GPO fees, which is seen as beneficial for innovators and patients by promoting clinical differentiation. The company emphasizes a 'both/and' approach to pricing, balancing compelling consumer self-pay options with proving long-term health benefits to compete for healthcare dollars, aiming to reach hundreds of millions of patients globally.

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