Slides
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Q3 2025 EARNINGS CALL ELI LILL Y AND COMPANY
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2025 Q3 EARNINGS Introduction and Key Events Dave Ricks, Chair and Chief Executive Officer Q3 2025 Financial Results Lucas Montarce, Chief Financial Officer R&D Update Dan Skovronsky, M.D., Ph.D., Chief Scientific Officer Question & Answer Session Agenda 3
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2025 Q3 EARNINGS Not for promotional use 4 Safe Harbor Provision and Other Information This presentation contains forward-looking statements that are based on management's current expectations, but actual results may differ materially due to various factors. The company's results may be affected by factors including, but not limited to, the risks and uncertainties in pharmaceutical research and development; competitive developments; regulatory actions; litigation and investigations; business development transactions; trade and economic conditions; and changes in laws and regulations, including healthcare reform. For additional information about the factors that affect the company's business, please see the company's latest Form 10-K and subsequent Forms 10-Q and 8-K filed with the Securities and Exchange Commission. Certain financial information in this presentation is presented on a non-GAAP basis. Investors should refer to the reconciliations included in this presentation and should consider the company's non- GAAP measures in addition to, not as a substitute for or superior to, measures prepared in accordance with GAAP. These materials are not intended to promote the products referenced herein or otherwise influence healthcare prescribing decisions. The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval or become commercially available for the uses being investigated. The company undertakes no duty to update forward-looking statements except as required by applicable law.
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2025 Q3 EARNINGS Not for promotional use 5 Q3 2025 Summary Speed Life-Changing MedicinesInvest in Future Innovation Delivered robust revenue growth of 54% driven by Key Products1 Lilly U.S. incretin analogs share of market increased to 57.9% of total prescriptions, with market growth of 36% versus prior year Raised midpoint of full year revenue guidance by over $2 billion Announced significant investments in manufacturing, including new facilities in Virginia and Texas and expansion of an existing facility in Puerto Rico Announced partnership with NVIDIA to accelerate drug discovery Opened new Lilly Gateway Labs in San Diego 1 Key products include Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio and Zepbound Note: Revenue growth rates reflect change vs. Q3 2024 U.S. FDA approved Inluriyo (imlunestrant) in ER+, HER2-, ESR1 mutated advanced or metastatic breast cancer Kisunla received marketing authorization in Europe for early symptomatic Alzheimer’s disease Orforglipron positive results in four additional Phase 3 trials Jaypirca significantly improved progression free survival in treatment-naïve CLL/SLL Deliver Revenue Growth
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2025 Q3 EARNINGS Not for promotional use 6 Strategic Deliverables RESEARCH & DEVELOPMENT $3.5B TOTAL REVENUE $17.6B CAPITAL INVESTMENTS (YTD) • Kisunla approved in the EU for early symptomatic Alzheimer’s disease APPROVALS / LAUNCHES STUDY RESULTS $1.3B $0.7B DISTRIBUTED VIA DIVIDENDS DISTRIBUTED IN SHARE REPURCHASES Invest in Current PortfolioInvest in Future InnovationDeliver Revenue Growth Speed Life-Changing Medicines Return Capital to Shareholders 54% KEY PRODUCT REVENUE $12.0B 104% 27% MARKETING, SELLING & ADMINISTRATIVE $2.7B 31% NON-GAAP EARNINGS PER SHARE $7.02 +$5.84 Note: Total revenue, key product revenue, research and development, marketing, selling and administrative, and Non-GAAP EPS growth rates reflect change vs. Q3 2024 $5.3B • Inluriyo (imlunestrant) approved in the U.S. for ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer • Jaypirca significantly improved progression-free survival in treatment-naïve CLL/SLL • Verzenio prolonged survival in HR+, HER2- high-risk early breast cancer • Orforglipron was successful in second obesity trial, triggering global regulatory submission in 2025 for the treatment of obesity • Orforglipron superior to oral semaglutide and dapagliflozin in two H2H Phase 3 trials 49%
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2025 Q3 EARNINGS Dollars in millions; except per share data Q3 2025 GAAP Reported Adjustments Non-GAAP Adjusted YoY Non-GAAP Adjusted Change TOTAL REVENUE $17,601 $ - $17,601 54% GROSS MARGIN 82.9% 0.7 pp 83.6% 1.4pp TOTAL OPERATING EXPENSE $7,227 $ (365) $6,862 (10)% OPERATING INCOME $7,365 $485 $7,850 NM OTHER INCOME (EXPENSE) $(133) $(48) $(181) NM EFFECTIVE TAX RATE 22.8% (5.1) pp 17.7% (19.9)pp NET INCOME $5,583 $729 $6,312 NM EPS $6.21 $0.81 $7.02 NM Acquired IPR&D Charge per share1 $0.71 $ - $0.71 (77)% Performance Margin2 45.6% 48.3% +8.3pp 1 Acquired IPR&D (in-process research and development) charge of $656 million (pre-tax). Numbers may not add due to rounding; NM = not meaningful Not for promotional use 7 Q3 Key Income Statement Measures (unaudited) 2 The Company defines Performance Margin as gross margin less research and development, marketing, selling and administrative, and asset impairment, restructuring and other special charges divided by revenue Note: The Non-GAAP Performance Margin excludes the amortization of intangible assets. The applicable impact of amortization of intangible assets can be found in the reconciliation tables on slide 20
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2025 Q3 EARNINGS Q3 2025 Amount Price FX Rate Volume Total CER U.S. $11,300 (15)% - 60% 45% 45% EUROPE $3,498 6% 10% 98% 115% 104% JAPAN $555 0% 5% 24% 29% 24% CHINA $560 0% 0% 21% 22% 22% REST OF WORLD $1,688 (1)% 1% 53% 52% 51% TOTAL REVENUE $17,601 (10)% 2% 62% 54% 52% CER = price change + volume changeNumbers may not add due to rounding Dollars in millions Not for promotional use 8 Price/Rate/Volume Effect on Revenue YTD 2025 Amount Price FX Rate Volume Total CER U.S. $30,604 (11)% - 54% 43% 43% EUROPE $8,461 (1)% 4% 86% 89% 85% JAPAN $1,478 (0)% 2% 16% 18% 15% CHINA $1,477 1% (1)% 19% 20% 21% REST OF WORLD $3,867 (0)% (2)% 22% 21% 22% TOTAL REVENUE $45,887 (7)% 0% 52% 46% 45% Dollars in millions
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2025 Q3 EARNINGS $0 $2,000 $4,000 $6,000 $8,000 $10,000 $12,000 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2023 2024 2025 Not for promotional use 9 Q3 2025 Update on Key Products MOUNJARO Gained U.S. type 2 diabetes incretin analogs SOM leadership with TRx SOM 45% and NBRx SOM 54% at end of Q3 2025 Increased U.S. TRx and NBRx share by 4pp each vs. end of Q2 2025 International revenue grew 56% vs. Q2 2025 ZEPBOUND U.S. branded anti-obesity TRx SOM 63% and NBRx SOM 71% at end of Q3 2025 TRx share decreased by 2pp vs. end of Q2 2025 driven by CVS excluding Zepbound from template plans NBRx share increased by 4pp vs. end of Q2 2025 with new patient starts rebounding post CVS template plans access change VERZENIO U.S. TRx grew 3% vs. Q3 2024 International volume grew 14% vs. Q3 2024 JAYPIRCA Q3 2025 sales of $143M; U.S. TRx increased 61% vs. Q3 2024 EBGLYSS Q3 2025 sales of $127M; U.S. TRx grew 41% vs. Q2 2025 OMVOH Q3 2025 sales of $65M; first IL-23p19 to show 4-year data in UC supporting long-term safety and benefit of continuous treatment KISUNLA Q3 2025 sales of $70M; received marketing authorization by European Commission Key Product Highlights: Millions
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2025 Q3 EARNINGS Not for promotional use 10 TOTAL PRESCRIPTIONS +36% in Q3 vs. PY NOVO SOM 41.7% LILLY SOM 57.9% Total Prescriptions 4 Week Rolling Average (thousands) Source: IQVIA weekly NPA total prescriptions, weekly data September 26, 2025; Incretin analogs market includes: injectable GLP-1s, oral GLP-1s and GLP-1/GIP dual agonists U.S. Incretin Analogs Market Incretin Analogs Market Key Highlights: U.S. market grew 36% in Q3 vs. prior year and 7% vs. Q2 2025 Lilly share of market increased to 57.9%, +1.0pp vs. prior quarter, despite Zepbound CVS template plans access change on 7/1/25 Lilly’s NBRx share of market increased to 65.1%, +1.3pp 0 300 600 900 1,200 1,500 1,800 2,100
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2025 Q3 EARNINGS $ in billions Dividend R&D* Capital Investments Business Development** Share Repurchase GrowthReturn * After tax ** Includes development milestones, closed acquisitions and cash outflows associated with equity investments YTD 2025 Capital Allocation Not for promotional use 11 Capital Allocation $2.6 $4.0 $3.5 $5.3 $7.9
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2025 Q3 EARNINGS Prior Updated Comments REVENUE $60.0 – $62.0 billion $63.0 – $63.5 billion Strong underlying business performance and updated foreign exchange rate expectations PERFORMANCE MARGIN1 (GAAP) 42.0% – 43.5% 43.5% – 44.5% Increased to reflect updated revenue expectations (NON-GAAP) 43.0% – 44.5% 45.0% – 46.0% OTHER INCOME/(EXPENSE) Decrease in net losses on investments in equity securities(GAAP) $(750) – $(650) million $(700) – $(600) million (NON-GAAP) $(700) – $(600) million Unchanged TAX RATE (GAAP) Approx. 19% Unchanged (NON-GAAP) Approx. 17% Unchanged EARNINGS PER SHARE2 (GAAP) $20.85 – $22.10 $21.80 – $22.50 (NON-GAAP) $21.75 – $23.00 $23.00 – $23.70 1 The Company defines Performance Margin as gross margin less research and development, marketing, selling and administrative and asset impairment, restructuring and other special charges divided by revenue 2 2025 assumes shares outstanding of approximately 899.3 million FX assumptions of 1.14 (Euro), 149 (Yen) and 7.1 (Yuan) Not for promotional use 12 2025 Guidance
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2025 Q3 EARNINGS -2.3 kg -5.5 kg -7.9 kg -10.4 kg Not for promotional use 13 Orforglipron A TT AIN-2 T opline Results People with type 2 diabetes and obesity Key Highlights: Orforglipron met the primary and all key secondary endpoints, demonstrating compelling efficacy The safety and tolerability of orforglipron was consistent with injectable GLP-1 medicines Body Weight Change at 52 Weeks BASELINE WEIGHT: 101.4 kg Placebo Orforglipron 6 mg Orforglipron 12 mg Orforglipron 36 mg -5.5% -7.8% -10.5% -2.2% A1C Change at 52 Weeks BASELINE A1C: 8.1% -0.1% -1.3% -1.6% -1.8% Lilly now has full clinical data package to initiate global regulatory submissions for orforglipron in obesity Note: Efficacy Estimand Results; Superiority test was adjusted for multiplicity with all three orforglipron doses
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2025 Q3 EARNINGS -3.6 kg -5.0 kg -6.6 kg -8.9 kg Not for promotional use 14 Orforglipron ACHIEVE-3 T opline Results People with type 2 diabetes Anticipated global regulatory submission for T2D in 1H 2026, pending completion of ACHIEVE-4 Orforglipron was superior to oral semaglutide in a H2H trial in adults with type 2 diabetes Key Highlights: Orforglipron 36 mg helped nearly three times as many participants reach near-normal A1C versus oral semaglutide 14 mg The safety and tolerability of orforglipron was consistent with injectable GLP-1 medicines Body Weight Change at 52 Weeks BASELINE WEIGHT: 97.0 kg Oral Semaglutide 7 mg Oral Semaglutide 14 mg Orforglipron 12 mg Orforglipron 36 mg -5.3% -6.7% -9.2% -3.7% A1C Change at 52 Weeks BASELINE A1C: 8.3% -1.1% -1.4% -1.9% -2.2% Note: Efficacy Estimand Results; Body weight for orforglipron 12 mg vs. oral semaglutide 14 mg was not controlled for family-wise type 1 error
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2025 Q3 EARNINGS Completion: Q1 2026 Submission: 1H 2026 ATTAIN-MAINTAIN Completion: 2025/2026 ATTAIN-OSA Completion: 2027 ATTAIN-OA PAIN Completion: 2027 ATTAIN-OSA Completion: 2027 Not for promotional use 15 OA=Osteoarthritis; OSA=obstructive sleep apnea; CLBP=Chronic Low Back Pain; CV=cardiovascular; MASLD=metabolic dysfunction-associated steatotic liver disease Upcoming Key Events in Cardiometabolic Health Orforglipron Retatrutide Completion: Q3 2025 ATTAIN-1 ATTAIN-2 ACHIEVE-1 ACHIEVE-4 ACHIEVE-2 ACHIEVE-5 ACHIEVE-3 ✓ ✓ ✓ ✓ ✓ ✓ Completion: 2027 Completion: 2026 TRIUMPH-1 TRIUMPH-3 TRIUMPH-2 TRIUMPH-4 TRANSCEND-1 TRANSCEND-2 TRANSCEND-3 TRIUMPH-OUTCOMES Completion: 2029 TRIUMPH-6 Completion: 2028 SYNERGY-OUTCOMES Completion: 2030 TRIUMPH-7 Completion: 2027 Note: Select Phase 3 trials for orforglipron and retatrutide; additional studies ongoing Upcoming read out
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2025 Q3 EARNINGS TIRZEPATIDE Higher Doses TIRZEPATIDE MASLD GBA1 GENE THERAPY Gaucher Disease Type 1 MORF-057 Crohn’s Disease CD19 ANTIBODY Rheumatoid Arthritis ELTREKIBART Ulcerative Colitis SIMEPDEKINRA Psoriasis SOLBINSIRAN CVD OCADUSERTIB Rheumatoid Arthritis OTOF GENE THERAPY Hearing Loss NAPERIGLIPRON Obesity NISOTIROSTIDE Diabetes MEVIDALEN AD Symptomatic MORF-057 Ulcerative Colitis GRN GENE THERAPY Frontotemporal Dementia MAZDUTIDE1 Obesity EPIREGULIN Ab Pain GBA1 GENE THERAPY Parkinson’s Disease ELORALINTIDE Obesity ELTREKIBART Hidradenitis Suppurativa BIMAGRUMAB Obesity CD19 ANTIBODY Multiple Sclerosis October 28, 2025 Not for promotional use 16 1China development with Innovent TARGETS UNDISCLOSED Twelve Additional NMEs UNC13A SSO (QRL-204) ALS SNCA siRNA Neurodegeneration VEPUGRATINIB Cancer SARM1 INHIBITOR Neurodegeneration SMARCA2 (BRM) Cancer PNPLA3 siRNA MASLD PTK7 ADC Cancer PCSK9 EDITOR (VERVE-102) ASCVD PI3Kα INH (STX-478) Cancer NECTIN-4 ADC 2 Cancer PAN KRAS Cancer NAV 1.8 INH (SM) Pain NECTIN-4 ADC 1 Cancer MACUPATIDE CMH MAPT siRNA Neurodegeneration KRAS G12D Cancer LA-ANP Heart Failure GS INSULIN RECEPTOR AGONIST II Diabetes INTEGRIN α5β1 CMH GIPR AGONIST LA CMH GS INSULIN RECEPTOR AGONIST Diabetes FXR AG (FXR314) Immunology GGG TRI-AGONIST III CMH BRENIPATIDE (GIP/GLP-1 COAG III) CMH FRa ADC Cancer ANTI-VEGF GENE THERAPY Vestibular Schwannoma AT2R ANTAGONIST Pain [Ac-225]-PSMA-62 Prostate Cancer ANGPTL3 EDITOR (VERVE-201) ASCVD ORFORGLIPRON Osteoarthritis Pain ORFORGLIPRON Stress Urinary Incontinence MIRIKIZUMAB + TIRZEPATIDE CD MIRIKIZUMAB + TIRZEPATIDE UC TIRZEPATIDE MMO TIRZEPATIDE Type 1 Diabetes SELPERCATINIB Adjuvant RET+ NSCLC TIRZEPATIDE CV Outcomes RETATRUTIDE CV / Renal Outcomes RETATRUTIDE Diabetes PIRTOBRUTINIB R/R MCL Monotherapy RETATRUTIDE CLBP PIRTOBRUTINIB 1L CLL Monotherapy PIRTOBRUTINIB R/R CLL Combination ORFORGLIPRON Hypertension ORFORGLIPRON Obstructive Sleep Apnea OLOMORASIB Adj KRAS G12C+ NSCLC (resected) ORFORGLIPRON Diabetes OLOMORASIB 1L KRAS G12C+ NSCLC (PD-L1 high) OLOMORASIB Adj KRAS G12C+ NSCLC (unresected) LEBRIKIZUMAB AR (perennial allergens) LEBRIKIZUMAB CRSwNP IXEKIZUMAB + TIRZEPATIDE PsA IXEKIZUMAB + TIRZEPATIDE Psoriasis DONANEMAB Preclinical Alzheimer’s Disease IMLUNESTRANT Adjuvant Breast Cancer RETATRUTIDE Obesity, OA, OSA MUVALAPLIN ASCVD ORFORGLIPRON Obesity REMTERNETUG Preclinical / MCI AD LEPODISIRAN ASCVD OLOMORASIB 1L KRAS G12C+ NSCLC (All PD-L1) TIRZEPATIDE Heart Failure pEF INSULIN EFSITORA ALFA Diabetes IMLUNESTRANT ER+ HER2- mBC Lilly Select Pipeline P2X7 INHIBITOR Pain ABEMACICLIB MBC Sequencing NME NILEX / Other UPDATES SINCE AUGUST 5, 2025 REMOVAL ADDITION OR MILESTONE ACHIEVED
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2025 Q3 EARNINGS PHASE 3 INITIATIONS Orforglipron for hypertension and overweight or obesity Olomorasib for resected adjuvant NSCLC1 Muvalaplin for ASCVD2 Retatrutide for chronic low back pain and overweight or obesity Olomorasib for unresected NSCLC1 Tirzepatide for type 1 diabetes Orforglipron for OA3 pain of the knee and overweight or obesity Retatrutide and Tirzepatide for MASLD4 Orforglipron for SUI5 and overweight or obesity Brenipatide for AUD6 PHASE 3 DATA DISCLOSURES Orforglipron for obesity [ATTAIN-1 ✓+ / 2 ✓+ ] Orforglipron for type 2 diabetes [ACHIEVE-1 ✓+ / 2 ✓+ / 3 ✓+ / 5 ✓+ ] Tirzepatide cardiovascular outcomes [SURPASS-CVOT] Pirtobrutinib 1L CLL vs. BR7 [BRUIN CLL-313] Pirtobrutinib 1L CLL vs. ibrutinib [BRUIN CLL-314] Retatrutide for OA3 pain of the knee and overweight or obesity [TRIUMPH-4] REGULATORY ACTIONS Mirikizumab for Crohn’s disease [US ✓+ / EU ✓+ / J ✓+] Tirzepatide for HFpEF [US ✓- /EU] Imlunestrant ER+, HER2- mBC [US ✓+ / J] Pirtobrutinib for CLL full approval [US / EU ✓+ / J] Donanemab for early Alzheimer’s disease [EU] NEW SINCE LAST UPDATE Not for promotional use 17 Potential Key Events 2025 1 Non-small cell lung cancer; 2 Atherosclerotic cardiovascular disease; 3 Osteoarthritis; 4 Metabolic dysfunction-associated steatotic liver disease; 5 Stress Urinary Incontinence; 6 Alcohol use disorder; 7 Bendamustine plus Rituximab ✓+ ✓+ ✓+ ✓+ ✓+ REGULATORY SUBMISSIONS Insulin efsitora alfa for type 2 diabetes [US ✓+ / EU ✓+ / J ] Orforglipron for obesity [US/EU/J] Tirzepatide for cardiovascular outcomes [US] Pirtobrutinib CLL full approval [US ✓+] Pirtobrutinib for 1L CLL [US/EU] Tirzepatide for Pediatric and Adolescent type 2 diabetes [US ✓+/ EU ✓+] ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+
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2025 Q3 EARNINGS Not for promotional use 18 Supplemental Slides
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2025 Q3 EARNINGS * Includes research and development expense; marketing, selling and administrative; acquired in-process research and development charges; and asset impairment, restructuring and other special charges (as applicable) NM = not meaningful Not for promotional use 19 2025 Income Statement – Reported Dollars in millions; except per share data Q3 2025 Change TOTAL REVENUE $17,601 54% GROSS MARGIN 82.9% 1.9pp TOTAL OPERATING EXPENSE* $7,227 (7)% OPERATING INCOME $7,365 NM OPERATING MARGIN 41.8% 28.5pp OTHER INCOME (EXPENSE) $(133) NM EFFECTIVE TAX RATE 22.8% (16.1)pp NET INCOME $5,583 NM EPS $6.21 NM
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2025 Q3 EARNINGS Not for promotional use 20 EPS Reconciliation Q3 2025 Q3 2024 % Change EARNINGS PER SHARE (REPORTED) $6.21 $1.07 NM U.S. TAX LAW CHANGE 0.39 - NM ASSET IMPAIRMENT, RESTRUCTURING AND OTHER SPECIAL CHARGES 0.36 0.07 NM AMORTIZATION OF INTANGIBLE ASSETS 0.11 0.12 (8)% NET LOSSES (GAINS) ON INVESTMENTS IN EQUITY SECURITIES (0.04) (0.09) (56)% EARNINGS PER SHARE (NON-GAAP) $7.02 $1.18 NM ACQUIRED IPR&D $0.71 $3.08 (77%) Numbers may not add due to rounding; see slide 21 for more details on these adjustments; NM = not meaningful
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2025 Q3 EARNINGS Q3 2025 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO EXCLUDE: • income taxes related to US tax law changes effective July 4, 2025, totaling $350.3 million, or $0.39 per share • asset impairment, restructuring and other special charges totaling $364.9 million (pre-tax), or $0.36 per share (after-tax) • amortization of intangibles (cost of sales) primarily associated with costs of marketed products acquired or licensed from third parties totaling $119.2 million (pre-tax), or $0.11 per share (after-tax) • net gains on investments in equity securities totaling $48.0 million (pre-tax), or ($0.04) per share (after-tax) Q3 2024 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO EXCLUDE: • amortization of intangibles (cost of sales) primarily associated with costs of marketed products acquired or licensed from third parties totaling $139.4 million (pre-tax), or $0.12 per share (after-tax) • asset impairment, restructuring and other special charges totaling $81.6 million (pre-tax), or $0.07 per share (after-tax) • net gains on investments in equity securities totaling $103.0 million (pre-tax), or ($0.09) per share (after-tax) Not for promotional use 21 Q3 Non-GAAP Adjustments
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2025 Q3 EARNINGS 0 200 400 600 800 1000 1200 1400 0% 10% 20% 30% 40% 50% 60% 70% Sep 2023 Dec 2023 Mar 2024 Jun 2024 Sep 2024 Dec 2024 Mar 2025 Jun 2025 Sep 2025 13 Wk RA TRx Market Size 13 Wk RA TRx SOM U.S. TRx SOM and Market Volume Source: IQVIA NPA TRx 3MMA, weekly data September 26, 2025; RA = rolling average TRx data is representative of the injectable incretin type 2 diabetes market Mounjaro $ in Millions U.S. sales were $3.6 billion International sales were $3.0 billion Market Not for promotional use 22 Q3 2025 Mounjaro Sales Increased $3.4B $1,807 $3,091 $3,113 $3,530 $3,842 $5,199 $6,515 Q1 Q2 Q3 Q4 2024 2025
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2025 Q3 EARNINGS 0 100 200 300 400 500 600 700 0% 10% 20% 30% 40% 50% 60% 70% 80% Dec 2023 Mar 2024 Jun 2024 Sep 2024 Dec 2024 Mar 2025 Jun 2025 Sep 2025 13 Wk RA TRx Market Size 13 Wk RA TRx SOM U.S. TRx SOM and Market Volume Source: IQVIA NPA TRx 3MMA, weekly data September 26, 2025; RA = rolling average TRx data is representative of the branded anti-obesity market Zepbound $ in Millions Market Not for promotional use 23 Q3 2025 Zepbound Sales Increased $2.3B 1 Japan and Canada marketing authorization approved for obesity under the brand name Zepbound U.S. sales were $3.6 billion International sales were $20 million1 $517 $1,243 $1,258 $1,907 $2,312 $3,381 $3,588 Q1 Q2 Q3 Q4 2024 2025
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2025 Q3 EARNINGS 6 7 8 9 10 11 0% 10% 20% 30% 40% 50% 60% Sep 2023 Dec 2023 Mar 2024 Jun 2024 Sep 2024 Dec 2024 Mar 2025 Jun 2025 Sep 2025 13 Wk RA TRx Market Volume 13 Wk RA TRx SOM U.S. sales were $880 million International sales were $590 million U.S. TRx SOM and Market Volume Market Verzenio $ in Millions Not for promotional use 24 Q3 2025 Verzenio Sales Increased 7% Source: IQVIA NPA TRx 3MMA, weekly data September 26, 2025; RA = rolling average $1,050 $1,332 $1,369 $1,555 $1,159 $1,489 $1,470 Q1 Q2 Q3 Q4 2024 2025
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2025 Q3 EARNINGS Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT04437511 Alzheimer's Disease A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) 3 1736 Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population) Apr 2023 Nov 2028 NCT057384861 Alzheimer's Disease A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) 3 1100 Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) May 2024 May 2027 NCT05508789 Alzheimer's Disease A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) 3 1500 Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) May 2028 July 2028 NCT05026866 Alzheimer's Disease A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3) 3 2996 Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS) Nov 2027 Nov 2027 Not for promotional use 25 Select Trials – Donanemab * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 1 clinicaltrials.gov update in progress
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2025 Q3 EARNINGS Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT04975308 Breast Neoplasms A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3) 3 874 Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B) Jun 2024 Aug 2027 NCT05514054 Breast Neoplasms A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4) 3 8000 Invasive Disease-Free Survival (IDFS) Oct 2027 Mar 2032 Not for promotional use 26 Select Trials – Imlunestrant * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 27 Select Trials – Lebrikizumab Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT05559359 Atopic Dermatitis A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-1) 3 360 Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline Dec 2025 Dec 2026 NCT05735483 Atopic Dermatitis A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-2) 3 310 Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) Dec 2027 Apr 2029 NCT06280716 Atopic Dermatitis A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis (ADvance-Asia) 3 301 Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) ≥75% Reduction in EASI Score for Mono Cohort Sep 2025 Aug 2026 NCT06339008 Perennial Allergic Rhinitis (PAR) A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1) 3 450 Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16 Sep 2026 Oct 2028 NCT06921759 Atopic Hand and Foot Dermatitis A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis (ADtouch) 3 206 Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline Jul 2026 Sep 2026 NCT06338995 Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP) 3 510 Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity May 2027 Mar 2028
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 28 Select Trials – Lepodisiran Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT06292013 Atherosclerotic Cardiovascular Disease (ASCVD)1 A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a) 3 16700 Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint Mar 2029 Mar 2029 1 Reduction of major adverse cardiovascular events (MACE) in patients with Atherosclerotic Cardiovascular Disease (ASCVD) and those at-risk for ASCVD
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 29 Select Trials – Mirikizumab Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT04232553 Crohn's Disease A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2) 3 778 Percentage of Participants Achieving Endoscopic Response Nov 2024 Dec 2026 NCT06937099 Crohn's Disease Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight (COMMIT-CD) 3 290 Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction May 2028 May 2028 NCT03519945 Ulcerative Colitis A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT-3) 3 1063 Percentage of Participants in Clinical Remission Jul 2026 Dec 2027 NCT06937086 Ulcerative Colitis Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study (COMMIT-UC) 3 350 Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction Apr 2028 Apr 2028
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 30 Select Trials – Muvalaplin Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT07157774 Elevated Lp(a) Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a) – (MOVE-Lp(a)) 3 10450 Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint Mar 2031 Mar 2031
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 31 Select Trials – Olomorasib Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT06119581 J3M-MC-JZQB Carcinoma, Non- Small-Cell Lung A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer (SUNRAY-01) 3 1016 Dose Optimization and Safety Lead-In Part B: Number of Participants with a Treatment Emergent Adverse Event(s) (TEAE) Oct 2026 Oct 2029 NCT068905981 J3M-MC-JZQH Carcinoma, Non- Small-Cell Lung Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer (SUNRAY-02) 3 700 Part A: Disease-Free Survival (DFS) by Investigator Assessment May 2029 Feb 2032 NCT049566402 J3M-OX-JZQA Carcinoma, Non- Small-Cell Lung Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C) 1|2 540 Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy Apr 2027 Apr 2027 1 Also lists AstraZeneca; 2 Also lists Merck Sharp & Dohme LLC
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 32 Select Trials – Orforglipron Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT05803421 Type 2 Diabetes A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk (ACHIEVE-4) 3 2749 Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death] Mar 2026 Mar 2026 NCT06948422 Hypertension A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension) 3 974 Change from baseline in systolic blood pressure Sep 2027 Sep 2027 NCT05869903 Obesity A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1) 3 3127 Mean Percent Change from Baseline in Body Weight Jul 2025 Oct 2027 NCT06584916 Obesity A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN) 3 300 Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5 Jan 2026 Jan 2026 NCT06672939 Obesity A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities 3 125 Percent Change from Baseline in Body Mass Index (BMI) Feb 2027 Mar 2027 NCT06972472 Obesity A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes 3 600 Change from Baseline in Hemoglobin A1c (HbA1c) Jan 2027 Aug 2027
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 33 Select Trials – Orforglipron (Cont.) Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT06972459 Obesity A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity 3 600 Percent Change from Baseline in Body Weight Jan 2027 Aug 2027 NCT06649045 OSA A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ATTAIN-OSA) 3 600 Change from Baseline in Apnea-Hypopnea Index (AHI) Nov 2026 Jan 2027 NCT07153471 Osteoarthritis A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee (ATTAIN-OA PAIN) 3 800 Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Apr 2028 May 2028 NCT07202884 Stress Urinary Incontinence A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight (RESTRAIN-SUI) 3 1000 Change from Baseline in Incontinence Episode Frequency (IEF) Mar 2028 Mar 2028 NCT06824051 Obesity A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight 1 120 Percent Change from Baseline in Visceral Adipose Tissue (VAT) Dec 2025 Dec 2025
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2025 Q3 EARNINGS Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 34 Select Trials – Pirtobrutinib Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT04666038 Chronic Lymphocytic Leukemia Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-321) 3 238 Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) Aug 2023 May 2027 NCT05023980 Chronic Lymphocytic Leukemia A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313) 3 309 To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B) Jul 2025 Aug 2026 NCT04965493 Chronic Lymphocytic Leukemia A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (BRUIN CLL-322) 3 600 To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B) Apr 2026 Jan 2027 NCT05254743 Chronic Lymphocytic Leukemia A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-314) 3 662 Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1 Jun 2025 Jan 2028 NCT04662255 Lymphoma, Mantle-Cell Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN MCL-321) 3 500 To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL) Jan 2027 Apr 2028 * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes
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2025 Q3 EARNINGS Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 35 Select Trials – Pirtobrutinib (Cont.) Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT07162181 Non-Hodgkin Lymphoma Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers 2 13 Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events May 2030 May 2030 NCT06721013 Immune Thrombocytopeni a (ITP) A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia 1|2 58 Ph. 1 -Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Dec 2026 Feb 2027 * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 36 Select Trials – Remternetug Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT05463731 Alzheimer's Disease A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1) 3 1667 Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo Apr 2024 Mar 2026 NCT06653153 Alzheimer's Disease A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3) 3 1400 Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate Scale (CDR) Apr 2029 Oct 2030
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 37 Select Trials – Retatrutide Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT05929066 Obesity A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (TRIUMPH-1) 3 2300 Percent Change From Baseline in Body Weight Apr 2026 May 2026 NCT05929079 Obesity A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight (TRIUMPH-2) 3 1000 Percent Change from Baseline in Body Weight May 2026 May 2026 NCT05882045 Obesity A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3) 3 1800 Percent Change from Baseline in Body Weight Apr 2026 May 2026 NCT05931367 Obesity A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee (TRIUMPH-4) 3 405 Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Dec 2025 Dec 2025 NCT06383390 Obesity The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-OUTCOMES) 3 10000 Time to First Occurrence of Composite Endpoints Feb 2029 Feb 2029
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 38 Select Trials – Retatrutide (Cont.) Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT06662383 Obesity A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5) 3 800 Percent Change from Baseline in Body Weight Dec 2026 Dec 2026 NCT06859268 Obesity A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity (TRIUMPH-6) 3 643 Percent Change from Baseline in Body Weight Apr 2028 Apr 2028 NCT06354660 Type 2 Diabetes Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1) 3 480 Change from Baseline in Hemoglobin A1c (HbA1c) Jan 2026 Feb 2026 NCT06297603 Type 2 Diabetes Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3) 3 320 Change from Baseline in Hemoglobin A1c (HbA1c) Sep 2026 Oct 2026 NCT06260722 Type 2 Diabetes Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2) 3 1250 Change from Baseline in Hemoglobin A1c (HbA1c) Aug 2026 Jan 2027
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 39 Select Trials – Retatrutide (Cont.) Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT07035093 Obesity A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain (TRIUMPH-7) 3 586 Percent Change from Baseline in Body Weight | Change from Baseline in Pain Intensity Per Numeric Rating Scale Sep 2027 Sep 2027 NCT05936151 Chronic Kidney Disease A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes 2 146 Change from Baseline in Glomerular Filtration Rate (mGFR) Nov 2025 Nov 2025 NCT06982846 Type 2 Diabetes Mellitus A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia 1 78 Time-to-Event of Recovery of Plasma Glucose (PG) Concentration from 48 Milligram per Deciliter (48 mg/dL) to 70 mg/dL (tPG_nadir-70 mg/dL) May 2026 May 2026 NCT06982859 Diabetes Mellitus A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus 1 95 Change from Baseline in Total Clamp Disposition Index (cDI) for Comparison of Retatrutide With Placebo Nov 2026 Nov 2026
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 40 Select Trials – Retevmo Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT04211337 Medullary Thyroid Cancer A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) 3 291 Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) May 2023 Feb 2026 NCT04194944 Non-Small Cell Lung Cancer A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (LIBRETTO-431) 3 261 Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (With Pembrolizumab) May 2023 Jun 2030 NCT03157128 Non-Small Cell Lung Cancer A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) 1|2 857 Phase 1: MTD, Incidence rate and category of dose limiting toxicities (DLTs) during the first 28-day cycle of LOXO-292 (selpercatinib) treatment Feb 2025 Feb 2027 NCT04819100 Carcinoma, Non- Small-Cell Lung A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (LIBRETTO-432) 3 152 Event-Free Survival (EFS), EFS by Investigator Assessment in the Primary Analysis Population Jan 2026 May 2028
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 41 Select Trials – Taltz Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT06588283 Psoriasis Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight (TOGETHER-PsO) 3 250 Percentage of Participants Who Simultaneously Achieved Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction Dec 2025 May 2026 NCT06588296 Psoriatic Arthritis Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight (TOGETHER-PsA) 3 250 Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction Nov 2025 Aug 2026
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 42 Select Trials – Tirzepatide Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT06047548 Obesity A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-MAINTAIN) 3 400 Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period May 2026 May 2026 NCT06075667 Obesity A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS) 3 150 Percent Change from Baseline in Body Mass Index (BMI) May 2026 Jul 2029 NCT06439277 Obesity A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2) 3 300 Percent Change from Baseline in Body Mass Index (BMI) Oct 2027 Dec 2030 NCT05556512 Obesity A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity (SURMOUNT-MMO) 3 15374 Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events) Oct 2027 Oct 2027 NCT06914895 Type 1 Diabetes A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight 3 905 Change from Baseline in Hemoglobin A1c (HbA1c) May 2027 May 2027
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 43 Select Trials – Tirzepatide (Cont.) Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT06962280 Type 1 Diabetes A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight 3 465 Change from Baseline in Hemoglobin A1c (HbA1c) Apr 2027 Dec 2027 NCT06037252 Type 2 Diabetes A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity 2 350 Percent Change From Baseline in Body Weight Jan 2026 Oct 2026 NCT05536804 CKD A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes (TREASURE-CKD) 2 140 Change from Baseline in Kidney Oxygenation in Participants With or Without T2D Sep 2026 Oct 2026
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 44 Select Trials – Verzenio Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion NCT031559971 Breast Cancer Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE) 3 5637 Invasive Disease-Free Survival (IDFS) Mar 2020 May 2029 NCT05169567 Breast Neoplasm Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer (postMonarch) 3 368 Progression-Free Survival (PFS) Feb 2024 Feb 2026 1 Also lists NSABP Foundation Inc
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2025 Q3 EARNINGS Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion Brenipatide (GIP/GLP-1 Coagonist III) NCT06606106 Healthy A Study of LY3537031 in Overweight, Obese, and Healthy Participants 1 302 Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration Jul 2026 Jul 2026 Bimagrumab NCT07030127 Healthy A Study of LY3985863 in Healthy Participants 1 24 Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Apr 2026 Apr 2026 Bimagrumab NCT06643728 Obesity A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight 2 240 Percent Change from Baseline in Body Weight Apr 2026 Jan 2027 Eloralintide NCT06230523 Obesity A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight 2 263 Percent Change from Baseline in Body Weight May 2025 August 2025 Eloralintide NCT06603571 Obesity A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes 2 350 Percent Change from Baseline in Body Weight Jun 2026 Aug 2026 GGG Tri-Agonist III NCT06945419 Healthy A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes 1 165 Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration Apr 2026 Apr 2026 * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 45 Select Trials – Early Phase Cardiometabolic Health
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2025 Q3 EARNINGS Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion GS Insulin Receptor Agonist1 NCT06280703 Healthy A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) 1 70 Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration Oct 2026 Oct 2026 LA-ANP NCT06148272 Healthy A Study of LY3971297 in Healthy Participants 1 225 Part A and F: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Dec 2025 Dec 2025 Macupatide NCT06557356 Obesity A Study of LY3532226 in Participants With Obesity 1 129 Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Nov 2025 Nov 2025 Nisotirostide NCT06897475 Type 2 Diabetes A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide 2 240 Change from Baseline in Hemoglobin A1c (HbA1c) Dec 2026 Jan 2027 Naperiglipron NCT06683508 Obesity A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight 2 275 Percent Change from Baseline in Body Weight Apr 2026 Sep 2026 PNPLA3 siRNA NCT05395481 Metabolic Dysfunction- associated Steatotic Liver Disease (MASLD) A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) 1 176 Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration Oct 2026 Oct 2026 Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 46 Select Trials – Early Phase Cardiometabolic Health * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes1 clinicaltrials.gov update in progress
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2025 Q3 EARNINGS Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion ANGPTL3 EDITOR (VERVE-201) NCT06451770 Hypercholester olemia Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia 1 36 Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Mar 2027 Mar 2027 PCSK9 EDITOR (VERVE-102) NCT06164730 Heterozygous Familial Hypercholester olemia A Study of VERVE-102 in Patients with Familial Hypercholesterolemia or Premature Coronary Artery Disease 1 36 Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) Aug 2026 Aug 2026 Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 47 Select Trials – Early Phase Cardiometabolic Health * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes
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2025 Q3 EARNINGS Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion CD19 Antibody NCT06220669 Multiple Sclerosis A Study of LY3541860 in Adult Participants With Relapsing Multiple Sclerosis 2 200 Cumulative Number of New T1 Gadolinium- Enhancing (GdE) Lesions Aug 2027 Aug 2028 CD19 Antibody NCT06859294 Rheumatoid Arthritis A Study of LY3541860 in Adult Participants With Moderately to Severely Active Rheumatoid Arthritis 2 40 Change from Baseline in Disease Activity Score - High-Sensitivity C-Reactive Protein (DAS28 - hsCRP) Feb 2026 Sep 2026 Eltrekibart NCT06046729 Hidradenitis Suppurativa A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa 2 352 Percentage of Participant Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) Sep 2025 Aug 2026 Eltrekibart NCT06598943 Ulcerative Colitis A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis 2 140 Percentage of Participants Achieving Clinical Remission Dec 2027 Sep 2028 Not for promotional use 48 Select Trials – Early Phase Immunology Source: clinicaltrials.gov, October 17, 2025 * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 49 Select Trials – Early Phase Immunology (Cont.) Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion MORF-057 NCT05611671 Ulcerative Colitis A Study to Evaluate MORF-057 in Adults with Moderately to Severely Active UC (EMERALD-2) 2 282 Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS) Nov 2024 Aug 2026 MORF-057 NCT07186101 Ulcerative Colitis LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis (TOPAZ-UC) 2 252 Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) May 2027 Mar 2029 MORF-057 NCT06226883 Crohn's Disease A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET) 2 210 Proportion of participants with endoscopic response at Week 14 determined using the Simple Endoscopic Score-CD (SES-CD) Nov 2026 Aug 2028 Ocadusertib1 NCT05848258 Rheumatoid Arthritis An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis 2 380 Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP) Feb 2026 Jul 2026 1 Also lists Rigel Pharmaceuticals
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 50 Select Trials – Early Phase Neuroscience Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion Anti-VEGF Gene Therapy NCT06517888 Vestibular Schwannoma Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma 1|2 27 AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device) Aug 2029 Aug 2029 Epiregulin Ab NCT06568042 Neuropathic Pain Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy 2 450 Mean Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Jun 2026 Sep 2026 GBA1 Gene Therapy NCT04127578 Parkinson’s Disease Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) 1|2 20 Cumulative number of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Dec 2030 Dec 2030 GBA1 Gene Therapy NCT05487599 Gaucher Disease A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED) 1|2 15 Incidence and severity of Treatment- emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Oct 2030 Oct 2030 GRN Gene Therapy NCT04408625 Frontotemporal Dementia Phase 1/2 Clinical Trial of LY3884963 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN) (PROCLAIM) 1|2 30 Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events Leading to discontinuation Apr 2030 Apr 2030
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 51 Select Trials – Early Phase Neuroscience (Cont.) Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion MAPT siRNA NCT06297590 Alzheimer’s Disease A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease 1 32 Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration Feb 2027 Feb 2027 Mazdutide NCT06817356 Alcohol Use Disorder A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder 2 300 Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method Aug 2026 Aug 2026 Mevidalen NCT06538116 Alzheimer’s Disease A Study of Mevidalen (LY3154207) in Participants With Alzheimer's Disease 2 300 Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Dec 2025 Jan 2026 OTOF Gene Therapy NCT05821959 Sensorineural Hearing Loss, Bilateral Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss 1|2 18 Frequency of Adverse Events (AEs) Oct 2028 Oct 2028 SNCA siRNA NCT06565195 Parkinson’s Disease A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease (PROSPECT) 1 108 Incidence of Serious Adverse Events (SAEs) May 2029 May 2029 UNC13A SSO (QRL-204) NCT07100119 Amyotrophic Lateral Sclerosis A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis 1 32 Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration Aug 2027 Sep 2027
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 52 Select Trials – Early Phase Oncology Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion 225Ac-PSMA-62 NCT06229366 Prostate Cancer [Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer (ACCEL) 1 142 Maximum tolerated dose (MTD), Phase 1a: Incidence of dose limiting toxicities (DLTs) Sep 2027 Dec 2032 VEPUGRATINIB NCT05614739 Urinary Bladder Neoplasms A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3 (FORAGER-1) 1 535 Phase 1a: To determine the recommended dose of LOXO-435: Safety, number of participants with dose-limiting toxicities (DLTs) Jun 2027 Jun 2027 Fra ADC NCT06400472 Ovarian Neoplasms A Study of LY4170156 in Participants With Selected Advanced Solid Tumors 1 360 Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156, Number of participants with dose-limiting toxicities (DLTs) Feb 2027 Apr 2027 KRAS G12D NCT06586515 Pancreatic Ductal Adenocarcinoma A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors (MOONRAY-01) 1 630 Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Mar 2029 Mar 2029 Nectin-4 ADC 1 NCT06238479 Metastatic Solid Tumor A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors (EXCEED) 1 490 Phase 1a: To determine the recommended dose of LY4101174: Number of participants with dose-limiting toxicities (DLTs) Mar 2027 Mar 2027 Nectin-4 ADC 2 NCT06465069 Metastatic Solid Tumor A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors 1 420 Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031 May 2027 May 2027
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2025 Q3 EARNINGS * Molecule may have multiple indications. ** Trial may have additional primary and other secondary outcomes Source: clinicaltrials.gov, October 17, 2025 Not for promotional use 53 Select Trials – Early Phase Oncology (Cont.) Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion PAN KRAS NCT06607185 Pancreatic Ductal Adenocarcinoma A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors 1 750 Number of Participants with Dose-limiting Toxicities (DLTs) Jan 2030 Jan 2030 SMARCA2 (BRM) NCT06561685 Metastatic Solid Tumor A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors 1 340 Phase 1a: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Oct 2027 Oct 2027 PI3Kα INH (STX-478) NCT05768139 Breast Cancer First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors (PIKALO-1) 1|2 720 Number of participants who experience at least 1 Dose Limiting Toxicity (DLT) Jul 2030 Jul 2030 PTK7 ADC NCT07046923 Carcinoma, Non- Small-Cell Lung A Study of LY4175408 in Participants With Advanced Cancer 1 240 Phase 1a-Number of Participants with Dose Limiting Toxicities of LY4175408 Jul 2030 Jul 2030
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2025 Q3 EARNINGS Not for promotional use 54 Trademarks All trademarks and trade names referred to in this earnings update are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this earnings update, the property of their respective owners. Solely for convenience, the trademarks and trade names in this earnings update are referred to without the ® and symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company’s or their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.