Investor Presentaiton

Made public by

sourced by PitchSend

50 of 62

Creator

PitchSend logo
PitchSend

Category

Pending

Published

Unknown

Slides

Transcriptions

#1Q2 2023 Earnings Call AUGUST 8, 2023 ||| Lilly#2Agenda INTRODUCTION AND RECENT KEY EVENTS Dave Ricks, Chair and Chief Executive Officer Q2 2023 FINANCIAL RESULTS Anat Ashkenazi, Chief Financial Officer R&D UPDATE Dan Skovronsky, M.D., Ph.D., Chief Scientific and Medical Officer CLOSING REMARKS Dave Ricks, Chair and Chief Executive Officer QUESTION AND ANSWER SESSION 2023 Q2 EARNINGS#3SAFE HARBOR PROVISION Lilly 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; economic conditions; and changes in laws and regulations, including health care reform. For additional information about the factors that affect the company's business, please see the company's latest Forms 10-K, 10-Q, and any 8-Ks 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. The company undertakes no duty to update forward-looking statements except as required by applicable law 2023 Q2 EARNINGS 3#4STRATEGIC DELIVERABLES PROGRESS SINCE THE LAST EARNINGS CALL Invest in Current Portfolio Gross Margin: Non-GAAP gross margin of 79.8% in Q2 SG&A: 18% increase in Q2 primarily driven by recent and upcoming product launches Invest in Future Innovation • R&D: 32% increase in Q2 driven by late- stage assets and early-stage research CAPEX: Commercial production initiated at the RTP facility Business Development: Completed the divestitures of Baqsimi and olanzapine; announced acquisitions of DICE Therapeutics, Sigilon Therapeutics and Versanis Bio Return Capital to Shareholders via: Deliver Revenue Growth Lilly 喝 Excluding Baqsimi® and sales of COVID-19 antibodies¹, revenue grew 22% in Q2, driven by volume growth of 23% Together, New Products and Growth Products2 contributed. approximately 26 percentage points of volume growth in Q2 Speed Life-Changing Medicines Dividend: Distributed over $1 billion in Q2 Announced positive results in the Phase 3 TRAILBLAZER- ALZ 2 study and the submission of donanemab for traditional approval to the FDA and in the EU; Announced the completed submission of tirzepatide in chronic weight management to the FDA and tirzepatide SURMOUNT-3 and -4 positive topline results; and Announced the approval of mirikizumab in the EU and re- submission in the U.S. Share Repurchase: $750 million YTD 1 Sales for COVID-19 antibodies include bamlanivimab, etesevimab and bebtelovimab sold pursuant to Emergency Use Authorization or similar regulatory authorizations 2 Refer to slide 9 for a list of New Products and Growth Products Not for promotional use 2023 Q2 EARNINGS 4#5KEY EVENTS SINCE THE LAST EARNINGS CALL Lilly REGULATORY . • • • Announced the completed regulatory submission of tirzepatide for chronic weight management to the FDA; Announced the regulatory submission of donanemab for traditional approval for early Alzheimer's disease in the US and EU; Announced mirikizumab received approval in the European Union (EU) for patients with ulcerative colitis and the resubmission to the FDA; Announced the submission of JaypircaⓇ to the FDA for accelerated approval in CLL patients based on the Phase 1/2 BRUIN study; Completed the submission of pirtobrutinib for relapsed or refractory mantle cell lymphoma in Japan; and Announced the FDA approval of Jardiance®1 to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes. CLINICAL Presented data at the 2023 Alzheimer's Association International Conference which showed that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease; and Announced topline data from two tirzepatide Phase 3 trials, SURMOUNT-3 and SURMOUNT-4, in which tirzepatide demonstrated significant and superior weight loss compared to placebo in both studies. OTHER • Announced an agreement to acquire DICE Therapeutics, a biopharmaceutical company that develops novel oral therapeutic candidates to treat chronic diseases in immunology; Announced an agreement to acquire Versanis Bio, a private clinical-stage biopharmaceutical company focused on the development of new medicines for the treatment of cardiometabolic diseases; Announced an agreement to acquire Sigilon Therapeutics, a biopharmaceutical company that seeks to develop functional cures for patients with a broad range of acute and chronic diseases; and Allocated an additional $50 million to our now $300 million Social Impact Venture Capital Portfolio, reflecting Lilly's commitment to going beyond the medicines it makes to have a positive impact on patients and society through for-profit investments. 1 Jardiance is part of the Boehringer Ingelheim (BI) and Lilly Alliance, and BI holds the marketing authorization for Jardiance Not for promotional use 2023 Q2 EARNINGS 5#6RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION; CERTAIN LINE ITEMS (UNAUDITED) Lilly Millions; except per share data Q2 2023 Non-GAAP GAAP Reported Adjustments Adjusted YoY Non-GAAP Adjusted Change TOTAL REVENUE $8,312 $ - $8,312 28% GROSS MARGIN 78.3% 1.5pp 79.8% (0.0)pp TOTAL OPERATING EXPENSE 4,379 4,379 14% OPERATING INCOME 2,126 126 2,252 69% OPERATING MARGIN 25.6% 1.5pp 27.1% 6.6pp OTHER INCOME (EXPENSE) (37) 54 17 NM EFFECTIVE TAX RATE 15.6% 0.5pp 16.1% 1.9pp NET INCOME $1,763 $141 $1,904 68% EPS $1.95 $0.16 $2.11 69% Acquired IPR&D Charges per share* $0.09 $ - $0.09 (80)% *Acquired IPR&D of $97 million (pre-tax) Numbers may not add due to rounding; see slide 25 for a complete list of adjustments Not for promotional use 2023 Q2 EARNINGS 6#7RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION; CERTAIN LINE ITEMS (UNAUDITED) Lilly Millions; except per share data 1H 2023 GAAP Reported Adjustments Non-GAAP Adjusted YoY Non-GAAP Adjusted Change TOTAL REVENUE $15,272 $ - $15,272 7% GROSS MARGIN 77.5% 1.7pp 79.2% 1.4pp TOTAL OPERATING EXPENSE 8,218 8,218 14% OPERATING INCOME 3,620 252 3,872 (2)% OPERATING MARGIN 23.7% 1.7pp 25.4% (2.2)p OTHER INCOME (EXPENSE) (1) 77 75 NM EFFECTIVE TAX RATE 14.1% 0.6pp 14.7% 3.1pp NET INCOME $3,108 $260 $3,368 (4)% EPS $3.44 $0.29 $3.73 (4)% Acquired IPR&D Charges per share* $0.19 $ - $0.19 (69)% *Acquired IPR&D of $202 million (pre-tax) Numbers may not add due to rounding; see slide 25 for a complete list of adjustments Not for promotional use 2023 Q2 EARNINGS 7#8PRICE/RATE/VOLUME EFFECT ON REVENUE Lilly Millions Q2 2023 Amount Price FX Rate Volume Total CER U.S. $5,531 2% 39% 41% 41% EUROPE 1,178 (6)% 1% 12% 7% 6% JAPAN 456 1% (7)% 7% 7% CHINA 399 (1)% (7)% 20% 13% 20% REST OF WORLD 748 (1)% (3)% 20% 16% 19% TOTAL REVENUE $8,312 (0)% (1)% 29% 28% 29% 1H 2023 Amount Price FX Rate Volume Total CER U.S. $9,968 (2)% 11% 9% 9% EUROPE 2,269 (6)% (3)% 13% 5% 7% JAPAN 843 - (10)% 7% (3)% 7% CHINA 772 (11)% (7)% 20% 2% 9% REST OF WORLD 1,422 1% (2)% 4% 2% 4% TOTAL REVENUE $15,272 (3)% (2)% 11% 7% 8% Numbers may not add due to rounding = CER price change + volume change Not for promotional use 2023 Q2 EARNINGS 8#9PRODUCTS DRIVING WW VOLUME GROWTH Contribution to 29% Q2 WW Volume Increase Growth Products New Products * All Other COVID-19 Antibodies -2.0% 5.6% 13.5% 12.1% *Includes $579 million from the sale of the worldwide rights for Baqsimi; Numbers may not add due to rounding New Products: Jaypirca, MounjaroⓇ, and OmvohⓇ Growth Products: CyramzaⓇ, EmgalityⓇ, Jardiance, Olumiant®, Retevmo®, TaltzⓇ, TrulicityⓇ, TyvytⓇ, and VerzenioⓇ COVID-19 Antibodies: bamlanivimab, etesevimab and bebtelovimab for the treatment of COVID-19 sold pursuant to Emergency Use Authorization or similar regulatory assumptions Not for promotional use 2023 Q2 EARNINGS Lilly 9#10Q2 2023 UPDATE ON SELECT PRODUCTS Millions $6,000 Growth Products New Products $5,000 $4,000 $3,000 $2,000 $1,000 $0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2020 2021 2022 2023 New Products: Jaypirca, Mounjaro, and Omvoh Growth Products: Cyramza, Emgality, Jardiance, Olumiant, Retevmo, Taltz, Trulicity, Tyvyt, and Verzenio Not for promotional use NEW PRODUCTS MOUNJARO • U.S. T2D launch in Q2 2022 Lilly U.S. T2D injectable incretins TRX SOM over 22% at end of Q2 2023 JAYPIRCA • U.S. MCL approval in Q1 2023 OMVOH Japan approval in Q1 2023; EU approval in Q2 2023 GROWTH PRODUCTS JARDIANCE • Market leader in U.S. with TRX SOM over 62% at the end of Q2 • U.S. TRX grew nearly 29% vs. Q2 2022, outpacing the market TALTZ U.S. TRX SOM at 6% at the end of Q2 • U.S. TRx grew over 11% vs. Q2 2022, outpacing the market TRULICITY . U.S. T2D injectable incretins TRX SOM of nearly 26% at the end of Q2 ⚫ U.S. TRx grew nearly 12% vs. Q2 2022 VERZENIO • U.S. TRx grew nearly 60% vs. Q2 2022 • Strong uptake in adjuvant breast cancer indication 2023 Q2 EARNINGS 10#11Prescriptions (TRX, 000s) Lilly Robust U.S. uptake bolstered by strong efficacy and a positive customer experience MOUNJARO U.S. LAUNCH PROGRESS 250 200 150 once weekly ▲ mounjaro (tirzepatide) injection тит 100 50 50 Mounjaro TRX Mounjaro Paid TRX* Trulicity TRX Semaglutide TRX L+1 L+4 L+7 L+10 L+13 L+16 L+19 L+22 L+25 L+28 L+31 L+34 L+37 L+40 L+43 L+46 L+49 L+52 L+55 Weeks Post Launch Mounjaro volume has significantly outpaced prior launches in the type 2 diabetes injectable incretin class *Internal estimate of weekly paid TRX IQVIA weekly data for week ending June 30, 2023 (type 2 diabetes injectable incretin class) Not for promotional use Access as of July 1st at 73% for patients with type 2 diabetes across total commercial and Part D lives Percentage of paid prescriptions rose to 67% in Q2 due to copay program dynamics and improved access Original non-covered $25 copay card ended June 30 Focus on driving new-to-brand growth while. continuing access expansion 2023 Q2 EARNINGS 11#12CAPITAL ALLOCATION Billions Return Growth Not for promotional use R&D* Capital Investments 1H 2023 Capital Allocation Lilly Business Development** $0.6 Dividend Share Repurchase * After tax $0.8 $1.4 $2.0 **Includes development milestones, closed acquisitions and cash outflows associated with equity investments; does not include cash inflows from divestitures 2023 Q2 EARNINGS $3.7 12#132023 GUIDANCE Prior Updated REVENUE $31.2 $31.7 billion $33.4 $33.9 billion GROSS MARGIN % OF REVENUE (GAAP) GROSS MARGIN % OF REVENUE (NON-GAAP) Approx. 77% Approx. 79% Approx. 78% Approx. 80% MKTG, SELLING & ADMIN. $7.0 $7.2 billion $7.2 $7.4 billion RESEARCH & DEVELOPMENT ACQUIRED IPR&D OTHER INCOME/(EXPENSE) (GAAP) OTHER INCOME/(EXPENSE) (NON-GAAP) TAX RATE EARNINGS PER SHARE (GAAP) EARNINGS PER SHARE (NON-GAAP) Assumes shares outstanding of 903 million Not for promotional use $8.3 $8.5 billion $8.9 $9.1 billion $105 million $202 million - $(200) $(100) million $(75) - $25 million $0 $100 million Approx. 13% 14% - 15% $8.18 $8.38 $8.65 - $8.85 $9.20 - $9.40 $9.70 - $9.90 2023 Q2 EARNINGS Lilly COMMENTS Increased range reflects revenue from the sales of rights for Baqsimi and olanzapine as well as strong performance in underlying business Increase driven by the sales of rights for Baqsimi and our olanzapine portfolio Increase reflects additional investments in recent launches and preparation for launches expected later this year Increase reflects additional investments in the late-stage portfolio and early-stage research and expected incremental expense from business development activities Incorporated IPR&D charges that have been incurred through Q2 2023; does not include any IPR&D charges associated with potential or pending business development transactions Increase driven by the interest impact of higher cash balances; reported guidance incorporates net losses on investments in equity securities Increase reflects the impact from the sales of rights for the olanzapine portfolio and Baqsimi FX assumptions: 1.12 (Euro), 139 (Yen) and 7.1 (Renminbi) 13#14ORFORGLIPRON: PHASE 2 TRIAL IN OBESITY DEMONSTRATED UP TO 14.7% MEAN BODY WEIGHT REDUCTION AT 36 WEEKS Percentage weight change from baseline 0- EFFICACY RESULTS Percentage Change in Body Weight by Week (efficacy estimand) Overall mean body weight at baseline -5- -10- -15- HOH HH Η HH HH HH = 109kg -2.3% -9.4% -12.5% -13.5% -14.7% KEY MESSAGES In the Phase 2 study of adults with obesity or overweight, 75% of participants achieved body weight reduction of 10% or more Safety profile was similar to other GLP-1 receptor agonists Lilly The ATTAIN Phase 3 program for orforglipron in chronic weight management began 1H of 2023 -20 24 8 12 16 20 26 32 36 Weeks Placebo (N=48) OFG 12 mg (N=44) OFG 24 mg (N=51) - OFG 36 mg (N=56) OFG 45 mg (N=57) Not for promotional use 2023 Q2 EARNINGS 14#15ORFORGLIPRON: PHASE 2 TRIAL IN TYPE 2 DIABETES DEMOSTATED MEAN REDUCTION IN HBA1C OF 2.1% IN PEOPLE WITH T2D AT 26 WEEKS HbA1c Change from Baseline (%) EFFICACY RESULTS 0 Mean reduction in HbA1c up to 2.1% -0.5- -1.0- -1.5- -2.0- PBO: -0.4 Dula: -1.1** 3 mg: -1.2** 24 mg: -1.8**## 12 mg -1.9**## 36 mg: -2.0**## 45 mg: -2.1**## KEY MESSAGES Over 90% of participants on the highest three doses achieved HbA1c levels less than 7%, and 18%-34% of participants reached HbA1C less than 5.7% Lilly -2.5 4 8 12 Weeks 16 20 26 Placebo (N=55) Dula 1.5 mg (N=49) OFG 3 mg (N=46) ✰ OFG 24 mg (N=42) OFG 36 mg (N=57) OFG 12 mg (N=49) OFG 45 mg (N=58) *p<0.05 vs PBO, **p<0.001 vs PBO, #p<0.05 vs dula, ##p<0.001 vs dula; Dula - dulaglutide, PBO - placebo Reduction in mean body weight up to 10.1 kg. Safety profile was similar to other incretin- based therapies The ACHIEVE Phase 3 program for orforglipron in type 2 diabetes is underway Not for promotional use 2023 Q2 EARNINGS 15#16RETATRUTIDE DEMONSTRATED A MEAN WEIGHT REDUCTION OF UP TO 24.2% AT 48 WEEKS Percent change in body weight (%) 10 -10 EFFICACY RESULTS 48 -30 36 1 4 8 12 16 20 24 Weeks since Randomization -2.1% -8.7% -16.3% -17.8% -21.7% -23.9% -24.2% Placebo RETA 1 mg RETA 8 mg [ID 2 mg] RETA 4 mg [ID 2 mg] RETA 4 mg [ID 4 mg] RETA 8 mg [ID 4 mg] Not for promotional use RETA 12 mg [ID 2 mg] KEY MESSAGES Lilly In the Phase 2 trial of adults with overweight and obesity, treatment was associated with improvements in cardiometabolic and hepatic measures at weeks 24 and 48 Safety profile was similar to other incretin-based therapies. Initiated the TRIUMPH Phase 3 program, which includes multiple studies that will evaluate safety and efficacy for chronic weight management, obstructive sleep apnea, and knee osteoarthritis in people with overweight and obesity In a Phase 2 trial in type 2 diabetes, participants achieved an HbA1c reduction of up to 2.0% on average; plan to advance retatrutide into Phase 3 for type 2 diabetes 2023 Q2 EARNINGS 16#17TIRZEPATIDE: SURMOUNT-3 & SURMOUNT-4 TRIALS DEMONSTRATED SIGNIFICANT AND SUPERIOR WEIGHT LOSS COMPARED TO PLACEBO Lilly SURMOUNT-3 SURMOUNT-3 evaluated the efficacy and safety of tirzepatide compared to placebo for 72 weeks after a 12- week intensive lifestyle intervention lead-in period Participants, after 12 weeks of intensive lifestyle intervention, achieved an additional 21.1% mean weight loss with tirzepatide for a total mean weight loss of 26.6% over 84 weeks Safety profile was similar to incretin-based therapies approved for the treatment of obesity and overweight SURMOUNT-4 SURMOUNT-4 evaluated the efficacy and safety of tirzepatide compared to placebo for 52 weeks after a 36- week open-label tirzepatide lead-in period Participants achieved 21.1% mean weight loss during a 36- week tirzepatide lead-in period and an additional 6.7% mean weight loss during a 52-week continued treatment period, for a total mean weight loss of 26.0% over 88 weeks Safety profile was similar to incretin-based therapies approved for the treatment of obesity and overweight Not for promotional use 2023 Q2 EARNINGS 17#18LILLY SELECT NME AND NILEX PIPELINE August 4, 2023 Lilly UCENPRUBART (CD200R MAB AGONIST) Immunology RETATRUTIDE Diabetes GBA1 GENE THERAPY Gaucher Disease Type 1 SSTR4 AGONIST Pain RELAXIN-LA Heart Failure TIRZEPATIDE NASH PIRTOBRUTINIB B-Cell Malignancies GBA1 GENE THERAPY Gaucher Disease Type 2 SOLBINSIRAN RET INHIBITOR II Cancer RIPK1 INHIBITOR Immunology SARM1 INHIBITOR Neurodegeneration NRG4 AGONIST Heart Failure NISOTIROSTIDE (PYY ANALOG) Diabetes KRAS G12C II Cancer KV1.3 ANTAGONIST Immunology PI3K SELECTIVE Cancer PNPLA3 siRNA NASH CVD NOT DISCLOSED Diabetes NOT DISCLOSED Pain P2X7 INHIBITOR Pain MAZDUTIDE Obesity MUVALAPLIN CVD LEPODISIRAN GIPR AGONIST LA Diabetes GIPR AGONIST LA II Diabetes CD19 ANTIBODY Immunology DACRA QW II Obesity AMYLIN AGONIST LA Obesity APOC3 siRNA CVD PHASE 1 IDH1/2 INHIBITOR Cancer GIP/GLP COAGONIST PEPTIDE Diabetes GITR ANTAGONIST Immunology FGFR3 SELECTIVE Cancer AT2R ANTAGONIST Pain (LPA siRNA) CVD GBA1 GENE THERAPY Parkinson's Disease BTLA MAB AGONIST Systemic Lupus Erythematosus PERESOLIMAB Rheumatoid Arthritis O-GLCNACASE INH Alzheimer's Disease MEVIDALEN Symptomatic LBD GRN GENE THERAPY Frontotemporal Dementia ELTREKIBART Hidradenitis Suppurativa PHASE 2 ORFORGLIPRON Diabetes TIRZEPATIDE MMO TIRZEPATIDE Obstructive Sleep Apnea NME NILEX TIRZEPATIDE Heart Failure pEF * Commercial Collaboration TIRZEPATIDE CV Outcomes SELPERCATINIB Adjuvant RET+ NSCLC PIRTOBRUTINIB R/R CLL Monotherapy PIRTOBRUTINIB 1L CLL Monotherapy IMLUNESTRANT Adjuvant Breast Cancer DONANEMAB Preclinical Alzheimer's Disease ABEMACICLIB Hormone Sensitive Prostate Cancer RETATRUTIDE Obesity REMTERNETUG Alzheimer's Disease IMLUNESTRANT ER+ HER2-mBC SELPERCATINIB 1L Med Thyroid Cancer PIRTOBRUTINIB R/R MCL Monotherapy PIRTOBRUTINIB R/R CLL Combination MIRIKIZUMAB Crohn's Disease EMPAGLIFLOZIN* Post MI ABEMACICLIB MBC Sequencing ABEMACICLIB Castrate Resistant Prostate Cancer ORFORGLIPRON Obesity INSULIN EFSITORA ALFA Diabetes PHASE 3 LEGEND MOVEMENT SINCE April 24, 2023 ADDITION or MILESTONE ACHIEVED REMOVAL Phase 3 in China with Innovent for T2DM and Obesity PIRTOBRUTINIB CLL Accelerated Approval TIRZEPATIDE Obesity LEBRIKIZUMAB Atopic Dermatitis DONANEMAB Alzheimer's Disease REG REVIEW EMPAGLIFLOZIN* Chronic Kidney Disease APPROVED Not for promotional use 2023 Q2 EARNINGS 18#19POTENTIAL KEY EVENTS 2023 New since last update Lilly Phase 3 Initiations Basal Insulin-Fc for type 2 diabetes (QWINT-1) Regulatory Submissions Tirzepatide for chronic weight management (US/EU) Tirzepatide for chronic weight management (H2H vs semaglutide 2.4 mg) Lebrikizumab for atopic dermatitis (J) ✓ Retatrutide for chronic weight management + ✓ Orforglipron for chronic weight management Orforglipron for type 2 diabetes Remternetug for early Alzheimer's disease (efficacy trials) Phase 3 Data Disclosures Donanemab for early Alzheimer's disease Tirzepatide for chronic weight management (SURMOUNT-2) Tirzepatide for chronic weight management (SURMOUNT-3) Tirzepatide for chronic weight management (SURMOUNT-4) Mirikizumab for Crohn's disease Abemaciclib for castrate-resistant prostate cancer (CYCLONE-2) Pirtobrutinib for CLL prior BTKI (BRUIN CLL-321) Empagliflozin for chronic kidney disease 1 (US/EU/J) Donanemab for early Alzheimer's disease 2 (US/EU/J) Pirtobrutinib for MCL prior BTKi (J) Pirtobrutinib for CLL prior BTKi and BCL213 Regulatory Actions Donanemab for early Alzheimer's disease³ (US) Lebrikizumab for atopic dermatitis (US/EU) Mirikizumab for ulcerative colitis (US/EU/J Pirtobrutinib for MCL prior BTKI (US/EU) Empagliflozin for chronic kidney disease 1 (US/EU/J) Tirzepatide for chronic weight management (US) Pirtobrutinib for CLL prior BTKi and BCL2i3 1 In collaboration with Boehringer Ingelheim 2 Under the traditional approval pathway 3 Under the FDA Accelerated Approval Program Not for promotional use 2023 Q2 EARNINGS 19#20Q2 2023 SUMMARY Lilly • Excluding COVID-19 antibodies and Baqsimi, revenue grew 22%, driven by 23% volume growth • Continued to speed life-changing medicines to patients with: • Positive results in the Phase 3 TRAILBLAZER-ALZ 2 study and the submission of donanemab for traditional approval to the FDA; • The completed submission of tirzepatide in chronic weight management to the FDA and SURMOUNT-3 and SURMOUNT-4 positive topline results; and • The approval of mirikizumab in the EU and re-submission in the U.S. • Announced several acquisitions and deployed over $1 billion to shareholders via the dividend Q2 investment growth driven by investments in new products and indications and late-stage pipeline Not for promotional use Invest in Current Portfolio Invest in Future Innovation Deliver Revenue Growth R Speed Life-Changing Medicines Return Capital to Shareholders 2023 Q2 EARNINGS 20 20#21SUPPLEMENTAL SLIDES ||| Lilly#222023 INCOME STATEMENT - REPORTED Lilly Millions; except per share data Q2 2023 Change 1H 2023 Change TOTAL REVENUE $8,312 28% $15,272 7% GROSS MARGIN 78.3% 0.3pp 77.5% 2.0pp TOTAL OPERATING EXPENSE* 4,379 14% 8,218 14% OPERATING INCOME 2,126 76% 3,620 OPERATING MARGIN 25.6% 6.9pp 23.7% (1.6)p OTHER INCOME (EXPENSE) (37) (69)% [1] (100)% EFFECTIVE TAX RATE 15.6% 2.9pp 14.1% 4.9pp NET INCOME $1,763 85% $3,108 9% EARNINGS PER SHARE $1.95 86% $3.44 9% * Includes research and development expense, marketing, selling and administrative expense, and acquired in-process research and development charges. Not for promotional use 2023 Q2 EARNINGS 22 22#23NON-GAAP OPERATING MARGIN % OF REVENUE Lilly 30.0% 29.0% 28.0% 27.0% 26.0% 25.0% 24.0% Q1 Q2 Q3 2021 MOVING ANNUAL TOTAL 70 Q4 Q1 00 Q2 03 Q3 Q4 Q1 Q2 2022 2023 Individual Quarter 23.1% 29.1% 27.9% 27.0% 33.4% 20.5% 28.9% 27.4% 23.3% 27.1% Op. Margin % of Revenue: Op. Margin impact of -4.6% -0.6% -2.6% -5.5% -2.1% -6.8% -0.9% -3.3% -1.5% -1.2% Acquired IPR&D Charges The line in the graph is a moving annual total (i.e. trailing 4 quarters) while the row of numbers is from specific quarters. Not for promotional use 2023 Q2 EARNINGS 23#24EFFECT OF FX ON 2023 RESULTS Year-on-Year Change Q2 2023 1H 2023 REPORTED With FX w/o FX With FX w/o FX TOTAL REVENUE 28% 29% 7% 8% COST OF SALES 26% 27% (2)% (1)% GROSS MARGIN 29% 30% 10% 11% OPERATING EXPENSE 14% 14% 14% 15% OPERATING INCOME 76% 81% 0% 3% EARNINGS PER SHARE 86% 92% 9% 13% NON-GAAP With FX w/o FX With FX w/o FX TOTAL REVENUE 28% 29% 7% 8% COST OF SALES 28% 29% 0% 1% GROSS MARGIN 28% 29% 9% 10% OPERATING EXPENSE 14% 14% 14% 15% OPERATING INCOME 69% 74% -2% 1% EARNINGS PER SHARE 69% 73% -4% -1% Lilly Presentation includes GAAP and non-GAAP figures excluding impact of foreign exchange rates. Current period figures recalculated by keeping constant the exchange rates from the base period. Not for promotional use 2023 Q2 EARNINGS 24#25EPS RECONCILIATION Lilly Q2 2023 Q2 2022 % Change 1H 2023 1H 2022 % Change EPS (REPORTED) $1.95 $1.05 86% $3.44 $3.16 9% AMORTIZATION OF INTANGIBLE 0.11 0.11 0.22 0.29 (24)% ASSETS NET LOSSES (GAINS) ON 0.05 0.09 44% 0.07 0.43 (84)% INVESTMENTS IN EQUITY SECURITIES EPS (NON-GAAP) $2.11 $1.25 69% $3.73 $3.87 (4)% Acquired IPR&D $0.09 $0.46 (80)% $0.19 $0.61 (69)% 2023 Q2 EARNINGS Numbers may not add due to rounding; see slides 26 & 27 for more details on these adjustments. Not for promotional use 25 25#26Q2 2023 INCOME STATEMENT NOTES Lilly Q2 2023 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO EXCLUDE: amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties totaling $126.4 million (pretax), or $0.11 per share (after-tax); and net losses on investments in equity securities totaling $53.9 million (pretax), or $0.05 per share (after-tax). Q2 2022 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO EXCLUDE: amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties totaling $121.3 million (pretax), or $0.11 per share (after-tax); and net losses on investments in equity securities totaling $106.3 million (pretax), or $0.09 per share (after-tax). Not for promotional use 2023 Q2 EARNINGS 26#271H 2023 INCOME STATEMENT NOTES Lilly 1H 2023 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO EXCLUDE: amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties totaling $252.2 million (pretax), or $0.22 per share (after-tax); and net losses on investments in equity securities totaling $76.5 million (pretax), or $0.07 per share (after-tax). 1H 2022 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO EXCLUDE: • amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties totaling $325.9 million (pretax), or $0.29 per share (after-tax); and net losses on investments in equity securities totaling $494.7 million (pretax), or $0.43 per share (after-tax). Not for promotional use 2023 Q2 EARNINGS 27#28COMPARATIVE EPS SUMMARY 2022/2023 Lilly 1Q22 2Q22 3Q22 4Q22 2022 1Q23 2Q23 3Q23 4Q23 2023 Reported 2.10 1.05 1.61 2.14 6.90 1.49 1.95 Non-GAAP 2.62 1.25 1.98 2.09 7.94 1.62 2.11 Numbers may not add due to rounding For a complete reconciliation to reported earnings, see slide 25 and our earnings press release dated August 8th, 2023 Not for promotional use 2023 Q2 EARNINGS 28#29Q2 2023 TRULICITY SALES DECREASED 5% Millions U.S. sales decreased 4% International sales decreased 8% Lilly U.S. TRX SOM and Market Volume 52% 1000 Market 48% 900 $1,977 $1,912 $1,936 $1,813 $1,850 $1,741 13 WK RA TRX SOM 44% 800 40% 700 36% 600 32% 500 Trulicity 28% 400 24% 300 Q1 Q2 Q3 Q4 Jun Sep Dec Mar Jun Sep Dec Mar 2021 2021 2021 2022 2022 2022 2022 2023 2023 Jun Not for promotional use 2022 12023 Source: IQVIA NPA TRX 3MMA, weekly data June 30, 2023; RA = rolling average TRX data is representative of the injectable incretin market 2023 Q2 EARNINGS 13 WK RA TRX Market Volume (000s) 29 29#30Q2 2023 VERZENIO SALES INCREASED 57% Millions U.S. sales increased 53% International sales increased 66% $927 $469 $751 $618 $588 $808 13 WK RA TRX SOM U.S. TRX SOM and Market Volume 46% 41% 36% 31% 26% 21% 10 Verzenio Market 16% Q1 Q2 Q3 Q4 Jun Sep Dec Mar Jun Sep Dec Mar 2021 2021 2021 2022 2022 2022 2022 2023 2023 Jun 12022 2023 Not for promotional use Source: IQVIA NPA TRX 3MMA, weekly data June 30, 2023; RA = rolling average 2023 Q2 EARNINGS Lilly 13 WK RA TRX Market Volume (000s) 30#31Q2 2023 JARDIANCE SALES INCREASED 45% Millions U.S. sales increased 54% International sales increased 34% $419 $578 $461 Q1 Q2 Not for promotional use Lilly U.S. TRX SOM and Market Volume 63% 580 Jardiance1 $668 $612 $573 540 62% 500 13 WK RA TRX SOM 61% Market 460 420 60% 380 340 59% 300 58% 260 Q3 Q4 Jun Sep Dec Mar Jun 2021 2021 2021 2022 2022 Sep 2022 Dec Mar Jun 2022 2023 2023 2022 2023 Source: IQVIA NPA TRX 3MMA, weekly data June 30, 2023; RA = rolling average Jardiance is part of Lilly's alliance with Boehringer Ingelheim. 1 Jardiance includes Glyxambi and Synjardy 2023 Q2 EARNINGS 13 WK RA TRx Market Volume (000s) 31#32Q2 2023 TALTZ SALES INCREASED 16% Millions U.S. sales increased 15% International sales increased 19% $704 $680 $606 $527 $488 Q1 Q2 Not for promotional use 2022 2023 $708 13 WK RA TRX SOM U.S. TRX SOM and Market Volume 7% 6% 5% 4% Lilly 230 Taltz 220 210 Market 200 190 3% 180 Q3 Q4 Jun 2021 Sep Dec Mar Jun Sep Dec Mar Jun 2021 2021 2022 2022 2022 2022 2023 2023 Source: IQVIA NPA TRX 3MMA, weekly data June 30, 2023; RA = rolling average TRx data is representative of the full molecule market 2023 Q2 EARNINGS 13 WK RA TRx Market Volume (000s) 32#33Q2 2023 HUMALOG SALES DECREASED 1% Millions U.S. sales decreased 4% International sales increased 1% $618 $548 $461 $447 $440 $447 13 WK RA TRX SOM 50% 40% 30% 20% 10% U.S. TRX SOM Lilly Humalog + Insulin Lispro Humalog Lilly Insulin Lispro 0% Q1 Q2 Q3 Q4 Jun 2021 Sep Dec Mar Jun Sep Dec Mar Jun 2021 2021 2022 2022 2022 2022 2023 2023 2022 2023 Not for promotional use Source: IQVIA NPA TRX 3MMA, weekly data June 30, 2023; RA = rolling average 2023 Q2 EARNINGS 33#34Q2 2023 CYRAMZA SALES INCREASED 13% Millions U.S. sales increased 24% International sales increased 5% $260 $230 $237 $231 $232 $278 Q1 Q2 Q3 Q4 2022 2023 Not for promotional use Lilly Sales by Major Geography $300 $250 $200 $150 $100 $50 $0 Q1 Q2 Q3 2021 2021 Q4 Q1 Q2 Q4 Q1 Q2 2021 2021 2022 2022 2022 2022 2023 2023 Q3 ■■OUS ex Japan Japan US 2023 Q2 EARNINGS 34#35Q2 2023 OLUMIANT SALES INCREASED 18% Millions U.S. sales were $51 million International sales were $168 million $256 $229 $219 $206 $186 $183 Q1 Q2 Q3 Q4 2022 2023 Not for promotional use • In the U.S., launched in rheumatoid arthritis in Q3 2018 and in alopecial areata in Q2 2022 Q2 year-over-year sales growth primarily driven by alopecia areata sales in the U.S. 2023 Q2 EARNINGS Lilly 35#36Q2 2023 EMGALITY SALES INCREASED 8% Millions U.S. sales increased 9% International sales increased 3% $169 $169 $149 $154 $157 Q1 Q2 Not for promotional use 2022 2023 $176 13 WK RA TRX SOM U.S. TRX SOM and Market Volume 44% 42% 40% 38% Emgality 80 76 Market 2 72 Lilly 64 68 88 13 WK RA TRx Market Volume (000s) | 36% 60 Q3 Q4 Jun Sep Dec Mar Jun Sep Dec Mar Jun 2021 2021 2021 2022 2022 2022 2022 2023 2023 Source: IQVIA NPA TRX 3MMA, weekly data June 30, 2023; RA = rolling average TRx data is representative of the injectable CGRP market 2023 Q2 EARNINGS 36#37SELECT TRIALS - INSULIN EFSITORA ALFA Study Indication* NCT05462756 Type 2 Diabetes NCT05275400 Type 2 Diabetes NCT05662332 Type 2 Diabetes NCT05463744 Type 1 Diabetes Title A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (QWINT-4) A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3) A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1) A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy (QWINT-5) A Study of Insulin Efsitora Alfa (LY3209590) Compared to NCT05362058 Diabetes Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-2) * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Phase Patients Primary Outcome* ** Lilly Primary Completion Completion 3 730 Change from Baseline in Hemoglobin A1c (HbA1c) Mar 2024 Mar 2024 3 986 Change from Baseline in Hemoglobin A1c (HbA1c) May 2024 May 2024 3 796 Change from Baseline in Hemoglobin A1c (HbA1c) Jul 2024 Jul 2024 3 692 Change from Baseline in Hemoglobin A1c (HbA1c) May 2024 May 2024 3 912 Change from Baseline in Hemoglobin A1c (HbA1c) Apr 2024 Apr 2024 Source: clinicaltrials.gov, July 13, 2023 2023 Q2 EARNINGS 37#38SELECT TRIALS - DONANEMAB Lilly Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion Mild NCT05108922 Cognitive Impairment A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4) 3 200 Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on donanemab versus aducanumab Sep 2022 Sep 2023 NCT04437511 Alzheimer A Study of Donanemab (LY3002813) in Participants With Disease Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) 3 1800 Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) Apr 2023 Aug 2025 NCT04640077 Alzheimer Disease A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT) 2 90 Part A: Correlation between VTC and on-site assessment for PAIR 1 for Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Mar 2024 Mar 2024 NCT05738486 Alzheimer Disease A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6) 3 800 Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion Mar 2024 May 2025 (ARIA-E) NCT05508789 Alzheimer Disease NCT05026866 Alzheimer Disease Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3) 3 1500 Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Apr 2027 Jun 2027 3 3300 Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS) Oct 2027 Nov 2027 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, July 20, 2023 2023 Q2 EARNINGS 38 38#39SELECT TRIALS - IMLUNESTRANT Study Indication* Title Phase Patients Primary Outcome* ** Lilly Primary Completion Completion Breast NCT04975308 Neoplasms Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3) 3 860 Progression Free Survival (PFS) in the Intent-to-Treat (IIT) Population Apr 2024 Aug 2027 NCT05514054 Breast Neoplasms A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER- 3 4) 6000 Invasive Disease-Free Survival (IDFS) Oct 2027 Mar 2032 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, July 17, 2023 2023 Q2 EARNINGS 39#40SELECT TRIALS - JARDIANCE Study Indication* Title Phase Patients Primary Outcome* ** Lilly Primary Completion Completion NCT04509674 Myocardial Infarction EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction) 3 6522 Composite of time to first heart failure hospitalisation or all-cause mortality Aug 2023 Aug 2023 In collaboration with Boehringer Ingelheim 1 Also lists Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead) * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use 2023 Q2 EARNINGS Source: clinicaltrials.gov, July 27, 2023 40 40#41SELECT TRIALS - LEBRIKIZUMAB Lilly Study Indication* Title Phase Patients Primary Outcome* ** Primary Completion Completion NCT05369403 Atopic Dermatitis NCT05372419 A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab (ADapt) A Study of (LY3650150) Lebrikizumab to Assess the Safety Atopic and Efficacy of Adult and Adolescent Participants With Dermatitis Moderate-to-Severe Atopic Dermatitis and Skin of Color (ADmirable) 3 120 Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) >75% Reduction in EASI Score Oct 2023 Mar 2024 3 80 Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% reduction from baseline Mar 2024 Aug 2024 in EASI) NCT05559359 NCT04392154 Atopic Dermatitis Atopic Dermatitis A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-1) Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin) 3 300 Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline Aug 2024 in EASI Score Jul 2025 3 1000 Percentage of Participants Discontinued from Study Treatment due to Adverse Events through the Last Treatment Visit Sep 2024 Sep 2024 NCT05735483 A Study to Assess the Long-Term Safety and Efficacy of Atopic Lebrikizumab (LY3650150) in Participants 6 Months to <18 Dermatitis Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-2) 3 250 Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) Nov 2025 Jun 2026 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, July 24, 2023 2023 Q2 EARNINGS 41#42SELECT TRIALS - MIRIKIZUMAB Lilly Completion Study Indication* Title Phase Patients Primary Outcome* ** Primary Completion NCT03926130 Crohn's A Study of Mirikizumab (LY3074828) in Participants With Disease Crohn's Disease (VIVID-1) 3 1100 Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 Aug 2023 Dec 2023 NCT04232553 Crohn's A Long-term Extension Study of Mirikizumab (LY3074828) Disease in Participants With Crohn's Disease (VIVID-2) 3 778 Percentage of Participants Achieving Endoscopic Response Jan 2025 Apr 2027 NCT03518086 Ulcerative Colitis An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT- 1) 3 1281 Percentage of Participants With Clinical Remission at Week 12 Jan 2021 Mar 2024 NCT03524092 Ulcerative Colitis A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT- 2) 3 1177 Percentage of Participants in Clinical Remission at Week 40 Nov 2021 Apr 2026 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) 3 960 Percentage of Participants in Clinical Remission Jun 2025 Apr 2029 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, July 13, 2023 2023 Q2 EARNINGS 222 42#43SELECT TRIALS-ORFORGLIPRON Lilly Primary Completion Completion Study Indication* Title Phase Patients Primary Outcome* ** NCT05971940 Type 2 Diabetes A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise (ACHIEVE-1) 3 520 Change from Baseline in Hemoglobin A1c (HbA1c) Jan 2025 Jan 2025 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 2620 Time to First Occurrence of Any Major Adverse Cardiovascular Event (MACE-4) [Myocardial Infarction (MI),| Stroke, Hospitalization for Unstable Angina, or Cardiovascular (CV) Death] Jan 2025 Sep 2025 NCT05872620 Obesity A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2) 3 1500 Mean Percent Change from Baseline in Body Weight Jun 2025 Jun 2025 NCT05931380 Obesity A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease (ATTAIN-J) 3 236 Mean Percent Change in Body Weight Jun 2025 Jul 2025 NCT05869903 Obesity A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1) 3 3000 Mean Percent Change from Baseline in Body Weight Sep 2025 Sep 2027 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, August 2, 2023 2023 Q2 EARNINGS 43#44SELECT TRIALS - PIRTOBRUTINIB Study Indication* Chronic NCT04666038 Lymphocytic Leukemia Chronic NCT05023980 Lymphocytic Leukemia Chronic NCT04965493 Lymphocytic Leukemia Title Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-321) 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) 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) A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-314) Phase Patients 3 250 Primary Outcome* ** To evaluate progression-free survival (PFS) of LOXO-305 monotherapy (Arm A) compared to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) (Arm B) Lilly Primary Completion Completion Dec 2023 May 2027 3 250 To evaluate progression-free survival (PFS) of pirtobrutinib |(Arm A) compared to bendamustine and rituximab (Arm B) Nov 2024 Jul 2026 3 600 To evaluate progression-free survival (PFS) of pirtobrutinib| plus venetoclax and rituximab (Arm A) compared to venetoclax and rituximab (Arm B) Oct 2025 Jan 2027 Chronic NCT05254743 Lymphocytic Leukemia 3 650 Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR) Mar 2028 Mar 2029 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) Apr 2025 Apr 2025 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use 2023 Q2 EARNINGS Source: clinicaltrials.gov, July 11, 2023 44#45SELECT TRIALS - REMTERNETUG Lilly Primary Completion Completion Study Indication* Title Phase Patients Primary Outcome** NCT05463731 Alzheimer A Study of Remternetug (LY3372993) in Participants With Disease Alzheimer's Disease (TRAILRUNNER-ALZ 1) 3 600 Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo Oct 2025 Oct 2026 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, July 24, 2023 2023 Q2 EARNINGS 45#46SELECT TRIALS - RETATRUTIDE Lilly Study Indication* Title Phase Patients Primary Outcome* ** Primary Completion Completion Chronic NCT05936151 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 2 120 Change from Baseline in Glomerular Filtration Rate (GFR) Feb 2025 Feb 2025 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 Percent Change from Baseline in Body Weight and Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score Oct 2025 Nov 2025 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 Nov 2025 Dec 2025 NCT05929066 Obesity A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight (TRIUMPH-1) 3 2100 Percent Change From Baseline in Body Weight Apr 2026 May 2026 NCT05929079 A Study of Retatrutide (LY3437943) in Participants With Obesity Type 2 Diabetes Mellitus Who Have Obesity or Overweight (TRIUMPH-2) 3 1000 Percent Change from Baseline in Body Weight May 2026 May 2026 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, July 18, 2023 46 2023 Q2 EARNINGS 40#47SELECT TRIALS - RETEVMO Study Indication* Title Phase Patients Primary Outcome* ** Lilly Primary Completion Completion Medullary NCT04211337 Thyroid Cancer A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) 3 400 Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) May 2024 Nov 2026 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|2 875 Non- Small Cell NCT04194944 NCT04819100 Lung Cancer Carcinoma, Non- Small-Cell A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (LIBRETTO-431) A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) (LIBRETTO-432) 3 170 Lung * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Phase 1: MTD; Phase 2: ORR Mar 2024 Sep 2024 3 250 Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (with Pembrolizumab) Dec 2024 Jul 2027 Event-Free Survival (EFS) Aug 2028 Nov 2032 Source: clinicaltrials.gov, July 13, 2023 47 2023 Q2 EARNINGS#48SELECT TRIALS - TIRZEPATIDE Study Indication* Title Phase Patients Primary Outcome* ** Lilly Primary Completion Completion NCT04184622 Obesity A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight (SURMOUNT-1) 3 2539 Percent Change from Baseline in Body Weight Apr 2022 Jul 2024 A Study of Tirzepatide (LY3298176) in Participants With NCT05822830 Obesity Obesity or Overweight With Weight Related Comorbidities NCT05556512 Obesity (SURMOUNT-5) A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity (SURMOUNT-MMO) 3 700 Percent Change from Baseline in Body Weight Nov 2024 Dec 2024 3 15000 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 NCT04255433 Type 2 Diabetes A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes (SURPASS-CVOT) 3 13299 Time to First Occurrence of Death from Cardiovascular [CV] Causes, Myocardial Infarction (MI), or Stroke (MACE- 3) Oct 2024 Oct 2024 NCT05260021 Type 2 Diabetes A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both (SURPASS-PEDS) 3 90 Change From Baseline in Hemoglobin A1c (HbA1c) Nov 2027 Dec 2027 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, July 14, 2023 2023 Q2 EARNINGS 48#49SELECT TRIALS - TIRZEPATIDE (CONT.) Lilly Primary Completion Completion Study Indication* Title Phase Patients Primary Outcome* ** NCT04166773 Steatohepatitis Nonalcoholic A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (SYNERGY-NASH) 2 196 Percentage of Participants with Absence of NASH with no Worsening of Fibrosis on Liver Histology Jan 2024 Feb 2024 NCT05412004 Sleep Apnea Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea (SURMOUNT-OSA) 3 469 Percent Change from Baseline in Apnea-Hypopnea Index (AHI) Mar 2024 Mar 2024 A Study of Tirzepatide (LY3298176) in Participants With NCT04847557 HFpEF Heart Failure With Preserved Ejection Fraction and Obesity 3 700 (SUMMIT) NCT05536804 CKD A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or 2 Without Type 2 Diabetes (TREASURE-CKD) 140 A Hierarchical Composite of All-Cause Mortality, Heart Failure Events, 6-minute Walk Test Distance (6MWD) and Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) Category Jun 2024 Jul 2024 Change from Baseline in Kidney Oxygenation in Participants With or Without T2D [ Time Frame: Baseline, Week 52 ]; Blood oxygenation-level dependent magnetic resonance imaging (BOLD MRI) Oct 2025 Nov 2025 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, July 25, 2023 2023 Q2 EARNINGS 49#50SELECT TRIALS - VERZENIO Study Indication* Title Phase Patients Primary Outcome* ** Lilly 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) 3 350 Progression-Free Survival (PFS) Nov 2023 Feb 2026 NCT03706365 Prostate Cancer NCT05288166 Prostatic |Neoplasms A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer (CYCLONE 2) A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3) 1 Also lists NSABP Foundation Inc * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use 2|3 350 Radiographic Progression-Free Survival (rPFS) Nov 2023 Jun 2026 3 900 Radiographic Progression-Free Survival (rPFS) Assessed by Investigator Oct 2025 Oct 2027 Source: clinicaltrials.gov, July 14, 2023 2023 Q2 EARNINGS 50#51SELECT TRIALS - EARLY PHASE DIABETES AND OBESITY Lilly Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion Lepodisiran (LPA siRNA) NCT05565742 Lipoprotein A Study of LY3819469 in Participants With Elevated Disorder Lipoprotein(a) [Lp(a)] (ALPACA) 2 254 Percent Change from Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Oct 2023 Oct 2024 Muvalaplin NCT05563246 Lipoprotein Disorder A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (KRAKEN) 2 233 Percent Change from Baseline in Lipoprotein (a) Lp(a) Jan 2024 Jan 2024 Solbinsiran NCT05256654 Dyslipidemias A Study of LY3561774 in Participants With Mixed Dyslipidemia (PROLONG-ANG3) 2 175 Percent Change from Baseline for Apolipoprotein B (ApoB) Mar 2024 Jun 2024 Relaxin-LA NCT05592275 Heart Failure A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction (HFPEF) 2 432 Change from Baseline in Left Atrial Reservoir Strain (LARS) Nov 2024 Jan 2025 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, August 1, 2023 2023 Q2 EARNINGS 51#52SELECT TRIALS - EARLY PHASE DIABETES AND OBESITY (CONT.) Lilly Molecule Study Indication* Title Phase Patients DACRA QW II NCT05380323 Obesity A Study of LY3541105 in Healthy and Overweight Participants 1 160 GIPR Agonist LA II NCT05407961 Diabetes Mellitus, Type 2 A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus 1 92 Primary Outcome** 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 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 Primary Completion Completion Oct 2023 Oct 2023 Oct 2023 Oct 2023 Nisotirostide Diabetes (PYY Analog NCT05377333 Agonist) Mellitus, Type 2 A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes 1 86 be Related to Study Drug Administration Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Nov 2023 Nov 2023 Amylin Agonist LA NCT05295940 Obesity A Study of LY3841136 in Healthy and Overweight Participants 1 160 Related to Study Drug Administration Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Jan 2024 Jan 2024 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Related to Study Drug Administration Source: clinicaltrials.gov, July 14, 2023 2023 Q2 EARNINGS 52 62#53SELECT TRIALS - EARLY PHASE DIABETES AND OBESITY (CONT.) Lilly Molecule Study Indication* Title Phase Patients APOC3 siRNA NCT05609825 Hypertriglyce A Study of LY3875383 in Healthy Participants and ridemia Participants With Hypertriglyceridemia 1 120 NRG4 Agonist NCT04840914| HFrEF A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction 1 50 PNPLA3 siRNA NCT05395481 Non- Alcoholic Fatty Liver Disease A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Nonalcoholic Fatty Liver Disease 1 176 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use 2023 Q2 EARNINGS Primary Outcome** Primary Completion Completion 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 Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Jan 2024 Jan 2024 Mar 2024 Mar 2024 Serious Adverse Event(s) (SAEs) Considered by the Nov 2024 Nov 2024 Investigator to be Related to Study Drug Administration Source: clinicaltrials.gov, July 13, 2023 53 53#54SELECT TRIALS - EARLY PHASE IMMUNOLOGY Lilly Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion Peresolimab NCT05516758 Rheumatoid Arthritis A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (RESOLUTION-1) 2 420 BTLA MAB Agonist NCT05123586 Systemic Lupus Erythematosus A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus 2 90 Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percentage of Participants with Arthritis and/or Rash at Baseline Who Achieve Remission of Arthritis and/or Rash Nov 2023 Jan 2025 Jan 2024 Apr 2024 Ucenprubart (CD200R MAB NCT05911841 Agonist) RIPK1 Inhibitor Atopic Dermatitis A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic 2 260 Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75 Sep 2024 Jul 2025 Dermatitis NCT05848258 Arthritis Rheumatoid An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis 2 380 hsCRP) GITR Antagonist NCT05486208 Healthy Antibody A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis 1 86 CD19 NCT05042310 Healthy A Study of LY3541860 in Healthy Japanese and Non- Japanese Participants 1 84 * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use 2023 Q2 EARNINGS Phase 2a: Change from Baseline in Disease Activity Score high-sensitivity C-reactive protein (DAS28- Feb 2026 Jul 2026 Number of Participants with One or More Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration 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 Jan 2024 Jan 2024 Jun 2024 Jun 2024 Source: clinicaltrials.gov, July 27, 2023 54#55SELECT TRIALS - EARLY PHASE NEURODEGENERATION Lilly Molecule Study Indication* Title Phase Patients O-GlcNAcase Inh. NCT05063539 Alzheimer Disease A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease 2 330 SARM1 CNS Inhibitor NCT05492201 Healthy A Study of LY3873862 in Healthy Participants 1 90 GRN Gene Therapy NCT04408625 Frontotemporal Dementia Phase 1/2 Clinical Trial of PR006 in Patients With Frontotemporal Dementia With Progranulin Mutations (FTD-GRN) (PROCLAIM) 1|2 15 GBA1 Gene Therapy NCT04411654 GBA1 Gene Therapy NCT04127578 Gaucher Disease, Type 2 Parkinson Disease Phase 1/2 Clinical Trial of PR001 in Infants With Type 2 Gaucher Disease (PROVIDE) 1|2 15 Primary Outcome** Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS)| 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 Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events Leading to discontinuation Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events leading to discontinuation Primary Completion Completion Jul 2024 Aug 2024 Apr 2024 Apr 2024 Dec 2027 Dec 2027 Sep 2028 Sep 2028 Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One 12 GBA1 Mutation (PROPEL) 20 Cumulative number of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Jun 2029 Jun 2029 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 Sep 2030 Sep 2030 (SAEs) * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use 2023 Q2 EARNINGS Source: clinicaltrials.gov, July 13, 2023 55#56SELECT TRIALS - EARLY PHASE ONCOLOGY Lilly Molecule Study Indication* Title Phase Patients Primary Outcome** Primary Completion Completion Carcinoma, KRAS G12C1 NCT04956640 Non-Small- Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C) 1 400 Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy Sep 2025 Sep 2025 Cell Lung PI3K Selective NCT05307705 Breast Cancer A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PIKASSO-01) 1 400 Phase 1a: To determine the MTD/RP2D of LOXO-783:| Number of patients with dose-limiting toxicities (DLTs) May 2025 May 2025 FGFR3 Selective RET Inhibitor || Urinary NCT05614739 Bladder Neoplasms Carcinoma, NCT05241834 Non-Small- Cell Lung A Study of LOXO-435 in Patients With Cancer With a Change in a Gene Called FGFR3 1 140 Phase 1a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-435: Number of patients with dose-limiting toxicities (DLTs) Jun 2025 Jun 2025 A Study of LOXO-260 in Cancer Patients With a Change in a Particular Gene (RET) That Has Not Responded to Treatment 1 110 Phase 1a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate Apr 2026 Apr 2026 Also lists Merck Sharp & Dohme LLC * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Source: clinicaltrials.gov, July 21, 2023 2023 Q2 EARNINGS 56#57SELECT TRIALS - EARLY PHASE PAIN Molecule Study Indication* Title A Chronic Pain Master Protocol (CPMP): A Study of P2X7 Inhibitor NCT05620576 Chronic Pain LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05) * Molecule may have multiple indications ** Trial may have additional primary and other secondary outcomes Not for promotional use Phase Patients Primary Outcome** Lilly Primary Completion Completion 2 125 Change from Baseline for Average Pain Intensity as measured by the Numeric Rating Scale (NRS) Jul 2023 Aug 2023 Source: clinicaltrials.gov, July 12, 2023 2023 Q2 EARNINGS 57#58Lilly

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Q4 & FY22 - Investor Presentation image

Q4 & FY22 - Investor Presentation

Financial Services

FY23 Results - Investor Presentation image

FY23 Results - Investor Presentation

Financial Services

Ferocious - Plant Growth Optimizer image

Ferocious - Plant Growth Optimizer

Agriculture

Market Outlook and Operational Insights image

Market Outlook and Operational Insights

Metals and Mining

2023 Investor Presentation image

2023 Investor Presentation

Financial

Leveraging EdTech Across 3 Verticals image

Leveraging EdTech Across 3 Verticals

Technology

Axis 2.0 Digital Banking image

Axis 2.0 Digital Banking

Sustainability & Digital Solutions

Capital One’s acquisition of Discover image

Capital One’s acquisition of Discover

Mergers and Acquisitions