Eli Lilly And Company · NYSE:LLY
Eli Lilly And — Q3 2024 Earnings Presentation
61 slides from Eli Lilly And's earnings presentation, Oct 30, 2024
Slide 1: A Medicine Company
A MEDICINE COMPANY
Slide 2: Eli Lilly and Company Q3 2024 Earnings Call
ELI LILLY AND COMPANY Q3 2024 EARNINGS CALL 10.30.24
Slide 3: Agenda
Agenda Introduction and Key Events Dave Ricks, Chair and Chief Executive Officer Q3 2024 Financial Results Lucas Montarce, Chief Financial Officer R&D Update Dan Skovronsky, M.D., Ph.D., Chief Scientific Officer Closing Remarks Dave Ricks, Chair and Chief Executive Officer Question & Answer Session
Slide 4: Safe Harbor Provision
Safe Harbor Provision 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 uncertaintie
Slide 5: Strategic Deliverables
Strategic Deliverables PROGRESS SINCE THE LAST EARNINGS CALL Invest in Current Portfolio Deliver Revenue Growth • Gross Margin: Non-GAAP gross margin of 82.2% in Q3 • Excluding the olanzapine portfolio sale in Q3 2023, revenue grew 42% in Q3 • SG&A: 16% increase primarily driven by promotional effor
Slide 6: Key Events Since Last Earnings Call
Key Events Since Last Earnings Call Regulatory Clinical (Cont) • Ebglyss approved in the U.S. for adults and children 12 years or older with • Disclosed that the Phase 3 EMBER-3 study evaluating our oral SERD, moderate-to-severe atopic dermatitis; and imlunestrant, in patients with second-line ER+ H
Slide 7: Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Q3)
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information; Certain Line Items (Unaudited) Dollars in millions; except per share data Q3 2024 YoY Non-GAAP GAAP Reported Adjustments Non-GAAP Adjusted Adjusted Change TOTAL REVENUE $11,439 $– $11,439 20% GROSS MARGIN 81.0% 1.2pp 82.2% 0.5pp TOTAL
Slide 8: Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (YTD)
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information; Certain Line Items (Unaudited) Dollars in millions; except per share data YTD 2024 YoY Non-GAAP GAAP Reported Adjustments Non-GAAP Adjusted Adjusted Change TOTAL REVENUE $31,510 $– $31,510 27% GROSS MARGIN 80.9% 1.3pp 82.2% 2.1pp TOTA
Slide 9: Price/Rate/Volume Effect on Revenue
Price/Rate/Volume Effect on Revenue Dollars in millions Q3 2024 Amount Price FX Rate Volume Total CER U.S. $7,814 11% – 35% 46% 46% EUROPE 1,628 (1)% (0)% (36)% (37)% (36)% JAPAN 429 (3)% (7)% 20% 10% 17% CHINA 460 4% 1% 13% 18% 17% REST OF WORLD 1,108 0% (3)% 45% 42% 45% TOTAL REVENUE $11,439 6% (1
Slide 10: Q3 2024 Update on Select Products
Q3 2024 Update on Select Products NEW PRODUCTS Millions MOUNJARO $10,000 • U.S. T2D injectable incretins TRx SOM nearly 34% and NBRx SOM nearly 41% at end of Q3 2024 $9,000 ZEPBOUND • U.S. branded anti-obesity TRx SOM nearly 43% and NBRx SOM over $8,000 51% at end of Q3 2024 JAYPIRCA $7,000 • Q3 202
Slide 11: Zepbound U.S. Launch Progress
Zepbound U.S. Launch Progress 700 650 600 Continued strong underlying prescription growth 550 Broad commercial formulary coverage in the U.S. – as of 500 Prescriptions (TRx, 000s) Oct 1 we had approximately 87% access 450 400 Ongoing progress expanding employer opt-ins 350 300 Launched single-dose 2
Slide 12: Capital Allocation
Capital Allocation $ in Billions YTD 2024 Capital Allocation R&D* Growth Capital Investments Business Development** Dividend Return Share Repurchase * After tax ** Includes development milestones, closed acquisitions and cash outflows associated with equity investments 2024 Q3 EARNINGS Not for promo
Slide 13: 2024 Guidance
2024 Guidance Prior Updated Comments The updated midpoint represents approximately 50% growth REVENUE $45.4 – $46.6 billion $45.4 – $46.0 billion in Q4 2024 compared to Q4 2023, demonstrating a continuation of revenue growth acceleration GROSS MARGIN – OPEX 1 REVENUE Incorporates change to revenue g
Slide 14: Donanemab TRAILBLAZER-ALZ 6 Phase 3 Study
Donanemab TRAILBLAZER-ALZ 6 Phase 3 Study Study1 evaluated different dosing regimens to understand their effect on ARIA-E Modified Titration Comparable Amyloid Reduction Reduction in ARIA-E 24% Adjusted mean amyloid change 0 from baseline ± SE (CL) -20 -40 Modified Enhanced titration -60 Standard St
Slide 15: Tirzepatide 176-week SURMOUNT-1 Phase 3 Study
Tirzepatide 176-week SURMOUNT-1 Phase 3 Study Study1 of tirzepatide in adults with pre-diabetes and obesity or overweight Risk Reduction Average Decrease in Body Weight 94% 22.9% Reduced risk of progression to type 2 Average decrease in body weight diabetes compared to placebo over with the 15 mg do
Slide 16: Lilly Select NME and NILEX Pipeline
Lilly Select NME and NILEX Pipeline October 29, 2024 MORF-057 LEGEND Crohn’s Disease MOVEMENT SINCE OLOMORASIB NME TIRZEPATIDE TIRZEPATIDE LEBRIKIZUMAB August 6, 2024 1L KRAS G12C+ NSCLC Higher Doses MASH CRSwNP NILEX ADDITION or (PD-L1 high) MILESTONE ACHIEVED MORF-057 GBA1 GENE THERAPY TIRZEPATIDE
Slide 17: Potential Key Events 2024
Potential Key Events 2024 New since last update Phase 3 Initiations Regulatory Submissions ✓+ Retatrutide for type 2 diabetes ✓+ Mirikizumab for Crohn’s disease [US ✓+ / EU ✓+ / J ✓+ ] ✓+ Retatrutide for cardiovascular outcomes in chronic weight management ✓+ Tirzepatide for obstructive sleep apnea
Slide 18: Q3 2024 Summary
Q3 2024 Summary • Excluding the olanzapine portfolio sale in Q3 2023, Revenue grew 42% driven by Mounjaro and Zepbound • Continued to speed life-changing medicines to patients: • Ebglyss approved in the U.S. for adults and children 12 years or older with moderate-to-severe atopic dermatitis • Kisunl
Slide 19: Supplemental Slides
Supplemental Slides Not for promotional use 19
Slide 20: 2024 Income Statement – Reported
2024 Income Statement – Reported Dollars in millions; except per share data Q3 2024 Change YTD 2024 Change TOTAL REVENUE $11,439 20% $31,510 27% GROSS MARGIN 81.0% 0.6pp 80.9% 2.3pp TOTAL OPERATING EXPENSE* $7,742 8% $17,745 15% OPERATING INCOME $1,526 NM $7,750 90% OPERATING MARGIN 13.3% 8.6pp 24.6
Slide 21: (Gross Margin – OPEX) / Revenue Ratio
(Gross Margin – OPEX1) / Revenue Ratio 37.0% NON-GAAP MOVING ANNUAL TOTAL 35.0% 33.0% 31.0% 29.0% 27.0% Q1 Q2 Q3 Q4 Q1 Q2 Q3 2023 2024 Non-GAAP Ratio (Gross Margin – OPEX1) / Revenue: 24.8% 28.3% 37.4% 34.3% 31.5% 39.3% 40.0% GAAP Ratio (Gross Margin – OPEX1) / Revenue: 23.0% 26.7% 36.1% 32.9% 29.9%
Slide 22: Effect of FX on 2024 Results
Effect of FX on 2024 Results Year-on-Year Change Q3 2024 YTD 2024 REPORTED With FX w/o FX With FX w/o FX TOTAL REVENUE 20% 21% 27% 28% COST OF SALES 17% 16% 14% 13% GROSS MARGIN 21% 22% 31% 32% OPERATING EXPENSE 8% 8% 15% 15% OPERATING INCOME 239% 247% 90% 93% EARNINGS PER SHARE NM NM 102% 105% NON-
Slide 23: EPS Reconciliation
EPS Reconciliation Q3 2024 Q3 2023 % Change YTD 2024 YTD 2023 % Change EARNINGS (LOSS) PER SHARE (REPORTED) $1.07 $(0.06) NM $6.83 $3.38 NM AMORTIZATION OF INTANGIBLE ASSETS 0.12 0.11 9% 0.37 0.33 12% ASSET IMPAIRMENT, RESTRUCTURING AND 0.07 – NM 0.45 – NM OTHER SPECIAL CHARGES NET LOSSES (GAINS) ON
Slide 24: Q3 2024 Income Statement Notes
Q3 2024 Income Statement Notes 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); and
Slide 25: YTD 2024 Income Statement Notes
YTD 2024 Income Statement Notes YTD 2024 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO EXCLUDE: • asset impairment, restructuring and other special charges totaling $516.6 million (pre-tax), or $0.45 per share (after-tax); and • amortization of intangibles (cost of sales) primarily associated with costs
Slide 26: Comparative EPS Summary 2023/2024
Comparative EPS Summary 2023/2024 Dollars 1Q23 2Q23 3Q23 4Q23 2023 1Q24 2Q24 3Q24 4Q24 2024 Reported 1.49 1.95 (0.06) 2.42 5.80 2.48 3.28 1.07 Non-GAAP 1.62 2.11 0.10 2.49 6.32 2.58 3.92 1.18 Numbers may not add due to rounding For a complete reconciliation to reported earnings, see slide 23 and our
Slide 27: Q3 2024 Mounjaro Sales Increased $1.7B
Q3 2024 Mounjaro Sales Increased $1.7B $ in Millions U.S. sales were $2.4 billion U.S. TRx SOM and Market Volume International sales were $728 million Market $3,091 $3,113 $2,206 Lilly T2D Injectable $1,807 Incretins $1,409 $980 Mounjaro $568 Q1 Q2 Q3 Q4 2023 2024 Note: Lilly T2D Injectable Incretin
Slide 28: Q3 2024 Verzenio Sales Increased 32%
Q3 2024 Verzenio Sales Increased 32% $ in Millions U.S. sales increased 28% U.S. TRx SOM and Market Volume International sales increased 38% Verzenio $1,332 $1,369 $1,145 $1,050 $1,040 $927 Market $751 Q1 Q2 Q3 Q4 2023 2024 Source: IQVIA NPA TRx 3MMA, weekly data September 27, 2024; RA = rolling ave
Slide 29: Q3 2024 Trulicity Sales Decreased 22%
Q3 2024 Trulicity Sales Decreased 22% $ in Millions U.S. sales decreased 26% U.S. TRx SOM and Market Volume International sales decreased 12% Market $1,977 $1,813 $1,674 $1,669 $1,456 Lilly T2D Injectable $1,246 $1,301 Incretins Trulicity Q1 Q2 Q3 Q4 2023 2024 Note: Lilly T2D Injectable Incretins co
Slide 30: Q3 2024 Taltz Sales Increased 18%
Q3 2024 Taltz Sales Increased 18% $ in Millions U.S. sales increased 18% U.S. TRx SOM and Market Volume International sales increased 19% $880 Taltz $825 $785 $744 $704 $604 $527 Market Q1 Q2 Q3 Q4 2023 2024 Source: IQVIA NPA TRx 3MMA, weekly data September 27, 2024; RA = rolling average TRx data is
Slide 31: Q3 2024 Jardiance Sales Decreased 2%
Q3 2024 Jardiance Sales Decreased 2% $ in Millions U.S. sales decreased 19% U.S. TRx SOM and Market Volume International sales increased 23% $798 Jardiance1 $770 $687 $701 $686 $668 $578 Market Q1 Q2 Q3 Q4 2023 2024 Source: IQVIA NPA TRx 3MMA, weekly data September 27, 2024; RA = rolling average 1 J
Slide 32: Q3 2024 Humalog Sales Increased 35%
Q3 2024 Humalog Sales Increased 35% $ in Millions U.S. sales increased 67% U.S. TRx SOM International sales increased 5% Humalog + Insulin Lispro $632 $539 $535 $461 $440 $395 $367 Humalog Lilly Insulin Lispro Q1 Q2 Q3 Q4 2023 2024 Source: IQVIA NPA TRx 3MMA, weekly data September 27, 2024; RA = rol
Slide 33: Select Trials – Donanemab
Select Trials – Donanemab Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Alzheimer’s A Study of Donanemab (LY3002813) in Participants Change from Baseline on the integrated Alzheimer's NCT04437511 3 1736 Apr 2023 Aug 2025 Disease With Early Alzheimer's Disease
Slide 34: Select Trials – Imlunestrant
Select Trials – Imlunestrant Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Imlunestrant, Investigator's Choice of Breast Endocrine Therapy, and Imlunestrant Plus Progression Free Survival (PFS) in the Intent-to-Treat NCT04975308 3 866 Jun 2024 Aug
Slide 35: Select Trials – Lebrikizumab
Select Trials – Lebrikizumab Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Lebrikizumab (LY3650150) in Adult and Percentage of Participants Achieving Eczema Area and Atopic Adolescent Participants With Moderate-to-Severe NCT05369403 3 120 Severity
Slide 36: Select Trials – Lebrikizumab (Cont.)
Select Trials – Lebrikizumab (Cont.) Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Perennial A Study of Lebrikizumab in Adult Participants With Mean Change From Baseline (CFBL) in Total Nasal NCT06339008 Allergic 3 450 May 2025 May 2026 Perennial Allergic Rhi
Slide 37: Select Trials – Lepodisiran
Select Trials – Lepodisiran Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Lipoprotein A Study of LY3819469 in Participants With Elevated Percent Change from Baseline in Time Averaged NCT05565742 2 216 Oct 2023 Oct 2024 Disorder Lipoprotein(a) [Lp(a)] (ALPACA)
Slide 38: Select Trials – Mirikizumab
Select Trials – Mirikizumab Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Long-term Extension Study of Mirikizumab Crohn's Percentage of Participants Achieving Endoscopic NCT04232553 (LY3074828) in Participants With Crohn's Disease 3 778 Nov 2024 Dec 2026 D
Slide 39: Select Trials – Olomorasib
Select Trials – Olomorasib Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of olomorasib (LY3537982) Plus Carcinoma, Immunotherapy With or Without Chemotherapy in Dose Optimization and Safety Lead-In Part B: Number NCT06119581 Non-Small-Cell Participant
Slide 40: Select Trials – Orforglipron
Select Trials – Orforglipron Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Orforglipron (LY3502970) in Adult Type 2 NCT05971940 Participants With Type 2 Diabetes and Inadequate 3 520 Change from Baseline in Hemoglobin A1c (HbA1c) Apr 2025 Apr 2025
Slide 41: Select Trials – Orforglipron (Cont.)
Select Trials – Orforglipron (Cont.) Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Once-Daily Oral Orforglipron (LY3502970) NCT05931380 Obesity in Japanese Adult Participants With Obesity Disease 3 236 Mean Percent Change in Body Weight Jun 2025 Ju
Slide 42: Select Trials – Pirtobrutinib
Select Trials – Pirtobrutinib Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Study of LOXO-305 Versus Investigator's Choice To evaluate progression-free survival (PFS) of LOXO- Chronic (IdelaR or BR) in Patients With Previously Treated 305 monotherapy (Arm A)
Slide 43: Select Trials – Remternetug
Select Trials – Remternetug Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Percentage of Participants Who Reach Amyloid Plaque Alzheimer’s A Study of Remternetug (LY3372993) in Participants NCT05463731 3 1667 Clearance on Amyloid PET Scan for Remternetug Jun 2
Slide 44: Select Trials – Retatrutide
Select Trials – Retatrutide Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Retatrutide (LY3437943) in Participants NCT05882045 Obesity With Obesity and Cardiovascular Disease 3 1800 Percent Change from Baseline in Body Weight Jan 2026 Feb 2026 (TRIU
Slide 45: Select Trials – Retatrutide (Cont.)
Select Trials – Retatrutide (Cont.) Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Retatrutide (LY3437943) on Renal Function Chronic Kidney in Participants With Overweight or Obesity and Change from Baseline in Glomerular Filtration Rate NCT05936151
Slide 46: Select Trials – Retevmo
Select Trials – Retevmo Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Selpercatinib (LY3527723) in Participants Medullary Progression Free Survival (PFS) by Blinded NCT04211337 With RET-Mutant Medullary Thyroid Cancer 3 291 May 2023 Feb 2026 Thyroi
Slide 47: Select Trials – Taltz
Select Trials – Taltz Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Ixekizumab Concomitantly Administered With Percentage of Participants Who Simultaneously NCT06588283 Psoriasis Tirzepatide in Adults With Moderate-to-Severe Plaque 3 250 Achieved Psoriasis Ar
Slide 48: Select Trials – Tirzepatide
Select Trials – Tirzepatide Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related NCT05822830 Obesity 3 700 Percent Change from Baseline in Body Weight Nov 2024 Nov 2024
Slide 49: Select Trials – Tirzepatide (Cont.)
Select Trials – Tirzepatide (Cont.) Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study to Evaluate Tirzepatide (LY3298176) in Type 2 Pediatric and Adolescent Participants With Type 2 NCT05260021 3 99 Change From Baseline in Hemoglobin A1c (HbA1c) Jul 2024
Slide 50: Select Trials – Verzenio
Select Trials – Verzenio Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Endocrine Therapy With or Without Abemaciclib NCT031559971 Breast Cancer (LY2835219) Following Surgery in Participants With 3 5637 Invasive Disease-Free Survival (IDFS) Mar 2020 May 2029 B
Slide 51: Select Trials – Early Phase Cardiometabolic Health
Select Trials – Early Phase Cardiometabolic Health Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Safety and Efficacy of Bimagrumab and Semaglutide in Bimagrumab NCT05616013 Obesity 2 507 Change from baseline in body weight at 48 weeks May 2024 Jun 20
Slide 52: Select Trials – Early Phase Cardiometabolic Health (Cont.)
Select Trials – Early Phase Cardiometabolic Health (Cont.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of LY3540378 in Participants With Worsening Change from Baseline in Left Atrial Reservoir Strain Volenrelaxin NCT05592275 Heart Failure C
Slide 53: Select Trials – Early Phase Cardiometabolic Health (Cont.)
Select Trials – Early Phase Cardiometabolic Health (Cont.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Part A: Number of Participants with One or More A Study of LY3885125 in Participants With Dyslipidemia SCAP siRNA NCT06007651 Dyslipidemias 1 112
Slide 54: Select Trials – Early Phase Immunology
Select Trials – Early Phase Immunology Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Proportion of participants in clinical remission at Week Ulcerative A Study to Evaluate MORF-057 in Adults with MORF-057 NCT05611671 2 280 12 as determined using the
Slide 55: Select Trials – Early Phase Immunology (Cont.)
Select Trials – Early Phase Immunology (Cont.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Rheumatoid An Adaptive Phase 2a/2b Study of LY3871801 in Adult Phase 2a: Change from Baseline in Disease Activity Ocadusertib1 NCT05848258 2 380 Feb 2026 Jul
Slide 56: Select Trials – Early Phase Neurodegeneration
Select Trials – Early Phase Neurodegeneration Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion O-GlcNAcase Alzheimer’s A Study of LY3372689 to Assess the Safety, Tolerability, Change from Baseline to End Time Point in Integrated NCT05063539 2 330 Jul 20
Slide 57: Select Trials – Early Phase Neurodegeneration (Cont.)
Select Trials – Early Phase Neurodegeneration (Cont.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Sensorineural OTOF Gene Gene Therapy Trial for Otoferlin Gene-mediated NCT05821959 Hearing Loss, 1|2 14 Frequency of Adverse Events (AEs) Oct 2028 Oct
Slide 58: Select Trials – Early Phase Oncology
Select Trials – Early Phase Oncology Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Urinary Phase 1a: To determine the recommended phase 2 dose A Study of LOXO-435 in Participants With Cancer With FGFR3 Selective NCT05614739 Bladder 1 180 (RP2D)/optim
Slide 59: Select Trials – Early Phase Oncology (Cont.)
Select Trials – Early Phase Oncology (Cont.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Phase 1a: Number of Participants with One or More SMARCA2 Metastatic A Study of LY4050784 in Participants With Advanced or NCT06561685 1 160 Treatment Emergent
Slide 60: Select Trials – Early Phase Pain
Select Trials – Early Phase Pain Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Diabetic A Study of LY3556050 in Adult Participants With Mean Change from Baseline for Average Pain Intensity Mazisotine NCT06074562 Peripheral 2 410 Jan 2025 Jan 2025 Dia
Slide 61: A Medicine Company
A MEDICINE COMPANY
Eli Lilly and Company — Q3 2024 Earnings Presentation on 6ix