Eli Lilly And Company · NYSE:LLY
Eli Lilly And — Q2 2024 Earnings Presentation
58 slides from Eli Lilly And's earnings presentation, Aug 8, 2024
Slide 1: A Medicine Company
A MEDICINE COMPANY
Slide 2: Eli Lilly and Company Q2 2024 Earnings Call
ELI LILLY AND COMPANY Q2 2024 EARNINGS CALL 08.08.24
Slide 3: Agenda
Agenda Introduction and Key Events Dave Ricks, Chair and Chief Executive Officer Q2 2024 Financial Results Gordon Brooks, Interim 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 S
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 82.0% in Q2 • Revenue grew 36% in Q2 driven by Mounjaro®, Zepbound®, and • SG&A: 10% increase primarily driven by investments in Verzenio®; New Pro
Slide 6: Key Events Since Last Earnings Call
Key Events Since Last Earnings Call Regulatory Clinical (Cont) • Kisunla approved in the U.S. for Alzheimer’s disease; received • Presented data from the SYNERGY-NASH Phase 2 trial of tirzepatide positive PMDA1 opinion for donanemab in Japan at the European Association for the Study of the Liver sho
Slide 7: Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Q2)
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information; Certain Line Items (Unaudited) Dollars in millions; except per share data Q2 2024 Non-GAAP YoY Non-GAAP GAAP Reported Adjustments Adjusted Adjusted Change TOTAL REVENUE $11,303 $– $11,303 36% GROSS MARGIN 80.8% 1.2pp 82.0% 2.2pp TOTAL
Slide 8: Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (1H)
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information; Certain Line Items (Unaudited) Dollars in millions; except per share data 1H 2024 Non-GAAP YoY Non-GAAP GAAP Reported Adjustments Adjusted Adjusted Change TOTAL REVENUE $20,071 $– $20,071 31% GROSS MARGIN 80.8% 1.4pp 82.2% 3.0pp TOTAL
Slide 9: Price/Rate/Volume Effect on Revenue
Price/Rate/Volume Effect on Revenue Dollars in millions Q2 2024 Amount Price FX Rate Volume Total CER U.S. $7,835 15% – 27% 42% 42% EUROPE 1,404 2% (1)% 18% 19% 20% JAPAN 463 (6)% (13)% 21% 2% 15% CHINA 395 (2)% (2)% 3% (1)% 1% REST OF WORLD 1,206 3% (0)% 58% 61% 61% TOTAL REVENUE $11,303 10% (1)% 2
Slide 10: Q2 2024 Update on Select Products
Q2 2024 Update on Select Products Millions NEW PRODUCTS $10,000 MOUNJARO • U.S. T2D injectable incretins TRx SOM nearly 32% and NBRx $9,000 SOM over 33% at end of Q2 2024 ZEPBOUND $8,000 • U.S. branded anti-obesity TRx and NBRx SOM approximately 36% at end of Q2 2024 $7,000 JAYPIRCA • Q2 2024 sales
Slide 11: Zepbound U.S. Launch Progress
Zepbound U.S. Launch Progress 500 Continue to see exceptional growth trends since launch that have accelerated as we ramp 450 production 400 All dosages of Zepbound currently listed as Prescriptions (TRx, 000s) 350 available on the FDA shortage website 300 Rapidly building commercial formulary 250 c
Slide 12: Capital Allocation
Capital Allocation $ in Billions 1H 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 Q2 EARNINGS Not for promot
Slide 13: 2024 Guidance
2024 Guidance Prior Updated Comments Reflects greater confidence in incretin supply outlook REVENUE $42.4 – $43.6 billion $45.4 – $46.6 billion and visibility into upcoming OUS launches, as well as strong momentum in non-incretin revenue growth GROSS MARGIN – OPEX 1 REVENUE (GAAP) 32% – 34% 36% – 38
Slide 14: Tirzepatide SUMMIT Phase 3 Study
Tirzepatide SUMMIT Phase 3 Study Phase 3 study of tirzepatide in adults with HFpEF and obesity % % Reduced risk of worsening Significantly reduced heart Reduced weight in people heart failure compared to failure symptom severity with and without type 2 placebo and physical limitations diabetes 38% r
Slide 15: Lilly Select NME and NILEX Pipeline
Lilly Select NME and NILEX Pipeline August 6, 2024 LEGEND MOVEMENT SINCE NME April 26, 2024 TIRZEPATIDE TIRZEPATIDE NILEX Higher Doses MASH ADDITION or MILESTONE ACHIEVED VOLENRELAXIN GBA1 GENE THERAPY REMOVAL Heart Failure Gaucher Disease Type 1 China development with Innovent for MAZISOTINE Obes
Slide 16: 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 [US
Slide 17: Tirzepatide SURMOUNT-OSA Phase 3 Studies
Tirzepatide SURMOUNT-OSA Phase 3 Studies Percentage of participants reaching criteria for disease resolution AHI < 5 or with AHI 5-14 and ESS ≤ 10 51.5%* Phase 3 studies evaluated tirzepatide in participants with moderate-to-severe OSA and obesity 43.0%* In a key secondary endpoint, up to 51.5% of p
Slide 18: Tirzepatide SYNERGY-NASH Phase 2 Study
Tirzepatide SYNERGY-NASH Phase 2 Study Percentage of participants with a decrease of ≥ 1 fibrosis stage and no worsening of MASH at week 52 Phase 2 study in adults with biopsy-proven MASH with 54.9% stage 2 or 3 fibrosis 51.3% 51.0% In a secondary endpoint, more than half of patients taking tirzepat
Slide 19: Q2 2024 Summary
Q2 2024 Summary • Revenue grew 36% driven by Mounjaro, Zepbound, and Verzenio • Continued to speed life-changing medicines to patients: • Kisunla approved in the U.S. for the treatment of adults with Alzheimer’s disease • Submitted tirzepatide for the treatment of moderate-to-severe obstructive slee
Slide 20: Supplemental Slides
Supplemental Slides Not for promotional use 20
Slide 21: 2024 Income Statement – Reported
2024 Income Statement – Reported Dollars in millions; except per share data Q2 2024 Change 1H 2024 Change TOTAL REVENUE $11,303 36% $20,071 31% GROSS MARGIN 80.8% 2.5pp 80.8% 3.3pp TOTAL OPERATING EXPENSE* $5,418 24% $10,003 22% OPERATING INCOME $3,715 75% $6,224 72% OPERATING MARGIN 32.9% 7.3pp 31.
Slide 22: (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 2023 2024 Non-GAAP Ratio (Gross Margin – OPEX1) / Revenue: 24.8% 28.3% 37.4% 34.3% 31.5% 39.3% GAAP Ratio (Gross Margin – OPEX1) / Revenue: 23.0% 26.7% 36.1% 32.9% 29.9% 38.1% 1
Slide 23: Effect of FX on 2024 Results
Effect of FX on 2024 Results Year-on-Year Change Q2 2024 1H 2024 REPORTED With FX w/o FX With FX w/o FX TOTAL REVENUE 36% 37% 31% 32% COST OF SALES 20% 20% 12% 12% GROSS MARGIN 40% 42% 37% 38% OPERATING EXPENSE 24% 24% 22% 22% OPERATING INCOME 75% 78% 72% 74% EARNINGS PER SHARE 68% 71% 67% 70% NON-G
Slide 24: EPS Reconciliation
EPS Reconciliation Q2 2024 Q2 2023 % Change 1H 2024 1H 2023 % Change EARNINGS PER SHARE (REPORTED) $3.28 $1.95 68% $5.76 $3.44 67% ASSET IMPAIRMENT, RESTRUCTURING 0.38 – NM 0.38 – NM AND OTHER SPECIAL CHARGES NET LOSSES (GAINS) ON 0.14 0.05 NM 0.12 0.07 71% INVESTMENTS IN EQUITY SECURITIES AMORTIZAT
Slide 25: Q2 2024 Income Statement Notes
Q2 2024 Income Statement Notes Q2 2024 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO EXCLUDE: • asset impairment, restructuring and other special charges totaling $435 million (pre-tax), or $0.38 per share (after-tax); and • net losses on investments in equity securities totaling $147.7 million (pre-tax
Slide 26: 1H 2024 Income Statement Notes
1H 2024 Income Statement Notes 1H 2024 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO EXCLUDE: • asset impairment, restructuring and other special charges totaling $435 million (pre-tax), or $0.38 per share (after-tax); and • amortization of intangibles (cost of sales) primarily associated with costs of
Slide 27: 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 Non-GAAP 1.62 2.11 0.10 2.49 6.32 2.58 3.92 Numbers may not add due to rounding For a complete reconciliation to reported earnings, see slide 24 and our earnings
Slide 28: Q2 2024 Mounjaro Sales Increased $2.1B
Q2 2024 Mounjaro Sales Increased $2.1B $ in Millions U.S. sales were $2.4 billion U.S. TRx SOM and Market Volume International sales were $677 million Market $3,091 $2,206 Lilly T2D Injectable $1,807 Incretins $1,409 $980 Mounjaro $568 Q1 Q2 Q3 Q4 2023 2024 Note: Lilly T2D Injectable Incretins consi
Slide 29: Q2 2024 Verzenio Sales Increased 44%
Q2 2024 Verzenio Sales Increased 44% $ in Millions U.S. sales increased 46% U.S. TRx SOM and Market Volume International sales increased 39% Verzenio $1,332 $1,145 $1,050 $1,040 $927 $751 Market Q1 Q2 Q3 Q4 2023 2024 Source: IQVIA NPA TRx 3MMA, weekly data June 28, 2024; RA = rolling average 2024 Q2
Slide 30: Q2 2024 Trulicity Sales Decreased 31%
Q2 2024 Trulicity Sales Decreased 31% $ in Millions U.S. sales decreased 36% U.S. TRx SOM and Market Volume International sales decreased 16% Market $1,977 $1,813 $1,674 $1,669 $1,456 Lilly T2D Injectable $1,246 Incretins Trulicity Q1 Q2 Q3 Q4 2023 2024 Note: Lilly T2D Injectable Incretins consist o
Slide 31: Q2 2024 Taltz Sales Increased 17%
Q2 2024 Taltz Sales Increased 17% $ in Millions U.S. sales increased 14% U.S. TRx SOM and Market Volume International sales increased 23% $825 Taltz $785 $744 $704 $604 $527 Market Q1 Q2 Q3 Q4 2023 2024 Source: IQVIA NPA TRx 3MMA, weekly data June 28, 2024; RA = rolling average TRx data is represent
Slide 32: Q2 2024 Jardiance Sales Increased 15%
Q2 2024 Jardiance Sales Increased 15% $ in Millions U.S. sales increased 11% U.S. TRx SOM and Market Volume International sales increased 21% Jardiance1 $770 $798 $687 $701 $668 $578 Market Q1 Q2 Q3 Q4 2023 2024 Source: IQVIA NPA TRx 3MMA, weekly data June 28, 2024; RA = rolling average 1 Jardiance
Slide 33: Q2 2024 Humalog Sales Increased 43%
Q2 2024 Humalog Sales Increased 43% $ in Millions U.S. sales increased 89% U.S. TRx SOM International sales decreased 7% Humalog + Insulin Lispro $632 $539 $461 $440 $395 $367 Humalog Lilly Insulin Lispro Q1 Q2 Q3 Q4 2023 2024 Source: IQVIA NPA TRx 3MMA, weekly data June 28, 2024; RA = rolling avera
Slide 34: Select Trials – Donanemab
Select Trials – Donanemab Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Donanemab (LY3002813) in Alzheimer Change from Baseline on the integrated NCT04437511 Participants With Early Alzheimer's Disease 3 1736 Apr 2023 Aug 2025 Disease Alzheimer's D
Slide 35: 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- NCT04975308 3 866 Jun 2024 Aug 2027
Slide 36: Select Trials – Lebrikizumab
Select Trials – Lebrikizumab Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Lebrikizumab (LY3650150) in Adult Percentage of Participants Achieving Eczema Atopic and Adolescent Participants With Moderate-to- NCT05369403 3 120 Area and Severity Index-
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 Percent Change from Baseline in Time Averaged NCT05565742 2 216 Oct 2023 Oct 2024 Disorder Elevated 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 3 778 Nov 2024 Dec 2026 Disease R
Slide 39: 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 Participants With Type 2 Diabetes and Change from Baseline in Hemoglobin A1c NCT05971940 3 520 Apr 2025 Apr 2025 Diabetes Inadequate
Slide 40: Select Trials – Orforglipron (Cont.)
Select Trials – Orforglipron (Cont.) Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Type 2 Change from Baseline in Hemoglobin A1c NCT06192108 Participants With Type 2 Diabetes and 3 888 O
Slide 41: Select Trials – Pirtobrutinib
Select Trials – Pirtobrutinib Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion To evaluate progression-free survival (PFS) of Study of LOXO-305 Versus Investigator's Choice Chronic LOXO-305 monotherapy (Arm A) compared to (IdelaR or BR) in Patients With Previous
Slide 42: Select Trials – Remternetug
Select Trials – Remternetug Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Remternetug (LY3372993) in Percentage of Participants Who Reach Amyloid Alzheimer NCT05463731 Participants With Alzheimer's Disease 3 600 Plaque Clearance on Amyloid PET Scan
Slide 43: Select Trials – Retatrutide
Select Trials – Retatrutide Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Retatrutide (LY3437943) in NCT05882045 Obesity Participants With Obesity and Cardiovascular 3 1800 Percent Change from Baseline in Body Weight Jan 2026 Feb 2026 Disease (TRIU
Slide 44: 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 Chronic Function in Participants With Overweight or Change from Baseline in Glomerular Filtration NCT05936151 Kidney 2 120 Nov 2025 N
Slide 45: Select Trials – Retevmo
Select Trials – Retevmo Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Medullary A Study of Selpercatinib (LY3527723) in Progression Free Survival (PFS) by Blinded NCT04211337 Thyroid Participants With RET-Mutant Medullary 3 291 May 2023 Feb 2026 Independent C
Slide 46: 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 NCT05822830 Obesity 3 700 Percent Change from Baseline in Body Weight Nov 2024 Nov 2024 Weight Related
Slide 47: 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 Pediatric and Adolescent Participants With Type Type 2 Change From Baseline in Hemoglobin A1c NCT05260021 2 Diabetes Mellitus Inad
Slide 48: Select Trials – Verzenio
Select Trials – Verzenio Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Endocrine Therapy With or Without Abemaciclib Breast NCT031559971 (LY2835219) Following Surgery in Participants 3 5637 Invasive Disease-Free Survival (IDFS) Mar 2020 May 2029 Cancer With B
Slide 49: 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 Bimagrumab NCT05616013 Obesity Semaglutide in Adults who are Overweight or 2 507 Change from baseline in body weigh
Slide 50: 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 Number of Participants with One or More Treatment A Study of LY3541105 in Healthy and Overweight Emergent Adverse Events (TEAEs) and Serious DACR
Slide 51: Select Trials – Early Phase Immunology
Select Trials – Early Phase Immunology Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Peresolimab (LY3462817) in Rheumatoid Percentage of Participants Achieving American Peresolimab NCT05516758 Participants With Moderately-to-Severely Activ
Slide 52: Select Trials – Early Phase Immunology (Cont.)
Select Trials – Early Phase Immunology (Cont.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion CD19 Multiple A Study of LY3541860 in Adult Participants Cumulative Number of New T1 Gadolinium- NCT06220669 2 200 Aug 2027 Aug 2028 Antibody Sclerosis With
Slide 53: Select Trials – Early Phase Neurodegeneration
Select Trials – Early Phase Neurodegeneration Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of LY3372689 to Assess the Safety, Change from Baseline to End Time Point in O-GlcNAcase Alzheimer NCT05063539 Tolerability, and Efficacy in Participa
Slide 54: 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 55: Select Trials – Early Phase Oncology
Select Trials – Early Phase Oncology Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of LY3537982 Plus Immunotherapy Carcinoma, With or Without Chemotherapy in Participants PFS per Response Evaluation Criteria in Solid Olomorasib NCT06119581 No
Slide 56: 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: To determine the recommended phase 2 Ovarian A Study of LY4170156 in Participants With FOLR1 ADC NCT06400472 1 220 dose (RP2D) of LY4170156, Number o
Slide 57: Select Trials – Early Phase Pain
Select Trials – Early Phase Pain Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Mazisotine Diabetic A Study of LY3556050 in Adult Participants Mean Change from Baseline for Average Pain (SSTR4 NCT06074562 Peripheral 2 410 Jan 2025 Jan 2025 With Diabet
Slide 58: A Medicine Company
A MEDICINE COMPANY
Eli Lilly and Company — Q2 2024 Earnings Presentation on 6ix