Eli Lilly And Company · NYSE:LLY
Eli Lilly And — Q1 2024 Earnings Presentation
56 slides from Eli Lilly And's earnings presentation, Apr 30, 2024
Slide 1: Eli Lilly and Company Q1 2024 Earnings Call
Eli Lilly and Company Q1 2024 Earnings Call April 30, 2024 1
Slide 2: 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 3: Agenda
Agenda Introduction and Key Events Dave Ricks, Chair and Chief Executive Officer Q1 2024 Financial Results Anat Ashkenazi, 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: Strategic Deliverables
Strategic Deliverables PROGRESS SINCE THE LAST EARNINGS CALL Invest in Current Portfolio Deliver Revenue Growth • Gross Margin: Non-GAAP gross margin of 82.5% in Q1 • Revenue grew 26% in Q1 driven by Mounjaro®, Zepbound®, • SG&A: 12% increase in Q1 primarily driven by Verzenio®, and Jardiance®1 prom
Slide 5: Key Events Since Last Earnings Call
Key Events Since Last Earnings Call Regulatory Clinical (Cont) • Submitted mirikizumab in the U.S. and EU for moderately to severely active • Presented results from a study of lebrikizumab in people with skin of color Crohn’s disease and atopic dermatitis • Resubmitted lebrikizumab in the U.S. for m
Slide 6: Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information; Certain Line Items (Unaudited) Dollars in millions; except per share data Q1 2024 YoY Non-GAAP GAAP Reported Adjustments Non-GAAP Adjusted Adjusted Change TOTAL REVENUE $8,768 $– $8,768 26% GROSS MARGIN 80.9% 1.6pp 82.5% 4.1pp TOTAL O
Slide 7: Price/Rate/Volume Effect on Revenue
Price/Rate/Volume Effect on Revenue Dollars in millions Q1 2024 Amount Price FX Rate Volume Total CER U.S. $5,694 16% – 12% 28% 28% EUROPE 1,441 1% 3% 28% 32% 29% JAPAN 364 (5)% (8)% 7% (6)% 2% CHINA 376 (4)% (3)% 8% 1% 4% REST OF WORLD 893 (0)% 1% 32% 33% 31% TOTAL REVENUE $8,768 10% (0)% 16% 26% 2
Slide 8: Q1 2024 Update on Select Products
Q1 2024 Update on Select Products NEW PRODUCTS Millions MOUNJARO $8,000 • U.S. T2D injectable incretins TRx SOM over 24% and NBRx SOM nearly 30% at end of Q1 2024 $7,000 ZEPBOUND • U.S. branded anti-obesity rolling 4-week TRx SOM nearly 40% and rolling 4-week NBRx SOM nearly 57% at end of Q1 2024 $6
Slide 9: Zepbound U.S. Launch Progress
Zepbound U.S. Launch Progress Exceptionally strong launch progress since U.S. FDA approval on November 8, 2023 v We are rapidly building access in the U.S. and, as of April 1, we have approximately 67% access in commercial v Continued focus on broadening formulary access and through employer opt-ins
Slide 10: Capital Allocation
Capital Allocation $ in Billions Q1 2024 Capital Allocation R&D* Capital Growth Investments Business Development** Dividend Return Share Repurchase * After tax ** Includes development milestones, closed acquisitions and cash outflows associated with equity investments Not for promotional use 2024 Q1
Slide 11: 2024 Guidance
2024 Guidance Prior Updated Comments New midpoint represents ~26% total growth and ~35% REVENUE $40.4 – $41.6 billion $42.4 – $43.6 billion growth excluding impact of global divestiture transactions GROSS MARGIN – OPEX 1 REVENUE (GAAP) 30% – 32% 32% – 34% Reflects increase in revenue guidance (NON-G
Slide 12: SURMOUNT-OSA Phase 3 Studies
SURMOUNT-OSA Phase 3 Studies Master Protocol to evaluate tirzepatide in two studies in In Study 1, tirzepatide was evaluated in distinct populations with moderate-to-severe OSA and obesity participants not on PAP therapy v In Study 2, tirzepatide was evaluated in participants who had used PAP therap
Slide 13: SURMOUNT-OSA Study 1 – Not on PAP Therapy
SURMOUNT-OSA Study 1 – Not on PAP Therapy Change in AHI from Baseline at 52 Weeks Study 1 – Not on PAP Therapy Tirzepatide led to a mean AHI reduction of 27.4 placebo tirzepatide events per hour, compared to 4.8 for placebo -5.0%* v Tirzepatide led to a mean AHI reduction of 55.0% ∆AHI = -4.8* from
Slide 14: SURMOUNT-OSA Study 2 – On PAP Therapy
SURMOUNT-OSA Study 2 – On PAP Therapy Change in AHI from Baseline at 52 Weeks Study 2 – On PAP Therapy Tirzepatide led to a mean AHI reduction of 30.4 placebo tirzepatide events per hour, compared to 6.0 for placebo -6.4%* v Tirzepatide led to a mean AHI reduction of 62.8% ∆AHI = -6.0* from baseline
Slide 15: Lilly Select NME and NILEX Pipeline
Lilly Select NME and NILEX Pipeline April 26, 2024 LEGEND TIRZEPATIDE TIRZEPATIDE MOVEMENT SINCE NME Higher Doses MASH February 5, 2023 NILEX ADDITION or ELORALINTIDE GBA1 GENE THERAPY Commercial MILESTONE ACHIEVED (AMYLIN AGONIST LA) * Gaucher Disease Type 1 Collaboration Obesity REMOVAL VOLENRELAX
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/ EU ] + L
Slide 17: Q1 2024 Summary
Q1 2024 Summary • Revenue grew 26% driven by Mounjaro, Zepbound, Verzenio, and Jardiance1 • Continued to speed life-changing medicines to patients with: • Positive topline results of tirzepatide in moderate-to-severe obstructive sleep apnea and obesity • Approval of the multi-dose KwikPen® delivery
Slide 18: Supplemental Slides
Supplemental Slides Not for promotional use 2024 Q1 EARNINGS Company Confidential © 2024 Eli Lilly and Company 18
Slide 19: 2024 Income Statement – Reported
2024 Income Statement – Reported Dollars in millions; except per share data Q1 2024 Change TOTAL REVENUE $8,768 26% GROSS MARGIN 80.9% 4.3pp TOTAL OPERATING EXPENSE* $4,586 19% OPERATING INCOME $2,509 68% OPERATING MARGIN 28.6% 7.1pp OTHER INCOME (EXPENSE) $27 (24)% EFFECTIVE TAX RATE 11.6% (0.5)pp
Slide 20: (Gross Margin – OPEX) / Revenue Ratio
(Gross Margin – OPEX1) / Revenue Ratio 35.0% NON-GAAP MOVING ANNUAL TOTAL 33.0% 31.0% 29.0% 27.0% 25.0% Q1 Q2 Q3 Q4 Q1 2023 2024 Non-GAAP (Gross Margin – OPEX1) / Revenue Ratio: 24.8% 28.3% 37.4% 34.3% 31.5% GAAP (Gross Margin – OPEX1) / Revenue Ratio: 23.0% 26.7% 36.1% 32.9% 29.9% 1 OPEX is defined
Slide 21: Effect of FX on 2024 Results
Effect of FX on 2024 Results Year-on-Year Change Q1 2024 REPORTED With FX w/o FX TOTAL REVENUE 26% 26% COST OF SALES 3% 2% GROSS MARGIN 33% 33% OPERATING EXPENSE 19% 19% OPERATING INCOME 68% 69% EARNINGS PER SHARE 66% 68% NON-GAAP With FX w/o FX TOTAL REVENUE 26% 26% COST OF SALES 2% 2% GROSS MARGIN
Slide 22: EPS Reconciliation
EPS Reconciliation Q1 2024 Q1 2023 % Change EARNINGS PER SHARE (REPORTED) $2.48 $1.49 66% AMORTIZATION OF INTANGIBLE ASSETS 0.12 0.11 9% NET (GAINS) LOSSES ON INVESTMENTS IN (0.02) 0.02 NM EQUITY SECURITIES EARNINGS PER SHARE (NON-GAAP) $2.58 $1.62 59% Acquired IPR&D $0.10 $0.10 – Numbers may not ad
Slide 23: Q1 2024 Income Statement Notes
Q1 2024 Income Statement Notes Q1 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 $139.1 million (pre-tax), or $0.12 per share (after-tax); and
Slide 24: 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 Non-GAAP 1.62 2.11 0.10 2.49 6.32 2.58 Numbers may not add due to rounding For a complete reconciliation to reported earnings, see slide 22 and our earnings press rele
Slide 25: Q1 2024 Mounjaro Sales Increased $1.2B
Q1 2024 Mounjaro Sales Increased $1.2B $ in Millions U.S. sales were $1.5 billion U.S. TRx SOM and Market Volume International sales were $286 million Market Lilly T2D Injectable Incretins Mounjaro Note: Lilly T2D Injectable Incretins consist of Mounjaro & Trulicity 13 Wk RA TRx SOM Source: IQVIA NP
Slide 26: Q1 2024 Trulicity Sales Decreased 26%
Q1 2024 Trulicity Sales Decreased 26% $ in Millions U.S. sales decreased 30% U.S. TRx SOM and Market Volume International sales decreased 13% Market Lilly T2D Injectable Incretins Trulicity Note: Lilly T2D Injectable Incretins consist of Mounjaro & Trulicity 13 Wk RA TRx SOM Source: IQVIA NPA TRx 3M
Slide 27: Q1 2024 Verzenio Sales Increased 40%
Q1 2024 Verzenio Sales Increased 40% $ in Millions U.S. sales increased 38% U.S. TRx SOM and Market Volume International sales increased 42% Verzenio Market Source: IQVIA NPA TRx 3MMA, weekly data March 29, 2024; RA = rolling average Not for promotional use 2024 Q1 EARNINGS 27
Slide 28: Q1 2024 Jardiance Sales Increased 19%
Q1 2024 Jardiance Sales Increased 19% $ in Millions U.S. sales increased 12% U.S. TRx SOM and Market Volume International sales increased 28% Jardiance1 Market Source: IQVIA NPA TRx 3MMA, weekly data March 29, 2024; RA = rolling average 1 Jardiance includes Glyxambi and Synjardy. Jardiance is part o
Slide 29: Q1 2024 Taltz Sales Increased 15%
Q1 2024 Taltz Sales Increased 15% $ in Millions U.S. sales increased 11% U.S. TRx SOM and Market Volume International sales increased 20% Taltz Market Source: IQVIA NPA TRx 3MMA, weekly data March 29, 2024; RA = rolling average TRx data is representative of the full molecule market Not for promotion
Slide 30: Q1 2024 Humalog Sales Increased 17%
Q1 2024 Humalog Sales Increased 17% $ in Millions U.S. sales increased 25% U.S. TRx SOM International sales increased 6% Humalog + Insulin Lispro Humalog Lilly Insulin Lispro Source: IQVIA NPA TRx 3MMA, weekly data March 29, 2024; RA = rolling average Not for promotional use 2024 Q1 EARNINGS 30
Slide 31: Select Trials – Insulin Efsitora Alfa
Select Trials – Insulin Efsitora Alfa Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Insulin Efsitora Alfa (LY3209590) Compared to NCT05362058 Diabetes Degludec in Adults With Type 2 Diabetes Who Are Starting Basal 3 928 Change from Baseline in Hemo
Slide 32: Select Trials – Donanemab
Select Trials – Donanemab Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Alzheimer A Study of Donanemab (LY3002813) in Participants With Early Change from Baseline on the integrated Alzheimer's Disease NCT04437511 3 1736 Apr 2023 Aug 2025 Disease Alzheimer's D
Slide 33: Select Trials – Imlunestrant
Select Trials – Imlunestrant Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Imlunestrant, Investigator's Choice of Endocrine Breast Progression Free Survival (PFS) in the Intent-to-Treat (IIT) NCT04975308 Therapy, and Imlunestrant Plus Abemaciclib i
Slide 34: Select Trials – Lebrikizumab
Select Trials – Lebrikizumab Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Atopic Percentage of Participants Achieving Eczema Area and Severity NCT05369403 Participants With Moderate-to-Severe Atopic
Slide 35: 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 Lipoprotein(a) NCT05565742 2 216 Oct 2023 Oct 2024 Disorder Lipoprotein(a) [
Slide 36: Select Trials – Mirikizumab
Select Trials – Mirikizumab Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Crohn's A Long-term Extension Study of Mirikizumab (LY3074828) in NCT04232553 3 778 Percentage of Participants Achieving Endoscopic Response Jan 2025 Dec 2026 Disease Participants With
Slide 37: Select Trials – Orforglipron
Select Trials – Orforglipron Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 NCT05971940 Type 2 Diabetes and Inadequate Glycemic Control With Diet and 3 520 Change from Baseline in Hemoglobin
Slide 38: Select Trials – Orforglipron (Cont.)
Select Trials – Orforglipron (Cont.) Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Orforglipron in Adult Participants With Obesity or NCT05872620 Obesity 3 1500 Mean Percent Change from Baseline in Body Weight Jun 2025 Jun 2025 Overweight and Type
Slide 39: Select Trials – Pirtobrutinib
Select Trials – Pirtobrutinib Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion To evaluate progression-free survival (PFS) of LOXO-305 Chronic Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in monotherapy (Arm A) compared to investigator's choice
Slide 40: Select Trials – Remternetug
Select Trials – Remternetug Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Alzheimer A Study of Remternetug (LY3372993) in Participants With Percentage of Participants Who Reach Amyloid Plaque NCT05463731 3 600 Oct 2025 Oct 2026 Disease Alzheimer's Disease (TR
Slide 41: Select Trials – Retatrutide
Select Trials – Retatrutide Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Chronic A Study of Retatrutide (LY3437943) on Renal Function in NCT05936151 Kidney Participants With Overweight or Obesity and Chronic Kidney 2 120 Change from Baseline in Glomerular Fi
Slide 42: Select Trials – Retatrutide (Cont.)
Select Trials – Retatrutide (Cont.) Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Effect of Retatrutide Compared With Placebo in Adult Type 2 NCT06354660 Participants With Type 2 Diabetes and Inadequate Glycemic 3 480 Change from Baseline in Hemoglobin A1c (H
Slide 43: Select Trials – Retevmo
Select Trials – Retevmo Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Medullary A Study of Selpercatinib (LY3527723) in Participants With RET- Progression Free Survival (PFS) by Blinded Independent Central NCT04211337 Thyroid 3 291 May 2023 Feb 2026 Mutant Me
Slide 44: 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 NCT04184622 Obesity 3 2539 Percent Change from Baseline in Body Weight Apr 2022 Jul 2024 or Overweight (SURMOUNT-1) A Stu
Slide 45: Select Trials – Tirzepatide (Cont.)
Select Trials – Tirzepatide (Cont.) Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Tirzepatide (LY3298176) Compared With Dulaglutide Type 2 Time to First Occurrence of Death from Cardiovascular (CV) NCT04255433 on Major Cardiovascular Events in Part
Slide 46: Select Trials – Verzenio
Select Trials – Verzenio Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Breast Endocrine Therapy With or Without Abemaciclib (LY2835219) NCT031559971 3 5637 Invasive Disease-Free Survival (IDFS) Mar 2020 May 2029 Cancer Following Surgery in Participants With B
Slide 47: Select Trials – Early Phase Diabetes and Obesity
Select Trials – Early Phase Diabetes and Obesity Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of LY3561774 in Participants With Mixed Percent Change from Baseline for Apolipoprotein B Solbinsiran NCT05256654 Dyslipidemias 2 175 Mar 2024 Jun
Slide 48: Select Trials – Early Phase Diabetes and Obesity (Cont.)
Select Trials – Early Phase Diabetes and Obesity (Cont.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time A Study of Carbon-14-Labelled [14C] LY3473329 in Muvalaplin NCT06342596 Healthy 1 16
Slide 49: Select Trials – Early Phase Diabetes and Obesity (Cont.)
Select Trials – Early Phase Diabetes and Obesity (Cont.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Number of Participants with One or More Serious A Study of LY3461767 in Participants With Chronic Heart NRG4 Agonist NCT04840914 HFrEF 1 50 Adverse
Slide 50: 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 Participants With Rheumatoid Percentage of Participants Achieving American College of Peresolimab NCT05516758 Moderately-to-Sev
Slide 51: Select Trials – Early Phase Immunology (Cont.)
Select Trials – Early Phase Immunology (Cont.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Multiple A Study of LY3541860 in Adult Participants With Cumulative Number of New T1 Gadolinium-Enhancing CD19 Antibody NCT06220669 2 200 Aug 2027 Aug 2028 S
Slide 52: Select Trials – Early Phase Neurodegeneration
Select Trials – Early Phase Neurodegeneration Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion O-GlcNAcase Alzheimer A Study of LY3372689 to Assess the Safety, Tolerability, Change from Baseline to End Time Point in Integrated NCT05063539 2 330 Jul 2024
Slide 53: 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 Hearing NCT05821959 Hearing Loss, 1|2 14 Frequency of Adverse Events (AEs) Oct
Slide 54: 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 With or Carcinoma, PFS per Response Evaluation Criteria in Solid Tumors Without Chemotherapy in Participants With Non-Small Olo
Slide 55: 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 Diabetic Mean Change from Baseline for Average Pain Intensity SSTR4 Agonist NCT06074562 Peripheral 2 410 Jan 2025
Slide 56: Not for promotional use 2024 Q1 EARNINGS
Not for promotional use 2024 Q1 EARNINGS
Eli Lilly and Company — Q1 2024 Earnings Presentation on 6ix