Eli Lilly And Company · NYSE:LLY
Eli Lilly And — Q4 2023 Earnings Presentation
62 slides from Eli Lilly And's earnings presentation, Feb 6, 2024
Slide 1: Eli Lilly and Company Q4 2023 Earnings Call
Eli Lilly and Company (4 2023 Earnings Call February 6, 2024
Slide 2: Forward-looking statements and non-GAAP disclaimer
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 re
Slide 3: Presenters
Dave Ricks, Chair and Chief Executive Officer Anat Ashkenazi, Chief Financial Officer Dan Skovronsky, M.D., Ph.D., Chief Scientific Officer Dave Ricks, Chair and Chief Executive Officer 3
Slide 4: Progress Since the Last Earnings Call
PROGRESS SINCE THE LAST EARNINGS CALL • Gross Margin: Non-GAAP gross margin of 82.3% in Q4 • Revenue grew 28% in Q4 driven by Mounjaro®, Verzenio®, • SG&A: 17% increase in Q4 primarily driven by launches Jardiance®1 and Zepbound® of new products and indications as well as higher • New Products2 grew
Slide 5: Regulatory and Business Highlights
• Announced the U.S. Food and Drug Administration (FDA) approved: • Published Zepbound data in The Journal of the American Medical Association • Zepbound for the treatment of obesity or overweight with weight- (JAMA) showing results from the Phase 3 SURMOUNT-4 study in adults with related comorbidit
Slide 6: Q4 2023 GAAP Reported to Non-GAAP
Dollars in millions; except per share data Q4 2023 YoY Non-GAAP GAAP Reported Adjustments Non-GAAP Adjusted Adjusted Change TOTAL REVENUE $9,353 $– $9,353 28% GROSS MARGIN 80.9% 1.4pp 82.3% 1.8pp TOTAL OPERATING EXPENSE 5,178 (68) 5,110 32% OPERATING INCOME 2,388 197 2,585 29% OPERATING MARGIN 25.5%
Slide 7: FY 2023 GAAP Reported to Non-GAAP
Dollars in millions; except per share data FY 2023 YoY Non-GAAP GAAP Reported Adjustments Non-GAAP Adjusted Adjusted Change TOTAL REVENUE $34,124 $– $34,124 20% GROSS MARGIN 79.2% 1.5pp 80.7% 1.9pp TOTAL OPERATING EXPENSE 20,584 (68) 20,516 41% OPERATING INCOME 6,458 574 7,032 (12)% OPERATING MARGIN
Slide 8: Revenue by Geography: Q4 and FY 2023
Dollars in millions Q4 2023 Amount Price FX Rate Volume Total CER U.S. $6,455 27% – 12% 39% 39% EUROPE 1,338 (5)% 8% 22% 24% 17% JAPAN 439 (2)% (4)% 17% 11% 15% CHINA 377 (3)% 0% 10% 7% 7% REST OF WORLD 744 (1)% 1% (9)% (10)% (10)% TOTAL REVENUE $9,353 16% 1% 11% 28% 27% FY 2023 Amount Price FX Rate
Slide 9: Contribution to Q4 Worldwide Volume Increase
Contribution to 11% Q4 WW Volume Increase New Products 7.9% Growth Products 7.0% All Other -3.8% New Products: Ebglyss, Jaypirca, Mounjaro, OmvohTM, and Zepbound Growth Products: Cyramza®, Emgality®, Jardiance, Olumiant®, Retevmo®, Taltz®, Trulicity®, Tyvyt®, and Verzenio Not for promotional use 9
Slide 10: New Products and Growth Products
Millions NEW PRODUCTS $8,000 MOUNJARO • U.S. T2D injectable incretins TRx SOM over 27% and NBRx SOM over 38% $7,000 at end of Q4 2023 ZEPBOUND • U.S. approval and launch in Q4 2023 $6,000 JAYPIRCA • U.S. MCL approval in Q1 2023 and U.S. CLL/SLL approval in Q4 2023 $5,000 OMVOH • Japan and EU approva
Slide 11: Mounjaro
Robust growth in prescriptions for type 2 diabetes patients Q4 U.S. revenue of $2.11 billion Prescriptions (TRx, 000s) o Continued expansion of access and decreased utilization of savings cards o One-time favorable change in estimates for rebates and discounts in Q4 2023; adjusting for this change,
Slide 12: Zepbound launch
FDA approval on November 8, 2023 and pharmacy availability announced December 5, 2023 Exceptional prescription uptake since launch v Strong early formulary access of approximately 1/3 of commercial lives covered as of February 1st; focused on expanding payer access and employer opt-in v Commercial s
Slide 13: FY 2023 Capital Allocation
Billions FY 2023 Capital Allocation * After tax ** Includes development milestones, closed acquisitions and cash outflows associated with equity investments; does not include cash inflows from divestitures Not for promotional use 13
Slide 14: Outlook
OUTLOOK • Gross Margin: Maintain at ~80% with • Deliver top-tier revenue growth driven by volume from productivity gains and volume growth innovative medicines offsetting price pressures and increased • Growth catalysts include recent launches of Mounjaro, Jaypirca, manufacturing costs Omvoh and Zep
Slide 15: 2024 Revenue Considerations
Momentum from recently launched products, including Mounjaro, Zepbound, Jaypirca and Omvoh Continued strong revenue contribution from Verzenio, Taltz and Jardiance1 Acceleration of revenue growth in all major geographies Timing and ramp of injectable incretin production, with more significant expans
Slide 16: 2024 Guidance
2023 Actuals 2024 Guidance 2024 Comments Midpoint represents ~20% total growth and ~29% growth REVENUE $34.1 billion $40.4 – $41.6 billion excluding impact of divestiture transactions Gross margin as a percent of revenue consistent with outlook GROSS MARGIN – OPEX 1 REVENUE Research and development
Slide 17: Tirzepatide SYNERGY-NASH Phase 2 results
Proportion of participants with absence of MASH and no worsening of fibrosis on liver histology at 52 weeks Phase 2 study in adults with biopsy-proven MASH with stage 2 or 3 fibrosis 73.9% v All doses met primary endpoint of absence of 63.1% MASH with no worsening of liver histology 51.8% v Secondar
Slide 18: Late-stage pipeline update
FEBRUARY 5, 2024 TIRZEPATIDE LEGEND NASH MOVEMENT SINCE NME RETATRUTIDE TIRZEPATIDE October 30, 2023 Diabetes Higher Doses NILEX ADDITION or Commercial MILESTONE ACHIEVED GBA1 GENE THERAPY GBA1 GENE THERAPY TIRZEPATIDE * Collaboration Gaucher Disease Type 1 Gaucher Disease Type 2 Obstructive Sleep A
Slide 19: Phase 3 initiations, submissions and actions since last update
New since last update Phase 3 Initiations Regulatory Submissions ✓+ Basal Insulin-Fc for type 2 diabetes [QWINT-1] ✓+ Tirzepatide for chronic weight management [US ✓+ /EU ✓+ ] ✓+ Tirzepatide H2H study vs. semaglutide [SURMOUNT-5] 1 ✓+ Lebrikizumab for atopic dermatitis [J] ✓+ Retatrutide for chronic
Slide 20: Anticipated Phase 3 initiations, submissions and actions
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] Lepodisiran [Lp(a) SiRNA] for cardiovascular disease Tirzepatide for
Slide 21: Summary
• Revenue grew 28% driven by Mounjaro, Verzenio, Jardiance1 and Zepbound • Continued to speed life-changing medicines to patients with: • FDA approval of Zepbound for the treatment of adults with obesity or overweight with weight-related comorbidities • FDA approval of Jaypirca under the Accelerated
Slide 22: Appendix
Company Confidential © 2024 Eli Lilly and Company 22 Not for promotional use
Slide 23: Reported income statement Q4 and FY 2023
Millions; except per share data Q4 2023 Change FY 2023 Change TOTAL REVENUE $9,353 28% $34,124 20% GROSS MARGIN 80.9% 2.1pp 79.2% 2.4pp TOTAL OPERATING EXPENSE* 5,178 32% 20,584 39% OPERATING INCOME 2,388 30% 6,458 (9)% OPERATING MARGIN 25.5% 0.4pp 18.9% (6.1)pp OTHER INCOME (EXPENSE) 121 (53)% 97 N
Slide 24: Year-on-year change with and without FX
Year-on-Year Change Q4 2023 FY 2023 REPORTED With FX w/o FX With FX w/o FX TOTAL REVENUE 28% 27% 20% 20% COST OF SALES 15% 17% 7% 8% GROSS MARGIN 31% 30% 23% 24% OPERATING EXPENSE 32% 31% 39% 39% OPERATING INCOME 30% 27% (9)% (9)% EARNINGS PER SHARE 13% 11% (16)% (16)% NON-GAAP With FX w/o FX With F
Slide 25: EPS reported to non-GAAP
Q4 2023 Q4 2022 % Change FY 2023 FY 2022 % Change EARNINGS PER SHARE (REPORTED) $2.42 $2.14 13% $5.80 $6.90 (16)% AMORTIZATION OF INTANGIBLE ASSETS 0.11 0.11 – 0.45 0.50 (10)% NET LOSSES (GAINS) ON INVESTMENTS IN (0.11) (0.19) (42)% 0.02 0.33 (94)% EQUITY SECURITIES ASSET IMPAIRMENT, RESTRUCTURING A
Slide 26: Q4 non-GAAP adjustments
Q4 2023 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 $129.0 million (pretax), or $0.11 per share (after-tax); • net gains on investments in equity
Slide 27: FY non-GAAP adjustments
FY 2023 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 $506.2 million (pretax), or $0.45 per share (after-tax); • asset impairment, restructuring an
Slide 28: Quarterly EPS reported and non-GAAP
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 (0.06) 2.42 5.80 Non-GAAP 2.62 1.25 1.98 2.09 7.94 1.62 2.11 0.10 2.49 6.32 Numbers may not add due to rounding For a complete reconciliation to reported earnings, see slide 25 and our earnings press releas
Slide 29: Mounjaro sales and TRx share
Millions U.S. sales were $2.1 billion U.S. TRx SOM and Market Volume International sales were $100 million Market Lilly T2D Injectable Incretins Mounjaro Note: Lilly T2D Injectable Incretins consists of Mounjaro & Trulicity 13 Wk RA TRx SOM Source: IQVIA NPA TRx 3MMA, weekly data December 29, 2023;
Slide 30: Trulicity sales and TRx share
Millions U.S. sales decreased 18% U.S. TRx SOM and Market Volume International sales increased 1% Market Lilly T2D Injectable Incretins Trulicity Note: Lilly T2D Injectable Incretins consists of Mounjaro & Trulicity 13 Wk RA TRx SOM Source: IQVIA NPA TRx 3MMA, weekly data December 29, 2023; RA = rol
Slide 31: Verzenio sales and TRx share
Millions U.S. sales increased 40% U.S. TRx SOM and Market Volume International sales increased 45% Verzenio Market Source: IQVIA NPA TRx 3MMA, weekly data December 29, 2023; RA = rolling average Not for promotional use 31
Slide 32: Jardiance sales and TRx share
Millions U.S. sales increased 29% U.S. TRx SOM and Market Volume International sales increased 32% Jardiance1 Market Source: IQVIA NPA TRx 3MMA, weekly data December 29, 2023; RA = rolling average 1 Jardiance includes Glyxambi and Synjardy. Jardiance is part of the company’s alliance with Boehringer
Slide 33: Taltz sales and TRx share
Millions U.S. sales increased 5% U.S. TRx SOM and Market Volume International sales increased 26% Taltz Market Source: IQVIA NPA TRx 3MMA, weekly data December 29, 2023; RA = rolling average TRx data is representative of the full molecule market Not for promotional use 33
Slide 34: Humalog and insulin lispro sales
Millions U.S. sales decreased 50% U.S. TRx SOM International sales decreased 6% Humalog + Insulin Lispro Humalog Lilly Insulin Lispro Source: IQVIA NPA TRx 3MMA, weekly data December 29, 2023; RA = rolling average Not for promotional use 34
Slide 35: Sales by Major Geography
Millions U.S. sales increased 7% Sales by Major Geography International sales decreased 17% Not for promotional use 35
Slide 36: Olumiant sales
Millions U.S. sales were $67 million International sales were $177 million • In the U.S., launched in rheumatoid arthritis in Q3 2018 and in alopecia areata in Q2 2022 • Q4 year-over-year sales growth primarily driven by alopecia areata sales in the U.S. Not for promotional use 36
Slide 37: Emgality sales and TRx share
Millions U.S. sales decreased 3% U.S. TRx SOM and Market Volume International sales increased 33% Emgality Market Source: IQVIA NPA TRx 3MMA, weekly data December 29, 2023; RA = rolling average TRx data is representative of the injectable CGRP market Not for promotional use 37
Slide 38: Insulin efsitora alfa Phase 3 trials
Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Type 2 NCT05462756 Insulin Compared to Insulin Glargine in Adult Participants With 3 730 Change from Baseline in Hemoglobin A1c (HbA1c) Mar 2024 Mar 2
Slide 39: Donanemab Phase 3 trials
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 1800 Apr 2023 Aug 2025 Disease Alzheimer's Disease (TRAILBLAZER-ALZ 2)
Slide 40: Imlunestrant Phase 3 trials
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 in Participants With 3 860 Apr
Slide 41: Lebrikizumab Phase 3 trials
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 Dermatitis 3 120 Jan 2024 De
Slide 42: Mirikizumab Phase 3 trials
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 Crohn's Disease (VIVID-2) An
Slide 43: Orforglipron Phase 3 trials, diabetes
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 A1c (HbA1c) Apr 2025 Apr 202
Slide 44: Orforglipron Phase 3 trials, obesity
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 2 Diabetes (ATTAIN-2) A Study of Once
Slide 45: Pirtobrutinib Phase 3 trials
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 of NCT04666038 Lymphocytic Pat
Slide 46: Remternetug Phase 3 trial
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 (TRAILRUNNER-ALZ 1) Clearance o
Slide 47: Retatrutide trials
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 Filtration Rate (GFR) Nov 2025
Slide 48: Selpercatinib trials
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 Medullary Thyroid Cancer (
Slide 49: Tirzepatide obesity trials
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 Study of Tirzepatide (LY3298176
Slide 50: Tirzepatide type 2 diabetes trials
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 Participants With Type 2 3 13299 Oct 202
Slide 51: Tirzepatide NASH, sleep apnea and HFpEF trials
Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Nonalcoholic A Study of Tirzepatide (LY3298176) in Participants With Percentage of Participants with Absence of NASH with no NCT04166773 Steatohepatitis 2 196 Jan 2024 Feb 2024 Nonalcoholic Steatohepatitis (SYNERG
Slide 52: Abemaciclib trials
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 Breast Cancer (monarchE) A
Slide 53: Lipoprotein disorder and bimagrumab Phase 2 trials
Primary Molecule 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 Lepodisiran NCT05565742 2 254 Oct 2023 Oct 2024 Disorder Lipoprotein(a) [Lp(a)] (ALPACA) Lipopr
Slide 54: Early-phase diabetes and obesity trials
Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Part A: Number of Participants with One or More Treatment Diabetes GIPR Agonist LA A Study of LY3532226 in Participants With Type 2 Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) NCT05407961
Slide 55: Early-phase cardiometabolic trials
Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Number of Participants with One or More Treatment Hypertriglycer A Study of LY3875383 in Healthy Participants and Emergent Adverse Events (TEAEs) and Serious Adverse APOC3 siRNA NCT05609825 1 120 Jan 2024
Slide 56: Immunology Phase 2 trials
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-Severely Active Rheumatoid Arthritis 2 491
Slide 57: Immunology early-phase trials
Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Number of participants with one or more Adverse Event Itaconate A First-In-Human Study of LY3839840 in Healthy (s) (AEs), Treatment Emergent Adverse Events (TEAEs) NCT06153355 Healthy 1 112 Jun 2024 Jun 2
Slide 58: Neurodegeneration trials
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 Aug 2024 Inh. Disease and Efficacy in Partici
Slide 59: Gene therapy trials
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 2028 Oct 2028 Therapy Bilateral Loss Gaucher GBA1 Gene
Slide 60: Olomorasib and PI3K oncology trials
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 Olomorasib Without Chemotherapy in Participants With Non-Small NCT06119581 Non-Small-Cell 3
Slide 61: SSTR4 agonist trial
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 Jan 2025 Peripheral Neuropathic P
Slide 62: Not for promotional use
Not for promotional use
Eli Lilly and Company — Q4 2023 Earnings Presentation on 6ix