Eli Lilly And Company · NYSE:LLY
Eli Lilly And — Q3 2023 Earnings Presentation
58 slides from Eli Lilly And's earnings presentation, Nov 2, 2023
Slide 1: Q3 2023 Earnings Call
Q3 2023 Earnings Call NOVEMBER 2, 2023 2023 Q3 EARNINGS
Slide 2: Agenda
Agenda INTRODUCTION AND RECENT KEY EVENTS Dave Ricks, Chair and Chief Executive Officer Q3 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 QUESTIO
Slide 3: 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 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 • Excluding the olanzapine portfolio and COVID-19 antibodies1, 81.7% in Q3 revenue grew 24% in Q3 • SG&A: 12% increase in Q3 primarily driven by •
Slide 5: Key Events Since the Last Earnings Call
KEY EVENTS SINCE THE LAST EARNINGS CALL REGULATORY CLINICAL (CONT) • Announced the U.S. Food and Drug Administration (FDA) approved: • Published Retevmo® Phase 3 data in The New England Journal of Medicine (NEJM) • Omvoh for the treatment of adults with moderately to severely active ulcerative and p
Slide 6: Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (Q3)
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION; CERTAIN LINE ITEMS (UNAUDITED) Millions; except per share data Q3 2023 Non-GAAP YoY Non-GAAP GAAP Reported Adjustments Adjusted Adjusted Change TOTAL REVENUE $9,499 $- $9,499 37% GROSS MARGIN 80.4% 1.3pp 81.7% 2.7pp TOTAL OPERATING EX
Slide 7: Reconciliation of GAAP Reported to Non-GAAP Adjusted Information (YTD)
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION; CERTAIN LINE ITEMS (UNAUDITED) Millions; except per share data YTD 2023 Non-GAAP YoY Non-GAAP GAAP Reported Adjustments Adjusted Adjusted Change TOTAL REVENUE $24,771 $- $24,771 17% GROSS MARGIN 78.6% 1.5pp 80.1% 1.9pp TOTAL OPERATING
Slide 8: Price/Rate/Volume Effect on Revenue
PRICE/RATE/VOLUME EFFECT ON REVENUE Millions Q3 2023 Amount Price FX Rate Volume Total CER U.S. $5,368 13% - 9% 21% 21% EUROPE 2,569 (11)% 7% 147% 143% 136% JAPAN 391 (2)% (4)% (14)% (20)% (16)% CHINA 391 (5)% (6)% 25% 14% 20% REST OF WORLD 780 (4)% 0% 28% 23% 23% TOTAL REVENUE $9,499 6% 1% 31% 37%
Slide 9: Products Driving WW Volume Growth
PRODUCTS DRIVING WW VOLUME GROWTH Contribution to 31% Q3 WW Volume Increase * *Includes $1.42 billion from the sale of the worldwide rights for the olanzapine portfolio; numbers may not add due to rounding New Products: Jaypirca®, Mounjaro®, and Omvoh Growth Products: Cyramza®, Emgality®, Jardiance,
Slide 10: Q3 2023 Update on Select Products
Q3 2023 UPDATE ON SELECT PRODUCTS Millions $7,000 NEW PRODUCTS Growth Products New Products MOUNJARO • U.S. T2D launch in Q2 2022 $6,000 • U.S. T2D injectable incretins TRx SOM over 22% at end of Q3 2023 JAYPIRCA $5,000 • U.S. MCL approval in Q1 2023 OMVOH $4,000 • Japan approval in Q1 2023; EU appr
Slide 11: Mounjaro U.S. Launch Progress
MOUNJARO U.S. LAUNCH PROGRESS 250 Access on October 1st was 78% for patients with type 2 diabetes across commercial and 200 Part D lives, including 85% in commercial Prescriptions (TRx, 000s) 150 Original non-covered $25 copay card expired June 30th; all Q3 prescriptions are considered paid 100 Moun
Slide 12: Capital Allocation
CAPITAL ALLOCATION Billions YTD 2023 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; does not include cash inflows from
Slide 13: 2023 Guidance
2023 GUIDANCE Prior Updated COMMENTS REVENUE $33.4 – $33.9 billion Unchanged GROSS MARGIN % OF REVENUE (GAAP) Approx. 78% Unchanged Trending toward the higher end of the estimate GROSS MARGIN % OF REVENUE (NON-GAAP) Approx. 80% MKTG, SELLING & ADMIN. $7.2 – $7.4 billion Unchanged Trending toward the
Slide 14: Lilly Select NME and NILEX Pipeline
LILLY SELECT NME AND NILEX PIPELINE OCTOBER 30, 2023 LEGEND TIRZEPATIDE TIRZEPATIDE TIRZEPATIDE MOVEMENT SINCE Higher Doses MMO Obstructive Sleep Apnea NME August 2, 2023 NILEX RETATRUTIDE TIRZEPATIDE TIRZEPATIDE TIRZEPATIDE ADDITION or Diabetes NASH CV Outcomes Heart Failure pEF Commercial MILESTON
Slide 15: Potential Key Events 2023
POTENTIAL KEY EVENTS 2023 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 for chronic weight management (H2H vs semaglutide 2.4 mg) + Lebrikizumab for atopic
Slide 16: Q3 2023 Summary
Q3 2023 SUMMARY • Excluding the olanzapine portfolio and COVID-19 antibodies, revenue grew 24% • Continued to speed life-changing medicines to patients with: • FDA approval of Omvoh for the treatment of adults with moderately to severely active ulcerative colitis and Jardiance1 for the treatment of
Slide 17: Supplemental Slides
SUPPLEMENTAL SLIDES 2023 Q3 EARNINGS
Slide 18: 2023 Income Statement – Reported
2023 INCOME STATEMENT – REPORTED Millions; except per share data Q3 2023 Change YTD 2023 Change TOTAL REVENUE $9,499 37% $24,771 17% GROSS MARGIN 80.4% 3.2pp 78.6% 2.5pp TOTAL OPERATING EXPENSE* 7,188 95% 15,406 42% OPERATING INCOME 450 (73)% 4,070 (23)% OPERATING MARGIN 4.7% (19.4)pp 16.4% (8.5)pp
Slide 19: Non-GAAP Operating Margin % of Revenue
NON-GAAP OPERATING MARGIN % OF REVENUE MOVING ANNUAL TOTAL Individual Quarter 23.1% 29.1% 27.9% 27.0% 33.4% 20.5% 28.9% 27.4% 23.3% 27.1% 6.1% 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% -31.3% Acquired IPR&D Charges The line in the graph
Slide 20: Effect of FX on 2023 Results
EFFECT OF FX ON 2023 RESULTS Year-on-Year Change Q3 2023 YTD 2023 REPORTED With FX w/o FX With FX w/o FX TOTAL REVENUE 37% 36% 17% 18% COST OF SALES 18% 20% 4% 6% GROSS MARGIN 42% 41% 21% 21% OPERATING EXPENSE 95% 95% 42% 42% OPERATING INCOME (73)% (78)% (23)% (22)% EARNINGS PER SHARE (104)% (109)%
Slide 21: EPS Reconciliation
EPS RECONCILIATION Q3 2023 Q3 2022 % Change YTD 2023 YTD 2022 % Change EARNINGS (LOSS) PER SHARE $(0.06) $1.61 NM $3.38 $4.76 (29)% (REPORTED) AMORTIZATION OF INTANGIBLE ASSETS 0.11 0.11 - 0.33 0.39 (15)% NET LOSSES (GAINS) ON INVESTMENTS 0.06 0.09 (33)% 0.12 0.52 (77)% IN EQUITY SECURITIES ASSET IM
Slide 22: Q3 2023 Income Statement Notes
Q3 2023 INCOME STATEMENT NOTES Q3 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 $125.0 million (pretax), or $0.11 per share (after-tax); and • net losses on i
Slide 23: YTD 2023 Income Statement Notes
YTD 2023 INCOME STATEMENT NOTES YTD 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 $377.2 million (pretax), or $0.33 per share (after-tax); and • net losses on
Slide 24: Comparative EPS Summary 2022/2023
COMPARATIVE EPS SUMMARY 2022/2023 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) Non-GAAP 2.62 1.25 1.98 2.09 7.94 1.62 2.11 0.10 Numbers may not add due to rounding For a complete reconciliation to reported earnings, see slide 21 and our earning
Slide 25: Q3 2023 Trulicity Sales Decreased 10%
Q3 2023 TRULICITY SALES DECREASED 10% Millions U.S. sales decreased 11% U.S. TRx SOM and Market Volume International sales decreased 4% Market Trulicity Source: IQVIA NPA TRx 3MMA, weekly data September 30, 2023; RA = rolling average TRx data is representative of the injectable incretin market Not f
Slide 26: Q3 2023 Verzenio Sales Increased 68%
Q3 2023 VERZENIO SALES INCREASED 68% Millions U.S. sales increased 65% U.S. TRx SOM and Market Volume International sales increased 75% Verzenio Market Source: IQVIA NPA TRx 3MMA, weekly data September 30, 2023; RA = rolling average Not for promotional use 2023 Q3 EARNINGS 26
Slide 27: Q3 2023 Jardiance Sales Increased 22%
Q3 2023 JARDIANCE SALES INCREASED 22% Millions U.S. sales increased 19% U.S. TRx SOM and Market Volume International sales increased 28% Jardiance1 Market Source: IQVIA NPA TRx 3MMA, weekly data September 30, 2023; RA = rolling average 1 Jardiance includes Glyxambi and Synjardy. Jardiance is part of
Slide 28: Q3 2023 Taltz Sales Increased 9%
Q3 2023 TALTZ SALES INCREASED 9% Millions U.S. sales increased 3% U.S. TRx SOM and Market Volume International sales increased 26% Taltz Market Source: IQVIA NPA TRx 3MMA, weekly data September 30, 2023; RA = rolling average TRx data is representative of the full molecule market Not for promotional
Slide 29: Q3 2023 Humalog Sales Decreased 12%
Q3 2023 HUMALOG SALES DECREASED 12% Millions U.S. sales decreased 22% U.S. TRx SOM International sales increased 1% Humalog + Insulin Lispro Humalog Lilly Insulin Lispro Source: IQVIA NPA TRx 3MMA, weekly data September 30, 2023; RA = rolling average Not for promotional use 2023 Q3 EARNINGS 29
Slide 30: Q3 2023 Cyramza Sales Decreased 3%
Q3 2023 CYRAMZA SALES DECREASED 3% Millions U.S. sales increased 1% Sales by Major Geography International sales decreased 6% Not for promotional use 2023 Q3 EARNINGS 30
Slide 31: Q3 2023 Olumiant Sales Increased 27%
Q3 2023 OLUMIANT SALES INCREASED 27% Millions U.S. sales were $66 million International sales were $166 million • In the U.S., launched in rheumatoid arthritis in Q3 2018 and in alopecia areata in Q2 2022 • Q3 year-over-year sales growth primarily driven by alopecia areata sales in the U.S. Not for
Slide 32: Q3 2023 Emgality Sales Were Flat
Q3 2023 EMGALITY SALES WERE FLAT Millions U.S. sales increased 11% U.S. TRx SOM and Market Volume International sales decreased 23% Market Emgality Source: IQVIA NPA TRx 3MMA, weekly data September 30, 2023; RA = rolling average TRx data is representative of the injectable CGRP market Not for promot
Slide 33: 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) as a Weekly Type 2 Basal Insulin Compared to Insulin Glargine in Adult NCT05462756 3 730 Change from Baseline in Hemoglobin A1c (H
Slide 34: 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 Change from Baseline on the integrated Alzheimer's NCT04437511 3 1800 Apr 2023 Aug 2025 Disease Early Alzheimer's Disease (
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 Endocrine Breast Therapy, and Imlunestrant Plus Abemaciclib in Progression Free Survival (PFS) in the Intent-to-Treat (IIT) NCT0497530
Slide 36: Select Trials – Jardiance
SELECT TRIALS – JARDIANCE Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion EMPACT-MI: A Study to Test Whether Empagliflozin1 Can Myocardial Composite of time to first heart failure hospitalisation or NCT04509674 Lower the Risk of Heart Failure and Death in Peopl
Slide 37: Select Trials – Lebrikizumab
SELECT TRIALS – LEBRIKIZUMAB Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Lebrikizumab (LY3650150) in Adult and Atopic Percentage of Participants Achieving Eczema Area and NCT05369403 Adolescent Participants With Moderate-to-Severe Atopic 3 120 Ja
Slide 38: 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) Percentage of Participants Achieving Endoscopic NCT04232553 3 778 Jan 2025 Apr 2027 Disease in Participants With Crohn's D
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 Participants Type 2 NCT05971940 With Type 2 Diabetes and Inadequate Glycemic Control 3 520 Change from Baseline in Hemoglobin A1c (HbA1c) A
Slide 40: 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 NCT05872620 Obesity 3 1500 Mean Percent Change from Baseline in Body Weight Jun 2025 Jun 2025 or Overweight and Type
Slide 41: Select Trials – Pirtobrutinib
SELECT TRIALS – PIRTOBRUTINIB Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Study of LOXO-305 Versus Investigator's Choice (IdelaR or To evaluate progression-free survival (PFS) of LOXO-305 Chronic BR) in Patients With Previously Treated Chronic monotherapy (
Slide 42: Select Trials – Remternetug
SELECT TRIALS – REMTERNETUG Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion Percentage of Participants Who Reach Amyloid Plaque Alzheimer A Study of Remternetug (LY3372993) in Participants With NCT05463731 3 600 Clearance on Amyloid PET Scan for Remternetug ver
Slide 43: 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 2 120 Change from Baseline in Glomerular Filtratio
Slide 44: 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 Progression Free Survival (PFS) by Blinded Independent NCT04211337 Thyroid 3 400 May 2023 Feb 2026 RET-Mutant Medullary T
Slide 45: Select Trials – Tirzepatide
SELECT TRIALS – TIRZEPATIDE Primary Study Indication* Title Phase Patients Primary Outcome** Completion Completion A Study of Tirzepatide (LY3298176) in Participants With NCT04184622 Obesity 3 2539 Percent Change from Baseline in Body Weight Apr 2022 Jul 2024 Obesity or Overweight (SURMOUNT-1) A Stu
Slide 46: 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 Time to First Occurrence of Death from Cardiovascular Type 2 NCT04255433 Dulaglutide on Major Cardiovascular Events in Participa
Slide 47: Select Trials – Tirzepatide (Cont.)
SELECT TRIALS – TIRZEPATIDE (CONT.) 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 2 196 Jan 2024 Feb 2024 Steatohepatitis
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 With Breast 3 5637 Invasive Disease-Free Survival (IDFS) Mar 2020 May 2029 C
Slide 49: 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 Lipoprotein A Study of LY3819469 in Participants With Elevated Percent Change from Baseline in Time Averaged Lepodisiran NCT05565742 2 254 Oct 2023 Oct 202
Slide 50: 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 Treatment Diabetes A Study of LY3457263 Alone and in Combination With Emergent Adverse Events (TEAEs) and S
Slide 51: 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 Treatment Emergent Adverse Events (TEAEs) and Serious Hypertriglyce A Study of LY3875383 in Healthy Partici
Slide 52: 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 Rheumatoid Percentage of Participants Achieving American Peresolimab NCT05516758 With Moderately-to-Severely Activ
Slide 53: Select Trials – Early Phase Immunology (Cont.)
SELECT TRIALS – EARLY PHASE IMMUNOLOGY (CONT.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Number of Participants with One or More Adverse GITR Events (AEs), Treatment Emergent Adverse Events A Study of LY3844583 in Healthy Participants and Antagon
Slide 54: 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, O-GlcNAcase Alzheimer Change from Baseline to End Time Point in NCT05063539 Tolerability, and Efficacy in Participa
Slide 55: Select Trials – Early Phase Neurodegeneration (Cont.)
SELECT TRIALS – EARLY PHASE NEURODEGENERATION (CONT.) Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Gaucher Number of Adverse Events (AEs), Serious Adverse GBA1 Gene Phase 1/2 Clinical Trial of PR001 in Infants With Type NCT04411654 Disease, 1|2 15 E
Slide 56: Select Trials – Early Phase Oncology
SELECT TRIALS – EARLY PHASE ONCOLOGY Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Carcinoma, Study of LY3537982 in Cancer Patients With a Phase 1a: To determine the recommended phase 2 KRAS G12C1 NCT04956640 Non-Small- 1 400 Sep 2025 Sep 2025 Specif
Slide 57: Select Trials – Early Phase Pain
SELECT TRIALS – EARLY PHASE PAIN Primary Molecule Study Indication* Title Phase Patients Primary Outcome** Completion Completion Diabetic SSTR4 A Study of LY3556050 in Adult Participants With Mean Change from Baseline for Average Pain NCT06074562 Peripheral 2 410 Jan 2025 Jan 2025 Agonist Diabetic P
Slide 58: 2023 Q3 Earnings
2023 Q3 EARNINGS
Eli Lilly and Company — Q3 2023 Earnings Presentation on 6ix