Eli Lilly And Company · NYSE:LLY
Eli Lilly And — Q2 2023 Earnings Presentation
58 slides from Eli Lilly And's earnings presentation, Aug 8, 2023
Slide 1: Q2 2023 Earnings Call
Q2 2023 Earnings Call AUGUST 8, 2023
Slide 2: Agenda
Agenda INTRODUCTION AND RECENT KEY EVENTS Dave Ricks, Chair and Chief Executive Officer Q2 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
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Slide 6: Reconciliation of GAAP Reported to Non-GAAP Adjusted Information, Q2 2023
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION; CERTAIN LINE ITEMS (UNAUDITED) Millions; except per share data Lilt Q2 2023 . Non-GAAP YoY Non-GAAP GAAP Reported Adjustments Adjusted Adjusted Change TOTAL REVENUE «$8,312 $ - $8,312 28% GROSS MARGIN 78.3% 1.5pp 79.8% (0.0)pp TOTAL O
Slide 7: Reconciliation of GAAP Reported to Non-GAAP Adjusted Information, 1H 2023
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION; CERTAIN LINE ITEMS (UNAUDITED) Millions; except per share data Lilt 1H 2023 GAAP Reported Adjustments usted, Adjusted Change TOTAL REVENUE $15,272 $ - $15,272 7% GROSS MARGIN | 77.5% | 1.7pp 79.2% 1.4pp TOTAL OPERATING EXPENSE 8,218 -
Slide 8: Price/Rate/Volume Effect on Revenue
PRICE/RATE/VOLUME EFFECT ON REVENUE Millions U.S. EUROPE JAPAN CHINA REST OF WORLD TOTAL REVENUE U.S. EUROPE JAPAN CHINA REST OF WORLD TOTAL REVENUE Numbers may not add due to rounding Not for promotional use Q2 2023 Amount Price FX Rate Volume Total CER $5,531 2% - 39% 41% 41% 1,178 (6)% 1% 12% 7%
Slide 9: Products Driving WW Volume Growth
PRODUCTS DRIVING WW VOLUME GROWTH Contribution to 29% Q2 WW Volume Increase All Other* 5.6% COVID-19 Antibodies -2.0% *Includes $579 million from the sale of the worldwide rights for Bagsimi; Numbers may not add due to rounding New Products: Jaypirca, Mounjaro®, and Omvoh® Growth Products: Cyramza®,
Slide 10: Q2 2023 Update on Select Products
Q2 2023 UPDATE ON SELECT PRODUCTS Millions [I New propucts m=Growth Products m™ New Products $6,000 > MOUNJARO : , + U.S. T2D launch in Q2 2022 $5,000 + U.S. T2D injectable incretins TRx SOM over 22% at end of Q2 2023 JAYPIRCA $4,000 + U.S. MCL approval in Q1 2023 OMVOH $3,000 + Japan approval in Q1
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Slide 12: Capital Allocation
CAPITAL ALLOCATION Billions 1H 2023 Capital Allocation Capital Business Development** $0.6 Share Repurchase $0.8 * After tax $2.0 ** Includes development milestones, closed acquisitions and cash outflows associated with equity investments; does not include cash inflows from divestitures Not for prom
Slide 13: 2023 Guidance
2023 GUIDANCE REVENUE GROSS MARGIN % OF REVENUE (GAAP) GROSS MARGIN % OF REVENUE (NON-GAAP) MKTG, SELLING & ADMIN. RESEARCH & DEVELOPMENT ACQUIRED IPR&D OTHER INCOME/(EXPENSE) (GAAP) OTHER INCOME/(EXPENSE) (NON-GAAP) TAX RATE EARNINGS PER SHARE (GAAP) EARNINGS PER SHARE (NON-GAAP) Assumes shares out
Slide 14: Percentage Change in Body Weight by Week
Percentage Change in Body Weight by Week (efficacy estimand) Overall mean body weight at baseline = 109kg 0 -2.3% change from baseline -5 Percentage weight -10 -9.4% -12.5% -13.5% -15 -14.7% -20 2 4 8 12 16 20 26 32 36 Weeks Not for promotional use 14
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*p<0.05 vs PBO, **p<0.001 vs PBO, #p<0.05 vs dula, ##p<0.001 vs dula; Dula – dulaglutide, PBO – placebo Not for promotional use 15
Slide 16: Retatrutide Demonstrated Mean Weight Reduction at 48 Weeks
RETATRUTIDE DEMONSTRATED A MEAN WEIGHT REDUCTION OF UP TO 24.2% AT 48 WEEKS EFFICACY RESULTS KEY MESSAGES 104 Percent change in body weight (%) TTrrrrert T T 14 8 12 16 20 24 36 48 Weeks since Randomization —e— Placebo RETA 1 mg = RETA8mg [ID 2 mg] RETA4mg[ID2mg] —s— RETA8mg [ID 4 mg] —e— RETA4mg[ID
Slide 17: Tirzepatide: SURMOUNT-3 & SURMOUNT-4
TIRZEPATIDE: SURMOUNT-3 & SURMOUNT-4 TRIALS DEMONSTRATED SIGNIFICANT AND SUPERIOR WEIGHT LOSS COMPARED TO PLACEBO J, SURMOUNT-3 SURMOUNT-4 (.) SURMOUNT-3 evaluated the efficacy and safety of (.) SURMOUNT-4 evaluated the efficacy and safety of tirzepatide compared to placebo for 72 weeks after a 12-
Slide 18: Late-stage pipeline
ORFORGLIPRON Diabetes LEGEND TIRZEPATIDE TIRZEPATIDE MOVEMENT SINCE MMO Obstructive Sleep Apnea NME April 24, 2023 NILEX ADDITION or TIRZEPATIDE TIRZEPATIDE CV Outcomes Heart Failure pEF Commercial MILESTONE ACHIEVED * Collaboration REMOVAL RETATRUTIDE TIRZEPATIDE SELPERCATINIB SELPERCATINIB Phase
Slide 19: New since last update
New since last update ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓- ✓+ ✓+ ✓- ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ Not for promotional use 19
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Slide 21: Slides
SLIDES
Slide 22: 2023 Income Statement - Reported
2023 INCOME STATEMENT - REPORTED Lilt Millions; except per share data Q2 2023 Change 1H 2023 Change TOTAL REVENUE $8,312 28% $15,272 7% GROSS MARGIN 78.3% 0.3pp ~=—s—t«é«iT7«8%H_—=Ss—=<Ci*«‘“C*« CW TOTAL OPERATING EXPENSE* 4379 14% 8218 14% OPERATING INCOME 2,126 78% 3,620 - OPERATING MARGIN 25.6% «
Slide 23: Non-GAAP Operating Margin % of Revenue
NON-GAAP OPERATING MARGIN % OF REVENUE MOVING ANNUAL TOTAL 30.0% 29.0% 28.0% 27.0% 26.0% 25.0% 24.0% | er) a2 | a3 | Qs ai 2021 Individual Quarter Op. Margin % of Revenue: 23.1% 29.1% 27.9% 27.0% 33.4% Q2 Q3 2022 20.5% 28.9% Q4 27.4% qa Q2 2023 23.3% 27.1% Op. Margin impact of “4 69 0 69 -2 69 559 2
Slide 24: Effect of FX on 2023 Results
EFFECT OF FX ON 2023 RESULTS Year-on-Year Change REPORTED TOTAL REVENUE COST OF SALES GROSS MARGIN OPERATING EXPENSE OPERATING INCOME EARNINGS PER SHARE NON-GAAP TOTAL REVENUE COST OF SALES GROSS MARGIN OPERATING EXPENSE OPERATING INCOME EARNINGS PER SHARE a2 2023 1H 2023 With FX w/oFX —-WithFX — w/
Slide 25: EPS Reconciliation
EPS RECONCILIATION Q2 2023 _Q22022_ %Change , EPS (REPORTED) $1.95 $1.05 86% AMORTIZATION OF INTANGIBLE on fo om te ASSETS Ww | OW NET LOSSES (GAINS) ON INVESTMENTS INEQUITYSEcuRITIEs °°5 == 9-09 44% EPS (NON-GAAP] $2.11 $1.25 69% Acquired IPR&D $0.09 $0.46 (80)% Numbers may not add due to rounding;
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Slide 28: Comparative EPS Summary 2022/2023
COMPARATIVE EPS SUMMARY 2022/2023 Lilt 1Q22 2022 3022 4Q22 2022 1Q23 2023 3023 4023 2023 Reported 2.10 1.05 1.61 2.14 6.90 1.49 1.95 Non-GAAP 2.62 1.25 1.98 2.09 7.94 1.62 2.11 Numbers may not add due to rounding For a complete reconciliation to reported earnings, see slide 25 and our earnings press
Slide 29: Q2 2023 Trulicity Sales Decreased 5%
Q2 2023 TRULICITY SALES DECREASED 5% Millions U.S. sales decreased 4% International sales decreased 8% $1,977 $1,74] $1,9126 913 $1,850 $1,936 qi Q2 Q3 era 2022 m2023 U.S. TRx SOM and Market Volume 52% 1000 48% | 900 Z| 44% 800 un | 40% 700 4 =| 36% 600 = 2] 32% 500 28% Trulicity 400 26% 300 Jun Sep
Slide 30: Q2 2023 Verzenio Sales Increased 57%
Q2 2023 VERZENIO SALES INCREASED 57% Lilt Millions U.S. sales increased 53% U.S. TRx SOM and Market Volume International sales increased 66% 5927 46% 10 =| Verzenio 3 $808 41% 7s $751 o = 8 — $618 S| 36% z & 7 2 El 31% Market 3 g ‘ 5 26% 5 é 21% 4 & 16% 3 [2 a2 Q3 a4 Jun Sep Dec Mar Jun Sep Dec Mar
Slide 31: Q2 2023 Jardiance Sales Increased 45%
Q2 2023 JARDIANCE SALES INCREASED 45% Millions U.S. sales increased 54% U.S. TRx SOM and Market Volume International sales increased 34% $668 $573 Q2 Q3 m 2022 m2023 63% 580 Jardiance! 540 $612 62% 500 61% 460 420 60% 380 13 Wk RA TRx SOM 340 59% 300 {13 Wk RA TRx Market Volume (000s} | 58% 260 Jun
Slide 32: Q2 2023 Taltz Sales Increased 16%
Q2 2023 TALTZ SALES INCREASED 16% Lilt U.S. sales increased 15% U.S. TRx SOM and Market Volume International sales increased 19% Millions 7% 230 a $704 $680 $708 s $606 ay, Taltz 220 |> =| o&% E fo} 2 a S & 210 |= Fl 59 Market g =| 5% = & 200 |= x = & 2 = —] 4% <s = 190 |& = 2 3% 180 a2 a3 a4 Jun Se
Slide 33: Q2 2023 Humalog Sales Decreased 1%
Q2 2023 HUMALOG SALES DECREASED 1% Millions U.S. sales decreased 4% International sales increased 1% $618 $548 $461 $447 $440 $447 : ai a2 a3 a4 m 2022 m2023 U.S. TRx SOM 50% Humalog+ Insulin Lispro 40% Humalog 30% 20% Lilly Insulin Lispro 13 Wk RA TRx SOM 10% 0% Jun Sep Dec Mar Jun Sep Dec Mar Jun
Slide 34: Q2 2023 Cyramza Sales Increased 13%
Q2 2023 CYRAMZA SALES INCREASED 13% Millions Lilt U.S. sales increased 24% International sales increased 5% $278 $260 | . Q2 Q3 Qa m2022 m2023 $230 $237 Qi $300 $250 $200 $150 $100 $5 o $0 Sales by Major Geography ai Q2 Q3 Q4 Qi Q2 Q3 Q4 Qi Q2 2021 2021 2021 2021 2022 2022 2022 2022 2023 2023 = OUSe
Slide 35: Q2 2023 Olumiant Sales Increased 18%
Q2 2023 OLUMIANT SALES INCREASED 18% Millions Lilt U.S. sales were $51 million International sales were $168 million $256 $229 $219 / | Qi Q2 Q3 2022 m2023 $206 Q4 * In the U.S., launched in rheumatoid arthritis in Q3 2018 and in alopecia areata in Q2 2022 * Q2 year-over-year sales growth primarily
Slide 36: Q2 2023 Emgality Sales Increased 8%
Q2 2023 EMGALITY SALES INCREASED 8% Millions U.S. sales increased 9% International sales increased 3% $169 $189 $176 | Q2 Q3 Q4 m 2022 m2023 $149 $184 qi U.S. TRx SOM and Market Volume 44% Emgality 80 1% Market 72 42% 40% 68 13 Wk RA TRx SOM 38% 64 3 8 s @ E 2 s 2 & = x & & < é S = 3 36% 60 Jun Sep
Slide 37: Insulin Efsitora Alfa
SELECT TRIALS - INSULIN EFSITORA ALFA Study Indication* le Phase Patients ry Outcome** Completion COMPLE’ A Study of Insulin Efsitora Alfa [LY3209590) as a Weekly Type 2 | Basal Insulin Compared to Insulin Glargine in Adult . . NCT05462756 | pisPtes| Participants With Type 2 Diabetes on Multiple Dai
Slide 38: Donanemab
SELECT TRIALS - DONANEMAB Phase Patients ry Outcome** Mild A Study of Donanemab (LY3002813) Compared With raue Clearance on Flo betey IrEId Poston Encion NCT05108922 | Cognitive | Aducanumab in Participants With Early Symptomatic | 3 | 200 Ta hy IPET] Scan Superiority] on d 5 | Sep 2022 | Sep 2023 I
Slide 39: Imlunestrant
SELECT TRIALS - IMLUNESTRANT Study Indication* Title Phase Patients Primary Outcome** |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] NCT04975308 |eopiasms| Participants Wi
Slide 40: Jardiance
SELECT TRIALS - JARDIANCE Study Indication* Phase Patients Primary Outcome** Myocardial EMPACT-MI: A Study to Test Whether Empagliflozin Can Composite of time to first heart failure hospitalisation or NCT04509674 |" Lower the Risk of Heart Failure and Death in People Who| 3 6522 P - P' Infarction i
Slide 41: Lebrikizumab
SELECT TRIALS - LEBRIKIZUMAB Phase Patients ry Outcome** Atopic A Study of Lebrikizumab (LY3650150] in Adult and Percentage of Participants Achieving Eczema Area and AoE 6 7408 aerate eee Wah Dernlureas(ADeeal | > |_'2°_ [Severity index-75 [EASI-75] »75% Reduction in EASI Score| Oct 7028 | Mar 2024
Slide 42: Mirikizumab
SELECT TRIALS - MIRIKIZUMAB Study Indication* le Phase Patients Primary Outcome** Compl Comple' Crohn's | A Study of Mirikizumab (LY3074828) in Participants With Percentage of Participants Achieving Clinical Response at NCT03926130 Disease Crohn's Disease [VIVID-1} 3 1100 Week 12 and Endoscopic Resp
Slide 43: Orforglipron
SELECT TRIALS - ORFORGLIPRON Study Indication* le Phase Patients Primary Outcome** Completion comple! Type 2 A Study of Orforglipron (LY3502970) in Adult Participants NCT05971940 | y¥Pe.c, | With Type 2 Diabetes and Inadequate Glycemic Control 520 Change from Baseline in Hemoglobin Alc (HbA1c] | Jan
Slide 44: Pirtobrutinib
SELECT TRIALS - PIRTOBRUTINIB Study Indication* le Phase Patients Pri ry Outcome** Compl chron | Study. of LOXO-305 Versus Investigator's Choice (ldelaR or To evaluate progression-free survival [PFS] of LOXO-305 ronic BR] in Patients With Previously Treated Chronic monotherapy (Arm A] compared to in
Slide 45: Remternetug
SELECT TRIALS - REMTERNETUG Primary Completion Study Indication* Phase Patients Primary Outcome** Completion| Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus | Oct 2025 | Oct 2026 Placebo Alzheimer] A Study of Remternetug (LY3372993] in Partic
Slide 46: Retatrutide
SELECT TRIALS - RETATRUTIDE Phase Patients ry Outcome** 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 Filtration Rate (GFR]| Feb 2025 | Feb 2025 Disease | Kidn
Slide 47: Retevmo
SELECT TRIALS - RETEVMO Phase Patients ry Outcome** Medullary| a . . . . . «| A Study of Selpercatinib (LY3527723) in Participants With Progression Free Survival (PFS) by Blinded Independent NOT04211337 | Thyroid |“ RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531] | ° | 40° Central Review (BICR] M
Slide 48: Tirzepatide
SELECT TRIALS - TIRZEPATIDE Study Indication* le Phase Patients Primary Outcome** Compl A Study of Tirzepatide (LY3298176] in Participants With . NCT04184622 | Obesity Obesity or Overweight (SURMOUNT-1) 3 2539 Percent Change from Baseline in Body Weight Apr 2022 | Jul 2024 A Study of Tirzepatide (LY
Slide 49: Tirzepatide (cont.)
SELECT TRIALS - TIRZEPATIDE (CONT.) Study Indication* le Phase Patients Primary Outcome** Completion COmPtE! Nonateohotic | A Study of Tirzepatide (LY3298176) in Participants With Percentage of Participants with Absence of NASH with no NCT04166773 |stesiressits| "Nonalcoholic Steatohepatitis (SYNERG
Slide 50: Verzenio
SELECT TRIALS - VERZENIO Phase Patients ry Outcome** Breast Endocrine Therapy or Without Abemacicli NCT03155997' Cancer (LY2835219) Following Surgery in Participants With Breast] 3 5637 Invasive Disease-Free Survival (IDFS) Mar 2020 | May 2029 Cancer [monarchE} Breast Abemaciclib (LY2835219) Plus Fu
Slide 51: Early Phase Diabetes and Obesity
SELECT TRIALS - EARLY PHASE DIABETES AND OBESITY Lite, Primary completion Molecule Study Indication* Phase Patients Primary Outcome** Completion Lepodisiran Lipoprotein | A Study of LY3819469 in Participants With Elevated Percent Change from Baseline in Time Averaged (LPA siRNA} NCT05565742 Disorder
Slide 52: Early Phase Diabetes and Obesity (cont.)
SELECT TRIALS - EARLY PHASE DIABETES AND OBESITY (CONT.) Molecule Study Indication* Phase Patients Primary Outcome** Primary Completion Lite, Completion Number of Participants with One or More Treatment . A Study of LY3541105 in Healthy and Overweight Emergent Adverse Events (TEAEs) and Serious Adve
Slide 53: Early Phase Diabetes and Obesity (cont.)
SELECT TRIALS - EARLY PHASE DIABETES AND OBESITY (CONT.) Molecule Study Indication* Phase Patients Number of Participants with One or More Treatment . . Emergent Adverse Events (TEAEs] and Serious A Study of LY3875383 in Healthy Participants and Adverse Eventls) (SAEs) Considered by the Participants
Slide 54: Early Phase Immunology
SELECT TRIALS - EARLY PHASE IMMUNOLOGY Primary Outcome** Lite, Primary completion Molecule Study Indication* Phase Patients Completion . | A Study of Peresolimab [LY3462817] in Participants : . Peresolimab |NCT05516758| Rheumatoid | "With Moderately-to-Severely Active Rheumatoid | 2 | 420 | Percenta
Slide 55: Early Phase Neurodegeneration
SELECT TRIALS - EARLY PHASE NEURODEGENERATION Molecule Study Indication* Phase Patients Primary Outcome** Completion Lite, Primary completion ‘A Study of LY3372689 to Assess the Safety, ; ; O-GlcNAcase| ietosogasa9] Alzheimer | Tolerability, and Efficacy in Participants With | 2 | 330 Change from Ba
Slide 56: Early Phase Oncology
SELECT TRIALS - EARLY PHASE ONCOLOGY Molecule Study Indication* Phase Patients Primary Outcome** gaa, n completion KRAS 612C! |NCT04956640 Kegon. Study of LY3537982 in Cancer Patients With a 1 409 | Phase 1a: To determine the recommended phase 2 | 9995 | sep 2025 Cell Lung Specific Genetic Mutation
Slide 57: Early Phase Pain
SELECT TRIALS — EARLY PHASE PAIN ee ; Primary ; M * oo lolecule Study Indication Phase Patients Primary Outcome’ Completion Completion AChronic Pain Master Protocol (CPMP): A Study of P2X7 Inhibitor NCT05620576|Chronic Pain] LY3857210 in Participants With Diabetic Peripheral | 2 | 125 | Change from
Slide 58: Lilly logo
Eli Lilly and Company — Q2 2023 Earnings Presentation on 6ix