Eli Lilly And Company · NYSE:LLY
Eli Lilly And — Q1 2023 Earnings Presentation
55 slides from Eli Lilly And's earnings presentation, Apr 27, 2023
Slide 1: Q1 2023 Earnings Call
Q1 2023 Earnings Call
Slide 2: Agenda
Agenda INTRODUCTION AND RECENT KEY EVENTS Dave Ricks, Chair and Chief Executive Officer Q1 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
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION; CERTAIN LINE ITEMS (UNAUDITED) Millions; except per share data Lilt Q1 2023 GAAP Reported Adjustments usted, Adjusted Change TOTAL REVENUE «$6,960 $ - $6,960 11)% GROSS MARGIN 76.6% 1.8pp 78.4% 2.3pp TOTAL OPERATING EXPENSE 3,839 - 3,
Slide 7: Price/Rate/Volume Effect on Revenue
PRICE/RATE/VOLUME EFFECT ON REVENUE Millions Q1 2023 Amount Price FX Rate Volume Total CER U.S. $4,436 — (5)% - ——— (10)% == (14) % —— (14)% EUROPE 1,091 = (6)% (8)% 13% 2% 8% JAPAN 387 (0% (13)% 8% (6)% 7% CHINA 373 —— (20)% = (7)% 19% ——— (8)% (1% REST OF WORLD 673 2% — (2)% (11% =~ *(10)% (9% TOT
Slide 8: Products Driving WW Volume
PRODUCTS DRIVING WW VOLUME Contribution to 4% Q1 WW Volume Decline Growth Products PF 12.7% New Products | | 7.3% All Other -5.5% COVID-19 Antibodies -18.8% Numbers may not tie due to rounding New Products: Jaypirca and Mounjaro® Growth Products: Cyramza®, Emgality®, Jardiance, Olumiant®, Retevmo®,
Slide 9: Q1 2023 Update on Select Products
Q1 2023 UPDATE ON SELECT PRODUCTS Millions $6,000 ~ I new propucts MOUNJARO : , + U.S. T2D launch in Q2 2022 $5,000 + U.S. T2D injectable incretins TRx SOM nearly 20% at end of Q1 2023 JAYPIRCA $4,000 + U.S. MCL approval in Q1 2023 IB crowt propucts $3,000 JARDIANCE + Market leader in U.S. with TRx
Slide 10: L+1 L+3 L+5
- 20 40 60 80 100 120 140 160 180 200 L+1 L+3 L+5 L+7 L+9 L+11 Not for promotional use L+13 L+15 L+17 L+19 L+21 L+23 L+25 L+27 L+29 L+31 L+33 L+35 L+37 L+39 L+41 L+43 L+45 v v 10
Slide 11: Capital Allocation
CAPITAL ALLOCATION Billions Q1 2023 Capital Allocation Capital | son Investments woe fie Dividend aaa st Repurchase F $0.8 * After tax ** Includes development milestones and cash outflows associated with equity investments Not for promotional use 2023 Q1 EARNINGS 11
Slide 12: 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) TAX RATE EARNINGS PER SHARE (GAAP) EARNINGS PER SHARE (NON-GAAP) 2023 assumes shares outstanding of 904 million Not for prom
Slide 13: SURMOUNT Program
SURMOUNT PROGRAM TIRZEPATIDE EVALUATED ACROSS A BROAD PATIENT POPULATION Phase 3 Study SURMOUNT-1 Weight Management in Participants with Obesity/Overweight* v v SURMOUNT-2 Weight Management in Participants with Obesity/Overweight with T2DM SURMOUNT-3 Maximizing Weight Loss Following Intensive Lifest
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Slide 15: SURMOUNT-2: Efficacy
SURMOUNT-2: EFFICACY MET THE CO-PRIMARY ENDPOINT OF ACHIEVING AT LEAST 5% BODY WEIGHT LOSS : 2. PERCENTAGE OF PATIENTS ACHIEVING WEIGHT LOSS (%) TARGET KEY EFFI CACY RESU LTS 86.4% ©) Greater than 81% of participants in the 10 mg arm 81.6% and 86% of participants in the 15 mg arm achieved 30.6% >= 5
Slide 16: SURMOUNT-2: Safety and Tolerability Data
SURMOUNT-2: SAFETY AND TOLERABILITY DATA OVERALL SAFETY PROFILE SIMILAR TO INCRETIN-BASED THERAPIES APPROVED FOR OBESITY J, Gl TOLERABILITY KEY SAFETY RESULTS 100% () Most common reported AEs were Gl-related, 90% generally mild-to-moderate in severity, and usually 80% occurred during dose escalation
Slide 17: Pipeline Legend and Movement
LEGEND GBA1 GENE THERAPY TIRZEPATIDE MOVEMENT SINCE NME Gaucher Disease Type 1 Obstructive Sleep Apnea January 30, 2023 NILEX ADDITION or RETATRUTIDE TIRZEPATIDE TIRZEPATIDE TIRZEPATIDE Commercial MILESTONE ACHIEVED Obesity NASH Heart Failure pEF MMO * Collaboration REMOVAL ORFORGLIPRON PIRTOBRUTINI
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Slide 20: Supplemental Slides
fo ma SUPPLEMENTAL oy, ae o\ SLIDES
Slide 21: 2023 Income Statement - Reported
2023 INCOME STATEMENT - REPORTED Millions; except per share data Q1 2023 Change TOTAL REVENUE $6,960 (11)% GROSS MARGIN 76.6% 3.1pp TOTAL OPERATING EXPENSE* 3,839 15% OPERATING INCOME 1,494 (38]% OPERATING MARGIN 21.5% (9.3]pp OTHER INCOME (EXPENSE) 36 NM EFFECTIVE TAX RATE 12.1% 4.8pp NET INCOME $1
Slide 22: 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% ce] Q2 Q3 Q4 ce] Q2 Q3 Q4 el] 2021 2022 2023 Individual Quarter 23.1% 29.1% 21.9% 27.0% 33.4% 20.5% 28.9% 27.4% 23.3% Op. Margin % of Revenu> Dp. Margin impact of 4.6% -0.6% -2.6% 5.5% -2.1% -6,8% -0
Slide 23: 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 Q1 2023 With FX — w/o FX (111% (91% (21)% (
Slide 24: EPS Reconciliation
EPS RECONCILIATION Q12023 _Q12022 _% Change EPS (REPORTED) $1.49 $2.10 (291% AMORTIZATION OF INTANGIBLE po 011 0.18 7 NET LOSSES (GAINS) ON 002k - INVESTMENTS IN EQUITY SECURITIES we EPS (NON-GAAP) $1.62 $2.62 (38)% Acquired IPR&D $0.10 $0.15 (33)% Numbers may not add due to rounding; see slide 26 f
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Slide 26: Comparative EPS Summary 2022/2023
COMPARATIVE EPS SUMMARY 2022/2023 1Q22 2022 3022 4Q22 2022 Reported 2.10 1.05 1.61 2.14 6.90 Non-GAAP 2.62 1.25 1.98 2.09 7.94 1Q23 2023 3023 4023 2023 1.49 1.62 Numbers may not add due to rounding For a complete reconciliation to reported earnings, see slide 26 and our earnings press release dated
Slide 27: Q1 2023 Trulicity Sales Increased 14%
Q1 2023 TRULICITY SALES INCREASED 14% Millions U.S. sales increased 18% International sales increased 1% $1,977 $1,912 $1,744 $1,850 $1,936 Qi a2 Q3 Q4 ™ 2022 m2023 U.S. TRx SOM and Market Volume 52% 920 Market 3g la e% arket , 840 |S > 760 e o| 44% 2 a 680 |S & 3 | 40% 600 |= z 5 & = =| 36% 520 | ”
Slide 28: Q1 2023 Verzenio Sales Increased 60%
Q1 2023 VERZENIO SALES INCREASED 60% Millions U.S. sales increased 53% International sales increased 73% $751 $588 $618 $469 a a2 Q3 = 2022 2023 $808 40% 35% 30% 25% 13 Wk RA TRx SOM 20% 15% U.S. TRx SOM and Market Volume 0 Verzenio Market a4 Mar 2021 3 Jun Sep Dec Mar Jun Sep Dec Mar 2021 2021 ©202
Slide 29: Q1 2023 Jardiance Sales Increased 38%
Q1 2023 JARDIANCE SALES INCREASED 38% Millions Lilt U.S. sales increased 43% International sales increased 31% $612 $578 $573 $461 $419 Ql Q2 Q3 m2022 m2023 63% Jardiance! 62% 61% 60% 13 Wk RA TRx SOM 59% 58% Mar = Jun Sep Dec Mar Jun Sep 04 2021 2021 2021 2021 2022 2022 2022 2022 U.S. TRx SOM and M
Slide 30: Q1 2023 Taltz Sales Increased 8%
Q1 2023 TALTZ SALES INCREASED 8% Millions Lilt International sales increased 19% $488 $527 $680 . | ; Qi Q2 Q3 Q4 U.S. sales increased 2% $708 2022 m2023 7% Taltz $% 5% Market 13 Wk RA TRx SOM 4% 3% Mar Jun Sep Dec Mar Jun Sep Dec Mar 2021 2021 2021 «2021 «2022 «2022 «2022 «2022 «2023 U.S. TRx SOM a
Slide 31: Q1 2023 Humalog Sales Decreased 25%
Q1 2023 HUMALOG SALES DECREASED 25% Millions U.S. sales decreased 26% International sales decreased 24% $618 $548 $461 $447 $447 ; ai a2 a3 a4 ™2022 ™2023 U.S. TRx SOM 50% Humalog+ Insulin Lispro 40% Humalog 30% 20% Lilly Insulin Lispro 13 Wk RA TRx SOM 10% 0% Mar Jun Sep. = Dec = Mar = Jun. Ss Sep.
Slide 32: Q1 2023 Cyramza Sales Increased 3%
Q1 2023 CYRAMZA SALES INCREASED 3% Millions U.S. sales increased 27% International sales decreased 10% $278 $230 $237 $231 $232 : a a2 03 a4 = 2022 2023 $300 $250 $200 $150 $100 $5 o $0 Sales by Major Geography Qi Q2 Q3 Q4 Qi Q2 Q3 Q4 Qi 2021 2021 2021 2021 2022 2022 2022 2022 2023 = OUSexJapan mJap
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Slide 34: Q1 2023 Emgality Sales Increased 3%
Q1 2023 EMGALITY SALES INCREASED 3% Millions U.S. sales were flat International sales increased 11% $169 $176 $149 $154 : : Qi a2 Q3 a4 2022 m2023 U.S. TRx SOM and Market Volume 44% Emgality 80 42% Market 40% 13 Wk RA TRx SOM 38% a g 8 s @ € 2 3 2 5 = x é & S Fs = 2 5 g 36% 55 Mar = Jun Sep Dec Mar
Slide 35: Insulin Efsitora Alfa (Basal Insulin-Fc)
SELECT TRIALS - INSULIN EFSITORA ALFA (BASAL INSULIN-FC) 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 | pi3hetes| Participants With Type 2 Diabet
Slide 36: Donanemab
SELECT TRIALS - DONANEMAB Phase Patients ry Outcome** vita A Study of Donanemab (LY3002813] Compared With Fee a eee ee rete emeio NCT05108922 | Cognitive | | Aducanumab in Participants With Early Symptomatic 3 200 einai aa ainda ositro SS!ON | Sep 2022 | Jul 2024 Impairment Alzheimer's Disease (TRAI
Slide 37: Imlunestrant
SELECT TRIALS - IMLUNESTRANT Study Indication* le Phase Patients Pri ry Outcome** Compl |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
Slide 38: Jardiance
SELECT TRIALS - JARDIANCE Primary Completion Study Indication* Phase Patients Primary Outcome** Completion| Myocardial EMPACT-MI: A Study to Test Whether Empagliflozin Can Composite of time to first heart failure hospitalization or NCT04509674 |" Lower the Risk of Heart Failure and Death in People W
Slide 39: Lebrikizumab
SELECT TRIALS - LEBRIKIZUMAB Phase Patients ry Outcome** Atopic A Study of Lebrikizumab (LY3650150] in Adult and Percentage of Participants Achieving Eczema Area and NCT05369403 Adolescent Participants With Moderate-to-Severe Atopic | 3 120 3 C Oct 2023 | Mar 2024 Dermatitis! " Dermatitis Previously
Slide 40: Mirikizumab
SELECT TRIALS - MIRIKIZUMAB Study Indication* le Phase Patients Pri ry Outcome** Comple' Compl 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 Respo
Slide 41: Orforglipron
SELECT TRIALS - ORFORGLIPRON Primary Completion Study Indication* Phase Patients Primary Outcome** Completion A Study of Daily Oral Orforglipron (LY3502970) Compared Time to First Occurrence of Any Major Adverse Type 2 | With Insulin Glargine in Participants With Type 2 Diabetes Cardiovascular Event
Slide 42: 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 43: 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 | Feb 2025 | Feb 2026 Placebo Alzheimer] A Study of Remternetug (LY3372993] in Partic
Slide 44: 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 45: Tirzepatide
SELECT TRIALS - TIRZEPATIDE Study Indication* le Phase Patients Primary Outcome** Compl NCT04184622 | Obesity | “Study Dhestt oc Overweight SURMOUNT with | 3) | 2539 Percent Change from Baseline in Body Weight Apr 2022 | May 2024 NCT04657016 | Obesity eet cowle Woah Love Progam (SURNGUNTSI 3 | 806 |
Slide 46: Tirzepatide (cont.)
SELECT TRIALS - TIRZEPATIDE (CONT.) Study Indication* le Phase Patients Primary Outcome** Compl Type 2 A Study of Tirzepatide (LY3298176] Compared With Time to First Occurrence of Death from Cardiovascular NCT04255433 Didhetes Dulaglutide on Major Cardiovascular Events in Participants} 3 | 13299 | (
Slide 47: Verzenio
SELECT TRIALS - VERZENIO Phase Patients ry Outcome** Endocrine Therapy or Without Abemacicli (LY2835219) Following Surgery in Participants With Breast] 3 5637 Invasive Disease Free Survival (IDFS) Mar 2020 | Jun 2029 Cancer [monarchE} Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus
Slide 48: Early Phase Diabetes and Obesity
SELECT TRIALS - EARLY PHASE DIABETES AND OBESITY Lite, Primary completion Molecule Study _Indication* Phase Patients Primary Outcome** eae . Lipoprotein | A Study of LY3819469 in Participants With Elevated Percent Change from Baseline in Time Averaged LPla] siRNA |NCTO5S65742 Disorder Lipoprotein{a)
Slide 49: 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 PYY Analog . . Emergent Adverse Events (TEAEs] and Serious Adverse Agonist |NCT05582096] Overweig
Slide 50: Early Phase Diabetes and Obesity (cont.)
SELECT TRIALS - EARLY PHASE DIABETES AND OBESITY (CONT.) Lite, Molecule Indication* Phase Patients Primary completion Completion Study sem A Study of LY3841136 in Healthy and 0 , Number of Participants with One or More Treatment mylin tudy 0 in Healthy and Overweight Emergent Adverse Events (TEAEs]
Slide 51: 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 420 | Percentage of
Slide 52: 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, , . 0-GleNAcase Alzheimer y Assess Change from Baseline to End Time Point in inh, |NCT05063599) “Disease | Tolerabi
Slide 53: Early Phase Oncology
SELECT TRIALS - EARLY PHASE ONCOLOGY Molecule Study Indication* Phase Patients Primary Outcome** gaa, n completion IDH1/2 sungwcaranama) Study of LY3410738 Administered to Patients With DH TNicT04521686|ornn Me ee ee pe ee 1 | 200 Recommended Phase 2 dose [RP2D] May 2023 | May 2023 KRas 612¢! |NcTo4
Slide 54: Early Phase Pain
SELECT TRIALS — EARLY PHASE PAIN ee ; Primary ; M * oo lolecule Study Indication Phase Patients Primary Outcome’ Completion Completion Knee A Chronic Pain Master Protocol [CPMP): A Study of Change from Baseline for Average Pain Intensity as P2X7 Inhibitor] NCT05620563 LY3857210 In Participants With
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Eli Lilly and Company — Q1 2023 Earnings Presentation on 6ix