Eli Lilly And Company · NYSE:LLY
Eli Lilly And — Q3 2022 Earnings Presentation
58 slides from Eli Lilly And's earnings presentation, November 2022
Slide 1: Q3 2022 Earnings Call
Lilt, Q3 2022 Earnings Call
Slide 2: Agenda
AGENDA INTRODUCTION AND KEY RECENT EVENTS Dave Ricks, Chair and Chief Executive Officer Q3 2022 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 Lilt 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 uncerta
Slide 4: Strategic Deliverables
STRATEGIC DELIVERABLES PROGRESS SINCE THE LAST EARNINGS CALL Grow Revenue * 2% revenue growth in Q3, or 7% growth ona constant currency basis * Q3 revenue driven by 14% volume growth + Key growth products? grew 19% and represented 70% of revenue, excluding sales from COVID-19 antibodies! Create Long
Slide 5: Key Events Since the Last Earnings Call
KEY EVENTS SINCE THE LAST EARNINGS CALL REGULATORY * The U.S. Food and Drug Administration (FDA] granted Fast Track designation for tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities. Rolling submission is expected to initiate in 2022, primarily bas
Slide 6: Reconciliation of GAAP Reported to Non-GAAP (Q3 2022)
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION; CERTAIN LINE ITEMS (UNAUDITED) Y, 20 Millions; except per share data Q3 2022 . Non-GAAP Non-GAAP GAAP Reported Adjustments Adjusted Adjusted Change TOTAL REVENUE $6,962 - $6,942 2% GROSS MARGIN 77.38% 1.7pp 79.0% (0.0)pp TOTAL OPERATI
Slide 7: Reconciliation of GAAP Reported to Non-GAAP (YTD 2022)
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION; CERTAIN LINE ITEMS (UNAUDITED) Y, 20 Millions; except per share data YTD 2022 Non-GAAP Non-GAAP GAAP Reported Adjustments Adjusted Adjusted Change TOTAL REVENUE «$21,240 - $21,240 5% GROSS MARGIN 76.1% 2.1pp 78.2% 0.3pp TOTAL OPERATIN
Slide 8: Price/Rate/Volume Effect on Revenue
PRICE/RATE/VOLUME EFFECT ON REVENUE Millions Q3 2022 Amount Price FX Rate Volume Total CER U.S. $4,422 4% - 15% = 11% 11% EUROPE 1,056 31% —-((15)% = 14% (4)% 11% JAPAN 488 4% —— (16)% 3% ——— (18]% —— (2)% CHINA 343 (67% —— (AI% 7% (1% —— (10)% REST OF WORLD 632 1% = (3% = (AN% (8)% —— (6)% TOTAL RE
Slide 9: Key Products Driving WW Volume Growth
KEY PRODUCTS DRIVING WW VOLUME GROWTH Contribution to 14% Q3 WW Volume Growth Key Growth Products* 17.8% COVID-19 Antibodies** 2.5% All Other 0.1% Numbers may not add due to rounding. * includes Cyramza®, Emgality®, Jardiance®, Mounjaro, Olumiant, Retevmo, Taltz®, Trulicity®, Tywyt®, and Verzenio® J
Slide 10: Update on Key Growth Products
UPDATE ON KEY GROWTH PRODUCTS Millions $5,000 $4,609 $4,500 $4,000 $3,500 $3,000 - $2,500 $2,000 $1,500 $1,000 $500 so a Q3 4 Qi a2 Q3 a4 a Q2 Q3 a4 at Q2 Q3 2019 2019 | 2020 2020 «©2020 «2020 ©2021 2021 2021 2021 2022 2022 2022 Jardiance is part of Lilly's alliance with Boehringer Ingelheim Source:
Slide 11: Mounjaro Launch Progress
MOUNJARO LAUNCH PROGRESS J, “000 Prowarenoven YY Srounere (_) Robust U.S. uptake bolstered by strong anoo mounjaro" fe comagutde efficacy and a positive customer experience 70,000 lan . . com (tirzepatide) injection osm (_) Approximately 70% of Mounjaro new therapy starts are naive to the type 2 dia
Slide 12: Capital Allocation
CAPITAL ALLOCATION Billions YTD 2022 Capital Allocation R&D* rrr Capital Business Development** Cy $0.8 Share Repurchase I $1 * After-tax ** Includes cash outflows associated with equity investments 2022 Q3 EARNINGS $4.7
Slide 13: 2022 Guidance
2022 GUIDANCE Updated Lilt Comments Prior TOTAL REVENUE $28.8 - $29.3 billion GROSS MARGIN % (GAAP) Approx. 76% GROSS MARGIN % (NON-GAAP) Approx. 78% MKTG, SELLING & ADMIN. $6.4 - $6.6 billion RESEARCH & DEVELOPMENT $7.1 - $7.3 billion ACQUIRED IPR&D & DEVT MILESTONES Approx. $610 million OTHER INCO
Slide 14: Tirzepatide and pipeline overview
TIRZEPATIDE MMO LEGEND TIRZEPATIDE TIRZEPATIDE Obesity Obstructive Sleep Apnea NME MOVEMENT SINCE August 1, 2022 TIRZEPATIDE TIRZEPATIDE NILEX ADDITION or CV Outcomes Heart Failure pEF Commercial MILESTONE ACHIEVED * Collaboration REMOVAL SARM1 INHIBITOR RETATRUTIDE TIRZEPATIDE SELPERCATINIB SELPERC
Slide 15: New since last update
New since last update ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓- ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓+ ✓- ✓+ ✓+ ✓+ ✓+
Slide 16: Q3 2022 Performance Summary
Q3 2022 PERFORMANCE SUMMARY J, * Revenue grew 2%, or 7% on a constant currency basis; revenue driven by 14% volume growth * Non-GAAP operating margin was 28.9%, including the negative impact of 90 basis points from acquired IPR&D and development milestone charges * Progressed on our innovation-based
Slide 17: Supplementary Slides
SUPPLEMENTARY SLIDES Lilt,
Slide 18: 2022 Income Statement - Reported
2022 INCOME STATEMENT - REPORTED Millions; except per share data Lilt Q3 2022 Change YTD 2022 Change TOTAL REVENUE $6,962 2% $21,260 5% GROSS MARGIN 773% ‘(.blpp, ss 781%~—SS.Opp TOTAL OPERATING EXPENSE* 3,686 1% 10,867 2% OPERATING INCOME 167% 11% 19% OPERATING MARGIN 26.2% «(36Ipp,——si2K9%~—SAp OT
Slide 19: Non-GAAP Gross Margin % of Revenue
NON-GAAP GROSS MARGIN % OF REVENUE MOVING ANNUAL TOTAL 81.0% 80.0% 79.0% 78.0% 77.0% a | a2 | a a | oe a aa 2020 2021 2022 Individual quarter GM % of Revenue: 80.3% 79.6% 79.1% 78.6% 75.4% 79.3% 79.0% 76.1% 76.1% 79.8% 79.0% The line in the graph is a moving annual total i.e. trailing 4 quarters) wh
Slide 20: Non-GAAP Operating Margin % of Revenue
NON-GAAP OPERATING MARGIN % OF REVENUE J, MOVING ANNUAL TOTAL a ak a1 a) a ow | 2020 2021 2022 Individual quarter Op. Margin % of Revenue: 29.2% 23.6% 26.2% 28.1% 23.1% 29.1% 27.9% 27.0% 33.4% 20.5% 28.9% Dp. Margin impact of Acquired IPR&D Lhd Development Milestone Charges -1-1% -4.5% 0.0% 6.2% 4.6
Slide 21: Effect of FX on 2022 Results
EFFECT OF FX ON 2022 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 Q3 2022 YTD 2022 With FX w/o FX With FX w/o
Slide 22: EPS Reconciliation
EPS RECONCILIATION J, Q3 2022 _Q32021 %Change YTD2022 YTD2021 %Change EPS (REPORTED) $1.61 $1.22 32% = $4.76 = $4.23 13% NET LOSSES (GAINS) ON INVESTMENTS INEQuITY secuRiTIEs °°? «= 19, = 520.22} AMORTIZATION OF INTANGIBLE ASSETS O11 012 0.89 03% ASSETIMPAIRMENT, RESTUCTURING = yp gg 19 | AND OTHER
Slide 23: Q3 2022 Income Statement Notes
Q3 2022 INCOME STATEMENT NOTES Q3 2022 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO ELIMINATE: * an intangible asset impairment charge for GBA1 Gene Therapy ([PR001) due to delays in the clinical development and estimated product launch totaling $206.5 million (pretax}, or $0.17 per share (after-tax);
Slide 24: YTD 2022 Income Statement Notes
YTD 2022 INCOME STATEMENT NOTES YTD 2022 NON-GAAP INFORMATION HAS BEEN ADJUSTED TO ELIMINATE: * net losses on investments in equity securities totaling $602.4 million [pretax], or $0.52 per share (after-tax); * amortization of intangibles primarily associated with costs of marketed products acquired
Slide 25: Comparative EPS Summary 2021/2022
COMPARATIVE EPS SUMMARY 2021/2022 1021 2021 3021 4Q21 2021 1022 2022 3022 4022 Reported 1.49 1.53 1.22 1.90 6.12 2.10 1.05 1.61 Non-GAAP 1.61 1.85 1.77 2.17. 7.39 2.62 1.25 = 1.98 2022 Numbers may not add due to rounding. For a complete reconciliation to reported earnings, see slide 22 and our earni
Slide 26: Q3 2022 Trulicity Sales Increased 16%
Q3 2022 TRULICITY SALES INCREASED 16% Lilt U.S. sales increased 18% U.S. TRx SOM and Market Volume International sales increased 8% Millions 50% 600 560 $1,912 $1,850 $1,884 520 $1,741 46% $1,600) ° $1,452 $1,536) 480 4h% 440 42% 400 40% 360 320 9, 38% 280 36% 240 a a2 a3 a4 Sep Dec Mar Jun Sep Dec
Slide 27: Q3 2022 Taltz Sales Increased 15%
Q3 2022 TALTZ SALES INCREASED 15% J, Millions U.S. sales increased 17% U.S. TRx SOM and Market Volume International sales increased 9% o Taltz og 210 3 $680 S sep 2608 $593 — 3] 5% Market 200) $488 & 190 z $403 & 1e0 = E “ 170 é = z 160 = 3% 150 Qi Q2 Q3 Q4 Sep Dec Mar Jun Sep Dec Mar Jun Sep 2020 2
Slide 28: Q3 2022 Verzenio Sales Increased 84%
Q3 2022 VERZENIO SALES INCREASED 84% J, Millions U.S. sales were $415 million U.S. TRx SOM and Market Volume International sales increased 49% Verzenio , 8 32% $588 $618 28% 7 Market $469 24% 6 $404 $341 $336 20% $269 5 16% 4 12% 8% 3 ai a2 Q3 Q4 Sep Dec Mar Jun Sep Dec Mar Jun Sep 2020 2020 2021 20
Slide 29: Q3 2022 Humalog Sales Decreased 29%
Q3 2022 HUMALOG SALES DECREASED 29% J, Millions U.S. sales decreased 29% U.S. TRx SOM International sales decreased 29% 50% Humalog + Insulin Lispro $617 $618 $608 $627 $602 40% Humalog $447 $447 30% y . oe 20% Lilly Insulin Lispro 10% 0% a a2 a3 a4 Sep Dec Mar Jun Sep Dec Mar Jun Sep 2020 2020 2021
Slide 30: Q3 2022 Jardiance Sales Increased 47%
Q3 2022 JARDIANCE SALES INCREASED 47% Lilt Millions U.S. sales increased 59% U.S. TRx SOM and Market Volume International sales increased 31% oon y Jardiance Family 460 [a $573 62% 8 y 420| 2 $. $461 $432 5 “me 3 419 x| ony s $357 $390 E 60% Market 380 A $312 | 59% 2 = 340 | X 2| 58% = é 57% 300 = 5
Slide 31: Q3 2022 Olumiant Sales Decreased 55%
Q3 2022 OLUMIANT SALES DECREASED 55% J, Millions International sales were $160 million ¢ Inthe U.S., launched in rheumatoid arthritis in $407 Q3 2018 and in alopecia areata in Q2 2022 $306 $256 * Q3 sales driven by Germany, Japan, and U.S. $194 $208 $186 $183 * Q3 decline primarily driven by lower u
Slide 32: Q3 2022 Emgality Sales Increased 20%
Q3 2022 EMGALITY SALES INCREASED 20% Millions Lilt U.S. sales increased 14% International sales increased 36% $169 $161 $149 $156 $157 $140 $119 ' Qi Q2 Q3 Q4 m2021 m2022 U.S. TRx SOM and Market Volume 46% Emgality 85 a 8 42% o 5 aE Q Market 3 | 40% 5 < 65 |= é 5 =| 38% . = e a & = 55 £ 9, 36% = 2 3
Slide 33: Q3 2022 Tyvyt Sales in China Decreased 39%
Q3 2022 TYVYT SALES IN CHINA DECREASED 39% J, Millions $126 sii $105 * Launched in China in Q1 2019 $85 $74 alll “re * Part of Lilly collaboration with Innovent * Q3 decline due to the impact of NRDL formulary, resulting in lower realized prices partially offset by increased volume, as well as incre
Slide 34: Q3 2022 Cyramza Sales Decreased 8%
Q3 2022 CYRAMZA SALES DECREASED 8% Millions Lilt U.S. sales increased 3% International sales decreased 14% $269 $270 $253 $240 $230 $231 $232 Qi Q2 Q3 Q4 2021 ™ 2022 $300 $250 $200 $150 $100 $50 $0 Sales by Major Geography Q3 Q4 Qi Q2 Q3 Q4 Qi Q2 Q3 2020 2020 2021 2021 2021 2021 2022 2022 2022 OUSex
Slide 35: Q3 2022 Retevmo Sales Were $41 Million
Q3 2022 RETEVMO SALES WERE $41 MILLION JL, Millions U.S. sales were $32 million ¢ First RET inhibitor approved for certain lung and thyroid cancers with RET fusions and mutations $45 $42 $41 $39 $34 * Q3 2022 U.S accelerated approval in tumor- $26 agnostic RET fusion-positive advanced or $7 metastat
Slide 36: Basal Insulin-Fc
SELECT TRIALS - BASAL INSULIN-FC Study _Indication* Phase Patients A Study of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 3 670 Change from Baseline in HbA1c Oct 2023 | Oct 2023 Diabetes on Multiple Daily Injections (QWINT-4) A Study of LY320959
Slide 37: Donanemab
SELECT TRIALS - DONANEMAB Phase Patients Outcome** Alzheimer] Study of Donanemab (LYS002813} Compared With ‘Baque Clearance on Forbetpir F18 Poston Emission NCT05108922 ‘ Aducanumab in Participants With Early Symptomatic 3 200 ‘ Sep 2022 | Jul 2024 Disease ee a: Tomography (PET] Scan (Superiority) o
Slide 38: Emgality
SELECT TRIALS - EMGALITY Primary Completion Study Indication* Phase Patients Primary Outcome** Completion A Study of Galcanezumab (LY2951742] in Adult Participants 4 575 Mean Monthly Percentage of Participants with a 50% NCT05127486 | Migraine With Episodic Migraine (CHALLENGE-MIG] Response Rate Mar
Slide 39: Imlunestrant
SELECT TRIALS - IMLUNESTRANT Phase Patients ER+ | A Study of Imlunestrant, Investigator’s Choice of Endocrine - i A Hton NCT04975308 | HER2- |Therapy, and Imlunestrant Plus Abemaciclibin Participants} 3 | goo | Progression Free Survival (PFS) in the Intent-to-Treat IT] | 4.2923 | Sep 2026 mBC With E
Slide 40: Jardiance
SELECT TRIALS - JARDIANCE J, Phase Patients Outcome** Interventional part: Time to first occurrence of kidney Chronic 4 . . disease progression (defined as ESKD, a sustained decline EMPA-KIDNEY (The Study of Heart and Kidney Protection | 3 | geo9 lin eGER to <10 mL/min/1.73m2, renal death, or a sust
Slide 41: Lebrikizumab
SELECT TRIALS - LEBRIKIZUMAB Study Indication* Phase Patients A Study of Lebrikizumab (LY3650150) in Combination With Percentage of Participants with an Investigators Global Topical Corticosteroids in Japanese Participants With 3 280 | Assessment (IGA) score of 0 or 1 and a reduction 22 points | Jul
Slide 42: Mirikizumab
SELECT TRIALS - MIRIKIZUMAB Indication* Phase Patients Outcome** 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 Response at Week 52 Aug 2023 | Dec
Slide 43: Pirtobrutinib
Indication* SELECT TRIALS - PIRTOBRUTINIB Phase Patients Outcome** chronic Study of LOXO-305 Versus Investigator's Choice (IdelaR or To evaluate progression-free survival (PFS) of LOXO-305 " BR) in Patients With Previously Treated Chronic monotherapy (Arm A] compared to investigator's choice of NCT0
Slide 44: Remternetug
SELECT TRIALS - REMTERNETUG Study Indication* Phase Patients Primary Outcome** Percentage of Participants Who Reach Amyloid Plaque Alzheimer} A Study of Remternetug (LY3372993] in Participants With 3 400 Clearance on Amyloid PET Scan for Remternetug versus | Mar 2024 | Mar 2025 NCT05463731 Disease A
Slide 45: Retevmo
SELECT TRIALS - RETEVMO Phase Patients Outcome** Medullary NCT04211337 | Thyroid Cancer A Study of Selpercatinib (LY3527723] in Participants With RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) Progression Free Survival (PFS) by Blinded Independent 3 | 400 Central Review (BICR] May 2024 | Nov 202
Slide 46: Solanezumab
SELECT TRIALS - SOLANEZUMAB Study Indication Phase Patients Primary Outcome* Cognition |Clinical Trial of Solanezumab for Older Individuals Who May| Change from Baseline of the Preclinical Alzheimer NeT02008357" Disorders be at Risk for Memory Loss (A4] 3 1180 Cognitive Composite (PACC] ‘Also lists
Slide 47: Tirzepatide
SELECT TRIALS - TIRZEPATIDE Study __Indication* Phase Patients Nonatcohatic| A Study of Tirzepatide (LY3298176} in Participants With Percentage of Participants with Absence of NASH with no NCTO4166775 Jcrestonepatti] Nonalcoholic Steatohepatitis [SYNERGY-NASH] 1% Worsening of Fibrosis on Liver Histo
Slide 48: Tirzepatide (cont.)
SELECT TRIALS - TIRZEPATIDE (CONT.) Study Indication* Phase Patients A Study of Tirzepatide (LY3298176] Versus Insulin Lispro Type 2 | (U100) in Participants With Type 2 Diabetes inadequately Change from Baseline in Hemoglobin Alc (HbAtc) (Pooled NCT04537923 | piabetes | Controlled on Insulin Glargi
Slide 49: Verzenio
SELECT TRIALS - VERZENIO Phase Patients Outcome** B Endocrine Therapy With or Without Abemaciclib (LY2835219] reast NCT03155997! Cancer Following Surgery in Participants With Breast Cancer 3 5637 Invasive Disease Free Survival (IDFS) Mar 2020 | Jun 2029 (monarchE) Breast Abemaciclib (LY2835219) Plus
Slide 50: Early Phase Diabetes
SELECT TRIALS - EARLY PHASE DIABETES Molecule Study Indication* Phase Patients Primary Outcome** Primary Completion Completion A Study of LY3437943 in Participants Who Have Ejection Fraction (HFpEF) (LARS) Retatrutide |NCT04881760| Obesity Ghent ochre ovenpciht 49% Mean Percent Change in Body Weight
Slide 51: Early Phase Diabetes (cont.)
SELECT TRIALS - EARLY PHASE DIABETES (CONT.) Primary Lilt Molecule Study _Indication* Phase Patients Primary Outcome** oerimary Completion Number of Participants with One or More Treatment GIPR Agonist Emergent Adverse Events (TEAEs) and Serious Adverse L8°'"|eTosasases] Healthy | —A'Study of LY9537
Slide 52: Early Phase Diabetes (cont.)
SELECT TRIALS - EARLY PHASE DIABETES (CONT.) Molecule Study Indication* Phase Patients Primary Outcome** Primary Completion Lilt Completion A Study of LY3461767 in Participants With Chronic Number of Participants with One or More Serious Adverse Eventls) (SAEs) Considered by the NRG4 Agonist/NCT0484
Slide 53: Early Phase Immunology
SELECT TRIALS - EARLY PHASE IMMUNOLOGY Lilt Primary completion Molecule Study Indication* Phase Patients Primary Outcome** Completion CXCR1/2L NCT04493502 Hidradenitis} A Study of LY3041658 in Adults With Hidradenitis 2 52 Percentage of Participants Achieving Hidradenitis Mar 2022| Nov 2022 mAb Supp
Slide 54: Early Phase Immunology (cont.)
SELECT TRIALS - EARLY PHASE IMMUNOLOGY (CONT.) Molecule Study Indication* Phase Patients Primary Outcome** Lilt, Primary completion Completion Rezpegaldesleukin’ NCT04081350 Atopic Dermatitis A Study of LY3471851 in Participants With Eczema Number of Participants with One or More Serious Adverse Eve
Slide 55: Early Phase Neurodegeneration
SELECT TRIALS - EARLY PHASE NEURODEGENERATION Molecule Study Indication* Phase Patients Primary Outcome** Lilt Primary completion Completion O-GleNAcase Alzheimer | A Study of LY3372689 to Assess the Safety, Change from Baseline to End Time Point in netosogasa9| AW Tolerability, and Efficacy in Part
Slide 56: Early Phase Oncology
SELECT TRIALS - EARLY PHASE ONCOLOGY Molecule Study Indication* Study of LY3410738 Administered to Patients With Phase Patients Primary Outcome** Primary : Completion completion OHI JNicT04521686ferenseremm] Advanced Solid Tumors With IDH1 or IDH2 200 Recommended Phase 2 dose (RP2D] May 2023 | May 2
Slide 57: Early Phase Pain
SELECT TRIALS - EARLY PHASE PAIN Molecule Study Indication* Phase Patients Primary Outcome** cea Completion Diabetic " Chronic Pain Master Protocol (CPMP]: A Study of ae . , TRPAT | ictos177094| Peripheral | 3596318 in Participants With Diabetic Peripheral] 2 | 150 | Change from Baseline in Average
Slide 58: Slide 58
Eli Lilly and Company — Q3 2022 Earnings Presentation on 6ix