Eli Lilly and : 2025 Earnings Presentation

Published: 2025-05-01 06:59:06 ET LLY

Published on 05/01/2025 at 06:59

ELI LILLY AND COMPANY

Q1 2025 EARNINGS CALL

Agenda

Dave Ricks, Chair and Chief Executive Officer

Lucas Montarce, Chief Financial Officer

Dan Skovronsky, M.D., Ph.D., Chief Scientific Officer

Dave Ricks, Chair and Chief Executive Officer

2025 Q1 EARNINGS

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 research and development; competitive developments; regulatory actions; litigation and investigations; business development transactions; economic conditions; and changes in laws and regulations, including healthcare reform.

For additional information about the factors that affect the company's business, please see the company's latest Form 10-K

and subsequent Forms 10-Q and 8-K filed with the Securities and Exchange Commission. Certain financial information in this presentation is presented on a non-GAAP basis. Investors should refer to the reconciliations included in this presentation and should consider the company's non-GAAP measures in addition to, not as a substitute for or superior to, measures prepared in accordance with GAAP. These materials are not intended to promote the products referenced herein or otherwise influence healthcare prescribing decisions. The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval or become commercially available for the uses being investigated.

The company undertakes no duty to update forward-looking statements except as required by applicable law.

2025 Q1 EARNINGS Not for promotional use 4

Deliver Revenue Growth

Invest in Future Innovation

Speed Life-Changing Medicines

Delivered robust revenue growth of 45% driven by Key Products1

Gained U.S. incretin analogs market leadership, with 53.3% share of market in total prescriptions

Reaffirmed 2025 Revenue

Guidance of $58.0B to $61.0B

Announced plans to double U.S. manufacturing investments to a total of $50B committed since 2020

Closed acquisition of Scorpion Therapeutics' mutant selective PI3Kα inhibitor program

Disclosed first positive Phase 3 trial for oral GLP-1, orforglipron

Orforglipron demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines

1 Key products include Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio and Zepbound Note: Revenue growth rates reflect change vs. Q1 2024

2025 Q1 EARNINGS

Not for promotional use 5

TOTAL

REVENUE

$12.7B

KEY

PRODUCT REVENUE

$7.5B

RESEARCH & DEVELOPMENT

CAPITAL INVESTMENTS

$2.7B

$50B

Committed U.S. manufacturing investments since 2020

MARKETING, SELLING

& ADMINISTRATIVE

$2.5B

NON-GAAP

EARNINGS PER SHARE

$3.34

APPROVALS / LAUNCHES

Jaypirca approved in the EU for relapsed or refractory CLL patients previously treated with a BTK inhibitor

STUDY RESULTS

Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and

a safety profile consistent with injectable GLP-1 medicines in a successful Phase 3 trial

Launched 7.5 mg and 10.0 mg single-dose Zepbound

vials exclusively through LillyDirect

Lilly's EBGLYSS single monthly maintenance injection achieved completely clear skin

at three years in half of patients with moderate-to-severe atopic dermatitis

Deliver Revenue Growth

Invest in Future Innovation

Invest in Current Portfolio

45%

26%

119%

29%

Speed Life-ChangingMedicines

Return Capital to Shareholders

$1.3B

DISTRIBUTED

VIA DIVIDENDS

$1.2B

DISTRIBUTED IN

SHARE REPURCHASES

Note: Total revenue, key product revenue, research and development, marketing, selling and administrative, and Non-GAAP EPS growth rates reflect change vs. Q1 2024

Dollars in millions; except per share data Q1 2025

GAAP Reported

Adjustments

Non-GAAP Adjusted

YoY Non-GAAP

Adjusted Change

TOTAL REVENUE

$12,729

$ -

$12,729

45%

GROSS MARGIN

82.5%

1.0pp

83.5%

1.0pp

TOTAL OPERATING EXPENSE

$6,809

$(35)

$6,774

48%

OPERATING INCOME

$3,695

$158

$3,853

46%

OTHER INCOME (EXPENSE)

$(239)

$152

$(87)

EFFECTIVE TAX RATE

20.2%

8.3pp

NET INCOME

$2,759

$245

$3,004

29%

EPS

$3.06

$0.28

$3.34

29%

Acquired IPR&D Charge per share1

$1.72

$ -

$1.72

1Acquired IPR&D (in-process research and development) charge of $1,572 million (pre-tax). Numbers may not add due to rounding; NM = not meaningful

Performance Margin2 41.4% 42.6% +11.1pp

2The Company defines Performance Margin as gross margin less research and development, marketing, selling and administrative, and asset impairment, restructuring and other special charges divided by revenue Note: The Non-GAAP Performance Margin excludes the amortization of intangible assets. The applicable impact of amortization of intangible assets can be found in the reconciliation tables on slide 20

Dollars in millions

Q1 2025

Amount

Price

FX Rate

Volume

Total

CER

U.S. $8,489

(7)%

57%

49%

EUROPE

$2,389

(7)%

(6)%

79%

66%

71%

JAPAN

$402

(1)%

(5)%

16%

11%

15%

CHINA

$451

(1)%

19%

20%

21%

REST OF WORLD

$997

(5)%

16%

12%

17%

TOTAL REVENUE

$12,729

(6)%

(2)%

53%

45%

47%

Numbers may not add due to rounding

CER = price change + volume change

2022

2023

2024

2025

Millions

$8,000

$7,000

$6,000

$5,000

$4,000

$3,000

$2,000

$1,000

Key Product Highlights:

MOUNJARO

U.S. type 2 diabetes incretin analogs TRx SOM 39%

and NBRx SOM 46% at end of Q1 2025

Increased TRx and NBRx share by 4pp each vs. end of Q4 2024

ZEPBOUND

U.S. branded anti-obesity TRx SOM over 60% and NBRx SOM 74% at end of Q1 2025

Increased TRx and NBRx share by 13pp and 17pp,

respectively, vs. end of Q4 2024

VERZENIO

U.S. TRx SOM 43% at end of Q1 2025

U.S. TRx grew 7% vs. Q1 2024

JAYPIRCA

Q1 2025 sales of $92 million and achieved regulatory approval for relapsed or refractory CLL after a BTK inhibitor in the EU

EBGLYSS

Q1 2025 sales of $60M and 1stline formulary access secured at 2 of the major PBMs in the U.S.

OMVOH

Approval and launch of Crohn's disease in Q1 2025

KISUNLA

Q1 2025 sales increased to $21 million

2025 Q1 EARNINGS Not for promotional use 9

2,000

TOTAL

PRESCRIPTIONS

+46% in Q1 vs. PY

Total Prescriptions 4 Week Rolling Average

(thousands)

1,500

1,000

LILLY SOM

53.3%

NOVO SOM 46.1%

500

Source: IQVIA weekly NPA total prescriptions, weekly data March 28, 2025; Incretin analogs market includes: injectable GLP-1s, oral GLP-1s and GLP-

1/GIP dual agonists

2025 Q1 EARNINGS

Incretin Analogs Market Key

Highlights:

Total prescriptions grew 46% in Q1

vs. prior year and 5% vs. Q4 2024

Lilly share of market increased to

53.3%, +5pp vs. prior quarter

Launched 7.5 mg and 10.0 mg single-

dose Zepbound vials exclusively through LillyDirect

Not for promotional use

$ in billions

Q1 2025 Capital Allocation

R&D*

Growth

Capital Investments

Business Development**

Return

Dividend

Share Repurchase

* After tax

** Includes development milestones, closed acquisitions and cash outflows associated with equity investments

Prior

Updated

Comments

REVENUE

$58.0 - $61.0 billion

Unchanged

PERFORMANCE MARGIN1

(GAAP)

(NON-GAAP)

40.5% - 42.5%

41.5% - 43.5%

Unchanged Unchanged

OTHER INCOME/(EXPENSE)

(GAAP) (NON-GAAP)

$(700) - $(600) million

$(850) - $(750) million Unchanged

Driven by net losses on investments in equity securities

TAX RATE

Approx. 16%

Approx. 17%

Driven by the tax impact of the non-deductible acquired IPR&D charge incurred in Q1

EARNINGS PER SHARE2

(GAAP) (NON-GAAP)

$22.05 - $23.55

$22.50 - $24.00

$20.17 - $21.67

$20.78 - $22.28

No changes to non-GAAP EPS, outside of Q1 acquired IPR&D charge of $1.72 per share

1 The Company defines Performance Margin as gross margin less research and development, marketing, selling and administrative and asset impairment, restructuring and other special charges divided by revenue

2 2025 assumes shares outstanding of approximately 900.6 million IPR&D = in-process research and development

FX assumptions of 1.06 (Euro), 152 (Yen) and 7.1 (Yuan)

-0.1%

HbA1c and Body Weight Change at 40 Weeks

HbA1c Change

Body Weight Change

-1.6%

-4.7%

-6.1%

-7.9%

-1.3 kg

-4.4 kg

Key Highlights:

First small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6%

More than 65% of participants taking the highest dose of orforglipron achieved an A1C less than or equal to 6.5%

-1.3%

-1.6%

-1.5%

-5.5 kg

-7.3 kg

Once-daily oral pill reduced weight by an average of 16.0 lbs (7.9%) at the highest dose

BASELINE HbA1c = 8.0%

BASELINE WEIGHT: 90.2 kg

Participants had not yet reached a weight plateau by the 40-week

Placebo Orforglipron 3 mg

Orforglipron 12 mg

Orforglipron 36 mg

endpoint

2025 Q1 EARNINGS Not for promotional use 13

Discontinuation Rates due to Adverse Events Tolerability Data

Placebo

Orforglipron

3 mg

Orforglipron

12 mg

Orforglipron

36 mg

13%

18%

16%

14%

19%

21%

26%

Nausea (%) 2%

Vomiting (%)

Diarrhea (%) 9%

3 mg 12 mg 36 mg

The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. Treatment discontinuations due to adverse events were low and consistent with the injectable GLP-1 class.

ACHIEVE Type 2 Diabetes Program and ATTAIN Obesity Program

ACHIEVE-1: vs. placebo, monotherapy

ACHIEVE-2: vs. dapagliflozin, combination with metformin

ACHIEVE-3: vs. oral semaglutide, combination with metformin

Expected Submissions

Obesity: Q4 2025

T2D: 1H 2026

ACHIEVE-4a: vs. insulin glargine, CV safety study, combination with multiple therapy

ACHIEVE-5: vs. placebo, combination with insulin

ATTAIN-1b: vs. placebo, without T2D, monotherapy

ATTAIN-2: vs. placebo, with T2D, OAMs allowed

Additional Trials Hypertension: Starting Q2 2025 OSA: Completing Q4 2026 Maintenance: Completing Q1 2026

Q1 Q2 Q3 Q4

2023 2024 2025 2026

aEvent-driven trial, minimum duration 104 weeks; b2-year extension for participants with prediabetes.

CV=cardiovascular; HTN=hypertension; OAM=oral anti-hyperglycemic medication; OSA=obstructive sleep apnea; T2D=type 2 diabetes.

UPDATES SINCE FEBRUARY 4, 2025

NME

REMOVAL ADDITION OR MILESTONE

ACHIEVED

NILEX

OLOMORASIB Adj KRAS

G12C+ NSCLC (resected)

TIRZEPATIDE

CV Outcomes

TIRZEPATIDE

MMO

RETATRUTIDE

Diabetes

SELPERCATINIB

Adjuvant RET+ NSCLC

PIRTOBRUTINIB

R/R MCL Monotherapy

RETATRUTIDE

CV / Rental Outcomes

PIRTOBRUTINIB

1L CLL Monotherapy

PIRTOBRUTINIB

R/R CLL Combination

ORFORGLIPRON

Diabetes

ORFORGLIPRON

Obstructive Sleep Apnea

LEBRIKIZUMAB

CRSwNP

OLOMORASIB 1L KRAS G12C+ NSCLC (PD-L1 high)

IXEKIZUMAB + TIRZEPATIDE PsA

LEBRIKIZUMAB

AR (perennial allergens)

IMLUNESTRANT

Adjuvant Breast Cancer

IXEKIZUMAB +

TIRZEPATIDE Psoriasis

ABEMACICLIB

MBC Sequencing

DONANEMAB Preclinical

Alzheimer's Disease

REMTERNETUG

Alzheimer's Disease

RETATRUTIDE

Obesity, OA, OSA

OLOMORASIB 1L KRAS

G12C+ NSCLC (All PD-L1)

ORFORGLIPRON

Obesity

TIRZEPATIDE

Heart Failure pEF

INSULIN EFSITORA ALFA

Diabetes

LEPODISIRAN

ASCVD

IMLUNESTRANT

ER+ HER2- mBC

PIRTOBRUTINIB

R/R CLL Monotherapy

April 29, 2025

PI3Kα INH (STX-478)

Cancer

TARGETS UNDISCLOSED

Six Additional NMEs

FXR AG (FXR314)

Immunology

INTEGRIN α5β1

CMH

SNCA siRNA

Neurodegeneration

ANTI-VEGF GENE THERAPY

Vestibular Schwannoma

SCAP siRNA

MASH

SMARCA2 (BRM)

Cancer

PNPLA3 siRNA

MASH

SARM1 INHIBITOR

Neurodegeneration

NISOTIROSTIDE

Diabetes

PAN KRAS

Cancer

NECTIN-4 ADC 1

Cancer

NECTIN-4 ADC 2

Cancer

MACUPATIDE

CMH

MAPT siRNA

Neurodegeneration

KRAS G12D

Cancer

LA-ANP

Heart Failure

GS INSULIN RECEPTOR

AGONIST Diabetes

ITACONATE MIMETIC

Immunology

GIP/GLP-1 COAGONIST III CMH

GIPR AGONIST LA

CMH

FGFR3 SELECTIVE

Cancer

FRa ADC

Cancer

[Ac-225]-PSMA-62

Prostate Cancer

AT2R ANTAGONIST

Pain

CD19 ANTIBODY

Rheumatoid Arthritis

TIRZEPATIDE

Higher Doses

TIRZEPATIDE

MASH

GBA1 GENE THERAPY

Gaucher Disease Type 1

MORF-057

Crohn's Disease

SOLBINSIRAN

CVD

ELTREKIBART

Ulcerative Colitis

P2X7 INHIBITOR

Pain

SIMEPDEKINRA

Psoriasis

OCADUSERTIB

Rheumatoid Arthritis

OTOF GENE THERAPY

Hearing Loss

MORF-057

Ulcerative Colitis

MUVALAPLIN

ASCVD

MAZISOTINE

Pain

MEVIDALEN

AD Symptomatic

MAZDUTIDE1

Obesity

KV1.3 ANTAGONIST

Psoriasis

GLP-1R NPA II

Obesity

GRN GENE THERAPY

Frontotemporal Dementia

EPIREGULIN Ab

Pain

GBA1 GENE THERAPY

Parkinson's Disease

ELORALINTIDE

Obesity

ELTREKIBART

Hidradenitis Suppurativa

BIMAGRUMAB

Obesity

CD19 ANTIBODY

Multiple Sclerosis

PHASE 1

PHASE 2

PHASE 3

REG REVIEW

APPROVED

1China development with Innovent for Obesity (reg review) and T2D (Ph3)

NEW SINCE LAST UPDATE

REGULATORY SUBMISSIONS

PHASE 3 INITIATIONS

Orforglipron for hypertension



+ Olomorasib for resected adjuvant NSCLC1

Muvalaplin for ASCVD2

Retatrutide for obesity and chronic low back pain

Insulin efsitora alfa for type 2 diabetes [US/EU/J] Orforglipron for obesity [US/EU/J]

Tirzepatide for cardiovascular outcomes [US] Pirtobrutinib CLL full approval [US +] Pirtobrutinib for 1L CLL [US/EU]

REGULATORY ACTIONS



+ Mirikizumab for Crohn's disease [US + / EU + / J +]

Tirzepatide for HFpEF [US - /EU]

Imlunestrant ER+, HER2- mBC [US/J]

Pirtobrutinib for CLL full approval [US / EU + / J]

Donanemab for early Alzheimer's disease [EU]

PHASE 3 DATA DISCLOSURES

Orforglipron for obesity [ATTAIN-1/2]

Orforglipron for type 2 diabetes [ACHIEVE-1 + /2/3/4/5]

Tirzepatide cardiovascular outcomes [SURPASS-CVOT] Pirtobrutinib 1L CLL vs. BR3[BRUIN CLL-313] Pirtobrutinib 1L CLL vs. ibrutinib [BRUIN CLL-314] Retatrutide for obesity and OA4of the knee [TRIUMPH-4]

1 Non-small cell lung cancer

2 Atherosclerotic cardiovascular disease

3 Bendamustine plus Rituximab

4 Osteoarthritis

2025 Q1 EARNINGS

Not for promotional use 18

Q1 2025 Change

Dollars in millions; except per share data

TOTAL REVENUE

$12,729

45%

GROSS MARGIN

82.5%

1.6pp

TOTAL OPERATING EXPENSE*

$6,809

48%

OPERATING INCOME

$3,695

47%

OPERATING MARGIN

29.0%

0.4pp

OTHER INCOME (EXPENSE)

$(239)

EFFECTIVE TAX RATE

20.2%

8.6pp

NET INCOME

$2,759

23%

EPS

$3.06

23%

* Includes research and development expense; marketing, selling and administrative; acquired in-process research and development charges; and asset impairment, restructuring and other special charges (as applicable) NM = not meaningful

Q1 2025 Q1 2024 % Change

EARNINGS PER SHARE (REPORTED)

$3.06

$2.48

23%

ASSET IMPAIRMENT, RESTRUCTURING AND OTHER SPECIAL CHARGES

0.03

NET LOSSES (GAINS) ON INVESTMENTS

IN EQUITY SECURITIES

0.13

(0.02)

AMORTIZATION OF INTANGIBLE ASSETS

0.11

0.12

(8%)

EARNINGS PER SHARE

(NON-GAAP)

$3.34

$2.58

29%

ACQUIRED IPR&D

$1.72

$0.10

Numbers may not add due to rounding; see slide 21 for more details on these adjustments; NM = not meaningful

Q1 2025 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 $123 million (pre-tax), or $0.11 per share (after-tax)

net losses on investments in equity securities totaling $152 million (pre-tax), or $0.13 per share (after-tax)

asset impairment, restructuring and other special charges related to intangible asset impairment totaling $35 million (pre-tax), or $0.03 per share (after-tax).

Q1 2024 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 $139.1 million (pre-tax), or $0.12 per share (after-tax)

net gains on investments in equity securities totaling $23.4 million (pre-tax), or ($0.02) per share (after-tax).

$ in Millions

U.S. sales were $2.7 billion International sales were $1.2 billion

70%

U.S. TRx SOM and Market Volume

13 Wk RA TRx Market Volume (000s)

1400

$3,842

$3,091 $3,113

$3,530

60%

13 Wk RA TRx SOM

50%

40%

Market

1200

1000

800

$1,807

30%

20%

Mounjaro

600

400

10% 200

Q1 Q2 Q3 Q4 2024 2025

Mar 2023

Jun 2023

Sep 2023

Dec 2023

Mar 2024

Jun 2024

Sep 2024

Dec 2024

Mar 2025

Source: IQVIA NPA TRx 3MMA, weekly data March 28, 2025; RA = rolling average TRx data is representative of the injectable incretin type 2 diabetes market

$ in Millions

U.S. sales were $2.3 billion International sales were $6 million1

80%

U.S. TRx SOM and Market Volume

13 Wk RA TRx Market Volume (000s)

600

$2,312

$1,243 $1,258

$1,907

70%

13 Wk RA TRx SOM

60%

50%

40%

Market

Zepbound

500

400

300

$517

30%

20%

10%

200

100

Q1 Q2 Q3 Q4 2024 2025

Dec 2023

Mar 2024

Jun 2024

Sep 2024

Dec 2024

Mar 2025

1 Japan marketing authorization approved for obesity under the brand name Zepbound

Source: IQVIA NPA TRx 3MMA, weekly data March 28, 2025; RA = rolling average TRx data is representative of the branded anti-obesity market

$ in Millions

U.S. sales increased 3% International sales increased 22%

$1,555

60%

50%

U.S. TRx SOM and Market Volume

13 Wk RA TRx Market Volume (000s)

Verzenio

$1,159

$1,050

$1,332 $1,369

13 Wk RA TRx SOM

40%

30%

20%

10%

Market 8

Q1 Q2 Q3 Q4 2024 2025

Mar 2023

Jun 2023

Sep 2023

Dec 2023

Mar 2024

Jun 2024

Sep 2024

Dec 2024

Mar 2025

Source: IQVIA NPA TRx 3MMA, weekly data March 28, 2025; RA = rolling average

Source: clinicaltrials.gov, April 22, 2025

Study

Indication*

Title

Phase

Patients

Primary Outcome**

Primary Completion

Completion

NCT04437511

Alzheimer's

Disease

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

1736

Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS)

Apr 2023

Aug 2025

NCT05738486

Alzheimer's

Disease

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

800

Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)

May 2024

May 2025

NCT05508789

Alzheimer's

Disease

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

1500

Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)

Apr 2027

NCT05026866

Alzheimer's

Disease

A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

2196

Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS)

Nov 2027

Source: clinicaltrials.gov, April 22, 2025

Study

Indication*

Title

Phase

Patients

Primary Outcome**

Primary Completion

Completion

NCT04975308

Breast Neoplasms

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3)

866

Progression Free Survival (PFS) in the Intent-to-Treat (IIT) Population

Jun 2024

Aug 2027

NCT05514054

Breast Neoplasms

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)

8000

Invasive Disease-Free Survival (IDFS)

Oct 2027

Mar 2032

Source: clinicaltrials.gov, April 22, 2025

Study

Indication*

Title

Phase

Patients

Primary Outcome**

Primary Completion

Completion

NCT05372419

Atopic Dermatitis

A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color (ADmirable)

Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% reduction from baseline in EASI)

May 2024

Feb 2025

NCT04392154

Atopic

Dermatitis

Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)

1188

Percentage of Participants Discontinued from Study Treatment due to Adverse Events through the Last Treatment Visit

Jun 2024

Apr 2025

NCT05559359

Atopic Dermatitis

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-1)

360

Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score

Feb 2026

Feb 2027

NCT05735483

Atopic Dermatitis

A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to

<18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-2)

310

Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)

Jun 2026

NCT06280716

Atopic Dermatitis

A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis (ADvance-Asia)

430

Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score

Dec 2025

Nov 2026

NCT06339008

Perennial Allergic Rhinitis (PAR)

A Study of Lebrikizumab in Adult Participants With

Perennial Allergic Rhinitis (PREPARED-1)

450

Mean Change From Baseline (CFBL) in Total Nasal

Symptom Score (TNSS) at week 16

Oct 2025

Feb 2027

Source: clinicaltrials.gov, April 22, 2025

Study

Indication*

Title

Phase

Patients

Primary Outcome**

Primary Completion

Completion

NCT06921759

Atopic Hand and Foot Dermatitis

A Study to Investigate the Efficacy and Safety of Lebrikizumab in Participants With Moderate-to-Severe Atopic Hand and Foot Dermatitis

206

Percentage of Participants Achieving a Hand and Foot Investigator Global Assessment (HF-IGA) Score of 0 or 1 with ≥2-point Improvement from Baseline

Jul 2026

Sep 2026

NCT06338995

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

510

Mean Change From Baseline (CFBL) in Participant

Reported Nasal Congestion Score (NCS) Severity

Oct 2026

Feb 2027

Source: clinicaltrials.gov, April 22, 2025

Study

Indication*

Title

Phase

Patients

Primary Outcome**

Primary Completion

Completion

NCT06292013

Atherosclerotic Cardiovascular Disease (ASCVD)1

A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) -ACCLAIM-Lp(a)

12500

Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint

Mar 2029

1 Reduction of major adverse cardiovascular events (MACE) in patients with Atherosclerotic Cardiovascular Disease (ASCVD)

Source: clinicaltrials.gov, April 22, 2025

Study

Indication*

Title

Phase

Patients

Primary Outcome**

Primary Completion

Completion

NCT04232553

Crohn's Disease

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2)

778

Percentage of Participants Achieving Endoscopic Response

Nov 2024

Dec 2026

NCT06937099

Crohn's Disease

Mirikizumab and Tirzepatide Concomitantly Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight (COMMIT-CD)

290

Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI)

May 2028

NCT03519945

Ulcerative Colitis

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT-3)

1063

Percentage of Participants in Clinical Remission

Jul 2026

Dec 2027

NCT06937086

Ulcerative Colitis

Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight (COMMIT-UC)

350

Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction

Apr 2028

Disclaimer

Eli Lilly and Company published this content on April 30, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 01, 2025 at 10:58 UTC.