Lilly reports first-quarter 2025 financial results and highlights pipeline momentum

Zawya

03-05-2025

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U.S. Mfg Boehringer Ingel Scorpion
Pipeline progress included positive Phase 3 trial results for orforglipron (small molecule oral GLP-1 agonist) in Type 2 diabetes in the first of seven obesity and diabetes Phase 3 trials
Q1 2025 EPS increased 23% to $3.06 on a reported basis and increased 29% to $3.34 on a non-GAAP basis, both inclusive of $1.72 of acquired IPR&D charges
Revenue guidance reaffirmed to be between $58.0 billion and $61.0 billion
Eli Lilly and Company (NYSE: LLY) today announced its financial results for the first-quarter of 2025.
"Lilly had a solid start to the year, with 45% year-over-year revenue growth driven by strong sales of Mounjaro and Zepbound," said David A. Ricks, Lilly chair and CEO. "Our pipeline continued to deliver across key therapeutic areas, with product approvals in oncology and immunology, and the exciting success of our oral incretin, orforglipron, in the first of seven late-stage studies in diabetes and obesity. To support global demand for our newest medicines, we're accelerating our manufacturing investments, as underscored by our recent announcement to build four new facilities."
Financial Results
$ in millions, except
per share data
First-Quarter
2025
2024
% Change
Revenue
$ 12,728.5
$ 8,768.0
45 %
Net income – Reported
2,759.3
2,242.9
23 %
Earnings per share – Reported
3.06
2.48
23 %
Net income – Non-GAAP
3,004.4
2,335.3
29 %
Earnings per share – Non-GAAP
3.34
2.58
29 %
A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."
First-Quarter Reported Results
In Q1 2025, worldwide revenue was $12.73 billion, an increase of 45% compared with Q1 2024, driven by a 53% increase in volume, partially offset by a 6% decrease due to lower realized prices and a 2% unfavorable impact of foreign exchange rates. Key Products1 revenue grew by $4.09 billion to $7.52 billion in Q1 2025, led by Mounjaro and Zepbound.
Revenue in the U.S. increased 49% to $8.49 billion, driven by a 57% increase in volume, partially offset by a 7% decrease due to lower realized prices. The increase in U.S. volume was driven by Zepbound and Mounjaro.
Revenue outside the U.S. increased 38% to $4.24 billion, driven by a 46% increase in volume. The volume increase outside the U.S. was driven primarily by Mounjaro and, to a lesser extent, Jardiance. Jardiance revenue included a one-time benefit of $370.0 million associated with an amendment to the company's collaboration with Boehringer Ingelheim. Pursuant to the amendment, we and Boehringer Ingelheim adjusted commercialization responsibilities for Jardiance within certain markets.
Gross margin increased 48% to $10.50 billion in Q1 2025. Gross margin as a percent of revenue was 82.5%, an increase of 1.6 percentage points. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.
In Q1 2025, research and development expenses increased 8% to $2.73 billion, or 21.5% of revenue, driven by continued investments in the company's early and late-stage portfolio.
Marketing, selling and administrative expenses increased 26% to $2.47 billion in Q1 2025, primarily driven by promotional efforts supporting ongoing and future launches.
In Q1 2025, the company recognized acquired in-process research and development (IPR&D) charges of $1.57 billion compared with $110.5 million in Q1 2024. The Q1 2025 charges primarily related to the acquisition of Scorpion Therapeutics, Inc.'s PI3Kα inhibitor program STX-478.
The effective tax rate was 20.2% in Q1 2025 compared with 11.6% in Q1 2024, primarily driven by the unfavorable tax impact of a non-deductible acquired IPR&D charge in Q1 2025. The 2025 and 2024 effective tax rates were impacted by discrete tax benefits in each period.
In Q1 2025, net income and earnings per share (EPS) were $2.76 billion and $3.06, respectively, compared with net income of $2.24 billion and EPS of $2.48 in Q1 2024. EPS in Q1 2025 and Q1 2024 included acquired IPR&D charges of $1.72 and $0.10, respectively.
First-Quarter Non-GAAP Measures
On a non-GAAP basis, Q1 2025 gross margin increased 47% to $10.63 billion. Gross margin as a percent of revenue was 83.5%, an increase of 1.0 percentage point. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.
The effective tax rate on a non-GAAP basis was 20.2% in Q1 2025 compared with 11.9% in Q1 2024, primarily driven by the unfavorable tax impact of a non-deductible acquired IPR&D charge in Q1 2025. The 2025 and 2024 effective tax rates were impacted by discrete tax benefits in each period.
On a non-GAAP basis, Q1 2025 net income and EPS were $3.00 billion and $3.34, respectively, compared with net income of $2.34 billion and EPS of $2.58 in Q1 2024. Non-GAAP EPS in Q1 2025 and Q1 2024 included acquired IPR&D charges of $1.72 and $0.10, respectively.
For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.
First-Quarter
2025
2024
% Change
Earnings per share (reported)
$ 3.06
$ 2.48
23 %
Amortization of intangible assets
.11
.12
Asset impairment, restructuring and other special charges
.03
—
Net losses (gains) on investments in equity securities
.13
(.02)
Earnings per share (non-GAAP)
$ 3.34
$ 2.58
29 %
Acquired IPR&D
1.72
.10
NM
Numbers may not add due to rounding
NM – not meaningful
Selected Revenue Highlights
(Dollars in millions)
First-Quarter
Selected Products
2025
2024
% Change
Mounjaro
$ 3,841.8
$ 1,806.5
113 %
Zepbound
2,311.9
517.4
NM
Verzenio
1,158.9
1,050.3
10 %
Total Revenue
12,728.5
8,768.0
45 %
Mounjaro
For Q1 2025, worldwide Mounjaro revenue increased 113% to $3.84 billion. U.S. revenue was $2.66 billion, an increase of 75%, reflecting continued strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $1.19 billion compared with $286.2 million in Q1 2024, primarily driven by volume growth, including entry into new markets, partially offset by lower realized prices.
Zepbound
For Q1 2025, U.S. Zepbound revenue was $2.31 billion, compared with $517.4 million in Q1 2024, primarily driven by increased demand, partially offset by lower realized prices.
Verzenio
For Q1 2025, worldwide Verzenio revenue increased 10% to $1.16 billion. U.S. revenue was $657.6 million, an increase of 3%, driven by higher realized prices. Increased demand was more than offset by wholesaler buying patterns and competitive dynamics. Revenue outside the U.S. was $501.3 million, an increase of 22%, primarily driven by volume growth, partially offset by the unfavorable impact of foreign exchange rates.
Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:
Regulatory
Lilly's Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European
Union for adults with relapsed or refractory chronic lymphocytic leukemia (CLL)
previously treated with a BTK inhibitor (announcement). Jaypirca was approved in
the EU subsequent to the positive CHMP opinion.
Lilly's statement about the CHMP opinion issued for donanemab (announcement).
Clinical
Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results
and a safety profile consistent with injectable GLP-1 medicines in successful Phase
3 trial (announcement).
Lilly's lepodisiran reduced levels of genetically inherited heart disease risk factor,
lipoprotein(a), by nearly 94% from baseline at the highest tested dose in adults with
elevated levels (announcement).
Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe
alopecia areata in Phase 3 BRAVE-AA-PEDS study (announcement).
Lilly's EBGLYSS® (lebrikizumab-lbkz) single monthly maintenance injection
achieved completely clear skin at three years in half of patients with moderate-to-
severe atopic dermatitis (announcement).
Most patients on Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease achieved
sustained clinical remission and endoscopic response at two years
(announcement).
Other
LillyDirect platform expands to facilitate access to Alzheimer's disease care
(announcement).
Lilly plans to more than double U.S. manufacturing investment since 2020
exceeding $50 billion (announcement).
Lilly launches additional Zepbound vial doses and offers new savings for self-pay
patients (announcement).
For information on important public announcements, visit the news section of Lilly's website.
2025 Financial Guidance
The company updated certain elements of its 2025 financial guidance to reflect the impact of the Q1 2025 acquired IPR&D charges.
The company reaffirms its previous 2025 revenue guidance and expects it to be between $58.0 billion and $61.0 billion.
The performance margin2 is still expected to be in the range of 40.5% and 42.5% on a reported basis and 41.5% and 43.5% on a non-GAAP basis.
Other income (expense) on a reported basis is now expected to be expense in the range of $850 million to $750 million due to net losses on investments in equity securities and is still expected to be expense in the range of $700 million to $600 million on a non-GAAP basis.
The 2025 estimated effective tax rate increased from approximately 16% to 17% on both a reported and non-GAAP basis, driven by the tax impact of the non-deductible acquired IPR&D charge incurred in Q1 2025.
Guidance for EPS for 2025 decreased to the range of $20.17 to $21.67 on a reported basis, driven by the acquired IPR&D charges and net losses on investments in equity securities and $20.78 to $22.28 on a non-GAAP basis, driven by the acquired IPR&D charges. The company's updated 2025 financial guidance reflects adjustments shown in the reconciliation table below.
The following table summarizes the company's updated 2025 financial guidance:
Prior
Updated(1) (2) (3)
Revenue
$58.0 to $61.0 billion
Unchanged
Performance Margin(4)
(reported)
40.5% to 42.5%
Unchanged
(non-GAAP)
41.5% to 43.5%
Unchanged
Other Income/(Expense) (reported)
($700) to ($600) million
($850) to ($750) million
Other Income/(Expense) (non-GAAP)
($700) to ($600) million
Unchanged
Tax Rate
Approx. 16%
Approx. 17%
Earnings per Share (reported)
$22.05 to $23.55
$20.17 to $21.67
Earnings per Share (non-GAAP)
$22.50 to $24.00
$20.78 to $22.28
(1) Non-GAAP guidance reflects adjustments presented in the earnings per share reconciliation table above.
(2) Guidance includes acquired IPR&D charges through Q1 2025 of $1.57 billion or $1.72 on a per share basis. Guidance does not include acquired IPR&D either incurred, or expected to be incurred, after Q1 2025.
(3) This guidance is based on the existing tariff and trade environment as of May 1, 2025, and does not reflect any policy shifts, including pharmaceutical sector tariffs, that could impact business.
(4) The Company defines performance margin as gross margin less R&D, Marketing, Selling, and Administrative, and Asset Impairment, Restructuring and Other Charges divided by revenue.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY