Lilly Reports Q2 2024 Financial Results, Raises Full-Year Revenue Guidance by $3 Billion
- Revenue in Q2 2024 increased 36%, driven by Mounjaro, Zepbound and Verzenio. When excluding
$579.0 million of revenue from the sale of rights for Baqsimi in Q2 2023, revenue in Q2 2024 increased 46%. Excluding the sale of rights for Baqsimi, non-incretin revenue increased 17% worldwide and 25% in theU.S. - Q2 2024 EPS increased 68% to
$3.28 on a reported basis and increased 86% to$3.92 on a non-GAAP basis, both inclusive of$0.14 of acquired IPR&D charges. - 2024 full-year revenue guidance raised by
$3 billion ; reported EPS guidance raised$2.05 to the range of$15.10 to$15.60 , and non-GAAP EPS guidance raised$2.60 to the range of$16.10 to$16.60 . - Pipeline progress included approval of Kisunla in the
U.S. for Alzheimer's disease and Jaypirca inJapan for relapsed or refractory mantle cell lymphoma. Additional progress included submission of tirzepatide in theU.S. and EU for obstructive sleep apnea and obesity, and positive topline results from the Phase 3 trial evaluating tirzepatide for heart failure with preserved ejection fraction and obesity.
"Mounjaro, Zepbound and Verzenio led our strong financial performance in the second quarter as we advanced our manufacturing expansion agenda, and it is equally exciting to see the growth around the world of our medicines for cancer, neurological disorders and autoimmune diseases," said
Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:
U.S. Food and Drug Administration (FDA) approval of Kisunla™ (donanemab-azbt) for the treatment of Alzheimer's disease;- Approval of Jaypirca® in
Japan for people with relapsed or refractory mantle cell lymphoma who are resistant or intolerant to other Bruton tyrosine kinase inhibitors; - Submission of tirzepatide in the
U.S. and EU for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity; - Submission of mirikizumab in
Japan for the treatment of moderately to severely active Crohn's disease; - Positive topline results from the SUMMIT Phase 3 clinical trial evaluating tirzepatide in adults with heart failure with preserved ejection fraction and obesity;
- Positive topline results from the QWINT-2 and QWINT-4 Phase 3 clinical trials that showed once-a-week dosing of insulin efsitora alfa in adults with type 2 diabetes delivers A1C reduction and safety profile consistent with daily insulin;
- The announcement of an agreement for Lilly to acquire Morphic Holding, Inc. to expand Lilly's immunology pipeline with oral integrin therapies for treatment of serious chronic diseases;
- The commitment of an additional
$5.3 billion manufacturing investment in the company's newestIndiana site to boost API production for tirzepatide and pipeline medicines; - The issuance of an open letter informing the public about potentially serious risks posed by the proliferation of counterfeit, fake, compounded, and other unsafe or untested versions of the company's FDA-approved tirzepatide medications and about the appropriate use of the company's authentic medicines; and
- Announcements regarding changes to the company's executive leadership team.
For information on important public announcements, visit the news section of Lilly's website.
Financial Results
$ in millions, except per share data |
Second Quarter |
||||
2024 |
2023 |
% Change |
|||
Revenue |
$ 11,302.8 |
$ 8,312.1 |
36 % |
||
Net income – Reported |
2,967.0 |
1,763.2 |
68 % |
||
Earnings per share – Reported |
3.28 |
1.95 |
68 % |
||
Net income – Non-GAAP |
3,541.2 |
1,904.4 |
86 % |
||
Earnings per share – Non-GAAP |
3.92 |
2.11 |
86 % |
||
A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."
Second-Quarter Reported Results
In Q2 2024, worldwide revenue was
Strong performance by the company's incretin medicines continued, as production increases resulted in improved channel dynamics and stocking levels in the
Higher realized prices were primarily driven by Mounjaro in the
(i) Lilly defines New Products as select products launched since 2022, which currently consist of Ebglyss, Jaypirca, Mounjaro, Omvoh and Zepbound. |
(ii) Lilly defines Growth Products as select products launched prior to 2022, which currently consist of Cyramza, Emgality, Jardiance, Olumiant, Retevmo, Taltz, Trulicity, Tyvyt and Verzenio |
Revenue in the U.S. increased 42% to
Revenue outside the
Gross margin increased 40% to
In Q2 2024, research and development expenses increased 15% to
Marketing, selling and administrative expenses increased 10% to
In Q2 2024, the company recognized acquired in-process research and development (IPR&D) charges of
Asset impairment, restructuring and other special charges were
Other income (expense) was expense of
The effective tax rate was 15.6% in both Q2 2024 and Q2 2023. The Q2 2024 tax rate reflects a mix of earnings in higher tax jurisdictions, while the Q2 2023 rate reflects the impact of earnings from the sale of rights for Baqsimi.
In Q2 2024, net income and earnings per share (EPS) were
Second-Quarter Non-GAAP Measures
On a non-GAAP basis, Q2 2024 gross margin increased 40% to
The effective tax rate on a non-GAAP basis was 16.5% in Q2 2024 compared with 16.1% in Q2 2023. The Q2 2024 tax rate reflects a mix of earnings in higher tax jurisdictions, while the Q2 2023 rate reflects the impact of earnings from the sale of rights for Baqsimi.
On a non-GAAP basis, Q2 2024 net income and EPS were
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.
Second Quarter |
|||||
2024 |
2023 |
% Change |
|||
Earnings per share (reported) |
$ 3.28 |
$ 1.95 |
68 % |
||
Asset impairment, restructuring and other special |
.38 |
— |
|||
Net losses on investments in equity securities |
.14 |
.05 |
|||
Amortization of intangible assets |
.12 |
.11 |
|||
Earnings per share (non-GAAP) |
$ 3.92 |
$ 2.11 |
86 % |
||
Numbers may not add due to rounding. |
|||||
Acquired IPR&D |
.14 |
.09 |
56 % |
Selected Revenue Highlights
(Dollars in millions) |
Second Quarter |
Year-to-Date |
|||||||||
Selected Products |
2024 |
2023 |
% Change |
2024 |
2023 |
% Change |
|||||
Mounjaro |
$ 3,090.8 |
$ 979.7 |
NM |
$ 4,897.4 |
$ 1,548.2 |
NM |
|||||
Trulicity |
1,245.6 |
1,812.5 |
(31) % |
2,701.9 |
3,789.6 |
(29) % |
|||||
Verzenio |
1,331.9 |
926.8 |
44 % |
2,382.2 |
1,677.7 |
42 % |
|||||
Zepbound |
1,243.2 |
— |
NM |
1,760.6 |
— |
NM |
|||||
Jardiance(a) |
769.6 |
668.3 |
15 % |
1,456.1 |
1,245.8 |
17 % |
|||||
Taltz |
824.7 |
703.9 |
17 % |
1,428.8 |
1,230.8 |
16 % |
|||||
Humalog(b) |
631.6 |
440.4 |
43 % |
1,170.3 |
901.4 |
30 % |
|||||
Total Revenue |
11,302.8 |
8,312.1 |
36 % |
20,070.8 |
15,272.1 |
31 % |
|||||
(a) Jardiance includes Glyxambi®, Synjardy® and Trijardy® XR (b) Humalog includes Insulin Lispro NM – not meaningful |
Mounjaro
For Q2 2024, worldwide Mounjaro revenue was
Trulicity
For Q2 2024, worldwide Trulicity revenue decreased 31% compared with Q2 2023 to
Verzenio
For Q2 2024, worldwide Verzenio revenue increased 44% compared with Q2 2023 to
Zepbound
For Q2 2024,
Jardiance
For Q2 2024, the company's worldwide Jardiance revenue increased 15% compared with Q2 2023 to
Jardiance is part of the company's alliance with
Taltz
For Q2 2024, worldwide Taltz revenue increased 17% compared with Q2 2023 to
Humalog
For Q2 2024, worldwide Humalog revenue increased 43% compared with Q2 2023 to
2024 Financial Guidance
2024 full-year revenue guidance increased by
The ratio of (Gross Margin - OPEX) / Revenue, where OPEX is defined as the sum of research and development expenses and marketing, selling and administrative expenses, is now expected to be in the range of 36% to 38% on a reported basis and 37% to 39% on a non-GAAP basis. Both ratios reflect the
Guidance on a reported basis now includes asset impairment, restructuring and other special charges of
Other income (expense) guidance is now expected to be a range of (
Tax rate guidance is now expected to be approximately 15% on both a reported and non-GAAP basis, driven by changes in the company's forecasted mix of earnings in higher tax jurisdictions.
Based on these changes, EPS guidance increased to the ranges of
2024 Guidance(1) |
|
Earnings per share (reported) |
|
Amortization of intangible assets |
.49 |
Asset impairment, restructuring, and other special charges |
.38 |
Net losses on investments in equity securities |
.12 |
Earnings per share (non-GAAP) |
|
Numbers may not add due to rounding |
|
(1) Reported and Non-GAAP EPS guidance both include |
The following table summarizes the company's 2024 financial guidance:
2024 Guidance(1) |
|||
Prior |
Updated(3) |
||
Revenue |
|
|
|
(Gross Margin - OPEX(2)) / Revenue: |
|||
(reported) |
32% to 34% |
36% to 38% |
|
(non-GAAP) |
33% to 35% |
37% to 39% |
|
Other Income/(Expense) (reported) |
( |
( |
|
Other Income/(Expense) (non-GAAP) |
( |
( |
|
Tax Rate |
Approx. 14% |
Approx. 15% |
|
Earnings per Share (reported) |
|
|
|
Earnings per Share (non-GAAP) |
|
|
|
(1) Non-GAAP guidance reflects adjustments presented in the earnings per share reconciliation table above. |
|||
(2) OPEX is defined as the sum of research and development expenses and marketing, selling and administrative expenses. |
|||
(3) Guidance includes Acquired IPR&D charges through Q2 2024 of |
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q2 2024 financial results conference call through a link on Lilly's website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at
Non-GAAP Financial Measures
Certain financial information is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with
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 more than 51 million 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. F-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains management's current intentions and expectations for the future, all of which are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "estimate", "project", "intend", "expect", "believe", "target", "anticipate", "may", "could", "aim", "seek", "will", "continue", and similar expressions are intended to identify forward-looking statements. Actual results may differ materially due to various factors. The following include some but not all of the factors that could cause actual results or events to differ from those anticipated, including the significant costs and uncertainties in the pharmaceutical research and development process, including with respect to the timing and process of obtaining regulatory approvals; the impact and uncertain outcome of acquisitions and business development transactions and related costs; intense competition affecting the company's products, pipeline, or industry; market uptake of launched products and indications; continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals, or reporting obligations related thereto; safety or efficacy concerns associated with the company's products; dependence on relatively few products or product classes for a significant percentage of the company's total revenue and an increasingly consolidated supply chain; the expiration of intellectual property protection for certain of the company's products and competition from generic and biosimilar products, and risks from the proliferation of counterfeit or illegally compounded products; the company's ability to protect and enforce patents and other intellectual property or changes in patent law or regulations related to data package exclusivity; information technology system inadequacies, inadequate controls or procedures, security breaches, or operating failures; unauthorized access, disclosure, misappropriation, or compromise of confidential information or other data stored in the company's information technology systems, networks, and facilities, or those of third parties with whom the company shares its data and violations of data protection laws or regulations; issues with product supply and regulatory approvals stemming from manufacturing difficulties, disruptions, or shortages, including as a result of unpredictability and variability in demand, labor shortages, third-party performance, quality, cyber-attacks, or regulatory actions related to the company's and third-party facilities; reliance on third-party relationships and outsourcing arrangements; the use of artificial intelligence or other emerging technologies in various facets of the company's operations which may exacerbate competitive, regulatory, litigation, cybersecurity, and other risks; the impact of global macroeconomic conditions, including uneven economic growth or downturns or uncertainty, trade disruptions, international tension, conflicts, regional dependencies, or other costs, uncertainties, and risks related to engaging in business globally; fluctuations in foreign currency exchange rates or changes in interest rates and inflation; litigation, investigations, or other similar proceedings involving past, current, or future products or activities; changes in tax law and regulations, tax rates, or events that differ from our assumptions related to tax positions; regulatory changes and developments; regulatory actions regarding the company's operations and products; regulatory compliance problems or government investigations; actual or perceived deviation from environmental-, social-, or governance-related requirements or expectations; asset impairments and restructuring charges; and changes in accounting and reporting standards. For additional information about the factors that could cause actual results or events to differ materially from forward-looking statements, please see the company's latest Form 10-K and subsequent Forms 8-K and 10-Q filed with the
Baqsimi® (glucagon, Amphastar Pharmaceuticals)
Cyramza® (ramucirumab, Lilly)
Ebglyss® (lebrikizumab, Lilly)
Emgality® (galcanezumab-gnlm, Lilly)
Glyxambi® (empagliflozin/linagliptin,
Humalog® (insulin lispro injection of recombinant DNA origin, Lilly)
Jardiance® (empagliflozin,
Jaypirca® (pirtobrutinib, Lilly)
Kisunla™ (donanemab-azbt injection, Lilly)
Mounjaro® (tirzepatide injection, Lilly)
Olumiant® (baricitinib, Lilly)
Omvoh® (mirikizumab, Lilly)
Retevmo® (selpercatinib, Lilly)
Synjardy® (empagliflozin/metformin,
Taltz® (ixekizumab, Lilly)
Trijardy® XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets,
Trulicity® (dulaglutide, Lilly)
Tyvyt® (sintilimab injection, Innovent)
Verzenio® (abemaciclib, Lilly)
Zepbound® (tirzepatide injection, Lilly)
Third-party trademarks used herein are trademarks of their respective owners.
|
|||||||||||||
Operating Results (Unaudited) – REPORTED |
|||||||||||||
(Dollars in millions, except per share data) |
|||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||
|
|
||||||||||||
2024 |
2023 |
% Chg. |
2024 |
2023 |
% Chg. |
||||||||
Revenue |
$ |
11,302.8 |
$ |
8,312.1 |
36 % |
$ |
20,070.8 |
$ |
15,272.1 |
31 % |
|||
Cost of sales |
2,170.2 |
1,807.4 |
20 % |
3,843.7 |
3,434.1 |
12 % |
|||||||
Research and development |
2,711.2 |
2,356.5 |
15 % |
5,234.0 |
4,341.6 |
21 % |
|||||||
Marketing, selling and |
2,117.3 |
1,925.4 |
10 % |
4,069.5 |
3,674.6 |
11 % |
|||||||
Acquired IPR&D |
154.3 |
97.1 |
59 % |
264.8 |
202.1 |
31 % |
|||||||
Asset impairment, restructuring and other special |
435.0 |
— |
NM |
435.0 |
— |
NM |
|||||||
Operating income |
3,714.8 |
2,125.7 |
75 % |
6,223.8 |
3,619.7 |
72 % |
|||||||
Net interest income (expense) |
(146.3) |
(74.3) |
(280.1) |
(142.9) |
|||||||||
Net other income (expense) |
(51.3) |
37.5 |
109.6 |
141.8 |
|||||||||
Other income (expense) |
(197.6) |
(36.8) |
NM |
(170.5) |
(1.1) |
NM |
|||||||
Income before income taxes |
3,517.2 |
2,088.9 |
68 % |
6,053.3 |
3,618.6 |
67 % |
|||||||
Income tax expense |
550.2 |
325.7 |
69 % |
843.4 |
510.5 |
65 % |
|||||||
Net income |
$ |
2,967.0 |
$ |
1,763.2 |
68 % |
$ |
5,209.9 |
$ |
3,108.1 |
68 % |
|||
Earnings per share - diluted |
$ |
3.28 |
$ |
1.95 |
68 % |
$ |
5.76 |
$ |
3.44 |
67 % |
|||
Dividends paid per share |
$ |
1.30 |
$ |
1.13 |
15 % |
$ |
2.60 |
$ |
2.26 |
15 % |
|||
Weighted-average shares |
904,248 |
902,699 |
904,025 |
902,991 |
|
||||||
Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) |
||||||
(Dollars in millions, except per share data) |
||||||
Three Months Ended |
Six Months Ended |
|||||
2024 |
2023 |
2024 |
2023 |
|||
Gross Margin - As Reported |
$ 9,132.6 |
$ 6,504.7 |
$ 16,227.1 |
$ 11,838.0 |
||
Increase for excluded items: |
||||||
Amortization of intangible assets |
139.1 |
126.4 |
278.2 |
252.2 |
||
Gross Margin - Non-GAAP |
$ 9,271.7 |
$ 6,631.1 |
$ 16,505.3 |
$ 12,090.2 |
||
Gross Margin as a percent of |
80.8 % |
78.3 % |
80.8 % |
77.5 % |
||
Gross Margin as a percent of revenue - |
82.0 % |
79.8 % |
82.2 % |
79.2 % |
Numbers may not add due to rounding. |
||
i. |
Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties. |
|
ii. |
Non-GAAP gross margin as a percent of revenue reflects the gross margin effects of the adjustments presented above. |
Three Months Ended |
Six Months Ended |
|||||
2024 |
2023 |
2024 |
2023 |
|||
Net Income - As Reported |
$ 2,967.0 |
$ 1,763.2 |
$ 5,209.9 |
$ 3,108.1 |
||
Increase (decrease) for excluded items: |
||||||
Amortization of intangible assets |
139.1 |
126.4 |
278.2 |
252.2 |
||
Asset impairment, restructuring and |
435.0 |
— |
435.0 |
— |
||
Net (gains) losses on investments in |
147.7 |
53.9 |
124.3 |
76.5 |
||
Corresponding tax effects (Income |
(147.6) |
(39.1) |
(170.9) |
(68.5) |
||
Net Income - Non-GAAP |
$ 3,541.2 |
$ 1,904.4 |
$ 5,876.5 |
$ 3,368.3 |
||
Effective tax rate - As Reported |
15.6 % |
15.6 % |
13.9 % |
14.1 % |
||
Effective tax rate - Non-GAAP(iii) |
16.5 % |
16.1 % |
14.7 % |
14.7 % |
||
Earnings per share (diluted) - As |
$ 3.28 |
$ 1.95 |
$ 5.76 |
$ 3.44 |
||
Earnings per share (diluted) - Non- |
$ 3.92 |
$ 2.11 |
$ 6.50 |
$ 3.73 |
Numbers may not add due to rounding. |
||
i. |
Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties. |
|
ii. |
For the three and six months ended |
|
iii. |
Non-GAAP tax rate reflects the tax effects of the adjustments presented above. |
Refer to: |
|
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