Lilly Reports First-Quarter 2024 Financial Results and Raises Full-Year Revenue Guidance by $2 Billion, Highlights Pipeline Momentum
Lilly reported a 26% increase in revenue in Q1 2024, driven by strong sales of Mounjaro, Zepbound, Verzenio, and Jardiance. The company saw positive pipeline progress with significant results from Phase 3 trials and various submissions. Q1 2024 EPS increased by 66%, and the full-year revenue guidance was raised by $2 billion. Key financials and product revenue highlights were discussed in the press release.
Lilly reported a 26% increase in revenue in Q1 2024 driven by strong sales of Mounjaro, Zepbound, Verzenio, and Jardiance.
The company saw positive pipeline progress with significant results from Phase 3 trials and various submissions.
Q1 2024 EPS increased by 66%, and the full-year revenue guidance was raised by $2 billion.
- None.
Insights
Eli Lilly's impressive 26% revenue increase in Q1 2024, primarily driven by its newer offerings like Mounjaro and Zepbound, signifies a robust growth trajectory and a strategic focus on innovative drugs that address critical healthcare needs. The expansion in the volume of sales by 16%, supplemented by a 10% increase through higher realized prices, showcases the company's ability to capitalize on its product mix and market dynamics.
Particularly noteworthy is the 66% surge in reported EPS to $2.48 and a 59% rise on a non-GAAP basis to $2.58, inclusive of $0.10 of acquired IPR&D charges. This outperformance is indicative of operational efficiency and suggests a strong underlying financial health of the company. The raised full-year revenue guidance by $2 billion and the increased EPS guidance, both on a reported and non-GAAP basis, reflect management's confidence in the sustained demand for Lilly's products and its capability to scale up production in response to this demand.
Investors should note the significant investments in R&D, amounting to 29% of revenue, which demonstrates Lilly's commitment to innovation. This could be a double-edged sword, as it points to potential future growth opportunities but also requires careful monitoring of the R&D spend efficacy. The increase in gross margin to 80.9%, driven by a favorable product mix and price hikes, bodes well for future profitability, although it is important for investors to watch for any potential pushback on drug pricing.
The strong performance of Lilly's incretin medicines, such as Mounjaro and the company's strategic expansion in manufacturing capacity to meet the burgeoning demand, is a testament to the agile supply chain management amidst tight supply conditions. Investors should recognize the importance of the pipeline momentum, with positive results from Phase 3 trials and regulatory submissions. Products such as tirzepatide for obstructive sleep apnea and mirikizumab for Crohn's disease could unlock new revenue streams upon approval and successful market entry.
It is important to observe the market dynamics around competitive drugs and patent cliffs that could affect future revenues. While the pipeline's progression is promising, the actual commercial success will depend on market adoption, competitive landscape and reimbursement policies. The announcement of the termination of the Verzenio prostate cancer program, despite the increase in revenue for other indications, is a reminder of the inherent risks in drug development and the importance of a diversified portfolio.
The investment in new manufacturing facilities as well as the expansion of existing production capabilities in the U.S. and Germany is a strategic move to not only address current supply shortages but also prepare for future demand, potentially giving Lilly a competitive edge in terms of supply chain reliability and responsiveness.
Lilly's first-quarter results are notable for retail investors due to the evident demand for its incretin medications, which are increasingly being used in the management of type 2 diabetes and weight-related conditions. The substantial sales growth of Mounjaro, in particular, reflects its market acceptance and potential to be a significant player in this therapeutic space.
Another aspect for investors to consider is the company's ability to navigate the complex regulatory environment, as seen with the ongoing resubmissions and submissions of drugs for various treatments and the FDA's plan to discuss the donanemab trials. These actions are critical steps towards future revenue expansion but come with inherent regulatory risk.
The fact that Lilly has raised its full-year guidance is a strong signal of expected continued performance and investor confidence. However, it is essential to balance this with an understanding of challenges such as pricing pressures or changes in healthcare policies that could impact profitability. Long-term investors should monitor how Lilly's strategic investments in its pipeline play out with regard to maintaining a sustainable portfolio amidst the ever-evolving healthcare landscape.
- Revenue in Q1 2024 increased
26% , driven by Mounjaro, Zepbound, Verzenio and Jardiance. - Pipeline progress included positive results from two Phase 3 trials of tirzepatide for obstructive sleep apnea; submission of mirikizumab for Crohn's disease in the
U.S. and EU; resubmission of lebrikizumab for atopic dermatitis in theU.S. ; and initiation of lepodisiran in a Phase 3 study for atherosclerotic cardiovascular disease. - Q1 2024 EPS increased
66% to on a reported basis and increased$2.48 59% to on a non-GAAP basis, both inclusive of$2.58 of acquired IPR&D charges.$0.10 - 2024 full-year revenue guidance raised by
; reported EPS guidance raised$2.0 billion to be in the range of$1.25 to$13.05 and non-GAAP EPS guidance raised$13.55 to be in the range of$1.30 to$13.50 .$14.00
"Lilly's first quarter performance reflects solid year-over-year revenue growth with strong sales of Mounjaro and Zepbound," said David A. Ricks, Lilly's chair and CEO. "Our progress in addressing some of the world's most significant health care challenges has resulted in increased demand for our medicines. As we continue to make pipeline investments that position us for future growth, we are rapidly expanding manufacturing capacity to make our incretin medicines available to more patients."
Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:
- The announcement of positive topline results of the SURMOUNT-OSA Phase 3 clinical trials that showed tirzepatide significantly reduced the apnea-hypopnea index compared to placebo in adults with moderate-to-severe obstructive sleep apnea and obesity;
- Submission of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease in the
U.S. and EU; - Resubmission of lebrikizumab for adult and adolescent patients with moderate-to-severe atopic dermatitis in the
U.S. with expected regulatory action in the second half of 2024; - Initiation of lepodisiran in a Phase 3 study evaluating the efficacy in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke;
- The
U.S. Food and Drug Administration's plan to convene an Advisory Committee meeting to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer's disease; - The announcement that the multi-dose Kwikpen delivery device for Mounjaro® was approved in the EU, adding to the
UK approval earlier in 2024, for both the type 2 diabetes and chronic weight management indications; - Results from a Phase 3 study of lebrikizumab, specifically designed for people with skin of color and moderate-to-severe atopic dermatitis, showed improvement in skin clearance and itch relief;
- The announcement that the EMPACT-MI Phase 3 clinical trial showed a
10% relative risk reduction in time to first hospitalization due to heart failure or all-cause mortality for Jardiance® versus placebo, which did not reach statistical significance; - The decision to terminate the Phase 3 CYCLONE-3 trial evaluating Verzenio® in metastatic hormone-sensitive prostate cancer for futility following an interim analysis;
- The announcement of an agreement for Lilly to acquire a new injectable medicine manufacturing facility from Nexus Pharmaceuticals, LLC, which, upon completion of the transaction, will expand Lilly's growing
U.S. capacity to produce medicines; and - The company broke ground at the previously announced
parenteral manufacturing site in$2.5 billion Germany .
For information on important public announcements, visit the news section of Lilly's website.
Financial Results
$ in millions, except per share data | First Quarter | ||||
2024 | 2023 | % Change | |||
Revenue | $ 8,768.0 | $ 6,960.0 | 26 % | ||
Net income – Reported | 2,242.9 | 1,344.9 | 67 % | ||
Earnings per share – Reported | 2.48 | 1.49 | 66 % | ||
Net income – Non-GAAP | 2,335.3 | 1,463.9 | 60 % | ||
Earnings per share – Non-GAAP | 2.58 | 1.62 | 59 % | ||
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 2024, worldwide revenue was
(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
Revenue outside the
Gross margin increased
In Q1 2024, research and development expenses increased
Marketing, selling and administrative expenses increased
In Q1 2024, the company recognized acquired in-process research and development (IPR&D) charges of
The effective tax rate was
In Q1 2024, net income and earnings per share (EPS) were
First-Quarter Non-GAAP Measures
On a non-GAAP basis, Q1 2024 gross margin increased
The effective tax rate on a non-GAAP basis was
On a non-GAAP basis, Q1 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.
First Quarter | |||||
2024 | 2023 | % Change | |||
Earnings per share (reported) | $ 2.48 | $ 1.49 | 66 % | ||
Amortization of intangible assets | .12 | .11 | |||
Net (gains) losses on investments in equity | (.02) | .02 | |||
Earnings per share (non-GAAP) | $ 2.58 | $ 1.62 | 59 % | ||
Numbers may not add due to rounding. | |||||
Acquired IPR&D | .10 | .10 | 0 % |
Selected Revenue Highlights
(Dollars in millions) | First Quarter | ||||
Selected Products | 2024 | 2023 | % Change | ||
Mounjaro | $ 1,806.5 | $ 568.5 | NM | ||
Trulicity | 1,456.3 | 1,977.1 | (26) % | ||
Verzenio | 1,050.3 | 750.9 | 40 % | ||
Jardiance(a) | 686.5 | 577.5 | 19 % | ||
Taltz | 604.1 | 527.0 | 15 % | ||
Humalog®(b) | 538.7 | 460.9 | 17 % | ||
Zepbound | 517.4 | — | NM | ||
Total Revenue | 8,768.0 | 6,960.0 | 26 % | ||
(a) Jardiance includes Glyxambi®, Synjardy® and Trijardy® XR (b) Humalog includes Insulin Lispro NM – not meaningful |
Mounjaro
For Q1 2024, worldwide Mounjaro revenue was
Trulicity
For Q1 2024, worldwide Trulicity revenue decreased
Verzenio
For Q1 2024, worldwide Verzenio revenue increased
Jardiance
For Q1 2024, the company's worldwide Jardiance revenue increased
Jardiance is part of the company's alliance with Boehringer Ingelheim. Lilly reports as revenue royalties received on net sales of Jardiance.
Taltz
For Q1 2024, worldwide Taltz revenue increased
Humalog
For Q1 2024, worldwide Humalog revenue increased
Zepbound
For Q1 2024,
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
Other income (expense) guidance remains unchanged at a range of (
Tax rate guidance also remains unchanged at approximately
Based on these changes, EPS guidance increased to the range of
2024 Guidance | |
Earnings per share (reported) | |
Amortization of intangible assets | .48 |
Net gains on investments in equity securities | (.02) |
Earnings per share (non-GAAP) | |
Numbers may not add due to rounding | |
The following table summarizes the company's 2024 financial guidance:
2024 Guidance(1) | |||
Prior | Updated(3) | ||
Revenue | |||
(Gross Margin - OPEX(2)) / Revenue: | |||
(reported) | |||
(non-GAAP) | |||
Other Income/(Expense) | ( | Unchanged | |
Tax Rate | Approx. | Unchanged | |
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 does not include Acquired IPR&D either incurred, or expected to be incurred, after Q1 2024. |
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q1 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 10 a.m. Eastern time today and will be available for replay via the website.
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; devaluations 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 Securities and Exchange Commission. You should not place undue reliance on forward-looking statements, which speak only as of the date of this release. Except as is required by law, the company expressly disclaims any obligation to publicly release any revisions to forward-looking statements to reflect events after the date of this release.
Cyramza® (ramucirumab, Lilly)
Ebglyss® (lebrikizumab, Lilly)
Emgality® (galcanezumab-gnlm, Lilly)
Glyxambi® (empagliflozin/linagliptin, Boehringer Ingelheim)
Humalog® (insulin lispro injection of recombinant DNA origin, Lilly)
Jardiance® (empagliflozin, Boehringer Ingelheim)
Jaypirca® (pirtobrutinib, Lilly)
Mounjaro® (tirzepatide injection, Lilly)
Olumiant® (baricitinib, Lilly)
Omvoh® (mirikizumab, Lilly)
Retevmo® (selpercatinib, Lilly)
Synjardy® (empagliflozin/metformin, Boehringer Ingelheim)
Taltz® (ixekizumab, Lilly)
Trijardy® XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets, Boehringer Ingelheim)
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.
Eli Lilly and Company | ||||||
Operating Results (Unaudited) – REPORTED | ||||||
(Dollars in millions, except per share data) | ||||||
Three Months Ended | ||||||
March 31, | ||||||
2024 | 2023 | % Chg. | ||||
Revenue | $ | 8,768.0 | $ | 6,960.0 | 26 % | |
Cost of sales | 1,673.5 | 1,626.7 | 3 % | |||
Research and development | 2,522.8 | 1,985.1 | 27 % | |||
Marketing, selling and administrative | 1,952.2 | 1,749.2 | 12 % | |||
Acquired IPR&D | 110.5 | 105.0 | 5 % | |||
Operating income | 2,509.0 | 1,494.0 | 68 % | |||
Net interest income (expense) | (133.8) | (68.6) | ||||
Net other income (expense) | 160.9 | 104.3 | ||||
Other income (expense) | 27.1 | 35.7 | (24) % | |||
Income before income taxes | 2,536.1 | 1,529.7 | 66 % | |||
Income tax expense | 293.2 | 184.8 | 59 % | |||
Net income | $ | 2,242.9 | $ | 1,344.9 | 67 % | |
Earnings per share - diluted | $ | 2.48 | $ | 1.49 | 66 % | |
Dividends paid per share | $ | 1.30 | $ | 1.13 | 15 % | |
Weighted-average shares outstanding (thousands) - diluted | 903,802 | 903,283 |
Eli Lilly and Company | |||
Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) | |||
(Dollars in millions, except per share data) | |||
Three Months Ended March 31, | |||
2024 | 2023 | ||
Gross Margin - As Reported | $ 7,094.5 | $ 5,333.3 | |
Increase for excluded items: | |||
Amortization of intangible assets (Cost of sales)(i) | 139.1 | 125.8 | |
Gross Margin - Non-GAAP | $ 7,233.6 | $ 5,459.1 | |
Gross Margin as a percent of revenue - As Reported | 80.9 % | 76.6 % | |
Gross Margin as a percent of revenue - Non-GAAP(ii) | 82.5 % | 78.4 % |
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 March 31, | |||
2024 | 2023 | ||
Net Income - As Reported | $ 2,242.9 | $ 1,344.9 | |
Increase (decrease) for excluded items: | |||
Amortization of intangible assets (Cost of sales)(i) | 139.1 | 125.8 | |
Net (gains) losses on investments in equity securities | (23.4) | 22.6 | |
Corresponding tax effects (Income taxes) | (23.3) | (29.4) | |
Net Income - Non-GAAP | $ 2,335.3 | $ 1,463.9 | |
Effective tax rate - As Reported | 11.6 % | 12.1 % | |
Effective tax rate - Non-GAAP(ii) | 11.9 % | 12.8 % | |
Earnings per share (diluted) - As Reported | $ 2.48 | $ 1.49 | |
Earnings per share (diluted) - Non-GAAP | $ 2.58 | $ 1.62 |
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 tax rate reflects the tax effects of the adjustments presented above. |
Refer to: | |
Joe Fletcher; jfletcher@lilly.com; (317) 296-2884 (Investors) |
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SOURCE Eli Lilly and Company