Lilly Reports Second-Quarter 2023 Financial Results, Highlights Accelerating Revenue Growth and Key Pipeline Advancements
- Q2 2023 revenue increased 28% to $8.31 billion
- EPS increased 86% to $1.95
- Positive results in Alzheimer's and obesity studies
- Acquisitions of DICE Therapeutics, Sigilon Therapeutics, and Versanis Bio announced
- None.
- Revenue in Q2 2023 increased
28% as a result of volume-driven growth from Mounjaro, Verzenio, Jardiance and Taltz, as well as from the sale of rights for Baqsimi. Excluding revenue from Baqsimi, and COVID-19 antibodies in 2022, revenue in Q2 2023 increased$579.0 million 22% . - Pipeline progress included positive results in the Phase 3 TRAILBLAZER-ALZ 2 study and the submissions of donanemab for traditional approval to the FDA and EMA; the completed submission of tirzepatide in chronic weight management to the FDA and positive results in the Phase 3 SURMOUNT-3 and -4 studies; and approval of mirikizumab in the EU and re-submission in the
U.S. - Business development activity included announcements of agreements to acquire DICE Therapeutics, Inc., Sigilon Therapeutics, Inc. and Versanis Bio.
- New Products(i) contributed
to revenue in Q2 2023, led by Mounjaro. Growth Products(ii) revenue increased$1.00 billion 16% to in Q2 2023, led by Verzenio, Jardiance and Taltz.$4.93 billion - Q2 2023 EPS increased
86% to on a reported basis and increased$1.95 69% to on a non-GAAP basis, both inclusive of$2.11 of EPS associated with the sale of rights for Baqsimi, as well as$0.43 of acquired IPR&D charges.$0.09 - 2023 reported EPS guidance raised
to the range of$1.02 to$9.20 and non-GAAP EPS guidance raised$9.40 to the range of$1.05 to$9.70 .$9.90
(i) Lilly defines New Products as select products launched since 2022, which currently consist of Jaypirca, Mounjaro and Omvoh. |
(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. |
"Lilly's financial results in Q2 were led by Mounjaro sales and a strong performance from Growth Products," said David A. Ricks, Lilly's chair and CEO. "Exciting scientific breakthroughs, such as TRAILBLAZER-ALZ 2 in Alzheimer's disease and SURMOUNT-3 and -4 in obesity, encourage us to continue to make significant investments that support our new medicines including multiple launches expected by the end of 2023 to help more patients around the world."
Lilly had numerous updates recently on key regulatory, clinical, business development and other events, including:
- Positive Phase 3 TRAILBLAZER-ALZ 2 results, which showed donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease, as well as donanemab's submissions for traditional approval to the
U.S. Food and Drug Administration (FDA) and European Medicines Agency with regulatory action expected in theU.S. by the end of 2023; - The completed submission of tirzepatide in chronic weight management to the FDA and positive Phase 3 SURMOUNT-3 and -4 results, which showed the highest level of weight loss observed in the SURMOUNT program to date;
- The approval of mirikizumab in the European Union and re-submission in the
U.S. ; - The announcements of agreements to acquire DICE Therapeutics, Inc., Sigilon Therapeutics, Inc. and Versanis Bio, which would advance Lilly's research and expertise in treatments for autoimmune and cardiometabolic diseases;
- FDA approval of Jardiance® to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes; and
- Allocation of an additional
to the company's now$50 million Social Impact Venture Capital Portfolio, aimed at making a positive impact on patients and society through for-profit investments.$300 million
For additional information on important public announcements, visit the news section of Lilly's website.
Financial Results
$ in millions, except per share data | Second Quarter | ||||
2023 | 2022 | % Change | |||
Revenue | 28 % | ||||
Net Income – Reported | 1,763.2 | 952.5 | 85 % | ||
EPS – Reported | 1.95 | 1.05 | 86 % | ||
Net Income – Non-GAAP | 1,904.4 | 1,131.3 | 68 % | ||
EPS – Non-GAAP | 2.11 | 1.25 | 69 % | ||
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 2023, worldwide revenue was
Revenue in the
Revenue outside the
Gross margin increased
In Q2 2023, research and development expenses increased
Marketing, selling and administrative expenses increased
In Q2 2023, the company recognized acquired in-process research and development (IPR&D) charges of
Other income (expense) was expense of
The effective tax rate was
In Q2 2023, net income and earnings per share (EPS) were
Second-Quarter Non-GAAP Measures
On a non-GAAP basis, Q2 2023 gross margin increased
The effective tax rate on a non-GAAP basis was
On a non-GAAP basis, Q2 2023 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 | |||||
2023 | 2022 | % Change | |||
Earnings per share (reported) | $ 1.95 | $ 1.05 | 86 % | ||
Amortization of intangible assets | .11 | .11 | |||
Net losses on investments in equity securities | .05 | .09 | |||
Earnings per share (non-GAAP) | $ 2.11 | $ 1.25 | 69 % | ||
Numbers may not add due to rounding. | |||||
Acquired IPR&D | .09 | .46 | (80) % |
Selected Revenue Highlights
(Dollars in millions) | Second Quarter | Year-to-Date | |||||||||
Selected Products | 2023 | 2022 | % Change | 2023 | 2022 | % Change | |||||
Trulicity | $ 1,812.5 | $ 1,911.9 | (5) % | $ 3,789.6 | $ 3,653.2 | 4 % | |||||
Verzenio | 926.8 | 588.5 | 57 % | 1,677.7 | 1,057.9 | 59 % | |||||
Mounjaro | 979.7 | 16.0 | NM | 1,548.2 | 16.0 | NM | |||||
Jardiance(a) | 668.3 | 461.0 | 45 % | 1,245.8 | 880.4 | 42 % | |||||
Taltz | 703.9 | 606.2 | 16 % | 1,230.8 | 1,094.3 | 12 % | |||||
Humalog(b) | 440.4 | 447.1 | (1) % | 901.4 | 1,065.3 | (15) % | |||||
Cyramza® | 260.3 | 231.3 | 13 % | 497.0 | 461.5 | 8 % | |||||
Olumiant(c) | 218.9 | 186.2 | 18 % | 447.8 | 441.8 | 1 % | |||||
Emgality® | 169.3 | 157.5 | 8 % | 323.6 | 306.7 | 6 % | |||||
Tyvyt® | 103.6 | 73.6 | 41 % | 164.6 | 159.0 | 4 % | |||||
Alimta | 60.9 | 227.7 | (73) % | 119.1 | 571.7 | (79) % | |||||
Retevmo® | 65.4 | 45.0 | 45 % | 116.8 | 86.8 | 35 % | |||||
COVID-19 antibodies(d) | — | 129.1 | (100) % | — | 1,598.9 | (100) % | |||||
Total Revenue | 8,312.1 | 6,488.0 | 28 % | 15,272.1 | 14,298.0 | 7 % | |||||
(a) Jardiance includes Glyxambi®, Synjardy® and Trijardy® XR (b) Humalog includes Insulin Lispro (c) Olumiant includes sales of baricitinib that were made pursuant to Emergency Use Authorization (EUA) or similar (d) COVID-19 antibodies include sales for bamlanivimab administered alone, for bamlanivimab and etesevimab NM – not meaningful |
Trulicity
For Q2 2023, worldwide Trulicity revenue decreased
Verzenio
For Q2 2023, worldwide Verzenio revenue increased
Mounjaro
For Q2 2023, worldwide Mounjaro revenue was
Jardiance
For Q2 2023, 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 Q2 2023, worldwide Taltz revenue increased
Humalog
For Q2 2023, worldwide Humalog revenue decreased
Olumiant
For Q2 2023, worldwide Olumiant revenue increased
Emgality
For Q2 2023, worldwide Emgality revenue increased
2023 Financial Guidance
The company updated its 2023 financial guidance on both a reported and non-GAAP basis.
Revenue guidance increased by
Gross margin as a percent of revenue guidance increased
The company's guidance for marketing, selling and administrative expenses increased by
Research and development expenses guidance increased by
Acquired IPR&D guidance increased by
Other income (expense) guidance was updated to the range of
The estimated effective tax rate increased to
Based on these changes, EPS guidance increased to the range of
2023 Expectations | |
Earnings per share (reported) | |
Amortization of intangible assets | .44 |
Net losses on investments in equity securities | .07 |
Earnings per share (non-GAAP) | |
Numbers may not add due to rounding | |
The following table summarizes the company's updated 2023 financial guidance:
2023 Guidance(1) | |||
Prior | Updated | ||
Revenue | |||
Gross Margin % of Revenue (reported) | Approx. | Approx. | |
Gross Margin % of Revenue (non-GAAP) | Approx. | Approx. | |
Marketing, Selling & Administrative | |||
Research & Development | |||
Acquired IPR&D | |||
Other Income/(Expense) (reported) | |||
Other Income/(Expense) (non-GAAP) | |||
Tax Rate | Approx. | ||
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) Guidance does not include acquired IPR&D either incurred, or that may potentially be incurred, after Q2 2023. |
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q2 2023 financial results conference call through a link on Lilly's website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 9 a.m. Eastern time today and will be available for replay via the website.
Non-GAAP Financial Measures
Certain financial information for 2023 and 2022 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 unites caring with discovery to create medicines that 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/newsroom. 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" 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 materially 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 outcome of acquisitions and business development transactions and related costs; the expiration of intellectual property protection for certain of the company's products and competition from generic and/or biosimilar products; the company's ability to protect and enforce patents and other intellectual property; changes in patent law or regulations related to data package exclusivity; competitive developments affecting current products and the company's pipeline; market uptake of recently launched products; information technology system inadequacies, 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; the impact of global macroeconomic conditions, trade disruptions, disputes, unrest, war, regional dependencies, or other costs, uncertainties and risks related to engaging in business globally; unexpected safety or efficacy concerns associated with the company's products; litigation, investigations, or other similar proceedings involving past, current, or future products or commercial activities as the company is largely self-insured; 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, or regulatory actions related to our facilities; dependence on certain products for a significant percentage of our total revenue and an increasingly consolidated supply chain; reliance on third-party relationships and outsourcing arrangements; the impact of public health outbreaks, epidemics, or pandemics, such as the COVID-19 pandemic; regulatory changes or other developments; regulatory actions regarding operations and products; continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and access to pharmaceuticals; devaluations in foreign currency exchange rates or changes in interest rates and inflation; changes in tax law, tax rates, or events that differ from the company's assumptions related to tax positions; asset impairments and restructuring charges; changes in accounting and reporting standards promulgated by the Financial Accounting Standards Board and the Securities and Exchange Commission (SEC); regulatory compliance problems or government investigations; and actual or perceived deviation from environmental-, social-, or governance-related requirements or expectations. 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 SEC. 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.
Alimta® (pemetrexed disodium, Lilly)
Baqsimi® (glucagon, Lilly)
Cyramza® (ramucirumab, 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)
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 | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2023 | 2022 | % Chg. | 2023 | 2022 | % Chg. | ||||||||
Revenue | $ | 8,312.1 | $ | 6,488.0 | 28 % | $ | 15,272.1 | $ | 14,298.0 | 7 % | |||
Cost of sales | 1,807.4 | 1,430.5 | 26 % | 3,434.1 | 3,502.6 | (2) % | |||||||
Research and development | 2,356.5 | 1,781.9 | 32 % | 4,341.6 | 3,392.0 | 28 % | |||||||
Marketing, selling and administrative | 1,925.4 | 1,625.1 | 18 % | 3,674.6 | 3,183.0 | 15 % | |||||||
Acquired IPR&D | 97.1 | 440.4 | (78) % | 202.1 | 606.0 | (67) % | |||||||
Operating income | 2,125.7 | 1,210.1 | 76 % | 3,619.7 | 3,614.4 | — % | |||||||
Net interest income (expense) | (74.3) | (71.0) | (142.9) | (148.9) | |||||||||
Net other income (expense) | 37.5 | (48.2) | 141.8 | (321.0) | |||||||||
Other income (expense) | (36.8) | (119.2) | (69) % | (1.1) | (469.9) | (100) % | |||||||
Income before income taxes | 2,088.9 | 1,090.9 | 91 % | 3,618.6 | 3,144.5 | 15 % | |||||||
Income tax expense | 325.7 | 138.4 | NM | 510.5 | 289.1 | 77 % | |||||||
Net income | $ | 1,763.2 | $ | 952.5 | 85 % | $ | 3,108.1 | $ | 2,855.4 | 9 % | |||
Earnings per share - diluted | $ | 1.95 | $ | 1.05 | 86 % | $ | 3.44 | $ | 3.16 | 9 % | |||
Dividends paid per share | $ | 1.13 | $ | .98 | 15 % | $ | 2.26 | $ | 1.96 | 15 % | |||
Weighted-average shares outstanding | 902,699 | 902,940 | 902,991 | 904,422 |
NM – not meaningful |
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 June 30, | Six Months Ended June 30, | |||||
2023 | 2022 | 2023 | 2022 | |||
Gross Margin - As Reported | $ 6,504.7 | $ 5,057.5 | $ 11,838.0 | $ 10,795.4 | ||
Increase for excluded items: | ||||||
Amortization of intangible assets (Cost of sales)(i) | 126.4 | 121.3 | 252.2 | 325.9 | ||
Gross Margin - Non-GAAP | $ 6,631.1 | $ 5,178.8 | $ 12,090.2 | $ 11,121.3 | ||
Gross Margin as a percent of revenue - As Reported | 78.3 % | 78.0 % | 77.5 % | 75.5 % | ||
Gross Margin as a percent of revenue - Non-GAAP(ii) | 79.8 % | 79.8 % | 79.2 % | 77.8 % |
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 June 30, | Six Months Ended June 30, | |||||
2023 | 2022 | 2023 | 2022 | |||
Net Income - As Reported | $ 1,763.2 | $ 952.5 | $ 3,108.1 | $ 2,855.4 | ||
Increase (decrease) for excluded items: | ||||||
Amortization of intangible assets (Cost of sales)(i) | 126.4 | 121.3 | 252.2 | 325.9 | ||
Net losses on investments in equity securities | 53.9 | 106.3 | 76.5 | 494.7 | ||
Corresponding tax effects (Income taxes) | (39.1) | (48.8) | (68.5) | (171.9) | ||
Net Income - Non-GAAP | $ 1,904.4 | $ 1,131.3 | $ 3,368.3 | $ 3,504.1 | ||
Effective tax rate - As Reported | 15.6 % | 12.7 % | 14.1 % | 9.2 % | ||
Effective tax rate - Non-GAAP(ii) | 16.1 % | 14.2 % | 14.7 % | 11.6 % | ||
Earnings per share (diluted) - As Reported | $ 1.95 | $ 1.05 | $ 3.44 | $ 3.16 | ||
Earnings per share (diluted) - Non-GAAP | $ 2.11 | $ 1.25 | $ 3.73 | $ 3.87 |
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) |
View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-reports-second-quarter-2023-financial-results-highlights-accelerating-revenue-growth-and-key-pipeline-advancements-301895134.html
SOURCE Eli Lilly and Company