Lilly Reports Third-Quarter 2023 Financial Results, Highlights Strong Sales Growth and Business Development Activity
- Revenue in Q3 2023 increased by 37%, driven by growth from Mounjaro, Verzenio, and Jardiance.
- The company earned $1.42 billion from the sale of rights for the olanzapine portfolio.
- Excluding revenue from the olanzapine portfolio and COVID-19 antibodies, revenue increased by 24%.
- Q3 2023 EPS was a loss of $0.06 on a reported basis and income of $0.10 on a non-GAAP basis.
- The company lowered its 2023 reported EPS guidance to $5.95 to $6.15 and non-GAAP EPS guidance to $6.50 to $6.70.
- None.
- Revenue in Q3 2023 increased
37% , driven by growth from Mounjaro, Verzenio and Jardiance, as well as from the sale of rights for the olanzapine portfolio (Zyprexa). Excluding revenue from the olanzapine portfolio and COVID-19 antibodies, revenue in Q3 2023 increased$1.42 billion 24% . - Pipeline progress included FDA approvals of Omvoh for the treatment of adults with moderately to severely active ulcerative colitis and an expanded indication for Jardiance in adults with chronic kidney disease, and positive results in the mirikizumab Phase 3 VIVID-1 study, which evaluated safety and efficacy for the treatment of adults with moderately to severely active Crohn's disease.
- Business development activity included completed acquisitions of DICE Therapeutics, Inc., Versanis Bio, Inc., Emergence Therapeutics AG and Sigilon Therapeutics, Inc., and the announcement of the agreement to acquire POINT Biopharma Global Inc.
- New Products(i) contributed
to revenue in Q3 2023, led by Mounjaro. Growth Products(ii) revenue increased$1.44 billion 12% to in Q3 2023, led by Verzenio and Jardiance.$4.96 billion - Q3 2023 EPS was a loss of
on a reported basis and income of$0.06 on a non-GAAP basis, both inclusive of an increase of$0.10 of EPS associated with the sale of rights for the olanzapine portfolio, as well as a decrease of$1.22 from acquired IPR&D charges.$3.29 - 2023 reported EPS guidance lowered to the range of
to$5.95 and non-GAAP EPS guidance lowered to the range of$6.15 to$6.50 , both primarily driven by the acquired IPR&D charges incurred in Q3.$6.70
(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 had another strong quarter in Q3 as Mounjaro and Verzenio continued to gain momentum," said David A. Ricks, Lilly's chair and CEO. "Lilly executed on business development priorities in the third quarter, including multiple acquisitions that expand our already robust pipeline. We remain focused on growth and delivering new, innovative medicines that make life better for millions of patients around the globe."
Lilly has had numerous updates recently on key regulatory, clinical, business development and other events, including:
- The
U.S. Food and Drug Administration (FDA) approval of Omvoh™ (mirikizumab) for the treatment of adults with moderately to severely active ulcerative colitis; - FDA approval of Jardiance® for the treatment of adults with chronic kidney disease;
- Positive Phase 3 VIVID-1 results, which evaluated the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease;
- Positive Phase 3 LIBRETTO-531 results, which showed that Retevmo® demonstrated superior progression-free survival compared to approved multikinase inhibitors in RET-mutant medullary thyroid cancer;
- Updated timing of expected FDA action on donanemab for the treatment of early symptomatic Alzheimer's disease to Q1 2024;
- The FDA's issuance of a complete response letter for lebrikizumab for the treatment of moderate-to-severe atopic dermatitis based on inspection findings at a third-party manufacturer with no stated concerns about the clinical data package, safety or label;
- Completion of the acquisitions of DICE Therapeutics, Inc., Versanis Bio, Inc., Emergence Therapeutics AG and Sigilon Therapeutics, Inc.;
- The announcement of an agreement to acquire POINT Biopharma Global Inc. to expand oncology capabilities into radioligand therapies; and
- The announcement of 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 | Third Quarter | ||||
2023 | 2022 | % Change | |||
Revenue | 37 % | ||||
Net income (loss) – Reported | (57.4) | 1,451.7 | NM | ||
Earnings (loss) per share – Reported | (0.06) | 1.61 | NM | ||
Net income – Non-GAAP | 94.8 | 1,789.2 | (95) % | ||
Earnings per share – Non-GAAP | 0.10 | 1.98 | (95) % | ||
A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."
Third-Quarter Reported Results
In Q3 2023, worldwide revenue was
Revenue in the
Revenue outside the
Gross margin increased
In Q3 2023, research and development expenses increased
Marketing, selling and administrative expenses increased
In Q3 2023, the company recognized acquired in-process research and development (IPR&D) charges of
There were no asset impairment, restructuring and other special charges recognized in Q3 2023. In Q3 2022, the company recognized asset impairment, restructuring and other special charges of
Other income (expense) was
The effective tax rate was
In Q3 2023, net income (loss) and earnings (loss) per share were
Third-Quarter Non-GAAP Measures
On a non-GAAP basis, Q3 2023 gross margin increased
The effective tax rate on a non-GAAP basis was
On a non-GAAP basis, Q3 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.
Third Quarter | |||||
2023 | 2022 | % Change | |||
Earnings (loss) per share (reported) | NM | ||||
Asset impairment, restructuring and other | — | .17 | |||
Amortization of intangible assets | .11 | .11 | |||
Net losses on investments in equity securities | .06 | .09 | |||
Earnings per share (non-GAAP) | (95) % | ||||
Numbers may not add due to rounding. | |||||
Acquired IPR&D | 3.29 | .06 | NM | ||
Selected Revenue Highlights
(Dollars in millions) | Third Quarter | Year-to-Date | |||||||||
Selected Products | 2023 | 2022 | % Change | 2023 | 2022 | % Change | |||||
Trulicity | (10) % | (1) % | |||||||||
Mounjaro | 1,409.3 | 187.3 | NM | 2,957.5 | 203.2 | NM | |||||
Verzenio | 1,040.2 | 617.7 | 68 % | 2,717.9 | 1,675.6 | 62 % | |||||
Taltz | 744.2 | 679.9 | 9 % | 1,975.0 | 1,774.2 | 11 % | |||||
Jardiance(a) | 700.8 | 573.3 | 22 % | 1,946.6 | 1,453.7 | 34 % | |||||
Humalog®(b) | 395.4 | 447.0 | (12) % | 1,296.8 | 1,512.3 | (14) % | |||||
Cyramza® | 224.1 | 232.1 | (3) % | 721.1 | 693.6 | 4 % | |||||
Olumiant®(c) | 231.4 | 182.9 | 27 % | 679.2 | 624.7 | 9 % | |||||
Emgality® | 168.5 | 168.5 | 0 % | 492.2 | 475.2 | 4 % | |||||
Tyvyt® | 115.1 | 76.8 | 50 % | 279.7 | 235.8 | 19 % | |||||
Retevmo | 63.4 | 40.5 | 56 % | 180.2 | 127.3 | 42 % | |||||
Alimta® | 53.5 | 119.4 | (55) % | 172.6 | 691.1 | (75) % | |||||
COVID-19 antibodies(d) | — | 386.6 | (100) % | — | 1,985.5 | (100) % | |||||
Total Revenue | 9,498.6 | 6,941.6 | 37 % | 24,770.7 | 21,239.6 | 17 % | |||||
(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 Q3 2023, worldwide Trulicity revenue decreased
Mounjaro
For Q3 2023, worldwide Mounjaro revenue was
Verzenio
For Q3 2023, worldwide Verzenio revenue increased
Taltz
For Q3 2023, worldwide Taltz revenue increased
Jardiance
For Q3 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.
Humalog
For Q3 2023, worldwide Humalog revenue decreased
Olumiant
For Q3 2023, worldwide Olumiant revenue increased
Emgality
For Q3 2023, worldwide Emgality revenue remained flat compared with Q3 2022 at
2023 Financial Guidance
The company updated certain elements of its 2023 financial guidance on both a reported and non-GAAP basis.
Revenue guidance remains unchanged with the range of
Gross margin as a percent of revenue remains unchanged at approximately
Marketing, selling and administrative expenses guidance remains unchanged with the range of
Acquired IPR&D guidance increased by
Other income (expense) guidance has been updated to the range of
The estimated effective tax rate increased to
Based on these changes, EPS guidance decreased to the range of
2023 Expectations | |
Earnings per share (reported) | |
Amortization of intangible assets | .44 |
Net losses on investments in equity securities | .12 |
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 | Unchanged | ||
Gross Margin % of Revenue (reported) | Approx. | Unchanged | |
Gross Margin % of Revenue (non-GAAP) | Approx. | Unchanged | |
Marketing, Selling & Administrative | Unchanged | ||
Research & Development | Unchanged | ||
Acquired IPR&D | |||
Other Income/(Expense) (reported) | |||
Other Income/(Expense) (non-GAAP) | Unchanged | ||
Tax Rate | |||
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 Q3 2023. | |||
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q3 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/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" 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)
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)
Zyprexa® (olanzapine, 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 | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2023 | 2022 | % Chg. | 2023 | 2022 | % Chg. | ||||||||
Revenue | $ | 9,498.6 | $ | 6,941.6 | 37 % | $ | 24,770.7 | $ | 21,239.6 | 17 % | |||
Cost of sales | 1,860.1 | 1,579.1 | 18 % | 5,294.2 | 5,081.7 | 4 % | |||||||
Research and development | 2,409.1 | 1,802.9 | 34 % | 6,750.7 | 5,194.9 | 30 % | |||||||
Marketing, selling and administrative | 1,803.9 | 1,614.2 | 12 % | 5,478.5 | 4,797.2 | 14 % | |||||||
Acquired IPR&D | 2,975.1 | 62.4 | NM | 3,177.2 | 668.4 | NM | |||||||
Asset impairment, restructuring | — | 206.5 | (100) % | — | 206.5 | (100) % | |||||||
Operating income | 450.4 | 1,676.5 | (73) % | 4,070.1 | 5,290.9 | (23) % | |||||||
Net interest income (expense) | (75.7) | (61.4) | (218.6) | (210.3) | |||||||||
Net other income (expense) | 52.5 | (49.6) | 194.3 | (370.6) | |||||||||
Other income (expense) | (23.2) | (111.0) | (79) % | (24.3) | (580.9) | (96) % | |||||||
Income before income taxes | 427.2 | 1,565.5 | (73) % | 4,045.8 | 4,710.0 | (14) % | |||||||
Income tax expense | 484.6 | 113.8 | NM | 995.1 | 402.9 | NM | |||||||
Net income (loss) | $ | (57.4) | $ | 1,451.7 | NM | $ | 3,050.7 | $ | 4,307.1 | (29) % | |||
Earnings (loss) per share - diluted | $ | (0.06) | $ | 1.61 | NM | $ | 3.38 | $ | 4.76 | (29) % | |||
Dividends paid per share | $ | 1.13 | $ | .98 | 15 % | $ | 3.39 | $ | 2.94 | 15 % | |||
Weighted-average shares | 899,838 | 903,782 | 903,051 | 904,480 |
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 September 30, | Nine Months Ended September 30, | |||||
2023 | 2022 | 2023 | 2022 | |||
Gross Margin - As Reported | $ 7,638.5 | $ 5,362.5 | $ 19,476.5 | $ 16,157.9 | ||
Increase for excluded items: | ||||||
Amortization of intangible assets (Cost | 125.0 | 124.1 | 377.2 | 450.0 | ||
Gross Margin - Non-GAAP | $ 7,763.5 | $ 5,486.6 | $ 19,853.7 | $ 16,607.9 | ||
Gross Margin as a percent of revenue - | 80.4 % | 77.3 % | 78.6 % | 76.1 % | ||
Gross Margin as a percent of revenue - | 81.7 % | 79.0 % | 80.1 % | 78.2 % |
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 September 30, | Nine Months Ended September 30, | |||||
2023 | 2022 | 2023 | 2022 | |||
Net Income (Loss) - As Reported | $ (57.4) | $ 1,451.7 | $ 3,050.7 | $ 4,307.1 | ||
Increase (decrease) for excluded items: | ||||||
Amortization of intangible assets (Cost | 125.0 | 124.1 | 377.2 | 450.0 | ||
Asset impairment, restructuring and | — | 206.5 | — | 206.5 | ||
Net losses on investments in equity | 65.3 | 107.7 | 141.8 | 602.4 | ||
Corresponding tax effects (Income | (38.1) | (100.8) | (106.6) | (272.7) | ||
Net Income - Non-GAAP | $ 94.8 | $ 1,789.2 | $ 3,463.1 | $ 5,293.3 | ||
Effective tax rate - As Reported | 113.4 % | 7.3 % | 24.6 % | 8.6 % | ||
Effective tax rate - Non-GAAP(ii) | 84.6 % | 10.7 % | 24.1 % | 11.3 % | ||
Earnings (loss) per share (diluted) - | $ (0.06) | $ 1.61 | $ 3.38 | $ 4.76 | ||
Earnings per share (diluted) - Non-GAAP | $ 0.10 | $ 1.98 | $ 3.83 | $ 5.85 |
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
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