Lilly Reports First-Quarter 2023 Financial Results, Highlights Continued Core Business Growth and Pipeline Momentum
Eli Lilly reported Q1 2023 revenue of
- Core business revenue increased 10% excluding COVID-19 antibodies.
- New products contributed
$573.6 million in revenue. - Growth products revenue rose 18% to
$4.56 billion . - Raised 2023 EPS guidance to
$8.18 to$8.38 (reported). - FDA approvals for tirzepatide and Verzenio expanded indications.
- Q1 2023 revenue decreased by 11% year-over-year.
- Q1 2023 EPS decreased 29% to
$1.49 (reported). - Research and development expenses increased 23% to
$1.99 billion .
- Revenue in Q1 2023 decreased
11% driven by a decline in revenue from COVID-19 antibodies. Excluding COVID-19 antibodies, revenue in Q1 2023 increased$1.47 billion 10% , driven by volume growth from Mounjaro, Trulicity, Verzenio and Jardiance. - Pipeline progress included positive results in the tirzepatide Phase 3 SURMOUNT-2 study; FDA approval of an expanded indication for Verzenio; approval of mirikizumab in
Japan ; and regulatory submissions of tirzepatide for obesity in the EU and lebrikizumab for atopic dermatitis inJapan . - New Products(i) contributed
to revenue in Q1 2023, led by Mounjaro. Growth Products(ii) revenue increased$573.6 million 18% to in Q1 2023, led by Verzenio, Trulicity, Jardiance and Taltz.$4.56 billion - Driven by the decline in COVID-19 antibodies revenue, Q1 2023 EPS decreased
29% to on a reported basis and decreased$1.49 38% to on a non-GAAP basis, both inclusive of$1.62 of acquired IPR&D.$0.10 - 2023 reported EPS guidance raised
to be in the range of$0.28 to$8.18 and non-GAAP EPS guidance raised$8.38 to be in the range of$0.30 to$8.65 .$8.85
(i) |
(ii) |
"Core business growth drove solid first-quarter financial results and a strong start for
- The announcement that tirzepatide achieved superior weight loss and met both co-primary objectives and all key secondary objectives compared to placebo at 72 weeks in the Phase 3 SURMOUNT-2 study;
- The
U.S. Food and Drug Administration's (FDA) approval of an expanded indication for Verzenio®, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence; - Price reductions of
70% for the company's most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at or less per month;$35 - The
FDA's issuance of a complete response letter for mirikizumab in ulcerative colitis, citing issues related to the proposed manufacturing of mirikizumab with no concerns about the clinical data package, safety or label; - The
FDA's acceptance of the supplemental New Drug Application for Jardiance® for children 10 years and older with type 2 diabetes; - The announcement that the company will invest an additional
at its two new manufacturing sites in$1.6 billion Indiana , bringing the company's total commitment to and up to 700 new jobs;$3.7 billion - The agreement to sell the rights of the olanzapine portfolio, including Zyprexa®, to
Cheplapharm Arzneimittel GmbH for in cash upon regulatory approval and successful closing of the transaction, with an additional$1.05 billion in cash upon the one year anniversary of closing and milestone payments of up to$305 million .$50 million - The agreement to sell the rights of Baqsimi® to Amphastar Pharmaceuticals, Inc. for
in cash upon regulatory approval and successful closing of the transaction, with an additional$500 million in cash upon the one year anniversary of closing and milestone payments of up to$125 million .$450 million - The collaboration with
International Agencies Ltd. to increase patient access and improve affordability for high-quality insulin for nearly one million people living with diabetes inBangladesh by 2030.
For additional information on important public announcements, visit the news section of
Financial Results
$ in millions, except per share data | First Quarter | ||||
2023 | 2022 | % Change | |||
Revenue | (11) % | ||||
Net Income – Reported | 1,344.9 | 1,902.9 | (29) % | ||
EPS – Reported | 1.49 | 2.10 | (29) % | ||
Net Income – Non-GAAP | 1,463.9 | 2,372.8 | (38) % | ||
EPS – Non-GAAP | 1.62 | 2.62 | (38) % | ||
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 2023, worldwide revenue was
Revenue in the
Revenue outside the
Gross margin decreased
In Q1 2023, research and development expenses increased
Marketing, selling and administrative expenses increased
In Q1 2023, the company recognized acquired in-process research and development (IPR&D) charges of
Other income (expense) was income of
The effective tax rate was
In Q1 2023, net income and earnings per share (EPS) were
First-Quarter Non-GAAP Measures
On a non-GAAP basis, Q1 2023 gross margin decreased
The effective tax rate on a non-GAAP basis was
On a non-GAAP basis, Q1 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.
First Quarter | |||||
2023 | 2022 | % Change | |||
Earnings per share (reported) | $ 1.49 | $ 2.10 | (29) % | ||
Amortization of intangible assets | .11 | .18 | |||
Net losses on investments in equity securities | .02 | .34 | |||
Earnings per share (non-GAAP) | $ 1.62 | $ 2.62 | (38) % | ||
Numbers may not add due to rounding. | |||||
Acquired IPR&D | .10 | .15 | (33) % |
Selected Revenue Highlights
(Dollars in millions) | First Quarter | ||||
Selected Products | 2023 | 2022 | % Change | ||
Trulicity | $ 1,977.1 | $ 1,741.3 | 14 % | ||
Verzenio | 750.9 | 469.4 | 60 % | ||
Jardiance(a) | 577.5 | 419.4 | 38 % | ||
Mounjaro | 568.5 | — | NM | ||
Taltz | 527.0 | 488.1 | 8 % | ||
Humalog(b) | 460.9 | 618.2 | (25) % | ||
Cyramza® | 236.8 | 230.3 | 3 % | ||
Olumiant®(c) | 228.9 | 255.6 | (10) % | ||
Emgality® | 154.3 | 149.3 | 3 % | ||
Tyvyt® | 61.0 | 85.5 | (29) % | ||
Alimta | 58.2 | 343.9 | (83) % | ||
Retevmo® | 51.4 | 41.8 | 23 % | ||
COVID-19 antibodies(d) | — | 1,469.8 | (100) % | ||
Total Revenue | 6,960.0 | 7,810.0 | (11) % | ||
(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 (d) COVID-19 antibodies include sales for bamlanivimab administered alone, for NM – not meaningful |
Trulicity
For Q1 2023, worldwide Trulicity revenue was
Verzenio
For Q1 2023, worldwide Verzenio revenue increased
Jardiance
The company's worldwide Jardiance revenue for Q1 2023 was
Jardiance is part of the company's alliance with
Mounjaro
For Q1 2023, worldwide Mounjaro revenue was
Taltz
For Q1 2023, worldwide Taltz revenue increased
Humalog
For Q1 2023, worldwide Humalog revenue decreased
Olumiant
For Q1 2023, worldwide Olumiant revenue decreased
Emgality
For Q1 2023, Emgality generated worldwide revenue of
2023 Financial Guidance
The company has updated certain elements of its 2023 financial guidance on both a reported and non-GAAP basis. Since announcing financial guidance in
Revenue guidance has been increased by
Gross margin as a percent of revenue guidance remains unchanged on both a reported and non-GAAP basis at approximately
Marketing, selling and administrative expenses were increased by
Research and development expenses were increased by
Acquired IPR&D of
Other income (expense) guidance remains unchanged at a range of (
Based on these changes, EPS guidance has been increased to the range of
2023 Expectations | |
Earnings per share (reported) | |
Amortization of intangible assets | .45 |
Net losses 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 updated 2023 financial guidance:
2023 Guidance(1) | |||
Prior | Updated | ||
Revenue | |||
Gross Margin % of Revenue (reported) | Approx. | Unchanged | |
Gross Margin % of Revenue (non-GAAP) | Approx. | Unchanged | |
Marketing, Selling & Administrative | |||
Research & Development | |||
Acquired IPR&D | n/a | ||
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) Guidance does not include acquired IPR&D either incurred, or that may potentially be incurred, after Q1 2023. |
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q1 2023 financial results conference call through a link on
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
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; 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
Alimta® (pemetrexed disodium,
Baqsimi® (glucagon,
Cyramza® (ramucirumab,
Emgality® (galcanezumab-gnlm,
Glyxambi® (empagliflozin/linagliptin,
Humalog® (insulin lispro injection of recombinant DNA origin,
Jardiance® (empagliflozin,
JaypircaTM (pirtobrutinib,
Mounjaro® (tirzepatide injection,
Olumiant® (baricitinib,
Retevmo® (selpercatinib,
Synjardy® (empagliflozin/metformin,
Taltz® (ixekizumab,
Trijardy® XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets,
Trulicity® (dulaglutide,
Tyvyt® (sintilimab injection, Innovent)
Verzenio® (abemaciclib,
Zyprexa® (olanzapine,
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 | ||||||
2023 | 2022 | % Chg. | ||||
Revenue | $ | 6,960.0 | $ | 7,810.0 | (11) % | |
Cost of sales | 1,626.7 | 2,072.1 | (21) % | |||
Research and development | 1,985.1 | 1,610.1 | 23 % | |||
Marketing, selling and administrative | 1,749.2 | 1,557.9 | 12 % | |||
Acquired IPR&D | 105.0 | 165.6 | (37) % | |||
Operating income | 1,494.0 | 2,404.3 | (38) % | |||
Net interest income (expense) | (68.6) | (77.9) | ||||
Net other income (expense) | 104.3 | (272.8) | ||||
Other income (expense) | 35.7 | (350.7) | NM | |||
Income before income taxes | 1,529.7 | 2,053.6 | (26) % | |||
Income tax expense | 184.8 | 150.7 | 23 % | |||
Net income | $ | 1,344.9 | $ | 1,902.9 | (29) % | |
Earnings per share - diluted | $ | 1.49 | $ | 2.10 | (29) % | |
Dividends paid per share | $ | 1.13 | .98 | 15 % | ||
Weighted-average shares outstanding (thousands) - diluted | 903,283 | 906,350 |
NM – not meaningful |
Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) | |||
(Dollars in millions, except per share data) | |||
Three Months Ended | |||
2023 | 2022 | ||
Gross Margin - As Reported | $ 5,333.3 | $ 5,737.9 | |
Increase for excluded items: | |||
Amortization of intangible assets (Cost of sales)(i) | 125.8 | 204.6 | |
Gross Margin - Non-GAAP | $ 5,459.1 | $ 5,942.5 | |
Gross Margin as a percent of revenue - As Reported | 76.6 % | 73.5 % | |
Gross Margin as a percent of revenue - Non-GAAP(ii) | 78.4 % | 76.1 % |
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 | |||
2023 | 2022 | ||
Net Income - As Reported | $ 1,344.9 | $ 1,902.9 | |
Increase (decrease) for excluded items: | |||
Amortization of intangible assets (Cost of sales)(i) | 125.8 | 204.6 | |
Net losses on investments in equity securities (Other income/expense) | 22.6 | 388.4 | |
Corresponding tax effects (Income taxes) | (29.4) | (123.1) | |
Net Income - Non-GAAP | $ 1,463.9 | $ 2,372.8 | |
Effective tax rate - As Reported | 12.1 % | 7.3 % | |
Effective tax rate - Non-GAAP(ii) | 12.8 % | 10.3 % | |
Earnings per share - As Reported | $ 1.49 | $ 2.10 | |
Earnings per share - Non-GAAP | $ 1.62 | $ 2.62 |
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: | |
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