Lilly Reports Strong Fourth-Quarter and Full-Year 2020 Financial Results
Eli Lilly (LLY) reported a 22% rise in fourth-quarter revenue, reaching $7.44 billion, and an impressive 42% growth in net income to $2.12 billion for Q4 2020. The full year revenue increased 10% to $24.54 billion, but net income fell 26% to $6.19 billion due to a prior year gain from the Elanco sale. Key growth came from new medicines and COVID-19 therapy sales, with gross margin at 76.9%. However, R&D expenses rose 16%.
The company also provided guidance for continued growth in 2021.
- Fourth-quarter revenue increased by 22% to $7.44 billion.
- Fourth-quarter net income rose by 42% to $2.12 billion.
- Full-year revenue increased by 10% to $24.54 billion.
- Non-GAAP EPS for Q4 up 59% to $2.75.
- Strong momentum in key growth products, contributing to 48% of total revenue.
- Full-year net income decreased by 26% to $6.19 billion due to prior year gains.
- Reported EPS for the year fell by 24% to $6.79.
- R&D expenses increased by 16%, driven by COVID-19 related investments.
INDIANAPOLIS, Jan. 29, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced financial results for the fourth quarter and full year of 2020.
$ in millions, except | Fourth Quarter | % | Full Year | % | |||||||||||||
2020 | 2019 | Change | 2020 | 2019 | Change | ||||||||||||
Revenue | $ | 7,440.0 | $ | 6,114.0 | $ | 24,539.8 | $ | 22,319.5 | |||||||||
Net Income – Reported | 2,116.8 | 1,495.7 | 6,193.7 | 8,318.4 | (26)% | ||||||||||||
EPS – Reported | 2.32 | 1.64 | 6.79 | 8.89 | (24)% | ||||||||||||
Net Income – Non-GAAP | 2,509.0 | 1,583.3 | 7,235.9 | 5,568.2 | |||||||||||||
EPS – Non-GAAP | 2.75 | 1.73 | 7.93 | 6.04 | |||||||||||||
Certain financial information for 2020 and 2019 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 U.S. generally accepted accounting principles (GAAP), include all revenue and expenses recognized during the periods, and reflect Elanco Animal Health (Elanco) as discontinued operations during the first quarter of 2019. Non-GAAP measures reflect adjustments for the items described in the reconciliation tables later in the release, and assume that the disposition of Elanco occurred at the beginning of 2019 (including the benefit from the reduction in shares of common stock outstanding). The company's 2021 financial guidance is being provided on both a reported and a non-GAAP basis. The non-GAAP measures are presented to provide additional insights into the underlying trends in the company's business.
"Lilly closed a complex year by delivering impressive results in the fourth quarter of 2020. We finished the year with strong momentum in our core business areas, as volume-based revenue growth for our newest medicines and initial sales of our COVID-19 antibody therapy, coupled with our ongoing productivity agenda, drove robust margin expansion and solid earnings growth," said David A. Ricks, Lilly's chairman and CEO. "I am also encouraged by exciting recent data readouts for three of our most important pipeline assets: tirzepatide, LOXO-305 and donanemab. Each of these potential medicines has a chance to significantly improve patient outcomes in areas of high unmet medical need, and, should they go on to receive approvals, reinforce our growth prospects for the decade ahead."
Key Events Over the Last Three Months
COVID-19
- The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for bamlanivimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. The U.S. government has committed to purchase a total of 1,450,000 doses of bamlanivimab, which includes 950,000 doses already delivered and an agreement earlier this week to deliver 500,000 additional doses no later than March 31, 2021.
- The FDA granted Emergency Use Authorization for baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Lilly and UnitedHealth Group announced a partnership to conduct a pragmatic study of bamlanivimab in high-risk, COVID-19 infected individuals. The study will identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions with a goal of reducing the severity of illness and hospitalizations.
- The company announced results from a Phase 3 clinical trial that showed that bamlanivimab significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities. The trial was conducted in partnership with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the COVID-19 Prevention Network.
- The company announced results from a Phase 3 clinical trial that showed that bamlanivimab 2800 mg and etesevimab 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19 by 70 percent, meeting the primary endpoint of the trial. Additionally, initial results from a separate ongoing Phase 2 trial demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together.
- The company announced a collaboration with Vir Biotechnology, Inc. and GlaxoSmithKline plc to evaluate a combination of two COVID-19 therapies, bamlanivimab 700mg and VIR-7831 500mg, in low-risk patients with mild to moderate COVID-19.
Regulatory
- The FDA accepted a supplemental New Drug Application for Jardiance® which is being investigated as a potential new treatment to reduce the risk of cardiovascular death and hospitalization for heart failure and to slow kidney function decline in adults with chronic heart failure with reduced ejection fraction, including those with and without type 2 diabetes.
Clinical
- The company announced results from a Phase 2 study for donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG, that showed significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease. Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer's Disease Rating Scale, slowing decline by 32 percent relative to placebo, which was statistically significant.
- The company announced topline results from a Phase 3 monotherapy study evaluating the efficacy and safety of tirzepatide compared to placebo. Tirzepatide led to superior A1C and body weight reductions from baseline in adults with type 2 diabetes after 40 weeks of treatment. Tirzepatide is a novel, investigational, once-weekly, dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule, representing a new class of medicines being studied for the treatment of type 2 diabetes.
- The company presented updated data from the LOXO-305 global Phase 1/2 clinical trial in mantle cell lymphoma (MCL) and other non-Hodgkin lymphomas, as well as in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), at the 2020 American Society of Hematology (ASH) Annual Meeting.
Business Development/Other Developments
- The company completed the acquisition of Prevail Therapeutics Inc. for
$22.50 per share in cash (or an aggregate of approximately$880 million ) plus one non-tradable contingent value right worth up to$4.00 per share in cash (or an aggregate of approximately$160 million ), for a total consideration of up to$26.50 per share in cash (or an aggregate of approximately$1.04 0 billion). Prevail is a biotechnology company developing potentially disease-modifying AAV9-based gene therapies for patients with neurodegenerative diseases. - The company announced a license agreement with Asahi Kasei Pharma Corporation, whereby Lilly will acquire the exclusive rights for AK1780, an orally bioavailable P2X7 receptor antagonist that recently completed Phase 1 single and multiple ascending dose and clinical pharmacology studies for the potential treatment of chronic pain conditions.
- The company announced a research collaboration and exclusive license agreement between Loxo Oncology at Lilly and Merus N.V. to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies.
- The company announced a
$30 million investment in Unseen Capital Health Fund LP, a newly-formed venture fund created by racially diverse and historically underrepresented business leaders that is intended to identify, fund and support underrepresented founders of early-stage healthcare companies and those building solutions for marginalized communities. - The company announced a research collaboration and exclusive license agreement with Precision BioSciences, Inc. to utilize Precision's proprietary ARCUS® genome editing platform for the research and development of potential in vivo therapies for genetic disorders, with an initial focus on Duchenne muscular dystrophy and two other undisclosed gene targets.
- The company announced a non-exclusive, global agreement with Ypsomed to advance an automated insulin delivery system as part of Lilly's connected diabetes solutions. Under the terms of the agreement, Lilly will commercialize the system, which is currently in development and will include an insulin pump developed and manufactured by Ypsomed.
- The board of directors elected Gabrielle Sulzberger as a new member, effective January 25, 2021. She will serve on both the Audit Committee and the Ethics and Compliance Committee.
Fourth-Quarter Reported Results
In the fourth quarter of 2020, worldwide revenue was
Revenue in the U.S. increased 31 percent, to
Revenue outside the U.S. increased 10 percent, to
Gross margin increased 18 percent, to
Total operating expenses in the fourth quarter of 2020, defined as the sum of research and development and marketing, selling, and administrative expenses, increased 3 percent to
In the fourth quarter of 2020, the company recognized acquired in-process research and development charges of
In the fourth quarter of 2020, the company recognized income for asset impairment, restructuring and other special charges of
Operating income in the fourth quarter of 2020 was
Other income was
The effective tax rate was 14.3 percent in the fourth quarter of 2020, as compared with 10.1 percent in the fourth quarter of 2019. The effective tax rates for both periods were impacted by net discrete tax items.
In the fourth quarter of 2020, net income and earnings per share were
Fourth-Quarter Non-GAAP Measures
On a non-GAAP basis, fourth-quarter 2020 gross margin increased 20 percent, to
Operating income on a non-GAAP basis increased
The effective tax rate on a non-GAAP basis was 14.4 percent in the fourth quarter of 2020, as compared with 12.6 percent in the fourth quarter of 2019. The effective tax rates for both periods were impacted by net discrete tax items.
On a non-GAAP basis, in the fourth quarter of 2020 net income increased 58 percent, to
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" table later in this press release.
Fourth Quarter | ||||||||
2020 | 2019 | % Change | ||||||
Earnings per share (reported) | $ | 2.32 | $ | 1.64 | ||||
Acquired in-process research and development | .35 | — | ||||||
Amortization of intangible assets | .11 | .05 | ||||||
Asset impairment, restructuring and other special charges | (.03) | .14 | ||||||
Gain on sale of China antibiotics business | — | (.26) | ||||||
Charge related to repurchase of debt | — | .22 | ||||||
Income taxes(a) | — | (.05) | ||||||
Earnings per share (non-GAAP) | $ | 2.75 | $ | 1.73 | ||||
Numbers may not add due to rounding. | ||||||||
(a) Amount relates to a tax benefit from a capital loss on the disposition of subsidiary stock. | ||||||||
Full Year Reported Results
For the full year 2020, worldwide revenue increased 10 percent to
Revenue in the U.S. in 2020 increased 12 percent to
Revenue outside the U.S. in 2020 increased 7 percent to
Gross margin increased 8 percent to
Total operating expenses, defined as the sum of research and development and marketing, selling, and administrative expenses, increased 3 percent to
In 2020, the company recognized acquired in-process research and development charges of
In 2020, the company recognized asset impairment, restructuring and other special charges of
Operating income in 2020 increased 22 percent compared with 2019 to
Other income was
For the full year 2020, the effective tax rate was 14.3 percent, compared with an effective tax rate of 11.9 percent for the full year 2019, driven by net discrete tax benefits in 2019.
For the full year 2020, net income and earnings per share were
Full Year Non-GAAP Measures
On a non-GAAP basis for the full year 2020, gross margin increased 9 percent, to
Operating income on a non-GAAP basis increased
Other income on a non-GAAP basis was
The effective tax rate on a non-GAAP basis was 14.2 percent for the full year 2020, compared with 11.8 percent for the full year 2019, driven by net discrete tax benefits in 2019.
On a non-GAAP basis, net income increased 30 percent and earnings per share increased 31 percent to
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" table later in this press release.
Full Year | ||||||||
2020 | 2019 | % Change | ||||||
Earnings per share (reported) | $ | 6.79 | $ | 8.89 | (24)% | |||
Discontinued operations | — | (3.93) | ||||||
Earnings per share from continuing operations (reported) | 6.79 | 4.96 | ||||||
Acquired in-process research and development | .64 | .21 | ||||||
Amortization of intangible assets | .36 | .18 | ||||||
Asset impairment, restructuring and other special charges | .14 | .58 | ||||||
Gain on sale of China antibiotics business | — | (.26) | ||||||
Charge related to repurchase of debt | — | .22 | ||||||
Lartruvo® charges | — | .14 | ||||||
Impact of reduced shares outstanding for non-GAAP reporting(a) | — | .07 | ||||||
Income taxes(b) | — | (.05) | ||||||
Earnings per share (non-GAAP) | $ | 7.93 | $ | 6.04 | ||||
Numbers may not add due to rounding. (a) Non-GAAP earnings per share assume that the disposition of Elanco occurred at the beginning of 2019 and, therefore, exclude the approximately 65.0 million shares of Lilly common stock retired in the Elanco exchange offer. (b) Amount relates to a tax benefit from a capital loss on the disposition of subsidiary stock. | ||||||||
Selected Revenue Highlights
Selected Revenue Highlights | |||||||||||||||||||||
(Dollars in millions) | Fourth Quarter | Full Year | |||||||||||||||||||
Selected Products | 2020 | 2019 | % Change | 2020 | 2019 | % Change | |||||||||||||||
Trulicity | $ | 1,502.4 | $ | 1,208.1 | $ | 5,068.1 | $ | 4,127.8 | |||||||||||||
Humalog(a) | 718.1 | 763.4 | (6)% | 2,625.9 | 2,820.7 | (7)% | |||||||||||||||
Alimta | 652.7 | 530.7 | 2,329.9 | 2,115.8 | |||||||||||||||||
Taltz | 495.3 | 420.1 | 1,788.5 | 1,366.4 | |||||||||||||||||
Humulin® | 324.4 | 348.0 | (7)% | 1,259.6 | 1,290.1 | (2)% | |||||||||||||||
Jardiance(b) | 313.6 | 268.0 | 1,153.8 | 944.2 | |||||||||||||||||
Basaglar | 282.1 | 307.2 | (8)% | 1,124.4 | 1,112.6 | ||||||||||||||||
Forteo | 254.4 | 360.2 | (29)% | 1,046.3 | 1,404.7 | (26)% | |||||||||||||||
Cyramza | 284.2 | 245.1 | 1,032.6 | 925.1 | |||||||||||||||||
Verzenio | 281.6 | 179.1 | 912.7 | 579.7 | |||||||||||||||||
Bamlanivimab(c) | 871.2 | — | NM | 871.2 | — | NM | |||||||||||||||
Olumiant | 192.2 | 127.8 | 638.9 | 426.9 | |||||||||||||||||
Emgality | 109.9 | 66.3 | 362.9 | 162.5 | NM | ||||||||||||||||
Tyvyt | 102.8 | 37.4 | NM | 308.7 | 134.0 | NM | |||||||||||||||
Baqsimi | 23.8 | 16.1 | 76.1 | 22.4 | NM | ||||||||||||||||
Retevmo | 18.7 | — | NM | 36.6 | — | NM | |||||||||||||||
Total Revenue | 7,440.0 | 6,114.0 | 24,539.8 | 22,319.5 | |||||||||||||||||
(a) Humalog includes Insulin Lispro (b) Jardiance includes Glyxambi®, Synjardy®, and Trijardy® XR (c) Bamlanivimab sales are pursuant to Emergency Use Authorization | |||||||||||||||||||||
Trulicity
Fourth-quarter 2020 worldwide Trulicity revenue was
For the full year 2020, worldwide Trulicity revenue was
Humalog
For the fourth quarter of 2020, worldwide Humalog revenue decreased 6 percent compared with the fourth quarter of 2019, to
For the full year 2020, worldwide Humalog revenue decreased 7 percent to
Alimta
For the fourth quarter of 2020, worldwide Alimta revenue increased 23 percent compared with the fourth quarter of 2019, to
For the full year 2020, worldwide Alimta revenue increased 10 percent to
Taltz
For the fourth quarter of 2020, worldwide Taltz revenue increased 18 percent compared with the fourth quarter of 2019, to
For the full year 2020, Taltz generated worldwide revenue of
Humulin
For the fourth quarter of 2020, worldwide Humulin revenue decreased 7 percent compared with the fourth quarter of 2019, to
For the full year 2020, worldwide Humulin revenue was
Jardiance
The company's worldwide Jardiance revenue during the fourth quarter of 2020 was
For the full year 2020, worldwide Jardiance revenue was
Basaglar
For the fourth quarter of 2020, worldwide Basaglar revenue was
For the full year of 2020, Basaglar generated worldwide revenue of
Forteo
For the fourth quarter of 2020, worldwide Forteo revenue decreased 29 percent compared with the fourth quarter of 2019, to
For the full year 2020, worldwide Forteo revenue decreased 26 percent to
The company expects further volume declines for Forteo as a result of the anticipated entry of generic and biosimilar competition due to the loss of patent exclusivity in the U.S., Japan and major European markets.
Cyramza
For the fourth quarter of 2020, worldwide Cyramza revenue was
For the full year 2020, worldwide Cyramza revenue was
Verzenio
For the fourth quarter of 2020, worldwide Verzenio revenue increased 57 percent compared with the fourth quarter of 2019, to
For the full year 2020, Verzenio generated worldwide revenue of
Olumiant
For the fourth quarter of 2020, Olumiant generated worldwide revenue of
For the full year 2020, Olumiant generated worldwide revenue of
Emgality
For the fourth quarter of 2020, Emgality generated worldwide revenue of
For the full year of 2020, Emgality generated worldwide revenue of
Tyvyt
The company's Tyvyt revenue in China during the fourth quarter of 2020 was
For the full year 2020, Tyvyt generated revenue in China of
Tyvyt is part of the company's alliance with Innovent in China. Lilly reports total sales of Tyvyt made by Lilly as revenue, with payments made to Innovent for its portion of the gross margin reported as cost of sales. Lilly also reports as revenue a portion of the gross margin for Tyvyt sales made by Innovent.
Baqsimi
For the fourth quarter of 2020, Baqsimi generated worldwide revenue of
For the full year 2020, Baqsimi generated worldwide revenue of
Retevmo
For the fourth quarter of 2020, Retevmo generated U.S. revenue of
For the full year 2020, Retevmo generated U.S. revenue of
Change in Non-GAAP Measures Beginning in 2021
Beginning in 2021, the company will exclude the gains and losses on investments in equity securities from its non-GAAP measures for other income (expense) and earnings per share. Reflecting this change in the company's full year 2020 financial results as detailed above would have lowered the company's full year 2020 earnings per share on a non-GAAP basis by
2021 Financial Guidance
The company has updated certain elements of its 2021 financial guidance on a reported basis. Earnings per share for 2021 are now expected to be in the range of
2021 | 2020 | % Change | |
Earnings per share (reported) | |||
Amortization of intangible assets | .50 | .36 | |
Acquired IPR&D(a) | .15 | .64 | |
Asset impairment, restructuring and other special charges(b) | — | .14 | |
Net gains on investments in equity securities | — | (1.15) | |
Earnings per share (non-GAAP)(c) | |||
Numbers may not add due to rounding (a) 2021 includes costs related to transactions with Precision (b) 2021 excludes estimated acquisition and integration costs related to (c) 2020 earnings per share on a non-GAAP basis excludes net gains on | |||
The company still anticipates 2021 revenue between
Gross margin as a percent of revenue for 2021 is still expected to be approximately 77 percent on a reported basis and approximately 79 percent on a non-GAAP basis.
Marketing, selling and administrative expenses for 2021 are still expected to be in the range of
Operating margin for 2021 is still expected to be approximately 30 percent on a reported basis and approximately 32 percent on a non-GAAP basis.
Other income (expense) for 2021 is still expected to be expense in the range of
The 2021 effective tax rate is still expected to be approximately 15 percent on both a reported basis and a non-GAAP basis.
The following table summarizes the company's 2021 financial guidance:
2021 Guidance | |||
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 | ||
Other Income/(Expense) | Unchanged | ||
Tax Rate | Approx. | Unchanged | |
Earnings per share (reported) | |||
Earnings per share (non-GAAP) | Unchanged | ||
Operating Margin (reported) | Approx. | Unchanged | |
Operating Margin (non-GAAP) | Approx. | Unchanged | |
Non-GAAP guidance reflects adjustments presented in the earnings per share table above. | |||
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the fourth-quarter 2020 financial results conference call through a link on Lilly's website at www.lilly.com. The conference call will begin at 9:00 a.m. Eastern time (ET) today and will be available for replay via the website.
Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. F-LLY
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. There are significant risks and uncertainties in pharmaceutical research and development. There can be no guarantees that pipeline products will receive the necessary clinical and manufacturing regulatory approvals or that they will prove to be commercially successful. The company's results may also be affected by such factors as the timing of anticipated regulatory approvals and launches of new products; market uptake of recently launched products; competitive developments affecting current products and the company's pipeline; the expiration of intellectual property protection for certain of the company's products; the company's ability to protect and enforce patents and other intellectual property; the impact of actions of governmental and private payers affecting the pricing of, reimbursement for, and access to pharmaceuticals; regulatory compliance problems or government investigations; regulatory actions regarding currently marketed products; unexpected safety or efficacy concerns associated with the company's products; issues with product supply stemming from manufacturing difficulties or disruptions; regulatory changes or other developments; changes in patent law or regulations related to data-package exclusivity; litigation involving past, current or future products; unauthorized disclosure, misappropriation, or compromise of trade secrets or other confidential data stored in the company's information systems, networks and facilities, or those of third parties with which the company shares its data; changes in tax law and regulations, including the impact of U.S. tax reform legislation enacted in December 2017 and related guidance; changes in inflation, interest rates, and foreign currency exchange rates; asset impairments and restructuring charges; changes in accounting standards promulgated by the Financial Accounting Standards Board and the Securities and Exchange Commission (SEC); acquisitions and business development transactions and related integration costs; information technology system inadequacies or operating failures; the impact of the evolving COVID-19 pandemic, and the global response thereto; reliance on third-party relationships and outsourcing arrangements; and global macroeconomic conditions. For additional information about the factors that could cause actual results 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)
Basaglar® (insulin glargine injection, Lilly)
Cialis® (tadalafil, Lilly)
Cyramza® (ramucirumab, Lilly)
Emgality® (galcanezumab-gnlm, Lilly)
Forteo® (teriparatide of recombinant DNA origin injection, Lilly)
Glyxambi® (empagliflozin/linagliptin, Boehringer Ingelheim)
Humalog® (insulin lispro injection of recombinant DNA origin, Lilly)
Humulin® (human insulin of recombinant DNA origin, Lilly)
Jardiance® (empagliflozin, Boehringer Ingelheim)
Lartruvo® (olaratumab, Lilly)
Olumiant® (baricitinib, Lilly)
Retevmo™ (selpercatinib, Lilly)
Synjardy® (empagliflozin/metformin, Boehringer Ingelheim)
Taltz® (ixekizumab, Lilly)
Tradjenta®(linagliptin, Boehringer Ingelheim)
Trijardy® XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets, Boehringer Ingelheim)
Trulicity® (dulaglutide, Lilly)
Tyvyt® (sintilimab injection, Lilly)
Verzenio® (abemaciclib, Lilly)
Vitrakvi® (larotrectinib, Bayer)
Third party trademarks used herein are trademarks of their respective owners.
Eli Lilly and Company Employment Information | ||||
December 31, 2020 | December 31, 2019 | |||
Worldwide Employees | 34,960 | 33,755 | ||
Eli Lilly and Company | |||||||||||||||||||
Operating Results (Unaudited) – REPORTED | |||||||||||||||||||
(Dollars in millions, except per share data) | |||||||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||||||
December 31, | December 31, | ||||||||||||||||||
2020 | 2019 | % Chg. | 2020 | 2019 | % Chg. | ||||||||||||||
Revenue | $ | 7,440.0 | $ | 6,114.0 | $ | 24,539.8 | $ | 22,319.5 | |||||||||||
Cost of sales | 1,719.8 | 1,282.6 | 5,483.3 | 4,721.2 | |||||||||||||||
Research and development | 1,838.0 | 1,581.4 | 6,085.7 | 5,595.0 | |||||||||||||||
Marketing, selling and administrative | 1,553.9 | 1,698.1 | (8)% | 6,121.2 | 6,213.8 | (1)% | |||||||||||||
Acquired in-process research and development | 366.3 | — | NM | 660.4 | 239.6 | NM | |||||||||||||
Asset impairment, restructuring and other special charges | (30.1) | 151.7 | NM | 131.2 | 575.6 | (77)% | |||||||||||||
Operating income | 1,992.1 | 1,400.2 | 6,058.0 | 4,974.3 | |||||||||||||||
Net interest income (expense) | (83.4) | (82.7) | (326.6) | (320.2) | |||||||||||||||
Net other income (expense) | 560.4 | 345.6 | 1,498.5 | 611.8 | |||||||||||||||
Other income (expense) | 477.0 | 262.9 | 1,171.9 | 291.6 | NM | ||||||||||||||
Income before income taxes | 2,469.1 | 1,663.1 | 7,229.9 | 5,265.9 | |||||||||||||||
Income tax expense | 352.3 | 167.4 | NM | 1,036.2 | 628.0 | ||||||||||||||
Net income from continuing operations | 2,116.8 | 1,495.7 | 6,193.7 | 4,637.9 | |||||||||||||||
Net income from discontinued operations | — | — | — | 3,680.5 | NM | ||||||||||||||
Net income | $ | 2,116.8 | $ | 1,495.7 | $ | 6,193.7 | $ | 8,318.4 | (26)% | ||||||||||
Earnings from continuing operations - diluted | $ | 2.32 | $ | 1.64 | $ | 6.79 | $ | 4.96 | |||||||||||
Earnings from discontinued operations - diluted | — | — | NM | — | 3.93 | NM | |||||||||||||
Earnings per share - diluted | $ | 2.32 | $ | 1.64 | $ | 6.79 | $ | 8.89 | (24)% | ||||||||||
Dividends paid per share | $ | .740 | $ | .645 | $ | 2.960 | $ | 2.580 | |||||||||||
Weighted-average shares outstanding (thousands) - | 912,591 | 914,678 | 912,505 | 935,684 | |||||||||||||||
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 | Three Months Ended | |||||||||||||||||
GAAP Reported | Adjustments(b) | Non-GAAP Adjusted(a) | GAAP Reported | Adjustments(c) | Non-GAAP Adjusted(a) | |||||||||||||
Cost of sales | $ | 1,719.8 | $ | (127.3) | $ | 1,592.5 | $ | 1,282.6 | $ | (53.2) | $ | 1,229.4 | ||||||
Acquired in-process | 366.3 | (366.3) | — | — | — | — | ||||||||||||
Asset impairment, | (30.1) | 30.1 | — | 151.7 | (151.7) | — | ||||||||||||
Other income (expense) | 477.0 | — | 477.0 | 262.9 | (57.3) | 205.6 | ||||||||||||
Income tax expense | 352.3 | 71.3 | 423.6 | 167.4 | 60.0 | 227.4 | ||||||||||||
Net income | 2,116.8 | 392.2 | 2,509.0 | 1,495.7 | 87.6 | 1,583.3 | ||||||||||||
Earnings per share - | 2.32 | .43 | 2.75 | 1.64 | .09 | 1.73 | ||||||||||||
Numbers may not add due to rounding. | ||||||||||||||||||
The table above reflects only line items with non-GAAP adjustments. | ||||||||||||||||||
(a) | The company uses non-GAAP financial measures that differ from financial statements reported in conformity with U.S. generally accepted accounting principles (GAAP). The company's non-GAAP measures adjust reported results to exclude amortization of intangibles and other items that are typically highly variable, difficult to predict, and of a size that could have a substantial impact on the company's reported operations for a period. The company believes that these non-GAAP measures provide useful information to investors. Among other things, they may help investors evaluate the company's ongoing operations. They can also assist in making meaningful period-over-period comparisons and in identifying operating trends that would otherwise be masked or distorted by the items subject to the adjustments. Management uses these non-GAAP measures internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. Investors should consider these non-GAAP measures in addition to, not as a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. |
(b) | Adjustments to certain GAAP reported measures for the three months ended December 31, 2020, include the following: |
(Dollars in millions, except per share data) | Amortization(i) | IPR&D(ii) | Other specified items(iii) | Total | ||||||||
Cost of sales | $ | (127.3) | $ | — | $ | — | $ | (127.3) | ||||
Acquired in-process research and development | — | (366.3) | — | (366.3) | ||||||||
Asset impairment, restructuring and other special charges | — | — | 30.1 | 30.1 | ||||||||
Income tax expense | 26.4 | 50.4 | (5.5) | 71.3 | ||||||||
Net income | 100.9 | 315.9 | (24.6) | 392.2 | ||||||||
Earnings per share - diluted | .11 | .35 | (.03) | .43 | ||||||||
Numbers may not add due to rounding. | ||
The table above reflects only line items with non-GAAP adjustments. | ||
i. | Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties. | |
ii. | Exclude costs associated with payments for acquired in-process research and development projects acquired in a transaction other than a business combination. These costs were related to business development transactions with Innovent Biologics, Inc., Disarm Therapeutics, Inc. and Fochon Pharmaceuticals, Ltd. | |
iii. | Exclude adjustments to prior period estimates for asset impairment and severance costs. | |
(c) | Adjustments to certain GAAP reported measures for the three months ended December 31, 2019, include the following: | |
(Dollars in millions, except per share | Amortization (i) | Other specified items(ii) | Income Taxes (iii) | Total | ||||||||
Cost of sales | $ | (53.2) | $ | — | $ | — | $ | (53.2) | ||||
Asset impairment, restructuring and other special charges | — | (151.7) | — | (151.7) | ||||||||
Other income (expense) | — | (57.3) | — | (57.3) | ||||||||
Income tax expense | 11.2 | 6.8 | 42.0 | 60.0 | ||||||||
Net income | 42.0 | 87.6 | (42.0) | 87.6 | ||||||||
Earnings per share - diluted | .05 | .10 | (.05) | .09 | ||||||||
Numbers may not add due to rounding. | ||
The table above reflects only line items with non-GAAP adjustments. | ||
i. | Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties. | |
ii. | Asset impairment, restructuring and other special charges excludes charges primarily associated with the company's decision to close and sell a research and development facility located in the United Kingdom, as well as severance costs incurred as a result of actions taken to reduce the company's cost structure. Other income (expense) exclude the gain on sale of the company's antibiotics business in China as well as charges related to the repurchase of debt. | |
iii. | Tax benefit from a capital loss on the disposition of subsidiary stock. | |
Eli Lilly and Company | ||||||||||||||||||
Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) | ||||||||||||||||||
(Dollars in millions, except per share data) | ||||||||||||||||||
Twelve Months Ended | Twelve Months Ended | |||||||||||||||||
GAAP Reported | Adjustments(b) | Non-GAAP Adjusted(a) | GAAP Reported | Adjustments(c) | Non-GAAP Adjusted(a) | |||||||||||||
Cost of sales | $ | 5,483.3 | $ | (415.2) | $ | 5,068.1 | $ | 4,721.2 | $ | (289.6) | $ | 4,431.6 | ||||||
Acquired in-process | 660.4 | (660.4) | — | 239.6 | (239.6) | — | ||||||||||||
Asset impairment, | 131.2 | (131.2) | — | 575.6 | (575.6) | — | ||||||||||||
Other income (expense) | 1,171.9 | — | 1,171.9 | 291.6 | (57.3) | 234.3 | ||||||||||||
Income tax expense | 1,036.2 | 164.6 | 1,200.8 | 628.0 | 117.2 | 745.2 | ||||||||||||
Net income from | 6,193.7 | 1,042.2 | 7,235.9 | 4,637.9 | 930.3 | 5,568.2 | ||||||||||||
Net income from | — | — | — | 3,680.5 | (3,680.5) | — | ||||||||||||
Net income | 6,193.7 | 1,042.2 | 7,235.9 | 8,318.4 | (2,750.2) | 5,568.2 | ||||||||||||
Earnings per share - | 6.79 | 1.14 | 7.93 | 8.89 | (2.85) | 6.04 | ||||||||||||
Weighted-average shares | 912,505 | — | 912,505 | 935,684 | (13,542) | 922,142 | ||||||||||||
Numbers may not add due to rounding. | |
The table above reflects only line items with non-GAAP adjustments. | |
(a) | The company uses non-GAAP financial measures that differ from financial statements reported in conformity with U.S. generally accepted accounting principles (GAAP). The company's non-GAAP measures adjust reported results to exclude amortization of intangibles and other items that are typically highly variable, difficult to predict, and of a size that could have a substantial impact on the company's reported operations for a period. The company believes that these non-GAAP measures provide useful information to investors. Among other things, they may help investors evaluate the company's ongoing operations. They can also assist in making meaningful period-over-period comparisons and in identifying operating trends that would otherwise be masked or distorted by the items subject to the adjustments. Management uses these non-GAAP measures internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. Investors should consider these non-GAAP measures in addition to, not as a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. |
(b) | Adjustments to certain GAAP reported measures for the twelve months ended December 31, 2020, include the following: |
(Dollars in millions, except per share data) | Amortization(i) | IPR&D(ii) | Other specified items(iii) | Total | ||||||||
Cost of sales | $ | (411.0) | $ | — | $ | (4.2) | $ | (415.2) | ||||
Acquired in-process research and development | — | (660.4) | — | (660.4) | ||||||||
Asset impairment, restructuring and other special charges | — | — | (131.2) | (131.2) | ||||||||
Income tax expense | 85.3 | 75.5 | 3.8 | 164.6 | ||||||||
Net income | 325.7 | 584.9 | 131.6 | 1,042.2 | ||||||||
Earnings per share – diluted | .36 | .64 | 0.14 | 1.14 | ||||||||
Numbers may not add due to rounding. | |||
The table above reflects only line items with non-GAAP adjustments. | |||
i. | Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties. | ||
ii. | Exclude costs associated with payments for acquired in-process research and development projects acquired in a transaction other than a business combination. These costs were related to both a business development transaction with a pre-clinical stage company as well as business development transactions with Sitryx, AbCellera Biologics Inc., Evox Therapeutics, Junshi Biosciences, Innovent Biologics, Inc., Disarm Therapeutics, and Fochon Pharmaceuticals, Ltd. | ||
iii. | Exclude primarily severance costs incurred as a result of actions taken worldwide to reduce the company's cost structure, as well as acquisition and integration costs incurred as part of the closing of the acquisition of Dermira. | ||
(c) | Adjustments to certain GAAP reported measures for the twelve months ended December 31, 2019, include the following: | ||
(Dollars in millions, | Amortization(i) | IPR&D(ii) | Other specified items(iii) | Reduced shares outstanding(iv) | Lartruvo charges(v) | Income Taxes(vi) | Discontinued operations(vii) | Total | ||||||||||||||||
Cost of sales | $ | (205.0) | $ | — | $ | — | $ | — | $ | (84.6) | $ | — | $ | — | $ | (289.6) | ||||||||
Acquired in-process | — | (239.6) | — | — | — | — | — | (239.6) | ||||||||||||||||
Asset impairment, | — | — | (563.5) | — | (12.1) | — | — | (575.6) | ||||||||||||||||
Other income (expense) | — | — | (57.3) | — | — | — | — | (57.3) | ||||||||||||||||
Income tax expense | 42.4 | 50.3 | 11.0 | — | (28.5) | 42.0 | — | 117.2 | ||||||||||||||||
Net income | 162.6 | 189.3 | 495.2 | — | 125.2 | (42.0) | (3,680.5) | (2,750.2) | ||||||||||||||||
Earnings per share - | .18 | .21 | .54 | .07 | .14 | (.05) | (3.93) | (2.85) | ||||||||||||||||
Numbers may not add due to rounding. | |
The table above reflects only line items with non-GAAP adjustments. | |
i. | Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties. |
ii. | Exclude costs associated with upfront payments for acquired in-process research and development projects acquired in a transaction other than a business combination. These costs were related to business development transactions with AC Immune, ImmuNext, Inc., Avidity Biosciences, and Centrexion Therapeutics Corporation. |
iii. | Asset impairment, restructuring and other special charges exclude charges primarily associated with the accelerated vesting of Loxo Oncology employee equity awards following the acquisition of Loxo Oncology. Other income (expense) exclude the gain on sale of the company's antibiotics business in China as well as charges related to the repurchase of debt. |
iv. | Non-GAAP earnings per share assume that the disposition of Elanco occurred at the beginning of 2019 and therefore include the benefit from the reduction in shares of common stock outstanding. |
v. | Exclude charges related to the suspension of promotion of Lartruvo. |
vi. | Tax benefit from a capital loss on the disposition of subsidiary stock. |
vii. | Exclude discontinued operations of Elanco. |
Refer to: | Mark Taylor; mark.taylor@lilly.com; (317) 276-5795 (Media) |
Kevin Hern; hern_kevin_r@lilly.com; (317) 277-1838 (Investors) |
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SOURCE Eli Lilly and Company
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