Lilly Reports Robust Third-Quarter 2021 Financial Results as Pipeline Success Strengthens Future Growth Potential
Eli Lilly reported third-quarter 2021 revenues of $6.773 billion, an 18% increase from 2020, driven by a 35% rise in revenue from newer medicines. Net income was $1.110 billion, with reported EPS of $1.22, an 8% decline year-over-year. Non-GAAP EPS increased 38% to $1.94. The company announced several drug approvals and regulatory submissions, enhancing its growth potential. Lilly expects full-year revenue between $27.2 billion and $27.6 billion, reflecting strong performance in key products despite a projected decline in certain older therapies.
- Revenue from newer medicines grew over 35%, representing nearly 60% of core business.
- Non-GAAP EPS rose by 38% to $1.94.
- Third-quarter revenue increased 18% to $6.773 billion.
- Full-year revenue guidance raised to $27.2 billion to $27.6 billion.
- Reported net income decreased 8% year-over-year to $1.110 billion.
- Reported EPS declined by 8% to $1.22.
- Other income (expense) was a loss of $635.9 million, compared to a gain of $158.9 million in Q3 2020.
INDIANAPOLIS, Oct. 26, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced financial results for the third quarter of 2021 today.
"Lilly demonstrated strong performance again this quarter. Revenue attributable to our newer medicines grew more than 35 percent and represented nearly 60 percent of our core business, an important indicator of our long-term growth potential," said David A. Ricks, Lilly's chairman and CEO. "With numerous positive pipeline events this quarter, we have the potential to continue to expand the number of patients we serve through new indications for both Verzenio and Jardiance. We also progressed innovative, potential best-in-class treatment options in areas with high unmet need through a regulatory submission for tirzepatide in diabetes, the initiation of a rolling submission for donanemab in early Alzheimer's disease, the submission of Jardiance in HFpEF, and positive Phase 3 results for lebrikizumab in patients with atopic dermatitis."
$ in millions, except per share data | Third Quarter | % | ||||||
2021 | 2020 | Change | ||||||
Revenue | $ | 6,772.8 | $ | 5,740.6 | ||||
Net Income – Reported | 1,110.1 | 1,208.4 | (8)% | |||||
EPS – Reported | 1.22 | 1.33 | (8)% | |||||
Net Income – Non-GAAP | 1,763.7 | 1,289.2 | ||||||
EPS – Non-GAAP | 1.94 | 1.41 | ||||||
Certain financial information for 2021 and 2020 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) and include all revenue and expenses recognized during the periods. Non-GAAP measures reflect adjustments for the items described in the reconciliation tables later in the release. Beginning in 2021, non-GAAP measures exclude gains and losses on investments in equity securities and 2020 amounts have been reclassified for comparability. 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.
Key Events Over the Last Three Months
Regulatory
- The company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application to the European Medicines Agency for tirzepatide for the treatment of adults with type 2 diabetes. A Priority Review Voucher was applied to the NDA, leading to an anticipated review time of eight months from the date of submission according to current FDA priority review timelines. Several additional submissions are planned around the world before the end of 2021.
- The company initiated rolling submission for donanemab to the FDA for accelerated approval in early Alzheimer's disease.
- In October 2021, the company and Pfizer discontinued the global clinical development program for tanezumab, an investigational nerve growth factor inhibitor. This decision was made following receipt of a Complete Response Letter from the FDA for the tanezumab application in osteoarthritis (OA) and a negative opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use on the tanezumab Marketing Authorization Application in OA.
- The company announced that the FDA approved Verzenio® as the first and only CDK4/6 inhibitor for certain people with HR+ HER2- high risk early breast cancer.
- The company announced that the FDA approved a new indication for Erbitux® in combination with Braftovi® for the treatment of certain adult patients with metastatic colorectal cancer with a BRAF V600E mutation.
- The FDA expanded the Emergency Use Authorization for bamlanivimab and etesevimab administered together to include post-exposure prophylaxis in certain individuals for the prevention of SARS-CoV-2 infection.
- The FDA granted Breakthrough Therapy designation for Jardiance® as an investigational treatment for adults with HFpEF, the company and Boehringer Ingelheim announced. The companies submitted Jardiance for regulatory approval in this indication to the FDA and in Europe.
- Jardiance was approved by the FDA to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF), the company and Boehringer Ingelheim announced.
- The FDA approved an expanded label for the company's rapid-acting insulin, Lyumjev®, indicated to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion with an insulin pump.
Clinical
- The company announced plans to conduct TRAILBLAZER-ALZ 4, a Phase 3 head-to-head clinical trial comparing donanemab to aducanumab to assess superiority of brain amyloid plaque clearance in early symptomatic Alzheimer's disease. Enrollment is expected to begin this year.
- The company announced that in two Phase 3 trials lebrikizumab led to significant improvements at 16 weeks with at least 75 percent skin clearance in more than half of people with moderate-to-severe atopic dermatitis, and key secondary endpoints were achieved, including early onset in skin clearance and itch relief, improvement in interference of itch on sleep and quality of life.
Business Development/Other Developments
- The Office of the Assistant Secretary for Preparedness and Response, alongside the FDA, resumed the shipment and distribution of bamlanivimab and etesevimab administered together.
- The company announced an additional purchase by the U.S. government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. As part of the agreement, the company will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the U.S. government, with approximately 250,000 doses shipped in the third-quarter of 2021 and the remaining to be shipped in fourth-quarter 2021.
- The company announced a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of bamlanivimab and etesevimab for the treatment of COVID-19. This agreement helps to provide access to these COVID-19 antibodies by enabling participating countries in the European Union and European Economic Area to purchase the products directly from Lilly, following national approval for emergency use, or marketing authorization at the EU level.
- The company announced it will lower the list price of Insulin Lispro Injection in the U.S. by an additional 40 percent effective Jan. 1, 2022, bringing the list price down to 2008 levels.
- The company issued its first sustainability bond, for 600.0 million euros in aggregate principal amount. The bond proceeds will be allocated toward environmental projects including pollution prevention, energy efficiency and renewable energy; as well as social projects to increase access to essential services and socioeconomic advancement and empowerment.
- The company and Lycia Therapeutics, Inc. announced a multi-year research collaboration and licensing agreement focused on the discovery, development and commercialization of novel targeted therapeutics using Lycia's proprietary lysosomal targeting chimera protein degradation technology.
Third-Quarter Reported Results
In the third quarter of 2021, worldwide revenue was
Revenue in the U.S. increased 26 percent, to
Revenue outside the U.S. increased 8 percent, to
Gross margin increased 21 percent, to
Total operating expenses in the third quarter of 2021, defined as the sum of research and development and marketing, selling, and administrative expenses, increased 8 percent to
In the third quarter of 2021, the company recognized acquired in-process research and development charges of
There were no asset impairment, restructuring and other special charges recognized in the third quarter of 2021. In the third quarter of 2020, the company recognized asset impairment, restructuring and other special charges of
Operating income in the third quarter of 2021 was
Other income (expense) was expense of
The effective tax rate was 10.9 percent in the third quarter of 2021, compared with 15.9 percent in the third quarter of 2020. The lower effective tax rate in the third quarter of 2021 compared to the same period in 2020 was primarily due to the income tax impact of the charge related to repurchase of higher-cost debt and the unfavorable mark-to-market adjustments on investments in equity securities, partially offset by a lower net discrete tax benefit compared to the same period in 2020.
In the third quarter of 2021, net income and EPS were
Third-Quarter Non-GAAP Measures
On a non-GAAP basis, third-quarter 2021 gross margin increased 18 percent, to
Operating income on a non-GAAP basis increased
Other income (expense) was expense of
The effective tax rate on a non-GAAP basis was 14.3 percent in the third quarter of 2021, compared with 15.0 percent in the third quarter of 2020. The lower effective tax rate in the third quarter of 2021 was driven by a mix of earnings in lower tax jurisdictions partially offset by a decrease in net discrete tax benefits compared to the same period in 2020.
On a non-GAAP basis, in the third quarter of 2021 net income increased 37 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.
Third Quarter | ||||||||
2021 | 2020 | % Change | ||||||
Earnings per share (reported) | $ | 1.22 | $ | 1.33 | (8)% | |||
Charge related to repurchase of higher-cost debt | .35 | — | ||||||
Net losses (gains) on investments in equity securities | .19 | (.13) | ||||||
Acquired in-process research and development | .16 | — | ||||||
Amortization of intangible assets | .12 | .11 | ||||||
Asset impairment, restructuring and other special charges | — | .11 | ||||||
Partial reversal of COVID-19 antibodies inventory charge | (.11) | — | ||||||
Earnings per share (non-GAAP) | $ | 1.94 | $ | 1.41 | ||||
Numbers may not add due to rounding. | ||||||||
Year-to-Date Reported Results
For the first nine months of 2021, worldwide revenue increased 19 percent to
Year-to-Date Non-GAAP Measures
For the first nine months of 2021, operating income was
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.
Year-to-Date | ||||||||
2021 | 2020 | % Change | ||||||
Earnings per share (reported) | $ | 4.23 | $ | 4.47 | (5)% | |||
Acquired in-process research and development | .45 | .30 | ||||||
Charge related to repurchase of higher-cost debt | .35 | — | ||||||
Amortization of intangible assets | .34 | .25 | ||||||
COVID-19 antibodies inventory charges | .33 | — | ||||||
Asset impairment, restructuring and other special charges | .19 | .17 | ||||||
Net gains on investments in equity securities | (.22) | (.71) | ||||||
Earnings per share (non-GAAP) | $ | 5.67 | $ | 4.48 | ||||
Numbers may not add due to rounding. |
Selected Revenue Highlights
Selected Revenue Highlights | ||||||||||||||||||||
(Dollars in millions) | Third Quarter | Year-to-Date | ||||||||||||||||||
Selected Products | 2021 | 2020 | % Change | 2021 | 2020 | % Change | ||||||||||||||
Trulicity | $ | 1,600.1 | $ | 1,106.6 | $ | 4,588.2 | $ | 3,565.7 | ||||||||||||
Humalog®(a) | 626.7 | 656.9 | (5)% | 1,851.3 | 1,907.8 | (3)% | ||||||||||||||
Alimta | 457.0 | 578.0 | (21)% | 1,626.6 | 1,677.2 | (3)% | ||||||||||||||
Taltz | 593.1 | 454.5 | 1,565.4 | 1,293.2 | ||||||||||||||||
COVID-19 antibodies(b) | 217.1 | — | NM | 1,176.2 | — | NM | ||||||||||||||
Jardiance(c) | 390.4 | 310.8 | 1,058.9 | 840.3 | ||||||||||||||||
Verzenio | 335.5 | 234.4 | 945.8 | 631.1 | ||||||||||||||||
Humulin® | 286.7 | 305.9 | (6)% | 923.8 | 935.2 | (1)% | ||||||||||||||
Olumiant(d) | 406.9 | 162.0 | NM | 809.1 | 446.7 | |||||||||||||||
Cyramza | 253.4 | 252.7 | 762.5 | 748.4 | ||||||||||||||||
Basaglar® | 192.8 | 248.2 | (22)% | 650.1 | 842.3 | (23)% | ||||||||||||||
Forteo® | 200.9 | 266.9 | (25)% | 617.8 | 791.9 | (22)% | ||||||||||||||
Emgality | 140.0 | 91.5 | 415.7 | 252.9 | ||||||||||||||||
Tyvyt | 125.6 | 84.4 | 340.2 | 205.9 | ||||||||||||||||
Retevmo | 33.6 | 11.6 | NM | 76.1 | 17.9 | NM | ||||||||||||||
Total Revenue | 6,772.8 | 5,740.6 | 20,318.5 | 17,099.8 | ||||||||||||||||
(a) Humalog includes Insulin Lispro (b) COVID-19 antibodies include sales for bamlanivimab administered alone as well as sales for bamlanivimab and etesevimab administered (c) Jardiance includes Glyxambi®, Synjardy®, and Trijardy® XR (d) Olumiant includes sales of baricitinib that were made pursuant to EUA NM – not meaningful |
Trulicity
Third-quarter 2021 worldwide Trulicity revenue was
Humalog
For the third quarter of 2021, worldwide Humalog revenue decreased 5 percent compared with the third quarter of 2020, to
Alimta
For the third quarter of 2021, worldwide Alimta revenue decreased 21 percent compared with the third quarter of 2020, to
The company expects continued volume decline for Alimta as a result of the entry of generic competition due to the loss of patent exclusivity in Japan and major European markets. The company expects generic entrants in the U.S. beginning in the first quarter of 2022.
Taltz
For the third quarter of 2021, worldwide Taltz revenue increased 30 percent compared with the third quarter of 2020, to
Jardiance
The company's worldwide Jardiance revenue during the third quarter of 2021 was
Verzenio
For the third quarter of 2021, worldwide Verzenio revenue increased 43 percent compared with the third quarter of 2020, to
Humulin
For the third quarter of 2021, worldwide Humulin revenue decreased 6 percent compared with the third quarter of 2020, to
Olumiant
For the third quarter of 2021, worldwide Olumiant revenue was
Cyramza
For the third quarter of 2021, worldwide Cyramza revenue remained essentially flat compared with the third quarter of 2020, at
Basaglar
For the third quarter of 2021, worldwide Basaglar revenue was
Forteo
For the third quarter of 2021, worldwide Forteo revenue decreased 25 percent compared with the third quarter of 2020, to
The company expects further volume declines for Forteo as a result of the entry of generic and biosimilar competition due to the loss of patent exclusivity in the U.S., Japan and major European markets.
Emgality
For the third quarter of 2021, Emgality generated worldwide revenue of
Tyvyt
For the third quarter of 2021, the company's Tyvyt revenue in China was
Tyvyt is part of the company's alliance with Innovent. 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.
Retevmo
For the third quarter of 2021, Retevmo generated U.S. revenue of
2021 Financial Guidance
The company has updated certain elements of its 2021 financial guidance on both a reported and non-GAAP basis. Earnings per share for 2021 are now expected to be in the range of
2021 Expectations | % Change vs | |
Earnings per share (reported) | (6)% to (5)% | |
Amortization of intangible assets | .47 | |
Acquired IPR&D(a) | .45 | |
Charge related to repurchase of higher-cost debt | .35 | |
COVID-19 antibodies inventory charges | .33 | |
Asset impairment, restructuring and other special charges | .19 | |
Net gains on investments in equity securities | (.22) | |
Earnings per share (non-GAAP) | ||
Numbers may not add due to rounding (a) includes costs related to business development transactions with |
The company now anticipates 2021 revenue to be between
Other income (expense) for 2021 is now expected to be expense in the range of
The 2021 effective tax rate is now expected to be approximately 11 percent on a reported basis, reflecting primarily the tax impacts of the charges related to repurchase of higher-cost debt and acquired IPR&D, as well as unfavorable mark-to-market adjustments on investments in equity securities in the third quarter of 2021. The 2021 effective tax rate is still expected to be approximately 13 percent on a non-GAAP basis.
The following table summarizes the company's 2021 financial guidance:
2021 Guidance | |||
Prior | Updated | ||
Revenue | |||
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) (reported) | |||
Other Income/(Expense) (non-GAAP) | Unchanged | ||
Tax Rate (reported) | Approx. | Approx. | |
Tax Rate (non-GAAP) | Approx. | Unchanged | |
Earnings per Share (reported) | |||
Earnings per Share (non-GAAP) | |||
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 third-quarter 2021 financial results conference call through a link on Lilly's website at www.lilly.com. The conference call will begin at 9 a.m. Eastern time 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. 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 impact of the evolving COVID-19 pandemic and the global response thereto; uncertainties related to the company's efforts to develop potential treatments for COVID-19; 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 of acquisitions and business development transactions and related integration 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 IT systems, networks, and facilities, or those of third parties with whom the company shares its data; 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 or disruptions, including as a result of regulatory actions related to our facilities; reliance on third-party relationships and outsourcing arrangements; regulatory changes or other developments; regulatory actions regarding currently marketed 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; the impact of global macroeconomic conditions and trade disruptions or disputes; changes in accounting and reporting standards promulgated by the Financial Accounting Standards Board and the Securities and Exchange Commission (SEC); and regulatory compliance problems or government investigations. 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)
Basaglar® (insulin glargine injection, Lilly)
Braftovi® (encorafenib, Pfizer)
Cialis® (tadalafil, Lilly)
Cyramza® (ramucirumab, Lilly)
Emgality® (galcanezumab-gnlm, Lilly)
Erbitux(R) (cetuximab, 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)
Olumiant® (baricitinib, Lilly)
QBREXZA® (glycopyrronium cloth, Dermira)
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, Lilly)
Verzenio® (abemaciclib, Lilly)
Third party trademarks used herein are trademarks of their respective owners.
Eli Lilly and Company Employment Information | ||||
September 30, 2021 | December 31, 2020 | |||
Worldwide Employees | 34,914 | 34,960 |
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, | ||||||||||||||||
2021 | 2020 | % Chg. | 2021 | 2020 | % Chg. | ||||||||||||
Revenue | $ | 6,772.8 | $ | 5,740.6 | $ | 20,318.5 | $ | 17,099.8 | |||||||||
Cost of sales | 1,430.8 | 1,326.4 | 5,262.6 | 3,763.5 | |||||||||||||
Research and development | 1,708.9 | 1,465.4 | 5,066.5 | 4,247.7 | |||||||||||||
Marketing, selling and administrative | 1,577.9 | 1,569.1 | 4,839.6 | 4,567.3 | |||||||||||||
Acquired in-process research and development | 174.0 | — | NM | 498.3 | 294.1 | ||||||||||||
Asset impairment, restructuring and other special charges | — | 101.4 | (100)% | 211.6 | 161.3 | ||||||||||||
Operating income | 1,881.2 | 1,278.3 | 4,439.9 | 4,065.9 | |||||||||||||
Net interest income (expense) | (76.6) | (83.8) | (240.4) | (243.2) | |||||||||||||
Net other income (expense) | (559.3) | 242.7 | 116.1 | 938.1 | |||||||||||||
Other income (expense) | (635.9) | 158.9 | NM | (124.3) | 694.9 | NM | |||||||||||
Income before income taxes | 1,245.3 | 1,437.2 | (13)% | 4,315.6 | 4,760.8 | (9)% | |||||||||||
Income tax expense | 135.2 | 228.8 | (41)% | 460.0 | 683.9 | (33)% | |||||||||||
Net income | $ | 1,110.1 | $ | 1,208.4 | (8)% | $ | 3,855.6 | $ | 4,076.9 | (5)% | |||||||
Earnings per share - diluted | $ | 1.22 | $ | 1.33 | (8)% | $ | 4.23 | $ | 4.47 | (5)% | |||||||
Dividends paid per share | $ | .85 | .74 | $ | 2.55 | $ | 2.22 | ||||||||||
Weighted-average shares outstanding (thousands) | 910,751 | 911,423 | 911,656 | 911,868 |
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, 2021 | Three Months Ended September 30, 2020 | |||||||||||||||||
GAAP | Adjustments(b) | Non-GAAP | GAAP | Adjustments(c) | Non-GAAP | |||||||||||||
Cost of sales | $ | 1,430.8 |
$ | (9.0) | $ | 1,421.8 | $ | 1,326.4 |
$ | (126.5) | $ | 1,199.9 | ||||||
Acquired in-process | 174.0 | (174.0) | — | — | — | — | ||||||||||||
Asset impairment, | — | — | — | 101.4 | (101.4) | — | ||||||||||||
Other income (expense) | (635.9) | 628.6 | (7.3) | 158.9 | (149.0) | 9.9 | ||||||||||||
Income tax expense | 135.2 | 158.0 | 293.2 | 228.8 | (1.9) | 226.9 | ||||||||||||
Net income | 1,110.1 | 653.6 | 1,763.7 | 1,208.4 | 80.8 | 1,289.2 | ||||||||||||
Earnings per share - | 1.22 | 0.72 | 1.94 | 1.33 | 0.09 | 1.41 | ||||||||||||
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 September 30, 2021, include the following: |
(Dollars in millions, except per | Amortization(i) | IPR&D(ii) | Equity | Repurchase of | Other specified | Total | ||||||||||||
Cost of sales | $ | (137.1) | $ | — | $ | — | $ | — | $ | 128.1 | $ | (9.0) | ||||||
Acquired in-process research and | — | (174.0) | — | — | — | (174.0) | ||||||||||||
Other income (expense) | — | — | 223.4 | 405.2 | — | 628.6 | ||||||||||||
Income tax expense | 28.8 | 24.5 | 46.5 | 85.1 | (26.9) | 158.0 | ||||||||||||
Net income | 108.3 | 149.5 | 176.9 | 320.1 | (101.2) | 653.6 | ||||||||||||
Earnings per share - diluted | 0.12 | 0.16 | 0.19 | 0.35 | (0.11) | 0.72 |
Numbers may not add due to rounding.
The table above reflects only line items with non-GAAP adjustments.
- Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties.
- 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 Protomer Technologies Inc., Kumquat Biosciences Inc., Lycia Therapeutics, Inc., and ProQR Therapeutics N.V.
- Exclude gains and losses on investments in equity securities.
- Exclude charge related to the repurchase of higher-cost debt.
- Exclude partial reversal of COVID-19 antibodies inventory charge.
(c) | Adjustments to certain GAAP reported measures for the three months ended September 30, 2020, include the following: |
(Dollars in millions, except per share data) | Amortization (i) | Equity | Other | Total | ||||||||
Cost of sales | $ | (126.5) | $ | — | $ | — | $ | (126.5) | ||||
Asset impairment, restructuring and other | — | — | (101.4) | (101.4) | ||||||||
Other income (expense) | — | (149.0) | — | (149.0) | ||||||||
Income tax expense | 26.3 | (31.3) | 3.1 | (1.9) | ||||||||
Net income | 100.2 | (117.7) | 98.3 | 80.8 | ||||||||
Earnings per share - diluted | 0.11 | (0.13) | 0.11 | 0.09 |
Numbers may not add due to rounding.
The table above reflects only line items with non-GAAP adjustments.
- Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties.
- Exclude gains and losses on investments in equity securities.
- Exclude primarily severance costs incurred related to restructuring.
Eli Lilly and Company | ||||||||||||||||||
Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) | ||||||||||||||||||
(Dollars in millions, except per share data) | ||||||||||||||||||
Nine Months Ended September 30, 2021 | Nine Months Ended September 30, 2020 | |||||||||||||||||
GAAP | Adjustments(b) | Non-GAAP | GAAP | Adjustments(c) | Non-GAAP | |||||||||||||
Cost of sales | $ | 5,262.6 | $ | (771.4) | $ | 4,491.2 | $ | 3,763.5 | $ | (287.9) | $ | 3,475.6 | ||||||
Acquired in-process | 498.3 | (498.3) | — | 294.1 | (294.1) | — | ||||||||||||
Asset impairment, | 211.6 | (211.6) | — | 161.3 | (161.3) | — | ||||||||||||
Other income (expense) | (124.3) | 156.6 | 32.3 | 694.9 | (814.7) | (119.8) | ||||||||||||
Income tax expense | 460.0 | 324.6 | 784.6 | 683.9 | (77.8) | 606.1 | ||||||||||||
Net income | 3,855.6 | 1,313.3 | 5,168.9 | 4,076.9 | 6.4 | 4,083.3 | ||||||||||||
Earnings per share - | 4.23 | 1.44 | 5.67 | 4.47 | 0.01 | 4.48 |
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 nine months ended September 30, 2021, include the following: |
(Dollars in millions, | Amortization(i) | IPR&D(ii) | Equity | Repurchase of | Other | Total | ||||||||||||
Cost of sales | $ | (395.0) | $ | — | $ | — | $ | — | $ | (376.4) | $ | (771.4) | ||||||
Acquired in-process | — | (498.3) | — | — | — | (498.3) | ||||||||||||
Asset impairment, | — | — | — | — | (211.6) | (211.6) | ||||||||||||
Other income (expense) | — | — | (248.5) | 405.2 | — | 156.6 | ||||||||||||
Income tax expense | 81.8 | 92.6 | (48.9) | 85.1 | 114.0 | 324.6 | ||||||||||||
Net income | 313.2 | 405.7 | (199.6) | 320.1 | 474.0 | 1,313.3 | ||||||||||||
Earnings per share – | 0.34 | 0.45 | (0.22) | 0.35 | 0.52 | 1.44 |
Numbers may not add due to rounding.
The table above reflects only line items with non-GAAP adjustments.
- Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties.
- 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 Rigel Pharmaceuticals, Inc., Precision Biosciences, Inc., Protomer Technologies Inc., Kumquat Biosciences Inc., Merus N.V., Lycia Therapeutics, Inc., ProQR Therapeutics N.V, MiNA Therapeutics Limited and Asahi Kasei Pharma Corporation.
- Exclude gains and losses on investments in equity securities.
- Excludes charge related to the repurchase of higher-cost debt.
- Excludes primarily the net inventory charge related to COVID-19 antibodies, an intangible asset impairment resulting from the sale of the rights to QBREXZA, and acquisition and integration costs recognized as part of the closing of the acquisition of Prevail Therapeutics Inc.
(c) | Adjustments to certain GAAP reported measures for the nine months ended September 30, 2020, include the following: |
(Dollars in millions, except per share | Amortization(i) | IPR&D(ii) | Equity | Other specified | Total | ||||||||||
Cost of sales | $ | (283.7) | $ | — | $ | — | $ | (4.2) | $ | (287.9) | |||||
Acquired in-process research and | — | (294.1) | — | — | (294.1) | ||||||||||
Asset impairment, restructuring and | — | — | — | (161.3) | (161.3) | ||||||||||
Other income (expense) | — | — | (814.7) | — | (814.7) | ||||||||||
Income tax expense | 58.9 | 25.0 | (171.1) | 9.4 | (77.8) | ||||||||||
Net income | 224.8 | 269.1 | (643.6) | 156.1 | 6.4 | ||||||||||
Earnings per share - diluted | 0.25 | 0.30 | (0.71) | 0.17 | 0.01 |
Numbers may not add due to rounding.
The table above reflects only line items with non-GAAP adjustments.
- Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties.
- 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 both a business development transaction with a pre-clinical stage company as well as business development transactions with Sitryx Therapeutics Limited, AbCellera Biologics Inc., Evox Therapeutics Limited, and Junshi Biosciences Co., Ltd.
- Exclude gains and losses on investments in equity securities.
- Exclude primarily severance costs incurred related to restructuring, as well as acquisition and integration costs as part of the closing of the acquisition of Dermira, Inc.
Refer to: | Molly McCully; mccully_molly@lilly.com; (317) 478-5423 (Media) |
Jordan Bishop; bishop_jordan@lilly.com; (317) 473-5712 (Media) | |
Kevin Hern; hern_kevin_r@lilly.com; (317) 277-1838 (Investors) |
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SOURCE Eli Lilly and Company