Lilly Reports Strong Fourth-Quarter and Full-Year 2020 Financial Results Eli Lilly and Company (NYSE: LLY) today announced financial results for the fourth quarter and full year of 2020. $ in millions, except per share...

INDIANAPOLIS , Jan. 29, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) today announced financial results for the fourth quarter and full year of 2020.

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

Business Development/Other Developments

Fourth-Quarter Reported Results

In the fourth quarter of 2020, worldwide revenue was $7.440 billion , an increase of 22 percent compared with the fourth quarter of 2019, driven by a 24 percent increase in volume and a 1 percent increase due to the favorable impact of foreign exchange rates, partially offset by a 4 percent decrease due to lower realized prices. The company recognized worldwide revenue of $871.2 million in the fourth quarter of 2020 for bamlanivimab, its COVID-19 antibody therapy. Excluding bamlanivimab revenue, worldwide revenue grew by 7 percent. Key growth products launched since 2014, consisting of Trulicity ® , Verzenio ® , Taltz ® , Tyvyt ® , Olumiant ® , Jardiance, Emgality ® , Cyramza ® , Retevmo ™ , Baqsimi ™ and Basaglar ® contributed nearly 12 percentage points of revenue growth and represented approximately 48 percent of total revenue for the quarter, or 55 percent of total revenue excluding bamlanivimab.

Revenue in the U.S. increased 31 percent, to $4.598 billion , driven by a 36 percent increase in volume, partially offset by a 5 percent decrease due to lower realized prices. The company recognized U.S. revenue of $850.0 million in the fourth quarter of 2020 for bamlanivimab. Excluding bamlanivimab revenue, revenue in the U.S. grew by 7 percent. Increased U.S. volume for key growth products, including Trulicity, Taltz, Verzenio, Emgality, Retevmo, Cyramza, Olumiant, Jardiance and Baqsimi, was partially offset by lower volume for certain other products, including Forteo ® and Tradjenta ® . Inventory stocking in the fourth quarter of 2020 was approximately $120 million higher than in the fourth quarter of 2019 due to lower than typical year-end stocking in 2019. The decrease in realized prices in the U.S. in the fourth quarter of 2020 was primarily driven by increased rebates to gain and maintain broad commercial access across the portfolio, partially offset by modest list price increases, largely for diabetes, and, to a lesser extent, by changes to estimates for rebates and discounts, most notably for Taltz. Segment mix was not a major driver of U.S. price performance in the fourth quarter of 2020, as increased utilization in more highly-rebated government segments was offset by lower utilization in the 340B segment, primarily for Trulicity and Humalog.

Revenue outside the U.S. increased 10 percent, to $2.842 billion , driven by a 9 percent increase in volume and a 3 percent increase due to the favorable impact of foreign exchange rates, partially offset by a 2 percent decrease due to lower realized prices. The increase in volume outside the U.S. was driven primarily by increased volume for key growth products, including Tyvyt, Trulicity, Olumiant, Taltz, Verzenio, Jardiance, Cyramza, Basaglar, Emgality and Baqsimi, as well as volume gains for Alimta ® , partially offset by decreased volume for Cialis ® , Forteo and Trajenta. In addition, revenue outside the U.S. in the fourth quarter of 2019 benefited from a milestone from Bayer Consumer Care AG resulting from its exclusive development and commercialization license for Vitrakvi ® . The decrease in realized prices outside the U.S. was driven primarily by the inclusion of Tyvyt in the government reimbursement programs in China .

Gross margin increased 18 percent, to $5.720 billion , in the fourth quarter of 2020 compared with the fourth quarter of 2019. Gross margin as a percent of revenue was 76.9 percent, a decrease of 2.1 percentage points compared with the fourth quarter of 2019. The decrease in gross margin percent was primarily due to unfavorable product mix driven by bamlanivimab sales, higher amortization of intangibles expense related to Retevmo, the unfavorable effect of foreign exchange rates on international inventories sold, and the impact of lower realized prices on revenue, partially offset by greater manufacturing efficiencies.

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 $3.392 billion compared with the fourth quarter of 2019. Research and development expenses increased 16 percent to $1.838 billion , or 24.7 percent of revenue, driven primarily by approximately $265 million of development expenses for COVID-19 antibody therapies and baricitinib. Excluding these COVID-19 expenses, research and development expenses remained flat. Marketing, selling, and administrative expenses decreased 8 percent to $1.554 billion , primarily due to lower marketing expenses, reflecting reduced promotional activity.

In the fourth quarter of 2020, the company recognized acquired in-process research and development charges of $366.3 million related to the previously-announced business development transactions with Innovent Biologics, Inc., Disarm Therapeutics, Inc., and Fochon Pharmaceuticals, Ltd. There were no acquired in-process research and development charges in the fourth quarter of 2019.

Operating income in the fourth quarter of 2020 was $1.992 billion , compared to $1.400 billion in the fourth quarter of 2019. The increase in operating income was primarily driven by higher gross margin, lower asset impairment, restructuring and other special charges, and lower marketing expenses, partially offset by higher acquired in-process research and development charges and higher research and development expenses. Operating margin, defined as operating income as a percent of revenue, was 26.8 percent.

Other income was $477.0 million in the fourth quarter of 2020, compared with other income of $262.9 million in the fourth quarter of 2019. The increase in other income was driven primarily by higher net gains on investment securities.

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 $2 .117 billion and $2.32 , respectively, compared with net income of $1 .496 billion and earnings per share of $1.64 in the fourth quarter of 2019. The increase in net income and earnings per share in the fourth quarter of 2020 was primarily driven by higher operating income and higher other income, partially offset by higher income tax expense.

Fourth-Quarter Non-GAAP Measures

On a non-GAAP basis, fourth-quarter 2020 gross margin increased 20 percent, to $5.848 billion compared with the fourth quarter of 2019. Gross margin as a percent of revenue was 78.6 percent, a decrease of 1.3 percentage points. The decrease in gross margin percent was primarily due to unfavorable product mix driven by bamlanivimab sales, the unfavorable effect of foreign exchange rates on international inventories sold, and the impact of lower realized prices on revenue, partially offset by greater manufacturing efficiencies.

Operating income on a non-GAAP basis increased $850.5 million , or 53 percent, to $2.456 billion in the fourth quarter of 2020 compared with the fourth quarter of 2019, due primarily to higher gross margin and lower marketing expenses, partially offset by higher research and development expenses. Operating margin was 33.0 percent on a non-GAAP basis.

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 $2.509 billion , while earnings per share increased 59 percent, to $2.75 , compared with $1.583 billion and $1.73 , respectively, in the fourth quarter of 2019. The increase in net income and earnings per share was driven primarily by higher operating income and higher other income, partially offset by higher income tax expense.

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 Reported Results

For the full year 2020, worldwide revenue increased 10 percent to $24.540 billion , compared with $22.319 billion in the same period in 2019. The increase in revenue was driven by a 15 percent increase in volume, partially offset by a 5 percent decrease due to lower realized prices. Excluding bamlanivimab revenue, worldwide revenue grew by 6 percent.

Revenue in the U.S. in 2020 increased 12 percent to $14.229 billion , driven by increased volume for key growth products, including Trulicity, Taltz, Emgality, Verzenio, Jardiance, Cyramza, Baqsimi, Retevmo, Olumiant and Basaglar, as well as the inclusion of revenue for bamlanivimab. Excluding bamlanivimab revenue, U.S. revenue grew 5 percent. The increase in revenue due to volume was partially offset by a decrease in realized prices, as well as lower revenue for Cialis, Tradjenta and Forteo. The decrease in realized prices in the U.S. was primarily driven by increased rebates to gain and maintain broad commercial access across the portfolio and, to a lesser extent, unfavorable segment mix and changes to estimates for rebates and discounts, most notably impacting Humalog. The decrease in realized prices in the U.S. was partially offset by modest list price increases and lower utilization in the 340B segment.

Revenue outside the U.S. in 2020 increased 7 percent to $10.310 billion , due to increased volume for key growth products, including Tyvyt, Trulicity, Olumiant, Verzenio, Taltz, Jardiance, Cyramza, Basaglar, Emgality and Baqsimi, partially offset by decreased volume for Forteo and Trajenta. Volume growth outside the U.S. for Tyvyt and Alimta benefited from inclusion in government reimbursement programs in China . Volume growth outside the U.S. was partially offset by a 6 percent decrease due to lower realized prices, driven primarily by the inclusion of Tyvyt and Alimta in government reimbursement programs in China .

Gross margin increased 8 percent to $19.057 billion in 2020. Gross margin as a percent of revenue was 77.7%, a decrease of 1.1 percentage points compared with 2019. The decrease in gross margin percent was primarily due to the impact of lower realized prices on revenue, the unfavorable effect of foreign exchange rates on international inventories sold, and higher amortization of intangibles expense related to Retevmo, partially offset by prior year charges resulting from the suspension of promotion of Lartruvo and greater manufacturing efficiencies. Gross margin percent for 2020 was also negatively impacted as a result of bamlanivimab sales in the fourth quarter of 2020.

Total operating expenses, defined as the sum of research and development and marketing, selling, and administrative expenses, increased 3 percent to $12.207 billion in 2020. Research and development expenses increased 9 percent to $6.086 billion , or 25 percent of revenue, driven primarily by approximately $450 million of development expenses for COVID-19 antibody therapies and baricitinib. Excluding these COVID-19 expenses, research and development expenses were relatively flat. Marketing, selling and administrative expenses decreased 1 percent to $6 .121 billion, primarily due to lower marketing activity.

In 2020, the company recognized acquired in-process research and development charges of $660.4 million resulting from the acquisition of a pre-clinical stage company as well as the previously announced business development transactions with Innovent Biologics, Inc., Disarm Therapeutics Inc., Sitryx Therapeutics Limited, Fochon Pharmaceuticals, Ltd., AbCellera Biologics Inc., Evox Therapeutics Ltd, and Shanghai Junshi Biosciences Co. Ltd. In 2019, the company recognized acquired in-process research and development charges of $239.6 million resulting from business development transactions with AC Immune SA, Centrexion Therapeutics Corporation, ImmuNext, Inc., and Avidity Biosciences, Inc.

In 2020, the company recognized asset impairment, restructuring and other special charges of $131.2 million . The charges were primarily related to severance costs incurred as a result of actions taken worldwide to reduce our cost structure, as well as acquisition and integration costs incurred as part of the acquisition of Dermira, Inc. In 2019, the company recognized asset impairment, restructuring and other special charges of $575.6 million . The charges were primarily associated with the accelerated vesting of Loxo Oncology employee equity awards as part of the acquisition of Loxo Oncology.

Operating income in 2020 increased 22 percent compared with 2019 to $6.058 billion , driven primarily by higher gross margin, lower asset impairment, restructuring and other special charges, and lower marketing expenses, partially offset by higher research and development expenses and higher acquired in-process research and development charges. Operating margin in 2020 was 24.7 percent.

Other income was $1.172 billion in 2020 compared with $291.6 million in 2019. The increase in other income was driven primarily by higher net gains on investment securities.

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 $6.194 billion and $6.79 , respectively, compared with $8.318 billion and $8.89 , respectively, in 2019. The decrease in net income and earnings per share during 2020 were driven primarily by the approximate $3.7 billion gain recognized on the disposition of Elanco in 2019, partially offset by higher operating income and higher other income in 2020.

Full Year Non-GAAP Measures

On a non-GAAP basis for the full year 2020, gross margin increased 9 percent, to $19.472 billion compared with the full year 2019. Gross margin as a percent of revenue for the full year 2020 was 79.3 percent, compared to 80.1 percent for the full year 2019. The decrease in gross margin percent was primarily due to the impact of lower realized prices on revenue and the unfavorable effect of foreign exchange rates on international inventories sold, partially offset by greater manufacturing efficiencies. Gross margin percent for 2020 was also negatively impacted as a result of bamlanivimab sales in the fourth quarter of 2020.

Operating income on a non-GAAP basis increased $1.186 billion , or 20 percent, to $7.265 billion driven by higher gross margin and lower marketing expenses, partially offset by higher research and development expenses. Operating margin was 29.6 percent, which was negatively affected by approximately 60 basis points due to the unfavorable financial impact of COVID-19 therapies.

Other income on a non-GAAP basis was $1.172 billion for the full year 2020, compared with $234.3 million for the full year 2019. The increase in other income was driven primarily by higher net gains on investment securities.

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 $7.236 billion , and $7.93 , respectively. The increase in net income and earnings per share was primarily driven by higher operating income and higher other income, partially offset by higher income tax expense.

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.

Selected Revenue Highlights

Fourth-quarter 2020 worldwide Trulicity revenue was $1.502 billion , an increase of 24 percent compared with the fourth quarter of 2019. U.S. revenue increased 23 percent, to $1.163 billion , driven by increased demand, partially offset by lower realized prices. Trulicity's lower realized prices in the U.S. were primarily due to higher contracted rebates, partially offset by a favorable segment mix that reflected lower utilization in the 340B segment, and modest list price increases. Revenue outside the U.S. was $339.7 million , an increase of 28 percent, driven by increased volume and, to a lesser extent, favorable foreign exchange rates.

For the full year 2020, worldwide Trulicity revenue was $5.068 billion , an increase of 23 percent compared with the full year 2019. U.S. revenue increased 22 percent, to $3.836 billion , driven by increased volume, partially offset by lower realized prices, primarily due to higher contracted rebates. Revenue outside of the U.S. increased 27 percent, to $1.232 billion , driven primarily by increased volume.

For the fourth quarter of 2020, worldwide Humalog revenue decreased 6 percent compared with the fourth quarter of 2019, to $718.1 million . Revenue in the U.S. decreased 11 percent, to $415.2 million , driven by lower realized prices, as changes to estimates for rebates and discounts were partially offset by lower utilization in the 340B segment. Lower realized prices in the U.S. were partially offset by higher demand. Revenue outside the U.S. increased 3 percent, to $302.9 million , driven by favorable foreign exchange rates and higher realized prices.

For the full year 2020, worldwide Humalog revenue decreased 7 percent to $2.626 billion compared with the full year 2019. U.S. revenue for 2020 was $1.486 billion , an 11 percent decrease, driven by lower realized prices, partially offset by higher demand. Revenue outside the U.S. was $1.140 billion , a 1 percent decrease, primarily driven by unfavorable foreign exchange rates.

For the fourth quarter of 2020, worldwide Alimta revenue increased 23 percent compared with the fourth quarter of 2019, to $652.7 million . U.S. revenue increased 6 percent, to $331 .8 million, primarily driven by higher realized prices. Revenue outside the U.S. increased 48 percent to $320.9 million , primarily driven by increased volume in Germany and, to a lesser extent, the favorable impact of foreign exchange rates and higher realized prices.

For the full year 2020, worldwide Alimta revenue increased 10 percent to $2.330 billion compared with the full year 2019. U.S. revenue for 2020 was $1.265 billion , a 4 percent increase, primarily driven by higher realized prices. Revenue outside the U.S. was $1.065 billion , a 19 percent increase, primarily driven by increased volume in China and Germany , partially offset by lower realized prices.

For the fourth quarter of 2020, worldwide Taltz revenue increased 18 percent compared with the fourth quarter of 2019, to $495 .3 million. U.S. revenue increased 9 percent, to $345 .7 million, primarily driven by increased demand, partially offset by lower realized prices. Revenue outside the U.S. increased 46 percent, to $149.7 million , primarily driven by increased volume and, to a lesser extent, the favorable impact of foreign exchange rates.

For the full year 2020, Taltz generated worldwide revenue of $1.788 billion , an increase of 31 percent compared with the full year 2019. U.S. revenue was $1.289 billion , an increase of 27 percent, primarily driven by increased demand. Revenue outside the U.S. was $500.0 million , an increase of 43 percent, primarily driven by increased volume.

For the fourth quarter of 2020, worldwide Humulin revenue decreased 7 percent compared with the fourth quarter of 2019, to $324.4 million . U.S. revenue decreased 7 percent, to $223.9 million , driven by lower realized prices, partially offset by increased volume. Revenue outside the U.S. decreased 7 percent, to $100.5 million , primarily due to decreased volume.

For the full year 2020, worldwide Humulin revenue was $1.260 billion , a decrease of 2 percent compared with the full year 2019. U.S. revenue was $866.4 million , a 2 percent decrease, driven by lower realized prices, partially offset by higher volume. Revenue outside the U.S. was $393.2 million , a 4 percent decrease, driven by decreased volume and the unfavorable impact of foreign exchange rates, partially offset by higher realized prices.

The company's worldwide Jardiance revenue during the fourth quarter of 2020 was $313.6 million , an increase of 17 percent compared with the fourth quarter of 2019. U.S. revenue increased 7 percent, to $167.8 million , driven by increased demand. Revenue outside the U.S. was $145.7 million , an increase of 32 percent, driven by increased volume and, to a lesser extent, the favorable impact of foreign exchange rates. Jardiance is part of the company's alliance with Boehringer Ingelheim. Lilly reports as revenue royalties received on net sales of Jardiance and its portion of Jardiance's gross margin in 2020 and 2019, respectively.

For the full year 2020, worldwide Jardiance revenue was $1.154 billion , an increase of 22 percent compared with the full year 2019. U.S. revenue increased 10 percent, to $620.8 million , driven by increased volume. Revenue outside of the U.S. increased 41 percent, to $533.0 million , driven primarily by increased volume.

For the fourth quarter of 2020, worldwide Basaglar revenue was $282.1 million , a decrease of 8 percent compared with the fourth quarter of 2019. U.S. revenue decreased 16 percent, to $203.6 million , driven by lower realized prices and, to a lesser extent, decreased demand caused by competitive pressures. Revenue outside the U.S. increased 23 percent, to $78 .5 million, driven by increased volume. Basaglar is part of the company's alliance with Boehringer Ingelheim. Lilly reports as cost of sales payments made to Boehringer Ingelheim for royalties and for its portion of the gross margin in 2020 and 2019, respectively.

For the full year of 2020, Basaglar generated worldwide revenue of $1.124 billion , an increase of 1 percent compared with the full year 2019. U.S. revenue was $842.3 million , a decrease of 4 percent, driven by lower realized prices. Revenue outside of the U.S. was $282.1 million , an increase of 19 percent, driven primarily by increased volume.

For the fourth quarter of 2020, worldwide Forteo revenue decreased 29 percent compared with the fourth quarter of 2019, to $254.4 million . U.S. revenue decreased 28 percent, to $123.5 million , driven by decreased demand and, to a lesser extent, lower realized prices. Revenue outside the U.S. decreased 31 percent to $130 .8 million, primarily driven by decreased volume and, to a lesser extent, lower realized prices.

For the full year 2020, worldwide Forteo revenue decreased 26 percent to $1.046 billion compared with the full year 2019. U.S. revenue for 2020 was $510.3 million , a 21 percent decrease driven primarily by decreased demand. Revenue outside the U.S. was $536.0 million , a 29 percent decrease driven by decreased volume and, to a lesser extent, lower realized prices.

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.

For the fourth quarter of 2020, worldwide Cyramza revenue was $284 .2 million, an increase of 16 percent compared with the fourth quarter of 2019. U.S. revenue was $104 .2 million, an increase of 19 percent, primarily driven by increased demand and, to a lesser extent, higher realized prices. Revenue outside the U.S. was $180 .0 million, an increase of 15 percent, driven primarily by increased volume.

For the full year 2020, worldwide Cyramza revenue was $1.033 billion , an increase of 12 percent compared with the full year 2019. U.S. revenue increased 14 percent, to $381.9 million , driven primarily by increased demand and, to a lesser extent, higher realized prices. Revenue outside of the U.S. increased 10 percent, to $650.8 million , driven primarily by increased volume.

For the fourth quarter of 2020, worldwide Verzenio revenue increased 57 percent compared with the fourth quarter of 2019, to $281.6 million . U.S. revenue was $188.2 million , an increase of 43 percent, primarily driven by increased demand and, to a lesser extent, higher realized prices. Revenue outside the U.S. was $93.4 million , an increase of 95 percent, primarily driven by increased volume and, to a lesser extent, higher realized prices.

For the full year 2020, Verzenio generated worldwide revenue of $912.7 million , an increase of 57 percent compared with the full year 2019. U.S. revenue increased 36 percent compared with the full year 2019 to $618.2 million , driven by increased demand and, to a lesser extent, higher realized prices. Revenue outside of the U.S. was $294.4 million , an increase of $169.5 million driven by higher volume.

For the fourth quarter of 2020, Olumiant generated worldwide revenue of $192.2 million , an increase of 50 percent compared with the fourth quarter of 2019. U.S. revenue was $24.8 million . Revenue outside the U.S. was $167.4 million , an increase of 46 percent, primarily driven by increased volume.

For the full year 2020, Olumiant generated worldwide revenue of $638.9 million , an increase of 50 percent compared with the full year 2019. U.S. revenue was $63.8 million . Revenue outside the U.S. was $575.0 million , an increase of 49 percent, driven primarily by increased volume.

For the fourth quarter of 2020, Emgality generated worldwide revenue of $109.9 million , an increase of 66 percent compared with the fourth quarter of 2019. U.S. revenue was $96.6 million , an increase of 53 percent driven by increased demand and, to a lesser extent, higher realized prices. Revenue outside of the U.S. was $13.3 million in the fourth quarter of 2020.

For the full year of 2020, Emgality generated worldwide revenue of $362.9 million , an increase of $200.3 million compared with the full year 2019. U.S. revenue was $325.9 million , an increase of $171.0 million driven by increased demand and, to a lesser extent, higher realized prices. Revenue outside of the U.S. was $37.0 million .

The company's Tyvyt revenue in China during the fourth quarter of 2020 was $102.8 million , an increase of $18.3 million compared with the third quarter of 2020.

For the full year 2020, Tyvyt generated revenue in China of $308.7 million , an increase of $174.7 million compared to the full year 2019.

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.

For the fourth quarter of 2020, Baqsimi generated worldwide revenue of $23.8 million , an increase of $3.0 million compared with the third quarter of 2020. U.S revenue was $19.8 million , while revenue outside the U.S. was $4.1 million .

For the full year 2020, Baqsimi generated worldwide revenue of $76.1 million , an increase of $53.8 million compared with the full year 2019. U.S. revenue was $63.7 million . Revenue outside of the U.S. was $12.4 million .

For the fourth quarter of 2020, Retevmo generated U.S. revenue of $18.7 million . Retevmo was approved by the FDA and launched in the U.S. during the second quarter of 2020.

For the full year 2020, Retevmo generated U.S. revenue of $36.6 million .

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 $1.15 .