INDIANAPOLIS, April 27, 2021 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced financial results for the first
quarter of 2021.
|
|
|
|
|
$ in millions,
except per share data
|
First
Quarter
|
%
|
|
2021
|
|
2020
|
Change
|
Revenue
|
$
|
6,805.6
|
|
|
$
|
5,859.8
|
|
16%
|
Net Income –
Reported
|
1,355.3
|
|
|
1,456.5
|
|
(7)%
|
EPS –
Reported
|
1.49
|
|
|
1.60
|
|
(7)%
|
|
|
|
|
|
Net Income –
Non-GAAP
|
1,701.9
|
|
|
1,471.1
|
|
16%
|
EPS –
Non-GAAP
|
1.87
|
|
|
1.61
|
|
16%
|
|
|
|
|
|
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.
"In the first quarter of 2021, Lilly continued to advance our
core business and make strategic progress to drive future growth,
all while delivering hundreds of thousands of doses of our COVID-19
antibodies to patients and receiving new data for our monoclonal
antibody therapies and new authorizations around the world to help
fight the COVID-19 pandemic," said David A.
Ricks, Lilly's chairman and CEO. "Our key growth products
gained volume and share, helped millions of patients with
significant diseases, and represented over half of our core
business. We also had a remarkable quarter in R&D beyond our
COVID-19 efforts, reading out key late-stage successes with
mirikizumab in ulcerative colitis, donanemab in Alzheimer's,
tirzepatide in diabetes, and baricitinib in alopecia areata, while
early-stage research continued to deliver and advance exciting
clinical-stage molecules across our core therapeutic areas."
Key Events Over the Last Three Months
COVID-19
- The company took several steps in order to transition to supply
bamlanivimab and etesevimab for administration together in the U.S.
for the treatment of COVID-19.
-
- The U.S. Food and Drug Administration (FDA) granted Emergency
Use Authorization (EUA) for investigational bamlanivimab and
etesevimab together. This therapy is authorized for the treatment
of mild to moderate COVID-19 in patients aged 12 and older who are
at high risk for progressing to severe COVID-19 and/or
hospitalization. As part of its previously reported collaboration
with the company, Amgen began manufacturing etesevimab.
- In connection with this transition, the company requested the
FDA revoke the EUA for bamlanivimab alone. This request was not due
to any new safety concern. The FDA subsequently revoked the EUA for
bamlanivimab alone.
- The European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) issued a positive scientific opinion
for bamlanivimab alone and bamlanivimab administered together with
etesevimab.
- The U.S. government agreed to purchase a minimum of 100,000
doses of bamlanivimab and etesevimab together for a purchase price
of $210 million. This purchase
agreement was subsequently modified to enable the supply of
etesevimab to complement doses of bamlanivimab the U.S. government
already purchased. In addition, the purchase agreement with the
U.S. government for bamlanivimab alone was terminated, and orders
were cancelled for the remaining 350,856 doses that were scheduled
to be delivered by the end of March
2021.
- The company announced new data from the randomized,
double-blind, placebo-controlled BLAZE-1 Phase 3 study,
demonstrating bamlanivimab and etesevimab together reduced COVID-19
related hospitalizations and deaths by 87 percent in high-risk
patients recently diagnosed with COVID-19.
- The company, Vir Biotechnology, Inc. and GlaxoSmithKline plc
announced top-line data from the expanded Phase 2 trial studying
low-risk adult patients with mild to moderate COVID-19. Results
showed that investigational bamlanivimab co-administered with
VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70
percent relative reduction in persistently high viral load at day 7
compared to placebo, meeting the primary endpoint.
- The company and Incyte announced results of a Phase 3 study
evaluating baricitinib 4 mg once daily plus standard of care (SoC)
versus placebo plus SoC in patients hospitalized with COVID-19. The
trial did not meet statistical significance on the primary
endpoint, which was defined as a difference in the proportion of
participants progressing to the first occurrence of non-invasive
ventilation including high flow oxygen or invasive mechanical
ventilation including extracorporeal membrane oxygenation (ECMO) or
death by day 28. However, in the study, treatment with baricitinib
in addition to SoC resulted in a significant reduction in death
from any cause by 38 percent by day 28.
Regulatory
- The FDA extended the review period for the supplemental New
Drug Application (sNDA) for baricitinib for the treatment of adults
with moderate to severe atopic dermatitis. The FDA extended the
action date to allow time to review additional data analyses
submitted by Lilly in response to recent information requests from
the FDA. The Prescription Drug User Fee Act (PDUFA) action date has
been extended three months to early in the third quarter of
2021.
- The company and Pfizer Inc. announced the outcome of the FDA
Joint Arthritis Advisory Committee and Drug Safety and Risk
Management Advisory Committee on tanezumab. There was a single
voting question focused on whether the proposed risk evaluation and
mitigation strategy (REMS) for tanezumab will ensure its benefits
outweigh its risks, and the Committee voted 1 in favor and 19
against. The companies will continue to work with the FDA as the
agency continues its review of the tanezumab application.
Clinical
- The company announced that mirikizumab met the primary and all
key secondary endpoints in a Phase 3 induction study evaluating the
efficacy and safety of mirikizumab for the treatment of patients
with moderate to severe ulcerative colitis.
- The company announced that the development program for
mirikizumab will henceforth focus on the ulcerative colitis and
Crohn's disease indications. While the OASIS program generated
positive results for mirikizumab with safety and efficacy similar
to other IL-23p19s, the company no longer plans to submit
mirikizumab for regulatory approval in psoriasis in any
geography.
- The company presented results at the International Conference
on Alzheimer's and Parkinson Diseases 2021 from a Phase 2 trial for
donanemab that expanded on previously reported top-line data that
found donanemab met its primary endpoint and showed significant
slowing of decline compared to placebo on the integrated
Alzheimer's Disease Rating Scale (iADRS), a composite measure of
cognition and daily function, in patients with early symptomatic
Alzheimer's disease.
- The company announced positive top-line results from three
Phase 3 clinical trials of tirzepatide in adults with type 2
diabetes in terms of A1C and body weight reductions from baseline.
The three trials compared tirzepatide to titrated insulin degludec,
to placebo, both as an add-on to titrated insulin glargine, and to
injectable semaglutide 1 mg.
- The company and Incyte announced top-line results from two
Phase 3 studies evaluating the efficacy and safety of once-daily
baricitinib 2-mg and 4-mg in adults with severe alopecia areata. In
both studies, both doses of baricitinib met the primary efficacy
endpoint at week 36, demonstrating a statistically significant
improvement in scalp hair regrowth compared to those randomized to
placebo.
Business Development/Other Developments
- The company announced several executive leadership transitions,
including the appointment of Anat Ashkenazi as senior vice
president and chief financial officer on February 9, 2021, the appointment of Edgardo Hernandez as senior vice president and
president of manufacturing operations effective May 2, 2021, the appointment of Diogo Rau as senior vice president and chief
information and digital officer effective May 17, 2021, and the appointment of Alonzo Weems as senior vice president,
enterprise risk management and chief ethics and compliance officer
effective June 27, 2021.
- The Lilly board of directors elected Kimberly H. Johnson as a new member, effective
February 16, 2021. She serves on both
the Compensation Committee and the Ethics and Compliance
Committee.
- The company and Rigel Pharmaceuticals, Inc. announced a global
exclusive license agreement and strategic collaboration to
co-develop and commercialize Rigel's R552, a receptor-interacting
serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all
indications including autoimmune and inflammatory diseases.
Pursuant to the collaboration, Lilly will lead all clinical
development of brain penetrating RIPK1 inhibitors in central
nervous system (CNS) diseases.
- The company and Welldoc, Inc. announced a collaboration and
licensing agreement to integrate Welldoc's software into Lilly's
connected insulin solutions currently in development. Under the
terms of the agreement, Lilly and Welldoc will collaborate to
create a new version of the BlueStar® insulin management solution
that integrates insulin dosing data for several Lilly insulins.
Lilly will commercialize the pen platform, which will include the
new app and Lilly's connected insulin pen solutions.
- The company announced a research collaboration and license
agreement with Biolojic Design Ltd. that will leverage Biolojic's
AI-based multibody platform to discover and develop a potential
novel antibody-based therapy for the treatment of diabetes.
First-Quarter Reported Results
In the first quarter of 2021, worldwide revenue was $6.806 billion, an increase of 16 percent
compared with the first quarter of 2020, driven by a 17 percent
increase in volume and a 3 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 $810.1 million in the first quarter of 2021
for its COVID-19 antibodies. Key growth products, consisting of
Trulicity®, Verzenio®, Olumiant®,
Tyvyt®, Emgality®, Jardiance®,
Retevmo®, Cyramza® and
Taltz®, contributed 8 percentage points of revenue
growth and represented approximately 46 percent of total revenue
for the first quarter of 2021, or 52 percent of total revenue
excluding revenue from COVID-19 antibodies. The company estimates
worldwide volume growth in the first quarter of 2020 was favorably
impacted by increased customer buying patterns and patient
prescription trends resulting from the COVID-19 pandemic that
increased worldwide revenue by approximately $250 million, including approximately
$200 million in the U.S. and
approximately $50 million outside the
U.S. Excluding $810.1 million of
revenue in the first quarter of 2021 from COVID-19 antibodies and
approximately $250 million of revenue
in the first quarter of 2020 from increased customer buying
patterns and patient prescription trends, worldwide revenue in the
first quarter of 2021 grew by 7 percent.
Revenue in the U.S. increased 18 percent, to $3.941 billion, driven by a 24 percent increase
in volume, partially offset by a 6 percent decrease due to lower
realized prices. The company recognized U.S. revenue of
$650.6 million in the first
quarter of 2021 for COVID-19 antibodies. Excluding COVID-19
antibodies, revenue in the U.S. declined by 1 percent, reflecting
the impact of customer buying patterns and patient prescription
trends in the first quarter of 2020 resulting from the COVID-19
pandemic. Increased U.S. volume for certain key growth products,
including Trulicity, Taltz, Verzenio, Retevmo, Emgality, Jardiance
and Olumiant was partially offset by lower volume for other
products, including Alimta®, Basaglar®,
Forteo® and Cialis®. The decrease in realized
prices in the U.S. in the first quarter of 2021 was primarily
driven by increased rebates to gain broad commercial access for
Taltz, partially offset by modest list price increases. Segment mix
was not a major driver of U.S. price performance in the first
quarter of 2021, as increased utilization in more highly-rebated
government segments was offset by lower utilization in the
340B segment, primarily for the
diabetes portfolio.
Revenue outside the U.S. increased 13 percent, to $2.864 billion, driven by a 9 percent increase in
volume and a 6 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 Olumiant, Tyvyt, Verzenio, Trulicity, Taltz,
Jardiance, Emgality, Cyramza and Retevmo, as well as $159.5 million of revenue recognized for
COVID-19 antibodies. Revenue outside the U.S. was also impacted by
volume gains for Alimta, partially offset by decreased volume for
Cialis, Forteo, Cymbalta® and Humalog®. The
decrease in realized prices outside the U.S. was driven primarily
by Trulicity, Olumiant and Forteo.
Gross margin increased 6 percent, to $4.927 billion, in the first quarter of 2021
compared with the first quarter of 2020. Gross margin as a percent
of revenue was 72.4 percent, a decrease of 6.9 percentage points
compared with the first quarter of 2020. The decrease in gross
margin percent was primarily due to unfavorable product mix driven
by sales of COVID-19 antibodies, the unfavorable effect of foreign
exchange rates on international inventories sold, higher
amortization of intangibles expense related to Retevmo, charges
resulting from excess inventory of COVID-19 antibodies due in part
to the termination of the purchase agreement with the U.S.
government for bamlanivimab following discontinuation of the
product's distribution on its own in the U.S., and, to a lesser
extent, the impact of lower realized prices on revenue.
Total operating expenses in the first quarter of 2021, defined
as the sum of research and development and marketing, selling, and
administrative expenses, increased 11 percent to $3.261 billion compared with the first quarter of
2020. Research and development expenses increased 21 percent to
$1.685 billion, or 24.8 percent of
revenue, driven primarily by approximately $220 million of research and development expenses
for COVID-19 antibody therapies and baricitinib, as well as higher
research and development expenses for late-stage assets. Marketing,
selling, and administrative expenses increased 2 percent to
$1.576 billion.
In the first quarter of 2021, the company recognized acquired
in-process research and development charges of $299.3 million related to business development
transactions with Rigel Pharmaceuticals, Inc., Precision
BioSciences, Inc., Merus N.V., and Asahi Kasei Pharma Corporation.
In the first quarter of 2020, the company recognized acquired
in-process research and development charges of $52.3 million related to a business development
transaction with Sitryx Therapeutics Ltd.
In the first quarter of 2021, the company recognized asset
impairment, restructuring and other special charges of $211.6 million. These charges related primarily
to an intangible asset impairment resulting from the decision to
sell the rights to QBREXZA®, as well as acquisition and
integration costs associated with the acquisition of Prevail
Therapeutics Inc. In the first quarter of 2020, the company
recognized asset impairment, restructuring and other special
charges of $59.9 million, related
primarily to acquisition and integration costs associated with the
acquisition of Dermira, Inc.
Operating income in the first quarter of 2021 was $1.155 billion, compared to $1.591 billion
in the first quarter of 2020. The decrease in operating income was
primarily driven by higher research and development expenses,
higher acquired in-process research and development charges, and
higher asset impairment, restructuring and other special charges,
partially offset by higher gross margin. Operating margin, defined
as operating income as a percent of revenue, was 17.0 percent.
Other income was $321.1 million in
the first quarter of 2021, compared with other income of
$89.1 million in the first quarter of
2020. The increase in other income was driven primarily by higher
net gains on investment securities.
The effective tax rate was 8.2 percent in the first quarter of
2021, as compared with 13.3 percent in the first quarter of 2020.
The effective tax rates for both periods were reduced by net
discrete tax benefits, with a larger net discrete tax benefit
reflected in the first quarter of 2021.
In the first quarter of 2021, net income and earnings per share
were $1.355 billion and
$1.49, respectively, compared with
net income of $1.457 billion and
earnings per share of $1.60 in the
first quarter of 2020. The decrease in net income and earnings per
share in the first quarter of 2021 was primarily driven by lower
operating income, partially offset by higher other income and lower
income tax expense.
First-Quarter Non-GAAP Measures
On a non-GAAP basis, first-quarter 2021 gross margin increased 9
percent, to $5.134 billion compared
with the first quarter of 2020. Gross margin as a percent of
revenue was 75.4 percent, a decrease of 4.9 percentage points. The
decrease in gross margin percent was primarily due to unfavorable
product mix driven by sales of COVID-19 antibodies, the unfavorable
effect of foreign exchange rates on international inventories sold,
and, to a lesser extent, the impact of lower realized prices on
revenue.
Operating income on a non-GAAP basis increased $111.8 million, or 6 percent, to $1.873 billion in the first quarter of 2021
compared with the first quarter of 2020, due primarily to higher
gross margin, partially offset by higher research and development
expenses. Operating margin was 27.5 percent on a non-GAAP
basis.
Other income was $34.6 million in
the first quarter of 2021, compared with other expense of
$72.6 million in the first quarter of
2020. The increase in other income was driven primarily by a
favorable patent settlement in Europe for Alimta in the first quarter of
2021.
The effective tax rate on a non-GAAP basis was 10.8 percent in
the first quarter of 2021, as compared with 12.9 percent in the
first quarter of 2020. The effective tax rates for both periods
were reduced by net discrete tax benefits, with a larger net
discrete tax benefit reflected in the first quarter of 2021.
On a non-GAAP basis, in the first quarter of 2021 net income
increased 16 percent, to $1.702
billion, while earnings per share increased 16 percent, to
$1.87, compared with $1.471 billion and $1.61, respectively, in the first quarter of
2020. The increase in net income and earnings per share was driven
primarily by higher operating income and higher other income.
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.
|
First
Quarter
|
|
2021
|
|
2020
|
% Change
|
Earnings per share
(reported)
|
$
|
1.49
|
|
|
$
|
1.60
|
|
(7)%
|
Acquired in-process
research and development
|
.26
|
|
|
.05
|
|
|
Asset impairment,
restructuring and other special charges
|
.19
|
|
|
.06
|
|
|
Amortization of
intangible assets
|
.11
|
|
|
.05
|
|
|
COVID-19 antibodies
excess inventory charges
|
.07
|
|
|
—
|
|
|
Net gains on
investments in equity securities
|
(.25)
|
|
|
(.14)
|
|
|
Earnings per share
(non-GAAP)
|
$
|
1.87
|
|
|
$
|
1.61
|
|
16%
|
Numbers may not add
due to rounding.
|
|
|
|
|
|
|
|
|
|
Selected Revenue Highlights
Selected Revenue
Highlights
|
|
|
|
|
(Dollars in
millions)
|
First
Quarter
|
Selected
Products
|
2021
|
|
2020
|
|
% Change
|
Trulicity
|
$
|
1,452.4
|
|
|
$
|
1,229.4
|
|
|
18%
|
COVID-19
antibodies(a)
|
810.1
|
|
|
—
|
|
|
NM
|
Humalog(b)
|
617.0
|
|
|
695.8
|
|
|
(11)%
|
Alimta
|
559.0
|
|
|
560.1
|
|
|
(0)%
|
Taltz
|
403.2
|
|
|
443.5
|
|
|
(9)%
|
Humulin®
|
321.7
|
|
|
315.7
|
|
|
2%
|
Jardiance(c)
|
312.0
|
|
|
267.5
|
|
|
17%
|
Verzenio
|
269.0
|
|
|
188.0
|
|
|
43%
|
Basaglar
|
246.6
|
|
|
303.7
|
|
|
(19)%
|
Cyramza
|
240.5
|
|
|
239.0
|
|
|
1%
|
Forteo
|
198.5
|
|
|
272.4
|
|
|
(27)%
|
Olumiant
|
193.8
|
|
|
139.7
|
|
|
39%
|
Emgality
|
119.5
|
|
|
74.0
|
|
|
61%
|
Tyvyt
|
109.7
|
|
|
57.4
|
|
|
91%
|
Retevmo
|
16.8
|
|
|
—
|
|
|
NM
|
|
|
|
|
|
|
Total
Revenue
|
6,805.6
|
|
|
5,859.8
|
|
|
16%
|
|
|
|
|
|
|
(a) COVID-19 antibodies include sales
for bamlanivimab administered alone as well as sales for
bamlanivimab and etesevimab administered together and were made
pursuant to Emergency Use Authorizations
(b)
Humalog includes Insulin Lispro
(c) Jardiance includes
Glyxambi®, Synjardy®, and
Trijardy® XR
NM – not
meaningful
|
Impact of COVID-19 on First-Quarter 2020 Revenue
In the first quarter of 2020, the company estimated that revenue
for many of its products was favorably impacted by increased
customer buying patterns and patient prescription trends resulting
from the COVID-19 pandemic that increased revenue by approximately
$250 million worldwide, including
approximately $200 million in the
U.S. and approximately $50 million
outside the U.S. The company believes that this increase in U.S.
revenue primarily impacted its portfolio of diabetes medicines,
with estimated increases of approximately $70 million to $80
million for insulin products and approximately $30 million to $40
million for Trulicity. The company also estimated that U.S.
revenue for Taltz was favorably impacted by approximately
$20 million to $25 million.
Trulicity
First-quarter 2021 worldwide Trulicity revenue was $1.452 billion, an increase of 18 percent
compared with the first quarter of 2020. U.S. revenue increased 20
percent, to $1.117 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 $335.7
million, an increase of 12 percent, driven by increased
volume and, to a lesser extent, favorable foreign exchange rates,
partially offset by lower realized prices.
Humalog
For the first quarter of 2021, worldwide Humalog revenue decreased
11 percent compared with the first quarter of 2020, to $617.0 million. Revenue in the U.S. decreased 17
percent, to $332.7 million, driven by
lower realized prices as higher contracted rebates and discounts
were partially offset by lower utilization in the 340B segment. Revenue outside the U.S. decreased
4 percent, to $284.4 million, driven
by decreased volume, partially offset by the favorable impact of
foreign exchange rates.
Alimta
For the first quarter of 2021, worldwide Alimta revenue remained
flat compared with the first quarter of 2020, at $559.0 million. U.S. revenue decreased 19
percent, to $261.1 million,
primarily driven by lower volume as a result of customer buying
patterns and, to a lesser extent, lower realized prices. Revenue
outside the U.S. increased 26 percent to $297.8 million, primarily driven by increased
volume in Germany and, to a lesser
extent, the favorable impact of foreign exchange rates.
The company expects volume declines in the second half of 2021
for Alimta as a result of the anticipated entry of generic
competition due to the loss of patent exclusivity in Japan and major European markets.
Taltz
For the first quarter of 2021, worldwide Taltz revenue decreased 9
percent compared with the first quarter of 2020, to $403.2 million. U.S. revenue decreased 24
percent, to $249.6 million,
primarily due to increased rebates to gain commercial access which
resulted in lower realized prices, partially offset by increased
demand. Revenue outside the U.S. increased 32 percent, to
$153.6 million, primarily driven by
increased volume and, to a lesser extent, the favorable impact of
foreign exchange rates.
Humulin
For the first quarter of 2021, worldwide Humulin revenue increased
2 percent compared with the first quarter of 2020, to $321.7 million. U.S. revenue increased 2 percent,
to $219.0 million, driven by higher
realized prices, partially offset by decreased demand. Revenue
outside the U.S. increased 1 percent, to $102.7 million, primarily due to the favorable
impact of foreign exchange rates and higher realized prices,
largely offset by decreased volume.
Jardiance
The company's worldwide Jardiance revenue during the first quarter
of 2021 was $312.0 million, an
increase of 17 percent compared with the first quarter of 2020.
U.S. revenue increased 5 percent, to $151.2
million, driven by increased demand. Revenue outside the
U.S. was $160.8 million, an increase
of 31 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.
Verzenio
For the first quarter of 2021, worldwide Verzenio revenue increased
43 percent compared with the first quarter of 2020, to $269.0 million. U.S. revenue was $172.8 million, an increase of 34 percent,
primarily driven by increased demand and, to a lesser extent,
higher realized prices. Revenue outside the U.S. was $96.2 million, an increase of 64 percent,
primarily driven by increased volume.
Basaglar
For the first quarter of 2021, worldwide Basaglar revenue was
$246.6 million, a decrease of 19
percent compared with the first quarter of 2020. U.S. revenue
decreased 24 percent, to $175.2
million, driven by decreased demand caused by competitive
pressures and, to a lesser extent, lower realized prices. Revenue
outside the U.S. decreased 3 percent, to $71.4 million, driven by lower realized
prices and decreased volume, partially offset by the favorable
impact of foreign exchange rates. Basaglar is part of the company's
alliance with Boehringer Ingelheim. Lilly reports as cost of sales
payments made to Boehringer Ingelheim for royalties.
Cyramza
For the first quarter of 2021, worldwide Cyramza revenue was
$240.5 million, an increase of 1
percent compared with the first quarter of 2020. U.S. revenue was
$80.2 million, a decrease of 10
percent, primarily driven by decreased demand and lower realized
prices. Revenue outside the U.S. was $160.3 million, an increase of 7 percent,
driven by the favorable impact of foreign exchange rates and
increased volume.
Forteo
For the first quarter of 2021, worldwide Forteo revenue decreased
27 percent compared with the first quarter of 2020, to $198.5 million. U.S. revenue decreased 20
percent, to $97.7 million, driven by
decreased demand, partially offset by higher realized prices.
Revenue outside the U.S. decreased 33 percent to $100.8 million, 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.
Olumiant
For the first quarter of 2021, worldwide Olumiant revenue increased
39 percent compared with first quarter of 2020, to $193.8 million. U.S. revenue was $24.7 million. Revenue outside the U.S. was
$169.1 million, an increase of 32
percent, driven by increased volume and, to a lesser extent, the
favorable impact of foreign exchange rates, partially offset by
lower realized prices.
Emgality
For the first quarter of 2021, Emgality generated worldwide revenue
of $119.5 million, an increase of 61
percent compared with the first quarter of 2020. U.S. revenue was
$101.5 million, an increase of 51
percent driven by higher realized prices and, to a lesser extent,
increased demand. Revenue outside of the U.S. was $18.0 million.
Tyvyt
For the first quarter of 2021, the company's Tyvyt revenue in
China was $109.7 million, an increase of 91 percent
compared with the first quarter of 2020.
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 first quarter of 2021, Retevmo generated U.S. revenue of
$16.8 million. Retevmo was approved
by the FDA and launched in the U.S. during the second quarter of
2020.
2021 Financial Guidance
The company has updated certain elements of its 2021 financial
guidance on a reported and a non-GAAP basis. Earnings per share for
2021 are now expected to be in the range of $7.03 to $7.23 on a
reported basis and $7.80 to
$8.00 on a non-GAAP basis. The update
to the company's 2021 financial guidance on a reported basis
reflects adjustments shown in the reconciliation table below. The
update to the company's 2021 financial guidance on a non-GAAP basis
reflects primarily lower expected revenue from COVID-19 antibody
sales due to lower expected demand and higher expected
research and development expenses.
|
2021
Expectations
|
% Change vs
2020
|
Earnings per share
(reported)
|
$7.03 to
$7.23
|
4% to
6%
|
Amortization of
intangible assets
|
.50
|
|
Acquired
IPR&D
|
.26
|
|
Asset impairment,
restructuring and other special charges
|
.19
|
|
COVID-19 antibodies
excess inventory charges
|
.07
|
|
Net gains on
investments in equity securities
|
(.25)
|
|
Earnings per share
(non-GAAP)
|
$7.80 to
$8.00
|
15% to
18%
|
Numbers may not add
due to rounding
|
|
|
The company now anticipates 2021 revenue to be between
$26.6 billion and $27.6 billion, including an estimated
$1 billion to $1.5 billion of revenue from COVID-19 therapies.
Revenue growth is additionally expected to be driven by volume from
key growth products, including Trulicity, Taltz, Verzenio,
Jardiance, Olumiant, Cyramza, Emgality, Tyvyt and Retevmo, as well
as by COVID-19 therapies. Revenue growth is expected to be
partially offset by lower revenue for products that have lost
patent exclusivity. The company expects mid-single digit net price
declines globally in 2021. In the U.S., the company expects
low-to-mid-single digit net price declines, driven primarily by
increased rebates to maintain broad commercial access and segment
mix, partially offset by lower utilization in the 340B segment. Outside the U.S., the company
expects net price declines in China, Japan,
and Europe.
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 $6.2
billion to $6.4 billion.
Research and development expenses for 2021 are now expected to be
in the range of $6.9 billion to
$7.1 billion, reflecting additional
investments in potential therapies for Alzheimer's disease
and approximately $400 million
to $500 million of continued
investment in COVID-19 therapies.
Operating margin for 2021 is now expected to be approximately 26
percent on a reported basis and approximately 31 percent on a
non-GAAP basis.
Other income (expense) for 2021 is now expected to be income in
the range of $150 million to
$250 million on a reported basis and
expense in the range of $100 million
to $200 million on a non-GAAP
basis.
The 2021 effective tax rate is now expected to be approximately
13 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
|
$26.5 to $28.0
billion
|
|
$26.6 to $27.6
billion
|
|
|
|
|
Gross Margin % of
Revenue (reported)
|
Approx.
77%
|
|
Unchanged
|
Gross Margin % of
Revenue (non-GAAP)
|
Approx.
79%
|
|
Unchanged
|
|
|
|
|
Marketing, Selling
& Administrative
|
$6.2 to $6.4
billion
|
|
Unchanged
|
|
|
|
|
Research &
Development
|
$6.5 to $6.7
billion
|
|
$6.9 to $7.1
billion
|
|
|
|
|
Other
Income/(Expense) (reported)
|
$(300) to $(200)
million
|
|
$150 to $250
million
|
Other
Income/(Expense) (non-GAAP)
|
$(300) to $(200)
million
|
|
$(200) to $(100)
million
|
|
|
|
|
Tax Rate
|
Approx.
15%
|
|
Approx.
13%
|
|
|
|
|
Earnings per Share
(reported)
|
$7.10 to
$7.75
|
|
$7.03 to
$7.23
|
Earnings per Share
(non-GAAP)
|
$7.75 to
$8.40
|
|
$7.80 to
$8.00
|
|
|
|
|
Operating Margin
(reported)
|
Approx.
30%
|
|
Approx.
26%
|
Operating Margin
(non-GAAP)
|
Approx.
32%
|
|
Approx.
31%
|
|
|
|
|
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
first-quarter 2021 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. 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's 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)
Cialis® (tadalafil, Lilly)
Cymbalta (duloxetine, 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)
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
|
|
|
March 31,
2021
|
|
December 31,
2020
|
|
Worldwide
Employees
|
34,690
|
|
34,960
|
|
Eli Lilly and
Company
|
Operating
Results (Unaudited) – REPORTED
|
(Dollars in millions,
except per share data)
|
|
|
Three Months
Ended
|
|
|
March 31,
|
|
|
2021
|
|
2020
|
% Chg.
|
|
|
|
|
|
|
Revenue
|
$
|
6,805.6
|
|
$
|
5,859.8
|
|
16%
|
|
|
|
|
|
|
Cost of
sales
|
|
1,878.6
|
|
|
1,215.1
|
|
55%
|
Research and
development
|
|
1,684.8
|
|
|
1,392.1
|
|
21%
|
Marketing, selling
and administrative
|
|
1,576.0
|
|
|
1,549.6
|
|
2%
|
Acquired in-process
research and development
|
|
299.3
|
|
|
52.3
|
|
NM
|
Asset impairment,
restructuring and other special charges
|
|
211.6
|
|
|
59.9
|
|
NM
|
|
|
|
|
|
|
Operating
income
|
|
1,155.3
|
|
|
1,590.8
|
|
(27)%
|
|
|
|
|
|
|
Net interest income
(expense)
|
|
(82.3)
|
|
|
(78.2)
|
|
|
Net other income
(expense)
|
|
403.4
|
|
|
167.3
|
|
|
Other income
(expense)
|
|
321.1
|
|
|
89.1
|
|
NM
|
|
|
|
|
|
|
Income before income
taxes
|
|
1,476.4
|
|
|
1,679.9
|
|
(12)%
|
Income tax
expense
|
|
121.1
|
|
|
223.4
|
|
(46)%
|
|
|
|
|
|
|
Net income
|
$
|
1,355.3
|
|
$
|
1,456.5
|
|
(7)%
|
|
|
|
|
|
|
Earnings per share -
diluted
|
$
|
1.49
|
|
$
|
1.60
|
|
(7)%
|
|
|
|
|
|
|
Dividends paid per
share
|
$
|
.850
|
|
|
.740
|
|
15%
|
Weighted-average
shares outstanding (thousands) - diluted
|
|
912,419
|
|
|
911,713
|
|
|
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 March 31, 2021
|
|
Three Months
Ended March 31, 2020
|
|
GAAP
Reported
|
Adjustments(b)
|
Non-GAAP
Adjusted(a)
|
|
GAAP
Reported
|
Adjustments(c)
|
Non-GAAP
Adjusted(a)
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
$
|
1,878.6
|
|
$
|
(207.2)
|
|
$
|
1,671.4
|
|
$
|
1,215.1
|
|
$
|
(58.6)
|
|
$
|
1,156.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process
research and development
|
|
299.3
|
|
|
(299.3)
|
|
|
—
|
|
|
52.3
|
|
|
(52.3)
|
|
|
—
|
|
Asset impairment,
restructuring and other special charges
|
|
211.6
|
|
|
(211.6)
|
|
|
—
|
|
|
59.9
|
|
|
(59.9)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
321.1
|
|
|
(286.5)
|
|
|
34.6
|
|
|
89.1
|
|
|
(161.7)
|
|
|
(72.6)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
121.1
|
|
|
85.0
|
|
|
206.1
|
|
|
223.4
|
|
|
(5.5)
|
|
|
217.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
1,355.3
|
|
|
346.6
|
|
|
1,701.9
|
|
|
1,456.5
|
|
|
14.6
|
|
|
1,471.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share -
diluted
|
|
1.49
|
|
|
0.38
|
|
|
1.87
|
|
|
1.60
|
|
|
0.01
|
|
|
1.61
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 March 31,
2021, include the following:
|
|
|
|
|
|
|
|
|
(Dollars in millions,
except per share data)
|
Amortization(i)
|
IPR&D(ii)
|
Other specified
items(iii)
|
Equity
investments (iv)
|
Total
|
Cost of
sales
|
$
|
(125.7)
|
|
$
|
—
|
|
$
|
(81.5)
|
|
$
|
—
|
|
$
|
(207.2)
|
|
|
|
|
|
|
|
Acquired in-process
research and development
|
—
|
|
(299.3)
|
|
—
|
|
—
|
|
(299.3)
|
|
|
|
|
|
|
|
Asset impairment,
restructuring and other special charges
|
—
|
|
—
|
|
(211.6)
|
|
—
|
|
(211.6)
|
|
|
|
|
|
|
|
Other income
(expense)
|
—
|
|
—
|
|
—
|
|
(286.5)
|
|
(286.5)
|
|
|
|
|
|
|
|
Income tax
expense
|
26.1
|
|
62.9
|
|
51.9
|
|
(55.9)
|
|
85.0
|
|
|
|
|
|
|
|
Net income
|
99.6
|
|
236.4
|
|
241.2
|
|
(230.6)
|
|
346.6
|
|
|
|
|
|
|
|
Earnings per share -
diluted
|
0.11
|
|
0.26
|
|
0.26
|
|
(0.25)
|
|
0.38
|
|
|
|
|
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 Rigel Pharmaceuticals, Inc.,
Precision BioSciences, Inc., Merus N.V., and Asahi Kasei Pharma
Corporation.
|
|
iii
|
Exclude primarily an
intangible asset impairment resulting from the decision to sell the
rights to QBREXZA, charges resulting from excess inventory due in
part to the discontinuation of bamlanivimab for use on its own, as
well as acquisition and integration costs recognized as part of the
closing of the acquisition of Prevail Therapeutics Inc.
|
|
iv
|
Exclude gains and
losses on investments in equity securities.
|
|
|
|
(c)
|
Adjustments to
certain GAAP reported measures for the three months ended March 31,
2020, include the following:
|
|
|
|
|
|
|
|
|
(Dollars in millions,
except per share data)
|
Amortization
(i)
|
IPR&D(ii)
|
Other
specified
items(iii)
|
Equity
investments (iv)
|
Total
|
Cost of
sales
|
$
|
(54.4)
|
|
$
|
—
|
|
$
|
(4.2)
|
|
$
|
—
|
|
$
|
(58.6)
|
|
|
|
|
|
|
|
Acquired in-process
research and development
|
—
|
|
(52.3)
|
|
—
|
|
—
|
|
(52.3)
|
|
|
|
|
|
|
|
Asset impairment,
restructuring and other special charges
|
—
|
|
—
|
|
(59.9)
|
|
—
|
|
(59.9)
|
|
|
|
|
|
|
|
Other income
(expense)
|
—
|
|
—
|
|
—
|
|
(161.7)
|
|
(161.7)
|
|
|
|
|
|
|
|
Income tax
expense
|
11.3
|
|
11.0
|
|
6.2
|
|
(34.0)
|
|
(5.5)
|
|
|
|
|
|
|
|
Net income
|
43.1
|
|
41.3
|
|
57.9
|
|
(127.7)
|
|
14.6
|
|
|
|
|
|
|
|
Earnings per share -
diluted
|
0.05
|
|
0.05
|
|
0.06
|
|
(0.14)
|
|
0.01
|
|
|
|
|
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 a business
development transaction with Sitryx.
|
|
iii
|
Exclude primarily
acquisition and integration costs associated with the acquisition
of Dermira, Inc.
|
|
iv
|
Exclude gains and
losses on investments in equity securities.
|
Refer
to:
|
Molly McCully;
mccully_molly@lilly.com; (317) 478-5423 (Media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; (317) 277-1838 (Investors)
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/lilly-delivers-first-quarter-2021-financial-results-adjusts-2021-financial-guidance-301277287.html
SOURCE Eli Lilly and Company