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."
|
|
|
|
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$ in millions,
except
per share
data
|
Third
Quarter
|
%
|
|
2021
|
|
2020
|
Change
|
Revenue
|
$
|
6,772.8
|
|
|
$
|
5,740.6
|
|
18%
|
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
|
|
37%
|
EPS –
Non-GAAP
|
1.94
|
|
|
1.41
|
|
38%
|
|
|
|
|
|
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 $6.773 billion, an increase of 18 percent
compared with the third quarter of 2020, driven by a 17 percent
increase in volume and a 1 percent increase due to the favorable
impact of foreign exchange rates, with net realized prices
remaining essentially flat. Key growth products, consisting of
Trulicity®, Taltz®, Verzenio, Jardiance,
Emgality®, Olumiant®, Tyvyt®,
Retevmo® and Cyramza®, contributed 17
percentage points of revenue growth and represented approximately
58 percent of total revenue for the third quarter of 2021,
excluding COVID-19 therapies. The company recognized worldwide
revenue of $423.5 million for
COVID-19 therapies during the quarter.
Revenue in the U.S. increased 26 percent, to $3.990 billion, driven by a 22 percent increase
in volume and a 4 percent increase due to higher realized prices.
The company recognized U.S. revenue of $392.9 million in the third quarter of 2021 for
COVID-19 therapies. Excluding that revenue, revenue in the U.S.
increased by 14 percent. The increase in U.S. volume was driven by
certain key growth products, including Trulicity, Olumiant, Taltz,
Jardiance, Verzenio, Retevmo and Emgality. Higher realized prices
in the U.S. during the third quarter of 2021 were driven by lower
utilization in the 340B segment,
unfavorable changes to estimates for rebates and discounts for
Trulicity in the third quarter of 2020, and modest list price
increases, partially offset by increased rebates to maintain access
for products across the business.
Revenue outside the U.S. increased 8 percent, to $2.783 billion, driven by an 11 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 increase in volume outside the
U.S. was primarily driven by increased volume for all key growth
products.
Gross margin increased 21 percent, to $5.342 billion, in the third quarter of 2021
compared with the third quarter of 2020. Gross margin as a percent
of revenue was 78.9 percent, an increase of 2.0 percentage points
compared to the third quarter of 2020. The increase in gross margin
percent was primarily due to favorable product mix and favorable
effect of foreign exchange rates on international inventories
sold.
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 $3.287 billion compared with the third quarter of
2020. Research and development expenses increased 17 percent to
$1.709 billion, or 25.2 percent of
revenue, driven primarily by higher development expenses for
late-stage assets. Research and development expenses for COVID-19
therapies were approximately $50
million in the third quarter of 2021. Marketing, selling and
administrative expenses increased 1 percent to $1.578 billion.
In the third quarter of 2021, the company recognized acquired
in-process research and development charges of $174.0 million related to business development
transactions with Protomer Technologies Inc., Kumquat Biosciences
Inc., Lycia Therapeutics, Inc., and ProQR Therapeutics N.V. There
were no acquired in-process research and development charges
recognized in the third quarter of 2020.
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 $101.4 million. These charges were primarily
related to severance costs incurred related to restructuring.
Operating income in the third quarter of 2021 was $1.881 billion, compared to $1.278 billion
in the third quarter of 2020. The increase in operating income was
driven by higher revenue and, to a lesser extent, lower asset
impairment, restructuring and other special charges, partially
offset by higher research and development expenses and acquired
in-process research and development charges. Operating margin,
defined as operating income as a percent of revenue, was 27.8
percent.
Other income (expense) was expense of $635.9 million in the third quarter of 2021,
compared with income of $158.9
million in the third quarter of 2020. The reduction in other
income (expense) was primarily driven by a charge of $405.2 million related to the repurchase of
higher-cost debt and unfavorable mark-to-market adjustments on
investments in equity securities in the third quarter of 2021
compared to favorable mark-to-market adjustments on investments in
equity securities in the third quarter of 2020.
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
$1.110 billion and $1.22, respectively, compared with net income of
$1.208 billion and EPS of
$1.33 in the third quarter of 2020.
Net income and EPS in the third quarter of 2021 decreased compared
to the same period in 2020 as higher operating income and lower
income tax expense were more than offset by a reduction in other
income (expense) in 2021.
Third-Quarter Non-GAAP Measures
On a non-GAAP basis, third-quarter 2021 gross margin increased 18
percent, to $5.351 billion compared
with the third quarter of 2020. Gross margin as a percent of
revenue was 79.0 percent, a decrease of 0.1 percentage points,
driven by favorable product mix (excluding COVID-19 therapies) and
favorable effect of foreign exchange rates on international
inventories sold, more than offset by lower gross margin on
COVID-19 therapies.
Operating income on a non-GAAP basis increased $558.0 million, or 37 percent, to $2.064 billion in the third quarter of 2021
compared with the third quarter of 2020, due to higher gross
margin, partially offset by higher research and development
expenses. Operating margin was 30.5 percent on a non-GAAP
basis.
Other income (expense) was expense of $7.3 million in the third quarter of 2021,
compared with income of $9.9 million
in the third quarter of 2020.
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 $1.764
billion, while EPS increased 38 percent, to $1.94, compared with $1.289 billion and $1.41, respectively, in the third quarter of
2020. The increases in net income and EPS were driven by higher
operating 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.
|
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
|
|
38%
|
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 $20.319 billion, compared
with $17.100 billion in the same
period in 2020. The increase in revenue was driven by a 19 percent
increase in volume and a 2 percent increase due to the favorable
impact of foreign exchange rates, partially offset by a 2 percent
decrease due to lower realized prices. Excluding $1.425 billion of revenue from COVID-19
therapies, worldwide revenue grew by 11 percent. For the first nine
months of 2021, operating income was $4.440
billion, an increase of 9 percent compared with $4.066 billion in the same period of 2020.
Reported net income and EPS for the first nine months of 2021 were
$3.856 billion and $4.23, respectively, compared with $4.077 billion and $4.47, respectively, for the same period of 2020.
The decreases in net income and EPS in the first nine months of
2021 were driven by lower other income (expense), partially offset
by higher operating income and lower income taxes.
Year-to-Date Non-GAAP Measures
For the first nine months of 2021, operating income was
$5.921 billion on a non-GAAP basis,
an increase of 23 percent compared with $4.809 billion in the same period of 2020.
Net income and EPS, on a non-GAAP basis, were $5.169 billion and $5.67, respectively, compared with $4.083 billion and $4.48, respectively, for the same period of
2020.
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
|
|
27%
|
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
|
|
|
45%
|
|
$
|
4,588.2
|
|
|
$
|
3,565.7
|
|
|
29%
|
|
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
|
|
|
30%
|
|
1,565.4
|
|
|
1,293.2
|
|
|
21%
|
|
COVID-19
antibodies(b)
|
217.1
|
|
|
—
|
|
|
NM
|
|
1,176.2
|
|
|
—
|
|
|
NM
|
|
Jardiance(c)
|
390.4
|
|
|
310.8
|
|
|
26%
|
|
1,058.9
|
|
|
840.3
|
|
|
26%
|
|
Verzenio
|
335.5
|
|
|
234.4
|
|
|
43%
|
|
945.8
|
|
|
631.1
|
|
|
50%
|
|
Humulin®
|
286.7
|
|
|
305.9
|
|
|
(6)%
|
|
923.8
|
|
|
935.2
|
|
|
(1)%
|
|
Olumiant(d)
|
406.9
|
|
|
162.0
|
|
|
NM
|
|
809.1
|
|
|
446.7
|
|
|
81%
|
|
Cyramza
|
253.4
|
|
|
252.7
|
|
|
0%
|
|
762.5
|
|
|
748.4
|
|
|
2%
|
|
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
|
|
|
53%
|
|
415.7
|
|
|
252.9
|
|
|
64%
|
|
Tyvyt
|
125.6
|
|
|
84.4
|
|
|
49%
|
|
340.2
|
|
|
205.9
|
|
|
65%
|
|
Retevmo
|
33.6
|
|
|
11.6
|
|
|
NM
|
|
76.1
|
|
|
17.9
|
|
|
NM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Revenue
|
6,772.8
|
|
|
5,740.6
|
|
|
18%
|
|
20,318.5
|
|
|
17,099.8
|
|
|
19%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Humalog includes Insulin
Lispro
(b) 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
(EUA)
(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 $1.600 billion, an increase of 45 percent
compared with the third quarter of 2020. U.S. revenue increased 52
percent, to $1.201 billion, driven by
increased demand and, to a lesser extent, higher realized prices
due to segment mix, including lower utilization in the 340B program, unfavorable changes to estimates
for rebates and discounts in the same period of 2020, and modest
list price increases, which were partially offset by increased
rebates to maintain access. Revenue outside the U.S. was
$398.8 million, an increase of 26
percent, driven by increased volume and, to a lesser extent, the
favorable impact of foreign exchange rates, partially offset by
lower realized prices.
Humalog
For the third quarter of 2021, worldwide Humalog revenue decreased
5 percent compared with the third quarter of 2020, to $626.7 million. Revenue in the U.S. decreased 11
percent, to $347.3 million, driven by
lower realized prices. Revenue outside the U.S. increased 5
percent, to $279.4 million, driven by
the favorable impact of foreign exchange rates and increased
volume, partially offset by lower realized prices.
Alimta
For the third quarter of 2021, worldwide Alimta revenue decreased
21 percent compared with the third quarter of 2020, to $457.0 million. U.S. revenue increased 2 percent,
to $297.2 million, primarily
driven by higher realized prices, partially offset by decreased
demand and customer buying patterns. Revenue outside the U.S.
decreased 44 percent to $159.8
million, primarily driven by decreased volume due to entry
of generic competition and, to a lesser extent, lower realized
prices.
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 $593.1 million. U.S. revenue increased 29
percent, to $422.2 million,
primarily driven by increased demand, partially offset by lower
realized prices. The lower realized prices were driven by increased
rebates to gain commercial access and unfavorable segment mix,
partially offset by changes to estimates for rebates and discounts.
Revenue outside the U.S. increased 33 percent, to $170.9 million, primarily driven by increased
volume, partially offset by lower realized prices.
Jardiance
The company's worldwide Jardiance revenue during the third quarter
of 2021 was $390.4 million, an
increase of 26 percent compared with the third quarter of 2020.
U.S. revenue increased 35 percent, to $221.2
million, primarily driven by increased demand. Revenue
outside the U.S. was $169.2 million,
an increase of 15 percent, driven by increased volume partially
offset by the unfavorable 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 third quarter of 2021, worldwide Verzenio revenue increased
43 percent compared with the third quarter of 2020, to $335.5 million. U.S. revenue was $199.6 million, an increase of 26 percent,
driven by increased demand, partially offset by lower realized
prices. Revenue outside the U.S. was $135.9
million, an increase of 80 percent, primarily driven by
increased volume.
Humulin
For the third quarter of 2021, worldwide Humulin revenue decreased
6 percent compared with the third quarter of 2020, to $286.7 million. U.S. revenue decreased 10
percent, to $193.4 million, driven by
lower realized prices and, to a lesser extent, decreased demand.
Revenue outside the U.S. increased 2 percent, to $93.4 million, due to higher realized prices and,
to a lesser extent, the favorable impact of foreign exchange rates,
largely offset by decreased volume.
Olumiant
For the third quarter of 2021, worldwide Olumiant revenue was
$406.9 million, an increase of
$244.9 million compared with the
third quarter of 2020. U.S. revenue was $194.0 million, representing growth of
$179.5 million compared with the
third quarter of 2020, driven by utilization for the treatment of
hospitalized patients with COVID-19 during the third quarter of
2021. Revenue outside the U.S. was $212.9
million, an increase of 44 percent, driven by increased
volume, partially offset by lower realized prices.
Cyramza
For the third quarter of 2021, worldwide Cyramza revenue remained
essentially flat compared with the third quarter of 2020, at
$253.4 million. U.S. revenue was
$84.8 million, a decrease of 10
percent, primarily driven by decreased demand, partially offset by
higher realized prices. Revenue outside the U.S. was $168.6 million, an increase of 7 percent,
driven by increased volume, partially offset by lower realized
prices and the unfavorable impact of foreign exchange rates.
Basaglar
For the third quarter of 2021, worldwide Basaglar revenue was
$192.8 million, a decrease of 22
percent compared with the third quarter of 2020. U.S. revenue
decreased 36 percent, to $114.7
million, driven by continued competitive pressures that
resulted in lower realized prices and, to a lesser extent,
decreased demand. Due to competitive pressures, continued price
decline and loss of market share over time is expected. Revenue
outside the U.S. increased 12 percent, to $78.1 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.
Forteo
For the third quarter of 2021, worldwide Forteo revenue decreased
25 percent compared with the third quarter of 2020, to $200.9 million. U.S. revenue decreased 24
percent, to $109.6 million, driven by
decreased demand and, to a lesser extent, lower realized prices.
Revenue outside the U.S. decreased 25 percent to $91.3 million, primarily driven by decreased
volume.
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 $140.0 million, an increase of 53
percent compared with the third quarter of 2020. U.S. revenue was
$99.9 million, an increase of 23
percent, driven by increased demand and higher realized prices.
Revenue outside the U.S. was $40.1
million, an increase of $30.0
million compared with the third quarter of 2020, driven by
increased demand.
Tyvyt
For the third quarter of 2021, the company's Tyvyt revenue in
China was $125.6 million, an increase of 49 percent
compared with the third quarter of 2020, driven primarily by
increased demand.
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
$29.2 million compared to revenue of
$22.5 million in the second quarter
of 2021. Retevmo launched outside the U.S. during the second
quarter of 2021 and generated revenue of $4.4 million in the third quarter of
2021.
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 $6.38 to $6.48 on a
reported basis and $7.95 to
$8.05 on a non-GAAP basis. The update
to the company's 2021 financial guidance reflects adjustments shown
in the reconciliation table below.
|
2021
Expectations
|
% Change vs
2020
|
Earnings per share
(reported)
|
$6.38 to
$6.48
|
(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)
|
$7.95 to
$8.05
|
17% to
19%
|
Numbers may not add
due to
rounding
(a) includes costs
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.
|
|
|
The company now anticipates 2021 revenue to be between
$27.2 billion and $27.6 billion. This increase reflects additional
revenue from COVID-19 antibodies and the underlying core business.
Estimated revenue from COVID-19 antibodies is now expected to be
approximately $1.3 billion.
Other income (expense) for 2021 is now expected to be expense in
the range of $250 million to
$150 million on a reported basis and
is still expected to be expense in the range of $100 million to $0
on a non-GAAP basis. The company's updated reported guidance
reflects the impact of the charge associated with the repurchase of
higher-cost debt and unfavorable mark-to-market adjustments on
investments in equity securities in the third quarter of 2021.
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
|
$26.8 to $27.4
billion
|
|
$27.2 to $27.6
billion
|
|
|
|
|
Gross Margin % of
Revenue (reported)
|
Approx.
75%
|
|
Unchanged
|
Gross Margin % of
Revenue (non-GAAP)
|
Approx.
79%
|
|
Unchanged
|
|
|
|
|
Marketing, Selling
& Administrative
|
$6.2 to $6.4
billion
|
|
Unchanged
|
|
|
|
|
Research &
Development
|
$6.9 to $7.1
billion
|
|
Unchanged
|
|
|
|
|
Other
Income/(Expense) (reported)
|
$375 to $475
million
|
|
$(250) to $(150)
million
|
Other
Income/(Expense) (non-GAAP)
|
$(100) million to
$0
|
|
Unchanged
|
|
|
|
|
Tax Rate
(reported)
|
Approx.
12%
|
|
Approx.
11%
|
Tax Rate
(non-GAAP)
|
Approx.
13%
|
|
Unchanged
|
|
|
|
|
Earnings per Share
(reported)
|
$6.73 to
$6.93
|
|
$6.38 to
$6.48
|
Earnings per Share
(non-GAAP)
|
$7.80 to
$8.00
|
|
$7.95 to
$8.05
|
|
|
|
|
Operating Margin
(reported)
|
Approx.
24%
|
|
Unchanged
|
Operating Margin
(non-GAAP)
|
Approx.
30%
|
|
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
|
18%
|
|
$
|
20,318.5
|
$
|
17,099.8
|
19%
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
1,430.8
|
|
1,326.4
|
8%
|
|
|
5,262.6
|
|
3,763.5
|
40%
|
Research and
development
|
|
1,708.9
|
|
1,465.4
|
17%
|
|
|
5,066.5
|
|
4,247.7
|
19%
|
Marketing, selling
and administrative
|
|
1,577.9
|
|
1,569.1
|
1%
|
|
|
4,839.6
|
|
4,567.3
|
6%
|
Acquired in-process
research and development
|
|
174.0
|
|
—
|
NM
|
|
|
498.3
|
|
294.1
|
69%
|
Asset impairment,
restructuring and other special
charges
|
|
—
|
|
101.4
|
(100)%
|
|
|
211.6
|
|
161.3
|
31%
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
1,881.2
|
|
1,278.3
|
47%
|
|
|
4,439.9
|
|
4,065.9
|
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)
- diluted
|
|
910,751
|
|
911,423
|
|
|
|
911,656
|
|
911,868
|
|
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
Reported
|
Adjustments(b)
|
Non-GAAP
Adjusted(a)
|
|
GAAP
Reported
|
Adjustments(c)
|
Non-GAAP
Adjusted(a)
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
$
|
1,430.8
|
$
|
(9.0)
|
$
|
1,421.8
|
$
|
1,326.4
|
$
|
(126.5)
|
$
|
1,199.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired
in-process
research and
development
|
|
174.0
|
|
(174.0)
|
|
—
|
|
—
|
|
—
|
|
—
|
Asset impairment,
restructuring and other
special charges
|
|
—
|
|
—
|
|
—
|
|
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
-
diluted
|
|
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
share data)
|
Amortization(i)
|
IPR&D(ii)
|
Equity
investments(iii)
|
Repurchase of
Debt (iv)
|
Other specified
items(v)
|
Total
|
Cost of
sales
|
$
|
(137.1)
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
$
|
128.1
|
|
$
|
(9.0)
|
|
|
|
|
|
|
|
|
Acquired in-process
research and
development
|
—
|
|
(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
investments(ii)
|
Other
specified
items(iii)
|
Total
|
Cost of
sales
|
$
|
(126.5)
|
|
$
|
—
|
|
$
|
—
|
|
$
|
(126.5)
|
|
|
|
|
|
|
Asset impairment,
restructuring and other
special charges
|
—
|
|
—
|
|
(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
Reported
|
Adjustments(b)
|
Non-GAAP
Adjusted(a)
|
|
GAAP
Reported
|
Adjustments(c)
|
Non-GAAP
Adjusted(a)
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
$
|
5,262.6
|
|
$
|
(771.4)
|
|
$
|
4,491.2
|
|
$
|
3,763.5
|
|
$
|
(287.9)
|
|
$
|
3,475.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired
in-process
research and
development
|
|
498.3
|
|
|
(498.3)
|
|
|
—
|
|
|
294.1
|
|
|
(294.1)
|
|
|
—
|
|
Asset impairment,
restructuring and other
special charges
|
|
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
-
diluted
|
|
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,
except per share data)
|
Amortization(i)
|
IPR&D(ii)
|
Equity
investments(iii)
|
Repurchase of
Debt(iv)
|
Other
specified
items(v)
|
Total
|
Cost of
sales
|
$
|
(395.0)
|
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
$
|
(376.4)
|
|
$
|
(771.4)
|
|
|
|
|
|
|
|
|
Acquired
in-process
research and
development
|
—
|
|
(498.3)
|
|
—
|
|
—
|
|
—
|
|
(498.3)
|
|
Asset impairment,
restructuring and other
special charges
|
—
|
|
—
|
|
—
|
|
—
|
|
(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
–
diluted
|
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
data)
|
Amortization(i)
|
IPR&D(ii)
|
Equity
investments(iii)
|
Other specified
items(iv)
|
Total
|
Cost of
sales
|
$
|
(283.7)
|
|
$
|
—
|
|
$
|
—
|
|
$
|
(4.2)
|
|
$
|
(287.9)
|
|
|
|
|
|
|
|
Acquired in-process
research and
development
|
—
|
|
(294.1)
|
|
—
|
|
—
|
|
(294.1)
|
|
Asset impairment,
restructuring and
other special charges
|
—
|
|
—
|
|
—
|
|
(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