- Revenue in Q4 2023 increased 28%. New Products(i)
revenue grew by $2.19 billion to
$2.49 billion in Q4 2023, led by
Mounjaro and Zepbound. Growth Products(ii) revenue
increased 9% to $5.27 billion in Q4
2023, led by Verzenio and Jardiance.
- Pipeline progress included FDA approval of
Zepbound for adults with obesity or overweight with weight-related
comorbidities and Jaypirca for chronic lymphocytic leukemia or
small lymphocytic lymphoma under the Accelerated Approval Program.
Additional progress included positive results from
SYNERGY-NASH, a Phase 2 study of tirzepatide in adults with
nonalcoholic steatohepatitis (NASH), also known as metabolic
dysfunction-associated steatohepatitis (MASH).
- Business development activity included the completed
acquisitions of POINT Biopharma Global Inc. and Mablink
Biosciences SAS.
- Q4 2023 EPS increased 13% to $2.42 on a reported basis and increased 19% to
$2.49 on a non-GAAP basis, both
inclusive of $0.62 of acquired
IPR&D charges.
- 2024 guidance issued with revenue in the range of
$40.4 billion to $41.6 billion, EPS in the range of $11.80 to $12.30
and non-GAAP EPS in the range of $12.20 to $12.70.
(i) Lilly defines New Products as select products launched
since 2022, which currently consist of Ebglyss, Jaypirca, Mounjaro,
Omvoh and Zepbound.
(ii) Lilly defines Growth Products as select products launched
prior to 2022, which currently consist of Cyramza, Emgality,
Jardiance, Olumiant, Retevmo, Taltz, Trulicity, Tyvyt and
Verzenio.
INDIANAPOLIS, Feb. 6, 2024
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced
its financial results for the fourth quarter of 2023.
"2023 was a year of tremendous achievement for Lilly, which
delivered life-changing medicines to more patients than ever before
resulting in strong revenue growth," said David A. Ricks, Lilly's chair and CEO. "We
advanced our pipeline of new medicines for serious diseases and
created new partnerships and innovative ways of collaborating to
add to that pipeline. Lilly invested in the quality, reliability
and resilience of our supply chain with new advanced manufacturing
plants and lines in the U.S. and in Europe. Entering 2024, we remain focused on
the opportunity in front of us, to help solve some of the most
challenging healthcare problems in the world and make life better
for millions of patients."
Lilly has had numerous updates recently on key regulatory,
clinical, business development and other events, including:
- U.S. Food and Drug Administration (FDA) approval
of Zepbound® (tirzepatide) for the treatment of
adult patients with obesity or overweight with weight-related
comorbidities;
- FDA approval of Jaypirca® for the treatment of
adult patients with chronic lymphocytic leukemia or small
lymphocytic lymphoma (CLL/SLL) who have received at least two prior
lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor,
under the Accelerated Approval Program;
- Positive results from SYNERGY-NASH, a Phase 2 study
of tirzepatide in adults with nonalcoholic steatohepatitis
(NASH), also known as metabolic dysfunction-associated
steatohepatitis (MASH), which met its primary endpoint where up to
74% of participants achieved an absence of MASH with no worsening
of fibrosis at 52 weeks, compared to nearly 13% of participants on
placebo;
- Negative Phase 3 CYCLONE-2 results, in which Verzenio
added to abiraterone did not meet the primary endpoint of improved
radiographic progression-free survival (rPFS) in men with
metastatic castration-resistant prostate cancer (mCRPC); the
overall safety and tolerability profile was consistent with the
known profiles of the medicines;
- Approval of Ebglyss® (lebrikizumab) for adult
and adolescent patients with moderate-to-severe atopic dermatitis
in the European Union and Japan
(Almirall S.A. has licensed the rights from Lilly to develop and
commercialize Ebglyss in Europe);
- Announcement of LillyDirect™, the company's
end-to-end digital healthcare experience;
- Announcement of further expansion of the company's injectable
manufacturing capacity with a planned investment of $2.5 billion to build a site in Germany;
- Completion of the acquisitions of POINT Biopharma Global Inc.
and Mablink Biosciences SAS;
- The sixth consecutive 15% annual increase in Lilly's quarterly
dividend, more than doubling the dividend since 2018; and
- Announcement of Johna Norton, Lilly executive vice
president of Global Quality, retirement after 34 years of service
with the company, effective July 31,
2024.
For information on important public announcements, visit the
news section of Lilly's website.
Financial Results
|
|
|
|
|
|
$ in millions,
except
per share
data
|
Fourth
Quarter
|
|
2023
|
|
2022
|
|
% Change
|
Revenue
|
$
9,353.4
|
|
$
7,301.8
|
|
28 %
|
|
|
|
|
|
|
Net income –
Reported
|
2,189.6
|
|
1,937.7
|
|
13 %
|
Earnings per share –
Reported
|
2.42
|
|
2.14
|
|
13 %
|
|
|
|
|
|
|
Net income –
Non-GAAP
|
2,249.4
|
|
1,893.1
|
|
19 %
|
Earnings per share –
Non-GAAP
|
2.49
|
|
2.09
|
|
19 %
|
|
|
|
|
|
|
A discussion of the non-GAAP financial measures is included
below under "Reconciliation of GAAP Reported to Selected Non-GAAP
Adjusted Information (Unaudited)."
Fourth-Quarter Reported Results
In Q4 2023, worldwide revenue was $9.35
billion, an increase of 28% compared with Q4 2022, driven by
increases of 16% due to higher realized prices, 11% in volume and
1% from the favorable impact of foreign exchange rates. Higher
realized prices were driven by Mounjaro® in the U.S.,
partially offset by lower realized prices for Humalog®
and Trulicity®. In the U.S., Mounjaro saw net price
positively impacted by savings card dynamics compared with Q4 2022,
as well as a favorable one-time change in estimates for rebates and
discounts. The volume increase was primarily driven by growth from
Mounjaro, Verzenio®, Zepbound, Jardiance® and
Taltz®, partially offset by declines in
Alimta® and Trulicity. New Products revenue grew by
$2.19 billion to $2.49 billion in Q4 2023. Growth Products revenue
increased 9% to $5.27 billion in Q4
2023.
Revenue in the U.S. increased 39% to $6.46 billion, driven by a 27% increase in
realized prices and a 12% increase in volume. The higher realized
prices in the U.S. were driven by Mounjaro, partially offset by
lower realized prices for Humalog and Trulicity. When excluding
Mounjaro, realized prices in the U.S. declined by high-single
digits for the quarter. The increase in U.S. volume was driven by
Mounjaro, Zepbound, Verzenio, Jardiance and Taltz, partially offset
by a decrease in Trulicity.
Revenue outside the U.S. increased 10% to $2.90 billion, driven by a 10% increase in volume
and a 3% increase from the favorable impact of foreign exchange
rates, partially offset by a 3% decrease due to lower realized
prices. The increase in volume outside the U.S. was driven by
Verzenio, Mounjaro, Jardiance, Tyvyt® and Taltz. Revenue
also benefited from $65 million
associated with milestones for the EU approval and launch of
Ebglyss. These drivers were partially offset by approximately
$130 million of one-time revenue in
2022 associated with the sale of the company's rights to Alimta in
Korea and Taiwan.
Gross margin increased 31% to $7.57
billion in Q4 2023. Gross margin as a percent of revenue was
80.9%, an increase of 2.1 percentage points. The increase in gross
margin percent was primarily driven by higher realized prices,
partially offset by increased manufacturing expenses related to
labor costs and investments in capacity expansion.
In Q4 2023, research and development expenses increased 28% to
$2.56 billion, or 27% of revenue,
primarily driven by development expenses for late-stage assets and
additional investments in early-stage research, as well as higher
incentive compensation costs.
Marketing, selling and administrative expenses increased 17% to
$1.92 billion in Q4 2023, primarily
driven by costs associated with launches of new products and
indications, as well as higher incentive compensation costs.
In Q4 2023, the company recognized acquired in-process research
and development (IPR&D) charges of $622.6 million compared with $240.1 million in Q4 2022. The Q4 2023 charges
primarily related to the acquisition of Mablink Biosciences SAS and
the business development transaction with Beam Therapeutics
Inc.
Other income (expense) was $121.0
million of income in Q4 2023, compared with $260.0 million of income in Q4 2022. The
decrease in income was driven by lower net gains on investments in
equity securities in Q4 2023 compared with Q4 2022 and, to a lesser
extent, higher net interest expenses.
The effective tax rate was 12.7% in Q4 2023 compared with 7.6%
in Q4 2022. The higher effective tax rate for Q4 2023 was primarily
driven by a lower net discrete tax benefit compared with Q4 2022
and the new Puerto Rico tax
regime.
In Q4 2023, net income and earnings per share (EPS) were
$2.19 billion and $2.42, respectively, compared with net income of
$1.94 billion and EPS of
$2.14 in Q4 2022. EPS in Q4 2023
included $0.62 of acquired IPR&D
charges compared with $0.23 in
Q4 2022.
Fourth-Quarter Non-GAAP Measures
On a non-GAAP basis, Q4 2023 gross margin increased 31% to
$7.69 billion. Gross margin as a
percent of revenue was 82.3%, an increase of 1.8 percentage points.
The increase in gross margin percent was primarily driven by higher
realized prices, partially offset by increased manufacturing
expenses related to labor costs and investments in capacity
expansion.
The effective tax rate on a non-GAAP basis was 13.1% in Q4 2023
compared with 7.3% in Q4 2022. The higher effective tax rate for Q4
2023 was primarily driven by a lower net discrete tax benefit
compared with Q4 2022 and the new Puerto
Rico tax regime.
On a non-GAAP basis, Q4 2023 net income and EPS were
$2.25 billion and $2.49, respectively, compared with net income of
$1.89 billion and EPS of $2.09 in Q4 2022. Non-GAAP EPS in Q4 2023
included $0.62 of acquired IPR&D charges compared
with $0.23 in Q4 2022.
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 (Unaudited)" table later in this
press release.
|
Fourth
Quarter
|
|
2023
|
|
2022
|
|
% Change
|
Earnings per share
(reported)
|
$
2.42
|
|
$
2.14
|
|
13 %
|
Amortization of
intangible assets
|
.11
|
|
.11
|
|
|
Asset impairment,
restructuring and other
special charges
|
.06
|
|
.03
|
|
|
Net gains on
investments in equity securities
|
(.11)
|
|
(.19)
|
|
|
Earnings per share
(non-GAAP)
|
$
2.49
|
|
$
2.09
|
|
19 %
|
Numbers may not add due
to rounding.
|
|
|
|
|
|
|
|
|
|
|
|
Acquired
IPR&D
|
.62
|
|
.23
|
|
NM
|
Selected Revenue Highlights
|
|
|
|
|
|
|
|
|
|
|
(Dollars in
millions)
|
Fourth
Quarter
|
|
Year-to-Date
|
Selected
Products
|
2023
|
|
2022
|
|
% Change
|
|
2023
|
|
2022
|
|
% Change
|
Trulicity
|
$
1,669.3
|
|
$
1,936.2
|
|
(14) %
|
|
$
7,132.6
|
|
$
7,439.7
|
|
(4) %
|
Mounjaro
|
2,205.6
|
|
279.2
|
|
NM
|
|
5,163.1
|
|
482.5
|
|
NM
|
Verzenio
|
1,145.4
|
|
808.0
|
|
42 %
|
|
3,863.4
|
|
2,483.5
|
|
56 %
|
Taltz
|
784.6
|
|
707.8
|
|
11 %
|
|
2,759.6
|
|
2,482.0
|
|
11 %
|
Jardiance(a)
|
798.1
|
|
612.3
|
|
30 %
|
|
2,744.7
|
|
2,066.0
|
|
33 %
|
Humalog(b)
|
366.6
|
|
548.3
|
|
(33) %
|
|
1,663.3
|
|
2,060.6
|
|
(19) %
|
Cyramza®
|
253.6
|
|
277.8
|
|
(9) %
|
|
974.7
|
|
971.4
|
|
0 %
|
Olumiant®(c)
|
243.5
|
|
205.8
|
|
18 %
|
|
922.6
|
|
830.5
|
|
11 %
|
Emgality®
|
186.1
|
|
175.6
|
|
6 %
|
|
678.3
|
|
650.9
|
|
4 %
|
Tyvyt
|
113.6
|
|
57.5
|
|
98 %
|
|
393.4
|
|
293.3
|
|
34 %
|
Retevmo®
|
73.4
|
|
64.6
|
|
14 %
|
|
253.6
|
|
191.9
|
|
32 %
|
Alimta
|
44.9
|
|
236.6
|
|
(81) %
|
|
217.5
|
|
927.7
|
|
(77) %
|
Zepbound
|
175.8
|
|
—
|
|
NM
|
|
175.8
|
|
—
|
|
NM
|
COVID-19
antibodies(d)
|
—
|
|
38.0
|
|
(100) %
|
|
—
|
|
2,023.5
|
|
(100) %
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Revenue
|
9,353.4
|
|
7,301.8
|
|
28 %
|
|
34,124.1
|
|
28,541.4
|
|
20 %
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
Jardiance includes Glyxambi®, Synjardy® and
Trijardy® XR
(b) Humalog
includes Insulin Lispro
(c) Olumiant
includes sales of baricitinib that were made pursuant to
Emergency Use Authorization (EUA) or similar
regulatory authorizations
(d) COVID-19
antibodies include sales for bamlanivimab administered alone, for
bamlanivimab and etesevimab
administered together, and for bebtelovimab, and were made pursuant
to EUAs or similar regulatory authorizations
NM – not
meaningful
|
Trulicity
For Q4 2023, worldwide Trulicity revenue decreased 14% compared
with Q4 2022 to $1.67 billion. U.S.
revenue decreased 18% to $1.26
billion, driven by decreased volume and lower realized
prices. Lilly has experienced and continues to expect intermittent
delays fulfilling orders of Trulicity. These delays have impacted
and are expected to continue to impact volume. Revenue outside the
U.S. increased 1% to $413.6 million,
driven by increased volume and the favorable impact of foreign
exchange rates, largely offset by lower realized prices. Volumes in
international markets continue to be affected by actions Lilly has
taken to manage demand amid tight supply, including measures to
minimize impact to existing patients.
Mounjaro
For Q4 2023, worldwide Mounjaro revenue was $2.21 billion compared with $279.2 million in Q4 2022. U.S. revenue was
$2.11 billion compared with
$256.7 million in Q4 2022 reflecting
higher realized prices due to decreased utilization of savings card
programs as access continued to expand, as well as increased
demand. U.S. revenue in Q4 2023 represented a sequential increase
of $828.1 million, or 65%, compared
with U.S. revenue of $1.28 billion in
Q3 2023. Q4 2023 U.S. Mounjaro revenue also benefited from a
favorable one-time change in estimates for rebates and discounts.
Adjusting for this one-time change, sequential net sales would have
grown by approximately 30% in Q4. Lilly has experienced and
continues to expect intermittent delays fulfilling orders of
certain Mounjaro doses given significant demand, which is expected
to affect volume. Revenue outside the U.S. was $100.5 million compared with $22.5 million in Q4 2022.
Verzenio
For Q4 2023, worldwide Verzenio revenue increased 42% compared with
Q4 2022 to $1.15 billion. U.S.
revenue was $774.8 million, an
increase of 40%, driven by increased demand and higher
realized prices. Revenue outside the U.S. was $370.6 million, an increase of 45%, driven by
increased demand and, to a lesser extent, the favorable impact of
foreign exchange rates, partially offset by lower realized
prices.
Taltz
For Q4 2023, worldwide Taltz revenue increased 11% compared with Q4
2022 to $784.6 million. U.S.
revenue increased 5% to $537.8 million, driven by increased demand,
partially offset by lower realized prices. Revenue outside the U.S.
increased 26% to $246.8 million,
driven by increased volume.
Jardiance
For Q4 2023, the company's worldwide Jardiance revenue increased
30% compared with Q4 2022 to $798.1
million. U.S. revenue was $468.9
million, an increase of 29%, driven by increased demand.
Revenue outside the U.S. was $329.1
million, an increase of 32%, 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.
Humalog
For Q4 2023, worldwide Humalog revenue decreased 33% compared with
Q4 2022 to $366.6 million. U.S.
revenue was $167.6 million, a
decrease of 50%, driven by lower realized prices primarily due to a
one-time impact related to the implementation of list price
decreases, partially offset by increased demand. Revenue outside
the U.S. was $199.0 million, a
decrease of 6%, driven by decreased volume, partially offset by the
favorable impact of foreign exchange rates.
Olumiant
For Q4 2023, worldwide Olumiant revenue increased 18% compared with
Q4 2022 to $243.5 million. U.S.
revenue increased 53% to $66.7
million, driven by increased demand, partially offset by
lower realized prices. Revenue outside the U.S. was $176.8 million, an increase of 9%, driven by
increased volume.
Emgality
For Q4 2023, worldwide Emgality revenue increased 6% compared with
Q4 2022 to $186.1 million. U.S.
revenue decreased 3% to $128.3 million, driven by lower realized
prices, largely offset by increased demand. Revenue outside the
U.S. increased 33% to $57.8 million,
driven by increased volume and higher realized prices.
Zepbound
For Q4 2023, worldwide Zepbound revenue was $175.8 million. Zepbound launched in the U.S. for
the treatment of adult patients with obesity or overweight with
weight-related comorbidities in November
2023.
2024 Financial Guidance
The company anticipates 2024 revenue to be in the range of
$40.4 billion to $41.6 billion. The growth in revenue compared to
2023 is expected to be largely driven by New Products, partially
offset by an expected continuation of the decline in Trulicity
sales. The company continues to execute on its manufacturing
expansion agenda, however, given strong demand and the time
required to bring manufacturing capacity fully online, the company
expects that demand for incretins is likely to outpace supply in
2024.
The company's guidance now includes a new ratio calculated by
subtracting research and development expenses and marketing,
selling and administrative expenses from gross margin, and
expressed as a percentage of revenue. The company anticipates this
ratio to be 30% to 32% on a reported basis and 31% to 33% on a
non-GAAP basis. Marketing, selling and administrative expenses are
expected to continue growing in 2024, though at a pace slower than
revenue growth with growth driven by marketing investments in
recently launched and upcoming launch products. Research and
development expenses are expected to increase at a higher rate than
marketing, selling and administrative expenses in 2024, driven by
investments in ongoing and new late-phase opportunities.
Consistent with 2023, the company is not including any potential
or pending acquired IPR&D charges in its initial 2024 guidance
and expects to update EPS guidance each quarter as acquired
IPR&D charges are incurred.
Other income (expense) is expected to be expense in the range of
$400 million to $500 million, primarily driven by higher interest
expense.
The 2024 effective tax rate is expected to be approximately 14%.
This rate does not assume deferral or repeal of the provision in
the 2017 Tax Act requiring capitalization and amortization of
research and development for tax purposes.
EPS for 2024 is expected to be in the range of $11.80 to $12.30 on
a reported basis and $12.20 to
$12.70 on a non-GAAP basis. The
company's 2024 financial guidance reflects adjustments shown in the
reconciliation table below.
|
2024
Guidance
|
Earnings per share
(reported)
|
$11.80 to
$12.30
|
Amortization of
intangible assets
|
.40
|
Earnings per share
(non-GAAP)
|
$12.20 to
$12.70
|
Numbers may not add due
to rounding
|
|
|
|
The following table summarizes the company's 2024 financial
guidance:
|
2024 Guidance(1)
|
|
|
|
|
Revenue
|
|
|
$40.4 to $41.6
billion
|
|
|
|
|
(Gross Margin -
OPEX(2)) / Revenue:
|
|
|
|
(reported)
|
|
|
30% to 32%
|
(non-GAAP)
|
|
|
31% to 33%
|
|
|
|
|
Other
Income/(Expense)
|
|
|
($500) to ($400)
million
|
|
|
|
|
Tax Rate
|
|
|
Approx. 14%
|
|
|
|
|
Earnings per Share
(reported)
|
|
|
$11.80 to
$12.30
|
Earnings per Share
(non-GAAP)
|
|
|
$12.20 to
$12.70
|
|
|
|
|
(1) Non-GAAP
guidance reflects adjustments presented in the earnings per share
reconciliation
table above.
|
(2) OPEX is
defined as the sum of research and development expenses and
marketing, selling
and administrative expenses.
|
Webcast of Conference Call
As previously announced,
investors and the general public can access a live webcast of the
Q4 2023 financial results conference call through a link on Lilly's
website at investor.lilly.com/webcasts-and-presentations. The
conference call will begin at 10 a.m.
Eastern time today and will be available for replay via the
website.
Non-GAAP Financial Measures
Certain financial
information 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. Related materials provide certain GAAP and
non-GAAP figures excluding the impact of foreign exchange rates.
Lilly recalculates current period figures on a constant currency
basis by keeping constant the exchange rates from the base period.
The company's 2024 financial guidance is 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.
About Lilly
Lilly is a medicine company turning
science into healing to make life better for people around the
world. We've been pioneering life-changing discoveries for nearly
150 years, and today our medicines help more than 51 million people
across the globe. Harnessing the power of biotechnology, chemistry
and genetic medicine, our scientists are urgently advancing new
discoveries to solve some of the world's most significant health
challenges: redefining diabetes care; treating obesity and
curtailing its most devastating long-term effects; advancing the
fight against Alzheimer's disease; providing solutions to some of
the most debilitating immune system disorders; and transforming the
most difficult-to-treat cancers into manageable diseases. With each
step toward a healthier world, we're motivated by one thing: making
life better for millions more people. That includes delivering
innovative clinical trials that reflect the diversity of our world
and working to ensure our medicines are accessible and affordable.
To learn more, visit Lilly.com and
Lilly.com/news. F-LLY
Cautionary Statement Regarding Forward-Looking
Statements
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", "may", "could", "aim", "seek", "will",
"continue" 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
from those anticipated, including 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 and uncertain outcome of
acquisitions and business development transactions and related
costs; intense competition affecting the company's products,
pipeline or industry; market uptake of launched products and
indications; continued pricing pressures and the impact of actions
of governmental and private payers affecting pricing of,
reimbursement for, and patient access to pharmaceuticals, or
reporting obligations related thereto; safety or efficacy concerns
associated with the company's products; dependence on relatively
few products or product classes for a significant percentage of the
company's total revenue and an increasingly consolidated supply
chain; the expiration of intellectual property protection for
certain of the company's products and competition from generic and
biosimilar products, and risks from the proliferation of
counterfeit or illegally compounded products; the company's ability
to protect and enforce patents and other intellectual property or
changes in patent law or regulations related to data package
exclusivity; information technology system inadequacies, inadequate
controls or procedures, security breaches, or operating failures;
unauthorized access, disclosure, misappropriation, or compromise of
confidential information or other data stored in the company's
information technology systems, networks, and facilities, or those
of third parties with whom the company shares its data and
violations of data protection laws or regulations; issues with
product supply and regulatory approvals stemming from manufacturing
difficulties, disruptions, or shortages, including as a result of
unpredictability and variability in demand, labor shortages,
third-party performance, quality, cyber-attacks, or regulatory
actions related to the company's and third-party facilities;
reliance on third-party relationships and outsourcing arrangements;
the use of artificial intelligence or other emerging technologies
in various facets of the company's operations may exacerbate
competitive, regulatory, litigation, cybersecurity and other risks;
the impact of global macroeconomic conditions, including uneven
economic growth or downturns or uncertainty, trade disruptions,
international tension, conflicts, regional dependencies, or other
costs, uncertainties and risks related to engaging in business
globally; devaluations in foreign currency exchange rates or
changes in interest rates and inflation; litigation,
investigations, or other similar proceedings involving past,
current, or future products or activities; changes in tax law and
regulations, tax rates, or events that differ from our assumptions
related to tax positions; regulatory changes and developments;
regulatory actions regarding the company's operations and products;
regulatory compliance problems or government investigations; actual
or perceived deviation from environmental-, social-, or
governance-related requirements or expectations; asset impairments
and restructuring charges; and changes in accounting and reporting
standards. For additional information about the factors that could
cause actual results or events 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)
Cyramza® (ramucirumab, Lilly)
Ebglyss® (lebrikizumab, Lilly)
Emgality® (galcanezumab-gnlm, Lilly)
Glyxambi® (empagliflozin/linagliptin, Boehringer
Ingelheim)
Humalog® (insulin lispro injection of recombinant DNA
origin, Lilly)
Jardiance® (empagliflozin, Boehringer Ingelheim)
Jaypirca® (pirtobrutinib, Lilly)
Mounjaro® (tirzepatide injection, Lilly)
Olumiant® (baricitinib, Lilly)
Omvoh™ (mirikizumab, Lilly)
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, Innovent)
Verzenio® (abemaciclib, Lilly)
Zepbound® (tirzepatide injection, Lilly)
Third-party trademarks used herein are trademarks of their
respective owners.
Eli Lilly and
Company
Operating Results
(Unaudited) – REPORTED
(Dollars in millions,
except per share data)
|
|
|
|
Three Months
Ended
|
|
|
Twelve Months
Ended
|
|
|
December 31,
|
|
|
December 31,
|
|
|
2023
|
|
2022
|
|
% Chg.
|
|
|
2023
|
|
2022
|
|
% Chg.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
$
|
9,353.4
|
$
|
7,301.8
|
|
28 %
|
|
$
|
34,124.1
|
$
|
28,541.4
|
|
20 %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
1,788.0
|
|
1,548.1
|
|
15 %
|
|
|
7,082.2
|
|
6,629.8
|
|
7 %
|
Research and
development
|
|
2,562.7
|
|
1,995.9
|
|
28 %
|
|
|
9,313.4
|
|
7,190.8
|
|
30 %
|
Marketing, selling
and
administrative
|
|
1,924.6
|
|
1,643.2
|
|
17 %
|
|
|
7,403.1
|
|
6,440.4
|
|
15 %
|
Acquired
IPR&D
|
|
622.6
|
|
240.1
|
|
NM
|
|
|
3,799.8
|
|
908.5
|
|
NM
|
Asset impairment,
restructuring
and other special charges
|
|
67.7
|
|
38.1
|
|
78 %
|
|
|
67.7
|
|
244.6
|
|
(72) %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
2,387.8
|
|
1,836.4
|
|
30 %
|
|
|
6,457.9
|
|
7,127.3
|
|
(9) %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income
(expense)
|
|
(93.7)
|
|
(58.5)
|
|
|
|
|
(312.3)
|
|
(268.8)
|
|
|
Net other income
(expense)
|
|
214.7
|
|
318.5
|
|
|
|
|
409.0
|
|
(52.1)
|
|
|
Other income
(expense)
|
|
121.0
|
|
260.0
|
|
(53) %
|
|
|
96.7
|
|
(320.9)
|
|
NM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income
taxes
|
|
2,508.8
|
|
2,096.4
|
|
20 %
|
|
|
6,554.6
|
|
6,806.4
|
|
(4) %
|
Income tax
expense
|
|
319.2
|
|
158.7
|
|
NM
|
|
|
1,314.2
|
|
561.6
|
|
NM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
$
|
2,189.6
|
$
|
1,937.7
|
|
13 %
|
|
$
|
5,240.4
|
$
|
6,244.8
|
|
(16) %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per share -
diluted
|
$
|
2.42
|
$
|
2.14
|
|
13 %
|
|
$
|
5.80
|
$
|
6.90
|
|
(16) %
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per
share
|
$
|
1.13
|
$
|
.98
|
|
15 %
|
|
$
|
4.52
|
$
|
3.92
|
|
15 %
|
Weighted-average
shares
outstanding (thousands) -
diluted
|
|
903,980
|
|
904,732
|
|
|
|
|
903,284
|
|
904,619
|
|
|
NM – not
meaningful
|
Eli Lilly and
Company
|
Reconciliation of GAAP
Reported to Selected Non-GAAP Adjusted Information
(Unaudited)
|
(Dollars in millions,
except per share data)
|
|
|
|
Three Months Ended
December 31,
|
|
Twelve Months Ended
December 31,
|
|
|
2023
|
2022
|
|
2023
|
2022
|
Gross Margin - As
Reported
|
|
$
7,565.4
|
$
5,753.7
|
|
$
27,041.9
|
$
21,911.6
|
|
|
|
|
|
|
|
Increase for excluded
items:
|
|
|
|
|
|
|
Amortization of
intangible assets
(Cost of sales)(i)
|
|
129.0
|
124.1
|
|
506.2
|
574.1
|
|
|
|
|
|
|
|
Gross Margin -
Non-GAAP
|
|
$
7,694.4
|
$
5,877.8
|
|
$
27,548.1
|
$
22,485.7
|
|
|
|
|
|
|
|
Gross Margin as a
percent of
revenue - As Reported
|
|
80.9 %
|
78.8 %
|
|
79.2 %
|
76.8 %
|
Gross Margin as a
percent of revenue -
Non-GAAP(ii)
|
|
82.3 %
|
80.5 %
|
|
80.7 %
|
78.8 %
|
Numbers may not add due
to rounding.
|
|
i.
|
Exclude amortization of
intangibles primarily associated with costs of marketed products
acquired or licensed from third parties.
|
|
ii.
|
Non-GAAP gross margin
as a percent of revenue reflects the gross margin effects of the
adjustments presented above.
|
|
|
Three Months Ended
December 31,
|
|
Twelve Months Ended
December 31,
|
|
|
2023
|
2022
|
|
2023
|
2022
|
Net Income - As
Reported
|
|
$
2,189.6
|
$
1,937.7
|
|
$
5,240.4
|
$
6,244.8
|
|
|
|
|
|
|
|
Increase (decrease) for
excluded items:
|
|
|
|
|
|
|
Amortization of
intangible assets
(Cost of sales)(i)
|
|
129.0
|
124.1
|
|
506.2
|
574.1
|
Asset impairment,
restructuring and
other special charges(ii)
|
|
67.7
|
38.1
|
|
67.7
|
244.6
|
Net (gains) losses on
investments in
equity securities (Other
income/expense)
|
|
(117.0)
|
(216.5)
|
|
24.8
|
385.9
|
Corresponding tax
effects (Income
taxes)
|
|
(19.9)
|
9.7
|
|
(126.6)
|
(263.0)
|
|
|
|
|
|
|
|
Net Income -
Non-GAAP
|
|
$
2,249.4
|
$
1,893.1
|
|
$
5,712.5
|
$
7,186.4
|
|
|
|
|
|
|
|
Effective tax rate -
As Reported
|
|
12.7 %
|
7.6 %
|
|
20.1 %
|
8.3 %
|
Effective tax rate -
Non-GAAP(iii)
|
|
13.1 %
|
7.3 %
|
|
20.1 %
|
10.3 %
|
Earnings per share
(diluted) - As
Reported
|
|
$
2.42
|
$
2.14
|
|
$
5.80
|
$
6.90
|
Earnings per share
(diluted) - Non-
GAAP
|
|
$
2.49
|
$
2.09
|
|
$
6.32
|
$
7.94
|
Numbers may not add due
to rounding.
|
|
i.
|
Exclude amortization of
intangibles primarily associated with costs of marketed products
acquired or licensed from third parties.
|
|
ii.
|
For the twelve months
ended December 31, 2022, excluded charges primarily include the
intangible asset impairment for GBA1 Gene Therapy (PR001) due to
changes in estimated launch timing.
|
|
iii.
|
Non-GAAP tax rate
reflects the tax effects of the adjustments presented
above.
|
Refer
to:
|
Jordan Bishop;
jordan.bishop@lilly.com; (317) 473-5712 (Media)
|
|
Joe Fletcher;
jfletcher@lilly.com; (317) 296-2884 (Investors)
|
View original content to download
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SOURCE Eli Lilly and Company