On November 2, 2023 Eli Lilly and Company (NYSE: LLY) reported its financial results for the third quarter of 2023 (Press release, Eli Lilly, NOV 2, 2023, View Source [SID1234636758]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Lilly had another strong quarter in Q3 as Mounjaro and Verzenio continued to gain momentum," said David A. Ricks, Lilly’s chair and CEO. "Lilly executed on business development priorities in the third quarter, including multiple acquisitions that expand our already robust pipeline. We remain focused on growth and delivering new, innovative medicines that make life better for millions of patients around the globe."
Lilly has had numerous updates recently on key regulatory, clinical, business development and other events, including:
The U.S. Food and Drug Administration (FDA) approval of Omvoh (mirikizumab) for the treatment of adults with moderately to severely active ulcerative colitis;
FDA approval of Jardiance for the treatment of adults with chronic kidney disease;
Positive Phase 3 VIVID-1 results, which evaluated the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn’s disease;
Positive Phase 3 LIBRETTO-531 results, which showed that Retevmo demonstrated superior progression-free survival compared to approved multikinase inhibitors in RET-mutant medullary thyroid cancer;
Updated timing of expected FDA action on donanemab for the treatment of early symptomatic Alzheimer’s disease to Q1 2024;
The FDA’s issuance of a complete response letter for lebrikizumab for the treatment of moderate-to-severe atopic dermatitis based on inspection findings at a third-party manufacturer with no stated concerns about the clinical data package, safety or label;
Completion of the acquisitions of DICE Therapeutics, Inc., Versanis Bio, Inc., Emergence Therapeutics AG and Sigilon Therapeutics, Inc.;
The announcement of an agreement to acquire POINT Biopharma Global Inc. to expand oncology capabilities into radioligand therapies; and
The announcement of changes to the company’s executive leadership team.
For information on important public announcements, visit the news section of Lilly’s website.
Financial Results
$ in millions, except
per share data
Third Quarter
2023
2022
% Change
Revenue
$9,498.6
$6,941.6
37 %
Net income (loss) – Reported
(57.4)
1,451.7
NM
Earnings (loss) per share – Reported
(0.06)
1.61
NM
Net income – Non-GAAP
94.8
1,789.2
(95) %
Earnings per share – Non-GAAP
0.10
1.98
(95) %
A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."
Third-Quarter Reported Results
In Q3 2023, worldwide revenue was $9.50 billion, an increase of 37% compared with Q3 2022, driven by increases of 31% in volume, 6% due to higher realized prices, and 1% from the favorable impact of foreign exchange rates. The volume increase was primarily driven by $1.42 billion from the sale of rights for the olanzapine portfolio (Zyprexa), and volume growth from Verzenio, Mounjaro, Jardiance, Taltz and Trulicity, partially offset by the absence of COVID-19 antibodies revenue in 2023. Excluding revenue from the olanzapine portfolio and the $386.6 million of COVID-19 antibodies sales in 2022, revenue in Q3 2023 increased 24%. New Products contributed $1.44 billion to revenue in Q3 2023. Growth Products revenue increased 12% to $4.96 billion in Q3 2023. Higher realized prices were primarily driven by Mounjaro savings card dynamics, partially offset by Trulicity.
Revenue in the U.S. increased 21% to $5.37 billion, driven by a 13% increase in realized prices and a 9% increase in volume. The higher realized prices in the U.S. were driven by Mounjaro savings card dynamics, partially offset by lower realized prices for Trulicity. When excluding Mounjaro, U.S. price declined high-single digits for the quarter. The increase in U.S. volume was driven by Mounjaro, Verzenio, Trulicity, Jardiance and Taltz, partially offset by the absence of revenue from COVID-19 antibodies in 2023. Excluding revenue from the olanzapine portfolio and COVID-19 antibodies, U.S. revenue increased 32%.
Revenue outside the U.S. increased 64% to $4.13 billion, driven by a 69% increase in volume and a 2% increase from the favorable impact of foreign exchange rates, partially offset by a 7% decrease due to lower realized prices. The increase in volume outside the U.S. was largely driven by the sale of rights for the olanzapine portfolio, as well as increased volume for Verzenio, Jardiance and Taltz. The lower realized prices were primarily driven by a new supply arrangement associated with the sale of rights for the olanzapine portfolio. Excluding revenue from the olanzapine portfolio, revenue outside the U.S. increased 10%.
Gross margin increased 42% to $7.64 billion in Q3 2023. Gross margin as a percent of revenue was 80.4%, an increase of 3.1 percentage points. The increase in gross margin percent was primarily driven by the sale of rights for the olanzapine portfolio and the absence of COVID-19 antibodies sales in Q3 2023, as well as higher realized prices, partially offset by increased manufacturing expenses related to labor costs and investments in capacity expansion.
In Q3 2023, research and development expenses increased 34% to $2.41 billion, or 25% of revenue, primarily driven by higher development expenses for late-stage assets and additional investments in early-stage research.
Marketing, selling and administrative expenses increased 12% to $1.80 billion in Q3 2023, primarily driven by costs associated with launches of new products and indications, as well as compensation and benefits costs.
In Q3 2023, the company recognized acquired in-process research and development (IPR&D) charges of $2.98 billion, compared with $62.4 million in Q3 2022. The Q3 2023 charges primarily related to the acquisitions of DICE Therapeutics, Inc., Versanis Bio, Inc. and Emergence Therapeutics AG.
There were no asset impairment, restructuring and other special charges recognized in Q3 2023. In Q3 2022, the company recognized asset impairment, restructuring and other special charges of $206.5 million.
Other income (expense) was $23.2 million of expense in Q3 2023 compared with $111.0 million of expense in Q3 2022. The decrease in expense was primarily driven by lower net losses on investments in equity securities in Q3 2023 compared with Q3 2022.
The effective tax rate was 113.4% in Q3 2023 compared with 7.3% in Q3 2022. The higher effective tax rate for Q3 2023 was primarily driven by the non-deductible acquired IPR&D charges.
In Q3 2023, net income (loss) and earnings (loss) per share were $(57.4) million and $(0.06), respectively, compared with net income of $1.45 billion and earnings per share (EPS) of $1.61 in Q3 2022. EPS in Q3 2023 was inclusive of an increase of $1.22 of EPS associated with the sale of rights for the olanzapine portfolio, as well as a decrease of $3.29 from acquired IPR&D charges, compared with a decrease of $0.06 from acquired IPR&D charges in Q3 2022.
Third-Quarter Non-GAAP Measures
On a non-GAAP basis, Q3 2023 gross margin increased 41% to $7.76 billion. Gross margin as a percent of revenue was 81.7%, an increase of 2.7 percentage points. The increase in gross margin percent was primarily driven by the sale of rights for the olanzapine portfolio and the absence of COVID-19 antibodies sales in Q3 2023, as well as 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 84.6% in Q3 2023 compared with 10.7% in Q3 2022. The higher effective tax rate for Q3 2023 reflected the non-deductible acquired IPR&D charges.
On a non-GAAP basis, Q3 2023 net income and EPS were $94.8 million and $0.10, respectively, compared with $1.79 billion and $1.98 in Q3 2022. Non-GAAP EPS in Q3 2023 was inclusive of an increase of $1.22 of EPS associated with the sale of rights for the olanzapine portfolio, as well as a decrease of $3.29 from acquired IPR&D charges, compared with a decrease of $0.06 from acquired IPR&D charges in Q3 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.
Third Quarter
2023
2022
% Change
Earnings (loss) per share (reported)
$(0.06)
$1.61
NM
Asset impairment, restructuring and other
special charges
—
.17
Amortization of intangible assets
.11
.11
Net losses on investments in equity securities
.06
.09
Earnings per share (non-GAAP)
$0.10
$1.98
(95) %
Numbers may not add due to rounding.
Acquired IPR&D
3.29
.06
NM
Selected Revenue Highlights
(Dollars in millions)
Third Quarter
Year-to-Date
Selected Products
2023
2022
% Change
2023
2022
% Change
Trulicity
$1,673.6
$1,850.4
(10) %
$5,463.2
$5,503.5
(1) %
Mounjaro
1,409.3
187.3
NM
2,957.5
203.2
NM
Verzenio
1,040.2
617.7
68 %
2,717.9
1,675.6
62 %
Taltz
744.2
679.9
9 %
1,975.0
1,774.2
11 %
Jardiance(a)
700.8
573.3
22 %
1,946.6
1,453.7
34 %
Humalog(b)
395.4
447.0
(12) %
1,296.8
1,512.3
(14) %
Cyramza
224.1
232.1
(3) %
721.1
693.6
4 %
Olumiant(c)
231.4
182.9
27 %
679.2
624.7
9 %
Emgality
168.5
168.5
0 %
492.2
475.2
4 %
Tyvyt
115.1
76.8
50 %
279.7
235.8
19 %
Retevmo
63.4
40.5
56 %
180.2
127.3
42 %
Alimta
53.5
119.4
(55) %
172.6
691.1
(75) %
COVID-19 antibodies(d)
—
386.6
(100) %
—
1,985.5
(100) %
Total Revenue
9,498.6
6,941.6
37 %
24,770.7
21,239.6
17 %
(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 Q3 2023, worldwide Trulicity revenue decreased 10% compared with Q3 2022 to $1.67 billion. U.S. revenue decreased 11% to $1.26 billion, primarily driven by changes to estimates for rebates and discounts in both periods, as well as unfavorable segment mix and higher contracted rebates, partially offset by wholesaler buying patterns and increased demand. Revenue outside the U.S. decreased 4% to $414.6 million, driven by lower realized prices and decreased volume, partially offset by the favorable impact of foreign exchange rates. Volumes in international markets were affected by actions Lilly has taken to manage strong demand amid tight supply, including measures to minimize impact to existing patients.
Mounjaro
For Q3 2023, worldwide Mounjaro revenue was $1.41 billion. U.S. revenue was $1.28 billion reflecting higher realized prices due to decreased utilization of savings card programs as access continues to expand and increased demand. In Q3 2023, Lilly experienced intermittent delays fulfilling orders of certain Mounjaro doses given significant demand, which affected volume. Revenue outside the U.S. was $132.4 million.
Verzenio
For Q3 2023, worldwide Verzenio revenue increased 68% compared with Q3 2022 to $1.04 billion. U.S. revenue was $684.6 million, an increase of 65%, driven by increased demand and, to a lesser extent, higher realized prices. Revenue outside the U.S. was $355.7 million, an increase of 75%, driven by increased demand, partially offset by lower realized prices.
Taltz
For Q3 2023, worldwide Taltz revenue increased 9% compared with Q3 2022 to $744.2 million. U.S. revenue increased 3% to $509.3 million, driven by increased demand, largely offset by lower realized prices. Revenue outside the U.S. increased 26% to $234.9 million, driven by increased volume and, to a lesser extent, the favorable impact of foreign exchange rates, partially offset by lower realized prices.
Jardiance
For Q3 2023, worldwide Jardiance revenue increased 22% compared with Q3 2022 to $700.8 million. U.S. revenue was $415.9 million, an increase of 19%, primarily driven by increased demand. Revenue outside the U.S. was $284.8 million, an increase of 28%, 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 Q3 2023, worldwide Humalog revenue decreased 12% compared with Q3 2022 to $395.4 million. U.S. revenue was $194.2 million, a decrease of 22%, driven by lower realized prices. Revenue outside the U.S. was $201.2 million, an increase of 1%.
Olumiant
For Q3 2023, worldwide Olumiant revenue increased 27% compared with Q3 2022 to $231.4 million. U.S. revenue increased to $65.7 million, driven by increased demand due to utilization for the treatment of alopecia areata, partially offset by lower realized prices. Revenue outside the U.S. was $165.7 million, an increase of 4%, driven by increased volume, partially offset by lower realized prices.
Emgality
For Q3 2023, worldwide Emgality revenue remained flat compared with Q3 2022 at $168.5 million. U.S. revenue increased 11% to $126.5 million, driven by increased demand, partially offset by lower realized prices. Revenue outside the U.S. decreased 23% to $42.1 million, driven by decreased volume resulting from customer buying patterns in Japan and lower realized prices.
2023 Financial Guidance
The company updated certain elements of its 2023 financial guidance on both a reported and non-GAAP basis.
Revenue guidance remains unchanged with the range of $33.4 to $33.9 billion.
Gross margin as a percent of revenue remains unchanged at approximately 78% on a reported basis and 80% on a non-GAAP basis, but is trending toward the higher end of this estimate.
Marketing, selling and administrative expenses guidance remains unchanged with the range of $7.2 to $7.4 billion, and research and development expenses guidance also remains unchanged with the range of $8.9 to $9.1 billion. Both expense categories are trending toward the top ends of these ranges.
Acquired IPR&D guidance increased by $2.98 billion to $3.18 billion, reflecting charges incurred through Q3 2023. Charges in Q3 2023 primarily related to the acquisitions of DICE Therapeutics, Inc., Versanis Bio, Inc. and Emergence Therapeutics AG.
Other income (expense) guidance has been updated to the range of $150 to $50 million of expense on a reported basis and remains unchanged on a non-GAAP basis with the range of $0 to $100 million of income. The update to the reported guidance reflects net losses on investments in equity securities incurred through Q3 2023.
The estimated effective tax rate increased to 19% to 20%, primarily driven by the non-deductible acquired IPR&D charges incurred in Q3 2023.
Based on these changes, EPS guidance decreased to the range of $5.95 to $6.15 on a reported basis and $6.50 to $6.70 on a non-GAAP basis. The company’s 2023 financial guidance reflects adjustments shown in the reconciliation table below.
2023
Expectations
Earnings per share (reported)
$5.95 to $6.15
Amortization of intangible assets
.44
Net losses on investments in equity securities
.12
Earnings per share (non-GAAP)
$6.50 to $6.70
Numbers may not add due to rounding
The following table summarizes the company’s updated 2023 financial guidance:
2023 Guidance(1)
Prior
Updated
Revenue
$33.4 to $33.9 billion
Unchanged
Gross Margin % of Revenue (reported)
Approx. 78%
Unchanged
Gross Margin % of Revenue (non-GAAP)
Approx. 80%
Unchanged
Marketing, Selling & Administrative
$7.2 to $7.4 billion
Unchanged
Research & Development
$8.9 to $9.1 billion
Unchanged
Acquired IPR&D
$202 million
$3.18 billion(2)
Other Income/(Expense) (reported)
$(75) to $25 million
$(150) to $(50) million
Other Income/(Expense) (non-GAAP)
$0 to $100 million
Unchanged
Tax Rate
14% to 15%
19% to 20%
Earnings per Share (reported)
$9.20 to $9.40
$5.95 to $6.15
Earnings per Share (non-GAAP)
$9.70 to $9.90
$6.50 to $6.70
(1) Non-GAAP guidance reflects adjustments presented in the earnings per share reconciliation table above.
(2) Guidance does not include acquired IPR&D either incurred, or that may potentially be incurred, after Q3 2023.
Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q3 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 9 a.m. Eastern time today and will be available for replay via the website.