Lilly Reports Strong First-Quarter Financial Results, Adjusts EPS Guidance
$ in millions, except per share data |
First Quarter |
% |
||||||
2020 |
2019 |
Change |
||||||
Revenue |
$ |
5,859.8 |
$ |
5,092.2 |
15% |
|||
Net Income – Reported |
1,456.5 |
4,241.6 |
(66)% |
|||||
EPS – Reported
|
1.60 |
4.31 |
(63)% |
|||||
Net Income – Non-GAAP |
1,598.8 |
1,236.7 |
29% |
|||||
EPS – Non-GAAP |
1.75 |
1.33 |
32% |
|||||
Certain financial information for 2020 and 2019 is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with
"
"
Key Events Over the Last Three Months
COVID-19
- The company entered into an agreement with the
National Institute of Allergy and Infectious Diseases (NIAID), part of theNational Institutes of Health , to study baricitinib as an arm in NIAID's Adaptive COVID-19 Treatment Trial. The Phase 3 study will investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients diagnosed with COVID-19. - The company announced that it will advance LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized with COVID-19 who are at a higher risk of progressing to acute respiratory distress syndrome (ARDS).
- The company entered into an agreement with AbCellera to co-develop antibody products for the potential treatment and prevention of COVID-19. The collaboration will leverage AbCellera's rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and
Lilly 's global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies. - The company announced an update on its clinical trial activities in light of the COVID-19 pandemic. The company has delayed most new study starts and has paused enrollment in most ongoing studies, but will continue ongoing clinical trials for patients who are already enrolled.
Regulatory
- The
U.S. Food and Drug Administration (FDA) approved Trulicity® for the reduction of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors. - The FDA approved a supplemental Biologics License Application (sBLA) for Taltz® for the treatment of pediatric patients (ages 6 to under 18) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- The company's newest mealtime insulin received approval in both the
European Union andJapan for the treatment of adults with diabetes as part of a multiple daily injection regimen or delivered by an insulin pump. This novel, fast-acting formulation of insulin lispro is for use by adults with type 1 and type 2 diabetes to reduce blood glucose. - The FDA issued a complete response letter for the supplemental New Drug Application (sNDA) of the investigational medicine empagliflozin 2.5 mg as an adjunct to insulin for adults with type 1 diabetes. The letter indicates that the FDA is unable to approve the application in its current form.
Clinical
- An analysis performed by
Washington University School of Medicine in the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study showed that solanezumab did not meet the primary endpoint of the study. At this time,Lilly does not plan to pursue a submission for solanezumab in people with dominantly inherited Alzheimer's disease (DIAD), also known as autosomal dominant Alzheimer's disease. - The company completed a Phase 4 study of Taltz in patients with moderate to severe psoriasis. Taltz demonstrated non-inferiority to guselkumab on the final secondary endpoint at week 24. As previously disclosed, Taltz achieved superiority compared to guselkumab on all primary and key secondary endpoints at week 12.
- Mirikizumab met the co-primary and key secondary endpoints in a Phase 3, placebo-controlled study, which evaluated the safety and efficacy of mirikizumab for the treatment of moderate to severe plaque psoriasis over 52 weeks. A second Phase 3, placebo- and active- controlled 52-week study is expected to be completed later in 2020.
Business Development/Other Developments
- The company entered into an exclusive global licensing and research collaboration with Sitryx, a biopharmaceutical company focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation. The collaboration will study up to four novel preclinical targets identified by Sitryx that could lead to potential new medicines for autoimmune diseases.
- The company completed the acquisition of
Dermira, Inc. The acquisition expandsLilly 's immunology pipeline with the addition of lebrikizumab, which is being evaluated in a Phase 3 clinical development program for the treatment of moderate to severe atopic dermatitis in adolescent and adult patients, ages 12 years and older. The acquisition also expandsLilly 's portfolio of marketed dermatology medicines with the addition of QBREXZA®, a medicated cloth approved by the FDA for the topical treatment of primary axillary hyperhidrosis.
First-Quarter Reported Results
In the first quarter of 2020, worldwide revenue was
Revenue in the
Revenue outside the
Gross margin increased 18 percent, to
Total operating expenses in the first quarter of 2020, defined as the sum of research and development and marketing, selling, and administrative expenses, increased 7 percent to
In the first quarter of 2020, the company recognized acquired in-process research and development charges of
In the first quarter of 2020, the company recognized asset impairment, restructuring and other special charges of
Operating income in the first quarter of 2020 was
Other income was
The effective tax rate was 13.3 percent in the first quarter of 2020, compared with 23.3 percent in the first quarter of 2019. The higher effective tax rate in the first quarter of 2019 was primarily due to the non-deductibility of the accelerated vesting of Loxo Oncology employee equity awards as part of the closing of the acquisition of Loxo Oncology, as well as tax expenses associated with the withdrawal of Lartruvo.
In the first quarter of 2020, net income and earnings per share were
First-Quarter Non-GAAP Measures
On a non-GAAP basis, first-quarter 2020 gross margin increased 15 percent, to
Operating income on a non-GAAP basis increased
The effective tax rate on a non-GAAP basis was 13.6 percent in the first quarter of 2020, compared with 12.9 percent in the first quarter of 2019. The higher effective tax rate for the first quarter of 2020 was driven primarily by a mix of earnings in higher tax jurisdictions, partially offset by an increase in net discrete tax benefits.
On a non-GAAP basis, in the first quarter of 2020 net income increased 29 percent, to
For further detail of non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information" table later in this press release.
First Quarter |
||||||||
2020 |
2019 |
% Change |
||||||
Earnings per share (reported) |
$ |
1.60 |
$ |
4.31 |
(63)% |
|||
Discontinued operations |
— |
(3.74) |
||||||
Earnings per share from continuing operations (reported) |
1.60 |
0.57 |
||||||
Asset impairment, restructuring and other special charges |
.06 |
.44 |
||||||
Lartruvo charges |
— |
.13 |
||||||
Amortization of intangible assets |
.05 |
.04 |
||||||
Acquired in-process research and development |
.05 |
.12 |
||||||
Impact of reduced shares outstanding for non-GAAP reporting(a) |
— |
.03 |
||||||
Earnings per share (non-GAAP) |
$ |
1.75 |
$ |
1.33 |
32% |
|||
Numbers may not add due to rounding. (a) Non-GAAP earnings per share assume that the disposition of |
Selected Revenue Highlights |
|||||||||
(Dollars in millions) |
First Quarter |
||||||||
Selected Products |
2020 |
2019 |
% Change |
||||||
Trulicity |
$ |
1,229.4 |
$ |
879.7 |
40% |
||||
Humalog(a) |
695.8 |
730.8 |
(5)% |
||||||
Alimta |
560.1 |
499.2 |
12% |
||||||
Taltz |
443.5 |
252.5 |
76% |
||||||
Humulin® |
315.7 |
297.7 |
6% |
||||||
Basaglar |
303.7 |
251.4 |
21% |
||||||
Forteo® |
272.4 |
312.9 |
(13)% |
||||||
Jardiance(b) |
267.5 |
203.6 |
31% |
||||||
Cyramza |
239.0 |
198.3 |
21% |
||||||
Cymbalta® |
210.4 |
164.1 |
28% |
||||||
Verzenio |
188.0 |
109.4 |
72% |
||||||
Olumiant |
139.7 |
82.1 |
70% |
||||||
Emgality |
74.0 |
14.2 |
NM |
||||||
Tyvyt |
57.4 |
9.9 |
NM |
||||||
Baqsimi |
17.8 |
— |
NM |
||||||
Total Revenue |
5,859.8 |
5,092.2 |
15% |
||||||
(a) Humalog includes Insulin Lispro (b) Jardiance includes Glyxambi®, Synjardy®, and Trijardy® XR NM – not meaningful; Numbers may not add due to rounding |
Impact of COVID-19 on First-Quarter 2020 Revenue
The company estimates that revenue in the first quarter of 2020 for many of its products was favorably impacted by increased customer buying patterns and patient prescription trends resulting from the COVID-19 pandemic that increased revenue by approximately
Trulicity
First-quarter 2020 worldwide Trulicity revenue was
Humalog
For the first quarter of 2020, worldwide Humalog revenue decreased 5 percent compared with the first quarter of 2019, to
Alimta
For the first quarter of 2020, worldwide Alimta revenue increased 12 percent compared with the first quarter of 2019, to
Taltz
For the first quarter of 2020, worldwide Taltz revenue increased 76 percent compared with the first quarter of 2019, to
Humulin
For the first quarter of 2020, worldwide Humulin revenue increased 6 percent compared with the first quarter of 2019, to
Basaglar
For the first quarter of 2020, worldwide Basaglar revenue increased 21 percent compared with the first quarter of 2019, to
Forteo
For the first quarter of 2020, worldwide Forteo revenue decreased 13 percent compared with the first quarter of 2019, to
The company expects further volume declines for Forteo as a result of competitive dynamics in the
Jardiance
The company's worldwide Jardiance revenue during the first quarter of 2020 was
Cyramza
For the first quarter of 2020, worldwide Cyramza revenue was
Cymbalta
For the first quarter of 2020, worldwide Cymbalta revenue increased 28 percent compared with the first quarter of 2019, to
Verzenio
For the first quarter of 2020, worldwide Verzenio revenue increased 72 percent compared with the first quarter of 2019, to
Olumiant
For the first quarter of 2020, Olumiant generated worldwide revenue of
Emgality
For the first quarter of 2020, Emgality generated worldwide revenue of
Tyvyt
The company's Tyvyt revenue during the first quarter of 2020 was
Baqsimi
For the first quarter of 2020, Baqsimi generated worldwide revenue of
2020 Financial Guidance
The company has updated certain elements of its 2020 financial guidance on a reported basis and a non-GAAP basis to reflect both management's expectations for operational performance and the uncertainty surrounding the extent and duration of the impact of the COVID-19 pandemic. Key management assumptions supporting the updated guidance include:
- The increased customer buying patterns and patient prescription trends associated with COVID-19 that were experienced in the first quarter of 2020 will largely be reversed over the course of 2020;
- The reduction in new-to-brand prescription trends will peak in the second quarter of 2020 in the
U.S. and much ofEurope ; - Healthcare activity, including non-COVID-19 related patient visits with their physicians, will align more closely with historical levels in the second half of 2020;
- Increased utilization of patient affordability programs and changes in segment mix due to increased
U.S. unemployment will negatively impactU.S. pricing; - Clinical trial enrollment in existing studies, as well as initiation of new clinical trials, will resume in the second half of 2020; and
- Investment in COVID-19 related research, testing and support will continue throughout 2020.
Based on the key assumptions outlined above, the company has adjusted earnings per share for 2020 to now be in the range of
2020 Expectations |
% Change from 2019 |
|
Earnings per share (reported)(a) |
|
25% to 29% |
Amortization of intangible assets |
.37 |
|
Acquired IPR&D(b) |
.07 |
|
Asset impairment, restructuring and other special charges
|
.06 |
|
Earnings per share (non-GAAP) |
|
11% to 14% |
Numbers may not add due to rounding (a) Reported earnings per share percent change from 2019 calculated based on change from 2019 earnings per share from continuing operations. (b) Includes upfront payments for acquired in-process research and development transactions with Sitryx and AbCellera.
|
The company still anticipates 2020 revenue between
Gross margin as a percent of revenue is still expected to be approximately 79.0 percent on a reported basis and approximately 81.0 percent on a non-GAAP basis.
Marketing, selling and administrative expenses are still expected to be in the range of
Operating margin percentage, defined as operating income as a percent of revenue, is still expected to be approximately 28 percent on a reported basis and 31 percent on a non-GAAP basis.
Other income (expense) is now expected to be in the range of
The 2020 effective tax rate is still expected to be approximately 15 percent on both a reported basis and a non-GAAP basis.
The following table summarizes the company's 2020 financial guidance:
2020 Guidance |
|||
Prior |
Updated |
||
Revenue |
|
Unchanged |
|
Gross Margin % of Revenue (reported) |
Approx. 79% |
Unchanged |
|
Gross Margin % of Revenue (non-GAAP) |
Approx. 81% |
Unchanged |
|
Marketing, Selling & Administrative |
|
Unchanged |
|
Research & Development |
|
Unchanged |
|
Other Income/(Expense) |
|
|
|
Tax Rate |
Approx. 15% |
Unchanged |
|
Earnings per share (reported) |
|
|
|
Earnings per share (non-GAAP) |
|
|
|
Operating Income % of Revenue (reported) |
28% |
Unchanged |
|
Operating Income % of Revenue (non-GAAP) |
31% |
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 first-quarter 2020 financial results conference call through a link on
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. There are significant risks and uncertainties in pharmaceutical research and development. There can be no guarantees that pipeline products will receive the necessary clinical and manufacturing regulatory approvals or that they will prove to be commercially successful. The company's results may also be affected by such factors as the timing of anticipated regulatory approvals and launches of new products; market uptake of recently launched products; competitive developments affecting current products and our pipeline; the expiration of intellectual property protection for certain of the company's products; the company's ability to protect and enforce patents and other intellectual property; the impact of actions of governmental and private payers affecting the pricing of, reimbursement for, and access to pharmaceuticals; regulatory compliance problems or government investigations; regulatory actions regarding currently marketed products; unexpected safety or efficacy concerns associated with the company's products; issues with product supply stemming from manufacturing difficulties or disruptions; regulatory changes or other developments; changes in patent law or regulations related to data-package exclusivity; litigation involving past, current or future products; unauthorized disclosure, misappropriation, or compromise of trade secrets or other confidential data stored in the company's information systems, networks and facilities, or those of third parties with which the company shares its data; changes in tax law and regulations, including the impact of
Alimta® (pemetrexed disodium,
Baqsimi™ (glucagon,
Basaglar® (insulin glargine injection,
Cialis® (tadalafil,
Cymbalta® (duloxetine,
Cyramza® (ramucirumab,
Emgality® (galcanezumab-gnlm,
Forteo® (teriparatide of recombinant DNA origin injection,
Glyxambi® (empagliflozin/linagliptin,
Humalog® (insulin lispro injection of recombinant DNA origin,
Humulin® (human insulin of recombinant DNA origin,
Jardiance® (empagliflozin,
Lartruvo® (olaratumab,
Olumiant® (baricitinib,
QBREXZA® (Glycopyrronium cloth,
Strattera® (atomoxetine,
Synjardy® (empagliflozin/metformin,
Taltz® (ixekizumab,
Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets,
Trulicity® (dulaglutide,
Tyvyt® (sintilimab injection,
Verzenio® (abemaciclib,
Third party trademarks used herein are trademarks of their respective owners.
Eli |
|
|
|||
Worldwide Employees |
33,815 |
33,755 |
|
|||||||||
Operating Results (Unaudited) – REPORTED |
|||||||||
(Dollars in millions, except per share data) |
|||||||||
Three Months Ended |
|||||||||
|
|||||||||
2020 |
2019 |
% Chg. |
|||||||
Revenue |
$ |
5,859.8 |
$ |
5,092.2 |
15% |
||||
Cost of sales |
1,215.1 |
1,138.7 |
7% |
||||||
Research and development |
1,392.1 |
1,230.5 |
13% |
||||||
Marketing, selling and administrative |
1,549.6 |
1,517.1 |
2% |
||||||
Acquired in-process research and development |
52.3 |
136.9 |
(62)% |
||||||
Asset impairment, restructuring and other special charges |
59.9 |
423.9 |
(86)% |
||||||
Operating income |
1,590.8 |
645.1 |
NM |
||||||
Net interest income (expense) |
(78.2) |
(55.9) |
|||||||
Net other income (expense) |
167.3 |
141.9 |
|||||||
Other income (expense) |
89.1 |
86.0 |
4% |
||||||
Income before income taxes |
1,679.9 |
731.1 |
NM |
||||||
Income tax expense |
223.4 |
170.0 |
31% |
||||||
Net income from continuing operations |
1,456.5 |
561.1 |
NM |
||||||
Net income from discontinued operations |
— |
3,680.5 |
NM |
||||||
Net income |
$ |
1,456.5 |
$ |
4,241.6 |
(66)% |
||||
Earnings from continuing operations - diluted |
1.60 |
0.57 |
NM |
||||||
Earnings from discontinued operations - diluted |
— |
3.74 |
NM |
||||||
Earnings per share - diluted |
$ |
1.60 |
$ |
4.31 |
(63)% |
||||
Dividends paid per share |
$ |
0.7400 |
$ |
0.6450 |
15% |
||||
Weighted-average shares outstanding (thousands) - diluted |
911,713 |
984,001 |
|||||||
NM – not meaningful |
|
||||||||||||||||||
Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited) |
||||||||||||||||||
(Dollars in millions, except per share data) |
||||||||||||||||||
Three Months Ended |
Three Months Ended |
|||||||||||||||||
GAAP Reported |
Adjustments(b) |
Non-GAAP Adjusted(a) |
GAAP Reported |
Adjustments(c) |
Non-GAAP Adjusted(a) |
|||||||||||||
Cost of sales |
$ |
1,215.1 |
$ |
(58.6) |
$ |
1,156.5 |
$ |
1,138.7 |
$ |
(128.2) |
$ |
1,010.5 |
||||||
Acquired in-process research and development |
52.3 |
(52.3) |
— |
136.9 |
(136.9) |
— |
||||||||||||
Asset impairment, restructuring and other special charges |
59.9 |
(59.9) |
— |
423.9 |
(423.9) |
— |
||||||||||||
Income tax expense |
223.4 |
28.5 |
251.9 |
170.0 |
13.4 |
183.4 |
||||||||||||
Net income from continuing operations |
1,456.5 |
142.3 |
1,598.8 |
561.1 |
675.6 |
1,236.7 |
||||||||||||
Net income from discontinued operations |
— |
— |
— |
3,680.5 |
(3,680.5) |
— |
||||||||||||
Net income |
1,456.5 |
142.3 |
1,598.8 |
4,241.6 |
(3,004.9) |
1,236.7 |
||||||||||||
Earnings per share - diluted |
1.60 |
0.15 |
1.75 |
4.31 |
(2.98) |
1.33 |
||||||||||||
Weighted-average shares outstanding (thousands) - diluted |
911,713 |
— |
911,713 |
984,001 |
(54,167) |
929,834 |
||||||||||||
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 |
(b) |
Adjustments to certain GAAP reported measures for the three months ended |
(Dollars in millions, except per share data) |
Amortization (i) |
IPR&D(ii) |
Other specified items(iii) |
Total |
||||||||
Cost of sales |
$ |
(54.4) |
$ |
— |
$ |
(4.2) |
$ |
(58.6) |
||||
Operating expenses |
— |
— |
||||||||||
Acquired in-process research and development |
— |
(52.3) |
— |
(52.3) |
||||||||
Asset impairment, restructuring and other special charges |
— |
— |
(59.9) |
(59.9) |
||||||||
Income taxes |
11.3 |
11.0 |
6.2 |
28.5 |
||||||||
Net income |
43.1 |
41.3 |
57.9 |
142.3 |
||||||||
Earnings per share - diluted |
0.05 |
0.05 |
0.06 |
0.15 |
Numbers may not add due to rounding. |
||
The table above reflects only line items with non-GAAP adjustments. |
||
i. |
Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties. |
|
ii. |
Exclude costs associated with upfront payments for acquired in-process research and development projects acquired in a transaction other than a business combination. These costs were related to a business development transaction with Sitryx. |
|
iii. |
Asset impairment, restructuring and other special charges exclude primarily acquisition and integration costs as part of the closing of the acquisition of |
(c) |
Adjustments to certain GAAP reported measures for the three months ended |
(Dollars in millions, except per share data) |
Amortization (i) |
IPR&D (ii) |
Other specified items(iii) |
Reduced shares outstanding(iv) |
Lartruvo charges (v) |
Discontinued operations(vi) |
Total |
|||||||||||||||
Cost of sales |
$ |
(43.6) |
$ |
— |
$ |
— |
$ |
— |
$ |
(84.6) |
$ |
— |
$ |
(128.2) |
||||||||
Acquired in-process research and development |
— |
(136.9) |
— |
— |
— |
— |
(136.9) |
|||||||||||||||
Asset impairment, restructuring and other special charges |
— |
— |
(411.8) |
— |
(12.1) |
— |
(423.9) |
|||||||||||||||
Income taxes |
8.9 |
28.7 |
4.2 |
— |
(28.5) |
— |
13.4 |
|||||||||||||||
Net income |
34.7 |
108.1 |
407.6 |
— |
125.2 |
(3,680.5) |
(3,004.9) |
|||||||||||||||
Earnings per share - diluted |
0.04 |
0.12 |
0.44 |
0.03 |
0.13 |
(3.74) |
(2.98) |
Numbers may not add due to rounding. |
||
The table above reflects only line items with non-GAAP adjustments. |
||
i. |
Exclude amortization of intangibles primarily associated with costs of marketed products acquired or licensed from third parties. |
|
ii. |
Exclude costs associated with upfront payments for acquired in-process research and development projects acquired in a transaction other than a business combination. These costs were related to business development transactions with AC Immune SA and |
|
iii. |
Exclude charges primarily associated with the accelerated vesting of Loxo Oncology employee equity awards as part of the closing of the acquisition of Loxo Oncology. |
|
iv. |
Non-GAAP earnings per share assume that the disposition of |
|
v. |
Exclude charges related to the withdrawal of Lartruvo. |
|
vi. |
Exclude discontinued operations of |
Refer to: |
|
|
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