INVESTORS & MEDIA
News Release
Regeneron Reports Fourth Quarter and Full Year 2021 Financial and Operating Results
- Fourth quarter 2021 revenues increased 104% to
$4.95 billion versus fourth quarter 2020 including$2.30 billion attributable to REGEN-COV®(2); revenues excluding REGEN-COV(1) increased 17% - Full year 2021 revenues increased 89% to
$16.07 billion compared to full year 2020 including$6.19 billion attributable to REGEN-COV(2); revenues excluding REGEN-COV(1) increased 19% - Fourth quarter 2021 EYLEA®
U.S. net sales increased 15% to$1.55 billion versus fourth quarter 2020 and full year 2021 EYLEAU.S. net sales increased 17% versus 2020 - Fourth quarter 2021 Dupixent® global net sales(3), which are recorded by Sanofi, increased 51% to
$1.77 billion versus fourth quarter 2020 and full year 2021 Dupixent global net sales increased 53% versus 2020 - Fourth quarter 2021 GAAP diluted EPS was
$19.69 and non-GAAP diluted EPS(1) was$23.72
"In 2021, Regeneron delivered strong results across our core business with impressive EYLEA and Dupixent growth, while also helping address the ongoing pandemic by delivering REGEN-COV to millions of patients," said
Financial Highlights
Three Months Ended |
Year Ended |
|||||||||||
($ in millions, except per share data) |
2021 |
2020 |
% Change |
2021 |
2020 |
% Change |
||||||
Total revenues |
$ 4,952 |
$ 2,423 |
104% |
$ 16,072 |
$ 8,497 |
89% |
||||||
GAAP net income |
$ 2,229 |
$ 1,149 |
94% |
$ 8,075 |
$ 3,513 |
130% |
||||||
GAAP net income per share - diluted |
$ 19.69 |
$ 10.24 |
92% |
$ 71.97 |
$ 30.52 |
136% |
||||||
Non-GAAP net income(1) |
$ 2,712 |
$ 1,080 |
151% |
$ 8,488 |
$ 3,666 |
132% |
||||||
Non-GAAP net income per |
$ 23.72 |
$ 9.53 |
149% |
$ 74.66 |
$ 31.47 |
137% |
"In 2021, Regeneron delivered solid top- and bottom-line growth driven by strong execution within our core business," said
Business Highlights
Key Pipeline Progress
Regeneron has over 30 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline in the fourth quarter of 2021 and 2022 to date include:
Dupixent® (dupilumab)
- In
October 2021 , theU.S. Food and Drug Administration (FDA) approved Dupixent for children aged 6 to 11 years with moderate-to-severe asthma. InJanuary 2022 , theEuropean Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to extend the approval of Dupixent in theEuropean Union (EU) for the treatment of severe asthma in children aged 6 to 11 years old. A final decision from theEuropean Commission (EC) regarding the regulatory application is expected in the coming months. - The
New England Journal of Medicine published positive results from the Phase 3 trial in children aged 6 to 11 years with moderate-to-severe asthma. - A supplemental Biologics License Application (sBLA) for Dupixent for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis was submitted. A regulatory submission is also expected to be completed in the EU in the coming months.
- In
January 2022 , the Company and Sanofi announced positive results from a second Phase 3 trial in adults with uncontrolled prurigo nodularis. The trial met its primary and key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo at 24 weeks. Regulatory submissions are expected to commence in the first half of 2022.
Antibodies to SARS-CoV-2 virus
- In the fourth quarter of 2021, the Company completed its final deliveries of drug product under its agreement with the
U.S. government, delivering an additional 1.1 million doses of REGEN-COV®, and recognizing$2.30 billion of REGEN-COV sales. - In
November 2021 , theEuropean Commission approved the casirivimab and imdevimab(2) antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent COVID-19. - In
November 2021 , the Company announced additional positive results from a Phase 3 COVID-19 prevention trial jointly run with theNational Institute of Allergy and Infectious Diseases (NIAID), showing that a single dose of REGEN-COV reduced the risk of contracting COVID-19 by 81.6% during the pre-specified follow-up period (months 2–8), maintaining the previously reported 81.4% risk reduction during the first month after administration (the primary endpoint). - Based on laboratory data that showed markedly decreased binding to the Omicron spike protein, REGEN-COV is highly unlikely to be active against the Omicron variant. In
January 2022 , the FDA revised the Emergency Use Authorization (EUA) for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron (B.1.1.529) that is not susceptible to the treatment. With this EUA revision, REGEN-COV is not currently authorized for use in anyU.S. states, territories, or jurisdictions, since Omicron is currently the dominant variant acrossthe United States . If, in the future, patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised in these areas. - The Company continues to progress "next generation" antibodies that are active against Omicron, Delta (B.1.617.2), and other variants of concern. Pending regulatory discussions, new therapeutic candidates could enter clinical development in the coming months.
Oncology Programs
- The FDA accepted the sBLA for Libtayo® (cemiplimab), in combination with chemotherapy, to treat patients with advanced non-small cell lung cancer (NSCLC), with a target action date of
September 19, 2022 . A regulatory application was also submitted in the EU. - In
January 2022 , the Company and Sanofi announced the voluntary withdrawal of the sBLA for Libtayo as a second-line treatment for patients with advanced cervical cancer. The decision was made after the companies and the FDA were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside ofthe United States are ongoing. - In
December 2021 , the Company announced results for higher dose level cohorts from the Phase 1 portion of the REGN5458 Phase 1/2 trial in patients with multiple myeloma, which were presented at theAmerican Society of Hematology (ASH) Annual Meeting. The results showed a 75% overall response rate in patients treated with the highest dose levels studied. REGN5458 is a bispecific antibody targeting BCMA and CD3. The Company expects to complete enrollment in a potentially pivotal Phase 2 trial in multiple myeloma in the first quarter of 2022. - The Company has additional CD3 bispecifics in clinical development, including a Phase 1 study of REGN4336, a bispecific antibody targeting PSMA and CD3, which was recently initiated in prostate cancer.
- The Company has ongoing clinical development for three costimulatory CD28 bispecifics targeting prostate cancer, ovarian cancer, and other solid tumors.
- In NSCLC, the Company is in dose expansion for REGN5093, which is a METxMET bispecific targeting cancers driven by MET mutations and/or amplifications. The Company is also studying REGN5093-M114, its first bispecific antibody-drug conjugate, in MET-altered advanced NSCLC.
Pozelimab
- A Phase 3 study of pozelimab, an antibody to C5, in combination with Alnylam's cemdisiran, an siRNA therapeutic, in paroxysmal nocturnal hemoglobinuria (PNH) was initiated.
Business Development Update
- In
January 2022 , the Company entered into a license and collaboration agreement for Ultragenyx Pharmaceutical Inc. to develop and commercialize Evkeeza® in countries outside ofthe United States .
Select 2022 Milestones
Programs |
Milestones |
|||
Aflibercept 8 mg |
- |
Report results from Phase 3 studies in neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME) |
||
Dupixent (dupilumab) |
- |
Complete rolling sBLA submission for eosinophilic esophagitis (EoE) in adults and adolescents |
||
- |
Report results from additional Phase 3 study for chronic spontaneous urticaria (CSU) |
|||
- |
FDA decision on sBLA for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis |
|||
Antibodies to SARS-CoV-2 virus |
- |
FDA decision on BLA (target action date of |
||
- |
Submit sBLA for COVID-19 treatment of hospitalized patients |
|||
- |
Initiate "next generation" monoclonal antibody clinical study |
|||
Libtayo (cemiplimab) |
- |
FDA decision on sBLA (target action date of |
||
REGN5458 (BCMA and CD3 |
- |
Report results from potentially pivotal Phase 2 study in multiple |
||
- |
Initiate Phase 1 and Phase 3 studies exploring combinations with |
|||
Odronextamab (CD20 and CD3 Bispecific Antibody) |
- |
Report additional results from potentially pivotal Phase 2 study in B-cell non-Hodgkin lymphoma (B-NHL) |
||
- |
Initiate |
|||
Solid Tumor Bispecific Antibodies |
- |
Report results from REGN4018 (MUC16 and CD3 bispecific antibody) Phase 1 study in platinum-resistant ovarian cancer |
||
- |
Report results from REGN5678 (PSMA and CD28 bispecific antibody) Phase 1 study in prostate cancer |
|||
- |
Report results from REGN5093 (bispecific antibody targeting two distinct MET epitopes) Phase 1 study in MET-altered advanced NSCLC |
Fourth Quarter and Full Year 2021 Financial Results
Revenues
Total revenues increased by 104% to
Net product sales recorded by the Company consist of the following:
($ in millions) |
Q4 2021 |
Q4 2020 |
% Change |
FY 2021 |
FY 2020 |
% Change |
||||||
EYLEA® |
$ 1,547 |
$ 1,343 |
15% |
$ 5,792 |
$ 4,947 |
17% |
||||||
Libtayo |
81 |
74 |
9% |
306 |
271 |
13% |
||||||
Praluent® |
40 |
55 |
(27%) |
170 |
151 |
13% |
||||||
REGEN-COV |
2,298 |
146 |
** |
5,828 |
186 |
** |
||||||
Evkeeza |
9 |
— |
** |
19 |
— |
** |
||||||
ARCALYST® |
— * |
4 |
** |
2 * |
13 |
** |
||||||
Total net product sales in |
$ 3,975 |
$ 1,622 |
145% |
$ 12,117 |
$ 5,568 |
118% |
||||||
* Effective |
||||||||||||
** Percentage not meaningful |
During the fourth quarter of 2021, the Company completed its final deliveries of REGEN-COV under its agreement with the
Total revenues also include collaboration revenues(3) of
Refer to Table 4 for a summary of collaboration revenue.
Other revenue decreased in the fourth quarter and full year of 2021, compared to the same periods of 2020, primarily due to lower amounts recognized in connection with the Company's agreement with the
Operating Expenses
GAAP |
% |
Non-GAAP(1) |
% |
|||||||||
($ in millions) |
Q4 2021 |
Q4 2020 |
Q4 2021 |
Q4 2020 |
||||||||
Research and development (R&D) |
$ 786 |
$ 745 |
6% |
$ 639 |
$ 675 |
(5%) |
||||||
Selling, general, and administrative |
$ 560 |
$ 304 |
84% |
$ 495 |
$ 381 |
30% |
||||||
Cost of goods sold (COGS) |
$ 812 |
$ 180 |
351% |
$ 559 |
$ 166 |
237% |
||||||
Cost of collaboration and contract |
$ 171 |
$ 174 |
(2%) |
* |
* |
n/a |
||||||
Other operating (income) expense, net |
$ (16) |
$ (145) |
(89%) |
* |
* |
n/a |
||||||
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded. |
GAAP |
% |
Non-GAAP(1) |
% |
|||||||||
($ in millions) |
FY 2021 |
FY 2020 |
FY 2021 |
FY 2020 |
||||||||
Research and development |
$ 2,908 |
$ 2,735 |
6% |
$ 2,548 |
$ 2,411 |
6% |
||||||
Selling, general, and administrative |
$ 1,825 |
$ 1,346 |
36% |
$ 1,606 |
$ 1,280 |
25% |
||||||
Cost of goods sold |
$ 1,773 |
$ 492 |
260% |
$ 1,470 |
$ 451 |
226% |
||||||
Cost of collaboration and contract |
$ 664 |
$ 628 |
6% |
* |
* |
n/a |
||||||
Other operating (income) expense, |
$ (46) |
$ (280) |
(84%) |
* |
* |
n/a |
||||||
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded. |
- GAAP and non-GAAP R&D expenses in the fourth quarter of 2021, compared to the fourth quarter of 2020, included lower costs incurred in connection with REGEN-COV development activities, additional costs incurred in connection with the Company's earlier-stage pipeline, higher headcount and headcount-related costs, and an increase in clinical manufacturing activities. Non-GAAP R&D expenses in the fourth quarter of 2021 excluded
$44 million of aggregate up-front payments, primarily in connection with the collaboration agreement with Nykode Therapeutics. - GAAP and non-GAAP R&D expenses for full year 2021, compared to full year 2020, included higher headcount and headcount related costs, an increase in facilities-related expenses, and lower costs incurred in connection with development activities for fasinumab and Kevzara (for the treatment of COVID-19). Non-GAAP R&D expenses for full year 2020 excluded
$85 million of up-front payments in connection with the Intellia collaboration agreement. - The increase in GAAP and non-GAAP SG&A expenses in the fourth quarter and full year 2021, compared to the same periods in the prior year, was primarily due to an increase in commercialization-related expenses for EYLEA, including direct-to-consumer advertising, educational campaigns related to COVID-19, and higher headcount-related costs. Non-GAAP SG&A expenses in the fourth quarter and full year 2020 excluded the reversal of accruals for Praluent litigation-related loss contingencies.
- The increase in GAAP and non-GAAP COGS in the fourth quarter and full year 2021, compared to the same periods in the prior year, was primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV in
the United States , in addition to a$260 million fourth quarter 2021 true-up payment owed to Roche in connection with global gross profits under the Company's collaboration agreement described above. Additionally, during the fourth quarter of 2021, the Company recorded a$232 million charge to write down its REGEN-COV inventory as a result of data that showed REGEN-COV was highly unlikely to be active against the Omicron variant and the FDA revision of the EUA for REGEN-COV, pursuant to which REGEN-COV was no longer authorized for use in anyU.S. states, territories, or jurisdictions. - Other operating (income) expense, net, for full year 2021 included the recognition of a cumulative catch-up adjustment of
$67 million , which was recorded as a reduction to other operating income, arising from an update to the estimate of the total R&D costs expected to be incurred under the Sanofi Immuno-oncology collaboration agreement. Other operating (income) expense, net, in the fourth quarter and full year 2020 included the recognition of cumulative catch-up adjustments of$100 million , which was recorded as an increase to other operating income, arising from an update to the estimate of total R&D costs expected to be incurred for certain collaboration programs.
Other Financial Information
GAAP other income (expense) included the recognition of net unrealized losses on equity securities of
In the fourth quarter and full year 2021, the Company's GAAP effective tax rate was 11.0% and 13.4%, respectively, compared to 6.2% and 7.8% in the fourth quarter and full year 2020, respectively. The increase in the fourth quarter and full year 2021 GAAP effective tax rate, compared to the same periods in the prior year, was due in part to the impact of higher REGEN-COV sales in
GAAP net income per diluted share was
In
Net cash provided by operating activities for the full year 2021 was
2022 Financial Guidance(4)
The Company's full year 2022 financial guidance consists of the following components:
GAAP |
Non-GAAP(1) |
|||
R&D |
|
|
||
SG&A |
|
|
||
Gross margin on net product sales(5) |
89%–91% |
90%–92% |
||
COCM(6) |
|
* |
||
Other operating (income) expense, net |
( |
* |
||
Capital expenditures |
|
* |
||
Effective tax rate (ETR) |
12%–14% |
13%–15% |
||
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded. |
A reconciliation of full year 2022 GAAP to Non-GAAP financial guidance is included below:
|
||||
($ in millions) |
Low |
High |
||
GAAP R&D |
$ 3,170 |
$ 3,400 |
||
R&D: Non-cash share-based compensation |
(370) |
(400) |
||
Non-GAAP R&D |
$ 2,800 |
$ 3,000 |
||
GAAP SG&A |
$ 1,890 |
$ 2,030 |
||
SG&A: Non-cash share-based |
(240) |
(260) |
||
Non-GAAP SG&A |
$ 1,650 |
$ 1,770 |
||
GAAP gross margin on net product sales |
89% |
91% |
||
Non-cash share-based compensation |
1% |
1% |
||
Non-GAAP gross margin on net product sales |
90% |
92% |
||
GAAP ETR |
12% |
14% |
||
Income tax effect of GAAP to non-GAAP |
1% |
1% |
||
Non-GAAP ETR |
13% |
15% |
(1) |
This press release uses non-GAAP R&D, non-GAAP SG&A, non-GAAP gross margin on net product sales, non-GAAP other income (expense), net, non-GAAP effective tax rate, non-GAAP net income, non-GAAP net income per share, total revenues excluding REGEN-COV (casirivimab and imdevimab), and free cash flow, which are financial measures that are not calculated in accordance with
The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control (such as the Company's stock price on the dates share-based grants are issued or changes in the fair value of the Company's investments in equity securities) or items that are not associated with normal, recurring operations (such as restructuring-related expenses). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. With respect to free cash flows, the Company believes that this non-GAAP measure provides a further measure of the Company's operations' ability to generate cash flows. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. |
(2) |
The casirivimab and imdevimab antibody cocktail is known as REGEN-COV in |
(3) |
The Company's collaborators provide it with estimates of the collaborators' respective sales and the Company's share of the profits or losses (if applicable) from commercialization of products for the most recent fiscal quarter. These estimates are revised, if necessary, in subsequent periods if the Company's actual share of the profits or losses differ from those estimates. |
(4) |
The Company's 2022 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release. |
(5) |
Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales less cost of goods sold. |
(6) |
Corresponding reimbursements from collaborators and others for manufacturing of commercial supplies is recorded within revenues. |
Conference Call Information
Regeneron will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2021 financial and operating results on
About
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases, and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the Company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
Non-GAAP Financial Measures
This press release and/or the financial results attached to this press release include amounts that are considered "non-GAAP financial measures" under
Contact Information: |
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Investor Relations |
Corporate Communications |
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914-847-3482 |
914-847-8827 |
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TABLE 1 |
||||
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (In millions) |
||||
|
||||
2021 |
2020 |
|||
Assets: |
||||
Cash and marketable securities |
$ 12,532.7 |
$ 6,722.6 |
||
Accounts receivable, net |
6,036.5 |
4,114.7 |
||
Inventories |
1,951.3 |
1,916.6 |
||
Property, plant, and equipment, net |
3,482.2 |
3,221.6 |
||
Deferred tax assets |
876.9 |
858.9 |
||
Other assets |
555.2 |
328.9 |
||
Total assets |
$ 25,434.8 |
$ 17,163.3 |
||
Liabilities and stockholders' equity: |
||||
Accounts payable, accrued expenses, and other liabilities |
$ 3,451.0 |
$ 2,806.8 |
||
Finance lease liabilities |
719.7 |
717.2 |
||
Deferred revenue |
515.3 |
635.5 |
||
Long-term debt |
1,980.0 |
1,978.5 |
||
Stockholders' equity |
18,768.8 |
11,025.3 |
||
Total liabilities and stockholders' equity |
$ 25,434.8 |
$ 17,163.3 |
TABLE 2 |
||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In millions, except per share data) |
||||||||
Three Months Ended |
Year Ended |
|||||||
2021 |
2020 |
2021 |
2020 |
|||||
Revenues: |
||||||||
Net product sales |
$ 3,975.2 |
$ 1,621.8 |
$ 12,117.2 |
$ 5,567.6 |
||||
Collaboration revenue |
890.3 |
677.7 |
3,673.3 |
2,372.5 |
||||
Other revenue |
86.2 |
123.4 |
281.2 |
557.0 |
||||
4,951.7 |
2,422.9 |
16,071.7 |
8,497.1 |
|||||
Expenses: |
||||||||
Research and development |
785.6 |
744.5 |
2,908.1 |
2,735.0 |
||||
Selling, general, and administrative |
559.6 |
303.5 |
1,824.9 |
1,346.0 |
||||
Cost of goods sold |
811.7 |
179.6 |
1,773.1 |
491.9 |
||||
Cost of collaboration and contract manufacturing |
170.9 |
173.5 |
664.4 |
628.0 |
||||
Other operating (income) expense, net |
(15.8) |
(145.2) |
(45.6) |
(280.4) |
||||
2,312.0 |
1,255.9 |
7,124.9 |
4,920.5 |
|||||
Income from operations |
2,639.7 |
1,167.0 |
8,946.8 |
3,576.6 |
||||
Other income (expense): |
||||||||
Other (expense) income, net |
(122.2) |
72.4 |
436.3 |
290.7 |
||||
Interest expense |
(14.1) |
(14.8) |
(57.3) |
(56.9) |
||||
(136.3) |
57.6 |
379.0 |
233.8 |
|||||
Income before income taxes |
2,503.4 |
1,224.6 |
9,325.8 |
3,810.4 |
||||
Income tax expense |
274.4 |
75.4 |
1,250.5 |
297.2 |
||||
Net income |
$ 2,229.0 |
$ 1,149.2 |
$ 8,075.3 |
$ 3,513.2 |
||||
Net income per share - basic |
$ 20.99 |
$ 10.90 |
$ 76.40 |
$ 32.65 |
||||
Net income per share - diluted |
$ 19.69 |
$ 10.24 |
$ 71.97 |
$ 30.52 |
||||
Weighted average shares outstanding - basic |
106.2 |
105.4 |
105.7 |
107.6 |
||||
Weighted average shares outstanding - diluted |
113.2 |
112.2 |
112.2 |
115.1 |
TABLE 3 |
||||||||
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (In millions, except per share data) |
||||||||
Three Months Ended |
Year Ended |
|||||||
2021 |
2020 |
2021 |
2020 |
|||||
GAAP R&D |
$ 785.6 |
$ 744.5 |
$ 2,908.1 |
$ 2,735.0 |
||||
R&D: Non-cash share-based compensation expense |
102.9 |
69.1 |
316.6 |
238.6 |
||||
R&D: Up-front payments related to license and collaboration |
44.0 |
— |
44.0 |
85.0 |
||||
Non-GAAP R&D |
$ 638.7 |
$ 675.4 |
$ 2,547.5 |
$ 2,411.4 |
||||
GAAP SG&A |
$ 559.6 |
$ 303.5 |
$ 1,824.9 |
$ 1,346.0 |
||||
SG&A: Non-cash share-based compensation expense |
64.2 |
38.6 |
213.3 |
153.0 |
||||
SG&A: Litigation contingencies and other |
— |
(115.8) |
5.6 |
(86.9) |
||||
Non-GAAP SG&A |
$ 495.4 |
$ 380.7 |
$ 1,606.0 |
$ 1,279.9 |
||||
GAAP COGS |
$ 811.7 |
$ 179.6 |
$ 1,773.1 |
$ 491.9 |
||||
COGS: Non-cash share-based compensation expense |
21.3 |
13.8 |
71.8 |
40.4 |
||||
COGS: REGEN-COV inventory reserve |
231.7 |
— |
231.7 |
— |
||||
COGS: Other |
— |
— |
— |
0.9 |
||||
Non-GAAP COGS |
$ 558.7 |
$ 165.8 |
$ 1,469.6 |
$ 450.6 |
||||
GAAP other income (expense), net |
$ (136.3) |
$ 57.6 |
$ 379.0 |
$ 233.8 |
||||
Other income/expense: Losses (gains) on investments |
137.6 |
(59.5) |
(387.0) |
(221.6) |
||||
Interest expense: Other |
— |
— |
— |
12.7 |
||||
Non-GAAP other income (expense), net |
$ 1.3 |
$ (1.9) |
$ (8.0) |
$ 24.9 |
||||
GAAP net income |
$ 2,229.0 |
$ 1,149.2 |
$ 8,075.3 |
$ 3,513.2 |
||||
Total of GAAP to non-GAAP reconciling items above |
601.7 |
(53.8) |
496.0 |
222.1 |
||||
Income tax effect of GAAP to non-GAAP reconciling items |
(119.2) |
14.8 |
(82.9) |
(38.9) |
||||
Income tax expense: Impact of sale of assets between foreign |
— |
(30.0) |
— |
(30.0) |
||||
Non-GAAP net income |
$ 2,711.5 |
$ 1,080.2 |
$ 8,488.4 |
$ 3,666.4 |
||||
Non-GAAP net income per share - basic |
$ 25.53 |
$ 10.25 |
$ 80.31 |
$ 34.07 |
||||
Non-GAAP net income per share - diluted |
$ 23.72 |
$ 9.53 |
$ 74.66 |
$ 31.47 |
||||
Shares used in calculating: |
||||||||
Non-GAAP net income per share - basic |
106.2 |
105.4 |
105.7 |
107.6 |
||||
Non-GAAP net income per share - diluted |
114.3 |
113.4 |
113.7 |
116.5 |
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (Unaudited) (continued) |
||||||||
Three Months Ended |
Year Ended |
|||||||
2021 |
2020 |
2021 |
2020 |
|||||
Revenue reconciliation: |
||||||||
Total revenues |
$ 4,951.7 |
$ 2,422.9 |
$ 16,071.7 |
$ 8,497.1 |
||||
REGEN-COV net product sales in |
2,297.9 |
145.5 |
5,828.0 |
185.7 |
||||
Global gross profit true-up payment from Roche in connection with |
— |
— |
361.8 |
— |
||||
Total revenues excluding REGEN-COV (casirivimab and imdevimab) |
$ 2,653.8 |
$ 2,277.4 |
$ 9,881.9 |
$ 8,311.4 |
||||
Effective tax rate reconciliation: |
||||||||
GAAP effective tax rate |
11.0 % |
6.2% |
13.4% |
7.8% |
||||
Income tax effect of GAAP to non-GAAP reconciling items |
1.7% |
1.5% |
0.2% |
1.3% |
||||
Non-GAAP effective tax rate |
12.7% |
7.7% |
13.6% |
9.1% |
||||
Year Ended |
||||||||
2021 |
2020 |
|||||||
Free cash flow reconciliation: |
||||||||
Net cash provided by operating activities |
$ 7,081.3 |
$ 2,618.1 |
||||||
Capital expenditures |
(551.9) |
(614.6) |
||||||
Free cash flow |
$ 6,529.4 |
$ 2,003.5 |
TABLE 4 |
||||||||
COLLABORATION REVENUE (Unaudited) (In millions) |
||||||||
Three Months Ended |
Year Ended |
|||||||
2021 |
2020 |
2021 |
2020 |
|||||
Sanofi collaboration revenue: |
||||||||
Antibody: |
||||||||
Regeneron's share of profits in connection with |
$ 387.8 |
$ 229.6 |
$ 1,363.0 |
$ 785.2 |
||||
Sales-based milestones earned |
— |
— |
50.0 |
50.0 |
||||
Reimbursement for manufacturing of commercial supplies |
127.6 |
93.0 |
488.8 |
368.0 |
||||
|
||||||||
Regeneron's share of losses in connection with commercialization |
(1.0) |
(8.4) |
(13.6) |
(25.7) |
||||
Reimbursement for manufacturing of commercial supplies |
3.5 |
2.9 |
14.0 |
8.9 |
||||
Total Sanofi collaboration revenue |
517.9 |
317.1 |
1,902.2 |
1,186.4 |
||||
Bayer collaboration revenue: |
||||||||
Regeneron's net profit in connection with commercialization of |
353.9 |
335.3 |
1,349.2 |
1,107.9 |
||||
Reimbursement for manufacturing of commercial supplies |
18.5 |
25.3 |
60.1 |
78.2 |
||||
Total Bayer collaboration revenue |
372.4 |
360.6 |
1,409.3 |
1,186.1 |
||||
Roche collaboration revenue: |
||||||||
Global gross profit true-up payment from Roche in connection |
— |
— |
361.8 |
— |
||||
Total collaboration revenue |
$ 890.3 |
$ 677.7 |
$ 3,673.3 |
$ 2,372.5 |
TABLE 5 |
||||||||||||||
NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) (In millions) |
||||||||||||||
Three Months Ended |
||||||||||||||
2021 |
2020 |
% Change |
||||||||||||
|
ROW |
Total |
|
ROW |
Total |
(Total Sales) |
||||||||
EYLEA(a) |
$ 1,547.2 |
$ 933.5 |
$ 2,480.7 |
$ 1,343.2 |
$ 858.8 |
$ 2,202.0 |
13% |
|||||||
Dupixent(b) |
$ 1,348.2 |
$ 425.6 |
$ 1,773.8 |
$ 925.6 |
$ 246.4 |
$ 1,172.0 |
51% |
|||||||
Libtayo(c) |
$ 80.8 |
$ 40.2 |
$ 121.0 |
$ 74.1 |
$ 23.2 |
$ 97.3 |
24% |
|||||||
Praluent(d) |
$ 40.0 |
$ 62.6 |
$ 102.6 |
$ 55.2 |
$ 45.7 |
$ 100.9 |
2% |
|||||||
REGEN-COV(e) |
$ 2,297.9 |
$ 572.7 |
$ 2,870.6 |
$ 145.5 |
— |
$ 145.5 |
(h) |
|||||||
Kevzara(b) |
$ 42.0 |
$ 61.9 |
$ 103.9 |
$ 36.6 |
$ 34.9 |
$ 71.5 |
45% |
|||||||
Evkeeza(f) |
$ 9.3 |
— |
$ 9.3 |
— |
— |
— |
(h) |
|||||||
ARCALYST(g) |
$ 18.7 |
— |
$ 18.7 |
$ 3.8 |
— |
$ 3.8 |
392% |
|||||||
ZALTRAP(b) |
$ 1.4 |
$ 20.3 |
$ 21.7 |
$ 0.9 |
$ 23.9 |
$ 24.8 |
(13%) |
|||||||
Year Ended |
||||||||||||||
2021 |
2020 |
% Change |
||||||||||||
|
ROW |
Total |
|
ROW |
Total |
(Total Sales) |
||||||||
EYLEA(a) |
$ 5,792.3 |
$ 3,592.4 |
$ 9,384.7 |
$ 4,947.2 |
$ 2,961.5 |
$ 7,908.7 |
19% |
|||||||
Dupixent(b) |
$ 4,713.0 |
$ 1,485.3 |
$ 6,198.3 |
$ 3,226.2 |
$ 818.6 |
$ 4,044.8 |
53% |
|||||||
Libtayo(c) |
$ 306.3 |
$ 151.9 |
$ 458.2 |
$ 270.7 |
$ 77.5 |
$ 348.2 |
32% |
|||||||
Praluent(d) |
$ 170.0 |
$ 251.1 |
$ 421.1 |
$ 186.0 |
$ 172.8 |
$ 358.8 |
17% |
|||||||
REGEN-COV(e) |
$ 5,828.0 |
$ 1,745.9 |
$ 7,573.9 |
$ 185.7 |
— |
$ 185.7 |
(h) |
|||||||
Kevzara(b) |
$ 161.9 |
$ 176.1 |
$ 338.0 |
$ 141.6 |
$ 128.3 |
$ 269.9 |
25% |
|||||||
Evkeeza(f) |
$ 18.4 |
— |
$ 18.4 |
— |
— |
— |
(h) |
|||||||
ARCALYST(g) |
$ 40.7 |
— |
$ 40.7 |
$ 13.1 |
— |
$ 13.1 |
211% |
|||||||
ZALTRAP(b) |
$ 5.3 |
$ 86.4 |
$ 91.7 |
$ 5.8 |
$ 97.9 |
$ 103.7 |
(12%) |
|||||||
(a) Regeneron records net product sales of EYLEA in |
||||||||||||||
(b) Sanofi records global net product sales of Dupixent, Kevzara, and ZALTRAP. The Company records its share of profits/losses in connection with global sales of Dupixent and Kevzara, and Sanofi pays the Company a percentage of net sales of ZALTRAP. |
||||||||||||||
(c) Regeneron records net product sales of Libtayo in |
||||||||||||||
(d) Effective |
||||||||||||||
(e) Regeneron records net product sales of REGEN-COV in connection with its agreements with the |
||||||||||||||
(f) Regeneron records net product sales of Evkeeza in |
||||||||||||||
(g) Effective |
||||||||||||||
(h) Percentage not meaningful |
View original content:https://www.prnewswire.com/news-releases/regeneron-reports-fourth-quarter-and-full-year-2021-financial-and-operating-results-301475382.html
SOURCE