INVESTORS & MEDIA
News Release
Regeneron Reports Second Quarter 2019 Financial and Operating Results
-- Second quarter 2019 revenues increased 20% to
- EYLEA® U.S. net sales increased 17% to
$1.16 billion versus second quarter 2018 - Dupixent® global net sales, which are recorded by the Company's collaborator
Sanofi , increased 166% to$557 million versus second quarter 2018
-- For the first time on a quarterly basis, the antibody collaboration with
-- Second quarter 2019 GAAP diluted EPS was
-- Important regulatory approvals
FDA approved EYLEA for diabetic retinopathy and Dupixent for chronic rhinosinusitis with nasal polyposisEuropean Commission approved Libtayo® for metastatic or locally advanced cutaneous squamous cell carcinoma and Dupixent for adolescents with atopic dermatitis
"We had a great quarter marked by top- and bottom-line growth as well as important advances across our innovative R&D engine," said
Financial Highlights |
|||||||||||
($ in millions, except per share data) |
Three Months Ended |
||||||||||
2019 |
2018 |
% Change |
|||||||||
Total revenues |
$ |
1,934 |
$ |
1,608 |
20 |
% |
|||||
GAAP net income |
$ |
193 |
$ |
551 |
(65) |
% |
|||||
GAAP net income per share - diluted |
$ |
1.68 |
$ |
4.82 |
(65) |
% |
|||||
Non-GAAP net income(1) |
$ |
690 |
$ |
624 |
11 |
% |
|||||
Non-GAAP net income per share - diluted(1) |
$ |
6.02 |
$ |
5.45 |
10 |
% |
Business Highlights
Key Pipeline Progress
Regeneron has 21 product candidates in clinical development, including five of the Company's
EYLEA® (aflibercept) Injection
- In
May 2019 , theFDA approved EYLEA for the treatment of diabetic retinopathy. - The supplemental Biologics License Application (sBLA) for EYLEA in a pre-filled syringe has a target action date of
August 12, 2019 .
Dupixent® (dupilumab)
- In
May 2019 , theEuropean Commission (EC) approved Dupixent for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma. - In
June 2019 , theFDA approved Dupixent for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. The European Commission approved Dupixent, extending its approval in theEuropean Union (EU) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.- In
August 2019 , the Company andSanofi announced that the Phase 3 trial to treat severe atopic dermatitis in children 6 to 11 years of age met its primary and secondary endpoints.
Libtayo® (cemiplimab)
- In
June 2019 , the EC granted conditional marketing authorization for Libtayo for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. - A Phase 3 adjuvant study in CSCC was initiated.
REGN1979, a bispecific antibody against CD20 and CD3
- In
June 2019 , the Company presented updated positive results from a study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma at theEuropean Hematology Association meeting. - A Phase 2 study in relapsed or refractory follicular lymphoma (FL) is recruiting patients.
Praluent® (alirocumab)
- In
April 2019 , based upon data from the Phase 3 ODYSSEY OUTCOMES trial, theFDA approved a new indication for Praluent to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. The label was also updated to include data showing that treatment with Praluent was associated with a reduction in death from any cause.
REGN3500, an antibody to IL-33
- In
June 2019 , the Company andSanofi announced that the Phase 2 study in asthma met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. In the trial, the greatest improvement was observed in patients with blood eosinophil levels ≥300 cells/microliter. Patients treated with Dupixent monotherapy did numerically better than REGN3500 across all endpoints. The combination of REGN3500 and Dupixent did not demonstrate increased benefit compared to Dupixent monotherapy in this trial.
Second Quarter 2019 Financial Results
Total Revenues: Total revenues increased by 20% to
Net product sales were
Total revenues also include
Refer to Table 4 for a summary of collaboration and other revenue.
Research and Development (R&D) Expenses: GAAP R&D expenses were
Selling, General, and Administrative (SG&A) Expenses: GAAP SG&A expenses were
Cost of Goods Sold (COGS): GAAP COGS was
Other Income (Expense): GAAP other income (expense), net, in the second quarter of 2019 and 2018 includes the recognition of
Income Taxes: In the second quarter of 2019, GAAP income tax expense was
GAAP and Non-GAAP Net Income(1): GAAP net income was
Non-GAAP net income was
The difference in GAAP net income and non-GAAP net income in the second quarter of 2019 was largely impacted by (i) the Alnylam up-front payment being recognized as GAAP R&D expense during the period and (ii) unrealized losses recorded in GAAP other income (expense) related to Alnylam common shares the Company purchased in connection with the collaboration agreement. A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.
2019 Financial Guidance(2)
The Company's updated full year 2019 financial guidance consists of the following components:
GAAP Sanofi collaboration revenue: Sanofi |
$500 million–$530 million |
GAAP Unreimbursed R&D(4) |
$2.300 billion–$2.380 billion (previously $2.280 billion–$2.400 billion) |
Non-GAAP Unreimbursed R&D(1)(3) |
$1.650 billion–$1.710 billion |
GAAP SG&A |
$1.705 billion–$1.785 billion (previously $1.695 billion–$1.800 billion) |
Non-GAAP SG&A(1)(3) |
$1.530 billion–$1.580 billion |
GAAP effective tax rate |
11%–13% (reaffirmed) |
Capital expenditures |
$380 million–$420 million |
(1) |
This press release uses non-GAAP net income, non-GAAP net income per share, non-GAAP unreimbursed R&D, and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP). These non-GAAP financial measures are computed by excluding certain non-cash and other items from the related GAAP financial measure. Non-GAAP adjustments also include the estimated income tax effect of reconciling items. |
(2) |
The Company's 2019 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release. |
(3) |
A reconciliation of full year 2019 non-GAAP to GAAP financial guidance is included below: |
Projected Range |
||||||||
(In millions) |
Low |
High |
||||||
GAAP unreimbursed R&D(4) |
$ |
2,300 |
$ |
2,380 |
||||
R&D: Non-cash share-based compensation expense |
(250) |
(270) |
||||||
R&D: Up-front payments related to license and collaboration agreements |
(400) |
(400) |
||||||
Non-GAAP unreimbursed R&D |
$ |
1,650 |
$ |
1,710 |
||||
GAAP SG&A |
$ |
1,705 |
$ |
1,785 |
||||
SG&A: Non-cash share-based compensation expense |
(165) |
(195) |
||||||
SG&A: Litigation contingencies |
(10) |
(10) |
||||||
Non-GAAP SG&A |
$ |
1,530 |
$ |
1,580 |
(4) |
Unreimbursed R&D represents R&D expenses reduced by R&D expense reimbursements from the Company's collaborators and/or customers. |
(5) |
The Company's collaborators provide it with estimates of the collaborators' respective sales and the Company's share of the profits or losses from commercialization of products for the most recent fiscal quarter. The Company's estimates for such quarter are reconciled to actual results in the subsequent fiscal quarter, and the Company's share of the profit or loss is adjusted on a prospective basis accordingly, if necessary. |
Conference Call Information
Regeneron will host a conference call and simultaneous webcast to discuss its second quarter 2019 financial and operating results on Tuesday, August 6, 2019, at
About
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to seven
Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and 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
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: |
||
Justin Holko |
Hala Mirza |
|
Investor Relations |
Corporate Communications |
|
914-847-7786 |
914-847-3422 |
|
TABLE 1 |
||||||||
REGENERON PHARMACEUTICALS, INC. |
||||||||
June 30, |
December 31, |
|||||||
2019 |
2018 |
|||||||
Assets: |
||||||||
Cash and marketable securities |
$ |
5,554.3 |
$ |
4,564.9 |
||||
Accounts receivable - trade, net |
1,920.2 |
1,723.7 |
||||||
Accounts receivable from Sanofi and Bayer |
535.7 |
519.5 |
||||||
Inventories |
1,317.2 |
1,151.2 |
||||||
Property, plant, and equipment, net |
2,676.6 |
2,575.8 |
||||||
Deferred tax assets |
821.6 |
828.7 |
||||||
Other assets |
348.0 |
370.7 |
||||||
Total assets |
$ |
13,173.6 |
$ |
11,734.5 |
||||
Liabilities and stockholders' equity: |
||||||||
Accounts payable, accrued expenses, and other liabilities |
$ |
1,388.6 |
$ |
1,352.0 |
||||
Deferred revenue |
1,317.8 |
916.7 |
||||||
Finance lease liabilities |
711.3 |
708.5 |
||||||
Stockholders' equity |
9,755.9 |
8,757.3 |
||||||
Total liabilities and stockholders' equity |
$ |
13,173.6 |
$ |
11,734.5 |
TABLE 2 |
||||||||||||||||
REGENERON PHARMACEUTICALS, INC. |
||||||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Revenues: |
||||||||||||||||
Net product sales |
$ |
1,205.3 |
$ |
996.4 |
$ |
2,309.7 |
$ |
1,984.3 |
||||||||
Sanofi collaboration revenue |
349.1 |
237.8 |
595.5 |
427.2 |
||||||||||||
Bayer collaboration revenue |
289.0 |
262.9 |
565.2 |
510.8 |
||||||||||||
Other revenue |
90.3 |
110.9 |
175.1 |
197.2 |
||||||||||||
1,933.7 |
1,608.0 |
3,645.5 |
3,119.5 |
|||||||||||||
Expenses: |
||||||||||||||||
Research and development |
1,048.3 |
529.3 |
1,690.1 |
1,027.9 |
||||||||||||
Selling, general, and administrative |
417.3 |
364.8 |
828.1 |
695.6 |
||||||||||||
Cost of goods sold |
67.0 |
36.0 |
137.9 |
105.2 |
||||||||||||
Cost of collaboration and contract manufacturing |
85.5 |
55.7 |
193.8 |
101.4 |
||||||||||||
1,618.1 |
985.8 |
2,849.9 |
1,930.1 |
|||||||||||||
Income from operations |
315.6 |
622.2 |
795.6 |
1,189.4 |
||||||||||||
Other income (expense), net |
(90.9) |
33.9 |
(24.8) |
52.1 |
||||||||||||
Income before income taxes |
224.7 |
656.1 |
770.8 |
1,241.5 |
||||||||||||
Income tax expense |
(31.6) |
(104.7) |
(116.6) |
(212.1) |
||||||||||||
Net income |
$ |
193.1 |
$ |
551.4 |
$ |
654.2 |
$ |
1,029.4 |
||||||||
Net income per share - basic |
$ |
1.77 |
$ |
5.12 |
$ |
6.00 |
$ |
9.56 |
||||||||
Net income per share - diluted |
$ |
1.68 |
$ |
4.82 |
$ |
5.69 |
$ |
8.97 |
||||||||
Weighted average shares outstanding - basic |
109.2 |
107.8 |
109.1 |
107.7 |
||||||||||||
Weighted average shares outstanding - diluted |
114.6 |
114.5 |
115.0 |
114.7 |
TABLE 3 |
||||||||||||||||
REGENERON PHARMACEUTICALS, INC. |
||||||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
GAAP net income |
$ |
193.1 |
$ |
551.4 |
$ |
654.2 |
$ |
1,029.4 |
||||||||
Adjustments: |
||||||||||||||||
R&D: Non-cash share-based compensation expense |
59.3 |
59.6 |
118.0 |
100.4 |
||||||||||||
R&D: Up-front payments related to license and |
400.0 |
— |
400.0 |
— |
||||||||||||
SG&A: Non-cash share-based compensation expense |
37.7 |
40.5 |
81.5 |
75.5 |
||||||||||||
SG&A: Litigation contingencies |
5.0 |
— |
10.0 |
— |
||||||||||||
COGS and COCM: Non-cash share-based |
8.8 |
6.7 |
14.2 |
13.3 |
||||||||||||
Other income/expense: Losses (gains) on investments |
116.9 |
(16.5) |
74.1 |
(25.9) |
||||||||||||
Income tax effect of reconciling items above |
(130.8) |
(18.0) |
(144.3) |
(32.3) |
||||||||||||
Non-GAAP net income |
$ |
690.0 |
$ |
623.7 |
$ |
1,207.7 |
$ |
1,160.4 |
||||||||
Non-GAAP net income per share - basic |
$ |
6.32 |
$ |
5.79 |
$ |
11.07 |
$ |
10.77 |
||||||||
Non-GAAP net income per share - diluted |
$ |
6.02 |
$ |
5.45 |
$ |
10.50 |
$ |
10.12 |
||||||||
Shares used in calculating: |
||||||||||||||||
Non-GAAP net income per share - basic |
109.2 |
107.8 |
109.1 |
107.7 |
||||||||||||
Non-GAAP net income per share - diluted |
114.6 |
114.5 |
115.0 |
114.7 |
TABLE 4 |
||||||||||||||||
REGENERON PHARMACEUTICALS, INC. |
||||||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Sanofi collaboration revenue: |
||||||||||||||||
Reimbursement of Regeneron research and development expenses |
$ |
118.3 |
$ |
141.6 |
$ |
239.2 |
$ |
275.8 |
||||||||
Reimbursement of Regeneron commercialization-related expenses |
122.8 |
105.7 |
241.7 |
192.3 |
||||||||||||
Regeneron's share of profits (losses) in connection with |
38.8 |
(68.8) |
11.0 |
(143.7) |
||||||||||||
Other |
69.2 |
59.3 |
103.6 |
102.8 |
||||||||||||
Total Sanofi collaboration revenue |
349.1 |
237.8 |
595.5 |
427.2 |
||||||||||||
Bayer collaboration revenue: |
||||||||||||||||
Regeneron's net profit in connection with commercialization of |
269.0 |
246.3 |
518.3 |
478.4 |
||||||||||||
Reimbursement of Regeneron development expenses |
8.0 |
3.9 |
10.6 |
7.8 |
||||||||||||
Other |
12.0 |
12.7 |
36.3 |
24.6 |
||||||||||||
Total Bayer collaboration revenue |
289.0 |
262.9 |
565.2 |
510.8 |
||||||||||||
Total Sanofi and Bayer collaboration revenue |
$ |
638.1 |
$ |
500.7 |
$ |
1,160.7 |
$ |
938.0 |
||||||||
Other revenue: |
||||||||||||||||
Reimbursement of Regeneron research and development expenses - |
$ |
36.5 |
$ |
34.3 |
$ |
68.7 |
$ |
73.4 |
||||||||
Reimbursement of Regeneron research and development expenses - |
3.7 |
3.9 |
12.1 |
6.6 |
||||||||||||
Other |
50.1 |
72.7 |
94.3 |
117.2 |
||||||||||||
Total other revenue |
$ |
90.3 |
$ |
110.9 |
$ |
175.1 |
$ |
197.2 |
TABLE 5 |
|||||||||||||||||||||||||
REGENERON PHARMACEUTICALS, INC. |
|||||||||||||||||||||||||
Three Months Ended |
|||||||||||||||||||||||||
2019 |
2018 |
||||||||||||||||||||||||
U.S. |
ROW |
Total |
U.S. |
ROW |
Total |
||||||||||||||||||||
EYLEA* |
$ |
1,160.3 |
$ |
715.3 |
$ |
1,875.6 |
$ |
992.0 |
$ |
665.9 |
$ |
1,657.9 |
|||||||||||||
Libtayo |
40.8 |
— |
40.8 |
— |
— |
— |
|||||||||||||||||||
ARCALYST |
4.2 |
— |
4.2 |
4.4 |
— |
4.4 |
|||||||||||||||||||
Net product sales recorded by |
$ |
1,205.3 |
$ |
996.4 |
|||||||||||||||||||||
Net product sales recorded by Sanofi*: |
|||||||||||||||||||||||||
Dupixent |
$ |
454.7 |
$ |
102.6 |
$ |
557.3 |
$ |
180.9 |
$ |
28.3 |
$ |
209.2 |
|||||||||||||
Praluent |
$ |
26.5 |
$ |
47.2 |
$ |
73.7 |
$ |
41.4 |
$ |
32.1 |
$ |
73.5 |
|||||||||||||
Kevzara |
$ |
34.2 |
$ |
24.3 |
$ |
58.5 |
$ |
18.8 |
$ |
5.3 |
$ |
24.1 |
|||||||||||||
ZALTRAP |
$ |
1.3 |
$ |
25.3 |
$ |
26.6 |
$ |
2.7 |
$ |
25.7 |
$ |
28.4 |
|||||||||||||
Six Months Ended |
|||||||||||||||||||||||||
2019 |
2018 |
||||||||||||||||||||||||
U.S. |
ROW |
Total |
U.S. |
ROW |
Total |
||||||||||||||||||||
EYLEA* |
$ |
2,234.4 |
$ |
1,384.7 |
$ |
3,619.1 |
$ |
1,976.0 |
$ |
1,289.9 |
$ |
3,265.9 |
|||||||||||||
Libtayo |
67.6 |
— |
67.6 |
— |
— |
— |
|||||||||||||||||||
ARCALYST |
7.7 |
— |
7.7 |
8.3 |
— |
8.3 |
|||||||||||||||||||
Net product sales recorded by |
$ |
2,309.7 |
$ |
1,984.3 |
|||||||||||||||||||||
Net product sales recorded by Sanofi*: |
|||||||||||||||||||||||||
Dupixent |
$ |
757.7 |
$ |
173.3 |
$ |
931.0 |
$ |
298.1 |
$ |
42.5 |
$ |
340.6 |
|||||||||||||
Praluent |
$ |
49.4 |
$ |
88.2 |
$ |
137.6 |
$ |
73.2 |
$ |
60.2 |
$ |
133.4 |
|||||||||||||
Kevzara |
$ |
54.9 |
$ |
37.3 |
$ |
92.2 |
$ |
28.2 |
$ |
8.3 |
$ |
36.5 |
|||||||||||||
ZALTRAP |
$ |
1.8 |
$ |
49.3 |
$ |
51.1 |
$ |
5.1 |
$ |
49.6 |
$ |
54.7 |
|||||||||||||
* Bayer records net product sales of EYLEA outside the United States and Sanofi records global net product sales |
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