INVESTORS & MEDIA
News Release
Regeneron Reports Third Quarter 2019 Financial and Operating Results
- Third quarter 2019 revenues increased 23% to
$2.05 billion versus third quarter 2018 - Third quarter EYLEA® U.S. net sales increased 16% to
$1.19 billion versus third quarter 2018 - Dupixent® global net sales(5), which increased 141% to
$633 million versus third quarter 2018, drove higher profitability from antibody collaboration withSanofi - Third quarter 2019 GAAP diluted EPS was
$5.86 and third quarter non-GAAP diluted EPS(1) was$6.67 - Company announces
$1.0 billion share repurchase program
"Regeneron delivered positive financial and operational results this quarter, marked by significant EYLEA and Dupixent sales growth and progress across our pipeline," said
"This quarter, we realized improving profitability from the
Financial Highlights |
|||||||||||
Three Months Ended |
|||||||||||
($ in millions, except per share data) |
2019 |
2018 |
% Change |
||||||||
Total revenues |
$ |
2,048 |
$ |
1,663 |
23 |
% |
|||||
GAAP net income |
$ |
670 |
$ |
595 |
13 |
% |
|||||
GAAP net income per share - diluted |
$ |
5.86 |
$ |
5.17 |
13 |
% |
|||||
Non-GAAP net income(1) |
$ |
762 |
$ |
675 |
13 |
% |
|||||
Non-GAAP net income per share - diluted(1) |
$ |
6.67 |
$ |
5.87 |
14 |
% |
Business Highlights
Key Pipeline Progress
Regeneron has 24 product candidates in clinical development, including five of the Company's
EYLEA® (aflibercept) Injection
- In
August 2019 , theFDA approved the EYLEA pre-filled syringe, which is expected to be launched before the end of this year. - A Phase 2 study exploring less frequent dosing intervals using a high-dose formulation of aflibercept in wet AMD was initiated.
- A Phase 3 study in retinopathy of prematurity was initiated.
Dupixent® (dupilumab)
- In
August 2019 , theEuropean Commission (EC) extended its approval of Dupixent in theEuropean Union 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. Submissions for a supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA) for this expanded atopic dermatitis indication in pediatric patients are expected by the end of the year. - In
October 2019 , the EC approved Dupixent in chronic rhinosinusitis with nasal polyposis (CRSwNP). - The Company and
Sanofi plan to initiate Phase 3 studies in bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, and additional type 2 inflammatory diseases.
Praluent® (alirocumab)
- In
August 2019 , the Company andSanofi announced theU.S. District Court for the District of Delaware ruled in their favor and found as a matter of law thatAmgen's asserted patent claims for antibodies targeting PCSK9 are invalid based on lack of enablement.
Evinacumab, an antibody to ANGPTL3
- In
August 2019 , the Company announced positive top-line results from a Phase 3 trial of evinacumab in patients with homozygous familial hypercholesterolemia (HoFH). The Company plans to submit a BLA in mid-2020.
REGN-EB3, a multi-antibody therapy to Ebola virus infection
- In
August 2019 , the Company announced that a randomized, controlled trial evaluating four investigational therapies for Ebola virus infection was stopped early because REGN-EB3 was superior to ZMapp (the control arm of the trial since it was considered standard-of-care) in preventing death. REGN-EB3 and another investigational drug are being further studied as part of the Extension Phase of this trial. - The
FDA granted Breakthrough Therapy designation for the treatment of Ebola virus infection and the Company has initiated a rolling BLA submission.
REGN5678, a bispecific antibody targeting PSMA and CD28
- A Phase 1 study evaluating this first-in-class co-stimulatory bispecific antibody was initiated in prostate cancer.
REGN5093, a bispecific antibody targeting two distinct MET epitopes
- A Phase 1 study evaluating this first-in-class bispecific antibody was initiated in MET-altered advanced non-small cell lung cancer.
Share Repurchase Program
In
Third Quarter 2019 Financial Results
Total Revenues: Total revenues increased by 23% 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
Income Taxes: In the third quarter of 2019, GAAP income tax expense was
GAAP and Non-GAAP Net Income(1): GAAP net income was
Non-GAAP net income was
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 reimbursement of Regeneron commercialization-related expenses |
$490 million–$510 million |
Unreimbursed R&D(4) |
$2.360 billion–$2.410 billion (previously $2.300 billion–$2.380 billion) |
Non-GAAP Unreimbursed R&D(1)(3) |
$1.680 billion–$1.710 billion |
GAAP SG&A |
$1.730 billion–$1.780 billion (previously $1.705 billion–$1.785 billion) |
Non-GAAP SG&A(1)(3) |
$1.550 billion–$1.580 billion |
GAAP effective tax rate |
12%–14% |
Capital expenditures |
$390 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 |
||||||
Unreimbursed R&D(4) |
$ |
2,360 |
$ |
2,410 |
||||
R&D: Non-cash share-based compensation expense |
(250) |
(270) |
||||||
R&D: Up-front payments related to license and |
(430) |
(430) |
||||||
Non-GAAP unreimbursed R&D |
$ |
1,680 |
$ |
1,710 |
||||
GAAP SG&A |
$ |
1,730 |
$ |
1,780 |
||||
SG&A: Non-cash share-based compensation |
(160) |
(180) |
||||||
SG&A: Other |
(20) |
(20) |
||||||
Non-GAAP SG&A |
$ |
1,550 |
$ |
1,580 |
(4) |
Unreimbursed R&D represents GAAP R&D expenses reduced by GAAP R&D expense reimbursements from the Company's collaborators and/or customers (refer to Table 4). |
(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 third quarter 2019 financial and operating results on Tuesday, November 5, 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 uses a unique genetically-humanized mouse 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
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 |
|
justin.holko@regeneron.com |
hala.mirza@regeneron.com |
TABLE 1 |
||||||||
REGENERON PHARMACEUTICALS, INC. |
||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) |
||||||||
(In millions) |
||||||||
September 30, |
December 31, |
|||||||
2019 |
2018 |
|||||||
Assets: |
||||||||
Cash and marketable securities |
$ |
5,990.5 |
$ |
4,564.9 |
||||
Accounts receivable - trade, net |
2,027.7 |
1,723.7 |
||||||
Accounts receivable from Sanofi and Bayer |
632.3 |
519.5 |
||||||
Inventories |
1,344.3 |
1,151.2 |
||||||
Property, plant, and equipment, net |
2,771.4 |
2,575.8 |
||||||
Deferred tax assets |
808.3 |
828.7 |
||||||
Other assets |
364.8 |
370.7 |
||||||
Total assets |
$ |
13,939.3 |
$ |
11,734.5 |
||||
Liabilities and stockholders' equity: |
||||||||
Accounts payable, accrued expenses, and other liabilities |
$ |
1,429.7 |
$ |
1,352.0 |
||||
Deferred revenue |
1,292.5 |
916.7 |
||||||
Finance lease liabilities |
712.7 |
708.5 |
||||||
Stockholders' equity |
10,504.4 |
8,757.3 |
||||||
Total liabilities and stockholders' equity |
$ |
13,939.3 |
$ |
11,734.5 |
TABLE 2 |
||||||||||||||||
REGENERON PHARMACEUTICALS, INC. |
||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) |
||||||||||||||||
(In millions, except per share data) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Revenues: |
||||||||||||||||
Net product sales |
$ |
1,238.3 |
$ |
1,025.5 |
$ |
3,548.0 |
$ |
3,009.8 |
||||||||
Sanofi collaboration revenue |
404.2 |
256.3 |
999.7 |
683.5 |
||||||||||||
Bayer collaboration revenue |
302.8 |
264.4 |
868.0 |
775.2 |
||||||||||||
Other revenue |
103.1 |
117.3 |
278.2 |
314.5 |
||||||||||||
2,048.4 |
1,663.5 |
5,693.9 |
4,783.0 |
|||||||||||||
Expenses: |
||||||||||||||||
Research and development |
663.4 |
557.0 |
2,353.5 |
1,584.8 |
||||||||||||
Selling, general, and administrative |
419.9 |
369.2 |
1,248.0 |
1,064.9 |
||||||||||||
Cost of goods sold |
115.9 |
30.8 |
253.8 |
136.1 |
||||||||||||
Cost of collaboration and contract manufacturing |
110.7 |
79.6 |
304.5 |
180.9 |
||||||||||||
1,309.9 |
1,036.6 |
4,159.8 |
2,966.7 |
|||||||||||||
Income from operations |
738.5 |
626.9 |
1,534.1 |
1,816.3 |
||||||||||||
Other income (expense), net |
30.0 |
9.0 |
5.2 |
61.0 |
||||||||||||
Income before income taxes |
768.5 |
635.9 |
1,539.3 |
1,877.3 |
||||||||||||
Income tax expense |
(98.9) |
(41.2) |
(215.5) |
(253.3) |
||||||||||||
Net income |
$ |
669.6 |
$ |
594.7 |
$ |
1,323.8 |
$ |
1,624.0 |
||||||||
Net income per share - basic |
$ |
6.12 |
$ |
5.50 |
$ |
12.12 |
$ |
15.06 |
||||||||
Net income per share - diluted |
$ |
5.86 |
$ |
5.17 |
$ |
11.54 |
$ |
14.14 |
||||||||
Weighted average shares outstanding - basic |
109.4 |
108.0 |
109.2 |
107.8 |
||||||||||||
Weighted average shares outstanding - diluted |
114.2 |
115.1 |
114.7 |
114.8 |
TABLE 3 |
||||||||||||||||
REGENERON PHARMACEUTICALS, INC. |
||||||||||||||||
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited) |
||||||||||||||||
(In millions, except per share data) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
GAAP net income |
$ |
669.6 |
$ |
594.7 |
$ |
1,323.8 |
$ |
1,624.0 |
||||||||
Adjustments: |
||||||||||||||||
R&D: Non-cash share-based compensation expense |
60.0 |
60.4 |
178.0 |
160.8 |
||||||||||||
R&D: Up-front payments related to license and |
— |
— |
400.0 |
— |
||||||||||||
SG&A: Non-cash share-based compensation expense |
40.8 |
42.9 |
122.3 |
118.4 |
||||||||||||
SG&A: Litigation contingencies |
— |
— |
10.0 |
— |
||||||||||||
COGS and COCM: Non-cash share-based compensation |
16.3 |
8.1 |
30.5 |
21.4 |
||||||||||||
Other income/expense: (Gains) losses on investments in |
(3.4) |
4.9 |
70.7 |
(21.0) |
||||||||||||
Income tax effect of reconciling items above |
(21.5) |
(23.7) |
(165.8) |
(55.8) |
||||||||||||
Income tax expense: Adjustment to previously recorded |
— |
(11.9) |
— |
(11.9) |
||||||||||||
Non-GAAP net income |
$ |
761.8 |
$ |
675.4 |
$ |
1,969.5 |
$ |
1,835.9 |
||||||||
Non-GAAP net income per share - basic |
$ |
6.96 |
$ |
6.25 |
$ |
18.04 |
$ |
17.03 |
||||||||
Non-GAAP net income per share - diluted |
$ |
6.67 |
$ |
5.87 |
$ |
17.16 |
$ |
15.98 |
||||||||
Shares used in calculating: |
||||||||||||||||
Non-GAAP net income per share - basic |
109.4 |
108.0 |
109.2 |
107.8 |
||||||||||||
Non-GAAP net income per share - diluted |
114.2 |
115.1 |
114.8 |
114.9 |
TABLE 4 |
||||||||||||||||
REGENERON PHARMACEUTICALS, INC. |
||||||||||||||||
COLLABORATION AND OTHER REVENUE (Unaudited) |
||||||||||||||||
(In millions) |
||||||||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||
Sanofi collaboration revenue: |
||||||||||||||||
Antibody: |
||||||||||||||||
Reimbursement of Regeneron research and development expenses |
$ |
60.2 |
$ |
76.2 |
$ |
216.5 |
$ |
201.0 |
||||||||
Reimbursement of Regeneron commercialization-related expenses |
111.6 |
103.7 |
349.3 |
292.8 |
||||||||||||
Reimbursement for Regeneron's manufacturing of commercial |
78.5 |
40.3 |
133.3 |
94.4 |
||||||||||||
Regeneron's share of profits (losses) in connection with |
94.2 |
(38.9) |
105.2 |
(182.6) |
||||||||||||
Other |
4.8 |
(7.2) |
(0.6) |
(12.3) |
||||||||||||
Immuno-oncology: |
||||||||||||||||
Reimbursement of Regeneron research and development expenses |
38.0 |
74.8 |
120.9 |
225.7 |
||||||||||||
Reimbursement of Regeneron commercialization-related expenses |
3.0 |
3.2 |
7.0 |
6.5 |
||||||||||||
Amounts recognized in connection with up-front payments |
18.5 |
7.9 |
73.8 |
65.2 |
||||||||||||
Other |
(4.6) |
(3.7) |
(5.7) |
(7.2) |
||||||||||||
Total Sanofi collaboration revenue |
404.2 |
256.3 |
999.7 |
683.5 |
||||||||||||
Bayer collaboration revenue: |
||||||||||||||||
Regeneron's net profit in connection with commercialization of |
275.0 |
243.2 |
793.3 |
721.5 |
||||||||||||
Reimbursement of Regeneron development expenses |
5.0 |
0.5 |
15.6 |
8.3 |
||||||||||||
Other |
22.8 |
20.7 |
59.1 |
45.4 |
||||||||||||
Total Bayer collaboration revenue |
302.8 |
264.4 |
868.0 |
775.2 |
||||||||||||
Other revenue: |
||||||||||||||||
Reimbursement of Regeneron research and development expenses |
34.2 |
27.6 |
102.9 |
101.1 |
||||||||||||
Reimbursement of Regeneron research and development expenses |
24.9 |
6.3 |
37.0 |
12.9 |
||||||||||||
Other |
44.0 |
83.4 |
138.3 |
200.5 |
||||||||||||
Total other revenue |
$ |
103.1 |
$ |
117.3 |
$ |
278.2 |
$ |
314.5 |
TABLE 5 |
|||||||||||||||||||||||||||
REGENERON PHARMACEUTICALS, INC. |
|||||||||||||||||||||||||||
NET PRODUCT SALES OF REGENERON-DISCOVERED PRODUCTS (Unaudited) |
|||||||||||||||||||||||||||
(In millions) |
|||||||||||||||||||||||||||
Three Months Ended |
|||||||||||||||||||||||||||
2019 |
2018 |
% Change |
|||||||||||||||||||||||||
U.S. |
ROW |
Total |
U.S. |
ROW |
Total |
(Total Sales) |
|||||||||||||||||||||
EYLEA* |
$ |
1,187.7 |
$ |
730.2 |
$ |
1,917.9 |
$ |
1,021.8 |
$ |
654.6 |
$ |
1,676.4 |
14 |
% |
|||||||||||||
Libtayo* |
47.6 |
3.9 |
51.5 |
— |
— |
— |
** |
||||||||||||||||||||
ARCALYST |
3.0 |
— |
3.0 |
3.7 |
— |
3.7 |
(19) |
% |
|||||||||||||||||||
Net product sales recorded by |
$ |
1,238.3 |
$ |
1,025.5 |
|||||||||||||||||||||||
Global net product sales recorded by Sanofi*: |
|||||||||||||||||||||||||||
Dupixent |
$ |
508.3 |
$ |
124.8 |
$ |
633.1 |
$ |
219.6 |
$ |
43.0 |
$ |
262.6 |
141 |
% |
|||||||||||||
Praluent |
$ |
33.5 |
$ |
36.2 |
$ |
69.7 |
$ |
48.4 |
$ |
31.8 |
$ |
80.2 |
(13) |
% |
|||||||||||||
Kevzara |
$ |
36.5 |
$ |
18.3 |
$ |
54.8 |
$ |
19.9 |
$ |
5.0 |
$ |
24.9 |
120 |
% |
|||||||||||||
ZALTRAP |
$ |
3.1 |
$ |
25.3 |
$ |
28.4 |
$ |
1.5 |
$ |
23.9 |
$ |
25.4 |
12 |
% |
|||||||||||||
Nine Months Ended |
|||||||||||||||||||||||||||
2019 |
2018 |
% Change |
|||||||||||||||||||||||||
U.S. |
ROW |
Total |
U.S. |
ROW |
Total |
(Total Sales) |
|||||||||||||||||||||
EYLEA* |
$ |
3,422.1 |
$ |
2,114.9 |
$ |
5,537.0 |
$ |
2,997.8 |
$ |
1,944.5 |
$ |
4,942.3 |
12 |
% |
|||||||||||||
Libtayo* |
115.2 |
3.9 |
119.1 |
— |
— |
— |
** |
||||||||||||||||||||
ARCALYST |
10.7 |
— |
10.7 |
12.0 |
— |
12.0 |
(11) |
% |
|||||||||||||||||||
Net product sales recorded by |
$ |
3,548.0 |
$ |
3,009.8 |
|||||||||||||||||||||||
Global net product sales recorded by Sanofi*: |
|||||||||||||||||||||||||||
Dupixent |
$ |
1,266.0 |
$ |
298.1 |
$ |
1,564.1 |
$ |
517.7 |
$ |
85.4 |
$ |
603.1 |
159 |
% |
|||||||||||||
Praluent |
$ |
82.9 |
$ |
124.4 |
$ |
207.3 |
$ |
121.5 |
$ |
92.0 |
$ |
213.5 |
(3) |
% |
|||||||||||||
Kevzara |
$ |
91.4 |
$ |
55.6 |
$ |
147.0 |
$ |
48.1 |
$ |
13.3 |
$ |
61.4 |
139 |
% |
|||||||||||||
ZALTRAP |
$ |
4.9 |
$ |
74.6 |
$ |
79.5 |
$ |
6.6 |
$ |
73.5 |
$ |
80.1 |
(1) |
% |
|||||||||||||
* Bayer records net product sales of EYLEA outside the U.S., and Sanofi records net product sales of Libtayo outside the U.S. and global net product sales of Dupixent, Praluent, Kevzara, and ZALTRAP. The Company records its share of profits/losses in connection with sales of EYLEA and Libtayo outside the U.S., and global sales of Dupixent, Praluent, and Kevzara, within collaboration revenue (see Table 4). Sanofi pays the Company a percentage of aggregate net sales of ZALTRAP. |
|||||||||||||||||||||||||||
** Percentage not meaningful |
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