Regeneron Reports Third Quarter 2017 Financial and Operating Results
- Third quarter 2017 EYLEA® (aflibercept) Injection
U.S. net sales increased 12% to$953 million versus third quarter 2016 - Third quarter 2017 EYLEA global net sales(1) increased 15% to
$1.52 billion versus third quarter 2016 - Third quarter 2017 GAAP net income per diluted share increased 46% to
$3.32 versus third quarter 2016. Third quarter 2017 non-GAAP net income per diluted share increased 27% to$3.99 versus third quarter 2016. - Phase 3 EYLEA PANORAMA study for the treatment of diabetic retinopathy is fully enrolled with
U.S. regulatory submission expected in 2018 - Appellate court ordered a new trial and vacated permanent injunction in
U.S. Praluent® patent case
Financial Highlights |
|||||||||||
($ in millions, except per share data) |
Three Months Ended | ||||||||||
2017 |
2016 |
% Change | |||||||||
EYLEA |
$ |
953 |
$ |
854 |
12% | ||||||
Total revenues |
$ |
1,501 |
$ |
1,220 |
23% | ||||||
GAAP net income |
$ |
388 |
$ |
265 |
46% | ||||||
GAAP net income per share - diluted |
$ |
3.32 |
$ |
2.27 |
46% | ||||||
Non-GAAP net income(2) |
$ |
470 |
$ |
365 |
29% | ||||||
Non-GAAP net income per share - diluted(2) |
$ |
3.99 |
$ |
3.13 |
27% |
"In the third quarter, Regeneron made significant progress with our commercialized medicines, including continued strong global sales for our retinal therapy EYLEA and the completion of enrollment in our Phase 3 PANORAMA study in diabetic retinopathy, which represents an important new potential indication for EYLEA. We also saw robust
Business Highlights
Marketed Product Update
EYLEA® (aflibercept) Injection for Intravitreal Injection
- In the third quarter of 2017, net sales of EYLEA in
the United States increased 12% to$953 million from$854 million in the third quarter of 2016. Overall distributor inventory levels remained within the Company's one- to two-week targeted range. - In the third quarter of 2017, enrollment was completed in the Phase 3 PANORAMA study in patients with non-proliferative diabetic retinopathy without diabetic macular edema (DME).
- Bayer commercializes EYLEA outside
the United States . In the third quarter of 2017, net sales of EYLEA outside ofthe United States (1) were$564 million , compared to$471 million in the third quarter of 2016. In the third quarter of 2017, Regeneron recognized$205 million from its share of net profit from EYLEA sales outsidethe United States , compared to$171 million in the third quarter of 2016.
Dupixent® (dupilumab) Injection
- Dupilumab, an antibody that blocks signaling of IL-4 and IL-13, is currently being studied in asthma, pediatric atopic dermatitis, nasal polyps, and eosinophilic esophagitis (EoE).
- In the third quarter of 2017, global net sales of Dupixent were
$89 million , which were almost exclusively inthe United States . Product sales for Dupixent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Dupixent. - In
September 2017 , theEuropean Commission granted marketing authorization for Dupixent for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. - In
September 2017 , the Company and Sanofi presented positive results from the Phase 3 LIBERTY AD CAFÉ study in atopic dermatitis at the annualEuropean Academy of Dermatology andVenereology (EADV) Congress . - In
September 2017 , the Company and Sanofi announced that the Phase 3 LIBERTY ASTHMA QUEST study of dupilumab in a broad population of adults and adolescents with uncontrolled, persistent asthma met its two primary endpoints. - In
October 2017 , the Company and Sanofi announced that the Phase 3 LIBERTY ASTHMA VENTURE study evaluating dupilumab in adults and adolescents with severe, steroid-dependent asthma met its primary endpoint and key secondary endpoints. - In
September 2017 , theFDA granted orphan drug designation for the treatment of EoE. - In
October 2017 , the Company and Sanofi presented positive results from the Phase 2 study in adults with active moderate-to-severe EoE at theWorld Congress of Gastroenterology .
Praluent® (alirocumab) Injection for the Treatment of Elevated Low-Density Lipoprotein (LDL) Cholesterol
- In the third quarter of 2017, global net sales of Praluent were
$49 million , compared to$38 million in the third quarter of 2016. Product sales for Praluent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Praluent. - In
October 2017 , theU.S. Court of Appeals for the Federal Circuit ordered a new trial on the issues of written description and enablement and vacated the permanent injunction in the ongoing PCSK9 litigation. - A Phase 3 study in homozygous familial hypercholesterolemia (HoFH) was initiated in the fourth quarter of 2017.
Kevzara® (sarilumab) Injection
- In the third quarter of 2017, global net sales of Kevzara were
$3 million . Product sales for Kevzara are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Kevzara. - In
September 2017 , thePharmaceuticals and Medical Devices Agency (PMDA) inJapan approved Kevzara for the treatment of adult patients with rheumatoid arthritis who have had an inadequate response to conventional treatments.
Pipeline Progress
Regeneron has sixteen product candidates in clinical development, which consist of EYLEA and fully human monoclonal antibodies generated using the Company's VelocImmune® technology, including six in collaboration with Sanofi. In addition to EYLEA, Dupixent, Praluent, and Kevzara discussed above, updates from the clinical pipeline include:
Cemiplimab (REGN2810), an antibody to programmed cell death protein 1 (PD-1), is being studied in patients with cancer.
- In the third quarter of 2017, the
FDA granted Breakthrough Therapy designation for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC. - A pivotal Phase 2 study in metastatic or locally advanced and unresectable CSCC is ongoing.
- A Phase 3 study in cervical cancer was initiated in the third quarter of 2017.
Fasinumab is an antibody targeting Nerve Growth Factor (NGF). A Phase 3 efficacy study of fasinumab compared to placebo or naproxen in patients with pain due to osteoarthritis of the knee or hip was initiated in the third quarter of 2017.
Suptavumab is an antibody to the Respiratory Syncytial Virus-F (RSV-F). In
Select Upcoming 2017 Milestones
Programs |
Milestones | |
EYLEA |
• |
File sBLA with |
Dupixent |
• |
Submit sBLA for asthma in adult/adolescent patients |
• |
Initiate Phase 3 studies in younger pediatric patients in | |
Praluent |
• |
Complete ODYSSEY OUTCOMES study (with data |
• |
File sBLA with | |
Cemiplimab (PD-1 Antibody) |
• |
Report interim data from pivotal Phase 2 CSCC study |
Fasinumab (NGF Antibody) |
• |
Initiate Phase 3 study in patients with both chronic low back |
Nesvacumab/aflibercept |
• |
Report top-line data from Phase 2 studies in |
REGN2477 (Activin A |
• |
Initiate Phase 2 study in patients with Fibrodysplasia |
Third Quarter 2017 Financial Results
Product Revenues: Net product sales were
Total Revenues: Total revenues, which include product revenues described above, increased by 23% to
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 Collaboration and Contract Manufacturing (COCM): GAAP COCM was
Income Tax Expense: In the third quarter of 2017, GAAP income tax expense was
GAAP and Non-GAAP Net Income(2): The Company reported GAAP net income of
The Company reported non-GAAP net income of
A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.
2017 Financial Guidance(3)
The Company's updated full year 2017 financial guidance consists of the following components:
EYLEA |
Approximately 10% growth over 2016 (reaffirmed) |
Sanofi reimbursement of Regeneron |
|
Non-GAAP unreimbursed R&D(2)(4) |
|
Non-GAAP SG&A(2)(4) |
|
Effective tax rate |
26% - 29% |
Capital expenditures |
|
(1) |
Regeneron records net product sales of EYLEA in the United States. Outside the United States, EYLEA net product sales comprise sales by Bayer in countries other than | ||||||||
(2) |
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 | ||||||||
(3) |
The Company's 2017 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release. | ||||||||
(4) |
A reconciliation of full year 2017 non-GAAP to GAAP financial guidance is included below: | ||||||||
| |||||||||
(In millions) |
Low |
High | |||||||
GAAP unreimbursed R&D (5) |
$ |
1,145 |
$ |
1,190 |
|||||
R&D: Non-cash share-based compensation expense |
(260) |
(275) |
|||||||
Non-GAAP unreimbursed R&D |
$ |
885 |
$ |
915 |
|||||
GAAP SG&A |
$ |
1,270 |
$ |
1,325 |
|||||
SG&A: Non-cash share-based compensation expense |
(200) |
(225) |
|||||||
Non-GAAP SG&A |
$ |
1,070 |
$ |
1,100 |
|||||
(5) |
Unreimbursed R&D represents R&D expenses reduced by R&D expense reimbursements from the Company's collaborators and/or customers. |
Conference Call Information
Regeneron will host a conference call and simultaneous webcast to discuss its third quarter 2017 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 nearly 30 years by physician-scientists, Regeneron's unique ability to repeatedly and consistently translate science into medicine has led to six
Regeneron is accelerating and improving the traditional drug development process through its proprietary VelociSuite® technologies, including VelociGene® and VelocImmune® to yield optimized fully human antibodies, and ambitious initiatives such as the Regeneron Genetics Center, 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: |
||
|
| |
Investor Relations |
Corporate Communications | |
914-847-5126 |
914-847-3422 | |
TABLE 1 | ||||||||
| ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||||
(In thousands) | ||||||||
|
| |||||||
2017 |
2016 | |||||||
Assets: |
||||||||
Cash and marketable securities |
$ |
2,706,247 |
$ |
1,902,944 |
||||
Accounts receivable - trade, net |
1,532,693 |
1,343,368 |
||||||
Accounts receivable from Sanofi and Bayer |
438,756 |
268,252 |
||||||
Inventories |
641,588 |
399,356 |
||||||
Property, plant, and equipment, net |
2,274,529 |
2,083,421 |
||||||
Deferred tax assets |
927,023 |
825,303 |
||||||
Other assets |
180,379 |
150,822 |
||||||
Total assets |
$ |
8,701,215 |
$ |
6,973,466 |
||||
Liabilities and stockholders' equity: |
||||||||
Accounts payable, accrued expenses, and other liabilities |
$ |
943,985 |
$ |
980,659 |
||||
Deferred revenue |
1,003,320 |
1,062,436 |
||||||
Capital and facility lease obligations |
702,317 |
481,126 |
||||||
Stockholders' equity |
6,051,593 |
4,449,245 |
||||||
Total liabilities and stockholders' equity |
$ |
8,701,215 |
$ |
6,973,466 |
TABLE 2 | ||||||||||||||||
| ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) | ||||||||||||||||
(In thousands, except per share data) | ||||||||||||||||
Three Months Ended |
Nine Months Ended | |||||||||||||||
2017 |
2016 |
2017 |
2016 | |||||||||||||
Revenues: |
||||||||||||||||
Net product sales |
$ |
957,367 |
$ |
857,468 |
$ |
2,739,745 |
$ |
2,475,869 |
||||||||
Sanofi collaboration revenue |
245,175 |
144,392 |
677,670 |
527,500 |
||||||||||||
Bayer collaboration revenue |
236,625 |
191,298 |
640,919 |
562,786 |
||||||||||||
Other revenue |
61,506 |
26,964 |
231,446 |
67,445 |
||||||||||||
1,500,673 |
1,220,122 |
4,289,780 |
3,633,600 |
|||||||||||||
Expenses: |
||||||||||||||||
Research and development |
529,749 |
543,047 |
1,547,159 |
1,573,089 |
||||||||||||
Selling, general, and administrative |
306,766 |
270,045 |
910,520 |
851,760 |
||||||||||||
Cost of goods sold |
46,388 |
29,901 |
149,774 |
150,090 |
||||||||||||
Cost of collaboration and contract manufacturing |
57,844 |
14,327 |
141,547 |
74,923 |
||||||||||||
940,747 |
857,320 |
2,749,000 |
2,649,862 |
|||||||||||||
Income from operations |
559,926 |
362,802 |
1,540,780 |
983,738 |
||||||||||||
Other income (expense), net |
5,679 |
3,079 |
(17,036) |
4,550 |
||||||||||||
Income before income taxes |
565,605 |
365,881 |
1,523,744 |
988,288 |
||||||||||||
Income tax expense |
(177,288) |
(101,077) |
(498,752) |
(345,881) |
||||||||||||
Net income |
$ |
388,317 |
$ |
264,804 |
$ |
1,024,992 |
$ |
642,407 |
||||||||
Net income per share - basic |
$ |
3.64 |
$ |
2.53 |
$ |
9.66 |
$ |
6.14 |
||||||||
Net income per share - diluted |
$ |
3.32 |
$ |
2.27 |
$ |
8.84 |
$ |
5.51 |
||||||||
Weighted average shares outstanding - basic |
106,706 |
104,833 |
106,108 |
104,586 |
||||||||||||
Weighted average shares outstanding - diluted |
117,028 |
116,466 |
115,994 |
116,567 |
TABLE 3 | ||||||||||||||||
| ||||||||||||||||
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited) | ||||||||||||||||
(In thousands, except per share data) | ||||||||||||||||
Three Months Ended |
Nine Months Ended | |||||||||||||||
2017 |
2016 |
2017 |
2016 | |||||||||||||
GAAP net income |
$ |
388,317 |
$ |
264,804 |
$ |
1,024,992 |
$ |
642,407 |
||||||||
Adjustments: |
||||||||||||||||
R&D: Non-cash share-based compensation |
70,123 |
80,572 |
213,174 |
237,991 |
||||||||||||
R&D: Upfront payments related to license and |
— |
25,000 |
— |
100,000 |
||||||||||||
SG&A: Non-cash share-based compensation |
47,672 |
49,369 |
146,192 |
157,181 |
||||||||||||
COGS and COCM: Non-cash share-based |
7,302 |
1,438 |
20,778 |
10,148 |
||||||||||||
Other expense: Loss on extinguishment of debt |
— |
— |
30,100 |
466 |
||||||||||||
Income tax effect of reconciling items above |
(42,958) |
(56,210) |
(141,458) |
(181,558) |
||||||||||||
Non-GAAP net income |
$ |
470,456 |
$ |
364,973 |
$ |
1,293,778 |
$ |
966,635 |
||||||||
Non-GAAP net income per share - basic |
$ |
4.41 |
$ |
3.48 |
$ |
12.19 |
$ |
9.24 |
||||||||
Non-GAAP net income per share - diluted |
$ |
3.99 |
$ |
3.13 |
$ |
11.09 |
$ |
8.28 |
||||||||
Shares used in calculating: |
||||||||||||||||
Non-GAAP net income per share - basic |
106,706 |
104,833 |
106,108 |
104,586 |
||||||||||||
Non-GAAP net income per share - diluted |
117,819 |
116,644 |
116,616 |
116,764 |
TABLE 4 | ||||||||||||||||
| ||||||||||||||||
COLLABORATION AND OTHER REVENUE (Unaudited) | ||||||||||||||||
(In thousands) | ||||||||||||||||
Three Months Ended |
Nine Months Ended | |||||||||||||||
2017 |
2016 |
2017 |
2016 | |||||||||||||
Sanofi collaboration revenue: |
||||||||||||||||
Reimbursement of Regeneron research and |
$ |
190,188 |
$ |
167,615 |
$ |
609,464 |
$ |
567,074 |
||||||||
Reimbursement of Regeneron |
90,339 |
64,418 |
251,002 |
213,957 |
||||||||||||
Regeneron's share of losses in connection with |
(98,315) |
(112,001) |
(328,998) |
(333,530) |
||||||||||||
Other |
62,963 |
24,360 |
146,202 |
79,999 |
||||||||||||
Total Sanofi collaboration revenue |
245,175 |
144,392 |
677,670 |
527,500 |
||||||||||||
Bayer collaboration revenue: |
||||||||||||||||
Regeneron's net profit in connection with |
205,367 |
170,854 |
571,126 |
484,181 |
||||||||||||
Reimbursement of Regeneron development |
13,378 |
9,652 |
26,447 |
21,351 |
||||||||||||
Other |
17,880 |
10,792 |
43,346 |
57,254 |
||||||||||||
Total Bayer collaboration revenue |
236,625 |
191,298 |
640,919 |
562,786 |
||||||||||||
Total Sanofi and Bayer collaboration revenue |
$ |
481,800 |
$ |
335,690 |
$ |
1,318,589 |
$ |
1,090,286 |
||||||||
Other revenue: |
||||||||||||||||
Reimbursement of Regeneron research and |
$ |
28,537 |
$ |
3,064 |
$ |
82,068 |
$ |
3,064 |
||||||||
Reimbursement of Regeneron research and |
150 |
933 |
3,562 |
1,553 |
||||||||||||
Substantive development milestones |
— |
— |
55,000 |
— |
||||||||||||
Other |
32,819 |
22,967 |
90,816 |
62,828 |
||||||||||||
Total other revenue |
$ |
61,506 |
$ |
26,964 |
$ |
231,446 |
$ |
67,445 |
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