Regeneron Reports First Quarter 2016 Financial and Operating Results
Financial Highlights | |||||||||||
($ in millions, except per share data) |
Three Months Ended | ||||||||||
2016 |
2015 |
% Change | |||||||||
EYLEA |
$ |
781 |
$ |
541 |
44% | ||||||
Total revenues |
$ |
1,201 |
$ |
870 |
38% | ||||||
Non-GAAP net income(2) |
$ |
293 |
$ |
336 |
(13%) | ||||||
Non-GAAP net income per share - diluted(2) |
$ |
2.57 |
$ |
2.88 |
(11%) | ||||||
GAAP net income |
$ |
166 |
$ |
76 |
118% | ||||||
GAAP net income per share - diluted |
$ |
1.45 |
$ |
0.66 |
120% | ||||||
"The year is off to a very productive start at Regeneron. This quarter, we saw continued strong sales growth with EYLEA, made additional launch progress with Praluent, prepared for the potential launch of sarilumab, and reported important new data across our pipeline," said
Business Highlights
Marketed Product Update
EYLEA® (aflibercept) Injection for Intravitreal Injection
- In the first quarter of 2016, net sales of EYLEA in
the United States increased 44% to$781 million from$541 million in the first quarter of 2015. Overall distributor inventory levels remained within the Company's one- to two-week targeted range. - Bayer commercializes EYLEA outside
the United States . In the first quarter of 2016, net sales of EYLEA outside ofthe United States (1) were$419 million , compared to$292 million in the first quarter of 2015. In the first quarter of 2016, Regeneron recognized$146 million from its share of net profit from EYLEA sales outsidethe United States , compared to$89 million in the first quarter of 2015. - A Phase 3 study of EYLEA for the treatment of non-proliferative diabetic retinopathy in patients without diabetic macular edema (DME) was initiated in the first quarter of 2016.
Praluent® (alirocumab) Injection for the Treatment of High Low-Density Lipoprotein (LDL) Cholesterol
- In the first quarter of 2016, net sales of Praluent were
$13 million . Product sales for Praluent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Praluent. Praluent was launched inthe United States in the third quarter of 2015 and in certain countries in theEuropean Union commencing in the fourth quarter of 2015. - In
March 2016 , the Company and Sanofi reported data from the Phase 3 ODYSSEY ESCAPE study in patients with heterozygous familial hypercholesterolemia (HeFH) who were undergoing LDL apheresis therapy. The trial achieved its primary endpoint, demonstrating that patients who added Praluent to their existing treatment regimen significantly reduced the frequency of their apheresis therapy by 75%, compared to placebo. - In the first quarter of 2016, the Data Monitoring Committee (DMC) of the ODYSSEY OUTCOMES study for Praluent completed the first interim analysis. In accordance with the protocol, the DMC performed a futility assessment. The DMC recommended the study continue with no changes. Regeneron remains blinded to the actual results of this analysis. The ongoing ODYSSEY OUTCOMES trial is assessing the potential of Praluent to demonstrate cardiovascular benefit.
Pipeline Progress
Regeneron has thirteen product candidates in clinical development. These consist of EYLEA and twelve fully human monoclonal antibodies generated using the Company's VelocImmune® technology, including four in collaboration with Sanofi. In addition to EYLEA and Praluent, highlights from the antibody pipeline include:
Sarilumab, the Company's antibody targeting IL-6R for rheumatoid arthritis, is currently being studied in the global Phase 3 SARIL-RA program.
- In
March 2016 , the Company and Sanofi reported results from the 24-week Phase 3 SARIL-RA-MONARCH study in adult patients with active rheumatoid arthritis who were inadequate responders to, intolerant of, or inappropriate candidates for methotrexate (MTX) therapy. The study met its primary endpoint, demonstrating that sarilumab monotherapy was superior to adalimumab monotherapy (marketed by AbbVie Inc. as HUMIRA®). - In
December 2015 , theU.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for sarilumab, with a target action date ofOctober 30, 2016 .
Dupilumab, the Company's antibody that blocks signaling of IL-4 and IL-13, is currently being studied in atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis.
- In
April 2016 , the Company and Sanofi reported that the Phase 3 LIBERTY AD SOLO 1 and SOLO 2 trials evaluating dupilumab in adult patients with inadequately controlled moderate-to-severe atopic dermatitis met their primary endpoints. - A Phase 2 study of dupilumab in pediatric patients (6-17 years of age) with moderate-to-severe atopic dermatitis is fully enrolled and ongoing.
- A Phase 3 pivotal study of dupilumab in patients with uncontrolled persistent asthma continues to enroll patients.
- A Phase 2 study of dupilumab in eosinophilic esophagitis is ongoing.
Fasinumab, the Company's antibody targeting Nerve Growth Factor (NGF), is currently being studied in patients with pain due to osteoarthritis and lower back pain.
- The Company recently reported results from a Phase 2/3 study evaluating fasinumab in patients with moderate-to-severe osteoarthritis pain of the hip or knee who have a history of inadequate pain relief or intolerance to current analgesic therapies. The study met its primary endpoint at 16 weeks.
- In the first quarter of 2016, the Company initiated a Phase 3 long-term safety and efficacy study of fasinumab in patients with pain due to osteoarthritis of the knee or hip, and this trial is currently enrolling patients.
- In the first quarter of 2016, the Company also initiated a Phase 2b/3 study of fasinumab in chronic lower back pain.
REGN2810, an antibody to programmed cell death protein 1 (PD-1), entered a potentially pivotal clinical study for the treatment of advanced cutaneous squamous cell carcinoma in the second quarter of 2016.
Nesvacumab/aflibercept, a combination product comprised of an antibody to angiopoietin-2 (Ang2) co-formulated with aflibercept for intravitreal injection for use in ophthalmology, entered Phase 2 clinical development for the treatment of neovascular age-related macular degeneration (wet AMD) and DME in the first quarter of 2016.
Evinacumab, an antibody to Angptl-3, was granted orphan-drug designation by the
Select Upcoming 2016 Milestones
Clinical Programs |
Milestones | |
REGN2176-3 (PDGFR-beta |
• |
Report results from Phase 2 study |
Praluent |
• |
DMC interim analysis of ODYSSEY OUTCOMES trial |
• |
Ongoing launch in additional countries | |
Sarilumab (IL-6R Antibody) |
• |
|
• |
File for regulatory approvals outside | |
Dupilumab (IL-4R Antibody) |
• |
Report primary endpoint results from Phase 3 |
• |
Complete rolling BLA submission for atopic dermatitis in | |
• |
Initiate Phase 3 study in pediatric patients in atopic | |
REGN2810 (PD-1 Antibody) |
• |
Report data from Phase 1 study in patients with cancer |
Human Genetics Initiative
- In the first quarter of 2016, the
New England Journal of Medicine published a Regeneron Genetics Center paper showing that inactivating mutations of the angiopoeitin-like 4 (ANGPTL4) gene are associated with a significantly reduced risk of coronary artery disease in humans. ANGPTL4 and ANGPTL3 are thought to be related inhibitors of lipoprotein lipase (LPL).
Business Development Update
- In
March 2016 , the Company and Bayer entered into a collaboration agreement to jointly develop a combination therapy of the Ang2 antibody nesvacumab and aflibercept for the treatment of serious eye diseases. - In
April 2016 , the Company andIntellia Therapeutics, Inc. entered into a license and collaboration agreement to advance CRISPR/Cas gene-editing technology for in vivo therapeutic development. In addition to the discovery, development and commercialization of new therapies, the companies will focus on technology development of the CRISPR/Cas platform.
First Quarter 2016 Financial Results
Product Revenues: Net product sales were
Total Revenues: Total revenues, which include product revenues described above, increased by 38% to
Refer to Table 4 for a summary of collaboration 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 Tax Expense: In the first quarter of 2016, GAAP income tax expense was
The non-GAAP income tax adjustment in the first quarter of 2016 is primarily related to the cash taxes the Company expects to be paid or payable in 2016 in connection with the immuno-oncology up-front payment that the Company received in 2015, partly offset by the excess tax benefit associated with stock option exercises. The non-GAAP income tax adjustment in the first quarter of 2015 was primarily related to the Company's tax credit carry-forwards available for tax purposes and excess tax benefits in connection with stock option exercises.
Non-GAAP and GAAP Net Income: The Company reported non-GAAP net income of
The Company reported GAAP net income of
A reconciliation of the Company's GAAP to non-GAAP results is included in Table 3 of this press release.
2016 Financial Guidance(3)
The Company's updated full year 2016 financial guidance consists of the following components:
EYLEA |
20% - 25% growth over 2015 |
Sanofi reimbursement of Regeneron |
|
Non-GAAP unreimbursed R&D(2) |
|
Non-GAAP SG&A(2) |
|
Cash tax as a % of non-GAAP pre-tax income(2) |
35% - 45%* (reaffirmed) |
Capital expenditures |
|
* - Includes a non-recurring tax payment of approximately | |
(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, non-GAAP SG&A, and cash tax as a percentage of non-GAAP pre-tax income, which are financial measures that are not calculated in accordance with |
(3) |
The Company's 2016 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release. |
Conference Call Information
Regeneron will host a conference call and simultaneous webcast to discuss its first quarter 2016 financial and operating results on
About
Regeneron is a leading science-based biopharmaceutical company based in
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 | |
914-847-5126 |
914-847-3422 | |
TABLE 1 | ||||||||
| ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||||
(In thousands) | ||||||||
|
| |||||||
2016 |
2015 | |||||||
Assets: |
||||||||
Cash and marketable securities |
$ |
1,404,389 |
$ |
1,677,385 |
||||
Accounts receivable - trade, net |
1,450,572 |
1,152,489 |
||||||
Accounts receivable from Sanofi and Bayer |
414,649 |
315,304 |
||||||
Inventories |
303,294 |
238,578 |
||||||
Deferred tax assets |
543,689 |
461,945 |
||||||
Property, plant, and equipment, net |
1,666,391 |
1,594,120 |
||||||
Other assets |
121,476 |
169,311 |
||||||
Total assets |
$ |
5,904,460 |
$ |
5,609,132 |
||||
Liabilities and stockholders' equity: |
||||||||
Accounts payable, accrued expenses, and other liabilities |
$ |
855,412 |
$ |
760,619 |
||||
Deferred revenue |
909,371 |
818,166 |
||||||
Facility lease obligations |
364,136 |
364,708 |
||||||
Convertible senior notes |
10,459 |
10,802 |
||||||
Stockholders' equity |
3,765,082 |
3,654,837 |
||||||
Total liabilities and stockholders' equity |
$ |
5,904,460 |
$ |
5,609,132 |
TABLE 2 | ||||||||
| ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) | ||||||||
(In thousands, except per share data) | ||||||||
Three Months Ended | ||||||||
2016 |
2015 | |||||||
Revenues: |
||||||||
Net product sales |
$ |
784,182 |
$ |
544,573 |
||||
Sanofi collaboration revenue |
219,694 |
173,356 |
||||||
Bayer collaboration revenue |
179,592 |
123,846 |
||||||
Other revenue |
17,381 |
27,837 |
||||||
1,200,849 |
869,612 |
|||||||
Expenses: |
||||||||
Research and development |
470,112 |
343,113 |
||||||
Selling, general, and administrative |
289,677 |
158,991 |
||||||
Cost of goods sold |
78,942 |
42,570 |
||||||
Cost of collaboration and contract manufacturing |
32,810 |
41,385 |
||||||
871,541 |
586,059 |
|||||||
Income from operations |
329,308 |
283,553 |
||||||
Other income (expense), net |
843 |
(7,030) |
||||||
Income before income taxes |
330,151 |
276,523 |
||||||
Income tax expense |
(164,415) |
(200,502) |
||||||
Net income |
$ |
165,736 |
$ |
76,021 |
||||
Net income per share - basic |
$ |
1.59 |
$ |
0.74 |
||||
Net income per share - diluted |
$ |
1.45 |
$ |
0.66 |
||||
Weighted average shares outstanding - basic |
104,290 |
102,227 |
||||||
Weighted average shares outstanding - diluted |
114,228 |
114,519 |
TABLE 3 | ||||||||
| ||||||||
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited) | ||||||||
(In thousands, except per share data) | ||||||||
Three Months Ended | ||||||||
2016 |
2015 | |||||||
GAAP net income |
$ |
165,736 |
$ |
76,021 |
||||
Adjustments: |
||||||||
R&D: Non-cash share-based compensation expense |
78,102 |
59,502 |
||||||
SG&A: Non-cash share-based compensation expense |
60,082 |
42,175 |
||||||
COGS and COCM: Non-cash share-based compensation expense |
4,066 |
2,082 |
||||||
Other expense: Non-cash interest and loss on extinguishment related to convertible |
84 |
3,190 |
||||||
Non-cash income taxes |
(15,271) |
152,568 |
||||||
Non-GAAP net income |
$ |
292,799 |
$ |
335,538 |
||||
Non-GAAP net income per share - basic |
$ |
2.81 |
$ |
3.28 |
||||
Non-GAAP net income per share - diluted (a) |
$ |
2.57 |
$ |
2.88 |
||||
Shares used in calculating: |
||||||||
Non-GAAP net income per share - basic |
104,290 |
102,227 |
||||||
Non-GAAP net income per share - diluted (b) |
113,859 |
116,506 |
(a) |
For diluted non-GAAP net income per share calculations, interest expense related to the contractual coupon interest rate on the Company's 1.875% convertible senior notes were excluded since these securities were dilutive. Such interest expense was not material for the three months ended |
(b) |
Weighted average shares outstanding includes the dilutive effect, if any, of employee stock options, restricted stock awards, convertible senior notes, and warrants. |
TABLE 4 | ||||||||
| ||||||||
COLLABORATION REVENUE (Unaudited) | ||||||||
(In thousands) | ||||||||
Three Months Ended | ||||||||
2016 |
2015 | |||||||
Sanofi collaboration revenue: |
||||||||
Reimbursement of Regeneron research and development expenses |
$ |
222,877 |
$ |
169,506 |
||||
Reimbursement of Regeneron commercialization-related expenses |
73,274 |
8,458 |
||||||
Regeneron's share of losses in connection with commercialization of antibodies |
(99,422) |
(22,405) |
||||||
Other |
22,965 |
17,797 |
||||||
Total Sanofi collaboration revenue |
219,694 |
173,356 |
||||||
Bayer collaboration revenue: |
||||||||
Regeneron's net profit in connection with commercialization of EYLEA outside the |
145,835 |
89,426 |
||||||
Sales milestones |
— |
15,000 |
||||||
Cost-sharing of Regeneron development expenses |
4,639 |
3,911 |
||||||
Other |
29,118 |
15,509 |
||||||
Total Bayer collaboration revenue |
179,592 |
123,846 |
||||||
Total collaboration revenue |
$ |
399,286 |
$ |
297,202 |
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