Regeneron Reports Second Quarter 2009 Financial and Operating Results
At
Current Business Highlights
ARCALYST® (rilonacept) – Inflammatory Diseases
The Company shipped
compared to
ARCALYST is in a Phase 3 clinical development program for the treatment of gout. The program includes four clinical trials, three of which are currently enrolling patients. Two Phase 3 clinical trials (called PRE-SURGE 1 and PRE-SURGE 2) are evaluating ARCALYST versus placebo for the prevention of gout flares in patients initiating urate-lowering drug therapy. A third Phase 3 trial in acute gout (SURGE) is evaluating treatment with ARCALYST alone versus ARCALYST in combination with a non-steroidal anti-inflammatory drug (NSAID) versus an NSAID alone. The Phase 3 clinical development program also includes a separate placebo-controlled safety study (RE-SURGE). The Company expects to report initial data from the Phase 3 program in 2010. Regeneron owns worldwide rights to ARCALYST.
Additional data from the previously reported Phase 2 study of ARCALYST
for the prevention of gout flares induced by the initiation of
urate-lowering drug therapy were presented at the annual meeting of the
European League Against Rheumatism (EULAR) in
Aflibercept (VEGF Trap) – Oncology
Aflibercept, an anti-angiogenic protein product candidate designed to
bind all forms of vascular endothelial growth factor A (VEGF-A), is
being developed worldwide by Regeneron and its collaborator,
sanofi-aventis. At the end of the second quarter of 2009, more than 60
percent of the planned number of patients were enrolled in four Phase 3
trials that are evaluating combinations of aflibercept with standard
chemotherapy regimens for the treatment of cancer. One trial (called
VELOUR) is evaluating aflibercept as a 2nd line treatment for
metastatic colorectal cancer in combination with FOLFIRI (folinic acid
(leucovorin), 5-fluorouracil, and irinotecan). A second trial (VANILLA)
is evaluating aflibercept as a 1st line treatment for
metastatic pancreatic cancer in combination with gemcitabine. A third
trial (VITAL) is evaluating aflibercept as a 2nd line
treatment for metastatic non-small cell lung cancer in combination with
docetaxel. The fourth trial (
Results of a Phase 2 single-agent study of aflibercept in advanced
ovarian cancer (AOC) patients with symptomatic malignant ascites (SMA)
were reported in a press release issued on
VEGF Trap-Eye – Ophthalmologic Diseases
VEGF Trap-Eye, a specially purified and formulated form of VEGF Trap for
use in intraocular treatment of retinal disease, is being developed by
Regeneron and its collaborator,
milestone payment.
Monoclonal Antibodies
Phase 1 clinical studies are underway with three human monoclonal antibodies generated by Regeneron using its VelocImmune® technology. REGN88 is an antibody to the interleukin-6 receptor (IL-6R) that is being evaluated in rheumatoid arthritis. REGN475, an antibody to Nerve Growth Factor (NGF) that binds NGF selectively without cross-reacting with other members of the neurotrophin family, is being developed for the treatment of pain. REGN421, an antibody to Delta-like ligand-4 (Dll4), is being studied in patients with advanced malignancies. These antibodies are being developed within the Company’s human antibody collaboration with sanofi-aventis. Over the course of the next several years, the Company and sanofi-aventis plan to advance an average of two to three new fully human monoclonal antibodies into clinical development each year.
Other
In
Financial Results
Revenues
Total revenues increased to
Contract research and development revenue relates primarily to the
Company’s aflibercept and antibody collaborations with sanofi-aventis
and the Company’s VEGF Trap-Eye collaboration with
Three months ended |
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June 30, | June 30, | |||||||||||
(In millions) |
2009 | 2008 | 2009 |
2008 | ||||||||
Contract research & development revenue | ||||||||||||
Sanofi-aventis | $ | 60.7 | $ | 38.6 | $ | 110.4 | $ | 74.3 | ||||
Bayer HealthCare | 12.8 | 10.2 | 22.8 | 19.2 | ||||||||
Other | 2.0 | 1.9 | 3.4 | 3.5 | ||||||||
Total contract research & development revenue | $ | 75.5 | $ | 50.7 | $ | 136.6 | $ | 97.0 |
For the three and six months ended
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June 30, | June 30, |
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(In millions) | 2009 | 2008 |
2009 | 2008 | ||||||||
Aflibercept: |
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Regeneron expense reimbursement | $ | 9.2 | $ | 10.3 | $ | 14.6 | $ | 22.0 | ||||
Recognition of deferred revenue related to up-front payments | 2.5 | 2.1 | 5.0 | 4.2 | ||||||||
Total aflibercept | 11.7 | 12.4 | 19.6 | 26.2 | ||||||||
Antibody: | ||||||||||||
Regeneron expense reimbursement | 45.7 | 23.6 | 84.1 | 42.9 | ||||||||
Recognition of deferred revenue related to up-front payment | 2.6 | 2.6 | 5.3 | 5.2 | ||||||||
Recognition of revenue related to VelociGene® agreement |
|
0.7 |
|
1.4 |
|
|||||||
Total antibody | 49.0 |
26.2 | 90.8 | 48.1 | ||||||||
Total sanofi-aventis contract research & development revenue | $ | 60.7 |
$ | 38.6 | $ | 110.4 | $ | 74.3 |
Sanofi-aventis’ reimbursement of Regeneron’s aflibercept expenses
decreased for the three and six months ended
Sanofi-aventis’ reimbursement of Regeneron’s expenses under the antibody
collaboration increased for the three and six months ended
For the three and six months ended
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Six months ended | |||||||||||
June 30, | June 30, | |||||||||||
(In millions) |
2009 | 2008 | 2009 |
2008 | ||||||||
Cost-sharing of Regeneron VEGF Trap-Eye development | ||||||||||||
expenses | $ | 10.4 | $ | 6.9 | $ | 17.9 | $ | 12.6 | ||||
Recognition of deferred revenue related to up-front and |
||||||||||||
milestone payments | 2.4 | 3.3 |
|
4.9 | 6.6 | |||||||
Total Bayer HealthCare contract research & development |
||||||||||||
revenue | $ | 12.8 | $ | 10.2 | $ | 22.8 | $ | 19.2 |
In periods when the Company recognizes VEGF Trap-Eye development
expenses that the Company incurs under the collaboration with
Technology Licensing Revenue
Regeneron has entered into non-exclusive license agreements with
Net Product Sales
Revenue and deferred revenue from product sales are recorded net of
applicable provisions for prompt pay discounts, product returns,
estimated rebates payable under governmental programs (including
(rilonacept) net product sales, respectively, for which the right of
return no longer exists and rebates can be reasonably estimated. At
Expenses
Total operating expenses for the second quarter of 2009 were
Research and development (R&D) expenses increased to
Selling, general, and administrative (SG&A) expenses decreased to
Other Income and Expense
Investment income decreased to
Interest expense in the second quarter and first half of 2008 was
attributable to the Company’s 5.5 percent Convertible Senior
Subordinated Notes; no Notes were outstanding in 2009. In the second
quarter of 2008, the Company repurchased
Revision of Previously Issued Financial Statements
The Company has revised its financial statements at
About
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and pain, and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron’s web site at www.regeneron.com.
This news release discusses historical information and includes
forward-looking statements about Regeneron and its products, development
programs, finances, and business, all of which involve a number of risks
and uncertainties, such as risks associated with preclinical and
clinical development of Regeneron’s drug candidates, determinations by
regulatory and administrative governmental authorities which may delay
or restrict Regeneron’s ability to continue to develop or commercialize
its product and drug candidates, competing drugs that are superior to
Regeneron’s product and drug candidates, uncertainty of market
acceptance of Regeneron’s product and drug candidates, unanticipated
expenses, the availability and cost of capital, the costs of developing,
producing, and selling products, the potential for any collaboration
agreement, including Regeneron’s agreements with the sanofi-aventis
Group and
REGENERON PHARMACEUTICALS, INC. | |||||||
CONDENSED BALANCE SHEETS (Unaudited) |
|||||||
(In thousands) | |||||||
June 30, | December 31, | ||||||
2009 | 2008 | ||||||
(Revised)* | |||||||
|
|||||||
ASSETS | |||||||
Cash, restricted cash, and marketable securities | $ | 466,363 | $ | 527,461 | |||
Receivables | 60,046 | 35,212 | |||||
Property, plant, and equipment, net | 195,408 | 142,035 | |||||
Other assets | 20,528 | 19,512 | |||||
Total assets | $ | 742,345 | $ | 724,220 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Accounts payable and accrued expenses | $ | 51,881 | $ |
36,168 | |||
Deferred revenue | 215,798 | 209,925 | |||||
Facility lease obligation | 62,925 | 56,019 | |||||
Other long term liabilities | 1,235 | 594 | |||||
Stockholders' equity | 410,506 | 421,514 | |||||
Total liabilities and stockholders' equity |
$ | 742,345 | $ | 724,220 | |||
* Revised as described in the paragraph of this press release
titled "Revision of Previously |
REGENERON PHARMACEUTICALS, INC. | ||||||||||||||||
CONDENSED STATEMENTS OF OPERATIONS (Unaudited) | ||||||||||||||||
(In thousands, except per share data) |
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|
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For the three months | For the six months | |||||||||||||||
ended June 30, |
ended June 30, | |||||||||||||||
2009 | 2008 |
2009 |
2008 | |||||||||||||
(Revised)* |
(Revised)* | |||||||||||||||
Revenues | ||||||||||||||||
Contract research and development | $ |
75,532 | $ |
50,653 | $ |
136,622 | $ |
97,036 | ||||||||
Technology licensing |
10,000 | 10,000 | 20,000 | 20,000 | ||||||||||||
Net product sales | 4,500 | 8,391 | ||||||||||||||
90,032 | 60,653 |
|
165,013 | 117,036 |
||||||||||||
Expenses | ||||||||||||||||
Research and development | 94,231 | 66,777 | 174,538 | 128,246 | ||||||||||||
Selling, general, and administrative | 11,632 | 13,495 | 23,052 | 24,549 | ||||||||||||
Cost of goods sold | 435 |
|
827 | |||||||||||||
106,298 | 80,272 | 198,417 | 152,795 |
|||||||||||||
Loss from operations | (16,266 | ) |
|
(19,619 | ) | (33,404 | ) | (35,759 | ) | |||||||
Other income (expense) | ||||||||||||||||
Investment income | 1,328 | 4,535 | 3,078 | 11,839 | ||||||||||||
Interest expense | (2,674 | ) | (5,685 |
) | ||||||||||||
Loss on early extinguishment of debt |
|
(931 | ) | (931 | ) | |||||||||||
1,328 | 930 | 3,078 | 5,223 |
|||||||||||||
Net loss | $ | (14,938 |
) | $ | (18,689 | ) | $ | (30,326 | ) | $ | (30,536 | ) | ||||
Net loss per share amounts, basic and diluted | $ | (0.19 |
) | $ | (0.24 | ) | $ | (0.38 | ) | $ | (0.39 | ) | ||||
Weighted average shares outstanding, basic and diluted | 79,626 |
78,689 |
79,562 |
78,591 |
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* Revised as described in the paragraph of this press release titled "Revision of Previously | ||||||||||||||||
Issued Financial Statements." |
Source:
Regeneron Pharmaceuticals, Inc.
Peter Dworkin, 914-345-7640
Investor
Relations
peter.dworkin@regeneron.com
or
Laura
Lindsay, 914-345-7800
Media Relations
laura.lindsay@regeneron.com