UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 31,
2008
REGENERON PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
| New York | 000-19034 | 13-3444607 | ||
| (State or other jurisdiction of | (Commission File No.) | (IRS Employer Identification No.) | ||
| Incorporation) |
777 Old Saw Mill River Road, Tarrytown, New York 10591-6707
(Address of principal executive offices, including zip code)
(Address of principal executive offices, including zip code)
(914) 347-7000
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02 | Results of Operations and Financial Condition. |
On July 31, 2008, Regeneron Pharmaceuticals, Inc. issued a press release announcing its
financial and operating results for the quarter ended June 30, 2008. The press release is being
furnished to the Securities and Exchange Commission pursuant to Item 2.02 of Form 8-K and is
attached as Exhibit 99.1 to this Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| 99.1 | Press Release dated July 31, 2008. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: July 31, 2008 | REGENERON PHARMACEUTICALS, INC. |
|||
| By: | /s/ Stuart Kolinski | |||
| Name: | Stuart Kolinski | |||
| Title: | Senior Vice President and General Counsel | |||
Exhibit Index
| Number | Description | |||
| 99.1 | Press Release dated July 31, 2008. |
|||
Exhibit 99.1
For Immediate Release
Press Release
Regeneron Reports Second Quarter 2008 Financial and
Operating Results
Operating Results
Tarrytown, New York (July 31, 2008) — Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today
announced financial and operating results for the second quarter of 2008. The Company reported a
net loss of $18.5 million, or $0.23 per share (basic and diluted), for the second quarter of 2008
compared with a net loss of $26.8 million, or $0.41 per share (basic and diluted), for the second
quarter of 2007. The Company reported a net loss of $30.1 million, or $0.38 per share (basic and
diluted), for the six months ended June 30, 2008 compared with a net loss of $56.7 million, or
$0.86 per share (basic and diluted), for the same period in 2007.
At June 30, 2008, cash, restricted cash, and marketable securities totaled $744.5 million compared
with $846.3 million at December 31, 2007. In the second quarter of 2008, the Company repurchased
$81.3 million of its convertible senior subordinated notes. At June 30, 2008, $118.7 million of
these convertible notes, which mature in October 2008, remained outstanding.
Current Business Highlights
ARCALYST® (rilonacept) – Inflammatory Diseases
In February 2008, the Company received marketing approval from the U.S. Food and Drug Administration (FDA) for ARCALYST® (rilonacept) Injection for Subcutaneous Use for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. In March 2008, ARCALYST became available for prescription in the United States and the Company began making shipments to its distributors. ARCALYST, an interleukin-1 (IL-1) blocker, is the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. ARCALYST has also received Orphan Drug designation in the European Union for the treatment of CAPS.
In February 2008, the Company received marketing approval from the U.S. Food and Drug Administration (FDA) for ARCALYST® (rilonacept) Injection for Subcutaneous Use for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. In March 2008, ARCALYST became available for prescription in the United States and the Company began making shipments to its distributors. ARCALYST, an interleukin-1 (IL-1) blocker, is the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. ARCALYST has also received Orphan Drug designation in the European Union for the treatment of CAPS.
Since ARCALYST became available for commercial sale, the Company has been transitioning the
patients who participated in the CAPS pivotal study from clinical study drug to commercial
quantities of ARCALYST. The Company expects this transition process to be completed this year
and
currently projects shipments of ARCALYST to its distributors to total approximately $10 million in 2008.
A Phase 2 safety and efficacy trial of ARCALYST is underway in the prevention of gout flares
induced by the initiation of uric acid-lowering drug therapy used to control gout, with results
expected in September 2008. The Company is also evaluating the potential use of
ARCALYST® (rilonacept) in other indications in which IL-1 may play a role.
Aflibercept (VEGF Trap) – Oncology
In their collaboration to develop aflibercept for the treatment of cancer, Regeneron and sanofi-aventis currently are enrolling patients in four Phase 3 trials that combine aflibercept with standard chemotherapy regimens. One trial 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 is evaluating aflibercept as a 1st line treatment for metastatic pancreatic cancer in combination with gemcitabine. A third trial is evaluating aflibercept as a 1st line treatment for metastatic androgen independent prostate cancer in combination with docetaxel/prednisone. The fourth trial is evaluating aflibercept as a 2nd line treatment for metastatic non-small cell lung cancer in combination with docetaxel. All four trials are studying the current standard of chemotherapy care for the cancer being studied with and without aflibercept. In addition, a Phase 2 study of aflibercept in 1st line metastatic colorectal cancer in combination with Folinic Acid (leucovorin), 5-fluorouracil, and oxaliplatin is expected to begin later in 2008.
In their collaboration to develop aflibercept for the treatment of cancer, Regeneron and sanofi-aventis currently are enrolling patients in four Phase 3 trials that combine aflibercept with standard chemotherapy regimens. One trial 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 is evaluating aflibercept as a 1st line treatment for metastatic pancreatic cancer in combination with gemcitabine. A third trial is evaluating aflibercept as a 1st line treatment for metastatic androgen independent prostate cancer in combination with docetaxel/prednisone. The fourth trial is evaluating aflibercept as a 2nd line treatment for metastatic non-small cell lung cancer in combination with docetaxel. All four trials are studying the current standard of chemotherapy care for the cancer being studied with and without aflibercept. In addition, a Phase 2 study of aflibercept in 1st line metastatic colorectal cancer in combination with Folinic Acid (leucovorin), 5-fluorouracil, and oxaliplatin is expected to begin later in 2008.
In May 2008, Regeneron and sanofi-aventis reported results of a randomized, double-blind, Phase 2
study of 215 women with advanced ovarian cancer (AOC) who were treated with aflibercept as a
single-agent at a dose of either 2 milligrams per kilogram (mg/kg) or 4 mg/kg every two weeks. The
study did not achieve its primary endpoint of demonstrating that patients in either arm of the
study achieved a RECIST response rate, as assessed by an independent review committee (IRC), that
was statistically significantly greater than 5 percent. Side effects of treatment with aflibercept
were typical of this class of anti-angiogenic agents, with hypertension being the most common grade
3/4 adverse event. The results were consistent with the interim data of the same trial reported at
the 2007 annual meeting of the American Society of Clinical Oncology (ASCO).
More than
13 studies are being or will be conducted in conjunction with the National Cancer Institute (NCI)
Cancer Therapy Evaluation Program (CTEP) evaluating aflibercept as a single agent or in combination
with chemotherapy regimens in a variety of cancer indications. At the 2008 ASCO meeting,
investigators reported preliminary results of a study of single-agent aflibercept in 48 patients
with either relapsed or first recurrence temozolomide-resistant glioblastoma multiforme or
anaplastic glioma. Responses were achieved in 50 percent of patients with anaplastic glioma and 30
percent of patients with glioblastoma. Grade 3 adverse events included fatigue, hypertension,
hand-foot syndrome, lymphopenia, thrombosis, and proteinuria.
VEGF Trap-Eye – Eye Diseases
VEGF Trap-Eye is a specially purified and formulated form of the VEGF Trap for use in intraocular applications. Regeneron and Bayer HealthCare initiated a Phase 3 global development
VEGF Trap-Eye is a specially purified and formulated form of the VEGF Trap for use in intraocular applications. Regeneron and Bayer HealthCare initiated a Phase 3 global development
program of
VEGF Trap-Eye in the neovascular form of Age-related Macular Degeneration (wet AMD) in the third
quarter of 2007. The first trial, known as VIEW 1 (VEGF Trap: Investigation of
Efficacy and Safety in Wet age-related macular degeneration), is comparing VEGF
Trap-Eye and ranibizumab (Lucentisâ, a registered trademark of Genentech, Inc.),
an anti-angiogenic agent
approved for use in wet AMD. The trial is evaluating dosing intervals of four and eight weeks for
VEGF Trap-Eye, compared with ranibizumab dosed according to its U.S. label every four weeks over the first year. In May 2008, Bayer HealthCare initiated a second, similar Phase 3 trial, known as VIEW 2, in the European Union
and other parts of the world outside the U.S.
In April 2008, Regeneron and Bayer HealthCare announced the 32-week endpoint results of a Phase 2
study evaluating VEGF Trap-Eye in wet AMD, which were presented at the 2008 Association for
Research in Vision and Ophthalmology (ARVO) meeting in Fort Lauderdale, Florida. The 32-week
analysis showed that VEGF Trap-Eye dosed on a PRN (as-needed) dosing schedule maintained the
statistically significant gain in visual acuity achieved after an initial 12-week fixed-dosing
phase.
Regeneron and Bayer HealthCare are also developing VEGF Trap-Eye in diabetic macular edema (DME)
and plan to initiate a Phase 2 study in patients with DME.
Monoclonal Antibodies
Regeneron and sanofi-aventis are collaborating on the discovery, development, and commercialization of fully human monoclonal antibodies generated by Regeneron using its VelocImmune® technology. The first therapeutic antibody to enter clinical development under the collaboration is REGN88, an antibody to the interleukin-6 receptor (IL-6R) that is being evaluated in rheumatoid arthritis. The Company plans to file Investigational New Drug Applications (INDs) for an antibody to Delta-like ligand-4 (Dll4) and one additional antibody product candidate by the end of 2008. The Company and sanofi-aventis plan to advance two to three new antibodies into clinical development each year.
Regeneron and sanofi-aventis are collaborating on the discovery, development, and commercialization of fully human monoclonal antibodies generated by Regeneron using its VelocImmune® technology. The first therapeutic antibody to enter clinical development under the collaboration is REGN88, an antibody to the interleukin-6 receptor (IL-6R) that is being evaluated in rheumatoid arthritis. The Company plans to file Investigational New Drug Applications (INDs) for an antibody to Delta-like ligand-4 (Dll4) and one additional antibody product candidate by the end of 2008. The Company and sanofi-aventis plan to advance two to three new antibodies into clinical development each year.
Financial Results
Revenue
Regeneron’s total revenue increased to $60.7 million in the second quarter of 2008 from $22.2 million in the same quarter of 2007 and to $117.0 million for the first six months of 2008 from $38.0 million for the same period of 2007. Contract research and development revenue in the first half of 2008 principally related to the Company’s aflibercept and antibody collaborations with sanofi-aventis and the Company’s VEGF Trap-Eye collaboration with Bayer HealthCare. In the first half of 2007, contract research and development revenue principally related to the Company’s aflibercept collaboration with sanofi-aventis. Technology licensing revenue related to the Company’s VelocImmune license agreements with AstraZeneca and Astellas.
Regeneron’s total revenue increased to $60.7 million in the second quarter of 2008 from $22.2 million in the same quarter of 2007 and to $117.0 million for the first six months of 2008 from $38.0 million for the same period of 2007. Contract research and development revenue in the first half of 2008 principally related to the Company’s aflibercept and antibody collaborations with sanofi-aventis and the Company’s VEGF Trap-Eye collaboration with Bayer HealthCare. In the first half of 2007, contract research and development revenue principally related to the Company’s aflibercept collaboration with sanofi-aventis. Technology licensing revenue related to the Company’s VelocImmune license agreements with AstraZeneca and Astellas.
Regeneron recognized contract research and development revenue of $12.4 million in the second
quarter of 2008 and $26.2 million for the first six months of 2008 related to the Company’s
aflibercept collaboration with sanofi-aventis, compared with $13.5 million and $25.3 million,
respectively, for the same periods of 2007. Contract research and development revenue from the
collaboration consisted of reimbursement of aflibercept development expenses incurred by the
Company plus recognition of amounts related to $105.0 million of previously received and deferred
non-refundable, up-front payments. Reimbursement of expenses decreased to $10.3 million in the
second quarter of 2008 from $11.3 million in the comparable quarter of 2007, and
increased to $22.0 million in the first six months of 2008 from $20.8 million in the same period of
2007. With respect to the $105.0 million of up-front payments from sanofi-aventis, $2.1 million
was recognized in the second quarter of 2008 compared to $2.2 million in the same quarter of 2007,
and $4.2 million was recognized in the first six months of 2008 compared to $4.5 million in the
same period of 2007.
Sanofi-aventis also incurs aflibercept development expenses directly and these expenses are
increasing because of the growing number of clinical trials sanofi-aventis is overseeing in the
oncology program. During the term of the aflibercept collaboration, sanofi-aventis pays 100
percent of agreed-upon aflibercept development expenses incurred by both companies. Following
commercialization of an aflibercept product, Regeneron, from its 50 percent share of aflibercept
profits, will reimburse sanofi-aventis for 50 percent of aflibercept development expenses
previously paid by sanofi-aventis.
Regeneron recognized contract research and development revenue of $26.2 million in the second
quarter of 2008 and $48.1 million in the first half of 2008 related to the Company’s antibody
collaboration with sanofi-aventis. In the second quarter, contract research and development
revenue from the antibody collaboration consisted of $17.3 million for reimbursement of the
Company’s expenses under the collaboration’s discovery agreement, $6.3 million for reimbursement of
the Company’s development expenses, primarily related to REGN88, and $2.6 million related to an
$85.0 million non-refundable, up-front payment, which was deferred upon receipt in December 2007.
In the first half of 2008, contract research and development revenue from the antibody
collaboration consisted of $32.4 million for reimbursement of the Company’s expenses under the
discovery agreement, $10.5 million for reimbursement of the Company’s development expenses,
primarily related to REGN88, and $5.2 million related to the $85.0 million up-front payment.
In connection with the Company’s VEGF Trap-Eye collaboration with Bayer HealthCare, the Company
received a $75.0 million non-refundable, up-front payment in October 2006 and a $20.0 million
milestone payment in August 2007. Through September 30, 2007 all payments received from Bayer
HealthCare, including the up-front and milestone payments and cost-sharing reimbursements were
fully deferred and included in deferred revenue. In the fourth quarter of 2007, the Company
commenced recognizing previously deferred payments from Bayer HealthCare and cost sharing of the
Company’s VEGF Trap-Eye development expenses in the Company’s Statement of Operations through a
cumulative catch-up. The $75.0 million non-refundable, up-front license payment and $20.0 million
milestone payment are being recognized as contract research and development revenue over the
related estimated performance period. In periods when the Company recognizes VEGF Trap-Eye
development expenses that it incurs under the collaboration, the Company also recognizes, as
contract research and development revenue, the portion of those VEGF Trap-Eye development expenses
that is reimbursable from Bayer HealthCare. In periods when Bayer HealthCare incurs agreed upon
VEGF Trap-Eye development
expenses that benefit the collaboration and Regeneron, the Company also
recognizes, as additional research and development expense, the portion of Bayer HealthCare’s VEGF
Trap-Eye development expenses that the Company is obligated to reimburse.
In the second quarter of 2008, the Company recorded $10.2 million of contract research and
development revenue from Bayer HealthCare, consisting of $3.3 million related to the $75.0 million
up-front licensing payment and the $20.0 million milestone payment and $6.9 million related to the
portion of the Company’s second quarter 2008 VEGF Trap-Eye development expenses that is
reimbursable from Bayer HealthCare. In the first half of 2008, the Company recorded $19.2 million
of contract research and development revenue from Bayer HealthCare, consisting of $6.6 million
related to the up-front and milestone payments and $12.6 million related to the portion of the
Company’s VEGF Trap-Eye development expenses for the first half of 2008 that is reimbursable from
Bayer HealthCare.
Regeneron has entered into non-exclusive license agreements with AstraZeneca and Astellas that
allow those companies to utilize VelocImmune® technology in their internal research
programs to discover human monoclonal antibodies. Each company made a $20.0 million up-front,
non-refundable payment in 2007 and agreed to make up to five additional annual payments of $20.0
million, subject to the ability to terminate their agreements after making three additional
payments. Upon receipt, these payments are deferred and are recognized as revenue ratably over
approximately the ensuing year of each agreement. Regeneron will also receive a mid-single-digit
royalty on sales of any antibodies discovered utilizing VelocImmune. In the second quarter and
for the first six months of 2008, the Company recognized $10.0 million and $20.0 million, respectively, of
technology licensing revenue related to these agreements. In the second quarter and for the first
six months of 2007, the Company recognized $6.3 million and $8.4 million, respectively, of
technology licensing revenue related to these agreements.
ARCALYST® (rilonacept) Product Sales
In March 2008, the Company commenced shipping ARCALYST to its distributors. During the second quarter and first half of 2008, the Company shipped $1.6 million and $2.4 million, respectively, of ARCALYST, which was fully deferred at June 30, 2008 and classified as deferred revenue in the Company’s financial statements.
In March 2008, the Company commenced shipping ARCALYST to its distributors. During the second quarter and first half of 2008, the Company shipped $1.6 million and $2.4 million, respectively, of ARCALYST, which was fully deferred at June 30, 2008 and classified as deferred revenue in the Company’s financial statements.
Expenses
Total operating expenses for the second quarter of 2008 were $80.0 million, 52 percent higher than the same period in 2007, and $152.3 million for the first six months of 2008, 49 percent higher than the same period in 2007. Average headcount increased to 771 in the second quarter of 2008 from 618 in the same period of 2007 and increased to 742 for the first half of 2008 from 602 in the same period of 2007, primarily as a result of the Company’s expanding research and development activities directed toward preclinical and clinical development of product candidates, including ARCALYST, aflibercept, VEGF Trap-Eye, and monoclonal antibodies (including REGN88 and the Dll4 antibody).
Total operating expenses for the second quarter of 2008 were $80.0 million, 52 percent higher than the same period in 2007, and $152.3 million for the first six months of 2008, 49 percent higher than the same period in 2007. Average headcount increased to 771 in the second quarter of 2008 from 618 in the same period of 2007 and increased to 742 for the first half of 2008 from 602 in the same period of 2007, primarily as a result of the Company’s expanding research and development activities directed toward preclinical and clinical development of product candidates, including ARCALYST, aflibercept, VEGF Trap-Eye, and monoclonal antibodies (including REGN88 and the Dll4 antibody).
Operating expenses included non-cash compensation expense related to employee stock option and
restricted stock awards of $8.2 million in the second quarter of 2008 and $16.5 million for the
first six months of 2008, compared with $6.9 million and $13.5 million, respectively, for the same
periods of 2007.
Research and development (R&D) expenses increased to $66.6 million in the second quarter of 2008
from $43.9 million in the comparable quarter of 2007, and to $127.8 million in the first six months
of 2008 from $85.1 million in the same period of 2007. The Company incurred higher R&D costs
primarily related to additional R&D headcount, clinical development costs for VEGF Trap-Eye and
ARCALYST, and costs related to manufacturing supplies of REGN88, VEGF
Trap-Eye, and the Dll4 antibody.
Selling, general, and administrative expenses increased to $13.4 million in the second quarter of
2008 from $8.9 million in the comparable quarter of 2007, and to $24.5 million in the first six
months of 2008 from $17.1 million in the same period of 2007. In the first half of 2008, the
Company incurred costs associated with the launch of ARCALYST. In addition, the Company incurred
higher compensation expense and recruitment costs associated with expanding the Company’s
headcount, and higher professional fees related to various general corporate matters.
Other Income and Expense
Investment income decreased to $4.5 million in the second quarter of 2008 from $6.8 million in the comparable quarter of 2007 and to $11.8 million in the first half of 2008 compared to $13.6 million in the first half of 2007. The decrease in investment income resulted primarily from lower yields on our cash and marketable securities, partly offset by higher cash and marketable securities balances in 2008 versus 2007.
Investment income decreased to $4.5 million in the second quarter of 2008 from $6.8 million in the comparable quarter of 2007 and to $11.8 million in the first half of 2008 compared to $13.6 million in the first half of 2007. The decrease in investment income resulted primarily from lower yields on our cash and marketable securities, partly offset by higher cash and marketable securities balances in 2008 versus 2007.
In the second quarter of 2008, the Company repurchased $81.3 million in principal amount of its 5.5
percent Convertible Senior Subordinated Notes due October 17, 2008. In connection with the repurchased
notes, the Company recognized a $0.9 million loss on early extinguishment of debt.
About Regeneron Pharmaceuticals
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, and inflammatory diseases, 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 Bayer HealthCare, to be canceled or to
terminate without any product success, risks associated with third party intellectual property, and
other material risks. A more complete description of these and other material risks can be found
in Regeneron’s filings with the United States Securities and Exchange Commission (SEC), including
its Form 10-K for the year ended December 31, 2007 and Form 10-Q for the quarter ended March 31,
2008. Regeneron does not undertake any
obligation to update publicly any forward-looking statement, whether as a result of new
information, future events, or otherwise unless required by law.
###
Contacts Information:
| Laura Lindsay | ||
Investor Relations |
Media Relations | |
914.345.7640 |
914.345.7800 | |
invest@regeneron.com |
laura.lindsay@regeneron.com | |
| Lauren Tortorete | ||
| Media Relations | ||
| 212.845.5609 | ||
| ltortorete@biosector2.com |
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS (Unaudited)
(In thousands)
CONDENSED BALANCE SHEETS (Unaudited)
(In thousands)
| June 30, | December 31, | |||||||
| 2008 | 2007 | |||||||
ASSETS |
||||||||
Cash, restricted cash, and marketable securities |
$ | 744,493 | $ | 846,279 | ||||
Receivables |
32,838 | 18,320 | ||||||
Property, plant, and equipment, net |
64,231 | 58,304 | ||||||
Other assets |
9,663 | 13,355 | ||||||
Total assets |
$ | 851,225 | $ | 936,258 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Accounts payable and accrued expenses |
$ | 38,289 | $ | 39,232 | ||||
Deferred revenue |
243,286 | 236,759 | ||||||
Notes payable |
118,653 | 200,000 | ||||||
Stockholders’ equity |
450,997 | 460,267 | ||||||
Total liabilities and stockholders’ equity |
$ | 851,225 | $ | 936,258 | ||||
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
| For the three months | For the six months | |||||||||||||||
| ended June 30, | ended June 30, | |||||||||||||||
| 2008 | 2007 | 2008 | 2007 | |||||||||||||
Revenues |
||||||||||||||||
Contract research and development |
$ | 50,653 | $ | 15,917 | $ | 97,036 | $ | 29,562 | ||||||||
Technology licensing |
10,000 | 6,278 | 20,000 | 8,421 | ||||||||||||
| 60,653 | 22,195 | 117,036 | 37,983 | |||||||||||||
Expenses |
||||||||||||||||
Research and development |
66,577 | 43,864 | 127,847 | 85,099 | ||||||||||||
Selling, general, and administrative |
13,465 | 8,935 | 24,489 | 17,137 | ||||||||||||
| 80,042 | 52,799 | 152,336 | 102,236 | |||||||||||||
Loss from operations |
(19,389 | ) | (30,604 | ) | (35,300 | ) | (64,253 | ) | ||||||||
Other income (expense) |
||||||||||||||||
Investment income |
4,535 | 6,841 | 11,839 | 13,584 | ||||||||||||
Interest expense |
(2,674 | ) | (3,011 | ) | (5,685 | ) | (6,022 | ) | ||||||||
Loss on early extinguishment of debt |
(931 | ) | (931 | ) | ||||||||||||
| 930 | 3,830 | 5,223 | 7,562 | |||||||||||||
Net loss |
$ | (18,459 | ) | $ | (26,774 | ) | $ | (30,077 | ) | $ | (56,691 | ) | ||||
Net loss per share amounts, basic and diluted |
$ | (0.23 | ) | $ | (0.41 | ) | $ | (0.38 | ) | $ | (0.86 | ) | ||||
Weighted average shares outstanding, basic and diluted |
78,689 | 65,950 | 78,591 | 65,757 | ||||||||||||