Regeneron Reports First Quarter Financial and Operating Results.TARRYTOWN, N.Y. -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced financial and operating results for the first quarter of 2006. The Company reported a net loss of $20.4 million, or $0.36 per share (basic and diluted) for the first quarter of 2006 compared with a net loss of $4.1 million, or $0.07 per share (basic and diluted) for the first quarter of 2005. Results for the first quarter of 2005 included a $25.0 million one-time, non-recurring payment from the sanofi-aventis Group in connection with an amendment to the Company's collaboration agreement with sanofi-aventis, which was recognized as other contract income. At March 31, 2006, cash and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has totaled $324.2 million compared with $316.7 million at December 31, 2005. In January 2006, Regeneron received an up-front payment of $25.0 million from sanofi-aventis related to the expansion of the companies' VEGF VEGF vascular endothelial growth factor. Trap collaboration program to include Japan. The Company's $200.0 million of convertible notes, which bear interest at 5.5% per annum Per annum Yearly. , mature in October 2008. Current Business Highlights In the first quarter of 2006, Regeneron continued to expand its broad-based clinical development program that is centered on product candidates in oncology, eye diseases, and inflammatory indications. In oncology, Regeneron's Vascular Endothelial Growth Factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature). (VEGF) Trap is being developed in collaboration with sanofi-aventis. The Company is independently developing the VEGF Trap-Eye, a specially purified and formulated form of the VEGF Trap for use in intraocular intraocular /in·tra·oc·u·lar/ (-ok´u-lar) within the eye. in·tra·oc·u·lar adj. Within the eyeball. Intraocular Literally, within the eye. applications, and the Interleukin-1 (IL-1) Trap for certain inflammatory indications. In the first quarter of 2006, Regeneron and sanofi-aventis initiated their phase 2 single-agent program for the VEGF Trap in cancer. Patient enrollment is underway in non-small cell lung adenocarcinoma adenocarcinoma: see neoplasm. (NSCLA), and two additional safety/efficacy studies in advanced ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast and symptomatic malignant ascites malignant ascites Excess peritoneal fluid evoked by malignancy, which causes subdiaphragmatic lymphatic obstruction–eg, of the thoracic duct and ↑ intraperitoneal fluid production Etiology Ovarian, breast, gastric, pancreatic, hepatic, colorectal CA, (SMA (1) See SMA connector. (2) (Shared Memory Architecture) See shared video memory. (3) (Software Maintenance Association) A membership organization that began in 1985 and ended in 1996. ) are planned to begin shortly. In addition, the companies intend to conduct three trials evaluating the safety and efficacy of the VEGF Trap in combination with standard chemotherapy regimens Chemotherapy regimens are often identified with acronyms, identifying the agents used in combination. Unfortunately, the letters used are not consistent across regimens, and in some cases (for example, "BEACOPP") the same letter is used to represent two different treatments. , the first of which is planned to begin in the second half of 2006. Currently, there are five safety and tolerability tol·er·a·ble adj. 1. Capable of being tolerated; endurable. 2. Fairly good; passable. See Synonyms at average. tol studies underway for the VEGF Trap in combination with standard chemotherapy regimens in a variety of cancer types. The companies are also finalizing plans with the National Cancer Institute (NCI See Liberate. ) Cancer Therapeutics Evaluation Program to commence at least ten other cancer trials in 2006. In the clinical development program for the treatment of eye diseases, at the May 2006 Annual Meeting of the Association for Research in Vision and Ophthalmology ophthalmology (ŏf'thălmŏl`əjē), branch of medicine specializing in the anatomy, function and diseases of the eye. Ophthalmologists specialize in the medical and surgical treatment of eye disorders, vision measurements for (ARVO ARVO Association for Research in Vision and Ophthalmology. ), the Company reported positive preliminary results from its phase 1 trial of the VEGF Trap-Eye in patients with the neovascular form of age-related macular degeneration Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. (wet AMD (Advanced Micro Devices, Inc., Sunnyvale, CA, www.amd.com) A major manufacturer of semiconductor devices including x86-compatible CPUs, embedded processors, flash memories, programmable logic devices and networking chips. ). A total of 21 patients received a single dose of VEGF Trap-Eye at doses ranging from .05 milligrams (mg) to 4 mg intravitreally (direct injection into the eye) and were evaluated for six weeks to measure the durability of effects and provide guidance for dosing regimens to be used in future trials. All dose levels were generally well tolerated, and a maximum tolerated dose was not reached in the study. Patients receiving the VEGF Trap-Eye demonstrated large, rapid, and sustained (at least six weeks) reductions in retinal retinal /ret·i·nal/ (ret´i-n'l) 1. pertaining to the retina. 2. the aldehyde of retinol, derived from absorbed dietary carotenoids or esters of retinol and having vitamin A activity. thickness, a clinical measure of disease activity in wet AMD as measured by ocular ocular /oc·u·lar/ (ok´u-lar) 1. of, pertaining to, or affecting the eye. 2. eyepiece. oc·u·lar adj. 1. Of or relating to the eye or the sense of sight. coherence tomography (OCT OCT ornithine carbamoyltransferase; oxytocin challenge test. OCT ornithine carbamoyl transferase, a liver specific enzyme. OCT Oxytocin stress test, see there ). As measured by the OCT reading center (posterior pole In ophthalmology, the posterior pole is the back of the eye, usually referring to the retina between the optic disc and the macula.[1] References 1. ^ Cassin, B. and Solomon, S. Dictionary of Eye Terminology. OCT scans), the median excess retinal thickness was 194 microns at baseline and 60 microns at 6 weeks. As measured by the computerized Fast Macular macular adjective Related to 1. A macule 2. The macula Scan protocol, the median excess retinal thickness was 119 microns at baseline and 27 microns at 6 weeks. Of the 20 patients evaluable for efficacy, 95 percent had stabilization or improvement in visual acuity visual acuity n. Sharpness of vision, especially as tested with a Snellen chart. Normal visual acuity based on the Snellen chart is 20/20. Visual acuity The ability to distinguish details and shapes of objects. , defined as less than or equal to 15 letter loss on the Early Treatment of Diabetic Retinopathy diabetic retinopathy n. Retinal changes occurring in long-term diabetes and characterized by punctate hemorrhages, microaneurysms, and sharply defined waxy exudates. Study (ETDRS ETDRS Early Treatment Diabetic Retinopathy Study ) eye chart. Patients were also evaluated for best-corrected visual acuity (BCVA BCVA Best Corrected Visual Acuity BCVA British Cattle Veterinary Association (Gloucestershire, UK) ), the best acuity acuity /acu·i·ty/ (ah-ku´i-te) clarity or clearness, especially of vision. a·cu·i·ty n. Sharpness, clearness, and distinctness of perception or vision. a person can achieve with glasses. BCVA for all patients in the study increased by a mean of 4.8 letters at 6 weeks. In the two highest dose groups (2 mg and 4 mg), the mean improvement in BCVA was 13.5 letters, with three of six patients gaining 15 or more letters. Based on the preliminary phase 1 results in wet AMD, the Company has initiated a 150 patient, 12 week, phase 2 trial of the VEGF Trap in wet AMD. The trial is designed to evaluate treatment with multiple doses of the VEGF Trap-Eye using different doses and different dosing regimens, as well as safety and efficacy. The Company plans to conduct an initial evaluation of study results after all patients have completed 12 weeks of treatment, which is expected to be prior to the end of 2006. Subject to a review of the initial phase 2 study results, Regeneron plans to initiate a phase 3 trial of the VEGF Trap in wet AMD in early 2007. Regeneron recently completed enrollment in the pivotal study of the IL-1 Trap in patients with CIAS CIAS Center for Integrated Agricultural Systems (UW-Madison) CIAS Changi International Airport Services (Singapore) CIAS Canadian International Air Show CIAS Canadian International Auto Show 1-Associated Periodic Syndrome (CAPS), a spectrum of rare diseases associated with mutations in the CIAS1 gene. Interleukin-1 (IL-1) appears to play a significant role in these diseases. Participants in the trial will receive a 160 milligram milligram /mil·li·gram/ (mg) (mil´i-gram) one thousandth (10-3) of a gram. mil·li·gram n. Abbr. mg A metric unit of mass equal to one thousandth (10-3) of a gram. dose of the IL-1 Trap once a week through subcutaneous subcutaneous /sub·cu·ta·ne·ous/ (sub?ku-ta´ne-us) beneath the skin. sub·cu·ta·ne·ous adj. Abbr. s.c., SQ Located, found, or placed just beneath the skin; hypodermic. self-administration. The six-month placebo-controlled, double-blind, efficacy phase is expected to be completed and preliminary data available by the end of 2006. The efficacy phase will be followed by a six-month open-label extension phase. In addition, Regeneron has ongoing proof-of-concept studies in other indications in which IL-1 may play a significant role, such as systemic juvenile idiopathic arthritis
Juvenile idiopathic arthritis (JIA), formerly known as juvenile rheumatoid arthritis (JRA),[1] (SJIA SJIA San Jose International Airport (California) ). The Company has received Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation for the IL-1 Trap in CAPS and SJIA. Financial Results Regeneron's total revenue increased to $18.2 million in the first quarter of 2006 from $16.2 million in the same period of 2005 due to increases of $1.1 million in contract research and development revenue and $0.9 million in contract manufacturing revenue in the first quarter of 2006 from the same period of 2005. Contract research and development revenue in the first quarter of 2006 principally related to the Company's VEGF Trap collaboration with sanofi-aventis in cancer indications. In the first quarter of 2005, contract research and development revenue related both to the Company's collaboration with sanofi-aventis and the Company's collaboration with The Procter & Gamble Company, which ended in June 2005. Contract manufacturing revenue relates to Regeneron's long-term manufacturing agreement with Merck & Co., Inc., which will expire in the second half of 2006. Regeneron recognized contract research and development revenue of $13.9 million in the first quarter of 2006 related to the Company's collaboration with sanofi-aventis, compared with $9.8 million in the same period of 2005. Contract research and development revenue from the sanofi-aventis collaboration consists of reimbursement of VEGF Trap development expenses plus recognition of amounts related to $105.0 million of previously received up-front, non-refundable payments. Reimbursement of expenses increased to $10.8 million in the first quarter of 2006 from $7.4 million in the same period of 2005, primarily due to higher costs in 2006 related to the Company's manufacture of VEGF Trap clinical supplies. With respect to the up-front payments from sanofi-aventis, $3.1 million was recognized as revenue in the first quarter of 2006 compared to $2.4 million in the same quarter of 2005. Sanofi-aventis also incurs VEGF Trap development expenses which are increasing because of the growing number of clinical trials sanofi-aventis is overseeing in the VEGF Trap oncology program. During the term of the collaboration, sanofi-aventis pays 100% of agreed-upon VEGF Trap development expenses incurred by both companies. Following commercialization of a VEGF Trap product by the collaboration, the Company will repay out of VEGF Trap profits 50% of these VEGF Trap development expenses previously paid by sanofi-aventis. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. for the first quarter of 2006 were $39.9 million, 10 percent lower than the same period in 2005, due, in part, to lower Company headcount. Average Company headcount declined to 587 in the first quarter of 2006 from 734 in the same period of 2005 primarily as a result of workforce reductions made in the fourth quarter of 2005. The Company recognized non-cash compensation expense related to employee stock option awards (Stock Option Expense) in accordance with Statement of Financial Accounting Standards No. (SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System ) 123 in 2005, and in accordance with SFAS 123R (which is a revision of SFAS 123), effective January 1, 2006. Operating expenses in the first quarter of 2006 and 2005 include a total of $3.9 million and $5.4 million, respectively of Stock Option Expense, as follows:
For the three months ended March 31,
------------------------------------
(in millions) 2006
----------------------------------------------
Expenses before Stock
inclusion of Stock Option Expenses as
Expenses Option Expense Expense Reported
-------- --------------------- ----------- -----------
Research and development $30.1 $2.0 $32.1
Contract manufacturing 1.8 0.1 1.9
General and
administrative 4.1 1.8 5.9
--------- ------- --------
Total operating expenses $36.0 $3.9 $39.9
========= ======== ========
For the three months ended March 31,
------------------------------------
(in millions) 2005
----------------------------------------------
Expenses before Stock
inclusion of Stock Option Expenses as
Expenses Option Expense Expense Reported
--------- --------------------- ----------- -----------
Research and development $32.5 $3.4 $35.9
Contract manufacturing 2.5 -- 2.5
General and
administrative 4.1 2.0 6.1
--------- ------- --------
Total operating expenses $39.1 $5.4 $44.5
========= ======= ========
Research and development (R&D) expenses decreased to $32.1 million in the first quarter of 2006 from $35.9 million in the comparable quarter of 2005. In addition to the impact of lower Company headcount, as described above, in the first quarter of 2006, the Company incurred lower development expenses for the IL-1 Trap and other clinical development programs, which were partly offset by higher development expenses for the VEGF Trap. Effective January 1, 2005, the Company adopted the fair value based method of accounting for stock-based employee compensation under the provisions of SFAS 123, Accounting for Stock-Based Compensation, using the modified prospective method described in SFAS 148, Accounting for Stock-Based Compensation - Transition and Disclosure. As a result, in 2005, the Company recognized compensation expense in an amount equal to the fair market value of share-based payments (including stock option awards) on their date of grant over the vesting Vesting The process by which employees accrue non-forfeitable rights over employer contributions that are made to the employee's qualified retirement plan account. Notes: period of the awards using the multiple-option approach. Under the modified prospective method, compensation expense for the Company is recognized for (a) all share-based payments granted on or after January 1, 2005 and (b) all awards granted to employees prior to January 1, 2005 that were unvested on that date. Effective January 1, 2006, the Company adopted the provisions of SFAS 123R, Share-Based Payment, which is a revision of SFAS 123. SFAS 123R requires companies to estimate the number of awards that are expected to be forfeited for·feit n. 1. Something surrendered or subject to surrender as punishment for a crime, an offense, an error, or a breach of contract. 2. Games a. at the time of grant and to revise this estimate, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Prior to the adoption of SFAS 123R, the Company recognized the effect of forfeitures in stock-based compensation cost in the period when they occurred, in accordance with SFAS 123. Upon adoption of SFAS 123R effective January 1, 2006, the Company was required to record a cumulative effect adjustment to reflect the effect of estimated forfeitures related to outstanding awards that are not expected to vest as of the SFAS 123R adoption date. This adjustment reduced the Company's loss by $0.8 million and is included in the Company's operating results for the first quarter of 2006 as a cumulative-effect adjustment of a change in accounting principle. About Regeneron Pharmaceuticals Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. . Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; , and has preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. programs in other diseases and disorders. This news release discusses historical information and includes forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. about Regeneron and its products, programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of our drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize our drug candidates, competing drugs that are superior to our product candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including our agreement with the sanofi-aventis Group, 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. Securities and Exchange Commission (SEC), including its Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2005. 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.
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS (Unaudited)
(In thousands)
March 31, December 31,
2006 2005
---------- ------------
ASSETS
Cash and marketable securities $324,229 $316,654
Receivables 11,010 36,521
Inventory 3,254 2,904
Property, plant, and equipment, net 57,421 60,535
Other assets 6,175 6,887
--------- ---------
Total assets $402,089 $423,501
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $18,383 $23,337
Deferred revenue 81,383 86,162
Notes payable 200,000 200,000
Stockholders' equity 102,323 114,002
--------- --------
Total liabilities and stockholders'
equity $402,089 $423,501
========= =========
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
For the three months
ended March 31,
2006 2005
---------- ----------
Revenues
Contract research and development $14,587 $13,502
Contract manufacturing 3,632 2,707
--------- --------
18,219 16,209
--------- --------
Expenses
Research and development 32,084 35,912
Contract manufacturing 1,852 2,491
General and administrative 5,946 6,146
--------- --------
39,882 44,549
--------- --------
Loss from operations (21,663) (28,340)
--------- --------
Other income (expense)
Other contract income 25,000
Investment income 3,481 2,230
Interest expense (3,011) (3,013)
--------- --------
470 24,217
--------- --------
Net loss before cumulative effect of a change in
accounting principle (21,193) (4,123)
Cumulative effect of adopting Statement of
Financial Accounting Standards No. 123R
("SFAS 123R") 813
--------- --------
Net loss ($20,380) ($4,123)
========= ========
Net loss per share amounts, basic and diluted:
Net loss before cumulative effect of a change
in accounting principle ($0.37) ($0.07)
Cumulative effect of adopting SFAS 123R 0.01
--------- --------
Net loss ($0.36) ($0.07)
========= ========
Weighted average shares outstanding,
basic and diluted 56,727 55,815
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