Enzon Reports Four-Fold Increase in Second Quarter Earnings.Business Editors & Health/Medical Writers PISCATAWAY Pis·cat·a·way A community of north-central New Jersey north of New Brunswick. Founded before 1693, it is a manufacturing center. Population: 42,223. , N.J.--(BUSINESS WIRE)--Feb. 13, 2002 Revenues triple over prior year and Phase II clinical trials Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II initiated for PROTHECAN in non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. Enzon, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ENZN) announced today its financial results for the quarter ended December 31, 2001, the second quarter of Enzon's fiscal year (FY) 2002. Total revenues for the quarter increased by $12.6 million, or 209 percent to $18.6 million, as compared to $6.0 million for the prior year period. The Company's net earnings for the second quarter FY 2002 climbed to $8.6 million or $0.20 per diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share, as compared to $2.1 million or $0.05 per diluted share, for the same period in FY 2001. The increase in revenues for the quarter was principally due to increased royalties earned on sales of PEG-INTRON(TM) by the Company's marketing partner, Schering-Plough Corporation. Total royalties on marketed products that utilize Enzon's PEG peg 1. To fix the price of a new security issue during the issuance period through buying and selling it in the open market in order to ensure that the price in the secondary market will not fall below the offering price. technology grew to $12.6 million during the second quarter of FY 2002, as compared to $960,000 for the same period in FY 2001. In October 2001, Schering-Plough launched PEG-INTRON and REBETOL Rebetol® Ribavirin, see there combination therapy in the U.S. for the treatment of chronic hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis C. The PEG-INTRON and REBETOL treatment regimen regimen /reg·i·men/ (rej´i-men) a strictly regulated scheme of diet, exercise, or other activity designed to achieve certain ends. reg·i·men n. 1. is the first and only pegylated interferon-based combination therapy approved in 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. . Combined sales of the Company's other two FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved products, ONCASPAR(R) and ADAGEN(R), increased by 17 percent to $5.9 million in the second quarter of FY 2002, as compared to $5.0 million for the same period in FY 2001 primarily due to increased sales of ONCASPAR. "We are pleased to present our shareholders with another quarter of strong earnings growth," said Arthur J. Higgins, Enzon's chairman and chief executive officer. "With PEG-INTRON's impressive emergence onto the U.S. marketplace as the gold standard for treating hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. and the enormous potential for continued market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market penetration - the act of entering into or through something; "the penetration of upper management by women" , Enzon is well positioned to enjoy a consistent and expanding revenue stream in coming quarters." Research and development expenses for the second quarter of FY 2002 increased by $1.5 million or 59 percent to $4.0 million, as compared to $2.5 million for the second quarter of FY 2001. The increase was due primarily to increased research and development expenditures related to preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. and clinical activities for PROTHECAN(R) (PEG-camptothecin), PEG-paclitaxel, and other PEG products in preclinical development. During the quarter ended December 31, 2001, Enzon initiated patient dosing in a Phase II clinical trial for PROTHECAN in patients with pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. . In July 2001, the Company initiated Phase II clinical trials for PROTHECAN in patients with small-cell lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. . The Company also announced today the initiation of Phase II clinical trials for PROTHECAN in patients with non-small cell lung cancer. The Company expects to initiate additional Phase II trials for PROTHECAN as both a single agent and in combination with other oncolytics. Research and development expenses are expected to continue to increase significantly as the Company continues the clinical advancement of its PEG product pipeline. Selling, general and administrative expenses for the second quarter of FY 2002 increased by $2.0 million or 80 percent to $4.5 million, as compared to $2.5 million for the second quarter of FY 2001. This increase was primarily due to increased payroll and related expenditures, as well as increased legal fees. During the second quarter of FY 2002, interest and other income increased to $4.7 million, as compared to $2.1 million for the second quarter of FY 2001. Interest expense increased to $4.9 million for the second quarter of FY 2002. For the second quarter of FY 2001 the Company did not record any interest expense. The increases in interest income and interest expense are due to the issuance of $400 million of 4.5% convertible subordinated notes during June 2001. As of December 31, 2001, Enzon had total cash and interest-bearing investments of $527 million. Company management of Enzon will be hosting a conference call today, February 13, 2002 at 9:45AM EST EST electroshock therapy. EST abbr. electroshock therapy . All interested parties can access the live call using the following information:
Domestic dial-in number 877-777-1967
International Dial-In Number 612-332-1210
Access Code 624361
Enzon's conference call will also be webcast in a "listen only" mode via the internet at http://www.vcall.com. Additionally, for those parties unable to listen at the time of Enzon's conference call, a rebroadcast will be available following the call from Wednesday, February 13, 2002 at approximately 3:15pm. This rebroadcast will end on Wednesday, February 20, 2002 at 11:59pm. The rebroadcast may be accessed using the following information:
Domestic Dial-In Number 800-475-6701
International Dial-In Number 320-365-3844
Access Code 624361
Enzon is a biopharmaceutical company that develops and commercializes enhanced therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. for life-threatening diseases through the application of its proprietary platform technologies: PEG Modification and single-chain antibodies (SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. (R)). Three products are currently marketed which utilize Enzon's technology: PEG-INTRON marketed by Schering-Plough for hepatitis C, ONCASPAR(R) for Acute Lymphoblastic Leukemia acute lymphoblastic leukemia n. Abbr. ALL Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia. (ALL), and ADAGEN(R) a treatment for a form of Severe Combined Immunodeficiency Disease Noun 1. severe combined immunodeficiency disease - a congenital disease affecting T cells that can result from a mutation in any one of several different genes; children with it are susceptible to infectious disease; if untreated it is lethal within the first year or (SCID SCID severe combined immunodeficiency (disease); see under immunodeficiency. SCID abbr. severe combined immunodeficiency SCID severe combined immunodeficiency disease. ), commonly known as the "Bubble A bit in bubble memory or a symbol in a bubble chart. Boy Disease." In addition to three approved products, Enzon has several products in various stages of clinical development by itself and with partners, including additional indications for PEG-INTRON with Schering-Plough. A Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the is being conducted for PEG-INTRON for the treatment of malignant melanoma Malignant Melanoma Definition Malignant melanoma is a type of cancer arising from the melanocyte cells of the skin. Melanocytes are cells in the skin that produce a pigment called melanin. . Enzon develops and markets products on its own and through strategic alliances, which in addition to Schering-Plough Corporation, include Alexion Pharmaceuticals, Inc., Baxter Healthcare Corporation, Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were Company, Eli Lilly Eli Lilly can refer to:
Except for the historical information herein, the matters discussed in this news release include 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. that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors, which are described in the Company's 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. , Form 10-Q's and Form 8-K's on file with the SEC, including without limitation, risks in obtaining and maintaining regulatory approval for indications and expanded indications, market acceptance of and continuing demand for Enzon's products and the impact of competitive products and pricing. This release is also available at http://www.enzon.com
ENZON, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months ended December 31, 2001 and 2000
(Unaudited)
December 31, December 31,
2001 2000
------------------------------
Revenues:
Net sales $5,872,315 $5,005,170
Royalties 12,629,473 959,531
Contract revenue 100,000 54,444
---------------- ----------------
Total revenues 18,601,788 6,019,145
---------------- ----------------
Costs and expenses:
Cost of sales 1,455,559 871,024
Research and development expenses 3,988,408 2,508,672
Selling, general and administrative
expenses 4,524,672 2,513,810
---------------- ----------------
Total costs and expenses 9,968,639 5,893,506
---------------- ----------------
Operating income 8,633,149 125,639
---------------- ----------------
Other income (expense):
Interest and other income 4,749,850 2,055,466
Interest expense (4,920,476) --
---------------- ----------------
(170,626) 2,055,466
---------------- ----------------
Income before taxes 8,462,523 2,181,105
Tax (benefit) provision (183,002) 43,622
---------------- ----------------
Net income $8,645,525 $2,137,483
================ ================
Basic earnings per common share $0.20 $0.05
================ ================
Diluted earnings per common share $0.20 $0.05
================ ================
Weighted average number of common shares
issued and outstanding - basic 42,766,699 41,568,723
================ ================
Weighted average number of common shares issued
and outstanding and dilutive potential
common shares outstanding 43,959,216 43,850,319
================ ================
ENZON, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Six Months ended December 31, 2001 and 2000
(Unaudited)
December 31, December 31,
2001 2000
--------------------------------------------
Revenues:
Net sales $10,953,805 $9,582,771
Royalties 19,616,786 1,291,698
Contract revenue 174,899 318,290
----------------- ----------------
Total revenues 30,745,490 11,192,759
----------------- ----------------
Costs and expenses:
Cost of sales 2,846,420 1,872,212
Research and development
expenses 7,485,565 5,145,269
Selling, general
and administrative
expenses 8,646,782 5,588,037
----------------- ----------------
Total costs and
expenses 18,978,767 12,605,518
----------------- ----------------
Operating income
(loss) 11,766,723 (1,412,759)
----------------- ----------------
Other income (expense):
Interest and other income 10,927,221 4,176,570
Interest expense (9,914,869) --
----------------- ----------------
1,012,352 4,176,570
----------------- ----------------
Income before taxes 12,779,075 2,763,811
Tax (benefit) provision (96,671) 55,276
----------------- ----------------
Net income $12,875,746 $2,708,535
================= ================
Basic earnings
per common share $0.30 $0.07
================= ================
Diluted earnings
per common share $0.29 $0.06
================= ================
Weighted average
number of common shares
Issued and outstanding
- basic 42,443,616 41,335,006
================= ================
Weighted average number
of common shares
issued and outstanding
and dilutive potential
common shares outstanding 43,791,837 43,555,087
================= ================
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