Enzon Reports Third Quarter Financial Results; Product Sales Increase by 28%.Business Editors/Health/Medical Writers BRIDGEWATER Bridgewater, town (1990 pop. 21,249), Plymouth co., E Mass.; inc. 1656. Manufacturing includes shoes and metal products. Its iron foundry industry dates from colonial times. Bridgewater State College and a state prison are there. , N.J.--(BUSINESS WIRE)--May 5, 2004 Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) announced today its financial results for the quarter ended March 31, 2004, the third quarter of Enzon's fiscal year (FY) 2004. During the quarter, Enzon completed several corporate milestones including: -- Establishing a commercialization partnership with Inex Pharmaceuticals Corporation (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension : IEX IEX Ion Exchange (chromatography) IEX Inter-Exchange Carrier ) for Inex's oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. drug, Onco TCS (Transportation Control System) A widely used integrated information system for railroad transportation developed by the Missouri Pacific Railroad Company in the late 1960s and early 1970s. It was later implemented by Union Pacific when the companies merged. . Inex completed a pivotal Phase 2/3 trial for Onco TCS in 2003 for patients with relapsed, aggressive non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma and several Phase 2 trials are also underway in various other cancers. -- Initiating patient dosing in a clinical trial designed to evaluate Pegamotecan as a single-agent, second-line therapy for the treatment of gastric gastric /gas·tric/ (gas´trik) pertaining to, affecting, or originating in the stomach. gas·tric adj. Of, relating to, or associated with the stomach. and gastroesophageal gastroesophageal /gas·tro·esoph·a·ge·al/ (-e-sof?ah-je´al) 1. pertaining to the stomach and esophagus. 2. proceeding from the stomach to the esophagus. junction cancers. This study was initiated based on the positive interim data yielded from the Company's ongoing Phase 2 trial for the treatment of gastric and gastroesophageal cancers. -- The filing of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Onco TCS and the requesting of a Priority Review, as Onco TCS is a product intended to address an unmet un·met adj. Not satisfied or fulfilled: unmet demands. medical need. Applications that are granted Priority Review status are targeted for action by the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) within six months from the date that the submission is complete. -- Launching a major new initiative in antifungal antifungal /an·ti·fun·gal/ (-fung´gal) 1. destructive to fungi, or suppressing their reproduction or growth; effective against fungal infections. 2. an agent that so acts. research with the introduction of the Company's proprietary CLEAR II(TM) patient registry The configuration database in all 32-bit versions of Windows that contains settings for the hardware and software in the PC it is installed in. The Registry is made up of the SYSTEM.DAT and USER.DAT files. Many settings previously stored in the WIN.INI and SYSTEM. . CLEAR II is a multi-center registry developed by and for clinicians to share and exchange online, real-time data Real-time data denotes information that is delivered immediately after collection. There is no delay in the timeliness of the information provided. Some uses of this term confuse it with the term dynamic data. on the clinical course of invasive invasive /in·va·sive/ (-siv) 1. having the quality of invasiveness. 2. involving puncture of the skin or insertion of an instrument or foreign material into the body; said of diagnostic techniques. fungal fungal /fun·gal/ (fun´g'l) fungous; pertaining to fungi. fun·gal or fun·gous adj. 1. Of, relating to, resembling, or characteristic of a fungus. 2. infections. Importantly, this registry captures information on physician clinical experiences with Enzon's ABELCET(R) (Amphotericin B Lipid Complex amphotericin B lipid complex Warning - High-alert drug! Abelcet Pharmacologic class: Systemic polyene antifungal Therapeutic class: Antifungal Injection), as well as other antifungal agents antifungal agents, n.pl agents that inhibit, control, or kill fungi. The most common yeastlike fungus occurring in or near the oral cavity is C. albicans. and the Company anticipates it will quickly become an important resource for physicians treating invasive fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. . "This quarter is highlighted by several notable achievements, with the most significant being adding Onco TCS to our product pipeline and soon thereafter submitting an NDA for this important product," said Arthur Arthur, king of Britain: see Arthurian legend. Arthur king and hero of Scotland, Wales, and England. [Arthurian Legend: Parrinder, 28] See : Heroism J. Higgins Higgins may refer to: People with the surname Higgins:
Financial Results The Company reported net income for the third quarter of FY 2004 of $5.1 million, or $0.12 cents 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, compared with net income of $7.6 million or $0.17 cents per diluted share for the third quarter of FY 2003. The Company's net income for the third quarter of FY 2004 includes a write-off Write-Off A reduction in the value of an asset or earnings by the amount of an expense or loss. Companies are able to write off certain expenses that are required to run the business, or have been incurred in the operation of the business and detract from retained revenues. of acquired in-process research and development costs of $12.0 million related to the acquisition of the North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. commercialization rights to Onco TCS from Inex in January January: see month. 2004 and a net gain on investments of $11.0 million principally related to the sale of approximately 50% of the Company's investment in Nektar 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. (Nasdaq: NKTR). Combined product sales for the Company's four internally marketed products (ABELCET(R), ONCASPAR(R), DEPOCYT(R), and ADAGEN(R)) increased by $6.1 million or 28% to $28.0 million compared with $21.9 million for the prior year's comparable quarter. This increase was primarily driven by an increase in sales of ABELCET. For the third quarter of FY 2004 North American sales of ABELCET were $17.6 million compared with $13.5 million for the third quarter of FY 2003 and ahead of the Company's expectations for the quarter of $16.5 million to $17.5 million. Sales of ONCASPAR for the third quarter of FY 2004 increased by $2.1 million or 75% to $4.9 million compared with $2.8 for the third quarter of FY 2003. Sales of DEPOCYT were $1.4 million for the third quarter of FY 2004, compared with $1.2 million for the third quarter of FY 2003. In January 2003, the Company in-licensed the North American rights to DEPOCYT from SkyePharma PLC. ADAGEN sales for the third quarter of FY 2004 were $4.1 million versus $4.3 million in the third quarter of FY 2003. During the quarter, the Company also recorded $5.0 million in manufacturing revenue related to the ABELCET business, which included approximately $1.7 million of revenue related to the settlement of certain disputed items. Manufacturing revenue for the third quarter of FY 2003 was $4.8 million. Total royalties for the third quarter of FY 2004 decreased by $5.1 million or 32% to $11.1 million compared with $16.2 million for the third quarter of FY 2003. Total royalties for the quarter were made up principally of royalties from sales of PEG-INTRON marketed by Schering-Plough Corporation (NYSE NYSE See: New York Stock Exchange : SGP SGP Singapore (ISO Country code) SGP Schering-Plough (stock symbol) SGP Stability and Growth Pact SGP Southern Great Plains SGP Staatkundig Gereformeerde Partij SGP Speedway Grand Prix ). The decrease was due to the ongoing competition in the pegylated alpha interferon interferon (ĭn'tərfēr`ŏn), any of a group of proteins produced by cells in the body in response to an attack by a virus. A cell infected by a virus releases minute amounts of interferons, which attach themselves to neighboring cells, market. To strengthen its 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. product line, in February 2004 Schering-Plough launched a new PEG-INTRON Redipen precision-dosing pen in the U.S. market, where Schering-Plough has reported it is being well received. The Company's investment in research and development increased by $5.6 million or 110% to $10.8 million in the third quarter of FY 2004 compared with $5.1 million for the third quarter of FY 2003. The increase was primarily attributable to the Company's shared product development costs with Inex for Onco TCS, which included costs related to the filing of the NDA in March 2004, as well as costs related to the Company's internal research and development programs, namely, the initiation of a clinical trial for Pegamotecan as a second-line therapy for the treatment of gastric and gastroesophageal junction cancers, preparation for the commencement of a Phase 3 trial for ATG ATG antithymocyte globulin. lymphocyte immune globulin (antithymocyte globulin equine, ATG, ATG equine, LIG) Atgam Pharmacologic class: Immunoglobulin Therapeutic class: Immunosuppressant Fresenius S Fresenius may mean:
Selling, general, and administrative expenses increased by $3.0 million or 32% to $12.5 million in the third quarter of FY 2004 versus $9.5 million for the third quarter of FY 2003. This increase was primarily attributable to expenditures related to ABELCET promotional activities, which included publications, presentations, and expenditures related to the March 2004 launch of the Company's CLEAR II registry at the Focus on Fungal Infections conference. Net investment income increased to $11.6 million in the third quarter of FY 2004, compared with $632,000 for the corresponding period in FY 2003. The increase is principally due to the sale of 880,075 shares of Nektar Therapeutics common stock, which resulted in a net gain of approximately $11.0 million. During the third quarter of FY 2004, the Company recorded a deferred tax benefit of approximately $5.5 million that was primarily attributable to the reversal of a deferred tax valuation allowance pertaining per·tain intr.v. per·tained, per·tain·ing, per·tains 1. To have reference; relate: evidence that pertains to the accident. 2. to the write down of the carrying value Carrying Value Also know as "book value," it is a company's total assets minus intangible assets and liabilities, such as debt. Notes: This is different than market value, as it can be higher or lower depending on the circumstances. of the Company's Nektar Therapeutics shares that were sold during the quarter. The deferred tax benefit was also attributable to a reduction in the Company's estimated taxable income Under the federal tax law, gross income reduced by adjustments and allowable deductions. It is the income against which tax rates are applied to compute an individual or entity's tax liability. The essence of taxable income is the accrual of some gain, profit, or benefit to a taxpayer. and effective tax rate due to the $12.0 million write-off of acquired in-process research and development costs related to the acquisition of the North American commercialization rights to Onco TCS. The Company's cash and investments totaled $174.5 million as of March 31, 2004 compared with $153.3 million as of June 30, 2003. The increase in cash and investments was primarily the result of cash proceeds of $17.4 million related to the Company's sale of 880,075 shares of Nektar Therapeutics common stock and positive cash flows provided by the Company's operations. These increases were partially offset by the payment of $12.0 million to Inex for acquired in-process research and development related to the acquisition of the North American commercialization rights to Onco TCS. The management of Enzon will be hosting a conference call today, May 5, 2004 at 4:30 PM EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT . All interested parties can access the live call using the following information:
Domestic Dial-In Number: 888-428-4479
International Dial-In Number: 651-291-0900
Access Code: 727692
Enzon's conference call will also be webcast in a "listen only" mode via the Internet Internet Publicly accessible computer network connecting many smaller networks from around the world. It grew out of a U.S. Defense Department program called ARPANET (Advanced Research Projects Agency Network), established in 1969 with connections between computers at the 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, May 5, 2004 at approximately 9:30 PM EDT. This rebroadcast will end on Wednesday, May 12, 2004 at midnight. 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: 727692
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases. The Company has developed or acquired a number of marketed products, including PEG-INTRON(R), marketed by Schering-Plough, and ABELCET(R), ONCASPAR(R), ADAGEN(R), and DEPOCYT(R), marketed in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. by Enzon's specialized spe·cial·ize v. spe·cial·ized, spe·cial·iz·ing, spe·cial·iz·es v.intr. 1. To pursue a special activity, occupation, or field of study. 2. sales force. Enzon's science-focused strategy includes an extensive drug development program that leverages the Company's macromolecular mac·ro·mol·e·cule n. A very large molecule, such as a polymer or protein, consisting of many smaller structural units linked together. Also called supermolecule. engineering technology platforms, including 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. modification and single-chain antibody (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)) technologies. Internal research and development efforts are complemented by strategic transactions that provide access to additional products and technologies. Enzon has several drug candidates in various stages of development, independently and with partners, including Onco TCS, for which a U.S. marketing application has been submitted for the treatment of relapsed, aggressive non-Hodgkin's lymphoma. Further information about Enzon, this press release, and the conference call can be found on the Company's web site at www.enzon.com. There are 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. contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimates," "continue," "anticipates," "intends," "expects," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments discussed above. Such factors include the risks that the NDA for Onco TCS may not be granted Priority Review status by the FDA and that Onco TCS may not receive regulatory approval from the FDA, as well as those described in Enzon'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. and Forms 10-Q on file with the SEC, such as Enzon's ability to successfully launch and market Onco TCS, Enzon's ability to sustain profitability, and positive cash flow; risks in obtaining and maintaining regulatory approval for indications and expanded indications for Enzon's products; market acceptance of and continuing demand for Enzon's products; timing and results of clinical trials, including, without limitation, the ongoing clinical trials of Pegamotecan for the treatment of gastric and gastroesophageal cancers; the risk that the FDA may not deem Pegamotecan eligible for accelerated approval under Subpart H of the Food and Drug Act; and the impact of competitive products and pricing. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. All information in this press release is as of May 5, 2004 and the Company undertakes no duty to update this information.
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months ended March 31, 2004 and 2003
(In thousands, except per share data)
(Unaudited)
March 31, March 31,
2004 2003
----------- -----------
Revenues:
Net sales $27,993 $21,875
Manufacturing revenue 5,035 4,762
Royalties 11,103 16,242
Contract revenue 248 284
----------- -----------
Total revenues 44,379 43,163
----------- -----------
Costs and expenses:
Cost of sales and manufacturing revenues 12,458 11,080
Research and development expenses 10,772 5,132
Acquired in-process research and development 12,000 --
Selling, general and administrative expenses 12,500 9,481
Merger expenses -- 1,398
Amortization of acquired intangibles 3,358 3,960
----------- -----------
Total costs and expenses 51,088 31,051
----------- -----------
Operating income (loss) (6,709) 12,112
----------- -----------
Other income (expense):
Investment income, net 11,564 632
Interest expense (4,957) (4,957)
Other income (expense) (337) 3
----------- -----------
6,270 (4,322)
----------- -----------
Income before taxes (439) 7,790
Tax provision (benefit) (5,505) 156
----------- -----------
Net income $5,066 $7,634
=========== ===========
Basic earnings per common share 0.12 0.18
=========== ===========
Diluted earnings per common share 0.12 0.17
=========== ===========
Weighted average number of common shares
issued and outstanding - basic 43,368 43,192
=========== ===========
Weighted average number of common shares
issued and outstanding and dilutive potential
common shares outstanding 43,817 43,634
=========== ===========
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Nine Months ended March 31, 2004 and 2003
(In thousands, except per share data)
(Unaudited)
March 31, March 31,
2004 2003
----------- -----------
Revenues:
Net sales $80,665 $36,250
Manufacturing revenue 8,826 5,496
Royalties 36,461 57,565
Contract revenue 769 417
----------- -----------
Total revenues 126,721 99,728
----------- -----------
Costs and expenses:
Cost of sales and manufacturing revenues 35,195 17,859
Research and development expenses 24,711 14,886
Acquired in-process research and development 12,000 --
Selling, general and administrative expenses 35,187 20,786
Merger expenses -- 1,398
Amortization of acquired intangibles 10,074 5,288
Write-down of carrying value of investments -- 27,237
----------- -----------
Total costs and expenses 117,167 87,454
----------- -----------
Operating income 9,554 12,274
----------- -----------
Other income (expense):
Investment income, net 12,744 8,430
Interest expense (14,871) (14,871)
Other income 71 3
----------- -----------
(2,056) (6,438)
----------- -----------
Income before taxes 7,498 5,836
Tax provision (benefit) (2,691) 662
----------- -----------
Net income 10,189 $5,174
=========== ===========
Basic earnings per common share 0.24 $0.12
=========== ===========
Diluted earnings per common share 0.23 $0.12
=========== ===========
Weighted average number of common shares
issued and outstanding - basic 43,322 43,061
=========== ===========
Weighted average number of common shares
issued and outstanding and dilutive potential
common shares outstanding 43,657 43,611
=========== ===========
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED BALANCE SHEETS
March 31, 2004 and June 30, 2003
(In thousands, except share data)
(Unaudited)
March 31, June 30,
2004 2003
----------- -----------
Assets
Current assets:
Cash and cash equivalents $83,370 $66,752
Short-term investments 9,741 25,047
Accounts receivable, net 29,623 33,173
Inventories 10,586 11,786
Deferred tax and other current assets 20,798 16,089
----------- -----------
Total current assets 154,118 152,847
Property and equipment, net 34,178 32,593
----------- -----------
Other assets:
Marketable securities 81,358 61,452
Investments in equity securities and
convertible note 65,274 56,364
Amortizable intangible assets, net 198,544 211,975
Goodwill 150,985 150,985
Deferred tax and other assets 53,132 62,350
----------- -----------
549,293 543,126
----------- -----------
Total assets $737,589 $728,566
=========== ===========
Liabilities and Stockholders' Equity
Current liabilities 26,517 $34,345
Notes payable 400,000 400,000
Other liabilities 6,671 2,637
Stockholders' equity 304,401 291,584
----------- -----------
Total liabilities and stockholders'
equity $737,589 $728,566
=========== ===========
Common stock shares outstanding 43,841 43,518
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