NPRO Napro Biotherapeutics (MM)

NaPro Reports Fourth Quarter and Full-Year 2003 Results BOULDER, Colo., March 11 /PRNewswire-FirstCall/ -- NaPro BioTherapeutics, Inc. today announced the results of operations for the fourth quarter and year ended December 31, 2003. The net income for the fourth quarter of 2003 was $49.1 million, or $1.59 basic income per share, and $1.56 diluted income per share, including a one-time gain from the sale of the generic injectable paclitaxel business of $54.6 million. This compares to a net lossof $1.1 million, or $0.04 basic and diluted loss per share for the fourth quarter of 2002. After tax income from discontinued operations was $55.5 million in the fourth quarter of 2003, compared with $3.9 million in income from discontinued operationsin the fourth quarter of 2002. For the year ended December 31, 2003, NaPro reported net income of $38.1 million, or $1.24 basic income per share, and $1.23 diluted income per share, including a one-time gain of $54.6 million from the sale of its generic injectable paclitaxel business. This compares to a net loss of $8.7 million for year ended December 31, 2002, or $0.29 basic and diluted loss per share. NaPro recognized after tax income from its discontinued operations of $60.0 million in 2003, compared to income of $11.5 million in 2002. As of December 31, 2003, NaPro had $50.8 million in cash, cash equivalents and marketable securities. "Calendar year 2003 was a pivotal year for NaPro BioTherapeutics," stated Leonard P. Shaykin, NaPro's Chairman and Chief Executive Officer. "With the sale of our paclitaxel business we changed the fundamental direction of the company. With the proceeds from this important sale we have begun to fund the pre-clinical development of our new proprietary therapeutic programs in both cancer and hereditary disease. We look forward, subject to regulatory clearance, to advancing two of these therapeutic candidates into human clinical trials this calendar year," continued Mr. Shaykin. 2003 Highlights Focus on Proprietary Therapeutics Development -- Two Sales Reposition NaPro Sale of the Worldwide Paclitaxel Business. In December 2003, NaPro completed the sale of its worldwide generic injectable paclitaxel business to Mayne Pharma (USA) Inc., a subsidiary of Mayne Group Ltd., for $71.7 million in cash minus an inventory adjustment of $4.6 million. From the proceeds of the sale, NaPro retired $21.9 million in debt (including accrued interest)and payables arising from its development relationship with Abbott Laboratories and entered calendar year 2004 with over $50 million dollars in cash and cash equivalents. Sale of Technical and Analytical Services Group. In April 2003, NaPro sold its technical and analytical services group to privately held ChromaDex, Inc., a leading supplier of phytochemical reference standards to the nutraceutical, dietary supplement, and functional food industries. NaPro transferred employees, specific physical assets, and real estate leases to the company, and in return, acquired an approximate 15% equity stake in ChromaDex, Inc. With the sales mentioned above, NaPro is re-positioned to support the ongoing development of its new proprietary therapeutic products in the areas of oncology and hereditary disease. NaPro currently has four pre-clinical oncology candidates, two of which are anticipated to enter human clinical trials this year. The Company also has two hereditary disease programs in pre-clinical development, one for the treatment of Huntington's Disease and the other for the treatment of Sickle Cell Disease. -- Mylan Litigation On October 6, 2003, the Federal District Court in the Western District of Pennsylvania made a number of rulings in favor of the Company in its patent infringement lawsuit against Mylan Laboratories, Inc. ("Mylan") regarding certainpaclitaxel formulation patents. The District Court ruled that Mylan infringes NaPro patents related to both stabilized formulations of paclitaxel and as well as methods for making stable formulations. The court also ruled that the inventors listed on the NaPro patents were the first to invent the compositions and methods claimed in such patents. The District Court also adopted NaPro's interpretations of the patent claims asserted against Mylan in this case. On December 23, 2003, the District Court ruled again in NaPro's favor that NaPro's patents were valid and that Mylan's claims that the patents were procured through inequitable conduct and fraud on the patent office were neither true nor justified. In February 2004, the Federal Circuit appellate court stayed the District Court's injunction order, which would have prevented Mylan from selling the infringing products, pending a ruling on Mylan's appealto the Federal Circuit. A trial to resolve any issues which may be remanded to the District Court as a result of Mylan's appeal, as well as determining any damages owed by Mylan in this case, has been set for February 2005. The patents, which are the subject of this litigation, were part of the sale of the paclitaxel business to Mayne Pharma. The terms of the sale provide that NaPro will be entitled to a portion of any cash award received with respect to the final adjudication or settlement of this litigation. Mayne Pharma, however, is in full control of the litigation, is responsible for the full cost of prosecuting it, and may direct it, or settle it, upon any terms it chooses. About NaPro BioTherapeutics NaPro BioTherapeutics, Inc. is a life science company focused on the development of therapies for the treatment of cancer and hereditary disease. For more information about NaPro and its technologies, visit NaPro's web site at http://www.naprobio.com/ . Forward Looking Statement The statements in this press release and on the Company's web site that are not historical facts are forward-looking statements that represent management's beliefs and assumptions as of the date of this presentation, based on currently available information. Forward-looking statements can be identified by the use of words such as "believes," "intends," "estimates," "may," "will," "should," "anticipates," "expected" or comparable terminology orby discussions of strategy. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it cannot assure that these expectations will prove to be correct. Such statements involve risks and uncertainties including those factors identified under the captions "Risk Factors," "Special Note Regarding Forward Looking Statements" or "Cautionary Note Regarding Forward Looking Statements" in the Company's documents filed from time to time with the SEC, including the Company's Current Report on Form 8-K/A, dated February 11, 2004. Should one or more of these risks materialize (or the consequences of such a development worsen), or should the underlying assumptions prove incorrect, actual results could differ materially from those forecasted or expected. The Company disclaims any intention or obligation to update publicly or revise such statements whether as a result of new information, future events or otherwise. For further information, please contact L. Robert Cohen, Vice President, Investor Relations of NaPro BioTherapeutics, Inc., +1-212-218-8715. NaPro BioTherapeutics, Inc. Balance Sheets (In thousands) December 31, December 31, 2003 2002 (Unaudited) (Unaudited) ASSETS Current assets: Cash and cash equivalents $40,785 $6,762 Short-term investments 9,997 -- Accounts receivable 1,495 -- Prepaid expense and other current assets 596 1,003 Assets held for sale 205 33,463 Total current assets 53,078 41,228 Property, plant and equipment, net 1,156 2,042 Other assets 3,532 2,058 Total assets $57,766 $45,328 LIABILITIES AND STOCKHOLDERS' EQUITY Total current liabilities $6,025 $7,633 Notes payable - long term 41 19,861 Deferred income - long term -- 5,887 Convertible debentures 5,702 5,151 Total stockholders' equity 45,998 6,796 Total liabilities and stockholders' equity $57,766 $45,328 NaPro BioTherapeutics, Inc. Statements of Operations (In thousands, except per sharedata) (Unaudited) Three Months Ended Year Ended December 31, December 31, 2003 2002 2003 2002 (Unaudited) (Unaudited) (Unaudited) (Unaudited) Operating Expenses: Research and development $3,071 $2,456 $9,890 $10,192 General and administrative 3,133 2,443 11,256 9,519 Operating loss 6,204 4,899 21,146 19,711 Other income (expense): Interest income 46 42 110 267 Interest expense (223) (205) (878) (723) Net loss from continuing operations (6,381) (5,062) (21,914) (20,167) Discontinued Operations: Income from discontinued operations (including gain on sale of $54,553 in 2003) 56,096 3,949 60,686 11,502 Provision for federal income tax (644) -- (644) -- Net income (loss) $49,071 $(1,113) $38,128 $(8,665) Basic and diluted loss per share from continuing operations $(0.21) $(0.17) $(0.71) $(0.68) Basic income (loss) per share from discontinued operations $1.80 $0.13 $1.95 $0.39 Diluted income (loss) per share from discontinued operations $1.76 $0.13 $1.94 $0.37 Basic income (loss) per share $1.59 $(0.04) $1.24 $(0.29) Diluted income (loss) per share $1.56 $(0.04) $1.23 $(0.29) Basic weighted average shares outstanding 30,842 29,826 30,801 29,606 Diluted weighted average shares outstanding relating to discontinued operations 31,483 29,943 30,955 31,268 Diluted weighted average shares outstanding 31,483 29,826 30,955 29,606 DATASOURCE: NaPro BioTherapeutics, Inc. CONTACT: L. Robert Cohen, Vice President, Investor Relations, of NaPro BioTherapeutics, Inc., +1-212-218-8715; or Investors, Lilian Stern of Stern Investor Relations, Inc., +1-212-362-1200; or Media, Peter Steinerman, +1-516-374-3031, both for NaPro BioTherapeutics, Inc. Web site: http://www.naprobio.com/

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