GLFD Guilford Pharmaceuticals (MM)

Guilford Pharmaceuticals Reports 2004 Third Quarter Results BALTIMORE, Nov. 8 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (NASDAQ:GLFD) today reported financial results for the third quarter ended September 30, 2004. For the third quarter, Guilford reported a net loss of $14.5 million, or $0.33 per common share, compared to a net loss of $13.3 million, or $0.46 per common share for the same period in 2003. Total revenues in the third quarter of 2004 were $17.3 million compared to $5.4 million in the third quarter of 2003. The increase in total revenues was largely attributable to sales of GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant) and AGGRASTAT(R) Injection (tirofiban hydrochloride) as well as a one-time payment from Angiotech resulting from a licensing transaction. Net product sales of GLIADEL(R) Wafer in the third quarter of 2004 were $6.9 million compared to $5.3 million for the same period in 2003. This increase in sales is attributable to increased unit sales of GLIADEL(R) and an increase in the average selling price. Net product sales of AGGRASTAT(R) were $3.5 million for the third quarter of 2004 and the Company had no sales of AGGRASTAT(R) in the same period in 2003. Total costs and expenses in the third quarter of 2004 were $32.3 million compared to $18.1 million for the same period in 2003. Cost of sales in the third quarter of 2004 were $2.1 million compared to $1.0 million for the corresponding period in 2003. Selling, general and administrative expenses were $14.1 million in the third quarter of 2004 compared to $7.9 million for the third quarter of 2003. Within SG&A, the costs incurred to market, sell and distribute GLIADEL(R) and AGGRASTAT(R) were $8.6 million compared to $3.5 million for the same period in 2003. Approximately $2.8 million of the increase in these expenses is attributable to expanding and training the sales force to sell two products, increased medical education expenses, and increased marketing efforts to support the launch of AGGRASTAT(R). General and administrative costs in the third quarter of 2004 were $5.5 million compared to $4.4 million in the third quarter of 2003. The increase is attributable to increased legal and professional expenses in connection with SEC filings and supporting activity mandated by the Sarbanes-Oxley Act of 2002 and to increased recruiting and relocation costs associated with the expansion of Guilford's sales force and clinical development teams to support increased clinical development activity, and increased patent costs. Research and development expenses in the third quarter of 2004 were $12.5 million compared to $9.1 million in the third quarter of 2003. Research and development expenses increased in the third quarter of 2004 due to the costs associated with initiating the Phase III clinical trials of AGGRASTAT(R) and AQUAVAN(R). At September 30, 2004, Guilford had $104.2 million in unrestricted and restricted cash, cash equivalents and investments. The $2.3 million increase in cash, cash equivalents and investments from $101.9 million at December 31, 2003 resulted primarily from the equity offering completed in the third quarter offset by our operating activities. "During the third quarter we initiated two Phase III clinical trials with AQUAVAN(R) for procedural sedation in patients undergoing colonoscopy and bronchoscopy procedures. These trials are the first of several Phase III studies Guilford expects to commence in its AQUAVAN(R) development program. Results from these studies are anticipated in the first half of 2005," commented Craig R. Smith M.D., President and Chief Executive Officer. "We also achieved several important milestones in our commercial programs," continued Dr. Smith. "GLIADEL(R) was assigned to a new Diagnosis Related Group which took effect on October 1, 2004 and should facilitate the medical community's adoption of this therapy. Also, GLIADEL(R) was granted expanded marketing authorization in Europe to include use during initial therapy. We also obtained Orphan Drug designation for GLIADEL(R) for first line therapy in the United States which entitles Guilford to market exclusivity until 2010. Finally, during the third quarter we prepared to initiate the Phase III AGGRASTAT(R) TENACITY trial in the United States and the Phase III superiority trial, to be conducted in Europe, which will assess the efficacy of our new high dose bolus regimen in patients undergoing percutaneous coronary intervention." About Guilford Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the research, development and commercialization of proprietary drugs that target the hospital and neurology markets. Presently, Guilford markets two commercial products, GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), for the treatment of brain cancer, and AGGRASTAT(R) Injection (tirofiban hydrochloride), a glycoprotein GP IIb/IIIa receptor antagonist, for the treatment of acute coronary syndrome (ACS). Guilford's product pipeline includes AQUAVAN(R) Injection, a novel sedative/anesthetic and drugs for treating peripheral nerve injury. For full prescribing information, please visit http://www.guilfordpharm.com/ under Products / Marketed Products. Conference Call Guilford will host a conference call to review its third quarter 2004 financial results. The conference call will take place at 4:00 p.m. Eastern Time on Monday, November 8, 2004. The dial-in number for participants in the U.S. is 800-299-7928 and for international callers is 617-614-3926. The participant passcode is 68168189. Conference Call Replay An audio replay of the conference call will be available for 72 hours beginning at approximately 6:00 p.m. on November 8, 2004 through 6:00 p.m. Eastern Time on November 11, 2004. To access the replay, U.S. residents should dial 888-286-8010 and international callers should dial 617-801-6888. The participant passcode is 45654677. Webcast Guilford will hold a live audio webcast of this conference call. To access the webcast, please visit our website at http://www.guilfordpharm.com/ under the investor / conference section and follow the instructions provided. An audio archive of the call will be available on the website until November 22, 2004. GUILFORD PHARMACEUTICALS INC. AND SUBSIDIARIES Financial Highlights (unaudited) Consolidated Statements of Operations (in thousands, except per share data) Three Months Ended September 30, 2004 2003 Revenues: Net product sales $10,430 $5,302 Other 6,892 118 Total revenues 17,322 5,420 Costs and expenses: Cost of sales 2,060 975 Research and development 12,521 9,056 Selling, general and administrative 14,098 7,862 Intangible amortization 1,713 210 Acquired in-process research and development 1,917 --- Total costs and expenses 32,309 18,103 Operating loss (14,987) (12,683) Investment and other income 630 585 Revenue interest expense (2,026) --- Interest expense (1,251) (1,184) Loss before minority interest (17,634) (13,282) Minority interest 3,173 --- Net loss $(14,461) $(13,282) Basic and diluted net loss per common share: $(0.33) $(0.46) Shares used in the calculation of basic & diluted net loss per share 43,457 28,967 Condensed Consolidated Balance Sheets (in thousands) September 30, December 31, 2004 2003 Assets: Cash and cash equivalents $51,574 $29,939 Investments, net 32,468 50,261 Investments, Symphony NeuroDevelopment Co. 35,295 --- Accounts receivable, net 4,387 3,460 Inventories, net 2,388 2,504 Prepaid expenses and other assets 2,776 1,787 Investments, restricted 20,159 21,743 Property and equipment, net 20,850 22,395 Intangible assets, net 77,656 82,796 Other assets 5,054 6,438 $252,607 $221,323 Liabilities and Stockholders' Equity: Current liabilities $21,687 $21,980 Long-term debt and other liabilities 87,472 88,885 Revenue interest obligation 44,043 42,155 Other liabilities 5,216 1,103 Minority interest 31,575 --- Stockholders' equity 62,614 67,200 $252,607 $221,323 Contact: Stacey Jurchison, Director, Corporate Communications -- 410-631-5022 Internet address: http://www.guilfordpharm.com/ This press release contains forward-looking statements that involve risks and uncertainties, including those described in the section entitled "Risk Factors" contained in the Company's Quarterly Report on Form 10-Q filed with the SEC on August 9, 2004, that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Among other things, there can be no assurance that the Company will be able to increase sales of GLIADEL(R) Wafer or AGGRASTAT(R) Injection, or that the Company will be able to successfully develop and commercialize any of its product candidates, including AQUAVAN(R) Injection. Further, the Company may not be successful in its attempt to expand the label for AGGRASTAT(R) Injection. DATASOURCE: Guilford Pharmaceuticals Inc. CONTACT: Stacey Jurchison, Director, Corporate Communications, Guilford Pharmaceuticals, +1-410-631-5022 Web site: http://www.guilfordpharm.com/ Company News On-Call: http://www.prnewswire.com/comp/112882.html

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