Guilford Pharmaceuticals Reports 2004 Third Quarter Results

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, [phone]



Web site:  http://www.guilfordpharm.com/ 



Company News On-Call:  http://www.prnewswire.com/comp/112882.html

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