Guilford Pharmaceuticals Reports 2004 Year-End Financial Results

Guilford Pharmaceuticals Reports 2004 Year-End Financial Results



BALTIMORE, March 1  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today reported financial results for the year ended December 31,
2004.  For 2004, Guilford reported a net loss of $87.9 million, or $2.25 per
share, compared to a net loss of $53.9 million, or $1.82 per share, for 2003.

Total revenues in 2004 increased to $47.9 million compared to $27.6 million in
2003.  Revenues for GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant)
increased $8.5 million, or 44%, to $27.7 million in 2004 compared to $19.2
million in 2003.  The increase in GLIADEL(R) revenues is attributable to the
FDA approving expanded labeling for the product in 2003 to permit its use at
the time of initial surgery for malignant glioma as an adjunct to surgery and
radiation.  Revenues for AGGRASTAT(R) Injection (tirofiban hydrochloride) in
2004 were $12.5 million, compared to $2.5 million in 2003.  The increase in
AGGRASTAT(R) revenues in 2004 is the result of a full year of sales activity,
following the Company's acquisition of AGGRASTAT(R) in October 2003. 
Additionally, in 2004 the Company received a payment of $6.6 million from
Angiodevice International GmbH related to the licensing of intellectual
property rights to certain of the Company's licensed biopolymer technologies.

Total costs and expenses in 2004 were $131.7 million compared to $79.8 million
in 2003.  Costs and expenses for 2004 include $6.9 million in non-cash
amortization expense and $14.0 million of non-cash expense for "acquired in-
process research and development" related to warrants to Symphony Neuro
Development Company (SNDC), and the acquisition of ProQuest Pharmaceuticals,
Inc., which allowed Guilford to obtain an irrevocable, royalty-free, fully-
paid, exclusive worldwide license to the intellectual property rights for
AQUAVAN(R).  Cost of sales in 2004 was $5.6 million compared to $4.1 million in
2003.  Gross profit percentage for 2004 was 86% compared to 81% in 2003.

Research and development expenses in 2004 were $46.6 million compared to $33.6
million in 2003.  The increase in research and development expense resulted
primarily from the commencement of Phase III clinical trials of AGGRASTAT(R) in
order to seek approval to expand its use to include percutaneous coronary
intervention (PCI), and, costs associated with SNDC expenses related to Phase
II studies of GPI 1485.  SNDC is consolidated as a variable interest entity
under FIN 46R and reversed in the minority interest line.

Selling, general and administrative costs totaled $58.8 million in 2004
compared to $32.1 million for 2003.  During 2004, the costs incurred to market,
sell and distribute GLIADEL(R) and AGGRASTAT(R) were $33.0 million compared to
$14.3 million in 2003.  This increase resulted primarily from expenses related
to expanding and training the Company's sales force to sell two products,
marketing costs to re-launch AGGRASTAT(R) and increased medical education
expenses for both products.  General and administrative expenses were $25.8
million in 2004 compared to $17.8 million in 2003.  This increase resulted
primarily from increased legal and professional services expenses related to
required filings and supporting activity, implementation of expanded evaluation
procedures for assessing internal controls and procedures for financial
reporting mandated by Sarbanes-Oxley Act of 2002, increased patent-related
costs, and the expenses related to a separation agreement with the Company's
former President and Chief Executive Officer as well as the recruitment of the
Company's new President and Chief Executive Officer.

At December 31, 2004, Guilford had $109.5 million in cash, cash equivalents and
marketable securities, including $19.9 million in restricted investments,
compared to $101.9 million at the end of 2003, including $21.7 million in
restricted investments.  This increase resulted primarily from the completion
of the Company's equity offering in July 2004, which raised net proceeds of
approximately $43.7 million and the completion of a sale and leaseback of the
Company's facilities in December 2004, which raised net proceeds of
approximately $19.4 million.  In addition, in January 2005 the Company paid off
$17.3 million in debt, which decreased the amount of restricted cash by $17.3
million and will lower interest expense on the Company's debt in 2005.

"We made good progress during the year, in particular, with our AQUAVAN(R)
clinical development program and in building the commercial infrastructure,"
commented Dean J. Mitchell, President and Chief Executive Officer.  "Over the
next year we'll be releasing results from our Phase III clinical trials of
AQUAVAN(R).  Pending the results of these trials, we expect to submit a New
Drug Application in the first half of 2006 seeking approval for AQUAVAN(R) for
procedural sedation.  We also anticipate announcing results from two ongoing
Phase II studies of GPI 1485 in Parkinson's disease.  Each of these trials is
expected to be completed later in the year, with results available by early
2006."

Finally, Mr. Mitchell commented that he expected 2005 to be an important year
for Guilford from a strategic perspective.  "As I am nearing the completion of
my first fiscal quarter with the Company, the Board of Directors and I are
completing a strategic review of the Company's assets and business strategy. 
Once this review is completed, I look forward to sharing Guilford's strategy
for the future."

About Guilford

Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the
research, development and commercialization of proprietary pharmaceutical
products that target the hospital and neurology market.  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 used for the treatment of acute coronary syndrome (ACS). Guilford's
product pipeline includes a novel sedative, AQUAVAN(R) Injection, and drugs for
treating Parkinson's disease and post-prostatectomy erectile dysfunction.  For
additional information about GLIADEL(R) and AGGRASTAT(R), please see
http://www.guilfordpharm.com/ under Products / Marketed Products.

Conference Call

Guilford will host a conference call to review its year-end 2004 results. The
conference call will take place at 4:00 p.m. E.T. on Tuesday, March 1, 2005. 
The dial-in number for participants in the U.S. is [phone], and for
international callers [phone].  The participant passcode is 99914317.

Conference Call Replay

An audio replay of the conference call will be available for 48 hours beginning
at approximately 6:00 p.m. ET on March 1, 2005 through 11:59 p.m. E.T. on March
3, 2005.  To access the replay, U.S. residents should dial [phone], and
international callers should dial [phone], passcode 19310134.

Webcast

Guilford will hold a live 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 March 7, 2005.

              GUILFORD PHARMACEUTICALS INC. AND SUBSIDIARIES
                           Financial Highlights

                  Consolidated Statements of Operations
                  (in thousands, except per share data)

                                                Years Ended December 31,

                                                    2004         2003
  Revenues:
    Net product sales                             $40,172      $21,717
    License fees, milestones and other revenues     7,739        5,888
  Total revenues                                   47,911       27,605

  Costs and Expenses:
    Cost of sales                                   5,578        4,110
    Research and development                       46,584       33,624
    Selling, general and administrative            58,758       32,076
    Intangible amortization                         6,854        1,912
    Acquired in-process research and development   13,951        8,093
  Total costs and expenses                        131,725       79,815

  Operating Loss                                  (83,814)     (52,210)

  Other Income / (Expense):
    Investment and other income                     2,213        3,002
    Revenue interest expense                       (8,781)      (1,557)
    Interest expense                               (5,252)      (3,182)

  Loss before Minority Interest                   (95,634)     (53,947)

  Minority Interest                                 7,756         ----

  Net Loss                                       $(87,878)    $(53,947)

  Basic and Diluted Loss per Common Share          $(2.25)      $(1.82)

  Weighted-average shares used to calculate
   basic and diluted loss per share                39,037       29,689



                  Condensed Consolidated Balance Sheets
                              (in thousands)

                                                      December 31,
                                                   2004         2003
  Assets:
    Cash, cash equivalents, marketable
     securities and restricted investments       $109,493     $101,943
    Investments held by Symphony Neuro
     Development Co.                               32,062         ----
    Accounts receivable, net                        4,666        3,460
    Inventories, net                                2,373        2,504
    Property and equipment, net                     1,758       22,395
    Intangibles, net and other assets              86,783       91,021
                                                 $237,135     $221,323

  Liabilities and Stockholders' Equity:
    Current liabilities                           $31,465      $21,980
    Long-term debt and other liabilities           95,713       89,988
    Revenue interest obligation                    44,932       42,155
    Minority interest                              28,132         ----
    Stockholders' equity                           36,893       67,200
                                                 $237,135     $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
November 8, 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 maintain or 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 or GPI 1485.  Furthermore, 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

Copyright