Guilford Pharmaceuticals Reports 2004 Second Quarter Results

Guilford Pharmaceuticals Reports 2004 Second Quarter Results



BALTIMORE, Aug. 9  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today reported financial results for the second quarter ended
June 30, 2004.  For the second quarter, Guilford reported a net loss of $21.3
million, or $0.63 per common share, compared to a net loss of $5.4 million, or
$0.18 per common share for the same period in 2003.  Results in the current
quarter included a one-time, non-cash charge of $5.2 million for the issuance
of warrants to secure the Company's future rights to its GPI 1485 product
pursuant to a financing transaction with SNDC Holdings, LLC.

Total revenues in the second quarter of 2004 were $11.1 million, substantially
all of which was attributable to revenue from the sale of GLIADEL(R) Wafer
(polifeprosan 20 with carmustine implant) and AGGRASTAT(R) Injection (tirofiban
hydrochloride).  This compared to $10.6 million in the second quarter of 2003,
which was comprised substantially of sales of GLIADEL(R) Wafer and a one-time
payment from Pfizer resulting from a licensing transaction.

Net product sales of GLIADEL(R) Wafer increased in the second quarter of 2004
to $7.1 million compared to $5.0 million for the same period in 2003. The
increase in sales is attributable to an expanded indication for GLIADEL(R),
granted by the Food and Drug Administration in February 2003, to include the
use of GLIADEL(R) at the time of initial surgery for high-grade malignant
glioma, a price increase, expanded sales force and marketing efforts, use in a
clinical trial and improved international performance.  Net product sales of
AGGRASTAT(R) were $3.6 million for the second quarter.

Cost of sales in the second quarter of 2004 were $1.2 million compared to $1.0
million for the corresponding period in 2003.  Gross profit percentage for
GLIADEL(R) in the second quarter of 2004 and 2003 was 86% and 79%,
respectively.  For the three months ended June 30, 2004, gross profit
percentage for AGGRASTAT(R) was 93%.

Total costs and expenses in the second quarter of 2004 were $31.5 million
compared to $16.5 million for the same period in 2003.  Selling, general and
administrative expenses were $14.4 million in the second quarter of 2004
compared to $7.9 million for the second quarter of 2003.  The costs incurred to
market, sell and distribute GLIADEL(R) and AGGRASTAT(R) were $9.0 million
compared to $3.9 million for the same period in 2003.  The increase in these
expenses resulted from costs associated with expanding and training the sales
force; increased medical education expenses, and increased marketing efforts to
support the first quarter launch of AGGRASTAT(R).

General and administrative costs totaled $5.4 million and $4.0 million for the
second quarters of 2004 and 2003, respectively.  The increase year on year is
due primarily to higher recruiting and relocation costs associated with the
expansion of both Guilford's sales force and clinical development teams to
support increased clinical development activity; increased patent costs, and
increased legal and professional expenses in connection with SEC filings and
supporting activity mandated by Sarbanes-Oxley Act of 2002.

Research and development expenses in the second quarters of 2004 and 2003 were
$8.9 million and $7.4 million, respectively.  Research and development expenses
increased in the second quarter of 2004 in preparation for beginning Phase III
clinical trials of AGGRASTAT(R) and AQUAVAN(R).

At June 30, 2004, Guilford had $74.1 million in unrestricted and restricted
cash, cash equivalents and investments, compared to $101.9 million at December
31, 2003.  Subsequent to the end of the quarter, Guilford completed a public
offering, which raised approximately $42.0 million through the issuance of
10,000,000 shares of the Company's common stock.

"During the second quarter, we made excellent progress in our commercial and
clinical development programs," remarked Craig R. Smith, M.D., President and
Chief Executive Officer.  "Our agreement with Symphony Neuro Development
Company (SNDC), announced during the second quarter, enables us to benefit from
the experience and expertise of SNDC and RRD, International, and accelerate the
development of our GPI 1485 program without increasing Guilford's cash burn
rate.  Instead, we can deploy our resources to advance the clinical development
of AQUAVAN(R), which continues to show promise. During the quarter we announced
additional Phase II data that further confirm previous findings for AQUAVAN(R)
in the procedural sedation setting.  The data from these trials suggest that
AQUAVAN(R) can sedate people quickly and maintain sedation during the length of
a procedure, usually with a single bolus dose, and, people awaken quickly
without some of the side effects typically seen with conventional sedatives
used in this setting.  We expect to begin patient enrollment in the first of a
series of Phase III trials of AQUAVAN(R) during the current quarter.  The
initial Phase III trial will be in colonoscopy, followed by additional Phase
III trials of AQUAVAN(R) in bronchoscopy, cardiac catheterization and minor
surgical procedures."

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 second quarter 2004
financial results.  The conference call will take place at 10:00 a.m. E.T. on
Monday, August 9, 2004.  The dial-in number for participants in the U.S. is
[phone], and for international callers [phone].  The participant
passcode is 66836765.

Conference Call Replay

An audio replay of the conference call will be available for 72 hours beginning
at approximately 1:00 p.m. E.T. on August 9, 2004 through 1:00 p.m. E.T. on
August 12, 2004.  To access the replay, U.S. residents should dial (888)
286-8010, and international callers should dial [phone], passcode
19740997.

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 August 16, 2004.

              GUILFORD PHARMACEUTICALS INC. AND SUBSIDIARIES
                           Financial Highlights
                               (unaudited)

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


                                                Three Months Ended June 30,
                                                      2004           2003
  Revenues:
    Net product sales                              $10,747         $5,002
    Other                                              402          5,600
  Total revenues                                    11,149         10,602

  Costs and expenses:
    Cost of sales                                    1,232          1,031
    Research and development                         8,852          7,410
    Selling, general and administrative             14,433          7,877
    Intangible amortization                          1,705            210
    Acquired in-process research and development     5,238            ---

  Total costs and expenses                          31,460         16,528

  Operating loss                                   (20,311)        (5,926)
  Investment and other income                          402            912
  Revenue interest expense                          (2,095)           ---
  Interest expense                                  (1,367)          (340)
  Loss before minority interest                    (23,371)         5,354

  Minority interest                                  2,104            ---

  Net loss                                        $(21,267)       $(5,354)

  Basic and diluted net loss per common share:      $(0.63)        $(0.18)

  Shares used in the calculation of
   basic & diluted net loss per share               33,954         29,750


                  Condensed Consolidated Balance Sheets
                              (in thousands)

                                                  June 30,   December 31,
                                                      2004           2003
  Assets:
    Cash, cash equivalents and investments*        $74,061       $101,943
    Investments, held by SNDC                       36,197            ---
    Accounts receivable, net                         4,103          3,460
    Inventories, net                                 3,541          2,504
    Prepaid expenses and other assets                1,492          1,787
    Property and equipment, net                     21,353         22,395
    Intangible assets, net                          79,370         82,796
    Other assets                                     9,061          6,438
                                                  $229,178       $221,323

  Liabilities and Stockholders' Equity:
    Current liabilities                            $22,248        $21,980
    Long-term debt and other liabilities            91,902         89,988
    Revenue interest obligation                     43,707         42,155
    Minority interest                               37,987            ---
    Stockholders' equity                            33,334         67,200
                                                  $229,178       $221,323

  * includes unrestricted and restricted cash, cash equivalents and
    investments.

   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 Current Report on Form 8-K filed with the SEC on
June 21, 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 Inc., [phone]



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



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

Copyright