Guilford Pharmaceuticals Reports 2005 First Quarter Results
BALTIMORE, May 9 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals
Inc. (NASDAQ:GLFD) today reported financial results for the quarter
ended March 31, 2005. For the first quarter, Guilford reported a
net loss of $54.5 million, or $1.19 per share, compared to a net
loss of $18.1 million, or $0.53 per share, for the corresponding
period in 2004. Net loss for the first quarter of 2005 included a
one time non-cash charge to operations of $31.0 million relating to
the impairment of the intangible assets for AGGRASTAT(R) Injection
(tirofiban hydrochloride) in accordance with SFAS No. 144,
"Accounting for Impairment or Disposal of Long-Lived Assets."
Excluding the one time charge, net loss for the quarter was $23.5
million, or $0.51 per share. Total revenue in the first quarter of
2005 was $10.7 million compared to $8.9 million in the first
quarter of 2004, largely attributable to GLIADEL(R) Wafer
(polifeprosan 20 with carmustine implant) net product revenue,
which increased by approximately 33% to $7.3 million from the first
quarter of 2004. Revenue for AGGRASTAT(R) in the first quarters of
each of 2005 and 2004 was $3.2 million. Total costs and expenses in
the first quarter of 2005 were $64.6 million, including the one
time non-cash impairment charge to operations of $31.0 million,
compared to $23.8 million in the first quarter of 2004. Cost of
sales in the first quarter of each of 2005 and 2004 was
approximately $1.0 million. Research and development expenses for
the first quarter of 2005 were $16.0 million compared to $9.4
million for the same period in 2004, an increase primarily due to
costs related to the initiation of the phase III clinical
development program for AQUAVAN(R) and costs associated with the
preparation and initiation of Phase III clinical trials of
AGGRASTAT(R) for use in percutaneous coronary intervention.
Selling, general and administrative costs were $14.9 million in the
first quarter of 2005 compared to $11.7 million for the same period
in 2004. Costs incurred to market, sell and distribute GLIADEL(R)
and AGGRASTAT(R) during the quarter increased $1.7 million to $8.6
million due to higher medical education expenses and an expanded
sales force for the marketing of two products. General and
administrative expenses increased $1.4 million during the quarter
to $6.3 million, primarily as a result of a one-time professional
services expense of $1.2 million related to the Company's long-term
strategic planning analysis. At March 31, 2005, Guilford had $71.1
million in cash, cash equivalents, marketable securities, and
restricted investments compared to $109.5 million at December 31,
2004. The decrease in cash, cash equivalents, marketable securities
and restricted investments was partly due to the repayment of a
term loan with Wachovia Bank and the termination of a related swap
agreement at a total cost of $17.8 million. The balance reflected
cash used in operating activities. "On April 6th, we launched a new
strategy for Guilford," commented Dean J. Mitchell, President and
Chief Executive Officer. "With the support of our Board and with
encouragement from investors, we made some very clear and concise
choices about the future of our Company. We selected the key assets
on which our near term future will rest, and are now positioning
Guilford to more effectively resource these assets to fully assure
market success. Under this new strategy we will achieve our vision
by focusing on our high potential key assets, GLIADEL(R) and
AQUAVAN(R), while eliminating expenses related to our other
activities, and capturing value in the near term from other assets
such as AGGRASTAT(R) and our research and development portfolio
through an expected combination of divestitures, licensing
agreements or other arrangements." Mr. Mitchell continued, "Our
results from the first quarter underscore the necessity for change
and support the strategy we have outlined. Growth in GLIADEL(R)
revenue continues in 2005. We also recently concluded a very
collaborative meeting with the Food and Drug Administration during
which we outlined a focused development strategy for AQUAVAN(R)
that we expect will enable us to complete our clinical studies and
file a New Drug Application in the second half of next year. We
view AQUAVAN(R) as a key driver behind our transformation of
Guilford into a focused, market-driven pharmaceutical company
capable of creating exceptional value. I look forward over the next
several quarters to achieving our objectives and delivering
tangible results." 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. 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
2005 first quarter results. The conference call will take place at
4:00 p.m. EDT on Monday, May 9, 2005. The dial in number for
participants in the U.S. is (800) 706-7749, and for international
callers (617) 614-3474. The participant passcode is 27937394.
Conference Call Replay An audio replay of the conference call will
be available for 48 hours beginning at approximately 6:00 p.m. EDT
on May 9, 2005 through 6:00 p.m. EDT on May 11, 2005. To access the
replay, U.S. residents should dial (888) 286- 8010, and
international callers should dial (617) 801-6888, passcode
47441563. 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 May 23, 2005.
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 Annual Report on
Form 10-K filed with the SEC on March 7, 2005 and Current Report on
Form 8-K filed with the SEC on April 6, 2005, 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) or that the Company will be successful in its
attempt to minimize the ongoing expenses related to AGGRASTAT(R),
or to implement an exit strategy for AGGRASTAT(R), or that the
Company will be able to successfully develop and commercialize any
of its product candidates, including AQUAVAN(R). (Tables Follow)
GUILFORD PHARMACEUTICALS INC. CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited) ($ in thousands, except per share data) Quarter Ended
March 31, 2005 2004 Revenue: Net product revenue $10,503 $8,727
Revenue from license fees, milestones and other 233 201 Total
revenue 10,736 8,928 Costs and Expenses: Cost of sales 985 991
Research and development 16,025 9,373 Selling, general and
administrative 14,861 11,747 Intangible amortization 1,713 1,722
Impairment of long-lived assets 31,025 - Total costs and expenses
64,609 23,833 Operating Loss (53,873) (14,905) Other
Income/(Expenses): Investment and other income 120 478 Revenue
interest expense (2,096) (2,335) Interest expense (1,233) (1,306)
Loss before Minority Interest (57,082) (18,068) Minority Interest
2,538 - Net Loss $(54,544) $(18,068) Basic and Diluted Loss per
Common Share $(1.19) $(0.53) Weighted-average shares used to
calculate basic and diluted loss per share 45,930 33,921 GUILFORD
PHARMACEUTICALS INC. CONSOLIDATED BALANCE SHEETS ($ in thousands,
except share data) March 31, December 31, 2005 2004 ASSETS
(unaudited) Cash and cash equivalents $40,068 $61,889 Marketable
securities 28,416 27,705 Investments - held by Symphony Neuro
Development Company 26,934 32,062 Accounts receivable, net 4,752
4,666 Inventories 2,775 2,373 Prepaid expenses and other current
assets 4,123 4,744 Total current assets 107,068 133,439 Investments
- restricted 2,587 19,899 Property and equipment, net 1,643 1,758
Intangibles, net 43,204 75,943 Other assets 5,642 6,096 Total
assets $160,144 $237,135 LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $10,042 $15,333 Current portion of long-term debt
1,917 2,916 Accrued payroll related costs 3,721 2,932 Accrued
contracted services 6,227 3,929 Accrued expenses and other current
liabilities 4,980 6,355 Total current liabilities 26,887 31,465
Long-term debt, excluding current portion 70,856 87,393 Revenue
interest obligation 45,406 44,932 Other liabilities 8,171 8,320
Total liabilities 151,320 172,110 Minority interest 24,873 28,132
Commitments and contingencies --- --- STOCKHOLDERS' EQUITY
(DEFICIT): Preferred stock, par value $0.01 per share; authorized
4,700,000 shares, none issued --- --- Series A junior participating
preferred stock, par value $0.01 per share; authorized 300,000
shares, none issued --- --- Common stock, par value $0.01 per
share; authorized 125,000,000 shares, 46,638,788 and 46,638,788
issued 466 466 Additional paid-in capital 435,841 435,130
Accumulated deficit (445,960) (391,416) Accumulated other
comprehensive loss (1,580) (2,130) Unearned compensation (3,870)
(3,653) Treasury stock, at cost; 191,081 and 304,336 shares (946)
(1,504) Total stockholders' equity (deficit) (16,049) 36,893 Total
liabilities and stockholders' equity (deficit) $160,144 $237,135
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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