Guilford (NASDAQ:GLFD)
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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