8-K

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): November 8, 2004

Guilford Pharmaceuticals Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

Delaware	000-23736	52-1841960
_____________________ (State or other jurisdiction	_____________ (Commission	______________ (I.R.S. Employer
of incorporation)	File Number)	Identification No.)
6611 Tributary Street, Baltimore, Maryland		21224
_________________________________ (Address of principal executive offices)		___________ (Zip Code)

Registrant’s telephone number, including area code: 410-631-6300

Not Applicable
______________________________________________
Former name or former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[  ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02. Results of Operations and Financial Condition.

On November 8, 2004, the Registrant issued a press release announcing its financial results for the quarter ended September 30, 2004. A copy of the Registrant’s press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

Exhibit 99.1--Press Release issued by the Registrant on November 8, 2004.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Guilford Pharmaceuticals Inc.
November 8, 2004	By:	Asher M. Rubin
		Name: Asher M. Rubin
		Title: Senior Vice President, General Counsel and Secretary

Exhibit Index

Exhibit No.	Description
99	Press Release issued by the Registrant on November 8, 2004

EX-99

FOR IMMEDIATE RELEASE

GUILFORD PHARMACEUTICALS REPORTS 2004 THIRD QUARTER RESULTS

BALTIMORE, MD, November 8, 2004 — 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^® Wafer (polifeprosan 20 with carmustine implant) and AGGRASTAT^® Injection (tirofiban hydrochloride) as well as a one-time payment from Angiotech resulting from a licensing transaction. Net product sales of GLIADEL^® 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 and an increase in the average selling price. Net product sales of AGGRASTAT^® were $3.5 million for the third quarter of 2004 and the Company had no sales of AGGRASTAT 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^® and AGGRASTAT^® 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^®. 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^® and AQUAVAN^®.

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^® 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^® 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^® 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^® was granted expanded marketing authorization in Europe to include use during initial therapy. We also obtained Orphan Drug designation for GLIADEL^® 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^® 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^®Wafer (polifeprosan 20 with carmustine implant), for the treatment of brain cancer, and AGGRASTAT^® Injection (tirofiban hydrochloride), a glycoprotein GP IIb/IIIa receptor antagonist, for the treatment of acute coronary syndrome (ACS). Guilford’s product pipeline includes AQUAVAN^® Injection, a novel sedative/anesthetic and drugs for treating peripheral nerve injury. For full prescribing information, please visit 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 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 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.

(Table Follows)

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

# # #

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^® Wafer or AGGRASTAT^® Injection, or that the Company will be able to successfully develop and commercialize any of its product candidates, including AQUAVAN^® Injection. Further, the Company may not be successful in its attempt to expand the label for AGGRASTAT^® Injection.