AVEO Announces Strategic Restructuring And Provides Third Quarter Financial Results

The listen-only webcast of the conference call can also be accessed by visiting the investors section of the AVEO website at investor.aveooncology.com. A replay of the webcast will be archived on the company’s website for two weeks following the call.

About AVEO

AVEO Oncology (NASDAQ: AVEO) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients’ lives. AVEO's proprietary Human Response Platform ^TM provides the company unique insights into cancer biology and is being leveraged in the discovery and clinical development of its cancer therapeutics. For more information, please visit the company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the planned launch and commercialization of tivozanib; AVEO’s planned transformation into an integrated oncology company, including its ability to deliver therapies to cancer patients in the future; AVEO’s plans to develop ficlatuzumab and certain discovery assets through external collaborations; AVEO’s plans to utilize its Human Response Platform™ to support development of tivozanib, advance biomarker identification and develop selected, novel programs; the expected benefits of its strategic restructuring, including expected cost savings provided by the restructuring; anticipated near and long term drivers of value; and AVEO’s estimates for its 2012 year-end cash balance and its estimate with respect to the availability of cash through 2013 to fund its operating plans. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: whether the results of AVEO’s Phase 3 TIVO-1 ( TIvozanib Versus s Orafenib in 1 ^st line advanced RCC) trial are sufficient to obtain marketing approval for tivozanib in the U.S. and abroad, which turns on the ability of AVEO to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities the safety and efficacy of tivozanib based upon the findings of TIVO-1, including its data with respect to progression-free survival, the rate of adverse events, overall survival and other information that the FDA may determine to be relevant to approvability; AVEO’s ability to demonstrate in subsequent trials any safety and efficacy it demonstrated in earlier trials of tivozanib; ongoing regulatory requirements with respect to the approval of tivozanib, including the risk that the FDA or any comparable foreign regulatory agency could require additional positive clinical trials as the basis for product approval; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to AVEO’s product candidates and technologies; unplanned operating expenses; AVEO’s ability to raise substantial additional funds to achieve its goals; adverse general economic and industry conditions; competitive factors; AVEO’s ability to successfully implement its strategic plans, including the planned cost savings for its restructuring; AVEO’s ability to maintain its collaboration with Astellas; AVEO’s and Astellas’ ability to successfully launch and commercialize tivozanib if and when it may be approved for commercialization by the FDA and/or foreign regulatory authorities; and those risks discussed in the section titled “Risk Factors” and elsewhere in AVEO’s most recent Quarterly Report on Form 10-Q and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date subsequent to the date of this press release.

Sutent ^® and Cimzia ^® are registered trademarks of Pfizer Inc. and UCB, Inc., respectively.

AVEO Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
		For the Three Months								For the Nine Months
		Ended September 30,								Ended September 30,
		2012				2011				2012				2011
Collaboration revenue		$	1,018			$	3,585			$	3,755			$	163,753
Operating expenses:
Research and development			21,099				20,098				67,325				83,193
General and administrative			9,300				6,582				27,469				22,181
			30,399				26,680				94,794				105,374
Income (loss) from operations			(29,381	)			(23,095	)			(91,039	)			58,379
Other income and expense:
Other income, net			46				62				279				17
Interest expense			(888	)			(953	)			(2,613	)			(2,911	)
Interest income			101				168				459				332
Other expense, net			(741	)			(723	)			(1,875	)			(2,562	)
Net income (loss)			(30,122	)		$	(23,818	)			(92,914	)		$	55,817
Basic net income (loss) per share
Net income (loss)		$	(0.69	)		$	(0.55	)		$	(2.14	)		$	1.45
Weighted average number of common shares outstanding			43,430				43,017				43,336				38,575
Diluted net income (loss) per share
Net income (loss)		$	(0.69	)		$	(0.55	)		$	(2.14	)		$	1.38
Weighted average number of common shares and dilutive common share equivalents outstanding			43,430				43,017				43,336				40,377

AVEO Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except par value amounts)
(unaudited)
	September 30,				December 31,
	2012				2011
Assets
Current assets:
Cash and cash equivalents	$	114,103			$	43,506
Marketable securities		75,589				177,622
Accounts receivable		9,298				7,210
Prepaid expenses and other current assets		7,770				6,057
Total current assets	$	206,760				234,395
Marketable securities		-				54,312
Property and equipment, net		7,862				5,471
Other assets		308				121
Restricted cash		3,600				751
Total assets	$	218,530			$	295,050
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	10,259			$	8,904
Accrued expenses		18,358				14,289
Loans payable, net of discount		4,334				8,551
Deferred revenue		1,294				1,294
Other liabilities		-				1,249
Deferred rent		421				322
Total current liabilities		34,666				34,609
Loans payable, net of current portion and discount		21,624				15,619
Deferred revenue, net of current portion		18,714				19,684
Deferred rent, net of current portion		4,096				359
Other liabilities		1,238				1,238
Stockholders’ equity:
Preferred Stock, $.001 par value: 5,000 shares authorized; no shares issued and outstanding		-				-
Common stock, $.001 par value: 100,000 shares authorized; 43,735 and 43,254 shares issued and outstanding at September 30, 2012 and December 31, 2011, respectively		44				43
Additional paid-in capital		436,937				429,531
Accumulated other comprehensive loss		(9	)			(167	)
Accumulated deficit		(298,780	)			(205,866	)
Total stockholders’ equity		138,192				223,541
Total liabilities and stockholders’ equity	$	218,530			$	295,050

« First ‹ Previous 1 2 3 4 Next › Last »