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AVEO Reports Second Quarter 2012 Financial Results

A 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 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. 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: AVEO’s plans to file for regulatory approval of tivozanib in the U.S.; the additional analyses to be included in the NDA submission relating to the OS data from TIVO-1; AVEO’s transformation into an integrated, sustainable oncology company, including its ability to deliver therapies to cancer patients in the future; AVEO’s clinical development plans related to ficlatuzumab and AV-203; and AVEO’s estimates for its 2012 financial performance (including its expected year-end cash balance and R&D spending) and AVEO’s estimates regarding its ability to fund its future operations. 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: difficulties, delays or failures in AVEO’s ability to successfully research, develop or obtain and maintain regulatory approvals for tivozanib, ficlatuzumab, AV-203 and AVEO’s other product candidates; the possibility that tivozanib will not achieve the regulatory approvals required for its successful commercialization either in the U.S. or abroad; AVEO’s inability to obtain and maintain adequate protection for intellectual property rights relating to AVEO’s product candidates and technologies; unplanned operating expenses; AVEO’s inability to raise substantial additional funds to achieve its goals; adverse general economic and industry conditions; 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.
AVEO Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
       
For the Three Months For the Six Months
Ended June 30, Ended June 30,
 
2012 2011 2012 2011
Collaboration revenue $ 1,877 $ 26,554 $ 2,737 $ 160,168
 
Operating expenses:
Research and development 21,450 25,078 46,226 63,095
General and administrative   9,186     6,371     18,169     15,599  
30,636 31,449 64,395 78,694
 
Income (loss) from operations (28,759 ) (4,895 ) (61,658 ) 81,474
 
Other income and expense:
Other income (expense), net (66 ) 11 233 (45 )
Interest expense (880 ) (946 ) (1,725 ) (1,958 )
Interest income   159     99     358     164  
Other expense, net (787 ) (836 ) (1,134 ) (1,839 )
 
Net income (loss)   (29,546 ) $ (5,731 )   (62,792 ) $ 79,635  
 
Basic net income (loss) per share
Net income (loss) $ (0.68 ) $ (0.16 ) $ (1.45 ) $ 2.19  
Weighted average number of common shares outstanding   43,322     36,849     43,288     36,318  
 
Diluted net income (loss) per share
Net income (loss) $ (0.68 ) $ (0.16 ) $ (1.45 ) $ 2.09  
Weighted average number of common shares and dilutive common share equivalents outstanding   43,322     36,849     43,288     38,120  
AVEO Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except par value amounts)
(unaudited)
   
June 30, December 31,
2012 2011
 
Assets
Current assets:
Cash and cash equivalents $ 85,789 $ 43,506
Marketable securities 130,105 177,622
Accounts receivable 9,182 7,210
Prepaid expenses and other current assets   5,208     6,057  
Total current assets 230,284 234,395
 
Marketable securities - 54,312
Property and equipment, net 6,626 5,471
Other assets 356 121
Restricted cash   3,600     751  
 
Total assets $ 240,866   $ 295,050  
 
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 4,276 $ 8,904
Accrued expenses 21,259 14,289
Loans payable, net of discount 1,946 8,551
Deferred revenue 1,294 1,294
Other liabilities - 1,249
Deferred rent   356     322  
Total current liabilities 29,131 34,609
 
Loans payable, net of current portion and discount 23,933 15,619
Deferred revenue, net of current portion 19,037 19,684
Deferred rent, net of current portion 1,695 359
Other liabilities 1,238 1,238
 
Stockholders’ equity:
Preferred Stock, $.001 par value: 5,000 shares authorized; no shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively - -
Common stock, $.001 par value: 100,000 shares authorized; 43,642 and 43,254 shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively 44 43
Additional paid-in capital 434,437 429,531
Accumulated other comprehensive income (loss) 9 (167 )
Accumulated deficit   (268,658 )   (205,866 )
Total stockholders’ equity   165,832     223,541  
 
Total liabilities and stockholders’ equity $ 240,866   $ 295,050  

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