AVEO Reports First Quarter 2013 Financial Results

  AVEO Reports First Quarter 2013 Financial Results

Business Wire

CAMBRIDGE, Mass. -- April 29, 2013

AVEO Oncology (NASDAQ: AVEO) today reported first quarter 2013 financial
results. In lieu of a quarterly financial update conference call, the AVEO
management team expects to host a conference call on May 2, 2013 following the
review by the U.S. Food and Drug Administration’s Oncologic Drugs Advisory
Committee (ODAC) of the company’s New Drug Application (NDA) for tivozanib.

“AVEO has several key events ahead this year, including the May 2 ODAC review
of our NDA for tivozanib for the treatment of patients with advanced renal
cell carcinoma and our PDUFA target action date of July 28,” said Tuan
Ha-Ngoc, president and chief executive officer of AVEO. “Our company, in
collaboration with our partner Astellas, is preparing for these important
milestones while continuing our launch readiness efforts in support of the
potential launch of tivozanib in the second half of the year.”

First Quarter 2013 Financial Results

• Total revenue for the first quarter of 2013 was approximately $0.3 million
compared with $0.9 million for the first quarter of 2012. Revenue in the first
quarter of 2013 related to AVEO’s collaboration agreements with Biogen and
Astellas. The decrease compared to the first quarter of 2012 is primarily due
to revenue related to AVEO’s collaboration agreement with Centocor, a unit of
Johnson & Johnson, which did not recur in the first quarter of 2013.

• Research and development (R&D) expense for the first quarter of 2013 was
$21.0 million compared with $24.8 million for the first quarter of 2012. The
decrease in R&D expense was primarily due to a decrease in clinical trial
costs primarily related to tivozanib. This decrease was partially offset by an
increase in rent expense, largely related to rent expense for our future
headquarters that was allocated to R&D expense.

• General and administrative (G&A) expense for the first quarter of 2013 was
$12.4 million compared with $9.0 million for the first quarter of 2012. The
increase in G&A expense was primarily driven by an increase in
personnel-related expenses, expenses related to pre-commercialization
activities for tivozanib, as well as an increase in rent expense, largely
related to rent expense for our future headquarters that was allocated to G&A
expense.

• Net loss for the first quarter of 2013 was $34.1 million, or basic and
diluted net loss per share of $0.69, compared with a net loss of $33.2
million, or basic and diluted net loss per share of $0.77, for the first
quarter of 2012.

• AVEO ended the first quarter of 2013 with cash, cash equivalents and
marketable securities of $191.6 million.

Financial Guidance

Based on current operating plans, AVEO continues to expect to end 2013 with
approximately $60 million in cash, cash equivalents and marketable securities,
and anticipates that this capital is sufficient to fund its operations into
the second quarter of 2014.

Key Recent Developments

  *ODAC Meeting Scheduled: As previously announced, ODAC will review the
    company’s NDA for tivozanib for the treatment of patients with advanced
    renal cell carcinoma (RCC) during the morning session of its meeting on
    May 2, 2013. ODAC reviews and evaluates data concerning the safety and
    effectiveness of marketed and investigational human drug products for use
    in the treatment of cancer, and makes recommendations to the Commissioner
    of Food and Drugs. According to the timelines established by the
    Prescription Drug User Fee Act (PDUFA), the review of the NDA is expected
    to be complete by July 28, 2013.
  *Completed public offering raising total net proceeds of approximately
    $53.6 million: In January 2013, AVEO completed an underwritten public
    offering of 7,667,050 shares of common stock, comprised of 6,667,000
    shares of common stock initially offered and an additional 1,000,050
    shares of common stock sold pursuant to the underwriters’ exercise of
    their over-allotment option, at a price to the public of $7.50 per share.
    Aggregate net proceeds to the company were approximately $53.6 million.

Post-ODAC Conference Call and Webcast Scheduled for May 2, 2013

In lieu of a quarterly financial update conference call, the AVEO management
team expects to host a conference call at 4:30 p.m. (ET) on May 2, 2013, to
discuss the ODAC panel’s review of the tivozanib NDA. The call can be accessed
by dialing 1-866-730-5771 (domestic) or 1-857-350-1595 (international) five
minutes prior to the start of the call and providing the passcode 79239089. A
replay of the call will be available approximately two hours after the
completion of the call and can be accessed by dialing 1-888-286-8010
(domestic) or 1-617-801-6888 (international), providing the passcode 70099254.
The replay will be available for two weeks from the date of the call.

A webcast of the conference call can also be accessed by visiting the
investors section of the AVEO website atinvestor.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 of tivozanib; the timing of
the review by ODAC and AVEO’s related conference call; AVEO’s estimates for
its 2013 year-end cash balance and its estimate with respect to the
availability of cash to fund its operating plans into the second quarter of
2014; the targeted date for the completion of the FDA’s review of the
tivozanib NDA; tivozanib’s potential in treating patients with kidney cancer;
and AVEO’s plans to leverage its Human Response Platform. 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
TIVO-1 study 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 the TIVO-1 study,
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 the safety and efficacy levels it demonstrated in earlier
trials of tivozanib; ongoing regulatory requirements with respect to the
approval of tivozanib, including the risk that 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 its product candidates
and technologies; unplanned operating expenses; AVEO’s ability to raise the
substantial additional funds required to achieve its goals; adverse general
economic and industry conditions; competitive factors; 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” included in AVEO’s
most recent Annual Report on Form 10-K and in its other filings with the SEC.
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.


Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
                                                             
                                                     For the Three Months
                                                     Ended March 31,
                                                                   
                                                     2013          2012
Collaboration revenue                                $ 323         $ 860
                                                                   
Operating expenses:
Research and development                               20,962        24,776
General and administrative                             12,449        8,983
Restructuring                                         67          -       
                                                       33,478        33,759
                                                                   
Loss from operations                                   (33,155 )     (32,899 )
                                                                   
Other income and expense:
Other income (expense), net                            (101    )     299
Interest expense                                       (870    )     (845    )
Interest income                                       41          199     
Other expense, net                                     (930    )     (347    )
                                                                   
Net loss                                              (34,085 )   $ (33,246 )
                                                                   
Net loss per share - basic and diluted               $ (0.69   )   $ (0.77   )
                                                                   
Weighted average number of common shares              49,380      43,254  
outstanding


Condensed Consolidated Balance Sheets
(In thousands, except par value amounts)
(Unaudited)
                                                            
                                                      March 31,   December 31,
                                                      2013        2012
                                                                  
Assets
Cash, cash equivalents and marketable                 $ 191,634   $   160,602
securities
Accounts receivable                                     9,181         20,649
Prepaid expenses and other current assets               9,744         9,430
Property and equipment, net                             13,331        12,867
Other assets                                           3,925        3,921
                                                                  
Total assets                                          $ 227,815   $   207,469
                                                                  
Liabilities and stockholders’ equity
Accounts payable and accrued expenses                 $ 26,150    $   30,171
Total loans payable                                     26,115        26,037
Total deferred revenue                                  19,361        19,685
Total deferred rent                                     13,769        11,400
Other liabilities                                       1,238         1,238
Stockholder's equity                                   141,182      118,938
                                                                  
Total liabilities and stockholders’ equity            $ 227,815   $   207,469

Contact:

Pure Communications
Caton Morris, 910-232-7166
or
Media Contact:
AVEO Oncology
Rob Kloppenburg, 617-930-5595
or
Pure Communications
Dan Budwick, 973-271-6085
 
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