AVEO Reports 2012 Financial Results and Highlights Recent Accomplishments

  AVEO Reports 2012 Financial Results and Highlights Recent Accomplishments

Business Wire

CAMBRIDGE, Mass. -- February 13, 2013

AVEO Oncology (NASDAQ: AVEO) today reported consolidated 2012 financial
results and reviewed key recent accomplishments.

“We continue to make significant progress with tivozanib, including reporting
the final overall survival results from TIVO-1, receiving the FDA’s acceptance
of the NDA submission and expanding tivozanib clinical development into
patients with triple negative breast cancer,” said Tuan Ha-Ngoc, president and
chief executive officer of AVEO. “On the heels of our recent financing, we are
continuing to build out our commercial infrastructure and remain focused on
preparing for the potential launch of tivozanib in advanced RCC in the second
half of 2013.”

Full Year 2012 Financial Results

• Total collaboration revenue for 2012 was approximately $19.3 million
compared with $164.8 million for 2011. Revenue in 2012 primarily consisted of
a $15.0 million milestone from Astellas recognized upon the acceptance of
AVEO’s NDA filing. The decrease compared to 2011 is primarily due to revenue
recognized in conjunction with the signing of AVEO’s collaboration agreement
with Astellas, as well as revenue from AVEO’s collaboration agreements with
OSI, Centocor, and Biogen that did not recur during 2012.

• Research and development (R&D) expense for 2012 was $91.4 million compared
with $101.7 million for 2011. The decrease in R&D expense was primarily due to
a decrease in licensing costs, largely related to a decrease in payments to
Kyowa Hakko Kirin, a decrease in manufacturing costs for ficlatuzumab and a
decrease in clinical trial costs. These decreases were partially offset by an
increase in personnel-related expenses.

• General and administrative (G&A) expense for 2012 was $36.9 million compared
with $29.2 million for 2011. The increase in G&A expense was primarily driven
by an increase in personnel-related expenses, expenses related to
pre-commercialization activities for tivozanib, and an increase in rent
expense, largely related to AVEO’s future headquarters.

• Restructuring expense for 2012 was $2.6 million, with no corresponding
expense for 2011. The restructuring expense related to the company’s strategic
restructuring, which the company announced on October 30, 2012.

• Net loss for 2012 was $114.4 million, or basic and diluted net loss per
share of $2.64, compared with net income of $30.6 million, or basic and
diluted net income per share of $0.77 and $0.74, respectively, for 2011.

• AVEO ended 2012 with cash, cash equivalents and marketable securities of
$160.6 million.

Financial Guidance

Based on current operating plans, AVEO expects 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

  *Reported Final Overall Survival Results from TIVO-1 Trial: AVEO and
    Astellas yesterday announced the final overall survival data from TIVO-1
    (Tivozanib Versus sOrafenib in 1^st line advanced RCC), a global,
    randomized, Phase 3, superiority clinical trial evaluating the efficacy
    and safety of tivozanib compared to sorafenib in 517 patients with
    advanced renal cell carcinoma (RCC). These data will be reviewed in more
    detail by AVEO management during the company’s conference call and webcast
    today at 10:00 a.m. (ET), and will be presented on Saturday, February 16,
    2013 at the 2013 Genitourinary Cancers Symposium (ASCO GU), abstract
    number 350.
  *Completed public offering raising total net proceeds of approximately
    $53.8 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 $53.8 million.
  *Received the FDA’s Acceptance for Filing the New Drug Application (NDA)
    for Tivozanib: In November 2012, AVEO and Astellas announced that the U.S.
    Food and Drug Administration (FDA) accepted for filing the NDA for
    tivozanib with the proposed indication for the treatment of patients with
    advanced RCC. 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.
  *Initiated BATON-BC Phase 2 Trial of Tivozanib in Patients with Triple
    Negative Breast Cancer: In December 2012, AVEO and Astellas announced the
    initiation of patient enrollment in a randomized, double-blind,
    multicenter Phase 2 clinical trial, called BATON-BC, evaluating the
    efficacy of tivozanib in combination with paclitaxel compared to placebo
    in combination with paclitaxel in patients with locally recurrent or
    metastatic triple negative breast cancer who have received no prior
    systemic therapy for advanced or metastatic breast cancer. BATON-BC is the
    third trial to be initiated as part of the BATON (Biomarker Assessment of
    Tivozanib in ONcology) clinical development program, which includes
    ongoing Phase 2 trials in advanced metastatic colorectal cancer and
    advanced RCC. Data from these trials is expected to be available in 2014.

Upcoming Activities

AVEO expects to present at the following investor conferences:

  *2013 RBC Capital Markets Global Healthcare Conference, February 26-27,
    2013 in New York City.
  *Barclays Annual Global Healthcare Conference, March 12-14, 2013 in Miami.

Today’s Conference Call and Webcast Reminder

The AVEO management team will host a conference call at 10:00 a.m. (ET) today.
The call can be accessed by dialing 1-866-831-6243 (domestic) or
1-617-213-8855 (international) five minutes prior to the start of the call and
providing the passcode 81400823. 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 61126312. 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; 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 NDA;
tivozanib’s potential in treating patients with kidney cancer; the timing of
availability of data from the BATON trials; 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 TIVO-1 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 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
Current Report on Form 8-K filed with the SEC on January 16, 2013 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.

AVEO Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(Unaudited)
                                                              
                        For the Three Months        For the Years
                        Ended December 31,          Ended December 31,
                                                                   
                         2012        2011        2012         2011    
Collaboration revenue   $ 15,531      $ 1,096       $ 19,286       $ 164,849
                                                                   
Operating expenses:
Research and              24,033        18,542        91,358         101,735
development
General and               9,463         6,986         36,932         29,167
administrative
Restructuring            2,633       -           2,633        -       
                          36,129        25,528        130,923        130,902
                                                                   
Income (loss) from        (20,598 )     (24,432 )     (111,637 )     33,947
operations
                                                                   
Other income and
expense:
Other income              (32     )     (7      )     247            10
(expense), net
Interest expense          (888    )     (925    )     (3,501   )     (3,836  )
Interest income          38          195         497          527     
Other expense, net        (882    )     (737    )     (2,757   )     (3,299  )
                                                                   
Net income (loss)       $ (21,480 )   $ (25,169 )   $ (114,394 )   $ 30,648  
                                                                   
Basic net income
(loss) per share
Net income (loss)       $ (0.49   )   $ (0.58   )   $ (2.64    )   $ 0.77    
Weighted average
number of common         43,486      43,132      43,374       39,715  
shares outstanding
                                                                   
Diluted net income
(loss) per share
Net income (loss)       $ (0.49   )   $ (0.58   )   $ (2.64    )   $ 0.74    
Weighted average
number of common
shares and dilutive      43,486      43,132      43,374       41,473  
common share
equivalents
outstanding

AVEO Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except par value amounts)
(Unaudited)
                                                              
                                                 December 31,     December 31,
                                                     2012             2011
                                                                  
Assets
Cash, cash equivalents and marketable            $   160,602      $   275,440
securities
Accounts receivable                                  20,649           7,210
Prepaid expenses and other current assets            9,430            6,057
Property and equipment, net                          12,867           5,471
Other assets                                        3,921           872
                                                                  
Total assets                                     $   207,469      $   295,050
                                                                  
Liabilities and stockholders’ equity
Accounts payable and accrued expenses            $   30,171       $   23,193
Total loans payable                                  26,037           24,170
Total deferred revenue                               19,685           20,978
Total deferred rent                                  11,400           681
Other liabilities                                    1,238            2,487
Stockholder's equity                                118,938         223,541
                                                                  
Total liabilities and stockholders’ equity       $   207,469      $   295,050

Contact:

AVEO Oncology
Investor Contact:
Monique Allaire, 617-299-5810
or
Media Contact:
Rob Kloppenburg, 617-930-5595
or
Pure Communications
Dan Budwick, 973-271-6085
 
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