CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 14, 2012--
AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO) today reported consolidated
2011 financial results and reviewed key progress achieved with its
tivozanib and ficlatuzumab development programs in the fourth quarter of
2011.
“The recent success of our Phase 3 registration trial of tivozanib in
RCC, TIVO-1, marks an important milestone for AVEO as we prepare for our
first NDA submission later this year,” said Tuan Ha-Ngoc, president and
chief executive officer of AVEO. “Tivozanib’s favorable efficacy and
tolerability have now been demonstrated in two large, well-controlled
studies. We believe the longest median progression-free survival
reported to-date in a first-line pivotal trial in treatment naïve RCC
patients combined with its well-tolerated safety profile positions
tivozanib to provide patients with a significantly differentiated
treatment option.”
Full Year 2011 Financial Results
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Total collaboration revenues for 2011 were $164.8 million compared
with $44.7 million for 2010. The primary driver for the increase was
revenue recognized in conjunction with AVEO’s collaboration agreements
with Astellas and Centocor, as well as revenue from OSI primarily
related to the exercise of its option to acquire certain rights to our
technology platform. These increases were partially offset by the fact
that no revenues were earned from Merck as a result of the termination
of the companies’ collaboration agreement in December 2010.
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Research and development (R&D) expense for 2011 was $101.7 million
compared with $86.3 million for 2010. The increase in R&D expense was
primarily due to an increase in contract manufacturing costs for
ficlatuzumab and tivozanib, payments to Kyowa Hakko Kirin related to
the up-front license payment received from Astellas, as well as an
increase in personnel-related expenses mainly due to increased support
for tivozanib development activities. These increases were partially
offset by reimbursable amounts under the cost sharing provisions of
AVEO’s collaboration agreement with Astellas.
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General and administrative (G&A) expense for 2011 was $29.2 million
compared with $14.8 million for 2010. The increase in G&A expense was
primarily driven by non-recurring expenses for strategic, legal and
financial advisors incurred in connection with AVEO’s collaboration
agreement with Astellas, an increase in personnel-related expenses and
expenses related to pre-commercialization activities for tivozanib.
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Net income for 2011 was $30.6 million, or basic and diluted earnings
per share of $0.77 and $0.74, respectively, compared with a net loss
of $58.8 million, or basic and diluted loss per share of $2.30 for
2010.
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AVEO ended 2011 with cash, cash equivalents and marketable securities
of $275.4 million.
Financial Guidance
AVEO expects year-end 2012 cash, cash equivalents and marketable
securities of at least $120 million, with R&D spending, net of cost
sharing with Astellas, of approximately $130 million. AVEO anticipates
that this capital is sufficient to fund its operations into the second
half of 2013 based on its current operating plans.
Fourth Quarter 2011 Key Accomplishments
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Completed top-line analysis of pivotal tivozanib Phase 3 trial,
TIVO-1: Notably, in the fourth quarter, AVEO completed top-line
analysis of TIVO-1, 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). Top-line data were announced in January 2012 and
showed that tivozanib successfully demonstrated superiority over
sorafenib in the primary endpoint of progression-free survival (PFS)
in TIVO-1. Key top-line findings from TIVO-1 include:
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Tivozanib demonstrated a statistically significant improvement in
PFS with a median PFS of 11.9 months compared to a median PFS of
9.1 months for sorafenib in the overall study population.
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Tivozanib demonstrated a statistically significant improvement in
PFS with a median PFS of 12.7 months compared to a median PFS of
9.1 months for sorafenib in the pre-specified subpopulation of
patients who were treatment naïve (no prior systemic anti-cancer
therapy); this subpopulation was approximately 70% of the total
study population and reflects the first-line RCC setting in North
America and Europe.
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Tivozanib demonstrated a well-tolerated safety profile consistent
with the Phase 2 experience; the most commonly reported side
effect was hypertension, a well-established on-target and
manageable effect of VEGFR inhibitors. The side effects commonly
associated with other VEGFR inhibitors, such as diarrhea, fatigue
and hand-foot syndrome, were notably low.
Based on these data and success of the TIVO-1 trial, AVEO and Astellas
are moving forward with plans for submitting the tivozanib NDA in RCC in
the third quarter of 2012, with the MAA submission to follow. Detailed
findings from TIVO-1 have been submitted for presentation at the 2012
Annual Meeting of the American Society of Clinical Oncology (ASCO) being
held June 1-5, 2012 in Chicago.
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Initiated enrollment in tivozanib Phase 2 trial in patients with
colorectal cancer, BATON-CRC: In December 2011, AVEO
announced the initiation of patient enrollment in an open-label,
multicenter, randomized Phase 2 clinical trial, called BATON-CRC,
evaluating tivozanib in combination with modified FOLFOX6 (mFOLFOX6)
compared to bevacizumab in combination with mFOLFOX6 as first-line
therapy in patients with advanced metastatic colorectal cancer (CRC).
BATON-CRC, which is being led by AVEO’s collaborator Astellas, is the
second trial to be initiated as part of the BATON (Biomarker
Assessment of Tivozanib
in ONcology) program, a series of
clinical trials to assess tivozanib efficacy and biomarkers in solid
tumors.
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Entered into manufacturing agreement for ficlatuzumab with
Boehringer Ingelheim: In December 2011, AVEO announced it
entered into an agreement with Boehringer Ingelheim for large-scale
process development and clinical manufacturing of ficlatuzumab, AVEO’s
novel HGF inhibitory antibody that is currently being evaluated in a
Phase 2 clinical trial as first-line therapy in combination with
gefitinib versus gefitinib monotherapy in patients with non-small cell
lung cancer. AVEO retains all rights to the development and
commercialization of ficlatuzumab.
Upcoming Activities
AVEO expects to present at the following investor conferences:
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Leerink Swann 2012 Global Healthcare Conference, February 15-16, 2012
in New York City.
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Citi 2012 Global Health Care Conference, February 27-29, 2012 in New
York City.
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2012 RBC Capital Markets’ Global Healthcare Conference, February
28-29, 2012 in New York City.
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Cowen and Company 32nd Annual Health Care Conference,
March 5-7, 2012 in Boston, Mass.
Today’s Conference Call and Webcast Reminder
The AVEO management team will host a conference call at 10:00 a.m. (EST)
today. The call can be accessed by dialing 1-866-800-8652 (domestic) or
1-617-614-2705 (international) five minutes prior to the start of the
call and providing the passcode 29955196. 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 99138406. The replay will be
available for two weeks from the date of the live call.
A live, listen-only webcast of the conference call can also be accessed
by visiting the investors section of the AVEO website
at investor.aveopharma.com. A replay of the webcast will be archived on
the company's website for two weeks following the call.
About AVEO
AVEO Pharmaceuticals (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™ 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.aveopharma.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: the potential for tivozanib to be a
differentiated treatment option for patients; AVEO’s continued
advancement of its clinical programs; AVEO’s plans to file for
regulatory approval of tivozanib in the U.S. and the E.U.; AVEO’s
estimates for its 2012 financial performance (including its expected
year-end cash balance) 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 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; potential delays in data
availability from ficlatuzumab; potential delays in the initiation of
other clinical trials of tivozanib; 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.
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AVEO Pharmaceuticals, Inc.
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Condensed Consolidated Statements of Operations
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(in thousands, except per share amounts)
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(unaudited)
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For the Three Months
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For the Years
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Ended December 31,
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Ended December 31,
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2011
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2010
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2011
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2010
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Collaboration revenue
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$
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1,096
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$
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11,957
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$
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164,849
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$
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44,682
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Operating expenses:
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Research and development
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18,542
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17,478
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101,735
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86,345
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General and administrative
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6,986
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4,564
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29,167
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14,763
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25,528
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22,042
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130,902
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101,108
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Income (loss) from operations
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(24,432
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)
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(10,085
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)
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33,947
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(56,426
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)
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Other income and expense:
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Other income (expense), net
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(7
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)
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760
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10
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900
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Interest expense
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(925
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(1,028
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(3,836
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(3,389
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Interest income
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195
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39
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527
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126
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Other expense, net
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(737
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(229
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)
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(3,299
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(2,363
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)
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Net income (loss)
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(25,169
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)
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(10,314
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30,648
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(58,789
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Basic net income (loss) per share
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Net income (loss)
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$
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(0.58
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)
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$
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(0.30
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$
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0.77
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$
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(2.30
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)
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Weighted average number of common shares outstanding
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43,132
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33,914
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39,715
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25,582
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Diluted net income (loss) per share
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Net income (loss)
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$
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(0.58
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)
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$
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(0.30
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)
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$
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0.74
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$
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(2.30
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)
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Weighted average number of common shares and dilutive common share
equivalents outstanding
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43,132
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33,914
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41,473
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25,582
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AVEO Pharmaceuticals, Inc.
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Condensed Consolidated Balance Sheets
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(in thousands)
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(unaudited)
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December 31,
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December 31,
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2011
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2010
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Assets
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Current assets:
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Cash and cash equivalents
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$
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43,506
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$
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45,791
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Marketable securities
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177,622
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94,407
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Accounts receivable
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7,210
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391
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Prepaid expenses and other current assets
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6,057
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4,864
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Total current assets
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234,395
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145,453
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Marketable securities
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54,312
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-
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Property and equipment, net
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5,471
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4,532
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Other assets
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121
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456
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Restricted cash
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751
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607
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Total assets
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$
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295,050
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$
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151,048
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Liabilities and stockholders’ equity
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Current liabilities:
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Accounts payable
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$
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8,904
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$
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9,247
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Accrued expenses
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14,289
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10,121
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Loans payable, net of discount
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8,551
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5,766
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Deferred revenue
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1,294
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16,693
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Other liabilities
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1,249
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-
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Deferred rent
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322
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266
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Total current liabilities
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34,609
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42,093
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Loans payable, net of current portion and discount
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15,619
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17,636
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Deferred revenue, net of current portion
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19,684
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16,509
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Deferred rent, net of current portion
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359
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553
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Other liabilities
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1,238
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2,487
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Stockholders’ equity:
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Preferred Stock, $.001 par value: 5,000 shares authorized; no shares
issued and outstanding at December 31, 2011 and 2010, respectively
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-
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Common stock, $.001 par value: 100,000 shares authorized; 43,254 and
35,604 shares issued and outstanding at December 31, 2011 and 2010,
respectively
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43
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36
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Additional paid-in capital
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429,531
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308,268
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Accumulated other comprehensive loss
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|
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(167
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)
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(20
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Accumulated deficit
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(205,866
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(236,514
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Total stockholders’ equity
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223,541
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71,770
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Total liabilities and stockholders’ equity
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$
|
295,050
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$
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151,048
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Source: AVEO Pharmaceuticals, Inc.
Investor Contact:
AVEO Pharmaceuticals, Inc.
Monique
Allaire, 617-299-5810
or
Media Contact:
Pure
Communications
Caton Lovett, 910-232-7166
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