AVEO Reports 2011 Financial Results and Highlights Fourth Quarter Progress
“The recent success of our Phase 3 registration trial of tivozanib in
Full Year 2011 Financial Results
Total collaboration revenues for 2011 were
$164.8 millioncompared with $44.7 millionfor 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.
Research and development (R&D) expense for 2011 was
$101.7 millioncompared with $86.3 millionfor 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 Kirinrelated 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.
General and administrative (G&A) expense for 2011 was
$29.2 millioncompared with $14.8 millionfor 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.
Net income for 2011 was
$30.6 million, or basic and diluted earnings per share of $0.77and $0.74, respectively, compared with a net loss of $58.8 million, or basic and diluted loss per share of $2.30for 2010.
AVEO ended 2011 with cash, cash equivalents and marketable securities
AVEO expects year-end 2012 cash, cash equivalents and marketable
securities of at least
Fourth Quarter 2011 Key Accomplishments
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 2012and 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:
- 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.
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 Americaand Europe.
- 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
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.
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.
AVEO expects to present at the following investor conferences:
Leerink Swann2012 Global Healthcare Conference, February 15-16, 2012in New York City.
Global Health Care Conference, February 27-29, 2012in New York City.
2012 RBC Capital Markets’ Global Healthcare Conference,
February 28-29, 2012in New York City.
Cowen and Company 32nd Annual Health Care Conference,
March 5-7, 2012in Boston, Mass.
Today’s Conference Call and Webcast Reminder
The AVEO management team will host a conference call at
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.
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
|AVEO Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|For the Three Months||For the Years|
|Ended December 31,||Ended December 31,|
|Research and development||18,542||17,478||101,735||86,345|
|General and administrative||6,986||4,564||29,167||14,763|
|Income (loss) from operations||(24,432||)||(10,085||)||33,947||(56,426||)|
|Other income and expense:|
|Other income (expense), net||(7||)||760||10||900|
|Other expense, net||(737||)||(229||)||(3,299||)||(2,363||)|
|Net income (loss)||(25,169||)||(10,314||)||30,648||(58,789||)|
|Basic net income (loss) per share|
|Net income (loss)||$||(0.58||)||$||(0.30||)||$||0.77||$||(2.30||)|
|Weighted average number of common shares outstanding||43,132||33,914||39,715||25,582|
|Diluted net income (loss) per share|
|Net income (loss)||$||(0.58||)||$||(0.30||)||$||0.74||$||(2.30||)|
|Weighted average number of common shares and dilutive common share equivalents outstanding||43,132||33,914||41,473||25,582|
|AVEO Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|December 31,||December 31,|
|Cash and cash equivalents||$||43,506||$||45,791|
|Prepaid expenses and other current assets||6,057||4,864|
|Total current assets||234,395||145,453|
|Property and equipment, net||5,471||4,532|
|Liabilities and stockholders’ equity|
|Loans payable, net of discount||8,551||5,766|
|Total current liabilities||34,609||42,093|
|Loans payable, net of current portion and discount||15,619||17,636|
|Deferred revenue, net of current portion||19,684||16,509|
|Deferred rent, net of current portion||359||553|
|Preferred Stock, $.001 par value: 5,000 shares authorized; no shares issued and outstanding at December 31, 2011 and 2010, respectively||-||-|
|Common stock, $.001 par value: 100,000 shares authorized; 43,254 and 35,604 shares issued and outstanding at December 31, 2011 and 2010, respectively||43||36|
|Additional paid-in capital||429,531||308,268|
|Accumulated other comprehensive loss||(167||)||(20||)|
|Total stockholders’ equity||223,541||71,770|
|Total liabilities and stockholders’ equity||$||295,050||$||151,048|
AVEO Pharmaceuticals, Inc.
Monique Allaire, 617-299-5810
Caton Lovett, 910-232-7166