AVEO Reports Second Quarter 2013 Financial Results
AVEO Reports Second Quarter 2013 Financial Results
"We are moving forward as an organization and are firmly focused on executing our revised business strategy," said Tuan Ha-Ngoc, president and chief executive officer of AVEO. "We continue to advance our programs in clinical development, including tivozanib in colorectal and breast cancer, which are currently in Phase 2 studies. Additionally, we are moving forward with AV-203, our ERBB3 inhibitory antibody candidate, which is currently in Phase 1 development. While the recent setback related to the tivozanib Complete Response Letter and the company's strategic restructuring was challenging, we remain confident about the company's future prospects and we will continue to work toward our goal of bringing clinically meaningful treatments to patients with cancer."
Second Quarter 2013 Financial Results
- Total collaboration revenue for the second quarter of 2013 was approximately $0.3 million compared with $1.9 million for the second quarter of 2012. The decrease was due to revenue recognized during the second quarter of 2012 related to milestones achieved under our collaboration agreement with OSI, as well as research funding under our collaboration agreement with Centocor, that did not recur during the second quarter of 2013. Revenue during the second quarter of 2013 was related to amortization of amounts previously deferred related to our collaboration agreements with Biogen and Astellas.
- Research and development (R&D) expense for the second quarter of 2013 was $16.2 million compared with $21.5 million for the second quarter of 2012. The decrease in R&D expense was primarily due to a decrease in personnel-related expenses following our strategic restructuring announced in October 2012, as well as a decrease in clinical trial costs due to a decrease in the number of active patients enrolled in our ficlatuzumab and tivozanib studies.
- General and administrative (G&A) expense for the second quarter of 2013 was $7.3 million compared with $9.2 million for the second quarter of 2012. The decrease in G&A expense was primarily due to the reversal of stock-based compensation expense for certain awards that are no longer probable of vesting and a decrease in personnel-related expenses related to our strategic restructuring announced on June 4, 2013.
- Restructuring expense for the three months ended June 30, 2013 was $7.9 million, with no corresponding expense for the three months ending June 30, 2012. The restructuring expense primarily consisted of employee severance and related benefits incurred in connection with our strategic restructuring announced on June 4, 2013, extending the company's cash runway beyond certain potential clinical milestones.
- Net loss for the second quarter of 2013 was $31.9 million, or basic and diluted net loss per share of $0.62, compared with a net loss of $29.5 million, or basic and diluted net loss per share of $0.68 for the second quarter of 2012.
- AVEO ended the second quarter of 2013 with cash, cash equivalents and marketable securities of $156.2 million.
Based on current operating plans, AVEO expects to end 2013 with approximately $115 million in cash, cash equivalents and marketable securities, and expects that its current cash, cash equivalents and marketable securities are sufficient to fund operations through at least the second quarter of 2015.
Key Recent Development
- Announced Strategic Restructuring: In connection with the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on June 10, 2013 informing us that the FDA will not approve in its present form our New Drug Application for tivozanib, our lead product candidate, for the treatment of patients with advanced renal cell carcinoma (RCC) and our subsequent decision not to pursue tivozanib development in RCC, we recently announced a strategic restructuring, pursuant to which we are eliminating approximately 140 positions across the organization. This strategic restructuring will refocus our efforts on the on-going clinical development of tivozanib in colorectal and breast cancer and on the advancement of other key pipeline and preclinical assets.
Upcoming Investor Conference
AVEO expects to present at the following investor conference:
- Canaccord Genuity 33rd Annual Growth Conference, August 14-15, 2013 in Boston
AVEO Oncology (NAS: AVEO) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients' lives. AVEO's proprietary Human Response PlatformTM 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: 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 through at least the second quarter of 2015; AVEO's plans regarding its strategic restructurings; AVEO's plans to advance its clinical development programs; 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: AVEO's ability to accomplish its strategic restructurings, execute on its revised business plan and manage the impact of unplanned operating expenses; AVEO's ability to successfully enroll and complete clinical trials and preclinical studies of its product candidates; AVEO's ability to demonstrate to the satisfaction of the FDA, or equivalent foreign regulatory agencies, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO's ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO's ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments and expenses related to AVEO's ongoing shareholder litigation and SEC inquiry; 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 strategic partnerships and relationships, including its collaboration with Astellas; and those risks discussed in the section titled "Risk Factors" included in AVEO's most recent Quarterly Report on Form 10-Q 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)|
|For the Three Months||For the Six Months|
|Ended June 30,||Ended June 30,|
|Research and development||16,203||21,450||37,165||46,226|
|General and administrative||7,324||9,186||19,773||18,169|
|Loss from operations||(31,072||)||(28,759||)||(64,227||)||(61,658||)|
|Other income and expense:|
|Other income (expense), net||(51||)||(66||)||(152||)||233|
|Other expense, net||(841||)||(787||)||(1,771||)||(1,134||)|
|Net loss per share - basic and diluted||$||(0.62||)||$||(0.68||)||$||(1.31||)||$||(1.45||)|
|Weighted average number of common shares outstanding||51,312||43,322||50,351||43,288|
|AVEO Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|(In thousands, except par value amounts)|
|June 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||156,170||$||160,602|
|Prepaid expenses and other current assets||9,217||9,430|
|Property and equipment, net||13,238||12,867|
|Liabilities and stockholders' equity|
|Accounts payable and accrued expenses||$||21,544||$||30,171|
|Total loans payable||23,893||26,037|
|Total deferred revenue||19,038||19,685|
|Total deferred rent||15,791||11,400|
|Total liabilities and stockholders' equity||$||190,410||$||207,469|
David Johnston, 617-299-5810
Kristie Wallis, 336-774-8666
KEYWORDS: United States North America Massachusetts
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