AVEO Oncology Reports Full Year 2014 Financial Results
“At the beginning of 2015,
Announced Presentation of Phase 2 Study Analysis Showing Longer PFS
with Tivozanib versus Bevacizumab in Low Serum NRP-1 Patients with
Advanced CRC – Today,
AVEOannounced the presentation of final results, including a predefined biomarker analysis, from the BATON-CRC study, a randomized Phase 2 clinical trial of modified FOLFOX6 combined with tivozanib or bevacizumab in metastatic colorectal cancer (CRC). The presentation, titled “Neuropilin-1 as a potential biomarker of progression-free survival benefit for tivozanib + mFOLFOX6 versus bevacizumab + mFOLFOX6 in metastatic colorectal cancer: post-hoc biomarker analysis of BATON-CRC Phase 2 trial,” will be presented in a poster session today at the American Association for Cancer Research (AACR) Tumor Angiogenesis and Vascular Normalization Conference, taking place March 5-8, 2015, in Orlando, FL.
Michael P. Baileyas President and Chief Executive Officer – In January 2015, AVEOannounced that its board of directors appointed Michael P. Baileyas the Company’s president and chief executive officer and has elected Mr. Bailey as a director. Mr. Bailey succeeds Tuan Ha-Ngoc, who was named chairman of AVEO’s board of directors.
Announced Corporate Restructuring – In
January 2015, AVEOannounced the elimination of its internal research function, as well as certain corporate support positions, to align resources with the Company’s future strategic plans, focusing on advancement of its pipeline in the clinical setting and reducing corporate expenses. AVEOexpects that the related severance and outplacement charges of approximately $4.5 millionincurred in connection with the restructuring will be included in its results of operations for the first quarter of 2015. The reduction in force is expected to reduce compensation expenses annually by approximately $6 millionand will further reduce AVEO’s facilities requirements, by more than 80% of its current space, including the elimination of lab and vivarium needs. The Company announced today that it will exit its current facility by the end of May 2015.
Michael N. Needle, M.D. as Chief Medical Officer – In January 2015, AVEOannounced the appointment of Michael N. Needle, M.D., to the position of chief medical officer. In this role, Dr. Needle, a board certified hematologist/oncologist, will take a leadership role in evaluating and implementing clinical development strategies for advancement of the Company’s proprietary and partnered clinical-stage programs.
Received Confirmation of Eligibility for Submission of a Tivozanib
Marketing Authorization Application (MAA) to the
European Medicines Agency– In January 2015, AVEOannounced that, in response to submission of a letter of intent, it has received written confirmation from the European Medicine Agency(EMA) that tivozanib is eligible for submission of an application for a European Union Marketing Authorization under the Agency’s centralized procedure. AVEOintends to evaluate the decision to submit a tivozanib Marketing Authorization Application (MAA) in Europefor the treatment of RCC. Confirmation of eligibility for submission is not predictive of the EMA’s approval of a MAA.
Entered into Research and Exclusive Option Agreement with
Ophthotechfor Tivozanib for the Treatment of Ocular Diseases – In November 2014, AVEOannounced its entry into a research and exclusive option agreement with Ophthotech Corporation, under which it has provided Ophthotechan exclusive license to investigate the potential of tivozanib outside of Asiafor the potential treatment of non-oncologic diseases of the eye. The agreement enables AVEOto potentially realize additional value for tivozanib in an indication outside of cancer, while retaining oncology rights for further development through additional potential partnerships.
Under the terms of the agreement, if
Full Year 2014 Financial Highlights
AVEOended 2014 with $52.3 millionin cash and cash equivalents.
Total collaboration revenue for 2014 was approximately
$18.1 millioncompared with $1.3 millionfor 2013. The increase was primarily due to recognition of an additional $13.7 millionof previously deferred revenue as a result of the modification of the Company’s arrangement with Biogen Idec. In addition, the Company recognized an additional $3.1 millionof collaboration revenue in connection with the change in the estimated period of performance associated with the Company’s collaboration with Astellas as a result of the termination of the agreement in August 2014.
Research and development (R&D) expense for 2014 was
$38.3 millioncompared with $68.5 millionfor 2013. The decrease in R&D expense was primarily due to a reduction in personnel-related expenses following AVEO’s June 2013strategic restructuring as well as a decrease in external clinical trial, research, and medical affairs costs associated with reduced tivozanib clinical trial activity, and a decrease of costs relating to the manufacturing of ficlatuzumab, which was completed in 2013.
General and administrative (G&A) expense for 2014 was
$18.6 millioncompared with $28.7 millionfor 2013.The decrease in G&A expense was primarily due to a reduction in personnel-related expenses following AVEO’s June 2013strategic restructuring as well as a decrease in marketing and consulting costs due to termination of work related to tivozanib pre-commercialization activities.
Restructuring and lease exit expense for 2014 was
$11.7 millioncompared with $8.0 millionfor 2013. The expenses incurred during 2014 relate to costs associated with partially vacating and subsequently terminating the agreement for the Company’s leased space. The expenses incurred during 2013 relate to severance and employee benefits incurred as part of the June 2013strategic restructuring.
Net loss for 2014 was
$52.7 million, or a net loss of $1.01per basic and diluted share compared with net loss of $107.0 millionor a net loss of $2.10per basic and diluted share for 2013.
Updated Financial Guidance
Based on its current operating plan, the Company expects its
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
|AVEO Pharmaceuticals, Inc.|
|Consolidated Balance Sheet Data|
|Cash, cash equivalents and marketable securities||$||52,306||$||118,506|
|Prepaid expenses and other current assets||4,481||9,429|
|Property and equipment, net||11,295||14,140|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||17,527||$||17,501|
|Total loans payable||20,652||19,205|
|Total deferred revenue||768||18,392|
|Total deferred rent||10,569||20,072|
|Total liabilities and stockholders’ equity||$||70,662||$||146,346|
|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||8,702||11,889||38,254||68,468|
|General and administrative||3,104||4,499||18,589||28,712|
|Restructuring and lease exit||1,302||4||11,729||8,017|
|Loss from operations||(12,993||)||(16,069||)||(50,449||)||(103,904||)|
|Other income and expense:|
|Other (expense) income, net||(37||)||(3||)||66||(123||)|
|Other expense, net||(901||)||(656||)||(2,290||)||(3,125||)|
|Basic and diluted net loss per share|
|Weighted average number of common shares outstanding||51,802||51,546||52,289||50,928|
Source: AVEO Oncology
Company, Media and Investor:
David Pitts, 212-600-1902