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AVEO Announces Strategic Restructuring And Provides Third Quarter Financial Results

Third Quarter 2012 Financial Results

  • Total collaboration revenue for the third quarter of 2012 was approximately $1.0 million compared with $3.6 million for the third quarter of 2011. The decrease was due to revenue recognized in the third quarter of 2011 under AVEO’s collaboration agreement with OSI that did not recur during the third quarter of 2012.
  • Research and development (R&D) expense for the third quarter of 2012 was $21.1 million compared with $20.1 million for the third quarter of 2011. The increase in R&D expense was primarily due to an increase in personnel-related expenses, as well as an increase in facility costs related to our future headquarters, partially offset by a decrease in clinical trial costs.
  • General and administrative (G&A) expense for the third quarter of 2012 was $9.3 million compared with $6.6 million for the third quarter of 2011. The increase in G&A expense was primarily driven by an increase in personnel-related expenses, as well as an increase in expenses related to pre-commercialization activities for tivozanib.
  • Net loss for the third quarter of 2012 was $30.1 million, or basic and diluted net loss per share of $0.69, compared with net loss of $23.8 million, or basic and diluted net loss per share of $0.55, for the third quarter of 2011.
  • AVEO ended the third quarter of 2012 with cash, cash equivalents and marketable securities of $189.7 million.

Updated Financial Guidance

AVEO is updating its financial guidance that it expects to end 2012 with approximately $135 million in cash, cash equivalents and marketable securities. Based on its revised operating plan, AVEO anticipates that this capital is sufficient to fund its operations through 2013.

Key Recent Developments

  • Tivozanib NDA submitted: AVEO submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for tivozanib in patients with advanced RCC. The submission is based on results of the global Phase 3 TIVO-1 ( TIvozanib Versus s Orafenib in 1st line advanced RCC) trial, in which tivozanib demonstrated a statistically significant improvement in progression-free survival versus sorafenib, an approved targeted agent, and a favorable tolerability profile.
  • Appointed vice president, sales: In preparation for the planned launch of tivozanib, AVEO has appointed Brad Bailey to the newly created position of vice president, sales, reporting to AVEO’s chief commercial officer. Mr. Bailey brings more than two decades of pharmaceutical and medical device industry leadership in field sales, operations, account management and reimbursement. Mr. Bailey’s experience includes serving as vice president of oncology sales and account management at Pfizer, where he led the launch of Sutent ® in RCC and gastrointestinal stromal tumors. He joins the company from UCB Biopharma where he served as senior director, immunology business unit and directed the company's national sales organization in the marketing of Cimzia ® for the treatment of rheumatoid arthritis and Crohn's disease.
  • New tivozanib clinical data presented at ESMO: New TIVO-1 data demonstrating the safety and tolerability profile of tivozanib versus sorafenib in the first-line setting for patients with RCC were presented at the ESMO 2012 Congress (European Society for Medical Oncology). Results showed that patients treated with tivozanib experienced fewer ≥Grade 3 drug-related adverse events (36.3% in tivozanib arm vs. 51.0% in sorafenib arm). ≥Grade 3 hypertension, an established on-target effect of angiogenesis inhibitors, was more common in the tivozanib group (23.6% vs. 15.2%) and ≥Grade 3 hand-foot syndrome (1.9% vs. 16.7%), diarrhea (1.9% vs. 5.8%) and lipase elevation (0.8% vs. 5.8%) were more common in the sorafenib group. Further, patients treated with tivozanib required fewer dose reductions (11.6% vs. 42.8%, p<0.001) and interruptions (17.8% vs. 35.4%, p<0.001) than those on sorafenib.
  • First patient enrolled in TAURUS patient preference study: AVEO and Astellas began enrolling patients in the TAURUS ( Tivoz Anib Use ve Rs Us Sunitinib in advanced renal cell carcinoma) patient preference study. The primary objective of the study is to compare patient preference for tivozanib or sunitinib.

Upcoming Activities

AVEO expects to present at the following investor conferences:

  • Lazard Capital Markets 9th Annual Healthcare Conference, November 13-14, 2012 in New York
  • dbAccess BioFEST, December 3-4, 2012 in Boston
  • 31st Annual J.P. Morgan Healthcare Conference, January 7-10, 2013 in San Francisco

AVEO expects to have a presence at the following oncology medical meeting:

  • San Antonio Breast Cancer Symposium (SABCS), December 4-8, 2012 in San Antonio

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 1-866-788-0543 (domestic) or 1-857-350-1681 (international) five minutes prior to the start of the call and providing the passcode 81107349. 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 32906283. The replay will be available for two weeks from the date of the call.

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