AVEO Pharmaceuticals, Inc. (AVEO - Free Report) incurred second-quarter 2019 loss of 2 cents per share, narrower than the Zacks Consensus Estimate of a loss of 6 cents and the year-ago loss of 6 cents as well.
AVEO’s top line comprises collaboration and licensing revenues plus partnership royalties. Total revenues in the reported quarter were approximately $0.7 million, up from $0.4 million registered in second-quarter 2018. However, revenues missed the Zacks Consensus Estimate of $2 million.
Shares of AVEO have plummeted 57.9% so far this year compared with the industry’s decrease of 0.9%.
In August 2017, AVEO and its partner EUSA Pharma received an approval from the European Commission for its VEGF tyrosine kinase inhibitor Fotivda (tivozanib) for the first-line treatment of advanced renal cell carcinoma (RCC). It is the first approved drug in the company’s portfolio. AVEO is focused on launching the medicine across various European countries.
Research & development expenses were down 46.9% year over year to $2.6 million. However, general and administrative expenses increased 7.1% year over year to $3 million.
AVEO expects that its present cash resources of $40.2 million along with the $25-million upfront payment from the Kyowa Kirin license amendment to be received in third-quarter 2019 will allow the company to invest in its planned operations through the third quarter of 2021.
In April this year, AVEO announced that it earned a $2-million milestone payment from EUSA pharma, triggered by the commercial launch and reimbursement of Fotivda in Spain. Last month, Fotivda was approved in New Zealand as a first-line treatment of adult patients with advanced RCC.
We would like to remind investors that AVEO faced a major setback when it had to delay the submission of a new drug application (NDA) for its vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) Fotivda (tivozanib) for the first-line treatment of advanced RCC in January this year. The company decided not to file an NDA in the United States after the FDA informed that it was not satisfied with the preliminary overall survival (OS) data reported along with the top-line results from the TIVO-3 study announced last November.
The phase III TIVO-3 program evaluated Fotivda in highly refractory advanced or metastatic RCC patients compared with Bayer AG’s (BAYRY - Free Report) Nexavar (sorafenib).
AVEO has planned an additional interim OS analysis this August, results of which are expected in the fourth quarter of 2019. Based on these mature OS results, the company will decide on the NDA filing following the FDA recommendation.
Meanwhile, AVEO is evaluating Fotivda combined with Bristol-Myers’ (BMY - Free Report) Opdivo (an immune checkpoint PD-1 inhibitor) in a phase II study for the treatment of advanced RCC. The company is also examining the drug in a phase I/II probe coupled with AstraZeneca’s (AZN - Free Report) Imfinzi for treating first-line hepatocellular carcinoma, a form of liver cancer.
Apart from Fotivda, AVEO has a promising candidate, ficlatuzumab, in its pipeline. It is currently being evaluated in early-mid/stage studies for various oncological indications. In April, the company along with partner Biodesix, Inc. announced positive results from the phase Ib expansion cohort of ficlatuzumab combined with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML).
AVEO Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
AVEO currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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