AVEO Pharmaceuticals, Inc. AVEO incurred first-quarter 2019 loss of 6 cents per share, wider than the Zacks Consensus Estimate of a loss of 5 cents but narrower than the year-ago loss of 8 cents.

AVEO’s top line comprises collaboration and licensing revenues plus partnership royalties. Total revenues in the reported quarter were approximately $1.6 million compared with $1 million registered in first-quarter 2018. However, revenues missed the Zacks Consensus Estimate of $2 million.

Shares of AVEO have plunged 43.8% so far this year versus the industry’s increase of 3.3%.

AVEO’s Fotivda (tivozanib) is the first approved drug in the company’s portfolio. It won the nod in the EU during August 2017 for the first-line treatment of advanced renal cell carcinoma (RCC). The company is focused on launching the medicine across various European countries.

Operating Expenses

Research & development expenses were up 25.9% year over year to $6.8 million. However, general and administrative expenses decreased 7.7% year over year to $2.4 million.

Cash Guidance

AVEO expects that its present cash resources of $23.5 million along with approximately $24.2 million in additional net funding received to date for the second quarter of 2019 will allow the company to invest in its planned operations through the fourth quarter of 2020.

Other Updates

In January this year, AVEO faced a major setback when it had to delay its submission of a new drug application (NDA), seeking an approval for Fotivda. 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 TIVO-3 study results on progression-free-survival last November.

The phase III TIVO-3 program evaluated Fotivda in highly refractory advanced or metastatic RCC patients compared with Bayer AG’s BAYRY Nexavar (sorafenib).

Previously, the company intended to submit the NDA in the first half of 2019. AVEO had planned a final analysis of OS come August 2019. Data from this interim analysis will be available during the fourth quarter of the ongoing year. With the FDA’s recommendation, AVEO will decide on the NDA filing following more mature OS results.

Meanwhile, the company is evaluating Fotivda in a phase II study combined with Bristol-Myers’ BMY Opdivo (an immune checkpoint PD-1 inhibitor) for the treatment of advanced RCC. The company is also examining Fotivda in a phase I/II probe coupled with AstraZeneca’s AZN Imfinzi for treating first-line hepatocellular carcinoma.

Last month, AVEO announced that it earned a $2-million milestone payment from EUSA pharma, triggered by the commercial launch and reimbursement of Fotivda in Spain.

AVEO Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

AVEO Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

AVEO Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | AVEO Pharmaceuticals, Inc. Quote

Zacks Rank

AVEO currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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