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AVEO Pharmaceuticals (AVEO) Q1 Earnings & Revenues Miss Mark
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AVEO Pharmaceuticals, Inc. 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 - Free Report) 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 - Free Report) 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 - Free Report) 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
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A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 7 stocks to watch. The report is only available for a limited time.
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AVEO Pharmaceuticals (AVEO) Q1 Earnings & Revenues Miss Mark
AVEO Pharmaceuticals, Inc. 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 - Free Report) 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 - Free Report) 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 - Free Report) 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-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.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 7 stocks to watch. The report is only available for a limited time.
See 7 breakthrough stocks now>>