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Is a Disappointment in Store for Zosano (ZSAN) Q3 Earnings?
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Investors will focus on pipeline updates when clinical-stage biopharmaceutical company, Zosano Pharma Corporation , reports third-quarter 2020 results.
In the last reported quarter, the company missed earnings estimates by 40%.
The company’s stock has plunged 74.9% year to date compared with the industry’s decline of 8.3%.
Let’s see, how things are shaping up for this announcement.
Factors at Play
In absence of a marketed product in the company’s portfolio, investors’ focus will be on pipeline updates related to Zosano’s pipeline development.
The company’s lead product candidate is Qtrypta (M207), which is a proprietary formulation of zolmitriptan. It is designed to be delivered via its transdermal microneedle system technology as an acute treatment for migraine.
However, the company suffered a setback as it recently received a complete response letter (CRL) from the FDA in connection with Qtrypta 505(b)(2) New Drug Application (NDA). The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA’s discipline review letter (received on Sep 30). The CRL noted differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the clinical studies and inadequate pharmacokinetic bridging between the lots, which in turn made it difficult to interpret some safety data. The CRL referenced unexpected high plasma concentrations of zolmitriptan observed in five study subjects enrolled in the company’s pharmacokinetic studies. Hence, the agency recommended that the company should conduct a repeat bioequivalence study between three of the lots used during the development. The NDA included data from a total of 774 subjects who were administered or dosed with Qtrypta across five trials.
Additionally, the CRL noted that additional product quality validation data, which were planned to be submitted following the approval, if received, were required to be submitted with the application. Moreover, the CRL mentioned that due to existing restrictions on travel, inspections of Zosano’s contract manufacturing facilities couldn’t be conducted but would be required before the application is approved.
As a result, the company will request a Type A meeting with the FDA to discuss strategies to address the issues mentioned.
Research and development expenses decreased in the previous quarter due to lower clinical trial costs resulting from the completion of the Qtrypta long-term safety study in 2019. The trend is expected to continue in the to-be-reported quarter.
Earnings Whispers
Our proven model does not conclusively predict an earnings beat for Zosano this season. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of a positive surprise. But this is not the case here. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Earnings ESP: Zosano has an Earnings ESP of 0.00%.
Zacks Rank: The company currently carries a Zacks Rank #4 (Sell).
Zosano Pharma Corporation Price, Consensus and EPS Surprise
Geron (GERN - Free Report) has an Earnings ESP of +6.25% and a Zacks Rank #3.
Mylan has an Earnings ESP of +1.69% and a Zacks Rank #3.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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Is a Disappointment in Store for Zosano (ZSAN) Q3 Earnings?
Investors will focus on pipeline updates when clinical-stage biopharmaceutical company, Zosano Pharma Corporation , reports third-quarter 2020 results.
In the last reported quarter, the company missed earnings estimates by 40%.
The company’s stock has plunged 74.9% year to date compared with the industry’s decline of 8.3%.
Let’s see, how things are shaping up for this announcement.
Factors at Play
In absence of a marketed product in the company’s portfolio, investors’ focus will be on pipeline updates related to Zosano’s pipeline development.
The company’s lead product candidate is Qtrypta (M207), which is a proprietary formulation of zolmitriptan. It is designed to be delivered via its transdermal microneedle system technology as an acute treatment for migraine.
However, the company suffered a setback as it recently received a complete response letter (CRL) from the FDA in connection with Qtrypta 505(b)(2) New Drug Application (NDA). The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA’s discipline review letter (received on Sep 30). The CRL noted differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the clinical studies and inadequate pharmacokinetic bridging between the lots, which in turn made it difficult to interpret some safety data. The CRL referenced unexpected high plasma concentrations of zolmitriptan observed in five study subjects enrolled in the company’s pharmacokinetic studies. Hence, the agency recommended that the company should conduct a repeat bioequivalence study between three of the lots used during the development. The NDA included data from a total of 774 subjects who were administered or dosed with Qtrypta across five trials.
Additionally, the CRL noted that additional product quality validation data, which were planned to be submitted following the approval, if received, were required to be submitted with the application. Moreover, the CRL mentioned that due to existing restrictions on travel, inspections of Zosano’s contract manufacturing facilities couldn’t be conducted but would be required before the application is approved.
As a result, the company will request a Type A meeting with the FDA to discuss strategies to address the issues mentioned.
Research and development expenses decreased in the previous quarter due to lower clinical trial costs resulting from the completion of the Qtrypta long-term safety study in 2019. The trend is expected to continue in the to-be-reported quarter.
Earnings Whispers
Our proven model does not conclusively predict an earnings beat for Zosano this season. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of a positive surprise. But this is not the case here. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Earnings ESP: Zosano has an Earnings ESP of 0.00%.
Zacks Rank: The company currently carries a Zacks Rank #4 (Sell).
Zosano Pharma Corporation Price, Consensus and EPS Surprise
Zosano Pharma Corporation price-consensus-eps-surprise-chart | Zosano Pharma Corporation Quote
Stocks to Consider
Here are a few companies worth considering, as per our model these have the right mix of elements to beat on earnings this reporting cycle.
Regenxbio, Inc. (RGNX - Free Report) has an Earnings ESP of +4.76% and a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Geron (GERN - Free Report) has an Earnings ESP of +6.25% and a Zacks Rank #3.
Mylan has an Earnings ESP of +1.69% and a Zacks Rank #3.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>