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Biohaven (BHVN) Misses on Q3 Earnings, Inks $1.24B Pfizer Deal
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Biohaven Pharmaceutical (BHVN - Free Report) incurred a loss of $2.63 per share in third-quarter 2021, wider than the Zacks Consensus Estimate of a loss of $2.44 but narrower than the year-ago loss of $3.27.
Adjusted loss, which excludes non-cash stock-based compensation and a few other non-cash expenses, for the third quarter was $1.91 per share compared with $2.67 in the year-ago period. The wider-than-expected loss was due to higher operating expense during the quarter.
Total revenues, solely from Nurtec ODT, were $135.7 million in the third quarter, up almost 46.1% sequentially. Revenues beat the Zacks Consensus Estimate of $133.8 million. The company recorded revenues of $17.7 million in the year-ago quarter. Please note that the company had launched Nurtec ODT in March 2020.
Shares of Biohaven declined 12.9% on Nov 9, following the mixed third-quarter results and announcement of the deal with Pfizer. However, the company's shares have gained 42.1% so far this year against the industry’s decrease of 12.1%.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development (R&D) expenses, including stock-based compensation, were $85.7 million in the quarter, up 50.2% year over year driven by higher pre-clinical and late-stage clinical activities.
Selling, general and administrative (SG&A) expenses were $164.5 million in the quarter, up 37.6% from the year-ago period. The significant increase in SG&A expense was driven by higher costs to support the commercialization of Nurtec.
As of Sep 30, 2021, Biohaven had cash and restricted cash worth $523.9 million compared with $368 million as of Jun 30, 2021.
Nurtec Update
Biohaven stated that its oral anti-CGRP drug, Nurtec ODT, has demonstrated strong uptake since its launch in March 2020. Sales of the drug increased during the first nine months of 2021 despite COVID-19 related disruptions. The drug remained the market leader for new oral migraine therapies during the third quarter. The drug’s sales during the third quarter were driven by growth in volumes as well higher net price.
We note that the FDA approved a label expansion of Nurtec ODT as a preventive treatment for migraine in May. The drug's expanded label brought additional revenues.
Please note that Nurtec competes with other FDA-approved anti-CGRP drugs including Amgen’s (AMGN - Free Report) Aimovig, Lilly’s (LLY - Free Report) Emgality and especially AbbVie’s (ABBV - Free Report) oral drug, Ubrelvy.
The company filed a marketing authorization application earlier this year in Europe seeking approval for Nurtec ODT for the treatment and prevention of migraine. It expects to gain regulatory approval for the drug in Europe in the first half of 2022.
Pfizer Deal
In a separate press release, Biohaven announced that it has inked a strategic agreement with Pfizer for the commercialization of Nurtec ODT in ex-U.S. markets. The drug is currently approved in the United States and is under review in Europe and several other countries. Per the agreement, Biohaven will receive an upfront payment of $500 million, including $150 million in cash and $350 million in equity investment. Biohaven is also eligible to receive up to $740 million in milestone payments and will also be entitled to double-digit royalties on ex-US net sales . Under the agreement, Biohaven also granted ex-U.S. rights to its CGRP receptor antagonist, zavegepant, to Pfizer. Biohaven is currently developing the intranasal and soft gel formulation of the candidate for treating migraine indications in late-stage studies.
Pipeline Update
Biohaven is developing three pipeline candidates, verdiperstat, troriluzole and zavegepant.
A phase III study is evaluating intranasal zavegepant as an acute treatment of migraine. Top-line data from the study is expected later in 2021.
In September, the company announced that verdiperstat failed to meet the primary and secondary endpoints of the phase III study evaluating it in patients with multiple system atrophy. Currently, the candidate is being evaluated as a potential treatment for amyotrophic lateral sclerosis (“ALS”) in a clinical study being conducted at Massachusetts General Hospital by Healey Center. Biohaven expects to complete enrollment in the ALS study in the fourth quarter of 2021.
A phase III study is currently evaluating troriluzole in patients with spinocerebellar ataxia. Top-line data is expected in the first half of 2022. Previously, the company had expected to report top-line data from the study by the end of this year or early next year. The company is also developing the candidate as a potential treatment for obsessive compulsive disorder (“OCD”) in two identical phase III studies. Top-line data from these studies are expected in the second half of 2022.
Biohaven Pharmaceutical Holding Company Ltd. Price, Consensus and EPS Surprise
Image: Bigstock
Biohaven (BHVN) Misses on Q3 Earnings, Inks $1.24B Pfizer Deal
Biohaven Pharmaceutical (BHVN - Free Report) incurred a loss of $2.63 per share in third-quarter 2021, wider than the Zacks Consensus Estimate of a loss of $2.44 but narrower than the year-ago loss of $3.27.
Adjusted loss, which excludes non-cash stock-based compensation and a few other non-cash expenses, for the third quarter was $1.91 per share compared with $2.67 in the year-ago period. The wider-than-expected loss was due to higher operating expense during the quarter.
Total revenues, solely from Nurtec ODT, were $135.7 million in the third quarter, up almost 46.1% sequentially. Revenues beat the Zacks Consensus Estimate of $133.8 million. The company recorded revenues of $17.7 million in the year-ago quarter. Please note that the company had launched Nurtec ODT in March 2020.
Shares of Biohaven declined 12.9% on Nov 9, following the mixed third-quarter results and announcement of the deal with Pfizer. However, the company's shares have gained 42.1% so far this year against the industry’s decrease of 12.1%.
Quarter in Detail
Research and development (R&D) expenses, including stock-based compensation, were $85.7 million in the quarter, up 50.2% year over year driven by higher pre-clinical and late-stage clinical activities.
Selling, general and administrative (SG&A) expenses were $164.5 million in the quarter, up 37.6% from the year-ago period. The significant increase in SG&A expense was driven by higher costs to support the commercialization of Nurtec.
As of Sep 30, 2021, Biohaven had cash and restricted cash worth $523.9 million compared with $368 million as of Jun 30, 2021.
Nurtec Update
Biohaven stated that its oral anti-CGRP drug, Nurtec ODT, has demonstrated strong uptake since its launch in March 2020. Sales of the drug increased during the first nine months of 2021 despite COVID-19 related disruptions. The drug remained the market leader for new oral migraine therapies during the third quarter. The drug’s sales during the third quarter were driven by growth in volumes as well higher net price.
We note that the FDA approved a label expansion of Nurtec ODT as a preventive treatment for migraine in May. The drug's expanded label brought additional revenues.
Please note that Nurtec competes with other FDA-approved anti-CGRP drugs including Amgen’s (AMGN - Free Report) Aimovig, Lilly’s (LLY - Free Report) Emgality and especially AbbVie’s (ABBV - Free Report) oral drug, Ubrelvy.
The company filed a marketing authorization application earlier this year in Europe seeking approval for Nurtec ODT for the treatment and prevention of migraine. It expects to gain regulatory approval for the drug in Europe in the first half of 2022.
Pfizer Deal
In a separate press release, Biohaven announced that it has inked a strategic agreement with Pfizer for the commercialization of Nurtec ODT in ex-U.S. markets. The drug is currently approved in the United States and is under review in Europe and several other countries. Per the agreement, Biohaven will receive an upfront payment of $500 million, including $150 million in cash and $350 million in equity investment. Biohaven is also eligible to receive up to $740 million in milestone payments and will also be entitled to double-digit royalties on ex-US net sales . Under the agreement, Biohaven also granted ex-U.S. rights to its CGRP receptor antagonist, zavegepant, to Pfizer. Biohaven is currently developing the intranasal and soft gel formulation of the candidate for treating migraine indications in late-stage studies.
Pipeline Update
Biohaven is developing three pipeline candidates, verdiperstat, troriluzole and zavegepant.
A phase III study is evaluating intranasal zavegepant as an acute treatment of migraine. Top-line data from the study is expected later in 2021.
In September, the company announced that verdiperstat failed to meet the primary and secondary endpoints of the phase III study evaluating it in patients with multiple system atrophy. Currently, the candidate is being evaluated as a potential treatment for amyotrophic lateral sclerosis (“ALS”) in a clinical study being conducted at Massachusetts General Hospital by Healey Center. Biohaven expects to complete enrollment in the ALS study in the fourth quarter of 2021.
A phase III study is currently evaluating troriluzole in patients with spinocerebellar ataxia. Top-line data is expected in the first half of 2022. Previously, the company had expected to report top-line data from the study by the end of this year or early next year. The company is also developing the candidate as a potential treatment for obsessive compulsive disorder (“OCD”) in two identical phase III studies. Top-line data from these studies are expected in the second half of 2022.
Biohaven Pharmaceutical Holding Company Ltd. Price, Consensus and EPS Surprise
Biohaven Pharmaceutical Holding Company Ltd. price-consensus-eps-surprise-chart | Biohaven Pharmaceutical Holding Company Ltd. Quote
Zacks Rank
Biohaven currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.