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Biohaven Pharmaceutical BHVN recorded loss of $3.62 per share in fourth-quarter 2020, wider than the Zacks Consensus Estimate of a loss of $2.89 as well as the year-ago loss of $2.85. Adjusted loss for the fourth quarter was $2.69 per share compared with $2.38 in the year-ago period.
Total revenues, solely from Nurtec ODT, were $35.1 million in the fourth quarter, up almost 98% sequentially. The top line slightly beat the Zacks Consensus Estimate of $35.01 million. The company did not record any revenues in the year-ago quarter.
Shares of Biohaven were down almost 3.7% on Mar 2, following the earnings release. However, the stock has gained 49.1% so far this year against the industry’s decrease of 2.2%.
Quarter in Detail
Research and development (R&D) expenses, including stock-based compensation, were $73.5 million in the quarter, up 11.4% year over year driven by an upfront payment of $9.9 million related to collaboration agreement with Sosei Heptares signed during the fourth quarter. The increase was partially offset by lower clinical activities related to rimegepant, following its approval as Nurtec ODT.
Selling, general and administrative (SG&A) expenses were $122.4 million in the quarter, compared with $69 million in the year-ago period. The significant increase in SG&A expense was driven by higher costs to support the commercial launch of Nurtec.
As of Dec 31, 2020, Biohaven had cash and restricted cash worth $355.3 million compared with $552 million as of Sep 30, 2020.
Biohaven reported revenues of $63.6 million, solely from Nurtec ODT sales. The company did not record any revenues in 2019. The company incurred a loss of $13.06 per share compared with $10.91 per share in the year-ago period. Adjusted loss for 2020 was $10.31 per share, wider than a loss of $6.11 per share in 2019.
Biohaven stated that Nurtec ODT has demonstrated strong uptake since its launch in March 2020. Sales of the drug almost doubled sequentially during the fourth quarter despite COVID-19 related disruptions. Sales of the drug were driven by rapid growth of the oral CGRP segment. The company has also expanded payer coverage for the drug to over 89% of commercial lives so far. Please note that Nurtec competes with other FDA-approved anti-CGRP drugs including Amgen’s AMGN Aimovig, Lilly’s LLY Emgality and especially AbbVie’s ABBV oral drug, Ubrelvy.
Biohaven’s Nurtec ODT is the only CGRP receptor antagonist available in an orally disintegrating tablet for the acute treatment of migraine. The company is also developing the drug as a potential preventive treatment of migraine. The company’s supplemental new drug application (sNDA) seeking approval for this indication is under review with the FDA and a decision is expected in the second quarter of 2021. A regulatory application seeking approval for rimegepant as potential acute as well as preventive treatment for migraine is under review in Europe. The company’s planned commercial name for rimegepant in Europe is Vydura.
Apart from Nurtec, the company is also developing three other pipeline candidates, verdiperstat, troriluzole and zavegepant.
A phase III study evaluating verdiperstat as a potential treatment for multiple system atrophy is ongoing. The candidate is also being evaluated as a potential treatment for amyotrophic lateral sclerosis in a clinical study being conducted at Massachusetts General Hospital by Healey Center. Top-line data from both studies are expected in the fourth quarter of 2021.
In January 2021, the company initiated the second phase III study on troriluzole to evaluate it as a potential treatment for obsessive compulsive disorder (“OCD”). Another identical phase III study on the candidate for OCD patients was initiated during the fourth quarter of 2020. Top-line data from these studies are expected next year. A phase III study is currently evaluating the candidate in patients with spinocerebellar ataxia. Top-line data is expected in the fourth quarter of 2021 or early 2022.
However, the company announced that troriluzole failed in a phase II/III study evaluating it as a potential treatment for Alzheimer's disease (“AD”) in January. The company is awaiting additional biomarker data and other secondary analyses to decide on the future path of the candidate in AD.
A phase III study is evaluating intranasal zavegepant as acute treatment of migraine. Top-line data from the study is expected in the second half of 2021. The company plans to initiate a phase III study to evaluate the candidate as preventive treatment of migraine by the end of March.
The company is also developing an oral formulation of the candidate in an early-stage study. The company is also developing the candidate in COVID-19 infected hospitalized patients requiring supplemental oxygen.
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
Biohaven currently has 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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