Biohaven Pharmaceutical ( BHVN Quick Quote BHVN - Free Report) recorded loss of $3.27 per share in third-quarter 2020, wider than the Zacks Consensus Estimate of $2.74 as well as the year-ago loss of $2.04. Adjusted loss for the third quarter was $2.67 per share compared with $1.55 in the year-ago period.
Total revenues, solely from Nurtec ODT, were $17.7 million in the third quarter. The top line missed the Zacks Consensus Estimate of $20.77 million. The company did not record any revenues in the year-ago quarter.
Shares of Biohaven were down almost 3.7% on Nov 9, 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 $57 million in the quarter, down 7.6% year over year driven by lower clinical activities related to rimegepant following its approval as Nurtec ODT.
Selling, general and administrative (SG&A) expenses were $119.5 million in the quarter, compared with $28.8 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 Sep 30, 2020, Biohaven had cash and restricted cash worth $552 million compared with $263.9 million as of Jun 30, 2020.
Biohaven stated that Nurtec ODT has demonstrated strong uptake since its launch in March 2020. Sales of the drug were up almost 80% sequentially during the third quarter despite COVID-19 related disruptions. Sales of the drug were driven by increasing market share in the rapidly growing oral CGRP segment. The company has also expanded payer coverage for the drug to over 87% of commercial lives so far. Please note that Nurtec competes with other FDA-approved anti-CGRP drugs including
Amgen’s ( AMGN Quick Quote AMGN - Free Report) Aimovig, Lilly’s ( LLY Quick Quote LLY - Free Report) Emgality and especially AbbVie’s ( ABBV Quick Quote ABBV - Free Report) oral drug, Ubrelvy. Pipeline Update
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 phase II study is evaluating the drug in patients with trigeminal neuralgia.
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. Top-line data is expected in the fourth quarter of 2021
The company plans to initiate two phase III studies on troriluzole by year-end to evaluate it as a potential treatment for obsessive compulsive disorder. A phase III study is currently evaluating the candidate in patients with spinocerebellar ataxia. Enrollment in the study is expected to be completed in the fourth quarter. The candidate is also being developed as a potential treatment for Alzheimer's disease in a phase II/III study. Top-line data is expected to be announced in the first quarter of 2021.
A phase III study evaluating intranasal zavegepant as acute treatment of migraine is enrolling patients. The company plans to develop an oral formulation of the candidate and received FDA clearance in September to initiate an early-stage study. The company is also developing the candidate in COVID-19 infected hospitalized patients requiring supplemental oxygen.
Biohaven currently has a Zacks Rank #4 (Sell).
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 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>