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Biohaven Pharmaceutical (BHVN) Q2 Earnings Lag, Sales Beat

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Biohaven Pharmaceutical (BHVN - Free Report) incurred a loss of $6.21 per share in second-quarter 2022, wider than the Zacks Consensus Estimate of $2.79. The company had reported a loss of $3.23 per share in the year-ago quarter.

Adjusted loss (excluding non-cash stock-based compensation and a few other non-cash expenses) in the second quarter was $3.82 per share compared with $2.62 in the year-ago quarter.

Total revenues were $215 million in the second quarter, which beat the Zacks Consensus Estimate of $209 million. The top line rose 131.4% year over year and 33% sequentially.

Shares of Biohaven have returned 6.6% this year against the industry’s decline of 17.4%.

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Quarter in Detail

Total revenues comprised product sales and collaboration and other revenues. During the quarter, Biohaven generated $194 million from Nurtec ODT product sales, up 108.7% year over year and 57% sequentially, driven by higher prescription values. In addition, an increase in average pills per prescription andimproved patient affordability support also boosted Nurtec ODT sales in the quarter

BHVN recorded $21.1 million of collaboration and other revenues derived from Pfizer (PFE - Free Report) as part of a strategic agreement signed last November for the commercialization of Nurtec ODT in the ex-U.S. markets.BHVN did not record any collaboration revenues in the year-ago period. Rimegepant was granted marketing authorization by the European Commission as an acute and preventive treatment for migraine in April. The drug will be marketed in Europe under the trade name Vydura.

In May, BHVN and Pfizer entered into a definitive agreement wherein the latter will acquire the former for $148.50 per share or an aggregate equity value of $11.6 million.The acquisition deal, unanimously approved by the boards of directors of both companies, is subject to customary closing conditions, including approval from Biohaven’s shareholders and regulatory authorities. The transaction is expected to be completed by early 2023.

Research and development (R&D) expenses, including stock-based compensation, were $218.5 million in the quarter, up 182.2% year over year, primarily driven by the acquisition of Kv7 Ion Channel Platform from Knopp Bioscineces in April, development milestones of BHV-7000, its epilepsy candidate, and other increased program expenses for rimegepant.

Selling, general and administrative (SG&A) expenses were $250.5 million in the quarter, up 47.3% from the year-ago period’s level. The significant increase in SG&A expenses is due to higher costs to support the commercialization of Nurtec.

As of Jun 30, 2022, Biohaven had cash and restricted cash worth $553.5 million compared with $602.5 million as of Mar 31, 2022.

2022 Guidance

Biohaven reiterated its financial guidance for 2022. BHVN expects product revenues from Nurtec ODT to be between $825 million and $900 million in 2022.

Pipeline Updates

In May, Biohaven announced that the FDA accepted its zavegepant new drug application (NDA) for review.The NDA is seeking approval for its intranasal formulation of the small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, zavegepant nasal spray, as an acute treatment of migraine.The FDA is expected to provide its decision related to zavegepant NDA in the first quarter of 2023.

The most advanced product candidate of the company, troriluzole, which is in multiple phase III studies.

In May, Biohaven reported top-line data from a phase III study evaluating the efficacy and safety of troriluzole, for spinocerebellar ataxia (SCA). The study failed to reach its primary endpoint. The post hoc analysis of efficacy measures by genotype suggested a treatment effect in patients with SCA Type 3 genotype (the most common form of SCA), which accounted for 41% of the study population. Due to the lack of FDA-approved treatments, the company intends to work with the FDA to move the program forward as a potential treatment for the disease.

The company also intends to complete patient enrollment in the phase III study of troriluzole for obsessive compulsive disorder.

Last year in December, the Global Coalition for Adaptive Research (GCAR) selected troriluzole in GBM AGILE, a patient-centered, adaptive platform study for patients with newly-diagnosed and recurrent gin glioblastoma (GBM). In July 2022, the Company and GCAR announced that enrollment has commenced in GBM AGILE for the evaluation of troriluzole.

In July, Biohaven initiated enrollment in a phase III study to assess the safety and efficacy of taldefgrobep alfa, a muscle-targeted recombinant protein, in patients with spinal muscle atrophy (SMA).The phase III RESILIENT study expects to enroll 180 patients.

 

Zacks Rank & Stock to Consider

Biohaven currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the same sector are Novavax (NVAX - Free Report) and Sesen Bio (SESN - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Novavax’s earnings estimates for 2022 have remained steady at $27.23 over the past 30 days. Shares of NVAX have declined 20.8% year to date. Earnings of Novavax missed estimates in all of the last four quarters. NVAX delivered a negative earnings surprise of 184.49%, on average.

Sesen Bio’s loss estimates for 2022 have remained steady at 44 cents per share over the past 30 days. Shares of SESN have declined 20.9% year to date. Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion. SESN delivered an earnings surprise of 69.94%, on average.