Biohaven Reports Second Quarter 2017 Results

Biohaven Pharmaceutical reported financial results for the quarter ended June 30, 2017.

"Biohaven continued to make significant progress in the second quarter of 2017 as we drive our development programs forward and prepare for the potential commercialization of multiple first-in-class and best-in-class products," said Vlad Coric, M.D., CEO of Biohaven. "In our CGRP-receptor antagonist platform, we are now underway with both of our pivotal Phase 3 clinical trials evaluating the safety and efficacy of rimegepant as an acute treatment for patients with migraine; and in our glutamate modulation platform, we are very pleased to announce that topline data from our Phase 2/3 clinical trial of trigriluzole in spinocerebellar ataxia is now advanced to the fourth quarter of this year, earlier than we had previously expected. Importantly, we continue to maintain tight financial control as we progress our key pipeline programs on or ahead of schedule, and simultaneously establish our initial commercial and business operations."

In July Biohaven announced that it commenced enrollment and dosing in both the first and the second of two pivotal Phase 3 clinical trials to evaluate the safety and efficacy of orally-dosed rimegepant (BHV-3000), a small-molecule, new chemical entity (NCE), for the acute treatment of patients with migraine. The co-primary endpoints of the trials are freedom from pain at two hours post-dosing and a demonstrated effect on the patient's most bothersome symptom (nausea, photophobia or phonophobia) at two hours post-dosing.

The company continues to progress toward filing an investigational new drug application (IND) later this year for BHV-3500, a third-generation small molecule CGRP-receptor antagonist, as a preventive treatment for patients with episodic and chronic migraine.

In August, Biohaven commenced dosing of all 141 randomized patients with SCA in its Phase 2/3 trial of trigriluzole (BHV-4157), an NCE prodrug. As a result, Biohaven now expects to receive topline results from the study in the fourth quarter of 2017, earlier than previously expected. SCA is a rare, debilitating, genetic neurodegenerative disorder with no currently approved drug treatments.

In May, the company announced that trigriluzole had received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with SCA. In addition, trigriluzole previously received Orphan Drug Designation from the FDA.

In July, the FDA granted Orphan Drug Designation to BHV-5000, an NCE, for the treatment of patients with Rett syndrome, a rare and severe genetic neurodevelopmental disorder, for which there are currently no approved drug therapies. The company expects to commence a Phase 1 pharmacokinetic trial with BHV-5000 this year.

The company continues to prepare for a bioequivalence study with BHV-0223, an NCE sub-lingual formulation of riluzole, as a potential treatment for patients with amyotrophic lateral sclerosis (ALS). The company expects to commence a bioequivalence study with BHV-0223 this year.

Cash as of June 30, 2017 was $204.3 million, compared to $52.3 million as of March 31, 2017. This increase primarily reflects the gross proceeds of approximately $194 million from the Company's initial public offering in May, partially offset by costs related to the offering and operating expenses during the quarter.

Research and development (R&D) expenses for the three and six months ended June 30, 2017, were $21.0 million and $31.8 million, respectively, compared to $5.7 million and $8.1 million for the same periods in 2016. The increases primarily reflect continued investment in Biohaven's clinical development strategy, manufacturing for product candidates, and planned growth of its development operations organization. In addition, R&D expenses includes increased non-cash incentive-based compensation.

General and administrative (G&A) expenses for the three and six months ended June 30, 2017, were $4.2 million and $8.0 million, respectively, compared to $1.1 million and $1.7 million for the same periods in 2016. The increases primarily reflect the full period impact of the company's management and administrative functions, impact of non-cash incentive-based compensation, and share appreciation of non-cash incentive-based compensation, and increases in professional fees related to the preparation, audit and review of the Company's historical financial statements.

The company reported a net loss attributable to common shareholders for the three and six months ended June 30, 2017 of ($46.4) million, or ($1.78) per share, and ($69.2) million, or ($3.54) per share, respectively, compared to ($6.8) million, or ($0.55) per share, and ($9.8) million, or ($0.81) per share for the same periods in 2016.