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EX - 99 2 a2021q2bhvnearningsprex991.htm EX - 99.1 Exhibit 99.1 BIOHAVEN REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS AND RECENT BUSINESS DEVELOPMENTS - NURTEC® ODT ( rimegepant ) becomes the first oral CGRP targeting agent approved for the prevention of migraine , and is the only migraine medication now approved for both acute and preventive treatment - NURTEC ODT brand performance continues to exceed expectations , reporting $ 93 million in net product revenue for the second quarter of 2021 , totaling approximately $ 200 million in net product revenues and over 875,000 prescriptions from product launch to date - Biohaven awarded ODT formulation patent for NURTEC ODT , as well as other CGRP inhibitors in an ODT form , extending the Company's intellectual property protection for the platform until 2039 - Neuroinnovation ™ Platform expects multiple Phase 3 study results in multiple system atrophy , spinocerebellar ataxia , amyotrophic lateral sclerosis , and obsessive - compulsive disorder in the next year NEW HAVEN , Conn . , Aug. 9 , 2021 / PRNewswire / – Biohaven Pharmaceutical Holding Company Ltd. ( NYSE : BHVN ) , a biopharmaceutical company with a portfolio of innovative , late - stage product candidates targeting neurological diseases including rare disorders , today reported financial results for the second quarter ended June 30 , 2021 , and provided a review of recent accomplishments and anticipated upcoming milestones . Vlad Coric , M.D. , Chief Executive Officer of Biohaven commented , " Once again , the Biohaven team has outperformed business expectations for our CGRP receptor antagonist platform . Demand for NURTEC ODT is strong and our differentiated product is changing the paradigm by which migraine is treated . We are extremely proud of the success of our platform over the quarter , unlocking a sizable opportunity through the landmark approval of NURTEC ODT for both the acute and preventive treatment of migraine , while simultaneously bolstering innovation , and advancing clinical programs outside of our CGRP receptor antagonist franchise . " Dr. Coric continued , “ We believe NURTEC ODT will continue to drive impressive revenue growth , but the true value is in the improved quality of life for those individuals who now have a one - stop solution for acute and preventive treatment of migraine . We are excited to pursue the science of CGRP antagonism with our broad platform of CGRP assets in pain adjacencies and non - migraine indications that we believe are driven by neuroimmune / neuroinflammatory interactions . The life - cycle management studies of NURTEC ODT and our other clinical CGRP - targeting assets including intranasal zavegepant , oral zavegepant , and BHV - 3100 will pursue multiple indications with the goal of growing an industry leading CGRP franchise . ” Second Quarter and Recent Business Highlights Continued strong uptake of NURTEC ODT – During the second quarter of 2021 , the Company saw significant net revenue growth , more than doubling over the first quarter of 2021 , driven by improvement in both net price realization and volume . We believe there continues to be a significant market opportunity for oral CGRP targeting agents ahead , with a potential $ 4-5 billion annual market in the U.S. alone for the acute treatment of migraine . We will continue to invest in NURTEC's long term success , driving its growth outside of the U.S. and continuing to expand commercial payer coverage . Despite the industry - wide commercial challenges throughout the pandemic , NURTEC ODT has now achieved over 875,000 prescriptions and over 44,000 unique prescribers to date and continues to exceed revenue expectations . FDA Approves NURTEC ODT ( rimegepant ) for Preventive Treatment of Migraine – In May , the Company announced that the FDA approved NURTEC ODT for the preventive treatment of episodic migraine . This milestone approval makes NURTEC ODT the first and only medication approved to both treat and prevent migraine attacks , expanding the product label to include the use of NURTEC ODT 75 mg up to 18 doses per month . In the pivotal Phase 3 clinical trial , NURTEC rapidly and effectively prevented migraine , reducing migraine days by 30 % after just 1 week of every other day treatment ; by 3 months of treatment , approximately half of patients experienced at least a 50 % reduction in moderate - to - severe migraine days .