{"id":525185,"date":"2021-08-09T07:04:23","date_gmt":"2021-08-09T11:04:23","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/biohaven-reports-second-quarter-2021-financial-results-and-recent-business-developments\/"},"modified":"2021-08-09T07:04:23","modified_gmt":"2021-08-09T11:04:23","slug":"biohaven-reports-second-quarter-2021-financial-results-and-recent-business-developments","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/biohaven-reports-second-quarter-2021-financial-results-and-recent-business-developments\/","title":{"rendered":"Biohaven Reports Second Quarter 2021 Financial Results And Recent Business Developments"},"content":{"rendered":"
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– NURTEC\u00ae 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<\/h2>\n

– 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<\/h2>\n

– 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<\/h2>\n

– Neuroinnovation\u2122 Platform expects multiple Phase 3 study results in multiple system atrophy, spinocerebellar ataxia, amyotrophic lateral sclerosis, and obsessive-compulsive disorder in the next year<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n NEW HAVEN, Conn.<\/span>, Aug. 9, 2021<\/span> \/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<\/span>, and provided a review of recent accomplishments and anticipated upcoming milestones. <\/p>\n

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\n Vlad Coric<\/span>, 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.”<\/p>\n

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.”<\/p>\n

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\n Second Quarter and Recent Business Highlights<\/u>
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\n Continued strong uptake of NURTEC ODT <\/b>\u2013During 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.\u00a0 We believe there continues to be a significant market opportunity for oral CGRP targeting agents ahead, with a potential $4<\/span>-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.<\/p>\n

\n FDA Approves NURTEC ODT (rimegepant) for Preventive Treatment of Migraine <\/b>\u2013 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. <\/p>\n

\n United States Patent and Trademark Office awards ODT drug product patent for NURTEC ODT \u2013 <\/b>In July, the Company received notice that the United States Patent and Trademark Office (USPTO) has awarded a patent directed to our drug product, NURTEC ODT (rimegepant), as well as other CGRP inhibitors, in an ODT form. This patent will expire in March 2039<\/span>, not including patent term adjustment or any potential patent term extension.\u00a0 The patent is also pending in major market countries throughout the world including countries in Europe<\/span>, Japan<\/span> and China.\u00a0 This issuance of this patent extends the Company’s intellectual property protection for our CGRP platform until 2039.<\/p>\n

\n Biohaven and Sosei Heptares collaboration initiates Phase 1 trial with novel small-molecule CGRP antagonist <\/b>\u2013 In June, Biohaven and the Sosei Group Corporation dosed the first patient with BHV-3100 in a Phase 1 clinical study. BHV-3100 is a novel, small molecule CGRP receptor antagonist discovered by Sosei Heptares, which has demonstrated promising and differentiated properties to target CGRP-mediated disorders in preclinical development. The trial is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of a single ascending dose and multiple ascending doses of subcutaneous BHV-3100. The trial aims to enroll 88 subjects at a single center in the UK and is expected to complete in 2022. <\/p>\n

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\n Kishen Mehta<\/span> appointed to Board of Directors<\/b>\u00a0\u2013 In June, Mr. Kishen Mehta<\/span> joined Biohaven’s board. Mr. Mehta has approximately 15 years of experience in the financial industry and is currently a Portfolio Manager at Suvretta Capital Management, LLC, responsible for its healthcare-focused investment strategy, Averill, which attempts to identify companies that are disruptive to the healthcare industry.\u00a0Previously, Mr. Mehta served as a strategic advisor to Biohaven Pharmaceuticals, where he advised the company on various business development, capital structure, and communication strategies. Mr. Mehta also had roles as a portfolio manager at Surveyor Capital, a Citadel LLC strategy, where he managed a portfolio focused on global small, mid, and large-capitalization biotechnology, pharmaceutical, specialty pharmaceutical, medical device, and healthcare services companies. Prior to Surveyor, Mr. Mehta was an analyst at Adage Capital where he evaluated and participated in numerous mezzanine and pre-IPO private healthcare investments. Mr. Mehta started his career as a mergers and acquisitions analyst at Evercore Partners, where he focused on life sciences.\u00a0<\/p>\n

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\n George Clark<\/span>, CPA appointed VP, Chief Accounting Officer<\/b> \u2013 In August, the Company appointed\u00a0Mr. George Clark<\/span> as its Vice President, Chief Accounting Officer.\u00a0 Mr. Clark has been with Biohaven since 2018 and serving as Vice President of Finance.\u00a0 Prior to joining Biohaven, Mr. Clark held roles with KPMG, LLP as a Senior Audit Manager; The Hartford Financial Services Group, Inc. in external reporting and investment accounting; and began his career at PricewaterhouseCoopers, LLP.\u00a0 Mr. Clark is a graduate of the University of Connecticut<\/span> where he earned Bachelor and Master of Science degrees in Accounting and is a Certified Public Accountant.<\/p>\n

\n Upcoming Milestones:
<\/b>Biohaven is continuing to support the launch of NURTEC ODT for the acute and preventive treatment of migraine, as well as develop our product candidates through clinical and preclinical programs in a number of common and rare disorders. The Company expects to reach significant pipeline milestones with its CGRP receptor antagonists, glutamate modulators, and myeloperoxidase inhibitors in the coming quarters.<\/p>\n

Biohaven expects to:<\/p>\n