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Nature of the Business and Basis of Presentation Biohaven Pharmaceutical Holding Company Ltd. (“we,” “us”, "our," "Biohaven" or the “Company”) was incorporated in Tortola, British Virgin Islands in September 2013. We are a biopharmaceutical company with a portfolio of innovative product candidates targeting neurological diseases, including rare disorders. The Company's lead product, NURTEC™ ODT (rimegepant), was approved by the U.S. Food and Drug Administration ("FDA") on February 27, 2020, which became available by prescription in U.S. pharmacies on March 12, 2020, and was approved for the preventive treatment of migraine on May 27, 2021. NURTEC ODT is the first and only calcitonin gene-related peptide ("CGRP") receptor antagonist available in a quick-dissolve orally dissolving tablet ("ODT") formulation that is approved by the FDA for both the acute and preventive treatment of migraine in adults. Our other late-stage product candidates are based on multiple mechanisms — CGRP receptor antagonists, glutamate modulators and myeloperoxidase inhibition—which we believe have the potential to significantly alter existing treatment approaches across a diverse set of neurological indications with high unmet need in both large and orphan indications.
The Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including, but not limited to, the risks associated with developing product candidates at each stage of non-clinical and clinical development; the challenges associated with gaining regulatory approval of such product candidates; the risks associated with commercializing pharmaceutical products for marketing and sale; the potential for development by third parties of new technological innovations that may compete with the Company’s products; the dependence on key personnel; the challenges of protecting proprietary technology; the need to comply with government regulations; the high costs of drug development; and the uncertainty of being able to secure additional capital when needed to fund operations.
Subsequent to its May 2017 initial public offering, the Company has primarily raised funds through sales of equity in private placements and public offerings, sales of revenue participation rights related to potential future royalties, and a debt financing. On November 9, 2021, the Company and certain of its affiliates (collectively, the “Company”) entered into a licensing and collaboration arrangement (the “Collaboration Agreement”) with a subsidiary of Pfizer Inc. (“Pfizer”) pursuant to which Pfizer would commercialize product candidates containing the Company’s proprietary compounds rimegepant (BHV-3000) and gain rights to zavegepant
(BHV-3500) (the “Licensed Products”) in all countries worldwide outside of the United States (the “Territory”). The Collaboration Agreement became effective on January 4, 2022. Refer to Note 19, "Subsequent Events," for further details.
The Company has incurred recurring losses since its inception, had an accumulated deficit as of December 31, 2021, and expects to continue to generate operating losses during the continued commercial launch of rimegepant. To execute its business plans, the Company will continue to require additional funding to support its continuing operations and pursue its growth strategy.
Through the date of the issuance of this Form 10-K, the Company has funded its operations primarily with proceeds from sales of preferred and common shares, issuance of debt and and proceeds from our Subscription Agreement and Collaboration Agreement with Pfizer (see Note 19). The Company has incurred recurring losses since its inception, including net losses attributable to the Company of $846,586, $766,796, and $528,805 during the years ended December 31, 2021, 2020 and 2019, respectively, and had an accumulated deficit of $2,585,755 as of December 31, 2021. As a result of the Company’s commercial launch of NURTEC ODT, the continued developmen