Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, today reported financial results for the third quarter ended September 30, 2020, and provided a review of recent accomplishments and anticipated upcoming milestones.

Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "In just over six months from launch, NURTEC ODT is changing the standard treatment paradigm of migraine as reflected by attaining more than 220,000 prescriptions written by over 20,000 health care providers in such a short period. We are very pleased to report NURTEC ODT net revenues of $17.7 million in the third quarter, which greatly exceeded our initial expectations, particularly given the challenges of the global pandemic. We believe a significant opportunity exists to expand the oral CGRP market, as this new mechanism represents a transformative solution for patients with migraine beyond generic and over the counter medications. NURTEC ODT's differentiated profile, marked by notably high levels of patient and physician satisfaction, continues to drive the success of our ongoing launch and our team continues to excel in attracting new patients and ensuring broad insurance coverage."

Dr. Coric added, "We believe oral CGRP antagonists for the acute treatment of migraine will become blockbuster drugs and have the potential to grow into a $4B to 5B annual market in the US alone. The successful launch of NURTEC ODT represents the very beginning of Biohaven's commitment to bring novel treatments to patients suffering from neurologic and neuropsychiatric disorders. We remain excited about the prospects for the remainder of our pipeline, particularly with respect to the acceptance of our recent sNDA filing for the preventive treatment of migraine, the upcoming Alzheimer's disease topline data with troriluzole and our rare disease portfolio. In addition to our commitment to common diseases such as migraine, OCD and Alzheimer's disease, we are advancing three therapies for devastating rare diseases which have the potential for significant value creation from our neuroinnovation pipeline of investigational drugs."

Third Quarter and Recent Business Highlights

Continued strong uptake of NURTEC™ ODT – The Company remains focused on investing in the long-term success of the launch by driving market share in this rapidly growing oral CGRP class and is beginning to observe a positive return on investment with an expanding base of patients benefiting from treatment and increasing physician advocacy for NURTEC ODT's differentiated profile. The Company expects this market growth and momentum to continue for years to come. The Company continues to expand payer coverage for NURTEC ODT to over 87% of commercial lives.

Third quarter prescription totals were fueled by strong oral CGRP class growth despite the challenges of COVID-19 on industry trends. The Company expects strong Net Sales of NURTEC ODT in the coming year and beyond.

The Company continues to prioritize the global expansion of NURTEC ODT and expects to make future regulatory filings in NURTEC ODT in Europe, Japan, China, and other regions.

U.S. FDA accepted Biohaven's NURTEC ODT sNDA filing for the preventative treatment of migraine - In October, the Company announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review its recently submitted supplemental New Drug Application (sNDA) for NURTEC ODT (rimegepant) for the preventive treatment of migraine. In addition to the proven acute treatment of migraine, NURTEC ODT has been shown to reduce monthly migraine days at the same 75 mg dose administered every other day for preventive treatment. NURTEC ODT is the first CGRP-targeting agent to file for regulatory approval as a single medication to treat both acute episodes and prevent future migraine attacks. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review is set for the second quarter of 2021.

Global expansion of clinical portfolio to take place in the Asia-Pacific region - In September, Biohaven's Asia-Pacific subsidiary, BioShin, raised $60.0 million in Series A funding. The Series A funds will be used to build out BioShin in China and advance the Company's clinical portfolio in the region, including the recent initiation of the NURTEC ODT (rimegepant) Phase 3 study for the acute treatment of migraine in China and Korea. BioShin also plans to initiate sites in China to participate in the global registrational trial of troriluzole in Spinocerebellar Ataxia (SCA). BioShin expects to begin both Asia-Pacific studies in the fourth quarter of 2020. BioShin has rights to the Biohaven portfolio for the entire Asia-Pacific region excluding Japan. After the transaction, Biohaven remains the majority shareholder of BioShin.

The BioShin investment signals Biohaven's commitment to the robust execution of established distribution agreements to ultimately bring NURTEC ODT to other regions outside the U.S., including Israel and the Middle East. Biohaven expects to submit regulatory filings for NURTEC ODT in Europe, Japan and China.

Biohaven's oral formulations of zavegepant received U.S. FDA authorization to proceed with human dosing – In September, Biohaven achieved first in human dosing in a Phase 1 trial designed to assess the safety and pharmacokinetic profile of oral zavegepant (formerly BHV-3500). Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist in development for both migraine and non-migraine indications including COVID-19 associated lung inflammation. The zavegepant program encompasses intranasal zavegepant as well as oral formulations of zavegepant for migraine and non-migraine indications. Intranasal zavegepant previously demonstrated superior efficacy to placebo in a Phase 2/3 study for the acute treatment of migraine -- a second Phase 3 trial of intranasal zavegepant for the acute treatment of migraine was initiated in October 2020. Intranasal zavegepant is also being studied in an ongoing double blind, randomized, placebo-controlled trial in COVID-19 infected hospitalized patients requiring supplemental oxygen.

Intra-entity intellectual property transfer to Irish subsidiary – In August, Biohaven completed an intra-entity asset transfer of rimegepant intellectual property to the Company's Irish subsidiary. As a result of the transfer, the Company recorded a deferred tax asset (DTA) of $875.0 million for the step up in tax basis received pursuant to Irish tax law. The Company established a full valuation allowance against the DTA due to the current lack of net operating income history of its subsidiary. Tax deductions for amortization of the DTA will be recognized in the future, if the Company generates adequate net operating income, and any amortization not deducted for tax purposes will be carried forward indefinitely under Irish tax laws.

Upcoming Milestones: Biohaven is continuing to support the launch of NURTEC ODT and develop its 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.

Biohaven expects to:

• Continue to advance the rimegepant NURTEC ODT program through commercialization for the acute treatment of migraine.
• Prepare to progress rimegepant toward commercialization in preventive treatment of migraine.
• Initiate two Phase 3 clinical trials for troriluzole in OCD in 2020 after receiving feedback from the FDA End of Phase 2 meeting.
• Complete enrollment in Phase 3 trial of troriluzole in Spinocerebellar Ataxia in the fourth quarter of 2020.
• Complete last patient, last visit in the ongoing troriluzole Phase 2/3 Alzheimer's disease trial in the fourth quarter of 2020 and report topline data by the first quarter of 2021.
• Continue enrolling patients in Phase 3 trial evaluating the safety and efficacy of intranasal zavegepant in the acute treatment of migraine.
• Continue enrolling patients in Phase 2 proof of concept trial evaluating the safety and efficacy of rimegepant in patients with treatment refractory trigeminal neuralgia.
• Report topline of verdiperstat for the treatment of multiple system atrophy (MSA) expected in the fourth quarter of 2021.
• Conduct ongoing non-clinical studies to support the advancement of TDP-43 and UC1MT, a therapeutic antibody targeting extracellular metallothionein.

Third Quarter Financial Results

Product Revenues, Net: We recorded net product revenues of $17.7 million in the third quarter of 2020, net of sales allowances and rebates, related to sales of NURTEC ODT.

Cash and Marketable Securities: Cash, restricted cash, and marketable securities as of September 30, 2020, was $552.0 million, compared to $263.9 million as of June 30, 2020. In addition, the Company has access to $100.0 million of the remaining $525.0 million non-equity-based financings entered into with Sixth Street Specialty Lending, Inc. and RPI Intermediate Finance Trust in August.

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $57.0 million for the three months ended September 30, 2020, compared to $61.7 million for the three months ended September 30, 2019. The decrease of $4.6 million was primarily due to no longer including drug supply of rimegepant in R&D expense now that the drug is approved. Non-cash share-based compensation expense was $5.3 million for the three months ended September 30, 2020, an increase of $1.6 million as compared to the same period in 2019.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses, including non-cash share-based compensation costs, were $119.5 million for the three months ended September 30, 2020, compared to $28.8 million for the three months ended September 30, 2019. The increase of $90.8 million was primarily due to increases in spending to support the commercial launch of NURTEC ODT in 2020. Less than half of the SG&A expense, or approximately $42.0 million, was for commercial organization personnel costs, excluding non-cash share-based compensation expense. Non-cash share-based compensation expense was $9.3 million for the three months ended September 30, 2020, an increase of $3.0 million as compared to the same period in 2019.

Net Loss: Biohaven reported a net loss attributable to common shareholders for the three months ended September 30, 2020 of $195.2 million, or $3.27 per share, compared to $106.2 million, or $2.04 per share for the same period in 2019. Non-GAAP adjusted net loss for the three months ended September 30, 2020 was $159.5 million, or $2.67 per share, compared to $80.8 million, or $1.55 per share for the same period in 2019. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges, non-cash interest expense related to the accounting for our mandatorily redeemable preferred shares and liability related to sale of future royalties, changes in the fair value of our derivatives, and losses from our equity method investment. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

About Biohaven

Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and MPO inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.