On November 9, 2021 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, reported financial results for the third quarter ended September 30, 2021, and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, Biohaven Pharmaceutical, NOV 9, 2021, View Source [SID1234594930]).

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"We are ecstatic with the success that our platform continued to achieve over the quarter, with NURTEC ODT impressively surpassing revenue expectations, and becoming the market leader in oral CGRP targeting migraine therapies," said Vlad Coric, M.D., Chief Executive Officer of Biohaven. "We are further encouraged by the overwhelmingly positive patient experience to date, recognizing the value of providing a solution that will further improve the quality of life of those who are now able to prevent the debilitating effects of migraine. While there remains significant upside for NURTEC ODT across new geographies and patient demographics given the expanded preventive treatment use, we also look forward to the continuous progress made outside of our CGRP franchise and within our broad pipeline."

Dr. Coric continued, "We are also excited to have announced a strategic collaboration with pharmaceutical powerhouse Pfizer for the global commercialization ex-US of NURTEC ODT, validating the medicine’s dual therapy potential and highlighting our commitment to the more than 1 billion patients worldwide suffering with migraine."

Link to Pfizer Press Release Here.

Third Quarter and Recent Business Highlights

Continued strong uptake of NURTEC ODT – Following the landmark approval of NURTEC ODT for the preventive treatment of migraine in May, we believe NURTEC ODT will continue its impressive growth as the first and only medication approved to both treat and prevent migraine attacks. NURTEC ODT has now achieved over 1,100,000 prescriptions, and over 53,000 unique prescribers to date, an increase of 15,000 prescribers from the second quarter signaling traction with physicians. The $136 million in net product revenues for the quarter represents a 46% increase from net product revenues over the second quarter, significantly exceeding expectations. We saw a continuation of the improvement in net price realization in the third quarter 2021, as compared to the first quarter of 2021.

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 US alone. 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.

Entered into second amendment to term loan financing facility – In September 2021, the Company, Biohaven Pharmaceuticals, Inc., a wholly-owned subsidiary of the Company (together with the Company, the "Borrowers"), and certain other of the Company’s subsidiaries entered into an Amendment No. 2 (the "Second Amendment") to its Financing Agreement dated as of August 7, 2020 with Sixth Street Specialty Lending, Inc. Pursuant to the Second Amendment, the parties agreed, among other things, to increase the total size of the credit facility by $250.0 million to $750.0 million, and reduce the interest rate margin (as defined in the Sixth Street Financing Agreement) by 0.75% on the amounts made available under the amendment and the remaining $100.0 million not previously drawn on the August 2020 agreement. On closing of the amendment, the Company drew $125.0 million made available from the amendment, and the $100.0 million remaining under the August 2020 agreement. The remaining $125.0 million available under the facility remains available at the Company’s discretion until December 31, 2021.

Presented expanded NURTEC ODT and intranasal zavegepant data at the International Headache Society – European Headache Federation Joint Congress – In September, the Company presented 17 abstracts, including three late-breaking abstracts and four oral presentations, highlighting the efficacy and safety of NURTEC ODT as both an acute and preventive treatment of migraine. Within the Phase 2/3 study, preventive effects of rimegepant were evident as early as the first week of treatment and sustained after 12 weeks. Results from an open label safety study of rimegepant demonstrated its preventive benefits when dosed on an as needed basis to treat migraine attacks, expressed as median time to 30% and 50% reduction in monthly migraine days observed to decrease at 12 weeks and 32 weeks respectively. Within the Phase 2/3 dose-ranging study evaluating the safety, efficacy and tolerability of intranasal zavegepant, it was found that both 10 mg and 20 mg doses were superior to placebo on the coprimary endpoints of pain freedom. Lastly, health economics and outcomes research posters highlighted the association between migraine-related absenteeism, healthcare utilization and cost of care.

Phase 3 clinical trial of verdiperstat in MSA did not statistically differentiate from placebo on the study’s prespecified primary or secondary efficacy measures – In September, the Company announced that verdiperstat did not demonstrate efficacy for the treatment of multiple system atrophy (MSA). Although the mechanism of action for verdiperstat, myeloperoxidase inhibition, was shown not to be effective for MSA, Biohaven maintains that there remains a strong rationale of targeting brain inflammation in other disease states. An ongoing clinical trial evaluating the efficacy of verdiperstat in amyotrophic lateral sclerosis (ALS) is being conducted in collaboration with the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and is expected to complete enrollment in the fourth quarter of 2021.

Upcoming Milestones:

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.

Biohaven expects to:

Continue to advance the commercialization of NURTEC ODT (rimegepant) for the acute and preventive treatment of migraine outside of the U.S.
Report topline of intranasal zavegepant in the acute treatment of migraine in the fourth quarter of 2021.
Complete enrollment of verdiperstat for the treatment of ALS in the fourth quarter of 2021.
Marketing Authorization Application for rimegepant dual activity, inclusive of acute and prevention of migraine expected regulatory approval in the first half of 2022.
Report topline of NURTEC ODT for the acute treatment of migraine in China and Korea in the first half of 2022.
Report topline of troriluzole in Spinocerebellar Ataxia in the first half of 2022.
Report topline of troriluzole in OCD in the second half of 2022.
Third Quarter Financial Results

Product Revenues, Net: Net product revenue was $135.7 million for the three months ended September 30, 2021, compared to $17.7 million for the three months ended September 30, 2020. The increase of $118.1 million in net product revenues is due to both increased NURTEC ODT sales volume and improvements in net price realization due to decreases in sales allowances during the three months ended September 30, 2021, compared to the three months ended September 30, 2020. Sales allowances and accruals mostly consisted of patient affordability programs, distribution fees and rebates.

Cash, Restricted Cash, and Marketable Securities: Cash, restricted cash, and marketable securities as of September 30, 2021, was $523.9 million, compared to $368.0 million as of June 30, 2021. In addition, the Company has access to $125.0 million in available borrowing under our credit facility, and Series B preferred share forward contracts with quarterly cash proceeds totaling $147.2 million until the fourth quarter of 2024.

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $85.7 million for the three months ended September 30, 2021, compared to $57.0 million for the three months ended September 30, 2020. The increase of $28.6 million was primarily due to an increase in both late-stage product candidates and preclinical research. Non-cash share-based compensation expense was $13.1 million for the three months ended September 30, 2021, an increase of $7.9 million as compared to the same period in 2020.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses, including non-cash share-based compensation costs, were $164.5 million for the three months ended September 30, 2021, compared to $119.5 million for the three months ended September 30, 2020. The increase of $45.0 million was primarily due to increases in spending to support increased commercial sales of NURTEC ODT for the three months ended September 30, 2021, compared to the three months ended September 30, 2020. Less than half of the SG&A expense was for commercial organization personnel costs, excluding non-cash share-based compensation expense. Non-cash share-based compensation expense was $14.9 million for the three months ended September 30, 2021, an increase of $5.5 million as compared to the same period in 2020.

Net Loss: Biohaven reported a net loss attributable to common shareholders for the three months ended September 30, 2021, of $171.8 million, or $2.63 per share, compared to $195.2 million, or $3.27 per share for the same period in 2020. Non-GAAP adjusted net loss for the three months ended September 30, 2021 was $125.1 million, or $1.91 per share, compared to $159.5 million, or $2.67 per share for the same period in 2020. 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 mandatorily redeemable preferred shares and liability related to sale of future royalties, changes in the fair value of derivatives, gains or losses from equity method investment, collaboration and license upfront expenses, and accrued development milestone payments. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

Conference Call Information

As previously announced, the Company will hold a conference call to discuss its third quarter 2021 results today at 8:00 a.m. EDT. To access the call, please dial 877-407-9120 (domestic) or 412-902-1009 (international). The conference call webcast, and accompanying slide presentation, can be accessed through the "Investors" section of Biohaven’s website at www.biohavenpharma.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the call will be made available for two weeks following the conference call. To hear a replay of the call, dial 877-660-6853 (domestic) or 201-612-7415 (international) with conference ID 13723890. An archived webcast will be available on Biohaven’s website.