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NEW HAVEN, Conn.<\/span><\/span>, Aug. 5, 2022<\/span><\/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, 2022<\/span>, and provided a review of recent accomplishments during and anticipated upcoming milestones.<\/p>\n<\/p>\n Vlad Coric<\/span>, M.D., Chairman and Chief Executive Officer of Biohaven, commented, “As expected, we observed a strong rebound in NURTEC ODT net revenue as first quarter seasonal dynamics abated. Net product revenue of $194 million<\/span> for the quarter represented a 57% sequential increase compared to the first quarter and reflects strong product demand. In addition, the sales mix of our 2-pack (16-tablet count) of Nurtec ODT continued to ramp in the second quarter. Investments made in first quarter copay programs drove volume and net revenue growth, and the benefits of the only ‘all-in-one’ therapy to treat and prevent migraine continued to resonate with and improve the lives of patients living with migraine. And now, with the intranasal zavegepant NDA filing acceptance, we are closer to bringing a new, critical medication to market that offers migraine patients ultra-rapid relief in as early as 15 minutes, and addresses the needs of patients experiencing nausea or vomiting who need non-oral treatment options.”<\/p>\n Dr. Coric continued, “We are excited about the vast opportunities beyond CGRP and have made tremendous strides across our broader pipeline, starting with our program in focal epilepsy with what we believe is a best-in-class approach to Kv7 potassium channel activation. We are working hard to expedite enrollment in our Phase 1 trial and look forward to exploring its potential in other epilepsy types as well as in pain and affective disorders. Likewise, we recently dosed the first subject in our Phase 3 trial evaluating taldefgrobep alfa in subjects with Spinal Muscular Atrophy (SMA); we look forward to driving enrollment in this trial and exploring the potential of taldefgrobep alfa in additional indications. We also remain on track to report topline results from the verdiperstat arm of the platform trial in ALS, sponsored by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital in the second half of the year. We are excited about the paradigm-shifting approaches we’re exploring across our expanding pipeline and will continue working determinedly to improve outcomes for patients living with neuroscience diseases.” <\/p>\n Second Quarter and Recent Business Highlights<\/span><\/p>\n Upcoming Milestones:<\/span><\/p>\n Biohaven is continuing to support the commercialization of NURTEC ODT for the acute and preventive treatment of migraine, as well as 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 across its platforms in the coming quarters.<\/p>\n Biohaven expects to:<\/p>\n Capital Position:<\/span><\/p>\n Cash, cash equivalents, and marketable securities as of June 30, 2022<\/span>, were $553.5 million<\/span>, excluding $0.8 million<\/span> of restricted cash, compared to $364.6 million<\/span> as of December 31, 2021<\/span>. On January 4, 2022<\/span>, we received $500.0 million<\/span> in upfront proceeds from Pfizer relating to our strategic collaboration arrangement, consisting of $150.0 million<\/span> cash and $350.0 million<\/span> in proceeds from the purchase of Biohaven common shares at a 25% market premium. In addition, during the second quarter of 2022 we drew $125.0 million<\/span> in non-dilutive committed capital from our credit facility with Sixth Street.<\/p>\n Second Quarter 2022 Financial Highlights<\/span><\/p>\n Product Revenue, Net: Net product revenue was $194.0 million<\/span> for the three months ended June 30, 2022<\/span>, compared to $92.9 million<\/span> for the three months ended June 30, 2021<\/span>. The increase of $101.0 million<\/span> in net product revenue was primarily due to increased NURTEC ODT sales volume as well as an increase in average pills per prescription during the three months ended June 30, 2022<\/span>, compared to the three months ended June 30, 2021<\/span>. The increase in the second quarter of 2022 compared to the second quarter of 2021 was also benefited from improved patient affordability support, partially offset by additional rebate related sales allowances.<\/p>\n Collaboration and Other Revenue: Collaboration and other revenue was $21.1 million<\/span> for the three months ended June 30, 2022<\/span>. No collaboration and other revenue was recognized for the three months ended June 30, 2021<\/span>. The collaboration and other revenue recognized during the three months ended June 30, 2022<\/span> was primarily due to $20.0 million<\/span> of variable consideration recognized as part of our collaboration arrangement with Pfizer.<\/p>\n Research and Development (“R&D”) Expenses: R&D expenses, including non-cash share-based compensation costs, were $218.5 million<\/span> for the three months ended June 30, 2022<\/span>, compared to $77.4 million<\/span> for the three months ended June 30, 2021<\/span>. The increase of $141.1 million<\/span> was primarily due to the acquisition of our Kv7 Platform from Knopp Biosciences LLC in April 2022<\/span> for $93.7<\/span> million and a $25.0 million<\/span> development milestone related to BHV-7000, increased program expenses for rimegepant, and increased personnel costs. Non-cash share-based compensation expense was $16.6 million<\/span> for the three months ended June 30, 2022<\/span>, an increase of $7.4 million<\/span> as compared to the same period in 2021.<\/p>\n Selling, General and Administrative (“SG&A”) Expenses: SG&A expenses, including non-cash share-based compensation costs, were $250.5 million<\/span> for the three months ended June 30, 2022<\/span>, compared to $170.1 million<\/span> for the three months ended June 30, 2021<\/span>. The increase of $80.4 million<\/span> was primarily due to increases in spending to support increased commercial sales of NURTEC ODT, including the launch of NURTEC ODT for the preventative treatment of migraine which was approved by the FDA in May of 2021. Additionally, approximately $9.6 million<\/span> of the increased SG&A expense related to fees incurred in connection with the Pfizer Merger, including increased legal and accounting costs. 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 $23.6 million<\/span> for the three months ended June 30, 2022<\/span>, an increase of $7.3 million<\/span> as compared to the same period in 2021.<\/p>\n Other Expense, Net: Other expense, net was $152.2 million<\/span> for the three months ended June 30, 2022<\/span>, compared to $34.9 million<\/span> for the three months ended June 30, 2021<\/span>. The increase of $117.3 million<\/span> in net expense was primarily due to a $109<\/span>.7 million change in fair value of derivative liabilities, as well as $9<\/span>.3 million of increased interest expense as a result of additional borrowings under our debt facility with Sixth Street Specialty Lending, Inc. (“Sixth Street”). The change in fair value of derivative liabilities was a result of derivative liabilities recorded in connection with change of control provisions associated with the pending acquisition of Biohaven by Pfizer for our series A and B preferred shares and term loans with Sixth Street.<\/p>\n Net Loss: Biohaven reported a net loss attributable to common shareholders for the three months ended June 30, 2022<\/span>, of $441.4 million<\/span>, or $6.21<\/span> per share, compared to $210.6 million<\/span>, or $3.23<\/span> per share for the same period in 2021. Anticipated closing of the merger agreement necessitates accounting of derivative losses in the amount of $1.57<\/span> per share resulting in a total second quarter reported net loss of $6.21<\/span> per share. Non-GAAP adjusted net loss for the three months ended June 30, 2022<\/span> was $271.4 million<\/span>, or $3.82<\/span> per share, compared to $170.9 million<\/span>, or $2.62<\/span> per share for the same period in 2021. 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 and gains or losses from equity method investment. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.<\/p>\n Non-GAAP Financial Measures<\/p>\n This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States<\/span> (GAAP), and also certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, adjusted to exclude the items below. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss and adjusted net loss per share, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance. These measures exclude (i) non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, (ii) interest expense related to the accounting for our mandatorily redeemable preferred shares and liability related to sale of future royalties, which are in excess of the actual interest owed, (iii) changes in the fair value of derivative liability, which does not correlate to actual cash payment obligations in the relevant periods, and (iv) gains or losses from equity method investment, which are non-cash and based on the financial results and valuation of another company that we did not manage or control.<\/p>\n Biohaven believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding Biohaven’s results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of Biohaven’s ongoing operating performance and are better able to compare Biohaven’s performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.<\/p>\n About Biohaven<\/p>\n Biohaven is a global commercial-stage biopharmaceutical company with a portfolio of innovative therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven’s Neuroinnovation\u2122 portfolio includes FDA-approved NURTEC® ODT (rimegepant) for the acute and preventive treatment of migraine (EMA-approved as VYDURA®<\/span> for the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month) and a broad pipeline of late-stage product candidates across five distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine and other CGRP-mediated diseases; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia; myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis; Kv7 ion channel activators for focal epilepsy and neuronal hyperexcitability, and myostatin inhibition for neuromuscular diseases. More information about Biohaven is available at www.biohavenpharma.com.<\/p>\n Forward-Looking Statements<\/p>\n This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe”, “continue”, “may”, “will”, “anticipate”, “expect” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven’s management about NURTEC ODT as an acute treatment for patients with migraine and preventive treatment for migraine. Factors that could affect these forward-looking statements include those related to: Biohaven’s ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven’s planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; the potential commercialization of Biohaven’s product candidates; the potential for Biohaven’s product candidates to be first in class or best in class therapies; and the effectiveness and safety of Biohaven’s product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2022<\/span>, and in Biohaven’s subsequent filings with the Securities and Exchange Commission. The forward-looking statements are made as of the date of this new release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.<\/p>\n BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.<\/span><\/p>\n<\/td>\n<\/tr>\n CONSOLIDATED STATEMENTS OF OPERATIONS<\/span><\/p>\n<\/td>\n<\/tr>\n (Amounts in thousands, except share and per share amounts)<\/span><\/p>\n<\/td>\n<\/tr>\n (Unaudited)<\/span><\/p>\n<\/td>\n<\/tr>\n Three Months Ended June 30,<\/span><\/p>\n<\/td>\n Six Months Ended June 30,<\/span><\/p>\n<\/td>\n<\/tr>\n 2022<\/span><\/p>\n<\/td>\n 2021<\/span><\/p>\n<\/td>\n 2022<\/span><\/p>\n<\/td>\n 2021<\/span><\/p>\n<\/td>\n<\/tr>\n Revenues:<\/span><\/p>\n<\/td>\n Product revenue, net<\/span><\/p>\n<\/td>\n $ 193,954<\/span><\/p>\n<\/td>\n $ 92,933<\/span><\/p>\n<\/td>\n $ 317,544<\/span><\/p>\n<\/td>\n $ 136,756<\/span><\/p>\n<\/td>\n<\/tr>\n Collaboration and other revenue<\/span><\/p>\n<\/td>\n 21,125<\/span><\/p>\n<\/td>\n \u2014<\/span><\/p>\n<\/td>\n 216,387<\/span><\/p>\n<\/td>\n \u2014<\/span><\/p>\n<\/td>\n<\/tr>\n Total revenue<\/span><\/p>\n<\/td>\n 215,079<\/span><\/p>\n<\/td>\n 92,933<\/span><\/p>\n<\/td>\n 533,931<\/span><\/p>\n<\/td>\n 136,756<\/span><\/p>\n<\/td>\n<\/tr>\n Operating expenses:<\/span><\/p>\n<\/td>\n Cost of sales<\/span><\/p>\n<\/td>\n 35,741<\/span><\/p>\n<\/td>\n 17,339<\/span><\/p>\n<\/td>\n 62,083<\/span><\/p>\n<\/td>\n 30,201<\/span><\/p>\n<\/td>\n<\/tr>\n Research and development<\/span><\/p>\n<\/td>\n 218,480<\/span><\/p>\n<\/td>\n 77,428<\/span><\/p>\n<\/td>\n 337,579<\/span><\/p>\n<\/td>\n 184,539<\/span><\/p>\n<\/td>\n<\/tr>\n Selling, general and administrative<\/span><\/p>\n<\/td>\n 250,455<\/span><\/p>\n<\/td>\n 170,057<\/span><\/p>\n<\/td>\n 477,698<\/span><\/p>\n<\/td>\n 329,580<\/span><\/p>\n<\/td>\n<\/tr>\n Total operating expenses<\/span><\/p>\n<\/td>\n 504,676<\/span><\/p>\n<\/td>\n 264,824<\/span><\/p>\n<\/td>\n 877,360<\/span><\/p>\n<\/td>\n 544,320<\/span><\/p>\n<\/td>\n<\/tr>\n Loss from operations<\/span><\/p>\n<\/td>\n (289,597)<\/span><\/p>\n<\/td>\n (171,891)<\/span><\/p>\n<\/td>\n (343,429)<\/span><\/p>\n<\/td>\n (407,564)<\/span><\/p>\n<\/td>\n<\/tr>\n Other income (expense):<\/span><\/p>\n<\/td>\n Interest expense<\/span><\/p>\n<\/td>\n (17,114)<\/span><\/p>\n<\/td>\n (7,836)<\/span><\/p>\n<\/td>\n (34,330)<\/span><\/p>\n<\/td>\n (15,567)<\/span><\/p>\n<\/td>\n<\/tr>\n Interest expense on mandatorily redeemable preferred shares<\/span><\/p>\n<\/td>\n (8,077)<\/span><\/p>\n<\/td>\n (8,042)<\/span><\/p>\n<\/td>\n (15,994)<\/span><\/p>\n<\/td>\n (15,985)<\/span><\/p>\n<\/td>\n<\/tr>\n Interest expense on liability related to sale of future royalties<\/span><\/p>\n<\/td>\n (18,045)<\/span><\/p>\n<\/td>\n (14,499)<\/span><\/p>\n<\/td>\n (35,359)<\/span><\/p>\n<\/td>\n (28,007)<\/span><\/p>\n<\/td>\n<\/tr>\n Change in fair value of derivatives<\/span><\/p>\n<\/td>\n (111,197)<\/span><\/p>\n<\/td>\n (1,490)<\/span><\/p>\n<\/td>\n (107,593)<\/span><\/p>\n<\/td>\n (1,700)<\/span><\/p>\n<\/td>\n<\/tr>\n Gain from equity method investment<\/span><\/p>\n<\/td>\n \u2014<\/span><\/p>\n<\/td>\n \u2014<\/span><\/p>\n<\/td>\n \u2014<\/span><\/p>\n<\/td>\n 5,261<\/span><\/p>\n<\/td>\n<\/tr>\n Other income (expense), net<\/span><\/p>\n<\/td>\n 2,229<\/span><\/p>\n<\/td>\n (3,051)<\/span><\/p>\n<\/td>\n 2,310<\/span><\/p>\n<\/td>\n (4,751)<\/span><\/p>\n<\/td>\n<\/tr>\n Total other expense, net<\/span><\/p>\n<\/td>\n (152,204)<\/span><\/p>\n<\/td>\n (34,918)<\/span><\/p>\n<\/td>\n (190,966)<\/span><\/p>\n<\/td>\n (60,749)<\/span><\/p>\n<\/td>\n<\/tr>\n Loss before provision for income taxes<\/span><\/p>\n<\/td>\n (441,801)<\/span><\/p>\n<\/td>\n (206,809)<\/span><\/p>\n<\/td>\n (534,395)<\/span><\/p>\n<\/td>\n (468,313)<\/span><\/p>\n<\/td>\n<\/tr>\n Provision for income taxes<\/span><\/p>\n<\/td>\n 84<\/span><\/p>\n<\/td>\n 4,350<\/span><\/p>\n<\/td>\n 24,387<\/span><\/p>\n<\/td>\n 8,174<\/span><\/p>\n<\/td>\n<\/tr>\n Net loss<\/span><\/p>\n<\/td>\n (441,885)<\/span><\/p>\n<\/td>\n (211,159)<\/span><\/p>\n<\/td>\n (558,782)<\/span><\/p>\n<\/td>\n (476,487)<\/span><\/p>\n<\/td>\n<\/tr>\n Net loss attributable to non-controlling interests<\/span><\/p>\n<\/td>\n 498<\/span><\/p>\n<\/td>\n 540<\/span><\/p>\n<\/td>\n 996<\/span><\/p>\n<\/td>\n 900<\/span><\/p>\n<\/td>\n<\/tr>\n Deemed dividend upon repurchase of preferred shares in consolidated subsidiary<\/span><\/p>\n<\/td>\n \u2014<\/span><\/p>\n<\/td>\n \u2014<\/span><\/p>\n<\/td>\n (92,673)<\/span><\/p>\n<\/td>\n \u2014<\/span><\/p>\n<\/td>\n<\/tr>\n Net loss attributable to common shareholders of Biohaven Pharmaceutical Holding Company Ltd.<\/span><\/p>\n<\/td>\n $ (441,387)<\/span><\/p>\n<\/td>\n $ (210,619)<\/span><\/p>\n<\/td>\n $ (650,459)<\/span><\/p>\n<\/td>\n $ (475,587)<\/span><\/p>\n<\/td>\n<\/tr>\n Net loss per share attributable to common shareholders of Biohaven Pharmaceutical Holding Company Ltd. \u2014 basic and diluted<\/span><\/p>\n<\/td>\n $ (6.21)<\/span><\/p>\n<\/td>\n $ (3.23)<\/span><\/p>\n<\/td>\n $ (9.20)<\/span><\/p>\n<\/td>\n $ (7.48)<\/span><\/p>\n<\/td>\n<\/tr>\n Weighted average common shares outstanding\u2014basic and diluted<\/span><\/p>\n<\/td>\n 71,043,693<\/span><\/p>\n<\/td>\n 65,112,179<\/span><\/p>\n<\/td>\n 70,689,949<\/span><\/p>\n<\/td>\n 63,584,932<\/span><\/p>\n<\/td>\n<\/tr>\n<\/table>\n\n
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