Biohaven Reports Second Quarter 2023 Financial Results and Recent Business Developments Cash, cash equivalents, and marketable securities totaled $349.0 million as of June 30, 2023 Announced positive interim data from BHV-7000 EEG...

NEW HAVEN, Conn. , July 31, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN ) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported financial results for the second quarter ended June 30, 2023 , and provided a review of recent accomplishments and anticipated upcoming milestones.

Vlad Coric , M.D., Chairman and Chief Executive Officer of Biohaven, commented, "In less than a year since our spin-off, the Biohaven team has driven strong and consistent progress across multiple drug development platforms. We were excited to recently report positive interim data from the ongoing EEG biomarker study of our lead Kv7 activator, BHV-7000. As expected, BHV-7000 demonstrated CNS activity consistent with what has been reported in EEG studies with other Kv7 channel activators in development that are clinically effective in treating epilepsy and with other approved anti-seizure medications. Importantly, BHV-7000 demonstrates CNS target engagement but is not associated with the typical CNS adverse events associated with other ASMs, like somnolence and fatigue. We look forward to completing the higher dose groups in this EEG study and initiating Phase 2/3 studies with our once daily, extended-release oral formulation later this year."

Dr. Coric continued, "We also shared a number of equally exciting announcements across our broader pipeline this quarter. We successfully administered the first three doses in the SAD portion of our ongoing SAD/MAD study evaluating BHV-8000, an oral, brain-penetrant, dual TYK2/JAK1 inhibitor. Potential therapeutic concentrations of BHV-8000 were achieved and BHV-8000 was well tolerated with only mild adverse events reported, reinforcing our plans to start a Phase 2 clinical trial with BHV-8000 in Parkinson's disease and potentially other neuroinflammatory diseases in 2024. In addition, we have advanced IND enabling preclinical studies and remain on track to submit an IND with our IgG degrader, BHV-1300, later this year. We also anticipate submitting an IND with our IgA degrader in 2024 as we continue to advance multiple clinical degrader candidates across a wide range of indications. We also shared key updates for our taldefgrobep alfa program (an anti-myostatin) with enrollment completion in our pivotal study in SMA and a planned Phase 2 trial initiation in obesity."

Second Quarter 2023 and Recent Business Highlights

Upcoming Milestones:

Biohaven is progressing its product candidates through clinical programs in a number of common and rare disorders. The Company plans to reach significant pipeline milestones in the coming periods. Biohaven expects to:

Capital Position:

Cash, cash equivalents and marketable securities as of June 30, 2023 was $349.0 million , including $13.9 million of restricted cash, and excluding $40.4 million of cash payable to Biohaven Pharmaceutical Holding Company Ltd. (the Former Parent), compared to $467.9 million , including $2.5 million of restricted cash, and excluding $35.2 million of cash payable to the Former Parent, as of December 31, 2022 1 .

Second Quarter 2023 Financial Highlights:

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $79.5 million for the three months ended June 30, 2023 , compared to $177.1 million for the three months ended June 30, 2022 . Non-cash share-based compensation expense was $2.5 million for the three months ended June 30, 2023 , a decrease of $10.3 million as compared to the same period in 2022. Non-cash share-based compensation expense was higher in the second quarter of 2022 primarily because expense allocated from the Former Parent equity plan, prior to the spin-off, was based on equity awards with higher grant date fair values.

General and Administrative (G&A) Expenses : General and administrative expenses were $14.5 million for the three months ended June 30, 2023 , compared to $20.0 million for the three months ended June 30, 2022 . The decrease of $5.5 million was primarily due to decreased non-cash share-based compensation costs. Non-cash share-based compensation expense was $2.2 million for the three months ended June 30, 2023 , a decrease of $5.8 million as compared to the same period in 2022. Non-cash share-based compensation expense was higher in the second quarter of 2022 primarily because expense allocated from the Former Parent equity plan, prior to the spin-off, was based on equity awards with higher grant date fair values.

Other Income (Expense), Net: Other income (expense), net was a net income of $5.8 million for the three months ended June 30, 2023 , compared to net expense of $0.1 million for the three months ended June 30, 2022 . The increase of $5.9 million was primarily due to an increase in net investment income and an increase of $1.7 million in other income related to our transition services provided to the Former Parent, which is largely non-recurring.

Net Loss: Biohaven reported a net loss for the three months ended June 30, 2023 , of $90.3 million , or $1.32 per share, compared to $203.3 million , or $5.16 per share, for the same period in 2022. Non-GAAP adjusted net loss for the three months ended June 30, 2023 was $85.7 million , or $1.25 per share, compared to $182.5 million , or $4.63 per share for the same period in 2022. 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. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below. For periods prior to Biohaven's spin-off from the Former Parent on October 3, 2022 (the "Spin-Off"), net loss per share and non-GAAP adjusted net loss per share were calculated based on the 39,375,944 common shares of Biohaven distributed to the Former Parent shareholders at the time of the distribution, including common shares issued in connection with the Former Parent share options that were settled on October 3, 2022 and common shares issued in connection with the Former Parent restricted share units that vested on October 3 , 2022. The same number of shares is being utilized for the calculation of basic and diluted earnings per share for all periods presented prior to the Spin-Off.

Non-GAAP Financial Measures This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, which are adjusted to exclude non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares. 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 and can assist investors in comparing 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 news release.

About Biohaven Biohaven is a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases. Biohaven's experienced management team brings with it a track record of delivering new drug approvals for products for diseases such as migraine, depression, bipolar and schizophrenia. The company is advancing a pipeline of therapies for diseases, many of which have limited or no treatment options, leveraging its proven drug development capabilities and proprietary platforms, including Kv7 ion channel modulation for epilepsy and neuronal hyperexcitability, glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia, myostatin inhibition for neuromuscular diseases and metabolic disorders, and brain-penetrant TYK2/JAK1 inhibition for neuroinflammatory disorders. Biohaven's portfolio of early- and late-stage product candidates also includes discovery research programs focused on TRPM3 channel activation for neuropathic pain, CD-38 antibody recruiting, bispecific molecules for multiple myeloma, antibody drug conjugates (ADCs), and targeted extracellular protein degradation platform technology (MoDE™) with potential application in neurological disorders, cancer, and autoimmune diseases.

Forward-looking Statements 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 "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: 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; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates; the potential for Biohaven's product candidates to be first in class therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". 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.

MoDEs is a trademark of Biohaven Therapeutics Ltd.

Investor Contact:

Jennifer Porcelli Vice President, Investor Relations jennifer.porcelli@biohavenpharma. com +1 (201) 248-0741

Mike Beyer Sam Brown Inc. [email protected] +1 (312) 961-2502

SOURCE Biohaven Ltd.