Full Press Release Details
NEW HAVEN, Conn. , Nov. 14, 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 third quarter ended September 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, "Our team at Biohaven continued to make tremendous progress this past quarter in advancing multiple development programs and innovating across our entire pipeline. Most recently, we shared important data from our molecular degrader of extracellular proteins (MoDE™) program and demonstrated the potential for this technology in the field of immunology where targeting pathologic antibodies has been shown to have important therapeutic potential. We have demonstrated that BHV-1300, our lead IgG degrader, has great potential with a differentiated profile including: rapid onset of action, deeper reductions in IgG levels compared to FcRN targeting agents, lack of anticipated mechanistic effects on albumin or cholesterol, potential for self-administered subcutaneous dosing, and the compatibility to dose in combination with standard of care biologic therapeutic agents. BHV-1300 offers a highly competitive mechanism of action and potential for favorable differentiation from FcRn targeting agents. In addition, our technology can be readily modified to expand therapeutic targets past IgG to include other immunoglobulins (IgA, IgM, IgE, etc) and antigen specific autoantibodies. With multiple opportunities to address rare and common diseases alike, we continue to be impressed by the expansive potential of our degrader program.
Beyond our extracellular degraders, we also shared key data from ongoing studies with BHV-7000, our highly selective Kv7.2/7.3 activator for epilepsy, mood disorders and pain. Consistent with results observed in clinical and non-clinical studies, EEG data reported last month confirmed CNS target engagement without showing waveform increases in frequencies typically associated with adverse events commonly associated with existing ASMs, such as somnolence and other CNS effects; we expect to present additional details and analyses from this EEG study at an upcoming scientific meeting soon. With target engagement now confirmed in EEG biomarker studies, a favorable safety profile demonstrated in Phase 1 studies, and development of a once-daily formulation of BHV-7000 complete, we look forward to initiating our Phase 3 program in focal epilepsy, which we expect to commence before the end of 2023 -- a program poised to offer paradigm shifting potential in preventing seizures without burdensome CNS side effects. Separately, we completed enrollment in RESILIENT, our Phase 3 pivotal study of taldefgrobep alfa in SMA in record time, thanks to our partnership with the global SMA community and the remarkably efficient clinical trial expertise that we have in-house at Biohaven."
Third Quarter 2023 and Recent Business Highlights
Expected Upcoming Milestones:
Biohaven is progressing its product candidates through clinical programs in a number of common and rare disorders. The Company expects to reach significant pipeline milestones in the coming periods. Biohaven expects to:
Capital Position:
Cash, cash equivalents, marketable securities and restricted cash totaled approximately $495 million as of October 5, 2023 , which included net proceeds of $242 million from completed public offering on October 5, 2023 .
Third Quarter 2023 Financial Highlights:
Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $95.5 million for the three months ended September 30, 2023 , compared to $52.8 million for the three months ended September 30, 2022 . The increase of $42.7 million was primarily due to increases in direct program spend for additional and advancing clinical trials, including late Phase 2/3 studies, and preclinical research programs in 2023, as compared to the same period in the prior year. Non-cash share-based compensation expense was $2.2 million for the three months ended September 30, 2023 , a decrease of $7.5 million as compared to the same period in 2022. Non-cash share-based compensation expense was higher in the third quarter of 2022 primarily because expense allocated from Biohaven Pharmaceutical Holding Company Ltd.'s (the Former Parent[1]) equity plan, prior to the spin-off, was based on equity awards with higher grant date fair values, which was partially offset by increased personnel costs related to increased headcount in 2023.
General and Administrative (G&A) Expenses : General and administrative expenses were $15.0 million for the three months ended September 30, 2023 , compared to $14.8 million for the three months ended September 30, 2022 . The increase of $0.2 million was increased personnel costs in the third quarter of 2023 due to a majority of the personnel costs in three months ended September 30, 2022 being allocated to the Former Parent, offset by decreased non-cash share-based compensation costs. Non-cash share-based compensation expense was $2.3 million for the three months ended September 30, 2023 , a decrease of $5.0 million as compared to the same period in 2022. Non-cash share-based compensation expense was higher in the third 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 $4.7 million for the three months ended September 30, 2023 . The Company did not record any other income (expense) for the three months ended September 30, 2022 . The increase of $4.7 million was primarily due to an increase in net investment income of $3.8 million and an increase of $1.2 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 September 30, 2023 , of $102.6 million , or $1.50 per share, compared to $68.9 million , or $1.75 per share, for the same period in 2022. Non-GAAP adjusted net loss for the three months ended September 30, 2023 was $98.1 million , or $1.44 per share, compared to $49.2 million , or $1.25 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 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, and transaction-related cost incurred relating to the company's spin-off from Biohaven Pharmaceutical Holding Company Ltd., which are limited to a specific period of time and related to Biohaven Ltd. being established as a standalone public company. 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 news 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.
| BIOHAVEN LTD. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands, except share and per share amounts) (Unaudited) | ||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Operating expenses: | ||||||||
| Research and development | $ 95,517 | $ 52,845 | $ 238,468 | $ 300,028 | ||||
| General and administrative | 15,030 | 14,792 | 43,872 | 54,492 | ||||
| Total operating expenses | 110,547 | 67,637 | 282,340 | 354,520 | ||||
| Loss from operations | (110,547) | (67,637) | (282,340) | (354,520) | ||||
| Other income (expense), net | 4,686 | — | 18,757 | (71) | ||||
| Loss before (benefit) provision for income taxes | (105,861) | (67,637) | (263,583) | (354,591) | ||||
| (Benefit) provision for income taxes | (3,287) | 1,216 | (171) | 14,581 | ||||
| Net loss | $ (102,574) | $ (68,853) | $ (263,412) | $ (369,172) | ||||
| Net loss per share — basic and diluted | $ (1.50) | $ (1.75) | $ (3.86) | $ (9.38) | ||||
| Weighted average common shares outstanding— basic and diluted | 68,320,125 | 39,375,944 | 68,258,757 | 39,375,944 |
| BIOHAVEN LTD. CONDENSED CONSOLIDATED BALANCE SHEETS (Amounts in thousands) | ||||
| September 30, 2023 | December 31, 2022 | |||
| (Unaudited) | ||||
| Assets | ||||
| Current assets: | ||||
| Cash and cash equivalents | $ 111,697 | $ 204,877 | ||
| Marketable securities | 128,899 | 260,464 | ||
| Prepaid expenses | 33,936 | 20,945 | ||
| Income tax receivable | 13,073 | 46,139 | ||
| Restricted cash held on behalf of Former Parent | 28 | 35,212 | ||
| Other current assets | 22,937 | 19,331 | ||
| Total current assets | 310,570 | 586,968 | ||
| Property and equipment, net | 17,669 | 17,512 | ||
| Intangible assets | 18,400 | 18,400 | ||
| Goodwill | 1,390 | 1,390 | ||
| Other non-current assets | 34,707 | 37,513 | ||
| Total assets | $ 382,736 | $ 661,783 | ||
| Liabilities and Equity | ||||
| Current liabilities: | ||||
| Accounts payable | $ 9,515 | $ 10,703 | ||
| Due to Former Parent | 28 | 35,212 | ||
| Accrued expenses and other current liabilities | 52,634 | 44,106 | ||
| Total current liabilities | 62,177 | 90,021 | ||
| Long-term operating lease liability | 28,286 | 30,581 | ||
| Other non-current liabilities | 2,267 | 2,410 | ||
| Total liabilities | 92,730 | 123,012 | ||
| Shareholders' Equity: | ||||
| Preferred shares, no par value; 10,000,000 shares authorized, no shares issued and outstanding as of September 30, 2023 and December 31, 2022 | — | — | ||
| Common shares, no par value; 200,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 68,364,143 and 68,190,479 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 618,761 | 615,742 | ||
| Additional paid-in capital | 25,623 | 13,869 | ||
| Accumulated deficit | (354,536) | (91,124) | ||
| Accumulated other comprehensive income | 158 | 284 | ||
| Total shareholders' equity | 290,006 | 538,771 | ||
| Total liabilities and shareholders' equity | $ 382,736 | $ 661,783 |
| BIOHAVEN LTD. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES (Amounts in thousands, except share and per share amounts) (Unaudited) | ||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Reconciliation of GAAP to Non-GAAP adjusted net loss: | ||||||||
| GAAP net loss | $ (102,574) | $ (68,853) | $ (263,412) | $ (369,172) | ||||
| Add: non-cash share-based compensation expense | 4,456 | 16,997 | 12,916 | 77,927 | ||||
| Add: Transaction-related costs | — | 2,641 | — | 5,863 | ||||
| Non-GAAP adjusted net loss | $ (98,118) | $ (49,215) | $ (250,496) | $ (285,382) | ||||
| Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted: | ||||||||
| GAAP net loss per share — basic and diluted | $ (1.50) | $ (1.75) | $ (3.86) | $ (9.38) | ||||
| Add: non-cash share-based compensation expense | 0.07 | 0.43 | 0.19 | 1.98 | ||||
| Add: Transaction-related costs | — | 0.07 | — | 0.15 | ||||
| Non-GAAP adjusted net loss per share — basic and diluted | $ (1.44) | $ (1.25) | $ (3.67) | $ (7.25) |
MoDEs is a trademark of Biohaven Therapeutics Ltd.
Investor Contact: Jennifer Porcelli Vice President, Investor Relations [email protected] +1 (201) 248-0741
Media Contact: Mike Beyer Sam Brown Inc. [email protected] +1 (312) 961-2502
SOURCE Biohaven Ltd.