Full Press Release Details
NEW HAVEN, Conn. , Nov. 12, 2024 /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, 2024 , and provided a review of recent accomplishments and anticipated upcoming developments.
Vlad Coric , M.D., Chairman and Chief Executive Officer of Biohaven, commented, "The team at Biohaven continues to advance multiple late and early stage assets that have the potential to change the current standard of care treatment paradigm across a number of diseases. Last quarter we announced positive topline results in our RWE trial assessing troriluzole for the treatment of spinocerebellar ataxia. Troriluzole (200 mg dosed orally) met the study's primary endpoint on the change from baseline in the f-SARA at 3 years in all study population genotypes, showed statistically significant superiority after both 1 and 2 years of treatment, and achieved statistically significant superiority on 9 consecutive, prespecified primary and secondary endpoints. This was truly a watershed moment for the Company, given the implications of potentially bending the arc of one of the most intractable neurological diseases with no currently approved treatment options. SCA robs patients of their ability to speak, walk, and take care of themselves, and often shortens lifespans and has unfortunate intergenerational implications. We were encouraged by the robust dataset gathered to date and look forward to submitting an NDA to the FDA."
Dr. Coric continued, "We continue to execute across our broad pipeline including the recent initiation of our Phase 2 trial with BHV-2100 in acute migraine. Migraine burden and disability remain high despite advances in treatment; we believe our TRPM3 antagonistic approach has the potential to be a highly-effective, non-sedating, non-opioid treatment for pain and migraine. In the final months of 2024, we expect to report on a number of updates including SMA topline data and data across our MoDE™ platform including a SAD/MAD update and multiple INDs spanning β1AR for the potential treatment of dilated cardiomyopathy, galactose deficient IgA for IgA nephropathy and a further optimized IgG degrader for use in rare diseases."
Third Quarter 2024 and Recent Business Highlights
Expected Upcoming Milestones:
We believe Biohaven is well positioned to achieve significant milestones in 2024 and 2025 across numerous programs:
Selective Kv7 Activator:
Taldefgrobep alfa:
First-in-class TRPM3 Antagonist:
TYK2/JAK1 Inhibitor:
Next Generation ADC Platform:
Capital Position:
Cash, cash equivalents, marketable securities and restricted cash as of October 2, 2024 totaled approximately $642 million , which includes net proceeds of $269.9 million from the public offering of 6,052,631 common shares completed on October 2, 2024 .
Third Quarter 2024 Financial Highlights:
Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $157.6 million for the three months ended September 30, 2024 , compared to $95.5 million for the three months ended September 30, 2023 . The increase of $62.1 million was due to additional and advancing clinical trials, including late Phase 3 and Phase 2/3 studies, and preclinical research programs in 2024, as compared to the same period in the prior year. Non-cash share-based compensation expense was $7.2 million for the three months ended September 30, 2024 , an increase of $5.0 million as compared to the same period in 2023. Non-cash share-based compensation expense was higher in the third quarter of 2024, primarily due to our annual equity incentive awards granted in the fourth quarter of 2023 and the first quarter of 2024.
General and Administrative (G&A) Expenses : G&A expenses were $20.6 million for the three months ended September 30, 2024 , compared to $15.0 million for the three months ended September 30, 2023 . The increase of $5.5 million was partly due to increased non-cash share-based compensation expense, which was $5.0 million for the three months ended September 30, 2024 , an increase of $2.7 million as compared to the same period in 2023. Non-cash share-based compensation expense was higher in the third quarter of 2024 primarily due to our annual equity incentive awards granted in the fourth quarter of 2023 and the first quarter of 2024.
Other Income, Net: Other income, net was $17.8 million for the three months ended September 30, 2024 , compared to other income, net of $4.7 million for the three months ended September 30, 2023 . The increase of $13.1 million was primarily due to non-cash changes in the fair value of our derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment), as well as increased investment income, partially offset by changes in the fair value of our forward contract liability recorded in connection with the Knopp Amendment.
Net Loss: Biohaven reported a net loss for the three months ended September 30, 2024 of $160.3 million , or $1.70 per share, compared to $102.6 million , or $1.50 per share, for the same period in 2023. Non-GAAP adjusted net loss for the three months ended September 30, 2024 was $164.1 million , or $1.74 per share, compared to $98.1 million , or $1.44 per share for the same period in 2023. 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 and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.
Non-GAAP Financial Measures This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and 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 changes in the fair value of derivative liabilities, which do not correlate to actual cash payment obligations in the relevant periods. 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 biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The company is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for OCD and SCA; myostatin inhibition for neuromuscular and metabolic diseases, including SMA and obesity; antibody recruiting bispecific molecules and antibody drug conjugates for cancer.
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. | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (Amounts in thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Operating expenses: | ||||||||
| Research and development | $ 157,607 | $ 95,517 | $ 628,398 | $ 238,468 | ||||
| General and administrative | 20,561 | 15,030 | 66,782 | 43,872 | ||||
| Total operating expenses | 178,168 | 110,547 | 695,180 | 282,340 | ||||
| Loss from operations | (178,168) | (110,547) | (695,180) | (282,340) | ||||
| Other income, net | 17,805 | 4,686 | 36,288 | 18,757 | ||||
| Loss before (benefit) provision for income taxes | (160,363) | (105,861) | (658,892) | (263,583) | ||||
| (Benefit) provision for income taxes | (59) | (3,287) | 687 | (171) | ||||
| Net loss | $ (160,304) | $ (102,574) | $ (659,579) | $ (263,412) | ||||
| Net loss per share — basic and diluted | $ (1.70) | $ (1.50) | $ (7.50) | $ (3.86) | ||||
| Weighted average common shares outstanding— basic and diluted | 94,372,159 | 68,320,125 | 87,936,923 | 68,258,757 |
| BIOHAVEN LTD. | ||||
| CONSOLIDATED BALANCE SHEETS | ||||
| (Amounts in thousands, except share amounts) | ||||
| September 30, 2024 | December 31, 2023 | |||
| (Unaudited) | ||||
| Assets | ||||
| Current assets: | ||||
| Cash and cash equivalents | $ 84,390 | $ 248,402 | ||
| Marketable securities | 294,426 | 133,417 | ||
| Prepaid expenses | 55,168 | 35,242 | ||
| Income tax receivable | 5,318 | 13,252 | ||
| Other current assets | 1,198 | 12,133 | ||
| Total current assets | 440,500 | 442,446 | ||
| Property and equipment, net | 18,276 | 17,191 | ||
| Intangible assets | 18,400 | 18,400 | ||
| Goodwill | 1,390 | 1,390 | ||
| Other non-current assets | 31,957 | 33,785 | ||
| Total assets | $ 510,523 | $ 513,212 | ||
| Liabilities and Shareholders' Equity | ||||
| Current liabilities: | ||||
| Accounts payable | $ 19,744 | $ 15,577 | ||
| Accrued expenses and other current liabilities | 63,520 | 39,846 | ||
| Forward contract liability | 69,030 | — | ||
| Total current liabilities | 152,294 | 55,423 | ||
| Non-current operating lease liabilities | 25,312 | 27,569 | ||
| Derivative liability, non-current | 12,320 | — | ||
| Other non-current liabilities | 4,591 | 2,245 | ||
| Total liabilities | 194,517 | 85,237 | ||
| Shareholders' Equity: | ||||
| Preferred shares, no par value; 10,000,000 shares authorized, no shares issued and outstanding as of September 30, 2024 and December 31, 2023 | — | — | ||
| Common shares, no par value; 200,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 94,899,193 and 81,115,723 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | 1,381,699 | 887,528 | ||
| Additional paid-in capital | 93,038 | 39,804 | ||
| Accumulated deficit | (1,158,871) | (499,292) | ||
| Accumulated other comprehensive income (loss) | 140 | (65) | ||
| Total shareholders' equity | 316,006 | 427,975 | ||
| Total liabilities and shareholders' equity | $ 510,523 | $ 513,212 |
| 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, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Reconciliation of GAAP to Non-GAAP adjusted net loss: | ||||||||
| GAAP net loss | $ (160,304) | $ (102,574) | $ (659,579) | $ (263,412) | ||||
| Add: non-cash share-based compensation expense | 12,160 | 4,456 | 59,269 | 12,916 | ||||
| Add: (gain) loss from change in fair value of derivatives | (15,990) | — | (17,030) | — | ||||
| Non-GAAP adjusted net loss | $ (164,134) | $ (98,118) | $ (617,340) | $ (250,496) | ||||
| Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted: | ||||||||
| GAAP net loss per share — basic and diluted | $ (1.70) | $ (1.50) | $ (7.50) | $ (3.86) | ||||
| Add: non-cash share-based compensation expense | 0.13 | 0.07 | 0.67 | 0.20 | ||||
| Add: (gain) loss from change in fair value of derivatives | (0.17) | — | (0.19) | — | ||||
| Non-GAAP adjusted net loss per share — basic and diluted | $ (1.74) | $ (1.44) | $ (7.02) | $ (3.67) |
MoDEs is a trademark of Biohaven Therapeutics Ltd. Libtayo is a registered trademark of Regeneron Pharmaceuticals, Inc.
Investor Contact:
Jennifer Porcelli Vice President, Investor Relations [email protected] +1 (201) 248-0741
Mike Beyer Sam Brown Inc. [email protected] +1 (312) 961-2502
SOURCE Biohaven Ltd.