Biohaven Reports First Quarter 2025 Financial Results and Recent Business Developments
- Secured $600 million non-dilutive capital agreement with Oberland Capital, with $250 million received upfront
- Strong cash position of $518 million as of April 30, 2025
- FDA mid-cycle review completed for troriluzole with maintained timeline and PDUFA date in Q3 2025
- Extensive pipeline progress with multiple clinical trials advancing across 10+ assets in 6 therapeutic areas
- Increased net loss to $221.7 million in Q1 2025 from $179.5 million in Q1 2024
- R&D expenses increased by $31.6 million to $187.6 million compared to Q1 2024
- G&A expenses rose by $6.7 million to $34.0 million versus Q1 2024
Insights
Biohaven secured $250M in non-dilutive financing while advancing late-stage clinical trials amid significant cash burn; troriluzole FDA review progressing.
Biohaven's Q1 2025 results reveal a company at a critical juncture with multiple catalysts approaching while managing a significant cash burn rate. The company ended March with
Their quarterly net loss widened to
On the regulatory front, Biohaven's NDA for troriluzole in spinocerebellar ataxia (SCA) has passed the mid-cycle review with the FDA and appears on track for its Q3 2025 PDUFA date. Notably, the FDA has not signaled plans for an Advisory Committee meeting, which is generally positive for approval prospects. The company is preparing for commercial launch in this rare disease indication, which would represent their first approved product since reforming as a company.
Biohaven's pipeline remains remarkably diverse for a clinical-stage biotech, spanning five platforms and multiple therapeutic areas. Near-term readouts include pivotal data for troriluzole in OCD (1H 2025) and BHV-7000 in major depressive disorder (2H 2025). Their novel protein degrader platform is advancing with three compounds completing Phase 1 studies in 1H 2025. This breadth of assets provides multiple shots on goal but also necessitates significant capital requirements.
The Oberland financing structure is particularly noteworthy - rather than traditional royalty financing on approved products, this deal funds pre-approval development with provisions for milestone payments (35% of funded amounts) and single-digit royalties on troriluzole sales. This indicates confidence in troriluzole's approval chances, as the deal hinges significantly on this program's success.
- Cash, cash equivalents, marketable securities and restricted cash as of April 30, 2025 totaled approximately
$518 million - Announced up to
$600 million $250 million - Completed
U.S. Food and Drug Administration ("FDA") mid-cycle review meeting and regulatory inspections of Biohaven and key clinical research sites for troriluzole new drug application ("NDA") for the treatment of SCA (all genotypes); continuity of the review process and timelines maintained throughout troriluzole's review. - Presented 13 abstracts, including 3 oral presentations and 10 posters, featured at the American Academy of Neurology ("AAN") Annual Meeting; breadth of presentations highlights Biohaven's leadership in neuroscience and immunoscience, as well as extensive development programs evaluating novel therapies to treat neurological and immunological diseases, with abstracts covering programs including Kv7 ion channel modulation, extracellular protein degradation, TYK2/JAK1 inhibition, glutamate modulation, and TRPM3 antagonism.
- Company to expound on clinical, regulatory, and operational progress across five platforms, including more than 10 assets in 6 therapeutic areas spanning immunology & inflammation, neuroscience, and oncology, at annual R&D Day at the Yale Innovation Summit on May 28, 2025.
Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "In spite of a challenging macroeconomic climate and economic uncertainty, our team has remained more focused than ever on strategic execution and creating a strong financial balance sheet to create value across our broad portfolio of innovative product candidates. Enthusiasm for our rare disease and degrader programs has grown, as we eagerly await the completion of the NDA review for troriluzole and continued advancement of our MoDE™ and TRAP™ degraders into the clinic. We expect to complete three separate Phase 1 studies in 1H 2025 with three innovative compounds, including BHV-1300 (IgG degrader targeting with first target indication in Graves' disease), BHV-1400 (Gd-IgA1 degrader for IgA nephropathy), and BHV-1600 (β1AR AAb degrader targeting PPCM), and are advancing four additional degrader molecules in parallel. We also look forward to delivering key clinical readouts, including pivotal topline data with troriluzole in obsessive compulsive disorder in 1H 2025 and with our selective Kv7 activator BHV-7000 in major depressive disorder ("MDD") in 2H 2025. In oncology, interim Phase 1 data remain on track for 2025 with our lead clinical Trop-2 antibody drug conjugate ("ADC") program, BHV-1510, and initiation of a Phase 1 study with the field's first FGFR3 ADC, BHV-1530, for patients with urothelial cancer & other tumors. With taldefgrobep alfa, our anti-myostatin agent, we continue to pursue a potential path forward in spinal muscular atrophy, while we hasten to initiate our Phase 2 study in obesity; we are also extremely excited about BHV-8000, our TYK2/JAK1 inhibitor, and eagerly anticipate initiating our Phase 2/3 study in Parkinson's disease in 1H 2025."
Dr. Coric continued, "Importantly, we remain steadfastly committed to the SCA community as we continue unwaveringly pursuing an approval in this indication and are now past the mid-cycle review. In addition, our recent
First Quarter 2025 and Recent Business Highlights
- Announced up to
$600 Million $600 million $250 million $600 million $150 million $200 million 35% of the amount funded, payable quarterly through December 31, 2030, and for the first tranche, single-digit royalty payments on global net sales of troriluzole for up to a maximum of 10 years from the closing date. These payments are capped at a multiple of amounts funded by Oberland Capital. - Troriluzole NDA mid-cycle review meeting with FDA completed — The Company completed a mid-cycle review meeting with the FDA of the NDA for troriluzole for the treatment of SCA. The FDA has not conveyed any intention of holding an Advisory Committee Meeting. The NDA had previously been accepted and granted priority review by the FDA with a Prescription Drug User Fee Act ("PDUFA") date expected in the third quarter of 2025.
- Oral and poster presentations at AAN showcased breadth of development work across the platform — In April 2025, the Company delivered 3 oral presentations and 10 posters at the AAN Annual Meeting, showcasing development programs including Kv7 ion channel modulation, MoDEs, TRPM3 antagonism, TYK2/JAK1 inhibition, and glutamate modulation.
- Biohaven's selective, brain-penetrant TYK2/JAK1 inhibitor, BHV-8000, was selected for an oral presentation at AAN, highlighting the efficacy demonstrated in a human alpha-synuclein overexpressing Parkinson's disease mouse model.
- Other oral presentations covered the safety, tolerability, and pharmacokinetics of BHV-2100, a first-in-class TRPM3 antagonist for pain and migraine, as well as the rapid, robust, and selective IgG reduction observed in preclinical models of BHV-1310, Biohaven's novel IgG degrader.
Expected Upcoming Milestones:
We believe Biohaven is well positioned to achieve significant milestones in 2025 and 2026 across numerous programs:
MoDE Platform
- IgG MoDE Degraders (1300/1310): BHV-1300 Phase 1 with the optimized subcutaneous formulation completing in 1H 2025. Expect to initiate Phase 1b study in Graves' disease in mid-2025, and additional programs in rheumatoid arthritis and myasthenia gravis continue to be pursued.
- Phase 1 studies with BHV-1400 and BHV-1600 expected to be completed in 1H 2025.
- Four additional degrader molecules advancing including: IgG4 degrader, PLA2R autoantibody degrader, pro-insulin autoantibody degrader, and TSH receptor autoantibody degrader.
Kv7 Activator (BHV-7000):
- Pivotal major depressive disorder topline results expected in 2H 2025.
- Focal epilepsy study pivotal topline results expected in 1H 2026.
Glutamate Modulator (Troriluzole):
- Preparing for commercial launch in all-genotype SCA in 2025, following NDA acceptance with Priority Review and 3Q 2025 PDUFA date.
- Pivotal topline data from two Phase 3 OCD trials expected in 1H 2025 and 2H 2025, respectively.
Myostatin (Taldefgrobep alfa):
- FDA interaction to discuss Spinal Muscular Atrophy ("SMA") registrational path planned in 1H 2025.
- Initiate taldefgrobep Phase 2 study in obesity in 1H 2025.
TRPM3 Antagonist (BHV-2100):
- Expect data from proof-of-concept trial with BHV-2100 in acute migraine in 1H 2025.
TYK2/JAK1 Inhibitor (BHV-8000):
- Initiate BHV-8000 Phase 2/3 study in Parkinson's disease in 1H 2025.
- Advance Alzheimer's disease, multiple sclerosis ("MS") and amyloid-related imaging abnormalities ("ARIA") programs.
Next Generation ADC Platform:
- Preliminary Phase 1 data with BHV-1510 and dose optimization as monotherapy and combination therapy with Libtayo® in epithelial tumors in 2025.
- Initiate Phase 1 trial of BHV-1530 in 1H 2025.
- Advance additional preclinical ADCs, including Merus and GeneQuantum collaborations (undisclosed targets) in 2025.
Capital Position:
Cash, cash equivalents, marketable securities and restricted cash as of March 31, 2025 totaled approximately
First Quarter 2024 Financial Highlights:
Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were
General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were
Other Income, Net: Other income, net was
Net Loss: Biohaven reported a net loss for the three months ended March 31, 2025 of
Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in
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; MoDE™ and TRAP™ 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, including statements regarding the expected timing and amounts of funding under the NPA. 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
BIOHAVEN LTD. | ||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
(Amounts in thousands, except share and per share amounts) | ||||
(Unaudited) | ||||
Three Months Ended March 31, | ||||
2025 | 2024 | |||
Operating expenses: | ||||
Research and development | $ 187,584 | $ 155,972 | ||
General and administrative | 33,977 | 27,268 | ||
Total operating expenses | 221,561 | 183,240 | ||
Loss from operations | (221,561) | (183,240) | ||
Other income, net | 493 | 4,305 | ||
Loss before provision for income taxes | (221,068) | (178,935) | ||
Provision for income taxes | 609 | 569 | ||
Net loss | $ (221,677) | $ (179,504) | ||
Net loss per share — basic and diluted | $ (2.17) | $ (2.20) | ||
Weighted average common shares outstanding— basic and diluted | 101,943,396 | 81,601,826 | ||
BIOHAVEN LTD. | ||||
CONSOLIDATED BALANCE SHEETS | ||||
(Amounts in thousands, except share amounts) | ||||
March 31, 2025 | December 31, 2024 | |||
(Unaudited) | ||||
Assets | ||||
Current assets: | ||||
Cash and cash equivalents | $ 98,417 | $ 99,134 | ||
Marketable securities | 224,332 | 386,857 | ||
Prepaid expenses | 56,390 | 49,376 | ||
Other current assets | 3,618 | 3,105 | ||
Total current assets | 382,757 | 538,472 | ||
Property and equipment, net | 17,788 | 17,320 | ||
Intangible assets | 18,400 | 18,400 | ||
Goodwill | 1,390 | 1,390 | ||
Other non-current assets | 38,611 | 39,525 | ||
Total assets | $ 458,946 | $ 615,107 | ||
Liabilities and Shareholders' Equity | ||||
Current liabilities: | ||||
Accounts payable | $ 19,142 | $ 18,029 | ||
Accrued expenses and other current liabilities | 56,572 | 51,487 | ||
Forward contract and derivative liability | 88,320 | 84,710 | ||
Total current liabilities | 164,034 | 154,226 | ||
Non-current operating lease liability | 30,804 | 32,782 | ||
Other non-current liabilities | 4,613 | 4,663 | ||
Total liabilities | 199,451 | 191,671 | ||
Shareholders' Equity: | ||||
Preferred shares, no par value; 10,000,000 shares authorized, no shares issued and outstanding as of March 31, 2025 and December 31, 2024 | — | — | ||
Common shares, no par value; 200,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 102,104,024 and 101,221,989 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively | 1,689,346 | 1,656,702 | ||
Additional paid-in capital | 137,467 | 112,369 | ||
Accumulated deficit | (1,567,391) | (1,345,714) | ||
Accumulated other comprehensive income | 73 | 79 | ||
Total shareholders' equity | 259,495 | 423,436 | ||
Total liabilities and shareholders' equity | $ 458,946 | $ 615,107 | ||
BIOHAVEN LTD. | ||||
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES | ||||
(Amounts in thousands, except share and per share amounts) | ||||
(Unaudited) | ||||
Three Months Ended March 31, | ||||
2025 | 2024 | |||
Reconciliation of GAAP to Non-GAAP adjusted net loss: | ||||
GAAP net loss | $ (221,677) | $ (179,504) | ||
Add: non-cash share-based compensation expense | 53,062 | 34,877 | ||
Add: loss from change in fair value of derivatives | 1,790 | — | ||
Non-GAAP adjusted net loss | $ (166,825) | $ (144,627) | ||
Reconciliation of GAAP to Non-GAAP adjusted net loss per share — basic and diluted: | ||||
GAAP net loss per share — basic and diluted | $ (2.17) | $ (2.20) | ||
Add: non-cash share-based compensation expense | 0.51 | 0.43 | ||
Add: loss from change in fair value of derivatives | 0.02 | — | ||
Non-GAAP adjusted net loss per share — basic and diluted | $ (1.64) | $ (1.77) | ||
MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd.
Libtayo is a registered trademark of Regeneron Pharmaceuticals, Inc.
Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741
Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502
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SOURCE Biohaven Ltd.
FAQ
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