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Biohaven Reports Third Quarter 2024 Financial Results and Recent Business Developments

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Biohaven reported its Q3 2024 financial results and recent business developments. As of October 2, 2024, the company had $642 million in cash and equivalents. Key achievements include positive topline results from a pivotal trial of troriluzole in spinocerebellar ataxia (SCA) and the initiation of a Phase 2 trial for BHV-2100 in acute migraine. Troriluzole met primary and secondary endpoints, showing significant improvements in SCA patients over three years. The company plans to submit an NDA in Q4 2024. Recent public offering raised $269.9 million. R&D expenses increased to $157.6 million, partly due to advancing clinical trials, while net loss widened to $160.3 million. Upcoming milestones include Phase 3 data for taldefgrobep alfa in SMA and continued progress across various programs.

Biohaven ha riportato i risultati finanziari per il terzo trimestre del 2024 e gli sviluppi aziendali recenti. Al 2 ottobre 2024, l'azienda aveva 642 milioni di dollari in contante e equivalenti. I risultati chiave includono risultati positivi dalla prova pivotale di troriluzolo nell'atassia spinocerebellare (SCA) e l'inizio di una prova di Fase 2 per BHV-2100 nell'emicrania acuta. Il troriluzolo ha raggiunto obiettivi primari e secondari, mostrando miglioramenti significativi nei pazienti con SCA nel corso di tre anni. L'azienda prevede di presentare un NDA nel quarto trimestre del 2024. Un'offerta pubblica recente ha raccolto 269,9 milioni di dollari. Le spese di ricerca e sviluppo sono aumentate a 157,6 milioni di dollari, in parte a causa dell'avanzamento delle prove cliniche, mentre la perdita netta è aumentata a 160,3 milioni di dollari. Tra i prossimi traguardi ci sono i dati di Fase 3 per taldefgrobep alfa nella SMA e progressi continui in vari programmi.

Biohaven informó sobre sus resultados financieros del tercer trimestre de 2024 y desarrollos empresariales recientes. Al 2 de octubre de 2024, la empresa contaba con 642 millones de dólares en efectivo y equivalentes. Los logros clave incluyen resultados positivos de un ensayo pivotal de troriluzole en la ataxia espinocerebelosa (SCA) y el inicio de un ensayo de Fase 2 para BHV-2100 en migraña aguda. El troriluzole cumplió con los objetivos primarios y secundarios, mostrando mejoras significativas en pacientes con SCA durante tres años. La compañía planea presentar una NDA en el cuarto trimestre de 2024. La oferta pública reciente recaudó 269,9 millones de dólares. Los gastos de I+D aumentaron a 157,6 millones de dólares, en parte debido al avance de los ensayos clínicos, mientras que la pérdida neta se amplió a 160,3 millones de dólares. Los próximos hitos incluyen datos de Fase 3 para taldefgrobep alfa en SMA y un progreso continuo en varios programas.

Biohaven는 2024년 3분기 재무 결과와 최근 사업 발전 사항을 보고했습니다. 2024년 10월 2일 기준으로, 회사는 6억 4,200만 달러의 현금 및 현금성 자산을 보유하고 있었습니다. 주요 성과로는 스피노세레벨라 아탁시아(SCA)에 대한 트로릴루졸의 주요 임상 시험에서 긍정적인 topline 결과와 급성 편두통에 대한 BHV-2100의 2상 시험 시작이 포함됩니다. 트로릴루졸은 주요 및 보조 목표를 충족하며, 3년 동안 SCA 환자에서 유의미한 개선을 보여주었습니다. 회사는 2024년 4분기에 NDA를 제출할 계획입니다. 최근의 공모에서 2억 6,990만 달러를 모금했습니다. 연구개발 비용은 1억 5,760만 달러로 증가했으며, 이는 임상 시험 진행에 따른 부분입니다. 순손실은 1억 6,030만 달러로 확대되었습니다. 다가오는 주요 이정표로는 SMA에 대한 탈데프그로베프 알파의 3상 데이터와 다양한 프로그램 전반의 지속적인 진전을 포함합니다.

Biohaven a rapporté ses résultats financiers pour le troisième trimestre 2024 et les développements récents de l'entreprise. Au 2 octobre 2024, la société disposait de 642 millions de dollars en liquidités et équivalents. Les réussites clés comprennent des résultats positifs de l'essai pivot du troriluzole dans l'ataxie spinocérébelleuse (SCA) et le lancement d'un essai de phase 2 pour le BHV-2100 dans la migraine aiguë. Le troriluzole a atteint les objectifs primaires et secondaires, montrant des améliorations significatives chez les patients atteints de SCA au cours de trois ans. La société prévoit de déposer une NDA au quatrième trimestre 2024. Une récente offre publique a permis de lever 269,9 millions de dollars. Les dépenses de R&D ont augmenté pour atteindre 157,6 millions de dollars, en partie en raison de l'avancement des essais cliniques, tandis que la perte nette s'est élargie à 160,3 millions de dollars. Parmi les prochaines étapes, on trouve des données de phase 3 pour le taldefgrobep alfa dans la SMA et des progrès continus dans divers programmes.

Biohaven hat seine Finanzzahlen für das 3. Quartal 2024 und aktuelle Geschäftsentwicklungen berichtet. Zum 2. Oktober 2024 hatte das Unternehmen 642 Millionen Dollar in bar und Barmitteläquivalenten. Zu den wichtigsten Erfolgen zählen positive Topline-Ergebnisse aus einer entscheidenden Studie zu Troriluzole bei spinozerebellärer Ataxie (SCA) und der Start einer Phase-2-Studie für BHV-2100 bei akuten Migräneanfällen. Troriluzole hat die primären und sekundären Endpunkte erreicht und deutliche Verbesserungen bei SCA-Patienten über drei Jahre gezeigt. Das Unternehmen plant, im 4. Quartal 2024 einen NDA-Antrag einzureichen. Eine kürzliche öffentliche Angebotserhöhung brachte 269,9 Millionen Dollar ein. Die Forschungs- und Entwicklungskosten stiegen auf 157,6 Millionen Dollar, was teilweise auf die Fortschritte bei klinischen Studien zurückzuführen ist, während der Nettoverlust auf 160,3 Millionen Dollar ausgeweitet wurde. Zu den bevorstehenden Meilensteinen gehören Daten der Phase 3 für Taldefgrobep-Alfa bei SMA und weiterer Fortschritt in verschiedenen Programmen.

Positive
  • Positive topline results from pivotal trial of troriluzole in SCA.
  • Planned NDA submission for troriluzole in Q4 2024.
  • Initiation of Phase 2 trial for BHV-2100 in acute migraine.
  • Raised $269.9 million from public offering.
  • Numerous upcoming milestones across various programs.
Negative
  • R&D expenses increased to $157.6 million.
  • Net loss widened to $160.3 million.

Insights

The Q3 results reveal significant developments and financial positioning. Cash position of $642 million, bolstered by a recent $269.9 million public offering, provides substantial runway for pipeline development. R&D expenses increased 65% year-over-year to $157.6 million, reflecting expanded clinical programs. Net loss widened to $160.3 million ($1.70 per share) from $102.6 million year prior.

The positive troriluzole trial results in SCA represent a potential breakthrough in an untreated market. With FDA fast track designation and planned Q4 2024 NDA submission, this could translate to accelerated revenue potential. Multiple late-stage catalysts across the pipeline in Q4 2024 and 2025 could drive significant value creation.

The troriluzole SCA trial results are particularly noteworthy, demonstrating 50-70% slowing of disease progression - equivalent to a 1.5-2.2 year delay over three years. The achievement of statistical significance across 9 consecutive endpoints is exceptional in neurological disease trials. The study's design, incorporating real-world evidence and FDA guidance, strengthens the regulatory submission strategy.

The diversified late-stage pipeline, including taldefgrobep alfa for SMA, BHV-7000 for epilepsy/mood disorders and BHV-2100 for migraine, presents multiple shots on goal in significant market opportunities. The advancement of novel platforms like MoDE and ADC programs adds long-term potential.

  • Cash, cash equivalents, marketable securities and restricted cash as of October 2, 2024 totaled approximately $642 million
  • Achieved positive topline trial results from pivotal trial with troriluzole in spinocerebellar ataxia (SCA)
    • Troriluzole 200 mg QD dosed orally in patients with SCA met the study's primary endpoint on the change from baseline on the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) at 3 years in all study population genotypes
    • Statistically significant superiority achieved on 9 consecutive, prespecified primary and secondary endpoints
    • Both the study protocol and statistical analysis plan were submitted to, and reviewed by, the U.S. Food and Drug Administration (FDA) prior to topline data analysis
    • Study designed in discussion with the FDA and utilized Phase 3 data and an external control of matched, untreated SCA subjects from the U.S. Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA) in accordance with the FDA's Guidance on Real-World Evidence (RWE) of effectiveness
    • CRC-SCA external control included contemporaneous natural history data gathered from 2010-2024
    • Planned New Drug Application (NDA) re-submission in 4Q 2024
    • Completed clarification meeting with CHMP Rapporteurs in 4Q 2024 and MAA documents are being updated to include the new positive BHV4157-206-RWE study data with broader indication to include all SCA genotypes
  • Taldefgrobep alfa, a myostatin-inhibitor, Phase 3 topline data in spinal muscular atrophy (SMA) in 4Q 2024 and Phase 2 trial protocol in obesity expected in 4Q 2024
  • Advancing extracellular Molecular Degrader of Extracellular Protein (MoDE) programs
    • 3 additional investigational agents expected to enter Phase 1 studies in the next quarter
    • Anticipate Phase 1 update for BHV-1300, including subcutaneous formulation, before year-end
  • Broad progress with TRPM3 antagonist
    • Initiated pivotal Phase 2 trial evaluating BHV-2100, a TRPM3 antagonist, in the acute treatment of migraine
    • Initiated separate proof of concept study with BHV-2100 in neuropathic pain
  • Patient enrollment continues across 5 Phase 2/3 trials with Kv7 activator, BHV-7000, in epilepsy and mood disorders (bipolar and major depressive disorder (MDD)) with potential for multiple data readouts in 2025
  • Continued progress with antibody drug conjugate (ADC) portfolio
    • BHV-1510 currently dosing cancer patients in Phase 1/2 study, advancing towards combination dosing of BHV-1510 with Libtayo® in 4Q 2024

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

  • Achieved positive topline results in pivotal study of troriluzole in SCA - In September 2024, the Company announced positive topline results from pivotal Study BHV4157-206-RWE demonstrating the efficacy of troriluzole on the mean change from baseline in the f-SARA after 3 years of treatment. The study achieved the primary endpoint and showed statistically significant improvements on the f-SARA at years 1 and 2. Additionally, troriluzole achieved statistically significant superiority on 9 consecutive, prespecified primary and secondary endpoints. SCA patients treated with troriluzole showed a 50-70% slowing of disease progression, representing 1.5-2.2 years delay in disease progression over the 3-year study period. The Company intends to submit an NDA to the FDA for troriluzole in the treatment of all SCA genotypes in 4Q 2024. The development program for troriluzole has been granted orphan and fast track designations, and is eligible for priority review. European Medicines Agency marketing authorization remains under review and Biohaven completed a clarification meeting with CHMP Rapporteurs in 4Q 2024. MAA documents are being updated to include the new positive BHV4157-206-RWE study data with broader indication to include all SCA genotypes.
     
  • Initiated Phase 2 trial evaluating BHV-2100 in the acute treatment of migraine - In September 2024, the Company initiated a Phase 2 study of an orally administered TRPM3 antagonist, BHV-2100, in the acute treatment of migraine. The study is a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of two doses (75 mg and 150 mg) of BHV-2100 in the acute treatment of migraine. The trial is designed to support registration with FDA-accepted co-primary endpoints of pain freedom and freedom from most bothersome symptom at 2 hours and is expected to enroll approximately 575 patients across 60 sites in the United States.
     
  • Public offering - On October 2, 2024, the Company closed its previously announced underwritten public offering of 6,052,631 of its common shares, which included the full exercise of the underwriters' option to purchase additional shares, at the public offering price of $47.50 per share. The net proceeds raised in the offering, after deducting underwriting discounts and estimated expenses of the offering payable by the Company, were approximately $269.9M. As of November 8, 2024, we had 101,122,246 common shares outstanding.

Expected Upcoming Milestones:

We believe Biohaven is well positioned to achieve significant milestones in 2024 and 2025 across numerous programs:

Selective Kv7 Activator: 

  • Continue 5 ongoing Phase 2/3 trials with BHV-7000 in focal epilepsy, idiopathic generalized epilepsy, MDD, and bipolar disorder

Troriluzole:

  • NDA submission to FDA on track for 4Q 2024, following release of pivotal topline results in SCA in September 2024
  • Two Phase 3 trials with troriluzole in OCD; expect to conduct interim analysis of the second Phase 3 OCD trial in 4Q 2024 and report topline data from first Phase 3 OCD trial in 1H 2025

Taldefgrobep alfa:

  • Report topline data from Phase 3 trial with taldefgrobep in SMA in 4Q 2024
  • Initiate Phase 2 trial with taldefgrobep in obesity in 4Q 2024 or early 2025

First-in-class TRPM3 Antagonist: 

  • Continue advancing enrollment in Phase 2 trial with BHV-2100 in acute migraine and neuropathic pain (laser-evoked potential experimental pain paradigm)

TYK2/JAK1 Inhibitor:

  • Complete SAD/MAD studies with BHV-8000 and advance to Phase 2 in the coming months

MoDE™ Platform

  • Submit a total of 4 INDs in 2024
  • Continue to advance Phase 1 SAD and MAD studies with subcutaneous BHV-1300, with a further study update in 4Q 2024

Next Generation ADC Platform:

  • Advance Phase 1 Trop-2 directed program BHV-1510 in multiple tumor types

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
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741

Media Contact:

Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/biohaven-reports-third-quarter-2024-financial-results-and-recent-business-developments-302303249.html

SOURCE Biohaven Ltd.

FAQ

What were Biohaven's financial results for Q3 2024?

Biohaven reported a net loss of $160.3 million for Q3 2024, with R&D expenses of $157.6 million.

What are the key developments for Biohaven's troriluzole in SCA?

Troriluzole achieved positive topline results in a pivotal trial, meeting primary and secondary endpoints. An NDA submission is planned for Q4 2024.

What is Biohaven's cash position as of October 2, 2024?

Biohaven had approximately $642 million in cash, cash equivalents, marketable securities, and restricted cash.

What were the outcomes of Biohaven's recent public offering?

Biohaven raised $269.9 million from a public offering of 6,052,631 common shares.

What upcoming milestones does Biohaven anticipate?

Biohaven anticipates Phase 3 data for taldefgrobep alfa in SMA, NDA submission for troriluzole, and progress in multiple clinical trials.

Biohaven Ltd.

NYSE:BHVN

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4.65B
85.41M
11.16%
86.75%
9.07%
Biotechnology
Pharmaceutical Preparations
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United States of America
NEW HAVEN