Financial Performance - Biohaven reported a net loss of $179.5 million, or $2.20 per share, for Q1 2024, compared to a net loss of $70.5 million, or $1.03 per share, for the same period in 2023[11]. - Total operating expenses for Q1 2024 were $183,240,000, a significant increase of 135% compared to $77,782,000 in Q1 2023[17]. - Net loss for Q1 2024 was $179,504,000, compared to a net loss of $70,492,000 in Q1 2023, representing an increase of 154%[17]. - Basic and diluted net loss per share for Q1 2024 was $(2.20), compared to $(1.03) in Q1 2023, reflecting a 113% increase in loss per share[17]. - Non-GAAP adjusted net loss for Q1 2024 was $144,627,000, compared to $66,727,000 in Q1 2023, indicating a 116% increase[26]. - Non-GAAP adjusted net loss per share for Q1 2024 was $(1.77), compared to $(0.98) in Q1 2023, reflecting an increase of 80.6%[26]. Cash and Assets - As of March 31, 2024, cash, cash equivalents, marketable securities, and restricted cash totaled approximately $287.6 million, excluding net proceeds of approximately $247.8 million from a public offering completed on April 22, 2024[7]. - Cash and cash equivalents decreased to $182,705,000 as of March 31, 2024, down from $248,402,000 at the end of 2023[23]. - Total assets decreased to $418,532,000 as of March 31, 2024, compared to $513,212,000 at the end of 2023, a decline of 18.5%[23]. - Total liabilities increased to $117,085,000 as of March 31, 2024, up from $85,237,000 at the end of 2023, marking a rise of 37.4%[23]. Research and Development - Research and Development (R&D) expenses for Q1 2024 were $156.0 million, a significant increase of $92.5 million compared to $63.5 million in Q1 2023, primarily due to increased spending on clinical trials and preclinical research[8]. - Research and development expenses rose to $155,972,000 in Q1 2024, up 145% from $63,461,000 in the same period last year[17]. - The company initiated Phase 2 and 3 programs for BHV-7000 in epilepsy, major depressive disorder (MDD), and bipolar disorder, with ongoing late-stage pivotal trials for taldefgrobep alfa in SMA and troriluzole in obsessive-compulsive disorder (OCD)[2]. - Preliminary data from the ongoing single ascending dose study of BHV-1300 indicated safety and target engagement, with no serious adverse events reported[3]. - The company plans to accelerate development across additional autoantibody-mediated targets based on initial findings from the BHV-1300 study[4]. - Upcoming milestones include the initiation of multiple Phase 2 studies in obesity and acute migraine, as well as the advancement of the BHV-8000 TYK2/JAK1 inhibitor to Phase 2 in the second half of 2024[6]. Offerings and Designations - Biohaven completed a public offering of 6,451,220 common shares at a price of $41.00 per share, raising approximately $247.8 million in net proceeds[4]. - The FDA granted rare pediatric disease designation for taldefgrobep alfa, which may provide a priority review voucher if approved for spinal muscular atrophy (SMA)[4].

License, Acquisition and Other Agreements From time to time, in the ordinary course of business, the Company is subject to litigation and regulatory examinations as well as information gathering requests, inquiries and investigations. As of | --- | --- | --- | --- | --- | --- | |------------------------------------------------------------------------------------------------------|---------------------------------|-------|-------------------------------------------|-------|------------| | non-contingent paym ...

Biotech stocks are full of intriguing innovators who could help pave the way for greater gains over the years ahead. Undoubtedly, it’s virtually impossible to tell exactly which pills, shots and treatments within a firm’s pipeline will eventually evolve into cash flows, let alone blockbuster cash cows. With many clinical trials to pass, even a promising late-stage candidate can still fall flat.Biotech investors may wish to play the odds game regarding a biotech innovator’s pipeline. Some treatments will get ...

These Biotechs and IPOs Inspire Big Insider Buying frender / iStock via Getty Images As tech giants and other sector leaders report their most recent quarterly results, one might expect notable insider purchases to be scarce. However, a couple of initial public offerings and a secondary offering inspired insiders to pick up some shares. Two of the companies featured here had management changes, and half of them are biotech firms.A well-known adage reminds us that corporate insiders and 10% owners really o ...

NEW HAVEN, Conn., April 22, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology, today announced the closing of its underwritten public offering of 6,451,220 of its common shares, which includes the full exercise of the underwriters' option to purchase 841,463 additional common shares, at a public offering price of $41.00 ...

NEW HAVEN, Conn., April 18, 2024 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology, today announced the pricing of its underwritten public offering of 5,609,757 of its common shares at a price to the public of $41.00 per share.  In addition, Biohaven has granted the underwriters a 30-day option to purchase up to an additiona ...

Biohaven's first-in-class Molecular Degrader of Extracellular Proteins (MoDE™) technology targeting IgG removal, BHV-1300, was selected for an oral presentation at AAN highlighting its novel mechanism of action and the latest preclinical data demonstrating rapid, robust, and selective target removal Biohaven announces it will present safety and IgG lowering data from its ongoing single ascending dose (SAD) study of BHV-1300 at the company's annual R&D day at the Yale Innovation Summit in New Haven, Connec ...

Exhibit 99.1 Biohaven Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Developments • Driving clinical, regulatory, and operational excellence across five innovative platforms focused on immunology, neuroscience, and oncology: ◦ Portfolio targeting large indications including obesity, epilepsy, bipolar disorder, depression, obsessivecompulsive disorder (OCD), migraine, pain, Alzheimer's disease, Parkinson's disease, multiple sclerosis, rheumatoid arthritis, and cancer. Also ad ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ____________________________________________________________________________ FORM 10-K ____________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to __ ...

Part I [Part I: Financial Information](index=1&type=section&id=Part%20I%20Financial%20Information) [Item 1: Condensed Consolidated Financial Statements (Unaudited)](index=1&type=section&id=Item%201%3A%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) Biohaven's unaudited financial statements for the period ended September 30, 2023, detail a **net loss of $263.4 million** and **total assets of $382.7 million** [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$382.7 million** as of September 30, 2023, primarily due to reduced cash and marketable securities Condensed Consolidated Balance Sheet Data (in thousands) | Account | Sep 30, 2023 (Unaudited) | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $111,697 | $204,877 | | Marketable securities | $128,899 | $260,464 | | Total current assets | $310,570 | $586,968 | | Total assets | $382,736 | $661,783 | | **Liabilities & Equity** | | | | Total current liabilities | $62,177 | $90,021 | | Total liabilities | $92,730 | $123,012 | | Total shareholders' equity | $290,006 | $538,771 | | Total liabilities and shareholders' equity | $382,736 | $661,783 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss decreased to **$263.4 million** for the nine months ended September 30, 2023, driven by lower R&D and G&A expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Research and development | $238,468 | $300,028 | | General and administrative | $43,872 | $54,492 | | Total operating expenses | $282,340 | $354,520 | | Loss from operations | ($282,340) | ($354,520) | | Net loss | ($263,412) | ($369,172) | | Net loss per share — basic and diluted | ($3.86) | ($9.38) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$216.8 million** for the nine months ended September 30, 2023, with a net decrease in cash of **$116.6 million** Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($216,844) | ($222,282) | | Net cash provided by (used in) investing activities | $133,744 | ($40,774) | | Net cash (used in) provided by financing activities | ($33,327) | $237,417 | | Net decrease in cash, cash equivalents, and restricted cash | ($116,614) | ($25,639) | | Cash, cash equivalents, and restricted cash at end of period | $125,990 | $51,418 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the spin-off, accounting policies, acquisitions, equity changes, and numerous license agreements with potential future milestone payments - The company became an independent, publicly traded entity on October 3, 2022, following a spin-off from its Former Parent, which was acquired by Pfizer[79](index=79&type=chunk)[80](index=80&type=chunk)[101](index=101&type=chunk) - In April 2022, the company acquired the Kv7 channel targeting platform from Knopp Biosciences for an upfront payment of **$35.0 million** in cash and approximately **$58.7 million** in common shares, with potential future milestone payments[157](index=157&type=chunk)[177](index=177&type=chunk) - The company has numerous license agreements with potential future milestone payments totaling approximately **$1.94 billion** across developmental (**$123.8 million**), regulatory (**$547.4 million**), and commercial (**$1.27 billion**) stages[188](index=188&type=chunk) - In March 2023, Biohaven entered into an exclusive license agreement with Hangzhou Highlightll for a brain-penetrant dual TYK2/JAK1 inhibitor program, with upfront consideration of **$10.0 million** in cash and **$10.0 million** in common shares, pending post-closing activities[24](index=24&type=chunk)[250](index=250&type=chunk) [Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial results, pipeline progress, and liquidity, highlighting decreased expenses and the upcoming change in filer status [Overview and Pipeline](index=29&type=section&id=Overview%20and%20Pipeline) Biohaven is advancing a diverse pipeline in neuroscience and rare diseases, with three programs currently in Phase 3 clinical trials - The company is advancing a broad pipeline with key platforms in Kv7 channel modulation, glutamate modulation, myostatin inhibition, and TYK2/JAK1 inhibition[61](index=61&type=chunk)[299](index=299&type=chunk) Key Clinical-Stage Milestones | Drug Name / Platform | Indication(s) | 2H 2023 Milestone | 2024 Milestone | | :--- | :--- | :--- | :--- | | **BHV-7000** (Kv7) | Focal Epilepsy | Initiate Phase 3 | - | | | Bipolar disorder | - | Initiate Phase 3 | | **BHV-7010** (Kv7) | Epilepsy & mood disorders | - | Submit IND | | **BHV-8000** (TYK2/JAK1) | Neuroinflammatory Disorders | - | Initiate Phase 2/3 (Parkinson's) | | **Troriluzole** | OCD | - | Complete Enrollment | | **Taldefgrobep Alfa** | SMA | Completed Enrollment | - | - An NDA for troriluzole in Spinocerebellar Ataxia Type 3 (SCA3) was submitted to the FDA but was not accepted for review; a Marketing Authorization Application (MAA) is currently under review by the EMA[285](index=285&type=chunk) - Enrollment was completed in September 2023 for the Phase 3 trial of taldefgrobep alfa in Spinal Muscular Atrophy (SMA)[307](index=307&type=chunk) [Results of Operations](index=42&type=section&id=Results%20of%20Operations) Operating expenses decreased for the nine months ended September 30, 2023, primarily due to lower R&D and G&A costs Comparison of Nine Months Ended Sep 30, 2023 and 2022 (in thousands) | Item | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $238,468 | $300,028 | ($61,560) | | General and administrative | $43,872 | $54,492 | ($10,620) | | Loss from operations | ($282,340) | ($354,520) | $72,180 | | Net loss | ($263,412) | ($369,172) | $105,760 | - The decrease in R&D expenses for the nine-month period was primarily due to a one-time **$93.7 million** expense for the Kv7 Platform Acquisition and a **$25.0 million** milestone payment in 2022, which did not recur in 2023[363](index=363&type=chunk) - The income tax provision decreased significantly, resulting in a benefit for 2023, due to new IRS guidance on R&D expenditure deductions[283](index=283&type=chunk)[366](index=366&type=chunk) [Liquidity and Capital Resources](index=47&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains strong liquidity with **$111.7 million** in cash and expects current capital to fund operations for over one year - As of September 30, 2023, the company had cash and cash equivalents of **$111.7 million** and marketable securities of **$128.9 million**[392](index=392&type=chunk) - In October 2023, the company closed a public offering of common shares, raising net proceeds of approximately **$242.4 million** for general corporate purposes[1](index=1&type=chunk)[183](index=183&type=chunk) - The company also entered an 'at-the-market' equity distribution agreement in October 2023, allowing for the sale of up to **$150.0 million** in common shares[184](index=184&type=chunk)[404](index=404&type=chunk) - Management expects existing cash, cash equivalents, and marketable securities to be sufficient to fund operating expenses and other cash requirements for more than one year[2](index=2&type=chunk)[105](index=105&type=chunk) - The company will lose its 'emerging growth company' and 'smaller reporting company' status effective December 31, 2023, which will increase compliance costs and disclosure requirements[410](index=410&type=chunk)[435](index=435&type=chunk) [Item 3: Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=Item%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure, including foreign currency, interest rate, and credit risk, is assessed as immaterial or well-managed - The company's exposure to foreign currency translation risk is currently immaterial[426](index=426&type=chunk)[440](index=440&type=chunk) - Interest rate risk is present in the investment portfolio; a hypothetical **1.00%** change in interest rates would impact the fair value by approximately **$0.2 million**[450](index=450&type=chunk) - Credit risk is managed by investing excess cash in highly-rated institutions and investment-grade securities, with policies to ensure diversification[428](index=428&type=chunk)[443](index=443&type=chunk) [Item 4: Controls and Procedures](index=50&type=section&id=Item%204%3A%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal controls - Based on an evaluation as of September 30, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[431](index=431&type=chunk) - There were no material changes to the company's internal control over financial reporting during the three months ended September 30, 2023[432](index=432&type=chunk) Part II [Part II: Other Information](index=52&type=section&id=Part%20II%20Other%20Information) [Item 1: Legal Proceedings](index=52&type=section&id=Item%201%3A%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and is unaware of any adverse pending actions - As of the report date, the company is not a party to any material legal proceedings and is not aware of any pending or threatened legal proceedings that could have a material adverse effect on its business[434](index=434&type=chunk) [Item 1A: Risk Factors](index=52&type=section&id=Item%201A%3A%20Risk%20Factors) No material changes to risk factors, except for increased compliance costs due to the upcoming change in filer status - The company's risk factors have not materially changed from its 2022 Form 10-K, except for a new risk related to its change in filer status[435](index=435&type=chunk) - Effective December 31, 2023, the company will become a 'large accelerated filer' and lose its 'emerging growth company' status, leading to increased compliance costs and regulatory requirements[410](index=410&type=chunk)[447](index=447&type=chunk) [Item 2: Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=Item%202%3A%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities, use of proceeds, or issuer purchases were reported during this period - None[412](index=412&type=chunk) [Item 6: Exhibits](index=53&type=section&id=Item%206%3A%20Exhibits) Exhibits filed with this report include CEO and CFO certifications and iXBRL data files for financial statements - The exhibits filed with this report include CEO and CFO certifications under the Sarbanes-Oxley Act and iXBRL formatted financial data[415](index=415&type=chunk)