Biohaven .(BHVN)

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Biohaven .(BHVN) - 2023 Q4 - Annual Results
2024-02-28 16:00
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 ...
Biohaven .(BHVN) - 2023 Q4 - Annual Report
2024-02-28 16:00
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 __ ...
Biohaven .(BHVN) - 2023 Q3 - Quarterly Report
2023-11-13 16:00
On October 5, 2023, we closed an underwritten public offering of 11,761,363 of its common shares, which included the exercise in full of the underwriters' option to purchase additional shares, at a price to the public of $22.00 per share. The net proceeds raised in the offering, after deducting underwriting discounts and expenses of the offering payable by us, were approximately $242.4 million. We intend to use the net proceeds received from the offering for general corporate purposes. We expect our expense ...
Biohaven .(BHVN) - 2023 Q2 - Quarterly Report
2023-07-30 16:00
Form 10-Q Table of Contents Preclinical and clinical data have demonstrated the potential for anti-myostatin therapies to produce physical and metabolic changes that are highly relevant to individuals living with overweight and obesity, including reducing total body fat and visceral adiposity, and improving insulin sensitivity and bone mineral density, while increasing lean muscle mass. In the fourth quarter of 2021, we initiated a Phase 1a/1b trial in multiple myeloma patients using its antibody recruiting ...
Biohaven .(BHVN) - 2023 Q1 - Quarterly Report
2023-05-11 16:00
Financial Performance - Net loss for the three months ended March 31, 2023, was $70,492 thousand, a decrease from a net loss of $97,032 thousand in the same period of 2022, representing a 27.3% improvement[44] - The company reported net cash used in operating activities of $77,638 thousand for the three months ended March 31, 2023, compared to $58,836 thousand for the same period in 2022[44] - The company recorded total operating expenses of $77.8 million for the three months ended March 31, 2023, a decrease of $11.99 million from $89.77 million in the same period of 2022[80] - The net loss for the three months ended March 31, 2023, was $70.49 million, an improvement of $26.54 million compared to a net loss of $97.03 million in the same period of 2022[80] - The income tax provision decreased to $0.9 million for the three months ended March 31, 2023, from $7.3 million in the same period of 2022, primarily due to R&D tax credits[82] - The company anticipates continued significant general and administrative expenses as it supports R&D activities and prepares for potential commercialization of product candidates[77] - The company has incurred significant operating losses and negative cash flows from operations, with no revenue from product sales until successful completion of clinical development[100] Cash Flow and Financing - Cash used in operating activities for the three months ended March 31, 2023, was $77,638 thousand, compared to $58,836 thousand in the same period of 2022, indicating an increase of 32%[44] - Cash, cash equivalents, and restricted cash at the end of the period were $190,590 thousand, down from $242,604 thousand at the beginning of the period, reflecting a decrease of 21.5%[44] - The company’s cash flows from financing activities included a net cash provided of $26,668 thousand for the three months ended March 31, 2023, compared to $23,030 thousand in the same period of 2022, showing an increase of 15.5%[44] - Net cash provided by financing activities was $26.7 million for Q1 2023, an increase of $3.6 million compared to $23.0 million in Q1 2022, driven by the advancement of discovery programs and clinical-stage assets[103] - The company expects to require additional capital for in-licenses or acquisitions of other product candidates, especially if regulatory approval is obtained for its product candidates[104] Research and Development - The company is advancing a pipeline of therapies targeting neurological and neuropsychiatric diseases, including Kv7 ion channel modulation and TYK2/JAK1 inhibition[46] - BHV-7000 has received Rare Pediatric Disease Designation from the FDA for the treatment of KCNQ2 developmental epileptic encephalopathy[56] - The company is exploring new product candidates, including therapies for neuropathic pain and autoimmune brain disorders, leveraging its proprietary platforms[46][59] - The company plans to enroll approximately 180 patients in a Phase 3 trial evaluating taldefgrobep as an adjunctive therapy for SMA[66] - The company initiated a Phase 1a/1b trial in multiple myeloma patients, planning to enroll 30 patients to assess safety and tolerability of BHV-1100[67] - The company expects to submit an IND application for BHV-1300 with the FDA in the second half of 2023, following a preclinical study showing a 75% reduction of IgG levels[74] Operating Expenses - R&D expenses for Q1 2023 were $63.5 million, a decrease of $6.6 million from $70.1 million in Q1 2022, primarily due to reduced personnel-related costs[98] - General and administrative expenses for Q1 2023 were $14.3 million, down from $19.7 million in Q1 2022, mainly due to decreased non-cash share-based compensation costs[99] - The total operating expenses for Q1 2023 were $77.8 million, a decrease of $12.0 million compared to $89.8 million in Q1 2022[80] Risks and Challenges - The company is subject to risks typical of early-stage biotechnology firms, including competition and the need for significant additional capital for product development[28] - The company has not generated any revenue since inception and expects to incur significant expenses for several years as it advances product candidates through clinical development and seeks regulatory approval[100] - The company is subject to risks common to early-stage biotechnology companies, including dependence on key personnel and the need for significant additional capital for product development[28] Internal Controls and Compliance - There have been no material changes to the company's internal control over financial reporting during the three months ended March 31, 2023[93] - The company maintains a portion of its cash deposits in government insured institutions in excess of government insured limits, believing these institutions have high credit quality[91] - The company is subject to taxation in the BVI, where it benefits from exemptions from the Income Tax Ordinance for non-residents[96] - The company does not engage in any hedging activities against changes in interest rates[108] - As of March 31, 2023, the company's disclosure controls and procedures were effective at the reasonable assurance level[110] - Management acknowledges that disclosure controls can only provide reasonable, not absolute, assurance of meeting objectives[110] - The evaluation of disclosure controls involved a cost-benefit analysis of possible procedures[110] - There are inherent limitations in the control system, which may lead to undetected misstatements due to error or fraud[110] - The design of controls is based on assumptions about the likelihood of future events, which may change over time[110] - The Chief Executive Officer and Chief Financial Officer conducted an evaluation of the disclosure controls as of March 31, 2023[110] - Controls may become inadequate due to changes in conditions or compliance levels over time[110] - The company recognizes that the effectiveness of controls may deteriorate under certain future conditions[110] - Management's judgment was applied in evaluating the design of disclosure controls[110] - There is no assurance that any design will succeed in achieving its stated goals under all potential future conditions[110]
Biohaven .(BHVN) - 2022 Q4 - Annual Report
2023-03-22 16:00
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, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to __ ...
Biohaven .(BHVN) - 2022 Q3 - Quarterly Report
2022-11-09 21:19
Financial Performance - For the three months ended September 30, 2022, total operating expenses were $67,637,000, an increase of 21.8% from $55,492,000 in the same period of 2021[9]. - The net loss attributable to common shareholders for the three months ended September 30, 2022, was $68,853,000, compared to a net loss of $54,365,000 for the same period in 2021, representing a 26.6% increase[9]. - The net loss per share attributable to common shareholders for the three months ended September 30, 2022, was $(1.75), compared to $(1.38) for the same period in 2021[9]. - For the nine months ended September 30, 2022, total operating expenses were $354.5 million, an increase of $186.5 million from $168.0 million in the same period of 2021[176]. - The company recorded a net loss of $68.9 million for the three months ended September 30, 2022, compared to a net loss of $54.4 million for the same period in 2021, an increase of $14.5 million[170]. - The provision for income taxes for the nine months ended September 30, 2022, was $14,581,000, compared to a benefit of $(1,091,000) in the same period of 2021[9]. Research and Development Expenses - Research and development expenses for the nine months ended September 30, 2022, were $300,028,000, compared to $139,668,000 for the same period in 2021, reflecting a 114.4% increase[9]. - Research and development expenses for the three months ended September 30, 2022, were $52.8 million, up from $47.0 million in the same period of 2021, reflecting an increase of $5.9 million[172]. - The Company recorded $25,000 thousand to R&D expense during the nine months ended September 30, 2022, for a regulatory milestone payment due to Knopp[52]. - Research and development expenses for the three months ended September 30, 2022, were $23,048,000, up from $17,396,000 in 2021, reflecting a year-over-year increase of 32.1%[97]. - Research and development expenses for the three months ended September 30, 2022, were $9,722, down from $10,187 in 2021, indicating a decrease of 4.6%[61]. Cash and Financing Activities - Cash and restricted cash at the end of the period on September 30, 2022, was $51,418,000, down from $362,690,000 at the end of the same period in 2021[14]. - As of October 3, 2022, the Company had a cash balance of approximately $257,799 following a cash contribution from the Former Parent[32]. - The Company completed a public offering on October 25, 2022, resulting in net proceeds of approximately $282,763[32]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $222,282,000, compared to $112,784,000 for the same period in 2021, showing an increase of 97%[14]. - The company completed a public offering of 28,750,000 common shares at a price of $10.50 per share, raising approximately $282.8 million in net proceeds[184]. Company Structure and Spin-Off - Biohaven Ltd. became an independent, publicly traded company following the spin-off from its former parent on October 3, 2022, with 35,832,557 common shares issued[19]. - Following the Spin-Off on October 3, 2022, the Company issued an aggregate of 35,832,557 common shares to holders of Former Parent common shares[119]. - The Transition Services Agreement with the Former Parent includes provisions for finance, IT, clinical study support, and other services to ensure an orderly transition post Spin-Off[107]. Future Outlook and Risks - The Company faces risks typical of early-stage biotechnology firms, including the need for significant additional capital for research and development efforts[21]. - The Company’s future viability depends on its ability to raise additional capital to finance operations[33]. - The Company has incurred recurring losses since its inception and anticipates ongoing operating losses for the foreseeable future[31]. - The company anticipates needing to raise additional capital until it becomes profitable[191]. Clinical Trials and Product Development - The Company is focused on developing therapies for neurological and neuropsychiatric diseases, including epilepsy and mood disorders, with a broad pipeline of drug candidates[16]. - BHV-7000, the lead asset from the Kv7 platform, is currently in Phase 1 clinical trials, with expected results by the first half of 2023[132]. - The company aims to initiate at least one pivotal trial for BHV-7000 in epilepsy patients in the second half of 2023 if the Phase 1 study is successful[135]. - Taldefgrobep alfa (BHV-2000) is a Phase 3-ready anti-myostatin adnectin licensed from BMS, targeting neuromuscular diseases[144]. - The company commenced enrollment in a Phase 3 clinical trial of BHV-2000 for Spinal Muscular Atrophy, expecting to enroll approximately 180 patients[145].
Biohaven .(BHVN) - 2021 Q4 - Earnings Call Transcript
2022-02-25 19:41
Financial Data and Key Metrics Changes - For Q4 2021, NURTEC ODT achieved net sales of $190 million, a 40% increase from Q3 and a 440% increase year-over-year, driven by increased sales volume and improved managed care reimbursement [36][41] - Full year 2021 net sales for NURTEC ODT reached $462.5 million, growing $399 million or 627% compared to the previous year [41][42] - R&D investment for Q4 2021 on a non-GAAP basis was $76.4 million, a 32% increase from the prior quarter [39] - SG&A expense for Q4 2021 on a non-GAAP basis was $189.3 million, a 66% increase from the prior year quarter [40] Business Line Data and Key Metrics Changes - The oral CGRP market generated over $1 billion in revenues in 2021, with Biohaven's revenues growing over 600% [36][37] - NURTEC ODT has become the number one prescribed migraine treatment in its class, with over 1.6 million prescriptions since launch [8][7] Market Data and Key Metrics Changes - The oral CGRP class recorded net sales of approximately $1 billion in 2021, representing a small fraction of about 5% to 6% of overall migraine prescriptions [16] - The oral CGRP class is expected to continue growing, with significant penetration into the generic triptan market [50][51] Company Strategy and Development Direction - The company is focused on expanding its global commercialization partnership with Pfizer for rimegepant, aiming to deliver dual therapy NURTEC ODT to a global market of approximately 1 billion migraine patients [19][20] - Biohaven is committed to advancing its pipeline with new acquisitions, including a Kv7 Ion Channel Activator for epilepsy and a myostatin targeting asset for spinal muscular atrophy [13][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of NURTEC ODT and the oral CGRP class, highlighting the need for innovative treatments in a highly dissatisfied market [50][51] - The company anticipates continued strong growth in 2022, despite typical seasonal factors affecting Q1 performance [53] Other Important Information - Biohaven announced the acquisition of Channel Biosciences, adding a Kv7 program for epilepsy to its pipeline, and licensed Taldefgrobep from Bristol-Myers Squibb for spinal muscular atrophy [27][90] - The company has access to approximately $1 billion of liquidity following its collaboration with Pfizer [44] Q&A Session Summary Question: Can you provide a sense of comfort around the Street's NURTEC-specific revenues for this year around $850 million? - Management did not provide specific guidance on revenue but indicated that they expect modest increases in expenses due to new promising assets [100][101] Question: Can you provide more color on the earlier returns to growth in Q1? - Management noted that while Q1 typically sees slower uptake, there has been a positive return to growth trends earlier than expected in 2022 [107][108]
Biohaven .(BHVN) - 2021 Q4 - Earnings Call Presentation
2022-02-25 16:35
NEUROINNOVATION® We Demand More for Patients. 4th Quarter and Full Year 2021 Earnings February 25, 2022 Ellie, living with migraine NYSE:BHVN © 2022 Biohaven Pharmaceuticals. All rights reserved. Agenda | --- | |---------------------------------------------------------------------------------------------------------------| | | | Opening Remarks \| Caroline Dircks, Ph.D., Vice President Corporate Operations | | Company Achievements \| Vlad Coric, M.D., Chief Executive Officer | | 4Q and Year End 2021 Financi ...
Biohaven .(BHVN) - 2021 Q3 - Earnings Call Transcript
2021-11-09 18:08
Financial Data and Key Metrics Changes - Biohaven reported net revenue of $136 million for NURTEC ODT in Q3 2021, a 46% increase compared to Q2 2021, bringing cumulative net revenue to approximately $336 million since launch [7][22] - The non-GAAP adjusted net loss for Q3 2021 was $125.1 million, or $1.91 per share, compared to a loss of $159.5 million, or $2.67 per share, for the same period in 2020 [24] - Year-to-date R&D investment for the first nine months of 2021 was $210.6 million, up from $137.6 million in the prior year, reflecting a $73 million increase [25] Business Line Data and Key Metrics Changes - NURTEC ODT achieved a 57% market share in the new-to-brand (NBRx) metric, indicating strong demand for its dual indication [8][22] - The oral CGRP class is outperforming initial launch expectations, with NURTEC ODT becoming the number one migraine treatment in its class [8][30] Market Data and Key Metrics Changes - Pfizer's global revenues were reported at $35.4 billion for Q3 2021, highlighting the potential for collaboration to reach a broader patient base [17] - The collaboration with Pfizer aims to accelerate access to Rimegepant for over 1 billion patients worldwide suffering from migraines [9][10] Company Strategy and Development Direction - The strategic collaboration with Pfizer is designed to leverage Biohaven's neuroscience R&D expertise alongside Pfizer's commercialization capabilities to enhance global access to Rimegepant [6][9] - Biohaven aims to maintain U.S. commercialization rights for NURTEC ODT while partnering with Pfizer for markets outside the U.S., allowing for a focus on global expansion [13][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the collaboration with Pfizer, emphasizing the potential to transform Rimegepant into a global brand and improve patient access [12][15] - The management team highlighted the importance of the dual indication of NURTEC ODT in changing the treatment paradigm for migraine patients [28][30] Other Important Information - Biohaven's cash position is expected to strengthen significantly with Pfizer's upfront investment of $150 million and an additional $350 million equity investment [10][21] - The company has over 45 completed clinical trials and approximately 40 ongoing trials, indicating a robust pipeline for future growth [35][39] Q&A Session Summary Question: Why not a complete exit with Pfizer potentially buying the whole company? - Management believes the current partnership preserves optionality in the U.S. while enhancing future revenue potential and operational capabilities globally [46][47] Question: Clarification on the $740 million in milestones related to the Pfizer deal? - Management indicated that details on the split between regulatory and commercial milestones would be provided in future filings, emphasizing that revenues would be realized sooner than anticipated [50][51] Question: How does NURTEC's profile compare to other CGRP treatments? - Management highlighted that NURTEC is unique as it offers both acute treatment and prevention in one pill, which resonates well with patients and healthcare providers [52][53] Question: Any strategic synergies between Biohaven and Pfizer? - The collaboration is expected to leverage Pfizer's global presence and expertise in primary care to enhance the reach of NURTEC [55][57] Question: How are conversations with payers going for preventive treatment? - Discussions with payers are progressing well, with confidence in maintaining coverage for acute therapy and positive feedback for preventive treatment [66][67] Question: Are there any clauses in the agreement that could prevent future expansions? - Management confirmed there are no standstill clauses in the agreement, allowing for potential future expansions [70][72]