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Biohaven Pharmaceuticals Reports Second Quarter 2018 Financial And Recent Business Results | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
By: PR Newswire Association LLC. - 14 Aug 2018 | Back to overview list |
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NEW HAVEN, Conn., Aug. 14, 2018 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders, today reported financial results for the quarter ended June 30, 2018, and provided a review of recent accomplishments and anticipated milestones. Vlad Coric, M.D., CEO of Biohaven commented, "In the second quarter, we successfully advanced our CGRP program with the announcement of data from two positive Phase 3 trials of rimegepant in migraine, and we obtained significant new funding to advance the full range of our pipeline programs well into next year." Dr. Coric added, "We believe we are well positioned to achieve anticipated milestones in the second half of 2018 including: 1) reporting topline results from our Phase 3 trial of rimegepant Zydis® ODT in acute treatment of migraine; 2) initiation of an additional Phase 3 trial of rimegepant for migraine prevention; 3) preliminary reporting of data of our rimegepant long-term safety study in Q4 2018, supporting our planned rimegepant NDA submission in 2019; 4) submission of an IND to enable first human dosing of BHV-3500, our third generation oral CGRP antagonist; 5) submission of an NDA for our sublingual BHV-0223 formulation for patients with amyotrophic lateral sclerosis; 6) reporting topline data from a Phase 2 investigator-initiated, double-blind, proof of concept study on public speaking in social anxiety disorder with BHV-0223; 7) continued enrollment of our Phase 2/3 Alzheimer's disease trial; and 8) initiation of second randomized controlled clinical trial of troriluzole in spinocerebellar ataxia." Second Quarter and Recent Business Highlights
Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist Platform - Recent Milestones and Next Steps
Glutamate Modulation Platform - Recent Milestones and Next Steps
Upcoming Milestones: Biohaven is progressing its product candidates through clinical programs in a number of common and rare disorders. The Company expects to reach significant pipeline milestones with its CGRP receptor antagonists and glutamate modulators in the coming periods.
Second Quarter and First Half 2018 Financial Results Cash Position: Cash as of June 30, 2018, was $217.5 million, compared to $104.2 million as of March 31, 2018. This increase primarily reflects the net proceeds of approximately $149.6 million from the Company's transaction with Royalty Pharma, offset by payments for operating expenses during the quarter. Research and Development (R&D) Expenses: R&D expenses for the three and six months ended June 30, 2018, were $29.1 million and $104.6 million, respectively, compared to $21.0 million and $31.8 million for the same periods in 2017. The increase of $8.0 million for the three months ended June 30, 2018, was primarily due to increases in direct costs of $7.0 million for the rimegepant program, and an increase of personnel costs, including non-cash share-based compensation, of $2.4 million. The increase of $72.9 million for the six months ended June 30, 2018, was primarily due to the upfront payment of $50.0 million related to the amendment of the Company's license agreement with Bristol-Myers Squibb Company (BMS) during the first quarter of 2018, increases in direct costs of $19.3 million for the rimegepant program and $1.7 million for the BHV-0223 program, and an increase of personnel costs, including non-cash share-based compensation, of $4.2 million. The increases in direct costs for the rimegepant program for the three and six months ended June 30, 2018, were primarily due to an increase in the number of clinical trials, in various stages of development, as compared to the same periods in 2017 General and Administrative (G&A) Expenses: G&A expenses for the three and six months ended June 30, 2018, were $9.1 million and $16.9 million, respectively, compared to $4.2 million and $8.0 million for the same periods in 2017. The increases of $4.9 million and $9.0 million for the three and six months ended June 30, 2018, respectively, were primarily due to increases in personnel-related costs, including non-cash share-based compensation, due to the hiring of additional personnel in the general and administrative functions, preparation for commercialization activities, professional fees supporting ongoing business operations and additional fees to comply with being a public company. Net Loss: The Company reported a net loss attributable to common shareholders for the three and six months ended June 30, 2018 of $39.3 million, or $1.01 per share, and $124.7 million, or $3.29 per share, respectively, compared to $46.4 million, or $1.78 per share, and $69.2 million, or $3.54 per share for the same periods in 2017. About Biohaven Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, Rutgers, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist and glutamate modulation platforms. The Company's common shares are listed on the New York Stock Exchange and traded under the ticker symbol BHVN. More information about Biohaven is available at www.biohavenpharma.com. Forward-Looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release, including statements regarding the expected commencement and completion of clinical trials, the anticipated timing of availability of data from those trials, the timing of expected regulatory submissions, the efficacy and safety profiles of the Company's product candidates and their expected benefits compared to other treatment options, the Company's ability to fund its operations and progress its development programs through 2019, and other statements regarding the Company's plans and objectives, expectations and assumptions of management are forward-looking statements. The use of certain words, including the words "expect," "anticipate," "will," "potential," "plan," "might" and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in the forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by the forward-looking statements including risks and uncertainties related to the timing of initiating, enrolling and completing clinical trials; the commencement or completion of enrollment in any clinical trial does not guarantee the continuation or successful outcome of the trial, or the acceptance by the FDA of a regulatory package for the drug candidate being tested; the submission of an IND does not guarantee that the FDA will permit clinical trials to begin; and those factors described in the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, filed with the Securities and Exchange Commission on August 14, 2018. The forward-looking statements are made as of this date and the Company 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.
For further information, contact Dr. Vlad Coric, Chief Executive Officer, at Vlad.Coric@biohavenpharma.com View original content with multimedia:http://www.prnewswire.com/news-releases/biohaven-pharmaceuticals-reports-second-quarter-2018-financial-and-recent-business-results-300697042.html SOURCE Biohaven Pharmaceutical Holding Company Ltd. |
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