Discount mulberry 2013 Outlet Biohaven Pharmaceuticals Reports Fourth Quarter And Full Year 20
Information contained on this page is provided by an independent third party content provider. Frankly and this Site make no warranties or representations in connection therewith. (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 fourth quarter and year ended December 31, 2017 and provided a review of recent accomplishments and anticipated upcoming milestones. “We have started 2018 with the same strong momentum as we prepare for important data announcements, drive toward key FDA filings, and continue to build our organization to support our expanded development pipeline and the eventual commercialization of approved products to help patients with severe neurological disorders.”
Full Year and Recent Business Highlights
CGRP Receptor Antagonist Platform Milestones and Next Steps
Enrollment complete in two pivotal Phase 3 clinical trials of rimegepant In November 2017, the Company completed enrollment in the second of two pivotal Phase 3 trials to evaluate the safety and efficacy of orally dosed rimegepant, a small molecule, new chemical entity (NCE) for the acute treatment of migraine. Topline results from both trials are expected in the first quarter of 2018. Food and Drug Administration (FDA) for registration. Long term safety study underway Biohaven continues to evaluate the long term safety of rimegepant in a third trial. Swindon Zydis Limited, a subsidiary of Catalent, Inc. (Catalent) to provide Catalent Zydis orally dissolving tablet (ODT) fast dissolving formulation for the development of rimegepant and an exclusive agreement for the use of the Zydis ODT formulation technology with small molecule CGRP receptor antagonists. In February 2018, a bioequivalence study was conducted to compare this new ODT formulation to the tablet in current clinical development and provided evidence of equivalence. Topline results confirmed that sublingual BHV 0223 (40 mg) achieves bioequivalent exposures relative to Rilutek (50 mg). In the study, 138 healthy volunteers were administered BHV 0223 and Rilutek under fasted conditions. In the pre specified primary analysis, BHV 0223 achieved area under the curve and peak exposures of approximately 90% and 113%, respectively, compared to those generated by generic riluzole. Trigriluzole is a novel third generation prodrug glutamate modulator that has been observed to have a favorable safety and tolerability profile in clinical trials. BHV 5000 is being developed as a potential treatment for neuropsychiatric disorders such as Rett syndrome. The Company also plans to explore development of BHV 5000 in other potential future indications including neuropathic pain and treatment resistant depression. First patient treated with trigriluzole in Rutgers Cancer Institute collaboration As part of a clinical collaboration with Drs. Ann Silk and James Goydos at the Rutgers Cancer Institute of New Jersey, trigriluzole is being evaluated for safety in a Phase 1 trial in combination with PD 1 blocking antibodies in patients with inoperable, advanced or refractory cancers. Cash as ofDecember 31, 2016, prior to the second closing of the Company Series A preferred share offering and initial public offering, was$23.6 million.
R Expenses:Research and development (R expenses for the year endedDecember 31, 2017 were$89.4 million compared to$55.5 millionin 2016, an increase of $33.9 million. Direct program costs increased $22.0 million, and personnel and other costs increased $11.9 million, including an increase of $4.5 million in share based compensation expense and an increase of $7.4 million in costs of additional personnel as the Company increased its development operations organization to support growing clinical activities. R expenses include non cash share based compensation expense of $6.9 million in 2017 compared to$2.4 million in 2016.
The increase in direct program costs reflects continued investment in clinical development and product supply. Development costs related to rimegepant increased $23.0 million in support of two Phase 3 clinical trials, a long term safety study, drug supply and a development milestone paid to Bristol Myers Squibb. BHV 3500 program spending increased $5.7 million related to formulation development and toxicology efforts, while BHV 0223 program development increased $3.6 million to advance a bioequivalence study. These increases were offset by a decrease of $11.6 million in 2017 for BHV 5000, as 2016 included expenses for upfront license fees and a contingent equity liability, both related to the Company license agreement with AstraZeneca.
G Expenses: General and administrative (G expenses for the year endedDecember 31, 2017 were$18.1 million compared to$5.1 millionin 2016. The increase of $13.0 million in G over the prior year primarily reflects an increase of $5.9 million in personnel related expenses, including an increase in non cash share based compensation expense of $4.1 million and a $1.8 million increase in costs of additional personnel within our commercial and administrative functions to prepare for commercialization and other organizational capabilities. In addition, professional fees increased $5.8 million, including costs to support compliance and other activities associated with preparing for and operating as a public company. G expenses include non cash share based compensation of $6.3 million in 2017 compared to $2.2 million in 2016.
Net Loss: The Company reported a net loss attributable to common shareholders for the year endedDecember 31, 2017of$139.2 million,or$5.00per share, compared to$63.7 million, or$5.05per share for 2016.
Financial Results for the Quarter endedDecember 31, 2017
R Expenses:R expenses for the quarter endedDecember 31, 2017 were$22.7 million compared to $20.4 millionin 2016, an increase of $2.3 million. The increase in R expenses reflects continued investment in Biohaven clinical development and product supply, primarily related to rimegepant, BHV 3500, and personnel costs.
The increase in development costs for rimegepant were attributable to two phase 3 clinical trials, a long term safety study and drug supply, while BHV 3500 program cost increases were the result of formulation and toxicology efforts. In addition, the Company increased its development operations organization to support growing clinical activities. These increases were offset by $12.5 million from an upfront license fee and a contingent equity liability, both related to the AstraZeneca license agreement. R expenses include non cash share based compensation of $0.5 million in the fourth quarter 2017 compared to $1.3 million in the fourth quarter 2016.
G Expenses: G expenses for the quarter endedDecember 31, 2017 were$5.6 million compared to $2.5 millionin 2016. The increase in G over the prior year primarily reflects hiring of additional personnel within our commercial and administrative functions to prepare for commercialization and other organizational capabilities, professional fees and the additional compliance and other costs associated with becoming a public company. G expenses include non cash share based compensation of $1.9 million in the fourth quarter 2017, compared to $1.1 million in the fourth quarter 2016. These forward looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company management. All statements, other than statements of historical facts, included in this press release regarding the Company business and product candidate plans and objectives are forward looking statements. Forward looking statements include those related to: the expected timing, commencement and outcomes of the Company planned and ongoing clinical trials, the timing of planned interactions with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of the Company product candidates and the potential for the Company product candidates to be first in class or best in class therapies. The use of certain words, including “believe”, “continue”, “may”, “on track”, “expects” and “will” and similar expressions, are intended to identify forward looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward looking statements. Additional important factors to be considered in connection with forward looking statements are described in the “Risk Factors” section of the Company Annual Report on Form 10 K filed with the Securities and Exchange Commission on March 6, 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.