Biohaven Pharmaceuticals Reports First Quarter 2018 Financial and Recent Business Results
Biohaven Pharmaceuticals Reports First Quarter 2018 Financial and Recent Business Results
-- Successful Achievement of Registrational Co-Primary Endpoints and Key Secondary Endpoints in Two Pivotal Phase 3 Trials with Rimegepant (Oral CGRP Receptor Antagonist) for the Acute Treatment of Migraine, with Safety and Tolerability Profile Similar to Placebo
-- Commenced Enrollment in Phase 3 Trial Evaluating Rimegepant Zydis® Orally Dissolving Tablets; Topline Results Anticipated Q4 2018
-- Restructured License Agreement with Bristol-Myers Squibb to Reduce Royalties Payable on Migraine Product Candidates and Revised Competitive Products Language
-- Completed Pre-NDA Meeting with FDA Regarding Sublingual BHV-0223 in ALS, Initiated Expanded Access Program and on Target for NDA Submission in 2H 2018
NEW HAVEN, Conn., May 15, 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 disorders, including rare disorders, reported financial results for the quarter ended March 31, 2018.
"In the first quarter of 2018, we continued our strong momentum across our CGRP receptor antagonist and glutamate modulator pipeline programs. The team's stellar performance and progress position us to expect a number of important data announcements and regulatory filings in 2018 and 2019," said Vlad Coric, M.D., CEO of Biohaven. "In our CGRP receptor antagonist platform, we announced positive data from both of our pivotal Phase 3 trials with rimegepant as an acute treatment for migraine, continued our long-term safety study of rimegepant and commenced a clinical trial of our Zydis® orally dissolving tablet formulation. We also progressed BHV-3500 toward the clinic for the acute treatment and prevention of migraine. And in our glutamate modulator programs, we continued to progress all three of our drug candidates across multiple indications. Ongoing studies continue with trigriluzole in spinocerebellar ataxia and OCD, while the Alzheimer's disease trial will begin in the second quarter of 2018. We were excited to initiate our expanded access program for sublingual BHV-0223 in ALS and remain on target to submit our NDA in the second half of 2018. Lastly, our oral, low-trapping NMDA antagonist, BHV-5000, is completing nonclinical and Phase 1 work to support later stage development. Our world-class team of clinical and commercial professionals remain dedicated and focused on achieving important milestones over the course of the year."
First Quarter and Recent Business Highlights:
-- Announced Successful Achievement of Both Co-Primary Regulatory Endpoints
along with Key Secondary Outcome Measures in Two Pivotal Phase 3 Trials
of Rimegepant - In March 2018, the Company announced positive top-line
results from both of its two Phase 3 clinical trials of rimegepant
(formerly known as BHV-3000), an oral calcitonin gene-related peptide
(CGRP) receptor antagonist for the acute treatment of migraine. In each
trial, rimegepant met the co-primary efficacy endpoints of superiority
to placebo, at two hours post-dose, on pain freedom and freedom from the
most bothersome symptom. The Company subsequently reported achievement
of benefit on key secondary outcome measures, including single-dose
durable headache relief and recovery of function endpoints. A single
dose of rimegepant, without any rescue medications, was superior to
placebo for pain freedom and pain relief at 2 hours post-dosing and
demonstrated a profile of increasing improvement throughout the first
eight hours that was sustained compared to placebo out to 24 and 48
hours. In both trials, rimegepant demonstrated a safety and tolerability
profile similar to placebo, including on liver function tests.
-- Restructured License Agreement with Bristol-Myers Squibb (BMS) - In
March 2018, the Company announced a restructuring of its global license
agreement with Bristol-Myers Squibb for Biohaven's small molecule CGRP
receptor antagonist platform (BMS Amendment). As part of the
restructuring, Biohaven paid BMS an upfront payment of $50 million in
return for a low single digit reduction in royalties payable on net
sales of rimegepant and a mid-single digit reduction in royalties
payable on net sales of BHV-3500. The upfront payment for the
restructuring was financed through a private placement of Biohaven
common shares to leading institutional investors. The restructuring also
removed BMS's right of first negotiation and clarified that antibodies
targeting CGRP are not prohibited as competitive compounds under the
non-competition clause of the agreement, thereby permitting Biohaven the
flexibility to potentially license rimegepant or BHV-3500 to a company
with a CGRP antibody program.
-- Commenced Enrollment in Phase 3 Clinical Trial Evaluating Rimegepant
Zydis(®) Orally Dissolving Tablet (ODT) - In March 2018, the Company
announced enrollment in a Phase 3 clinical trial assessing the onset of
action, patient satisfaction, efficacy and safety of the fast-dissolve
Zydis(®) ODT formulation of rimegepant. The trial will randomize
approximately 850 patients across two treatment arms, rimegepant 75 mg
ODT versus placebo, and topline results are anticipated in the fourth
quarter of 2018. Biohaven has been working with Catalent U.K. Swindon
Zydis Limited, a subsidiary of Catalent, Inc. (NYSE: CTLT) ("Catalent")
to develop this new ODT formulation of rimegepant and extend additional
delivery formulations across its CGRP receptor antagonist platform and
has entered into an exclusive agreement with Catalent for the use of the
Zydis(®) ODT formulation technology in the development of small
molecule CGRP receptor antagonists. The Company had previously reported
positive top-line results from the bioequivalence study demonstrating
pharmacokinetic equivalence of the rimegepant Zydis(®) ODT formulation
compared to the rimegepant tablet formulation used in the Phase 3
program.
-- Advanced Sublingual BHV-0223 Towards New Drug Application (NDA)
Submission - In March 2018, the Company had a Pre-NDA meeting with Food
and Drug Administration (FDA) regarding sublingual BHV-0223 in
amyotrophic lateral sclerosis (ALS) and is on schedule for NDA
submission in the second half of 2018. In anticipation of the NDA filing
for BHV-0223, the Company recently established an expanded access
program with sublingual BHV-0223 for patients with ALS. Through this
program, physicians may be able to obtain BHV-0223 for their eligible
patients with ALS at no cost.
-- Initiated Clinical Development of BHV-5000 - In January 2018, the
Company announced initiation of a Phase 1 trial evaluating BHV-5000, a
novel low-trapping N-methyl-D-aspartate (NMDA) antagonist which is being
developed as a potential treatment for neuropsychiatric conditions such
as Rett syndrome, neuropathic pain and treatment-resistant depression.
Enrollment of subjects has started for the investigational new drug
application (IND) opening study, which will test single and multiple
doses of a solid-dose formulation of BHV-5000 in healthy volunteers.
Nonclinical studies are also underway to support later stage development
of the compound.
Upcoming Milestones:
Biohaven is progressing drug 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 quarters.
-- In its CGRP receptor antagonist platform, the Company expects to:
-- Report initial results from a long-term safety study evaluating
rimegepant in Q4 2018
-- Report top-line results from a Phase 3 rimegepant Zydis(®) ODT
trial in Q4 2018
-- Submit an IND and initiate a Phase 1 trial evaluating BHV-3500 for
the acute treatment and prevention of migraine in 2018
-- Submit an NDA for rimegepant to the FDA in 2019, having previously
announced positive topline data from its first two pivotal Phase 3
trials.
-- In its glutamate modulator platform, the Company expects to:
-- Complete enrollment in a Phase 2 trial evaluating trigriluzole in
OCD in 2018
-- Report top-line results from a Phase 3 spinocerebellar ataxia
long-term extension study in Q4 2018
-- Initiate a Phase 2 clinical trial evaluating trigriluzole in
Alzheimer's disease in collaboration with the Alzheimer's Disease
Cooperative Study Group in Q2 2018
-- Submit an NDA to the FDA via the 505(b)(2) pathway for BHV-0223 in
patients with ALS in the second half of 2018
-- Complete a Phase 1 trial for BHV-5000 in 2018
First Quarter 2018 Financial Results
Cash Position: Cash as of March 31, 2018 was $104.2 million, compared to $131.5 million as of December 31, 2017.
R&D Expenses: Research and development (R&D) expenses were $75.6 million for the three months ended March 31, 2018, compared to $10.7 million for the three months ended March 31, 2017. The increase of $64.8 million was primarily due to the upfront payment of $50 million related to the BMS Amendment, increases in direct costs of $12.4 million for the rimegepant program and $1.1 million for the BHV-0223 program, and an increase of personnel costs, including non-cash share-based compensation, of $1.8 million. The increase in direct costs for rimegepant was primarily due to an increase in the number of clinical trials in various stages of development for the three months ended March 31, 2018 as compared to the same period in 2017, where only one clinical trial was underway.
G&A Expenses: General and administrative (G&A) expenses were $7.9 million for the three months ended March 31, 2018, compared to $3.8 million for the three months ended March 31, 2017. The increase of $4.1 million was primarily due to increases in personnel-related costs, including non-cash share-based compensation of $1.7 million, due to the hiring of additional personnel in general and administrative functions, and due to preparation for marketing activities, professional fees supporting ongoing business operations, and fees to comply with being a public company.
Net Loss: The Company reported a net loss attributable to common shareholders of $85.5 million or $2.32 per share in Q1 2018, compared to $22.8 million, or $1.74 per share, in Q1 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, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist and glutamate modulator 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 and the availability of data from those trials and statements regarding the timing of expected regulatory submissions, as well as 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 "estimate," "intend," "expect," "believe," "anticipate," "will, "potential," "plan," "could," "may" 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 our 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 March 31, 2018, filed with the Securities and Exchange Commission on May 15, 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.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
March 31,
---------
2018 2017
---- ----
Operating expenses:
Research and development $75,579 $10,740
General and administrative 7,857 3,757
----- -----
Total operating expenses 83,436 14,497
------ ------
Loss from operations (83,436) (14,497)
------- -------
Other income (expense):
Interest expense (8) (305)
Change in fair value of warrant
liability (1,182) (454)
Change in fair value of derivative
liability - 289
Change in fair value of contingent
equity liability - (3,375)
Loss from equity method investment (728) (218)
Other (21) -
--- ---
Total other income (expense), net (1,939) (4,063)
------ ------
Loss before provision for income taxes (85,375) (18,560)
Provision for income taxes 87 193
--- ---
Net loss and comprehensive loss (85,462) (18,753)
Accretion of beneficial conversion
feature on Series A preferred shares - (4,000)
--- ------
Net loss attributable to common
shareholders of Biohaven Pharmaceutical $(85,462) $(22,753)
Holding Company Ltd.
===
Net loss per share attributable to
common shareholders of Biohaven $(2.32) $(1.74)
Pharmaceutical Holding Company Ltd. -basic and
diluted
===
Weighted average common shares
outstanding-basic and diluted 36,770,868 13,088,861
========== ==========
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
(Unaudited)
March 31, December 31,
2018 2017
---- ----
Assets
Current assets:
Cash $104,206 $131,468
Prepaid expenses and other current assets 10,467 5,197
------ -----
Total current assets 114,673 136,665
Property and equipment, net 2,936 2,344
Equity method investment 8,494 7,847
Other assets 32 32
--- ---
Total assets $126,135 $146,888
======== ========
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $9,051 $4,721
Accrued expenses 7,814 4,708
----- -----
Total current liabilities 16,865 9,429
Warrant liability - 4,021
Other long-term liabilities 1,454 1,467
----- -----
Total liabilities 18,319 14,917
------ ------
Total shareholders' equity 107,816 131,971
------- -------
Total liabilities and shareholders' equity $126,135 $146,888
======== ========
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-first-quarter-2018-financial-and-recent-business-results-300648881.html
SOURCE Biohaven Pharmaceutical Holding Company Ltd.
