|
|
|
British Virgin Islands
|
|
Not applicable
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
|
|
|
c/o Biohaven Pharmaceuticals, Inc.
215 Church Street, New Haven, Connecticut
|
|
06510
|
(Address of principal executive offices)
|
|
(Zip Code)
|
Large accelerated filer x
|
|
Accelerated filer o
|
|
|
|
Non-accelerated filer o
|
|
Small reporting company o
|
|
|
|
|
|
Emerging growth company o
|
Title of each class
|
Trading Symbol
|
Name of each exchange on which registered
|
Common Shares, no par value
|
BHVN
|
New York Stock Exchange
|
|
|
|
|
|
Page
|
|
|
|
|
||
|
||
|
||
|
||
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
||||
|
|
(Unaudited)
|
|
|
||||
Assets
|
|
|
|
|
||||
Current assets:
|
|
|
|
|
||||
Cash
|
|
$
|
217,407
|
|
|
$
|
264,249
|
|
Prepaid expenses and other current assets (Note 4)
|
|
9,966
|
|
|
8,090
|
|
||
Total current assets
|
|
227,373
|
|
|
272,339
|
|
||
Property and equipment, net
|
|
7,157
|
|
|
6,248
|
|
||
Equity method investment (Note 5)
|
|
10,514
|
|
|
11,414
|
|
||
Other assets
|
|
36
|
|
|
11
|
|
||
Total assets
|
|
$
|
245,080
|
|
|
$
|
290,012
|
|
Liabilities and Shareholders’ Equity
|
|
|
|
|
||||
Current liabilities:
|
|
|
|
|
||||
Accounts payable
|
|
$
|
8,210
|
|
|
$
|
10,752
|
|
Accrued expenses (Note 6)
|
|
15,483
|
|
|
8,782
|
|
||
Total current liabilities
|
|
23,693
|
|
|
19,534
|
|
||
Liability related to sale of future royalties (Note 7)
|
|
124,332
|
|
|
117,515
|
|
||
Other long-term liabilities
|
|
44
|
|
|
2,043
|
|
||
Total liabilities
|
|
$
|
148,069
|
|
|
$
|
139,092
|
|
Commitments and contingencies (Note 12)
|
|
|
|
|
|
|
||
Shareholders’ equity:
|
|
|
|
|
||||
Common shares, no par value; 200,000,000 shares authorized as of March 31, 2019 and December 31, 2018; 44,282,994 and 44,197,549 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively
|
|
556,345
|
|
|
554,384
|
|
||
Additional paid-in capital
|
|
46,538
|
|
|
40,104
|
|
||
Accumulated deficit
|
|
(505,872
|
)
|
|
(443,568
|
)
|
||
Total shareholders’ equity
|
|
$
|
97,011
|
|
|
$
|
150,920
|
|
Total liabilities and shareholders’ equity
|
|
$
|
245,080
|
|
|
$
|
290,012
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Operating expenses:
|
|
|
|
|
||||
Research and development
|
|
$
|
41,003
|
|
|
$
|
75,579
|
|
General and administrative
|
|
13,462
|
|
|
7,857
|
|
||
Total operating expenses
|
|
54,465
|
|
|
83,436
|
|
||
Loss from operations
|
|
(54,465
|
)
|
|
(83,436
|
)
|
||
Other income (expense):
|
|
|
|
|
||||
Non-cash interest expense on liability related to sale of future royalties
|
|
(6,813
|
)
|
|
—
|
|
||
Change in fair value of warrant liability
|
|
—
|
|
|
(1,182
|
)
|
||
Loss from equity method investment
|
|
(900
|
)
|
|
(728
|
)
|
||
Other
|
|
(17
|
)
|
|
(29
|
)
|
||
Total other expense, net
|
|
(7,730
|
)
|
|
(1,939
|
)
|
||
Loss before provision for income taxes
|
|
$
|
(62,195
|
)
|
|
$
|
(85,375
|
)
|
Provision for income taxes
|
|
109
|
|
|
87
|
|
||
Net loss and comprehensive loss
|
|
$
|
(62,304
|
)
|
|
$
|
(85,462
|
)
|
Net loss per share — basic and diluted
|
|
$
|
(1.41
|
)
|
|
$
|
(2.32
|
)
|
Weighted average common shares outstanding—basic and diluted
|
|
44,242,070
|
|
|
36,793,090
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
|
||||
Net loss
|
|
$
|
(62,304
|
)
|
|
$
|
(85,462
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
||||
Non-cash share-based compensation expense
|
|
7,330
|
|
|
3,088
|
|
||
Non-cash interest expense on liability related to sale of future royalties
|
|
6,813
|
|
|
—
|
|
||
Change in fair value of warrant liability
|
|
—
|
|
|
1,182
|
|
||
Loss from equity method investment
|
|
900
|
|
|
728
|
|
||
Other non-cash items
|
|
133
|
|
|
17
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
||||
Prepaid expenses and other current assets
|
|
(1,876
|
)
|
|
(5,270
|
)
|
||
Other assets
|
|
(25
|
)
|
|
—
|
|
||
Accounts payable
|
|
(2,542
|
)
|
|
4,224
|
|
||
Accrued expenses
|
|
6,701
|
|
|
(27
|
)
|
||
Other long-term liabilities
|
|
(1,999
|
)
|
|
(13
|
)
|
||
Net cash used in operating activities
|
|
$
|
(46,869
|
)
|
|
$
|
(81,533
|
)
|
Cash flows from investing activities:
|
|
|
|
|
||||
Purchases of property and equipment
|
|
(1,038
|
)
|
|
(357
|
)
|
||
Purchase of equity method investment
|
|
—
|
|
|
(1,375
|
)
|
||
Net cash used in investing activities
|
|
$
|
(1,038
|
)
|
|
$
|
(1,732
|
)
|
Cash flows from financing activities:
|
|
|
|
|
||||
Proceeds from issuance of common shares
|
|
—
|
|
|
55,000
|
|
||
Proceeds from exercise of stock options
|
|
1,065
|
|
|
1,003
|
|
||
Net cash provided by financing activities
|
|
$
|
1,065
|
|
|
$
|
56,003
|
|
Net increase in cash
|
|
(46,842
|
)
|
|
(27,262
|
)
|
||
Cash at beginning of period
|
|
264,249
|
|
|
131,468
|
|
||
Cash at end of period
|
|
$
|
217,407
|
|
|
$
|
104,206
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
||||
Cash paid for interest
|
|
$
|
—
|
|
|
$
|
—
|
|
Cash paid for income taxes
|
|
$
|
408
|
|
|
$
|
80
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
|
||||
Offering costs included in accounts payable and accrued expenses
|
|
$
|
—
|
|
|
$
|
2,987
|
|
|
|
Warrant
Liability
|
||
Balance at December 31, 2017
|
|
$
|
4,021
|
|
Change in fair value
|
|
$
|
1,182
|
|
Reclassification to equity
|
|
(5,203
|
)
|
|
Balance at March 31, 2018
|
|
$
|
—
|
|
|
|
As of March 31, 2019
|
|
As of December 31, 2018
|
||||
Prepaid clinical trial costs
|
|
$
|
9,212
|
|
|
$
|
7,210
|
|
Prepaid insurance
|
|
83
|
|
|
393
|
|
||
Other
|
|
671
|
|
|
487
|
|
||
|
|
$
|
9,966
|
|
|
$
|
8,090
|
|
|
Carrying Value
|
||
Balance at December 31, 2018
|
$
|
11,414
|
|
Loss recognized in connection with equity method investment
|
(900
|
)
|
|
Balance at March 31, 2019
|
$
|
10,514
|
|
|
|
||
Balance at December 31, 2017
|
$
|
7,847
|
|
Purchases of Kleo common stock
|
1,375
|
|
|
Loss recognized in connection with equity method investment
|
(728
|
)
|
|
Balance at March 31, 2018
|
$
|
8,494
|
|
|
|
As of March 31, 2019
|
|
As of December 31, 2018
|
||||
Accrued development milestones payable (Note 12)
|
|
$
|
6,000
|
|
|
$
|
—
|
|
Accrued employee compensation and benefits
|
|
1,046
|
|
|
108
|
|
||
Accrued clinical trial costs
|
|
3,939
|
|
|
6,753
|
|
||
Accrued professional fees
|
|
3,758
|
|
|
1,636
|
|
||
Other
|
|
740
|
|
|
285
|
|
||
|
|
$
|
15,483
|
|
|
$
|
8,782
|
|
|
|
Common Shares
|
|
|
|
|
|
|
||||||||||
|
|
Shares
|
|
Amount
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Total Shareholders' Equity (Deficit)
|
||||||||
Balances as of December 31, 2018
|
|
44,197,549
|
|
$
|
554,384
|
|
|
$
|
40,104
|
|
|
$
|
(443,568
|
)
|
|
$
|
150,920
|
|
Exercise of stock options
|
|
85,445
|
|
1,961
|
|
|
(896
|
)
|
|
—
|
|
|
1,065
|
|
||||
Non-cash share-based compensation expense
|
|
0
|
|
—
|
|
|
7,330
|
|
|
—
|
|
|
7,330
|
|
||||
Net loss
|
|
0
|
|
—
|
|
|
—
|
|
|
(62,304
|
)
|
|
(62,304
|
)
|
||||
Balances as of March 31, 2019
|
|
44,282,994
|
|
556,345
|
|
|
46,538
|
|
|
(505,872
|
)
|
|
97,011
|
|
|
|
Common Shares
|
|
|
|
|
|
|
||||||||||
|
|
Shares
|
|
Amount
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Total Shareholders' Equity (Deficit)
|
||||||||
Balances as of December 31, 2017
|
|
36,057,748
|
|
$
|
311,061
|
|
|
$
|
23,556
|
|
|
$
|
(202,646
|
)
|
|
$
|
131,971
|
|
Issuance of common shares upon completion of private placement equity offering, net of offering costs
|
|
2,000,000
|
|
52,013
|
|
|
—
|
|
|
—
|
|
|
52,013
|
|
||||
Exercise of ALS Biopharma warrants, net settlement of shares
|
|
228,219
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Reclassification of warrant liability to equity
|
|
0
|
|
—
|
|
|
5,203
|
|
|
—
|
|
|
5,203
|
|
||||
Exercise of stock options
|
|
321,050
|
|
4,656
|
|
|
(3,653
|
)
|
|
—
|
|
|
1,003
|
|
||||
Non-cash share-based compensation expense
|
|
0
|
|
—
|
|
|
3,088
|
|
|
—
|
|
|
3,088
|
|
||||
Net loss
|
|
0
|
|
—
|
|
|
—
|
|
|
(85,462
|
)
|
|
(85,462
|
)
|
||||
Balances as of March 31, 2018
|
|
38,607,017
|
|
$
|
367,730
|
|
|
$
|
28,194
|
|
|
$
|
(288,108
|
)
|
|
$
|
107,816
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2019
|
|
2018
|
||||
Numerator:
|
|
|
|
|
|
|
||
Net loss
|
|
$
|
(62,304
|
)
|
|
$
|
(85,462
|
)
|
Denominator:
|
|
|
|
|
||||
Weighted average common shares outstanding—basic and diluted
|
|
44,242,070
|
|
|
36,793,090
|
|
||
Net loss per share attributable to common shareholders of Biohaven Pharmaceutical Holding Company Ltd.—basic and diluted
|
|
$
|
(1.41
|
)
|
|
$
|
(2.32
|
)
|
|
|
Three Months Ended March 31,
|
||||
|
|
2019
|
|
2018
|
||
Options to purchase common shares
|
|
7,923,334
|
|
|
5,979,093
|
|
Warrants to purchase common shares
|
|
221,751
|
|
|
546,751
|
|
|
|
8,145,085
|
|
|
6,525,844
|
|
Product
|
|
Platform
|
|
Indication
|
|
Development Stage
|
Rimegepant
|
|
CGRP
|
|
Acute treatment and prevention of migraine
|
|
Three pivotal Phase 3 trials for acute treatment complete; long-term safety study ongoing. Phase 3 trial for prevention initiated in the fourth quarter of 2018. Advancing Zydis ODT and tablet formulation development programs towards potential commercialization for the acute treatment of migraine.
|
Rimegepant
|
|
CGRP
|
|
Trigeminal Neuralgia
|
|
Phase 2 proof of concept trial planned for 2019.
|
BHV-3500
|
|
CGRP
|
|
Acute treatment and prevention of migraine
|
|
Phase 2/3 trial ongoing.
|
Troriluzole
|
|
Glutamate
|
|
Ataxias
|
|
Phase 2/3 randomization phase in SCA complete; extension trial ongoing. Phase 3 trial ongoing.
|
Troriluzole
|
|
Glutamate
|
|
Obsessive Compulsive Disorder ("OCD")
|
|
Phase 2/3 ongoing.
|
Troriluzole
|
|
Glutamate
|
|
Alzheimer’s disease
|
|
Phase 2/3 ongoing.
|
Troriluzole
|
|
Glutamate
|
|
Generalized Anxiety Disorder ("GAD")
|
|
Phase 2/3 ongoing.
|
Nurtec
|
|
Glutamate
|
|
Amyotrophic Lateral Sclerosis ("ALS")
|
|
NDA filed with FDA in fourth quarter of 2018. Prescription Drug User Fee Act ("PDUFA") date of July 21, 2019.
|
BHV-5000
|
|
Glutamate
|
|
Neuropsychiatric disorders
|
|
Phase 1 trial completed 2018; additional nonclinical studies anticipated in 2019.
|
Verdiperstat
|
|
MPO
|
|
Neuroinflammation
|
|
Phase 3 trial for the treatment of multiple system atrophy ("MSA") expected to begin in third quarter of 2019.
|
•
|
expenses incurred under agreements with contract research organizations (“CROs”) or contract manufacturing organizations (“CMOs”), as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services;
|
•
|
manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials and commercial materials, including manufacturing validation batches;
|
•
|
employee-related expenses, including salaries, benefits, travel and non-cash share-based compensation expense for employees engaged in research and development functions;
|
•
|
costs related to compliance with regulatory requirements;
|
•
|
payments made in cash, equity securities or other forms of consideration under third-party licensing agreements.
|
•
|
the scope, progress, outcome and costs of our preclinical development activities, clinical trials and other research and development activities;
|
•
|
establishment of an appropriate safety profile with IND-enabling studies;
|
•
|
successful patient enrollment in, and the initiation and completion of, clinical trials;
|
•
|
the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
|
•
|
establishment of commercial manufacturing capabilities or making arrangements with third-party manufacturers;
|
•
|
development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial launch;
|
•
|
acquisition, maintenance, defense and enforcement of patent claims and other intellectual property rights;
|
•
|
significant and changing government regulation;
|
•
|
initiation of commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; and
|
•
|
maintenance of a continued acceptable safety profile of the product candidates following approval.
|
|
|
Three Months Ended March 31,
|
|
|
||||||||
|
|
2019
|
|
2018
|
|
Change
|
||||||
|
|
(in thousands)
|
||||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|||
Research and development
|
|
$
|
41,003
|
|
|
$
|
75,579
|
|
|
$
|
(34,576
|
)
|
General and administrative
|
|
13,462
|
|
|
7,857
|
|
|
5,605
|
|
|||
Total operating expenses
|
|
54,465
|
|
|
83,436
|
|
|
(28,971
|
)
|
|||
Loss from operations
|
|
(54,465
|
)
|
|
(83,436
|
)
|
|
28,971
|
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|||||
Non-cash interest expense on liability related to sale of future royalties
|
|
(6,813
|
)
|
|
—
|
|
|
(6,813
|
)
|
|||
Change in fair value of warrant liability
|
|
—
|
|
|
(1,182
|
)
|
|
1,182
|
|
|||
Loss from equity method investment
|
|
(900
|
)
|
|
(728
|
)
|
|
(172
|
)
|
|||
Other
|
|
(17
|
)
|
|
(29
|
)
|
|
12
|
|
|||
Total other income (expense), net
|
|
(7,730
|
)
|
|
(1,939
|
)
|
|
(5,791
|
)
|
|||
Loss before provision for income taxes
|
|
(62,195
|
)
|
|
(85,375
|
)
|
|
23,180
|
|
|||
Provision for income taxes
|
|
109
|
|
|
87
|
|
|
22
|
|
|||
Net loss and comprehensive loss
|
|
$
|
(62,304
|
)
|
|
$
|
(85,462
|
)
|
|
$
|
23,158
|
|
|
|
Three Months Ended March 31,
|
|
|
||||||||
|
|
2019
|
|
2018
|
|
Change
|
||||||
|
|
(in thousands)
|
||||||||||
Direct research and development expenses by program:
|
|
|
|
|
|
|
|
|
|
|||
Nurtec
|
|
$
|
527
|
|
|
$
|
1,309
|
|
|
$
|
(782
|
)
|
Troriluzole
|
|
6,234
|
|
|
2,794
|
|
|
3,440
|
|
|||
Rimegepant
|
|
17,347
|
|
|
15,341
|
|
|
2,006
|
|
|||
BHV-3500
|
|
7,777
|
|
|
1,446
|
|
|
6,331
|
|
|||
BHV-5000
|
|
358
|
|
|
498
|
|
|
(140
|
)
|
|||
Verdiperstat
|
|
1,048
|
|
|
—
|
|
|
1,048
|
|
|||
Unallocated research and development costs:
|
|
|
|
|
|
|
||||||
Personnel related (including non-cash share-based compensation)
|
|
7,064
|
|
|
3,692
|
|
|
3,372
|
|
|||
BMS Amendment upfront license payment
|
|
—
|
|
|
50,000
|
|
|
(50,000
|
)
|
|||
Other
|
|
648
|
|
|
499
|
|
|
149
|
|
|||
Total research and development expenses
|
|
$
|
41,003
|
|
|
$
|
75,579
|
|
|
$
|
(34,576
|
)
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2019
|
|
2018
|
||||
|
|
(in thousands)
|
||||||
Net cash used in operating activities
|
|
$
|
(46,869
|
)
|
|
$
|
(81,533
|
)
|
Net cash used in investing activities
|
|
(1,038
|
)
|
|
(1,732
|
)
|
||
Net cash provided by financing activities
|
|
1,065
|
|
|
56,003
|
|
||
Net increase in cash
|
|
$
|
(46,842
|
)
|
|
$
|
(27,262
|
)
|
•
|
Continue to advance the rimegepant development programs towards commercialization for the acute treatment of migraine;
|
•
|
complete our ongoing Phase 3 clinical trial to evaluate rimegepant as a preventive therapy for migraine;
|
•
|
complete the ongoing extension phase of the Phase 2/3 clinical trial of troriluzole in SCA and our ongoing Phase 2/3 trials of troriluzole in OCD, Alzheimer’s disease and GAD and, complete our ongoing Phase 3 randomized controlled trial to assess the efficacy of troriluzole in SCA;
|
•
|
conduct support activities for future clinical trials of BHV-5000;
|
•
|
complete the ongoing Phase 2/3 clinical trial of BHV-3500 and related support activities;
|
•
|
conduct our planned Phase 3 clinical trial of verdiperstat in MSA;
|
•
|
continue to initiate and progress other supporting studies required for regulatory approval of our product candidates, including long-term safety studies, drug-drug interaction studies, preclinical toxicology and carcinogenicity studies;
|
•
|
make required milestone and royalty payments under the license agreements by which we acquired some of the rights to our product candidates;
|
•
|
make required royalty payments to RPI under the Funding Agreement;
|
•
|
initiate preclinical studies and clinical trials for any additional indications for our current product candidates and any future product candidates that we may pursue;
|
•
|
continue to build our portfolio of product candidates through the acquisition or in-license of additional product candidates or technologies;
|
•
|
continue to develop, maintain, expand and protect our intellectual property portfolio;
|
•
|
pursue regulatory approvals for our current and future product candidates that successfully complete clinical trials, including rimegepant and Nurtec;
|
•
|
ultimately establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval;
|
•
|
hire additional clinical, medical, commercial, and development personnel; and
|
•
|
incur additional legal, accounting and other expenses in operating as a public company.
|
•
|
the scope, progress, results and costs of researching and developing our product candidates, and conducting preclinical studies and clinical trials;
|
•
|
the costs, timing and outcome of regulatory review of our product candidates;
|
•
|
the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;
|
•
|
the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;
|
•
|
the costs and timing of hiring new employees to support our continued growth;
|
•
|
the costs of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;
|
•
|
the extent to which we acquire or in-license other product candidates and technologies;
|
•
|
the costs of manufacturing commercial-grade product and necessary inventory to support commercial launch;
|
•
|
the costs associated with payment of milestones and royalties under existing contractual arrangements and/or in-licensing additional products candidates to augment our current pipeline; and
|
•
|
the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any.
|
•
|
accrued research and development expenses;
|
•
|
Non-cash share-based compensation;
|
•
|
equity method investment, including related impairment;
|
•
|
non-cash interest expense on liability related to sale of future royalties; and
|
•
|
valuation of warrant liability.
|
•
|
the FDA, EMA, National Medical Products Administration or the applicable foreign regulatory agency’s disagreement with the number, design, conduct or implementation of our preclinical studies and clinical trials;
|
•
|
negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA, EMA, National Medical Products Administration or any comparable foreign regulatory agency for approval;
|
•
|
serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates;
|
•
|
our inability to demonstrate to the satisfaction of the FDA, EMA, National Medical Products Administration or the applicable foreign regulatory agency that our product candidates are safe and effective for their proposed indications;
|
•
|
the FDA’s, EMA’s, National Medical Products Administration's or the applicable foreign regulatory agency’s disagreement with the interpretation of data from preclinical studies or clinical trials;
|
•
|
actions by the CROs that we retain to conduct our preclinical studies and clinical trials, which are outside of our control and that materially adversely impact our preclinical studies and clinical trials;
|
•
|
the FDA’s, EMA’s, National Medical Products Administration's or other applicable foreign regulatory agencies’ disagreement with the interpretation of data from preclinical studies or clinical trials;
|
•
|
our inability to demonstrate the clinical and other benefits of our product candidates outweigh any safety or other perceived risks;
|
•
|
the FDA’s, EMA’s, National Medical Products Administration's or the applicable foreign regulatory agency’s requirement for additional preclinical studies or clinical trials;
|
•
|
the FDA’s, EMA’s, National Medical Products Administration's or the applicable foreign regulatory agency’s disagreement regarding the formulation, labeling or the specifications of our product candidates;
|
•
|
the FDA’s, EMA’s, National Medical Products Administration's or the applicable foreign regulatory agency’s failure to approve the manufacturing processes or facilities of third-party manufacturers with which we contract; or
|
•
|
the potential for approval policies or regulations of the FDA, EMA, National Medical Products Administration or the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval.
|
Exhibit No.*
|
|
Description
|
2.1(1)
|
|
|
|
|
|
3.1(2)
|
|
|
|
|
|
10.1
|
|
|
|
|
|
31.1
|
|
|
|
|
|
31.2
|
|
|
|
|
|
32.1‡
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
(1)
|
Incorporated by reference to the exhibit to the Registrant’s Current Report on Form 8-K, Commission file number 001-38080, filed on March 18, 2019. The number given in parentheses indicated the corresponding exhibit number in such Form 8-K.
|
(2)
|
Incorporated by reference to the exhibit to the Registrant’s Current Report on Form 8-K, Commission file number 001-38080, filed on April 8, 2019. The number given in parentheses indicated the corresponding exhibit number in such Form 8-K.
|
*
|
The XBRL instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document.
|
‡
|
These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
|
|
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
|
|
Dated: May 8, 2019
|
|
|
|
By:
|
/s/ Vlad Coric, M.D.
|
|
|
Vlad Coric, M.D.
|
|
|
Chief Executive Officer
|
|
|
(On behalf of the Registrant and as the Principal Executive Officer)
|
|
|
|
|
By:
|
/s/ Jim Engelhart
|
|
|
Jim Engelhart
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
|
|
|
|
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
|
|
|
|
|
|
By:
|
/s/ Vlad Coric MD
|
|
Name: Vlad Coric MD
|
|
Title: Chief Executive Officer
|
|
|
|
|
|
|
RPI FINANCE TRUST
|
|
|
|
By:
|
Wilmington Trust Company, not in its individual capacity but solely in its capacity as owner trustee
|
|
|
|
|
By:
|
/s/ Cynthia L. Major
|
|
Name: Cynthia L. Major
|
|
Title: Officer
|
|
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
/s/ Vlad Coric, M.D.
|
|
Vlad Coric, M.D.
|
|
President and Chief Executive Officer
|
|
(principal executive officer)
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
/s/ Jim Engelhart
|
|
Jim Engelhart
|
|
Chief Financial Officer
|
|
(principal financial officer)
|
/s/ Vlad Coric, M.D.
|
|
/s/ Jim Engelhart
|
Vlad Coric, M.D.
|
|
Jim Engelhart
|
President and Chief Executive Officer (principal executive officer)
|
|
Chief Financial Officer (principal financial officer)
|