- Antitrust approvals have been granted by the relevant governing
authorities, including the Federal Trade Commission ("FTC"), with
respect to the previously announced Pfizer Inc. acquisition of
Biohaven Pharmaceutical Holding Company Ltd.; preliminary proxy
statement has been filed with the SEC
- NURTEC® ODT (rimegepant) TRx volumes grew 11% and net product
revenue was $194 million, up
sequentially 57%
- Anticipated closing of the merger agreement necessitates
accounting of derivative losses in the amount of $1.57 per share resulting in a total second
quarter reported net loss of $6.21
per share; non-GAAP adjusted net loss1 for the second
quarter was $3.82 per share
- Featured 31 new and encore presentations, including three
late-breakers and three oral presentations, spotlighting robust
Nurtec ODT and zavegepant migraine data at the 64th annual
scientific meeting of the American Headache Society; oral
presentations included first of its kind study in migraine
reporting on the safety and benefits of Nurtec ODT when used as
preventive treatment and as-needed for acute treatment of
migraine
- Zavegepant nasal spray New Drug Application ("NDA") filing
accepted by the U.S. Food and Drug Administration ("FDA"), with a
Prescription Drug User Fee Act goal date set for first quarter of
2023
- Commenced enrollment in Phase 3 clinical trial assessing
efficacy and safety of taldefgrobep alfa in patients with Spinal
Muscular Atrophy
NEW
HAVEN, Conn., Aug. 5, 2022
/PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE:
BHVN), a biopharmaceutical company with a portfolio of innovative,
late-stage product candidates targeting neurological diseases,
including rare disorders, today reported financial results for the
second quarter ended June 30, 2022,
and provided a review of recent accomplishments during and
anticipated upcoming milestones.
Vlad Coric, M.D., Chairman and
Chief Executive Officer of Biohaven, commented, "As expected, we
observed a strong rebound in NURTEC ODT net revenue as first
quarter seasonal dynamics abated. Net product revenue of
$194 million for the quarter
represented a 57% sequential increase compared to the first quarter
and reflects strong product demand. In addition, the sales mix of
our 2-pack (16-tablet count) of Nurtec ODT continued to ramp in the
second quarter. Investments made in first quarter copay programs
drove volume and net revenue growth, and the benefits of the only
'all-in-one' therapy to treat and prevent migraine continued to
resonate with and improve the lives of patients living with
migraine. And now, with the intranasal zavegepant NDA filing
acceptance, we are closer to bringing a new, critical medication to
market that offers migraine patients ultra-rapid relief in as early
as 15 minutes, and addresses the needs of patients experiencing
nausea or vomiting who need non-oral treatment options."
Dr. Coric continued, "We are excited about the vast
opportunities beyond CGRP and have made tremendous strides across
our broader pipeline, starting with our program in focal epilepsy
with what we believe is a best-in-class approach to Kv7 potassium
channel activation. We are working hard to expedite enrollment in
our Phase 1 trial and look forward to exploring its potential
in other epilepsy types as well as in pain and affective disorders.
Likewise, we recently dosed the first subject in our Phase 3 trial
evaluating taldefgrobep alfa in subjects with Spinal Muscular
Atrophy (SMA); we look forward to driving enrollment in this trial
and exploring the potential of taldefgrobep alfa in additional
indications. We also remain on track to report topline results from
the verdiperstat arm of the platform trial in ALS, sponsored by the
Sean M. Healey & AMG Center for ALS at Massachusetts General
Hospital in the second half of the year. We are excited about the
paradigm-shifting approaches we're exploring across our expanding
pipeline and will continue working determinedly to improve outcomes
for patients living with neuroscience diseases."
Second Quarter and Recent Business Highlights
- Q2 2022 net product revenue from sales of NURTEC ODT totaled
$194 million, up sequentially 57%
compared to Q1 2022 – NURTEC ODT has now achieved over
2,200,000 prescriptions, and over 79,000 unique prescribers through
June 30, 2022, an increase of 11,500
prescribers from the first quarter, signaling continued traction
across the prescribing community. The $194
million in net product revenues for the quarter represents a
109% increase over the second quarter of 2021 and a 57% increase
from net product revenues over the first quarter of 2022. The
increase of $70 million in net
product revenues as compared to the first quarter of 2022 is due
primarily to increased NURTEC ODT prescription sales volume and
favorable pack mix per prescription. In addition, we continue
to see improvements in patient affordability / copay support needs
as patients satisfy annual deductible obligations. These are
marginally offset by additional rebates during the second quarter
of 2022 compared to the first quarter of 2022. The Company remains
on track to meet full year 2022 net product sales guidance of
$825 - $900
million.
- Antitrust approval granted for proposed acquisition by
Pfizer; other closing conditions – As previously
disclosed, Biohaven entered into an agreement and plan of
merger with Pfizer, Inc. ("Pfizer") on May
10, 2022, under which Pfizer will acquire Biohaven (the
"Merger"). Under the terms of the agreement, Pfizer will acquire
all outstanding shares of Biohaven not already owned by Pfizer for
$148.50 per share in cash. Biohaven
common shareholders, including Pfizer, will also receive 0.5 of a
share of New Biohaven, a new publicly traded company that will
retain Biohaven's non-CGRP development stage pipeline compounds,
per Biohaven common share. The boards of directors of both Biohaven
and Pfizer have unanimously approved the transaction. Pfizer will
pay transaction consideration totaling approximately $11.6 billion in cash. Pfizer will also make
payments at closing to settle Biohaven's third party debt and for
the redemption of all outstanding shares of Biohaven's redeemable
preferred stock.
-
- Consummation of the Merger is conditioned upon, among other
things, expiration or termination of any applicable waiting period
under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended (the "HSR Act"). The applicable waiting period under the
HSR Act expired at 11:59 p.m., ET, on
June 27, 2022.
- In addition to antitrust approval in the United States, the Merger was cleared by
the German Federal Cartel Office on June 13,
2022, and was cleared by the Austrian Federal Competition
Authority on June 23, 2022. On
June 24, 2022, in response to a
briefing paper filed by Pfizer on May 20,
2022, the UK Competition and Markets Authority confirmed
that no further information is required on the Merger.
- The Merger transaction is also subject to completion of the New
Biohaven spin-off transaction and customary closing conditions,
including the approval of Biohaven's shareholders. The Company
filed a preliminary proxy statement with the United States
Securities and Exchange Commission ("SEC") on July 1, 2022.
- U.S. FDA accepted Biohaven's zavegepant NDA filing for the
acute treatment of migraine in adults – In May, the Company
announced that the FDA filed and accepted for review the Company's
recently submitted NDA for zavegepant, the only small molecule
calcitonin gene-related peptide ("CGRP") receptor antagonist in an
intranasal formulation, for the acute treatment of migraine in
adults. The Prescription Drug User Fee Act ("PDUFA") goal date for
completion of the FDA review of the NDA is set for the first
quarter of 2023. The Company had announced the achievement of
positive results in the pivotal trial of zavegepant for the acute
treatment of migraine in adults in December, 2021.
- Commenced enrollment in Phase 3 Spinal Muscular Atrophy
("SMA") study – In July, the Company commenced enrollment
in a Phase 3 clinical trial assessing the efficacy and safety of
taldefgrobep alfa in Spinal Muscular Atrophy (SMA). Taldefgrobep
targets myostatin, a natural protein that limits skeletal muscle
growth, through two mechanisms: lowering myostatin directly and
blocking key downstream signaling mechanisms. The Company expects
to enroll approximately 180 patients in this randomized,
double-blind, placebo-controlled global trial.
- Global Coalition for Adaptive Research ("GCAR") commenced
enrollment in Glioblastoma Adaptive Global Innovative Learning
Environment ("GBM Agile") Phase 2-3 adaptive platform
trial for patients with glioblastoma – In July, GCAR announced
the activation of Biohaven's troriluzole and Vigeo Therapeutics'
VT1021 in GBM AGILE, a patient-centered, adaptive platform trial
for registration that tests multiple therapies for patients with
newly-diagnosed and recurrent glioblastoma ("GBM"). GBM AGILE is an
international, innovative platform trial designed to more rapidly
identify and confirm effective therapies for patients with
glioblastoma through response adaptive randomization. The new
interventions are opening first at Henry Ford Health Cancer in
Detroit under Henry Ford site Principal Investigator Dr.
Tom Mikkelsen and will subsequently
open at more than 40 trial sites across the United States with additional global sites
to follow.
- Phase 3 clinical trial of troriluzole did not reach
statistical significance in overall SCA population – In
May, the Company announced top-line results from a Phase 3 clinical
trial evaluating the efficacy and safety of its investigational
therapy, troriluzole, in patients with spinocerebellar ataxia
(SCA). The primary endpoint, change from baseline to Week 48 on the
modified functional Scale for the Assessment and Rating of Ataxia
(f-SARA), did not reach statistical significance in the overall SCA
population as there was less than expected disease progression over
the course of the study. However, post hoc analysis of efficacy
measures by genotype suggested a treatment effect in patients with
the SCA Type 3 (SCA3) genotype, which represents the most common
form of SCA and accounted for 41 percent of the study population.
In the SCA3 subgroup, troriluzole showed a numerical treatment
benefit on the change in f-SARA score from baseline to Week 48
compared to placebo. Given the debilitating nature of the
disease and lack of approved therapies, the Company intends to
share the SCA3 genotype data with regulators and work with the FDA
to address a path forward for troriluzole in SCA.
- Presented new Nurtec ODT, zavegepant, and migraine health
economics and outcomes research (HEOR) data at the American
Headache Society Annual Scientific Meeting – In June, the
Company presented 31 new and encore presentations, including three
late-breakers and three oral presentations, at the 64th
annual scientific meeting of the American Headache Society. Key
updates:
-
- The Company presented full Phase 3 results for zavegepant nasal
spray as an acute treatment of migraine as well as data from a
52-week open label extension study of Nurtec® ODT (rimegepant)
evaluating every other day preventive treatment of migraine plus as
an as-needed acute treatment, and estimated reductions in monthly
migraine days (MMDs) with rimegepant acute treatment.
- Late-breaking submissions highlighted new data about patterns
of medication utilization and migraine frequency for adults using
Nurtec ODT as a preventive and acute treatment, results from a
Phase 1 trial of Nurtec ODT in healthy Chinese adults, and outcomes
of a Phase 3 study of Nurtec ODT conducted in China and Korea
as an acute treatment of migraine.
- Several HEOR posters notably highlighted (1) reductions in the
prevalence of medication overuse headache following Nurtec ODT
initiation, (2) reduced mean monthly quantity of dispensed Nurtec
ODT which is potentially reflective of MMD reductions, (3) patient
survey studies that illustrate preference for ODT oral formulations
versus injectable or IV treatments in prevention, (4) improvements
in health-related quality of life with long-term Nurtec ODT
treatment, (5) the high interictal burden of migraine, and (6)
patient reported attenuation of effect with biologic treatment in
prevention.
Upcoming Milestones:
Biohaven is continuing to support the commercialization of
NURTEC ODT for the acute and preventive treatment of migraine, as
well as develop its product candidates through clinical and
preclinical programs in a number of common and rare disorders. The
Company expects to reach significant pipeline milestones across its
platforms in the coming quarters.
Biohaven expects to:
- Consummate the acquisition by Pfizer by early 2023, subject to
the completion of the new Biohaven spin-off transaction and other
customary closing conditions.
- Advance Phase 1 study of BHV-7000 (Kv7) in focal epilepsy.
- Continue to advance the commercialization of NURTEC ODT
(rimegepant) for the acute and preventive treatment of
migraine.
- Continue to advance the zavegepant (intranasal spray) program
towards commercialization for the acute treatment of migraine.
- Submit an NDA for the acute treatment of migraine in
China in the second half of
2022.
- Report topline of verdiperstat in ALS in the second half of
2022.
- Complete enrollment in Phase 3 study of troriluzole in
Obsessive-Compulsive Disorder in 2023.
Capital Position:
Cash, cash equivalents, and marketable securities as of
June 30, 2022, were $553.5 million, excluding $0.8 million of restricted cash, compared to
$364.6 million as of December 31, 2021. On January 4, 2022, we received $500.0 million in upfront proceeds from Pfizer
relating to our strategic collaboration arrangement, consisting of
$150.0 million cash and $350.0 million in proceeds from the purchase of
Biohaven common shares at a 25% market premium. In addition, during
the second quarter of 2022 we drew $125.0
million in non-dilutive committed capital from our credit
facility with Sixth Street.
Second Quarter 2022 Financial Highlights
Product Revenue, Net: Net product revenue was
$194.0 million for the three months
ended June 30, 2022, compared to
$92.9 million for the three months
ended June 30, 2021. The increase of
$101.0 million in net product revenue
was primarily due to increased NURTEC ODT sales volume as well as
an increase in average pills per prescription during the three
months ended June 30, 2022, compared
to the three months ended June 30,
2021. The increase in the second quarter of 2022 compared to
the second quarter of 2021 was also benefited from improved patient
affordability support, partially offset by additional rebate
related sales allowances.
Collaboration and Other Revenue: Collaboration and
other revenue was $21.1 million for
the three months ended June 30, 2022.
No collaboration and other revenue was recognized for the
three months ended June 30, 2021. The
collaboration and other revenue recognized during the three months
ended June 30, 2022 was primarily due
to $20.0 million of variable
consideration recognized as part of our collaboration arrangement
with Pfizer.
Research and Development ("R&D")
Expenses: R&D expenses, including non-cash share-based
compensation costs, were $218.5
million for the three months ended June 30, 2022, compared to $77.4 million for the three months ended
June 30, 2021. The increase of
$141.1 million was primarily due to
the acquisition of our Kv7 Platform from Knopp Biosciences LLC in
April 2022 for $93.7 million and a $25.0 million development milestone related to
BHV-7000, increased program expenses for rimegepant, and increased
personnel costs. Non-cash share-based compensation expense was
$16.6 million for the three months
ended June 30, 2022, an increase of
$7.4 million as compared to the same
period in 2021.
Selling, General and Administrative ("SG&A")
Expenses: SG&A expenses, including non-cash share-based
compensation costs, were $250.5
million for the three months ended June 30, 2022, compared to $170.1 million for the three months ended
June 30, 2021. The increase of
$80.4 million was primarily due to
increases in spending to support increased commercial sales of
NURTEC ODT, including the launch of NURTEC ODT for the preventative
treatment of migraine which was approved by the FDA in May of 2021.
Additionally, approximately $9.6
million of the increased SG&A expense related to fees
incurred in connection with the Pfizer Merger, including increased
legal and accounting costs. Less than half of the SG&A expense
was for commercial organization personnel costs, excluding non-cash
share-based compensation expense. Non-cash share-based compensation
expense was $23.6 million for the
three months ended June 30, 2022, an
increase of $7.3 million as compared
to the same period in 2021.
Other Expense, Net: Other expense, net was
$152.2 million for the three months
ended June 30, 2022, compared to
$34.9 million for the three months
ended June 30, 2021. The increase of
$117.3 million in net expense was
primarily due to a $109.7 million change in fair value of
derivative liabilities, as well as $9.3 million of increased interest expense
as a result of additional borrowings under our debt facility with
Sixth Street Specialty Lending, Inc. ("Sixth Street"). The change
in fair value of derivative liabilities was a result of derivative
liabilities recorded in connection with change of control
provisions associated with the pending acquisition of Biohaven by
Pfizer for our series A and B preferred shares and term loans with
Sixth Street.
Net Loss: Biohaven reported a net loss attributable
to common shareholders for the three months ended June 30, 2022, of $441.4
million, or $6.21 per share,
compared to $210.6 million, or
$3.23 per share for the same period
in 2021. Anticipated closing of the merger agreement necessitates
accounting of derivative losses in the amount of $1.57 per share resulting in a total second
quarter reported net loss of $6.21
per share. Non-GAAP adjusted net loss for the three months ended
June 30, 2022 was $271.4 million, or $3.82 per share, compared to $170.9 million, or $2.62 per share for the same period in 2021.
These non-GAAP adjusted net loss and non-GAAP adjusted net loss per
share measures, more fully described below under "Non-GAAP
Financial Measures," exclude non-cash share-based compensation
charges, non-cash interest expense related to the accounting for
mandatorily redeemable preferred shares and liability related to
sale of future royalties, changes in the fair value of derivatives
and gains or losses from equity method investment. A reconciliation
of the GAAP financial results to non-GAAP financial results is
included in the tables below.
Non-GAAP Financial Measures
This press release includes financial results prepared in
accordance with accounting principles generally accepted in
the United States (GAAP), and also
certain non-GAAP financial measures. In particular, Biohaven has
provided non-GAAP adjusted net loss and adjusted net loss per
share, adjusted to exclude the items below. Non-GAAP financial
measures are not an alternative for financial measures prepared in
accordance with GAAP. However, Biohaven believes the presentation
of non-GAAP adjusted net loss and adjusted net loss per share, when
viewed in conjunction with GAAP results, provides investors with a
more meaningful understanding of ongoing operating performance.
These measures exclude (i) non-cash share-based compensation, which
is substantially dependent on changes in the market price of common
shares, (ii) interest expense related to the accounting for our
mandatorily redeemable preferred shares and liability related to
sale of future royalties, which are in excess of the actual
interest owed, (iii) changes in the fair value of derivative
liability, which does not correlate to actual cash payment
obligations in the relevant periods, and (iv) gains or losses from
equity method investment, which are non-cash and based on the
financial results and valuation of another company that we did not
manage or control.
Biohaven believes the presentation of these non-GAAP financial
measures provides useful information to management and investors
regarding Biohaven's results of operations. When GAAP financial
measures are viewed in conjunction with these non-GAAP financial
measures, investors are provided with a more meaningful
understanding of Biohaven's ongoing operating performance and are
better able to compare Biohaven's performance between periods. In
addition, these non-GAAP financial measures are among those
indicators Biohaven uses as a basis for evaluating performance, and
planning and forecasting future periods. These non-GAAP financial
measures are not intended to be considered in isolation or as a
substitute for GAAP financial measures. A reconciliation between
these non-GAAP measures and the most directly comparable GAAP
measures is provided later in this press release.
About Biohaven
Biohaven is a global commercial-stage biopharmaceutical company
with a portfolio of innovative therapies to improve the lives of
patients with debilitating neurological and neuropsychiatric
diseases, including rare disorders. Biohaven's Neuroinnovation™
portfolio includes FDA-approved NURTEC® ODT (rimegepant) for the
acute and preventive treatment of migraine (EMA-approved as
VYDURA® for the acute treatment of migraine with or
without aura, and prophylaxis of episodic migraine in adults who
have at least four migraine attacks per month) and a broad pipeline
of late-stage product candidates across five distinct mechanistic
platforms: CGRP receptor antagonism for the acute and preventive
treatment of migraine and other CGRP-mediated diseases; glutamate
modulation for obsessive-compulsive disorder and spinocerebellar
ataxia; myeloperoxidase (MPO) inhibition for amyotrophic lateral
sclerosis; Kv7 ion channel activators for focal epilepsy and
neuronal hyperexcitability, and myostatin inhibition for
neuromuscular diseases. 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.
The use of certain words, including "believe", "continue", "may",
"will", "anticipate", "expect" and similar expressions, are
intended to identify forward-looking statements. These
forward-looking statements involve substantial risks and
uncertainties, including statements that are based on the current
expectations and assumptions of Biohaven's management about NURTEC
ODT as an acute treatment for patients with migraine and preventive
treatment for migraine. Factors that could affect these
forward-looking statements include those related to: Biohaven's
ability to effectively commercialize NURTEC ODT, delays or problems
in the supply or manufacture of NURTEC ODT, complying with
applicable U.S. regulatory requirements, the expected timing,
commencement and outcomes of Biohaven's planned and ongoing
clinical trials; the timing of planned interactions and filings
with the FDA; the timing and outcome of expected regulatory
filings; the potential commercialization of Biohaven's product
candidates; the potential for Biohaven's product candidates to be
first in class or best in class therapies; and the effectiveness
and safety of Biohaven's product candidates. Various important
factors could cause actual results or events to differ materially
from those that may be expressed or implied by 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's Annual Report on Form 10-K
filed with the Securities and Exchange Commission on February 25, 2022, and in Biohaven's subsequent
filings with the Securities and Exchange Commission. The
forward-looking statements are made as of the date of this new
release, and Biohaven 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.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
(Amounts in
thousands, except share and per share amounts)
|
(Unaudited)
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Revenues:
|
|
|
|
|
|
|
|
|
Product revenue,
net
|
|
$
193,954
|
|
$
92,933
|
|
$
317,544
|
|
$
136,756
|
Collaboration and
other revenue
|
|
21,125
|
|
—
|
|
216,387
|
|
—
|
Total
revenue
|
|
215,079
|
|
92,933
|
|
533,931
|
|
136,756
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
35,741
|
|
17,339
|
|
62,083
|
|
30,201
|
Research and
development
|
|
218,480
|
|
77,428
|
|
337,579
|
|
184,539
|
Selling, general and
administrative
|
|
250,455
|
|
170,057
|
|
477,698
|
|
329,580
|
Total operating
expenses
|
|
504,676
|
|
264,824
|
|
877,360
|
|
544,320
|
Loss from
operations
|
|
(289,597)
|
|
(171,891)
|
|
(343,429)
|
|
(407,564)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(17,114)
|
|
(7,836)
|
|
(34,330)
|
|
(15,567)
|
Interest expense on
mandatorily redeemable preferred shares
|
|
(8,077)
|
|
(8,042)
|
|
(15,994)
|
|
(15,985)
|
Interest expense on
liability related to sale of future royalties
|
|
(18,045)
|
|
(14,499)
|
|
(35,359)
|
|
(28,007)
|
Change in fair value
of derivatives
|
|
(111,197)
|
|
(1,490)
|
|
(107,593)
|
|
(1,700)
|
Gain from equity
method investment
|
|
—
|
|
—
|
|
—
|
|
5,261
|
Other income
(expense), net
|
|
2,229
|
|
(3,051)
|
|
2,310
|
|
(4,751)
|
Total other expense,
net
|
|
(152,204)
|
|
(34,918)
|
|
(190,966)
|
|
(60,749)
|
Loss before provision
for income taxes
|
|
(441,801)
|
|
(206,809)
|
|
(534,395)
|
|
(468,313)
|
Provision for income
taxes
|
|
84
|
|
4,350
|
|
24,387
|
|
8,174
|
Net loss
|
|
(441,885)
|
|
(211,159)
|
|
(558,782)
|
|
(476,487)
|
Net loss attributable
to non-controlling interests
|
|
498
|
|
540
|
|
996
|
|
900
|
Deemed dividend upon
repurchase of preferred shares in consolidated
subsidiary
|
|
—
|
|
—
|
|
(92,673)
|
|
—
|
Net loss attributable
to common shareholders of Biohaven Pharmaceutical Holding Company
Ltd.
|
|
$ (441,387)
|
|
$ (210,619)
|
|
$
(650,459)
|
|
$ (475,587)
|
Net loss per share
attributable to common shareholders of Biohaven Pharmaceutical
Holding Company Ltd. — basic and diluted
|
|
$
(6.21)
|
|
$
(3.23)
|
|
$
(9.20)
|
|
$
(7.48)
|
Weighted average common
shares outstanding—basic and diluted
|
|
71,043,693
|
|
65,112,179
|
|
70,689,949
|
|
63,584,932
|
BIOHAVEN
PHARMACEUTICAL HOLDING COMPANY LTD.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(Amounts in
thousands)
|
|
|
|
June 30,
2022
|
|
December 31,
2021
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
235,807
|
|
$
171,945
|
Marketable
securities
|
|
317,679
|
|
192,648
|
Trade receivables,
net
|
|
352,449
|
|
308,269
|
Inventory
|
|
106,561
|
|
80,608
|
Prepaid
expenses
|
|
100,360
|
|
88,838
|
Other current
assets
|
|
61,485
|
|
33,946
|
Total current
assets
|
|
1,174,341
|
|
876,254
|
Property and equipment,
net
|
|
15,727
|
|
14,690
|
Intangible assets,
net
|
|
75,112
|
|
56,438
|
Other assets
|
|
121,069
|
|
129,830
|
Total
assets
|
|
$
1,386,249
|
|
$
1,077,212
|
Liabilities and
Shareholders' Deficit
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
64,149
|
|
$
51,683
|
Accrued expenses and
other current liabilities
|
|
545,307
|
|
420,019
|
Current portion of
mandatorily redeemable preferred shares
|
|
62,500
|
|
62,500
|
Total current
liabilities
|
|
671,956
|
|
534,202
|
Long-term
debt
|
|
764,983
|
|
626,720
|
Liability related to
sale of future royalties, net
|
|
388,027
|
|
367,645
|
Mandatorily redeemable
preferred shares, net
|
|
180,213
|
|
155,737
|
Derivative
liabilities
|
|
110,129
|
|
13,110
|
Obligation to perform
R&D services
|
|
29,972
|
|
50,571
|
Other long-term
liabilities
|
|
46,527
|
|
12,236
|
Total
liabilities
|
|
2,191,807
|
|
1,760,221
|
Contingently redeemable
non-controlling interests
|
|
—
|
|
60,000
|
Total shareholders'
deficit attributable to Biohaven Pharmaceutical Holding Company
Ltd.
|
|
(800,933)
|
|
(739,380)
|
Non-controlling
interests in consolidated subsidiaries
|
|
(4,625)
|
|
(3,629)
|
Total shareholders'
deficit
|
|
(805,558)
|
|
(743,009)
|
Total liabilities and
shareholders' deficit
|
|
$
1,386,249
|
|
$
1,077,212
|
BIOHAVEN
PHARMACEUTICAL HOLDING COMPANY LTD.
|
RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL MEASURES
|
(Amounts in
thousands, except share and per share amounts)
|
(Unaudited)
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss:
|
|
|
|
|
GAAP net loss
attributable to Biohaven Pharmaceutical Holding Company
Ltd.
|
|
$
(441,387)
|
|
$
(210,619)
|
|
$
(650,459)
|
|
$
(475,587)
|
Add: non-cash
share-based compensation expense
|
|
40,765
|
|
25,586
|
|
123,091
|
|
74,312
|
Add: non-cash interest
expense on mandatorily redeemable preferred shares
|
|
—
|
|
—
|
|
—
|
|
7,943
|
Add: non-cash interest
expense on liability related to sale of future royalties
|
|
18,042
|
|
12,176
|
|
35,351
|
|
24,148
|
Add: (gain) loss from
change in fair value of derivatives
|
|
111,197
|
|
1,490
|
|
107,593
|
|
1,700
|
Add: (gain) loss from
equity method investment
|
|
—
|
|
—
|
|
—
|
|
(5,261)
|
Non-GAAP adjusted net
loss attributable to Biohaven Pharmaceutical Holding Company
Ltd.
|
|
$
(271,383)
|
|
$
(170,867)
|
|
$
(384,424)
|
|
$
(359,802)
|
|
|
|
|
|
|
|
|
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss per share — basic and
diluted:
|
|
|
|
|
GAAP net loss per share
attributable to Biohaven Pharmaceutical Holding Company Ltd. —
basic and diluted
|
|
$
(6.21)
|
|
$
(3.23)
|
|
$
(9.20)
|
|
$
(7.48)
|
Add: non-cash
share-based compensation expense
|
|
0.57
|
|
0.40
|
|
1.74
|
|
1.17
|
Add: non-cash interest
expense on mandatorily redeemable preferred shares
|
|
—
|
|
—
|
|
—
|
|
0.12
|
Add: non-cash interest
expense on liability related to sale of future royalties
|
|
0.25
|
|
0.19
|
|
0.50
|
|
0.38
|
Add: (gain) loss from
change in fair value of derivatives
|
|
1.57
|
|
0.02
|
|
1.52
|
|
0.03
|
Add: (gain) loss from
equity method investment
|
|
—
|
|
—
|
|
—
|
|
(0.08)
|
Non-GAAP adjusted net
loss per share attributable to Biohaven Pharmaceutical Holding
Company Ltd. — basic and diluted
|
|
$
(3.82)
|
|
$
(2.62)
|
|
$
(5.44)
|
|
$
(5.66)
|
About NURTEC ODT
NURTEC ODT (rimegepant) is the first and only calcitonin
gene-related peptide (CGRP) receptor antagonist available in a
quick-dissolve ODT formulation that is approved by the U.S. Food
and Drug Administration (FDA) for the acute treatment of migraine
with or without aura and the preventive treatment of episodic
migraine in adults. The activity of the neuropeptide CGRP is
thought to play a causal role in migraine pathophysiology. NURTEC
ODT is a CGRP receptor antagonist that works by reversibly blocking
CGRP receptors, thereby inhibiting the biologic activity of the
CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg,
taken as needed, up to once daily to treat or every other day to
help prevent migraine attacks. For more information about NURTEC
ODT, visit www.nurtec.com. The most common adverse reaction
was nausea and abdominal pain/indigestion. Avoid concomitant
administration of NURTEC ODT with strong inhibitors of CYP3A4,
strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP.
Avoid another dose of NURTEC ODT within 48 hours when it is
administered with moderate inhibitors of CYP3A4.
Indication
NURTEC ODT orally disintegrating tablets is a prescription
medicine that is used to treat migraine in adults. It is for the
acute treatment of migraine attacks with or without aura and the
preventive treatment of episodic migraine. It is not known if
NURTEC ODT is safe and effective in children.
Important Safety Information
Do not take NURTEC ODT if you are allergic to NURTEC
ODT (rimegepant) or any of its ingredients.
Before you take NURTEC ODT, tell your healthcare provider
(HCP) about all your medical conditions, including if you:
- have liver problems,
- have kidney problems,
- are pregnant or plan to become pregnant,
- breastfeeding or plan to breastfeed.
Tell your HCP about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements.
NURTEC ODT may cause serious side effects including allergic
reactions, including trouble breathing and rash. This can happen
days after you take NURTEC ODT. Call your HCP or get emergency help
right away if you have swelling of the face, mouth, tongue, or
throat or trouble breathing. This occurred in less than 1% of
patients treated with NURTEC ODT.
The most common side effects of NURTEC ODT were
nausea (2.7%) and stomach pain/indigestion (2.4%). These are not
the only possible side effects of NURTEC ODT. Tell your HCP if you
have any side effects.
You are encouraged to report side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088 or report side effects to Biohaven at
1-833-4Nurtec.
Please click here for full Prescribing information and
Patient Information.
Biohaven Contacts
Investor Relations
Jennifer
Porcelli, VP, Investor Relations
Biohaven Pharmaceuticals
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741
Media
Mike Beyer, Media
Relations Counselor
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502
NURTEC, NURTEC ODT and VYDURA are registered trademarks of
Biohaven Pharmaceutical Ireland DAC. Neuroinnovation is a
trademark of Biohaven Pharmaceutical Holding Company Ltd.
1 Adjusted net loss per share is a non GAAP measure
as defined below. See the tables below for a reconciliation to the
most comparable GAAP measure.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.