- Pfizer Inc. and Biohaven Pharmaceutical Holding Company Ltd.
today announced that the companies have entered into a definitive
agreement under which Pfizer will acquire Biohaven
- Record reported revenues of $319
million
- NURTEC® ODT (rimegepant) TRx volumes grew 8% versus
the fourth quarter and net product revenue was $124 million for the first quarter of 2022
- Net product sales guidance of $825 - $900 million
provided for 2022
- Received EU approval from the European Commission ("EC") for
rimegepant 75 mg for the acute and preventive treatment of
migraine; EC marketing authorization valid in all 27 member
countries of the European Union
- Expanded payer coverage for NURTEC ODT, extending coverage to
96 percent of total commercial lives and approximately 263 million
people in all payer channels
- Featured 13 abstracts, including two oral presentations, at the
2022 American Academy of Neurology Annual Meeting, notably
highlighting NURTEC ODT's clinical utility as demonstrated by a
reduction in opioid prescriptions filled and medication overuse
headache following treatment
- U.S. Food and Drug Administration ("FDA") approved NURTEC ODT
label amendment to include clinical lactation data
- Initiated enrollment in two new Phase 2/3 clinical trials
assessing the safety and efficacy of NURTEC ODT 75 mg in patients
with sinusitis and temporomandibular disorder
NEW
HAVEN, Conn., May 10, 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
first quarter ended March 31, 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, "NURTEC ODT
continues to be the leading migraine therapy in the oral CGRP class
and demonstrated 8% sequential TRx growth compared to the previous
quarter. The approval of the prevention indication last year has
established NURTEC ODT as the only "all-in-one" migraine therapy
and contributed to the substantial year-over-year first quarter
revenue growth of 182%. Although strong growth in the mix of 2-pack
(16-tablet count) sales help to drive additional volume growth and
increases the net price per prescription, seasonal resetting of
commercial insurance plan annual deductibles largely explains the
expected pressure observed on first quarter net revenue generation
compared to the fourth quarter. Growing Nurtec ODT volume and
access for patients requires significant investment. In these
important initial years of product launch, our strategy has been to
drive brand trial and adoption of Nurtec ODT by investing in
patient support programs and working with payers to ensure patient
access, which also results in payer rebates and volume discounts
related to the investments we made for incremental access. We
expect the investments we made in first quarter copay programs will
drive volume and net revenue growth for NURTEC ODT in the rest of
the year."
Dr. Coric continued, "In addition to continued success in the US
market, we are excited about bringing the only 'all-in-one' therapy
to both treat and prevent migraine to the approximately one billion
migraine patients worldwide. With EU approval for rimegepant now
secured and additional regulatory submissions planned in
China and South Korea in the second half of 2022, we
believe we are well positioned to grow future sales of NURTEC ODT
outside of the US. We also look forward to providing an update on
zavegepant following the submission of our NDA in the first
quarter. If approved, zavegepant will be the first and only
intranasal CGRP receptor antagonist, offering a rapid onset of
action and an important treatment alternative for patients who
experience nausea or vomiting at the time of their migraine
attacks. We continue to believe our migraine franchise is unmatched
and we could not be more excited about the opportunities for
continued market expansion in the months and years to come."
First Quarter and Recent Business Highlights
CGRP Antagonist Platform - Milestones and Next
Steps
- Q1 2022 net product revenue from sales of NURTEC ODT totaled
$123.6 million – NURTEC ODT has
now achieved 2,000,000 prescriptions, and over 69,000 unique
prescribers to date, an increase of 5,400 prescribers from the
fourth quarter signaling continued traction across the prescribing
community. $123.6 million in net
product revenues for the quarter represents a 182% increase over Q1
2021 and a 35% decrease from net product revenues over Q4 2021. The
substantial year-over-year revenue growth was due to prescription
volume growth of 122% and a higher price/Rx due to increased sales
of 2-packs (16-tablet count) in relation to 1-pack
(8-tablet count) sales. Sequentially, TRx volumes
grew 8% vs. the fourth quarter. The sequential decrease in
quarter-over-quarter net revenue was largely driven by seasonality
related to renewed patient deductibles and prescription
reauthorizations, and a corresponding increase in costs for patient
affordability programs. The Company is providing FY 2022 net
product sales guidance of $825 -
$900 million and believes that a
significant market opportunity for oral CGRP targeting agents
exists.
- Received EU approval of rimegepant 75 mg for the acute and
preventive treatment of migraine, from the European Commission
("EC") – In April, the Company announced that the EC has
approved rimegepant 75 mg (available as an orally dissolving
tablet), intended for the prophylaxis and acute treatment of
migraine; VYDURA® (rimegepant) will be the commercial
name for rimegepant in the EU. The full indication for VYDURA is
the acute treatment of migraine with or without aura in adults and
preventive treatment of episodic migraine in adults who have at
least four migraine attacks per month. The EC approval will be
valid in the 27 member countries of the EU as well as Iceland, Liechtenstein, and Norway and local reimbursement approval will
follow. The Company had previously received positive opinion
recommending the granting of a marketing authorization for
rimegepant 75 mg from the Committee for Medicinal Products for
Human Use in February of 2022.
- Achieved broader commercial insurance coverage – In May,
the Company expanded the total number of commercial lives covered
to 96 percent and approximately 263 million people in all payer
channels.
- Demonstrated decreased opioid use in migraine patients
following NURTEC® ODT Therapy – In April, the Company presented
findings pertaining to the benefit of NURTEC® ODT in decreasing the
burden of opioid use among a significant number of migraine
patients in real world clinical practice. The findings were
presented as a podium presentation at the American Association of
Neurology (AAN) 2022 Annual Meeting. Opioid discontinuation rate
after NURTEC® ODT initiation was 40.5%.
- Reported positive topline results from pivotal trial of
NURTEC ODT for the acute treatment of migraine in China and South
Korea – In February, the Company announced positive
topline results from the Phase 3 clinical trial of NURTEC ODT in
China and South Korea in adults for the acute treatment
of migraine. Led by BioShin Limited, a subsidiary of Biohaven, the
randomized, double-blind, placebo-controlled, regional,
multi-center study met the co-primary endpoints evaluating the
efficacy and safety of the orally dissolving tablet ("ODT")
formulation of rimegepant, an oral CGRP receptor antagonist. This
is the fifth positive pivotal study of rimegepant and the first to
be conducted in Asia Pacific. The
study met its co-primary endpoints of freedom from pain
(p<0.0001) and freedom from most bothersome migraine–associated
symptom ("MBS") including either nausea, phonophobia or photophobia
(p<0.0001) at 2-hours following a single oral dose of
rimegepant. The early onset, durable 48-hour efficacy, and
favorable safety and tolerability profile were consistent with
prior clinical trial results in the
United States. In addition to the co-primary endpoints,
NURTEC ODT preliminary data demonstrated significant relief of
multiple migraine symptoms with rapid onset efficacy that was
statistically superior to placebo as early as 45 minutes for both
pain relief and freedom from MBS (p<0.05), at 60 minutes for
return to normal function (p = 0.0023), and at 90 minutes for pain
freedom (p = 0.0012). NURTEC ODT demonstrated sustained efficacy on
all four of these clinically important efficacy outcomes through 48
hours. The use of rescue medication within 24 hours was
significantly lower for NURTEC ODT-treated patients than for
placebo (p < 0.0001). Detailed data from the study will be
presented at future medical meetings to help inform ongoing and
future research.
- Commenced enrollment in Phase 2/3 sinusitis study – In
February, the Company announced the enrollment of the first patient
in the Phase 2/3 clinical trial assessing the safety and efficacy
of NURTEC ODT (rimegepant) 75 mg in patients with chronic
rhinosinusitis (CRS) with or without nasal polyps. The Company
expects to enroll approximately 200 patients across approximately
25 sites in the United States. The
primary outcome measure will be the pain/pressure/fullness score on
a Numerical Rating Scale (0-10).
- Commenced enrollment in Phase 2/3 temporomandibular disorder
("TMD") study – In April, the Company enrolled the first
patient in the Phase 2/3 clinical trial assessing the safety and
efficacy of NURTEC ODT (rimegepant) 75 mg in patients with
temporomandibular disorder ("TMD"). Consistent with the sinusitis
study, the Company expects to enroll approximately 200 patients
across approximately 25 sites in the
United States. The primary outcome measure will be the
change from baseline of pain on a Numerical Rating Scale
(0-10).
- Published NURTEC (Rimegepant) breastfeeding clinical study
in Breastfeeding Medicine – In April, the Company
announced that data from a Phase 1, single-center, open-label study
evaluating the excretion of a single dose of rimegepant 75 mg in
the human milk of healthy lactating women was published in the peer
reviewed journal, Breastfeeding Medicine. Migraine affects
more than 30 million women in America, and migraine attacks may
subside during pregnancy but resume within 4 weeks of childbirth.
In April, the Company reported that the FDA approved a label
amendment of the NURTEC ODT (rimegepant) Prescribing and Patient
Information to include clinical lactation data in the Use in
Specific Populations section as it relates to women who are
breastfeeding.
- Published real-world study highlighting increased healthcare
utilization among Americans with episodic migraine have higher
levels of migraine-related disability – In April, the Company
announced the publication of new real-world research showing that
as migraine-related disability increases, healthcare utilization
also increases among Americans with episodic migraine. Targeting
high disability patients with effective treatments may reduce
disability and improve the cost-effectiveness of medical care among
primary care and specialty providers. These findings were published
in the March issue of Headache: The Journal of Head and Face
Pain, the official journal of the American Headache
Society.
Other Programs and Partnerships – Milestones and Next
Steps
- Acquired Kv7 channel platform for treatment of epilepsy and
other neurologic disorders from Channel Biosciences, LLC – In
February, the company announced that it had entered into a
definitive agreement with Channel Biosciences, LLC, a subsidiary of
Knopp Biosciences, LLC, to acquire a Kv7 channel targeting
platform, adding the latest advances in ion-channel modulation to
Biohaven's growing neuroscience portfolio. BHV-7000 (formerly known
as KB-3061) is the lead asset from the Kv7 platform and is a
potentially best-in-class potassium channel activator with a
profile suggestive of a wide therapeutic index, high selectivity,
and significantly reduced GABA-ergic activity. Biohaven intends to
bring BHV-7000 to the clinic in 2022 in preparation for a
development program in focal epilepsy.
- Entered into a worldwide license agreement with BMS for
taldefgrobep alfa, a Phase 3-ready anti-myostatin adnectin for
spinal muscular atrophy ("SMA") – In February, the Company
announced that it entered into a worldwide license agreement with
BMS for the development and commercialization rights to
taldefgrobep alfa (formerly known as BMS-986089), a novel, Phase
3-ready anti-myostatin adnectin. Taldefgrobep is a muscle-targeted
experimental treatment developed for neuromuscular disease and
offers the opportunity for combination therapy. The in-licensing of
taldefgrobep expands Biohaven's portfolio of innovative, late-stage
product candidates for the treatment of neurologic,
neuroinflammatory, and psychiatric indications. Biohaven plans to
initiate a Phase 3 clinical trial of taldefgrobep alfa in SMA in
mid-2022.
- Entered into exclusive license and research collaboration
agreement with KU Leuven to develop and commercialize
first-in-class TRPM3 antagonists for the treatment of chronic
pain – In January, the Company announced that it entered into
an exclusive global license and research agreement with the Center
for Drug Design and Discovery ("CD3") and the Laboratory of Ion
Channel Research ("LICR") at Katholieke Universiteit Leuven ("KU
Leuven") to develop and commercialize first-in-class transient
receptor potential melastatin-3 ("TRPM3") channel antagonists.
BHV-2100 is the lead TRPM3 antagonist from the platform and an
orally-bioavailable small molecule TRPM3 antagonist.
- Expanded migraine awareness and education via key
sponsorships – In April, the Company became the sole sponsor of
the National Headache Foundation's Veterans/Military Outreach
program to raise awareness about migraine and elevate the
discussion about the disease among active-duty military and
veterans. In February, the Company partnered with Jessica Horwell on the Hardware LDN exhibit at
New York Fashion Week, aiming to empower the people walking the
runway and attending the show to get back to their lives. These
partners and others help Biohaven achieve its mission of empowering
sufferers of migraine from all backgrounds.
- Global Coalition for Adaptive Research ("GCAR") announced
update on Glioblastoma Adaptive Global Innovative Learning
Environment ("GBM Agile") Phase 2-3 adaptive platform trial
for patients with glioblastoma – In January, GCAR announced
that Biohaven's troriluzole and Vigeo Therapeutics' VT1021 were
selected to participate in GBM AGILE, a revolutionary
patient-centered, adaptive platform trial for registration that
tests multiple therapies for patients with newly-diagnosed and
recurrent glioblastoma ("GBM"), the deadliest form of brain cancer.
They will be evaluated in all patient subgroups of the trial which
include newly-diagnosed methylated MGMT, newly-diagnosed
unmethylated MGMT, and recurrent GBM. Troriluzole and VT1021 were
the fourth and fifth arms to join the trial, respectively. GBM
AGILE allows multiple drugs from different pharmaceutical companies
to be evaluated simultaneously and/or over time against a common
standard of care control.
Corporate Updates:
- Appointed Irina Antonijevic,
M.D., Ph.D. to Board of Directors - In April, the Company
announced the appointment of Irina
Antonijevic, M.D., Ph.D. to its Board of Directors starting
May 1, 2022. Dr. Antonijevic is
currently Chief Medical Officer ("CMO") and Head of R&D at
Triplet Therapeutics, a company developing novel therapeutics for
repeat expansion disorders such as Huntington's disease, spinocerebellar ataxias
and Myotonic Dystrophy. Prior to that, she served as VP of
Translational Medicine and Development at Wave Life Sciences, CMO
at vasopharm GmbH, developing a treatment for severe traumatic
brain injury, and Head of Early Development, MS, Neurology and
Ophthalmology at Sanofi Genzyme. Dr. Antonijevic has been a member
of the supervisory board of 4SC AG since 2012, and of Paion AG from
2017 through early 2022. Dr. Antonijevic is board certified in
Psychiatry and completed her residency in psychiatry and neurology
at the Max Planck Institute for Psychiatry. Dr. Antonijevic
obtained her venia legendi from the Berlin University and her PhD from the
University of Edinburgh, UK.
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:
- Continue to advance the commercialization of NURTEC ODT
(rimegepant) for the acute and preventive treatment of
migraine.
- Submit an NDA for the acute treatment of migraine in
China in the second half of
2022.
- Report topline of troriluzole in Spinocerebellar Ataxia in
mid-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 the second half of 2022.
- Enroll first patient in Phase 3 spinal muscular atrophy study
with taldefgrobep alfa in mid-2022.
- Enroll first patient in Phase 1 focal epilepsy study with
BHV-7000 (Kv7) in the second half of 2022.
Capital Position:
Cash, cash equivalents, and marketable securities as of
March 31, 2022, were $602.5 million, excluding $5.3 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 the 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. We also have
$125.0 million in non-dilutive
committed capital from our credit facility with Sixth Street.
First Quarter 2022 Financial Highlights
Product Revenue, Net: Net product revenue was
$123.6 million for the three months
ended March 31, 2022, compared to
$43.8 million for the three months
ended March 31, 2021. The increase of
$79.8 million in net product revenue
is due to both increased NURTEC ODT sales volume and improvements
in net price realization due to decreases in sales allowances
during the three months ended March 31,
2022, compared to the three months ended March 31, 2021. Sales allowances and accruals
mostly consisted of patient affordability programs, distribution
fees and rebates.
Collaboration and Other Revenue: Collaboration and
other revenue was $195.3 million for
the three months ended March 31,
2022. No collaboration and other revenue was recognized
for the three months ended March 31,
2021. The collaboration and other revenue recognized during
the three months ended March 31, 2022
was primarily due to $194.4 million
recognized upon the satisfaction of our performance obligation for
the delivery of the license and sublicense to commercialize
Rimegepant outside the U.S. as part of our Collaboration Agreement
with Pfizer.
Research and Development ("R&D")
Expenses: R&D expenses, including non-cash share-based
compensation costs, were $119.1
million for the three months ended March 31, 2022, compared to $107.1 million for the three months ended
March 31, 2021. The increase of
$12.0 million was primarily due to
increased personnel costs partially offset by decreased program
expenses. Non-cash share-based compensation expense was
$34.0 million for the three months
ended March 31, 2022, an increase of
$13.9 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 $227.2
million for the three months ended March 31, 2022, compared to $159.5 million for the three months ended
March 31, 2021. The increase of
$67.7 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.
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
$47.9 million for the three months
ended March 31, 2022, an increase of
$19.2 million as compared to the same
period in 2021.
Net Loss: Biohaven reported a net loss attributable
to common shareholders for the three months ended March 31, 2022, of $209.1
million, or $2.97 per share,
compared to $265.0 million, or
$4.27 per share for the same period
in 2021. Non-GAAP adjusted net loss for the three months ended
March 31, 2022 was $114.0 million, or $1.62 per share, compared to $201.4 million, or $3.25 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,
best-in-class 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 March 31,
|
|
|
2022
|
|
2021
|
Revenues:
|
|
|
|
|
Product revenue, net
|
|
$ 123,590
|
|
$
43,823
|
Collaboration and other revenue
|
|
195,262
|
|
—
|
Total revenue
|
|
318,852
|
|
43,823
|
Operating
expenses:
|
|
|
|
|
Cost of sales
|
|
26,342
|
|
12,862
|
Research and development
|
|
119,099
|
|
107,111
|
Selling, general and administrative
|
|
227,243
|
|
159,523
|
Total operating
expenses
|
|
372,684
|
|
279,496
|
Loss from
operations
|
|
(53,832)
|
|
(235,673)
|
Other income
(expense):
|
|
|
|
|
Interest expense
|
|
(17,216)
|
|
(7,731)
|
Interest expense on mandatorily redeemable preferred
shares
|
|
(7,917)
|
|
(7,943)
|
Interest expense on liability related to sale of future
royalties
|
|
(17,314)
|
|
(13,508)
|
Change in fair value of derivatives
|
|
3,604
|
|
(210)
|
Gain from equity method investment
|
|
—
|
|
5,261
|
Other income (expense), net
|
|
81
|
|
(1,700)
|
Total other expense,
net
|
|
(38,762)
|
|
(25,831)
|
Loss before provision
for income taxes
|
|
(92,594)
|
|
(261,504)
|
Provision for income
taxes
|
|
24,303
|
|
3,824
|
Net loss
|
|
(116,897)
|
|
(265,328)
|
Less: Net loss attributable to non-controlling
interests
|
|
(498)
|
|
(360)
|
Less: Deemed dividend upon repurchase of preferred shares in
consolidated subsidiary
|
|
92,673
|
|
—
|
Net loss attributable
to common shareholders of Biohaven Pharmaceutical Holding
Company Ltd.
|
|
$ (209,072)
|
|
$ (264,968)
|
Net loss per share
attributable to common shareholders of Biohaven Pharmaceutical
Holding Company Ltd. — basic and diluted
|
|
$
(2.97)
|
|
$
(4.27)
|
Weighted average common
shares outstanding—basic and diluted
|
|
70,332,274
|
|
62,040,715
|
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY
LTD.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Amounts in
thousands)
(Unaudited)
|
|
|
|
March 31, 2022
|
|
December 31, 2021
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
169,065
|
|
$
171,945
|
Marketable securities
|
|
433,410
|
|
192,648
|
Trade receivables, net
|
|
328,342
|
|
308,269
|
Inventory
|
|
91,281
|
|
80,608
|
Prepaid expenses
|
|
104,891
|
|
88,838
|
Other current assets
|
|
44,096
|
|
33,946
|
Total current assets
|
|
1,171,085
|
|
876,254
|
Property and equipment,
net
|
|
14,534
|
|
14,690
|
Intangible assets,
net
|
|
55,910
|
|
56,438
|
Other assets
|
|
130,188
|
|
129,830
|
Total assets
|
|
$
1,371,717
|
|
$
1,077,212
|
Liabilities and Shareholders'
Deficit
|
|
|
|
|
Current liabilities:
|
|
|
|
|
Accounts payable
|
|
$
56,202
|
|
$
51,683
|
Accrued expenses and other current liabilities
|
|
457,412
|
|
420,019
|
Current portion of mandatorily
redeemable preferred shares
|
|
62,500
|
|
62,500
|
Total current
liabilities
|
|
576,114
|
|
534,202
|
Long-term
debt
|
|
634,106
|
|
626,720
|
Liability related to
sale of future royalties, net
|
|
377,998
|
|
367,645
|
Mandatorily redeemable
preferred shares, net
|
|
162,994
|
|
155,737
|
Derivative
liability
|
|
9,120
|
|
13,110
|
Obligation to perform
R&D services
|
|
36,016
|
|
50,571
|
Other long-term
liabilities
|
|
41,782
|
|
12,236
|
Total liabilities
|
|
1,838,130
|
|
1,760,221
|
Contingently redeemable
non-controlling interests
|
|
—
|
|
60,000
|
Total shareholders' deficit
attributable to Biohaven Pharmaceutical
Holding Company
Ltd.
|
|
(462,286)
|
|
(739,380)
|
Non-controlling interests in
consolidated subsidiaries
|
|
(4,127)
|
|
(3,629)
|
Total shareholders'
deficit
|
|
(466,413)
|
|
(743,009)
|
Total liabilities and
shareholders' deficit
|
|
$
1,371,717
|
|
$
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 March 31,
|
|
|
2022
|
|
2021
|
Reconciliation of GAAP to Non-GAAP adjusted net
loss:
|
GAAP net loss attributable to Biohaven Pharmaceutical Holding
Company Ltd.
|
|
$
(209,072)
|
|
$
(264,968)
|
Add: non-cash share-based
compensation expense
|
|
81,330
|
|
48,726
|
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
|
|
17,309
|
|
11,972
|
Add: (gain) loss from change in
fair value of derivatives
|
|
(3,604)
|
|
210
|
Add: (gain) loss from equity
method investment
|
|
—
|
|
(5,261)
|
Non-GAAP adjusted net loss attributable to Biohaven
Pharmaceutical Holding
Company Ltd.
|
|
$
(114,037)
|
|
$
(201,378)
|
|
|
|
|
|
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
|
|
$
(2.97)
|
|
$
(4.27)
|
Add: non-cash share-based
compensation expense
|
|
1.16
|
|
0.78
|
Add: non-cash interest expense
on mandatorily redeemable preferred shares
|
|
—
|
|
0.13
|
Add: non-cash interest expense
on liability related to sale of future royalties
|
|
0.25
|
|
0.19
|
Add: (gain) loss from change in
fair value of derivatives
|
|
(0.05)
|
|
—
|
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
|
|
$
(1.62)
|
|
$
(3.25)
|
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.
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SOURCE Biohaven Pharmaceutical Holding Company Ltd.