- Cash, cash equivalents, marketable securities and restricted
cash totaled approximately $440
million on June 30, 2024
- Biohaven's Molecular Degrader of Extracellular Proteins
(MoDE™) platform advancing multiple new targets and reported
positive interim data from its lead investigational drug in an
ongoing Phase 1 study of BHV-1300:
- The Company reported dose-dependent and rapid IgG
reductions in its ongoing Phase 1 trial with its lead
investigational degrader BHV-1300
- No serious adverse events (SAEs) reported with BHV-1300 to
date; most adverse events (AEs) were mild, deemed unrelated to
study drug and resolved spontaneously
- Phase 1 study also completed an assessment of an optimized
subcutaneous (SC) formulation of BHV-1300 that demonstrated
approximately a 44% higher than expected exposure compared to the
dose-equivalent intravenous formulation previously studied; this
new human data further confirms feasibility of convenient
self-administered SC auto-injector and the SC formulation was not
associated with injection site reactions
- Degrader platform expected to deliver 3 INDs for new MoDE
programs before year-end in addition to continued data from SAD/MAD
with BHV-1300
- Biohaven's beta-1 adrenergic receptor (β1AR) autoantibody
targeting MoDE, BHV-1600, granted INTERACT meeting with FDA in 2H
2024 regarding development program for dilated cardiomyopathy
- Advancing novel ion channel program targeting Kv7 activation
and TRPM3 antagonism across multiple neurological, pain and
neuropsychiatric disease indications:
- 5 Phase 2/3 trials with BHV-7000 underway in epilepsy and mood
disorders
- Released positive Phase 1 data with TRPM3 antagonist BHV-2100
showing drug concentrations above EC90 target and well-tolerated
profile across all doses in SAD/MAD study; advancing Phase 2 study
in acute migraine and proof-of-concept (POC) study in pain in 2H
2024
- Taldefgrobep alfa, a myostatin-inhibitor, progressing on track
with Phase 3 topline data in spinal muscular atrophy (SMA) and
Phase 2 trial initiation in obesity expected in 2H 2024
- Taldefgrobep alfa has demonstrated direct effects on reducing
adipose tissue (including lipid storage and mitochondrial content)
independent of increases in muscle mass
- In a MAD study, conducted in healthy adults, taldefgrobep alfa
(45 mg SC QW) produced significant reductions in total body fat
while increasing total body lean mass
- Preclinical data released at the 2024 American Diabetes
Association conference demonstrated that taldefgrobep alfa, as a
monotherapy or in combination with a GLP-1 agonist, demonstrated
significant reductions in fat and total body weight. Taldefgrobep
alfa-treated animals showed significant increases in lean muscle,
despite co-administration with a GLP-1 receptor agonist
- Tyrosine Kinase 2/Janus Kinase 1 (TYK2/JAK1) selective
inhibitor, BHV-8000, completed Phase 1 and confirmed biomarker
target engagement with reductions in inflammatory markers and
demonstrated central nervous system penetration with confirmed
cerebrospinal fluid (CSF) target exposures in healthy subjects
- Advancing registrational programs for Parkinson's disease and
prevention of Amyloid-Related Imaging Abnormalities (ARIA)
following interactions with the FDA
- Expect interim data analysis from second ongoing Phase 3 OCD
trial with troriluzole in 2H 2024; topline data from first Phase 3
OCD trial expected in 1H 2025
- SCA interactions with troriluzole filing in Europe ongoing and constructive interactions
in the US with the FDA
- New real-world evidence (RWE) protocol, incorporating feedback
from the FDA, assessing 3-years of treatment with troriluzole
expected to deliver topline results in 2H 2024
- Biohaven antibody drug conjugate (ADC) portfolio positioned to
deliver differentiated profiles and address unmet needs in
oncology:
- BHV-1510 currently dosing cancer patients in Phase1/2 study and
now advancing towards combination with Libtayo® by 4Q 2024
- Portfolio of multiple advanced nonclinical BHVN ADCs
demonstrate improved plasma stability and in vitro/in vivo
differentiation
NEW
HAVEN, Conn., Aug. 8, 2024
/PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the
Company), a global clinical-stage biopharmaceutical company focused
on the discovery, development and commercialization of
life-changing therapies to treat a broad range of rare and common
diseases, today reported financial results for the second quarter
ended June 30, 2024, and provided a
review of recent accomplishments and anticipated upcoming
developments.
![(PRNewsfoto/BIOHAVEN LTD) (PRNewsfoto/BIOHAVEN LTD)](https://mma.prnewswire.com/media/1912969/Biohaven_Full_Color_rgb_2022SEPT03_Logo.jpg)
Vlad Coric, M.D., Chairman and
Chief Executive Officer of Biohaven, commented, "Last quarter, we
showcased an array of exciting updates across our pipeline spanning
immunology, neuroscience, obesity, and oncology at our annual
R&D Day. First, it has been incredible working with Yale
Professor David Spiegel and my
colleagues at Biohaven to drive the advancement of groundbreaking
degrader science represented by BHV-1300 using our Molecular
Degrader of Extracellular Protein (MoDE™) technology — we consider
our initial Phase 1 data to be paradigm-shifting and we are
accelerating our entire platform based upon these early results.
BHV-1300 has been well-tolerated with no significant adverse
effects and no clinically significant lab abnormalities or ECG
changes observed to date and emerging subcutaneous data from our
Phase 1 study highlights the ease of use of this technology. The
platform represents a brand-new technology that has potential to
treat diseases like Type 1 diabetes, autoimmune dilated
cardiomyopathy, IgA nephropathy, and many others. Our
differentiation continues to focus on convenient SC patient
self-administration, rapid onset of action, potential for deeper
IgG reduction and concurrent use with Fc containing standard of
care biologics. We are excited that we remain on timelines with
multiple INDs from our MoDE platform for later this year, including
drug candidates that target autoantibodies against β-1AR for the
potential treatment of dilated cardiomyopathy, galactose deficient
IgA for IgA nephropathy and a further optimized IgG degrader for
use in rare diseases."
Dr. Coric continued, "While our degrader program continues to
garner significant focus, our broader pipeline is increasingly
derisked with several potentially paradigm-shifting treatments for
conditions including epilepsy, mood disorders, pain, immunology,
rare diseases, obesity and neurodegenerative disorders. Starting
with our ion channel platform; five studies with Kv7 activator
BHV-7000 (three in epilepsy and two in major depressive disorder
and bipolar) are underway with brisk patient enrollment. In
addition, our TRPM3 antagonist BHV-2100 has completed its initial
Phase 1 SAD/MAD study, attaining an exceptional PK/PD profile for
the treatment of migraine and other pain disorders. All doses being
advanced have reached the targeted EC90 for this molecule with
excellent preliminary safety. We are excited about being back in
the migraine space with this novel target and will initiate a Phase
2 study in migraine before year end, as well as initiate a POC
study as a non-opiate pain treatment. With BHV-8000, our oral and
brain penetrant TYK2/JAK1 inhibitor, we have aligned with the FDA
on two novel study designs: one for the prevention of ARIA
associated with amyloid lowering agents in Alzheimer's disease and
another with the goal of slowing disease progression in early
Parkinson's disease. The Phase 1 profile of BHV-8000 is
invigorating our translational team as we have data confirming both
CNS penetration and biomarker engagement of inflammatory targets in
humans. Regarding our anti-myostatin taldefgrobep alfa, we shared
new preclinical data demonstrating improved, durable weight
reduction and lean mass preservation in combo with
GLP-1 semaglutide, which was particularly noteworthy, given
the muscle wasting limitations that have plagued the GLP-1 class.
We also showed that taldefgrobep has direct effects on
modulating fat in addition to increasing muscle mass. Our oncology
platform has also emerged into the clinic with our lead Trop-2 ADC,
BHV-1510, enrolling cancer patients and our efforts advancing a
portfolio of several Biohaven ADCs. We are excited to get
preliminary safety and efficacy data from cancer patients suffering
with select advanced or metastatic epithelial tumors in the Phase
1/2 study of BHV-1510 and will be evaluating the combination of
BHV-1510 with Regeneron's anti-PD1 Libtayo — combination dosing
with BHV-1510 and Libtayo is anticipated to begin in 2H 2024.
Finally, with our glutamate platform represented by troriluzole,
topline data from an interim analysis of the second OCD trial is
expected in 2H 2024 and our first OCD trial is expected to read out
in 1H 2025. Separately, we continue to have constructive dialogue
with the FDA regarding our SCA development program and our European
Medicines Agency application for SCA3 remains under review. We now
expect topline data from a new RWE protocol assessing the efficacy
of troriluzole in SCA patients treated for up to 3 years— this
includes new patient data that has not previously been available. I
never cease to be amazed by the power of our small but mighty
Biohaven R&D team that has innovated across each of these
important medical areas. We are driven to fulfill a promise to
patients and our investors that we will diligently evaluate and
advance potentially transformative therapies to those suffering
from disease."
Second Quarter 2024 and Recent Business Highlights
- Additional data supports the paradigm-shifting potential
of the MoDE Platform for the treatment of immunological and
inflammatory disorders – In May 2024, the Company disclosed positive new data
from its ongoing Phase 1 SAD study in healthy subjects with
BHV-1300, a first-in-human IgG degrader from its innovative MoDE
platform. Results from the initial dose cohorts in the SAD study
confirmed that BHV-1300 rapidly and selectively lowers IgG in a
dose-dependent manner. Emerging Phase 1 data also showed that our
novel SC formulation of BHV-1300 delivered exposures higher than
the intravenous formulation, enabling the profile of a convenient
patient administered auto-injector to attain targeted reduction of
IgG. The Company expects to provide an update from our SAD and MAD
studies of BHV-1300 in the second half of 2024 and is on schedule
to file multiple new MoDE INDs this year. FDA granted INTERACT
meeting request for BHV-1600, β1AR autoantibody MoDE, development
program.
- Ion Channel Platform: Kv7 activator and TRPM3 antagonist
candidates represent transformational targets in neurology and
neuropsychiatry – The Company is enrolling
participants in five ongoing pivotal clinical trials with Kv7
activator, BHV-7000, targeting focal epilepsy, generalized
epilepsy, bipolar disorder and major depressive disorder;
separately, Phase 2 and POC studies are planned in migraine and
pain, respectively, with the TRPM3 antagonist, BHV-2100, in 2H
2024.
- Committed to improving muscle health with Myostatin
Platform – In May
2024, the Company presented new preclinical data showing
that administration of taldefgrobep alfa directly reduced the
increased adipose fat storage caused by myostatin; the Company also
presented new preclinical data from a diet-induced obesity mouse
model showing treatment with taldefgrobep alfa together with a
GLP-1 agonist produced greater reductions in body weight and fat
mass, and a larger increase in lean muscle mass, compared to
treatment with GLP-1 alone. The Company plans to initiate a Phase 2
study in obesity in 2H2024. Separately, the Company continues to
expect Phase 3 study topline results in SMA in 2H 2024.
- Selectively targeting the immune system to treat
neurodegenerative diseases with neuroinflammation platform
– In May 2024, the Company
reported positive results from the Phase 1 SAD and MAD study with
our brain-penetrant TYK2/JAK1 inhibitor, BHV-8000 in healthy
subjects, including demonstration of CSF target exposures and
biomarker engagement along with a well-tolerated safety profile.
The Company also announced key regulatory updates, including the
successful completion of two FDA meetings with favorable feedback
enabling registrational programs for Parkinson's disease and for
the prevention of ARIA, a novel indication.
- Oncology Platform: Antibody Drug Conjugate portfolio:
positioned to achieve enhanced stability and improved
efficacy – In May
2024, the Company announced that its novel Trop-2 ADC,
BHV-1510, entered into the clinic for patients with advanced or
metastatic epithelial tumors; the first patient was dosed in a
Phase 1/2 clinical trial as monotherapy. Biohaven also entered into
a clinical supply agreement with Regeneron to study the combination
of BHV-1510 with Regeneron's anti-PD1 Libtayo (cemiplimab-rwlc) in
the clinical study.
Expected Upcoming Milestones:
We believe Biohaven is well positioned to achieve significant
milestones in 2024 and 2025 across numerous programs:
Selective Kv7 Activator:
- Continue 5 ongoing Phase 2/3 trials with BHV-7000 in focal
epilepsy, idiopathic generalized epilepsy, MDD, and bipolar
disorder
Troriluzole:
- Topline results from a new RWE protocol of 3-year data from
troriluzole treated patients in SCA in 2H 2024
- Two Phase 3 trials with troriluzole in OCD: conduct interim
analysis of the second Phase 3 OCD trial in 2H 2024 and report
topline data from first Phase 3 OCD trial in 1H 2025
Taldefgrobep alfa:
- Initiate Phase 2 trial with taldefgrobep in obesity in 2H
2024
- Report topline data from Phase 3 trial with taldefgrobep in SMA
in 2H 2024
First-in-class TRPM3 Antagonist:
- Initiate Phase 2 trial with BHV-2100 in acute migraine in 2H
2024
- Initiate POC study with BHV-2100 for pain in 2H 2024
TYK2/JAK1 Inhibitor:
- Complete SAD/MAD studies with BHV-8000 and advance to Phase 2
in the coming months
MoDE™ Platform
- Submit a total of 4 INDs in 2024
- Continue to advance Phase 1 SAD and MAD studies with BHV-1300,
with a further study update in 2H 2024
- INTERACT meeting with FDA regarding BHV-1600, β1AR autoantibody
degrader, in 2H 2024
Next Generation ADC Platform:
- Advance Phase 1 Trop-2 directed program BHV-1510 into a Phase 1
study in multiple tumor types
Capital Position:
Cash, cash equivalents, marketable securities and restricted
cash totaled approximately $440
million on June 30, 2024.
Second Quarter 2024 Financial Highlights:
Research and Development (R&D) Expenses: R&D
expenses, including non-cash share-based compensation costs, were
$314.8 million for the three months
ended June 30, 2024, compared to
$79.5 million for the three months
ended June 30, 2023. The increase was
primarily due to a one-time, non-cash expense of $171.9 million paid to Knopp Biosciences, LLC
(Knopp) for a milestone and royalty buyback related to our BHV-7000
and broader Kv7 platform that was recognized during the three
months ended June 30, 2024 (the
buyback reduced our potential future milestone payments by
$867.5 million, and replaced the
scaled high single digit to low teens royalty payment obligations
with a flat royalty payment in the mid-single digits for the Kv7
programs). The increase in R&D expenses was also due to
advancing our 6 clinical platforms including 5 Phase 3 starts for
BHV-7000, follow-on Kv7 assets, preclinical research programs, and
increases in direct program spend for additional and advancing
multiple clinical development programs. Non-cash share-based
compensation expense was $7.1 million
for the three months ended June 30,
2024, an increase of $4.6
million as compared to the same period in 2023. Non-cash
share-based compensation expense was higher in the second quarter
of 2024, primarily due to our annual equity incentive awards
granted in the fourth quarter of 2023 and the first quarter of
2024.
General and Administrative (G&A) Expenses: General
and administrative expenses were $19.0
million for the three months ended June 30, 2024, compared to $14.5 million for the three months ended
June 30, 2023. The increase of
$4.4 million was primarily due to
increased non-cash share-based compensation expense, which was
$5.2 million for the three months
ended June 30, 2024, an increase of
$2.9 million as compared to the same
period in 2023. Non-cash share-based compensation expense was
higher in the second quarter of 2024 primarily due to our annual
equity incentive awards granted in the fourth quarter of 2023 and
the first quarter of 2024.
Other Income, Net: Other income, net was a net other
income of $14.2 million for the three
months ended June 30, 2024, compared
to a net other income of $5.8 million
for the three months ended June 30,
2023. The increase of $8.3
million was primarily due to a $9.2
million gain recorded upon the settlement of our forward
contract liability for share consideration issued under the
amendment entered into with Knopp in May
2024, and increased investment income, partially offset by a
decrease in other income recognized during the three months ended
June 30, 2024, as compared to the
same period in 2023 related to the Transition Services Agreement
entered into with Biohaven Pharmaceutical Holding Company Ltd. (the
Former Parent).
Net Loss: Biohaven reported a net loss for the three
months ended June 30, 2024 of
$319.8 million, or $3.64 per share, compared to $90.3 million, or $1.32 per share, for the same period in 2023.
Non-GAAP adjusted net loss for the three months ended June 30, 2024 was $307.4
million, or $3.50 per share,
compared to $85.7 million, or
$1.25 per share for the same period
in 2023. 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 and losses from the change in fair value of derivatives. 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 certain non-GAAP financial
measures. In particular, Biohaven has provided non-GAAP adjusted
net loss and adjusted net loss per share, which are adjusted to
exclude non-cash share-based compensation, which is substantially
dependent on changes in the market price of common shares, and
changes in the fair value of derivative liabilities, which do not
correlate to actual cash payment obligations in the relevant
periods. 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 and can assist
investors in comparing 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 news release.
About Biohaven
Biohaven is a biopharmaceutical
company focused on the discovery, development, and
commercialization of life-changing treatments in key therapeutic
areas, including immunology, neuroscience, and oncology. The
company is advancing its innovative portfolio of therapeutics,
leveraging its proven drug development experience and multiple
proprietary drug development platforms. Biohaven's extensive
clinical and preclinical programs include Kv7 ion channel
modulation for epilepsy and mood disorders; extracellular protein
degradation for immunological diseases; TRPM3 antagonism for
migraine and neuropathic pain; TYK2/JAK1 inhibition for
neuroinflammatory disorders; glutamate modulation for OCD and SCA
(spinocerebellar ataxia); myostatin inhibition for neuromuscular
and metabolic diseases, including SMA and obesity; antibody
recruiting bispecific molecules and antibody drug conjugates for
cancer.
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 "continue", "plan", "will", "believe", "may", "expect",
"anticipate" and similar expressions, is intended to identify
forward-looking statements. Investors are cautioned that any
forward-looking statements, including statements regarding the
future development, timing and potential marketing approval and
commercialization of development candidates, are not guarantees of
future performance or results and involve substantial risks and
uncertainties. Actual results, developments and events may differ
materially from those in the forward-looking statements as a result
of various factors including: 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; complying with
applicable U.S. regulatory requirements; the potential
commercialization of Biohaven's product candidates; the potential
for Biohaven's product candidates to be first in class therapies;
and the effectiveness and safety of Biohaven's product candidates.
Additional important factors to be considered in connection with
forward-looking statements are described in Biohaven's filings with
the Securities and Exchange Commission, including within the
sections titled "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations". The
forward-looking statements are made as of the date of this news
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
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,
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
314,819
|
|
$
79,490
|
|
$
470,791
|
|
$
142,951
|
General and
administrative
|
|
18,953
|
|
14,521
|
|
46,221
|
|
28,842
|
Total operating
expenses
|
|
333,772
|
|
94,011
|
|
517,012
|
|
171,793
|
Loss from
operations
|
|
(333,772)
|
|
(94,011)
|
|
(517,012)
|
|
(171,793)
|
Other income,
net
|
|
14,178
|
|
5,842
|
|
18,483
|
|
14,071
|
Loss before provision
for income taxes
|
|
(319,594)
|
|
(88,169)
|
|
(498,529)
|
|
(157,722)
|
Provision for income
taxes
|
|
177
|
|
2,177
|
|
746
|
|
3,116
|
Net loss
|
|
$ (319,771)
|
|
$
(90,346)
|
|
$ (499,275)
|
|
$ (160,838)
|
Net loss per share —
basic and diluted
|
|
$
(3.64)
|
|
$
(1.32)
|
|
$
(5.93)
|
|
$
(2.36)
|
Weighted average
common shares outstanding— basic and diluted
|
|
87,766,069
|
|
68,248,023
|
|
84,174,099
|
|
68,227,564
|
BIOHAVEN
LTD.
|
|
CONSOLIDATED BALANCE
SHEETS
|
|
(Amounts in
thousands, except share amounts)
|
|
|
|
|
|
|
|
June 30,
2024
|
|
December 31,
2023
|
|
|
(Unaudited)
|
|
|
Assets
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
239,147
|
|
$
248,402
|
Marketable
securities
|
|
197,801
|
|
133,417
|
Prepaid
expenses
|
|
59,532
|
|
35,242
|
Income tax
receivable
|
|
7,522
|
|
13,252
|
Other current
assets
|
|
7,266
|
|
12,133
|
Total current
assets
|
|
511,268
|
|
442,446
|
Property and
equipment, net
|
|
18,665
|
|
17,191
|
Intangible
assets
|
|
18,400
|
|
18,400
|
Goodwill
|
|
1,390
|
|
1,390
|
Other non-current
assets
|
|
32,918
|
|
33,785
|
Total assets
|
|
$
582,641
|
|
$
513,212
|
Liabilities and
Shareholders' Equity
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
17,259
|
|
$
15,577
|
Accrued expenses and
other current liabilities
|
|
57,728
|
|
39,846
|
Forward contract and
derivative liabilities
|
|
81,220
|
|
—
|
Total current
liabilities
|
|
156,207
|
|
55,423
|
Non-current operating
lease liabilities
|
|
26,193
|
|
27,569
|
Derivative liability,
non-current
|
|
12,180
|
|
—
|
Other non-current
liabilities
|
|
4,321
|
|
2,245
|
Total
liabilities
|
|
198,901
|
|
85,237
|
Shareholders'
Equity:
|
|
|
|
|
Preferred shares, no
par value; 10,000,000 shares authorized, no shares issued
and outstanding as of June 30, 2024 and December 31,
2023
|
|
—
|
|
—
|
Common shares, no par
value; 200,000,000 shares authorized as of June 30,
2024 and December 31, 2023; 92,346,332 and 81,115,723 shares issued
and
outstanding as of June 30, 2024 and December 31, 2023,
respectively
|
|
1,298,553
|
|
887,528
|
Additional paid-in
capital
|
|
83,832
|
|
39,804
|
Accumulated
deficit
|
|
(998,567)
|
|
(499,292)
|
Accumulated other
comprehensive loss
|
|
(78)
|
|
(65)
|
Total shareholders'
equity
|
|
383,740
|
|
427,975
|
Total liabilities and
shareholders' equity
|
|
$
582,641
|
|
$
513,212
|
BIOHAVEN
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,
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss:
|
|
|
|
|
|
|
|
|
GAAP net
loss
|
|
$
(319,771)
|
|
$ (90,346)
|
|
$
(499,275)
|
|
$
(160,838)
|
Add: non-cash
share-based compensation expense
|
|
12,232
|
|
4,695
|
|
47,109
|
|
8,460
|
Add: loss from change
in fair value of derivatives
|
|
110
|
|
—
|
|
110
|
|
—
|
Non-GAAP adjusted net
loss
|
|
$
(307,429)
|
|
$ (85,651)
|
|
$
(452,056)
|
|
$
(152,378)
|
|
|
|
|
|
|
|
|
|
Reconciliation of
GAAP to Non-GAAP adjusted net loss per share — basic and
diluted:
|
|
|
|
|
GAAP net loss per share
— basic and diluted
|
|
$
(3.64)
|
|
$
(1.32)
|
|
$
(5.93)
|
|
$
(2.36)
|
Add: non-cash
share-based compensation expense
|
|
0.14
|
|
0.07
|
|
0.56
|
|
0.13
|
Add: loss from change
in fair value of derivatives
|
|
—
|
|
—
|
|
—
|
|
—
|
Non-GAAP adjusted net
loss per share — basic and diluted
|
|
$
(3.50)
|
|
$
(1.25)
|
|
$
(5.37)
|
|
$
(2.23)
|
MoDEs is a trademark of Biohaven Therapeutics Ltd.
Libtayo is a registered trademark of Regeneron Pharmaceuticals,
Inc.
Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741
Media Contact:
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Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502
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SOURCE Biohaven Ltd.