Axovant Announces Second Fiscal Quarter Financial Results and Corporate Updates
November 02 2017 - 4:30PM
Axovant Sciences (Nasdaq:AXON) today announced financial results
for its second fiscal quarter and first half ended September 30,
2017, and provided an update on its clinical programs.
Key Highlights
- Strong balance sheet with $235.4 million of cash as of
September 30, 2017 supports Company's current clinical development
plans and business development activities.
Intepirdine
- The Company is reevaluating endpoints for the Phase 2b HEADWAY
trial evaluating 35mg and 70mg doses of intepirdine in patients
with dementia with Lewy bodies (DLB), and plans to have a
discussion with the U.S. Food and Drug Administration (FDA) to help
determine the most feasible and expeditious pathway to potential
registration for this indication which has received Fast Track
designation. Given this planned FDA interaction, top-line data are
expected to be reported in January 2018.
- Top-line data from the Phase 2 study of the effects of
intepirdine on gait and balance in subjects with Alzheimer’s
disease, DLB and Parkinson’s disease dementia (PDD) are expected to
be reported in January 2018.
- The Company has decided to keep the open-label extension (OLE)
study of MINDSET open while it evaluates the feasibility of
studying higher doses of intepirdine in the OLE study population,
an analysis that may be influenced by any potential signals seen at
the 70mg intepirdine dose in the HEADWAY study.
Nelotanserin
- Top-line data from the Phase 2 study evaluating nelotanserin
for treatment of subjects with Lewy Body Dementia (LBD) who
experience frequent visual hallucinations are expected to be
reported in January 2018.
- Top-line data from the Phase 2 study evaluating nelotanserin
for treatment of REM Behavior Disorder in subjects with LBD are
expected in the second quarter of 2018.
Second-Quarter Financial SummaryFor the second
fiscal quarter ended September 30, 2017, research and development
expenses were $38.6 million, of which $5.9 million was attributable
to non-cash, share-based compensation expense. General and
administrative expenses for the second quarter were $30.1 million,
of which $9.4 million was attributable to non-cash, share-based
compensation expense. Net loss for the quarter ended September 30,
2017 was $69.1 million, or $0.64 per share.
First-Half Financial SummaryFor the first
fiscal half ended September 30, 2017, research and development
expenses were $82.3 million, of which $12.2 million was
attributable to non-cash, share-based compensation expense. General
and administrative expenses for the first half ended September 30,
2017 were $51.6 million, of which $18.8 million was attributable to
non-cash, share-based compensation expense. Net loss for the six
months ended September 30, 2017 was $138.4 million, or $1.29 per
share.
Axovant held cash of $235.4 million at September 30, 2017. Net
cash used in operating activities was $109.6 million for the six
months ended September 30, 2017.
About Axovant SciencesAxovant is a
clinical-stage biopharmaceutical company focused on developing and
commercializing innovative medicines to broadly address multiple
forms of dementia and related neurological disorders. Axovant is
developing a pipeline of product candidates that focuses on the
cognitive, functional and behavioral aspects of debilitating
conditions such as Alzheimer’s disease, Lewy body dementia and
other neurological disorders. For more information, visit
www.axovant.com.
Forward-Looking StatementsThis press release
contains forward-looking statements, including statements regarding
Axovant’s expectations about timing of the results for the Phase 2b
HEADWAY-DLB study of intepirdine in patients with DLB, the Phase 2
gait and balance study in patients with Alzheimer’s disease, DLB
and PDD, the Phase 2 study of nelotanserin in patients with LBD
suffering from visual hallucinations, the Phase 2 study of
nelotanserin in patients with LBD suffering from RBD, the proof of
concept and related studies of RVT-104 in patients with Alzheimer's
disease and DLB; evaluation of the feasibility of studying higher
doses of intepirdine in the OLE study population, including the
potential influence on such evaluation by the results of the
HEADWAY study; and other elements of its clinical development and
regulatory strategy. Forward-looking statements can be identified
by the words “believe,” “anticipate,” “continue,” “estimate,”
“project,” “expect,” “plan,” “potential,” “intends,” “will,”
“would,” “could,” “should” or the negative or plural of these words
or other similar expressions that are predictions or indicate
future events, trends or prospects. Forward-looking statements are
subject to risks and uncertainties that could cause actual results
to differ materially and reported results should not be considered
as an indication of future performance. These risks and
uncertainties include, but are not limited to: risks associated
with the success, cost and timing of our product development
activities and clinical trials; the approval and commercialization
of our product candidates intepirdine, nelotanserin and RVT-104;
and increased regulatory requirements. These statements are subject
to the risk that clinical trial data are subject to differing
interpretations, and regulatory agencies, medical and scientific
experts and others may not share Axovant’s views of the clinical
study data. There can be no assurance that the clinical
programs for intepirdine, nelotanserin or RVT-104 will be
successful in demonstrating safety and/or efficacy, that we will
not encounter problems or delays in clinical development, or that
any of our product candidates will ever receive regulatory approval
or be successfully commercialized. For a further description
of the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as
well as risks relating to Axovant’s business in general, see the
“Risk Factors” section of our quarterly report on Form 10-Q to
be filed with the Securities and Exchange Commission on or about
November 2, 2017, and other filings that Axovant makes with the SEC
from time to time. These forward-looking statements are based on
information available to Axovant as of the date of this press
release and speak only as of the date of this release. Axovant
disclaims any obligation to update these forward-looking
statements, except as may be required by law.
|
AXOVANT SCIENCES LTD. |
Condensed Consolidated Statements of
Operations |
(Unaudited, in thousands, except share and per share
amounts) |
|
|
Three Months Ended September 30, |
|
Six Months Ended September 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development expenses |
|
|
|
|
|
|
|
(includes
share-based compensation expense of $5,916 and $4,473 for the three
months ended September 30, 2017 and 2016 and $12,172 and $9,437 for
the six months ended September 30, 2017 and 2016,
respectively) |
$ |
38,555 |
|
|
$ |
32,074 |
|
|
$ |
82,267 |
|
|
$ |
57,350 |
|
General and
administrative expenses |
|
|
|
|
|
|
|
(includes
share-based compensation expense of $9,424 and $3,464 for the three
months ended September 30, 2017 and 2016 and $18,768 and $10,061
for the six months ended September 30, 2017 and 2016,
respectively) |
30,112 |
|
|
9,449 |
|
|
51,630 |
|
|
22,080 |
|
Total
operating expenses |
68,667 |
|
|
41,523 |
|
|
133,897 |
|
|
79,430 |
|
|
|
|
|
|
|
|
|
Interest
expense |
1,878 |
|
|
— |
|
|
3,752 |
|
|
— |
|
Other
expense (income) |
131 |
|
|
— |
|
|
(226 |
) |
|
— |
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes |
(70,676 |
) |
|
(41,523 |
) |
|
(137,423 |
) |
|
(79,430 |
) |
|
|
|
|
|
|
|
|
Income tax (benefit)
expense |
(1,590 |
) |
|
729 |
|
|
929 |
|
|
877 |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(69,086 |
) |
|
$ |
(42,252 |
) |
|
$ |
(138,352 |
) |
|
$ |
(80,307 |
) |
|
|
|
|
|
|
|
|
Net loss per common
share — basic and diluted |
$ |
(0.64 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.29 |
) |
|
$ |
(0.81 |
) |
Weighted average common
shares outstanding — basic and diluted |
107,593,609 |
|
|
99,160,445 |
|
|
107,000,519 |
|
|
99,155,251 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AXOVANT SCIENCES LTD. |
Condensed Consolidated Balance
Sheets |
(Unaudited, in thousands) |
|
|
September 30, 2017 |
|
March 31, 2017 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash |
$ |
235,373 |
|
|
$ |
212,573 |
|
Prepaid
expenses and other current assets |
4,587 |
|
|
6,457 |
|
Income
tax receivable |
2,813 |
|
|
658 |
|
Total
current assets |
242,773 |
|
|
219,688 |
|
Property and equipment,
net |
3,367 |
|
|
142 |
|
Deferred tax
assets |
— |
|
|
2,709 |
|
Total
assets |
$ |
246,140 |
|
|
$ |
222,539 |
|
|
|
|
|
Liabilities and
Shareholders’ Equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
2,860 |
|
|
$ |
8,551 |
|
Due to
Roivant Sciences Ltd. and Roivant Sciences, Inc. |
4,242 |
|
|
2,919 |
|
Accrued
expenses |
33,794 |
|
|
34,796 |
|
Total
current liabilities |
40,896 |
|
|
46,266 |
|
|
|
|
|
Long term debt |
52,068 |
|
|
51,436 |
|
|
|
|
|
Total
liabilities |
92,964 |
|
|
97,702 |
|
Total
shareholders’ equity |
153,176 |
|
|
124,837 |
|
Total liabilities and
shareholders’ equity |
$ |
246,140 |
|
|
$ |
222,539 |
|
|
|
|
|
|
|
|
|
Contact:Investors &
MediaSamina BariVice President, Corporate
Affairsinvestors@axovant.com or media@axovant.com
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