Nexvet Biopharma (Nasdaq:NVET) today announced its financial
results for the three and nine month periods ended March 31, 2017.
Recent highlights:
- In April 2017, entered into a Transaction Agreement for Zoetis
to acquire all Nexvet shares for $6.72 per ordinary share in cash,
valuing Nexvet at approximately $85 million
- Advanced key clinical programs and implemented a cost reduction
program
- Signed a licensing agreement with Pfizer regarding certain
anti-NGF mAb patents
The Company is continuing a pivotal field efficacy and safety
study for frunevetmab. This study is a placebo-controlled,
randomized, double-blinded study with a target enrolment of 250
cats with osteoarthritis at approximately 20 clinical sites around
the United States. As at March 31, 169 cats had been enrolled into
the study. Enrolled cats are randomly assigned to receive
frunevetmab or placebo at a 2:1 ratio. Each cat receives three
doses, with each dose given 28 days apart. This study has received
protocol concurrence from the Center for Veterinary Medicine (CVM)
at the United States Food and Drug Administration (FDA) and will
utilize a comparison of owner-assessed responses, before and after
treatment, as its primary endpoint.
The pivotal target animal safety study, which commenced in late
October 2016, is examining the safety of frunevetmab in cats
according to standard International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH) guidance and a protocol concurred with the CVM. The
in-life phase of the pivotal target animal safety study is complete
and Nexvet expects to report data from both studies in the fourth
quarter of calendar 2017.
In support of the Company’s planned frunevetmab CMC technical
section submission to the CVM, a third 200 liter batch of
frunevetmab was successfully produced during the quarter at BioNua,
the Company’s wholly-owned manufacturing facility, which is also
being prepared for commercial manufacturing of Nexvet’s products.
The first and second 200 liter batch of ranevetmab was also
successfully produced during the quarter.
In February 2017, the Company entered into a license agreement
with Pfizer Inc. (“Pfizer”), pursuant to which the Company received
a non-exclusive license to certain patents in the Pfizer portfolio
for anti-NGF antibodies. The Company paid Pfizer a $1.0 million
upfront license fee, and may pay Pfizer (i) additional amounts
based on regulatory and sales milestones and (ii) a low,
single-digit royalty based on net sales of the Company’s anti-NGF
product candidates for the life of the relevant patents.
In March 2017, the Company implemented a cost reduction program
focused on early stage research programs and general and
administrative activities, which resulted in a reduction of 11
employees. The net cost reflected in the quarter was $0.8
million.
Since March 31, 2017
In April 2017, Zoetis Inc., entered into an agreement to acquire
the Company, by means of a “scheme of arrangement” under Irish
law. The Transaction Agreement provides that shareholders of
the Company will be entitled to receive $6.72 in cash per ordinary
share of the Company and values the Company at approximately $85
million.
The Nexvet board has unanimously recommended this offer to
shareholders in the absence of a superior offer. The Company
is expecting completion of the transaction in the second half of
2017.
Financial Results
As of March 31, 2017, Nexvet had cash of $14.5 million.
Three months ended March 31, 2017
For the three months ended March 31, 2017, Nexvet reported a net
loss of $6.0 million which reflected one off items, namely
$1.0 million to Pfizer for a patent license and $0.8 million in
cost reduction costs, compared to $5.7 million for the three
months ended March 31, 2016. Net loss per share attributable to
ordinary shareholders (basic and diluted) for the three months
ended March 31, 2017 was $0.51, compared to $0.50 for the three
months ended March 31, 2016.
The net loss of $6.0 million for the three months ended
March 31, 2017 included operating expenses of $7.2 million,
reflecting $5.6 million in research and development expenses
and $1.6 million in general and administrative expenses. Other
income of $1.1 million comprised research and development income of
$0.6 million, government grant income of $0.4 million and an
exchange gain of $0.1 million.
The net loss of $5.7 million for the three months ended March
31, 2016 included operating expenses of $5.9 million, reflecting
$4.3 million in research and development expenses and $1.7 million
in general and administrative expenses. Other income of $0.2
million comprised research and development income of $0.4 million
offset by an exchange loss of $0.2 million.
Nine months ended March 31, 2017
For the nine months ended March 31, 2017, Nexvet reported a net
loss of $16.5 million which reflected one off items, namely $1.0
million to Pfizer for a patent license and $0.8 million in cost
reduction costs, compared to $15.4 million for the nine months
ended March 31, 2016. Net loss per share attributable to ordinary
shareholders (basic and diluted) for the nine months ended March
31, 2017 was $1.41, compared to $1.34 for the nine months ended
March 31, 2016.
The net loss of $16.5 million for the nine months ended March
31, 2017 included operating expenses of $18.0 million, reflecting
$12.8 million in research and development expenses and $5.2 million
in general and administrative expenses. Other income of $1.5
million comprised research and development income of $1.6 million,
government grant income of $0.8 million and interest income of $0.1
million, offset by an exchange loss of $1.0 million.
The net loss of $15.4 million for the nine months ended March
31, 2016 included operating expenses of $17.1 million, reflecting
$11.8 million in research and development expenses and $5.3 million
in general and administrative expenses. Other income of $1.7
million comprised research and development income of $1.4 million,
interest income $0.1 million and an exchange gain of $0.2
million.
About Nexvet
(www.nexvet.com)
Nexvet is a clinical-stage biopharmaceutical company focused on
transforming the therapeutic market for companion animals, such as
dogs and cats, by developing and commercializing novel,
species-specific biologics. Nexvet’s proprietary PETization
platform is designed to rapidly design monoclonal antibodies (mAbs)
that are recognized as “self” or “native” by an animal’s immune
system, a property Nexvet refers to as “100% species-specificity.”
Nexvet’s product candidates build upon the safety and efficacy data
from clinically tested human therapies, thereby reducing clinical
risk and development cost.
Nexvet is leveraging diverse global expertise and incentives to
build a vertically integrated biopharmaceutical company, which
conducts drug discovery in Australia, conducts clinical
development in the United States and Europe and conducts
manufacturing in Ireland.
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(unaudited) |
(in thousands, except share and per share
amounts) |
|
|
March 31, 2017 |
|
June 30, 2016 |
Assets |
|
|
|
Current assets |
|
|
|
Cash |
$ |
14,521 |
|
|
$ |
31,481 |
|
Other
income receivable |
|
2,816 |
|
|
|
2,201 |
|
Prepaid
expenses and other |
|
1,619 |
|
|
|
1,280 |
|
Total
current assets |
|
18,956 |
|
|
|
34,962 |
|
Noncurrent assets |
|
|
|
Other
income receivable |
|
599 |
|
|
|
251 |
|
Prepaid
expenses and other |
|
98 |
|
|
|
129 |
|
Total
noncurrent assets |
|
697 |
|
|
|
380 |
|
Property, plant and
equipment, net |
|
5,020 |
|
|
|
4,908 |
|
Intangible assets,
net |
|
72 |
|
|
|
74 |
|
Total
assets |
$ |
24,745 |
|
|
$ |
40,324 |
|
Liabilities and
Shareholders’ Equity |
|
|
|
Current
liabilities |
|
|
|
Accounts
payable |
$ |
1,088 |
|
|
$ |
1,729 |
|
Accrued
expenses and other liabilities |
|
2,409 |
|
|
|
3,295 |
|
Deferred
income |
|
58 |
|
|
|
23 |
|
Total current
liabilities |
|
3,555 |
|
|
|
5,047 |
|
Noncurrent
liabilities |
|
|
|
Accrued
expenses and other liabilities |
|
41 |
|
|
|
104 |
|
Deferred
income |
|
234 |
|
|
|
37 |
|
Total
noncurrent liabilities |
|
275 |
|
|
|
141 |
|
Total
liabilities |
$ |
3,830 |
|
|
$ |
5,188 |
|
Commitments and
contingencies (Note 13) |
|
|
|
Shareholders’
equity |
|
|
|
Ordinary
shares, $0.125 nominal value per share, 100,000,000 shares
authorized as of March 31, 2017 and June 30, 2016—11,905,639 and
11,565,133 shares issued and outstanding as of March 31, 2017 and
June 30, 2016, respectively |
$ |
1,488 |
|
|
$ |
1,446 |
|
Euro
deferred shares, €100 nominal value per share, 400 shares
authorized as of March 31, 2017 and June 30, 2016—400 shares issued
and outstanding as of March 31, 2017 and June 30, 2016,
respectively |
|
13 |
|
|
|
13 |
|
Additional paid-in capital |
|
83,795 |
|
|
|
82,030 |
|
Accumulated other comprehensive loss |
|
(4,835 |
) |
|
|
(5,333 |
) |
Accumulated deficit |
|
(59,546 |
) |
|
|
(43,020 |
) |
Total
shareholders’ equity |
|
20,915 |
|
|
|
35,136 |
|
Total
liabilities and shareholders’ equity |
$ |
24,745 |
|
|
$ |
40,324 |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS |
|
(unaudited) |
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
|
March 31, |
|
|
March 31, |
|
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
Total
revenue |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Operating
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
5,583 |
|
|
|
4,260 |
|
|
|
12,802 |
|
|
|
11,775 |
|
|
General and
administrative |
|
|
1,605 |
|
|
|
1,680 |
|
|
|
5,245 |
|
|
|
5,329 |
|
|
Total
operating expenses |
|
|
7,188 |
|
|
|
5,940 |
|
|
|
18,047 |
|
|
|
17,104 |
|
|
Loss from
operations |
|
|
(7,188 |
) |
|
|
(5,940 |
) |
|
|
(18,047 |
) |
|
|
(17,104 |
) |
|
Other Income
(Expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development income |
|
|
635 |
|
|
|
418 |
|
|
|
1,605 |
|
|
|
1,441 |
|
|
Government grant
income |
|
|
429 |
|
|
|
— |
|
|
|
785 |
|
|
|
4 |
|
|
Exchange gain
(loss) |
|
|
76 |
|
|
|
(259 |
) |
|
|
(958 |
) |
|
|
151 |
|
|
Interest income |
|
|
29 |
|
|
|
36 |
|
|
|
89 |
|
|
|
112 |
|
|
Net
loss |
|
$ |
(6,019 |
) |
|
$ |
(5,745 |
) |
|
$ |
(16,526 |
) |
|
$ |
(15,396 |
) |
|
Net loss per share
attributable to ordinary shareholders, basic and diluted |
|
$ |
(0.51 |
) |
|
$ |
(0.50 |
) |
|
$ |
(1.41 |
) |
|
$ |
(1.34 |
) |
|
Weighted-average
ordinary shares outstanding, basic and diluted |
|
|
11,780,865 |
|
|
|
11,559,056 |
|
|
|
11,741,242 |
|
|
|
11,502,409 |
|
|
Comprehensive
Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(6,019 |
) |
|
$ |
(5,745 |
) |
|
$ |
(16,526 |
) |
|
$ |
(15,396 |
) |
|
Net (loss) gain in
foreign currency translation adjustments |
|
|
(19 |
) |
|
|
210 |
|
|
|
498 |
|
|
|
(634 |
) |
|
Total comprehensive
loss |
|
$ |
(6,038 |
) |
|
$ |
(5,535 |
) |
|
$ |
(16,028 |
) |
|
$ |
(16,030 |
) |
|
Forward looking statements
This press release contains forward looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). Forward looking statements consist of
all statements other than statements of historical fact, including
statements regarding our future results of operations and financial
position, potential acquisition by Zoetis, ability to access
financing on acceptable terms or at all, results of any current or
future pivotal study, future expenditures relating to our lead
product candidates, time for completion of any of our studies or
facilities upgrades, ability to develop our pipeline of product
candidates, business strategy, prospective products, ability to
successfully manufacture our own product candidates, ability to
meet conditions for the receipt of government grants, time for
regulatory submissions or ability to qualify for conditional
licensure or obtain product approvals, research and development
costs, timing and likelihood of success, plans and objectives of
management for future operations, and future results of current and
anticipated products. These statements relate to future
events or to our future financial performance and involve known and
unknown risks, uncertainties and other factors which may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward looking statements. The
words “anticipate,” “assume,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “might,” “objective,”
“plan,” “potential,” “predict,” “project,” “position,” “seek,”
“should,” “target,” “will,” “would,” or the negative of these terms
or other similar expressions are intended to identify forward
looking statements, although not all forward looking statements
contain these identifying words. These forward looking
statements are based on current expectations, estimates, forecasts
and projections about our business and the industry in which we
operate, and management’s beliefs and assumptions are not
guarantees of future performance or development and involve known
and unknown risks, uncertainties and other factors.
Factors that could cause actual results to differ materially
from our expectations expressed in this report include those
summarized under Risk Factors in our reports on Forms 10-Q and 10-K
and the other documents we file from time to time with the
Securities and Exchange Commission. Given these risks and
uncertainties, you should not place undue reliance on these forward
looking statements. Also, forward looking statements
represent management’s beliefs and assumptions only as of the date
of this press release. Except as required by law, we do not
intend, and undertake no obligation, to revise or update these
forward looking statements or to update the reasons actual results
could differ materially from those anticipated in these forward
looking statements, even if new information becomes available in
the future.
Further information
Investors
Hershel Berry
Blueprint Life Science Group
+1 415-375-3340 Ext. 1
hberry@bplifescience.com
Company
Damian Lismore
CFO, Nexvet Biopharma plc
+61 417-351-272 (Aus.)
damian.lismore@nexvet.com
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