Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) (the "Company") today
announced its financial results for the three month period ended
December 31, 2014, which is the second quarter of the Company's
2015 fiscal year, and also provided an update on recent corporate
developments.
"We are off to a great start in 2015 with the initiation of the
Phase 2b SPIRITUS trial of vapendavir in patients with
moderate-to-severe asthma, an above average quarter of royalties
associated with an increase in seasonal Relenza® and Inavir® sales,
continued progress with our RSV program towards filing an IND and
the successful resolution of the majority of the financial
provisions related to the termination of our BARDA contract last
year," commented Dr. Joseph Patti, President and Chief Executive
Officer of Biota Pharmaceuticals. "We ended the quarter with $76.6
million in cash, cash equivalents and investments and believe we
are currently well-capitalized to continue to execute on the
strategic plan adopted in August 2014."
Recent Corporate Developments
Vapendavir – The Company reported today that it
has commenced patient screening for its Phase 2b SPIRITUS trial of
vapendavir in patients with moderate-to-severe asthma. The goal of
the study is to enroll approximately 150 laboratory-confirmed human
rhinovirus (HRV) infected patients over the next 12 months and to
report top-line data in mid-2016. The primary endpoint of this
multi-center, randomized, double-blind, placebo-controlled
dose-ranging study is the change from baseline to study day 14 in
asthma control questionnaire (ACQ)-6 total score. The secondary
endpoints are focused on safety and tolerability, lung function
assessments such as forced expiratory volume in one second (FEV1),
incidence of asthma exacerbations, assessments of the severity and
duration of cold symptoms measured by the Wisconsin Upper
Respiratory Symptom Survey-21 (WURSS-21), and virology assessments
such as changes in viral load.
BTA-C585 and RSV Program – The Company reported
today that is has successfully completed the requisite in vitro
studies to support an Investigational New Drug (IND) application
for its respiratory syncytial virus (RSV) fusion inhibitor,
BTA-C585, and pending successful completion of ongoing in vivo
studies, the Company intends to file the IND application by
mid-year 2015. In addition, the Company has identified a series of
potent RSV non-fusion inhibitors that it intends to further develop
and believes could be useful as a stand-alone treatment or
potentially in combination therapy with BTA-C585 for the treatment
of patients infected with RSV.
BARDA Contract Termination – During the
Company's second fiscal quarter, it resolved the majority of its
outstanding claims with the Biomedical Advanced Research and
Development Authority (BARDA) associated with the termination of
its contract in May 2014. As of December 31, 2014, the Company had
$7.4 million in accounts receivable due from BARDA, of which $5.4
million was collected in early January, 2015. The Company believes
that pursuant to applicable government regulations, it is entitled
to be reimbursed for the remaining $2.0 million of accounts
receivable it had recorded at December 31, 2014 related to the
terminated BARDA contract. At this time, the Company cannot
determine when and to what extent a final termination settlement
will be reached with BARDA.
Laninamivir Octanoate (LANI)– The Company plans
to meet with the U.S. Food and Drug Administration (FDA) in the
second quarter of the 2015 calendar year to discuss the results of
the LANI Phase 1 asthma and Thorough QT/QTc (TQT) studies, the
Phase 1/2 pediatric study, and the Phase 2 IGLOO study to determine
the appropriate primary endpoint for, and which patient reported
outcome tools would be acceptable for use in prospective
registration trials of LANI to treat uncomplicated influenza.
Further, the Company is pursuing partnering opportunities for Phase
3 development and the commercialization of LANI outside of
Japan.
Financial Results for the Three Month Period Ended
December 31, 2014
The Company reported net income of $6.5 million for the three
month period ended December 31, 2014, as compared to a net loss of
$0.1 million in the same period of the prior fiscal year. The $6.6
million change in net income from the prior fiscal year period was
primarily due to a $9.8 million decrease in the cost of revenue, a
$1.4 million increase in foreign exchange gain, a $0.5 million
decrease in general and administrative expense and a $0.1 million
increase in interest income, offset in part by a $4.6 million
decrease in revenue and a $0.6 million increase in research and
development expense. Basic and diluted net income per share was
$0.19 for the three month period ended December 30, 2014, as
compared to a basic and diluted net loss per share of zero in the
same period of 2013.
Revenue decreased to $13.9 million for the three month period
ended December 31, 2014 from $18.5 million in the same period of
2013 due to a $5.0 million decrease in revenue from services
related to the termination of the Company's contract with BARDA on
May 7, 2014 and a $0.1 million decrease in other revenue due to a
reduced level of grant-related research activities, offset in part
by a $0.5 million increase in royalty revenues primarily related to
an increase in seasonal sales of Relenza® and Inavir®.
Cost of revenue decreased to $1.6 million for the three month
period ended December 31, 2014 from $11.4 million in the same
period in 2013 due to a decrease of $8.6 million in direct
third-party clinical costs and manufacturing activities and a $1.2
million decrease in salaries, benefits and share-based compensation
expense incurred to develop laninamivir octanoate under the
Company's terminated contract with BARDA.
Research and development expense increased to $4.8 million for
the three month period ended December 31, 2014 from $4.2 million in
the same period of 2013. The $0.6 million increase was the result
of a $1.7 million increase in preclinical, clinical and
manufacturing costs related to the advancement of the Company's
vapendavir and RSV programs, offset in part by a $0.8 million
reduction in salaries, benefits and share-based compensation
expense and a $0.3 million decrease in other expenses due to
reduced research activities.
General and administrative expense decreased to $2.6 million for
the three month period ended December 31, 2014 from $3.1 million in
the same period of 2013, due to a $0.2 million decrease in
salaries, benefits and share-based compensation expense, a $0.2
million reduction in other expenses and a $0.1 million decrease in
professional and legal fees.
Conference Call and Webcast Information
Biota Pharmaceuticals will host a conference call today to
review these second quarter fiscal year 2015 financial results, as
well as provide a general update on the Company via a webcast and
conference call at 9:00 a.m. EST. To access the conference call,
please dial (877) 312-5422 (domestic) or (253) 237-1122
(international). A live audio webcast of the call and the archived
webcast will be available in the Investors section of the Biota
website at http://www.biotapharma.com.
About Biota Pharmaceuticals, Inc.
Biota Pharmaceuticals, Inc. is a company focused on the
discovery and development of products to treat serious viral
respiratory infectious diseases. The Company currently has two
late-stage product candidates: (i) laninamivir octanoate, which is
being developed as a one-time, inhaled treatment for influenza A
and B infections; and (ii) vapendavir, a potent, broad spectrum
capsid inhibitor of enteroviruses in development for the treatment
of human rhinovirus infected patients with underlying respiratory
illnesses, such as moderate-to-severe asthma and chronic
obstructive pulmonary disease (COPD). The Company is also
conducting IND-enabling studies with BTA-C585, an orally
bioavailable F protein inhibitor, in development for the treatment
of respiratory syncytial virus infections. For additional
information about the Company, please visit
www.biotapharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve known and unknown risks and uncertainties concerning
Biota's business, operations and financial performance. Any
statements that are not of historical facts may be deemed to be
forward-looking statements, including: the Company's belief that it
is well-capitalized to continue to execute the strategic plan it
adopted in August 2014; the time frames in which the Company may
fully enroll and report top line-data from its recently initiated
Phase 2 SPIRITUS clinical trial of vapendavir; the anticipated time
to complete ongoing in vivo preclinical studies and file an IND for
BTA-C585; for the potential of the Company's RSV non-fusion
inhibitors as a stand-alone treatment or in combination therapy
with BTA-C585; the amount and timing of proceeds the Company
believes it is entitled to receive under its terminated contract
with BARDA; the Company's plan to meet and discuss with the FDA to
determine the appropriate primary endpoint for any prospective
registration trials for laninamivir octanoate and the Company's
pursuit of partnering opportunities for Phase 3 development and
commercialization of LANI outside of Japan.
Various important factors could cause actual results,
performance, events or achievements to materially differ from those
expressed or implied by forward-looking statements, including: the
Company, the FDA or a similar regulatory body in another country, a
data safety monitoring board, or an institutional review board,
delaying, limiting, suspending or terminating the clinical
development of vapendavir, laninamivir octanoate, BTA-C585 or any
of the Company's product candidates at any time for a lack of
safety, tolerability, anti-viral activity, commercial viability,
regulatory or manufacturing issues, or any other reason whatsoever;
the Company's ability to secure, manage and retain qualified
third-party clinical research, preclinical research, data
management and contract manufacturing organizations upon which it
relies to assist in the design, development, implementation and
execution of the clinical and preclinical development of all its
product candidates; ongoing IND-enabling studies of BTA-C585 being
successfully completed and continuing to support the filing of an
IND; the Company being able to negotiate an acceptable resolution
and final termination settlement with BARDA; the Company being able
to meet with and reach agreement with the FDA on an appropriate
primary endpoint for any prospective registration trials for
laninamivir octanoate, and the Company's ability to identify viable
potential partners to advance the development of laninamivir
octanoate, and other cautionary statements contained elsewhere in
this press release in this press release and in the Company's
Annual Report on Form 10-K for the year ended June 30, 2014, as
filed with the U.S. Securities and Exchange Commission, on
September 30, 2014 and in the Company's Quarterly Report on Form
10-Q on November 7, 2014.
There may be events in the future that the Company is unable to
predict, or over which it has no control, and the Company's
business, financial condition, results of operations and prospects
may change in the future. The Company may not update these
forward-looking statements more frequently than quarterly unless it
has an obligation under U.S. Federal securities laws to do so.
Biota is a registered trademark of Biota Pharmaceuticals, Inc.
Relenza® is a registered trademark of GlaxoSmithKline plc and
Inavir® is a registered trademark of Daiichi Sankyo.
BIOTA PHARMACEUTICALS,
INC. |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
|
(in millions, except per share
amounts) |
|
|
December 31,
2014 |
June 30, 2014 |
|
(unaudited) |
(audited) |
|
|
|
ASSETS |
Current assets |
|
|
Cash and cash equivalents |
$63.7 |
$81.7 |
Short-term investments |
7.1 |
-- |
Contract-related accounts receivable |
7.4 |
17.8 |
Other accounts receivable |
7.0 |
0.9 |
Prepaid and other current assets |
1.0 |
0.7 |
Total current assets |
86.2 |
101.1 |
Non-current assets: |
|
|
Long-term investments |
5.8 |
10.0 |
Property and equipment, net |
1.1 |
2.0 |
Deferred tax asset |
0.3 |
0.9 |
Total non-current assets |
7.2 |
12.9 |
Total assets |
$93.4 |
$114.0 |
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
Current liabilities: |
|
|
Contract-related accounts payable and
accrued expenses |
$4.4 |
$18.6 |
Other accrued expenses |
3.7 |
3.4 |
Other accounts payable |
1.7 |
2.8 |
Accrued severance obligations |
0.8 |
1.2 |
Deferred tax liability |
0.3 |
0.9 |
Total current liabilities |
10.9 |
26.9 |
Non-current liabilities: |
|
|
Other liabilities, net of current
portion |
0.1 |
0.2 |
Total liabilities |
11.0 |
27.1 |
Stockholders' equity: |
|
|
Common stock, $0.10 par value;
200,000,000 shares authorized 35,100,961 and 35,100,961 shares
issued and outstanding at December 31, 2014 and June 30, 2014,
respectively |
3.5 |
3.5 |
Additional paid-in capital |
147.4 |
146.4 |
Accumulated other comprehensive
income |
21.7 |
26.8 |
Accumulated deficit |
(90.2) |
(89.8) |
Total stockholders' equity |
82.4 |
86.9 |
Total liabilities and stockholders'
equity |
$93.4 |
$114.0 |
|
BIOTA PHARMACEUTICALS,
INC. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(in millions, except per share
amounts) |
|
|
Three Months
Ended |
Six Months
Ended |
|
December
31, |
December
31, |
|
2014 |
2013 |
2014 |
2013 |
Revenue: |
|
|
|
|
Royalty revenue and milestones |
$6.5 |
$6.0 |
$6.5 |
$6.0 |
Revenue from services |
7.4 |
12.4 |
8.1 |
24.6 |
Other |
-- |
0.1 |
-- |
0.2 |
Total revenue |
13.9 |
18.5 |
14.6 |
30.8 |
|
|
|
|
|
Operating expense: |
|
|
|
|
Cost of revenue |
1.6 |
11.4 |
3.3 |
22.2 |
Research and development |
4.8 |
4.2 |
9.7 |
7.1 |
General and administrative |
2.6 |
3.1 |
5.0 |
5.5 |
Foreign exchange loss (gain) |
(1.5) |
(0.1) |
(2.8) |
0.2 |
Total operating expense |
7.5 |
18.6 |
15.2 |
35.0 |
Income (loss) from operations |
6.4 |
(0.1) |
(0.6) |
(4.2) |
|
|
|
|
|
Non-operating income: |
|
|
|
|
Interest income |
0.1 |
-- |
0.2 |
0.1 |
Total non-operating income |
0.1 |
-- |
0.2 |
0.1 |
|
|
|
|
|
Income (loss) before tax |
6.5 |
(0.1) |
(0.4) |
(4.1) |
Income tax benefit |
-- |
-- |
-- |
0.1 |
Net income (loss) |
$6.5 |
$(0.1) |
$(0.4) |
$(4.0) |
|
|
|
|
|
|
|
|
|
|
Basic income (loss) per share |
$0.19 |
$(0.00) |
$(0.01) |
$(0.14) |
Diluted income (loss) per share |
$0.19 |
$(0.00) |
$(0.01) |
$(0.14) |
|
|
|
|
|
Basic weighted-average shares
outstanding |
35,100,961 |
28,291,665 |
35,100,961 |
28,286,404 |
Diluted weighted-average shares
outstanding |
35,103,086 |
28,291,665 |
35,100,961 |
28,286,404 |
CONTACT: Joseph M. Patti, PhD
President and Chief Executive Officer
(678) 221-3352
j.patti@biotapharma.com
Sarah McCabe
Stern Investor Relations, Inc.
(267) 909-9237
sarah@sternir.com
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