Biota Pharmaceuticals, Inc. (NASDAQ:BOTA) today announced its
financial results for the three month period ended December 31,
2015, which is the second quarter of the Company's 2016 fiscal
year, and also provided an update on recent corporate developments.
“I am very pleased today to report that significant progress is
being made with our antiviral pipeline for respiratory indications
and we remain on track to have Phase 2 data readouts in the second
half of the year from both the HRV and RSV programs. Our oral RSV
fusion inhibitor, BTA585, successfully completed a robust Phase 1
single ascending dose study showing a favorable safety and
pharmacokinetic profile. We are nearing completion of the Phase 1
multiple ascending dose study and plan to initiate the Phase 2 RSV
challenge study next quarter. Additionally we are progressing with
enrollment in the Phase 2b SPIRITUS trial of vapendavir and
anticipate top-line data in the second half of this year. Not only
is this our lead program but it is the most advanced direct-acting
antiviral in the field targeting HRV and has the potential to treat
problematic upper respiratory infections in the almost 11 million
moderate-to-severe asthmatics in the U.S.,” stated Joseph M. Patti,
PhD, president and chief executive officer at Biota
Pharmaceuticals.
"I am glad to report that we have begun screening patients for
the Phase 2 study of BTA074, our first-in-class direct-acting
antiviral for the treatment of condyloma caused by HPV types 6
& 11, which is the most common manifestation of HPV infection
and also the most common sexually-transmitted viral disease
worldwide. Current topical treatments do not act on the virus
directly so there is a need for a therapy with improved efficacy
and reduced local skin reactions to address this contagious
infection."
Recent Highlights
Announced positive Phase 1 data for
BTA585. The top-line results were from a blinded,
placebo-controlled single ascending dose study, which tested doses
of up to 800 mg of BTA585, an oral fusion inhibitor in development
for the treatment and prevention of respiratory syncytial virus
(RSV) infections. Findings included:
- No serious or severe adverse events
- Low incidence of adverse events
- Pharmacokinetic (PK) data demonstrated that all doses of 100 mg
or greater achieved BTA585 plasma levels that exceeded the mean
EC50 of RSV clinical isolates for 24 hours. The EC50 represents the
concentration of drug that is required for 50% inhibition of viral
replication in vitro
- BTA585 plasma Cmax was rapidly achieved at approximately one
hour following oral dosing and the half-life (T1/2) was
approximately five to six hours across the dose range
- Dosing of BTA585 with a high fat meal did not adversely affect
the PK
Commenced dosing in Phase 1 multiple
ascending dose (MAD) study of BTA585. This study will
evaluate the safety and PK of BTA585 in healthy volunteers
following seven days of oral dosing. Top-line data is anticipated
to be available in the first quarter of 2016.
Enrollment on track for
Phase 2b SPIRITUS trial for vapendavir.
Top-line data are expected in the second half of 2016 from the
multi-center, randomized, double-blind, placebo-controlled
dose-ranging study in moderate-to-severe adult asthmatics with
symptomatic human rhinovirus (HRV) and a history of asthma
exacerbation from colds.
Corporate Updates
Appointed Mark P. Colonnese as Executive Vice President
and Chief Financial Officer on November 2, 2015. The
Company announced the appointment of Mark Colonnese as Executive
Vice President and Chief Financial Officer. Mr. Colonnese has held
a number of senior executive positions in the pharmaceutical
industry and, most recently, was Chief Financial Officer of Stealth
BioTherapeutics, Inc.
Financial Results for the Three Month Period Ended
December 31, 2015
The Company reported a net loss of $6.5 million for the three
month period ended December 31, 2015, as compared to net income of
$6.5 million in the same quarter of the prior fiscal year. Basic
and diluted net loss per share was $0.17 for the three month period
ended December 31, 2015, as compared to a basic and diluted net
income per share of $0.19 in the same period of 2014.
Revenue decreased to $1.7 million for the three month
period ended December 31, 2015 from $13.9 million in the same
period in 2014 due to a $4.8 million decrease in royalty revenues,
related to a larger Relenza® government stockpile order received in
the prior year, as well as lower seasonal sales of Relenza® and
Inavir® reflecting an earlier than normal flu season in 2014, and
$7.4 million decrease in revenue from services as a result of the
termination of the Company’s contract with BARDA in 2014.
Cost of revenue decreased to zero for the three month period
ended December 31, 2015 from $1.6 million in the same period last
year due to the termination of the Company’s contract with BARDA in
2014.
Research and development expense increased to $6.3 million for
the three month period ended December 31, 2015 from $4.8 million in
the same period in 2014. The $1.5 million increase was the result
of a $2.8 million increase in clinical costs related to the ongoing
Phase 2b SPIRITUS trial for vapendavir; the Phase 1 SAD and MAD
trials for BTA585; and startup expenses for the Phase 2 trial for
BTA074. These costs were offset in part by a $0.8 million decrease
in compensation expenses and a decrease of $0.5 million in
depreciation and facility related expenses associated with the
closure of the Company’s early-stage research facility in March
2015.
General and administrative expense decreased to $2.1 million for
the three month period ended December 31, 2015 from $2.6 million in
the same period in 2014, due largely to lower compensation expenses
as a result of administrative staff reductions related to the
facility closure in March 2015.
The Company held $57.2 million in cash, cash equivalents, and
short and long-term investments as of December 31, 2015.
Conference Call and Webcast
Information
Biota Pharmaceuticals will host a conference call today to
review these second quarter fiscal year 2016 financial results, as
well as provide a general update on the Company, via a webcast and
conference call at 9:00 a.m. ET. To access the conference call,
please dial (877) 312-5422 (domestic) or (253) 237-1122
(international) and refer to conference ID number 31712361. A live
audio webcast of the call and the archived webcast will be
available in the Investors section of the Company’s website at
http://www.biotapharma.com.
About Biota Pharmaceuticals,
Inc.
Biota Pharmaceuticals is focused on the
discovery and development of direct-acting antivirals to treat
infections that have limited therapeutic options and affect a
significant number of patients globally. The Company has three
product candidates in clinical development. These include
vapendavir, an oral treatment for human rhinovirus infections in
moderate-to-severe asthmatics currently being evaluated in the
Company’s ongoing Phase 2b SPIRITUS trial; BTA074, a topical
antiviral treatment in Phase 2 development for condyloma caused by
human papillomavirus types 6 & 11; and BTA585, an oral fusion
(F) protein inhibitor in Phase 1 development for the treatment of
respiratory syncytial virus (RSV) infections. The Company
also has a preclinical stage RSV non-fusion inhibitor program. 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 timing of data readouts
on our Phase 2 HRV and RSV programs, the availability of top-line
PK and safety data from the BTA585 Phase 1 multiple ascending dose
trial; and the planned initiation of the Phase 2a challenge study
for BTA585.
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
U.S. Food and Drug Administration (FDA) or a similar regulatory
body in another country, a data safety monitoring board, or an
institutional review board delaying, limiting, suspending or
terminating any of the Company’s clinical development programs 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; and these third-party
organizations fulfilling their contractual obligations on a timely
and satisfactory basis; the safety or efficacy data from planned or
ongoing future preclinical and clinical studies of any of its
product candidates not supporting the clinical development of that
product candidate; the successful enrollment of the requisite
number of study participants on a timely basis; the Company’s
ability to comply with applicable government regulations in various
countries and regions in which we are conducting, or expect to
conduct, clinical trials; the Company’s ability to retain and
recruit sufficient staff, including key executive management and
employees, to manage our business; the Company’s ability to
maintain, protect or defend its proprietary rights from
unauthorized use by others, or not infringe on the intellectual
property rights of others; changes in the general economic business
or competitive conditions in the industry or with respect to our
product candidates; and other cautionary statements contained
elsewhere in this press release and in the Company’s Annual Report
on Form 10-K for the year ended June 30, 2015, as filed with the
U.S. Securities and Exchange Commission on September 11, 2015 and
in the Company’s Quarterly Report on Form 10-Q, as filed on
November 6, 2015.
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, 2015 |
|
June 30, 2015 |
|
(unaudited) |
|
(audited) |
ASSETS |
Current assets |
|
|
|
Cash and cash equivalents |
$ |
39.0 |
|
|
$ |
44.7 |
|
Short-term investments |
|
13.0 |
|
|
|
12.9 |
|
Accounts receivable, net of
allowance |
|
5.1 |
|
|
|
12.6 |
|
Prepaid and other current
assets |
|
1.5 |
|
|
|
0.6 |
|
Total current assets |
|
58.6 |
|
|
|
70.8 |
|
Non-current assets: |
|
|
|
Long-term investments |
|
5.2 |
|
|
|
7.9 |
|
Property and equipment, net |
|
0.4 |
|
|
|
0.2 |
|
Deferred tax asset |
|
- |
|
|
|
0.5 |
|
Total non-current assets |
|
5.6 |
|
|
|
8.6 |
|
Total assets |
$ |
64.2 |
|
|
$ |
79.4 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
1.3 |
|
|
$ |
1.9 |
|
Accrued expenses |
|
4.3 |
|
|
|
5.4 |
|
Short term note payable |
|
0.4 |
|
|
|
0.2 |
|
Contract payables (BARDA) |
|
- |
|
|
|
1.0 |
|
Deferred tax liability |
|
- |
|
|
|
0.5 |
|
Total current liabilities |
|
6.0 |
|
|
|
9.0 |
|
Non-current liabilities: |
|
|
|
Long term note payable, net of
current portion |
|
0.5 |
|
|
|
0.8 |
|
Other liabilities, net of current
portion |
|
0.2 |
|
|
|
0.1 |
|
Total liabilities |
|
6.7 |
|
|
|
9.9 |
|
Stockholders’ equity: |
|
|
|
Common stock, $0.10 par value;
200,000,000 shares authorized 38,636,946 and 38,609,086
shares issued and outstanding at December 31, 2015 and June 30,
2015, respectively |
|
3.9 |
|
|
|
3.9 |
|
Additional paid-in capital |
|
156.8 |
|
|
|
155.6 |
|
Accumulated other comprehensive
income |
|
18.9 |
|
|
|
18.9 |
|
Accumulated deficit |
|
(122.1 |
) |
|
|
(108.9 |
) |
Total stockholders’ equity |
|
57.5 |
|
|
|
69.5 |
|
Total liabilities and stockholders’
equity |
$ |
64.2 |
|
|
$ |
79.4 |
|
BIOTA
PHARMACEUTICALS, INC. |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(in millions,
except per share amounts) |
(unaudited) |
|
|
|
|
|
|
Three Months Ended December 31, |
|
Six Months Ended December 31, |
|
|
|
2015 |
|
|
2014 |
|
|
|
2015 |
|
|
2014 |
|
Revenue: |
|
|
|
|
|
Royalty revenue and milestones |
$ |
1.7 |
|
$ |
6.5 |
|
|
$ |
3.4 |
|
$ |
6.5 |
|
Revenue from services |
|
- |
|
|
7.4 |
|
|
|
- |
|
|
8.1 |
|
Total revenue |
|
1.7 |
|
|
13.9 |
|
|
|
3.4 |
|
|
14.6 |
|
|
|
|
|
|
|
Operating expense: |
|
|
|
|
|
Cost of revenue |
|
- |
|
|
1.6 |
|
|
|
- |
|
|
3.3 |
|
Research and development |
|
6.3 |
|
|
4.8 |
|
|
|
11.8 |
|
|
9.7 |
|
General and administrative |
|
2.1 |
|
|
2.6 |
|
|
|
4.4 |
|
|
5.0 |
|
Foreign exchange loss (gain) |
|
(0.2 |
) |
|
(1.5 |
) |
|
|
0.5 |
|
|
(2.8 |
) |
Total operating expense |
|
8.2 |
|
|
7.5 |
|
|
|
16.7 |
|
|
15.2 |
|
Income (loss) from operations |
|
(6.5 |
) |
|
6.4 |
|
|
|
(13.3 |
) |
|
(0.6 |
) |
|
|
|
|
|
|
Non-operating income: |
|
|
|
|
|
Interest income |
|
- |
|
|
0.1 |
|
|
|
0.1 |
|
|
0.2 |
|
Total non-operating income |
|
- |
|
|
0.1 |
|
|
|
0.1 |
|
|
0.2 |
|
|
|
|
|
|
|
Income (loss) before tax |
|
(6.5 |
) |
|
6.5 |
|
|
|
(13.2 |
) |
|
(0.4 |
) |
Income tax benefit |
|
- |
|
|
- |
|
|
|
- |
|
|
- |
|
Net income (loss) |
$ |
(6.5 |
) |
$ |
6.5 |
|
|
$ |
(13.2 |
) |
$ |
(0.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic income (loss) per share |
$ |
(0.17 |
) |
$ |
0.19 |
|
|
$ |
(0.34 |
) |
$ |
(0.01 |
) |
Diluted income (loss) per share |
$ |
(0.17 |
) |
$ |
0.19 |
|
|
$ |
(0.34 |
) |
$ |
(0.01 |
) |
|
|
|
|
|
|
Basic weighted-average shares
outstanding |
|
38,636,946 |
|
|
35,100,961 |
|
|
|
38,630,587 |
|
|
35,100,961 |
|
Diluted weighted-average shares
outstanding |
|
38,636,946 |
|
|
35,103,086 |
|
|
|
38,630,587 |
|
|
35,100,961 |
|
|
|
|
|
|
|
Contacts:
Mark P. Colonnese
Executive Vice President and Chief Financial Officer
Biota Pharmaceuticals, Inc.
(678) 221-3381
m.colonnese@biotapharma.com
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
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