Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) (the "Company"), a
biopharmaceutical company focused on the discovery and development
of products to prevent and treat serious and potentially
life-threatening viral respiratory infectious diseases, today
announced its financial results for the three month period ended
March 31, 2015, which is the third quarter of the Company's 2015
fiscal year, and also provided an update on recent corporate
developments.
"We are very encouraged by the recent advancement of our
pipeline on several fronts," commented Dr. Joseph Patti, President
and Chief Executive Officer of Biota Pharmaceuticals, Inc. "We are
actively screening and dosing patients with moderate-to-severe
asthma in our Phase 2b SPIRITUS trial of vapendavir at 58 clinical
sites in the U.S. and Central Europe, and have successfully
completed all of the required GLP studies to support the filing of
an IND application this quarter for BTA-C585, which we are
developing for the treatment of respiratory syncytial virus
infections. Furthermore, we are pleased to report that the French
Ministry of Finance and Economics has approved our acquisition of
Anaconda Pharma. We believe its lead product, AP611074, is uniquely
positioned to significantly improve the treatment paradigm for
condyloma, as well as the orphan disease recurrent respiratory
papillomatosis. Subject to closing this acquisition, we plan on
initiating a randomized, placebo-controlled, double-blind, Phase 2
trial of AP611074 in the second half of 2015."
Recent Corporate Developments
Acquisition of Anaconda Pharma Nears
Completion. The Company reported today that it has
received approval from the French Ministry of Finance and Economics
for its proposed acquisition of Anaconda Pharma, which was one of
the closing conditions for this transaction. Anaconda Pharma is a
privately-held biotechnology company based in Paris, France, whose
lead candidate, AP611074, is a patented, direct-acting antiviral
with activity against human papillomavirus (HPV) types 6 and 11.
AP611074 is in development for the treatment of condyloma, or
anogenital warts, as well as recurrent respiratory papillomatosis
(RRP). Anaconda Pharma has successfully completed a Phase 2a
clinical trial of AP611074 (5% gel), which demonstrated a
significant reduction in the surface area of condyloma while
exhibiting favorable local skin tolerability.
Under the terms of the definitive agreement, which was announced
in February 2015, all of Anaconda Pharma's outstanding shares will
be acquired for 3.5 million shares of Biota common stock and $8.0
million in cash, subject to certain closing and post-closing
adjustments. The Company intends to fund the cash portion of the
purchase price with cash on hand. The transaction also includes
additional contingent financial consideration of (i) up to $30.0
million conditional upon the successful achievement of certain
future clinical and regulatory milestones, and (ii) a royalty. The
closing of the transaction, which is expected to occur within the
quarter, is subject to the finalization of other closing
conditions, including approval of the proposed Phase 2 protocol by
the Argentine National Administration of Drugs, Foods and Medical
Devices (ANMAT).
Vapendavir Phase 2b SPIRITUS Trial Actively Enrolling
Patients. The Company reported today that it is screening
and dosing patients in its Phase 2b SPIRITUS trial of vapendavir at
58 clinical sites in the U.S. and Central Europe. In March 2015,
the Company reported the initiation of this trial, the goal of
which is to enroll approximately150 laboratory-confirmed human
rhinovirus (HRV) infected patients with moderate-to-severe asthma
over the next year 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 symptoms and lung function as measured by
the asthma control questionnaire (ACQ)-6 total score. Key secondary
endpoints include 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 as measured by the Wisconsin Upper
Respiratory Symptom Survey-21 (WURSS-21) and virological
assessments such as changes in viral load.
BTA-C585 Phase 1 Trial Planned for Q3 2015. The
Company reported today that is has successfully completed all good
laboratory practice (GLP) studies required to support the filing of
an Investigational New Drug (IND) application for its respiratory
syncytial virus (RSV) fusion inhibitor, BTA-C585. The Company
intends to file an IND application later this quarter and to
initiate a Phase 1 single ascending dose trial in the third quarter
of 2015.
Relenza® Intellectual Property Status. The
Company reported today that it has filed a request for a rehearing
with the United States Patent Trial and Appeal Board in relation to
the pending patent application No. 08/737,141 related to Relenza®.
On March 19, 2015, the Company reported that the United States
Patent Trial and Appeal Board had issued a decision denying the
appeal and affirming the Examiner's prima facie case of obviousness
rejection under 35 U.S.C. 103(a).
Restructuring Plan Completed. The Company
announced today it has fully completed its previously announced
(June 2014) restructuring plan and all activities related to the
closure of its Melbourne, Australia operation and facilities.
Laninamivir Octanoate (LANI). The Company
reported that it is planning a Type C meeting with the FDA to
discuss clinical development strategy for LANI. The Company is
preparing a detailed briefing document to outline the proposed
primary endpoints and acceptable patient reported outcome tools for
use in prospective registration trials of LANI to treat
uncomplicated influenza. The Company anticipates filing the Type C
meeting request this later quarter.
Financial Results for the Three Month Period Ended March
31, 2015
The Company reported net income of $1.2 million for the three
month period ended March 31, 2015, as compared to net income of
$3.2 million in the same quarter of the prior fiscal year. The $2.0
million decrease in net income from the prior fiscal year was
primarily due to a $23.6 million decrease in revenue, a $0.7
million increase in research and development expense, a $0.7
million increase in general and administrative expense and a $0.2
million loss on disposal of assets, offset in part by a $19.0
million decrease in cost of revenue, a $4.1 million increase in
foreign exchange gain and a $0.1 increase in interest income. Basic
and diluted net income per share was $0.03 for the three month
period ended March 31, 2015, as compared to a basic and diluted net
income per share of $0.09 in the same period of 2014.
Revenue decreased to $5.9 million for the three month period
ended March 31, 2015 from $29.5 million in the same period last
year due to a $21.0 million decrease in revenue from services
related to the termination of the Company's contract with the
Biomedical Advanced Research and Development Authority (BARDA) in
May 2014, and a $2.6 million decrease in royalty revenues primarily
related to a decrease in net sales of both Relenza® and
Inavir®.
Cost of revenue decreased to $0.3 million for the three month
period ended March 31, 2015 from $19.3 million in the same period
last year due to a decrease of $17.8 million in direct third-party
clinical costs and manufacturing activities and a $1.2 million
decrease in salaries, benefits and share-based compensation expense
and other expenses 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 March 31, 2015 from $4.1 million in
the same period last year. The $0.7 million increase was the result
of a $1.2 million increase in preclinical, clinical and
manufacturing costs related to the Company's Phase 2b SPIRITUS
trial for vapendavir and conducting IND-enabling studies for
BTA-C585 (the Company's leadRSV compound), offset in part by a $0.3
million reduction in salaries, benefits and share-based
compensation expense and a $0.2 million decrease in other expenses
due to reduced research activities.
General and administrative expense increased to $3.2 million for
the three month period ended March 31, 2015 from $2.5 million in
the same period of 2014 due to a $0.4 million increase in
professional and legal fees related to the pending acquisition of
Anaconda Pharma, a $0.2 million increase in salaries, benefits and
share-based compensation expense and a $0.1 million increase in
other expenses.
Conference Call and Webcast Information
Biota Pharmaceuticals will host a conference call today to
review these third 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. EDT. To access the conference call,
please dial (877) 312-5422 (domestic) or (253) 237-1122
(international) and refer to conference ID number 33437959. 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 biopharmaceutical 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) 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); and (ii)
laninamivir octanoate, which is being developed as a one-time,
inhaled treatment for influenza A and B infections. The Company has
also completed IND-enabling studies for BTA-C585, an orally
bioavailable F-protein inhibitor in development for the treatment
of respiratory syncytial virus infections and anticipates
initiating clinical trials of BTA-C585 in the third quarter of
2015. 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 time frames in which the
Company plans to fully enroll and report top line-data from the
Phase 2b SPIRITUS clinical trial; the anticipated time to file an
IND and initiate a Phase 1 clinical trial for BTA-C585; and the
occurrence and timing of the planned closing of the acquisition of
Anaconda Pharma and the initiation of a Phase 2 clinical trial for
AP611074.
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 ,
AP611074 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; the Company's ability to complete and file an
IND for BTA-C585 on a timely basis that is acceptable to the U.S.
Food and Drug Administration (FDA); ANMAT delaying, imposing
additional conditions, requiring additional studies or not
approving the Phase 2 protocol for AP611074, 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,
2014, as filed with the U.S. Securities and Exchange Commission, on
September 30, 2014 and in the Company's Quarterly Reports on Form
10-Q on November 7, 2014 and February 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) |
(unaudited) |
|
March 31, 2015 |
June 30, 2014 |
|
|
|
ASSETS |
Current assets |
|
|
Cash and cash equivalents |
$61.5 |
$81.7 |
Short-term investments |
12.0 |
-- |
Contract-related accounts
receivable |
2.9 |
17.8 |
Other accounts receivable |
10.1 |
0.9 |
Prepaid and other current
assets |
0.9 |
0.7 |
Total current assets |
87.4 |
101.1 |
Non-current assets: |
|
|
Long-term investments |
0.9 |
10.0 |
Property and equipment,
net |
0.3 |
2.0 |
Deferred tax asset |
0.2 |
0.9 |
Total non-current assets |
1.4 |
12.9 |
Total assets |
$88.8 |
$114.0 |
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
Current liabilities: |
|
|
Contract-related accounts
payable and accrued expenses |
$1.1 |
$18.6 |
Other accrued expenses |
4.5 |
3.4 |
Other accounts payable |
1.0 |
2.8 |
Accrued severance
obligations |
0.4 |
1.2 |
Deferred tax liability |
0.2 |
0.9 |
Total current liabilities |
7.2 |
26.9 |
Non-current liabilities: |
|
|
Other liabilities, net of
current portion |
0.1 |
0.2 |
Total liabilities |
7.3 |
27.1 |
Stockholders' equity: |
|
|
Common stock, $0.10 par value;
200,000,000 shares authorized 35,124,728 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 |
148.0 |
146.4 |
Accumulated other comprehensive
income |
19.0 |
26.8 |
Accumulated deficit |
(89.0) |
(89.8) |
Total stockholders' equity |
81.5 |
86.9 |
Total liabilities and
stockholders' equity |
$88.8 |
$114.0 |
|
BIOTA PHARMACEUTICALS,
INC. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(in millions, except per
share amounts) |
(unaudited) |
|
|
Three Months
Ended March 31, |
Nine Months Ended
March 31, |
|
2015 |
2014 |
2015 |
2014 |
Revenue: |
|
|
|
|
Royalty revenue and
milestones |
$5.5 |
$8.1 |
$12.0 |
$14.1 |
Revenue from services |
0.4 |
21.4 |
8.5 |
46.1 |
Other |
-- |
-- |
-- |
0.1 |
Total revenue |
5.9 |
29.5 |
20.5 |
60.3 |
|
|
|
|
|
Operating expense: |
|
|
|
|
Cost of revenue |
0.3 |
19.3 |
3.6 |
41.4 |
Research and development |
4.8 |
4.1 |
14.5 |
11.3 |
General and administrative |
3.2 |
2.5 |
8.2 |
8.0 |
Foreign exchange loss
(gain) |
(3.7) |
0.4 |
(6.5) |
0.6 |
Loss on disposal of assets |
0.2 |
-- |
0.2 |
-- |
Total operating expense |
4.8 |
26.3 |
20.0 |
61.3 |
Income (loss) from operations |
1.1 |
3.2 |
0.5 |
(1.0) |
|
|
|
|
|
Non-operating income: |
|
|
|
|
Interest income |
0.1 |
-- |
0.3 |
0.1 |
Total non-operating income |
0.1 |
-- |
0.3 |
0.1 |
|
|
|
|
|
Income (loss) before tax |
1.2 |
3.2 |
0.8 |
(0.9) |
Income tax benefit |
-- |
-- |
-- |
0.1 |
Net income (loss) |
$1.2 |
$3.2 |
$0.8 |
$(0.8) |
|
|
|
|
|
|
|
|
|
|
Basic income (loss) per share |
$0.03 |
$0.09 |
$0.02 |
$(0.03) |
Diluted income (loss) per share |
$0.03 |
$0.09 |
$0.02 |
$(0.03) |
|
|
|
|
|
Basic weighted-average shares
outstanding |
35,105,978 |
33,890,470 |
35,102,609 |
30,127,156 |
Diluted weighted-average shares
outstanding |
35,143,178 |
34,260,715 |
35,127,013 |
30,127,156 |
CONTACT: Joseph M. Patti, PhD
President and Chief Executive Officer
(678) 221-3352
j.patti@biotapharma.com
Sarah McCabe
Stern Investor Relations, Inc.
(212) 362-1200
sarah@sternir.com
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