Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) (the "Company") today
announced its financial results for the three month and nine month
periods ended March 31, 2014, and provided an update on recent
corporate developments.
"We are pleased with the significant improvement in our
operating results for the quarter and year to-date, which reflect
our continuing efforts to reduce and align our overhead costs, an
increased level of clinical trial and manufacturing activities
associated with the development of laninamivir octanoate under the
BARDA contract and an increase in royalty revenue from both Inavir®
and Relenza® during the periods," stated Russell H. Plumb,
President and CEO of Biota Pharmaceuticals, Inc. "As announced last
week, we are complying with the Stop-Work Order we received from
ASPR/BARDA pertaining to a number of activities under the BARDA
contract, and continue to await an official response from that
office regarding its pending decision from a recent inter-agency
in-process review of this contract."
Financial Results for the Three Month Period Ended March
31, 2014
The Company reported net income of $3.2 million for the three
month period ended March 31, 2014, as compared to net income of
$0.2 million in the same period of 2013. The $3.0 million increase
in net income in 2014 was primarily the result of a $17.0 million
increase in revenue related to higher revenue from both services
and royalties, as well as lower research and development expense,
general and administrative expense and foreign currency loss of
$0.4 million, $0.9 million, and $0.1 million respectively, offset
in part by a $15.2 million increase in the cost of revenue and
lower interest income of $0.2 million. Basic and diluted net income
per share were $0.09 for the three month period ended March 31,
2014, as compared to a basic and diluted net income per share of
$0.01 in the same period of 2013.
Revenue increased to $29.5 million for the three months ended
March 31, 2014 from $12.5 million in the same quarter of 2013,
primarily as a result of a $16.6 million increase in service
revenue related to the ongoing clinical trials of and product
development and manufacturing activities related to advancing
laninamivir octanoate under our BARDA contract, as well as an
increase in net royalty revenues and milestones of $0.4
million.
Cost of revenue increased to $19.3 million in the three month
period ended March 31, 2014 from $4.1 million in the same period in
2013 due to an increase in direct, third-party clinical and product
development expenses associated with the ongoing clinical trials of
and product development and manufacturing activities related to
advancing laninamivir octanoate under the BARDA contract.
Research and development expense decreased to $4.1 million for
the three months ended March 31, 2014 from $4.5 million in the same
period of 2013. The decrease was the result of a $0.4 million
decrease in salaries, benefits and share-based compensation
expenses resulting from reductions in the Company's workforce that
occurred in April and November of 2013.
General and administrative expense decreased to $2.5 million for
the three months ended March 31, 2014 from $3.4 million in the same
period of 2013, primarily due to a decrease in salaries, benefits
and share-based compensation expenses resulting from reductions in
the Company's workforce that occurred in April and November of 2013
and other expenses as a result of a smaller administrative
structure.
Recent Corporate Developments
Laninamivir Octanoate/BARDA - On April 29, 2014, the Company
announced that it had been notified by the U.S. Department of
Health and Human Services (HHS) office of the Assistant Secretary
for Preparedness and Response (ASPR) and Biomedical Advanced
Research and Development Authority (BARDA) that pending a decision
regarding the outcome of a recent In-Process Review (IPR) of the
Company's contract for the development of laninamivir octanoate,
ASPR/BARDA has issued a Stop-Work Order notifying the Company to
discontinue work on a number of activities under this contract. In
the interim, the Company indicated it intends to comply with the
order and is focusing its efforts on critical path activities not
covered by the order, namely completing the conduct of and
finalizing the data from its Phase 2 IGLOO trial. The Company also
reported that it anticipates top-line data from the IGLOO trial
will be available in the third quarter of 2014.
On April 30, 2014, the Company announced that an interim update
had been provided from HHS and BARDA with respect to the Stop-Work
Order and the pending IPR decision, with BARDA indicating that a
Stop-Work Order was not a contract termination, and due to fact
that the project was at a natural pause following the end of the
influenza season for the Northern Hemisphere, HHS/BARDA was
considering the best next step for the Biota project and the
overall influenza antiviral drug development program before going
forward with clinical studies in the Southern Hemisphere and
manufacturing optimization and validation.
Public Offering – In January 2014, the Company reported that it
had priced a public offering of 5,813,900 shares of the Company's
common stock at a purchase price of $4.30 per share. Later in
January, the Company further reported that the underwriter had
exercised its option to purchase 872,085 additional shares at the
public offering price to cover over-allotments. The net proceeds to
the Company from the sale of the shares, including the
overallotment, after underwriting discounts and commissions and
other offering expenses, were approximately $26.8 million. The
Company intends to use the net proceeds from the offering for
working capital and general corporate purposes.
About Biota
Biota Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the discovery and development of products to prevent and
treat serious and potentially life-threatening infectious diseases.
The Company currently has two Phase 2 clinical-stage product
candidates: laninamivir octanoate, which the Company is developing
for the treatment of influenza A and B infections in the United
States through a contract with BARDA that is intended to provide up
to $231 million in financial support to complete its clinical
development and file a New Drug Application (NDA); and vapendavir,
a potent, oral broad spectrum capsid inhibitor of enteroviruses,
including human rhinovirus. In addition to these clinical-stage
development programs, the Company has preclinical programs focused
on developing treatments for respiratory syncytial virus. For
additional information about the Company, please visit
www.biotapharma.com.
Conference Call and Webcast Information
Russell H. Plumb, President and Chief Executive Officer of Biota
Pharmaceuticals Inc., and other members of management will review
the Company's third quarter operating results and financial
position, as well as provide a general update on the Company via a
webcast and conference call today at 4:30 p.m. EDT. To access the
conference call, 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.
Safe Harbor Statement
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
the Company's business, operations and financial performance. Any
statements that are not of historical facts may be deemed to be
forward-looking statements, including statements related to the
anticipated time in which ASPR/BARDA may render a decision from the
IPR, the time in which top-line results of the Phase 2 IGLOO trial
may be available, the Company's continued efforts to reduce and
align its overhead costs, the Company's intention to comply with
the Stop-Work Order and the intended use of net proceeds from the
public offering. 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, BARDA, 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 laninamivir octanoate at
any time for a lack of safety, tolerability, anti-viral activity,
commercial viability, regulatory or manufacturing issues, or any
other reason whatsoever; BARDA terminating, suspending or
significantly amending the Company's existing contract to support
the development of laninamivir octanoate; the Company's ability to
secure, manage and retain qualified third-party clinical research,
preclinical research, data management and contract manufacturing
organizations which it relies on to assist in the design,
development and implementation of the clinical development of
laninamivir octanoate, 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, 2013, as filed with the
U.S. Securities and Exchange Commission, or SEC, on September 27,
2013 and its Form 10-Q's as filed with the SEC on November 12, 2013
and February 10, 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 Company,
Ltd.
|
|
BIOTA PHARMACEUTICALS,
INC. |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(in millions, except per share
amounts) |
|
|
March 31, 2014 |
June 30, 2013 |
|
(unaudited) |
|
ASSETS |
|
|
Current assets |
|
|
Cash and cash equivalents |
$80.1 |
$66.8 |
Accounts receivable |
36.5 |
11.0 |
Prepaid and other current
assets |
0.9 |
2.2 |
Total current assets |
117.5 |
80.0 |
Non-current assets: |
|
|
Property and equipment,
net |
2.8 |
3.7 |
Intangible assets, net |
0.2 |
0.6 |
Total non-current assets |
3.0 |
4.3 |
Total assets |
$120.5 |
$84.3 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$7.3 |
$4.4 |
Accrued expenses |
16.1 |
8.4 |
Accrued severance
obligations |
0.9 |
3.0 |
Deferred revenue |
-- |
0.3 |
Total current liabilities |
24.3 |
16.1 |
Non-current liabilities: |
|
|
Other liabilities, net of
current portion |
0.2 |
0.2 |
Total liabilities |
24.5 |
16.3 |
Stockholders' equity: |
|
|
Common stock, $0.10 par value;
200,000,000 shares authorized 35,095,161 shares issued and
28,352,326 shares outstanding at March 31, 2014 and June 30, 2013,
respectively |
3.5 |
2.8 |
Additional paid-in capital |
146.2 |
118.7 |
Accumulated other comprehensive
income |
25.9 |
25.3 |
Accumulated deficit |
(79.6) |
(78.8) |
Total stockholders' equity |
96.0 |
68.0 |
Total liabilities and
stockholders' equity |
$120.5 |
$84.3 |
|
|
BIOTA PHARMACEUTICALS,
INC. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(in millions, except per share
amounts) |
|
|
Three Months
Ended March 31, |
Nine Months Ended
March 31, |
|
2014 |
2013 |
2014 |
2013 |
Revenue: |
|
|
|
|
Royalty revenue and
milestones |
$8.1 |
$7.7 |
$14.1 |
$9.6 |
Revenue from services |
21.4 |
4.8 |
46.1 |
14.5 |
Other |
-- |
-- |
0.1 |
0.2 |
Total revenue |
29.5 |
12.5 |
60.3 |
24.3 |
|
|
|
|
|
Operating expense: |
|
|
|
|
Cost of revenue |
19.3 |
4.1 |
41.4 |
12.7 |
Research and development |
4.1 |
4.5 |
11.3 |
13.6 |
General and administrative |
2.5 |
3.4 |
8.0 |
13.7 |
Foreign exchange (gain)
loss |
0.4 |
0.5 |
0.6 |
(0.1) |
Total operating expense |
26.3 |
12.5 |
61.3 |
40.0 |
(Loss) income from operations |
3.2 |
(0.0) |
(1.0) |
(15.7) |
|
|
|
|
|
Non-operating income: |
|
|
|
|
Gain recorded on merger |
-- |
-- |
-- |
7.6 |
Research and development
credit |
-- |
-- |
-- |
4.4 |
Interest income |
-- |
0.2 |
0.1 |
1.2 |
Total non-operating income |
-- |
0.2 |
0.1 |
13.2 |
|
|
|
|
|
(Loss) income before tax |
3.2 |
0.2 |
(0.9) |
(2.5) |
Income tax benefit (expense) |
-- |
-- |
0.1 |
0.1 |
Net (loss) income |
$3.2 |
$0.2 |
$(0.8) |
$(2.4) |
|
|
|
|
|
|
|
|
|
|
Basic (loss) income per share |
$0.09 |
$0.01 |
$(0.03) |
$(0.09) |
Diluted (loss) income per share |
$0.09 |
$0.01 |
$(0.03) |
$(0.09) |
|
|
|
|
|
Basic weighted-average shares
outstanding |
33,890,470 |
28,162,295 |
30,127,156 |
28,145,541 |
Diluted weighted-average shares
outstanding |
34,260,715 |
28,182,697 |
30,127,156 |
28,145,541 |
|
|
|
|
|
CONTACT: Russell H. Plumb
Chief Executive Officer
(678) 221-3351
r.plumb@biotapharma.com
Lee M. Stern
The Trout Group
(646) 378-2922
lstern@troutgroup.com
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