Breaking News

Tweet TWEET

Biota Pharmaceuticals Reports Fourth Quarter and Fiscal Year-End Financial Results

Biota Pharmaceuticals Reports Fourth Quarter and Fiscal Year-End Financial
Results

ATLANTA, Sept. 18, 2013 (GLOBE NEWSWIRE) -- Biota Pharmaceuticals, Inc.
(Nasdaq:BOTA) (the "Company") today announced financial results for its fourth
quarter and fiscal year ended June 30, 2013, and provided an update on recent
corporate developments and its financial guidance.

"We are pleased with the transformation we have made since the merger in
November 2012, including the implementation of a new corporate strategy and
operating plan, the transition of our board of directors, and the initiation
of our ongoing Phase 2 clinical trial for laninamivir," stated Russell H.
Plumb, President and CEO of Biota Pharmaceuticals, Inc. "We are excited about
the anticipated progress of our laninamivir program over the next year in
concert with BARDA, and believe we are well positioned to continue our
evolution to a more clinically-focused company."

Recent Corporate Developments

Laninamivir Octanoate – On June 11, the Company announced that it had
commenced dosing in a multi-national, randomized, double blind,
placebo-controlled, parallel arm Phase 2 clinical trial of laninamivir
octanoate, a long-acting neuraminidase inhibitor the Company is developing for
the treatment of influenza A and B. The trial, which the Company refers to as
"IGLOO", is designed to enroll 636 subjects to evaluate the safety and
efficacy of 40 mg and 80 mg of laninamivir octanoate as compared with placebo,
all delivered by a TwinCaps^® inhaler in adults with symptomatic influenza A
or B infection. The Company initiated IGLOO in several countries in the
southern hemisphere, with a goal of completing enrollment in the trial by the
end of the upcoming flu season in the northern hemisphere and having top-line
data available from the trial in mid-2014.

Changes to the Board of Directors – On May 6, August 19 and September 10, the
Company reported various changes to its Board of Directors, namely the
resignations of Dr. Raafat Fahim, Mr. Paul Bell, Dr. Jeffrey Errington and Mr.
Peter Cook, as well the appointments of Ms. Anne M. VanLent, Mr. Michael R.
Dougherty and Mr. John Richard to fill those vacancies.

Vapendavir (BTA798) – The Company no longer plans to independently continue
the clinical development of vapendavir in patients with asthma or chronic
obstructive pulmonary disease (COPD), but rather intends to seek
collaboration, co-development or license arrangements with third parties to
advance its clinical development. In March 2012, the Company completed a
300-patient, Phase 2b clinical trial that evaluated the safety and clinical
benefit of vapendavir for the treatment of human rhinovirus (HRV) infections
in patients with mild to moderate asthma. The trial successfully met its
primary endpoint, which was a reduction of cold symptoms based on the
Wisconsin Upper Respiratory Symptom Survey (WURSS) severity score.

Relenza^® Royalty Revenue – Due to a recent increase in the amount of returns
of Relenza^® from distributors to GlaxoSmithKline, the Company recorded no
royalty revenue in the quarter ended June 30, 2013, and anticipates earning an
equal or lesser amount of royalty revenue from net sales of Relenza^® in 2014
than in 2013.

Financial Guidance

As of June 30, 2013, the Company held $66.8 million in cash and cash
equivalents. On April 15, 2013, the Company provided financial guidance
indicating that it anticipated having between $62-$67 million of cash, cash
equivalents and short-term investments on hand at June 30, 2014. Due primarily
to the significant increase in the value of the U.S. dollar (the Company's
reporting currency) as compared to the Australian dollar since April 2013, and
to a lesser extent its lower expectations with respect to Relenza^® royalty
revenue in fiscal 2014, the Company now anticipates having approximately
$57-$62 million of cash, cash equivalents and short-term investments on hand
at June 30, 2014. This estimate includes anticipated operating expenses,
revenue under its existing BARDA contract based upon its current development
plans for laninamivir octanoate, and royalty revenue, but excludes the impact
of any incremental costs associated with in-licensing, acquiring and/or
further advancing another clinical development program, or significant changes
in foreign exchange rates associated with the Company's foreign, non-U.S.
dollar denominated cash balances.

Financial Results for the Three Month Period Ended June 30, 2013

The Company reported a net loss of $6.5 million in the three month period
ended June 30, 2013, as compared to a net loss of $5.9 million in the same
period of 2012. The $0.6 million increase in net loss from 2012 to 2013 was
the result of a $2.0 million increase in operating expenses that included a
$1.8 million reduction in expenses from a foreign exchange gain, a $0.5
million decrease in interest income and a $0.3 million increase in income tax
expense, offset in part by a $2.2 million increase in revenue. Basic and
diluted net loss per share were $0.23 for the three month period ended June
30, 2013, as compared to a basic and diluted net loss per share of $0.26 in
the same period of 2012.

Revenue increased to $9.3 million for the three months ended June 30, 2013
from $7.1 million in the same period of 2012, primarily as a result of a $4.6
million increase in service revenue related to the advancement of laninamivir
octanoate into a Phase 2 clinical trial under the BARDA contract, offset in
part by a decrease of $2.2 million in royalty revenue from net sales of
Relenza^® and Inavir^®.

Cost of revenue increased to $7.7 million in the three month period ended June
30, 2013 from $3.8 million in the same period in 2012 due to the advancement
of laninamivir octanoate into a Phase 2 clinical trial under the BARDA
contract. Direct clinical and product development expenses increased by $3.4
million and salaries, benefits and share-based compensation expenses increased
by $0.5 million due to more resources being deployed on the laninamivir
octanoate program in 2013.

Research and development expense decreased to $5.5 million for the three
months ended June 30, 2013 from $6.3 million in the same period of 2012. The
$0.8 million decrease was the result of a $0.9 million decrease in salaries,
benefits and share-based compensation expenses resulting from more resources
being deployed on the laninamivir octanoate program in 2013 and a reduction in
workforce that occurred in May 2013, lower preclinical and other development
expenses of $0.7 million and a decrease in clinical expenses of $0.3 million
due to the completion of the Phase 2 vapendavir clinical trial in 2012, offset
in part by a $1.1 million charge for termination benefits that was recorded in
2013.

General and administrative expense increased to $4.3 million in the three
months ended June 30, 2013 from $3.6 million in the same period of 2012, due
to a $1.3 million charge for termination benefits that was recorded in 2013,
increased salaries, benefits and share-based compensation expenses of $0.6
million associated with adding personnel in the U.S., and a net increase in
other expenses of $0.1 million, offset in part by a decrease in non-recurring
merger expenses of $1.3 million that were incurred in 2012 associated with the
merger with Nabi Pharmaceuticals, Inc.

Foreign exchange gain increased to $1.8 million in the three months ended June
30, 2013 from zero in the same period of 2012, primarily due to the
significant increase in the value of the U.S. dollar relative to the
Australian dollar during the quarter ended June 30, 2013.

Year End 2013 Financial Results

For the fiscal year ended June 30, 2013, the Company reported a net loss of
$8.7 million, as compared to $19.2 million in fiscal 2012. The $10.5 million
decrease in net loss in 2013 was the result of a $13.2 million increase in
revenue, a $7.8 million gain recorded in November 2012 pursuant to the merger,
and an increase of $4.4 million in research and development tax credits
received in 2013, offset in part by a $12.4 million increase in operating
expenses that included a $1.8 million reduction from a foreign exchange gain,
a $1.9 million decrease in interest and other income, and $0.6 million
decrease in income tax benefit. Basic and diluted net loss per share were
$0.31 for the year ended June 30, 2013, as compared to a basic and diluted net
loss per share of $0.85 in 2012.

Revenue increased to $33.6 million for the year ended June 30, 2013 from $20.4
million in 2012, as a result of the Company earning increased service revenue
of $12.8 million in 2013 due to the advancement of laninamivir octanoate into
a Phase 2 clinical trial under the BARDA contract, as well as a net increase
of $0.8 million in royalty revenue and sales milestones for Relenza^® and
Inavir^®, offset in part by a $0.4 million decrease in grant revenue.

Cost of revenue increased to $20.4 million for the year ended June 30, 2013
from $9.9 million in 2012 due to the advancement of laninamivir octanoate into
a Phase 2 clinical trial under the BARDA contract. Direct clinical and product
development expenses increased by $8.9 million, salaries, benefits and
share-based compensation expenses increased by $1.5 million due principally to
more staff being deployed on the laninamivir octanoate program in 2013, and
other expenses increased by $0.1 million.

Research and development expense decreased to $19.2 million for the year ended
June 30, 2013 from $24.1 million in 2012 as a result of a $3.1 million
decrease in direct clinical and product development expenses due to the
completion ofa Phase 2 vapendavir clinical trial in 2012, a $1.5 million
decrease in preclinical and other development expenses associated with a
decrease in the number of preclinical programs, a $1.7 million decrease in
salaries, benefits and share-based compensation expenses resulting principally
from more staff being deployed on the laninamivir octanoate program in 2013,
and a net reduction in other expenses of $0.5 million, offset in part by a
charge for termination benefits of $1.1 million that was recorded in 2013 and
higher manufacturing expenses of $0.8 million for preclinical studies.

General and administrative expense increased to $18.0 million for the year
ended June 30, 2013 from $9.4 million in 2012 due to a $2.2 million increase
in share-based compensation primarily associated with the accelerated vesting
of prior year's equity grants pursuant to the completion of the merger in 2013
and the hiring of executives in the U.S., a $1.6 million charge recorded for
termination benefits in 2013, a $1.3 million increase in salaries and benefits
associated with adding personnel in the U.S., a $1.6 million increase in
non-recurring consulting, professional, and legal fees associated with the
merger, a $1.1 million increase in corporate governance expenses due to the
Company's listing on Nasdaq exchange, and a net increase in other expenses of
$0.8 million.

Foreign exchange gain increased to $1.9 million for the year end June 30, 2013
from $0.1 million in 2012 primarily due to the significant increase in value
of the U.S. dollar relative to the Australian dollar during the last fiscal
quarter of 2013.

Non-operating income increased to $13.5 million for the year ended June 30,
2013 from $3.2 million in 2012 due to Company recording of a $7.8 million gain
related to the merger in November 2012, as well as the receipt of $4.4
millionfrom a research and development credit, offset in part by a decrease
of $1.9 million in interest income due to generally lower available interest
rates in 2013 as compared to 2012, and lower average cash balances held in
2013 compared to 2012.

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 U.S. through a contract with the U.S. Office of Biomedical Advanced
Research and Development Authority (BARDA) that provides up to $231 million in
financial support to complete its clinical development; and vapendavir, a
potent, oral broad spectrum capsid inhibitor of enteroviruses, including human
rhinovirus. In addition to these clinical-stage programs, the Company has
preclinical programs focused on developing treatments for respiratory
syncytial virus and gram-negative, multi-drug resistant bacterial infections.
For additional information about the Company, please visit
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. All statements, other than historical facts,
including statements regarding the Company's goal to complete its Phase 2
IGLOO clinical trial and have top-line data available in mid-2014, the
Company's plan to seek collaboration, co-development or license arrangements
with third parties to advance the clinical development of vapendavir,
anticipated royalty revenue from net sales of Relenza^® in fiscal 2014, and
anticipated cash, cash equivalents and short-term investments on-hand at June
30, 2013 or any financial guidance provided, are forward looking statements.
Various important factors could cause actual results, performance, events or
achievements to materially differ from those expressed or implied by the
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 or
significantly amending the Company's existing contract to develop laninamivir
octanoate; the Company's ability to comply with extensive government
regulations in various countries and regions in which it expects to conduct
its clinical trials; 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; the Company's ability to recruit and manage clinical
trials worldwide; the severity and seasonality of influenza in regions where
the Company is conducting its clinical trials of laninamivir octanoate;
royalty revenues the Company receives in fiscal 2014 not being materially less
than anticipated levels; future changes in the Company's strategy and the
implementation of those changes; the Company's ability to successfully manage
its expenses, operating results and financial position in line with its plans
and expectations; and other cautionary statements contained elsewhere in this
press release and in the Company's Quarterly Reports on Form 10-Q for the
quarters ended December 31, 2012 and March 31, 2013, as filed with the U.S.
Securities and Exchange Commission, or SEC, on February 11, 2013 and May 10,
2013, respectively.

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.

Biotais a registered trademark of Biota Holdings Limited. Relenza^® is a
registered trademark of GlaxoSmithKline plc, Inavir^® is a registered
trademark of Daiichi Sankyo Company, Ltd and TwinCaps^® is a registered
trademark of Hovione FarmaCiencia SA.

BIOTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS                                       
(in millions, except per share amounts)
                                                                  
                                                           As of June 30, 
                                                           2013    2012
ASSETS                                                             
Current assets:                                                    
Cash and cash equivalents                                   $66.8   53.8
Accounts receivable                                         11.0    6.0
Prepaid expenses and other assets                           2.2     1.4
                                                                  
Total current assets                                        80.0    61.2
Non-current assets:                                                
Property and equipment, net                                 3.7     4.9
Intangible assets, net                                      0.6     1.8
Deferred tax assets                                         —       1.4
                                                                  
Total assets                                                84.3    69.3
                                                                  
LIABILITIES AND STOCKHOLDERS' EQUITY                               
Current liabilities:                                               
Accounts payable                                            4.4     2.9
Accrued expenses and other current liabilities              8.2     6.1
Accrued severance obligations                               3.0     —
Deferred revenue                                            0.3     0.4
Deferred tax liabilities                                    —       0.1
Total current liabilities                                   15.9    9.5
                                                                  
Other liabilities                                           0.2     0.5
                                                                  
Total liabilities                                           16.1    10.0
                                                                  
                                                                  
Stockholders' equity:                                              
Common stock, $0.10 par value; 200,000,000 shares
authorized 28,352,326 shares issued and 22,713,566 shares   2.8     100.4
outstanding at June 30, 2013 and June 30, 2012,
respectively
Common stock Treasury                                       —       (1.4)
Additional paid-in capital                                  118.7   0.7
Accumulated other comprehensive income                      25.3    29.5
Accumulated deficit                                         (78.6)  (69.9)
                                                                  
Total stockholders' equity                                  68.2    59.3
                                                                  
Total liabilities and stockholders' equity                  84.3    69.3




BIOTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in millions, except per share amounts)
                                                       
                                  Three Months Ended    Twelve Months Ended
                                   June 30,              June 30,
                                  2013       2012       2013       2012
Revenue:                           (unaudited)                     
Royalty revenue and milestones     $ --       $2.2       $9.6       $8.8
Revenue from services              9.3        4.7        23.8       11.0
Other                              --         0.2        0.2        0.6
Total revenue                      9.3        7.1        33.6       20.4
                                                                
Operating expense:                           `                    
Cost of revenue                    7.7        3.8        20.4       9.9
Research and development           5.5        6.3        19.2       24.1
General and administrative         4.3        3.6        18.0       9.4
Foreign exchange gain              (1.8)     --         (1.9)      (0.1)
Total operating expense            15.7       13.7       55.7       43.3
Loss from operations               (6.4)      (6.6)      (22.1)     (22.9)
                                                                
Non-operating income:                                            
Gain recorded on merger            --         --         7.8        --
Research and development credit    --         --         4.4        --
Interest income                    0.1        0.6        1.3        3.2
                                                                
Loss before tax                    (6.3)      (6.0)      (8.6)      (19.7)
Income tax benefit (expense)       (0.2)      0.1        (0.1)      0.5
Net loss                           $(6.5)     $(5.9)     $(8.7)     $(19.2)
                                                                
                                                                
Basic loss per share               $(0.23)    $(0.26)    $(0.31)    $(0.85)
Diluted loss per share             $(0.23)    $(0.26)    $(0.31)    $(0.85)
                                                                
Basic weighted-average shares      28,352,329 22,709,008 28,217,515 22,713,566
outstanding
Diluted weighted-average shares    28,352,329 22,709,008 28,217,515 22,713,566
outstanding
                                                                

CONTACT: Russell H. Plumb
         Chief Executive Officer
         (678) 221-3351
         r.plumb@biotapharma.com
        
         Lee M. Stern
         The Trout Group
         lstern@troutgroup.com

Biota Pharmaceuticals, Inc
 
Press spacebar to pause and continue. Press esc to stop.