Biota Pharmaceuticals, Inc. (NASDAQ:BOTA) (the "Company"), a
biopharmaceutical company focused on the discovery and development
of direct-acting antivirals to treat infections that have limited
therapeutic options, today announced its financial results for the
fourth quarter and 2015 fiscal year ended June 30, 2015 and also
provided an update on recent corporate developments.
"This has been a tremendous year of progress for our Company,
and today our pipeline includes multiple clinical-stage
direct-acting antiviral programs. We advanced our vapendavir and
RSV programs on schedule and acquired Anaconda Pharma for its
first-in-class antiviral for human papilloma virus infections,
while still maintaining our strong financial position due to
increased royalty revenues, a favorable termination settlement with
BARDA, and the successful completion of our corporate restructuring
plan," commented Dr. Joseph Patti, President and Chief Executive
Officer of Biota Pharmaceuticals. "Looking ahead, we anticipate
completing enrollment in robust Phase 2 trials for vapendavir,
BTA074, and BTA585 and announcing data from each of these important
programs in 2016."
Pipeline and Corporate Highlights
BTA585 Phase 1 Trial Ongoing. In August 2015,
the Company commenced dosing in a 50-subject, randomized,
placebo-controlled, Phase 1 single ascending dose (SAD) clinical
trial to evaluate the safety and pharmacokinetics (PK) of BTA585 in
healthy volunteers. BTA585, a potent inhibitor of viral entry into
cells, is an orally bioavailable compound in clinical development
for the treatment of acute respiratory syncytial virus (RSV)
infections in children, the elderly and immunocompromised patients.
The ongoing Phase 1 SAD clinical trial has five dose level cohorts
ranging from 50 mg to 500 mg and will include an evaluation of the
effect of food on the plasma PK of BTA585. Following a safety
assessment of the initial dose level cohorts of the SAD trial, the
Company plans to begin dosing in a Phase 1 multiple ascending dose
(MAD) clinical trial in the fourth quarter of calendar year 2015.
The Company expects to report Phase 1 SAD data in fourth quarter of
calendar year 2015 and MAD data in the first quarter of calendar
year 2016.
Initiation of Phase 2 Trial with BTA074 Planned for Q4,
2015. In June 2015, the Company reported closing the
acquisition of Anaconda Pharma. Anaconda Pharma was a
privately-held Paris-based biotechnology company, whose lead
candidate, BTA074 (AP611074), is a novel, direct-acting antiviral
with activity against human papillomavirus types 6 and 11. BTA074
is in development for the treatment of genital warts or condyloma,
as well as recurrent respiratory papillomatosis. Prior to the
acquisition, Anaconda Pharma had completed a Phase 2a clinical
trial, which demonstrated a 38% reduction in the total condyloma
area after six weeks of treatment with BTA074 5% gel while
exhibiting a favorable local skin tolerability profile. The Company
plans on initiating a double-blind placebo-controlled, randomized,
Phase 2 study to assess the safety, tolerability, pharmacokinetics
and efficacy of twice daily up to 16 week topical applications of
BTA074 (5% gel) in approximately 210 adult condyloma patients in
the fourth quarter of calendar year 2015.
Vapendavir Phase 2b SPIRITUS Trial Ongoing. The
multi-center, randomized, double-blind, placebo-controlled
dose-ranging study trial is designed and powered to equally
randomize approximately 190 laboratory-confirmed human rhinovirus
infected patients across three treatment arms. The primary endpoint
of the trial is the change from baseline to study day 14 in asthma
symptoms and lung function as measured by the asthma control
questionnaire-6 total score. Key secondary endpoints include safety
and tolerability, specific lung function assessments such as forced
expiratory volume in one second, forced vital capacity, peak
expiratory flow, daily b2-agonist use and the incidence of moderate
and severe asthma exacerbations. Based upon the number of patients
screened to date, the Company anticipates top-line data from this
trial to be available in mid-2016.
Relenza® Related Intellectual Property Status.
The Company reported today that on August 21, 2015 it filed an
appeal in relation to the pending patent application No. 08/737,141
related to Relenza® to the United States Court of Appeals for the
Federal Circuit. On March 19, 2015, the Company reported that the
United States Patent Trial and Appeal Board (USPTAB) had issued a
decision rejecting the previous appeal affirming the Examiner's
prima facie case of obviousness rejection under 35 U.S.C. 103(a).
On May 12, 2015 the Company filed a request for rehearing under 37
C.F.R. § 41.50 (b)(2) with the USPATB. On June 23, 2015 the USPATB
denied the Company's request for rehearing.
BARDA Contract Termination. The Company
reported today that it has resolved all outstanding claims and has
collected all payments due from the Biomedical Advanced Research
and Development Authority (BARDA) associated with the termination
of its contract in May 2014.
Financial Results for the Three Month Period Ended June
30, 2015
The Company held $65.5 million in cash, cash equivalents, and
short and long-term investments as of June 30, 2015 and further
collected an additional $10.9 million of its outstanding accounts
receivable related to fiscal year 2015 Relenza® royalty revenue in
early July 2015.
The Company reported a net loss of $19.9 million for the three
month period ended June 30, 2015, as compared to net loss of $10.2
million in the same quarter of the prior fiscal year. The $9.7
million increase in net loss from the prior period was primarily
due to a $17.6 million non-recurring, in-process research and
development (IPR&D) expense recorded in connection with the
acquisition of Anaconda Pharma in June 2015. Further contributing
to the increase in net loss was a $7.5 million decrease in revenue
from services related to the termination of the Company's BARDA
contract in May 2014 and a $0.2 million reduction in income tax
benefit, offset in part by a $9.7 million decrease in cost of
revenue, a $3.1 million increase in royalty revenues, a $1.1
million decrease in research and development expense, a $0.9
million decrease in general and administrative expense, and a $0.8
million decrease in foreign exchange loss. Basic and diluted net
loss per share was $0.55 for the three month period ended June 30,
2015, as compared to a basic and diluted net loss per share of
$0.29 in the same period of 2014.
Revenue decreased to $4.1 million for the three month period
ended June 30, 2015 from $8.5 million in the same period last year
due to a $7.5 million decrease in revenue from services related to
the termination of the Company's contract with BARDA in May 2014,
offset in part by a $3.1 million increase in royalty revenues in
2015 primarily related to a Relenza® government stockpile
order.
Cost of revenue decreased to zero for the three month period
ended June 30, 2015 from $9.7 million in the same period last year
due to the termination of the Company's contract with BARDA in May
2014.
Research and development expense decreased to $5.2 million for
the three month period ended June 30, 2015 from $6.3 million in the
same period last year. The $1.1 million decrease was the result of
a $1.3 million decrease in depreciation and facility related
expenses associated with the closure of the Company's Melbourne,
Australia research facility in March 2015, a $0.5 million decrease
in salaries, benefits and share-based compensation expense as a
result of non-recurring severance expenses in 2014 related to the
closure of the Melbourne, Australia research facility and a $0.1
million decrease in other expenses due to reduced research, offset
in part by a $0.8 million increase in preclinical, clinical and
manufacturing costs related to the ongoing Phase 2b SPIRITUS trial
for vapendavir and the completion of Investigational New Drug
(IND)-enabling studies for BTA585, the Company's RSV compound.
As noted above, the Company recorded an IPR&D expense of
$17.6 million during the three month period ended June 30, 2015
related to the acquisition of Anaconda Pharma. Due to the
development stage of Anaconda, the acquisition of Anaconda did not
constitute a business, according to United States generally
accepted accounting principles (U.S. GAAP). The Company therefore
accounted for the total consideration paid at closing as an
IPR&D with no alternative future use resulting in no goodwill
being recognized and the amount being charged to expense at the
acquisition date. As part of the IPR&D expense the Company also
recorded $1.0 million of transaction costs directly related to the
acquisition, which included expenditures for advisory, legal,
accounting and other similar services. No such expenses were
incurred in same period of the prior year.
General and administrative expense decreased to $1.3 million for
the three month period ended June 30, 2015 from $2.2 million in the
same period last year due to a $1.0 million decrease in
professional and legal fees, primarily as a result of $0.8 million
of expenses related to the acquisition of Anaconda Pharma being
reclassified to IPR&D expense upon the closing of the
transaction in June 2015 and a $0.3 million decrease in other
expenses, offset in part by $0.4 million increase in salaries,
benefits and share-based compensation expenses.
Financial Results for the Fiscal Year Ended June 30,
2015
The Company reported a net loss of $19.1 million for its fiscal
year ended June 30, 2015, as compared to a net loss of $11.0
million in the prior year. The $8.1 million increase in net loss
from the prior year was primarily due to the non-recurring $17.6
million IPR&D expense recorded during the three month period
ended June 30, 2015 related to the acquisition of Anaconda Pharma,
a $44.1 million decrease in revenues due to the cancellation of the
BARDA contract, a $2.3 million increase in research and development
expense related to an increase in preclinical, clinical and
manufacturing costs related to the Company's vapendavir clinical
development program and IND-enabling studies for BTA585, a $0.2
million reduction in income tax benefits and a $0.2 million loss on
disposal of assets, offset in part by a $47.5 million decrease in
cost of revenue related to the cancellation of the BARDA contract,
a $7.9 million change in foreign exchange from a loss to a gain, a
$0.8 million decrease in general and administrative expense and
$0.1 million increase in other income. Basic and diluted net loss
per share was $0.54 for the fiscal year ended June 30, 2015, as
compared to a basic and diluted net loss per share of $0.35 in the
prior year.
Conference Call and Webcast Information
Biota Pharmaceuticals will host a conference call today to
review these fourth quarter and fiscal year ended 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
16443675. 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 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 four 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 Phase 2 topical antiviral treatment for
genital warts caused by human papillomavirus types 6 & 11;
BTA585, an oral fusion (F) protein inhibitor in Phase 1 development
for the treatment of respiratory syncytial virus A & B
infections; and laninamivir octanoate, a one-time, inhaled
treatment in Phase 2 development for influenza A and B infections.
The Company also has a preclinical stage RSV non-fusion inhibitor
program that it believes can complement its fusion-protein
inhibitor BTA585. 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 planned initiation of
dosing in the Phase 1 multiple ascending dose for BTA585; the
planned initiation of a Phase 2 clinical trial for BTA074; the time
frame in which the Company plans to report Phase 1 SAD and MAD data
for BTA585; the time frames in which the Company plans to fully
enroll and report top line-data from its Phase 2b SPIRITUS clinical
trial; and the time frame in which the Company anticipates
reporting top-line data from its Phase 2 trials of BTA074 and
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
Company, the U.S. Food and Drug Administration (FDA), Argentina
National Administration of Drugs, Foods and Medical Devices
(ANMAT), European Medicines Agency (EMA) 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, BTA585, BTA074
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 safety or efficacy data from planned and
ongoing future preclinical and clinical studies of any of its
product candidates not supporting the clinical development of that
product candidate; the Company's capacity to successfully enroll,
manage and conduct worldwide clinical trials 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
manufacture and maintain sufficient quantities of preclinical and
clinical trial material on hand to support and complete its
preclinical studies or clinical trials on a timely basis; the
Company's ability, or that of its clinical research organizations
or clinical investigators, to enroll a sufficient number of
patients in its clinical trials on a timely basis; the Company's
third-party contract research, data management and manufacturing
organizations fulfilling their contractual obligations on a timely
basis or otherwise performing satisfactorily in the future; 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 the Company's
Quarterly Reports on Form 10-Q for the quarter ended September 30,
2014 and December 31, 2014, and March 31, 2015 as filed with the
U.S. Securities and Exchange Commission on November 7, 2014 and
February 6, 2015, and May 8, 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) |
|
|
June 30, 2015 |
June 30, 2014 |
|
|
|
ASSETS |
Current assets |
|
|
Cash and cash equivalents |
$44.7 |
$81.7 |
Contract receivable
(BARDA) |
-- |
17.8 |
Accounts receivable, net of
allowance |
12.6 |
0.9 |
Short-term investments |
12.9 |
-- |
Prepaid and other current
assets |
0.6 |
0.7 |
Total current assets |
70.8 |
101.1 |
Non-current assets: |
|
|
Long-term investments |
7.9 |
10.0 |
Property and equipment,
net |
0.2 |
2.0 |
Deferred tax asset |
0.5 |
0.9 |
Total non-current assets |
8.6 |
12.9 |
Total assets |
$79.4 |
$114.0 |
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
Current liabilities: |
|
|
Contract payables (BARDA) |
$1.0 |
$18.6 |
Accounts payable |
1.9 |
2.8 |
Accrued expenses |
5.3 |
3.4 |
Accrued severance
obligations |
0.1 |
1.2 |
Deferred tax liability |
0.5 |
0.9 |
Short term note payable |
0.2 |
-- |
Total current liabilities |
9.0 |
26.9 |
Non-current liabilities: |
|
|
Long term note payable, net of
current portion |
0.8 |
-- |
Other liabilities, net of
current portion |
0.1 |
0.2 |
Total liabilities |
9.9 |
27.1 |
Stockholders' equity: |
|
|
Common stock, $0.10 par value;
200,000,000 shares authorized 38,609,086 and 35,100,961 shares
issued and outstanding at June 30, 2015 and June 30, 2014,
respectively |
3.9 |
3.5 |
Additional paid-in capital |
155.6 |
146.4 |
Accumulated other comprehensive
income |
18.9 |
26.8 |
Accumulated deficit |
(108.9) |
(89.8) |
Total stockholders' equity |
69.5 |
86.9 |
Total liabilities and
stockholders' equity |
$79.4 |
$114.0 |
|
BIOTA PHARMACEUTICALS,
INC. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(in millions, except per share
amounts) |
(unaudited) |
|
|
Three Months
Ended June 30, |
Twelve Months
Ended June 30, |
|
2015 |
2014 |
2015 |
2014 |
Revenue: |
|
|
|
|
Royalty revenue and
milestones |
$4.1 |
$1.0 |
$16.1 |
$15.1 |
Revenue from services
(BARDA) |
-- |
7.5 |
8.4 |
53.5 |
Other |
-- |
-- |
0.1 |
0.1 |
Total revenue |
4.1 |
8.5 |
24.6 |
68.7 |
|
|
|
|
|
Operating expense: |
|
|
|
|
Cost of revenue |
-- |
9.7 |
3.6 |
51.1 |
Research and development |
5.2 |
6.3 |
19.8 |
17.5 |
In-process research and
development (IPR&D) |
17.6 |
-- |
17.6 |
-- |
General and administrative |
1.3 |
2.2 |
9.4 |
10.2 |
Foreign exchange loss
(gain) |
-- |
0.8 |
(6.5) |
1.4 |
Loss on disposal of assets |
-- |
-- |
0.2 |
-- |
Total operating expense |
24.1 |
19.0 |
44.1 |
80.2 |
Income (loss) from operations |
(20.0) |
(10.5) |
(19.5) |
(11.5) |
|
|
|
|
|
Non-operating income: |
|
|
|
|
Other income |
0.1 |
0.1 |
0.3 |
0.2 |
Total non-operating income |
0.1 |
0.1 |
0.3 |
0.2 |
|
|
|
|
|
Loss before tax |
(19.9) |
(10.4) |
(19.2) |
(11.3) |
Income tax benefit |
-- |
0.2 |
0.1 |
0.3 |
Net loss |
($19.9) |
($10.2) |
($19.1) |
($11.0) |
|
|
|
|
|
|
|
|
|
|
Basic loss per share |
($0.55) |
($0.29) |
($0.54) |
($0.35) |
Diluted loss per share |
($0.55) |
($0.29) |
($0.54) |
($0.35) |
|
|
|
|
|
Basic weighted-average shares
outstanding |
36,143,337 |
35,023,500 |
35,360,841 |
31,347,888 |
Diluted weighted-average shares
outstanding |
36,143,337 |
35,023,500 |
35,360,841 |
31,347,888 |
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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