Aviragen Therapeutics Reports Third Quarter Fiscal Year 2017 Financial Results
May 04 2017 - 7:00AM
Aviragen Therapeutics, Inc. (NASDAQ:AVIR) today announced its
financial results for the three month period ended March 31,
2017, which is the third quarter of the Company's 2017 fiscal year.
“We are expeditiously working with our Board and
financial advisors to consider a wide range of strategic
alternatives in a process that is intended to enhance shareholder
value both in the near and long term,” commented Joseph M.
Patti, PhD, President and Chief Executive Officer of Aviragen
Therapeutics. “We remain confident about the overall value
proposition of Aviragen based on our fuller review of data from our
clinical trials that reported topline results earlier this year,
our ongoing Phase 2 study of BTA074 and our solid financial
position.”
Corporate Review:
- Strategic Review Process: The Company is
actively engaged, with the assistance of its financial advisor,
Stifel, Nicolaus & Company, Incorporated, in evaluating a wide
range of strategic alternatives that include a business combination
or strategic merger, in-licensing clinical stage programs, an
acquisition, or other transaction that would complement the
Company’s pipeline.
- BTA074: The Phase 2 trial of BTA074, a topical
antiviral treatment for condyloma caused by human papillomavirus
(HPV), is ongoing with completion of enrollment in the 210 patient
trial anticipated in the second half of 2017. Top-line safety and
efficacy data are expected in the first half of 2018.
- Vapendavir: The Company is working with
several key opinion leaders in evaluating a potential clinical
development path for the drug based on the consistent antiviral
effect observed in all of its Phase 2 clinical studies, and its
favorable safety profile.
- RSV Programs: The Company continues to
progress non-clinical activities in support of its response to the
U.S. Food and Drug Administration regarding the clinical hold on
BTA585 for the treatment of respiratory syncytial virus (RSV)
infections. In addition the Company is making progress in
identifying several compounds for its non-nucleoside inhibitor
program in the same indication.
- Overhead Expense: The Company has reduced its
headcount by approximately 25% and has taken several additional
steps to preserve cash during the strategic review process.
Financial Results for the Three Month
Period Ended March 31, 2017
The Company reported a net loss of $4.4 million
for the three month period ended March 31, 2017, as compared to a
net loss of $5.2 million in the same quarter of the prior fiscal
year. Basic and diluted net loss per share was $0.11 for the three
month period ended March 31, 2017, as compared to a basic and
diluted net loss per share of $0.14 in the same period in 2016. The
major components of net loss in both periods are detailed
below.
Revenue decreased to $4.9 million for the
three month period ended March 31, 2017 from $5.3 million in the
same period in 2016 mainly due to a $0.6 million decrease in
Relenza royalties which was partially offset by a $0.2 million
increase in Inavir® royalties. Of the total $3.8 million
Inavir royalties received for the third quarter in 2017, $0.8
million are related to the sale of certain royalty rights to
HealthCare Royalty Partners III, L.P. (HCRP) in April 2016 and will
be passed through to HCRP. These are accounted for as non-cash
royalty revenue in the Consolidated Statement of
Operations.
Research and development expense decreased to
$6.8 million for the three month period ended March 31, 2017 from
$8.5 million in the same period in 2016. The $1.7 million decrease
largely reflected reduced clinical trial activity and manufacturing
costs as two of our three Phase 2 clinical trials came to a
close.
General and administrative expense decreased to
$1.8 million for the three month period ended March 31, 2017 from
$2.3 million for the same period in 2016 due mostly to lower
employee costs and professional fees.
Non-cash implied interest expense was $0.5
million for the three month period ended March 31, 2017 related to
the royalty interest sale in April 2016. There was no non-cash
implied interest expense for the same period in
2016.
The Company held $37.6 million in cash, cash
equivalents, and short-term investments as of March 31, 2017.
About Aviragen Therapeutics
Aviragen Therapeutics is focused on the
discovery and development of the next generation of direct-acting
antivirals to treat infections that have limited therapeutic
options and affect a significant number of patients globally. The
Company has three Phase 2 clinical stage compounds: vapendavir, a
capsid inhibitor for the prevention or treatment of rhinovirus (RV)
upper respiratory infections; BTA585 (enzaplatovir), a fusion
protein inhibitor in development for the treatment of respiratory
syncytial virus infections; and BTA074, an antiviral treatment for
condyloma caused by human papillomavirus types 6 & 11. The
Company also receives royalties from marketed influenza products,
Relenza® and Inavir®. For additional information about the Company,
please visit www.aviragentherapeutics.com.
Aviragen Therapeutics® is a registered
trademark. Relenza® is a registered trademark of GlaxoSmithKline
Pharmaceuticals, Ltd., and Inavir® is a registered trademark of
Daiichi Sankyo Company, Ltd.
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 Aviragen Therapeutics’ business,
operations and financial performance. Any statements that are not
of historical facts may be deemed to be forward-looking statements,
including timing or outcome of the evaluation of a wide range of
strategic alternatives that could maximize both near and long-term
value for our shareholders, the timing to complete enrollment and
availability of top-line efficacy data from the Phase 2 trial of
BTA074, and the potential of BTA074 and our other direct-acting
antivirals to deliver future shareholder value, 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) 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 any of the Company's
product candidates at any time for a lack of efficacy, safety,
tolerability, regulatory or manufacturing issues, or any other
reason whatsoever; the Company's ability to secure, manage and
retain qualified third-party clinical research, data management and
contract manufacturing organizations upon which it relies to assist
in the design, development, implementation and execution of the
clinical development of all its product candidates and those
organizations’ ability to successfully execute their contracted
responsibilities; 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; and other
cautionary statements contained elsewhere in this press release and
in our Annual Report on Form 10-K and our other reports filed with
the Securities and Exchange Commission. 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.
|
AVIRAGEN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(in millions, except per share amounts) |
|
|
March 31, 2017 |
|
June 30, 2016 |
|
(unaudited) |
|
(audited) |
ASSETS |
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
11.8 |
|
|
$ |
49.7 |
|
Short-term investments |
|
25.8 |
|
|
|
19.3 |
|
Accounts
receivable, net of allowance |
|
6.6 |
|
|
|
0.7 |
|
Prepaid
and other current assets |
|
2.2 |
|
|
|
2.7 |
|
Total
current assets |
|
46.4 |
|
|
|
72.4 |
|
Non-current
assets: |
|
|
|
Property
and equipment, net |
|
0.3 |
|
|
|
0.3 |
|
Total
non-current assets |
|
0.3 |
|
|
|
0.3 |
|
Total
assets |
$ |
46.7 |
|
|
$ |
72.7 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
1.8 |
|
|
$ |
3.9 |
|
Accrued
expenses |
|
3.0 |
|
|
|
3.6 |
|
Short-term note payable |
|
0.3 |
|
|
|
0.4 |
|
Liabilities related to sale of future royalties, net of deferred
financing costs |
|
0.4 |
|
|
|
1.3 |
|
Total
current liabilities |
|
5.5 |
|
|
|
9.2 |
|
Non-current
liabilities: |
|
|
|
Long-term
note payable, net of current portion |
|
0.1 |
|
|
|
0.3 |
|
Liabilities related to sale of future royalties, net of deferred
financing costs and current portion |
|
16.7 |
|
|
|
16.8 |
|
Other
long-term liabilities, net of current portion |
|
0.2 |
|
|
|
0.2 |
|
Total
liabilities |
|
22.5 |
|
|
|
26.5 |
|
Stockholders’
equity: |
|
|
|
Preferred
stock, $0.10 par value; 5,000,000 shares authorized and none issued
and outstanding as of March 31, 2017 and June 30, 2016 |
|
- |
|
|
|
- |
|
Common
stock, $0.10 par value; 200,000,000 shares authorized 38,649,237
and 38,640,487 shares issued and outstanding at March 31, 2017 and
June 30, 2016, respectively |
|
3.9 |
|
|
|
3.9 |
|
Additional paid-in capital |
|
159.1 |
|
|
|
157.6 |
|
Accumulated other comprehensive income |
|
19.0 |
|
|
|
19.0 |
|
Accumulated deficit |
|
(157.8 |
) |
|
|
(134.3 |
) |
Total
stockholders’ equity |
|
24.2 |
|
|
|
46.2 |
|
Total
liabilities and stockholders’ equity |
$ |
46.7 |
|
|
$ |
72.7 |
|
AVIRAGEN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (in millions, except per share
amounts)(unaudited) |
|
|
Three Months Ended March 31, |
|
Nine Months Ended March 31, |
|
|
2017 |
|
|
2016 |
|
|
|
2017 |
|
|
2016 |
|
Revenue: |
|
|
|
|
|
Royalty
revenue |
$ |
4.1 |
|
$ |
5.3 |
|
|
$ |
5.8 |
|
$ |
8.8 |
|
Non-cash
royalty revenue related to the sale of future royalties |
|
0.8 |
|
|
- |
|
|
|
3.0 |
|
|
- |
|
Total revenue |
|
4.9 |
|
|
5.3 |
|
|
|
8.8 |
|
|
8.8 |
|
|
|
|
|
|
|
Operating expense: |
|
|
|
|
|
Research
and development |
|
6.8 |
|
|
8.5 |
|
|
|
24.6 |
|
|
20.4 |
|
General
and administrative |
|
1.8 |
|
|
2.3 |
|
|
|
6.0 |
|
|
6.7 |
|
Foreign
exchange loss (gain), net |
|
0.1 |
|
|
(0.3 |
) |
|
|
0.1 |
|
|
0.2 |
|
Total operating
expense |
|
8.7 |
|
|
10.5 |
|
|
|
30.7 |
|
|
27.3 |
|
Loss from
operations |
|
(3.8 |
) |
|
(5.2 |
) |
|
|
(21.9 |
) |
|
(18.5 |
) |
|
|
|
|
|
|
Non-operating income
(expense): |
|
|
|
|
|
Non-cash
interest expense on liability related to sale of future royalties
|
|
(0.5 |
) |
|
- |
|
|
|
(1.4 |
) |
|
- |
|
Interest
income, net |
|
0.1 |
|
|
- |
|
|
|
0.1 |
|
|
0.1 |
|
Total non-operating
income (expense) |
|
(0.4 |
) |
|
- |
|
|
|
(1.3 |
) |
|
0.1 |
|
|
|
|
|
|
|
Loss before tax |
|
(4.2 |
) |
|
(5.2 |
) |
|
|
(23.2 |
) |
|
(18.4 |
) |
Income tax expense |
|
0.2 |
|
|
- |
|
|
|
0.3 |
|
|
- |
|
Net loss |
$ |
(4.4 |
) |
$ |
(5.2 |
) |
|
$ |
(23.5 |
) |
$ |
(18.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per
share |
$ |
(0.11 |
) |
$ |
(0.14 |
) |
|
$ |
(0.61 |
) |
$ |
(0.48 |
) |
Diluted loss per
share |
$ |
(0.11 |
) |
$ |
(0.14 |
) |
|
$ |
(0.61 |
) |
$ |
(0.48 |
) |
|
|
|
|
|
|
Basic weighted-average
shares outstanding |
|
38,647,487 |
|
|
38,640,254 |
|
|
|
38,642,786 |
|
|
38,633,786 |
|
Diluted
weighted-average shares outstanding |
|
38,647,487 |
|
|
38,640,254 |
|
|
|
38,642,786 |
|
|
38,633,786 |
|
|
|
|
|
|
|
Contacts:
Mark Colonnese
Executive Vice President and Chief Financial Officer
Aviragen Therapeutics, Inc.
(678) 221-3381
mcolonnese@aviragentherapeutics.com
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
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