Aviragen Therapeutics, Inc. (NASDAQ:AVIR) today announced its
financial results for the three months and fiscal year
ended June 30, 2017.
“We have made great strides, working with our
Board and financial advisors, in honing in on a select number of
strategic alternatives,” commented Joseph M. Patti, PhD, President
and Chief Executive Officer of Aviragen Therapeutics. “Importantly,
we have also taken actions to minimize cash spending in order to
maintain the Company’s solid financial position as evidenced by our
reported cash position of $38.6 million.”
Corporate Update:
- Strategic Review Process: The Company is actively engaged, with
the assistance of its financial advisor, Stifel, Nicolaus
& Company, Incorporated, in evaluating strategic alternatives
that are intended to enhance shareholder value, both in the near-
and long-term.
- BTA074: The Phase 2 trial of BTA074, a topical antiviral
treatment for condyloma caused by human papillomavirus (HPV), is
ongoing and the Company anticipates that enrollment in the 210
patient trial will be completed in the fourth quarter of calendar
year 2017. Top-line safety and efficacy data is expected in the
second quarter of calendar year 2018.
- BTA585: The Company has completed the non-clinical studies
requested by the U.S. Food and Drug Administration (FDA) to support
a response to the ongoing clinical hold, but has subsequently put
all activities related to the BTA585 program on hold until
completion of the Company’s strategic review process.
Financial Results for the Three Month
Period Ended June 30, 2017
The Company reported a net loss of $5.9 million
for the three month period ended June 30, 2017, as compared to a
net loss of $7.1 million in the same quarter of the prior fiscal
year. Basic and diluted net loss per share was $0.15 for the three
month period ended June 30, 2017, as compared to a basic and
diluted net loss per share of $0.18 in the same period in 2016. The
major components of net loss in both periods are detailed
below.
Revenue was $0.1 million for the three month
period ended June 30, 2017 compared to $0.6 million in the same
period in 2016. The 2016 revenue was comprised of $0.4 million in
Relenza royalties and $0.2 million in non-cash royalty revenue
related to certain royalty rights that were sold to HealthCare
Royalty Partners III, L.P. (HCRP) in April 2016. The $0.2 million
was passed through to HCRP.
Research and development expense decreased to
$3.7 million for the three month period ended June 30, 2017 from
$6.0 million in the same period in 2016. The $2.3 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 increased to
$2.0 million for the three month period ended June 30, 2017 from
$1.2 million for the same period in 2016 due mostly to higher legal
and professional fees.
Non-cash implied interest expense increased
slightly to $0.4 million for the three month period ended June 30,
2017 from $0.3 million for the same period in 2016, reflecting an
additional month of interest in this year’s quarter since the
royalty rights sale occurred in April 2016.
The Company held $38.6 million in cash, cash
equivalents, and short-term investments as of June 30, 2017.
Financial Results for the Fiscal Year
Ended June 30, 2017
The Company reported a net loss of $29.4
million for its fiscal year ended June 30, 2017, as
compared to a net loss of $25.4 million in the prior
year. The $4.0 million increase in net loss from the
prior year was primarily due to a $0.4 million decrease
in royalty revenue, principally related to Relenza®, a $2.0
million increase in research and development expense, largely
related to costs for the Company's vapendavir, BTA585 and BTA074
clinical development programs and a $1.5 million increase in
non-cash interest expense related to certain royalty rights that
were sold to HCRP in April 2016. Basic and diluted net loss per
share was $0.76 for the fiscal year ended June 30,
2017, as compared to $0.66 in the prior year.
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: BTA074, an
antiviral treatment for condyloma caused by human papillomavirus
types 6 & 11; vapendavir, a capsid inhibitor for the prevention
or treatment of rhinovirus (RV) upper respiratory infections; and
BTA585 (enzaplatovir), a fusion protein inhibitor in development
for the treatment of respiratory syncytial virus infections. 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 the evaluation 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;
the Company’s inability to successfully conclude its Strategic
Review process; 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) |
|
|
June 30, 2017 |
|
June 30, 2016 |
|
(unaudited) |
|
(audited) |
ASSETS |
Current assets: |
|
|
|
Cash and
cash equivalents |
$ |
17.7 |
|
|
$ |
49.7 |
|
Short-term investments |
|
20.9 |
|
|
|
19.3 |
|
Accounts
receivable, net of allowance |
|
0.6 |
|
|
|
0.7 |
|
Prepaid
and other current assets |
|
0.7 |
|
|
|
2.7 |
|
Total
current assets |
|
39.9 |
|
|
|
72.4 |
|
Non-current
assets: |
|
|
|
Property
and equipment, net |
|
0.2 |
|
|
|
0.3 |
|
Total
non-current assets |
|
0.2 |
|
|
|
0.3 |
|
Total
assets |
$ |
40.1 |
|
|
$ |
72.7 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
Current
liabilities: |
|
|
|
Accounts
payable |
$ |
1.4 |
|
|
$ |
3.9 |
|
Accrued
expenses |
|
2.9 |
|
|
|
3.6 |
|
Short-term note payable |
|
0.2 |
|
|
|
0.4 |
|
Liabilities related to sale of future royalties, net of deferred
financing costs |
|
1.4 |
|
|
|
1.3 |
|
Total
current liabilities |
|
5.9 |
|
|
|
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 |
|
15.3 |
|
|
|
16.8 |
|
Other
long-term liabilities, net of current portion |
|
0.1 |
|
|
|
0.2 |
|
Total
liabilities |
|
21.4 |
|
|
|
26.5 |
|
Stockholders’
equity: |
|
|
|
Preferred
stock, $0.10 par value; 5,000,000 shares authorized and none issued
and outstanding as of June 30, 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 June 30, 2017 and
June 30, 2016, respectively |
|
3.9 |
|
|
|
3.9 |
|
Additional paid-in capital |
|
159.6 |
|
|
|
157.6 |
|
Accumulated other comprehensive income |
|
19.0 |
|
|
|
19.0 |
|
Accumulated deficit |
|
(163.8 |
) |
|
|
(134.3 |
) |
Total
stockholders’ equity |
|
18.7 |
|
|
|
46.2 |
|
Total
liabilities and stockholders’ equity |
$ |
40.1 |
|
|
$ |
72.7 |
|
AVIRAGEN THERAPEUTICS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in millions, except per share amounts) |
(unaudited) |
|
|
Three Months Ended June 30, |
|
Year Ended June 30, |
|
2017 |
2016 |
|
2017 |
2016 |
Revenue: |
|
|
|
|
|
Royalty
revenue |
$ |
(0.1 |
) |
$ |
0.4 |
|
|
$ |
5.7 |
|
$ |
9.1 |
|
Non-cash
royalty revenue related to the sale of future royalties |
|
0.2 |
|
|
0.2 |
|
|
|
3.2 |
|
|
0.2 |
|
Total revenue |
|
0.1 |
|
|
0.6 |
|
|
|
8.9 |
|
|
9.3 |
|
|
|
|
|
|
|
Operating expense: |
|
|
|
|
|
Research
and development |
|
3.7 |
|
|
6.0 |
|
|
|
28.3 |
|
|
26.3 |
|
General
and administrative |
|
2.0 |
|
|
1.2 |
|
|
|
8.0 |
|
|
8.0 |
|
Foreign
exchange loss (gain), net |
|
- |
|
|
0.1 |
|
|
|
0.1 |
|
|
0.2 |
|
Total operating
expense |
|
5.7 |
|
|
7.3 |
|
|
|
36.4 |
|
|
34.5 |
|
Loss from
operations |
|
(5.6 |
) |
|
(6.7 |
) |
|
|
(27.5 |
) |
|
(25.2 |
) |
|
|
|
|
|
|
Non-operating income
(expense): |
|
|
|
|
|
Non-cash
interest expense on liability related to sale of future
royalties |
|
(0.4 |
) |
|
(0.3 |
) |
|
|
(1.8 |
) |
|
(0.3 |
) |
Interest
income (expense), net |
|
0.1 |
|
|
(0.1 |
) |
|
|
0.2 |
|
|
0.1 |
|
Total non-operating
income (expense) |
|
(0.3 |
) |
|
(0.4 |
) |
|
|
(1.6 |
) |
|
(0.2 |
) |
|
|
|
|
|
|
Loss before tax |
|
(5.9 |
) |
|
(7.1 |
) |
|
|
(29.1 |
) |
|
(25.4 |
) |
Income tax expense |
|
- |
|
|
- |
|
|
|
(0.3 |
) |
|
- |
|
Net loss |
$ |
(5.9 |
) |
$ |
(7.1 |
) |
|
$ |
(29.4 |
) |
$ |
(25.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share |
$ |
(0.15 |
) |
$ |
(0.18 |
) |
|
$ |
(0.76 |
) |
$ |
(0.66 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
weighted-average shares outstanding |
|
38,649,237 |
|
|
38,640,487 |
|
|
|
38,644,395 |
|
|
38,635,452 |
|
|
|
|
|
|
|
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
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Vaxart (NASDAQ:VXRT)
Historical Stock Chart
From Sep 2023 to Sep 2024