ALISO VIEJO, Calif.,
Feb. 5, 2014 /PRNewswire/ --
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today reported
financial results for the three months ended December 31, 2013.
(Logo:
http://photos.prnewswire.com/prnh/20130207/LA55901LOGO)
Quarterly Financial Highlights
- Total company net revenues of $26.7
million
- Gross and net NUEDEXTA® sales increased to $31.3 million and $23.3
million, respectively
- Cash, cash equivalents, and restricted investments of
$46.5 million as of December 31, 2013.
"The accomplishments of the team since the launch of NUEDEXTA
three years ago are significant," said Keith A. Katkin, president and CEO of
Avanir. "I am delighted with the continued quarterly
double-digit growth in NUEDEXTA revenue and the help NUEDEXTA has
provided to thousands of patients with PBA. Additionally early
indicators are that our co-promote partnership is bearing fruit.
With the recent NDA filing of AVP-825, our investigational
drug-device product for the acute treatment of migraine we are now
poised to deliver upon the promise of a potential new treatment for
migraine sufferers."
Fiscal 2014 First Quarter Results
- Total net revenues for the first quarter fiscal 2014 were
$26.7 million, compared with
$16.5 million for the comparable
quarter in fiscal 2013, representing 62% year-over-year growth.
Total net revenues consist of NUEDEXTA revenue, co-promotion
revenues and royalty revenue from Abreva®.
- Total operating expenses were $36.7
million in the first quarter of fiscal 2014, compared with
$27.6 million in the comparable
period in fiscal 2013.
- Cash used in operations was $9.8
million in the first quarter of fiscal 2014.
- Net loss for the fiscal 2014 first quarter was $10.9 million, or $0.07 per share, compared with a net loss of
$12.1million, or $0.09 per share, for the same period in fiscal
2013.
Cash, Cash Equivalents & Marketable Securities
As of December 31, 2013 Avanir had
cash, cash equivalents and investments in securities totaling
$46.5 million, including cash and
cash equivalents of $43.9
million.
Quarter and Recent Business Highlights
- Achieved NUEDEXTA net revenue growth of 15% versus the prior
quarter.
- Launched the co-promote of Merck's type 2 diabetes therapies
JANUVIA® (sitagliptin) and the sitagliptin family of products in
the long-term care institutional setting in the United States.
- Submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for approval of AVP-825, the company's
innovative Breath Powered™ investigational drug-device combination
product for the acute treatment of migraine.
- Enrolled the first patient in a proof of concept, Phase II
clinical trial investigating the use of AVP-923 for the treatment
of levodopa induced dyskinesia (LID) in patients with Parkinson's
disease (PD).
- Announced plans to initiate a treatment resistant major
depressive disorder clinical program for AVP-786.
Note to Investors: As previously announced, Avanir will
hold a conference call to discuss fiscal 2014 first quarter
financial results today, February 5,
2014, beginning at 1:30 p.m. Pacific
Time. You can listen to this call by dialing 1 (866)
318-8611 for domestic callers or +1 (617) 399-5130 for
international callers, and entering passcode 19078797. Those
interested in listening to the conference call live via the
internet may do so by visiting http://ir.avanir.com.
About AVP-825
AVP-825 is an investigational
drug-device combination product consisting of low-dose sumatriptan
powder delivered intranasally utilizing a novel breath-powered
delivery technology. If approved, AVP-825 would be the first and
only fast-acting, dry-powder intranasal form of sumatriptan for the
treatment of migraine.
About AVP-786
AVP-786 is a novel investigational drug product consisting of a
combination of deuterium modified dextromethorphan and ultra-low
dose quinidine, used as a metabolic inhibitor. Incorporation of
deuterium into specific positions of the dextromethorphan molecule
strengthens the chemical bonds and reduces susceptibility to enzyme
cleavage and first pass metabolism, but without altering its
pharmacology. AVP-786 is an investigational drug not approved by
the FDA.
About AVP-923
AVP-923 is a combination of two well-characterized compounds, the
active CNS ingredient dextromethorphan hydrobromide (an
uncompetitive NMDA receptor antagonist and sigma-1 receptor
agonist) plus low-dose quinidine sulfate (a CYP2D6 enzyme
inhibitor), which serves to increase the bioavailability of
dextromethorphan. Several dose strengths of AVP-923 are being
studied in multiple ongoing clinical trials including agitation in
Alzheimer's disease, and levodopa-induced dyskinesia in Parkinson's
disease. AVP-923 at the 20/10 mg dose strength is approved by the
FDA for the treatment of pseudobulbar affect (PBA) and marketed
under the trade name NUEDEXTA (see description below).
AVP-923 is an investigational drug not approved by the FDA for any
uses other than PBA.
About NUEDEXTA
NUEDEXTA is an innovative combination of two well-characterized
components; dextromethorphan hydrobromide (20 mg), the ingredient
active in the central nervous system, and quinidine sulfate (10
mg), a metabolic inhibitor enabling therapeutic dextromethorphan
concentrations. NUEDEXTA acts on sigma-1 and NMDA receptors in the
brain, although the mechanism by which NUEDEXTA exerts therapeutic
effects in patients with PBA is unknown.
NUEDEXTA Important Safety Information
NUEDEXTA is indicated for the treatment of pseudobulbar affect
(PBA). PBA occurs secondary to a variety of otherwise unrelated
neurological conditions, and is characterized by involuntary,
sudden, and frequent episodes of laughing and/or crying. PBA
episodes typically occur out of proportion or incongruent to the
underlying emotional state.
Studies to support the effectiveness of NUEDEXTA were performed
in patients with amyotrophic lateral sclerosis (ALS) and multiple
sclerosis (MS). NUEDEXTA has not been shown to be safe and
effective in other types of emotional lability that can commonly
occur, for example, in Alzheimer's disease and other dementias.
NUEDEXTA and certain other medicines can interact, causing
serious side effects. If you take certain drugs or have certain
heart problems, NUEDEXTA may not be right for you.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating
NUEDEXTA in patients at risk for QT prolongation and torsades de
pointes, electrocardiographic (ECG) evaluation should be conducted
at baseline and 3-4 hours after the first dose.
The most common adverse reactions are diarrhea, dizziness,
cough, vomiting, asthenia, peripheral edema, urinary tract
infection, influenza, increased gamma-glutamyltransferase, and
flatulence. NUEDEXTA may cause dizziness.
These are not all the risks from use of NUEDEXTA. Please refer
to full Prescribing Information at www.NUEDEXTA.com.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused
on bringing innovative medicines to patients with central nervous
system disorders of high unmet medical need. As part of our
commitment, we have extensively invested in our pipeline and are
dedicated to advancing medicines that can substantially improve the
lives of patients and their loved ones. For more information about
Avanir, please visit www.avanir.com.
Avanir® and NUEDEXTA® are registered trademarks owned by Avanir
Pharmaceuticals, Inc. All other trademarks are the property of
their respective owners.
©2014 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking Statements
Except for the historical information contained herein, the
matters set forth in this press release, including statements
regarding Avanir's plans, potential opportunities, financial or
other expectations, projections, goals objectives, milestones,
strategies, market growth, timelines, legal matters, product
pipeline, clinical studies, product development and the potential
benefits of its commercialized products and products under
development are forward-looking statements within the meaning of
the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are subject to
risks and uncertainties that may cause actual results to differ
materially, including the risks and uncertainties associated with
Avanir's operating performance and financial position, the market
demand for and acceptance of Avanir's products domestically and
internationally, research, development and commercialization of new
products domestically and internationally, obtaining additional
indications, obtaining and maintaining regulatory approvals
domestically and internationally, and other risks detailed from
time to time in the Company's most recent Annual Report on Form
10-K and other documents subsequently filed with or furnished to
the Securities and Exchange Commission. These forward-looking
statements are based on current information that may change and you
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
All forward-looking statements are qualified in their entirety by
this cautionary statement, and the Company undertakes no obligation
to revise or update any forward-looking statement to reflect events
or circumstances after the issuance of this press release.
Avanir Investor & Media Contact
Ian Clements, PhD
ir@avanir.com
+1 (949) 389-6700
AVANIR
PHARMACEUTICALS, INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
December
31,
|
|
September
30,
|
|
2013
|
|
2013
|
|
(unaudited)
|
|
(audited)
|
ASSETS
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
43,897,733
|
|
$
55,259,073
|
Restricted cash and cash
equivalents
|
1,316,896
|
|
965,986
|
Trade receivables,
net
|
4,199,014
|
|
12,525,992
|
Inventories, net
|
605,833
|
|
710,179
|
Prepaid expenses and other
current assets
|
6,088,662
|
|
2,382,410
|
Total current assets
|
56,108,138
|
|
71,843,640
|
Restricted long-term
investments
|
1,303,938
|
|
1,303,938
|
Property and
equipment, net
|
2,568,341
|
|
1,592,791
|
Non-current
inventories, net
|
773,130
|
|
784,186
|
Other
assets
|
517,069
|
|
554,452
|
TOTAL
ASSETS
|
$
61,270,616
|
|
$
76,079,007
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
|
Accounts payable, accrued expenses and other liabilities
|
$
20,608,748
|
|
$
25,560,756
|
Current portion of note payble
|
10,870,170
|
|
7,942,945
|
Current portion of deferred royalty revenues
|
640,465
|
|
1,288,514
|
Total current
liabilities
|
32,119,383
|
|
34,792,215
|
Accrued expenses and
other liabilities, net of current portion
|
1,611,046
|
|
1,393,075
|
Note
Payable
|
18,596,831
|
|
21,422,163
|
Total
liabilities
|
52,327,260
|
|
57,607,453
|
Total stockholders' equity
|
8,943,356
|
|
18,471,554
|
TOTAL LIABILITIES
AND STOCKHOLDERS' EQUITY
|
$
61,270,616
|
|
$
76,079,007
|
AVANIR
PHARMACEUTICALS, INC.
|
CONDENSED
STATEMENT OF OPERATIONS
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
2013
|
|
2012
|
REVENUES
|
|
|
|
Net
product sales
|
$
23,299,027
|
|
$
14,879,262
|
Revenues
from royalties
|
2,089,314
|
|
1,626,010
|
Revenues
from copromote activities
|
1,358,078
|
|
-
|
Revenue
from research grant services
|
-
|
|
15,000
|
Total revenues
|
26,746,419
|
|
16,520,272
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
Cost of
product sales
|
1,292,411
|
|
838,129
|
Cost of
research grant services
|
-
|
|
9,398
|
Research
and development
|
9,525,320
|
|
6,648,091
|
Selling
and marketing
|
17,475,404
|
|
13,522,419
|
General
and administrative
|
8,449,890
|
|
6,538,403
|
Total operating expenses
|
36,743,025
|
|
27,556,440
|
|
|
|
|
Loss from
operations
|
(9,996,606)
|
|
(11,036,168)
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
Interest
income
|
4,552
|
|
19,331
|
Interest
expense
|
(954,895)
|
|
(1,059,245)
|
Other,
net
|
412
|
|
-
|
|
|
|
|
Loss before
provision for income taxes
|
(10,946,537)
|
|
(12,076,082)
|
|
|
|
|
Provision for income taxes
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
$
(10,946,537)
|
|
$
(12,076,082)
|
|
|
|
|
Basic and diluted
net loss per share
|
$
(0.07)
|
|
$
(0.09)
|
|
|
|
|
Basic and diluted
weighted average number of common shares
outstanding
|
152,100,388
|
|
136,772,557
|
SOURCE Avanir Pharmaceuticals, Inc.