ALISO VIEJO, Calif.,
May 6, 2014 /PRNewswire/
-- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today
reported financial results for the three and six months ended
March 31, 2014.
Quarterly Financial Highlights
- Total company net revenues of $26.9
million
- Net NUEDEXTA® sales of $24.4
million
- Cash, cash equivalents, and restricted investments of
$56.5 million as of March 31, 2014.
"We are extremely pleased with the recent outcome of the
NUEDEXTA ANDA litigation," said Keith A.
Katkin, president and CEO of Avanir. "With this patent
litigation behind us and 12-plus years of market exclusivity, we
are committed to investing in the NUEDEXTA business to maximize the
long term revenue potential. NUEDEXTA has brought relief to tens of
thousands of patients suffering from PBA and achieved its twelfth
successive sequential quarter over quarter growth. Through
the remainder of 2014 we anticipate reporting on important results
from our two ongoing phase II studies and the PRISM2 study."
Fiscal 2014 Second Quarter Results
- Total net revenues for the second quarter fiscal 2014 were
$26.9 million, compared with
$17.4 million for the comparable
quarter in fiscal 2013, representing 55 percent year-over-year
growth. Total net revenues consist of NUEDEXTA revenue, Abreva®
royalties and co-promotion revenues.
- Total operating expenses were $38.7
million in the second quarter of fiscal 2014, compared with
$32.9 million in the comparable
period in fiscal 2013.
- Cash used in operations was $15.7
million in the second quarter of fiscal 2014.
- Net loss for the fiscal 2014 second quarter was $12.7 million, or $0.08 per share, compared with a net loss of
$16.5 million, or $0.12 per share, for the same period in fiscal
2013.
Fiscal 2014 Six-Month Results
- Total net revenues for the first six-months of fiscal 2014
totaled $53.7 million, compared with
$34.0 million for the first six
months of fiscal 2013.
- Total operating expenses were $75.5
million in the first six-months of fiscal 2014, compared to
$60.5 million in the comparable
period for fiscal 2013.
- Cash used in operations was $25.5
million in the first six months of fiscal 2014.
- Net loss for the first six-months of fiscal 2014 was
$23.6 million, or $0.15 per share, compared with a net loss of
$28.6 million, or $0.21 per share for the comparable period in
fiscal 2013.
Cash, Cash Equivalents & Marketable Securities
As
of March 31, 2014 Avanir had cash,
cash equivalents and investments in securities totaling
$56.5 million, including cash and
cash equivalents of $53.9
million.
Quarter and Recent Business Highlights
- Submitted and received acceptance of 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. The company has received a PDUFA date of
November 26, 2014.
- Presented data from a benchmark study of veterans with mild
traumatic brain injury, showing that approximately 60 percent of
758 respondents reported PBA symptoms, characterized by the
presence of involuntary, uncontrollable episodes of crying and/or
laughing that were exaggerated or even contrary to how they felt at
the time. In addition to patient burden, the data show that
presence of PBA symptoms are associated with increased health care
costs.
- Announced the addition of Dr. Mark
Corrigan to the company's board of directors.
- Announced the publication of research showing dextromethorphan
has antidepressant-like effects in vivo. The data shows that
dextromethorphan exerts antidepressant-like actions mediated at
least in part through sigma-1 receptors.
- Showcased the company's central nervous system therapeutic
franchise at the 66th Annual Meeting of the American Academy of
Neurology.
Note to Investors: As previously announced, Avanir will
hold a conference call to discuss fiscal 2014 second quarter
financial results today, May 6, 2014,
beginning at 1:30 p.m. Pacific Time.
You can listen to this call by dialing 1 (866) 318-8614 for
domestic callers or +1 (617) 399-5133 for international callers,
and entering passcode 89833749. 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. AVP-825 is an investigational drug-device
combination product not approved by the FDA. In the phase III
clinical trial the most common AEs (incidence >5%) reported for
AVP-825 were product taste (22%), nasal discomfort (13%), and
rhinitis (6%); local AEs were almost exclusively mild to moderate
in severity and transient. Sumatriptan is contraindicated for
certain patients, including those with a history of coronary artery
disease (CAD) or coronary vasospasm.
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
|
|
|
|
|
|
March
31,
|
|
September
30,
|
|
2014
|
|
2013
|
|
(unaudited)
|
|
(audited)
|
ASSETS
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
53,888,058
|
|
$
55,259,073
|
Restricted cash and cash
equivalents
|
1,318,033
|
|
965,986
|
Trade receivables,
net
|
17,215,906
|
|
12,525,992
|
Inventories, net
|
640,853
|
|
710,179
|
Prepaid expenses and other
current assets
|
4,629,980
|
|
2,382,410
|
Total current assets
|
77,692,830
|
|
71,843,640
|
Restricted long-term
investments
|
1,303,580
|
|
1,303,938
|
Property and
equipment, net
|
3,153,568
|
|
1,592,791
|
Non-current
inventories, net
|
773,129
|
|
784,186
|
Other
assets
|
686,154
|
|
554,452
|
TOTAL
ASSETS
|
$
83,609,261
|
|
$
76,079,007
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Current
liabilities:
|
|
|
|
Accounts payable, accrued expenses and other liabilities
|
$
26,902,884
|
|
$
25,560,756
|
Current portion of note payble
|
11,158,907
|
|
7,942,945
|
Current portion of deferred royalty revenues
|
178,786
|
|
1,288,514
|
Total current
liabilities
|
38,240,577
|
|
34,792,215
|
Accrued expenses and
other liabilities, net of current portion
|
2,019,000
|
|
1,393,075
|
Note
Payable
|
15,696,511
|
|
21,422,163
|
Total
liabilities
|
55,956,088
|
|
57,607,453
|
Total stockholders' equity
|
27,653,173
|
|
18,471,554
|
TOTAL LIABILITIES
AND STOCKHOLDERS' EQUITY
|
$
83,609,261
|
|
$
76,079,007
|
|
|
|
|
|
|
|
AVANIR
PHARMACEUTICALS, INC.
|
CONDENSED
STATEMENT OF OPERATIONS
|
|
|
Three Months Ended
March 31,
|
|
Six Months Ended
March 31,
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
REVENUES
|
|
|
|
|
|
|
|
Net
product sales
|
$
24,379,159
|
|
$
16,535,059
|
|
$
47,678,186
|
|
$
31,414,321
|
Revenues
from royalties
|
475,281
|
|
899,129
|
|
2,564,595
|
|
2,525,139
|
Revenue
from co-promotion with Merck
|
2,092,264
|
|
-
|
|
3,450,342
|
|
-
|
Revenue
from research grant services
|
-
|
|
-
|
|
-
|
|
15,000
|
Total revenues
|
26,946,704
|
|
17,434,188
|
|
53,693,123
|
|
33,954,460
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Cost of
product sales
|
1,370,001
|
|
933,426
|
|
2,662,412
|
|
1,771,555
|
Cost of
research grant services
|
-
|
|
69,090
|
|
-
|
|
78,488
|
Research
and development
|
9,892,256
|
|
8,874,298
|
|
19,417,576
|
|
15,522,389
|
Selling
and marketing
|
18,904,244
|
|
16,061,408
|
|
36,379,648
|
|
29,583,827
|
General
and administrative
|
8,555,381
|
|
6,978,684
|
|
17,005,271
|
|
13,517,087
|
Total operating expenses
|
38,721,882
|
|
32,916,906
|
|
75,464,907
|
|
60,473,346
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(11,775,178)
|
|
(15,482,718)
|
|
(21,771,784)
|
|
(26,518,886)
|
|
|
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
|
|
Interest
income
|
4,987
|
|
15,065
|
|
9,539
|
|
34,396
|
Interest
expense
|
(898,316)
|
|
(1,059,245)
|
|
(1,853,211)
|
|
(2,118,490)
|
Other,
net
|
(9,249)
|
|
197
|
|
(8,837)
|
|
197
|
|
|
|
|
|
|
|
|
Loss before
provision for income taxes
|
(12,677,756)
|
|
(16,526,701)
|
|
(23,624,293)
|
|
(28,602,783)
|
|
|
|
|
|
|
|
|
Provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
$
(12,677,756)
|
|
$
(16,526,701)
|
|
$
(23,624,293)
|
|
$
(28,602,783)
|
|
|
|
|
|
|
|
|
Basic and diluted
net loss per share
|
$
(0.08)
|
|
$
(0.12)
|
|
$
(0.15)
|
|
$
(0.21)
|
|
|
|
|
|
|
|
|
Basic and diluted
weighted average number of common shares
outstanding
|
154,633,853
|
|
139,173,746
|
|
153,353,200
|
|
137,959,958
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Logo -
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SOURCE Avanir Pharmaceuticals, Inc.