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8-K - FORM 8-K - AVANIR PHARMACEUTICALS, INC. | a58537e8vk.htm |
Exhibit 99.1
AVANIR PHARMACEUTICALS ANNOUNCES FISCAL 2011 FIRST QUARTER
FINANCIAL RESULTS
FINANCIAL RESULTS
ALISO VIEJO, Calif., February 3, 2011 AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR)
today reported unaudited financial results for the three months ended December 31, 2010.
For the first quarter of fiscal 2011, AVANIR reported a net loss of $12.1 million, or
$0.11 loss per share, compared with a net loss of $4.8 million, or $0.06 loss per share, for the
same period in fiscal 2010. Net revenues consisting primarily of royalty revenue were $1.8 million
and $1.5 million for the first quarter of fiscal 2011 and fiscal 2010, respectively. Total
operating expenses were $13.9 million in the first quarter of fiscal 2011, compared with $6.3
million in the comparable fiscal 2010 period. The increase in total operating expenses was
primarily attributed to costs incurred in preparation for the commercial launch of NUEDEXTA
(dextromethorphan hydrobromide and quinidine sulfate). Cash used in operations during the first
quarter of fiscal 2011 was $14.1 million.
During the past quarter we continued to focus our efforts on preparing for a successful launch of
NUEDEXTA, the first and only treatment for pseudobulbar affect, said Keith Katkin,
AVANIRs President and CEO. With NUEDEXTA now available through retail pharmacies across
the country and our experienced and dedicated sales force commencing physician promotion on
February 7, 2011, we are thrilled to finally have NUEDEXTA available by prescription for the many
patients in the U.S. suffering from PBA. We are confident that we have the right strategy,
resources and the sales and marketing expertise to ensure that NUEDEXTA is a long term commercial
success.
RECENT HIGHLIGHTS AND UPCOMING MILESTONES:
CLINICAL PROGRAMS AND PIPELINE
| Received FDA approval on October 29, 2010 for NUEDEXTA as the first and only treatment for PBA. | ||
| Announced that NUEDEXTA is now available by prescription at retail pharmacies in the United States and the Avanir sales force will initiate physician promotional activity on February 7, 2011. |
COMPANY OPERATIONS UPDATE
| The Company has completed the recruitment of the NUEDEXTA commercial team with 75 sales representatives, 7 sales managers, 9 managed care account managers and a director of trade relations. | ||
| Announced that the Wholesale Acquisition Cost (WAC) of NUEDEXTA is $489 per month of therapy. | ||
| Announced a suite of patient support services, including a reimbursement counseling hotline and a co-pay assistance program for NUEDEXTA. | ||
| Completed a public offering of the Companys common stock on November 22, 2010, raising $83.0 million in net proceeds to fund the launch of NUEDEXTA and ongoing company operations. |
BALANCE SHEET HIGHLIGHTS
As of December 31, 2010, AVANIR had cash, cash equivalents and investments in securities
totaling $119.0 million, including cash and cash equivalents of $117.7 million and restricted
investments in securities of $1.3 million.
Conference Call and Webcast
Management will host a conference call with a simultaneous webcast today beginning at 9:00 a.m.
Eastern Time / 6:00 a.m. Pacific Time to discuss its financial results and recent business
developments. The call will feature Keith Katkin, President and Chief Executive Officer; Randall
Kaye, MD, Senior Vice President and Chief Medical Officer; and Christine Ocampo, Vice President of
Finance to discuss financial results and answer questions. Investors are invited to listen to the
live webcast by visiting AVANIRs corporate website at www.avanir.com.
An archived copy of the webcast will be available on AVANIRs website for 30 days, and a
telephone replay will be available through February 8, 2011, by dialing (800) 642-1687 (domestic)
or (706) 645-9291 (international) and entering the conference ID number 40636357.
About NUEDEXTA
NUEDEXTA is the first and only FDA-approved treatment for pseudobulbar affect (PBA). 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 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 patients 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 Alzheimers disease and other
dementias. The primary outcome measure, laughing and crying episodes, was significantly lower in
the NUEDEXTA arm compared to placebo. The secondary outcome measure, the Center for Neurologic
Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score
from baseline for the NUEDEXTA arm compared to placebo.
NUEDEXTA Important Safety Information
NUEDEXTA can interact with other medications causing significant changes in blood levels of those
medications and/or NUEDEXTA. NUEDEXTA is contraindicated in patients receiving drugs that both
prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not
be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. NUEDEXTA is
contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have
taken MAOIs within the preceding 14 days. NUEDEXTA is contraindicated in patients with a known
hypersensitivity to its components.
NUEDEXTA may cause serious side effects, including possible changes in heart rhythm. NUEDEXTA is
contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history
suggestive of torsades de pointes, in patients with heart failure as well as patients with, or at
risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker.
NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk of QT
prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should
be conducted at baseline and 3-4 hours after the first dose.
The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough,
vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver
enzymes, and flatulence.
NUEDEXTA may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly
for patients with motor impairment affecting gait or a history of falls.
Patients should take NUEDEXTA exactly as prescribed. Patients should not take more than 2 capsules
in a 24- hour period, make sure that there is an approximate 12-hour interval between doses, and
not take a double dose after they miss a dose.
These are not all the risks from use of NUEDEXTA. For additional important safety information about
NUEDEXTA, please see the full Prescribing Information at www.NUEDEXTA.com.
About PBA
Patients suffering from existing neurological disease or brain injury may also suffer the added
burden of
pseudobulbar affect, or 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 patients underlying
emotional state. PBA outbursts result from a short circuit in the brain caused by another
neurologic conditionsuch as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), stroke,
or traumatic brain injury. PBA can have a debilitating impact on the lives of patients, caregivers
and loved ones. For more information about PBA, please visit
www.PBAinfo.org.
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.
About Forward-Looking Statements
Statements in this press release that are not historical facts, including statements that are
preceded by, followed by, or that include such words as estimate, intend, anticipate,
believe, plan, goal, expect, project, or similar statements, may be forward-looking
statements that are subject to certain risks and uncertainties that could cause actual results to
differ materially from the future results expressed or implied by such statements. These statements
include, but are not limited to, that we will successfully launch NUEDEXTA in February 2011 and the
safety and efficacy of NUEDEXTA. Risks that could cause actual results to differ include the
occurrence of adverse safety events with NUEDEXTA, that NUEDEXTA may not gain acceptance by the
medical field, our dependence on third parties for manufacturing and distribution of NUEDEXTA, that
we may not adequately build or maintain the necessary sales, marketing, supply chain management and
reimbursement capabilities on our own or enter into arrangements with third parties to perform
these functions in a timely manner or on acceptable terms, and other risks that are described in
further detail in our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on
Form 10-Q, and from time-to time in other publicly available information regarding the Company.
Copies of this information are available from us upon request. We disclaim any intent to update
these forward-looking statements.
All numbers disclosed in this press release are approximate.
AVANIR and NUEDEXTA are trademarks owned by AVANIR Pharmaceuticals, Inc.
©2011 AVANIR Pharmaceuticals, Inc. All Rights Reserved.
AVANIR Investor Contacts
Eric Benevich
Brenna Mullen
ir@avanir.com
949-389-6700
Eric Benevich
Brenna Mullen
ir@avanir.com
949-389-6700