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8-K - FORM 8-K - AVANIR PHARMACEUTICALS, INC. | a55997e8vk.htm |
EXHIBIT 99.1
AVANIR PHARMACEUTICALS ANNOUNCES FISCAL 2010 SECOND
QUARTER FINANCIAL RESULTS
QUARTER FINANCIAL RESULTS
*COMPLETE RESPONSE TO THE OCTOBER 30, 2006 ZENVIA NDA APPROVABLE
LETTER FILED WITH FDA*
LETTER FILED WITH FDA*
ALISO VIEJO, Calif., May 3, 2010 Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today
reported unaudited financial results for the three and six months ended March 31, 2010.
For the second quarter of fiscal 2010, Avanir reported a net loss of $6.4 million, or
$0.08 loss per share, compared with a net loss of $4.9 million, or $0.06 loss per share, for the
same period in fiscal 2009. Net revenues for the second quarter of fiscal 2010 were $1.0 million,
compared with $812,000 for the same period in fiscal 2009. Total operating expenses were $7.4
million in the second quarter of fiscal 2010, compared with $5.8 million in the comparable fiscal
2009 period. The increase in total operating expenses was primarily due to costs associated with
Zenvia pre-commercialization expenses. Cash used in operations during the second quarter of fiscal
2010 was $4.7 million.
For the first six months of fiscal 2010, Avanir reported a net loss of $11.3 million, or
$0.14 per share, compared with a net loss of $10.1 million, or $0.13 per share for the comparable
period in fiscal 2009. Total net revenues for the first six months of fiscal 2010 were $2.5
million compared with $2.6 million for the first six months of fiscal 2009. Total operating
expenses were $13.8 million in the first six months of fiscal 2010, compared to $12.8 million in
the comparable fiscal 2009 period. In addition, cash used in operations was $11.2 million in the
first six months of fiscal 2010 and $11.2 million in the first six months of fiscal 2009.
We continue to make excellent progress with our Zenvia clinical development program in PBA and are
very excited that we have filed our Complete Response with the FDA, said Keith Katkin,
Avanirs President and CEO. With the FDA decision on the PBA application expected before
the end of the year, we are now engaging in market development activities to support a commercial
launch planned for the first quarter of 2011. The recent issuance of a new U.S. patent gives us
additional intellectual property protection which sets the stage for approximately 15 years of
revenue generation after our planned launch. Overall, we believe that we are well positioned to
create substantial value for our stockholders and potentially help the significant number of
patients in the U.S. who are currently suffering from PBA.
RECENT HIGHLIGHTS AND UPCOMING MILESTONES:
CLINICAL PROGRAMS AND PIPELINE
Zenvia in PBA
| Announced that the Company filed the Complete Response to the October 30, 2006 NDA Approvable Letter with an approval decision on the PBA application consequently expected in the fourth calendar quarter of 2010. | ||
| Presented detailed Zenvia safety and efficacy data from the double-blind and open-label extension of the Phase III confirmatory STAR trial in three data posters at the American Academy of Neurology Annual Meeting in Toronto. |
COMPANY OPERATIONS
| Announced that the United States Patent and Trademark Office issued the Company a new patent in the United States that extends patent protection for Zenvia in the treatment of PBA into late 2025. | ||
| Announced that the Company hired Michael McFadden as Vice President of U.S. Sales and Managed Markets to construct, staff and lead the Avanir field sales and managed care account teams. |
BALANCE SHEET HIGHLIGHTS
As of March 31, 2010, Avanir had cash, cash equivalents and investments in securities
totaling $20.7 million, including cash and cash equivalents of $20.3 million and restricted
investments in securities of approximately $402,000.
Conference Call and Webcast
Management will host a conference call with a simultaneous webcast today beginning at 11:00 a.m.
Eastern Time / 8:00 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 May 8, 2010, by dialing (800) 642-1687 (domestic) or
(706) 645-9291 (international) and entering the conference ID number 71373523.
About Avanir
AVANIR Pharmaceuticals, Inc., is a biopharmaceutical company focused on acquiring, developing, and
commercializing novel therapeutic products for the treatment of central nervous system disorders.
AVANIRs lead product candidate, Zenvia, has completed a confirmatory Phase III trial in the
treatment
of pseudobulbar affect (PBA) and has successfully completed a Phase III trial for
diabetic peripheral neuropathic (DPN) pain. AVANIR has filed an application for regulatory approval in the PBA
indication and expects an FDA approval decision in the fourth calendar quarter of 2010. AVANIR
sold its anthrax monoclonal antibody program to Emergent BioSolutions. The Companys first
commercialized product, Abreva® (docosanol), is marketed in North America by GlaxoSmithKline
Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores.
Further information about AVANIR can be found at www.avanir.com and further information about
pseudobulbar affect can be found at www.PBAinfo.org.
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, are 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. For example,
there can be no assurance that the U.S. Food and Drug Administration (FDA) will approve Zenvia for
any indication, that the Company will meet projected timelines, or that the Companys patents will
provide the expected patent protection. Risks and uncertainties affecting the Companys financial
condition and operations also include the risks set forth in Avanirs 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 Avanir upon request. Avanir disclaims any intent to update these
forward-looking statements.
To be included on Avanirs e-mail alert list; click on the link below or visit
Avanirs website:
http://www.b2i.us/irpass.asp?BzID=958&to=ea&s=0
Avanir Investor Contacts
Eric Benevich
Brenna Mullen
ir@avanir.com
(949) 389-6700
Eric Benevich
Brenna Mullen
ir@avanir.com
(949) 389-6700