NovaDel Reports Unaudited Financial Results for the Nine Months Ended September 30, 2012
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- NovaDel Pharma Inc. (NVDL.PK) reported unaudited financial results for the nine months ended September 30, 2012.
As previously reported, the Company continues to seek financing or a strategic partner. The Company, at the end of March 2012, deregistered its common stock and exited the Securities and Exchange Commission reporting system.
The Company recorded a loss of $1,302,000 or $(0.01) per share for the nine months ended September 30, 2012 compared to a net loss of $6,425,000 or $(0.05) per share in the nine months ended September 30, 2011.
During the nine months of 2012, the Company earned royalties from the license of NitroMist and Zolpimist in the amount of $345,000. The Company also received $200,000 from the sale of NitroMist rights outside the US, Canada and Mexico. Also included in revenue is the recognition of previously received payments under various license agreements.
Expenses for the nine months ended September 30, 2012 were $2,010,000 as compared to $3,339,000 and include amounts to maintain our intellectual property base, FDA fees for our marketed products, as well as an expense under a severance agreement with a former officer of the Company. No product development activities have been undertaken this year. The company continues to closely manage its expenses as well as actively negotiating with its creditors to reduce its outstanding debts.
As of September 30, 2012, the Company has approximately $61,000 in cash and cash equivalents.
The accounts payable and accrued expenses of the Company, at September 30, 2012, of $2,396,000 include fees due to the FDA approximating $1,500,000. In October, 2012 the Company received an additional invoice from the FDA of $1,250,000 for fees relating to the period October 1, 2012 to September 30, 2013. The imposition of these fees is an impediment to our ability to raise capital to continue to develop our product opportunities or find a strategic partner. The Company has filed an appeal with the FDA for relief of the fees currently imposed and future fees relating to our licensed and marketed products. There is no assurance that our request will be granted nor are we certain as to the time frame for a response to our request of the FDA.
The remaining liabilities at September 30, 2012 of $6,298,000 primarily represent deferred revenue to be recognized over the term of various license agreements.
The Company is effectively insolvent and is actively engaged in seeking capital or a strategic relationship. To date this effort has not been successful.
ABOUT NOVADEL PHARMA
NovaDel Pharma Inc. is a specialty pharmaceutical company that develops oral spray formulations of marketed pharmaceutical products. The Company's patented oral spray drug delivery technology seeks to improve the efficacy, safety, patient compliance, and patient convenience for a broad range of prescription pharmaceuticals. NovaDel has two marketed products that have been approved by the FDA: NitroMist® for the treatment of angina, and Zolpimist™ for the treatment of insomnia. NovaDel's leading product candidate, DuroMist™, is being developed for the treatment of erectile dysfunction. The Company also has product candidates that target nausea, migraine headache and disorders of the central nervous system. NovaDel plans to develop these and other products independently and through collaborative arrangements with pharmaceutical and biotechnology companies. To find out more about NovaDel Pharma Inc. ( NVDL.PK), visit our website at www.novadel.com.
Except for historical information contained herein, this document may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks and uncertainties that may cause the Company's actual results or outcomes to be materially different from those anticipated and discussed herein including, but not limited to, the Company's ability to obtain additional required financing or achieve other strategic alternatives (the lack of which would cause the Company to file for bankruptcy), the ability of third parties to successfully commercialize the Company's products, the successful completion of its clinical trials, including pilot pharmacokinetic feasibility studies, the successful completion of its preclinical studies, the ability to develop products (independently and through collaborative arrangements), the ability to commercialize and obtain FDA and other regulatory approvals for products under development, and the acceptance in the marketplace for oral spray products. The Company operates in industries where securities may be volatile and may be influenced by regulatory and other factors beyond the Company's control.
In addition, our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any of our products could materially impact the Company's actual results. Important factors that the Company believes might cause such differences are discussed in the risk factors detailed in the Company's Quarterly Report on Form 10-Q for the period ended September 30, 2011 filed with the Securities and Exchange Commission. In assessing forward-looking statements contained herein, if any, the reader is urged to carefully read all cautionary statements contained in such filings. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
NOVADEL PHARMA INC.
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NOVADEL PHARMA INC.
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NovaDel Pharma Inc.
Steve Ratoff, 520-245-6905
KEYWORDS: United States North America New Jersey
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