NovaDel Reports Financial Results for the Year Ended December 31, 2008
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FLEMINGTON, N.J.--(Business Wire)--
NovaDel Pharma Inc. (NYSE Amex LLC: NVD), a specialty pharmaceutical company
developing oral spray formulations for a broad range of marketed treatments,
today reported financial results for the year ended December 31, 2008. For the
year ended December 31, 2008, the Company reported a net loss of $9.6 million,
or $0.16 cents per share, compared to a net loss of $17.0 million, or $0.29
cents per share, for the year ended December 31, 2007. Cash and cash equivalents
totaled $4.3 million at December 31, 2008.
On March 30, the Company filed with the SEC its Annual Report on Form 10-K,
which included an audit opinion with a "going concern" explanatory paragraph.
The going-concern explanatory paragraph from NovaDel`s independent registered
public accounting firm expressed substantial doubt, based upon current financial
resources, as to whether NovaDel can continue to meet its obligations beyond
2009 without access to additional working capital. The Company discusses this
matter, including its plans to address future financing needs, in its Annual
Report on Form 10-K.
Financial Results
Total revenues for the full year 2008 were $361,000, as compared to $469,000 for
the year ended December 31, 2007. The decrease was primarily due to a milestone
payment received in the year ended December 31, 2007 from our license agreement
with Velcera Pharmaceuticals.
Research and development expenses decreased from $11.9 million for the year
ended December 31, 2007 to $3.9 million for the year ended December 31, 2008.
The decrease was primarily attributable to lower expenses in the year ended
December 31, 2008 related to the Company`s New Drug Application (NDA) for
Zolpimist indicated for the treatment of insomnia which was approved by the FDA
on December 19, 2008. The Company has significantly reduced clinical development
activities on its product candidate pipeline, such that it has limited its
expenditures primarily to those required to support its two approved products
NitroMist and Zolpimist and minor expenditures to support formulation
development activities for certain other products. Consulting, selling, general
and administrative expenses decreased to $4.7 million for the year ended
December 31, 2008, as compared to $6.7 million for the year ended December 31,
2007 as we continued our efforts to manage our costs. Total operating expenses
for the year ended December 31, 2008 were $9.0 million, as compared to $18.7
million for the year ended December 31, 2007.
Interest income for the year decreased from $632,000 for the year ended December
31, 2007, to $137,000 for the year ended December 31, 2008, as a result of
significantly lower balances of cash and cash equivalents. Interest expense for
the year ended December 31, 2008 was $1,868,000, of which $1,837,000 related to
the convertible notes that were issued during 2008. This included $1,498,000
related to the amortization of the debt discount related to the beneficial
conversion feature and fair value of the warrants, as well as $213,000 related
to the amortization of the deferred financing costs. Income tax benefit for 2008
and 2007 reflects proceeds from the sale of state net operating losses.
ABOUT NOVADEL PHARMA
NovaDel Pharma Inc. is a specialty pharmaceutical company developing oral spray
formulations for a broad range of marketed drugs. The Company`s proprietary
technology offers, in comparison to conventional oral dosage forms, the
potential for faster absorption of drugs into the bloodstream leading to quicker
onset of therapeutic effects and possibly reduced first pass liver metabolism,
which may result in lower doses. Oral sprays eliminate the requirement for water
or the need to swallow, potentially improving patient convenience and adherence.
NovaDel`s oral spray technology is focused on addressing unmet medical needs for
a broad array of existing and future pharmaceutical products. The Company`s most
advanced oral spray candidates target angina, nausea, insomnia, migraine
headaches 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. (NYSE Amex LLC: NVD), visit our website at www.novadel.com.
FORWARD-LOOKING STATEMENTS:
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 successful completion of its pilot pharmacokinetic
feasibility 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 filing of an NDA with the FDA is an
important step in the approval process in the United States. Acceptance for
filing by the FDA does not mean that the NDA has been or will be approved, nor
does it represent an evaluation of the adequacy of the data submitted. Further,
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 most recent Annual
Report on Form 10-K and Registration Statements, 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.
For more detailed information regarding NovaDel`s 2008 financial results and its
product pipeline, please review the Company`s SEC filings on Form 10-K at the
Investor Relations section of www.novadel.com.
NOVADEL PHARMA INC.
STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED DECEMBER 31, 2008 AND DECEMBER 31, 2007
Year Ended
December 31, December 31,
2008 2007
License Fees and Milestone Payments Earned from Related Parties $ 361,000 $ 469,000
Research and Development Expenses 3,878,000 11,940,000
Consulting, Selling, General and Administrative Expenses 4,722,000 6,716,000
Loss on Assets Held for Sale 351,000 -
Total Operating Expenses 8,951,000 18,656,000
Loss From Operations (8,590,000 ) (18,187,000 )
Other Loss, net - (66,000 )
Interest Expense (1,868,000 ) -
Interest Income, net 137,000 632,000
Loss Before Income Tax Benefit (10,321,000 ) (17,621,000 )
Income Tax Benefit (735,000 ) (658,000 )
Net Loss $ (9,586,000 ) $ (16,963,000 )
Basic and Diluted Loss Per Common Share $ (0.16 ) $ (0.29 )
Weighted Average Number of Common Shares Used in Computation of Basic and Diluted Loss Per Common Share 59,592,000 59,497,000
NOVADEL PHARMA INC.
BALANCE SHEETS
AS OF DECEMBER 31, 2008 AND DECEMBER 31, 2007
ASSETS December 31, December 31,
2008 2007
Current Assets:
Cash and cash equivalents $ 4,328,000 $ 6,384,000
Assets held for sale 299,000 492,000
Deferred financing costs, net of accumulated amortization of $213,000 25,000 -
Prepaid expenses and other current assets 958,000 1,146,000
Total Current Assets 5,610,000 8,022,000
Property and equipment, net 1,447,000 1,972,000
Other assets 259,000 369,000
TOTAL ASSETS $ 7,316,000 $ 10,363,000
LIABILITIES AND STOCKHOLDERS` EQUITY
Current Liabilities:
Secured convertible notes payable, net of accumulated debt discount of $403,000 $ 3,597,000 $ -
Accounts payable 654,000 1,632,000
Accrued expenses and other current liabilities 924,000 2,267,000
Current portion of deferred revenue 266,000 148,000
Current portion of capitalized lease obligations 122,000 164,000
Total Current Liabilities 5,563,000 4,211,000
Non-current portion of deferred revenue 4,468,000 1,830,000
Non-current portion of capitalized lease obligations 26,000 148,000
Total Liabilities 10,057,000 6,189,000
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS` EQUITY
Preferred stock, $.001 par value:
Authorized 1,000,000 shares, none issued - -
Common stock, $.001 par value:
Authorized 200,000,000 shares, Issued 60,692,260 and 59,592,260 shares at December 31, 2008 and December 31, 2007, respectively 60,000 59,000
Additional paid-in capital 72,034,000 69,364,000
Accumulated deficit (74,829,000 ) (65,243,000 )
Less: Treasury stock, at cost, 3,012 shares (6,000 ) (6,000 )
Total Stockholders` Equity (2,741,000 ) 4,174,000
TOTAL LIABILITIES AND STOCKHOLDERS` EQUITY $ 7,316,000 $ 10,363,000
NovaDel Pharma Inc.
Deni M. Zodda, Ph.D., 908-782-3431 ext. 2424
Beginning April 1, 2009, Interim Chief Financial Officer
dzodda@novadel.com
Copyright Business Wire 2009
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