Attached files
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| 8-K - CURRENT REPORT - NOVADEL PHARMA INC | form8k3510.htm |
Exhibit
99.1
NovaDel
Reports Financial Results for Year Ended December 31, 2009
Bridgewater, NJ – March 4, 2010 -
NovaDel Pharma Inc. (the “Company”) (OTCBB: NVDL), a specialty
pharmaceutical company developing oral spray formulations for a number of
marketed products, reported financial results for the year ended December 31,
2009. For the year ended December 31, 2009, the Company reported a
net loss of $7.6 million, or $0.12 cents per share, compared to a net loss of
$9.6 million, or $0.16 per share, for the year ended December 31,
2008. Cash and cash equivalents totaled $2.7 million at December 31,
2009.
Highlights
during the 2009 fiscal year included:
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·
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Entered
into licensing agreements with Mist Acquisition, LLC and ECR
Pharmaceuticals Company, Inc. to manufacture and commercialize NitroMist™
and ZolpiMist™, respectively.
|
|
·
|
Entered
into an agreement with Seaside 88, LP to purchase up to 13.0 million
shares of common stock.
|
|
·
|
Entered
into an agreement with ProQuest Investments L.P. to convert the
outstanding convertible notes and associated liquidated damages notes and
accrued interest into shares of the Company’s common
stock.
|
Steven B.
Ratoff, the Company’s Chairman and Chief Executive Officer, said “The licensing
of Nitromist and Zolpimist as well as the strengthening of our balance sheet
provides a solid foundation for accelerating our product development,
particularly development of Duromist, a sildenafil citrate oral spray for
erectile dysfunction. Furthermore, we look forward to the commercialization of
our approved products with the expectation that our partners will formally
launch Nitromist and Zolpimist in the second half of 2010.”
Financial
Results
Total
revenues for the years ended December 31, 2009 and 2008 were $0.4
million.
Research
and development expenses decreased from $3.9 million for the year ended December
31, 2008 to $2.5 million for the year ended December 31, 2009. The Company
limited its expenditures to support NitroMist™ and ZolpiMist™. As the
Company continued its efforts to manage costs, general and administrative
expenses decreased to $4.0 million for the year ended December 31, 2009, as
compared to $4.7 million for the year ended December 31, 2008. Total
operating expenses for the year ended December 31, 2009 were $6.5 million, as
compared to $9.0 million for the year ended December 31, 2008.
Net loss
on other items for the year ended December 31, 2009, was $0.4 million consisting
of $0.7 million loss on the disposition of fixed assets and non-cash income of
$0.3 million relating to expiration of certain warrants. Interest
expense for the year ended December 31, 2009 was $2.2 million, primarily related
to the conversion of convertible notes and accrued interest associated with such
notes.
The
Company strengthened its Balance Sheet at December 31, 2009 with the conversion
of $3.7 million of convertible notes and related accrued interest and the
receipt of $4.0 million of non- refundable licensee fees during the fourth
quarter. The license fees are reported as current portion of deferred
revenue at December 31, 2009.
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. (OTCBB: NVDL), 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 ability of third parties to commercialize the Company’s
products, the successful completion of its pilot pharmacokinetic feasibility
studies, the ability to develop products (independently and through
collaborative arrangements), the Company’s ability to obtain additional required
financing to fund its research programs, 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 2009 financial results and its product
pipeline, please review the Company’s SEC filings on Form 10-Q at the Investor
Relations section of www.novadel.com.
Contacts:
Steven B.
Ratoff
(908)
203-4640
Chairman
and Chief Executive Officer
NovaDel
Pharma Inc.
sratoff@novadel.com
NOVADEL
PHARMA INC.
BALANCE
SHEETS
AS
OF DECEMBER 31, 2009 and 2008
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ASSETS
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December
31, 2009
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December
31, 2008
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||||||
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Current
Assets:
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||||||||
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Cash
and cash equivalents
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$ | 2,663,000 | $ | 4,328,000 | ||||
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Assets
held for sale
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— | 299,000 | ||||||
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Deferred
financing costs, net of accumulated amortization of
$213,000
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— | 25,000 | ||||||
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Prepaid
expenses and other current assets
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1,430,000 | 958,000 | ||||||
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Total
Current Assets
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4,093,000 | 5,610,000 | ||||||
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Property
and equipment, net
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324,000 | 1,447,000 | ||||||
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Other
assets
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36,000 | 259,000 | ||||||
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TOTAL
ASSETS
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$ | 4,453,000 | $ | 7,316,000 | ||||
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LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
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||||||||
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Current
Liabilities:
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||||||||
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Secured
convertible notes payable, net of unamortized discount of
$403,000
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$ | — | $ | 3,597,000 | ||||
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Accounts
payable
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195,000 | 654,000 | ||||||
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Accrued
expenses and other current liabilities
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117,000 | 924,000 | ||||||
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Current
portion of deferred revenue
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4,266,000 | 266,000 | ||||||
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Current
portion of capital lease obligations
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10,000 | 122,000 | ||||||
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Total
Current Liabilities
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4,588,000 | 5,563,000 | ||||||
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Non-current
portion of deferred revenue
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4,202,000 | 4,468,000 | ||||||
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Non-current
portion of capital lease obligations
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4,000 | 26,000 | ||||||
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Total
Liabilities
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8,794,000 | 10,057,000 | ||||||
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COMMITMENTS
AND CONTINGENCIES
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||||||||
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STOCKHOLDERS’
EQUITY (DEFICIT)
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||||||||
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Preferred
stock, $.001 par value:
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||||||||
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Authorized
1,000,000 shares, none issued
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— | — | ||||||
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Common
stock, $.001 par value:
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||||||||
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Authorized
200,000,000 shares, Issued 88,343,457 and 60,692,260 at December 31, 2009
and 2008, respectively
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89,000 | 60,000 | ||||||
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Additional
paid-in capital
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78,342,000 | 72,034,000 | ||||||
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Accumulated
deficit
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(82,766,000 | ) | (74,829,000 | ) | ||||
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Less: Treasury
stock, at cost, 3,012 shares
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(6,000 | ) | (6,000 | ) | ||||
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Total
Stockholders’ Equity (Deficit)
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(1,341,000 | ) | (2,741,000 | ) | ||||
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TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
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$ | 4,453,000 | $ | 7,316,000 | ||||
NOVADEL
PHARMA INC.
STATEMENTS
OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31, 2009 AND 2008
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Years
Ended December 31,
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||||||||||||
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2009
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2008
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2007
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License
Fees and Milestone Payments Earned from Related Parties
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$ | 422,000 | $ | 361,000 | $ | 469,000 | ||||||
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Research
and Development Expenses
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2,473,000 | 3,878,000 | 11,940,000 | |||||||||
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Consulting,
Selling, General and Administrative Expenses
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4,044,000 | 4,722,000 | 6,716,000 | |||||||||
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Loss
on Assets Held for Sale
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— | 351,000 | — | |||||||||
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Total
Expenses
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6,517,000 | 8,951,000 | 18,656,000 | |||||||||
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Loss
From Operations
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(6,095,000 | ) | (8,590,000 | ) | (18,187,000 | ) | ||||||
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Other,
net
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(385,000 | ) | — | (66,000 | ) | |||||||
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Interest
Expense
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(2,160,000 | (1,868,000 | ) | — | ||||||||
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Interest
Income
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6,000 | 137,000 | 632,000 | |||||||||
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Loss
Before Income Tax Benefit
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(8,634,000 | (10,321,000 | ) | (17,621,000 | ) | |||||||
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Income
Tax Benefit
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(1,057,000 | ) | (735,000 | ) | (658,000 | ) | ||||||
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Net
Loss
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$ | (7,577,000 | ) | $ | (9,586,000 | ) | $ | (16,963,000 | ) | |||
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Basic
and Diluted Loss Per Common Share
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$ | (0.12 | ) | $ | (0.16 | ) | $ | (0.29 | ) | |||
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Weighted
Average Number of Common Shares Used in Computation of Basic and Diluted
Loss Per Common Share
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61,345,671 | 59,592,000 | 59,497,000 | |||||||||