NovaDel Pharma Inc. (the “Company”) (NYSE AMEX: NVD), a
specialty pharmaceutical company developing oral spray formulations
for a broad range of marketed treatments, reported financial
results for its third quarter and nine months ended September 30,
2009. For the quarter and nine months ended September 30, 2009,
NovaDel reported a net loss of $1.4 million, or $0.02 per share,
and $5.2 million, or $0.09 per share, respectively, compared to a
net loss of $2.5 million, or $0.04 per share, and $7.7 million, or
$0.13 per share, respectively, for the quarter and nine months
ended September 30, 2008.
For the quarter ended September 30, 2009, the loss from
operations was $1.4 million as compared to $2.5 million for the
quarter ended September 30, 2008. The decrease of $1.1 million is
attributable to further reductions in overall spending as the
Company has postponed project related activities due to resource
constraints.
As of September 30, 2009, NovaDel’s cash and cash equivalents
were $0.3 million. The Company had negative working capital of
$(4.2) million as of September 30, 2009, as compared to working
capital of $0.1 million as of December 31, 2008, representing a net
decrease in working capital of approximately $(4.3) million,
principally due to the net cash used in operations of $(3.6)
million, the $1.0 million payment to ProQuest against the First
Tranche Notes slightly offset by the proceeds of $0.7 million
received from Seaside 88, LP related to the stock purchase
agreement dated June 26, 2009.
On October 27, 2009, the Company entered into a licensing
agreement with privately-held Mist Acquisition, LLC to manufacture
and commercialize the NitroMist lingual spray version of
nitroglycerine, a widely-prescribed and leading short-acting
nitrate for the treatment of angina pectoris. Under the terms of
the agreement, the Company received a $1,000,000 licensing fee upon
execution of the agreement, and will receive milestone payments
totaling an additional $1,000,000 over the next twelve months and
ongoing performance payments of up to seventeen percent (17%) of
net sales.
Today we also announced an exclusive license and distribution
agreement with ECR Pharmaceuticals Company, Inc., a wholly owned
subsidiary of Hi-Tech Pharmacal Co., Inc. to commercialize and
manufacture ZolpiMist™ in the United States and Canada. ZolpiMist™
is our oral spray formulation of zolpidem tartrate approved by the
FDA in December of 2008.
Under the terms of the agreement, ECR paid NovaDel $3 million
upon the execution of the agreement. ECR will assume responsibility
for manufacturing and marketing the product in the United States
and Canada. In addition, ECR will pay royalties of up to 15% on net
sales of ZolpiMist™ as well as an additional milestone payment if
sales reach a specified level.
Steven B. Ratoff, Chairman and Interim CEO said, “We believe
that these two agreements will allow us to initiate further
development of our product pipeline utilizing our patented
NovaMist™ oral spray technology.”
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: 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 ability of third parties to commercialize
the Company's products, the successful completion of its pilot
pharmacokinetic feasibility studies, the Company's ability to
develop product candidates (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.
NOVADEL PHARMA INC.
CONDENSED STATEMENTS OF
OPERATIONS
FOR THE THREE MONTHS AND NINE
MONTHS ENDED
SEPTEMBER 30, 2009 AND
SEPTEMBER 30, 2008
(UNAUDITED)
Three Months Ended Nine
Months Ended
September 30,
2009
September 30,
2008
September 30,
2009
September 30,
2008
License Fees and Milestone
FeesEarned
$223,000 $104,000 $356,000 $258,000
Research and Development Expenses 530,000 705,000 1,980,000
3,151,000
Consulting, Selling, General
andAdministrative Expenses
973,000 1,164,000 3,167,000 3,473,000 Loss on Assets Held-for-Sale
— 9,000 — 351,000 Total Expenses
1,503,000 1,878,000 5,147,000 6,975,000
Loss From Operations (1,280,000) (1,774,000) (4,791,000)
(6,717,000) Other Income — — 301,000 — Interest Expense
(81,000) (750,000) (717,000) (1,044,000) Interest Income —
21,000 6,000 84,000 Net Loss $(1,361,000)
$(2,503,000) $(5,201,000) $(7,677,000)
Basic and Diluted Loss Per
CommonShare
$(0.02) $(0.04) $(0.09) $(0.13)
Weighted Average Number ofCommon
Shares Used inComputation of Basic and DilutedLoss Per Common
Share
61,385,722 59,592,000 60,458,548 59,592,000
NOVADEL PHARMA INC.
CONDENSED BALANCE
SHEETS
AS OF SEPTEMBER 30, 2009
(UNAUDITED) AND DECEMBER 31, 2008
ASSETS
September 30, 2009
(unaudited)
December 31, 2008
Current Assets: Cash and cash equivalents $327,000 $4,328,000
Assets held-for-sale 299,000 299,000
Deferred financing costs, net of
accumulated amortization of $238,000and $213,000, respectively
— 25,000 Prepaid expenses and other current assets 553,000
958,000 Total Current Assets 1,179,000 5,610,000 Property
and equipment, net 1,060,000 1,447,000 Other assets 32,000
259,000 TOTAL ASSETS $2,271,000 $7,316,000
LIABILITIES AND STOCKHOLDERS’ DEFICIENCY Current Liabilities:
Secured convertible notes payable,
net of unamortized debt discount ofzero and $403,000,
respectively
$3,000,000 $3,597,000 Notes payable 159,000 — Accounts payable
924,000 654,000 Accrued expenses and other current liabilities
1,019,000 924,000 Current portion of deferred revenue 266,000
266,000 Current portion of capital lease obligations 34,000
122,000 Total Current Liabilities 5,402,000 5,563,000
Non-current portion of deferred revenue 4,269,000 4,468,000
Non-current portion of capital lease obligations 7,000
26,000 Total Liabilities 9,678,000 10,057,000
COMMITMENTS AND CONTINGENCIES STOCKHOLDERS’ DEFICIENCY
Preferred stock, $.001 par value: Authorized 1,000,000 shares, none
issued — — Common stock, $.001 par value:
Authorized 200,000,000, issued
63,606,374 and 60,692,260 shares atSeptember 30, 2009 and December
31, 2008, respectively
64,000 60,000 Additional paid-in capital 72,925,000 72,034,000
Accumulated deficit (80,390,000) (74,829,000) Less: treasury stock,
at cost, 3,012 shares (6,000) (6,000) Total Stockholders’
Deficiency (7,407,000) (2,741,000) TOTAL LIABILITIES
AND STOCKHOLDERS’ DEFICIENCY $2,271,000 $7,316,000
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