Novadel (AMEX:NVD)
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5 Years : From May 2008 to May 2013
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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