NovaDel Reports Results For Fiscal 2004
10K Filing includes non-cash restatement of FY 2003
FLEMINGTON, N.J., Nov. 16 /PRNewswire-FirstCall/ --
NovaDel Pharma Inc.
(AMEX:NVD) reported results for the fiscal year ended July 31, 2004 and
restated results for fiscal 2003.
Net losses for the period were $6,341,000, or 24 cents per share, compared to
year-ago restated net losses of $6,956,000, or 45 cents per share. At July 31,
2004, the company had cash, cash equivalents, and investment securities of
$9,684,000, compared to $3,086,000 at July 31, 2003. As previously announced,
the company discovered that, as a result of a cashless option exercise
provision that had been approved in January 2002, its outstanding stock options
were subject to variable accounting under APB No. 25. This required the
company to restate its financials for all of the intervening reporting periods
in its current 10-K. While the overall impact of the variable accounting
treatment was deemed to be material, the changes were relevant only to non-cash
compensation expense and have no bearing on the company's cash flow, liquidity
or capital resources position or total shareholders' equity.
The company has revisited its option plan provisions and rescinded the
"cashless exercise" provision. Variable accounting is not anticipated to be
applied to the company's accounting after first quarter of fiscal 2005. The
company previously reported a net loss for fiscal 2003 of $5,815,000. As
restated, the net loss for fiscal 2003 of $6,956,000 includes a variable plan
accounting charge of $1,141,000. For fiscal 2004, the net loss of $6,341,000
was impacted by a variable plan accounting credit of $736,000.
Net cash used in operating activities for fiscal 2004 was $6,120,000 compared
to $4,320,000 in the year ago period. This increase was primarily attributable
to R&D expenditures which were $2,492,000, a substantial increase over the year
ago R&D expense of $1,087,000.
Commenting on the year, Gary A. Shangold, MD, NovaDel's president and chief
executive officer said, "We have made substantial progress on several fronts
during the past year. We submitted our first NDA and completed important proof
of concept studies on two of our Tier I priority projects, with another study
underway and two more studies to begin shortly. Further, our aggressive
business development efforts have resulted in multiple partnerships which will
generate revenue for the company while also helping to fund our product
development programs, as seen in our report for fiscal year 2004, during which
our R&D activity increased significantly."
Highlights of the fiscal year just ended and subsequent events include:
-- Submission of company's first New Drug Application to the US FDA which
was accepted for filing under PDUFA guidelines in September.
-- Execution of an aggressive business development strategy that led to
product partnerships with: (1) Par Pharmaceutical Companies (NYSE:PRX)
for nitroglycerin (for angina pectoris); and (2) Hana Biosciences, Inc.
(OTCBB: HNAB) for ondansetron, the leading anti-emetic.
-- A broad partnering and licensing agreement for animal health market
applications of NovaDel's lingual spray technology was entered into
with Velcera Pharmaceuticals, Inc.
-- Pilot studies of two other lingual spray candidates, sumatriptan and
alprazolam, were conducted; successful results of the sumatriptan study
were announced last month
-- A $14 million private placement was completed in January, key staff
positions were filled, including Jean Whitehead Frydman as vice
president and general counsel, facilities were expanded, and the
company's IP was strengthened with two new patents. The company has
been awarded five US and four international patents to date. A total of
28 applications are pending worldwide.
Commenting on 2005, Dr. Shangold said he expects it to be another year of key
accomplishments, with plans on schedule for achieving several important
business and clinical milestones.
-- The company's PDUFA date for a response from the US FDA on its lingual
spray nitroglycerin NDA is June 4, 2005. The product is partnered with
Par Pharmaceutical for the US and Canada. If approved as submitted, it
will be indicated for acute relief of an attack or acute prophylaxis of
angina pectoris due to coronary artery disease.
-- Pilot studies of lingual spray versions of ondansetron (the leading
antiemetic marketed as Zofran(R)), and zolpidem (the leading sleep-
inducing agent marketed as Ambien(R)) will be started shortly and
completed during the first half of 2005.
-- The pilot study of alprazolam (the leading anti-anxiety drug marketed
as Xanax(R)) will be completed before the end of 2004.
-- Preparation for an IND filing has begun and the clinical program is
expected to continue during 2005 for lingual spray sumatriptan (the
leading migraine remedy marketed as Imitrex(R)) in support of a
505(b)(2) NDA submission.
-- Velcera, the exclusive licensee for NovaDel's lingual spray delivery
technology for animal health applications, expects to start and
complete several pilot studies in preparation for expanded animal
trials and marketing approval.
-- Revenue increases in FY 2005 are anticipated to result from upfront
payments from new partnerships, milestone payments from existing
partnerships, and the potential for royalties from the company's
nitroglycerin partnership with Par Pharmaceutical, assuming timely FDA
approval.
About NovaDel
NovaDel Pharma Inc. is a specialty pharmaceutical company engaged in the
development of novel drug delivery systems for prescription and over-the-
counter drugs. The Company's proprietary lingual spray technology delivery
system offers the patient the potential for (i) fast onset of action; (ii)
improved drug safety by reducing the required drug dosage and reducing side
effects; (iii) improved patient convenience and compliance; and (iv) enhanced
dosage reliability. The Company plans to develop such products independently
and through collaborative arrangements with major pharmaceutical and biotech
companies. To find out more about NovaDel Pharma Inc. (AMX: NVD), visit our
website at http://www.novadel.com/.
Except for historical information contained herein, this document contains
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 lingual spray products.. 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. 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 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.
Contact:
Barry C. Cohen
VP Business & New Product Development
NovaDel Pharma Inc.
908.782-3431 x 2160
Thomas Redington
Redington, Inc.
203.222.7399
212.926.1733
DATASOURCE: NovaDel Pharma Inc.
CONTACT: Barry C. Cohen, VP Business & New Product Development of
NovaDel Pharma Inc. +1-908-782-3431 ext. 2160; or Thomas Redington of
Redington, Inc. for NovaDel, +1-203-222-7399, +1-212-926-1733, or
Web site: http://www.novadel.com/