EXHIBIT 99.1
FOR IMMEDIATE RELEASE
NASTECH ANNOUNCES FOURTH QUARTER AND 2003 FINANCIAL RESULTS
-CASH AND INVESTMENTS GROWS 278% AND R&D SPEND GROWS 47% FROM PRIOR YEAR-
BOTHELL, WA, MARCH 10, 2004 -- Nastech Pharmaceutical Company Inc. (Nasdaq:
NSTK), today announced a net loss of $5.9 million, or $0.50 per share for the
quarter ended December 31, 2003, compared to a net loss of $5.8 million, or
$0.57 per share for the fourth quarter of 2002. Total revenue for the fourth
quarter of 2003 was $911,000, a decrease of $846,000 from the fourth quarter of
2002. This decrease in revenue was partially offset by a $606,000 decrease in
operating expenses. Comparing expenses in Q4-2003 to Q4-2002, research and
development expense grew $2.3 million due to clinical trials and other
expenditures in support of our R&D programs, general and administrative expense
decreased $1.6 million and sales and marketing expense decreased $662,000.
Net loss for the full year 2003 was $2.1 million, or $0.20 per share, compared
to a net loss of $13.5 million, or $1.34 per share, for 2002. For 2003, total
revenue was $19.4 million compared to $8.9 million for 2002. The increase in
revenue for 2003 resulted primarily from a divestiture agreement with Pharmacia
under which Nastech reacquired all rights to Apomorphine Nasal Spray for Sexual
Dysfunction, and thereby recognized $16.3 million in connection with the
divestiture and collaboration agreements, compared to $7.4 million related to
the collaboration agreement in the same period of 2002.
Nastech ended 2003 with $25.1 million in cash, cash equivalents and investments
compared to $9.0 million at December 31, 2002.
"During 2003 and early 2004, we accelerated our most advanced and nearest-term
commercialization opportunities, including Calcitonin Nasal Spray for
osteoporosis, Apomorphine Nasal Spray for sexual dysfunction, and PYY Nasal
Spray for obesity," stated Steven C. Quay, M.D., Ph.D., Chairman, President, and
Chief Executive Officer. "The significant improvement in our working capital as
compared to the end of 2002 will help us achieve our near-term operating goals
for these important programs."
RECENT CORPORATE HIGHLIGHTS
- PYY 3-36 Nasal Spray for Obesity
In January 2004, Nastech initiated a Phase I-B dose-range finding study in
overweight healthy subjects. Today, the Company announced the successful
completion of this Phase I-B study. Results indicate that PYY significantly
reduces appetite, and significantly reduces calorie intake both at the lunch
meal 60 minutes after administration as well as for the entire 24-hour period.
PYY administration was well tolerated, with an acceptable side effect profile.
Detailed findings from this study will be discussed on today's conference call.
- Apomorphine Nasal Spray for Sexual Dysfunction
Today, Nastech announced that its Phase II Maximum Tolerated Dose clinical trial
reached completion and the results identify a dose that is safe and well
tolerated that is significantly above doses demonstrated in prior studies to
produce efficacy in erectile dysfunction. The results of this study support
moving forward with this sexual dysfunction clinical development program.
Detailed findings from this study will be discussed on today's conference call.
Nastech will seek a commercialization partner for this program before commencing
Phase 3 clinical trials.
- Calcitonin Nasal Spray for Osteoporosis
Nastech's ANDA filing was accepted for review by the FDA in February 2004.
Nastech is seeking a commercialization partner for this product.
- Tight Junction and siRNA Technologies
In February 2004, Nastech received a world-wide, non-exclusive license to the
Fire et al. patents and patent applications titled "Genetic Inhibition by
Double-Stranded RNA" (including U.S. Patent # 6,506,559 B1) from the Carnegie
Institute of Washington, D.C. Nastech is using small interfering RNA (siRNA)
technology in its tight junction research and to develop therapeutics based upon
siRNA technology. The Company will discuss its research programs in these areas
on today's conference call.
CONFERENCE CALL INFORMATION
Dr. Steven C. Quay will host a conference call reviewing the Company's year-end
financial results, product portfolio, including an update on the development
progress of the Company's obesity, osteoporosis, and sexual dysfunction
programs, and other business developments, on Wednesday, March 10th at 11:00
a.m. Eastern Time. To access the live call or the two-day archive via the
Internet, log on to http://www.nastech.com. Please connect to the Company's
website at least 15 minutes prior to the conference call to ensure adequate time
for any software download that may be needed to hear the webcast. We advise
turning off any pop-up blockers in order to access the call via the Internet.
Telephone replay is available approximately two hours after the call through
March 17, 2004. To access the replay, please call 800-428-6051 (U.S.) or
973-371-5319 (international). The conference ID number is 335861.
ABOUT NASTECH
Nastech Pharmaceutical Company Inc. is an emerging pharmaceutical company
developing products based on applying our proprietary drug delivery
technologies, with approximately 195 patents and applications filed. The Company
is developing molecular biology based technologies for delivering both small and
large molecule drugs by nasal administration, along with an extended release
oral delivery technology. The Company's intranasal drug delivery technology may
lead to greater drug efficacy, speed of action, safety, and patient compliance.
Nastech is developing a diverse product portfolio across multiple therapeutic
areas, including products targeted for the treatment of male and female sexual
dysfunction, obesity, pain management, osteoporosis, and multiple sclerosis.
Additional information about Nastech is available at http://www.Nastech.com.
NASTECH SAFE HARBOR STATEMENT
Statements contained herein that are not historical fact may be forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended,
that are subject to a variety of risks and uncertainties. There are a number of
important factors that could cause actual results to differ materially from
those projected or suggested in any forward-looking statement made by the
Company. These factors include, but are not limited to: (i) the ability of the
Company to obtain additional funding; (ii) the ability of the Company to attract
and/or maintain manufacturing, research, development and commercialization
partners; (iii) the Company's and/or a partner's ability to successfully
complete product research and development, including pre-clinical and
clinical studies and commercialization; (iv) the Company's and/or a partner's
ability to obtain required governmental approvals, including product and patent
approvals; and (v) the Company's and/or the Company's partner's ability to
develop and commercialize products that can compete favorably with those of
competitors. In addition, significant fluctuations in quarterly results may
occur as a result of the timing of milestone payments, the recognition of
revenue from Milestone payments and other sources not related to product sales
to third parties, and the timing of costs and expenses related to the Company's
research and development program. Additional factors that would cause actual
results to differ materially from those projected or suggested in any
forward-looking statements are contained in the Company's filings with the
Securities and Exchange Commission, including those factors discussed under the
caption "Risk Factors" in the Company's most recent Annual Report on Form 10-K
and Quarterly Reports on Form 10-Q, which the Company urges investors to
consider. The Company undertakes no obligation to publicly release the revisions
in such forward-looking statements that may be made to reflect events or
circumstances after the date hereof or to reflect the occurrences of
unanticipated events or circumstances, except as otherwise required by
securities and other applicable laws.
# # #
CONTACT:
Matthew D. Haines
Director, Corporate Communications
(212) 297-6198
mhaines@nastech.com
Burns McClellan
Aline Schimmel (Investors)
Kathy L. Jones, Ph.D. (Media)
(212) 213-0006
TABLE FOLLOWS
NASTECH PHARMACEUTICAL COMPANY INC.
SELECTED FINANCIAL INFORMATION
Statement of Operations Data (in thousands, except per share amounts)
TWELVE MONTHS ENDED QUARTER ENDED
DECEMBER 31, DECEMBER 31,
(UNAUDITED) (UNAUDITED)
---------------------- ----------------------
2003 2002 2003 2002
-------- -------- -------- --------
Revenue:
Product revenue, net ..................... $ 1,805 $ 1,408 $ 8 $ 916
License and research fees ............... 17,635 7,515 903 841
-------- -------- -------- --------
Total revenue .......................... 19,440 8,923 911 1,757
-------- -------- -------- --------
Operating expenses:
Cost of product revenue .................. 498 289 63 133
Research and development ................. 17,097 11,622 5,141 2,860
Sales and marketing ...................... 2,377 1,863 262 924
General and administrative ............... 5,679 8,138 1,378 2,938
Restructuring charge ..................... -- 595 -- 595
-------- -------- -------- --------
Total operating expenses ............... 25,651 22,507 6,844 7,450
-------- -------- -------- --------
Net loss from operations .................... (6,211) (13,584) (5,933) (5,693)
Gain on sale of intangible asset ............ 4,236 -- -- --
Interest income ............................. 227 278 71 48
Interest expense ............................ (393) (162) (55) (149)
-------- -------- -------- --------
Net loss .................................... $ (2,141) $(13,468) $ (5,917) $ (5,794)
======== ======== ======== ========
Net loss per common share - basic and diluted $ (0.20) $ (1.34) $ (0.50) $ (0.57)
======== ======== ======== ========
Shares outstanding- basic and diluted ....... 10,751 10,028 11,839 10,190
======== ======== ======== ========
DECEMBER 31, DECEMBER 31,
BALANCE SHEET DATA 2003 2002
-------- --------
Cash and cash equivalents $ 16,792 $ 9,021
Investments 8,289 --
Property, intangibles and other assets $ 6,057 $ 14,029
Total assets $ 31,138 $ 23,050
Working capital $ 14,766 $ 3,342
Accumulated deficit $(54,844) $(52,703)
Stockholders' equity $ 17,906 $ 8,645