Nastech Announces Fourth Quarter and Full Year 2007 Financial Results
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Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) today reported
financial results for the fourth quarter and year ended December 31,
2007.
Revenue for the three months ended December 31, 2007 was $6.4 million,
compared to $4.8 million for the quarter ended December 31, 2006. The
fourth quarter 2007 period included recognition of approximately $5.5
million in previously deferred revenue related to our Parathyroid
Hormone (PTH1-34) nasal spray collaboration with
Procter & Gamble Pharmaceuticals, Inc. ("P&G”).
Revenue for the year ended December 31, 2007 was $18.1 million, compared
to $28.5 million for the year ended December 31, 2006.
In addition to the $5.5 million in previously deferred revenue
recognized in the fourth quarter of 2007, the 2007 period included
receipt and recognition of a $2.0 million payment from QOL Medical, LLC
related to the June 2007 issuance of a patent by the U.S. Patent and
Trademark Office for Nascobal®
nasal spray, $4.3 million in research and development reimbursements
recognized related to our collaboration agreement with P&G,
approximately $0.4 million in revenue from our government grant and
revenue from our other collaboration and feasibility agreements and
Nascobal® product
sales. The prior year period included recognition of approximately $3.7
million in previously deferred revenue from Merck & Co., Inc. related to
our PYY(3-36) obesity program, a $7.0 million milestone payment and
$11.9 million in reimbursement revenue related to our development
agreement with P&G, revenue from other agreements, $0.5 million in
revenue from our government grants and approximately $0.7 million in
Nascobal® product
revenue.
Net loss for the three months ended December 31, 2007 was $12.0 million,
or $0.47 per share, as compared to a net loss of $10.7 million, or $0.50
per share for the prior year period. The net loss for the year ended
December 31, 2007 was $52.4 million or $2.10 per share, as compared to
$26.9 million, or $1.27 per share, for the prior year period. The
increase in the net loss from the prior year period was due to a
combination of lower revenue and higher spending due to increased
clinical activities, higher average headcount, and expenses related to
research and development projects. The net loss for the prior year
period included a cumulative benefit from the accounting change of
adopting SFAS123(R) in January 2006 of approximately $0.3 million
reflecting the net cumulative impact of estimating future forfeitures in
the determination of period expense for restricted stock awards, rather
than recording forfeitures when they occur as permitted prior to 2006.
In comparison to the prior year periods, research and development
expenses increased by $0.6 million to approximately $12.8 million for
the three months ended December 31, 2007, and increased $9.0 million to
approximately $52.3 million for the year ended December 31, 2007. In
2007, we initiated Phase 2 clinical trials to evaluate our PYY(3-36)
nasal spray in obese patients and our rapid acting insulin nasal spray
in patients with type 2 diabetes, a PK and safety study to evaluate our
PTH(1-34) nasal spray for the treatment of osteoporosis and a Phase 1
study for our carbetocin nasal spray for patients with autism, causing a
related increase in R&D expenses. The prior year period included a $4.1
million charge due to in-process R&D expenses related to our acquisition
of RNAi intellectual property from Galenea Corp. in the first quarter
2006.
Selling, general and administrative expenses increased by $2.1 million
to approximately $5.8 million for the three months ended December 31,
2007, and increased $6.1 million to approximately $20.3 million for the
year ended December 31, 2007, each in comparison to the prior year
periods, primarily due to increased legal, consulting and other
administrative costs in support of our corporate activities in 2007.
We ended the fourth quarter of 2007 with approximately $41.6 million in
cash, cash equivalents and investments compared to $51.0 million at
December 31, 2006, including $2.2 million in restricted cash at each
date.
In our Annual Report on Form 10-K for the year ended December 31, 2007,
filed on March 17, 2008 with the Securities and Exchange Commission,
KPMG LLP, our Independent Registered Public Accounting Firm, stated that
our consolidated financial statements presented fairly, in all material
respects, the consolidated financial position of the Company and the
consolidated results of our operations and our cash flows, in conformity
with U.S. generally accepted accounting principles. The KPMG LLP report
also noted that we have suffered recurring losses, we have had recurring
negative cash flows from operations, and we have an accumulated deficit
that raise substantial doubt about our ability to continue as a going
concern. As announced previously, we have recently commenced a major
restructuring of our business and are implementing plans to address our
liquidity needs, including restructuring our operations, reducing our
workforce, facilities consolidations, renegotiating existing agreements
with vendors and taking other actions to limit our expenditures. The
full text of this report and a discussion of our plans to discuss our
liquidity needs can be found in our Annual Report on Form 10-K.
Recent Corporate Highlights
Filed 83 patent applications directed toward 144 different genes with
siRNAs designed and modified using Nastech’s
proprietary RNAi technologies.
Completed enrollment of 551 patients in a Phase 2 clinical trial for
PYY(3-36) Nasal Spray for obesity
Established MDRNA, Inc., our wholly-owned subsidiary focused on
developing RNA-based technologies and therapeutics, and transferred
related intellectual property
Announced the promotion of Henry R. Costantino, Ph.D., to Chief
Scientific Officer, Delivery, Gordon C. Brandt, M.D., to President and
Bruce R. York to Secretary and Chief Financial Officer
Entered into a feasibility agreement with an undisclosed company to
develop a non-injectable dosage form of Factor IX to control bleeding
Received a notice of allowance for a U.S. Patent related to a method
for identifying cell-specific targeting peptides
Reacquired all rights and data associated with our Parathyroid Hormone
(PTH1-34) nasal spray following termination
of our development and commercialization agreement with P&G
Initiated a corporate restructuring plan to significantly reduce
expenses and focus our resources on efforts to partner our Phase 2
clinical programs, continuation of research and development activities
focused on MDRNA and our funded partnerships
About Nastech
Nastech is a clinical stage biopharmaceutical company focusing on the
development and commercialization of innovative therapeutic products
based on our proprietary molecular biology-based drug delivery
technologies and our proprietary ribonucleic acid interference
technology. Nastech and its collaboration partners are developing
products for multiple therapeutic areas including diabetes, obesity,
osteoporosis, autism, respiratory diseases and inflammatory conditions.
Additional information about Nastech is available at http://www.nastech.com.
Nastech Forward Looking Statements
Statements made in this press release may be forward-looking statements
within the meaning of Federal Securities laws that are subject to
certain risks and uncertainties and involve factors that may cause
actual results to differ materially from those projected or suggested.
Factors that could cause actual results to differ materially from those
in forward-looking statements include, but are not limited to: (i) the
ability of Nastech or a subsidiary to obtain additional funding; (ii)
the ability of Nastech or a subsidiary to attract and/or maintain
manufacturing, research, development and commercialization partners;
(iii) the ability of Nastech, a subsidiary and/or a partner to
successfully complete product research and development, including
preclinical and clinical studies and commercialization; (iv) the ability
of Nastech, a subsidiary and/or a partner to obtain required
governmental approvals; and (v) the ability of Nastech, a subsidiary
and/or a partner to develop and commercialize products that can compete
favorably with those of competitors. Additional factors that could cause
actual results to differ materially from those projected or suggested in
any forward-looking statements are contained in Nastech's most recent
periodic reports on Form 10-K and Form 10-Q that are filed with the
Securities and Exchange Commission. Nastech assumes no obligation to
update and supplement forward-looking statements because of subsequent
events.
Financial Tables Follow NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In Thousands, Except Per Share Data)
Three Months Ended Years Ended December 31, December 31,
2006
2007
2006
2007
(Unaudited)
Revenue
License and research fees
$
4,598
$
6,152
$
27,265
$
17,349
Government grants
105
126
488
433
Product revenue
113
110
737
355
Total revenue
4,816
6,388
28,490
18,137
Operating expenses:
Cost of product revenue
41
32
355
100
Research and development
12,194
12,842
43,244
52,254
Selling, general and administrative
3,679
5,824
14,208
20,314
Total operating expenses
15,914
18,698
57,807
72,668
Loss from operations
(11,098
)
(12,310
)
(29,317
)
(54,531
)
Other income (expense):
Interest income
682
586
2,789
3,308
Interest and other expense
(246 )
(291 )
(640 )
(1,149 )
Loss before cumulative effect of change in accounting principle
(10,662
)
(12,015
)
(27,168
)
(52,372
)
Cumulative effect of change in accounting principle
--
--
291
--
Net loss
$ (10,662 ) $ (12,015 ) $ (26,877 ) $ (52,372 )
Basic and diluted net loss per share:
Prior to cumulative effect of change in accounting principle
$
(0.50
)
$
(0.47
)
$
(1.28
)
$
(2.10
)
Cumulative effect of change in accounting principle
--
--
0.01
--
Net loss per common share — basic and
diluted
$ (0.50
)
$ (0.47 ) $ (1.27
)
$ (2.10 )
Shares used in computing net loss per share - basic and diluted
21,524
25,444
21,218
24,995
Selected Balance Sheet Data (In Thousands) December 31, 2006
December 31, 2007
Cash, cash equivalents and investments
(includes restricted cash of approximately $2,155)
$
50,993
$
41,573
Accounts receivable, net
2,798
324
Property and equipment, inventories and other assets
20,041
19,719
Total assets
73,832
61,616
Working capital
42,833
31,111
Accumulated deficit
(142,493
)
(194,865
)
Stockholders’ equity
43,336
39,220