Filed Pursuant to Rule 424(b)(5)
Registration Statement No. 333-148771
PROSPECTUS SUPPLEMENT
(to Prospectus dated February 4, 2008)
Nastech Pharmaceutical Company Inc.
4,590,277 Shares of Common Stock
and
Warrants to Purchase 5,967,361 Shares of Common Stock
We are offering directly to selected investors 4,590,277 shares of our common stock and warrants to
purchase 5,967,361 shares of our common stock pursuant to this prospectus supplement and the
accompanying prospectus. The common stock is being offered at a per share purchase price of $1.728.
The shares of common stock and warrants will be issued separately but can only be purchased
together in this offering.
Our common stock is listed on the NASDAQ Global Market under the symbol NSTK. On April 24, 2008,
the last reported sale price for our common stock on the NASDAQ Global Market was $2.18 per share.
The closing bid price was $2.16 per share.
We have retained Maxim Group, LLC as our placement agent to use its reasonable best efforts to
solicit offers to purchase our common stock and warrants in this offering. The placement agent has
no obligation to buy any of the shares of our common stock or warrants from us or to arrange for
the purchase or sale of any specific number or dollar amount of the shares of common stock and the
warrants. See Plan of Distribution beginning on page S-13 of this prospectus supplement for more
information regarding these arrangements.
Investing in our securities involves a high degree of risk. See Risk Factors contained in Item 1A
of our Annual Report on Form 10-K for the fiscal year ended December 31, 2007, beginning on page 24
thereof, to read about factors you should consider before buying shares of the common stock.
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Per
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Share
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Total
1
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Public offering price
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$
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1.728
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$
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7,932,000
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Placement Agents fees
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$
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0.1209
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$
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555,240
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Proceeds, before expenses, to us
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$
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1.607
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$
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7,376,760
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(1)
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Assumes all 4,590,277 shares offered under this prospectus supplement and accompanying
prospectus are sold. Does not include any proceeds to be received from the exercise of the
warrants, if any.
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Of the warrants being offered by this prospectus supplement, 4,590,277 have an exercise price of
$2.376 per share and are exercisable during the seven year period beginning on October 25, 2008,
and 1,377,084 have an exercise price of $2.17 per share and are exercisable during the 90-day
period beginning on October 25, 2008.
We expect the total offering expenses, excluding the placement agency fee, to be approximately
$135,500 for all sales pursuant to this prospectus supplement and accompanying prospectus. Because
there is no minimum offering amount required as a condition to closing in this offering, the actual
offering amount, placement agents fees and net proceeds to us, if any, in this offering are not
presently determinable and may be substantially less than the total maximum offering amount set
forth above.
Delivery of the securities will be made to purchasers on or about April 29, 2008. The shares of
common stock will be delivered in book-entry form through The Depository Trust Company, New York,
New York or by the issuance of physical certificates. Purchaser funds will be deposited into an
escrow account and held until jointly released by us and the placement agent on the date the
securities are to be delivered to the purchasers. All funds received will be held in a non-interest
bearing account. The warrants sold in this offering will be delivered directly to investors.
You should carefully read this prospectus supplement and the accompanying prospectus, together with
the documents we incorporate by reference, before you invest in our common stock.
Neither the Securities and Exchange Commission nor any state securities commission has approved or
disapproved of these securities or determined if this prospectus supplement or the accompanying
prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
Maxim Group, LLC
The date of this prospectus supplement is April 30, 2008
TABLE OF CONTENTS
Prospectus Supplement
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Page
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ii
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S-1
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S-3
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S-6
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S-7
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S-8
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S-9
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S-10
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S-11
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S-14
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S-16
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S-16
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S-17
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S-17
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Prospectus dated February 4, 2008
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Page
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About This Prospectus
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1
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Forward-Looking Statements
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1
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Information About The Company
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3
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Risk Factors
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5
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Use of Proceeds
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16
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Ratio of Earnings to Fixed Charges
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16
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Plan of Distribution
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16
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Description of Capital Stock
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18
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Description of Debt Securities
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19
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Description of Warrants
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27
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Description of Units
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28
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Legal Matters
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29
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Experts
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30
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Where You Can Find More Information
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30
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Incorporation of Certain Information by Reference
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30
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i
ABOUT THIS PROSPECTUS SUPPLEMENT
A registration statement on Form S-3 (File no. 333-148771) utilizing a shelf registration
process relating to the securities described in this prospectus supplement was filed with the
Securities and Exchange Commission, or the SEC, on January 22, 2008 and was declared effective on
February 4, 2008. Under this shelf registration process, of which this offering is a part, we may,
from time to time, sell up to an aggregate of $50.0 million of our securities.
This document is in two parts. The first part is this prospectus supplement, which describes
the terms of this offering of our common stock and warrants and also adds, updates and changes
information contained in the accompanying prospectus and the documents incorporated by reference.
The second part is the accompanying prospectus, which gives more general information, some of which
may not apply to this offering of our common stock and warrants. To the extent the information
contained in this prospectus supplement differs or varies from the information contained in the
accompanying prospectus or any document filed prior to the date of this prospectus supplement and
incorporated by reference, the information in this prospectus supplement will control.
You should rely only on the information contained in or incorporated by reference into this
prospectus supplement and the accompanying prospectus. We have not, and the placement agent has
not, authorized anyone to provide you with information that is different. This prospectus
supplement is not an offer to sell or solicitation of an offer to buy these shares of our common
stock or warrants in any circumstances under which the offer or solicitation is unlawful. You
should not assume that the information we have included in this prospectus supplement or the
accompanying prospectus is accurate as of any date other than the date of this prospectus
supplement or the accompanying prospectus, respectively, or that any information we have
incorporated by reference is accurate as of any date other than the date of the document
incorporated by reference, regardless of the time of delivery of this prospectus supplement or of
any shares of our common stock or warrants.
This prospectus supplement and the accompanying prospectus include product names, trade names,
trademarks and service marks of us and other companies. All such product names, trade names,
trademarks and service marks are the property of their respective holders.
ii
FORWARD-LOOKING
STATEMENTS
Some of the statements contained in this prospectus supplement and the documents incorporated
herein by reference contain forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities
Exchange Act of 1934, as amended, or the Exchange Act. These forward-looking statements reflect our
current views with respect to future events or our financial performance, and involve certain known
and unknown risks, uncertainties and other factors, including those identified below, which may
cause our or our industrys actual or future results, levels of activity, performance or
achievements to differ materially from those expressed or implied by any forward-looking statements
or from historical results. We intend such forward-looking statements to be covered by the safe
harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and
Section 21E of the Exchange Act. Forward-looking statements include information concerning our
possible or assumed future results of operations and statements preceded by, followed by, or that
include the words may, will, could, would, should, believe, expect, plan,
anticipate, intend, estimate, predict, potential or similar expressions.
Forward-looking statements are inherently subject to risks and uncertainties, many of which we
cannot predict with accuracy and some of which we might not even anticipate. Although we believe
that the expectations reflected in such forward-looking statements are based upon reasonable
assumptions at the time made, we can give no assurance that such expectations will be achieved.
Future events and actual results, financial and otherwise, may differ materially from the results
discussed in the forward-looking statements. Readers are cautioned not to place undue reliance on
these forward-looking statements. We have no duty to update or revise any forward-looking
statements after the date of this prospectus supplement or to conform them to actual results, new
information, future events or otherwise.
The following factors, among others, could cause our or our industrys future results to
differ materially from historical results or those anticipated:
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our ability to obtain additional funding for our company and for our subsidiaries;
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our efforts to establish and maintain collaboration partnerships for the development of
PYY(3-36) nasal spray, PTH(1-34) nasal spray, insulin nasal spray, exenatide nasal spray,
carbetocin nasal spray, generic calcitonin-salmon nasal spray, RNA interference or other
programs;
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the success or failure of our research and development programs or the programs of our partners;
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the advantages and disadvantages of pharmaceuticals delivered intranasally;
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the need for improved and alternative drug delivery methods;
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our efforts to collaborate with pharmaceutical and biotechnology companies that have products
under development;
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our ability to successfully complete product research and development, including pre-clinical
and clinical trials and commercialization;
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our ability to obtain governmental approvals, including product and patent approvals;
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our ability to successfully manufacture the products of our research and development programs
and our marketed products to meet current good manufacturing practices and to manufacture these
products at a financially acceptable cost;
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our ability to attract and retain our key officers and employees and manufacturing, sales,
distribution and marketing partners;
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S-1
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costs associated with any product liability claims, patent prosecution, patent infringement
lawsuits and other lawsuits;
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our ability to develop and commercialize our products before our competitors; and
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the projected size of the drug delivery market.
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These factors and the risk factors incorporated by reference into this prospectus supplement,
including, without limitation, those contained in Item 1A. Risk factors in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2007, are all of the important factors of which we
are currently aware that could cause actual results, performance or achievements to differ
materially from those expressed in any of our forward-looking statements. We operate in a
continually changing business environment, and new risk factors emerge from time to time. Other
unknown or unpredictable factors also could have material adverse effects on our future results,
performance or achievements. We cannot assure you that projected results or events will be achieved
or will occur.
S-2
PROSPECTUS
SUPPLEMENT SUMMARY
This summary highlights selected information appearing elsewhere or incorporated by reference
in this prospectus supplement and the accompanying prospectus and may not contain all of the
information that is important to you. This prospectus supplement and the accompanying prospectus
include information about the shares of our common stock and warrants we are offering as well as
information regarding our business and detailed financial data. You should read this prospectus
supplement and the accompanying prospectus in their entirety, including the information
incorporated by reference in this prospectus supplement and the accompanying prospectus.
Unless the context requires otherwise, the words Nastech, we, company, us and our
refer to Nastech Pharmaceutical Company Inc. and its subsidiaries.
Overview
We are a clinical-stage biopharmaceutical company focusing on the development and
commercialization of innovative therapeutic products based on our proprietary ribonucleic acid
interference (RNAi) technology and our proprietary molecular biology-based nasal drug delivery
technology. Our history has been based on nasal delivery; however, our future plans focus on our
RNAi programs, and we have proposed that our stockholders approve a name change to MDRNA, Inc. at
our annual meeting to be held on June 10, 2008.
In connection with our change in focus, we have recently taken steps to restructure certain
aspects of our business, including significantly reducing our workforce and reducing certain
operating costs. In November 2007, we terminated 72 employees across all areas of our operations
and at all of our principal locations, thus reducing our workforce to approximately 160 full-time
employees. In connection with this restructuring, we incurred approximately $0.8 million of
employee severance and related costs, of which approximately $0.6 million was paid in the fourth
quarter of 2007, $0.1 million was paid in the first quarter of 2008 and the remainder will be paid
in the second quarter of 2008. In February 2008, we terminated approximately 70 additional
employees across all areas of our operations, thus reducing our workforce to approximately 85
employees. In connection with the second reduction in force, we expect to incur approximately
$1.6 million of employee severance and related costs, of which $0.6 million was paid in the first
quarter of 2008 and the remainder of which we expect to pay in the second quarter of 2008. In
addition, we also incurred approximately $0.3 million in net clinical trial termination fees
related to our decision in the first quarter 2008 to place our Phase 2 PTH (1-34) clinical trial on
hold until further funding has been obtained. Our goal is to successfully partner this program in
2008, which partner will then fund and manage the remaining development and commercialization of
PTH(1-34).
We cannot currently estimate the amount of non-cash impairment charges which shall be recorded
related to the impairment of long-lived assets, including certain fixed assets and leasehold
improvements. We are also currently contemplating various options that may result in the
consolidation of our Bothell, Washington headquarters into a single facility. Because we have not
yet finalized the course of action for implementation of our facilities consolidation plan,
assuming such plan is implemented at all, we cannot currently estimate the costs that will be
associated with each type of major cost associated with the plan, the total amount to be incurred
in connection with the plan, or the charges associated with the plan that will result in future
cash expenditures.
Our business model now centers on continuation of research and development activities focused
on RNAi, completion and partnering of our Phase 2 clinical programs and our funded partnerships. We
will also continue to manufacture Nascobal
®
spray under our agreement with QOL Medical, LLC
(QOL). There can be no assurance that our focus on these programs will produce acceptable
results. If we are not successful in implementing or operating under this new business model, our
stock price could suffer. Moreover, any other future changes to our business may not prove
successful in the short or long term due to a variety of factors, including competition, success of
research efforts or our ability to partner our product candidates, and may have a material impact
on our financial results.
In addition, we have in the past and may in the future find it advisable to restructure
operations and reduce expenses, including, without limitation, such measures as reductions in the
workforce, discretionary spending, and/or capital expenditures, as well as other steps to reduce
expenses. We have streamlined operations and reduced
S-3
expenses as a result of the reductions in workforce. Effecting any restructuring places
significant strains on management, our employees and our operational, financial and other
resources. Furthermore, restructurings take time to fully implement and involve certain additional
costs, including severance payments to terminated employees, and we may also incur liabilities from
early termination or assignment of contracts, potential litigation or other effects from such
restructuring. There can be no assurance that we will be successful in implementing our
restructuring program, or that following the completion of our restructuring program, we will have
sufficient cash reserves to allow us to fund our business plan until such time as we achieve
profitability. Such effects from our restructuring program could have a material adverse affect on
our ability to execute on our business plan.
Our goal is to become a leader in both the development and commercialization of RNAi
therapeutics, as well as in innovative nasal drug delivery products and technologies. We will seek
to establish strategic collaborations with pharmaceutical and biotechnology companies. We will
continue to focus our research and development efforts on therapeutic siRNA, especially in the
pre-clinical area, and we have been acquiring and developing our RNAi technologies and IP estate,
and eventually expanding our RNAi pipeline to additional therapeutic areas. As of April 25, 2008,
we had, either through ownership of or access to, through exclusive licenses, 59 patents issued and
613 pending patent applications to protect our proprietary technologies.
RNAi programs
We believe that we are at the forefront of small interfering RNA (siRNA) therapeutic
research and development. Our RNAi programs are targeted at developing and delivering novel
therapeutics using siRNA to down-regulate the expression of certain disease-causing proteins that
are over-expressed in inflammation, viral respiratory infections, cancer and other diseases. Our
lead siRNA program has demonstrated efficacy in animals against multiple influenza strains,
including avian flu strains (H5N1). The development of siRNA targeting sequences that are highly
conserved across all flu genomes, including avian and other types having pandemic potential,
provide one solution to the influenza virus ability to develop drug resistance. We believe our
lead candidate represents a viable approach to fighting influenza and is one of the most advanced
anti-influenza compounds based on RNAi. Our lead candidate can be administered by inhalation to
maximize delivery to the lung tissue and has the potential to be delivered to the nasal cavity to
prevent or abate early viral infections. The product is being designed for ease of use by patients
and for long-term stability, both essential for stockpiling the product for rapid mobilization
during a flu epidemic. We have formed MDRNA Research, Inc. (formerly MDRNA, Inc.), a wholly-owned
subsidiary incorporated under the laws of the State of Delaware, and assigned and/or licensed
certain intellectual property to it, as a key first step toward realizing the potential value from
our RNAi assets.
Nasal delivery programs
Using our nasal drug delivery technology, we create and utilize novel formulation components
or excipients that can reversibly open tight junctions between cells in various tissues and
thereby deliver therapeutic drugs to the blood stream. Tight junctions are cell-to-cell connections
in various tissues of the body, including the epithelial layer of the nasal mucosa, the
gastrointestinal tract and the blood-brain barrier, which function to regulate the transport and
passage of molecules across these natural boundaries.
Through our expertise in tight junction biology, we are developing clinical product candidates
in multiple therapeutic areas. Our rapid-acting nasal insulin product has entered a Phase 2
clinical trial in patients with type 2 diabetes. Results from the trial will be presented at the
American Diabetes Association meeting in June 2008. Previous clinical data suggests that our nasal
insulin may improve efficacy and avoid pulmonary side effects associated with the inhalation of
insulin.
Peptide YY(3-36), or PYY (3-36),our nasal version of a naturally occurring human hormone, is
being studied in a fully enrolled Phase 2 clinical trial involving obese patients and we expect
results in the third quarter of 2008. PYY(3-36) is produced naturally by specialized endocrine
cells (L-cells) in the gut in proportion to the calorie content of a meal. Research has indicated a
role for PYY(3-36) in regulating appetite control and thus its potential relevance in obesity.
PTH(1-34), a fragment of human parathyroid hormone that helps regulate calcium and phosphorus
metabolism and may cause bone growth, is a nasal version of the active ingredient that is being
marketed as an injectable
S-4
product by Eli Lilly & Company (Lilly), under the trade name Forteo
®
. We had planned a Phase
2B clinical trial to evaluate the effect of nasally delivered PTH(1-34) on bone density in patients
with osteoporosis; however, our Phase 2 PTH(1-34) clinical trial is on hold until further funding
has been obtained. Our goal is to successfully partner this program in 2008, which partner will
then fund and manage the remaining development and commercialization of PTH(1-34).
Exenatide, marketed by Amylin Pharmaceuticals, Inc. (Amylin) and Lilly as Byetta
®
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stimulates insulin secretion in response to elevated plasma glucose levels. In June 2006, we
entered into an agreement with Amylin to develop a nasal spray formulation of the product, for the
treatment of diabetes. Preclinical studies and a Phase 1 clinical trial have been completed by
Amylin and additional clinical trials are being evaluated.
Our generic calcitonin-salmon product is under review at the U.S. Food and Drug
Administration, and is partnered with Par Pharmaceutical Companies, Inc.
Carbetocin, a long-acting analog of oxytocin, is a naturally produced hormone that may benefit
autistic patients. We had planned to initiate Phase 2 clinical trials for this program in the first
half of 2008; however, this program is currently on hold pending further funding.
We believe our nasal drug delivery technology offers advantages over injectable routes of
administration for large molecules, such as peptides and proteins. These advantages may include
improved safety, clinical efficacy and increased patient compliance, due to the elimination of
injection site pain or irritation. In addition, we believe our nasal drug delivery technology can
potentially offer advantages over oral administration by providing for faster absorption into the
bloodstream, and improved effectiveness by avoiding problems relating to gastrointestinal side
effects and first-pass liver metabolism. Although some of our product candidates use our expertise
outside this area, this technology is the foundation of our nasal drug delivery platform and we use
it to develop commercial products with our collaboration partners or, in select cases, to develop,
manufacture and commercialize some product candidates on our own.
Our Corporate Information
We were incorporated in Delaware on September 23, 1983. Our principal executive offices are
located at 3830 Monte Villa Parkway, Bothell, Washington 98021, and our telephone number at that
address is (425) 908-3600. We maintain an Internet website at
www.nastech.com
. We have not
incorporated by reference into this prospectus supplement or the accompanying prospectus the
information in, or that can be accessed through, our website, and you should not consider it to be
a part of this prospectus supplement or the accompanying prospectus.
S-5
THE
OFFERING
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Securities we are offering:
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4,590,277 shares of our common stock
and warrants to purchase 5,967,361
shares of our common stock
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Issue price:
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$1.728 per share
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Common Stock:
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Number of shares outstanding before this offering:
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26,713,124 shares
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Number of shares to be outstanding after completion
of this offering:
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37,270,762 shares, assuming all
shares are sold and all warrants
offered hereby are fully exercised
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Warrants:
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Number of warrants outstanding before this offering:
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None
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Number of warrants to be outstanding after
completion of this offering:
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Warrants to purchase 5,967,361 shares
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Exercise Price:
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The seven-year warrants have an
exercise price of $2.376 per share,
and the 90-day warrants have an
exercise price of $2.17 per share
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Exercise period:
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Warrants to purchase up to 4,590,277
shares will be exercisable for seven
years beginning on October 25, 2008,
and warrants to purchase up to
1,377,084 shares will be exercisable
for 90 days beginning on October 25,
2008
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Use of Proceeds:
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For general corporate purposes. See
Use of Proceeds.
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NASDAQ Global Market symbol:
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NSTK
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The number of shares of our common stock to be outstanding before and after this offering is
based on 26,713,124 shares outstanding as of April 24, 2008, and excludes:
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warrants to purchase 144,430 shares of common stock with an exercise price of $11.09 per
share outstanding at April 24, 2008, and 144,430 shares of common stock issuable upon
exercise of such warrants;
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2,919,941 shares of common stock issuable upon the exercise of options outstanding at
April 24, 2008 with a weighted average exercise price of $11.04 per share;
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152,572 shares of common stock reserved for future grants and awards under our equity
incentive plans and 257,568 shares of common stock reserved for future issuance under our
employee stock purchase plan, each as of April 24, 2008; and
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warrants to purchase 229,514 shares of common stock at
an exercise price of $2.376 per share to be issued to the placement
agent for this offering.
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Rights of Participation. For a period of 24 months following this offering, investors in this
offering will have a pro rata right to participate in any future sales of our capital stock,
securities convertible into our capital stock or certain forms of indebtedness up to 100% of such
offering, other than shares that are issued in sales that are customarily excluded from such right.
Restrictions on Subsequent Equity Sales. For a period of 90 days following this offering, we have
agreed not to issue additional shares of our common stock or securities convertible into or
exchangeable for our common stock, other than issuances that are customarily excluded from such
right. We have also agreed, for a period of 12 months following this offering, not to issue, or
enter into any agreement to issue, additional shares of our common stock, securities convertible
into or exchangeable for our common stock or certain forms of indebtedness that are issued in a
registered offering. Moreover, we agreed not to enter into any Variable Rate Transaction (as such
term is defined in the Securities Purchase Agreement) until such time as the investors in this
offering no longer hold any securities issued to them in this offering (including any shares of
common stock issuable upon exercise of the warrants sold in this offering).
The foregoing summary of the participation rights and restrictions on subsequent equity sales
does not purport to be complete and is qualified in its entirety by reference to the Securities
Purchase Agreement, which has been filed as an exhibit to a current report on Form 8-K that is
incorporated herein by reference.
S-6
RISK
FACTORS
Investing in our common stock involves a high degree of risk. In addition to the other
information included and incorporated by reference in this prospectus supplement and accompanying
prospectus, and the risk factors set forth below, you should carefully consider the risks described
under the heading Item 1A. Risk factors in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2007, filed with the SEC on March 17, 2008, and incorporated by reference into
this prospectus supplement.
Risks Related to this Offering
Management will have broad discretion as to the use of the proceeds from this offering, and we may
not use the proceeds effectively.
Our management will have broad discretion as to the application of the net proceeds from this
offering and could use them for purposes other than those contemplated at the time of this
offering. Our stockholders may not agree with the manner in which our management chooses to
allocate and spend the net proceeds. Moreover, our management may use the net proceeds for
corporate purposes that may not increase our profitability or market value.
You will experience immediate dilution in the book value per share of the common stock you
purchase.
Because the price per share of our common stock being offered is substantially higher than the
book value per share of our common stock, you will suffer substantial dilution in the net tangible
book value of the common stock you purchase in this offering. Based on an offering price of
$1.728 per share, if you purchase shares in this offering, you will suffer immediate and
substantial dilution of approximately $0.25 per share in the net tangible book value of the common
stock. See the section entitled Dilution below for a more detailed discussion of the dilution you
will incur if you purchase common stock in this offering.
Our ability to utilize our net operating loss carryforwards is limited to certain annual
limitations, and may be further limited by a change of control as a result of this offering.
At December 31, 2007, we had available net operating loss carryforwards for federal and state
income tax reporting purposes of approximately $176.5 million and $33.1 million, respectively, and
had available tax credits of approximately $7.6 million, which are available to offset future
taxable income. A portion of these carryforwards will expire in 2008, and will continue to expire
through 2027 if not otherwise utilized. Our ability to use such net operating losses and tax
credit carryforwards is subject to an annual limitation due to change of control provisions under
Sections 382 and 383 of the Internal Revenue Code. An additional change of control could result
from this offering, causing an additional limitation on the usage of our net operating losses and
tax credit carryforwards.
S-7
USE OF PROCEEDS
We
estimate that the net proceeds from this offering will be
approximately $7.2 million, after
deducting the placement agency fees and the estimated offering expenses payable by us. We will not
receive any proceeds from the sale of common stock issuable upon exercise of the warrants we are
offering unless and until such warrants are exercised. If the warrants are fully exercised for
cash, we will receive additional proceeds of approximately
$13.9 million.
We intend to use the net proceeds from this offering for general corporate purposes,
including, without limitation, the funding of our clinical research and development programs, the
clinical development of our product candidates, capital expenditures and working capital needs.
Although we have identified some of the potential uses of the proceeds from this offering, we
have and reserve broad discretion in the application of these proceeds. Accordingly, we reserve the
right to use these proceeds for different purposes or uses which we have not listed above.
Pending any ultimate use of any portion of the proceeds from this offering, we intend to
invest the proceeds in short-term U.S. governmental securities.
S-8
CAPITALIZATION
The following table sets forth our cash, cash equivalents and short-term investments and
capitalization as of December 31, 2007:
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on an actual basis; and
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on an as adjusted basis to give effect to the issuance and sale by us of 4,590,277
shares of our common stock and warrants to purchase 5,967,361 shares of our common stock in
this offering at a price of $1.728 per share, and after deducting the placement agency fees
and estimated offering expenses payable by us.
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This table should be read in conjunction with Managements Discussion and Analysis of
Financial Condition and Results of Operations and our financial statements and notes thereto that
are incorporated by reference in this prospectus supplement and the accompanying prospectuses.
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As of December 31, 2007
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Actual
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As Adjusted
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(unaudited, in thousands
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except per share amounts)
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Cash, cash equivalents and short-term investments(1)
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$
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41,573
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$
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48,814
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Long-term
liabilities(2)
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8,828
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8,828
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Stockholders equity:
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Preferred stock, $0.01 par value; 100,000 authorized; no shares issued and
outstanding, actual and as adjusted
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Common stock and additional paid in capital, $0.006 par
value; 50,000,000 shares authorized; 26,753,430 shares
outstanding, actual; 31,343,707 shares outstanding, as
adjusted(2)
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234,065
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241,306
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Accumulated deficit
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(194,865
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)
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(194,865
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Accumulated other comprehensive loss
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(20
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(20
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Total stockholders equity
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39,220
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46,461
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Total capitalization
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$
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48,048
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$
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55,289
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(1)
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Includes $2,155 of restricted cash and short-term investments.
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(2)
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This pro forma table assumes all proceeds were allocated to
the common stock. Accounting for the transaction in the second
quarter of 2008 and future periods will likely include liability
accounting for the warrants that would increase long-term liabilities
and decrease common stock balances.
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The number of shares of common stock outstanding is based on the number of shares outstanding
as of December 31, 2007, and excludes:
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warrants to purchase 144,430 shares of common stock with an exercise price of $11.09 per
share outstanding at December 31, 2007, and 144,430 shares of common stock issuable upon
exercise of such warrants;
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2,412,318 shares of common stock issuable upon the exercise of options outstanding at
December 31, 2007 with a weighted average exercise price of $13.26 per share; and
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579,942 shares of common stock reserved for future grants and awards under our equity
incentive plans and 300,000 shares of common stock reserved for future issuance under our
employee stock purchase plan.
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S-9
DILUTION
If you purchase any of the shares of common stock offered by this prospectus supplement, you
will experience dilution to the extent of the difference between the offering price per share of
common stock you pay in this offering and the net tangible book value per share of our common stock
immediately after this offering. Our unaudited net tangible book value as of December 31, 2007 was
approximately $39.2 million, or $1.46 per share of common stock. Net tangible book value per share
is equal to our total tangible assets minus total liabilities, all divided by the number of shares
of common stock outstanding.
After giving effect to the assumed sale of 4,590,277 shares of common stock and warrants to
purchase 5,967,361 shares of common stock in this offering at a price of $1.728 share, and after
deducting the placement agency fees and our estimated offering expenses, our as adjusted net
tangible book value as of December 31, 2007 would have been approximately $46.5 million, or
approximately $1.48 per share of common stock. This represents an immediate increase in net
tangible book value of approximately $0.02 per share to existing stockholders and an immediate
dilution of approximately $0.25 per share to new investors. Our net tangible book value calculation
assumes no exercise of the warrants offered hereby. The following table illustrates this
calculation on a per share basis:
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Offering price per share
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$
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1.728
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Net tangible book value per share as of December 31, 2007
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$
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1.466
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Increase per share attributable to this offering
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.016
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As adjusted net tangible book value per share after this offering
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$
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1.482
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Dilution per share to new investors
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$
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0.246
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The number of shares of common stock outstanding used for existing stockholders in the table
and calculations above is based on 26,753,430 shares outstanding as of December 31, 2007, and
excludes:
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warrants to purchase 144,430 shares of common stock with an exercise price of $11.09 per
share outstanding at December 31, 2007, and 144,430 shares of common stock issuable upon
exercise of such warrants;
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2,412,318 shares of common stock issuable upon the exercise of options outstanding at
December 31, 2007 with a weighted average exercise price of $13.26 per share; and
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579,942 shares of common stock reserved for future grants and awards under our equity
incentive plans and 300,000 shares of common stock reserved for future issuance under our
employee stock purchase plan, each as of December 31, 2007.
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S-10
DESCRIPTION OF SECURITIES
Set forth below is a description of our capital stock. The following description of our
capital stock is a summary and is subject to and qualified by the applicable provisions of our
certificate of incorporation, our bylaws and the relevant provisions of the laws of the State of
Delaware.
Description of Common Stock
For a complete description of our common stock, see the Description of Capital Stock section
in the accompanying prospectus dated February 4, 2008 on page 20 thereof.
Description of Warrants
Each warrant offered by this prospectus supplement represents the right to purchase one share
of common stock at an initial exercise price equal to: (i) in the case of the seven-year warrants,
$2.376 per share; and (ii) in the case of the 90-day warrants, $2.17 per share, which in each case
is subject to adjustment. Warrants to purchase up to 4,590,277 shares may be exercised at any time
and from time to time during the seven-year period beginning on October 25, 2008, and warrants to
purchase up to 1,377,084 shares may be exercised at any time and from time to time during the
90-day period beginning on October 25, 2008.
Exercise
. Holders of the warrants may exercise their warrants to purchase shares of our common
stock on or before the expiration date by delivering (i) an exercise notice, appropriately
completed and duly signed, and (ii) if such holder is not utilizing the cashless exercise
provisions, payment of the exercise price for the number of shares with respect to which the
warrant is being exercised. Warrants may be exercised in whole or in part, but only for full shares
of common stock, and any portion of a warrant not exercised prior to the expiration date shall be
and become void and of no value. We provide certain buy-in rights to a holder if we fail to deliver
the shares of common stock underlying the warrants by the third business day after the date on
which delivery of such stock certificate is required by the warrant. The buy-in rights apply if
after such third business day, but prior to cure by us, the holder purchases (in an open market
transaction or otherwise) shares of our common stock to deliver in satisfaction of a sale by the
holder of the warrant shares that the holder anticipated receiving from us upon exercise of the
warrant. In this event, at the request of and in the holders discretion, we will:
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pay cash to the holder in an amount equal to (i) the buy-in price, meaning the holders
total purchase price (including brokerage commissions, if any) for the shares of common
stock so purchased minus (ii) the aggregate sale price of the shares of common stock giving
rise to the buy-in purchase which the holder had attempted to obtain through exercise; and
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at the holders option, either (a) deliver to the holder a certificate or certificates
representing the shares of common stock underlying the exercised warrant or (b) reinstate
the portion of the warrant and equivalent number of shares of common stock underlying the
warrant for which such exercise was not honored.
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In addition, the warrant holders are entitled to a cashless exercise option if, at any time
of exercise, there is no effective registration statement registering, or no current prospectus
available for, the resale of the shares underlying the warrant. This option entitles the warrant
holder to elect to receive fewer shares of common stock without paying the cash exercise price. The
number of shares to be issued would be determined by a formula based on the total number of shares
to which the warrant holder is entitled, the volatility-weighted average price of the common stock
on the trading day before the date of exercise and the applicable exercise price of the warrants.
The shares of common stock issuable on exercise of the warrants will be, when issued in
accordance with the warrants, duly and validly authorized, issued and fully paid and
non-assessable. We will authorize and reserve at least that number of shares of common stock equal
to the number of shares of common stock issuable upon exercise of all outstanding warrants.
Fundamental Transaction
. If, at any time while the warrant is outstanding, (1) we effect any
merger or consolidation with or into another person or entity after which our shareholders as of
immediately prior to the
S-11
transaction own less than a majority of the outstanding stock of the surviving entity, (2) we
effect any sale of all or substantially all of our assets in one or a series of related
transactions, (3) any tender offer or exchange offer (whether by us or another person or entity) is
completed pursuant to which holders of common stock are permitted to tender or exchange their
shares for other securities, cash or property, or (4) we effect any reclassification of the common
stock or any compulsory share exchange pursuant to which the common stock is effectively converted
into or exchanged for other securities, cash or property (in any such case, a Fundamental
Transaction), then the holder shall have the right thereafter to receive, upon exercise of the
warrant, the same amount and kind of securities, cash or property as it would have been entitled to
receive upon the occurrence of such Fundamental Transaction if it had been, immediately prior to
such Fundamental Transaction, the holder of the number of warrant shares then issuable upon
exercise of the warrant (the Alternate Consideration). We shall not effect any such Fundamental
Transaction unless prior to or simultaneously with the consummation thereof, any successor to us,
surviving entity or the corporation purchasing or otherwise acquiring such assets shall assume the
obligation to deliver to the holder such Alternate Consideration as the Holder may be entitled to
purchase, and the other obligations under the warrant.
Delivery of Certificates
. Upon the holders exercise of a warrant, we will promptly, but in no
event later than three business days after the exercise date, issue and deliver, or cause to be
issued and delivered, a certificate for the shares of common stock issuable upon exercise of the
warrant or deliver the shares electronically through The Depository Trust Corporation through its
Deposit Withdrawal Agent Commission System or another established clearing corporation performing
similar functions.
If we have not obtained shareholder approval that may be required under applicable law, rules
or regulations, then we may not issue upon exercise of the warrant a number of shares of common
stock, which, when aggregated with any shares of common stock issued upon prior exercise of the
warrant or any other warrant issued pursuant to the subscription agreements, would exceed 4.99% of
the total number of issued and outstanding shares of common stock. However, by written notice to
us, which notice will not be effective until the 61
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day after such notice is delivered
to us, the holder of the warrant may change the beneficial ownership limitation to 9.99%.
If we at any time on or after the issue date of the warrant subdivide (by any stock split,
stock dividend, recapitalization or otherwise) one or more classes of our outstanding shares of
common stock into a greater number of shares, the exercise price in effect immediately prior to
such subdivision will be the same thereafter and the number of warrant shares will be increased in
proportion to the total outstanding shares immediately prior to such subdivision divided by the
total outstanding shares immediately after the subdivision. If we at any time on or after the issue
date of the warrant combine (by combination, reverse stock split or otherwise) one or more classes
of our outstanding shares of common stock into a smaller number of shares, the exercise price in
effect immediately prior to such combination will be the same thereafter and the number of warrant
shares will be decreased in proportion to the total outstanding shares immediately prior to such
combination divided by the total outstanding shares immediately after the combination.
Other Adjustments
. The exercise price and the number of shares of common stock purchasable
upon the exercise of the warrants are subject to adjustment upon the occurrence of specific events,
including stock dividends, stock splits, and combinations of our common stock. If we at any time on
or after the issue date of the warrant issue any shares of common stock at a price per share less
than the exercise price of the warrant, the number of shares of common stock issuable under the
warrant will be proportionately increased and the exercise price of the warrant will be reduced to
the issuance price such that the aggregate exercise price of the entire warrant will remain the
same as the aggregate exercise price immediately prior to the issuance. In addition, if we at any
time on or after the issue date of the warrant issue any rights, options, warrants, indebtedness or
assets (including cash and dividends) to all holders of common stock to the exclusion of the
holders of the warrants, the exercise price will be subject to further adjustment.
We will provide notice to holders of the warrants to provide such holders with a practical
opportunity to exercise their warrants and hold common stock in order to participate in or vote on
the following corporate events:
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if we declare a dividend or distribution of cash, securities or other property in
respect of our common stock;
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S-12
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if we authorize, approve, or enter into any agreement contemplating or soliciting
approval for a merger, sale or similar transaction pursuant to which common stock is
converted or exchanged for cash, securities or property; or
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if we authorize a voluntary dissolution, liquidation or winding up of our affairs.
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Additional Provisions
. The above summary of certain terms and provisions of the warrants is
qualified in its entirety by reference to the detailed provisions of the warrants, the form of
which has been filed as an exhibit to a current report on Form 8-K that is incorporated herein by
reference. We are not required to issue fractional shares upon the exercise of the warrants. No
holders of the warrants will possess any rights as a shareholder under those warrants until the
holder exercises those warrants. The warrants may be transferred independent of the common stock
they were issued with, on a form of assignment, subject to all applicable laws.
S-13
PLAN OF DISTRIBUTION
Maxim Group, LLC, which we refer to as the placement agent, has entered into a placement
agency agreement with us in which the placement agent has agreed, on a reasonable best efforts
basis, to introduce us to investors who will purchase our common stock and warrants in this
offering. The placement agent has no obligation to buy any of the shares of common stock or
warrants from us or to arrange the purchase or sale of any specific number or dollar amount of the
shares of common stock or warrants. We have entered into a securities purchase agreement directly
with investors in connection with this offering.
Certain investor funds may be deposited into an escrow account set up at American Stock
Transfer & Trust Company, as escrow agent. Before the closing date, the escrow agent will notify
the placement agent when funds to pay for the shares have been received. Unless the investors have
requested physical delivery, we will deposit the shares of common stock with The Depository Trust
Company upon receiving notice from the placement agent. At the closing, The Depository Trust
Company will credit the shares of common stock to the respective accounts of the investors. The
warrants will be delivered directly to the investors. If the conditions to this offering are not
satisfied or waived, then all investor funds that were deposited into escrow will be returned to
investors and this offering will terminate.
We have agreed to pay the placement agent a fee equal to 7% of the aggregate gross proceeds
raised in this offering, plus warrants to purchase that number of shares of common stock as is
equal to 5% of the aggregate number of shares of common stock sold in the offering. The warrants to
be issued to the placement agent will be exercisable during the seven year period beginning on
October 25, 2008. The following table shows the per share and total fees we will pay to the
placement agent assuming all of the shares of common stock and warrants offered by this prospectus
supplement are issued and sold by us.
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Placement Fees
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Per Share
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Total
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Maxim Group, LLC
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$
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0.1209
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$
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555,240
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We estimate that our total expenses of this offering, excluding the placement agents fees,
will be approximately $135,500. Included in such amount are the fees and disbursements of counsel
to the placement agent in connection with the Financial Institutions Regulatory Authoritys review
and approval of the placement agents participation in this offering, which we estimate to be
$5,500. We have also agreed to reimburse the placement agent for the actual and accountable fees
and expenses of counsel to the placement agent in an amount up to $20,000, which is also included
in the total expenses listed herein.
In compliance with the guidelines of FINRA, the maximum consideration or discount to be
received by any FINRA member or any independent broker-dealer may not exceed 8.0% of the aggregate
amount of the securities offered pursuant to this prospectus supplement.
We have agreed to indemnify the placement agent against liabilities relating to the offering,
including liabilities under the Securities Act, or to contribute to payments that the placement
agent may be required to make in this respect.
This is a brief summary of the material provisions of the placement agency agreement and does
not purport to be a complete statement of its terms and conditions. A copy of the placement agency
agreement will be on file with the SEC as an exhibit to a Form 8-K to be filed by us.
We have agreed, subject to customary exceptions, not to sell, contract to sell, grant options
to purchase, or otherwise dispose of any shares of our common stock or securities exchangeable for
or convertible into our common stock for a period of 90 days after the date of this prospectus
supplement without the prior written consent of the placement agent.
S-14
From time to time, the placement agent and its affiliates have provided, and may from time to
time in the future provide, investment banking and other services to us for which they receive
customary fees and commissions.
The placement agent has informed us that it does not intend to engage in overallotment,
stabilizing transactions or syndicate covering transactions in connection with this offering.
A prospectus supplement and the accompanying prospectus in electronic format may be made
available on the web site maintained by the placement agent and the placement agent may distribute
the prospectus supplement and the accompanying prospectus electronically.
S-15
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other information with the
SEC. Our SEC filings are available to the public over the Internet at the SECs website at
http://www.sec.gov.
The SECs website contains reports, proxy and information statements and other
information regarding issuers, such as us, that file electronically with the SEC. You may also read
and copy any document we file with the SEC at the SECs Public Reference Room at 100 F Street,
N.E., Room 1580, Washington, D.C. 20549. You may also obtain copies of these documents at
prescribed rates by writing to the SEC. Please call the SEC at 1-800-SEC-0330 for further
information on the operation of its Public Reference Room. We maintain a website at
www.nastech.com.
We have not incorporated by reference into this prospectus supplement or the
accompanying prospectus the information in, or that can be accessed through, our website, and you
should not consider it to be a part of this prospectus supplement or the accompanying prospectus.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference into this prospectus supplement the
information we have filed with the SEC. The information we incorporate by reference into this
prospectus supplement is an important part of this prospectus supplement. Any statement in a
document we have filed with the SEC prior to the date of this prospectus supplement and which is
incorporated by reference into this prospectus supplement will be considered to be modified or
superseded to the extent a statement contained in this prospectus supplement or any other
subsequently filed document that is incorporated by reference into this prospectus supplement
modifies or supersedes that statement. The modified or superseded statement will not be considered
to be a part of this prospectus supplement, except as modified or superseded.
We incorporate by reference into this prospectus supplement the information contained in the
documents listed below, which is considered to be a part of this prospectus supplement:
(1)
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2007, as filed with the
SEC on March 17, 2008;
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(2)
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our current reports on Form 8-K, as filed with the SEC on January 7, 2008, January 22, 2008,
February 13, 2008, February 19, 2008, February 29, 2008, March 4, 2008, March 10, 2008, March
17, 2008 and April 30, 2008;
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(3)
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our preliminary proxy statement on Schedule 14A, and our definitive proxy statement on
Schedule 14A, each relating to the annual meeting of stockholders to be held on June 10, 2008,
as filed with the SEC on April 18, 2008 and April 29, 2008, respectively;
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(4)
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the description of our common stock and the description of certain provisions of Delaware Law
contained or incorporated by reference in:
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our registration statement on Form 8-A, filed with the SEC on August 12, 1985 (file no.
000-13789), including any amendments or reports filed for the purposes of updating this
description;
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our Restated Certificate of Incorporation dated July 20, 2005 and filed as Exhibit 3.1
to our current report on Form 8-K, as filed with the SEC on July 25, 2005 (file no.
000-13789); and
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our Amended and Restated Bylaws dated September 19, 2007 and filed as Exhibit 3.1 to our
current report on Form 8-K, as filed with the SEC on September 25, 2007 (file no.
000-13789);
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(5)
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the description of our preferred stock purchase rights contained in our registration
statement on Form 8-A, filed with the SEC on March 16, 2000 (file no. 000-13789), including
any amendment or reports filed for the purposes of updating this description; and
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S-16
(6)
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future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange
Act after the date of this prospectus supplement but prior to the termination of the offering
of the securities covered by this prospectus supplement.
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You may request a copy of these filings, at no cost, by writing or telephoning us at the
following address:
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Nastech Pharmaceutical Company Inc.
3830 Monte Villa Parkway
Bothell, WA 98021
(425) 908-3600
LEGAL MATTERS
The validity of the issuance of the shares of our common stock and warrants offered by this
prospectus supplement is being passed upon for us by Pryor Cashman LLP, New York, New York. Feldman
Weinstein & Smith LLP is counsel for the placement agent in connection with this offering.
EXPERTS
Our consolidated financial statements as of December 31, 2007 and 2006, and for each of the
years in the three-year period ended December 31, 2007, and managements assessment of the
effectiveness of internal control over financial reporting as of December 31, 2007 have been
incorporated by reference herein in reliance upon the reports of KPMG LLP, independent registered
public accounting firm, incorporated by reference herein and in the registration statement of which
this prospectus supplement is a part, and upon the authority of said firm as experts in accounting
and auditing. The audit report covering the December 31, 2007 financial statements refers to a
change in the method of accounting for all stock-based awards made to employees and directors
effective January 1, 2006.
S-17
Nastech Pharmaceutical Company Inc.
$50,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
We may, from time to time, offer and sell any combination of shares of common stock and/or
preferred stock, various series of debt securities, and/or warrants to purchase any of such
securities, either individually or in units comprised of any of such securities.
The maximum aggregate offering price for these securities will not exceed $50,000,000. We will
describe the terms of any such offering in a supplement to this prospectus. Any prospectus
supplement may also add, update, or change information contained in this prospectus. Such
prospectus supplement will contain the following information about the offered securities:
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title and amount;
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offering price, underwriting discounts and commissions, and our net proceeds;
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any market listing and trading symbol;
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names of lead or managing underwriters and description of underwriting arrangements; and
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the specific terms of the offered securities.
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Our shares of common stock trade on the Nasdaq Global Market under the symbol NSTK. On
January 18, 2008, the last sale price of the shares as reported on the Nasdaq Global Market was
$3.05 per share. You are urged to obtain current market quotations for our common stock.
You should carefully read and consider the risk factors appearing throughout this prospectus,
including, without limitation, those appearing under the heading Risk Factors beginning on page 5
of this prospectus.
Our mailing address and telephone number are:
3830 Monte Villa Parkway
Bothell, Washington 98021
(425) 908-3600
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The
date of this prospectus is February 4, 2008
TABLE OF CONTENTS
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1
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1
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3
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5
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30
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30
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30
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You should rely only on the information contained in or incorporated by reference into this
prospectus or any prospectus supplement. We have not authorized any person to give any information
or to make any representations other than those contained or incorporated by reference in this
prospectus, and, if given or made, you must not rely upon such information or representations as
having been authorized. This prospectus does not constitute an offer to sell or the solicitation of
an offer to buy any securities other than our shares of common stock and/or preferred stock,
various series of debt securities and/or warrants to purchase any of such securities, either
individually or in units, each as described in this prospectus or an offer to sell or the
solicitation to buy such securities in any circumstances in which such offer or solicitation is
unlawful. You should not assume that the information we have included in this prospectus is
accurate as of any date other than the date of this prospectus or that any information we have
incorporated by reference is accurate as of any date other than the date of the document
incorporated by reference regardless of the time of delivery of this prospectus or of any
securities registered hereunder.
This document includes product names, trade names and trademarks of other companies. All such
product names and trademarks appearing in this document are the property of their respective
holders.
i
Unless the context otherwise requires, all references in this prospectus to Nastech,
Company, registrant, we, us or our include Nastech Pharmaceutical Company Inc., a
Delaware corporation, and any subsidiaries or other entities controlled by us.
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement on Form S-3 that we filed with the
Securities and Exchange Commission, or SEC, utilizing a shelf registration process. Under this
shelf registration statement, we may, from time to time, sell any combination of common stock
and/or preferred stock, various series of debt securities and/or warrants to purchase any of such
securities, either individually or in units comprised of any of such securities, in one or more
offerings, for a total maximum offering price not to exceed $50,000,000. This prospectus provides
you with a general description of the securities we may offer.
If required, each time we sell securities, we will provide a prospectus supplement that will
contain specific information about the terms of the securities being offered. The prospectus
supplement may add, update or change information contained in this prospectus and may include a
discussion of any risk factors or other special considerations that apply to the offered
securities. If there is any inconsistency between the information in this prospectus and a
prospectus supplement, you should rely on the information in that prospectus supplement. Before
making an investment decision, it is important for you to read and consider the information
contained in this prospectus and any prospectus supplement, together with the additional
information described under the heading Where You Can Find More Information.
FORWARD-LOOKING STATEMENTS
Some of the statements in this prospectus and in documents incorporated by reference herein
contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as
amended, or the Exchange Act. These forward-looking statements reflect our current views with
respect to future events or our financial performance, and involve certain known and unknown risks,
uncertainties and other factors, including those identified below, which may cause our or our
industrys actual or future results, levels of activity, performance or achievements to differ
materially from those expressed or implied by any forward-looking statements or from historical
results. We intend such forward-looking statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the
Exchange Act. Forward-looking statements include information concerning our possible or assumed
future results of operations and statements preceded by, followed by, or that include the words
may, will, could, would, should, believe, expect, plan, anticipate, intend,
estimate, predict, potential or similar expressions.
Forward-looking statements are inherently subject to risks and uncertainties, many of which we
cannot predict with accuracy and some of which we might not even anticipate. Although we believe
that the expectations reflected in such forward-looking statements are based upon reasonable
assumptions at the time made, we can give no assurance that such expectations will be achieved.
Future events and actual results, financial and otherwise, may differ materially from the results
discussed in the forward-looking statements. Readers are cautioned not to place undue reliance on
these forward-looking statements. We have no duty to update or revise any forward-looking
statements after the date of this prospectus or to conform them to actual results, new information,
future events or otherwise.
The following factors, among others, could cause our or our industrys future results to
differ materially from historical results or those anticipated:
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our ability to obtain additional funding;
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our efforts to establish and maintain collaboration partnerships for the development of PTH(1-34)
nasal spray, PYY nasal spray, generic calcitonin-salmon nasal spray, exenatide nasal spray, insulin nasal
spray, carbetocin nasal spray, RNA interference or other programs;
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the success or failure of our research and development programs or the programs of our partners;
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the advantages and disadvantages of pharmaceuticals delivered intranasally;
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the need for improved and alternative drug delivery methods;
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our efforts to collaborate with other pharmaceutical and biotechnology companies that have products
under development;
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our ability to successfully complete product research and development, including pre-clinical and
clinical trials and commercialization;
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our ability to obtain governmental approvals, including product and patent approvals;
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our ability to successfully manufacture the products of our research and development programs and our
marketed products to meet current good manufacturing practices and to manufacture these products at a
financially acceptable cost;
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our ability to attract and retain our key officers and employees and manufacturing, sales,
distribution and marketing partners;
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costs associated with any product liability claims, patent prosecution, patent infringement lawsuits
and other lawsuits;
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our ability to develop and commercialize our products before our competitors; and
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the projected size of the drug delivery market.
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We assume no obligation to update and supplement forward-looking statements that become untrue
because of subsequent events. These factors and the factors disclosed under the heading Risk
Factors below are all of the important factors of which we are currently aware that could cause
actual results, performance or achievements to differ materially from those expressed in any of our
forward-looking statements. We operate in a continually changing business environment, and new risk
factors emerge from time to time. Other unknown or unpredictable factors also could have material
adverse effects on our future results, performance or achievements. We cannot assure you that
projected results or events will be achieved or will occur.
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INFORMATION ABOUT THE COMPANY
Business Overview
We are a biopharmaceutical company focusing on the development and commercialization of
innovative therapeutic products based on our proprietary molecular biology-based drug delivery
technology. Using our technology, we create and utilize novel formulation components or excipients
that can reversibly open the tight junctions between cells in various tissues and thereby deliver
therapeutic drugs to the blood stream. Tight junctions are cell-to-cell connections in various
tissues of the body, including the epithelial layer of the nasal mucosa, the gastrointestinal tract
and the blood brain barrier, which function to provide barrier integrity and to regulate the
transport and passage of molecules across these natural boundaries.
We believe our nasal drug delivery technology offers advantages over injectable routes of
administration for large molecules, such as peptides and proteins. These advantages may include
improved safety, clinical efficacy and increased patient compliance, due to the avoidance of
injection site pain or irritation. In addition, we believe our nasal drug delivery technology can
potentially offer advantages over oral administration by providing for faster absorption into the
bloodstream and improved effectiveness by avoiding problems relating to gastrointestinal side
effects and first-pass liver metabolism. Although some of our product candidates use our expertise
outside this area, this technology is the foundation of our nasal drug delivery platform and we use
it to develop commercial products with our collaboration partners or, in select cases, we may
choose to develop, manufacture and commercialize some product candidates on our own.
We believe we are also at the forefront of small interfering RNA, or siRNA, therapeutic
research and development. Our RNA interference, or RNAi, therapeutic programs are targeted at both
developing and delivering novel therapeutics using siRNA to down-regulate the expression of certain
disease causing proteins that are over-expressed in inflammation, viral respiratory infections and
other diseases. As more fully described under the heading Establishment of MDRNA below, we have
formed MDRNA, Inc., a wholly-owned subsidiary incorporated under the laws of the State of Delaware
referred to in this prospectus as MDRNA, as a key first step toward realizing the potential value
from our RNAi assets.
Business Strategy
Our goal is to become a leader in both the development and commercialization of innovative,
nasal drug delivery products and technologies, as well as in RNAi therapeutics. Key elements of our
strategy include:
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Applying Our Tight Junction Technology and Other Drug Delivery Methods
to Product Candidates.
We focus our research and development efforts on product
candidates, including peptides, large and small molecules and therapeutic
siRNA, for which our proprietary technologies may offer clinical advantages,
such as improved safety and clinical efficacy, or increased patient compliance.
We also will continue to search for applications of our tight junction
technology to improve other forms of drug delivery, including oral, pulmonary
and intravenous delivery.
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Pursuing Collaborations with Pharmaceutical and Biotechnology
Companies.
We will continue to establish strategic collaborations with
pharmaceutical and biotechnology companies. Typically, we collaborate with
partners to commercialize our internal product candidates by utilizing their
late stage clinical development, regulatory, marketing and sales capabilities.
We also assist our collaboration partners in developing more effective drug
delivery methods for their product candidates that have already completed early
stage clinical trials or are currently marketed. We generally structure our
collaborative arrangements to receive research and development funding and
milestone payments during the development phase, revenue from manufacturing
upon commercialization and patent-based royalties on future sales of products.
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Developing and Commercializing Our Own Product Candidates.
In select
cases where we deem it to be strategically advantageous to us, we plan to
internally develop, manufacture and commercialize our products.
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Leveraging Our Manufacturing Expertise and Capabilities.
We have
invested substantial time, money and intellectual capital in developing our
manufacturing facilities and know-how, which we believe would be difficult for
our collaborators and competitors to replicate in the near term. These
capabilities give us competitive advantages, including the ability to prepare
the chemistry, manufacturing and controls, or CMC, section of new drug
application, or NDA, filings with the U.S. Food and Drug Administration, or
FDA, and to maintain a high-level of quality control in manufacturing product
candidates for clinical trials and FDA-approved products for commercialization.
We believe our manufacturing capabilities will meet our projected capacity
needs for the foreseeable future.
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We are engaged in a variety of preclinical research and clinical development efforts. We and
our collaboration partners have been developing a diverse portfolio of clinical-stage product
candidates for multiple therapeutic areas utilizing our molecular biology-based drug delivery
technology. In addition, we have been expanding our RNAi research and development efforts. As of
January 15, 2008, we had 48 patents issued and 491 pending patent applications to protect our
proprietary technologies.
Recent Developments
Establishment of MDRNA
We are engaged in developing therapeutic products based upon ribonucleic acid interference, or
RNAi, which has the potential to effectively treat a broad array of diseases by interfering with
the expression of targeted disease-associated genes. In order to fully realize the potential value
of our RNAi technologies, on December 12, 2007, we assigned and/or transferred to MDRNA certain
intellectual property assets relating to our RNAi therapeutics program in consideration for the
issuance to us by MDRNA of 1,839,080 shares of MDRNA Series A Participating Preferred Stock, par
value $0.001 per share. The assigned intellectual property consisted primarily of a portfolio of
patent applications, as well as licenses to us from the Massachusetts Institute of Technology, the
Carnegie Institute of Washington and City of Hope. It is contemplated that, following the closing
of one or more transactions, or series of related transactions, in which MDRNA issues and sells
shares of its common stock and/or other securities convertible or exchangeable into common stock so
as to result in the receipt by MDRNA of aggregate gross proceeds which equal or exceed $30.0
million, in each case on terms and conditions approved by us, we will
sell and/or transfer to MDRNA all of the
remaining assets and properties related exclusively to our RNAi therapeutics program.
As a result of these transactions, we own, as of the date of this prospectus, all of the
issued and outstanding equity securities of MDRNA. MDRNAs therapeutic programs are targeted at
both developing and delivering novel therapeutics using siRNA to down-regulate the expression of
certain disease causing proteins that are expressed in inflammation, viral respiratory infections
and other diseases. If prevailing market conditions are favorable, we anticipate seeking
independent financing for MDRNA through the sale of the equity securities of MDRNA to third party
investors in a public or private transaction, and possibly converting a portion of our MDRNA Series
A Stock and distributing the common stock received on conversion of such MDRNA Series A Stock as a
dividend to our stockholders. There can be no assurance as to whether any such financing will be
available to us on terms that are acceptable to us or at all, or as to the timing or amount of such
dividend or distribution. Any proposed dividend to our stockholders of MDRNA shares would be
subject to approval of our board of directors and compliance with applicable SEC rules and the
requirements of the Delaware General Corporation Law. Any such dividend may be taxable to us,
although any applicable taxes due may be off-set by our net operating loss carryforwards; however
there is no assurance that our current net operating loss carryforwards will be sufficient to cover
any such taxable event, and if they are not, then we might be required to pay income tax.
Reduction in Force
In November 2007, we implemented a plan to reduce our operating costs and appropriately align
our operations with our business priorities following the termination
by Procter & Gamble Pharmaceuticals, Inc. of its collaboration
partnership with us with respect to PTH(1-34) nasal spray for the treatment of osteoporosis. As
part of this plan, we terminated an aggregate of 72 employees across all areas of our operations
and at all of our principal locations, thus reducing our workforce to approximately 160 full-time
employees. In connection with this restructuring, we incurred approximately $0.8 million of
employee severance and related costs, of which $0.6 million was paid in the fourth quarter of 2007.
The remaining $0.2 million in employee severance costs will be paid in the first half of 2008. Our
resources are now focused on our Phase 2 clinical programs for PYY(3-36) nasal spray for obesity,
insulin nasal spray for type 2 diabetes, and PTH(1-34) nasal spray for osteoporosis, as well as our
partnership with Amylin Pharmaceuticals, Inc.
Our Corporate Information
We were incorporated in Delaware on September 23, 1983. Our principal executive offices are
located at 3830 Monte Villa Parkway, Bothell, Washington 98021, and our telephone number is
(425) 908-3600. We maintain an Internet website at
www.nastech.com
. We have not incorporated by
reference into this prospectus the information in, or that can be accessed through, our website,
and you should not consider it to be a part of this prospectus.
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RISK FACTORS
Following are some specific factors that should be considered for a better understanding of
our operations and financial condition. These factors and the other matters discussed herein are
important factors that could cause actual results or outcomes for us to differ materially from
those discussed in the forward-looking statements included elsewhere in this document. New factors
emerge from time to time, and it is not possible for management to predict all of the factors, nor
can it assess the effect of each factor on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ materially from those contained in any
forward-looking statement.
Risks Related to our Financial Position and Need for Additional Capital
We do not generate operating income and will require additional financing in the future. If
additional capital is not available, we may have to curtail or cease operations.
Our business currently does not generate the cash that is necessary to finance our operations.
We incurred net losses of approximately $32.2 million in 2005 and $26.9 million in 2006. Net losses
were $16.2 million in the nine months ended September 30, 2006 and $40.4 million in the nine months
ended September 30, 2007. Subject to the success of our development programs and potential
licensing transactions, we will need to raise additional capital to:
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conduct research and development;
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develop and commercialize our product candidates;
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enhance existing services;
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respond to competitive pressures; and
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acquire complementary businesses or technologies.
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Our future capital needs depend on many factors, including:
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the scope, duration and expenditures associated with our research and development
programs;
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continued scientific progress in these programs;
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the outcome of potential licensing transactions, if any;
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competing technological developments;
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our proprietary patent position, if any, in our products; and
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the regulatory approval process for our products.
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We may seek to raise necessary funds through public or private equity offerings, debt
financings or additional strategic alliances and licensing arrangements. We may not be able to
obtain additional financing on terms favorable to us, if at all. General market conditions may make
it very difficult for us to seek financing from the capital markets. We may be required to
relinquish rights to our technologies or drug candidates, or grant licenses on terms that are not
favorable to us, in order to raise additional funds through alliance, joint venture or licensing
arrangements. If adequate funds are not available, we may have to delay, reduce or eliminate one or
more of our research or development programs and reduce overall overhead expenses. These actions
would likely reduce the market price of our common stock.
We may not be able to obtain independent financing for MDRNA, in which case we will have to
continue to satisfy all of the financial obligations associated with our RNA interference business.
If prevailing market conditions are favorable, we anticipate seeking independent financing for
MDRNA, our wholly-owned subsidiary focused on RNA interference therapeutic research and
development, through the sale of the equity securities of MDRNA to
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third party investors in a public or private transaction. There can be no assurance as to
whether any such financing will be available to us on terms that are acceptable to us or at all. If
we cannot obtain independent financing for MDRNA, we will have to continue to satisfy all of the
financial obligations of MDRNA using our own resources, including the proceeds obtained through the
sale of securities under this prospectus. The use of such funds for the MDRNA business will reduce
the aggregate funds available to implement that portion of our business plan that does not relate
to RNA interference, and could lead to us delaying or otherwise limiting the implementation of such
business plan. It may also cause us to seek raise additional funds sooner than we would otherwise
anticipate.
We have not been profitable on an annual basis for ten years, and we may never become
profitable.
We have incurred net losses in each of the past ten years. As of September 30, 2007, we had an
accumulated deficit of approximately $182.9 million and expect additional losses in the future as
we continue our research and development activities.
The process of developing our products requires significant research and development efforts,
including basic research, pre-clinical and clinical development, and FDA regulatory approval. These
activities, together with our sales, marketing, general and administrative expenses, have resulted
in operating losses in the past, and there can be no assurance that we can achieve profitability in
the future. Our ability to achieve profitability depends on our ability, alone or with our
collaborators, to develop our drug candidates, conduct clinical trials, obtain necessary regulatory
approvals, and manufacture, distribute, market and sell our drug products. We cannot assure you
that we will be successful at any of these activities or predict when we will ever become
profitable.
We have restructured our business to focus on our Phase 2 clinical programs for PYY(3-36)
nasal spray for obesity, insulin nasal spray for type 2 diabetes, and PTH(1-34) nasal spray for
osteoporosis, as well as our partnership with Amylin. Even after giving effect to this
restructuring, we may not have sufficient cash to execute our current business plan and any
restructuring may impact our ability to execute on our business plan.
We have taken steps to restructure certain aspects of our business, including significantly
reducing our workforce and reducing certain operating costs. However, restructurings take time to
fully implement and involve certain additional costs, including severance payments to terminated
employees. There can be no assurance that we will be successful in implementing our restructuring
program or that, following the completion of our restructuring program, we will have sufficient
cash reserves to allow us to fund our business plan until such time as we achieve profitability.
Furthermore, our restructuring program could have material adverse affect on our ability to execute
on our business plan.
Risks Related to the Development and Regulatory Approval of our Drug Candidates
Clinical trials of our product candidates are expensive and time-consuming, and the results of
these trials are uncertain.
Many of our research and development programs are at an early stage. Clinical trials in
patients are long, expensive and uncertain processes. The length of time generally varies
substantially according to the type of drug, complexity of clinical trial design, regulatory
compliance requirements, intended use of the drug candidate and rate of patient enrollment for the
clinical trials. Clinical trials may not be commenced or completed on schedule, and the FDA may not
ultimately approve our product candidates for commercial sale. Further, even if the results of our
pre-clinical studies or clinical trials are initially positive, it is possible that we will obtain
different results in the later stages of drug development or that results seen in clinical trials
will not continue with longer term treatment. Drugs in late stages of clinical development may fail
to show the desired safety and efficacy traits despite having progressed through initial clinical
testing. For example, positive results in early Phase 1 or Phase 2 clinical trials may not be
repeated in larger Phase 2 or Phase 3 clinical trials. All of our potential drug candidates are
prone to the risks of failure inherent in drug development. The clinical trials of any or all of
our drugs or drug candidates, including PYY(3-36) nasal spray, PTH(1-34), generic calcitonin-salmon
nasal spray and insulin could be unsuccessful, which would prevent us from commercializing these
drugs. The FDA conducts its own independent analysis of some or all of the pre-clinical and
clinical trial data submitted in a regulatory filing and often comes to different and potentially
more negative conclusions than the analysis performed by the drug sponsor. Our failure to develop
safe, commercially viable drugs approved by the FDA would substantially impair our ability to
generate revenues and sustain our operations and would materially harm our business and adversely
affect our stock price. In addition, significant delays in clinical trials will impede our ability
to seek regulatory approvals, commercialize our drug candidates and generate revenue, as well as
substantially increase our development costs.
We are subject to extensive government regulation, including the requirement of approval
before our products may be manufactured or marketed.
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We, our collaboration partners and our product candidates are subject to extensive regulation
by governmental authorities in the U.S. and other countries. Failure to comply with applicable
requirements could result in, among other things, any of the following actions: warning letters;
fines and other civil penalties; unanticipated expenditures; delays in approving or refusal to
approve a product candidate; product recall or seizure; interruption of manufacturing or clinical
trials; operating restrictions; injunctions; and criminal prosecution.
Our product candidates cannot be marketed in the U.S. without FDA approval or clearance. The
FDA has approved only two of our product candidates, our Nascobal® nasal gel and our Nascobal®
nasal spray, and cleared only one, our MASCT device, for sale in the U.S. Our other product
candidates are in development, and will have to be approved by the FDA before they can be marketed
in the U.S. Obtaining FDA approval requires substantial time, effort, and financial resources, and
may be subject to both expected and unforeseen delays, including without limitation citizens
petitions or other filings with the FDA, and there can be no assurance that any approval will be
granted on a timely basis, if at all, or that delays will be resolved favorably or in a timely
manner. If the FDA does not approve our product candidates in a timely fashion, or does not approve
them at all, our business and financial condition may be adversely affected. We, our collaboration
partners or the FDA may suspend or terminate human clinical trials at any time on various grounds,
including a finding that the patients are being exposed to an unacceptable health risk.
In addition, both before and after regulatory approval, we, our collaboration partners and our
product candidates are subject to numerous FDA requirements covering, among other things, testing,
manufacturing, quality control, labeling, advertising, promotion, distribution and export. The
FDAs requirements may change and additional government regulations may be promulgated that could
affect us, our collaboration partners or our product candidates. We cannot predict the likelihood,
nature or extent of government regulation that may arise from future legislation or administrative
action, either in the U.S. or abroad. There can be no assurance that we will not be required to
incur significant costs to comply with such laws and regulations in the future or that such laws or
regulations will not have a material adverse effect upon our business.
Our ability to commercialize our products after FDA approval is subject to exclusivity periods
provided by law.
Under U.S. law, the FDA awards 180 days of market exclusivity to the first generic
manufacturer who challenges the patent of a branded product. However, amendments to the Drug Price
Competition and Patent Term Restoration Act of 1984 (also known as the Hatch-Waxman Act) will
affect the future availability of this market exclusivity in many cases. These amendments now
require generic applicants to launch their products within certain time frames or risk losing the
marketing exclusivity that they had gained through being a first-to-file applicant. Apotex has
filed a generic application for its intranasal calcitonin-salmon product with a filing date that has
priority over our ANDA for our generic calcitonin-salmon nasal spray. The amendments to the
Hatch-Waxman Act do not apply to the Apotex intranasal calcitonin-salmon product, which preceded the
adoption of such amendments.
We use hazardous chemicals and radioactive and biological materials in our business. Any
disputes relating to improper use, handling, storage or disposal of these materials could be
time-consuming and costly.
Our research and development operations involve the use of hazardous, radioactive and
biological, potentially infectious, materials. We are subject to the risk of accidental
contamination or discharge or any resultant injury from these materials. Federal, state and local
laws and regulations govern the use, manufacture, storage, handling and disposal of these
materials. We could be subject to damages, fines or penalties in the event of an improper or
unauthorized release of, or exposure of individuals to, these hazardous materials, and our
liability could exceed our total assets. Compliance with environmental laws and regulations may be
expensive, and current or future environmental regulations may impair our business.
Failure to comply with foreign regulatory requirements governing human clinical trials and
marketing approval for drugs could prevent us from selling our drug candidates in foreign markets,
which may adversely affect our operating results and financial condition.
The requirements governing the conduct of clinical trials, product licensing, pricing, and
reimbursement for marketing our drug candidates outside the U.S. vary greatly from country to
country. We have limited experience in obtaining foreign regulatory approvals. The time required to
obtain approvals outside the U.S. may differ from that required to obtain FDA approval. We may not
obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not
ensure approval by regulatory authorities in other countries, and approval by one foreign
regulatory authority does not ensure approval by regulatory authorities in other countries or by
the FDA. Failure to comply with these regulatory requirements or obtain required approvals could
impair our
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ability to develop foreign markets for our drug candidates and may have a material adverse
effect on our consolidated financial condition or results of operations.
Risks Related to our Dependence on Third Parties
We depend on a limited number of customers for a significant percentage of our revenue. These
customers may be able to terminate their contracts with us on short notice, with or without cause.
The loss of, or delay in receiving payment from, one or a small number of customers could have a
significant impact on our revenues, operating results and cash flows.
A small number of customers account for a significant percentage of our revenue. For example,
Procter & Gamble Pharmaceuticals, Inc., or P&G, represented 49% of our revenue in the nine months ended September 30, 2007 and 75% of our
revenue in the nine months ended September 30, 2006. Novo
Nordisk A/S, or Novo, represented 2% and 24% of our
revenue in the nine months ended September 30, 2006 and 2007, respectively. We believe that a small
number of customers may continue to account for a significant percentage of our revenue for the
foreseeable future. As a result, the termination by one of our significant customers of its
relationship with us, combined with our inability to replace the revenue that we anticipated to
generate from such relationship, could have a material adverse impact on our revenue, operating
results and cash flows. For instance, P&G terminated their Product Development and License
Agreement for PTH(1-34) nasal spray for the treatment of osteoporosis with us in November 2007, and
on January 16, 2008 Novo advised us that they intend to cease development under their
feasibility study agreement with us. Our inability to obtain new collaboration partners for our
current Phase 2 programs for PTH(1-34) to replace the revenue we would have expected to generate
during 2008 from our relationship with P&G or new feasibility study partners could have a material
adverse impact on our revenue, operating results and cash flows.
We are dependent on our collaborative arrangements with third parties for a substantial
portion of our revenue, and our development and commercialization activities may be delayed or
reduced if we fail to negotiate or maintain successful collaborative arrangements.
We are dependent on our current and any other possible future collaborators to commercialize
many of our product candidates and to provide the regulatory compliance, sales, marketing and
distribution capabilities required for the success of our business. If we fail to secure or
maintain successful collaborative arrangements, our development and commercialization activities
will be delayed or reduced and our revenues could be materially and adversely impacted.
We
entered into collaborative partnerships with Merck & Co., Inc.,
or Merck, in
September 2004, Par Pharmaceutical Companies, Inc. in
October 2004, Amylin Pharmaceuticals, Inc. in November 2004,
P&G in January 2006 and Novo in March 2006. The
strategic collaboration that we entered into with Merck in September 2004 for PYY(3-36) was
terminated in March 2006, the collaboration with P&G was terminated in November 2007, and Novo
advised us in January 2008 that they intend to cease development under their feasibility study
agreement with us. Over the next several years, we will depend on these types of collaboration
partnerships for a significant portion of our revenue. The expected future milestone payments and
cost reimbursements from collaboration agreements will provide an important source of financing for
our research and development programs, thereby facilitating the application of our technology to
the development and commercialization of our products. These collaborative agreements can be
terminated either by us or by our partners at their discretion upon the satisfaction of certain
notice requirements. Our partners may not be precluded from independently pursuing competing
products and drug delivery approaches or technologies. Even if our partners continue their
contributions to our collaborative arrangements, they may nevertheless determine not to actively
pursue the development or commercialization of any resulting products. Our partners may fail to
perform their obligations under the collaborative arrangements or may be slow in performing their
obligations. In addition, our partners may experience financial difficulties at any time that could
prevent them from having available funds to contribute to these collaborations. If our
collaboration partners fail to conduct their commercialization, regulatory compliance, sales and
marketing or distribution activities successfully and in a timely manner, we will earn little or no
revenue from those products and we will not be able to achieve our objectives or build a
sustainable or profitable business.
We are also dependent on contracts with government agencies to fund certain product
development candidates. There is currently work being performed and reimbursed by governmental
agencies for the development of one of our drug candidates. Any contracts with governmental
agencies may not be completed on terms favorable to us, or at all, and any revenues under such
contracts may not cover the development costs of our programs. These grants are subject to review
and audit by the federal government and any such audit could lead to requests for reimbursement for
any expenditure disallowed under the terms of the grant. Additionally, any noncompliance with the
terms of these grants could lead to loss of current or future awards.
Our success depends to a significant degree upon the commercial success of products
manufactured by us pursuant to supply agreements or marketed by our collaboration partners.
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Even if we are able to develop products and obtain the necessary regulatory approvals, our
success depends to a significant degree on the commercial success of products manufactured by us
pursuant to supply agreements or marketed by our collaboration partners. If these products fail to
achieve or subsequently maintain market acceptance or commercial viability, our business could be
significantly harmed because our future revenue is dependent upon sales of these products.
An interruption in the supply of our raw and bulk materials needed to make our products could
cause our product development and commercialization to be slowed or stopped.
We currently obtain supplies of critical raw and bulk materials used in our research and
development and manufacturing efforts from several suppliers. However, we do not have long-term
contracts with any of these suppliers. While our existing arrangements supply sufficient quantities
of raw and bulk materials needed to accomplish the clinical development of our product candidates,
there can be no assurance that we would have the capability to manufacture sufficient quantities of
our product candidates to meet our needs if our suppliers are unable or unwilling to supply such
materials. Any delay or disruption in the availability of raw or bulk materials could slow or stop
product development and commercialization of the relevant product. Our dependence upon third
parties for the manufacture of our bottles, pumps and cap components of our nasal products and the
related supply chain may adversely affect our cost of goods, our ability to develop and
commercialize products on a timely and competitive basis, and the production volume of our nasal
products.
We rely on third parties to conduct our clinical trials, and those third parties may not
perform satisfactorily, including failing to meet established deadlines for the completion of such
clinical trials.
We are dependent on contract research organizations, third-party vendors and investigators for
pre-clinical testing and clinical trials related to our drug discovery and development efforts and
we will likely continue to depend on them to assist in our future discovery and development
efforts. These parties are not our employees and we cannot control the amount or timing of
resources that they devote to our programs. If they fail to devote sufficient time and resources to
our drug development programs or if their performance is substandard, it will delay the development
and commercialization of our product candidates. The parties with which we contract for execution
of our clinical trials play a significant role in the conduct of the trials and the subsequent
collection and analysis of data. Their failure to meet their obligations could adversely affect
clinical development of our product candidates. Moreover, these parties also may have relationships
with other commercial entities, some of which may compete with us. If they assist our competitors,
it could harm our competitive position.
If we lose our relationship with any one or more of these parties, we could experience a
significant delay in both identifying another comparable provider and then contracting for its
services. We may then be unable to retain an alternative provider on reasonable terms, if at all.
Even if we locate an alternative provider, is it likely that this provider may need additional time
to respond to our needs and may not provide the same type or level of service as the original
provider. In addition, any provider that we retain will be subject to Good Laboratory Practices, or
cGLP, and similar foreign standards and we do not have control over compliance with these
regulations by these providers. Consequently, if these practices and standards are not adhered to
by these providers, the development and commercialization of our product candidates could be
delayed.
We have limited experience in marketing or selling our products, and we may need to rely on
marketing partners or contract sales companies.
Even if we are able to develop our products and obtain necessary regulatory approvals, we have
limited experience or capabilities in marketing or commercializing our products. We currently have
a limited sales, marketing and distribution infrastructure. Accordingly, we are dependent on our
ability to build this capability ourselves or to find collaborative marketing partners or contract
sales companies for commercial sale of our internally-developed products. Even if we find a
potential marketing partner, we may not be able to negotiate a licensing contract on favorable
terms to justify our investment or achieve adequate revenues.
Risks Related to our Intellectual Property and Other Legal Matters
If we are unable to adequately protect our proprietary technology from legal challenges,
infringement or alternative technologies, our competitive position may be hurt and our operating
results may be negatively impacted.
We specialize in the nasal delivery of pharmaceutical products and rely on the issuance of
patents, both in the U.S. and internationally, for protection against competitive drug delivery
technologies. Although we believe we exercise the necessary due
9
diligence in our patent filings, our proprietary position is not established until the
appropriate regulatory authorities actually issue a patent, which may take several years from
initial filing or may never occur.
Moreover, even the established patent positions of pharmaceutical companies are generally
uncertain and involve complex legal and factual issues. Although we believe our issued patents are
valid, third parties may infringe our patents or may initiate proceedings challenging the validity
or enforceability of our patents. The issuance of a patent is not conclusive as to its claim scope,
validity or enforceability. Challenges raised in patent infringement litigation we initiate or in
proceedings initiated by third parties may result in determinations that our patents have not been
infringed or that they are invalid, unenforceable or otherwise subject to limitations. In the event
of any such determinations, third parties may be able to use the discoveries or technologies
claimed in our patents without paying us licensing fees or royalties, which could significantly
diminish the value of these discoveries or technologies. As a result of such determinations, we may
be enjoined from pursuing research, development or commercialization of potential products or may
be required to obtain licenses, if available, to the third party patents or to develop or obtain
alternative technology. Responding to challenges initiated by third parties may require significant
expenditures and divert the attention of our management and key personnel from other business
concerns.
Furthermore, it is possible others will infringe or otherwise circumvent our issued patents
and that we will be unable to fund the cost of litigation against them or that we would elect not
to pursue litigation. In addition, enforcing our patents against third parties may require
significant expenditures regardless of the outcome of such efforts. We also cannot assure you that
others have not filed patent applications for technology covered by our pending applications or
that we were the first to invent the technology. There may also exist third party patents or patent
applications relevant to our potential products that may block or compete with the technologies
covered by our patent applications and third parties may independently develop IP similar to our
patented IP, which could result in, among other things, interference proceedings in the PTO to
determine priority of invention.
In addition, we may not be able to protect our established and pending patent positions from
competitive drug delivery technologies, which may provide more effective therapeutic benefit to
patients and which may therefore make our products, technology and proprietary position obsolete.
If we are unable to adequately protect our proprietary technology from legal challenges,
infringement or alternative technologies, we will not be able to compete effectively in the
pharmaceutical delivery business.
Because intellectual property rights are of limited duration, expiration of intellectual
property rights and licenses will negatively impact our operating results.
Intellectual property rights, such as patents and license agreements based on those patents,
generally are of limited duration. Our operating results depend on our patents and IP licenses.
Therefore, the expiration or other loss of rights associated with IP and IP licenses can negatively
impact our business.
Our patent applications may be inadequate in terms of priority, scope or commercial value.
We apply for patents covering our discoveries and technologies as we deem appropriate.
However, we may fail to apply for patents on important discoveries or technologies in a timely
fashion or at all. Also, our pending patent applications may not result in the issuance of any
patents. These applications may not be sufficient to meet the statutory requirements for
patentability, and therefore we may be unable to obtain enforceable patents covering the related
discoveries or technologies we may want to commercialize. In addition, because patent applications
are maintained in secrecy for approximately 18 months after filing, other parties may have filed
patent applications relating to inventions before our applications covering the same or similar
inventions. In addition, foreign patent applications are often published initially in local
languages, and until an English language translation is available it can be impossible to determine
the significance of a third party invention. Any patent applications filed by third parties may
prevail over our patent applications or may result in patents that issue alongside patents issued
to us, leading to uncertainty over the scope of the patents or the freedom to practice the claimed
inventions.
Although we have a number of issued patents, the discoveries or technologies covered by these
patents may not have any therapeutic or commercial value. Also, issued patents may not provide
commercially meaningful protection against competitors. Other parties may be able to design around
our issued patents or independently develop products having effects similar or identical to our
patented product candidates. In addition, the scope of our patents is subject to considerable
uncertainty and competitors or other parties may obtain similar patents of uncertain scope.
10
We may be required to defend lawsuits or pay damages for product liability claims.
Our business inherently exposes us to potential product liability claims. We face substantial
product liability exposure in human clinical trials and for products that we sell, or manufacture
for others to sell, after regulatory approval. The risk exists even with respect to those drugs
that are approved by regulatory agencies for commercial distribution and sale and are manufactured
in facilities licensed and regulated by regulatory agencies. Any product liability claims,
regardless of their merits, could be costly, divert managements attention and adversely affect our
reputation and the demand for our products.
We currently have product liability insurance coverage in the amount of $20.0 million per
occurrence and a $20.0 million aggregate limitation, subject to a deductible of $10,000 per
occurrence. From time to time, participants in the pharmaceutical industry have experienced
difficulty in obtaining product liability insurance coverage for certain products or coverage in
the desired amounts or with the desired deductibles. We cannot assure you that we will be able to
obtain the levels or types of insurance we would otherwise have obtained prior to these market
changes or that the insurance coverage we do obtain will not contain large deductibles or fail to
cover certain liabilities or that it will otherwise cover all potential losses.
Risks Related to the Commercialization of our Drug Candidates
Our product development efforts may not result in commercial products.
Our future results of operations depend, to a significant degree, upon our and our
collaboration partners ability to successfully commercialize additional pharmaceutical products.
The development and commercialization process, particularly with respect to innovative products, is
both time consuming and costly and involves a high degree of business risk. Successful product
development in the pharmaceutical industry is highly uncertain, and very few research and
development projects result in a commercial product. Product candidates that appear promising in
the early phases of development, such as in early human clinical trials, may fail to reach the
market for a number of reasons, such as:
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a product candidate may not perform as expected in later or broader trials in humans and
limit marketability of such product candidate;
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necessary regulatory approvals may not be obtained in a timely manner, if at all;
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a product candidate may not be able to be successfully and profitably produced and
marketed;
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third parties may have proprietary rights to a product candidate, and do not allow sale
on reasonable terms;
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a product candidate may not be financially successful because of existing therapeutics
that offer equivalent or better treatments; or
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suppliers of product pumps or actuators required to atomize our formulations may increase
their price or cease to manufacture them without prior notice.
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To date, except for our Nascobal® nasal gel and our Nascobal® nasal spray (the NDAs for which
have been transferred to QOL), none of our other product candidates utilizing our current nasal
drug delivery technology have been approved by the FDA. Accordingly, there can be no assurance that
any of our product candidates currently in development will ever be successfully commercialized,
and delays in any part of the process or our inability to obtain regulatory approval could
adversely affect our operating results by restricting introduction of new products by us or our
collaboration partners.
Even if we are successful in commercializing a product candidate, it is possible that the
commercial opportunity for nasally-administered products will be limited.
None of our product candidates utilizing our nasal drug delivery technology have been brought
to market except for our Nascobal® nasal gel and our Nascobal® nasal spray. Accordingly, while we
believe there is a commercial market for our nasal drug delivery technology, there can be no
assurance that our nasal drug delivery technology will become a viable commercial alternative to
other drug delivery methods. Many factors may affect the market acceptance and commercial success
of any potential products, including:
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establishment and demonstration of the effectiveness and safety of the drugs;
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timing of market entry as compared to competitive products;
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the benefits of our drugs relative to their prices and the comparative price of competing
products;
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actual and perceived benefits and detriments of nasal drug delivery, which may be
affected by press and academic literature;
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marketing and distribution support of our products; and
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any restrictions on labeled indications.
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Our revenues and profits from any particular generic pharmaceutical products decline as our
competitors introduce their own generic equivalents.
In October 2004, we entered into a license and supply agreement granting Par Pharmaceutical
the exclusive U.S. distribution and marketing rights to our generic calcitonin-salmon nasal spray.
Under the terms of our agreement with Par Pharmaceutical, we will seek to obtain FDA approval,
manufacture and supply finished generic calcitonin-salmon nasal spray to Par Pharmaceutical, and
Par Pharmaceutical will distribute the product in the U.S. Novartis, the supplier of a branded
calcitonin-salmon nasal spray, may introduce a generic version through Sandoz US, its wholly-owned
subsidiary, and Apotex has filed with the FDA a generic application of nasal salmon-calcitonin with
a filing date that has priority over our ANDA. Selling prices of generic drugs typically decline,
sometimes both rapidly and dramatically, as additional companies receive approvals for a given
product and competition intensifies. To the extent that our collaboration partner and we succeed in
being the first to market a generic version of a significant product, our initial sales and
profitability following the introduction of such product will be subject to material reduction upon
a competitors introduction of the equivalent product. Our ability to sustain our sales and
profitability on any product over time is dependent on both the number of new competitors for such
product and the timing of their approvals.
If we have a problem with our manufacturing facilities, we may not be able to market our
products or conduct clinical trials.
A substantial portion of our products for both clinical and commercial use is, or will be,
manufactured at our facilities in Hauppauge, New York, and in Bothell, Washington. The
manufacturing capacity of our Hauppauge facility is approximately six million product units per
year, and the manufacturing capacity of our Bothell facility will be approximately 54 million
product units per year. Any problems we experience at either of our manufacturing facilities could
cause a delay in our clinical trials or our supply of product to market. Any significant delay or
failure to manufacture could jeopardize our performance contracts with collaboration partners,
resulting in material penalties to us and jeopardizing the commercial viability of our products.
Our facilities are subject to risks of natural disasters, including earthquakes and floods.
Although we believe we have adequate insurance against such risks, there can be no assurance that
any business disruption caused by a natural disaster would be fully reimbursed or that it would not
delay our product development processes. Our current facilities are leased and there can be no
assurance that we will be able to negotiate future lease extensions at reasonable rates.
Risks Related to our Industry
Reforms in the healthcare industry and the uncertainty associated with pharmaceutical pricing,
reimbursement and related matters could adversely affect the marketing, pricing and demand for our
products.
Increasing expenditures for healthcare have been the subject of considerable public attention
in the U.S. Both private and government entities are seeking ways to reduce or contain healthcare
costs. Numerous proposals that would effect changes in the U.S. healthcare system have been
introduced or proposed in Congress and in some state legislatures, including reductions in the cost
of prescription products and changes in the levels at which consumers and healthcare providers are
reimbursed for purchases of pharmaceutical products. For example, the Medicare Prescription Drug,
Improvement and Modernization Act of 2003 and the proposed rules thereunder impose new requirements
for the distribution and pricing of prescription drugs, which could reduce reimbursement of
prescription drugs for healthcare providers and insurers. Although we cannot predict the full
effect on our business of the implementation of this legislation, we believe that legislation that
reduces reimbursement for our products could adversely impact how much or under what circumstances
healthcare providers will prescribe or administer our products. This could materially and adversely
impact our business by reducing our ability to generate revenue, raise capital, obtain additional
collaborators and market
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our products. In addition, we believe the increasing emphasis on managed care in the U.S. has
and will continue to put pressure on the price and usage of our products, which may adversely
impact product sales.
Coverage and reimbursement status of newly-approved drugs is uncertain and the failure to
obtain adequate reimbursement coverage could limit our ability to generate revenue.
Our products may prove to be unsuccessful if various parties, including government health
administration authorities, private healthcare insurers and other healthcare payers, such as health
maintenance organizations and self-insured employee plans that determine reimbursement to the
consumer, do not accept our products for reimbursement. Sales of therapeutic and other
pharmaceutical products depend in significant part on the availability of reimbursement to the
consumer from these third-party payers. Third-party payers are increasingly challenging the prices
charged for medical products and services. We cannot assure you that reimbursement will be
available at all or at levels sufficient to allow our marketing partners to achieve profitable
price levels for our products. If we fail to achieve adequate reimbursement levels, patients may
not purchase our products and sales of these products will be absent or reduced.
We may be unable to compete successfully against our current and future competitors.
Competition in the drug industry is intense. Although we are not aware of any other companies
that have the scope of proprietary technologies and processes that we have developed, there are a
number of competitors who possess capabilities relevant to the drug delivery field.
Many of our competitors have substantially greater capital resources, research and development
resources and experience, manufacturing capabilities, regulatory expertise, sales and marketing
resources, and established collaborating relationships with pharmaceutical companies. Our
competitors, either alone or with their collaboration partners, may succeed in developing drug
delivery technologies that are similar or preferable in effectiveness, safety, cost and ease of
commercialization, and our competitors may obtain IP protection or commercialize such products
sooner than we do. Developments by others may render our product candidates or our technologies
obsolete or, if developed earlier than our products, may achieve market acceptance which could
negatively impact the opportunities for our products regardless of the merits of our technology.
Risks Related to Employee Matters and Managing Growth
If we lose our key personnel, or if we are unable to attract and retain additional personnel,
then we may be unable to successfully develop our business.
If we are unable to retain one or more of our corporate officers, including Dr. Steven C.
Quay, Chairman of the Board and Chief Executive Officer (CEO), Dr. Gordon C. Brandt, President,
Bruce R. York, Secretary and Interim Chief Financial Officer (CFO), Timothy M. Duffy, Executive
Vice President, Marketing and Business Development, Dr. Henry R. Costantino, Chief Scientific
Officer, Delivery, or any of our other key managers or key technical personnel, our business could
be seriously harmed. Except for the employment agreements with Dr. Quay, Dr. Costantino, Mr. Duffy
and Dr. Brandt, we generally do not execute employment agreements with members of our management
team. Whether or not a member of management has executed an employment agreement, there can be no
assurance that we will be able to retain our key managers or key technical personnel or replace any
of them if we lose their services for any reason. Although we make a significant effort and
allocate substantial resources to recruit candidates to our Bothell and Hauppauge facilities,
competition for competent managers and technical personnel is intense. Failure to retain our key
personnel may compromise our ability to negotiate and enter into additional collaborative
arrangements, delay our ongoing discovery research efforts, delay pre-clinical or clinical testing
of our product candidates, delay the regulatory approval process or prevent us from successfully
commercializing our product candidates. In addition, if we have to replace any of these
individuals, we may not be able to replace knowledge that they have about our operations.
If we make strategic acquisitions, we will incur a variety of costs and might never realize
the anticipated benefits.
We have very limited experience in independently identifying acquisition candidates and
integrating the operations of acquisition candidates with our company. Currently, we are not a
party to any acquisition agreements, nor do we have any understanding or commitment with respect to
any such acquisition. If appropriate opportunities become available, however, we might attempt to
acquire approved products, additional drug candidates or businesses that we believe are a strategic
fit with our business. If we pursue any transaction of that sort, the process of negotiating the
acquisition and integrating an acquired product, drug candidate or business might result in
operating difficulties and expenditures and might require significant management attention that
would otherwise be
13
available for ongoing development of our business, whether or not any such transaction is ever
consummated. Moreover, we might never realize the anticipated benefits of any acquisition. Future
acquisitions could result in potentially dilutive issuances of equity securities, the incurrence of
debt, contingent liabilities, or impairment expenses related to goodwill, and impairment or
amortization expenses related to other intangible assets, which could harm our financial condition.
Failure of our internal control over financial reporting could harm our business and financial
results.
Our management is responsible for establishing and maintaining adequate internal control over
financial reporting. Internal control over financial reporting is a process to provide reasonable
assurance regarding the reliability of financial reporting for external purposes in accordance with
accounting principles generally accepted in the U.S. Internal control over financial reporting
includes maintaining records that in reasonable detail accurately and fairly reflect our
transactions; providing reasonable assurance that transactions are recorded as necessary for
preparation of the financial statements; providing reasonable assurance that receipts and
expenditures of our assets are made in accordance with management authorization; and providing
reasonable assurance that unauthorized acquisition, use or disposition of our assets that could
have a material effect on the financial statements would be prevented or detected on a timely
basis. Because of its inherent limitations, internal control over financial reporting is not
intended to provide absolute assurance that a misstatement of our financial statements would be
prevented or detected. Our rapid growth and entry into new products and markets will place
significant additional pressure on our system of internal control over financial reporting. Any
failure to maintain an effective system of internal control over financial reporting could limit
our ability to report our financial results accurately and timely or to detect and prevent fraud.
Risks Related to our Common Stock
We cannot assure you that our stock price will not decline.
The market price of our common stock could be subject to significant fluctuations. Among the
factors that could affect our stock price are:
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negative results from our clinical or pre-clinical trials or adverse FDA decisions
related to our product candidates or third party products that are in the same drug class
as our products;
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changes in revenue estimates or publication of research reports related to our company
by analysts;
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failure to meet analysts revenue estimates;
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speculation in the press or investment community;
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strategic actions by our company or our competitors, such as acquisitions or
restructurings;
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actions by institutional stockholders and other significant stockholders;
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low average daily trading volumes due to relatively small number of shares outstanding;
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general market conditions; and
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domestic and international economic factors unrelated to our performance.
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Additionally, numerous factors relating to our business may cause fluctuations or declines in
our stock price.
The stock markets in general, and the markets for pharmaceutical stocks in particular, have
experienced extreme volatility that has often been unrelated to the operating performance of
particular companies. This may in part be related to the increasing influence of hedge funds, which
can use stock shorting and other techniques that increase volatility. These broad market
fluctuations may adversely affect the trading price of our common stock.
We have never paid cash or stock dividends on our common stock and we do not anticipate paying
dividends in the foreseeable future.
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We have paid no cash or stock dividends on our common stock to date, and we currently intend
to retain our future earnings, if any, to fund the development and growth of our business. The
terms of any future debt or credit facility may preclude us from paying any dividends. As a result,
capital appreciation, if any, of our common stock may be the sole source of potential gain for the
foreseeable future.
The anti-takeover provisions of our stockholder rights plan may entrench management, may delay
or prevent beneficial takeover bids by third parties and may prevent or frustrate any stockholder
attempt to replace or remove the current management even if the stockholders consider it beneficial
to do so.
We have a stockholder rights plan designed to protect our stockholders from coercive or unfair
takeover tactics. Under the plan, we declared a dividend of one preferred stock purchase right for
each share of common stock outstanding on March 17, 2000. Each preferred stock purchase right
entitles the holder to purchase from us 1/1000 of a share of Series A Junior Participating
Preferred Stock for $50.00. In the event any acquiring entity or group accumulates or initiates a
tender offer to purchase 15% or more of our common stock, then each holder of a preferred stock
purchase right, other than the acquiring entity and its affiliates, will have the right to receive,
upon exercise of the preferred stock purchase right, shares of our common stock or shares in the
acquiring entity having a value equal to two times the exercise price of the preferred stock
purchase right.
The intent of the stockholder rights plan is to protect our stockholders interests by
encouraging anyone seeking control of our company to negotiate with
our board of directors. However, our stockholder rights plan could make it more difficult for a third party to
acquire us without the consent of our board of directors, even if doing so may be beneficial to our
stockholders. This plan may discourage, delay or prevent a tender offer or takeover attempt,
including offers or attempts that could result in a premium over the market price of our common
stock. This plan could reduce the price that investors might be willing to pay for shares of our
common stock in the future. Furthermore, the anti-takeover provisions of our stockholder rights
plan may entrench management and make it more difficult for stockholders to replace management even
if the stockholders consider it beneficial to do so.
Our operating results are subject to significant fluctuations and uncertainties, and our
failure to meet expectations of public market analysts or investors regarding operating results may
cause our stock price to decline.
Our operating results are subject to significant fluctuations and uncertainties due to a
number of factors including, among others:
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timing and achievement of licensing transactions, including milestones and other
performance factors associated with these contracts;
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time and costs involved in patent prosecution and development of our proprietary
position;
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continued scientific progress and level of expenditures in our research and development
programs;
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cost of manufacturing scale-up and production batches, including vendor provided
activities and costs;
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time and costs involved in obtaining regulatory approvals;
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changes in general economic conditions and drug delivery technologies;
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expiration of existing patents and related revenues; and
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new products and product enhancements that we or our competitors introduce.
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As a result of these factors and other uncertainties, our operating results have fluctuated
significantly in recent years, resulting in net losses of
approximately $32.2 million in 2005 and
$26.9 million in 2006. Net losses were approximately $16.2 million in the nine months ended
September 30, 2006 and approximately $40.4 million in the nine months ended September 30, 2007.
Our revenues and operating results, particularly those reported on a quarterly basis, will
continue to fluctuate significantly. This fluctuation makes it difficult to forecast our operating
results. Therefore, we believe that quarterly comparisons of our operating results may not be
meaningful, and you should not rely on them as an indication of our future performance. In
addition, our operating results in a future quarter or quarters may fall below the expectations of
public market analysts or investors. If this were to occur, the price of our stock could decline.
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A significant number of shares of our common stock are subject to options and warrants, and we
expect to sell additional shares of our common stock in the future. Sales of these shares will
dilute the interests of other security holders and may depress the price of our common stock.
As of September 30, 2007, there were 25,792,519 shares of common stock outstanding. As of
September 30, 2007, there were vested outstanding options to purchase 1,909,124 shares of common
stock, unvested outstanding options to purchase 506,194 shares of common stock and outstanding
warrants to purchase 660,814 shares of common stock. At September 30, 2007, there were
843,539 shares of common stock available for future issuance under our stock compensation plans. In
addition, we may issue additional common stock and warrants from time to time to finance our
operations. We may also issue additional shares to fund potential acquisitions or in connection
with additional stock options or restricted stock granted to our employees, officers, directors and
consultants under our stock option plans. The issuance, perception that issuance may occur, or
exercise of warrants or options will have a dilutive impact on other stockholders and could have a
material negative effect on the market price of our common stock.
USE OF PROCEEDS
Unless otherwise specified in the applicable prospectus supplement, we intend to use the net
proceeds from the sale of our securities offered by this prospectus for general corporate purposes,
including, without limitation, the funding of our clinical research and development programs, the
clinical development of our product candidates, capital expenditures and working capital needs.
Pending the application of the net proceeds, we expect to invest the proceeds in investment grade,
interest bearing securities. As of the date of this prospectus, we cannot specify with certainty
all of the particular uses for the net proceeds we will have upon completion of this offering.
Accordingly, our management will have broad discretion in the application of net proceeds, if any.
RATIO OF EARNINGS TO FIXED CHARGES
The ratio of earnings to fixed charges for each of the periods indicated is as follows:
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Years ended December 31,
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Nine (9) months ended
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(in thousands)
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2002
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2003
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2004
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2005
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2006
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September 30, 2007
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Ratio of earnings
to fixed charges
(1)
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(1)
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For the purposes of computing the ratio of earnings to fixed charges, earnings consist of
income (loss) from continuing operations before the cumulative effect of changes in accounting
principle, plus fixed charges. Fixed charges consist of interest charges and that portion of rental
payments under operating leases we believe to be an appropriate representation of interest, which
is calculated as one-third of rental expenses expensed each period. Earnings for the years ended
December 31, 2002, 2003, 2004, 2005 and 2006 and for the nine months ended September 30, 2007, were
insufficient to cover fixed charges by $13,039, $1,271, $27,709, $31,113, $25,261 and $38,637 (in
thousands), respectively.
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PLAN OF DISTRIBUTION
We may sell the securities registered under this prospectus:
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through underwriting syndicates represented by one or more managing underwriters;
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to or through underwriters or dealers;
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through agents;
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directly to one or more purchasers, including upon the exercise of rights to acquire
shares of our common or preferred stock;
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equity lines of credit;
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through a block trade in which the broker or dealer engaged to handle the block
trade will attempt to sell the securities as agent, but may position and resell
a portion of the block as principal to facilitate the transaction; or
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through a combination of any of these methods of sale.
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We may, from time to time, authorize underwriters acting as our agents to offer and sell the
securities upon the terms and conditions as are set forth in the applicable prospectus supplement.
We will describe the name or names of any underwriters and the purchase price of the securities in
a prospectus supplement relating to the securities. Any underwritten offering may be on a best
efforts or a firm commitment basis. The obligations, if any, of the underwriters to purchase any
securities will be subject to certain conditions.
If a dealer is used in an offering of securities, we may sell the securities to the dealer as
principal. We will describe the name or names of any dealers and the purchase price of the
securities in a prospectus supplement relating to the securities. The dealer may then resell the
securities to the public at varying prices to be determined by the dealer at the time of sale. Any
public offering price and any discounts or concessions allowed, re-allowed, or paid to dealers may
be changed from time to time and will be described in a prospectus supplement relating to the
securities.
We, or any underwriter, dealer or agent, may distribute the securities from time to time in
one or more transactions at:
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a fixed price or prices, which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to prevailing market prices; or
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at negotiated prices.
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Any of these prices may represent a discount from the prevailing market prices.
To the extent permitted by and in accordance with Regulation M under the Exchange Act, in
connection with an offering an underwriter may engage in over-allotments, stabilizing transactions,
short covering transactions and penalty bids. Over-allotments involve sales in excess of the
offering size, which creates a short position. Stabilizing transactions permit bids to purchase the
underlying security so long as the stabilizing bids do not exceed a specified maximum. Short
covering transactions involve purchases of the securities in the open market after the distribution
is completed to cover short positions. Penalty bids permit the underwriters to reclaim a selling
concession from a dealer when the securities originally sold by the dealer are purchased in a
covering transaction to cover short positions. Those activities may cause the price of the
securities to be higher than it would be otherwise. If commenced, the underwriters may discontinue
any of these activities at any time. We will describe any of these activities in the prospectus
supplement.
We may authorize underwriters, dealers or agents to solicit offers by certain institutions to
purchase our securities at the public offering price under delayed delivery contracts. If we use
delayed delivery contracts, we will disclose that we are using them in the prospectus supplement
and will tell you when we will demand payment and delivery of the securities under the delayed
delivery contracts. These delayed delivery contracts will be subject only to the conditions that we
set forth in the prospectus supplement. We will indicate in our prospectus supplement the
commission that underwriters and agents soliciting purchases of our securities under delayed
delivery contracts will be entitled to receive.
In connection with the sale of the securities and as further set forth in an applicable
prospectus supplement, underwriters may receive compensation from us or from purchasers of the
securities for whom they may act as agents, in the form of discounts, concessions or commissions.
Underwriters may sell the securities to or through dealers, and these dealers may receive
compensation in the form of discounts, concessions or commissions from the underwriters and/or
commissions from the purchasers for whom they may act as agents. Underwriters, dealers and agents
that participate in the distribution of the securities may be deemed to be underwriters, and any
discounts or commissions they receive from us, and any profit on the resale of the securities they
realize, may be deemed to be underwriting discounts and commissions under the Securities Act. The
prospectus supplement will identify any underwriter or agent and will describe any compensation
they receive from us.
Unless otherwise specified in the prospectus supplement, each series of the securities will be
a new issue with no established trading market, other than our common stock, which is currently
listed on the Nasdaq Global Market. We will apply to the Nasdaq Global Market to list any
additional shares of common stock that we offer and sell pursuant to a prospectus supplement. To
the extent permitted by and in accordance with Regulation M under the Exchange Act, any
underwriters who are qualified market makers on the Nasdaq Global Market may engage in passive
market making transactions in the securities on the Nasdaq Global Market during the
business day prior to the pricing of an offering, before the commencement of offers or sales
of the securities. Passive market makers
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must comply with applicable volume and price limitations
and must be identified as passive market makers. In general, a passive market maker must display
its bid at a price not in excess of the highest independent bid for such security; if all
independent bids are lowered below the passive market makers bid, however, the passive market
makers bid must then be lowered when certain purchase limits are exceeded. It is possible that one
or more underwriters may make a market in our securities, but underwriters will not be obligated to
do so and may discontinue any market making at any time without notice. Therefore, we can give no
assurance about the liquidity of our securities that may be sold pursuant to this prospectus.
Under agreements we may enter into, we may indemnify underwriters, dealers and agents who
participate in the distribution of the securities against certain liabilities, including
liabilities under the Securities Act.
Certain of the underwriters, dealers and agents and their affiliates may be customers of,
engage in transactions with, and perform services for us and our subsidiaries from time to time in
the ordinary course of business. Any such relationships will be disclosed in an applicable
prospectus supplement.
If indicated in the prospectus supplement, we will authorize underwriters or other persons
acting as our agents to solicit offers by institutions to purchase securities from us pursuant to
contracts providing for payment and delivery on a future date. Institutions with which we may make
these contracts include commercial and savings banks, insurance companies, pension funds,
investment companies, educational and charitable institutions and others. The obligations of any
purchaser under any such contract will be subject to the condition that the purchase of the
securities shall not at the time of delivery be prohibited under the laws of the jurisdiction to
which the purchaser is subject. The underwriters and other agents will not have any responsibility
with regard to the validity or performance of these contracts.
DESCRIPTION OF CAPITAL STOCK
Set forth below is a description of our capital stock. The following description of our
capital stock is a summary and is subject to and qualified by the applicable provisions of our
certificate of incorporation, our bylaws and the relevant provisions of the laws of the State of
Delaware. The particular terms of any offering of our securities will be described in a prospectus
supplement relating to such offering. The prospects supplement may provide that our capital stock
will be issuable upon the exercise of warrants to purchase our capital stock.
Common Stock
We are currently authorized to issue up to 50,000,000 shares of common stock, par value $.006
per share. As of September 30, 2007, 25,792,519 shares of our common stock were issued and
outstanding, 843,539 unissued shares of common stock were reserved for future issuance under our
equity compensation plans, and 660,814 unissued shares of common stock were reserved for issuance
upon the exercise of outstanding warrants, leaving approximately 22,703,128 shares of common stock
unissued and unreserved.
All shares of common stock issued will be duly authorized, fully paid and non-assessable. The
holders of our common stock are entitled to one vote for each share held of record on all matters
submitted to a vote of the holders of our common stock. Under Delaware law, stockholders generally
are not liable for our debts or obligations. Our certificate of incorporation does not authorize
cumulative voting for the election of directors. Subject to the rights of the holders of any class
of our capital stock having any preference or priority over our common stock, the holders of shares
of our common stock are entitled to receive dividends that are declared by the board of directors
out of legally available funds. In the event of our liquidation, dissolution or winding-up, the
holders of common stock are entitled to share ratably in our net assets remaining after payment of
liabilities, subject to prior rights of preferred stock, if any, then outstanding. Our common stock
has no preemptive rights, conversion rights, redemption rights or sinking fund provisions, and
there are no dividends in arrears or default. All shares of our common stock have equal
distribution, liquidation and voting rights, and have no preferences or exchange rights.
Our common stock currently is trading on the Nasdaq Global Market. We will apply to the Nasdaq
Global Market to list any additional shares of common stock that we offer and sell pursuant to a
prospectus supplement.
Stockholder Rights Plan
On February 22, 2000, our board of directors adopted a stockholder rights plan and declared a
dividend of one preferred share purchase right for each outstanding share of common stock. Each
right entitles the holder, once the right becomes exercisable, to
purchase from us one one-thousandth of a share of our Series A Junior Participating Preferred
Stock, par value $.01 per share. We
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issued these rights on March 17, 2000 to each stockholder of
record on such date, and these rights attach to shares of common stock subsequently issued. The
rights will cause substantial dilution to a person or group that attempts to acquire us on terms
not approved by our board of directors and could, therefore, have the effect of delaying or
preventing someone from taking control of us, even if a change of control were in the best interest
of our stockholders.
Holders of our preferred share purchase rights are generally entitled to purchase from us one
one-thousandth of a share of Series A preferred stock at a price of $50.00, subject to adjustment
as provided in the Stockholder Rights Agreement. These preferred share purchase rights will
generally be exercisable only if a person or group becomes the beneficial owner of 15 percent or
more of our outstanding common stock or announces a tender offer for 15 percent or more of our
outstanding common stock. Each holder of a preferred share purchase right, excluding an acquiring
entity or any of its affiliates, will have the right to receive, upon exercise, shares of our
common stock, or shares of stock of the acquiring entity, having a market value equal to two times
the purchase price paid for one one-thousandth of a share of Series A preferred stock. The
preferred share purchase rights expire on March 17, 2010, unless we extend the expiration date or
in certain limited circumstances, we redeem or exchange such rights prior to such date.
Transfer Agent
American Stock Transfer & Trust Company is the transfer agent and registrar for our common
stock.
Preferred Stock
We are currently authorized to issue 100,000 shares of preferred stock, par value $.01 per
share, with 90,000 shares undesignated and 10,000 shares of previously undesignated preferred stock
designated as Series A Junior Participating Preferred Stock.
We may issue shares of our authorized but unissued preferred stock in one or more series
having the rights, privileges, and limitations, including voting rights, conversion rights,
liquidation preferences, dividend rights and redemption rights, as may, from time to time, be
determined by our board of directors. Preferred stock may be issued in the future in connection
with acquisitions, financings, or other matters, as our board of directors deems appropriate. In
the event that we determine to issue any shares of our authorized but unissued preferred stock, a
certificate of designation containing the rights, privileges and limitations of this series of
preferred stock will be filed with the Secretary of State of the State of Delaware. The effect of
this preferred stock designation power is that our board of directors alone, subject to Federal
securities laws, applicable blue sky laws, and Delaware law, may be able to authorize the issuance
of preferred stock which could have the effect of delaying, deferring, or preventing a change in
control without further action by our stockholders, and may adversely affect the voting and other
rights of the holders of our common stock.
DESCRIPTION OF DEBT SECURITIES
Any debt securities which we offer by this prospectus will be issued under an indenture
between us and a trustee to be identified in the prospectus supplement. The terms of the debt
securities will include those stated in the indenture and those made part of the indenture by
reference to the Trust Indenture Act of 1939, as amended, or the Trust Indenture Act, as in effect
on the date of the indenture. The following description summarizes only the material provisions of
the indenture. Accordingly, you should read the form of indenture, a copy of which has been filed
as an exhibit to the registration statement of which this prospectus forms a part, because it, and
not this description, defines your rights as holders of our debt securities. You should also read
the applicable prospectus supplement for additional information and the specific terms of the debt
securities.
General
We may, at our option, issue debt securities in one or more series from time to time. Debt
securities may include senior debt, senior subordinated debt or subordinated debt. The particular
terms of the debt securities offered by any prospectus supplement, and the extent, if any, to which
such general provisions do not apply to the debt securities, will be described in the prospectus
supplement relating to such debt securities. The following sets forth certain general terms and
provisions of the indenture and the debt securities. The prospectus supplement relating to a series
of debt securities being offered will contain the following terms, if applicable:
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the title and ranking;
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the aggregate principal amount and any limit on such amount;
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the price at which such debt securities will be issued;
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the date on which the debt securities mature;
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the fixed or variable rate at which the debt securities will bear interest, or
the method by which such rate shall be determined;
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the timing, place and manner of making principal, interest and any premium
payments on the debt securities, and, if applicable, where such debt securities may
be surrendered for registration of transfer or exchange;
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the date or dates, if any, after which the debt securities may be converted or
exchanged into or for shares of our common stock or another companys securities or
properties or cash and the terms of any such conversion or exchange;
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any redemption or early repayment provisions;
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any sinking fund or similar provisions;
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the authorized denominations;
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any applicable subordination provisions;
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any guarantees of such securities by our subsidiaries or others;
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the currency in which we will pay the principal, interest and any premium
payments on such debt securities;
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whether the amount of payments of principal of (and premium, if any) or interest,
if any, on the debt securities may be determined with reference to an index, formula
or other method and the manner in which such amounts shall be determined;
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the time period within which, the manner in which and the terms and conditions
upon which the purchaser of the securities can select the payment currency;
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the provisions, if any, granting special rights to the holders of debt securities
upon certain events;
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any additions to or changes in the events of default or covenants of Nastech with
respect to the debt securities and any change in the right of the trustee or the
holders to declare the principal, premium and interest with respect to such
securities to be due and payable;
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whether and under what circumstances we will pay any additional amounts on such
debt securities for any tax, assessment or governmental charge and, if so, whether
we will have the option to redeem such debt securities instead of paying such
amounts;
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the form (registered and/or bearer securities), any restrictions applicable to
the offer, sale or delivery of bearer securities and the terms, if any, upon which
bearer securities may be exchanged for registered securities and vice versa;
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the date of any bearer securities or any global security, if other than the date
of original issuance of the first security of the series to be issued;
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the person to whom and manner in which any interest shall be payable;
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whether such securities will be issued in whole or in part in the form of one or
more global securities;
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the identity of the depositary for global securities;
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whether a temporary security is to be issued with respect to such series and
whether any interest payable prior to the issuance of definitive securities of the
series will be credited to the account of the persons entitled thereto;
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the terms upon which beneficial interests in a temporary global security may be
exchanged in whole or in part for beneficial interests in a definitive global
security or for individual definitive securities and the terms upon which such
exchanges may be made;
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the securities exchange(s), if any, on which the securities will be listed;
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whether any underwriter(s) will act as market maker(s) for the securities;
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the form (certificated or book-entry);
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the form and/or terms of certificates, documents or conditions which may be
necessary, if any, for the debt securities to be issuable in final form; and
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additional terms not inconsistent with the provisions of the indenture.
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One or more series of debt securities may be sold at a substantial discount below their stated
principal amount bearing no interest or interest at a rate below the market rate at the time of
issuance. One or more series of debt securities may be variable rate debt securities that may be
exchanged for fixed rate debt securities. In such cases, all material United States federal income
tax and other considerations applicable to any such series will be described in the applicable
prospectus supplement.
We will comply with Section 14(e) under the Exchange Act, to the extent applicable, and any
other tender offer rules under the Exchange Act, which may then be applicable, in connection with
any obligation of Nastech to purchase debt securities at the option of the holders thereof. Any
such obligation applicable to a series of debt securities will be described in the applicable
prospectus supplement.
Exchange, Registration, Transfer and Payment
We expect payment of principal, premium, if any, and any interest on the debt securities to be
payable, and the exchange and the transfer of debt securities will be registerable, at the office
of the trustee or at any other office or agency we maintain for such purpose. We expect to issue
debt securities in denominations of U.S. $1,000 or integral multiples thereof. No service charge
will be made for any registration of transfer or exchange of the debt securities, but we may
require a payment to cover any tax or other governmental charges payable in connection therewith.
Global Debt Securities
Unless we indicate otherwise in the applicable prospectus supplement, the following provisions
will apply to all debt securities.
The debt securities of a series may be issued in whole or in part in the form of one or more
global securities that will be deposited with a depositary that we will identify in a prospectus
supplement. Each global security will be deposited with the depositary and will bear a legend
regarding any related restrictions or other matters as may be provided for pursuant to the
applicable indenture.
Unless a prospectus supplement states otherwise, no global security may be transferred to, or
registered or exchanged for debt securities registered in the name of, any person or entity other
than the depositary, unless:
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the depositary has notified us that it is unwilling or unable or is no longer
qualified to continue as depositary;
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we order the trustee that such global security shall be so transferable,
registrable and exchangeable, and such transfers shall be registrable; or
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other circumstances, if any, as may be described in the applicable prospectus
supplement.
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All debt securities issued in exchange for a global security or any portion thereof will be
registered in such names as the depositary may direct. The specific terms of the depositary
arrangement with respect to any portion of a series of debt securities to be represented by a
global security will be described in the applicable prospectus supplement.
Debt securities which are to be represented by a global security to be deposited with or on
behalf of a depositary will be represented by a global security registered in the name of such
depositary or its nominee. Upon the issuance of such global security, and the deposit of such
global security with the depositary, the depositary will credit, on its book-entry registration and
transfer system, the respective principal amounts of the debt securities represented by such global
security to the accounts of institutions that have accounts with such depositary or its nominee
(the Participants). The accounts to be credited will be designated by the underwriters or agents
of such debt securities or by us, if such debt securities are offered and sold directly by us.
Ownership of beneficial interests in such global security will be limited to Participants or
persons that may hold interests through Participants. Ownership of beneficial interests in such
global security will be shown on, and the transfer of that ownership interest will be effected only
through, records maintained by the depositary or its nominee for such global security or by
Participants or persons that hold through Participants.
The laws of some jurisdictions require that certain purchasers of securities take physical
delivery of such securities in certificated form. The foregoing limitations and such laws may
impair the ability to transfer beneficial interests in such global securities.
So long as the depositary, or its nominee, is the registered owner of such global security,
such depositary or such nominee, as the case may be, will be considered the sole owner or holder of
the debt securities represented by such global security for all purposes under the indenture.
Payment of principal of, and premium and interest, if any, on debt securities will be made to the
depositary or its nominee as the registered owner or bearer as the case may be of the global
security representing such debt securities. Each person owning a beneficial interest in such global
security must rely on the procedures of the depositary and, if such person is not a Participant, on
the procedures of the Participant through which such person owns its interest, to exercise any
rights of a holder under the indenture. If we request any action of holders or if an owner of a
beneficial interest in such global security desires to give any notice or take any action a holder
is entitled to give or take under the indenture, the depositary will authorize the Participants to
give such notice or take such action, and Participants would authorize beneficial owners owning
through such Participants to give such notice or take such action or would otherwise act upon the
instructions of beneficial owners owning through them.
The rights of any holder of a debt security to receive payment of principal and premium, if
any, and interest on such debt security, on or after the respective due dates expressed or provided
for in such debt security, or to institute suit for the enforcement of any such payment on or after
such respective dates, shall not be impaired or affected without the consent of the holders.
Neither we, the trustee, any paying agent nor the security registrar for such debt securities
will have any responsibility or liability for any aspect of the records relating to or payments
made on account of beneficial ownership interests of the global security for such debt securities
or for maintaining, supervising or receiving any records relating to such beneficial ownership
interests.
We expect that the depositary or its nominee, upon receipt of any payment of principal,
premium or interest, will credit immediately Participants accounts with payments in amounts
proportionate to their respective beneficial interests in the principal amount of the global
security for such debt securities as shown on the records of such depositary or its nominee. We
also expect that payments by Participants to owners of beneficial interests in such global security
held through such Participants will be governed by standing instructions and customary practices,
as is now the case with securities held for the accounts of customers in bearer form or registered
in street name, and will be the responsibility of such Participants.
If the depositary for a global security representing debt securities of a particular series is
at any time unwilling or unable to continue as depositary and we do not appoint a successor
depositary within 90 days, we will issue debt securities of such series in definitive form in
exchange for such global security. In addition, we may at any time and in our sole discretion
determine not to have the debt securities of a particular series represented by one or more global
securities and, in such event, will issue debt securities of such series in definitive form in
exchange for all of the global securities representing debt securities of such series.
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Covenants
Except
as permitted under the heading Consolidation, Merger and Sale of Assets, the indenture will
require us to do or cause to be done all things necessary to preserve and keep in full force and
effect our existence, rights (declaration and statutory) and franchises;
provided
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however
, that we shall not be required to preserve any right or franchise if we determine
that the preservation thereof is no longer desirable in the conduct of our business and that the
loss thereof is not disadvantageous in any material respect to the holders of the debt securities.
The indenture will require us to pay or discharge or cause to be paid or discharged, before
the same shall become delinquent, all taxes, assessments and governmental charges levied or imposed
upon us except any tax, assessment, charge or claim whose amount or applicability is being
contested in good faith.
Reference is made to the indenture and applicable prospectus supplement for information with
respect to any additional covenants specific to a particular series of debt securities.
Consolidation, Merger and Sale of Assets
Except as set forth in the applicable prospectus supplement, the indenture will provide that
we shall not consolidate with, or sell, assign, transfer, lease or convey all or substantially all
of our assets to, or merge into, any person unless:
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we are the surviving entity or, in the event that we are not the surviving
entity, the person formed by the transaction (in a consolidation) or the entity
which received the transfer of assets:
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is a corporation organized under the laws of any state of the United States
of America or the District of Columbia; and
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assumes all of our obligations under the debt securities and the indenture;
and
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immediately after giving effect to the transaction, no event of default, as
defined in the indenture, shall have occurred and be continuing.
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Notwithstanding the foregoing, we may merge with another person or acquire by purchase or
otherwise all or any part of the property or assets of any other corporation or person in a
transaction in which we are the surviving entity.
Events of Default
Unless otherwise specified in the applicable prospectus supplement, the following are events
of default with respect to any series of debt securities issued under the indenture:
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failure to pay principal of any debt security of that series when due and payable
at maturity, upon acceleration, redemption or otherwise;
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failure to pay any interest on any debt security of that series when due, and the
default continues for 30 days;
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failure to comply with any covenant or warranty contained in the indenture, other
than covenants or warranties contained in the indenture solely for the benefit of
other series of debt securities, and the default continues for 30 days after notice
from the trustee or the holders of at least 25% in principal amount of the then
outstanding debt securities of that series;
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certain events of bankruptcy, insolvency or reorganization; and
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any other event of default provided with respect to that particular series of
debt securities.
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If an event of default occurs and continues, then upon written notice to us the trustee or the
holders of at least 25% in principal amount of the outstanding debt securities of that series may
declare the unpaid principal amount of, and any accrued and unpaid
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interest on, all debt securities
of that series to be due and payable immediately. However, at any time after a declaration of
acceleration with respect to debt securities of any series has been made, the holders of a majority
in principal amount of the outstanding debt securities of that series may rescind and annul such
acceleration:
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if all events of default other than the nonpayment of principal of or interest on
the debt securities of that series which have become due solely because of the
acceleration have been waived or cured; and
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the rescission would not conflict with any judgment or decree of a court of
competent jurisdiction. For information as to waiver of defaults, see Amendment,
Supplement and Waiver below.
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The indenture will provide that, subject to the duty of the trustee during an event of default
to act with the required standard of care, the trustee will be under no obligation to exercise any
of its rights or powers under the indenture at the request or direction of any of the holders,
unless such holders shall have offered to the trustee reasonable security or indemnity. Subject to
certain provisions, including those requiring security or indemnification of the trustee, the
holders of a majority in principal amount of the outstanding debt securities of any series will
have the right to direct the time, method and place of conducting any proceeding for any remedy
available to the trustee, or exercising any trust or power conferred on the trustee, with respect
to the debt securities of that series.
We will be required to furnish to the trustee under the indenture annually a statement as to
the performance by us of our obligations under that indenture and as to any default in such
performance.
Discharge of Indenture and Defeasance
Except as otherwise set forth in the applicable prospectus supplement, we may terminate our
obligations under the debt securities of any series, and the corresponding obligations under the
indenture when:
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we have paid or deposited with the trustee funds or United States government
obligations in an amount sufficient to pay at maturity all outstanding debt
securities of such series, including interest other than destroyed, lost or stolen
debt securities of such series which have not been replaced or paid;
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all outstanding debt securities of such series have been delivered (other than
destroyed, lost or stolen debt securities of such series which have not been
replaced or paid) to the trustee for cancellation; or
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all outstanding debt securities of any series have become due and payable; and
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we have paid all other sums payable under the indenture.
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In addition, we may terminate substantially all our obligations under the debt securities of
any series and the corresponding obligations under the indenture if:
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we have paid or deposited with the trustee, in trust an amount of cash or United
States government obligations sufficient to pay all outstanding principal of and
interest on the then outstanding debt securities of such series at maturity or upon
their redemption, as the case may be;
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such deposit will not result in a breach of, or constitute a default under, the
indenture;
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no default or event of default shall have occurred and continue on the date of
deposit and no event of default as a result of a bankruptcy or event which with the
giving of notice or the lapse of time would become a bankruptcy event of default
shall have occurred and be continuing on the 91st day after such date;
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we deliver to the trustee a legal opinion that we have received from, or there
has been published by, the United States Internal Revenue Service a ruling, or there
has been a change in tax law, in either case to the effect that the holders of the
debt securities of such series will not recognize income, gain or loss for Federal
income tax purposes as a result of our exercise of such option and shall be subject
to Federal income tax on the same amounts and in the
same manner and at the same times as would have been the case if such option had not
been exercised; and
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certain other conditions are met.
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We shall be released from our obligations with respect to the covenants to deliver reports
required to be filed with the SEC and an annual compliance certificate, and to make timely payments
of taxes (including covenants described in a prospectus supplement) and any event of default
occurring because of a default with respect to such covenants as they related to any series of debt
securities if:
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we deposit or cause to be deposited with the trustee in trust an amount of cash
or United States government obligations sufficient to pay and discharge when due the
entire unpaid principal of and interest on all outstanding debt securities of any
series;
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such deposit will not result in a breach of, or constitute a default under, the
indenture;
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no default or event of default shall have occurred and be continuing on the date
of deposit and no event of default as a result of a bankruptcy or event which with
the giving of notice or the lapse of time would become a bankruptcy event of default
shall have occurred and be continuing on the 91st day after such date;
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we deliver to the trustee a legal opinion that the holders of the debt securities
of such series will not recognize income, gain or loss for Federal income tax
purposes as a result of our exercise of such option and shall be subject to Federal
income tax on the same amounts and in the same manner and at the same times as would
have been the case if such option had not been exercised; and
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certain other conditions are met.
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Upon satisfaction of such conditions, our obligations under the indenture with respect to the
debt securities of such series, other than with respect to the covenants and events of default
referred to above, shall remain in full force and effect.
Notwithstanding the foregoing, no discharge or defeasance described above shall affect the
following obligations to or rights of the holders of any series of debt securities:
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rights of registration of transfer and exchange of debt securities of such
series;
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rights of substitution of mutilated, defaced, destroyed, lost or stolen debt
securities of such series;
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rights of holders of debt securities of such series to receive payments of
principal thereof and premium, if any, and interest thereon when due;
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rights, obligations, duties and immunities of the trustee;
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rights of holders of debt securities of such series as beneficiaries with respect
to property deposited with the trustee and payable to all or any of them; and
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our obligations to maintain an office or agency in respect of the debt securities
of such series.
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Transfer and Exchange
A holder of debt securities may transfer or exchange such debt securities in accordance with
the indenture. The registrar for the debt securities may require a holder, among other things, to
furnish appropriate endorsements and transfer documents, and to pay any taxes and fees required by
law or permitted by the indenture. The registrar is not required to transfer or exchange any debt
security selected for redemption or any debt security for a period of 15 days before a selection of
debt security to be redeemed.
The registered holder of a debt security may be treated as the owner of such security for all
purposes.
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Amendment, Supplement and Waiver
Subject to certain exceptions, the terms of the indenture or the debt securities may be
amended or supplemented by us and the trustee with the written consent of the holders of at least a
majority in principal amount of the outstanding debt securities of each series affected by the
amendment with each series voting as a separate class. Without the consent of any holder of the
debt securities, we and the trustee may amend the terms of the indenture or the debt securities to:
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cure any ambiguity, defect or inconsistency;
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provide for the assumption of our obligations to holders of the debt securities
by a successor corporation;
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provide for uncertificated debt securities in addition to certificated debt
securities;
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make any change that does not adversely affect the rights of any holder of the
debt securities in any material respect;
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add to, change or eliminate any other provisions of the indenture in respect of
one or more series of debt securities if such change would not (i) apply to any
security of any series created prior to the execution of a supplemental indenture
and entitled to the benefit of such provision and (ii) modify the rights of the
holder of any such security with respect to such provision or become effective only
when there is no outstanding security of any series created prior to the execution
of such supplemental indenture and entitled to such benefits;
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establish any additional series of debt securities; or
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comply with any requirement of the SEC in connection with the qualification of
the indenture under the Trust Indenture Act.
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However, holders of each series of debt securities affected by a modification must consent to
modifications that have the following effect:
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reduce the principal amount of debt securities the holders of which must consent
to an amendment, supplement or waiver of any provision of the indenture;
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reduce the rate or change the time for payment of interest on any debt security;
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reduce the principal of or change the fixed maturity of any debt securities;
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change the date on which any debt security may be subject to redemption or
repurchase, or reduce the redemption or repurchase price therefor;
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make any debt security payable in currency other than that stated in the debt
security;
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waive any existing default or event of default and the consequences with respect
to that series;
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modify the right of any holder to receive payment of principal or interest on any
debt security on or after the respective due dates expressed or provided for in the
debt security;
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impair the right of any holder to institute suit for the enforcement of any
payment in or with respect to any such debt security; or
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make any change in the foregoing amendment provisions which require each holders
consent.
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Any existing default may be waived with the consent of the holders of at least a majority in
principal amount of the then outstanding debt securities of the series affected thereby.
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The consent of the holders of debt securities is not necessary to approve the particular form
of any proposed amendment to any indenture. It is sufficient if any consent approves the substance
of the proposed amendment.
Replacement Securities
Any mutilated certificate representing a debt security or a certificate representing a debt
security with a mutilated coupon will be replaced by us at the expense of the holder upon surrender
of such certificate to the trustee. Certificates representing debt securities or coupons that
become destroyed, stolen or lost will be replaced by us at the expense of the holder upon delivery
to us and the trustee of evidence of any destruction, loss or theft satisfactory to us and the
trustee, provided that neither we nor the trustee has been notified that such certificate or coupon
has been acquired by a bona fide purchaser. In the case of any coupon which becomes destroyed,
stolen or lost, such coupon will be replaced by issuance of a new certificate representing the debt
security in exchange for the certificate representing the debt security to which such coupon
appertains. In the case of a destroyed, lost or stolen certificate representing the debt security
or coupon, an indemnity bond satisfactory to the trustee and us may be required at the expense of
the holder of such debt security before a replacement certificate will be issued.
Regarding the Trustee
We will identify in the prospectus supplement relating to any series of debt securities, the
trustee with respect to such series. The indenture and provisions of the Trust Indenture Act
incorporated by reference therein contain certain limitations on the rights of the trustee, should
it become a creditor of Nastech, to obtain payment of claims in certain cases, or to realize on
certain property received in respect of any such claim, as security or otherwise. The trustee and
its affiliates may engage in, and will be permitted to continue to engage in, other transactions
with us and our affiliates;
provided
,
however
, that if it acquires any conflicting
interest, as defined in the Trust Indenture Act, it must eliminate such conflict or resign.
The holders of a majority in principal amount of the then outstanding debt securities of any
series will have the right to direct the time, method and place of conducting any proceeding for
exercising any remedy available to the trustee. The Trust Indenture Act and the indenture provide
that in case an event of default shall occur, and be continuing, the trustee will be required, in
the exercise of its rights and powers, to use the degree of care and skill of a prudent man in the
conduct of his own affairs. Subject to such provision, the trustee will be under no obligation to
exercise any of its rights or powers under the indenture at the request of any of the holders of
the debt securities issued thereunder, unless they have offered to the trustee indemnity
satisfactory to it.
DESCRIPTION OF WARRANTS
The following description of our warrants in this prospectus contains the general terms and
provisions of the warrants. The particular terms of any offering of warrants will be described in a
prospectus supplement relating to such offering. The statements below describing the warrants are
subject to and qualified by the applicable provisions of our certificate of incorporation, bylaws
and the relevant provisions of the laws of the State of Delaware.
General
We may issue warrants for the purchase of our common stock, preferred stock or debt
securities. We may issue warrants independently or together with any of our securities, and
warrants also may be attached to our securities or independent of them. We may issue series of
warrants under a separate warrant agreement between us and a specified warrant agent described in
the prospectus supplement. The warrant agent will act solely as our agent in connection with the
warrants and will not assume any obligation or relationship of agency or trust for or with any
holders or beneficial owners of warrants.
As of September 30, 2007, the only warrants issued and outstanding consist of warrants to
purchase up to 660,814 shares of our common stock.
Terms
A prospectus supplement will describe the specific terms of any warrants that we issue
or offer, including:
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the title of the warrants;
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the aggregate number of warrants;
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the price or prices at which the warrants will be issued;
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the currencies in which the price or prices of the warrants may be payable;
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the designation, amount and terms of our capital stock or debt securities purchasable upon exercise of the warrants;
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the designation and terms of our other securities, if any, that may be issued in connection with the warrants, and the
number of warrants issued with each corresponding security;
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if applicable, the date that the warrants and the securities purchasable upon exercise of the warrants will be
separately transferable;
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the prices and currencies for which the securities purchasable upon exercise of the warrants may be purchased;
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the date that the warrants may first be exercised;
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the date that the warrants expire;
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the minimum or maximum amount of warrants that may be exercised at any one time;
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information with respect to book-entry procedures, if any;
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a discussion of certain federal income tax considerations; and
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any other material terms of the warrants, including terms, procedures and limitations relating to the exchange and
exercise of the warrants.
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Exercise of Warrants
Each warrant will entitle the holder to purchase for cash the principal amount of debt
securities or shares of preferred stock or common stock at the applicable exercise price set forth
in, or determined as described in, the applicable prospectus supplement. Warrants may be exercised
at any time up to the close of business on the expiration date set forth in the applicable
prospectus supplement. After the close of business on the expiration date, unexercised warrants
will become void.
Warrants may be exercised by delivering to the corporation trust office of the warrant agent
or any other officer indicated in the applicable prospectus supplement (a) the warrant certificate
properly completed and duly executed and (b) payment of the amount due upon exercise. As soon as
practicable following exercise, we will forward the debt securities or shares of preferred stock or
common stock purchasable upon exercise. If less than all of the warrants represented by a warrant
certificate are exercised, a new warrant certificate will be issued for the remaining warrants.
DESCRIPTION OF UNITS
The following description, together with the additional information we may include in any
applicable prospectus supplements, summarizes the material terms and provisions of the units that
we may offer under this prospectus. While the terms we have summarized below will apply generally
to any units that we may offer under this prospectus, we will describe the particular terms of any
series of units in more detail in the applicable prospectus supplement. The terms of any units
offered under a prospectus supplement may differ from the terms described below. However, no
prospectus supplement will fundamentally change the terms that are set forth in this prospectus or
offer a security that is not registered and described in this prospectus at the time of its
effectiveness.
We will file as exhibits to the registration statement of which this prospectus is a part, or
will incorporate by reference from a current report on Form 8-K that we file with the SEC, the form
of unit agreement that describes the terms of the series of units we are offering, and any
supplemental agreements, before the issuance of the related series of units. The following
summaries of material terms and provisions of the units are subject to, and qualified in their
entirety by reference to, all the provisions of the unit agreement
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and any supplemental agreements applicable to a particular series of units. We urge you to
read the applicable prospectus supplement related to the particular series of units that we sell
under this prospectus, as well as the complete unit agreement and any supplemental agreements that
contain the terms of the units.
General
We may issue units comprised of one or more debt securities, shares of common stock, shares of
preferred stock and warrants in any combination. Each unit will be issued so that the holder of the
unit is also the holder of each security included in the unit. Thus, the holder of a unit will have
the rights and obligations of a holder of each included security. The unit agreement under which a
unit is issued may provide that the securities included in the unit may not be held or transferred
separately, at any time or at any time before a specified date.
We will describe in the applicable prospectus supplement the terms of the series of units,
including:
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the designation and terms of the units and of the securities comprising the
units, including whether and under what circumstances those securities may be held or
transferred separately;
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any provisions of the governing unit agreement that differ from those described
below; and
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any provisions for the issuance, payment, settlement, transfer or exchange of the
units or of the securities comprising the units.
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The provisions described in this section, as well as those described under
the headings Description of
Capital Stock, Description of Debt Securities and Description of Warrants will apply to each
unit and to any common stock, preferred stock, debt security or warrant included in each unit,
respectively.
Issuance in Series
We may issue units in such amounts and in numerous distinct series as we determine.
Enforceability of Rights by Holders of Units
Each unit agent will act solely as our agent under the applicable unit agreement and will not
assume any obligation or relationship of agency or trust with any holder of any unit. A single bank
or trust company may act as unit agent for more than one series of units. A unit agent will have no
duty or responsibility in case of any default by us under the applicable unit agreement or unit,
including any duty or responsibility to initiate any proceedings at law or otherwise, or to make
any demand upon us. Any holder of a unit may, without the consent of the related unit agent or the
holder of any other unit, enforce by appropriate legal action its rights as holder under any
security included in the unit.
Title
Nastech, the unit agent and any of their agents may treat the registered holder of any unit
certificate as an absolute owner of the units evidenced by that certificate for any purposes and as
the person entitled to exercise the rights attaching to the units so requested, despite any notice
to the contrary.
LEGAL MATTERS
The validity of the shares of our common stock offered by this prospectus is being passed upon
for us by Pryor Cashman LLP, New York, New York.
29
EXPERTS
Our consolidated financial statements as of December 31, 2006 and 2005, and for each of the
years in the three-year period ended December 31, 2006, and managements assessment of the
effectiveness of internal control over financial reporting as of December 31, 2006 have been
incorporated by reference herein in reliance upon the reports of KPMG LLP, independent registered
public accounting firm, incorporated by reference herein and in the registration statement of which
this prospectus is a part, and upon the authority of said firm as experts in accounting and
auditing. The audit report covering the December 31, 2006 financial statements refers to a change
in the method of accounting for all stock-based awards made to employees and directors effective
January 1, 2006.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the reporting requirements of the Exchange Act, and in accordance with such
laws we file annual, quarterly and current reports and other information with the SEC. The SEC
maintains a website that contains annual, quarterly and current reports, proxy and information
statements and other information filed with the SEC. The SECs website address is
http://www.sec.gov. You may also read and copy any document we file with the SEC at the SECs
public reference room, 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330 for further information on the operation of its public reference room. The
information we file with the SEC and other information about us is also available on our website at
http://www.nastech.com. However, the information on our website is not a part of, nor is such
information to be deemed incorporated by reference into, this prospectus.
We have filed with the SEC a registration statement on Form S-3 (of which this prospectus is a
part) under the Securities Act, with respect to the securities offered by this prospectus. This
prospectus does not contain all of the information set forth in the registration statement, certain
portions of which have been omitted as permitted by the rules and regulations of the SEC.
Statements contained in this prospectus as to the contents of any contract or other document are
not necessarily complete, and in each instance please see the copy of such contract or other
document filed as an exhibit to the registration statement, each such statement being qualified in
all respects by such reference and the exhibits and schedules thereto. For further information
regarding us and the securities offered by this prospectus, please refer to the registration
statement and such exhibits and schedules which may be obtained from the SEC at its principal
office in Washington, D.C. upon payment of the fees prescribed by the SEC, or from its web site.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference into this prospectus the information we have
filed with the SEC. The information we incorporate by reference into this prospectus is an
important part of this prospectus. Any statement in a document we have filed with the SEC prior to
the date of this prospectus and which is incorporated by reference into this prospectus will be
considered to be modified or superseded to the extent a statement contained in this prospectus or
any other subsequently filed document that is incorporated by reference into this prospectus
modifies or supersedes that statement. The modified or superseded statement will not be considered
to be a part of this prospectus, except as modified or superseded.
We incorporate by reference into this prospectus the information contained in the documents
listed below, which is considered to be a part of this prospectus:
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our annual report on Form 10-K for the fiscal year
ended December 31, 2006, filed with the SEC on March 7,
2007 (file no. 000-13789);
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our quarterly reports filed on Form 10-Q for the
fiscal quarters ended March 31, 2007, June 30, 2007 and
September 30, 2007, filed with the SEC on May 7, 2007,
August 8, 2007 and October 29, 2007, respectively (file no.
000-13789);
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our current reports on Form 8-K, as filed with the
SEC on January 19, 2007, February 12, 2007, March 7, 2007,
April 11, 2007, May 7, 2007, August 8, 2007, September 25,
2007, October 4, 2007, October 29, 2007, November 7, 2007,
November 14, 2007, November 15, 2007, November 21, 2007,
December 7, 2007, December 20, 2007, January 7, 2008 and
January 22, 2007 (file no. 000-13789);
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our definitive proxy statement on Schedule 14A,
relating to the annual meeting of stockholders held on
June 13, 2007, as filed with the SEC on April 30, 2007;
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the description of our common stock and the
description of certain provisions of Delaware Law contained
or incorporated by reference in:
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our registration
statement on Form 8-A,
filed with the SEC on
August 12, 1985 (file no.
000-13789), including any
amendments or reports
filed for the purposes of
updating this description;
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our Restated
Certificate of
Incorporation dated
July 20, 2005 and filed as
Exhibit 3.1 to our current
report on Form 8-K, as
filed with the SEC on
July 25, 2005 (file no.
000-13789); and
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our Amended and
Restated Bylaws dated
September 19, 2007 and
filed as Exhibit 3.1 to
our current report on
Form 8-K, as filed with
the SEC on September 25,
2007 (file no. 000-13789);
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the description of our preferred stock purchase
rights contained in our registration statement on Form 8-A,
filed with the SEC on March 16, 2000 (file no. 000-13789),
including any amendments or reports filed for the purposes
of updating this description; and
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future filings we make with the SEC under
Sections 13(a), 13(c), 14, or 15(d) of the Exchange Act
after the date of this prospectus supplement but prior to
the termination of the offering of the securities covered
by this prospectus supplement.
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You may request a copy of these filings, at no cost, by writing or telephoning us at the
following address:
Nastech Pharmaceutical Company Inc.
3830 Monte Villa Parkway
Bothell, Washington 98021
(425) 908-3600
31
Nastech Pharmaceutical Company Inc.
4,590,277 Shares of Common Stock
and
Warrants to Purchase 5,967,361 Shares of Common Stock
April 30, 2008
Nastech Pharmaceutical Company (MM) (NASDAQ:NSTK)
過去 株価チャート
から 12 2024 まで 1 2025
Nastech Pharmaceutical Company (MM) (NASDAQ:NSTK)
過去 株価チャート
から 1 2024 まで 1 2025