Adhera Therapeutics, Inc. - Quarter Report: 2006 September (Form 10-Q)
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarter Ended September 30, 2006
Commission File Number 000-13789
NASTECH PHARMACEUTICAL COMPANY INC.
(Exact name of registrant as specified in its charter)
Delaware | 11-2658569 | |
(State or other jurisdiction of | ||
incorporation or organization) | (I.R.S. Employer Identification No.) | |
3830 Monte Villa Parkway, Bothell, WA | 98021 | |
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (425) 908-3600
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer or a non-accelerated filer. See definition of accelerated filer and large accelerated filer
in Rule 12b-2 of the Exchange Act. (Check One):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
Yes
o
No
þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as
of the latest practicable date:
Date | Class | Shares Outstanding | ||
October 30, 2006 | Common stock $0.006 par value | 22,004,264 |
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
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EXHIBIT 10.19 | ||||||||
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EXHIBIT 31.2 | ||||||||
EXHIBIT 32.1 | ||||||||
EXHIBIT 32.2 |
Items 1, 2, 3, 4 and 5 of PART II have not been included as they are not applicable.
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PART I FINANCIAL INFORMATION
ITEM 1 FINANCIAL STATEMENTS
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In Thousands, Except Share Data)
December 31, | September 30, | |||||||
2005 | 2006 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 26,769 | $ | 21,081 | ||||
Restricted cash and short-term investments |
998 | 2,155 | ||||||
Short-term investments |
32,142 | 33,174 | ||||||
Accounts receivable |
189 | 2,589 | ||||||
Inventories |
2,733 | 2,758 | ||||||
Prepaid expenses and other current assets |
1,545 | 1,097 | ||||||
Total current assets |
64,376 | 62,854 | ||||||
Property and equipment, net |
8,173 | 14,401 | ||||||
Security deposits and other assets |
404 | 408 | ||||||
Total assets |
$ | 72,953 | $ | 77,663 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 2,944 | $ | 3,433 | ||||
Accrued payroll and employee benefits |
1,740 | 2,277 | ||||||
Accrued expenses |
474 | 611 | ||||||
Capital lease obligations current portion |
2,431 | 3,560 | ||||||
Deferred revenue current portion |
1,589 | 4,074 | ||||||
Total current liabilities |
9,178 | 13,955 | ||||||
Capital lease obligations, net of current portion |
3,170 | 6,093 | ||||||
Deferred revenue, net of current portion |
4,250 | 4,933 | ||||||
Other liabilities |
788 | 1,168 | ||||||
Total liabilities |
17,386 | 26,149 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.01 par value; 100,000 authorized: no shares issued and outstanding: |
| | ||||||
Common stock, $0.006 par value; 50,000,000 authorized: 20,750,477 and 21,968,342
shares outstanding at December 31, 2005 and September 30, 2006, respectively |
124 | 132 | ||||||
Additional paid-in capital |
176,068 | 183,250 | ||||||
Deferred compensation |
(4,902 | ) | | |||||
Accumulated deficit |
(115,616 | ) | (131,831 | ) | ||||
Accumulated other comprehensive loss |
(107 | ) | (37 | ) | ||||
Total stockholders equity |
55,567 | 51,514 | ||||||
Total liabilities and stockholders equity |
$ | 72,953 | $ | 77,663 | ||||
See accompanying notes to condensed consolidated financial statements.
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NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In Thousands, Except Share Data)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2005 | 2006 | 2005 | 2006 | |||||||||||||
Revenues |
||||||||||||||||
Product revenue, net |
| $ | 32 | | $ | 624 | ||||||||||
License and research fees |
$ | 1,223 | 5,130 | $ | 6,155 | 22,667 | ||||||||||
Government grants |
| 383 | | 383 | ||||||||||||
Total revenue |
1,223 | 5,545 | 6,155 | 23,674 | ||||||||||||
Operating expenses: |
||||||||||||||||
Cost of product revenue |
| 13 | | 314 | ||||||||||||
Research and development |
8,099 | 10,483 | 22,559 | 31,050 | ||||||||||||
Sales and marketing |
345 | 505 | 963 | 1,335 | ||||||||||||
General and administrative |
2,019 | 2,942 | 6,949 | 9,194 | ||||||||||||
Total operating expenses |
10,463 | 13,943 | 30,471 | 41,893 | ||||||||||||
Loss from operations |
(9,240 | ) | (8,398 | ) | (24,316 | ) | (18,219 | ) | ||||||||
Other income (expense): |
||||||||||||||||
Interest income |
496 | 751 | 1,321 | 2,107 | ||||||||||||
Interest expense |
(75 | ) | (162 | ) | (265 | ) | (405 | ) | ||||||||
Other income and expense, net |
5 | 1 | 15 | 11 | ||||||||||||
Loss before change in accounting principle |
(8,814 | ) | (7,808 | ) | (23,245 | ) | (16,506 | ) | ||||||||
Cumulative effect of change in accounting principle |
| | | 291 | ||||||||||||
Net Loss |
$ | (8,814 | ) | $ | (7,808 | ) | $ | (23,245 | ) | $ | (16,215 | ) | ||||
Basic and diluted net loss per share: |
||||||||||||||||
Loss before change in accounting principle |
$ | (0.46 | ) | $ | (0.36 | ) | $ | (1.28 | ) | $ | (0.78 | ) | ||||
Cumulative effect of change in accounting principle |
| | | 0.01 | ||||||||||||
Net loss per common share basic and diluted |
$ | (0.46 | ) | $ | (0.36 | ) | $ | (1.28 | ) | $ | (0.77 | ) | ||||
Shares used in computing net loss per share basic and diluted |
19,009 | 21,408 | 18,208 | 21,115 |
See accompanying notes to condensed consolidated financial statements.
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NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS EQUITY
AND COMPREHENSIVE LOSS
For the Nine Months Ended September 30, 2006
(Unaudited)
(In Thousands, Except Share Data)
Accumulated | ||||||||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||||||||
Common Stock | Paid-In | Accumulated | Deferred | Comprehensive | Stockholders | |||||||||||||||||||||||
Shares | Amount | Capital | Deficit | Compensation | Loss | Equity | ||||||||||||||||||||||
Balance December 31, 2005 |
20,750,477 | $ | 124 | $ | 176,068 | $ | (115,616 | ) | $ | (4,902 | ) | $ | (107 | ) | $ | 55,567 | ||||||||||||
Proceeds from the exercise of
options |
277,899 | 2 | 3,054 | | | | 3,056 | |||||||||||||||||||||
Proceeds from the exercise of
warrants |
694,856 | 4 | 5,506 | | | | 5,510 | |||||||||||||||||||||
Compensation related to
restricted stock |
245,110 | 2 | 1,751 | | | | 1,753 | |||||||||||||||||||||
Compensation related to stock
options |
| | 2,064 | | | | 2,064 | |||||||||||||||||||||
Cumulative effect of change
in accounting principle |
| | (5,193 | ) | | 4,902 | | (291 | ) | |||||||||||||||||||
Net loss |
| | | (16,215 | ) | | | (16,215 | ) | |||||||||||||||||||
Change in unrealized loss on
available-for-sale securities |
| | | | | 70 | 70 | |||||||||||||||||||||
Comprehensive loss |
| | | (16,215 | ) | | 70 | (16,145 | ) | |||||||||||||||||||
Balance September 30, 2006 |
21,968,342 | $ | 132 | $ | 183,250 | $ | (131,831 | ) | | $ | (37 | ) | $ | 51,514 | ||||||||||||||
See accompanying notes to condensed consolidated financial statements.
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NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In Thousands)
Nine Months Ended | ||||||||
September 30, | ||||||||
2005 | 2006 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (23,245 | ) | $ | (16,215 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Non-cash compensation related to stock options |
287 | 2,064 | ||||||
Non-cash compensation related to restricted stock |
1,006 | 1,753 | ||||||
Depreciation and amortization of property and equipment |
1,289 | 1,957 | ||||||
Loss on disposition of property and equipment |
124 | 24 | ||||||
Cumulative effect of change in accounting principle |
| (291 | ) | |||||
Changes in assets and liabilities: |
||||||||
Accounts receivable |
(582 | ) | (2,400 | ) | ||||
Inventories |
(977 | ) | (25 | ) | ||||
Prepaid expenses and other assets |
(646 | ) | 444 | |||||
Accounts payable |
1,233 | 489 | ||||||
Deferred revenue |
(1,624 | ) | 3,168 | |||||
Accrued expenses and other liabilities |
(234 | ) | 1,054 | |||||
Net cash used in operating activities |
(23,369 | ) | (7,978 | ) | ||||
Investing activities: |
||||||||
Property and equipment acquisitions |
(4,209 | ) | (8,209 | ) | ||||
Purchases of investments |
(104,280 | ) | (61,529 | ) | ||||
Sales and maturities of investments |
93,699 | 60,567 | ||||||
Net cash used in investing activities |
(14,790 | ) | (9,171 | ) | ||||
Financing activities: |
||||||||
Change in restricted cash and short-term investments |
8,002 | (1,157 | ) | |||||
Payments on notes payable |
(8,352 | ) | | |||||
Borrowings under capital lease obligations |
2,940 | 6,286 | ||||||
Payments on capital lease obligations |
(1,350 | ) | (2,234 | ) | ||||
Proceeds from exercise of stock options |
5,385 | 3,056 | ||||||
Proceeds from exercise of warrants |
| 5,510 | ||||||
Public offering of common shares |
21,648 | | ||||||
Net cash provided by financing activities |
28,273 | 11,461 | ||||||
Net decrease in cash and cash equivalents |
(9,886 | ) | (5,688 | ) | ||||
Cash and cash equivalents beginning of period |
25,797 | 26,769 | ||||||
Cash and cash equivalents end of period |
$ | 15,911 | $ | 21,081 | ||||
Supplemental disclosures of investing and financing activities: |
||||||||
Cash paid for interest |
$ | 250 | $ | 405 | ||||
Non-cash investing activity: |
||||||||
Change in unrealized loss on available-for-sale securities |
$ | 54 | $ | 70 | ||||
See accompanying notes to condensed consolidated financial statements.
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NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For the nine months ended September 30, 2006 and September 30, 2005 (Unaudited)
Note 1 Business and Summary of Significant Accounting Policies
Business
Nastech Pharmaceutical Company Inc. (Nastech, or the Company) is a pharmaceutical company
focusing on the development and commercialization of innovative therapeutic products based on the
Companys proprietary molecular biology-based drug delivery technology for delivering both large
and small molecule drugs across mucosal barriers, initially the nasal mucosa, and small interfering
RNA (siRNA) therapeutics. Using this intranasal technology, the Company creates or utilizes novel
formulation components or excipients that can reversibly open tight junctions between cells in
various tissues and thereby allow therapeutic drugs to reach the blood stream. Tight junctions are
cell-to-cell connections in various tissues of the body, including the epithelial layer of the
intranasal mucosa, the gastrointestinal tract, and the blood brain barrier. They function to
provide barrier integrity and to regulate the transport and passage of molecules across these
natural boundaries.
The Company believes its intranasal drug delivery technology could potentially offer
advantages over injectable routes for the administration of large molecules such as peptides and
proteins. These advantages may include improved safety and clinical efficacy and increased patient
compliance due to the elimination of injection site pain and avoidance of injection site
irritation. In addition, the Company believes its intranasal drug delivery technology can
potentially offer advantages over oral administration by providing for faster absorption into the
bloodstream, reduced side effects and improved effectiveness by avoiding problems relating to
gastrointestinal and liver metabolism. Although some of the Companys product candidates use
expertise outside this area, this technology is the foundation of its intranasal drug delivery
platform and the Company is using it to develop commercial products with collaboration partners or,
in select cases, the Company will internally develop, manufacture and commercialize the Companys
products.
The Companys RNA interference (RNAi) therapeutic programs are targeted at both developing
and delivering novel therapeutics using small interfering RNA (siRNA) to down-regulate the
expression of certain disease causing proteins that are expressed in inflammation, viral
respiratory infections and other diseases.
The Company and its collaboration partners are developing a diverse portfolio of product
candidates for multiple therapeutic areas including osteoporosis, obesity, pain, viral infections,
inflammation and metabolic diseases. As of September 30, 2006, the Company had 29 patents issued
and 281 patent applications filed to protect its proprietary technologies.
As of September 30, 2006, the Company had an accumulated deficit of approximately $131.8
million and expects to incur additional operating losses in the future as it continues its research
and development activities. The Company has funded its operating losses primarily through the sale
of common stock in the public markets and private placements and also through revenues provided by
its collaborative partners. During 2004, the Company received net proceeds of approximately $65.2
million from public offerings of its common stock pursuant to two shelf registration statements.
During 2005, the Company received net proceeds of approximately $21.6 million from a public
offering of its common stock pursuant to a shelf registration statement. At September 30, 2006,
approximately $10.1 million is available on the Companys remaining shelf registration statement.
On October 19, 2006, the Company filed a shelf registration statement on Form S-3 for $125.0
million of common stock which includes the remaining $10.1 million balance from one of the
Companys previous shelf registration statements. As of the date of this filing, the new $125.0
million shelf has not been declared effective by the SEC. At September 30, 2006, the Company had
cash, cash equivalents and short-term investments of approximately $56.4 million, including
approximately $2.2 million in restricted cash.
The Company faces certain risks and uncertainties regarding its ability to generate positive
operating cash flow and profits. These risks include, but are not limited to, its ability to obtain
additional capital, protect its patents and property rights, overcome uncertainties regarding its
technologies, competition and technological change, obtain government approval for products and
attract and retain key officers and employees. For a more thorough discussion of risks and
uncertainties facing the Company, investors should also read and carefully consider the risk
factors beginning on p. 25 of the Companys Annual Report on Form 10-K for the year ended December
31, 2005 as may be supplemented or amended by our Quarterly Reports on Form 10-Q.
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Basis of Preparation
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with U.S. generally accepted accounting principles for interim financial information and
in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
they do not include all of the information and note disclosures required by U.S. generally accepted
accounting principles for complete financial statements. The accompanying unaudited financial
information should be read in conjunction with the audited financial statements, including the
notes thereto, as of and for the year ended December 31, 2005, included in the Companys 2005
Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC). The
information furnished in this report reflects all adjustments (consisting of normal recurring
adjustments), which are, in the opinion of management, necessary for a fair presentation of the
Companys financial position, results of operations and cash flows for each period presented. The
results of operations for the interim periods ended September 30, 2006 are not necessarily
indicative of the results for the year ending December 31, 2006 or for any future period.
Reclassifications
Certain reclassifications have been made to the 2005 information to conform to the current
period presentation including presentation of other income (expense).
Principles of Consolidation
The consolidated financial statements include the financial statements of Nastech
Pharmaceutical Company Inc. and its wholly-owned subsidiary, Atossa HealthCare Inc. (collectively,
the Company). All inter-company balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting
principles requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and the disclosure of contingent assets and liabilities at the date of
the financial statements, and reported amounts of revenues and expenses during the reporting
periods. Actual results could differ from those estimates.
Inventories
At December 31, 2005 and September 30, 2006, net inventory balances were $2.7 million and $2.8
million and were comprised of raw materials, consisting primarily of bottles, actuators and
calcitonin-salmon active pharmaceutical ingredient for the Companys calcitonin-salmon nasal spray
that were acquired by the Company in furtherance of satisfying its supply obligations under its
agreement with Par Pharmaceutical. For a discussion of the status of our collaboration with Par
Pharmaceutical, See Note 3: Contractual Agreements Par Pharmaceutical.
Revenue Recognition
Most of the Companys revenues are generated from research and licensing arrangements. These
research and licensing arrangements may include upfront non-refundable payments, development
milestone payments, revenue from product manufacturing, payments for research and development
services performed and product sales royalties or revenue. The Companys revenue recognition
policies are based on the requirements of SEC Staff Accounting Bulletin No. 104 Revenue
Recognition, and, for contracts with multiple deliverables, the Company determines the
appropriateness of separate units of accounting and allocates arrangement consideration based on
the fair value of the elements under guidance from Emerging Issues Task Force Issue 00-21 (EITF
00-21), Revenue Arrangements with Multiple Deliverables. Under EITF 00-21, revenue arrangements
with multiple deliverables are divided into separate units of accounting such as product
development and contract manufacturing. Revenue is allocated to these units based upon relative
fair values with revenue recognition criteria considered separately for each unit.
Nonrefundable upfront technology license fees, for product candidates where the Company is
providing continuing services related to product development, are deferred and recognized as
revenue over the development period or as the Company provides the services required under the
agreement. The ability to estimate total development effort and costs can vary significantly for
each product candidate due to the inherent complexities and uncertainties of drug development.
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Milestones, in the form of additional license fees, typically represent nonrefundable payments
to be received in conjunction with the achievement of a specific event identified in the contract,
such as initiation or completion of specified clinical development activities. The Company believes
that a milestone represents the culmination of a distinct earnings process when it is not
associated with ongoing research, development or other performance on the Companys part. The
Company recognizes such milestones as revenue when they become due and collection is reasonably
assured. When a milestone does not represent the culmination of a distinct earnings process,
revenue is either recognized when the earnings process is deemed to be complete or in a manner
similar to that of an upfront technology license fee.
The timing and amount of revenue that the Company recognizes from licenses of technology,
either from upfront fees or milestones where the Company is providing continuing services related
to product development, is dependent upon on the Companys estimates of filing dates or development
costs. As product candidates move through the development process, it is necessary to revise these
estimates to consider changes to the product development cycle, such as changes in the clinical
development plan, regulatory requirements, or various other factors, many of which may be outside
of the Companys control. The impact on revenue of changes in the Companys estimates and the
timing thereof, is recognized prospectively, over the remaining estimated product development
period.
Royalty revenue is generally recognized at the time of product sale by the licensee.
Revenue from research and development services performed is generally received for services
performed under collaboration agreements, and is recognized as services are performed. Payments
received in excess of amounts earned are recorded as deferred revenue.
Product sales revenue is recognized when the manufactured goods are shipped to the purchaser
and title has transferred under our contracts where there is no right of return.
Under the guidance of EITF Issue 01-14, reimbursements received for direct out-of-pocket
expenses related to research and development costs are recorded as revenue in the income statement
rather than as a reduction in expenses.
Government grant revenue is recognized during the period qualifying expenses are incurred for
the research that is performed as set forth under the terms of the grant award agreements, and when
there is reasonable assurance that the company will comply with the terms of the grant and that the
grant will be received.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and
liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax
bases and operating loss and tax credit carry-forwards. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the years in which those
temporary differences are expected to be recovered or settled. The effect on deferred tax assets
and liabilities of a change in tax rates is recognized in income in the period that includes the
enactment date. The Company continues to record a valuation allowance for the full amount of
deferred tax assets since realization of such tax benefits is not considered to be more likely than
not.
Research and Development Costs
All research and development (R&D) costs are charged to operations as incurred. The
Companys R&D expenses consist of costs incurred for internal and external R&D. These costs include
direct and research-related overhead expenses. Clinical trial expenses, which are included in R&D
expenses, represent obligations resulting from the Companys contracts with various clinical
research organizations in connection with conducting clinical trials for the Companys product
candidates. The Company recognizes expenses for these contracted activities based on a variety of
factors, including actual and estimated labor hours, clinical site initiation activities, patient
enrollment rates, estimates of external costs and other activity-based factors. The Company
believes that this method best approximates the efforts expended on a clinical trial with the
expenses recorded. The Company adjusts its rate of clinical expense recognition if actual results
differ from its estimates.
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When the Company acquires intellectual properties from others, the purchase price is
allocated, as applicable, between In-Process Research and Development (IPR&D), other identifiable
intangible assets and net tangible assets. The Companys policy defines IPR&D as the value assigned
to those projects for which the related products have not yet reached technological feasibility and
have no alternative future use. Determining the portion of the purchase price allocated to IPR&D
requires the Company to make significant estimates. The amount of the purchase price allocated to
IPR&D is determined by estimating the future cash flows of each project of technology and
discounting the net cash flows back to their present values. The discount rate used is determined
at the acquisition date, in accordance with accepted valuation methods, and includes consideration
of the assessed risk of the project not being developed to a stage of commercial feasibility.
Amounts recorded as IPR&D are charged to R&D expense upon acquisition.
Recent Accounting Pronouncements
In May 2005, the FASB issued Statement of Financial Accounting Standards No. 154, Accounting
Changes and Error Corrections, (SFAS 154). SFAS 154 replaces APB Opinion No. 20, Accounting
Changes, and SFAS No. 3, Reporting Accounting Changes in Interim Financial Statements, and
changes the requirements for the accounting for and reporting of a change in accounting principle.
The Company adopted SFAS 154 in 2006. The Companys results of operations and financial condition
will only be impacted by SFAS 154 if the Company implements changes in accounting principles that
are addressed by the standard or corrects accounting errors in future periods.
In September 2005, the EITF reached a consensus on Issue No. 04-13, Accounting for Purchases
and Sales of Inventory with the Same Counterparty. Under EITF 04-13, purchases and sales of
inventory with the same counterparty should be considered a single nonmonetary transaction when
transacted in contemplation of each other. Nonmonetary exchanges of inventory within the same line
of business should be recognized at fair value when finished goods inventory is exchanged for the
same or a different type of inventory within the same line of business. The EITF is effective for
any transactions completed after March 15, 2006. Adoption of EITF 04-13 did not have a significant
impact on the Companys financial position or results of operations.
In November 2005, the FASB issued FASB Staff Position No. 123R-3, Transition Election Related
to Accounting for the Tax Effects of Share-Based Payment Awards. The FSP provides an alternative
method of calculating excess tax benefits (the APIC pool) from the method defined in SFAS123R for
stock-based payments. A one-time election to adopt the alternate method in this FSP is available to
those entities adopting SFAS 123R using either the modified retrospective or modified prospective
method. The Company elected not to use this alternate method to calculate its APIC pool at adoption
of SFAS 123R.
In November 2005, the FASB issued FASB Staff Position No. 115-1 and SFAS 124-1, The Meaning
of Other-Than-Temporary Impairment and Its Application to Certain Investments. The FSP addresses
when an investment is considered impaired, whether the impairment is other-than-temporary and the
measurement of an impairment loss. The FSP also includes accounting considerations subsequent to
the recognition of an other-than-temporary impairment and requires certain disclosures about
unrealized losses that have not been recognized as other-than-temporary. The FSP is effective for
reporting periods beginning after December 15, 2005 with earlier application permitted. The
adoption of this accounting principle did not have a significant impact on the Companys financial
position or results of operations.
In February 2006, the FASB issued FASB Staff Position SFAS No. 123R-4 Classification of
Options and Similar Instruments Issued as Employee Compensation That Allow for Cash Settlement upon
the Occurrence of a Contingent Event. The FSP amends SFAS 123R for awards with contingent events
that are not probable and outside the control of the employee that are settled in cash to classify
such awards as an equity award. If the contingent event later becomes probable and the award had
been reported as an equity award, the change in classification would be accounted for as a
modification. This FSP did not have an impact on the Companys financial statements or results of
operations since the Company does not have such awards.
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes (FIN 48), which prescribes a recognition threshold and measurement process for recording in
the financial statements uncertain tax positions taken or expected to be taken in a tax return.
Additionally, FIN 48 provides guidance on the recognition, classification, accounting in interim
periods and disclosure requirements for uncertain tax positions. The accounting provisions of FIN
48 will be effective for the Company beginning January 1, 2007. The Company is in the process of
determining the effect, if any, that the adoption of FIN 48 will have on its consolidated financial
position or results of operations.
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In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, (SFAS 157). SFAS
157 defines fair value, establishes a framework for measuring fair value and requires enhanced
disclosures about fair value measurements. SFAS 157 requires companies to disclose the fair value
of its financial instruments according to a fair value hierarchy (i.e., levels 1, 2, and 3, as
defined). Additionally, companies are required to provide enhanced disclosure regarding instruments
in the level 3 category, including a reconciliation of the beginning and ending balances separately
for each major category of assets and liabilities. SFAS 157 is effective for financial statements
issued for fiscal years beginning after November 15, 2007 and interim periods within those fiscal
years. The Company is currently evaluating the impact, if any, adoption may have on its
consolidated financial condition or results of operations.
In September 2006, the FASB released SFAS No. 158, Employers Accounting for Defined Benefit
Pension and Other Postretirement Plans: an amendment of FASB Statements No. 87, 88, 106, and
132(R), (SFAS 158). SFAS 158 requires an employer to recognize the over funded or under funded
status of defined benefit and other postretirement plans as an asset or liability in its statement
of financial position and to recognize changes in that funded status in the year in which the
changes occur through an adjustment to comprehensive income. This statement also requires an
employer to measure the funded status of a plan as of the date of its year-end statement of
financial position, with limited exceptions. SFAS 158 is effective as of December 31, 2006. It is
expected that SFAS 158 will not have a significant impact on the Companys consolidated financial
condition or results of operations.
In September 2006, the SEC issued Staff Accounting Bulletin No. 108, Considering the Effects
of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements
(SAB 108). SAB 108 provides interpretive guidance on how the effects of the carryover or reversal
of prior year misstatements should be considered in quantifying a current year misstatement. The
SEC staff believes that registrants should quantify errors using both a balance sheet and income
statement approach and evaluate whether either approach results in quantifying a misstatement that,
when all relevant quantitative and qualitative factors considered, is material. SAB 108 is
effective for fiscal years ending on or after November 15, 2006, with early application encouraged.
It is expected that SAB 108 will not have a significant impact on the Companys consolidated
financial condition or results of operations.
In October 2006, the FASB issued FASB Staff Position No. 123R-5, Amendment of FASB Staff
Position FAS 123(R)-1, (FSP 123(R)-5). FSP 123(R)-5 amends FSP 123(R)-1 for equity instruments
that were originally issued as employee compensation and then modified, with such modification made
solely to reflect an equity restructuring that occurs when the holders are no longer employees. In
such circumstances, no change in the recognition or the measurement date of those instruments will
result if both of the following conditions are met: a) there is no increase in fair value of the
award (or the ratio of intrinsic value to the exercise price of the award is preserved, that is,
the holder is made whole), or the antidilution provision is not added to the terms of the award in
contemplation of an equity restructuring; and b) all holders of the same class of equity
instruments (for example, stock options) are treated in the same manner. In September 2006, the
Companys Board of Directors authorized a modification to its stock option plans to provide
antidilution adjustments for outstanding stock options in the event of an equity restructuring.
These modifications were not added in contemplation of an equity restructuring. In accordance with
FSP 123(R)-5, there was no change in the recognition date for the
modified options, all holders will be treated in the same manner, and
there was no accounting impact and no effect
on the Companys financial condition or results of operations.
Stock-based Compensation
On January 1, 2006 the Company adopted Statement of Financial Accounting Standards No. 123R,
Share-Based Payment (Revised 2004), which requires the measurement and recognition of
compensation for all stock-based awards made to employees and directors including stock options and
employee stock purchases under a stock purchase plan based on estimated fair values. SFAS 123R
supersedes previous accounting under Accounting Principles Board Opinion No. 25, Accounting for
Stock Issued to Employees for periods beginning in fiscal 2006. In March 2005, the Securities and
Exchange Commission issued Staff Accounting Bulletin No. 107 relating to application of SFAS 123R.
The Company has applied the provisions of SAB 107 in its adoption of SFAS 123R. In addition to the
recognition of expense in the financial statements, under SFAS 123R, any excess tax benefits
received upon exercise of options will be presented as a financing activity inflow. The adoption of
SFAS 123R will result in recognition of additional non-cash stock-based compensation expense and,
accordingly, will increase net loss in amounts which likely will be considered material.
The Company adopted SFAS 123R using the modified prospective transition method, which requires
the application of the accounting standard as of January 1, 2006. In accordance with the modified
prospective transition method, the Companys consolidated financial statements for periods prior to
January 1, 2006 have not been restated to reflect this change. Stock-based
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compensation recognized during current periods is based on the value of the portion of the
stock-based award that will vest during the period, adjusted for expected forfeitures. Stock-based
compensation recognized in the Companys condensed consolidated financial statements for the three
and nine month periods ended September 30, 2006 includes compensation cost for stock-based awards
granted prior to, but not fully vested as of December 31, 2005 and stock-based awards granted
subsequent to December 31, 2005. The compensation cost for awards granted prior to January 1, 2006
is based on the grant date fair value estimated in accordance with the pro forma provisions of SFAS
123 while awards granted after December 31, 2005 follow the provisions of SFAS 123R to determine
the grant date fair value and compensation cost. Compensation cost for all stock-based awards is
recognized using the straight-line method over the vesting period.
The adoption of SFAS 123R resulted in a cumulative benefit from accounting change of $291,000
as of January 1, 2006, which reflects the net cumulative impact of estimating future forfeitures in
the determination of period expense for restricted stock awards, rather than recording forfeitures
when they occur as previously permitted. The impact from the Companys adoption of SFAS 123R is
further described in Note 2.
Net Loss per Common Share
Basic and diluted net loss per common share is computed by dividing the net loss by the
weighted average number of common shares outstanding during the periods. The effect of employee
stock options, unvested restricted stock and warrants at September 30, 2005 and 2006 was not
included in the net loss per share calculation for the interim periods then ended as the effect
would have been anti-dilutive. Outstanding warrants, employee stock options and unvested restricted
stock totaled approximately 4.6 million and 3.8 million shares at September 30, 2005 and 2006,
respectively.
Note 2 Stock-based compensation plans
Determining Fair Value Under SFAS 123R
Upon adoption of SFAS 123R the Company continued to use the Black-Scholes option pricing model
as its method of valuation for stock options. The Companys determination of the fair value of
stock-based awards on the date of grant using an option pricing model is affected by the Companys
stock price as well as assumptions regarding a number of highly complex and subjective variables.
These variables include, but are not limited to the expected life of the award, expected stock
price volatility over the term of the award and actual and projected exercise behaviors. Although
the fair value of stock options is determined in accordance with SFAS 123R and SAB 107, the
Black-Scholes option pricing model requires the input of highly subjective assumptions, and other
reasonable assumptions could provide differing results.
Valuation and Amortization Method. The Company estimates the fair value of stock-based awards
on the grant date using the Black-Scholes option valuation model. The Company amortizes the fair
value of all awards on a straight-line basis over the requisite service periods, which are
generally the vesting periods.
Expected Life. The expected life of awards granted represents the period of time that they are
expected to be outstanding. The Company uses the simplified method prescribed under SAB 107 to
determine the expected life based on the average of the vesting period(s) and the contractual life
of the option. Stock options granted during the three and nine month periods ended September 30,
2005 have vesting periods of one, three or four years and contractual terms of ten years, resulting
in expected terms ranging from five to six-and-one-quarter years. There were no stock options
granted during the three month period ended September 30, 2006. Stock options granted during the
nine month period ended September 30, 2006 have vesting periods of three years and contractual
terms of ten years, resulting in an expected term of six years. Options vesting over multiple years
vest proportionately on each annual anniversary date. Outstanding options granted prior to January
1, 2006 have vesting periods of one, three or four years.
Expected Volatility. The Company estimates the volatility of its common stock at the date of
grant based solely on the historical volatility of its common stock. The volatility factor used in
the Black-Scholes option valuation model is based on the Companys historical stock prices over the
most recent period commensurate with the estimated expected life of the award.
Risk-Free Interest Rate. The Company bases the risk-free interest rate used in the
Black-Scholes option valuation model on the implied yield currently available on U.S. Treasury
zero-coupon issues with an equivalent remaining term equal to the expected life of the award.
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Expected Dividend Yield. The Company has never paid any cash dividends on its common stock and
does not anticipate paying any cash dividends in the foreseeable future. Consequently, the Company
uses an expected dividend yield of zero in the Black-Scholes option valuation model.
Expected Forfeitures. The Company uses historical data to estimate pre-vesting option
forfeitures and records stock-based compensation only for those awards that are expected to vest.
A summary of the weighted average assumptions and fair values for options granted during the
periods presented is as follows:
Three months ended | Nine months ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2005 | 2006 | 2005 | 2006 | |||||||||||||
Expected dividend yield |
0 | % | * | 0 | % | 0 | % | |||||||||
Risk free interest rate |
4.1 | % | * | 4.0 | % | 4.8 | % | |||||||||
Expected stock volatility |
0.77 | * | 0.79 | 0.69 | ||||||||||||
Expected option life |
6 years | * | 6 years | 5.7 years | ||||||||||||
Weighted average fair value granted during period |
$ | 10.36 | * | $ | 8.65 | $ | 9.05 |
* | No options were granted in the three months ended September 30, 2006. |
Stock-based Compensation Under SFAS 123R
The following table summarizes stock-based compensation expense related to stock-based awards
under SFAS 123R for the three and nine month periods ended September 30, 2006:
Three months ended | Nine months ended | |||||||
September 30, 2006 | September 30, 2006 | |||||||
(dollars in thousands) | ||||||||
Stock-based compensation: |
||||||||
Research and development |
$ | 598 | $ | 1,576 | ||||
Sales and marketing |
58 | 178 | ||||||
General and administrative |
589 | 2,063 | ||||||
Total stock-based compensation |
$ | 1,245 | $ | 3,817 | ||||
There were no options granted during the three month period ended September 30, 2006. The
weighted average grant-date fair value for options granted during the nine month period ended
September 30, 2006 was $9.05. As of September 30, 2006, the Company had approximately $3.9 million
of total unrecognized compensation cost related to unvested stock options granted under all equity
compensation plans. Total unrecognized compensation cost will be adjusted for future changes in
estimated forfeitures. The Company expects to recognize this cost over a weighted average period of
approximately 1.5 years.
The following table presents the impact of the adoption of SFAS 123R on selected line items
from the Companys condensed consolidated financial statements for the three and nine month periods
ended September 30, 2006 (in thousands, except per share amounts):
Three months ended | Nine months ended | |||||||||||||||
September 30, 2006 | September 30, 2006 | |||||||||||||||
As Reported | If Reported | As Reported | If Reported | |||||||||||||
Following | Following | Following | Following | |||||||||||||
SFAS 123R | APB 25 | SFAS 123R | APB 25 | |||||||||||||
Condensed consolidated statement of operations: |
||||||||||||||||
Net loss |
$ | (7,808 | ) | $ | (7,225 | ) | $ | (16,215 | ) | $ | (14,824 | ) | ||||
Net loss per share |
||||||||||||||||
Basic and Diluted |
$ | (0.36 | ) | $ | (0.34 | ) | $ | (0.77 | ) | $ | (0.70 | ) | ||||
Condensed consolidated statement of cash flows: |
||||||||||||||||
Net cash provided by (used in) operating activities |
$ | 7,093 | $ | 7,093 | $ | (7,978 | ) | $ | (7,978 | ) | ||||||
Net cash provided by financing activities |
$ | 2,667 | $ | 2,667 | $ | 11,461 | $ | 11,461 |
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Stock Option Activity
At September 30, 2006, The Company had four stock compensation plans (including its 1990 Stock
Option Plan under which no shares are available for future issuance). As of September 30, 2006,
under all of the Companys plans, options to purchase an aggregate of 2.5 million shares were
outstanding, and an additional 1.0 million shares were authorized for future grants under the
plans. The Company generally issues new shares for option exercises unless treasury shares are
available for issuance. The Company has no treasury shares as of September 30, 2006 and has no
plans to purchase any in the next year, however, the Company may accept the surrender of vested
restricted shares from employees to cover tax requirements at its discretion.
Options granted, exercised, canceled and expired under all of its stock compensation plans are
summarized as follows (options and aggregate intrinsic value in thousands):
Weighted | ||||||||||||||||
Weighted | Average | |||||||||||||||
Average | Remaining | Aggregate | ||||||||||||||
Exercise | Contractual | Intrinsic | ||||||||||||||
Options | Price | Life | Value | |||||||||||||
Outstanding December 31, 2005 |
2,688 | $ | 12.92 | |||||||||||||
Options granted |
124 | 13.98 | ||||||||||||||
Options exercised |
(278 | ) | 11.81 | |||||||||||||
Options canceled |
(7 | ) | 11.05 | |||||||||||||
Options expired |
(2 | ) | 12.65 | |||||||||||||
Outstanding at September 30, 2006 |
2,525 | $ | 13.10 | 5.9 years | $ | 6,458 | ||||||||||
Exercisable at September 30, 2006 |
1,868 | $ | 12.71 | 4.9 years | $ | 5,744 | ||||||||||
At September 30, 2006, approximately 1.9 million vested stock options were issued, outstanding
and exercisable with a weighted-average exercise price of $12.71 and approximately 0.7 million
unvested stock options were issued and outstanding with a weighted average exercise price of
$14.20. The $6.5 million aggregate intrinsic value of all stock options outstanding at September
30, 2006 is based on the $15.26 closing market price of the Companys common stock on that date,
and is calculated by aggregating the difference between $15.26 and the exercise price of each of
the approximately 2.4 million outstanding vested and unvested stock options which have an exercise
price less than $15.26. The total intrinsic value of options exercised during the three and nine
month periods ended September 30, 2006 was approximately $0.2 million and $1.5 million, determined
as of the date of exercise. The total fair value of options that vested during the three and nine
month periods ended September 30, 2006 was approximately $1.9 million and $3.8 million,
respectively. The total fair value of options that were forfeited during the three and nine month
periods ended September 30, 2006 was approximately $0 and $65,000, respectively.
The following table summarizes information about stock options outstanding at September 30,
2006:
Options Outstanding | ||||||||||||||||||||
Weighted- | Options Exercisable | |||||||||||||||||||
Average | Weighted- | Weighted- | ||||||||||||||||||
Remaining | Average | Average | ||||||||||||||||||
Contractual Life | Exercise | Exercise | ||||||||||||||||||
Range of Exercise Prices | Outstanding | (Years) | Price | Exercisable | Price | |||||||||||||||
$5.62 - $9.99 |
351,867 | 2.4 | $ | 8.20 | 320,336 | $ | 8.10 | |||||||||||||
$10.00 - $12.43 |
325,100 | 4.6 | 10.95 | 305,268 | 10.94 | |||||||||||||||
$12.94 - $12.94 |
800,000 | 5.6 | 12.94 | 800,000 | 12.94 | |||||||||||||||
$13.35 - $16.00 |
948,433 | 7.9 | 14.53 | 342,201 | 14.48 | |||||||||||||||
$25.00 - $25.00 |
100,000 | 5.6 | 25.00 | 100,000 | 25.00 | |||||||||||||||
Totals |
2,525,400 | 5.9 | $ | 13.10 | 1,867,805 | $ | 12.71 | |||||||||||||
Pro Forma Information
Prior to 2006, stock-based compensation plans were accounted for using the intrinsic value
method prescribed in APB 25 and related Interpretations. Stock-based compensation reflected in net
loss in the three and nine month periods ended September 30, 2005 related to restricted stock and
to one 2002 below-market stock option grant and one 2002 consultant stock option grant, both of
which fully vested in 2005. All other stock options granted had exercise prices equal to or greater
than the market value of the underlying
common stock on the date of grant. Had compensation cost for the plans been determined based
on the fair value at the grant dates for
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stock options granted in accordance with the method of
SFAS 123R, net loss and basic and diluted net loss per share for the three and nine month periods
ended September 30, 2005 would have been changed to the pro forma amounts indicated below (in
thousands, except per share data):
Three months ended | Nine months ended | |||||||
September 30, 2005 | September 30, 2005 | |||||||
(dollars in thousands) | ||||||||
Net loss as reported |
$ | (8,814 | ) | $ | (23,245 | ) | ||
Add: Stock-based employee compensation included in the reported net loss |
536 | 1,293 | ||||||
Deduct: Stock-based employee compensation, determined under fair value
based methods |
(1,025 | ) | (3,391 | ) | ||||
Pro forma net loss |
$ | (9,303 | ) | $ | (25,343 | ) | ||
Net Loss per share |
||||||||
Basic and diluted as reported |
$ | (0.46 | ) | $ | (1.28 | ) | ||
Basic and diluted pro forma |
$ | (0.49 | ) | $ | (1.39 | ) |
Note 3 Contractual Agreements
Procter & Gamble (P&G): On January 27, 2006, the Company entered into a Product Development
and License Agreement with P&G to develop and commercialize the Companys PTH(1-34) nasal spray for
the treatment of osteoporosis. Clinical and non-clinical studies on PTH(1-34) nasal spray are being
completed in preparation for Phase III clinical development. Under terms of the agreement, the
Company has granted P&G rights to the worldwide development and commercialization of PTH(1-34)
nasal spray in exchange for an upfront fee, potential future milestone payments and royalties on
product sales.
Payments include a $10 million initial payment upon execution of the agreement, a $7 million
milestone payment received in June 2006 and the potential for additional contractual payments of up
to $15 million during the remainder of 2006. The $10 million initial payment has been recorded as
deferred revenue and is being amortized into revenue over the estimated development period. The $7
million milestone payment was recognized in full as revenue in the three month period ended June
30, 2006. In total, milestone payments could reach $577 million over the life of the project
depending upon the successful completion of specified development, regulatory and commercialization
goals, although there can be no assurance that any such milestones will be achieved. Under the
agreement, the Company is eligible to receive double-digit patent-based royalties, with the rate
escalating upon the achievement of certain sales levels.
The Company and P&G will jointly develop PTH(1-34) nasal spray and P&G will reimburse the
Company for any development activities performed by the Company under the agreement. P&G will
assume responsibility for clinical and non-clinical studies and will direct regulatory approval and
worldwide sales, marketing and promotion of PTH(1-34) nasal spray while Nastech will be responsible
for the chemistry, manufacturing and controls (CMC) sections of the FDA regulatory submission. In
June 2006 the Company announced an agreement with P&G to manufacture and supply PTH(1-34) nasal
spray for both clinical and commercial product of this investigational treatment for osteoporosis.
Under terms of the supply agreement, the Company will be the exclusive manufacturer of the
PTH(1-34) nasal spray and will manufacture the product and supply it to P&G at a transfer price
that includes a manufacturing profit if the product is approved.
Galenea: In February 2006, the Company acquired the RNAi intellectual property (IP) estate
and other RNAi technologies from Galenea Corporation (Galenea). The IP acquired from Galenea
includes patent applications licensed from the Massachusetts Institute of Technology that have
early priority dates in the antiviral RNAi field focused on viral respiratory infections, including
influenza, rhinovirus, and other respiratory diseases. The Company also acquired Galeneas research
and IP relating to pulmonary drug delivery technologies for RNAi. Additionally, the Company assumed
Galeneas awarded and pending grant applications from the National Institute of Allergy and
Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), and the
Department of Defense to support the development of RNAi-based antiviral drugs.
RNAi-based therapeutics offers a potentially effective treatment for a future influenza
pandemic, which the Company believes is an urgent global concern. This program complements the
Companys current TNF-alpha RNAi program targeting inflammation, since a consequence of influenza
infection can be life-threatening respiratory and systemic inflammation.
Consideration for the acquisition consisted of an upfront payment and may include contingent
payments based upon the regulatory filing, approval and sale of products. In connection with the
transaction, the Company recorded a charge of approximately $4.1
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million for acquired research
associated with products in development for which, at the acquisition date, technological
feasibility had not been established and there was no alternative future use as set forth in
Statement of Financial Accounting Standard No. 2, Accounting for Research and Development Costs.
This charge has been included in research and development expense for the nine months ended
September 30, 2006. Additionally, approximately $0.1 million was allocated to purchased fixed
assets to be depreciated over estimated remaining useful lives.
Amylin Pharmaceuticals, Inc. In June 2006, the Company announced an agreement with Amylin
Pharmaceuticals, Inc. (Amylin) to develop a nasal spray formulation of exenatide for the
treatment of diabetes. Preclinical studies of the formulation have been completed in preparation
for initiating studies in human subjects. Amylin filed an
Investigational New Drug application (IND) with the
FDA in July 2006 to allow clinical trials to begin, and began clinical trials in the three month
period ended September 30, 2006.
Under terms of the agreement, the Company will receive milestone payments and royalties on
product sales. If the development program is successful and the product continues to move forward,
milestone payments could reach up to $89 million in total, based on specific development,
regulatory, and commercialization goals. Royalty rates escalate with product success.
Amylin and the Company will jointly develop the nasal spray formulation utilizing the
Companys proprietary nasal delivery technology, and Amylin will reimburse the Company for any
development activities performed by the Company under the agreement. Amylin has overall
responsibility for the development program including clinical, non-clinical and regulatory
activities, while the Companys efforts will focus on drug delivery and chemistry, manufacturing
and controls (CMC) activities. If a supply agreement is reached between the companies, the Company
may supply commercial product to Amylin and their exenatide collaboration partner, Eli Lilly and
Company, however, there can be no assurance that such a supply agreement will be executed.
Par Pharmaceutical In October 2004, the Company entered into a license and supply agreement
with Par Pharmaceutical for the exclusive U.S. distribution and marketing rights to generic
calcitonin-salmon nasal spray for the treatment of osteoporosis. Under the terms of the agreement
with Par Pharmaceutical, the Company will manufacture and supply finished calcitonin-salmon nasal
spray product to Par Pharmaceutical, while Par Pharmaceutical will distribute the product in the
US. The financial terms of the agreement include milestone payments, product transfer payments for
manufactured product and a profit sharing following commercialization.
In December 2003, the Company filed with the FDA an Abbreviated New Drug Application (ANDA)
for a calcitonin-salmon nasal spray for the treatment of osteoporosis, and in February 2004, the
FDA accepted the filing of the Companys ANDA for the product with no request for additional
clinical studies. To date, the FDA has conducted Pre-Approval Inspections (PAI) of both of the
Companys nasal spray manufacturing facilities and has informed the Company the facilities were
approved for supplying calcitonin-salmon nasal spray. On September 2, 2005, a citizens petition
was filed with the FDA requesting that the FDA not approve the ANDA as filed prior to additional
studies for safety and bioequivalence. On October 13, 2005, the Company filed a response requesting
that the FDA deny this citizens petition on the grounds that no additional information is
necessary from a scientific or medical basis and that such additional information is not required
under the law. On March 15, 2006, the petitioner submitted an additional request to the FDA in
response to the Companys assertions in its October 13, 2005 submission to the FDA. On May 11, 2006
the Company filed an additional response requesting that the FDA deny the citizens petition.
In addition, Apotex, Inc. (Apotex) has filed a generic application for its nasal
calcitonin-salmon product with a filing date that has priority over the Companys ANDA for its
calcitonin-salmon nasal spray which prevents the Company from marketing its product until 180 days
after Apotex commences marketing its product. In November 2002, Novartis AG (Novartis) brought a
patent infringement action against Apotex claiming that Apotexs nasal calcitonin-salmon product
infringes on Novartis patents, seeking damages and requesting injunctive relief. That action is
still pending. The Company is unable to predict what, if any, effect the Novartis action will have
on Apotexs ability or plans to commence marketing its product or when, if at all, Apotex will
commence marketing its product.
On July 10, 2006, the Company received written notification from the FDA stating that the
Companys ANDA for nasal calcitonin-salmon was not approvable at this time. The FDA expressed a
concern relating to the potential for immunogenicity that might result from a possible interaction
between calcitonin-salmon and chlorobutanol, the preservative in the formulation although no
allergic reactions have been observed in any of the clinical trials conducted by the Company and
other existing marketed nasal spray products contain chlorobutanol as the preservative. On
September 29, 2006, the Company announced that it had submitted a complete response to the FDAs
Office of Generic Drugs regarding the potential for such immunogenicity. The FDA has accepted the Companys submission for review, indicating that the generic division of
the FDA has maintained jurisdiction of the Companys filing. Furthermore, the FDA has indicated
that the Companys response is classified as a major amendment to the ANDA, and the Company
therefore expects that the FDA will take at least six months to complete its review of the
Companys submission. If the Company is not
successful at
keeping this application as an ANDA then a 505(b)(2) NDA may be pursued or the application may
be withdrawn. At this time the Company is not able to determine when, if at all, the Companys
calcitonin product will receive marketing approval from the FDA.
16
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The Companys formulation of calcitonin-salmon nasal spray was specifically developed to be
similar to Novartis currently marketed calcitonin-salmon nasal spray, Miacalcin®, in order to
submit the application as an ANDA. Thus, the Companys formulation does not utilize the Companys
advanced tight junction drug delivery technology, which is currently being used in development of
its proprietary pipeline of peptide and protein therapeutics.
Questcor Pharmaceuticals, Inc. In September 2003, the Company completed the sale of certain
assets relating to its Nascobal® brand products, including the Nascobal® (Cyanocobalamin USP) nasal
gel and nasal spray, to Questcor Pharmaceuticals, Inc. (Questcor). The Company filed a New Drug
Application (NDA) of a nasal spray product configuration of Nascobal® in 2003 and was to continue
to prosecute the pending U.S. patents for the Nascobal® nasal spray product on behalf of Questcor.
The Company recognized a gain of approximately $4.2 million on the sale of the assets in 2003. The
gain was calculated as $14 million in non-contingent proceeds, less the net book value of the
assets of $8.1 million, less costs and fees. At the date of the sale, approximately $1 million of
the gain relating to the fair value of work to be completed on the filing of the NDA for the
Nascobal® nasal spray product was deferred and recognized later in 2003 as revenue.
Under the terms of the Asset Purchase Agreement, between the Company and Questcor, Questcor
paid the Company $9 million at closing, $3 million in September 2003 and approximately $2.2 million
in December 2003. In connection with the sale, the Company paid in full a $6.9 million promissory
note and accrued interest of $110,000 due to the company that Nastech had acquired Nascobal® from,
which such company subsequently released its security interest in Nascobal® assets. Questcor also
agreed to make payments of: (i) $2.0 million contingent upon FDA approval of a New Drug Application
for the Nascobal® nasal spray product; and (ii) $2.0 million contingent upon issuance of a U.S.
patent for the Nascobal® nasal spray product. FDA approval for the Nascobal® nasal spray product
was granted in January 2005, and the $2.0 million payment due upon this milestone was received from
Questcor in February 2005.
Under the terms of a supply agreement between the parties, subject to certain limitations, the
Company was obligated to manufacture and supply all of Questcors requirements and Questcor was
obligated to purchase from the Company all of its requirements for Nascobal® nasal gel and spray.
Questcor assignment to QOL Medical, LLC On October 17, 2005, with the consent of the
Company, Questcor assigned all of its rights and obligations under the Questcor Asset Purchase and
Supply Agreements dated September 2003 to QOL Medical, LLC (QOL). The Company received $2.0
million from Questcor on October 19, 2005 in consideration for its consent to the assignment and in
connection with the Company entering into an agreement with QOL which modified certain terms of the
Asset Purchase and Supply Agreements. The $2.0 million is being recognized on a straight-line basis
over the five-year life of the QOL agreement.
Alnylam Pharmaceuticals, Inc. On July 20, 2005, the Company announced that it had acquired
an exclusive InterfeRx license from Alnylam Pharmaceuticals, Inc. (Alnylam) to discover,
develop, and commercialize RNAi therapeutics directed against TNF-alpha, a protein associated with
inflammatory diseases including rheumatoid arthritis and certain chronic respiratory diseases.
Under the agreement, Alnylam received an initial license fee from the Company and is entitled to
receive annual and milestone fees and royalties on sales of any products covered by the licensing
agreement. The initial license fee was expensed as research and development expenses by the Company
in 2005.
Merck/PYY In September 2004, the Company entered into an Exclusive Development,
Commercialization and License Agreement and a separate Supply Agreement (collectively, the
Agreements) with Merck, for the global development and commercialization of PYY Nasal Spray, the
Companys product for the treatment of obesity. Under the Agreements, the Company received an
initial cash payment of $5 million in 2004. The $5 million initial payment was being amortized over
the estimated development period, and was initially recorded as deferred revenue in the
accompanying balance sheet. The Agreements entered into with Merck in September 2004 for PYY were
terminated on March 1, 2006. Under the agreement, Nastech reacquired its rights in the PYY program.
The unamortized $3.7 million balance of the $5 million initial payment was recognized as revenue in
the nine-month period ended September 30, 2006.
The Company has continued PYY product development on its own, and on August 14, 2006, the
Company announced the initiation of a dose ranging study designed to evaluate the pharmacokinetic
parameters, appetite, food intake and safety of various doses of Nastechs PYY nasal spray in obese
subjects.
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Government Grants On August 29, 2006, the Company announced that the NIH awarded the Company
a Phase 1 Small Business Innovation Research (SBIR) grant of $383,000 to further develop the
Companys siRNA therapeutics to prevent and treat influenza. These funds were received by the
Company in September 2006 and recognized as grant revenue during the three month period ended
September 30, 2006. On September 26, 2006, the Company announced that the NIH awarded the Company a
$1.9 million Research Project (R01) grant to prevent and treat influenza.
Note 4 Stockholders Equity
Common Stock Offerings In a 2001 private offering, the Company granted warrants to purchase
68,000 shares of its common stock at any time prior to May 11, 2005, at an exercise price of $7.50
per share of common stock. As of December 31, 2005, all warrants relating to this private placement
have been exercised. In connection with such private placement, the Company granted additional
warrants to purchase 595,155 shares of its common stock, of which 430,062 warrants were exercisable
at any time prior to March 22, 2006 and 165,093 warrants were exercisable at any time prior to May
11, 2006, at an exercise price of $6.34 per share. As of September 30, 2006, all warrants issued in
connection with these private placements have been exercised.
In September 2003, the Company completed the sale of 1,513,069 units, each unit consisting of
one share of common stock and one five year warrant convertible into 0.35 common shares, to certain
accredited investors in a private placement transaction for an aggregate purchase price of $11
million, prior to the deduction of fees and commissions totaling $1,037,000. The units were sold at
$7.27 per unit, which was an 18% discount from the volume weighted average stock price for the 10
days prior to the completion of the private placement transaction. The warrants are exercisable for
529,574 shares of common stock at an exercise price per share of $11.09, subject to adjustment from
time to time for stock splits, stock dividends, distributions or similar transactions. The warrants
expire in September 2008. At September 30, 2006, 337,001 warrants issued in connection with this
private placement had been exercised.
In June, 2004, the Company completed the sale of 1,136,364 shares of its common stock, and
warrants to purchase up to 511,364 shares of common stock at an exercise price of $14.40 per share,
pursuant to its $30 million effective shelf registration
statement. Subsequent dilution has resulted in a contractual
reduction in exercise price to $14.26 and an increase in warrants
outstanding to 516,384. The offering resulted in gross
proceeds of approximately $12.5 million to the Company prior to the deduction of fees and
commissions of $229,000. The warrants vested in December 2004, and are exercisable until June 2009.
At September 30, 2006, no warrants issued in connection with this private placement have been
exercised.
In December 2004, the Company completed the public offering of 4,250,000 shares of its common
stock at a public offering price of $13.50 per share pursuant to its $80 million effective shelf
registration statement. The offering resulted in gross proceeds of approximately $57.4 million to
the Company, prior to the deduction of fees and commissions of $4.5 million.
In August 2005, the Company completed the public offering of 1,725,000 shares of its common
stock at a public offering price of $13.50 per share pursuant to its $80 million effective shelf
registration statement and a $0.7 million post effective amendment filed on August 25, 2005
pursuant to Rule 462(b) of the Securities Act. The offering resulted in gross proceeds of
approximately $23.3 million to the Company, prior to the deduction of fees and commissions of
approximately $1.7 million.
Warrants Additional information on warrants for the Companys common stock is as follows:
Exercise Price of Warrants | Total | |||||||||||||||
$6.34 | $11.09 | $14.26 | Warrants | |||||||||||||
Warrants outstanding at December 31, 2005 |
458,395 | 433,288 | 516,384 | 1,408,067 | ||||||||||||
Exercised during the nine months ended September 30, 2006 |
(458,395 | ) | (240,715 | ) | | (699,110 | ) | |||||||||
Warrants outstanding at September 30, 2006 |
| 192,573 | 516,384 | 708,957 | ||||||||||||
Warrants expiring in September 2008 |
| 192,573 | | 192,573 | ||||||||||||
Warrants expiring in June 2009 |
| | 516,384 | 516,384 |
Restricted Stock Awards Pursuant to restricted stock awards granted under the Companys 2004
Plan, the Company has issued shares of restricted stock to certain employees and members of the
board of directors. Non-cash compensation expense is being recognized on a straight-line basis over
the applicable vesting periods of one to four years of the restricted shares based on the fair
value of such restricted stock on the grant date. Additional information on restricted shares is as
follows:
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Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2005 | 2006 | 2005 | 2006 | |||||||||||||
Unvested restricted shares outstanding, beginning of period |
148,823 | 493,228 | 145,620 | 444,322 | ||||||||||||
Restricted shares issued |
308,169 | 125,710 | 389,052 | 276,656 | ||||||||||||
Restricted shares forfeited |
(15,955 | ) | (2,328 | ) | (25,515 | ) | (14,635 | ) | ||||||||
Restricted shares vested |
(14,703 | ) | (76,096 | ) | (82,823 | ) | (165,829 | ) | ||||||||
Unvested restricted shares outstanding, end of period |
426,334 | 540,514 | 426,334 | 540,514 | ||||||||||||
Non-cash restricted stock compensation expense, net of forfeitures |
$ | 492,000 | $ | 547,000 | $ | 1,006,000 | $ | 1,753,000 | ||||||||
Average award price during period |
$ | 14.59 | $ | 13.04 | $ | 13.85 | $ | 14.26 |
Shelf Registration Statement At September 30, 2006, the Company had one effective shelf
registration statement on Form S-3. A shelf registration statement enables the Company to raise
capital from the offering of securities covered by the shelf registration statements, as well as
any combination thereof, from time to time and through one or more methods of distribution, subject
to market conditions and cash needs. In December 2003, the Company filed a shelf registration
statement with the SEC, which was declared effective by the SEC on January 14, 2004, pursuant to
which it may issue common stock or warrants, up to an aggregate of $30 million. The balance
remaining on this shelf registration at September 30, 2006 is approximately $10.1 million. On
October 19, 2006, the Company filed a shelf registration statement on Form S-3 for $125.0 million
of common stock which includes the remaining $10.1 million balance from one of the Companys
previous shelf registration statements. As of the date of this filing, the new $125.0 million shelf
has not been declared effective by the SEC.
Stockholders Rights Plan In 2000, the Company enacted a stockholder rights plan designed to
protect its stockholders from coercive or unfair takeover tactics. Under the plan, the Company
declared a dividend of one preferred stock purchase right for each share of common stock and
entered into a Rights Agreement with the Companys stock transfer agent. Each preferred stock
purchase right entitles the holder to purchase from the Company 1/1000 of a share of its Series A
Junior Participating Preferred Stock for $50. In the event any acquiring entity or group
accumulates or initiates a tender offer to purchase 15% or more of the Companys common stock, then
each holder of the Companys common stock shall receive a separate certificate evidencing the
rights (the Rights Distribution). Each holder of preferred stock purchase rights, other than the
acquiring entity, will have the right to receive, upon exercise of the preferred stock purchase
rights, shares of the Companys common stock or shares in the acquiring entity having a value equal
to two times the exercise price of the preferred stock purchase rights.
ITEM 2 MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
Statements contained herein that are not historical fact may be forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, that are subject to a variety of risks and
uncertainties. There are a number of important factors that could cause actual results to differ
materially from those projected or suggested in any forward-looking statement made by us. These
factors include, but are not limited to: (i) our ability to obtain additional funding; (ii) our
ability to attract and/or maintain manufacturing, research, development and commercialization
partners; (iii) our and/or a partners ability to successfully complete product research and
development, including pre-clinical and clinical studies and commercialization; (iv) our and/or a
partners ability to obtain required governmental approvals, including product and patent
approvals; and (v) our and/or a partners ability to develop and commercialize products that can
compete favorably with those of competitors. In addition, significant fluctuations in quarterly
results may occur as a result of the timing of milestone payments, the recognition of revenue from
milestone payments and other sources not related to product sales to third parties, and the timing
of costs and expenses related to our research and development programs. Additional factors that
would cause actual results to differ materially from those projected or suggested in any
forward-looking statements are contained in our filings with the Securities and Exchange
Commission, including those factors discussed under the captions Forward-Looking Information and
Risk Factors in our most recent Annual Report on Form 10-K, as may be supplemented or amended by
our Quarterly Reports on Form 10-Q, which we urge investors to consider. We undertake no obligation
to publicly release revisions in such forward-looking statements that may be made to reflect events
or circumstances after the date hereof or to reflect the occurrences of unanticipated events or
circumstances, except as otherwise required by securities and other applicable laws.
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We are a pharmaceutical company focusing on the development and commercialization of
innovative therapeutic products based on our proprietary molecular biology-based drug delivery
technology for delivering both large and small molecule drugs across mucosal barriers, initially
the nasal mucosa, and small interfering RNA (siRNA) therapeutics. Using our intranasal
technology, we create or utilize novel formulation components or excipients that can reversibly
open tight junctions between cells in various tissues and thereby allow therapeutic drugs to
reach the blood stream. Tight junctions are cell-to-cell connections in various tissues of the
body, including the epithelial layer of the intranasal mucosa, the gastrointestinal tract, and the
blood brain barrier. They function to provide barrier integrity and to regulate the transport and
passage of molecules across these natural boundaries.
We believe our intranasal drug delivery technology could potentially offer advantages over
injectable routes for the administration of large molecules such as peptides and proteins. These
advantages may include improved safety and clinical efficacy and increased patient compliance due
to the elimination of injection site pain and avoidance of injection site irritation. In addition,
we believe our intranasal drug delivery technology can potentially offer advantages over oral
administration by providing for faster absorption into the bloodstream, reduced side effects and
improved effectiveness by avoiding problems relating to gastrointestinal and liver metabolism.
Although some of our product candidates use our expertise outside this area, this technology is the
foundation of our intranasal drug delivery platform and we are using it to develop commercial
products with collaboration partners or, in select cases, we internally develop, manufacture and
commercialize our products.
Our 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 expressed in inflammation, viral respiratory infections and other diseases.
Our goal is to become a leader in both the development and commercialization of innovative,
intranasal drug delivery products and technologies and in therapeutic RNAi. Key elements of our
strategy include:
| Applying Our Tight Junction Technology and Other Drug Delivery Methods to Product Candidates. We will focus our research and development efforts on product candidates, including, peptides, large molecules, small molecules and therapeutic siRNA, where our proprietary technologies utilizing tight junctions may offer clinical advantages such as improved safety and clinical efficacy or increased patient compliance due to elimination of injection site pain and avoidance of injection site irritation. We will also continue to search for applications of our tight junction technology to improve other forms of drug delivery, including oral, pulmonary and intravenous delivery. | ||
| Pursuing Collaborations with Pharmaceutical and Biotechnology Companies. We will continue to try to establish strategic collaborations with pharmaceutical and biotechnology companies. Typically, we collaborate with partners to commercialize our product candidates by utilizing their research and development, regulatory compliance, marketing and distribution capabilities. We may 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 even currently marketed. We intend to 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. | ||
| Strategically Developing and Commercializing Product Candidates on Our Own. In select cases where we deem it to be strategically advantageous to us, we plan to internally develop, manufacture and distribute our products. | ||
| Utilizing 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 competitors to replicate easily. These capabilities give us competitive advantages including the ability to prepare the chemistry, manufacturing and controls section of the new drug application (the NDA) filing with the U.S. Food and Drug Administration (the FDA) and 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. |
We are engaged in a variety of research, preclinical and clinical development activities to
identify and develop viable product candidates in therapeutic areas including osteoporosis,
obesity, pain, antivirals, inflammation and metabolic diseases. 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
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development efforts, especially in the pre-clinical area, and have been acquiring and
developing an RNAi IP estate and expanding our RNAi pipeline in multiple therapeutic areas. As of
September 30, 2006, we had 29 patents issued and 281 patent applications filed to protect our
proprietary technologies.
As of September 30, 2006, we had an accumulated deficit of $131.8 million and expect
additional operating losses in the future as we continue our research and development activities.
Our development efforts and the future revenues from sales of these products are expected to
generate contract research revenues, milestone payments, license fees, patent-based royalties and
manufactured product sales for us. As discussed elsewhere, in February 2006, we received a $10.0
million license fee from P&G and in June 2006 we received a $7.0 million milestone payment from
P&G. We expect to receive additional contractual payments in 2006 from P&G under the February 2006
license agreement.
Procter & Gamble Partnership
On January 27, 2006, we entered into a Product Development and License Agreement with P&G to
develop and commercialize our PTH(1-34) nasal spray for the treatment of osteoporosis. Clinical and
non-clinical studies on PTH(1-34) nasal spray are being completed in preparation for Phase III
clinical development. Under terms of the agreement, we have granted P&G rights to the worldwide
development and commercialization of PTH(1-34) nasal spray in exchange for an upfront fee, research
and development expense reimbursements and the potential for future milestone payments and
royalties on product sales.
Payments include a $10 million license fee received upon execution of the agreement, a $7
million milestone fee received in June 2006 and the potential for additional contractual payments
of up to $15 million during the remainder of 2006. The $10 million initial payment received in has
been recorded as deferred revenue and is being amortized into revenue over the estimated
development period. The $7 million milestone payment was recognized in full as revenue in the three
months ended June 30, 2006. In total, milestone payments could reach $577 million over the life of
the project depending upon the successful continuation of the development program, completion of
specified development, regulatory and commercialization goals, although there can be no assurance
that any such milestones will be achieved. Under the agreement, upon commercialization we are
eligible to receive double-digit percentage patent-based royalties, with the rate escalating upon
the achievement of certain sales levels.
We will jointly develop PTH(1-34) nasal spray with P&G and will be reimbursed by P&G for
development activities we perform under the agreement. P&G will assume responsibility for clinical
and non-clinical studies and regulatory approval while we will be responsible for the chemistry,
manufacturing and controls sections of regulatory submissions. In June 2006 we announced an
agreement with P&G to manufacture and supply PTH(1-34) nasal spray for both clinical and commercial
product of this investigational treatment for osteoporosis. Under terms of the supply agreement,
Nastech will be the exclusive manufacturer of the PTH(1-34) nasal spray and will manufacture the
product and supply it to P&G at a transfer price that includes a manufacturing profit if the
product is approved by the FDA. P&G will direct worldwide sales, marketing, and promotion of
PTH(1-34) nasal spray.
PTH(1-34), a part of the naturally occurring human parathyroid hormone that helps regulate
calcium and phosphorus metabolism and causes bone growth is the same active ingredient that is
being marketed as an injectable product, Forteo® by Eli Lilly and Company (Lilly). We have
developed a proprietary intranasal formulation of PTH(1-34) and as of September 30, 2006 have filed
ten U.S. patent applications containing an aggregate of 317 claims, and one Patent Cooperation
Treaty (PCT) Application.
We launched the clinical program for PTH(1-34) intranasal spray in 2004 and have completed
four Phase I clinical trials. In March 2005, we met with the FDA at which time they advised us
that, based on their current interpretation of FDA regulations, we may submit a Section 505(b)(2)
application for our PTH(1-34) intranasal spray. The 505(b)(2) pathway is a regulatory pathway for
certain drugs that are already approved and on the market, but for which a change in dose, a change
in indication, or a change in delivery route is being pursued. Through the 505(b)(2) process, the
FDA can use their administrative findings of safety and efficacy of another sponsors NDA, in this
case, Forteo®, to allow us to conduct a limited pre-clinical and clinical program, which we believe
will shorten the timeline for the achievement of full commercialization and reduce the cost for
developing the program. Once we submit our 505(b)(2) application, the FDA will review it as it does
any other application.
Amylin Pharmaceuticals, Inc. In June 2006, we announced an agreement with Amylin
Pharmaceuticals, Inc. (Amylin) to develop a nasal spray formulation of exenatide for the
treatment of diabetes. Preclinical studies of the formulation have been completed in preparation
for initiating studies in human subjects. Amylin filed an
Investigational New Drug application (IND) with the
FDA in July 2006 to allow clinical trials to begin, and began clinical trials in the three month
period ended September 30, 2006.
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Under terms of the agreement, we will receive milestone payments and royalties on product
sales. If the development program is successful and the product continues to move forward,
milestone payments could reach up to $89 million in total, based on specific development,
regulatory, and commercialization goals. Royalty rates escalate with product success.
We and Amylin will jointly develop the nasal spray formulation utilizing our proprietary nasal
delivery technology, and Amylin will reimburse us for any development activities performed by us
under the agreement. Amylin has overall responsibility for the development program including
clinical, non-clinical and regulatory activities, while our efforts will focus on drug delivery and
chemistry, manufacturing and controls (CMC) activities. If a supply agreement is reached between
the companies, we may supply commercial product to Amylin and their exenatide collaboration
partner, Eli Lilly and Company, however, there can be no assurance that such a supply agreement
will be executed.
Par Pharmaceutical Partnership
Under our collaborative arrangement with Par Pharmaceutical Inc. (Par Pharmaceutical)
executed in October 2004, we granted Par Pharmaceutical the exclusive U.S. distribution and
marketing rights to our generic calcitonin-salmon nasal spray. Under the terms of the agreement
with Par Pharmaceutical, we will obtain FDA approval, manufacture and supply finished
calcitonin-salmon nasal spray product to Par Pharmaceutical. Par Pharmaceutical will distribute the
product in the United States. The financial terms of the agreement include milestone payments,
product transfer payments for manufactured product and profit sharing upon commercialization.
In December 2003, we submitted to the FDA an Abbreviated New Drug Application (ANDA) for a
calcitonin-salmon nasal spray for the treatment of osteoporosis, and in February 2004, the FDA
accepted our ANDA for the product for review with no request for additional clinical studies. To
date, the FDA has conducted Pre-Approval Inspections (PAIs) of both of our nasal spray
manufacturing facilities and has informed us the facilities were approved for supplying
calcitonin-salmon nasal spray. On September 2, 2005, a citizens petition was filed with the FDA
requesting that the FDA not approve the ANDA as submitted prior to additional studies for safety
and bioequivalence. On October 13, 2005, we filed a response requesting that FDA deny this
citizens petition on the grounds that no additional information was necessary from a scientific or
medical basis and that such additional information is not required under the law. On March 15,
2006, the petitioner submitted an additional request to the FDA in response to our assertions in
our October 13, 2005 submission to the FDA. On May 11, 2006 we filed an additional response
requesting that the FDA deny the citizens petition.
In addition, Apotex, Inc. (Apotex) has filed a generic application for its nasal
calcitonin-salmon product with a filing date that has priority over our ANDA for our
calcitonin-salmon nasal spray and which prevents us from marketing our product until 180 days after
Apotex commences marketing its product. In November 2002, Novartis AG (Novartis) brought a patent
infringement action against Apotex claiming that Apotexs nasal calcitonin-salmon product infringes
on Novartis patents, seeking damages and requesting injunctive relief. That action is still
pending. We are unable to predict what, if any, effect the Novartis action will have on Apotexs
ability or plans to commence marketing its product. At this time we are not able to determine
whether or not the citizens petition will delay the FDAs approval of our ANDA, nor can we
determine when, if at all, Apotex will commence marketing its product.
On July 10, 2006, we received written notification from the FDA stating that our ANDA for
nasal calcitonin-salmon was not approvable at this time. The FDA expressed a concern relating to
the potential for immunogenicity that might result from a possible interaction between
calcitonin-salmon and chlorobutanol, the preservative in the formulation, although no allergic
reactions have been observed in any of the clinical trials conducted by us and other existing
marketed nasal spray products contain chlorobutanol as the preservative. On September 29, 2006, we
announced that we had submitted a complete response to the FDAs Office of Generic Drugs regarding
the potential for immunogenicity that might result from a possible interaction between
calcitonin-salmon and chlorobutanol. The FDA has accepted our submission for review, indicating that the generic division of the FDA has
maintained jurisdiction of our filing. Furthermore, the FDA has indicated that our response is
classified as a major amendment to the ANDA, and we therefore expect that the FDA will take at
least six months to complete its review of our submission. If we are not successful at keeping this application as an
ANDA then a 505(b)(2) NDA may be pursued or the application may be withdrawn. At this time we are
not able to determine when, if at all, the Companys calcitonin product will receive marketing
approval from the FDA.
Our formulation of calcitonin-salmon nasal spray was specifically developed to be similar to
Novartis currently marketed calcitonin-salmon nasal spray, Miacalcin®, in order to submit the
application as an ANDA. Thus, our formulation does not utilize our
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advanced tight junction drug delivery technology, which is currently being used in development
of our proprietary pipeline of peptide and protein therapeutics.
Merck Partnership/PYY
The strategic collaboration that we entered into with Merck in September 2004 for PYY was
terminated on March 1, 2006. Under the agreement, Nastech reacquired its rights in the PYY program.
We have continued PYY product development on our own, and on August 14, 2006, we announced the
initiation of a dose ranging study designed to evaluate the pharmacokinetic parameters, appetite,
food intake and safety of various doses of Nastechs PYY nasal spray in obese subjects.
RNAi Technology and Intellectual Property Acquisitions
We are also applying our drug delivery technology to a promising new class of therapeutics
based on RNA interference (RNAi). Small interfering RNAs (siRNAs) are double-stranded RNA
molecules that are able to silence specific genes and reduce the amount of protein these genes
produce. The specific protein may be involved in causing a disease or necessary for the replication
of a pathogenic virus. The therapeutic use of RNAi in this manner requires the ability to deliver
siRNA-based drugs inside the cells where the target proteins are produced. We have continued our
research and development program to enhance the delivery of this potential new class of therapeutic
drugs and have strengthened our RNAi development strategy through the acquisition of key
technologies, IP, and licensing agreements.
Alnylam. We entered into a license agreement on July 20, 2005 with Alnylam Pharmaceuticals,
Inc. (Alnylam), a biopharmaceutical company focused on developing RNAi based drugs, pursuant to
Alnylams InterfeRx licensing program. Under the license, we acquired the exclusive rights to
discover, develop and commercialize RNAi therapeutics directed against TNF-alpha, a protein
associated with inflammatory diseases including rheumatoid arthritis and certain chronic diseases.
Under our agreement with Alnylam, we paid an initial license fee to Alnylam, and we are obligated
to pay annual and milestone fees and royalties on sales of any products covered by the license
agreement.
Galenea Corp./MIT. We have expanded our RNAi pipeline by initiating an RNAi therapeutics
program targeting influenza and respiratory diseases. In connection with this new program, in
February 2006 we acquired Galeneas RNAi IP estate and other technologies. The IP acquired from
Galenea includes patent applications licensed from MIT that have early priority dates in the
antiviral RNAi field focused on viral respiratory infections, including influenza, rhinovirus, and
other respiratory diseases. We also acquired Galeneas research and IP relating to pulmonary drug
delivery technologies for siRNA. Additionally, we assumed Galeneas awarded and pending grant
applications from the National Institute of Allergy and Infectious Diseases, a division of the
National Institutes of Health, and the Department of Defense to support the development of
RNAi-based antiviral drugs.
RNAi-based therapeutics offer potentially effective treatments for a future influenza
pandemic, which is an urgent global concern. This program complements our current TNF-alpha RNAi
program targeting inflammation, since a consequence of influenza infection can be life-threatening
respiratory and systemic inflammation, caused by excess TNF-alpha production.
The lead siRNA product candidate licensed from Galenea, G00101, has demonstrated efficacy
against multiple influenza strains, including avian flu strains (H5N1) in animals. The development
of siRNA targeting sequences that are highly conserved across all flu genomes, including avian and
others having pandemic potential, have a reduced potential of drug resistance and is a novel
approach to the development of new therapies against influenza viruses. We believe G00101
represents a first-in-class approach to fight influenza and is one of the most advanced
anti-influenza compounds based on RNAi, although there can be no assurance that clinical trials
will be successful or that our research efforts with respect to G00101 or other siRNA targeting
sequences will lead to commercial products. G00101 can be administered by inhalation to maximize
delivery to the lung epithelium and has the potential to be delivered to the nasal cavity using our
tight junction modulation technology 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.
Government Grants. On August 29, 2006, we announced that the NIH awarded us a Phase 1 Small
Business Innovation Research (SBIR) grant to further our siRNA therapeutics to prevent and treat
influenza. The grant, in the amount of $0.4 million, was received
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by us in September 2006 and recognized as grant revenue during the three month period ended
September 30, 2006. On September 26, 2006, we announced that the NIH awarded us a $1.9 million
Research Project (R01) grant to prevent and treat influenza.
Cash Position and Recent Financings
As of September 30, 2006, we had approximately $56.4 million in cash, cash equivalents and
short-term investments, including approximately $2.2 million in restricted cash and short-term
investments. We believe, although there can be no assurance, that our current cash position
provides us with adequate working capital for at least the next 12 months, or longer depending upon
the degree to which we exploit our various current opportunities that are in the pipeline and the
success of our collaborative arrangements. This belief is based, in part, on the assumption that we
have completed and are planning to enter into various collaborations to accelerate our research and
development programs which will provide us with additional financing. To the extent these
collaborations do not proceed as planned, we may be required to reduce our research and development
activities or, if necessary and possible, raise additional capital from new investors or in the
public markets.
In June 2004, we completed the sale of 1,136,364 shares of our common stock, and warrants to
purchase up to 511,364 shares of common stock at an exercise price of $14.40 per share, pursuant to
our $30 million shelf registration statement that was declared effective by the SEC on January 14,
2004. The offering resulted in gross proceeds of approximately $12.5 million to us prior to the
deduction of fees and commissions of $229,000. The warrants vested on December 25, 2004, and are
exercisable until June 25, 2009. At September 30, 2006, the amount remaining available on this
shelf registration statement was approximately $10.1 million. On October 19, 2006, we filed a shelf
registration statement on Form S-3 for $125.0 million of common stock which includes the remaining
$10.1 million balance from one of our previous shelf registration statements. As of the date of
this filing, the new $125.0 million shelf has not been declared effective by the SEC.
In December 2004, we completed the public offering of 4,250,000 shares of our common stock at
a price of $13.50 per share pursuant to our $80 million shelf registration statement that was
declared effective by the SEC on October 8, 2004. The offering resulted in gross proceeds of
approximately $57.4 million to us, prior to the deduction of fees and commissions of $4.5 million.
In August 2005, we completed a public offering of 1,725,000 shares of our common stock at a price
of $13.50 per share pursuant to our $80 million shelf registration statement and a $0.7 million
post effective amendment filed on August 25, 2005 pursuant to Rule 462(b) of the Securities Act.
The offering resulted in gross proceeds of approximately $23.3 million to the Company, prior to the
deduction of fees and commissions of approximately $1.7 million. At September 30, 2006, no shares
remained available on this shelf registration statement.
Critical Accounting Policies and Estimates
We prepare our consolidated financial statements in conformity with U.S. generally accepted
accounting principles. As such, we are required to make certain estimates, judgments and
assumptions that we believe are reasonable based upon the information available. These estimates
and assumptions affect the reported amounts of assets and liabilities at the date of the
consolidated financial statements and the reported amounts of revenue and expenses during the
periods presented. Actual results could differ significantly from those estimates under different
assumptions and conditions. We believe that the following discussion addresses our most critical
accounting estimates which are those that are most important to the portrayal of our financial
condition and results of operations and which require our most difficult and subjective judgments,
often as a result of the need to make estimates about the effect of matters that are inherently
uncertain. Other key estimates and assumptions that affect reported amounts and disclosures include
depreciation and amortization, inventory reserves, asset impairments, requirements for and
computation of allowances for doubtful accounts, allowances for product returns, expense accruals
and goodwill valuation. We also have other policies that we consider key accounting policies;
however, these policies do not meet the definition of critical accounting estimates, because they
do not generally require us to make estimates or judgments which are difficult or subjective.
Revenue Recognition
Most of our revenues result from research and licensing arrangements. These research and
licensing arrangements may include upfront non-refundable payments, development milestone payments,
payments for research and development services performed, revenue from product manufacturing and
product sales royalties or revenue. Our revenue recognition policies are based on the requirements
of SEC Staff Accounting Bulletin No. 104 Revenue Recognition, and, for contracts with multiple
deliverables, we allocate arrangement consideration based on the fair value of the elements under
guidance from Emerging Issues Task Force Issue 00-
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21 (EITF 00-21), Revenue Arrangements with Multiple Deliverables. Under EITF 00-21,
revenue arrangements with multiple deliverables may be divided into separate units of accounting
such as product development and contract manufacturing. Revenue is allocated to these units based
upon relative fair values with revenue recognition criteria considered separately for each unit.
Nonrefundable upfront technology license fees, for product candidates where we are providing
continuing services related to product development, are deferred and recognized as revenue over the
development period or as we provide the services required under the agreement. The ability to
estimate total development effort and costs can vary significantly for each product candidate due
to the inherent complexities and uncertainties of drug development. If we cannot estimate the costs
to complete development, but can estimate an expected NDA filing date, we will recognize license
fee revenue ratably through the NDA filing date. If we are unable to reasonably estimate either
total costs to complete development or an expected NDA filing date (performance period), we will
defer revenue recognition until one of those estimates can be made or the project is discontinued.
Milestones, in the form of additional license fees, typically represent nonrefundable payments
to be received in conjunction with the achievement of a specific event identified in the contract,
such as initiation or completion of specified clinical development activities. We believe that a
milestone represents the culmination of a distinct earnings process when it is not associated with
ongoing research, development or other performance on our part. We recognize such milestones as
revenue when they become due and collection is reasonably assured. When a milestone does not
represent the culmination of a distinct earnings process, revenue is either recognized when the
earnings process is deemed to be complete or in a manner similar to that of an upfront technology
license fee.
The timing and amount of revenue that we recognize from licenses of technology, either from
upfront fees or milestones where we are providing continuing services related to product
development, is dependent upon our estimates of filing dates or development costs. As product
candidates move through the development process, it is necessary to revise these estimates to
consider changes to the product development cycle, such as changes in the clinical development
plan, regulatory requirements, or various other factors, many of which may be outside of our
control. The impact on revenue of changes in our estimates and the timing thereof, is recognized
prospectively, over the remaining estimated product development period.
Royalty revenue is generally recognized at the time of product sale by the licensee.
Revenue from research and development services performed is generally received for services
performed under collaboration agreements, and is recognized as services are performed. Payments
received in excess of amounts earned are recorded as deferred revenue.
Product sales revenue is recognized when the manufactured goods are shipped to the purchaser
and title has transferred.
Under the guidance of EITF Issue 01-14, reimbursements received for direct out-of-pocket
expenses related to research and development costs are recorded as revenue in the income statement
rather than as a reduction in expenses.
Government grant revenue is recognized during the period qualifying expenses are incurred for
the research that is performed as set forth under the terms of the grant award agreements, and when
there is reasonable assurance that we will comply with the terms of the grant and that the grant
will be received.
Stock-Based Compensation
On January 1, 2006, we adopted Statement of Financial Accounting Standards No. 123R,
Share-Based Payment (Revised 2004), which requires the measurement and recognition of
compensation for all stock-based awards made to employees and directors including stock options and
employee stock purchases under a stock purchase plan based on estimated fair values. SFAS 123R
supersedes previous accounting under Accounting Principles Board Opinion No. 25, Accounting for
Stock Issued to Employees for periods beginning in fiscal 2006. In March 2005, the Securities and
Exchange Commission issued Staff Accounting Bulletin No. 107 relating to application of SFAS 123R.
We have applied the provisions of SAB 107 in our adoption of SFAS 123R.
We adopted SFAS 123R using the modified prospective transition method, which requires the
application of the accounting standard as of January 1, 2006. In accordance with the modified
prospective transition method, our condensed consolidated financial statements for periods prior to
January 1, 2006 have not been restated to reflect this change. Stock-based compensation recognized
during current periods is based on the value of the portion of the stock-based award that will vest
during the period, adjusted for
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expected forfeitures. Stock-based compensation recognized in our condensed consolidated
financial statements for the nine months ended September 30, 2006 includes compensation cost for
stock-based awards granted prior to, but not fully vested as of, December 31, 2005 and stock-based
awards granted subsequent to December 31, 2005. The compensation cost for awards granted prior to
January 1, 2006 is based on the grant date fair value estimated in accordance with the pro forma
provisions of SFAS 123 while awards granted after December 31, 2005 follow the provisions of SFAS
123R to determine the grant date fair value and compensation cost. Compensation cost for all
stock-based awards is recognized using the straight-line method over the vesting period.
The adoption of SFAS 123R resulted in a cumulative benefit from accounting change of $291,000
as of January 1, 2006, which reflects the net cumulative impact of estimating future forfeitures in
the determination of period expense for restricted stock awards, rather than recording forfeitures
when they occur as previously permitted.
Upon adoption of SFAS 123R we continued to use the Black-Scholes option pricing model as our
method of valuation for stock-based awards. Our determination of the fair value of stock-based
awards on the date of grant using an option pricing model is affected by our stock price as well as
assumptions regarding a number of highly complex and subjective variables. These variables include,
but are not limited to the expected life of the award, our expected stock price volatility over the
term of the award and actual and projected exercise behaviors. Although the fair value of
stock-based awards is determined in accordance with SFAS 123R and SAB 107, the Black-Scholes option
pricing model requires the input of highly subjective assumptions, and other reasonable assumptions
could provide differing results. The adoption of SFAS 123R will result in recognition of additional
non-cash stock-based compensation expense and, accordingly, will increase net loss in amounts which
likely will be considered material. Our stock-based compensation philosophy did not change with the
adoption of SFAS 123R. Since mid-2004, we have granted options and restricted stock to executive
management and directors, and restricted stock to employees. There was no acceleration of vesting
associated with the adoption of SFAS 123R. Our total unrecognized compensation cost related to
unvested stock options was approximately $3.9 million at September 30, 2006, and we expect to
recognize this cost over a weighted average period of approximately 1.5 years.
Income Taxes
A critical estimate is the full valuation allowance for deferred taxes that was recorded based
on the uncertainty that such tax benefits will be realized in future periods. To the extent we
achieve profitability such deferred tax allowance would be reversed.
Research and Development Costs
All research and development (R&D) costs are charged to operations as incurred. Our R&D
expenses consist of costs incurred for internal and external R&D. These costs include direct and
research-related overhead expenses. Clinical trial expenses, which are included in R&D expenses,
represent obligations resulting from our contracts with various clinical research organizations in
connection with conducting clinical trials for our product candidates. We recognize expenses for
these contracted activities based on a variety of factors, including actual and estimated labor
hours, clinical site initiation activities, patient enrollment rates, estimates of external costs
and other activity-based factors. We believe that this method best approximates the efforts
expended on a clinical trial with the expenses we record. We adjust our rate of clinical expense
recognition if actual results differ from our estimates.
When we acquire intellectual properties from others, the purchase price is allocated, as
applicable, between In-Process Research and Development (IPR&D), other identifiable intangible
assets and net tangible assets. Our policy defines IPR&D as the value assigned to those projects
for which the related products have not yet reached technological feasibility and have no
alternative future use. Determining the portion of the purchase price allocated to IPR&D requires
us to make significant estimates. The amount of the purchase price allocated to IPR&D is determined
by estimating the future cash flows of each project of technology and discounting the net cash
flows back to their present values. The discount rate used is determined at the acquisition date,
in accordance with accepted valuation methods, and includes consideration of the assessed risk of
the project not being developed to a stage of commercial feasibility. Amounts recorded as IPR&D are
charged to R&D expense upon acquisition.
Results of Operations
Revenue and cost of revenue
Our revenue consists of product sales and license and research fees. Revenue totaled
approximately $5.5 million and $23.7 million for the three month and nine month periods ended
September 30, 2006, increases of approximately $4.3 million and $17.5 million over the prior year
periods. The increases are due primarily to the revenue recognized under the collaboration
agreement with P&G including a portion of the $10.0 million license fee, revenue for R&D services
performed and recognition of a $7.0 million milestone
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payment. In addition, in the 2006 periods we recognized approximately $3.7 million in deferred
license fees as a result of the termination of our collaboration with Merck and revenue earned
under contracts with other collaborative partners over their estimated remaining development
periods. Estimated development periods may be revised over time based upon changes in clinical
development plans, regulatory requirements or other factors, many of which may be out of our
control. We recognized a $2.0 million payment from Questcor relating to the FDA approval of our
Nascobal® nasal spray product in the nine months ended September 30, 2005.
Our product revenue consists of sales of Nascobal® nasal gel and nasal spray. During the three
and nine month periods ended September 30, 2006, we recognized approximately $32,000 and $624,000
of product revenue, respectively. During the interim periods ended September 30, 2005, we did not
produce or ship any Nascobal® nasal gel or nasal spray under the supply agreement with Questcor.
Effective in October 2005, the distribution of our Nascobal® nasal gel and spray products has been
transferred from Questcor to QOL. Cost of product revenue as a percent of product revenue was
approximately 41% and 50% for the three and nine month periods ended September 30, 2006. We expect
to continue to receive product revenue under the QOL supply agreement.
The dollar and percentage increases in revenue may not be indicative of performance in future
periods. Additional information on our revenue is as follows:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2005 | 2006 | 2005 | 2006 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Product revenue, net |
$ | | $ | 32 | $ | | $ | 624 | ||||||||
License and research fees |
||||||||||||||||
Questcor FDA approval milestone payment |
| | 2,000 | | ||||||||||||
Revenue recognized under the terminated Merck agreements |
913 | | 2,789 | 3,741 | ||||||||||||
Revenue recognized under the P&G agreement |
| 4,752 | | 17,660 | ||||||||||||
Other license and research fees |
310 | 378 | 1,366 | 1,266 | ||||||||||||
License and research fees, total |
1,223 | 5,130 | 6,155 | 22,667 | ||||||||||||
Government grant revenue |
| 383 | | 383 | ||||||||||||
Total revenue |
$ | 1,223 | $ | 5,545 | $ | 6,155 | $ | 23,674 | ||||||||
Dollar increase |
$ | 4,322 | $ | 17,519 | ||||||||||||
Percentage increase |
353 | % | 285 | % |
Research and development
Research and development expense consists primarily of salaries and other personnel-related
expenses, costs of clinical trials, consulting and other outside service, laboratory supplies,
facilities costs, FDA filing fees, other costs and, in 2006 purchased In-Process Research and
Development expenses (IPR&D). Excluding purchased IPR&D, research and development expense by
project as a percentage of total research and development project expense, and total research and
development expense, are as follows:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2005 | 2006 | 2005 | 2006 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
PTH(1-34) |
17 | % | 33 | % | 15 | % | 29 | % | ||||||||
Tight Junctions and RNAi |
29 | % | 21 | % | 25 | % | 24 | % | ||||||||
Insulin |
| 10 | % | | 11 | % | ||||||||||
Influenza |
| 9 | % | | 8 | % | ||||||||||
Calcitonin |
18 | % | 5 | % | 30 | % | 7 | % | ||||||||
Peptide YY |
22 | % | 4 | % | 16 | % | 4 | % | ||||||||
Other R&D projects (1) |
14 | % | 18 | % | 14 | % | 17 | % | ||||||||
100 | % | 100 | % | 100 | % | 100 | % | |||||||||
Total R&D expense |
$ | 8,099 | $ | 10,483 | $ | 22,559 | $ | 26,956 | (2) | |||||||
Dollar increase |
2,384 | 4,397 | ||||||||||||||
Percentage increase |
29 | % | 19 | % |
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(1) | Other research and development projects include our feasibility projects, oral abuse-resistant opioid, morphine gluconate and other projects. | |
(2) | Excludes purchased in-process R&D from Galenea of approximately $4.1 million in the nine months ended September 30, 2006. We believe that presenting R&D expense without the Galenea transaction allows for better comparability between periods given the significance of the amount relative to total R&D expense. |
The 29% increase in research and development expense in the three month period ending
September 30, 2006 compared to the same period in 2005 resulted primarily from the following:
| Personnel-related expenses increased by approximately 44% to $4.9 million compared to $3.4 million in the prior year period due to an increase in headcount in support of our research and development programs and due to an increase of approximately $0.4 million in non-cash stock compensation. R&D headcount increased from 100 at September 30, 2005 to 151 at September 30, 2006. | ||
| Costs of clinical trials, consulting, outside services and laboratory supplies increased by approximately 23% to $3.2 million compared to $2.6 million in the prior year period due to purchases of active pharmaceutical ingredients used in our PTH and RNAi programs and clinical trials initiated for our PYY and insulin programs. | ||
| Facilities and equipment costs increased approximately 67% to $2.0 million from $1.2 million in the prior year period due to rent and related expenses on additional space leased and an increase in depreciation of equipment resulting from capital expenditures to acquire needed technical capabilities and to support increased capacity. | ||
| Research and development administrative expenses decreased by approximately 56% to $0.4 million from $0.9 million in the prior year period due to patent license fees incurred in 2005. |
The 19% increase in research and development expense (excluding purchased IPR&D) in the nine month
period ending September 30, 2006 compared to the same period in 2005 resulted primarily from the
following:
| Personnel-related expenses increased by approximately 48% to $13.9 million compared to $9.4 million in the prior year period due to an increase in headcount in support of our research and development programs and due to an increase of approximately $1.3 million in non-cash stock compensation. | ||
| Costs of clinical trials, consulting, outside services and laboratory supplies decreased by approximately 15% to $7.1 million compared to $8.4 million in the prior year period as the 2005 period included significant clinical trial expenses for calcitonin. | ||
| Facilities and equipment costs increased approximately 43% to $5.0 million from $3.5 million in the prior year period due to rent and related expenses on additional space leased and an increase in depreciation of equipment resulting from capital expenditures to acquire needed technical capabilities and to support increased capacity. | ||
| Research and development administrative expenses decreased by approximately 31% to $0.9 million from $1.3 million in the prior year period due to patent license fees incurred in 2005. |
Purchased IPR&D expenses, excluded from the table above but included in total research and
development expense, were approximately $4.1 million in the nine months ended September 30, 2006
compared to zero in the prior year period and related to purchased in-process research and
development costs from Galenea Corp. in the field of RNAi related to influenza.
We expect a continued increase in research and development expense from the amounts presented
in the table above which exclude purchased IPR&D expenses in the foreseeable future as we continue
to expand our research and development activities. These expenditures are subject to uncertainties
in timing and cost to completion. We test compounds in numerous preclinical studies for safety,
toxicology and efficacy. We then conduct early stage clinical trials for each drug candidate. If we
are not able to engage a collaboration partner prior to the commencement of later stage clinical
trials, or if we decide to pursue a strategy of maintaining commercialization rights to a program,
we may fund these trials ourselves. As we obtain results from trials, we may elect to discontinue
or delay clinical trials for certain products in order to focus our resources on more promising
products. Completion of clinical trials by us and our collaboration partners may take several years
or more, but the length of time varies substantially according to the type, complexity, novelty and
intended use of a drug candidate. The cost of clinical trials may vary significantly over the life
of a project as a result of differences arising during clinical development, including:
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| the number of sites included in the clinical trials; | ||
| the length of time required to enroll suitable patient subjects; | ||
| the number of patients that participate in the trials; | ||
| the duration of patient follow-up that seems appropriate in view of results; and | ||
| the number and complexity of safety and efficacy parameters monitored during the study. |
None of our current product candidates utilizing our intranasal drug delivery technology has
received FDA or foreign regulatory marketing approval, except Nascobal® nasal gel and nasal spray.
In order to achieve marketing approval, the FDA or foreign regulatory agencies must conclude that
our and our collaboration partners clinical data establishes the safety and efficacy of our drug
candidates. Furthermore, our strategy includes entering into collaborations with third parties to
participate in the development and commercialization of our products. In the event that the
collaboration partner has control over the development process for a product, the estimated
completion date would largely be under control of such partner. We cannot forecast with any degree
of certainty how such collaboration arrangements will affect our development spending or capital
requirements.
As a result of the uncertainties discussed above, we are often unable to determine the
duration and completion costs of our research and development projects or when and to what extent
we will receive cash inflows from the commercialization and sale of a product.
Sales and marketing
Sales and marketing expense consists primarily of salaries and other personnel-related
expenses, consulting, sales materials, trade shows and advertising. Total sales and marketing
expense and dollar and percentage changes are as follows:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2005 | 2006 | 2005 | 2006 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Total sales and marketing expense |
$ | 345 | $ | 505 | $ | 963 | $ | 1,335 | ||||||||
Dollar increase |
160 | 372 | ||||||||||||||
Percentage increase |
46 | % | 39 | % |
The increases in the three and nine month periods ended September 30, 2006 over the same
periods in 2005 resulted primarily from increased business development personnel costs and
increases in spending on market research, conference related activities, non-cash stock
compensation and business development efforts. We expect sales and marketing costs, which includes
business development staff and activities, to increase moderately in the foreseeable future to
support activities associated with partnering our drug candidates.
General and administrative
General and administrative expense consists primarily of salaries and other personnel-related
expenses to support our research and development activities, amortization of non-cash deferred
stock option and restricted stock compensation for general and administrative personnel and
non-employee board members, professional fees such as accounting and legal, corporate insurance and
facilities costs. Total general and administrative expense and dollar and percentage changes are as
follows:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2005 | 2006 | 2005 | 2006 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Total general and administrative expense |
$ | 2,019 | $ | 2,943 | $ | 6,949 | $ | 9,194 | ||||||||
Dollar increase |
924 | 2,245 | ||||||||||||||
Percentage increase |
46 | % | 32 | % |
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The increases in the three and nine month periods ended September 30, 2006 over the same
periods in 2005 were due primarily to increases in non-cash stock compensation of $0.3 million and
$1.1 million, respectively. The remaining increases were due to increased compensation-related
expenses related to the hiring of additional personnel supporting R&D and compliance activities,
legal fees, corporate insurance and annual and board meeting expenses. We expect general and
administrative expenses to remain stable or to increase in the foreseeable future, depending on the
growth of our research and development and other corporate activities.
Interest Income
The following table sets forth information on interest income, average funds available for
investment and average interest rate earned:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2005 | 2006 | 2005 | 2006 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Interest income |
$ | 496 | $ | 751 | $ | 1,321 | $ | 2,107 | ||||||||
Average funds available for investment |
$ | 59,800 | $ | 60,800 | $ | 61,400 | $ | 59,500 | ||||||||
Average interest rate, annualized |
3.3 | % | 5.1 | % | 2.9 | % | 4.7 | % |
The increase in interest income in the three and nine month periods ended September 30, 2006
over the 2005 periods was due primarily to increases in prevailing market interest rates in the
current year period.
Interest Expense
We incur interest expense on our capital leases and, formerly, on notes payable. The following
table sets forth information on interest expense, average borrowings and average interest rate
earned:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2005 | 2006 | 2005 | 2006 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Interest expense |
$ | 75 | $ | 162 | $ | 265 | $ | 405 | ||||||||
Average borrowings under capital leases and notes payable |
$ | 4,300 | $ | 7,600 | $ | 5,400 | $ | 6,300 | ||||||||
Average interest rate, annualized |
7.0 | % | 8.5 | % | 7.0 | % | 8.6 | % |
The increase in interest expense in the three and nine month periods ended September 30, 2006
is due to a combination of higher average borrowing rates and amounts borrowed during the 2006
periods compared to the 2005 periods. Interest rates on outstanding borrowings under the GE
Capital leases range from approximately 8% to approximately 11%.
Liquidity and Capital Resources
Cash Requirements
Our capital requirements consist primarily of the need for working capital, including funding
research and development activities and capital expenditures for the purchase of equipment. From
time to time, we may also require capital for investments involving acquisitions and strategic
relationships. We have an accumulated deficit of approximately $131.8 million as of September 30,
2006, and expect additional operating losses in the foreseeable future as we continue to expand our
research and development activities. In addition, we are planning to enter into various
collaborations in furtherance of our research and development programs. To the extent these
collaborations do not proceed as planned, we may be required to reduce our research and development
activities or, if necessary and possible, raise additional capital from new investors or in the
public markets.
Sources and Uses of Cash
We have financed our operations primarily through the sale of common stock and warrants
through private placements and in the public markets, revenues received from our collaboration
partners, and to a lesser extent equipment financing facilities and notes payable.
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In December 2003, we filed a shelf registration statement with the SEC, which was declared
effective by the SEC in January 2004, pursuant to which we may issue common stock or warrants, up
to an aggregate of $30 million. In September 2004, we filed another shelf registration statement
with the SEC, which was declared effective by the SEC in October 2004, pursuant to which we may
issue common stock, warrants or debt securities, up to an aggregate of $80 million. These shelf
registration statements enable us to raise capital from the offering of securities covered by the
shelf registration statements, as well as any combination thereof, from time to time and through
one or more methods of distribution, subject to market conditions and our cash needs.
In June 2004, we completed the sale of 1,136,364 shares of our common stock, and warrants to
purchase up to 511,364 shares of common stock at an exercise price of $14.40 per share, pursuant to
our $30 million effective shelf registration statement. The offering resulted in gross proceeds of
approximately $12.5 million to us prior to the deduction of fees and commissions of $229,000. The
warrants vested on December 25, 2004, and are exercisable until June 25, 2009. At September 30,
2006, the amount remaining available on this shelf registration statement was approximately $10.1
million. In December 2004, we completed the public offering of 4,250,000 shares of our common stock
at a price of $13.50 per share pursuant to our $80 million shelf registration statement that was
declared effective by the SEC in October 2004. The offering resulted in gross proceeds of
approximately $57.4 million to us, prior to the deduction of fees and commissions of $4.5 million.
On August 30, 2005, we completed a public offering of 1,725,000 shares of our common stock at a
price of $13.50 per share pursuant to our $80 million shelf registration statement and a $0.7
million post effective amendment filed on August 25, 2005 pursuant to Rule 462(b) of the Securities
Act. The offering resulted in gross proceeds of approximately $23.3 million to the Company, prior
to the deduction of fees and commissions of approximately $1.7 million. At September 30, 2006, the
amount remaining available on this shelf registration statement was zero. On October 19, 2006, we
filed a shelf registration statement on Form S-3 for $125.0 million of common stock which includes
the remaining $10.1 million balance from one of our previous shelf registration statements. As of
the date of this filing, the new $125.0 million shelf has not been declared effective by the SEC.
In the nine months ended September 30, 2006, we received approximately $5.5 million from the
exercise of common stock warrants and approximately $3.1 million from the exercise of common stock
options.
Our research and development efforts and collaborative arrangements with our partners enable
us to generate contract research revenues, milestone payments, license fees, royalties and
manufactured product sales for us.
| Under our collaborative arrangement with P&G, we received an initial cash payment of $10 million in February 2006. The $10 million initial payment has been recorded as deferred revenue and is being amortized into revenue over the estimated development period. In the three months ended June 30, 2006 we received and recognized a $7.0 million milestone payment from P&G. The arrangement includes the potential for additional contractual payments of up to $15 million during the remainder of 2006. In total, contractual payments could reach $577 million over the life of the project depending upon the successful completion of specified development, regulatory and commercialization goals, although there can be no assurance that any such milestones will be achieved. Under our agreement with P&G, we are eligible to receive double-digit patent-based royalties, with the rate escalating upon the achievement of certain sales levels. | ||
| Under our collaborative arrangement with Merck, we received an initial cash payment of $5 million in October 2004. The $5 million initial payment was being amortized over the estimated development period until the collaboration with Merck for PYY was terminated on March 1, 2006, at which time the $3.7 million balance of the unamortized license payment was recognized as revenue. Under the agreement, Nastech reacquired its rights in the PYY program. | ||
| Under our collaborative arrangement with Par Pharmaceutical, we received an initial cash payment in October 2004 which was amortized over the estimated development period. | ||
| Under our supply agreement with Questcor, in February 2005 we received and recognized a payment of $2 million from Questcor upon FDA approval of a New Drug Application for the Nascobal® nasal spray product. On October 17, 2005, with our consent, Questcor assigned all of its rights and obligations under the Questcor Asset Purchase and Supply Agreements dated June 2003 to QOL. We received $2.0 million from Questcor on October 19, 2005 in consideration for our consent to the assignment and in connection with us entering into an agreement with QOL which modified certain terms of the Asset Purchase and Supply Agreements. The $2.0 million is being recognized ratably over the five-year life of the QOL agreement. QOL has assumed Questcors obligation to pay us an additional $2.0 million contingent upon issuance of a U.S. patent for the Nascobal® nasal spray product. |
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Total sources and uses of cash for the periods indicated are as follows:
Nine Months Ended | ||||||||
September 30, | ||||||||
2005 | 2006 | |||||||
(dollars in thousands) | ||||||||
Cash used in operating activities |
$ | (23,369 | ) | $ | (7,978 | ) | ||
Cash used in investing activities |
(14,790 | ) | (9,171 | ) | ||||
Cash provided by financing activities |
28,273 | 11,461 | ||||||
Net decrease in cash and cash equivalents |
$ | (9,886 | ) | $ | (5,688 | ) | ||
Our operating activities used cash of $8.0 million in the first nine months of 2006 compared
to $23.4 million in the first nine months of 2005. Cash used in operating activities relates
primarily to funding net losses, adjusted by changes in balance sheet account balances and
partially offset by non-cash charges related to depreciation and amortization of property and
equipment and stock compensation. Deferred revenue provided approximately $3.2 million in operating
cash in the current period due primarily to the recording of a $10 million 2006 receipt from P&G as
deferred revenue, compared to using approximately $1.6 million in the prior year period as a result
of amortization of Merck and Par deferred revenue. We received a $383,000 government grant in the
2006 period compared to zero in the 2005 period. We expect to use cash for operating activities in
the foreseeable future as we continue our research and development activities.
Our investing activities used cash of $9.2 million in the first nine months of 2006 compared
to $14.8 million in the first nine months of 2005. Changes in cash from investing activities are
due primarily to purchases of short-term investments, net of maturities and investments in property
and equipment. We expect to continue to invest in our research and development infrastructure,
including the purchase of equipment to support our research and development activities.
Our financing activities provided cash of $11.5 million in the first nine months of 2006
compared to providing cash of $28.3 million in the first nine months of 2005. Cash provided in the
2006 period primarily resulted from proceeds from the exercise of common stock options of
approximately $3.1 million and common stock warrants of approximately $5.5 million. During the nine
months ended September 30, 2006, we drew down approximately $6.3 million on a capital lease
facility. During the nine months ended September 30, 2005, we repaid approximately $8.4 million on
our Revolving Line of Credit and terminated the facility, and we drew down approximately $2.9
million on a capital lease facility. As a result of the loan payoff in the 2005 period, our
restricted cash balance decreased by $8.0 million.
Liquidity
We had a working capital (current assets minus current liabilities) surplus of $48.9 million
as of September 30, 2006 and $55.2 million as of December 31, 2005. As of September 30, 2006, we
had approximately $56.4 million in cash, cash-equivalents and short-term investments, including
approximately $2.2 million in restricted cash and short-term investments. Our cash position for the
nine months ended September 30, 2006 decreased by approximately $5.7 million. During the comparable
2005 period, our cash position decreased by approximately $9.9 million. Revenue recognized in the
nine months ended September 30, 2006 was higher than that of the prior year period and the current
period net loss was lower than that of the prior year period, primarily due to the uneven timing of
revenue recognition of contractual payments, period and higher expenses in 2006 compared to
2005. Additionally we had higher levels of warrant and option exercises in 2006 compared to 2005. In
light of these factors, we caution that the current period results may not be indicative of
performance in future periods. We believe, although there can be no assurance, that our current
cash position provides us with adequate working capital for at least the next 12 months, or longer
depending upon the degree to which we exploit our various current opportunities that are in the
pipeline and the success of our collaborative arrangements. This belief is based, in part, on the
assumption that we have completed and are planning to enter into various collaborations to
accelerate our research and development programs which will provide us with additional financing.
To the extent these collaborations do not proceed as planned, we may be required to reduce our
research and development activities or, if necessary and possible, raise additional capital from
new investors or in the public markets.
As of September 30, 2006, the unused portion of our 2006 capital lease credit line of $7.5
million for financing equipment and leasehold assets was approximately $1.3 million.
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Contractual Obligations
Our contractual obligations have changed since December 31, 2005 to September 30, 2006 as
follows:
| At September 30, 2006 our operating lease obligations increased to approximately $30.4 million (through February 2016) from approximately $19.3 million at December 31, 2005. This is due to a new facility lease signed in 2006 adding approximately $12.6 million in rental payments through February 2016, partially offset by approximately $1.5 million in rents paid during the nine months ended September 30, 2006. | ||
| Our capital lease obligations increased by approximately $4.9 million to approximately $11.2 million (including future interest payments) at September 30, 2006 due to approximately $7.5 million (including approximately $1.2 million of future interest payments) in new leases funded offset by approximately $2.6 million in payments (including $0.4 million in interest payments made during the nine months ended September 30, 2006. | ||
| Our purchase obligations increased by approximately $2.9 million from approximately $0.6 million to approximately $3.5 million at September 30, 2006 due to purchase order activity (primarily for PTH(1-34)) during the nine months ended September 30, 2006. |
Off-Balance Sheet Arrangements
As of September 30, 2006, we did not have any off-balance sheet arrangements, as defined in
Item 303(a)(4)(ii) of SEC Regulation S-K.
ITEM 3 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to financial market risk resulting from changes in interest rates. We do not
engage in speculative or leveraged transactions, nor do we utilize derivative financial
instruments. We invest in interest-bearing instruments that are classified as cash and cash
equivalents, restricted cash and short-term investments. Our investment policy is to manage our
total invested funds to preserve principal and liquidity while maximizing the return on the
investment portfolio through the full investment of available funds. We invest in debt instruments
of U.S. Government agencies and, prior to October 5, 2005, also invested in high quality corporate
issues (Standard & Poors double AA rating and higher). Unrealized gains or losses related to
fluctuations in interest rates are reflected in other comprehensive income or loss. Based on our
cash and cash equivalents, restricted cash and short-term investments balances at September 30,
2006, a 100 basis point increase or decrease in interest rates would result in an increase or
decrease of approximately $550,000 to interest income on an annual basis.
ITEM 4 CONTROLS AND PROCEDURES
(a) Disclosure Controls and Procedures. As of the end of the period covered by this Quarterly
Report on Form 10-Q, the Company carried out an evaluation, under the supervision and with the
participation of senior management, including the Companys Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the design and operation of its disclosure controls and
procedures. Based upon that evaluation, the Companys Chief Executive Officer and Chief Financial
Officer concluded that the Companys disclosure controls and procedures are effective for
gathering, analyzing and disclosing the information that the Company is required to disclose in
reports filed under the Securities Exchange Act of 1934, as amended.
(b) Internal Control Over Financial Reporting. There have been no changes in the Companys
internal controls over financial reporting or in other factors during the fiscal quarter ended
September 30, 2006, that materially affected, or are reasonably likely to materially affect, the
Companys internal control over financial reporting subsequent to the date the Company carried out
its most recent evaluation.
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PART II OTHER INFORMATION
ITEM 1A RISK FACTORS
The disclosures in Item 1A Risk Factors in our annual report on Form 10-K for the year ended
December 31, 2005 (the 10-K) under the captions we are dependent on our collaborative
arrangement 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 on page 26 of the 10-K, is hereby supplemented by adding the
following at the end of such disclosure:
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.
ITEM 6 EXHIBITS
The exhibits required by this item are set forth in the Exhibit Index attached hereto.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned, duly authorized, in Bothell, State of
Washington, on November 1, 2006.
NASTECH PHARMACEUTICAL COMPANY INC. |
||||
By: | /s/ Steven C. Quay | |||
Steven C. Quay, M.D., Ph.D. | ||||
Chairman of the Board, President and Chief Executive Officer | ||||
By: | /s/ Philip C. Ranker | |||
Philip C. Ranker | ||||
Chief Financial Officer |
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EXHIBIT INDEX
Exhibit | ||
No. | Description | |
2.1
|
Agreement and Plan of Reorganization, dated August 8, 2000, among the Company, Atossa Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of the Company, and Atossa HealthCare, Inc. (filed as Exhibit 2.1 to the Companys Current Report on Form 8-K dated August 8, 2000, and incorporated herein by reference). | |
2.2
|
Asset Purchase Agreement, dated September 30, 2002, with Schwarz Pharma, Inc.(filed as Exhibit 2.1 to the Companys Current Report on Form 8-K dated September 30, 2002 and incorporated herein by reference). | |
3.1
|
Restated Certificate of Incorporation of the Company dated July 20, 2005 (filed as Exhibit 3.1 to our Current Report on Form 8-K dated July 20, 2005, and incorporated herein by reference). | |
3.2
|
Amended and Restated Bylaws of the Company dated August 11, 2004 (filed as Exhibit 3.10 to our Registration Statement on Form S-3, File No. 333-119429, and incorporated herein by reference). | |
4.1
|
Investment Agreement, dated as of February 1, 2002, by and between the Company and Pharmacia & Upjohn Company (filed as Exhibit 4.1 to the Company Current Report on Form 8-K dated February 1, 2002 and incorporated herein by reference). | |
4.2
|
Rights Agreement, dated February 22, 2000, between the Company and American Stock Transfer & Trust Company as Rights Agent (filed as Exhibit 1 to our Current Report on Form 8-K dated February 22, 2000 and incorporated herein by reference). | |
4.3
|
Securities Purchase Agreement dated as of June 25, 2004 (filed as Exhibit 99.2 to our Current Report on Form 8-K dated June 25, 2004 and incorporated herein by reference). | |
4.4
|
Form of Warrant (filed as Exhibit 99.3 to the Companys Current Report on Form 8-K dated June 25, 2004 and incorporated herein by reference). | |
10.1
|
Lease Agreement for facilities at 45 Davids Drive, Hauppauge, NY, effective as of July 1, 2005 (filed as Exhibit 10.30 to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 and incorporated herein by reference). | |
10.2
|
Lease Agreement, dated April 23, 2002, with Phase 3 Science Center LLC, Ahwatukee Hills Investors LLC and J. Alexanders LLC (filed as Exhibit 10.26 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended March 31, 2002 and incorporated herein by reference). | |
10.3
|
First Amendment, dated June 17, 2003, to Lease Agreement dated April 23, 2002, with Phase 3 Science Center LLC, Ahwatukee Hills Investors LLC and J. Alexanders LLC (filed as Exhibit 10.2 to the Companys Quarterly Report on Form 10-Q for the Quarter ended June 30, 2003 and incorporated herein by reference). | |
10.4
|
Second Amendment, dated February 4, 2004, to Lease Agreement dated April 23, 2002, with Phase 3 Science Center LLC, Ahwatukee Hills Investors LLC and J. Alexanders LLC (filed as Exhibit 10.24 to the Companys Annual Report on Form 10-K for the year ended December 31, 2003 and incorporated herein by reference). | |
10.5
|
Lease Agreement for facilities at 80 Davids Drive, Hauppauge, NY, effective as of July 1, 2005 (filed as Exhibit 10.5 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended June 30, 2005 and incorporated herein by reference). | |
10.6
|
Lease Agreement for facilities at 3830 Monte Villa Parkway, Bothell, WA, with Ditty Properties Limited Partnership, effective as of March 1, 2006 (filed as Exhibit 10.1 to Amendment No. 1 to the Companys Current Report on Form 8-K/A dated March 1, 2006 and filed on July 26, 2006 and incorporated herein by reference).(1) |
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Exhibit | ||
No. | Description | |
10.7
|
First Amendment, dated July 17, 2006, to Lease Agreement dated March 1, 2006 with Ditty Properties Limited Partnership for facilities at 3830 Monte Villa Parkway, Bothell, WA (filed as Exhibit 10.7 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 and incorporated herein by reference). | |
10.8
|
Amended and Restated Employment Agreement, dated May 2, 2002, with Steven C. Quay, M.D., Ph.D. (filed as Exhibit 10.27 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended March 31, 2002 and incorporated herein by reference). | |
10.9
|
Employment Agreement dated June 3, 2005 by and between Nastech Pharmaceutical Company Inc. and Steven C. Quay, M.D., Ph.D. (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated June 3, 2005 and incorporated herein by reference). | |
10.10
|
Amended and Restated Employment Agreement dated December 16, 2005 by and between Nastech Pharmaceutical Company Inc. and Steven C. Quay, M.D., Ph.D. (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated December 16, 2005 and incorporated herein by reference). | |
10.11
|
Employment Agreement effective as of January 1, 2006 by and between Nastech Pharmaceutical Company Inc. and Philip C. Ranker (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated January 1, 2006 and incorporated herein by reference). | |
10.12
|
Employment Agreement effective as of August 17, 2006 by and between Nastech Pharmaceutical Company Inc. and Gordon C. Brandt, M.D. (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated August 17, 2006 and incorporated herein by reference). | |
10.13
|
Employment Agreement effective as of September 15, 2006 by and between Nastech Pharmaceutical Company Inc. and Timothy M. Duffy (field as Exhibit 10.1 to the Companys Current Report on Form 8-K dated September 15, 2006 and incorporated herein by reference). | |
10.14
|
Termination and Mutual Release Agreement, dated September 30, 2002, with Schwarz Pharma, Inc. (Filed as Exhibit 10.3 to the Companys Current Report on Form 8-K dated September 30, 2002 and incorporated herein by reference). | |
10.15
|
Divestiture Agreement, dated January 24, 2003, with Pharmacia & Upjohn Company (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated January 24, 2003 and incorporated herein by reference). | |
10.16
|
Nastech Pharmaceutical Company Inc. 1990 Stock Option Plan (filed as Exhibit 4.2 to the Companys Registration Statement on Form S-8, File No. 333-28785, and incorporated herein by reference). | |
10.17
|
Amended and Restated Nastech Pharmaceutical Company Inc. 2000 Nonqualified Stock Option Plan (filed as Exhibit 4.4 to the Companys Registration Statement on Form S-8, File No. 333-49514, and incorporated herein by reference). | |
10.18
|
Amendment No. 1 to the Amended and Restated Nastech Pharmaceutical Company Inc. 2000 Nonqualified Stock Option Plan. (filed as Exhibit 10.18 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference). | |
10.19
|
Amendment No. 2 to the Amended and Restated Nastech Pharmaceutical Company Inc. 2000 Nonqualified Stock Option Plan. (2). | |
10.20
|
Nastech Pharmaceutical Company Inc. 2002 Stock Option Plan (filed as Exhibit 10.28 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended June 30, 2002 and incorporated herein by reference). |
36
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Exhibit | ||
No. | Description | |
10.21
|
Amendment No. 1 to the Nastech Pharmaceutical Company Inc. 2002 Stock Option Plan. (filed as Exhibit 10.20 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference). | |
10.22
|
Nastech Pharmaceutical Company Inc. 2004 Stock Incentive Plan (filed as Exhibit 99 to the Companys Registration Statement on Form S-8, File No. 333-118206, and incorporated herein by reference). | |
10.23
|
Amendment No. 1 to Nastech Pharmaceutical Company Inc. 2004 Stock Incentive Plan (filed as Exhibit 10.4 to the Companys Current Report on Form 8-K dated July 20, 2005 and incorporated herein by reference). | |
10.24
|
Amendment No. 2 to Nastech Pharmaceutical Company Inc. 2004 Stock Incentive Plan (filed as Exhibit 10.18 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2005 and incorporated herein by reference). | |
10.25
|
Amendment No. 3 to Nastech Pharmaceutical Company Inc. 2004 Stock Incentive Plan. (filed as Exhibit 10.24 to the Companys Annual Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by reference). | |
10.26
|
Amendment No. 4 to Nastech Pharmaceutical Company Inc. 2004 Stock Incentive Plan. (filed as Exhibit 10.5 to the Companys Registration Statement on Form S-8, File No. 333-135724, and incorporated herein by reference). | |
10.27
|
Amendment No. 5 to Nastech Pharmaceutical Company Inc. 2004 Stock Incentive Plan. (2). | |
10.28
|
Restricted Stock Grant Agreement effective July 20, 2005 by and between Nastech Pharmaceutical Company Inc. and Dr. Steven C. Quay, M.D., Ph.D. (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated July 20, 2005 and incorporated herein by reference). | |
10.29
|
Incentive Stock Option Grant Agreement effective July 20, 2005 by and between Nastech Pharmaceutical Company Inc. and Dr. Steven C. Quay, M.D., Ph.D. (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated July 20, 2005 and incorporated herein by reference). | |
10.30
|
Non-Qualified Stock Option Grant Agreement effective July 20, 2005 by and between Nastech Pharmaceutical Company Inc. and Dr. Steven C. Quay, M.D., Ph.D. (filed as Exhibit 10.3 to the Companys Current Report on Form 8-K dated July 20, 2005 and incorporated herein by reference). | |
10.31
|
Amendments to Certain Grant Agreements effective as of July 20, 2005 by and between Nastech Pharmaceutical Company Inc. and Steven C. Quay, M.D., Ph.D. (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated December 16, 2005 and incorporated herein by reference). | |
10.32
|
Stock Option Agreement dated as of August 25, 2004 between Nastech Pharmaceutical Company Inc. and Mr. Philip C. Ranker (filed as Exhibit 10.34 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2005 and incorporated herein by reference). | |
10.33
|
Restricted Stock Grant Agreement effective August 25, 2004 by and between Nastech Pharmaceutical Company Inc. and Mr. Philip C. Ranker (filed as Exhibit 10.35 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2005 and incorporated herein by reference). | |
10.34
|
Restricted Stock Grant Agreement effective July 1, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Philip C. Ranker (filed as Exhibit 10.36 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2005 and incorporated herein by reference). |
37
Table of Contents
Exhibit | ||
No. | Description | |
10.35
|
Restricted Stock Grant Agreement effective September 7, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Philip C. Ranker. (filed as Exhibit 10.38 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2005 and incorporated herein by reference). | |
10.36
|
Restricted Stock Grant Agreement effective as of January 1, 2006 by and between Nastech Pharmaceutical Company Inc. and Philip C. Ranker (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated January 1, 2006 and incorporated herein by reference). | |
10.37
|
Incentive Stock Option Grant Agreement dated as of January 1, 2006 by and between Nastech Pharmaceutical Company Inc. and Philip C. Ranker (filed as Exhibit 10.3 to the Companys Current Report on Form 8-K dated January 1, 2006 and incorporated herein by reference). | |
10.38
|
Non-Qualified Stock Option Grant Agreement dated as of January 1, 2006 by and between Nastech Pharmaceutical Company Inc. and Philip C. Ranker (filed as Exhibit 10.4 to the Companys Current Report on Form 8-K dated January 1, 2006 and incorporated herein by reference). | |
10.39
|
Restricted Stock Grant Agreement effective January 21, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Gordon Brandt, M.D. (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated January 21, 2005 and incorporated herein by reference). | |
10.40
|
Stock Option Agreement dated as of January 21, 2005 between Nastech Pharmaceutical Company Inc. and Mr. Gordon Brandt, M.D.(filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated January 21, 2005 and incorporated herein by reference). | |
10.41
|
Restricted Stock Grant Agreement effective December 16, 2005 by and between Nastech Pharmaceutical Company Inc. and Dr. Gordon C. Brandt (filed as Exhibit 10.3 to the Companys Current Report on Form 8-K dated December 16, 2005 and incorporated herein by reference). | |
10.42
|
Stock Option Agreement dated as of December 16, 2005 between Nastech Pharmaceutical Company Inc. and Dr. Gordon C. Brandt (filed as Exhibit 10.4 to the Companys Current Report on Form 8-K dated December 16, 2005 and incorporated herein by reference). | |
10.43
|
Restricted Stock Grant Agreement effective January 21, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Paul H. Johnson, Ph.D. (filed as Exhibit 10.3 to the Companys Current Report on Form 8-K dated January 21, 2005 and incorporated herein by reference). | |
10.44
|
Restricted Stock Grant Agreement effective October 5, 2005 by and between Nastech Pharmaceutical Company Inc. and Dr. Paul H. Johnson, Ph.D (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated October 5, 2005 and incorporated herein by reference). | |
10.45
|
Stock Option Agreement dated as of January 21, 2005 between Nastech Pharmaceutical Company Inc. and Mr. Paul H. Johnson, Ph.D. (filed as Exhibit 10.4 to the Companys Current Report on Form 8-K dated January 21, 2005 and incorporated herein by reference). | |
10.46
|
Stock Option Agreement dated as of October 5, 2005 between Nastech Pharmaceutical Company Inc. and Dr. Paul H. Johnson, Ph.D. (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated October 5, 2005 and incorporated herein by reference). | |
10.47
|
Restricted Stock Grant Agreement effective May 25, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. David E. Wormuth (filed as Exhibit 10.3 to the Companys Current Report on Form 8-K dated May 25, 2005 and incorporated herein by reference). |
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Exhibit | ||
No. | Description | |
10.48
|
Stock Option Agreement dated as of May 25, 2005 between Nastech Pharmaceutical Company Inc. and Mr. David E. Wormuth (filed as Exhibit 10.4 to the Companys Current Report on Form 8-K dated May 25, 2005 and incorporated herein by reference). | |
10.49
|
Restricted Stock Grant Agreement effective as of January 30, 2006 by and between Nastech Pharmaceutical Company Inc. and Timothy M. Duffy (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated January 30, 2006 and incorporated herein by reference). | |
10.50
|
Incentive Stock Option Grant Agreement dated as of January 30, 2006 by and between Nastech Pharmaceutical Company Inc. and Timothy M. Duffy (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated January 30, 2006 and incorporated herein by reference). | |
10.51
|
Non-Qualified Stock Option Grant Agreement dated as of January 30, 2006 by and between Nastech Pharmaceutical Company Inc. and Timothy M. Duffy (filed as Exhibit 10.3 to the Companys Current Report on Form 8-K dated January 30, 2006 and incorporated herein by reference). | |
10.52
|
Restricted Stock Grant Agreement effective August 11, 2004 by and between Nastech Pharmaceutical Company Inc. and Mr. Bruce R. York. (filed as Exhibit 10.33 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2005 and incorporated herein by reference). | |
10.53
|
Restricted Stock Grant Agreement effective July 1, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Bruce R. York (filed as Exhibit 10.37 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2005 and incorporated herein by reference). | |
10.54
|
Restricted Stock Grant Agreement effective September 7, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Bruce R. York (filed as Exhibit 10.39 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2005 and incorporated herein by reference). | |
10.55
|
Restricted Stock Grant Agreement effective July 14, 2006 by and between Nastech Pharmaceutical Company Inc. and Mr. Bruce R. York (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated July 14, 2006 and incorporated herein by reference). | |
10.56
|
Amendments to Certain Grant Agreements by and between Nastech Pharmaceutical Company Inc. and Gordon C. Brandt, M.D. (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated August 17, 2006 and incorporated herein by reference). | |
10.57
|
Amendments to Certain Grant Agreements by and between Nastech Pharmaceutical Company Inc. and Timothy M. Duffy (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated September 15, 2006 and incorporated herein by reference). | |
10.58
|
Asset Purchase Agreement dated June 16, 2003, by and between the Company and Questcor Pharmaceuticals, Inc. (filed as Exhibit 2.1 to the Companys Current Report on Form 8-K dated June 17, 2003 and incorporated herein by reference). | |
10.59
|
Form of Purchase Agreement (filed as Exhibit 99.2 to the Companys Current Report on Form 8-K dated September 4, 2003 and incorporated herein by reference). | |
10.60
|
Form of Warrant (filed as Exhibit 99.3 to the Companys Current Report on Form 8-K dated September 4, 2003, and incorporated herein by reference). | |
10.61
|
Revolving Line of Credit Agreement with Wells Fargo Bank, dated December 19, 2003 (filed as Exhibit 10.20 to the Companys Annual Report on Form 10-K for the year ended December 31, 2003 and incorporated herein by reference). |
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Exhibit | ||
No. | Description | |
10.62
|
Addendum to Promissory Note with Wells Fargo Bank, dated January 20, 2004 (filed as Exhibit 10.21 to the Companys Annual Report on Form 10-K for the year ended December 31, 2003 and incorporated herein by reference). | |
10.63
|
Security Agreement Securities Account with Wells Fargo Bank, dated December 19, 2003 (filed as Exhibit 10.22 to the Companys Annual Report on Form 10-K for the year ended December 31, 2003 and incorporated herein by reference). | |
10.64
|
Addendum to Security Agreement: Securities Account with Wells Fargo Bank, dated December 19, 2003 (filed as Exhibit 10.23 to the Companys Annual Report on Form 10-K for the year ended December 31, 2003 and incorporated herein by reference). | |
10.65
|
Revolving Line of Credit Agreement with Wells Fargo Bank, dated October 20, 2004 (filed as Exhibit 10.29 to the Companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2004 and incorporated herein by reference). | |
10.66
|
Exclusive Development, Commercialization and License Agreement by and between Merck & Co., Inc. and the Company effective as of September 24, 2004 (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated September 24, 2004 and incorporated herein by reference).(1) | |
10.67
|
Supply Agreement by and between the Company and Merck & Co., Inc. effective as of September 24, 2004 (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated September 24, 2004 and incorporated herein by reference).(1) | |
10.68
|
License and Supply Agreement by and between Par Pharmaceutical, Inc. and Nastech Pharmaceutical Company Inc. effective as of October 22, 2004 (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated October 22, 2004 and incorporated herein by reference).(1) | |
10.69
|
Agreement dated as of September 23, 2005 by and between Nastech Pharmaceutical Company Inc. and QOL Medical, LLC. (filed as Exhibit 10.1 to Amendment No. 1 to the Companys Current Report on Form 8-K/A dated October 17, 2005 and filed on July 26, 2006 and incorporated herein by reference).(1) | |
10.70
|
Product Development and License Agreement by and between Nastech Pharmaceutical Company Inc. and Procter & Gamble Pharmaceuticals, Inc. dated January 27, 2006 (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated January 27, 2006 and incorporated herein by reference).(1) | |
10.71
|
Supply Agreement by and between Nastech Pharmaceutical Company Inc. and Procter & Gamble Pharmaceuticals, Inc. dated June 2, 2006 (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated June 2, 2006 and incorporated herein by reference).(1) | |
10.72
|
Development and License Agreement by and between Nastech Pharmaceutical Company Inc. and Amylin Pharmaceuticals, Inc. dated June 23, 2006.(1) (filed as exhibit 10.66 to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 and incorporated herein by reference). | |
10.73 |
Employment Agreement effective as of November 1, 2006 by and between Nastech Pharmaceutical Company Inc. and Paul H. Johnson, Ph.D. (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated November 1, 2006 and incorporated herein by reference). | |
31.1
|
Certification of the Companys Chairman of the Board, President and Chief Executive Officer pursuant to Rules 13a14 and 15d-14 under the Securities Exchange Act of 1934, as amended.(2) | |
31.2
|
Certification of the Companys Chief Financial Officer pursuant to Rules 13a14 and 15d-14 under the Securities Exchange Act of 1934, as amended.(2) | |
32.1
|
Certification of the Companys Chairman of the Board, President and Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.(2) |
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Exhibit | ||
No. | Description | |
32.2
|
Certification of the Companys Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.(2) |
(1) | Portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, amended, and the omitted material has been separately filed with the Securities and Exchange Commission. | |
(2) | Filed Herewith. |
41