Adhera Therapeutics, Inc. - Quarter Report: 2005 June (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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
SECURITIES EXCHANGE ACT OF 1934
For the Quarter Ended June 30, 2005
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 | (I.R.S. Employer Identification No.) | |
incorporation or organization) |
3450 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 an accelerated filer (as defined in Rule
12b-2 of the Exchange Act).
Yes þ No o
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 | ||||
July 20, 2005
|
Common stock $0.006 par value | 18,821,754 |
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
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EXHIBIT 10.5 | ||||||||
EXHIBIT 31.1 | ||||||||
EXHIBIT 31.2 | ||||||||
EXHIBIT 32.1 | ||||||||
EXHIBIT 32.2 |
Items 1, 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 and Per Share Data)
(In Thousands, Except Share and Per Share Data)
December 31, | June 30, | |||||||
2004 | 2005 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 25,797 | $ | 11,078 | ||||
Restricted cash |
9,000 | 998 | ||||||
Short term investments |
39,677 | 39,903 | ||||||
Accounts receivable, net |
| 888 | ||||||
Inventories |
57 | 313 | ||||||
Prepaid expenses and other current assets |
674 | 1,512 | ||||||
Total current assets |
75,205 | 54,692 | ||||||
Property and equipment, net |
5,160 | 6,751 | ||||||
Security deposits and other assets |
410 | 460 | ||||||
Total assets |
$ | 80,775 | $ | 61,903 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,652 | $ | 3,249 | ||||
Accrued expenses and other liabilities |
2,533 | 2,948 | ||||||
Notes payable |
8,352 | | ||||||
Deferred revenue current portion |
2,774 | 2,326 | ||||||
Capital lease obligations current portion |
1,532 | 1,949 | ||||||
Total current liabilities |
16,843 | 10,472 | ||||||
Deferred revenue, net of current portion |
3,483 | 2,945 | ||||||
Capital lease obligation, net of current portion |
1,719 | 2,157 | ||||||
Other liabilities |
582 | 671 | ||||||
Total liabilities |
22,627 | 16,245 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $.01 par value; 100,000 authorized: no shares issued and
outstanding: |
| | ||||||
Common
stock, $0.006 par value; 50,000,000 authorized: 17,895,976 and
18,154,990 shares outstanding at December 31, 2004 and June 30, 2005,
respectively |
107 | 109 | ||||||
Additional paid-in capital |
142,853 | 144,882 | ||||||
Deferred compensation |
(1,358 | ) | (1,429 | ) | ||||
Accumulated deficit |
(83,453 | ) | (97,884 | ) | ||||
Accumulated other comprehensive loss |
(1 | ) | (20 | ) | ||||
Total stockholders equity |
58,148 | 45,658 | ||||||
Total liabilities and stockholders equity |
$ | 80,775 | $ | 61,903 | ||||
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 Per Share Data)
(In Thousands, Except Per Share Data)
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
Revenue: |
||||||||||||||||
Product revenue, net |
$ | | $ | | $ | 95 | $ | | ||||||||
License and research fees |
45 | 1,602 | 98 | 4,932 | ||||||||||||
Total revenue |
45 | 1,602 | 193 | 4,932 | ||||||||||||
Operating expenses: |
||||||||||||||||
Cost of product revenue |
| | 64 | | ||||||||||||
Research and development |
5,261 | 7,229 | 11,111 | 14,460 | ||||||||||||
Sales and marketing |
212 | 294 | 365 | 618 | ||||||||||||
General and administrative |
2,012 | 2,769 | 3,696 | 4,930 | ||||||||||||
Total operating expenses |
7,485 | 10,292 | 15,236 | 20,008 | ||||||||||||
Loss from operations |
(7,440 | ) | (8,690 | ) | (15,043 | ) | (15,076 | ) | ||||||||
Interest income |
43 | 416 | 99 | 825 | ||||||||||||
Interest and other expense, net |
(94 | ) | (70 | ) | (191 | ) | (180 | ) | ||||||||
Net loss |
$ | (7,491 | ) | $ | (8,344 | ) | $ | (15,135 | ) | $ | (14,431 | ) | ||||
Net loss per common share basic and diluted |
$ | (0.62 | ) | $ | (0.47 | ) | $ | (1.26 | ) | $ | (0.81 | ) | ||||
Shares used in computing net loss per share
- basic and diluted: |
12,117 | 17,852 | 12,005 | 17,801 | ||||||||||||
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 Six Months Ended June 30, 2005
(Unaudited)
(In Thousands, Except Share Data)
(Unaudited)
(In Thousands, Except Share Data)
Accumulated | ||||||||||||||||||||||||||||
Additional | Other | Total | ||||||||||||||||||||||||||
Common Stock | Paid-in | Deferred | Accumulated | Comprehensive | Stockholders | |||||||||||||||||||||||
Shares | Amount | Capital | Compensation | Deficit | Loss | Equity | ||||||||||||||||||||||
Balance December 31, 2004 |
17,895,976 | $ | 107 | $ | 142,853 | $ | (1,358 | ) | $ | (83,453 | ) | $ | (1 | ) | $ | 58,148 | ||||||||||||
Proceeds from the exercise
of options and warrants |
187,691 | 1 | 1,202 | | | | 1,203 | |||||||||||||||||||||
Compensation related to
restricted stock |
71,323 | 1 | 819 | (306 | ) | | | 514 | ||||||||||||||||||||
Compensation related to
stock options |
| | 8 | 235 | | | 243 | |||||||||||||||||||||
Net loss |
| | | | (14,431 | ) | | (14,431 | ) | |||||||||||||||||||
Change in unrealized loss on
available-for-sale
securities |
| | | | | (19 | ) | (19 | ) | |||||||||||||||||||
Comprehensive loss |
| | | | (14,431 | ) | (19 | ) | (14,450 | ) | ||||||||||||||||||
Balance June 30, 2005 |
18,154,990 | $ | 109 | $ | 144,882 | $ | (1,429 | ) | $ | (97,884 | ) | $ | (20 | ) | $ | 45,658 | ||||||||||||
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)
(In Thousands)
Six Months Ended | ||||||||
June 30, | ||||||||
2004 | 2005 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (15,135 | ) | $ | (14,431 | ) | ||
Adjustments to reconcile net loss to net cash used in
operating activities: |
||||||||
Non-cash compensation related to stock options |
252 | 243 | ||||||
Non-cash compensation related to restricted stock |
43 | 514 | ||||||
Depreciation and amortization of property and equipment |
726 | 829 | ||||||
Net loss on retirements of property and equipment |
| 116 | ||||||
Changes in assets and liabilities: |
||||||||
Accounts receivable |
74 | (888 | ) | |||||
Inventories |
73 | (256 | ) | |||||
Prepaid expenses and other assets |
121 | (888 | ) | |||||
Accounts payable |
(521 | ) | 1,597 | |||||
Deferred revenue |
| (986 | ) | |||||
Accrued expenses and other liabilities |
106 | 504 | ||||||
Net cash used in operating activities |
(14,261 | ) | (13,646 | ) | ||||
Investing activities: |
||||||||
Property and equipment acquisitions |
(950 | ) | (2,536 | ) | ||||
Purchases of investments |
(7,607 | ) | (72,814 | ) | ||||
Maturities of investments |
6,200 | 72,569 | ||||||
Net cash used in investing activities |
(2,357 | ) | (2,781 | ) | ||||
Financing activities: |
||||||||
Proceeds from notes payable |
2,227 | | ||||||
Restricted cash released |
| 8,002 | ||||||
Payments on notes payable |
(146 | ) | (8,352 | ) | ||||
Borrowings under capital lease obligations |
1,039 | 1,699 | ||||||
Payments on capital lease obligations |
(445 | ) | (844 | ) | ||||
Exercise of stock options |
1,159 | 1,203 | ||||||
Private placement of common shares |
12,271 | | ||||||
Net cash provided by financing activities |
16,105 | 1,708 | ||||||
Net decrease in cash and cash equivalents |
(513 | ) | (14,719 | ) | ||||
Cash and cash equivalents beginning of period |
16,792 | 25,797 | ||||||
Cash and cash equivalents end of period |
$ | 16,279 | $ | 11,078 | ||||
Supplemental disclosures of investing and financing activities: |
||||||||
Cash paid for interest |
$ | 191 | $ | 191 | ||||
Non-cash investing activity: |
||||||||
Change in unrealized loss on available-for-sale securities |
| $ | 19 | |||||
See accompanying notes to condensed consolidated financial statements.
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NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(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 development and commercialization of innovative products based on proprietary molecular
biology-based intranasal drug delivery technology for delivering both small and large molecule
drugs. Using this technology, the Company creates or utilizes novel formulation components or
excipients that can transiently manipulate or 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 epithelial and endothelial
layers 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. This technology is the foundation of the Companys intranasal drug
delivery platform, although some of the Companys product candidates utilize this expertise outside
this area. Generally, the Company seeks to apply its technology to compounds that the Company
licenses to, or acquires from, collaborators or other third parties.
The Company believes its intranasal drug delivery technology offers 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 offers 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. The Company
is utilizing its technologies to develop commercial products, initially with collaboration
partners. In select cases, the Company also plans to internally develop, manufacture and
commercialize its products.
The Company and its collaborative partners are developing a diverse portfolio of product
candidates for multiple therapeutic areas including obesity, osteoporosis and breakthrough cancer
pain. The Companys lead product candidate, Peptide YY3-36 (PYY) for obesity, is in
Phase I clinical trials and is being developed with its collaboration partner, Merck & Co., Inc.
(Merck). Additionally, the Company is developing two product candidates for the treatment of
osteoporosis. Parathyroid Hormone (PTH(1-34)) is in Phase I clinical trials, and the
Company has filed an abbreviated new drug application (ANDA) for its generic calcitonin-salmon
intranasal spray which the Company is developing with its collaboration partner Par Pharmaceutical,
Inc. (Par Pharmaceutical). As of June 30, 2005, the Company has 33 patents issued and 165 patent
applications filed to protect its proprietary technologies.
As of June 30, 2005, the Company has an accumulated deficit of approximately $97.9 million and
expects additional operating losses in the foreseeable 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. The Company currently has two effective shelf registration statements with
a total of approximately $33 million remaining available pursuant to which the Company may issue
and sell common stock, warrants and debt securities, subject to market conditions and the Companys
capital needs. At June 30, 2005, the Company has cash, cash equivalents and investments of
approximately $52.0 million, including $1.0 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 in the Companys Annual Report on Form 10-K/A for the year ended December 31, 2004.
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Basis of Preparation
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of America 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 accounting principles generally accepted in the United States 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, 2004, included in the Companys 2004 Annual Report on Form 10-K/A 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 June 30, 2005 are not necessarily indicative of the results for the year ending
December 31, 2005 or for any future period.
Reclassifications
Certain reclassifications have been made to the 2004 information to conform to the current
period presentation.
Recent Accounting Pronouncements
In December 2004, the FASB released its revised standard, SFAS No. 123R (SFAS 123R),
Share-Based Payment. SFAS 123R requires that a public entity measure the cost of equity based
service awards based on the grant-date fair value of the award. That cost will be recognized over
the period during which an employee is required to provide service in exchange for the award or the
vesting period. A public entity will initially measure the cost of liability based service awards
based on its current fair value and the fair value of that award will be remeasured subsequently at
each reporting date through the settlement date. Changes in fair value during the requisite service
period will be recognized as compensation cost over that period. In April 2005, the SEC released
Staff Accounting Bulletin No. 107 providing additional guidance on the adoption of SFAS 123R and
amended its previously adopted rule to modify compliance dates for SFAS 123R, requiring adoption
for fiscal years beginning after June 15, 2005. The Company is evaluating SFAS 123R and believes it
will likely result in recognition of additional non-cash stock-based compensation expense and,
accordingly, would increase net loss in amounts which likely will be considered material.
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 accounting principles generally
accepted in the United States of America requires the Companys 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.
Revenue Recognition
Most of the Companys revenues result 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 Staff Accounting Bulletin No. 104 Revenue Recognition, and, for
contracts with multiple deliverables, the Company determines the
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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, if certain criteria are met, 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 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.
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 recognized in 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 at the time the services are performed.
Payments received in excess of amounts earned are recorded as deferred revenue.
Product sales revenue is recognized at the time the manufactured goods are shipped to the
purchaser and title and risk of loss has transferred.
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 in the full amount of
deferred tax assets since realization of such tax benefits is not considered to be more likely than
not.
Stock-based compensation
The Company accounts for stock-based compensation using the intrinsic value method in
accordance with APB No. 25, Accounting for Stock Issued to Employees. The Company follows the
disclosure requirements of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS 123) and
related pronouncements, which require
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the disclosure of pro forma net income and earnings per share as if the fair value-based
method was utilized in measuring compensation expense.
The per share weighted average fair value of stock options granted during the three months
ended June 30, 2004 and 2005 was $8.26, and $8.22, respectively, and for the six months ended June
30, 2004 and 2005 was $7.54 and $7.79, respectively, on the date of grant using the Black-Scholes
option-pricing model with the following assumptions:
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
Expected dividend yield |
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
Risk free interest rate |
3.7 | % | 3.9 | % | 3.4 | % | 4.0 | % | ||||||||
Expected stock volatility |
0.83 | 0.81 | 0.82 | 0.80 | ||||||||||||
Expected option life |
5 years | 6 years | 5 years | 6 years |
Had compensation cost been determined based on the fair value at the grant date for stock
options under SFAS No. 123, net loss would have been reported as the pro forma amounts indicated
below:
Three months ended | Six months ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Net loss as reported |
$ | (7,491 | ) | $ | (8,344 | ) | $ | (15,135 | ) | $ | (14,431 | ) | ||||
Add: Stock-based employee
compensation included in the
reported net loss |
169 | 367 | 295 | 757 | ||||||||||||
Deduct: Stock-based employee
compensation, determined under
fair value based methods |
(1,194 | ) | (1,252 | ) | (2,363 | ) | (2,366 | ) | ||||||||
Pro forma net loss |
$ | (8,516 | ) | $ | (9,229 | ) | $ | (17,203 | ) | $ | (16,040 | ) | ||||
Net Loss per share |
||||||||||||||||
Basic and diluted as reported |
$ | (0.62 | ) | $ | (0.47 | ) | $ | (1.26 | ) | $ | (0.81 | ) | ||||
Basic and diluted- pro forma |
$ | (0.70 | ) | $ | (0.52 | ) | $ | (1.43 | ) | $ | (0.90 | ) |
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. Outstanding employee
stock options, unvested restricted stock and warrants totaled approximately 4.6 million and 4.2
million shares at June 30, 2004 and 2005, respectively. The effect of employee stock options,
unvested restricted stock and warrants at June 30, 2004 and 2005 was not included in the net loss
per share calculation for the interim periods then ended as the effect would have been
anti-dilutive.
Note 2 Contractual Agreements
Merck 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 Phase I product for the treatment of obesity. The Agreements provide that Merck will
assume primary responsibility for conducting and funding clinical and non-clinical studies and
regulatory approval, while the Company will be responsible for all manufacturing of PYY-related
product. Merck will lead and fund commercialization, subject to the Companys exercise of an
option to co-promote the product in the United States.
Under the Agreements, the Company received an initial cash payment of $5 million in 2004. The
$5 million initial payment is being amortized over the estimated development period, a portion of
which is recorded as deferred revenue in the accompanying condensed consolidated balance sheets.
If certain development and approval milestones are achieved, the Company will be eligible to
receive up to an additional $131 million from Merck. If certain sales-related milestones are
achieved, the Company would be eligible to receive up to an additional $210 million from Merck
subject to certain other conditions. In addition to the $5 million license fee, and the other
items
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discussed above, Merck will pay the Company for manufacturing-related development activities
and will purchase all clinical supply and finished product upon commercialization from the Company.
The Company will also receive royalties on product sales.
Thiakis Limited In September 2004, the Company announced it acquired exclusive worldwide
rights to the Imperial College Innovations and Oregon Health & Science University PYY patent
applications in the field of intranasal delivery of PYY and the use of glucagons-like peptide-1
(GLP-1) used in conjunction with PYY for the treatment of obesity, diabetes and other metabolic
conditions. Under the agreement, Nastech made an equity investment in and paid an initial license
fee to Thiakis, Ltd. (Thiakis). The equity investment and initial license fee were expensed as
research and development expenses by the Company in 2004. Under the agreement, Thiakis is entitled
to receive an annual fee, additional milestone fees, patent-based royalties, and additional equity
investments based upon future progress of the intellectual property and product development
processes.
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 its generic
calcitonin-salmon nasal spray. Under the terms of the agreement with Par Pharmaceutical, the
Company will manufacture and supply finished generic 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. The Company filed its ANDA with the Food and Drug Administration (the FDA) in December 2003, which was accepted in February 2004.
Questcor Pharmaceuticals, Inc. In June 2003, the Company completed the sale of certain
assets relating to its Nascobal® brand products, including the Nascobal® (Cyanocobalamin USP) nasal
gel, to Questcor Pharmaceuticals, Inc. (Questcor). The Company filed a New Drug Application
(a NDA) of a nasal spray product configuration of Nascobal® in 2003 and will 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.
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. Questcor has also agreed to make payments of: (i) $2 million contingent upon
FDA approval of a New Drug Application (NDA) for the Nascobal® nasal spray product; and (ii) $2 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 million payment was
received from Questcor in February 2005 and recognized as revenue in the three months ended March
31, 2005.
In connection with the sale, Questcor and the Company entered into an agreement (the Security
Agreement) pursuant to which Questcor granted the Company a collateral interest in all the assets
related to the Nascobal® (Cyanocobalamin USP) nasal gel acquired by Questcor.
Under the terms of a supply agreement between the parties, subject to certain limitations, the
Company is obligated to manufacture and supply all of Questcors requirements and Questcor is
obligated to purchase from the Company all of its requirements, for the Nascobal® nasal gel and,
upon FDA approval, the Nascobal® nasal spray.
Note 3 Stockholders Equity
Common Stock Offerings In June 2004, the Company completed the public offering of 1,136,364
shares of its common stock at a public offering price of $11.00 per share, 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. 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 on December 25, 2004, and are exercisable until June 25, 2009. At
June 30, 2005, no warrants issued in connection with this offering 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
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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.
SEC Shelf Registration Statements The Company currently has two effective shelf registration
statements on Form S-3. On December 18, 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. At June 30, 2005, the amount
remaining available on this shelf registration statement was approximately $10.1 million. On
September 30, 2004 the Company filed another shelf registration statement with the SEC, which was
declared effective by the SEC on October 8, 2004, pursuant to which it may issue common stock,
warrants or debt securities, up to an aggregate of $80 million. At June 30, 2005, the amount
remaining available on this shelf registration statement was approximately $22.6 million. These
shelf registration statements enable 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.
Increase in Authorized Shares On July 20, 2005, the stockholders of the Company approved an
increase in the number of authorized shares of common stock from 25,000,000 to 50,000,000.
Equity Compensation Awards
Stock Option Plans. In June 2004, the Company established the 2004 Stock Incentive Plan (the
2004 Plan) under which a total of 600,000 shares were originally reserved for issuance. As of
June 30, 2005, 216,943 shares of restricted common stock have been issued under the 2004 Plan which
vest between one and three years and 383,057 authorized shares are available for future issuance.
In July 2005, the Companys Chairman of the Board, President and Chief Executive Officer
exercised options to purchase common stock scheduled to expire on August 7, 2005, including 106,719
at an exercise price of $4.09 per share, 200,000 at an exercise price of $12.00 per share and
54,154 at an exercise of $15.00 per share resulting in proceeds to the Company of $3,648,791. Of
the total of 360,873 options exercised, 286,154 shares were sold.
On July 20, 2005, stockholders approved amendments to the 2004 Plan, including an amendment to
increase the number of shares authorized for issuance under the 2004 Plan by 750,000 shares to
1,350,000 shares. Additionally, on July 20, 2005, 600,000 options to purchase shares of common
stock and 168,000 shares of restricted common stock were granted to the Companys Chairman of the
Board, President and Chief Executive Officer as a component of his employment agreement that was
executed on June 3, 2005. The grants vest annually in four equal installments.
In 2002, the Company established the 2002 Stock Option Plan, pursuant to which options to
purchase an aggregate of 1,360,500 shares of common stock were outstanding and 26,166 authorized
shares were available for future issuance as of June 30, 2005.
In 2000, the Company established the 2000 Nonqualified Stock Option Plan, pursuant to which
options to purchase an aggregate of 572,366 shares of common stock were outstanding and 147,656
authorized shares were available for future issuance as of June 30, 2005. On July 20, 2005, 61,500
options to purchase shares of common stock were granted to non-employee directors.
In 1990, the Company established the 1990 Stock Option Plan, pursuant to which options to
purchase an aggregate of 170,000 shares of common stock were outstanding and no shares were
available for future issuance as of June 30, 2005.
In addition, in 2002 the Company approved and ratified the issuance of 561,719 stock options
outside the plans to certain executive officers in connection with the commencement of their
employment with the Company. The Company has filed separate registration statements on Form S-8
registering awards under each of the Companys equity compensation plans and the 561,719 options
awarded outside the plans. At June 30, 2005, options to purchase 471,719 shares remained
outstanding related to these awards.
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Restricted Stock Awards. Pursuant to certain restricted stock awards granted under to the
Companys 2004 Plan, the Company has issued shares of restricted common 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 common stock on the grant date. During the
three- and six-month periods ended June 30, 2005, 39,562 and 80,883 shares of restricted stock were
granted and issued and approximately 2,760 and 9,560 unvested shares of restricted stock were
forfeited. In connection with these restricted stock grants, the Company recorded approximately
$440,000 and $891,000 as deferred compensation and approximately $250,000 and $514,000 as stock
compensation expense during the three- and six-month periods ended June 30, 2005, respectively.
There were 84,360 shares of restricted stock issued during the three- and six- month periods ended
June 30, 2004. On July 20, 2005, 61,500 shares of restricted stock were granted to non-employee
directors vesting in one year, and 168,000 shares of restricted common stock vesting in equal
annual installments over four years were granted to the Companys Chairman of the Board, President
and Chief Executive Officer as a component of his employment agreement that was executed on June 3,
2005.
Note 4 Subsequent Event
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. Under the agreement, Alnylam
received an initial license fee from Nastech and is entitled to receive annual and milestone fees
and royalties on sales of any products covered by the licensing agreement.
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/A, 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 development and commercialization of innovative
products based on proprietary molecular biology-based intranasal drug delivery technology for
delivering both small and large molecule drugs. Using this technology, we create or utilize novel
formulation components or excipients that can transiently manipulate or 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 epithelial
and endothelial layers 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. This technology is the foundation of our intranasal drug
delivery platform, although some of our product candidates utilize our expertise outside this area.
Generally, we seek to apply our technology to compounds that we license to, or acquire from,
collaborators or other third parties.
We believe our intranasal drug delivery technology offers 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 offers 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. We are
utilizing our technologies to develop commercial products with collaboration partners or, in select
cases, we also plan to internally develop, manufacture and commercialize our products.
Merck Partnership
The strategic collaboration that we entered into with Merck in September 2004, which included
upfront and potential license and milestone payments aggregating up to $346 million, is an example
of how we have applied our molecular-biology based tight junction technology to identify a
formulation of our lead product candidate, PYY, that we believe can be developed into a viable
therapeutic drug for the treatment of obesity. We possess a broad and effective PYY intellectual
property estate. Under our collaborative arrangement, Merck will assume primary responsibility for
conducting and funding clinical and regulatory development, while we will be responsible for all
manufacturing of PYY-related product. Merck will lead and fund world-wide commercialization, and we
have the right to co-promote the product in the United States. Under our agreement with Merck, we
received an initial cash payment of $5 million. If certain development and approval milestones are
achieved, we will be eligible to receive up to $131 million from Merck. If certain sales related
milestones are achieved, we will be eligible to receive up to an additional $210 million from Merck
subject to certain other conditions. Merck will also pay us for manufacturing-related development
activities and will purchase from us all clinical supply and finished product. We will also receive
royalties on product sales based on certain sales-related thresholds.
On January 26, 2005, we announced that Merck initiated a Phase I study for PYY intranasal
spray for the treatment of obesity. This study being conducted by Merck builds upon our previous
PYY clinical programs, under which more than 60 subjects have received more than 900 doses of
intranasal PYY or matching placebo.
We believe our collaboration with Merck demonstrates we have taken a significant step toward
becoming a leader in the development of innovative, intranasal drug delivery products and
technologies. We also believe this collaboration partnership demonstrates the value PYY holds as a
potential treatment option for obesity.
Independent Product Development
While we have partnered our PYY program with Merck to maximize its development potential with
the greatest value to our stockholders, we are also applying our technology and experience to
develop other product candidates on our own (i.e., without a partner), such as PTH 1-34
for the treatment of osteoporosis. PTH(1-34) is part of the naturally occurring human
parathyroid hormone that helps regulate calcium and phosphorus metabolism. PTH(1-34) is the same active ingredient that is being
marketed as Forteo by Eli Lilly & Company (Lilly). We have developed a proprietary intranasal
formulation of PTH(1-34) and have filed two U.S. patent applications containing an
aggregate of 79 claims.
We launched the clinical program for PTH(1-34) intranasal spray in the second quarter of 2004 and
have completed two Phase I clinical trials. Our clinical trials to date provide the basis for formulation
optimization of our PTH(1-34) intranasal spray. In March
2005, we met with the U.S. Food and Drug
Administration (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,
which generally is less costly and time-consuming than preparing a full new drug application that includes
results from all new studies and new information because the FDA can
rely on its previous findings on the
safety and effectiveness of Forteo.
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Par Pharmaceutical Partnership
Under our collaborative arrangement with Par Pharmaceutical
that we entered into in October 2004, we granted Par Pharmaceutical the
exclusive U.S. distribution and marketing rights to our generic calcitonin-salmon intranasal spray.
Under the terms of the agreement with Par Pharmaceutical, we will be
responsible for obtaining FDA approval, manufacturing
and supplying finished generic calcitonin-salmon intranasal 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 filed with the FDA an ANDA for a generic calcitonin-salmon intranasal
spray for the treatment of osteoporosis, and in February 2004, the FDA accepted the filing of our
ANDA for the product. The FDA also has conducted a successful Pre-Approval Inspection of our
generic calcitonin-salmon intranasal spray manufacturing facility with no cited deviations from
current Good Manufacturing Practices (cGMP).
Product Portfolio Expansion Strategy
To expand our product portfolio, we engage in a variety of pre-clinical initiatives, alone and
with partners, to explore the range of potential therapeutic applications of our tight junction
technology. Certain of these initiatives include funded feasibility studies where our tight
junction drug delivery technology is combined with already approved therapeutics, or product
candidates currently in development to determine if formal pre-clinical studies are warranted. We are currently
participating in four feasibility studies with four different partners to evaluate the development
of proprietary formulations for the intranasal delivery of the following: 1) an injected compound
for the treatment of type 2 diabetes; 2) an oral compound for the treatment of Alzheimers disease;
3) an injected compound not related to PYY for the treatment of obesity; and 4) an injected
compound for the treatment of serum anemia. Feasibility studies, typically lasting under a year,
allow us to efficiently evaluate opportunities where our tight junction technology provides
therapeutic and commercial promise.
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 20-22 nucleotides in length that are able to silence a specific gene and reduce the
amount of the disease-causing protein the gene produces. The application of RNAi in this manner
requires the ability to deliver RNAi-based therapeutics inside the cells where the target proteins
are produced. We have established a research and development program to enhance systematic delivery
of this potential new class of therapeutic drugs.
As part of our RNAi strategy, on July 20, 2005, we entered into a license agreement 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. 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.
As of June 30, 2005, we had an accumulated deficit of $97.9 million and expect additional
operating losses in the foreseeable 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, royalties and manufactured
product sales for us. As of June 30, 2005, we had approximately $52.0 million in cash, cash
equivalents and investments including $1.0 million in restricted cash. 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 public offering of 1,136,364 shares of our common stock at a
public offering of $11.00 per share, 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 June 30,
2005, 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 public offering 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. At June 30, 2005, the amount remaining available on this shelf registration statement
was approximately $22.6 million.
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Critical Accounting Policies and Estimates
We prepare our condensed consolidated financial statements in conformity with accounting
principles generally accepted in the United States of America. 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. 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,
revenue from product manufacturing, payments for research and development services performed 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 00-21 (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.
We apply Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to
Employees, and related interpretations in accounting for our stock-based employee compensation
plans, rather than the alternative fair value accounting method provided for under Statement of
Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation, (SFAS 123). In
the Notes to Condensed Consolidated Financial Statements, we provide pro-forma disclosures in
accordance with SFAS 123 and related pronouncements. Under APB 25, compensation expense is
recorded on the date of grant of an option to an employee or member of the Board only if the fair
market value of the underlying stock at the time of grant exceeds the exercise price. In addition,
we have granted options to certain outside consultants, which are required to be measured at fair
value and recognized as compensation expense in our Condensed Consolidated Statements of
Operations. We apply the Black-Scholes option-pricing model for estimating the fair value of
options, which involves a number of judgments and variables including estimates of the life of the
options and expected volatility which are subject to significant change. A change in the fair
value estimate could have a significant effect on the amount of compensation expense calculated.
In June 2004, our 2004 Stock Incentive Plan was approved by our shareholders and,
subsequently, restricted stock grants have been issued to certain directors and employees. Non-cash
compensation expense is being recognized over the applicable vesting periods of one to four years
of the restricted shares.
In December 2004, the FASB released its revised standard, SFAS No. 123R (SFAS 123R),
"Share-Based Payment. SFAS 123R requires that a public entity measure the cost of equity based
service awards based on the grant-date fair value of the award. That cost will be recognized over
the period during which an employee is required to provide service in exchange for the award or the
vesting period. A public entity will initially measure the cost of liability based service awards
based on its current fair value and the fair value of that award will be remeasured subsequently at
each reporting date through the settlement date. Changes in fair value during the requisite service
period will be recognized as compensation cost over that period. In April 2005, the SEC released
Staff Accounting Bulletin No. 107 providing additional guidance on the adoption of SFAS 123R and
amended its previously adopted rule to modify the compliance dates for SFAS 123R, requiring
adoption for fiscal years beginning after June 15, 2005. We are evaluating SFAS 123R and believe it
will likely result in recognition of additional non-cash stock-based compensation expense and,
accordingly, would increase net loss in amounts which likely will be considered material.
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 valuation allowance could be reversed.
Clinical Trial Expenses
Clinical trial expenses, which are included in research and development 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.
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Results of Operations
Revenue and cost of revenue
The following table sets forth revenue information:
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Product revenue, net |
$ | | $ | | $ | 95 | $ | | ||||||||
License and research fees |
45 | 1,602 | 98 | 4,932 | ||||||||||||
Total revenue |
$ | 45 | $ | 1,602 | $ | 193 | $ | 4,932 | ||||||||
Dollar increase |
$ | 1,557 | $ | 4,739 |
License and research fees were higher for the three months ended June 30, 2005 as compared to
the same period in 2004, due primarily to the recognition of current period research and
development fees and deferred license fees received from Merck, Par Pharmaceutical and other
collaborative partners over the estimated remaining development periods.
License and research fees were higher for the six months ended June 30, 2005 as compared to
the same period in 2004, due primarily to a $2.0 million milestone payment received from Questcor
and to the recognition of current period research and development fees and deferred license fees
received in 2004 from Merck, Par Pharmaceutical and other collaborative partners over the estimated
remaining development periods.
The following table sets forth information on product revenue, cost of product revenue and
cost of product revenue as a percentage of product revenue:
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Product revenue, net |
$ | | $ | | $ | 95 | $ | | ||||||||
Cost of product revenue |
| | 64 | | ||||||||||||
Cost of product revenue as a % of product revenue |
| | 67 | % | |
Product revenue consists of sales of Nascobal® nasal gel to Questcor. During the six months
ended June 30, 2004, we earned product revenue under the supply agreement. During the interim
periods ended June 30, 2005, we did not produce or ship any Nascobal® nasal gel. In the future we
expect to receive continued product revenue under the supply agreement.
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 and other costs. 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:
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Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
Peptide YY |
43 | % | 11 | % | 53 | % | 9 | % | ||||||||
Calcitonin |
19 | % | 33 | % | 15 | % | 36 | % | ||||||||
Tight Junctions and RNAi |
16 | % | 22 | % | 14 | % | 21 | % | ||||||||
PTH(1-34) |
10 | % | 15 | % | 6 | % | 14 | % | ||||||||
Apomorphine |
1 | % | | % | 5 | % | | % | ||||||||
Other R&D projects (1) |
11 | % | 19 | % | 7 | % | 20 | % | ||||||||
100 | % | 100 | % | 100 | % | 100 | % | |||||||||
(dollars in thousands) |
||||||||||||||||
Total R&D expense |
$ | 5,261 | $ | 7,229 | $ | 11,111 | $ | 14,460 | ||||||||
Dollar increase |
1,968 | 3,349 | ||||||||||||||
Percentage increase |
37 | % | 30 | % |
1. | Other R&D projects include, without limitation, our oral abuse-resistant opioid, feasibility studies and other projects. |
The increase in the three-month period ended June 30, 2005 over the same period in 2004
resulted primarily from the following costs:
| Costs of clinical trials, consulting, outside services and laboratory supplies increased to $2.9 million from $1.9 million due primarily to the timing of clinical trials performed for our calcitonin, PYY, PTH(1-34) and RNAi products under development; | ||
| personnel-related expenses increased to $3.1 million from $2.2 million due to an increase in staffing our research and development personnel in support of our research and development program; and | ||
| facilities-related costs increased to $1.0 million from $0.9 million due to rent and related expenses on additional space leased in the Bothell facility and increased depreciation and maintenance on equipment. |
The increase in the six-month period ended June 30, 2005 over the same period in 2004 resulted
primarily from the following costs:
| Costs of clinical trials, consulting, outside services and laboratory supplies increased to $5.9 million from $4.7 million due primarily to the timing of clinical trials performed for our calcitonin, PYY, PTH(1-34) and RNAi products under development; | ||
| personnel-related expenses increased to $5.9 million from $4.3 million due to an increase in staffing our research and development personnel in support of our research and development programs; and | ||
| facilities-related costs increased to $2.2 million from $1.7 million due to rent and related expenses on additional space leased in the Bothell facility and increased depreciation and maintenance on equipment. |
We expect a continued increase in research and development expense in the foreseeable future as we
continue to expand our research and development activities primarily relating to our PYY and
PTH(1-34) product candidates and our RNAi research programs. However, we do not
anticipate incurring any significant research and development expenses in the foreseeable future
relating to the development of our apomorphine or beta interferon product candidates until, and
only if, we are able to identify a partner to continue development of either such product
candidate. 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:
| 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; |
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| 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. |
Except for our Nascobal® nasal spray, which received FDA approval in January 2005, none of our
other current product candidates has received FDA or foreign regulatory marketing approval. 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 plans 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 | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Total sales and marketing expense |
$ | 212 | $ | 294 | $ | 365 | $ | 618 | ||||||||
Dollar increase |
82 | 253 | ||||||||||||||
Percentage increase |
39 | % | 69 | % |
The increase in the three- and six-month periods ended June 30, 2005 over the same periods in
2004 resulted primarily from increased business development personnel costs and increases in
spending on market research. We expect sales and marketing costs, which includes business
development staff and activities, to continue to increase in the foreseeable future to support
activities associated with partnering our other 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, 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 | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Total general and administrative expense |
$ | 2,012 | $ | 2,769 | $ | 3,696 | $ | 4,930 | ||||||||
Dollar increase |
757 | 1,234 | ||||||||||||||
Percentage increase |
38 | % | 33 | % |
The increase in the three- and six-months periods ended June 30, 2005 over the same periods in
2004 was due primarily to increased compensation-related expenses due to the hiring of additional
personnel supporting R&D and compliance activities, legal and accounting fees, corporate insurance,
non-cash stock compensation expense related to restricted stock grants and other administrative
costs. 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.
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Interest Income
We earn interest income on our invested cash and investments. The following table sets forth
information on interest income, average funds available for investment and average interest rate
earned:
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Interest income |
$ | 43 | $ | 416 | $ | 99 | $ | 825 | ||||||||
Average funds available for investment |
$ | 19,100 | $ | 54,800 | $ | 20,200 | $ | 60,900 | ||||||||
Average interest rate |
0.9 | % | 3.0 | % | 1.0 | % | 2.7 | % |
The increase in interest income in the three- and six-month periods ended June 30, 2005 over
the same periods in 2004 was due primarily to higher average balances available for investment in
the current year periods and, to a lesser extent, increases in prevailing market interest rates.
Interest Expense
We incur interest expense on our capital leases and, formerly, on our notes payable. The
following table sets forth information on interest expense, average borrowings and average interest
rate incurred:
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Interest expense (excluding other expense) |
$ | 94 | $ | 70 | $ | 191 | $ | 180 | ||||||||
Ave. borrowings under capital leases and notes payable |
$ | 11,000 | $ | 3,800 | $ | 10,000 | $ | 5,900 | ||||||||
Average interest rate |
3.4 | % | 7.4 | % | 3.8 | % | 6.5 | % |
The change in interest expense in the three- and six-month periods ended June 30, 2005 over
the same periods in 2004 was due to an increase in the prevailing interest rates, combined with an
overall reduction in borrowings and a shift in the borrowing mix from cash-secured bank debt to
asset lease financing.
In the three-month period ended June 30, 2005, average borrowings under the Wells Fargo note
were zero, and average borrowings under the GE Capital leases were approximately $3.8 million at
interest rates ranging from approximately 8.3% to 10.0%. In the three-month period ended June 30,
2004, average borrowings under the Wells Fargo note were approximately $8.4 million at
approximately 2.0% interest, and average borrowings under the GE Capital leases were approximately
$2.7 million at interest rates ranging from approximately 8.3% to 10.0%.
In the six-month period ended June 30, 2005, average borrowings under the Wells Fargo note
were approximately $2.4 million at 3.25% interest, and average borrowings under the GE Capital
leases were approximately $3.5 million at interest rates ranging from approximately 8.3% to 10.0%.
In the six-month period ended June 30, 2004, average borrowings under the Wells Fargo note were
approximately $7.4 million at approximately 2.0% interest, and average borrowings under the GE
Capital leases were approximately $2.6 million at interest rates ranging from approximately 8.3% to
10.0%.
In June 2003, we entered into a note payable with Wells Fargo bank at a rate of LIBOR plus
0.75%. As of December 31, 2004, the balance on the note payable with Wells Fargo was $8,352,000
and the interest rate was approximately 3.3% per annum. In February 2005, the Wells Fargo note was
paid off in full and cancelled. The outstanding balance at June 30, 2005 is zero.
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Table of Contents
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 $97.9 million as of June 30, 2005,
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, and we may be required to
reduce our research and development activities or raise additional funds 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, equipment financing facilities and notes payable.
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 public offering of 1,136,364 shares of our common stock at a
public offering price of $11.00 per share, 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 June 30, 2005, 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 public offering price of $13.50 per share pursuant to our $80 million effective shelf
registration statement. 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. At June 30, 2005, the amount
remaining available on this shelf registration statement was approximately $22.6 million.
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, including:
| Under our collaborative arrangement with Merck, we received an initial cash payment of $5 million in October 2004. The $5 million initial payment is being amortized over the estimated development period. We are also eligible to receive milestone payments upon achievement of specified product development goals or sales targets. If certain development and approval milestones are achieved, we will be eligible to receive up to $131 million from Merck. If certain sales related milestones are achieved, we will be eligible to receive up to an additional $210 million from Merck, subject to certain other conditions. Merck will also pay us for manufacturing-related development activities and will purchase from us clinical supply and finished product. We will also receive royalties on product sales based on certain sales-related thresholds. | ||
| Under our collaborative arrangement with Par Pharmaceutical, we received an initial cash payment which is being amortized over the estimated development period. We expect in the future to receive additional revenue from Par Pharmaceutical in the form of milestone payments, product transfer payments for |
21
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manufactured product and a profit sharing upon commercialization of generic calcitonin-salmon intranasal spray. | |||
| In January 2005, we received FDA approval of our Nascobal® nasal spray and we received a $2 million payment from Questcor in February 2005. |
Total sources and uses of cash for the six-month periods ending June 30, 2004 and 2005 are as
follows:
Six Months Ended | ||||||||
June 30, | ||||||||
2004 | 2005 | |||||||
(dollars in thousands) | ||||||||
Cash used in operating activities |
$ | (14,261 | ) | $ | (13,646 | ) | ||
Cash used in investing activities |
(2,357 | ) | (2,781 | ) | ||||
Cash provided by financing activities |
16,105 | 1,708 | ||||||
Net decrease in cash and cash equivalents |
$ | (513 | ) | $ | (14,719 | ) |
Our operating activities used cash of $13.6 million in the six months ended June 30, 2005
compared to $14.3 million in the six months ended June 30, 2004. 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. 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 $2.8 million in the six months ended June 30, 2005,
compared to $2.4 million in the six months ended June 30, 2004. 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 $1.7 million in the six months ended June 30, 2005,
compared to $16.1 million in the six months ended June 30, 2004. Cash provided in the 2004 period
primarily resulted from an increase in borrowing of $2.2 million and net proceeds from a private
placement of common shares of approximately $12.3 million. During the six months ended June 30,
2005, we repaid approximately $8.4 million on our Revolving Line of Credit and drew down
approximately $1.7 million on a capital lease facility. As a result of the loan payoff, our
restricted cash balance decreased by $8.0 million.
Liquidity
We had a working capital (current assets minus current liabilities) surplus of $44.2 million
as of June 30, 2005 and $58.4 million as of December 31, 2004. As of June 30, 2005, we had
approximately $52.0 million in cash, cash-equivalents and investments, including $1.0 million in
restricted cash. 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 June 30, 2005, we had unused capital lease credit lines of approximately $2.4 million
out of total available credit lines of approximately $4.0 million. Our loan balance of
approximately $8.4 million at December 31, 2004 was paid in full and cancelled in February 2005.
Our available capital lease line of $4.0 million expires December 31, 2005 and is available for use
in financing equipment and leasehold assets.
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Contractual Obligations
Our contractual obligations have changed since December 31, 2004 to June 30, 2005 as follows:
| At June 30, 2005 we have a zero balance in notes payable compared to approximately $8.6 million (including interest) at December 31, 2004 due to the payoff of the note in February 2005; | ||
| At June 30, 2005 our operating lease obligations decreased to approximately $20.2 million (through 2016) from approximately $20.4 million at December 31, 2004. This is due to one facility lease renewal and one new warehouse lease adding approximately $0.7 million in rental payments from July 2005 through June 2010, partially offset by approximately $0.9 million in rents paid during the six months ended June 30, 2005; | ||
| Our capital lease obligations increased by approximately $1.3 million to approximately $4.6 million (including interest) at June 30, 2005 due to approximately $1.7 million in new leases signed offset by payments made during the six months ended June 30, 2005; and | ||
| Our purchase obligations increased by approximately $2.5 million to approximately $2.7 million at June 30, 2005 due to purchase order activity during the six months ended June 30, 2005. |
Off-Balance Sheet Arrangements
As of June 30, 2005, 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
Our exposure to market rate risk for changes in interest rates relates primarily to our
investment of cash in excess of near term requirements. We have a prescribed methodology whereby
we invest our excess cash in debt instruments of U.S. government agencies and high quality
corporate issuers (Standard & Poors A rating and higher or Moodys Investors Service A2 rating
and higher). To mitigate market risk, securities have a maturity date within 18 months, no
category of issue can exceed 50% of the portfolio, and holdings of any one issuer excluding the
U.S. government do not exceed 20% of the portfolio. Periodically, the portfolio is reviewed and
adjusted if the credit rating of a security held has deteriorated. Because of the relatively short
maturities of our investments, we do not expect interest rate fluctuations to materially affect the
aggregate value of our financial assets. We do not utilize derivative financial instruments.
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 June
30, 2005, 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 2 UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Warrants. During the three months ended June 30, 2005 the Company issued 12,356 shares of
common stock to holders of common stock warrants (the Warrants) upon the exercise of such
Warrants in private offerings pursuant to Section 4(2) of the Securities Act of 1933, as amended
(the Securities Act). The holders of the Warrants were accredited investors under Rule 501 of
the Securities Act. The Company has registered the resale of such shares under the Securities Act.
10,256 of the Warrants were exercisable for an equal number of shares of common stock at an
exercise price of $6.3375 per share, and 2,100 of the Warrants were exercisable for an equal number
of shares of common stock at an exercise price of $7.50 per share.
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 August 1, 2005.
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/ Gregory L. Weaver | |||||
Gregory L. Weaver | ||||||
Chief Financial Officer |
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Table of Contents
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 1, 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. (2) |
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Table of Contents
Exhibit | ||
No. | Description | |
10.6
|
Amended and Restated Employment Agreement, dated May 2, 2002, with Dr. 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). | |
10.7
|
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). | |
10.8
|
Employment Agreement with Gregory L. Weaver, dated April 30, 2002 (filed as Exhibit 10.29 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended June 30, 2002 and incorporated herein by reference). | |
10.9
|
Change-in-Control Severance Agreement with Gregory L. Weaver, dated July 31, 2002 (filed as Exhibit 10.1 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended September 30, 2002 and incorporated herein by reference). | |
10.10
|
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). | |
10.11
|
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). | |
10.12
|
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). | |
10.13
|
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). | |
10.14
|
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). | |
10.15
|
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). | |
10.16
|
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). | |
10.17
|
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). | |
10.18
|
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). | |
10.19
|
Non-Qualified Stock Option Grant Agreement effective July 20, 2005 by and between |
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Table of Contents
Exhibit | ||
No. | Description | |
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). | ||
10.20
|
Stock option agreement with Gregory L. Weaver (filed as Exhibit 10.25 to the Companys Annual Report on Form 10-K for the year ended December 31, 2002 and incorporated herein by reference). | |
10.21
|
Restricted Stock Grant Agreement effective May 25, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Gregory L. Weaver (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated May 25, 2005 and incorporated herein by reference). | |
10.22
|
Stock Option Agreement dated as of May 25, 2005 between Nastech Pharmaceutical Company Inc. and Mr. Gregory L. Weaver (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated May 25, 2005 and incorporated herein by reference). | |
10.23
|
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). | |
10.24
|
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). | |
10.25
|
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). | |
10.26
|
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). | |
10.27
|
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). | |
10.28
|
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). | |
10.29
|
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). | |
10.30
|
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). | |
10.31
|
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). | |
10.32
|
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 |
27
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Exhibit | ||
No. | Description | |
December 31, 2003 and incorporated herein by reference). | ||
10.33
|
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). | |
10.34
|
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). | |
10.35
|
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). | |
10.36
|
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). | |
10.37
|
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) | |
10.38
|
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) | |
10.39
|
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) | |
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) | |
32.2
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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. |
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