Adhera Therapeutics, Inc. - Quarter Report: 2005 September (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 September 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 incorporation or organization) |
(I.R.S. Employer Identification No.) |
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 by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as
of the latest practicable date:
Date | Class | Shares Outstanding | ||||
October 24, 2005
|
Common stock $0.006 par value | 20,651,472 |
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
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EXHIBIT 10.38 | ||||||||
EXHIBIT 10.39 | ||||||||
EXHIBIT 31.1 | ||||||||
EXHIBIT 31.2 | ||||||||
EXHIBIT 32.1 | ||||||||
EXHIBIT 32.2 |
Items 1, 3 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, | September 30, | |||||||
2004 | 2005 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 25,797 | $ | 15,911 | ||||
Restricted cash |
9,000 | 998 | ||||||
Short term investments |
39,677 | 50,204 | ||||||
Accounts receivable, net |
| 582 | ||||||
Inventories |
57 | 1,034 | ||||||
Prepaid expenses and other current assets |
674 | 1,299 | ||||||
Total current assets |
75,205 | 70,028 | ||||||
Property and equipment, net |
5,160 | 7,956 | ||||||
Security deposits and other assets |
410 | 431 | ||||||
Total assets |
$ | 80,775 | $ | 78,415 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,652 | $ | 2,885 | ||||
Accrued expenses and other liabilities |
2,533 | 2,159 | ||||||
Notes payable |
8,352 | | ||||||
Deferred revenue current portion |
2,774 | 1,666 | ||||||
Capital lease obligations current portion |
1,532 | 2,193 | ||||||
Total current liabilities |
16,843 | 8,903 | ||||||
Deferred revenue, net of current portion |
3,483 | 2,967 | ||||||
Capital lease obligations, net of current portion |
1,719 | 2,648 | ||||||
Other liabilities |
582 | 722 | ||||||
Total liabilities |
22,627 | 15,240 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.01 par value; 100,000
authorized: no shares issued and outstanding: |
| | ||||||
Common stock, $0.006 par value; 50,000,000
authorized: 17,895,976 and 20,637,232 shares
outstanding at December 31, 2004 and September
30, 2005, respectively |
107 | 124 | ||||||
Additional paid-in capital |
142,853 | 174,985 | ||||||
Deferred compensation |
(1,358 | ) | (5,181 | ) | ||||
Accumulated deficit |
(83,453 | ) | (106,698 | ) | ||||
Accumulated other comprehensive loss |
(1 | ) | (55 | ) | ||||
Total stockholders equity |
58,148 | 63,175 | ||||||
Total liabilities and stockholders equity |
$ | 80,775 | $ | 78,415 | ||||
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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
Revenues |
$ | 203 | $ | 1,223 | $ | 396 | $ | 6,155 | ||||||||
Operating expenses: |
||||||||||||||||
Cost of product revenue |
126 | | 190 | | ||||||||||||
Research and development |
4,919 | 8,099 | 16,030 | 22,559 | ||||||||||||
Sales and marketing |
291 | 345 | 656 | 963 | ||||||||||||
General and administrative |
2,394 | 2,019 | 6,090 | 6,949 | ||||||||||||
Total operating expenses |
7,730 | 10,463 | 22,966 | 30,471 | ||||||||||||
Loss from operations |
(7,527 | ) | (9,240 | ) | (22,570 | ) | (24,316 | ) | ||||||||
Interest income |
83 | 496 | 182 | 1,321 | ||||||||||||
Interest and other expense, net |
(111 | ) | (70 | ) | (302 | ) | (250 | ) | ||||||||
Net loss |
$ | (7,555 | ) | $ | (8,814 | ) | $ | (22,690 | ) | $ | (23,245 | ) | ||||
Net loss per
common share basic and diluted |
$ | (0.57 | ) | $ | (0.46 | ) | $ | (1.83 | ) | $ | (1.28 | ) | ||||
Shares used
in computing net loss per share basic and diluted |
13,250 | 19,009 | 12,412 | 18,208 | ||||||||||||
See accompanying notes to condensed consolidated financial statements.
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NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS EQUITY
AND COMPREHENSIVE LOSS
For the Nine Months Ended September 30, 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
issuance of common
shares in
connection with a
public offering,
net |
1,725,000 | 10 | 21,638 | | | | 21,648 | |||||||||||||||||||||
Proceeds from the
exercise of options
and warrants |
652,719 | 4 | 5,381 | | | | 5,385 | |||||||||||||||||||||
Compensation
related to
restricted stock |
363,537 | 3 | 5,105 | (4,102 | ) | | | 1,006 | ||||||||||||||||||||
Compensation
related to stock
options |
| | 8 | 279 | | | 287 | |||||||||||||||||||||
Net loss |
| | | | (23,245 | ) | | (23,245 | ) | |||||||||||||||||||
Change in
unrealized loss on
available-for-sale
securities |
| | | | | (54 | ) | (54 | ) | |||||||||||||||||||
Comprehensive loss |
| | | | (23,245 | ) | (54 | ) | (23,299 | ) | ||||||||||||||||||
Balance September
30, 2005 |
20,637,232 | $ | 124 | $ | 174,985 | $ | (5,181 | ) | $ | (106,698 | ) | $ | (55 | ) | $ | 63,175 | ||||||||||||
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)
Nine Months Ended | ||||||||
September 30, | ||||||||
2004 | 2005 | |||||||
Operating activities: |
||||||||
Net loss |
$ | (22,690 | ) | $ | (23,245 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Non-cash compensation related to stock options |
378 | 287 | ||||||
Non-cash compensation related to restricted stock |
252 | 1,006 | ||||||
Depreciation and amortization of property and equipment |
1,083 | 1,289 | ||||||
Net loss on retirements of property and equipment |
39 | 124 | ||||||
Changes in assets and liabilities: |
||||||||
Accounts receivable, net |
(5,003 | ) | (582 | ) | ||||
Inventories |
121 | (977 | ) | |||||
Prepaid expenses and other assets |
564 | (646 | ) | |||||
Accounts payable |
(572 | ) | 1,233 | |||||
Deferred revenue |
4,996 | (1,624 | ) | |||||
Accrued expenses and other liabilities |
311 | (234 | ) | |||||
Net cash used in operating activities |
(20,521 | ) | (23,369 | ) | ||||
Investing activities: |
||||||||
Property and equipment acquisitions |
(1,597 | ) | (4,209 | ) | ||||
Purchases of investments |
(7,865 | ) | (104,280 | ) | ||||
Maturities of investments |
10,300 | 93,699 | ||||||
Net cash provided by (used in) investing activities |
838 | (14,790 | ) | |||||
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 |
1,423 | 2,940 | ||||||
Payments on capital lease obligations |
(749 | ) | (1,350 | ) | ||||
Exercise of stock options |
1,407 | 5,385 | ||||||
Public offering of common shares |
| 21,648 | ||||||
Private placement of common shares |
12,271 | | ||||||
Net cash provided by financing activities |
16,433 | 28,273 | ||||||
Net decrease in cash and cash equivalents |
(3,250 | ) | (9,886 | ) | ||||
Cash and cash equivalents beginning of period |
16,792 | 25,797 | ||||||
Cash and cash equivalents end of period |
$ | 13,542 | $ | 15,911 | ||||
Supplemental disclosures of investing and financing activities: |
||||||||
Cash paid for interest |
$ | 302 | $ | 250 | ||||
Non-cash investing activity: |
||||||||
Unrealized loss on available-for-sale securities |
| $ | 54 | |||||
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 not all of the Companys product candidates utilize this expertise.
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 September 30, 2005, the Company had 30 patents issued and 172
patent applications filed to protect its proprietary technologies.
As of September 30, 2005, the Company had an accumulated deficit of approximately $106.7
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 an effective shelf registration
statement with approximately $10.1 million remaining available pursuant to which the Company may
issue and sell common stock and warrants, subject to market conditions and the Companys capital
needs. At September 30, 2005, the Company had cash, cash equivalents and short-term investments of
approximately $67.1 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
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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.
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 September 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 Financial Accounting Standards Board (FASB) released its revised
standard, Statement of Financial Accounting Standards 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 re-measured 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.
In May 2005, the FASB issued Statement of Financial Accounting Standards No. 154, Accounting
Changes and Error Corrections, (SFAS 154). SFAS 154 replaces APB Opinion No. 20, Accounting
Changes, and SFAS No. 3, Reporting Accounting Changes in Interim Financial Statements, and
changes the requirements for the accounting for and reporting of a change in accounting principle.
The Company is required to adopt SFAS 154 in 2006. The Companys results of operations and
financial condition will only be impacted by SFAS 154 if the Company implements changes in
accounting principles that are addressed by the standard or corrects accounting errors in future
periods.
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.
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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 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 the Company is
providing continuing services related to product development, are deferred and recognized as
revenue over the development period or as the Company provides the services required under the
agreement. The ability to estimate total development effort and costs can vary significantly for
each product candidate due to the inherent complexities and uncertainties of drug development.
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.
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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 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 September 30, 2004 and 2005 was $7.66, and $10.36, respectively, and for the nine months
ended September 30, 2004 and 2005 was $7.57 and $8.65, respectively, on the date of grant using the
Black-Scholes option-pricing model with the following assumptions:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
Expected dividend yield |
0 | % | 0 | % | 0 | % | 0 | % | ||||||||
Risk free interest rate |
3.5 | % | 4.1 | % | 3.4 | % | 4.0 | % | ||||||||
Expected stock volatility |
81 | % | 77 | % | 82 | % | 79 | % | ||||||||
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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Net loss as reported |
$ | (7,555 | ) | $ | (8,814 | ) | $ | (22,690 | ) | $ | (23,245 | ) | ||||
Add: Stock-based employee
compensation included in the reported
net loss |
335 | 536 | 630 | 1,293 | ||||||||||||
Deduct: Stock-based employee
compensation, determined under fair
value-based methods |
(1,232 | ) | (1,025 | ) | (3,596 | ) | (3,391 | ) | ||||||||
Pro forma net loss |
$ | (8,452 | ) | $ | (9,303 | ) | $ | (25,656 | ) | $ | (25,343 | ) | ||||
Net Loss per share |
||||||||||||||||
Basic and diluted as reported |
$ | (0.57 | ) | $ | (0.46 | ) | $ | (1.83 | ) | $ | (1.28 | ) | ||||
Basic and diluted- pro forma |
$ | (0.64 | ) | $ | (0.49 | ) | $ | (2.07 | ) | $ | (1.39 | ) |
Net Loss per Common Share
Basic and diluted net loss per common share is computed by dividing the net loss by the
weighted average number of common shares outstanding during the periods. The effect of employee
stock options, unvested restricted stock and warrants at September 30, 2004 and 2005 was not
included in the net loss per share calculation for the
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interim periods then ended as the effect would have been anti-dilutive. Outstanding warrants,
employee stock options and unvested restricted stock totaled approximately 4.7 million and 4.6
million shares at September 30, 2004 and 2005, respectively.
Inventory
At December 31, 2004 and September 30, 2005, net inventory balances were $0.1 million and $1.0
million and were composed of raw materials.
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 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.
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 U.S. The financial
terms of the agreement include milestone payments, product transfer payments for manufactured
product and 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.
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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. A $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 the
Nascobal® nasal spray.
See Note 4 Subsequent Event for additional information related to the assignment of the
Questcor agreements to QOL Medical, LLC in October 2005.
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. The initial license fee was expensed as
research and development expenses by the Company in the three month period ended September 30,
2005. 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.
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
September 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 offering resulted in gross proceeds of approximately $57.4 million to
the Company, prior to the deduction of fees and commissions of approximately $4.5 million.
On August 30, 2005 the Company completed the public offering of 1,725,000 shares of its common
stock at a public offering price of $13.50 per share pursuant to its $80 million effective shelf
registration statement and a $0.7 million post effective amendment filed on August 25, 2005
pursuant to Rule 462(b) of the Securities Act of 1933, as amended (the Securities Act). The
offering resulted in gross proceeds of approximately $23.3 million to the Company, prior to the
deduction of fees and commissions of approximately $1.6 million.
SEC Shelf Registration Statements Shelf registration statements enable the Company to raise
capital from the offering of securities covered by the shelf registration statements from time to
time and through one or more methods of distribution, subject to market conditions and cash needs.
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The Company currently has one remaining effective shelf registration statement 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 September 30, 2005, the amount remaining available
on this shelf registration statement was approximately $10.1 million.
On September 30, 2004 the Company filed a separate 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. On August 25, 2005, the
Company filed a post-effective amendment to the shelf registration pursuant to Rule 462(b) of the
Securities Act to increase the total by approximately $0.7 million. On August 30, 2005, the
Company utilized the previously remaining $22.6 million and the additional $0.7 million in a public
offering of its common stock. At September 30, 2005, the amount remaining available on this shelf
registration statement was zero.
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. 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.
In addition, on October 5, 2005, the Board of Directors adopted an amendment to the 2004 Plan that
provides for discretionary vesting of restricted stock awards. As of September 30, 2005, 537,072
shares of restricted common stock have been issued under the 2004 Plan which vest between one and
four years, including 168,000 shares of restricted common stock granted on July 20, 2005 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. Additionally, on July 20, 2005, 600,000
options to purchase shares of 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. These option grants vest annually in four equal installments. At September 30,
2005, no other options had been awarded under the 2004 Plan and there were 240,843 authorized
shares available for future issuance.
In 2002, the Company established the 2002 Stock Option Plan, pursuant to which options to
purchase an aggregate of 1,329,667 shares of common stock were outstanding and 56,999 authorized
shares were available for future issuance as of September 30, 2005.
In 2000, the Company established the 2000 Nonqualified Stock Option Plan, pursuant to which
options to purchase an aggregate of 559,266 shares of common stock were outstanding and 86,856
authorized shares were available for future issuance as of September 30, 2005. On July 20, 2005,
61,500 options to purchase shares of common stock were granted to non-employee directors from the
2000 Plan.
In 1990, the Company established the 1990 Stock Option Plan, pursuant to which options to
purchase an aggregate of 100,000 shares of common stock were outstanding and no shares were
available for future issuance as of September 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. 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
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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. An additional 45,846 of these options expired unexercised on August 7, 2005. At
September 30, 2005, options to purchase 125,000 shares remained outstanding related to these
awards.
Restricted Stock Awards. Pursuant to certain restricted stock awards granted under to the
Companys 2004 Plan, the Company has issued shares of restricted stock to certain employees and
members of the board of directors. Non-cash compensation expense is being recognized on a
straight-line basis over the applicable vesting periods of one to four years of the restricted
shares based on the fair value of such restricted stock on the grant date. On July 20, 2005,
61,500 shares of restricted stock were granted to non-employee
directors vesting on the earlier of the first anniversary of the date
of grant or the date of the Companys next annual meeting of Stockholders 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. Additional information on
restricted shares is as follows:
Nine Months Ended | ||||||||
September 30, | ||||||||
2004 | 2005 | |||||||
Unvested restricted shares outstanding, beginning of period |
0 | 145,620 | ||||||
Restricted shares issued |
133,420 | 389,052 | ||||||
Restricted shares forfeited |
0 | (25,515 | ) | |||||
Restricted shares lapsed (vested in period) |
0 | (82,823 | ) | |||||
Unvested restricted shares outstanding, end of period |
133,420 | 426,334 | ||||||
Non-cash restricted stock compensation expense, net of
forfeitures |
$ | 252,000 | $ | 1,006,000 |
Note 4 Subsequent Event
Questcor assignment to QOL Medical, LLC On October 17, 2005, with the consent of the
Company, Questcor assigned all of its rights and obligations under the Questcor Asset Purchase and
Supply Agreements dated June 2003 to QOL Medical, LLC (QOL). The Company received $2.0 million
from Questcor on October 19, 2005 in consideration for its consent to the assignment and in
connection with the Company entering into an agreement with QOL which modified certain terms of the
Asset Purchase and Supply Agreements.
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
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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.
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.
PTH(1-34) Development
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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 and one Paris Convention Treaty (PCT) Application consisting of an aggregate of 107
claims.
We launched the clinical program for PTH(1-34) intranasal spray in the second
quarter of 2004 and have completed three Phase I clinical trials. At September 30, 2005 we have
one additional Phase I clinical trial in progress. In September 2005 we completed a
pharmacokinetic study in healthy human subjects and initiated a follow-on pharmacokinetic study in
the elderly. The studies are part of the previously announced clinical development program
supporting a 505(b)(2) submission to the FDA for approval. 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 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.
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). On September 2, 2005, a citizens petition was
filed with the FDA requesting that the FDA not approve the ANDA as filed prior to additional
studies for safety and bioequivalence. We filed a response with the FDA to the citizens petition
on October 13, 2005. At this time we are not able to determine whether or not this petition or
other factors will delay the approval process for the ANDA.
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. In addition to collaborative feasibility studies, in
October 2005 we announced the initiation of our own project to evaluate intranasal insulin.
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
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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 September 30, 2005, we had an accumulated deficit of $106.7 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 September 30, 2005, we had approximately $67.1 million in
cash, cash equivalents and short-term 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
September 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 approximately $4.5 million.
On August 30, 2005 we completed the public offering of 1,725,000 shares of our common stock at
a public offering price of $13.50 per share pursuant to our $80 million effective shelf
registration statement and a $0.7 million post effective amendment filed on August 25, 2005
pursuant to Rule 462(b) of the Securities Act. The offering resulted in gross proceeds of
approximately $23.3 million to the Company, prior to the deduction of fees and commissions of
approximately $1.6 million. At September 30, 2005, the amount remaining available on this shelf
registration statement was zero.
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
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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.
Stock-Based Compensation
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 re-measured 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.
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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 sustained 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.
Results of Operations
Revenue and cost of revenue
Our revenue consists of product sales and license and research fees. Revenue totaled
approximately $1.2 million for the three months ended September 30, 2005, an increase of
approximately $1 million over the prior year period. The increase is due primarily to the
recognition of current period research and development fees and recognition of deferred license
fees received from Merck, Par Pharmaceutical and other collaborative partners over the estimated
remaining development periods. For the nine months ended September 30, 2005, revenue increased by
approximately $5.8 million compared to the prior year period to approximately $6.2 million due
primarily to receipt and recognition of a $2.0 million milestone payment received from Questcor in
addition to the recognition of current period research and development fees and of deferred license
fees received in 2004 from Merck, Par Pharmaceutical and other collaborative partners over the
estimated development periods.
Our product revenue consists of sales of Nascobal® nasal gel to Questcor. During the three-
and nine-month periods ended September 30, 2004, we recognized approximately $180,000 and $300,000
of product revenue, respectively, under the supply agreement. During the interim periods ended
September 30, 2005, we did not produce or ship any Nascobal® nasal gel. Cost of product revenue as
a percent of product revenue was 70% for the three months ended September 30, 2004 and 63% for the
nine months ended September 30, 2004. Effective in October 2005, the distribution of our Nascobal®
nasal gel and spray products has been transferred from Questcor to QOL. (See Subsequent Event Note
4 to our Condensed Consolidated Financial Statements.) We expect to receive continued product
revenue under a new QOL 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:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
Peptide YY |
36 | % | 22 | % | 49 | % | 16 | % | ||||||||
Calcitonin |
23 | % | 18 | % | 17 | % | 30 | % | ||||||||
Tight Junctions and RNAi |
24 | % | 29 | % | 16 | % | 25 | % | ||||||||
PTH(1-34) |
4 | % | 17 | % | 5 | % | 15 | % |
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Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
Apomorphine |
4 | % | | % | 5 | % | | % | ||||||||
Other R&D projects (1) |
9 | % | 14 | % | 8 | % | 14 | % | ||||||||
100 | % | 100 | % | 100 | % | 100 | % | |||||||||
(dollars in thousands) |
||||||||||||||||
Total R&D expense |
$ | 4,919 | $ | 8,099 | $ | 16,030 | $ | 22,559 | ||||||||
Dollar increase |
3,180 | 6,529 | ||||||||||||||
Percentage increase |
65 | % | 41 | % |
(1) | Other R&D projects include, without limitation, our oral abuse-resistant opioid, feasibility studies and other projects. |
The $3.2 million increase in the three-month period ended September 30, 2005 over the
same period in 2004 resulted primarily from the following costs:
| personnel-related expenses increased to $3.4 million from $2.2 million due to increased personnel in support of our research and development programs; | ||
| costs of clinical trials, consulting, outside services and laboratory and manufacturing supplies increased to $2.6 million from $1.4 million due to a clinical study for calcitonin and other projects under development; | ||
| facilities-related costs increased to $1.2 million from $0.8 million due to rent and related expenses on additional space leased in the Bothell facility and increased depreciation and maintenance on equipment; and | ||
| administrative costs increased to $0.9 million from $0.5 million due primarily to patent license fees incurred. |
The $6.5 million increase in the nine-month period ended September 30, 2005 over the same
period in 2004 resulted primarily from the following costs:
| personnel-related expenses increased to $9.4 million from $6.5 million due to increased personnel in support of our research and development programs; | ||
| costs of clinical trials, consulting, outside services and laboratory and manufacturing supplies increased to $8.4 million from $6.1 million due to a clinical study for calcitonin and more projects under development; | ||
| facilities-related costs increased to $3.5 million from $2.5 million due to rent and related expenses on additional space leased in the Bothell facility and increased depreciation and maintenance on equipment; and; | ||
| administrative costs increased to $1.2 million from $0.9 million due primarily to patent license fees incurred. |
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; | ||
| 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. |
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Except for 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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Total sales and marketing expense |
$ | 291 | $ | 345 | $ | 656 | $ | 963 | ||||||||
Dollar increase |
54 | 307 | ||||||||||||||
Percentage increase |
19 | % | 47 | % |
The increases in the three- and nine-month periods ended September 30, 2005 over the same
periods in 2004 resulted primarily from increased business development personnel costs and
increases in spending on market research, conference related activities and business development
efforts. We expect sales and marketing costs, which include 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 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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Total general and administrative expense |
$ | 2,394 | $ | 2,019 | $ | 6,090 | $ | 6,949 | ||||||||
Dollar increase (decrease) |
(375 | ) | 859 | |||||||||||||
Percentage increase |
(16 | %) | 14 | % |
The $0.4 million decrease in the three-month period ended September 30, 2005 from the same
period in 2004 was due primarily to lower spending on legal fees on patents and collaborations,
partially offset by increased compensation-related expenses related to the hiring of additional
personnel supporting R&D and compliance activities, non-cash depreciation and stock compensation
expense. The $0.9 million increase in the nine-month period ended September 30, 2005 over the same
period in 2004 was due primarily to increased compensation-related expenses related to the hiring
of additional personnel supporting R&D and compliance activities, legal and
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accounting fees, corporate insurance, non-cash depreciation and stock compensation expense.
We expect general and administrative expenses to remain stable or to increase in the foreseeable
future, depending on the growth of our research and development and other corporate activities.
Interest Income
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 | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Interest income |
$ | 83 | $ | 496 | $ | 182 | $ | 1,321 | ||||||||
Average funds available for investment |
$ | 22,200 | $ | 59,800 | $ | 20,400 | $ | 61,400 | ||||||||
Average interest rate, annualized |
1.5 | % | 3.3 | % | 1.2 | % | 2.9 | % |
The increase in interest income in the three- and nine-month periods ended September 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, previously, on our notes payable. The
following table sets forth information on interest expense, average borrowings and average interest
rate incurred:
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2004 | 2005 | 2004 | 2005 | |||||||||||||
(dollars in thousands) | ||||||||||||||||
Interest expense (excluding other expense, net) |
$ | 111 | $ | 75 | $ | 302 | $ | 265 | ||||||||
Avg. borrowings under capital leases and notes payable |
$ | 11,400 | $ | 4,300 | $ | 10,400 | $ | 5,400 | ||||||||
Average interest rate, annualized |
4 | % | 7 | % | 4 | % | 7 | % |
The decreases in interest expense in the three- and nine-month periods ended September 30,
2005 over the same periods in 2004 was due to an overall reduction in borrowings partially offset
by higher average borrowing rates. 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. Approximate
average interest rates on the Wells Fargo note in the three- and nine-month periods ended September
30, 2004 were 3.3% and 2.4%, respectively. In February 2005, the Wells Fargo note was paid off in
full and canceled. As a result of this note repayment, our average loan balances have decreased
when comparing the current year periods to the prior year periods. Interest rates on outstanding
borrowings under the GE Capital leases range from 8.3% to 10%.
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 $106.7 million as of September 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
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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 September 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. On August 30, 2005 we
completed the public offering of 1,725,000 shares of our common stock at a public offering price of
$13.50 per share pursuant to our $80 million effective shelf registration statement and a $0.7
million post effective amendment filed on August 25, 2005 pursuant to Rule 462(b) of the Securities
Act. The offering resulted in gross proceeds of approximately $23.3 million to the Company, prior
to the deduction of fees and commissions of approximately $1.6 million. At September 30, 2005, the
amount remaining available on this shelf registration statement was zero.
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, 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 believe, although there can be no assurance, that in the future we will receive additional revenue from Par Pharmaceutical in the form of milestone payments, product transfer payments for manufactured product and a profit sharing upon commercialization of generic calcitonin-salmon intranasal spray. |
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| 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 nine-month periods ending September 30, 2004 and 2005 are as
follows:
Nine Months Ended | ||||||||
September 30, | ||||||||
2004 | 2005 | |||||||
(dollars in thousands) | ||||||||
Cash used in operating activities |
$ | (20,521 | ) | $ | (23,369 | ) | ||
Cash provided by (used in) investing activities |
838 | (14,790 | ) | |||||
Cash provided by financing activities |
16,433 | 28,273 | ||||||
Net decrease in cash and cash equivalents |
$ | (3,250 | ) | $ | (9,886 | ) | ||
Our operating activities used cash of $23.4 million in the nine months ended September 30,
2005 compared to $20.5 million in the nine months ended September 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 $14.8 million in the nine months ended September 30,
2005, compared to providing $0.8 million in the nine months ended September 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 $28.3 million in the nine months ended September 30,
2005, compared to $16.4 million in the nine months ended September 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 nine months ended
September 30, 2005, we received net proceeds of approximately $21.7 million, we repaid
approximately $8.4 million on our Revolving Line of Credit and we drew down approximately $2.9
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 $61.1 million
as of September 30, 2005 and $58.4 million as of December 31, 2004. As of September 30, 2005, we
had approximately $67.1 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 September 30, 2005, we had unused capital lease credit lines of approximately $1.1
million out of total available credit lines of approximately $4.0 million. Our available capital
lease line of $4.0 million expires December 31, 2005 and is available for use in financing
equipment and leasehold assets. Our loan balance of approximately $8.4 million at December 31,
2004 was paid in full and canceled in February 2005.
Contractual Obligations
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Our contractual obligations have changed since December 31, 2004 to September 30, 2005 as
follows:
| At September 30, 2005 we have a zero balance in notes payable compared to approximately $8.6 million (including accrued interest) at December 31, 2004 due to the payoff of the note in February 2005; | ||
| At September 30, 2005 our operating lease obligations decreased to approximately $19.8 million (through January 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 through June 2010, partially offset by approximately $1.3 million in rents paid during the nine months ended September 30, 2005; | ||
| Our capital lease obligations increased by approximately $2.2 million to approximately $5.5 million (including future interest payments) at September 30, 2005 due to approximately $2.9 million in new leases signed offset by payments made during the nine months ended September 30, 2005; and | ||
| Our purchase obligations increased by approximately $3.4 million to approximately $3.6 million at September 30, 2005 due to purchase order activity (primarily for calcitonin and PYY) during the nine months ended September 30, 2005. |
Off-Balance Sheet Arrangements
As of September 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 does 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 Interim
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
Interim Chief Financial Officer concluded that the Companys disclosure controls and procedures are
effective for gathering, analyzing and disclosing the information that the Company is required to
disclose in reports filed under the Securities Exchange Act of 1934, as amended.
(b) Internal Control Over Financial Reporting. There have been no changes in the Companys
internal controls over financial reporting or in other factors during the fiscal quarter ended
September 30, 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 September 30, 2005 the Company issued 20,255 shares of
common stock to a holder of common stock warrants (the Warrants) upon the exercise of such
Warrants in a private offering pursuant to Section 4(2) of the Securities Act. The holder of the
Warrants was an accredited investor under Rule 501 of the Securities Act. The Company has
registered the resale of such shares under the Securities Act. The Warrants were exercisable for
an equal number of shares of common stock at an exercise price of $6.3375 per share.
ITEM 4 SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Our stockholders approved the following
proposals at our Annual Meeting of Stockholders held on
Wednesday, July 20, 2005:
1) | The election of the following eleven (11) directors, each to hold office for a term of one (1) year or until their respective successors have been duly elected or appointed: |
Nominee | Votes FOR | Votes WITHHELD | ||||||
Dr. Steven C. Quay |
16,812,873 | 565,445 | ||||||
Susan B. Bayh |
17,278,657 | 99,661 | ||||||
J. Carter Beese, Jr. |
16,755,739 | 622,579 | ||||||
Dr. Alexander D. Cross |
17,283,349 | 94,969 | ||||||
Dr. Ian R. Ferrier |
16,708,284 | 670,034 | ||||||
Myron Z. Holubiak |
16,785,906 | 592,412 | ||||||
Leslie D. Michelson |
16,808,981 | 569,337 | ||||||
John V. Pollock |
16,786,506 | 591,812 | ||||||
Gerald T. Stanewick |
16,809,475 | 568,843 | ||||||
Bruce R. Thaw |
16,816,075 | 562,243 | ||||||
Devin N. Wenig |
16,740,351 | 637,967 |
2) | The appointment of KPMG LLP as our independent registered public accountants for the year ending December 31, 2005: |
Votes FOR | Votes AGAINST | Votes ABSTAINED | Broker NON-VOTES | |||||||||
17,281,295 |
69,519 | 27,504 | 0 |
3) | The approval of a proposed change to our capital structure increasing the number of authorized shares of common stock from 25,000,000 to 50,000,000: |
Votes FOR | Votes AGAINST | Votes ABSTAINED | Broker NON-VOTES | |||||||||
16,513,141 |
824,594 | 40,583 | 0 |
4) | The approval of a proposed Restated Certificate of Incorporation of the Company, including certain changes to modernize, clarify and otherwise make our current Certificate of Incorporation consistent with our Amended and Restated Bylaws and Delaware law: |
Votes FOR | Votes AGAINST | Votes ABSTAINED | Broker NON-VOTES | |||||||||
9,700,758 |
360,103 | 46,535 | 7,270,922 |
5) | The approval of amendments to our 2004 Stock Incentive Plan, including an increase in the number of shares authorized by 750,000 shares, from 600,000 shares to 1,350,000 shares: |
Votes FOR | Votes AGAINST | Votes ABSTAINED | Broker NON-VOTES | |||||||||
9,003,741 |
1,001,134 | 102,521 | 7,270,922 |
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ITEM 6 EXHIBITS
The exhibits required by this item are set forth in the Exhibit Index attached hereto.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned, duly authorized, in Bothell,
State of Washington, on November 2, 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/ Philip C. Ranker | |||
Philip C. Ranker | ||||
VP Finance and Interim Chief Financial Officer |
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EXHIBIT INDEX
Exhibit | ||
No. | Description | |
2.1
|
Agreement and Plan of Reorganization, dated August 8, 2000, among the Company, Atossa Acquisition Corporation, a Delaware corporation and wholly-owned subsidiary of the Company, and Atossa HealthCare, Inc. (filed as Exhibit 2.1 to the Companys Current Report on Form 8-K dated August 8, 2000, and incorporated herein by reference). | |
2.2
|
Asset Purchase Agreement, dated September 30, 2002, with Schwarz Pharma, Inc.(filed as Exhibit 2.1 to the Companys Current Report on Form 8-K dated September 30, 2002 and incorporated herein by reference). | |
3.1
|
Restated Certificate of Incorporation of the Company dated July 20, 2005 (filed as Exhibit 3.1 to our Current Report on Form 8-K dated July 20, 2005, and incorporated herein by reference). | |
3.2
|
Amended and Restated Bylaws of the Company dated August 11, 2004 (filed as Exhibit 3.10 to our Registration Statement on Form S-3, File No. 333-119429, and incorporated herein by reference). | |
4.1
|
Investment Agreement, dated as of February 1, 2002, by and between the Company and Pharmacia & Upjohn Company (filed as Exhibit 4.1 to the Company Current Report on Form 8-K dated February 1, 2002 and incorporated herein by reference). | |
4.2
|
Rights Agreement, dated February 22, 2000, between the Company and American Stock Transfer & Trust Company as Rights Agent (filed as Exhibit 1 to our Current Report on Form 8-K dated February 22, 2000 and incorporated herein by reference). | |
4.3
|
Securities Purchase Agreement dated as of June 25, 2004 (filed as Exhibit 99.2 to our Current Report on Form 8-K dated June 25, 2004 and incorporated herein by reference). | |
4.4
|
Form of Warrant (filed as Exhibit 99.3 to the Companys Current Report on Form 8-K dated June 25, 2004 and incorporated herein by reference). | |
10.1
|
Lease Agreement for facilities at 45 Davids Drive, Hauppauge, NY, effective as of July 1, 2005 (filed as Exhibit 10.30 to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 and incorporated herein by reference). | |
10.2
|
Lease Agreement, dated April 23, 2002, with Phase 3 Science Center LLC, Ahwatukee Hills Investors LLC and J. Alexanders LLC (filed as Exhibit 10.26 to the Companys Quarterly Report on Form 10-Q for the Quarter Ended March 31, 2002 and incorporated herein by reference). | |
10.3
|
First Amendment dated June 17, 2003, to Lease Agreement dated April 23, 2002, with Phase 3 Science Center LLC, Ahwatukee Hills Investors LLC and J. Alexanders LLC (filed as Exhibit 10.2 to the Companys Quarterly Report on Form 10-Q for the Quarter ended June 30, 2003 and incorporated herein by reference). | |
10.4
|
Second Amendment, dated February 4, 2004, to Lease Agreement dated April 23, 2002, with Phase 3 Science Center LLC, Ahwatukee Hills Investors LLC and J. Alexanders LLC (filed as Exhibit 10.24 to the Companys Annual Report on Form 10-K for the year ended December 31, 2003 and incorporated herein by reference). | |
10.5
|
Lease Agreement for facilities at 80 Davids Drive, Hauppauge, NY, effective as of July 1, 2005 (filed as Exhibit 10.5 to the Companys Quarterly Report on Form 10-Q for the Quarter ended June 30, 2005 and incorporated herein by reference). | |
10.6
|
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 |
28
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Exhibit | ||
No. | Description | |
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
|
Agreement, Release and Waiver dated Sept. 7, 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 September 7, 2005 and incorporated herein by reference). | |
10.11
|
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). | |
10.12
|
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). | |
10.13
|
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). | |
10.14
|
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). | |
10.15
|
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). | |
10.16
|
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). | |
10.17
|
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). | |
10.18
|
Amendment No. 2 to Nastech Pharmaceutical Company Inc. 2004 Stock Incentive Plan. (2) | |
10.19
|
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). | |
10.20
|
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). |
29
Table of Contents
Exhibit | ||
No. | Description | |
10.21
|
Non-Qualified Stock Option Grant Agreement effective July 20, 2005by and between Nastech Pharmaceutical Company Inc. and Dr. Steven C. Quay, M.D., Ph.D. (filed as Exhibit 10.3 to the Companys Current Report on Form 8-K dated July 20, 2005 and incorporated herein by reference). | |
10.22
|
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). | |
10.23
|
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). | |
10.24
|
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). | |
10.25
|
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). | |
10.26
|
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). | |
10.27
|
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). | |
10.28
|
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). | |
10.29
|
Restricted Stock Grant Agreement effective October 5, 2005 by and between Nastech Pharmaceutical Company Inc. and Dr. Paul H. Johnson, Ph.D. (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated October 5, 2005 and incorporated herein by reference). | |
10.30
|
Stock Option Agreement effective October 5, 2005 by and between Nastech Pharmaceutical Company Inc. and Dr. Paul H. Johnson, Ph.D. (filed as Exhibit 10.2 to the Companys Current Report on Form 8-K dated October 5, 2005 and incorporated herein by reference). | |
10.31
|
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). | |
10.32
|
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). | |
10.33
|
Restricted Stock Grant Agreement effective August 11, 2004 by and between Nastech Pharmaceutical Company Inc. and Mr. Bruce R. York. (2) | |
10.34
|
Stock Option Agreement dated as of August 25, 2004 between Nastech Pharmaceutical Company Inc. and Mr. Philip C. Ranker. (2). | |
10.35
|
Restricted Stock Grant Agreement effective August 25, 2004 by and between Nastech Pharmaceutical |
30
Table of Contents
Exhibit | ||
No. | Description | |
Company Inc. and Mr. Philip C. Ranker. (2) | ||
10.36
|
Restricted Stock Grant Agreement effective July 1, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Philip C. Ranker. (2) | |
10.37
|
Restricted Stock Grant Agreement effective July 1, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Bruce R. York. (2) | |
10.38
|
Restricted Stock Grant Agreement effective September 7, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Philip C. Ranker. (2) | |
10.39
|
Restricted Stock Grant Agreement effective September 7, 2005 by and between Nastech Pharmaceutical Company Inc. and Mr. Bruce R. York. (2) | |
10.40
|
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). | |
10.41
|
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). | |
10.42
|
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). | |
10.43
|
Revolving Line of Credit Agreement with Wells Fargo Bank, dated December 19, 2003 (filed as Exhibit 10.20 to the Companys Annual Report on Form 10-K for the year ended December 31, 2003 and incorporated herein by reference). | |
10.44
|
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). | |
10.45
|
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). | |
10.46
|
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). | |
10.47
|
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). | |
10.48
|
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) | |
10.49
|
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) | |
10.50
|
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 |
31
Table of Contents
Exhibit | ||
No. | Description | |
on Form 8-K dated October 22, 2004 and incorporated herein by reference). (1) | ||
10.51
|
Agreement dated as of September 23, 2005 by and between Nastech Pharmaceutical Company Inc. and QOL Medical, LLC (filed as Exhibit 10.1 to the Companys Current Report on Form 8-K dated October 17, 2005 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 Interim 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
|
Certification of the Companys Interim 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. |
32