UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarter Ended March 31, 2004
Commission File Number 000-13789
NASTECH PHARMACEUTICAL COMPANY INC.
Delaware | 11-2658569 | |
(State or other jurisdiction of | (I.R.S. Employer Identification No.) | |
incorporation or organization) | ||
3450 Monte Villa Parkway, Bothell, WA | 98021 | |
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (425) 908-3600
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes [ü] No [ ]
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes [ü] No [ ]
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 | ||||||
May 4, 2004 |
Common stock - $ .006 par value | 11,963,828 |
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
TABLE OF CONTENTS
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21 | ||||||||
22 | ||||||||
CERTIFICATIONS |
23 | |||||||
EXHIBIT 31.1 | ||||||||
EXHIBIT 31.2 | ||||||||
EXHIBIT 32.1 | ||||||||
EXHIBIT 32.2 |
Items 1, 2, 3, 4 and 5 have not been included as they are not applicable.
PART I FINANCIAL INFORMATION
ITEM 1 FINANCIAL STATEMENTS
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
March 31, | December 31, | |||||||
2004 |
2003 |
|||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 11,185 | $ | 16,792 | ||||
Short term investments |
8,031 | 8,289 | ||||||
Accounts receivable, net |
111 | 89 | ||||||
Royalties, fees and other receivables |
23 | 15 | ||||||
Inventories |
75 | 180 | ||||||
Prepaid expenses and other assets |
711 | 469 | ||||||
Total current assets |
20,136 | 25,834 | ||||||
Property and equipment, net |
4,797 | 4,474 | ||||||
Security deposits and other assets |
741 | 740 | ||||||
Goodwill |
90 | 90 | ||||||
Total assets |
$ | 25,764 | $ | 31,138 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,850 | $ | 2,390 | ||||
Accrued expenses and other liabilities |
1,528 | 1,510 | ||||||
Note payable |
8,352 | 6,271 | ||||||
Capital lease obligations current portion |
1,016 | 897 | ||||||
Total current liabilities |
12,476 | 11,068 | ||||||
Capital lease obligation, net of current portion 246 273 |
1,584 | 1,569 | ||||||
Other liabilities |
518 | 595 | ||||||
Total liabilities |
14,848 | 13,232 | ||||||
Stockholders equity: |
||||||||
Preferred stock, $.01 par value; 100,000 authorized: no shares issued and
outstanding: |
| | ||||||
Common stock, $0.006 par value; 25,000,000 authorized: 11,962,328 and
11,849,128 shares outstanding at March 31, 2004 and December 31, 2003,
respectively |
72 | 71 | ||||||
Additional paid-in capital |
73,963 | 73,428 | ||||||
Deferred compensation |
(631 | ) | (749 | ) | ||||
Accumulated deficit |
(62,488 | ) | (54,844 | ) | ||||
Total stockholders equity |
10,916 | 17,906 | ||||||
Commitments and contingencies |
||||||||
Total liabilities and stockholders equity |
$ | 25,764 | $ | 31,138 | ||||
See accompanying notes to consolidated financial statements
2
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
Three Months Ended March 31, |
||||||||
2004 |
2003 |
|||||||
Revenues: |
||||||||
Product revenue, net |
$ | 120 | $ | 1,010 | ||||
License and research fees |
28 | 1,307 | ||||||
Total revenues |
148 | 2,317 | ||||||
Costs and expenses: |
||||||||
Cost of product revenue |
64 | 145 | ||||||
Research and development |
5,850 | 2,809 | ||||||
Sales and marketing |
153 | 846 | ||||||
General and administrative |
1,684 | 1,349 | ||||||
Total operating expenses |
7,751 | 5,149 | ||||||
Net loss from operations |
(7,603 | ) | (2,832 | ) | ||||
Interest income |
56 | 52 | ||||||
Interest expense |
(97 | ) | (145 | ) | ||||
Net loss |
$ | (7,644 | ) | $ | (2,925 | ) | ||
Net loss per common share-basic and diluted |
$ | (0.64 | ) | $ | (0.29 | ) | ||
Shares used in computing net loss per share
basic and diluted |
11,893 | 10,196 | ||||||
See accompanying notes to consolidated financial statements
3
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
Common Stock |
Additional Paid-in |
Deferred | Accumulated | Total Stockholders |
||||||||||||||||||||
Shares |
Amount |
Capital |
Compensation |
Deficit |
Equity |
|||||||||||||||||||
Balance December 31,
2002 |
10,193,706 | $ | 61 | $ | 62,506 | $ | (1,219 | ) | $ | (52,703 | ) | $ | 8,645 | |||||||||||
Proceeds from
issuance of common
shares and warrants
in connection with
private placement,
net |
1,513,069 | 9 | 9,954 | | | 9,963 | ||||||||||||||||||
Shares issued in
connection with
options |
142,353 | 1 | 911 | | | 912 | ||||||||||||||||||
Compensation related
to stock options |
| | 57 | 470 | | 527 | ||||||||||||||||||
Net loss |
| | | | (2,141 | ) | (2,141 | ) | ||||||||||||||||
Balance December 31,
2003 |
11,849,128 | 71 | 73,428 | (749 | ) | (54,844 | ) | 17,906 | ||||||||||||||||
Shares issued in
connection with
options |
113,200 | 1 | 527 | | | 528 | ||||||||||||||||||
Compensation related
to stock options |
| | 8 | 118 | | 126 | ||||||||||||||||||
Net loss |
| | | | (7,644 | ) | (7,644 | ) | ||||||||||||||||
Balance March 31, 2004 |
11,962,328 | $ | 72 | $ | 73,963 | $ | (631 | ) | $ | (62,488 | ) | $ | 10,916 | |||||||||||
See accompanying notes to consolidated financial statements
4
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
Three Months Ended | ||||||||
March 31, |
||||||||
2004 |
2003 |
|||||||
Operating activities: |
||||||||
Net loss |
$ | (7,644 | ) | $ | (2,925 | ) | ||
Adjustments to reconcile net loss to net cash provided
by (used in) operating activities: |
||||||||
Non-cash compensation related to stock options |
126 | 118 | ||||||
Depreciation and amortization |
280 | 473 | ||||||
Changes in assets and liabilities: |
||||||||
Accounts and other receivables |
(30 | ) | 326 | |||||
Inventories |
105 | 45 | ||||||
Prepaid expenses and other assets |
(243 | ) | (89 | ) | ||||
Accounts payable |
(540 | ) | (314 | ) | ||||
Deferred revenue |
| 11,729 | ||||||
Accrued expenses and other liabilities |
(59 | ) | (356 | ) | ||||
Net cash provided by (used) in operating activities |
(8,005 | ) | 9,007 | |||||
Investing activities: |
||||||||
Property and equipment acquisitions |
(603 | ) | (755 | ) | ||||
Purchases of investments |
(2,742 | ) | | |||||
Maturities of investments |
3,000 | | ||||||
Net cash used in investing activities |
(345 | ) | (755 | ) | ||||
Financing activities: |
||||||||
Proceeds from notes payable |
2,227 | | ||||||
Payments on notes payable |
(146 | ) | (382 | ) | ||||
Borrowings under capital lease line |
333 | | ||||||
Payments on capital leases |
(199 | ) | (28 | ) | ||||
Exercise of stock options |
528 | 18 | ||||||
Net cash provided by (used in) financing activities |
2,743 | (392 | ) | |||||
Net increase (decrease) in cash and cash equivalents |
(5,607 | ) | 7,860 | |||||
Cash and cash equivalents beginning of period |
16,792 | 9,021 | ||||||
Cash and cash equivalents end of period |
$ | 11,185 | $ | 16,881 | ||||
Supplemental disclosures of investing and financing activities: |
||||||||
Cash paid for interest |
97 | 145 |
See accompanying notes to consolidated financial statements
5
NASTECH PHARMACEUTICAL COMPANY INC. AND SUBSIDIARY
Note 1 General
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, 2003, included in the Companys 2003 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2004. The consolidated financial statements include the financial statements of Nastech Pharmaceutical Company and its wholly owned subsidiary, Atossa HealthCare Inc (collectively, the Company). All intercompany balances and transactions have been eliminated in consolidation.
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States 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 footnotes required by accounting principles generally accepted in the United States for complete financial statements. The information furnished in this report reflects all adjustments (consisting of only normal recurring accruals), which are, in the opinion of management, necessary for a fair presentation of the results for the interim periods. The results of operations for the three-month period ended March 31, 2004 are not necessarily indicative of the results for a full year or for any future period.
Certain reclassifications have been made to the 2003 information to conform to the current year presentation.
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. Effective July 1, 1996, the Company adopted the disclosure requirements of SFAS No. 123, Accounting for Stock-Based Compensation, which requires the disclosure of pro forma net income and earnings per share as if the fair value-based method in measuring compensation expense was adopted as of the beginning of fiscal 1996.
The per share weighted average fair value of stock options granted during the three months ended March 31, 2004, and 2003 was $5.06, and $4.92, respectively, on the date of grant using the Black Scholes option-pricing model with the following weighted-average assumptions:
Three months ended March 31, |
||||||||
2004 |
2003 |
|||||||
Expected dividend yield |
0 | % | 0 | % | ||||
Risk free interest rate |
3.0 | % | 2.9 | % | ||||
Expected stock volatility |
82 | % | 93 | % | ||||
Expected option life |
5 years | 5 years |
6
Had compensation cost been determined based on the fair value at the grant date for our stock options under SFAS No. 123, net loss would have been reported as the pro forma amounts indicated below:
Three months ended March 31, |
||||||||
2004 |
2003 |
|||||||
Net loss, as reported |
$ | (7,644 | ) | $ | (2,925 | ) | ||
Add; Stock-based employee compensation included in the reported net loss |
126 | 118 | ||||||
Deduct; Stock-based employee compensation, determined under fair value
based methods |
(1,183 | ) | (1,204 | ) | ||||
Pro forma net loss |
$ | (8,701 | ) | $ | (4,011 | ) | ||
Loss per share |
||||||||
Basic and diluted as reported |
$ | (0.64 | ) | $ | (0.29 | ) | ||
Basic and diluted pro forma |
$ | (0.73 | ) | $ | (0.39 | ) |
Note 2 Business
The Company is an emerging pharmaceutical company developing products based on applying proprietary drug delivery technologies, with approximately 195 patents and applications filed. The Company is developing molecular biology-based technologies for delivering both small and large molecule drugs by nasal administration, along with an extended release oral delivery technology. The Companys intranasal drug delivery technology may lead to greater drug efficacy, speed of action, safety, and patient compliance. The Company is developing a diverse product portfolio across multiple therapeutic areas, including products targeted for the treatment of sexual dysfunction, obesity, pain management, osteoporosis, and multiple sclerosis.
The Company is building a pharmaceutical company leveraging its unique drug delivery capabilities and technologies as the means to develop commercial products initially with partners, then on the Companys own. The key elements of the Companys business model are to:
| develop proprietary active delivery molecules from its tight junction and siRNA technologies; | |||
| focus on molecules where its portfolio of technologies will offer significant clinical advantages; | |||
| conduct preclinical, clinical and manufacturing steps to generate validated clinical leads and products; | |||
| partner to complete or assist the Company to complete development and commercialization; and | |||
| provide turn-key commercial manufacturing of nasal delivery products. |
The Company is a leader in molecular-biology based delivery, which involves the pharmaceutical manipulation of tight junctions. Tight junctions are the cell-to-cell connections that comprise various tissues of the body and that regulate the transport and passage of therapeutic drugs across these natural barriers. The Company also has expertise in formulation science, a systematic approach to drug development using biophysics, physical chemistry and pharmacology to maximize therapeutic efficacy and safety, which sometimes involves a change in route of administration. The Companys drug delivery technology is essential in designing an optimized, customizable dosage form and in delivering proteins and large molecule drugs that can currently only be delivered by injection or other non-optimized routes.
The Companys core technical competency in molecular-biology based drug delivery involves the research, development and manufacture of nasally administered prescription pharmaceuticals. The Company investigates the commercial weaknesses of pharmaceutical products currently available in oral, injectable or other dosage forms, and determines the advantages an alternative drug delivery system, such as intranasal, would have for the same drug in the market place. For example, while the oral route of drug delivery is the most popular and least expensive method of delivery, gastrointestinal and liver metabolism can reduce an oral drugs effectiveness. Generally, a nasal delivery system will provide faster absorption
7
into the blood stream than an oral product thereby resulting in faster onset of action. Other advantages of this therapy may include lower drug doses, fewer side effects, greater safety and efficacy, greater convenience to the patient, better patient compliance of prescribed drug therapy and lower overall health care costs for the patient when compared to established methods of delivery.
The Companys current business strategy seeks to broaden applications of its commitment to tight junction technology and formulation science, allowing drugs to be more safe and effective in patient treatment, with particular emphasis on the applications for nasal drug delivery, in the prescription and over-the-counter markets.
As of March 31, 2004, the Company has an accumulated deficit of $62.5 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 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, negotiate or maintain successful collaborative arrangements, protect its patents and proprietary technology, overcome uncertainties regarding its technologies, competition and technological change, obtain government approval for products and attract and retain key officers and employees. .
Note 3 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 and warrants totaling approximately 4,050,835 and 3,476,155 shares at March 31, 2004 and 2003, respectively, were not included in the net loss per share calculation because their effect would have been antidilutive.
Note 4 Contractual Agreements
(a) 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 has filed the New Drug Application, and will continue to prosecute the pending U.S. patents, in each case for the Nascobal® nasal spray product on behalf of Questcor.
Under the terms of a supply agreement between the parties, subject to certain limitations, the Company is obligated to manufacture and supply all of Questcors requirements and Questcor is obligated to purchase from the Company all of its requirements, for the Nascobal® nasal gel and, upon FDA approval, the Nascobal® nasal spray. During the three months ended March 31, 2004, the Company recognized $120,000 of product revenue related to the supply agreement.
(b) Pharmacia & Upjohn Company On January 24, 2003, the Company entered into a divestiture agreement (the Divestiture Agreement) with Pharmacia & Upjohn Company (Pharmacia), under which the Company reacquired all rights to the intranasal apomorphine product that was the subject of the collaboration and license agreement that the Company and Pharmacia entered into in February 2002 (the Pharmacia Agreement). Upon the signing of the Divestiture Agreement in January 2003, Pharmacia made a cash payment to the Company of $13.5 million consisting of a $6.0 million divestiture payment, $7.0 million in research and development funds and $500,000 for reimbursement of expenses of the divestiture transaction. During the three months ended March 31, 2003, the Company recognized $1.0
8
million in license and research fees and $500,000 of legal expense reimbursement which was recorded as a reduction of general and administrative expenses, relating to the $13.5 million payment.
Under the terms of the Pharmacia Agreement, Pharmacia had received exclusive, worldwide rights to develop and market intranasal apomorphine for the treatment of male and female sexual dysfunction and had agreed to manage and fund all future development in these indications. The Company received an upfront payment at signing in February 2002 of $3.0 million and an additional payment of $2.0 million for transfer of the apomorphine Investigational New Drug application to Pharmacia in April 2002. The $3.0 million upfront payment and $2.0 million additional payment were being amortized over the estimated development period on a straight-line basis through December 31, 2005. During the three months ended March 31, 2003, the Company recognized $273,000 in license fee revenue related to these payments. In April 2003, the Company recognized all remaining deferred revenue from the license fees due to the termination of the Pharmacia Agreement.
Under the terms of the Pharmacia Agreement, Pharmacia also agreed to pay the Company for certain research and development costs for activities conducted by the Company since the execution of the Pharmacia Agreement. During the three months ended March 31, 2003, the Company recognized revenue of $11,000, related to such activities, all of which is included in license and research fee revenue.
Note 5 Notes Payable
On September 30, 2002, the Company purchased any and all rights pursuant to a license agreement from Schwarz Pharma related to the Nascobal® product. Under the terms of the agreement, the Company agreed to pay Schwarz Pharma a total of $8.75 million, comprised of an upfront payment of $1.5 million, with the remaining balance of $7.25 million paid by a note issued to Schwarz Pharma. Under the terms of the note, the Company made a payment of $654,000 to Schwarz Pharma on March 31, 2003, which was comprised of $382,000 in principal on the note and $272,000 of accrued interest. In June 2003, the Company entered into an agreement to sell Nascobal® to Questcor Pharmaceuticals. In connection with the sale, the remaining $6.9 million note payable to Schwarz Pharma and accrued interest of approximately $110,000 were paid in full. Schwarz Pharma subsequently released its security interest in certain assets that relate specifically to Nascobal®, including, without limitation, patents, trademarks, copyrights, licenses and permits, inventory, receivables and manufacturing equipment.
In June 2003, the Company issued a cash secured Revolving Reducing Note to Wells Fargo Bank (the Wells Fargo Note). Under the terms of the Wells Fargo Note, the Company could draw down up to $7.0 million for a one-year term and fix the interest rate for one, two or three months at a rate of three-quarters percent above LIBOR. If the interest rate and term are not fixed, the interest rate will be 1.5% below prime. Interest accrued on the note is due monthly on the first day of the following month. The amount available under the note decreased by $145,833 per month as of the first day of each month and the Company was required to make a principal payment on the first day of the month in an amount sufficient to reduce the then outstanding principal balance to the new maximum principal amount available. In December 2003, the Company terminated the June 2003 note agreement and issued a new cash secured Revolving Line of Credit Note to Wells Fargo Bank to allow for borrowings up to $9.0 million through December 31, 2004. Monthly principal payments are no longer required under the new note and the interest rate and monthly interest payments are the same as the original note. The entire balance of the note is due December 31, 2004. In January 2004, the Revolving Line of Credit Note was amended to incorporate a Letter of Credit Subfeature (the Subfeature). Under the Subfeature, $648,000 of the $9.0 million line of credit is reserved for issuance of a standby letter of credit agreement to the Companys landlord for its Bothell facility under the terms of its lease for that facility. On March 26, 2004, the Company drew down $2.3 million on the note which represented all remaining available funds. As of March 31, 2004, the balance on the note was $8,352,000 and the interest rate was fixed for a 30 day term at an interest rate of 1.875% per annum.
9
Note 6 Capital Lease Obligation
In April 2002, the Company entered into a capital lease agreement with GE Capital Corporation (the GE Lease) to fund the Companys fixed asset purchases. In December 2003, the GE Lease was amended to allow the Company to finance up to $2.75 million in additional purchases through December 31, 2004. In March 2004, the Company drew down approximately $333,000 on the GE Lease at an interest rate of 8.3%. As of March 31, 2004, the Company has approximately $1,974,000 which it may drawn down through December 31, 2004.
Note 7 Related Party Transactions
The Company pays certain monthly expenses incurred by a company that is owned primarily by its Chief Executive Officer in exchange for use of this companys laboratory facility for certain research and development work. Under this arrangement, during the three months ended March 31, 2004 and March 31, 2003, the Company paid rent of approximately $1,500 and $9,200, respectively. In January 2004, the Company entered into an agreement to sublet this facility to a third party through May 31, 2004 which is the remaining term of the lease.
In October 2003, the Company entered into a consulting agreement with Dr. Ian Ferrier, a member of the Companys Board of Directors, for the purpose of advising the company on its strategic planning. Under the agreement, Dr. Ferrier was paid $45,000 in the three months ended March 31, 2004. The agreement terminated on April 30, 2004.
10
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 the Company. These factors include, but are not limited to: (i) the ability of the Company to obtain additional funding; (ii) the ability of the Company to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the Companys and/or a partners ability to successfully complete product research and development, including pre-clinical and clinical studies and commercialization; (iv) the Companys and/or a partners ability to obtain required governmental approvals, including product and patent approvals; and (v) the Companys and/or the Companys 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 the Companys 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 the Companys filings with the Securities and Exchange Commission, including those factors discussed under the caption Risk Factors in the Companys most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which the Company urges investors to consider. The Company undertakes no obligation to publicly release the 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.
Nastech Pharmaceutical Company Inc. is an emerging pharmaceutical company developing products based on applying proprietary drug delivery technologies, with approximately 195 patents and applications filed. We are developing molecular biology-based technologies for delivering both small and large molecule drugs by nasal administration, along with an extended release oral delivery technology. Our intranasal drug delivery technology may lead to greater drug efficacy, speed of action, safety, and patient compliance. We are developing a diverse product portfolio across multiple therapeutic areas, including products targeted for the treatment of sexual dysfunction, obesity, pain management, osteoporosis, and multiple sclerosis.
We are building a pharmaceutical company leveraging our unique drug delivery capabilities and technologies as the means to develop commercial products initially with partners, then on our own. The key elements of our business model are to:
| develop proprietary active delivery molecules from our tight junction and siRNA technologies; | |||
| focus on molecules where our portfolio of technologies will offer significant clinical advantages; | |||
| conduct preclinical, clinical and manufacturing steps to generate validated clinical leads and products; | |||
| partner to complete or assist us to complete development and commercialization; and | |||
| provide turn-key commercial manufacturing of nasal delivery products. |
We are a leader in molecular-biology based drug delivery, which involves the pharmaceutical manipulation of tight junctions. Tight junctions are the cell-to-cell connections that comprise various tissues of the body and that regulate the transport and passage of therapeutic drugs across these natural barriers. We also have expertise in formulation science, a systematic approach to drug development using biophysics, physical chemistry and pharmacology to maximize therapeutic efficacy and safety, which
11
sometimes involves a change in route of administration. Our drug delivery technology is essential in designing an optimized, customizable dosage form and in delivering proteins and large molecule drugs that can currently only be delivered by injection or other non-optimized routes.
Our core technical competency in molecular-biology based drug delivery involves the research, development and manufacture of nasally administered prescription pharmaceuticals. We investigate the commercial weaknesses of pharmaceutical products currently available in oral, injectable or other dosage forms, and we determine the advantages an alternative drug delivery system, such as intranasal, would have for the same drug in the market place. For example, while the oral route of drug delivery is the most popular and least expensive method of delivery, gastrointestinal and liver metabolism can reduce an oral drugs effectiveness. Generally, a nasal delivery system will provide faster absorption into the blood stream than an oral product thereby resulting in faster onset of action. Other advantages of this therapy may include lower drug doses, fewer side effects, greater safety and efficacy, greater convenience to the patient, better patient compliance of prescribed drug therapy and lower overall health care costs for the patient when compared to established methods of delivery.
Our current business strategy seeks to broaden applications of our commitment to tight junction technology and formulation science, allowing drugs to be more safe and effective in patient treatment, with particular emphasis on the applications for nasal drug delivery, in the prescription and over-the-counter markets.
We have an accumulated deficit of $62.5 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 March 31, 2004, we had approximately $19.2 million in cash, cash equivalents and shortterm investments. We believe that our current cash position provides us with adequate working capital through at least March 31, 2005. In addition, we are planning to enter into various collaborations to accelerate our R&D programs, and to the extent these collaborations do not occur, we may be required to reduce our research and development activities or raise additional funds from new investors or in the public markets. On December 18, 2003, we filed a shelf registration statement on Form S-3 with the SEC, pursuant to which we may issue common stock and warrants from time to time, up to an aggregate of $30.0 million. The terms of any future offering would be established at the time of the offering. The shelf registration statement was declared effective by the SEC on January 14, 2004. The shelf registration statement will enable us to raise funds from the offering of any individual security covered by the shelf registration statement, as well as any combination thereof, from time to time and through one or more methods of distribution, subject to market conditions and our capital needs. We plan to use the proceeds from any offering under the registration statement for general corporate purposes, including financing our clinical development and research programs.
Critical Accounting Estimates
We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the United States of America. As such, we are required to make certain estimates, judgments and assumptions that we believe are reasonable based upon the information available. These estimates and assumptions affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the periods presented. Actual results could differ significantly from those estimates under different assumptions and conditions. We believe that the following discussion addresses our most critical accounting estimates which are those that are most important to the portrayal of our financial condition and results of operations and which require our most difficult and subjective judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. We also have other policies that we consider key accounting policies; however, these policies do not meet the definition of critical accounting estimates, because they do not generally require us to make estimates or judgments which are difficult or subjective.
12
Revenue Recognition
Most of our revenues are generated from complex research and licensing arrangements. These research and licensing arrangements may include upfront non-refundable payments, milestone payments, royalties, revenue from R&D services performed and product sales revenue.
Upfront non-refundable fees received under research collaboration agreements are generally recognized over the term of the related research period. Changes in estimated development time or costs of development are recognized prospectively. Any such changes could impact future revenue recognition depending on whether estimated time or costs increase or decrease. Upfront non-refundable fees received under license agreements, which do not require any further research and development activities or other continuing involvement on our part are recognized upon receipt.
Milestone payments are typically progress payments for specific events of development, such as completion of preclinical or clinical activities, regulatory submission or approval, or manufacturing objectives prior to commercialization of a product. These milestone payments are generally non-refundable and recognized as revenue based on the percentage of actual product research and development costs incurred to date to the estimated total of such costs to be incurred over the development period.
Royalty revenue is generally recognized at the time of product sale by the licensee.
Revenue from R&D services performed is generally services performed under collaboration agreements and is recognized at the time the services are performed.
Product sales revenue is recognized at the time the manufactured goods are shipped to the purchaser and title has transferred.
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 Note 1 of the Notes to 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 of Directors only if the fair market value of the underlying stock at the time of grant exceeds the exercise price. In the three months ended March 31, 2004 and 2003, our stock option grants were based on the closing price of our stock on the date of grant. 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 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.
Income Taxes
A critical estimate is the full valuation allowance for deferred taxes that was recorded based on the uncertainty that such tax benefits will be realized in future periods. To the extent we achieve profitability such deferred tax allowance would be reversed at that time.
Results of Operations
Revenue
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Revenue and dollar and percentage change as compared to the same period in the prior year are as follows (dollar amounts are presented in thousands):
Three Months Ended March 31, |
||||||||||||||||
Percentage | ||||||||||||||||
2004 |
2003 |
Dollar decrease |
decrease |
|||||||||||||
Product revenue, net |
$ | 120 | $ | 1,010 | ($ | 890 | ) | (88 | %) | |||||||
License and research fees |
28 | 1,307 | ($ | 1,279 | ) | (98 | %) | |||||||||
Total revenue |
$ | 148 | $ | 2,317 | ($ | 2,169 | ) | (94 | %) | |||||||
The decrease in license and research fees in the first three months of 2004 over the same period in 2003 was due to fees received in 2003 as a result of the divestiture agreement which we entered into with Pharmacia under which we reacquired all rights to the intranasal apomorphine product.
The following table sets forth information on product revenue, cost of product revenue and cost of product revenue as a percentage of product revenue for the three months ended March 31, 2004 and 2003 (dollar amounts are presented in thousands):
Three Months Ended March 31, |
||||||||
2004 |
2003 |
|||||||
Product revenue, net |
$ | 120 | $ | 1,010 | ||||
Cost of product revenue |
$ | 64 | $ | 145 | ||||
Cost of product revenue as a percentage
of product revenue |
53 | % | 14 | % |
Product revenue consists of sales of Nascobal® nasal gel. During the three months ended March 31, 2003, we earned revenue from our own direct sales of Nascobal® nasal gel to drug wholesalers using a contract sales organization and contract distributor. On June 17, 2003, we completed the sale of certain assets relating to our Nascobal® brand products to Questcor. In connection with the sale, we entered into a supply agreement with Questcor under which Questcor is obligated to purchase from us all of its requirements for the Nascobal® nasal gel and, upon FDA approval, the Nascobal® nasal spray. During the three months ended March 31, 2004, we earned manufacturing revenue under the supply agreement. As a result of the change from earning revenue from our own direct sales of Nascobal® in 2003 to earning manufacturing revenue under the supply agreement in 2004, product revenue decreased significantly. In addition, gross profit margins in 2004 were derived from manufacturing revenue as compared to the higher margins earned in 2003 from our own direct sales to drug wholesalers. . In the future, we expect to receive manufacturing revenue under the supply agreement.
Research and development
Research and development expense consists primarily of salaries and other personnel-related expenses, costs of clinical trials, consulting and other outside services, laboratory supplies, facilities costs, FDA filing fees and other costs. Research and development expense by project as a percentage of total R&D expense and total R&D expense as compared to the same period in the prior year are as follows (dollar amounts are presented in thousands):
Three Months Ended March 31, |
||||||||
2004 |
2003 |
|||||||
Apomorphine Hydrochloride |
7 | % | 10 | % | ||||
Calcitonin |
12 | % | 26 | % | ||||
Peptide YY |
60 | % | 13 | % | ||||
Other R&D projects(1) |
21 | % | 51 | % | ||||
100 | % | 100 | % | |||||
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Three Months Ended March 31, |
||||||||
2004 |
2003 |
|||||||
Total R&D expense |
$ | 5,850 | $ | 2,809 | ||||
Dollar increase |
$ | 3,041 | ||||||
Percentage increase |
108 | % |
1. | Other R&D projects include our tight junctions and RNAi research, oral abuse-resistant opioid and Nascobal® nasal spray programs and other projects. |
The increase in the three months ended March 31, 2004 over the same period in 2003 resulted primarily from the following costs:
| Personnelrelated expenses increased 37% to $2.1 million due to an increase in staffing our research and development personnel in support of our research and development programs. | |||
| Costs of clinical trials, consulting, outside services and laboratory supplies increased 452% to $2.9 million due to clinical trials performed for our PYY, calcitonin and apomorphine products under development. | |||
| Facilities costs increased 12% to $730,000 due to rent and related expenses on additional space leased in the Bothell facility. |
We expect an increase in research and development costs in the foreseeable future as we continue our research and development activities. These expenditures are subject to numerous 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, 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 generally 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, among others:
| the number of sites included in the clinical trials; | |||
| the length of time required to enroll suitable patient subjects; | |||
| the number of participants in the trials; | |||
| the duration of participant follow-up that seems appropriate in view of results; and | |||
| the number and complexity of safety and efficacy parameters monitored during the study |
None of our current pipeline of drug 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 third parties have control over the development process for a product, the estimated completion date would largely be under control of that third party rather than under our control. We cannot forecast with any degree of certainty how such collaboration arrangements will affect our development plans or capital requires.
As a result of the uncertainties discussed above, we are 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, advertising, and in the first three months of 2003 costs of using a
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contract sales organization and contract distributor for Nascobal® nasal gel,. Total sales and marketing expense and dollar and percentage changes as compared to the same period in the prior year are as follows (dollar amounts are presented in thousands):
Three Months Ended March 31, |
||||||||
2004 |
2003 |
|||||||
Total sales and marketing expense |
$ | 153 | $ | 846 | ||||
Dollar decrease |
($ | 693 | ) | |||||
Percentage decrease |
(82 | %) |
The decrease in the three months ended March, 31 2004 over the same period in 2003 is due to the sale of Nascobal® which occurred in June 2003. In the first three months of 2003, we incurred costs associated with marketing programs to support our own direct sales of Nascobal® nasal gel. After the sale of Nascobal® in June 2003, we no longer receive revenue from our own direct sales of Nascobal® and this level of spending on sales and marketing was no longer necessary. We expect sales and marketing costs which includes business development staff and activities to increase somewhat in the foreseeable future to support activities associated with partnering our drug candidates.
General and administrative
General and administrative expense consists primarily of salaries and other personnel-related expenses to support our R&D and corporate activities, amortization of non-cash deferred stock option compensation, professional fees such as accounting and legal, corporate insurance, amortization of intangibles and facilities costs. Total general and administrative expense and dollar and percentage changes as compared to the same period in the prior year are as follows (dollar amounts are presented in thousands):
Three Months Ended March 31, |
||||||||
2004 |
2003 |
|||||||
Total general and administrative expense |
$ | 1,684 | $ | 1,349 | ||||
Dollar increase |
$ | 335 | ||||||
Percentage increase |
25 | % |
The increase in the three months ended March 31, 2004 over the same period in 2003 resulted primarily from the following costs:
| Costs of legal fees, accounting fees, corporate insurance and other administrative costs increased $565,000 to $800,000. This increase is due to a $500,000 reimbursement of legal expenses received in 2003 as part of the divestiture agreement with Pharmacia, which was recorded as a reduction in general administrative expenses in the three months ended March 31, 2003. | |||
| Amortization of intangibles decreased $216,000 in 2004. In 2003, we recorded amortization of intangibles expense of $216,000 on the Nascobal® related assets. In June 2003, we completed the sale of certain assets relating to our Nascobal® brand products to Questcor, at which time the amortization of the related tangibles ceased. |
We expect general and administrative expenses to remain stable in the foreseeable future in support of our research and development and corporate activities.
Interest Income
The following table sets forth information on interest income, average funds available for investment and average interest rate earned for the three months ended March 31, 2004, and 2003 (dollar amounts are presented in thousands):
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Three Months Ended March 31, |
||||||||
2004 |
2003 |
|||||||
Interest income |
$ | 56 | $ | 52 | ||||
Average funds available for investment |
$ | 20,600 | $ | 11,600 | ||||
Average interest rate |
1.1 | % | 1.8 | % |
The increase in interest income in the three months ended March 31, 2004 over the same period in 2003 was driven primarily by an increase in the average funds available for investment offset by a decrease in the average interest rate earned due to a decrease in the prevailing market interest rates.
Interest Expense
We incur interest expense on our capital leases and our notes payable. The following table sets forth information on interest expense, average borrowings and average interest rate earned for the three months ended March 31, 2004 and 2003 (dollar amounts are presented in thousands):
Three Months Ended March 31, |
||||||||
2004 |
2003 |
|||||||
Interest expense |
$ | 97 | $ | 145 | ||||
Average borrowings under capital leases and notes payable |
$ | 9,200 | $ | 7,600 | ||||
Average interest rate |
4.2 | % | 7.6 | % |
The decrease in interest expense in the three months ended March 31, 2004 over the same period in 2003 was driven primarily by a decrease in the average interest rate. In the three months ended March 31, 2003, average borrowings under the Schwarz Pharma note were $7,250,000 at an interest rate of $7.5% and average borrowings under the GE Capital leases were approximately $350,000 at interest rates ranging from 9.54% to 9.96%. In June 2003, we paid off the note payable to Schwarz Pharma in connection with our sale of Nascobal® to Questcor. In June 2003, we entered into a note payable with Wells Fargo bank at a rate of LIBOR plus 0.75%. As of March 31, 2004, the balance on the note payable with Wells Fargo was $8,352,000 and the interest rate was fixed for a 30 day term at a rate of 1.875% per annum.
Liquidity and Capital Resources
Cash Requirements
We have financed our operations primarily through the sale of common stock and warrants in private placements and in the public markets, revenues received from our collaborative partners, equipment financing facilities and notes payable. As of March 31, 2004, we had approximately $19.2 million in cash, cash-equivalents and short-term investments.
We have an accumulated deficit of $62.5 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. We believe that our current cash position provides us with adequate working capital through at least March 31, 2005. In addition, we are planning to enter into various collaborations to accelerate our R&D programs, and to the extent these collaborations do not occur, we may be required to reduce our research and development activities or raise additional funds from new investors or in the public markets. On December 18, 2003, we filed a shelf registration statement on Form S-3 with the SEC, pursuant to which we may issue common stock and warrants from time to time, up to an aggregate of $30.0 million. The terms of any future offering would be established at the time of the offering. The shelf registration statement was declared effective by the SEC on January 14, 2004. The shelf registration statement will enable us to raise funds from the offering of any individual security covered by the shelf registration statement, as well as any combination thereof, from time to time and through one or more methods of distribution, subject to market conditions
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and our capital needs. We plan to use the proceeds from any offering under the registration statement for general corporate purposes, including financing our clinical development and research programs.
Sources and Uses of Cash
Total sources and uses of cash for the three months ending March 31, 2004 and 2003 are as follows (dollar amounts presented in thousands):
Three Months Ended March 31, |
||||||||
2004 |
2003 |
|||||||
Cash provided by (used in) operating activities |
($8,005 | ) | $ | 9,007 | ||||
Cash used in investing activities |
(345 | ) | (755 | ) | ||||
Cash provided by (used in) financing activities |
2,743 | (392 | ) | |||||
Net increase (decrease) in cash and cash equivalents |
($5,607 | ) | $ | 7,860 | ||||
Our operating activities used cash of $8.0 million in the three months ended March 31, 2004, compared to providing cash of $9.0 million in the same period in 2003. Cash used in operating activities relates primarily to funding net losses and changes in deferred revenue from collaborators, partially offset by non-cash charges related to depreciation and amortization of deferred stock compensation and intangibles. In the three months ended March 31, 2003 we received a payment of $13.5 million from Pharmacia related to the divestiture agreement of which $1.0 million was recognized as revenue and $500,000 was recognized as legal expense reimbursement during the same time period. The remaining funds were recorded as deferred revenue. 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 $345,000 in the three months ended March 31, 2004, compared to $755,000 in the same period in 2003. Changes in cash from investing activities are due primarily to purchases of short-term investments net of maturities and purchases of equipment. We expect to continue to make significant investments in our research and development infrastructure, including the purchase of equipment to support our research and development activities.
Our financing activities provided cash of $2.7 million in the three months ended March 31, 2004, compared to using cash of $392,000 in the same period in 2003. Changes in cash from financing activities are primarily due to issuance of common stock and warrants, issuance of notes payable and proceeds from equipment financing facilities. We finance equipment purchases through equipment financing facilities, such as capital leases and our Revolving Line of Credit. During the three months ended March 31, 2004, we drew down approximately $2.3 million on our Revolving Line of Credit and $333,000 on a capital lease. On December 18, 2003, we filed a shelf registration statement on Form S-3 with the SEC, pursuant to which we may issue common stock and warrants from time to time, up to an aggregate of $30.0 million. The shelf registration statement was declared effective by the SEC on January 14, 2004. We plan to use the proceeds from any offering under the registration statement for general corporate purposes, including financing our clinical development and research programs. Over the next several years, we are required to make certain payments on our contractual obligations.
Off-Balance Sheet Arrangements
As of March 31, 2004, we did not have any significant off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.
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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 double AA rating and higher). To mitigate market risk, securities have a maturity date within 15 months, no category of issue can exceed 50% of the portfolio, and holdings of any one issuer excluding the U.S. government do not exceed 20% of the portfolio. Periodically, the portfolio is reviewed and adjusted if the credit rating of a security held has deteriorated. We do not utilize derivative financial instruments.
ITEM 4 CONTROLS AND PROCEDURES
(a) As of the end of the period covered by this Quarterly Report on Form 10-Q, the Company carried out an evaluation, under the supervision and with the participation of senior management, including the Companys Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of its disclosure controls and procedures. Based upon that evaluation, the Companys Chief Executive Officer and Chief Financial Officer concluded that the Companys disclosure controls and procedures are effective for gathering, analyzing and disclosing the information that the Company is required to disclose in reports filed under the Securities Exchange Act of 1934.
(b) There have been no significant changes in the Companys internal controls over financial reporting or in other factors during the fiscal quarter ended March 31, 2004 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 6 EXHIBITS AND REPORTS ON FORM 8-K
(a) | Exhibits |
The following documents are filed as part of this report:
Exhibit No. |
Description |
|
31.1
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 | |
31.2
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 | |
32.1
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 | |
32.2
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 |
(b) | Reports on Form 8-K |
(1) | We filed a Current Report on Form 8-K, dated March 10, 2004, in which we reported under Item 12 our financial results for the fiscal year ended December 31, 2003. | |||
(2) | We filed a Current Report on Form 8-K, dated March 10, 2004, in which we reported under Item 5 that on March 10, 2004, we reported positive PYY and apomorphine clinical trial data. | |||
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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 May 7, 2004. |
NASTECH PHARMACEUTICAL COMPANY INC.
By: | /s/ Steven C. Quay | |||
Steven C. Quay, M.D., Ph.D. President, Chief Executive Officer and Chairman of the Board |
||||
(Principal Executive Officer) | ||||
By: | /s/ Gregory L. Weaver | |||
Gregory L. Weaver, CPA Chief Financial Officer |
||||
(Principal Financial and Accounting Officer) |
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INDEX TO EXHIBITS
Exhibit Number | Description | |
31.1
|
Chief Executive Officer Certification required by Rules 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. | |
31.2
|
Chief Financial Officer Certification required by Rules 13a-14 and 15d-14 under the Securities Exchange Act of 1934, as amended. | |
32.1
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 | |
32.2
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002 |
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