10-Q 1 j5788_10q.htm 10-Q

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 10-Q


 

ý

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2002

 

Commission File No. 0-16614

 

NEORX CORPORATION

(Exact name of Registrant as specified in its charter)

 

Washington

 

91-1261311

(State or other jurisdiction of
incorporation or organization)

 

(IRS Employer Identification No.)

 

 

 

410 West Harrison Street, Seattle, Washington 98119-4007

(Address of principal executive offices)

 

 

 

Registrant’s telephone number, including area code: (206) 281-7001

 

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      ý      No     o

 

As of November 14, 2002, 26,765,082 shares of the Registrant’s common stock, $.02 par value per share, were outstanding.

 

 



 

TABLE OF CONTENTS

 

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, 2002

 

 

PART I

FINANCIAL INFORMATION

 

 

Item 1.

Financial Statements (Unaudited):

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2002 and December 31, 2001

 

 

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2002 and 2001

 

 

 

Condensed Consolidated Statements Of Cash Flows for the Nine Months Ended September 30, 2002 and 2001

 

 

 

Notes to Condensed Consolidated Financial Statements

 

 

Item 2.

Management’s Discussion and Analysis of Results of Operations and Financial Condition

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

 

Item 4.

Controls and Procedures

 

 

PART II
OTHER INFORMATION
 
 

Item 5.

Other Information

 

 

Item 6.

Exhibits

 

 

 

Signature

 

 

 

Certifications

 

2



 

PART I.  FINANCIAL INFORMATION

Item 1.  Financial Statements

 

NEORX CORPORATION AND SUBSIDIARY

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

(unaudited)

 

 

 

September 30, 2002

 

December 31, 2001

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

1,110

 

$

4,097

 

Investment securities

 

11,268

 

29,484

 

Notes receivable

 

68

 

177

 

Prepaid expenses and other current assets

 

1,199

 

907

 

Total current assets

 

13,645

 

34,665

 

 

 

 

 

 

 

Facilities and equipment, net

 

9,083

 

15,222

 

Other assets, net

 

736

 

1,141

 

 

 

 

 

 

 

Total assets

 

$

23,464

 

$

51,028

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

844

 

$

1,537

 

Accrued liabilities

 

1,834

 

1,701

 

Current portion of note payable

 

478

 

304

 

Total current liabilities

 

3,156

 

3,542

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

Note payable, net of current portion

 

5,347

 

5,696

 

Other

 

25

 

75

 

Total long-term liabilities

 

5,372

 

5,771

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Preferred stock, $.02 par value, 3,000,000 shares authorized:

 

 

 

 

 

Convertible preferred stock, Series 1, 205,340 shares issued and outstanding at September 30, 2002 and December 31, 2001 (entitled in liquidation to $5,175 at September 30, 2002 and December 31, 2001)

 

4

 

4

 

Common stock, $.02 par value, 60,000,000 shares authorized, 26,765,082 and 26,571,098 shares issued and outstanding at September 30, 2002 and December 31, 2001, respectively

 

535

 

532

 

Additional paid-in capital

 

224,031

 

223,905

 

Accumulated other comprehensive income – unrealized gain on investment securities

 

32

 

578

 

Accumulated deficit

 

(209,666

)

(183,304

)

Total shareholders’ equity

 

14,936

 

41,715

 

Total liabilities and shareholders’ equity

 

$

23,464

 

$

51,028

 

 

See accompanying notes to the condensed consolidated financial statements.

 

3



 

NEORX CORPORATION AND SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2002

 

2001

 

2002

 

2001

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

507

 

$

263

 

$

2,036

 

$

1,437

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

4,369

 

5,663

 

17,403

 

14,334

 

General and administrative

 

1,535

 

2,755

 

5,137

 

6,014

 

Asset impairment loss

 

5,658

 

 

5,658

 

 

Restructuring

 

529

 

 

529

 

 

Total operating expenses

 

12,091

 

8,418

 

28,727

 

20,348

 

Loss from operations

 

(11,584

)

(8,155

)

(26,691

)

(18,911

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Realized gain on sale of securities

 

20

 

154

 

142

 

253

 

Loss on disposal of equipment

 

(69

)

 

(69

)

 

Interest income

 

204

 

656

 

912

 

2,314

 

Interest expense

 

(75

)

(133

)

(281

)

(285

)

Total other income

 

80

 

677

 

704

 

2,282

 

Net loss

 

(11,504

)

(7,478

)

(25,987

)

(16,629

)

Preferred stock dividends

 

(125

)

(125

)

(375

)

(375

)

Net loss applicable to common shares

 

$

(11,629

)

$

(7,603

)

$

(26,362

)

$

(17,004

)

Net loss per common share - basic and diluted

 

$

(0.44

)

$

(0.29

)

$

(0.99

)

$

(0.65

)

Weighted average common shares outstanding - basic and diluted

 

26,634

 

26,433

 

26,604

 

26,358

 

 

See accompanying notes to the condensed consolidated financial statements.

 

4



 

NEORX CORPORATION AND SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2002

 

2001

 

 

 

 

 

 

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(25,987

)

$

(16,629

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation and amortization

 

1,337

 

929

 

Gain on sale of securities

 

(142

)

(253

)

Loss on disposal of equipment

 

69

 

 

Asset impairment loss

 

5,658

 

 

Restructuring

 

529

 

 

Common stock issued for services

 

68

 

148

 

Stock options and warrants issued for services

 

42

 

921

 

Change in operating assets and liabilities:

 

 

 

 

 

Decrease in notes receivable

 

109

 

2,555

 

(Increase) decrease in prepaid expenses and other assets

 

(129

)

497

 

Decrease in accounts payable

 

(693

)

(607

)

Increase in accrued liabilities

 

(521

)

820

 

Net cash used in operating activities

 

(19,660

)

(11,619

)

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Proceeds from sales and maturities of investment securities

 

25,661

 

40,933

 

Purchases of investment securities

 

(7,849

)

(25,335

)

Facilities and equipment purchases

 

(683

)

(7,350

)

Net cash provided by investing activities

 

17,129

 

8,248

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Proceeds from stock options and warrants exercised

 

19

 

329

 

Repayment of note payable principal

 

(175

)

 

Repayment of capital lease obligation

 

(50

)

 

Preferred stock dividends

 

(250

)

(250

)

Net cash (used in) provided by financing activities

 

(456

)

79

 

 

 

 

 

 

 

Net decrease in cash and cash equivalents

 

(2,987

)

(3,292

)

 

 

 

 

 

 

Cash and cash equivalents:

 

 

 

 

 

Beginning of period

 

4,097

 

8,389

 

End of period

 

$

1,110

 

$

5,097

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURE OF NONCASH FINANCING AND INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

 

 

 

Assets acquired through assumption of liabilities

 

$

 

$

6,175

 

Issuance of stock warrants

 

 

1,288

 

 

See accompanying notes to the condensed consolidated financial statements.

 

5



 

NEORX CORPORATION AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Note 1.  Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements include the accounts of NeoRx Corporation and subsidiary (the Company).  All significant intercompany balances and transactions have been eliminated in consolidation.

 

The interim financial statements contained herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission.  Certain information and note disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information presented not misleading.  These financial statements should be read in conjunction with the Company’s annual report on Form 10-K for the year ended December 31, 2001.

 

In the opinion of management, the interim financial statements reflect all adjustments, consisting only of normal recurring accruals necessary to present fairly the Company’s financial position as of September 30, 2002 and the results of its operations and cash flows for the periods ended September 30, 2002 and 2001.

 

The results of operations for the quarters ended September 30, 2002 and 2001 are not necessarily indicative of the expected operating results for the full year.

 

Note 2.  Net Loss Per Common Share

 

Basic and diluted loss per share are based on net loss applicable to common shares, which is comprised of net loss and preferred stock dividends in all periods presented. Shares used to calculate basic loss per share are based on the weighted average number of common shares outstanding during the period.  Shares used to calculate diluted loss per share are based on the potential dilution that would occur upon the exercise or conversion of securities into common stock using the treasury stock method.  Calculations of basic and diluted loss per share for the quarters ended September 30, 2002 and 2001 exclude the effect of options and warrants to purchase additional shares of common stock because the share increments would be antidilutive.

 

The computation of diluted net loss per share excludes the following options and warrants to acquire shares of common stock for the periods indicated because their effect would be antidilutive:

 

 

 

September 30,
2002

 

September 30,
2001

 

 

 

 

 

 

 

Common stock options

 

4,714,779

 

4,414,789

 

Weighted average exercise price per share

 

$

4.63

 

$

5.10

 

Common stock warrants

 

890,000

 

1,070,000

 

Weighted average exercise price per share

 

$

9.62

 

$

8.72

 

 

In addition, 234,088 shares of common stock that would be issuable upon conversion of the Company’s preferred stock are not included in the calculation of diluted loss per share for the quarters ended September 30, 2002 and 2001 because the effect of including such shares would be antidilutive.

 

Note 3.  Comprehensive Loss

 

The Company’s comprehensive loss for the quarters ended September 30, 2002 and 2001 was $11,608,000 and $7,464,000, respectively.  The comprehensive loss for the quarters ended September 30, 2002 and 2001 consisted of net loss of $11,504,000 and $7,478,000, respectively, and a net unrealized gain (loss) on investment securities of $(104,000) and $14,000 for the quarters ended September 30, 2002 and 2001, respectively.  The Company’s comprehensive loss for the nine months ended September 30, 2002 and 2001 was $26,533,000 and $16,283,000, respectively.  The comprehensive loss for the nine months ended September 30, 2002 and 2001 consisted of net loss of $25,987,000 and $16,629,000, respectively, and a net unrealized gain (loss) on investment securities of $(546,000) and $346,000 for the nine month periods ended September 30, 2002 and 2001, respectively.

 

6



 

Note 4.  New Accounting Pronouncements

 

In July 2001, the FASB issued Statement No. 141, Business Combinations, and Statement No. 142, Goodwill and Other Intangible Assets.  Statement 141 requires that all business combinations be accounted for under a single method – the purchase method. Use of the pooling-of-interests method is no longer permitted.  Statement 141 requires that the purchase method be used for business combinations initiated after June 30, 2001.  Statement 142 requires that goodwill no longer be amortized to earnings, but instead be reviewed for impairment.  The amortization of goodwill ceases upon adoption of the Statement, which was adopted by the Company on January 1, 2002.  The adoption of Statements No. 141 and 142 did not have any impact on the Company’s consolidated financial statements.

 

In August 2001, the FASB issued Statement No. 143, Accounting for Asset Retirement Obligations, which addresses financial accounting and reporting obligations associated with the retirement of tangible long-lived assets and the associated asset retirement costs.  The standard applies to legal obligations associated with the retirement of long-lived assets that result from the acquisition, construction, development, and (or) normal use of the asset.  Statement No. 143 requires that the fair value of a liability for an asset retirement obligation be recognized in the period in which it is incurred if a reasonable estimate of fair value can be made.  The fair value of the liability is added to the carrying amount of the associated asset and this additional carrying amount is depreciated over the life of the asset.  If the obligation is settled for other than the carrying amount of the liability, the Company will recognize a gain or loss on settlement. The Company will adopt this Statement on January 1, 2003.  Management has not yet determined the impact of adopting this statement on its consolidated financial statements.

 

In October 2001, the FASB issued Statement No. 144, Accounting for Impairment or Disposal of Long-Lived Assets, which addresses financial accounting and reporting for the impairment or disposal of long-lived assets.  While Statement No. 144 supersedes FASB Statement No. 121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of, it retains many of the fundamental provisions of that Statement.  Statement No. 144 also supersedes the accounting and reporting provisions of APB Opinion No. 30, Reporting the Results of Operations-Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions, for the disposal of a segment of a business.  However, it retains the requirement in Opinion No. 30 to report separately discontinued operations and extends that reporting to a component of an entity that either has been disposed of (by sale, abandonment, or in distribution to owners) or is classified as held for sale.  The Company adopted the provisions of Statement No. 144 on January 1, 2002.  The adoption of this statement impacted the Company’s consolidated financial statements as disclosed in Note 5.

 

In July 2002, the FASB issued Statement No. 146, Accounting for Costs Associated with Exit or Disposal Activities, which addresses financial accounting and reporting for costs associated with exit or disposal activities.  Statement No. 146 nullifies EITF Issue No. 94-3, “Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring).” The principal difference between Statement No. 146 and Issue No. 94-3 relates to the recognition of a liability for a cost associated with an exit or disposal activity.  Statement No. 146 requires that a liability be recognized for those costs only when the liability is incurred, that is, when it meets the definition of a liability in the FASB’s conceptual framework.  In contrast, under Issue No. 94-3, a company recognized a liability for an exit cost when it committed to an exit plan.  Statement No. 146 also establishes fair value as the objective for initial measurement of liabilities related to exit or disposal activities.  The Statement is effective for exit or disposal activities that are initiated after December 31, 2002 although earlier application is encouraged.  The Company will adopt this Statement on January 1, 2003.  Management has not yet determined the impact of adopting this statement on its consolidated financial statements.

 

Note 5.  Asset Impairment Loss

 

In September 2002, the Company recognized a non-cash asset impairment loss on certain facilities and equipment resulting from the Company’s decisions to reduce staff at its Denton, Texas radiopharmaceutical manufacturing facility, decrease the development of contract manufacturing activities in Denton, and curtail Pretarget® activities at its Seattle, Washington research and development facility. The loss on the Denton, Texas

 

7



 

manufacturing facility and related equipment was determined via outside appraisals.  The loss on the equipment at the Seattle facility was determined via estimates of potential sales values of used equipment.  In addition, the estimated useful life of other intangibles associated with the Denton facility was reduced to two years.  The following table summarizes information related to the impairment charges:

 

Description

 

Impairment Loss

 

Post Impairment
Carrying Value

 

 

 

 

 

 

 

Equipment – Seattle, Washington

 

$

306,000

 

$

4,837,000

 

Equipment – Manufacturing Facility, Denton, Texas

 

2,393,000

 

1,122,000

 

Manufacturing Facility, Denton, Texas

 

2,895,000

 

5,680,000

 

Intangibles – Denton, Texas

 

64,000

 

 

Total

 

$

5,658,000

 

$

11,639,000

 

 

Note 6.  Restructuring

 

In July 2002, the Company restructured its operations and reduced its work force by 31 employees.  The employees were no longer with the Company at September 30, 2002 and will not be providing future services to the Company.  The Company incurred a severance charge of approximately $529,000 as a result of the restructuring.  The accrued severance payable at September 30, 2002 was approximately $241,000, of which approximately $155,000 will be paid in 2002 and $86,000 will be paid in 2003.

 

Note 7.  Liquidity

 

The Company has incurred losses annually since inception and has limited working capital.  On November 12, 2002, the Company entered into an agreement with IDEC Pharmaceuticals Corporation (IDEC) relating to the sale to IDEC of certain NeoRx intellectual property and the grant to IDEC of certain license and option rights.  The Company received $7.9 million in cash and may receive in the future royalty payments with respect to certain products.  Taking into account the cash funds received in the IDEC transaction, the Company believes its existing working capital will only be sufficient to fund operations into the fourth quarter of 2003. In July 2002, the Company decided to focus its efforts on its STR product candidate and discontinue its Pretarget® technology activities.  Also in July 2002, the Company reduced its staff by 31 persons, or approximately 30%.  The cost associated with the reduction in force was approximately $529,000 and will be incurred primarily over a four-month time period beginning in August 2002.  In October 2002, the Company further reduced its staff, primarily in its Denton manufacturing facility, by an additional 13 persons, or approximately 15% of the Company’s total work force.  The cost associated with the reduction in force was approximately $122,000 and will be incurred primarily over a four-month time period beginning in October 2002.  In an effort to further reduce cash expenditures and unused office space, in October 2002 the Company terminated its lease at the 410 West Harrison Street location in Seattle, Washington, effective April 2003.  The lease originally was effective through May 2006.  The cost of terminating the lease was three months base rent, or approximately $110,000, which was paid in October 2002. The administrative offices were consolidated into the 300 Elliott Avenue West location in Seattle, Washington.

 

The Company’s decisions to curtail Pretarget® activities and reduce staff were in response to the anticipated clinical development timeline of the Pretarget® product candidates and the current economic environment.  The discontinued Pretarget® activities include development of the Pretarget® Lymphoma and Pretarget® Carcinoma product candidates beyond the phase I trials, for which patient enrollment has concluded, and manufacturing development activities associated with the Pretarget® project. The Company will seek to sell or outlicense the Pretarget® patent portfolio and other assets in an effort to raise additional funds. The Company also is addressing its need for additional capital by exploring opportunities for the licensing or divestiture of certain intellectual property and other assets, by seeking partnering or outlicensing opportunities for its STR product development program, and through the sale of securities.  In the event that sufficient additional funds are not obtained through asset sales, strategic partnering opportunities and/or sales of securities on a timely basis, the Company plans to reduce expenses through the delay, reduction, or curtailment of STR development activities and/or the further reduction of costs for facilities and administration.

 

The Company’s actual capital requirements will depend on numerous factors, including the conditions in the

 

8



 

capital markets in general and in the life sciences capital markets specifically, which may affect potential financing sources for the development of the Company’s business; the rate of progress and results of research and development activities and clinical trials; actions by the U.S. Food and Drug Administration (FDA) and other regulatory authorities; the levels of resources that the Company devotes to establishing and maintaining marketing and manufacturing capabilities; the emergence of competing technologies and other adverse market developments; the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and other intellectual property rights; and the timing and amount of revenues and expense reimbursements resulting from relationships with third parties or collaborative agreements.  There can be no assurance that the Company will be able to obtain such additional capital or enter into relationships with corporate partners on a timely basis, on favorable terms, or at all.  These financial statements are prepared on a going concern basis, however if the Company were forced to liquidate its assets, it may not recover the carrying amount of such assets.

 

Note 8.  Subsequent Events

 

On November 12, 2002, the Company entered into an agreement with IDEC Pharmaceuticals Corporation relating to the sale to IDEC of certain NeoRx intellectual property and the grant to IDEC of certain license and option rights.  NeoRx received $7.9 million in cash and may receive in the future royalty payments with respect to certain products.  The purchase price was determined by arms length negotiations.

 

The intellectual property addressed by this agreement includes a portfolio of NeoRx US and international patents and certain associated technology and know-how relating to antibody-based therapeutics and ligand-linker technology.  The intellectual property rights being transferred to IDEC do not include rights to NeoRx’s STR or Pretarget® programs.  With respect to the patents involved in the sale, NeoRx retains a license for the development of certain NeoRx products.

 

9



 

NEORX CORPORATION AND SUBSIDIARY

Item 2.  Management’s Discussion and Analysis of Results of Operations and Financial Condition

 

This Form 10-Q contains forward-looking statements. These statements relate to future events or future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “propose” or “continue,” the negative of these terms or other terminology.  These statements are only predictions. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors described below in the section entitled “Additional factors that may affect results.” These factors may cause our actual results to differ materially from any forward-looking statement.

 

Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. You should not place undue reliance on our forward-looking statements, which speak only as of the date of this report.

 

Critical Accounting Policies and Estimates

 

Basis of Revenue Recognition: To date, the Company does not have any significant ongoing revenue sources.  On occasion, the Company derives significant revenue from licensing its patented technologies and government grants.  Pursuant to the Securities and Exchange Commission Staff Accounting Bulletin No. 101, revenues from collaborative agreements are recognized as earned as the Company performs research activities under the terms of each agreement.  Billings in excess of amounts earned are classified as deferred revenue.  Non-refundable upfront technology license fees, where the Company is providing continuing services related to product development, are deferred.  Such fees are recognized as revenue over the product development periods based on estimated total development costs.

 

Impairment of Long-Lived Assets: In September 2002, the Company recognized a non-cash asset impairment loss on certain facilities and equipment resulting from the Company’s decisions to reduce staff at its Denton, Texas radiopharmaceutical manufacturing facility, decrease the development of contract manufacturing activities in Denton, and curtail Pretarget® activities at its Seattle, Washington research and development facility. The loss on the Denton, Texas manufacturing facility and related equipment was determined via outside appraisals.  The loss on the equipment at the Seattle facility was determined via estimates of potential sales values of used equipment.  In addition, the estimated useful life of other intangibles associated with the Denton facility was reduced to two years.

 

Quarter and nine months ended September 30, 2002 compared to quarter and nine months ended September 30, 2001

 

Revenue for the quarter ended September 30, 2002 was $507,000 compared to $263,000 for the quarter ended September 30, 2001.  Revenue for the quarters ended September 30, 2002 and 2001 consisted primarily of revenue from government grants and a facilities lease agreement.  Revenue for the nine months ended September 30, 2002 was $2,036,000 compared to $1,437,000 for the nine months ended September 30, 2001.  Revenue for the nine months ended September 30, 2002 consisted of a milestone payment of $1,000,000 from Angiotech Pharmaceuticals, Inc., along with revenue from government grants and a facilities lease agreement. Revenue for the nine months ended September 30, 2001 consisted primarily of revenue from government grants and a facilities lease agreement.  The Company recognizes revenue from government grants as earned.  The Company does not have any significant revenue sources.  On occasion, the Company derives revenue from licensing its patented technologies and from government grants. Pursuant to SAB 101, the timing and amount of license revenue recognized during an accounting period is determined by the nature of the contractual provisions included in the license arrangement.

 

10



 

Total operating expenses for the quarter ended September 30, 2002 increased 44% to $12,091,000 from $8,418,000 in the quarter ended September 30, 2001, and increased 41% to $28,727,000 for the nine months ended September 30, 2002 from $20,348,000 for the nine months ended September 30, 2001.  Total operating expenses for the third quarter of 2002 included a non-cash asset impairment charge of $5,658,000.  Additionally, severance of $529,000 was incurred relating to the curtailment of the Company’s Pretarget® Lymphoma and Pretarget® Carcinoma clinical product development programs and the resulting reduction in force implemented in July 2002.  Research and development expenses for the quarter ended September 30, 2002 decreased 23% to $4,369,000 from $5,663,000 for the same time period in 2001, and increased 21% to $17,403,000 for the nine months ended September 30, 2002 from $14,334,000 for the nine months ended September 30, 2001.  The decrease in research and development expenses for the third quarter of 2002 ended September 30, 2002 was predominantly due to the curtailment of the Company’s Pretarget® Lymphoma and Pretarget® Carcinoma clinical product development programs and the resulting reduction in force implemented in July 2002.  The increase in research and development expenses for the nine months ended September 30, 2002 was predominantly due to the addition of the Company’s radiopharmaceutical manufacturing facility in Denton, Texas and costs associated with Pretarget® project activities.

 

In July 2002, the Company began enrolling and dosing multiple myeloma patients in a dosimetry study for STR.  This study was requested by the FDA to validate the method proposed for calculating radiation dose in a planned pivotal clinical trial program.  Enrollment of multiple myeloma patients in our STR dosimetry study is in progress, with three clinical sites actively treating patients. The Company is in discussions with the FDA on the design of its STR pivotal program and is currently reassessing how and on what timeline to proceed.

 

We expect research and development expenses to decrease by approximately 15% to 20% during the fourth quarter of 2002, due to the curtailment of Pretarget® project activities and  reductions in staff.  The discontinued Pretarget® activities include our Pretarget® Lymphoma and Pretarget® Carcinoma phase I trials, for which patient enrollment has concluded, and manufacturing development activities associated with the Pretarget® project. We will seek to sell or license our Pretarget® patent portfolio, pursue partnering and outlicensing opportunities in connection with our STR technology, and sell or license other assets in an effort to raise additional funds.  In an effort to further reduce cash expenditures and unused office space, in October 2002, the Company terminated its lease at the 410 West Harrison Street location in Seattle, Washington, effective April 2003.  The lease originally was effective through May 2006.  The cost of terminating the lease was three months base rent, or approximately $110,000, which was paid in October 2002. The administrative offices were consolidated into the 300 Elliott Avenue West location in Seattle, Washington.

 

General and administrative expenses for the quarter ended September 30, 2002 decreased 44% to $1,535,000 versus $2,755,000 for the quarter ended September 30, 2001, and decreased 15% to $5,137,000 for the nine months ended September 30, 2002 compared to $6,014,000 for the nine months ended September 30, 2001.  The decrease in general and administrative costs during the third quarter and nine months ended September 30, 2002 was due to the accrual of one-time severance costs for the former CEO in the third quarter of 2001 and the overall effort to reduce expenses to conserve cash.  In the second and third quarter of 2002, the Company implemented two reductions in its work force, resulting in an overall reduction of its staff size by 45%.  Costs for general and administrative are also expected to decrease in the fourth quarter of 2002 as a result of the reductions in force taken by the Company.

 

Other income for the third quarter of 2002 was $80,000 compared to $677,000 for the third quarter of 2001.  Other income for the nine months ended September 30, 2002 was $704,000 compared to $2,282,000 for the same time period in 2001.  Other income included interest income for the third quarter of 2002 of $204,000 compared to $656,000 for the third quarter of 2001.  Other income included interest income for the nine months ended September 30, 2002 of $912,000 compared to $2,314,000 for the same time period in 2001.  Other income is expected to decline due to declining balances of cash and cash equivalents.

 

Liquidity and capital resources

 

The Company has financed its operations primarily through the sale of equity securities, collaborative agreements and debt instruments.  The Company invests excess cash in investment securities that will be used to fund future operating costs.  Cash, cash equivalents and investment securities totaled $12,378,000 at September 30, 2002 versus $33,581,000 at December 31, 2001.  The Company primarily funds current operations with its existing cash and investments.  On occasion, the Company derives revenue from licensing its patent technologies and from

 

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government grants.

 

The Company currently maintains a line of credit with Pharmaceutical Product Development, Inc. (PPD) of up to $5.0 million to assist in funding the pivotal phase III trial of its STR product in development.   This line of credit is available to the Company only upon the successful resumption of phase III trials and the proceeds can only be applied to the expenses related to the phase III trials.  The Company has not drawn funds on this line of credit to date, which carries an annual interest rate of 16%.

 

In January 2002, the Company sold the remainder of its investment in Angiotech Pharmaceuticals, Inc. for $1.4 million and recognized a gain on the sale of approximately $109,000.

 

On November 12, 2002, the Company entered into an agreement with IDEC Pharmaceuticals Corporation relating to the sale to IDEC of certain NeoRx intellectual property and the grant to IDEC of certain license and option rights.  NeoRx received $7.9 million in cash and may receive in the future royalty payments with respect to certain products. The intellectual property addressed by this agreement includes a portfolio of NeoRx US and international patents and certain associated technology and know-how relating to antibody-based therapeutics and ligand-linker technology.  The intellectual property rights being transferred to IDEC do not include rights to NeoRx’s STR or Pretarget® programs.  With respect to the patents involved in the sale, NeoRx retains a license for the development of certain NeoRx products.

 

The Company will need to raise additional capital to fund its planned STR pivotal clinical trial program, and its current operating cash needs.  The Company expects that its cash, including the consideration received in the transaction with IDEC, cash equivalents, investment securities and interest income will be sufficient to fund its anticipated working capital and capital requirements into the fourth quarter of 2003. In July 2002, the Company decided to discontinue all of its Pretarget® technology activities.  The discontinued Pretarget® activities include its Pretarget® Lymphoma and Pretarget® Carcinoma phase I trials, for which patient enrollment has concluded, and manufacturing development activities associated with the Pretarget® project. Also in July 2002, the Company reduced its staff size by 31 persons, or 30%.  The cost associated with the reduction in force is approximately $529,000 and will be incurred primarily over a four-month time period beginning in August 2002. In October 2002, the Company further reduced its staff, primarily in its Denton manufacturing facility, by an additional 13 persons, or approximately 15% of the Company’s total work force.  The cost associated with this reduction in force was approximately $122,000 and will be incurred primarily over a four-month time period beginning in October 2002.  In an effort to further reduce cash expenditures and unused office space, in October 2002 the Company terminated its lease at the 410 West Harrison Street location in Seattle, Washington effective April 2003.  The lease originally was effective through May 2006.  The cost of terminating the lease was three months base rent, or approximately $110,000, which was paid in October 2002.

 

The Company’s decision to curtail Pretarget® activities and reduce staff was in response to the anticipated clinical development timeline of the Pretarget® candidates and the current economic environment.   The Company will seek to sell or outlicense the Pretarget® patent portfolio and other assets in an effort to raise additional funds. The Company also is addressing its need for additional capital by pursuing opportunities for the licensing or divestiture of certain intellectual property and other assets, by seeking partnering or outlicensing opportunities for its STR technology, and through the sale of  securities.  In the event that sufficient additional funds are not obtained through asset sales, strategic partnering opportunities and/or sales of securities on a timely basis, the Company plans to reduce expenses through the delay, reduction or curtailment of STR development activities and/or further reduction of costs for facilities and administration.  The Company’s actual capital requirements will depend on numerous factors, including conditions in the capital markets in general and in the life sciences capital markets specifically, which may affect potential financing sources for the development of the Company’s business; the progress and results of research and development activities and clinical trials; actions by the FDA and other regulatory authorities; the levels of resources that the Company devotes to establishing and maintaining marketing and manufacturing capabilities; the emergence of competitive technologies and other adverse market developments and the timing and amount of revenues and expense reimbursements resulting from relationships with third parties or collaborative agreements.  There can be no assurance that the Company will be able to obtain such additional capital or enter into relationships with corporate partners on a timely basis, on favorable terms, or at all.  These financial statements are prepared on a going concern basis, however if the Company were forced to liquidate its assets, it may not recover the carrying amount of such assets.

 

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Related party transactions

 

The Company’s Chairman of the Board of Directors, Dr. Fred Craves, had a consulting agreement with the Company that provided that he shall be retained as a general advisor and consultant to the Company’s management on all matters pertaining to the Company’s business.  In exchange for such services, he was compensated $30,000 for each calendar quarter of services, plus reasonable travel and other expenses.  Compensation payments under this agreement totaled $30,000 for the third quarter ended September 30, 2001, and $90,000 for the nine months then ended.  In addition, payments for travel and other expenses totaled approximately $10,000 for the quarter ended September 30, 2001, and $39,600 for the nine months then ended. In 2002, the Company did not renew this agreement with Dr. Craves.

 

Dr. Craves is a founder and Managing Director of Bay City Capital BD LLC, also known as BCC, a merchant bank focused on the life sciences industry.  As of September 30, 2002, BCCF, an affiliate of BCC, owned 8.89% of the Company’s common stock.  Dr. Carl Goldfischer, a member of the NeoRx Board of Directors, is a Managing Director of BCC; Jack L. Bowman, a member of the NeoRx Board of Directors, is on the business advisory board of BCC; and Dr. Douglass B. Given, President and CEO and a Director of NeoRx, is an Executive in Residence at BCC.

 

The Company and BCC entered into an agreement whereby BCC will act as the Company’s advisor for the purpose of identifying opportunities to enter into strategic alliances. The Company paid a retainer fee of $50,000 in cash for each calendar quarter through the end of 2001. The Company renewed the agreement for 2002 and pays a retainer fee of $80,000 per quarter, plus reasonable travel and other expenses. The agreement also includes a percentage of consideration, ranging from one to five percent, depending on the ultimate amount of capital raised.  Retainer fee payments under this agreement totaled $80,000 and $50,000 for the quarters ended September 30, 2002 and 2001, respectively, and $240,000 and $200,000 for the nine months ended September 30, 2002 and 2001, respectively, which included the balance payable of $100,000 at December 31, 2000.  In addition, payments for travel and other expenses totaled approximately $14,100 for the quarter ended September 30, 2002 and approximately $45,700 for the nine months ended September 30, 2002.  The Company also paid BCC approximately $612,000 during the second quarter of 2001 for commissions related to the Company’s purchase of the radiopharmaceutical manufacturing facility located in Denton, Texas.

 

In connection with an agreement to provide financial consulting services in 2001, Dr. Goldfischer received fees in the third quarter ended September 30, 2001 of $30,000 and $75,000 during the nine months then ended, along with stock option grants of 10,000 shares in December 2000 and 150,000 shares in January 2001.  Services related to these stock options were fully provided by December 31, 2001, after which this agreement was terminated.  As of January 29, 2002, vesting was accelerated for those options granted under the agreement that had not already vested. The Company recorded an expense in the amount of $526,000 during 2001 for the fair value of the option grants on the date the services were completed.

 

In connection with consulting services performed in 2002 and 2001, Dr. Paul G. Abrams, the former CEO of the Company, received consulting fees in the amount of $229,905 and $127,725, respectively.  Prior to his appointment as CEO in July 2001, Dr. Given provided consulting services to the Company.  The total consulting fees paid to Dr. Given in 2001 were $225,000.

 

The Company had a demand note receivable from an officer with a balance of approximately $49,675 as of June 30, 2001 that was recorded in other assets. This note was paid in full on July 31, 2001.  The Company had another demand note receivable from an officer with a balance of approximately $90,990 during the first half of 2002.  This note was paid in full on May 24, 2002.  There were no demand note receivables to related parties outstanding at September 30, 2002.

 

Additional factors that may affect results

 

In addition to the other information contained in this report, the following factors could affect the Company’s actual results and could cause our actual results to differ materially from those achieved in the past or expressed in our forward-looking statements.

 

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We have a history of operating losses, we expect to continue to incur losses, and we may never become profitable.

 

We have not been profitable for any year since our formation in 1984.  As of September 30, 2002, we had an accumulated deficit of $210 million. These losses have resulted principally from costs incurred in our research and development programs and from our general and administrative activities.  To date, we have been engaged only in research and development activities and have not generated any significant revenues from product sales.  We do not anticipate that our proposed STR product will be commercially available for several years. We expect to incur additional operating losses in the future. These losses may increase significantly if we expand development and clinical trial efforts.  Our ability to achieve long-term profitability is dependent upon obtaining regulatory approvals for our STR and any other proposed products and successfully commercializing our products alone or with third parties.  However, our operations may not be profitable even if we succeed in commercializing any product.

 

We will need to raise additional capital, and our future access to capital is uncertain.

 

It is expensive to develop cancer therapy products and conduct clinical trials for these products.  Although we currently are focusing on our STR product candidate, we may in the future simultaneously conduct clinical trials and preclinical research for a number of different indications and cancer therapy product candidates, which is costly. Our future revenues may not be sufficient to support the expense of our operations and the conduct of our clinical trials and preclinical research.  We will need to raise additional capital:

 

                                          to fund operations;

 

                                          to continue the research and development of our STR product candidate; and

 

                                          to commercialize our STR and any other proposed products.

 

We expect that our cash, cash equivalents, investment securities and interest income will only be sufficient to fund our anticipated working capital and capital requirements into the fourth quarter of 2003.

 

We will seek to sell or outlicense our Pretarget® patent portfolio and other assets in an effort to raise additional funds. We also are addressing our need for additional capital by pursuing opportunities for the licensing or divestiture of certain intellectual property and other assets, by seeking partnering or outlicensing opportunities for our STR technology and through the sale of securities.

 

In the event that sufficient additional funds are not obtained through asset sales, strategic partnering opportunities and/or sales of securities on a timely basis, the Company plans to reduce expenses through the delay, reduction or curtailment of STR development activities and/or further reduction of costs for facilities and administration.

 

The amount of additional financing we need within this time frame depends on a number of factors, including the following:

 

                                          the rate of progress and costs of our clinical trial and research and development activities;

 

                                          actions taken by the FDA and other regulatory authorities;

 

                                          the costs of developing and maintaining manufacturing operations;

 

                                          the costs of discontinuing projects and technologies or decommissioning existing facilities, if we undertake those activities;

 

                                          the timing and amount of milestone payments we might receive from potential strategic partners;

 

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                                          the timing and amount of payments we might receive from potential licenses;

 

                                          our degree of success in commercializing STR or other cancer therapy product candidates;

 

                                          the emergence of competing technologies and other adverse market developments;

 

                                          the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and other intellectual property rights.

 

We may not be able to obtain additional financing on favorable terms or at all.  If we are unable to raise additional funds when we need them, we may be required further to delay, reduce or eliminate some or all of our STR development activities and clinical trials.  We also may be required to enter into relationships with third parties to develop or commercialize products or technologies that we otherwise would have sought to develop independently.  If we raise additional funds by issuing equity securities, further dilution to shareholders may result, and new investors could have rights superior to current security holders.

 

The financial statements included in this report are prepared on a going concern basis, however if we were forced to liquidate our assets, we may not recover the carrying amount of such assets.

 

Our potential products must undergo rigorous clinical testing and regulatory approvals, which could be costly, time consuming, and subject us to unanticipated delays or prevent us from marketing any products.

 

The manufacture and marketing of our proposed products and our research and development activities are subject to regulation for safety, efficacy and quality by the FDA in the United States and comparable authorities in other countries.

 

The process of obtaining FDA and other required regulatory approvals, including foreign approvals, is expensive, often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved.  Our STR product candidate is novel; therefore, regulatory agencies lack direct experience with it. This may lengthen the regulatory review process, increase our development costs and delay or prevent commercialization of our STR product candidate. An earlier phase III study of STR was placed on clinical hold by the FDA after some patients in our STR phase I/II multiple myeloma trials developed a serious delayed toxicity.  The FDA requested that we collect additional radiation dosimetry data from a small number of patients to validate the method proposed for calculating radiation dose in our planned pivotal trial program.  Under the ongoing dosimetry study, which will enroll approximately 12 patients, tracer doses of the STR therapeutic initially are administered to determine skeletal uptake and eligibility for treatment.  Eligible patients then receive a treatment dose of the STR therapeutic, followed by high-dose chemotherapy and peripheral blood stem cell transplantation to restore bone marrow function.  Patients are carefully monitored throughout the study.  Follow-up evaluations will include assessments of STR safety and efficacy.  Enrollment of multiple myeloma patients in our STR dosimetry study for STR is in progress, with three clinical sites actively treating patients.   We have discussed with the FDA a revised plan for a pivotal clinical trial program for STR in patients with multiple myeloma, and have submitted to the FDA a draft protocol for the proposed pivotal program. Based on the results of the dosimetry study and subject to authorization by the FDA, we plan to resume STR clinical trials under a revised pivotal phase III program.  The time to initiation of the proposed pivotal program, if undertaken at all, will depend upon numerous factors, including our ability to obtain adequate funding, actions taken by the FDA and other regulatory agencies, and the timing thereof; the rate of progress and costs of our clinical trial and research and development activities; our ability to maintain sufficient, reliable and affordable third-party supplies of materials used in the manufacture of STR, including holmium-166, the radionuclide used in our STR product candidate; the costs of developing and maintaining manufacturing operations; scheduling conflicts with participating clinicians and clinical institutions; and potential difficulties in identifying and enrolling patients who meet trial eligibility criteria.

 

In July 2002, we decided to curtail further Pretarget® product development activities.  The discontinued Pretarget® activities include our Pretarget® Lymphoma and Pretarget® Carcinoma phase I trials and manufacturing development activities associated with the Pretarget® programs.  We will seek to sell or license our Pretarget® patent portfolio.  We have completed patient enrollment in phase I safety studies for Pretarget® Lymphoma in patients with non-Hodgkin’s lymphoma, and for Pretarget® Carcinoma in patients with gastrointestinal adenocarcinoma. The FDA

 

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has required that we complete a 90-day follow-up on all patients treated to date with Pretarget® Lymphoma and review the data with the FDA. We plan to complete the necessary patient follow-up and review, but do not plan to enroll additional patients in either the Pretarget® Lymphoma or Pretarget® Carcinoma program, or otherwise further pursue development of these Pretarget® product candidates internally.

 

No cancer product using our technologies has been approved for marketing. Consequently, there is no precedent for the successful commercialization of products based on our technologies.  In addition, we have had only limited experience in filing and pursuing applications necessary to gain regulatory approvals.  This may impede our ability to obtain timely approvals from the FDA or foreign regulatory agencies, if at all. We will not be able to commercialize STR until we obtain regulatory approval, and consequently any delay in obtaining, or inability to obtain, regulatory approval could harm our business.

 

If we violate regulatory requirements at any stage, whether before or after marketing approval is obtained, we may be fined, forced to remove a product from the market or experience other adverse consequences, including delay, which could materially harm our financial results.  Additionally, we may not be able to obtain the labeling claims necessary or desirable for product promotion.  We also may be required to undertake post-marketing trials.  In addition, if we or other parties identify side effects after any of our products are on the market, or if manufacturing problems occur, regulatory approval may be withdrawn and reformulation of our products, additional clinical trials, changes in labeling of our products, and additional marketing applications may be required.

 

The requirements governing the conduct of clinical trials and manufacturing and marketing of our proposed STR product outside the United States vary widely from country to country.  Foreign approvals may take longer to obtain than FDA approvals and can involve additional testing.  Foreign regulatory approval processes include all of the risks associated with the FDA approval processes.  Also, approval of a product by the FDA does not ensure approval of the same product by the health authorities of other countries.

 

We may take longer to complete our clinical trials than we project, or we may be unable to complete them at all.

 

Although for planning purposes we project the commencement, continuation and completion of our clinical trials, a number of factors, including availability of funds, actions by the FDA, scheduling conflicts with participating clinicians and clinical institutions and difficulties in identifying and enrolling patients who meet trial eligibility criteria, may cause significant delays.  We may not commence or complete our proposed pivotal clinical trial program for our STR product candidate as projected, may not conduct it successfully, or may not conduct it at all.

 

We currently rely on academic institutions and clinical research organizations to conduct, supervise or monitor some or all aspects of clinical trials involving our STR and any other proposed products.  Further, we plan to explore partnering or outlicensing opportunities for our STR technology.  To the extent that we now or in the future participate in such collaborative arrangements, we will have less control over the timing, planning and other aspects of our clinical trials.  In addition, if sufficient additional funds are not obtained by the Company through asset sales, strategic partnering opportunities and/or sales of securities on a timely basis, the Company may be required to reduce expenses by delaying, reducing or curtailing its STR development activities.  If we fail to commence or complete, or experience delays in or are forced to curtail our planned clinical trials, our stock price and our ability to conduct our business could be harmed.

 

If testing of a particular product does not yield successful results, we will be unable to commercialize that product.

 

Our research and development programs are designed to test the safety and efficacy of our proposed products in humans through extensive preclinical and clinical testing.  We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of our STR and any other proposed products, including the following:

 

                                          safety and efficacy results attained in early human clinical trials may not be indicative of results that are obtained in later clinical trials;

 

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                                          the results of preclinical studies may be inconclusive, or they may not be indicative of results that will be obtained in human clinical trials;

 

                                          after reviewing test results, we or any potential collaborators may abandon projects that we previously believed were promising;

 

                                          our potential collaborators or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks; and

 

                                          the effects of our potential products may not be the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved.

 

Clinical testing is very expensive, can take many years, and the outcome is uncertain.  We cannot at this time predict if, when or under what conditions we will initiate our revised pivotal phase III program for STR.  The data collected from our clinical trials may not be sufficient to support regulatory approval of our proposed STR multiple myeloma product, or any other proposed products.  The clinical trials of our proposed STR multiple myeloma product and other proposed products may not be completed on schedule, and the FDA or foreign regulatory agencies may not ultimately approve any of our product candidates for commercial sale.  Our failure to adequately demonstrate the safety and efficacy of a cancer therapy product under development would delay or prevent regulatory approval of the product, which could prevent us from achieving profitability.

 

We are dependent on suppliers for the timely delivery of materials and services and may experience in the future interruptions in supply.

 

To be successful, we need to develop and maintain reliable and affordable third-party suppliers of commercial quantities of holmium-166, the radionuclide used in our STR product candidate, and DOTMP, the small-molecule compound used in our STR product candidate to deliver holmium-166 to the bone.  Sources of these materials may be limited, and we may be unable to obtain these materials in amounts and at prices necessary to successfully commercialize our proposed STR product.  Timely delivery of materials is critical to our success.  For example, holmium-166 loses its effectiveness for treating patients within a short period of time.  As a result, the STR product must be shipped within 24 hours of its manufacture to the site where the patient is to be treated.  Failures or delays in the manufacturing and shipping processes could compromise the quality and effectiveness of our product.  We currently depend on a single source vendor, University of Missouri Research Reactor facility group (MURR), for the holmium-166 component of our STR product candidate.  There are, in general, relatively few alternative sources of holmium-166. While the current vendor generally has provided us these materials with acceptable quality, quantity and cost in the past, it may be unable or unwilling to meet our future demands. If we have to switch to a replacement vendor, the manufacture and delivery of our STR product could be interrupted for an extended period.

 

In December 2001 we entered into a contract with MURR to supply holmium-166. MURR is responsible for the manufacture of holmium-166, including process qualification, quality control, packaging and shipping, from its Columbia, Missouri reactor facility.  This supply contract follows a previous arrangement in which MURR provided NeoRx supplies of holmium-166 for the STR product in development.  Our business and operations could be materially adversely affected if MURR does not continue to perform satisfactorily under this agreement.  We may pursue negotiation of a long-term supply contract for holmium-166, for the proposed pivotal program.  If MURR is unable or unwilling to provide supplies of holmium-166 in a satisfactory manner, we may suffer delays in, or be prevented from, initiating or completing pivotal phase III clinical trials of our STR product.

 

If we fail to negotiate and maintain collaborative arrangements with third parties, our research, development, manufacturing, clinical testing, sales and marketing activities may be delayed or reduced.

 

We rely in part on third parties to perform for us or assist us with a variety of important functions, including research and development, manufacturing and clinical trials management.  We also license technology from others to enhance or supplement our technologies.  We may not be able to locate suppliers to manufacture our product components or products at a cost or in quantities necessary to make them commercially viable.  We intend to rely on third-party contract manufacturers to produce large quantities of certain materials needed for clinical trials and

 

17



 

product commercialization.  Third-party manufacturers may not be able to meet our needs with respect to timing, quantity or quality.  If we are unable to contract for a sufficient supply of needed materials on acceptable terms, or if we should encounter delays or difficulties in our relationships with manufacturers, our clinical testing may be delayed, thereby delaying the submission of products for regulatory approval or market introduction and subsequent sales.  Any such delay may lower our revenues and potential profitability.

 

Moreover, any potential third–party manufacturers and NeoRx must continually adhere to current Good Manufacturing Practices (cGMP) regulations enforced by the FDA through its facilities inspection program.  If our facilities, or the facilities of these manufacturers, cannot pass a pre-approval plant inspection, the FDA will not grant pre-market approval of our cancer therapy product candidates. In complying with cGMP and foreign regulatory requirements, we and any of our third-party manufacturers will be obligated to expend time, money and effort in production, record-keeping and quality control to assure that our products meet applicable specifications and other requirements.  If any of our third-party manufacturers or we fail to comply with these requirements, we may be subject to regulatory action.

 

In April 2001, we purchased a radiopharmaceutical manufacturing and distribution facility and certain other assets located in Denton, Texas from International Isotopes Inc.  In addition to the manufacturing facility, we purchased existing equipment, documentation, and certain processes. The facility has achieved cGMP status and has been issued appropriate radiation permits by the State of Texas.

 

Our radiopharmaceutical manufacturing facility in Denton is the principal manufacturing site for the proposed STR product for our multiple myeloma clinical trials.  This facility is responsible for all aspects of the manufacture of STR, including process qualification, quality control, packaging and shipping.  The agreement with our previous supplier of STR for the phase I/II clinical trials, ABC Laboratories, Inc. (ABC), expired on June 30, 2002.  The Denton facility continues to manufacture the STR therapy used in the Company’s STR dosimetry study.  We believe that the Denton facility, despite the recent reduction in force, would be sufficient to meet our needs to continue the production of STR for our dosimetry trial.

 

If we are unable to maintain the necessary cGMP status and permits for our Denton radiopharmaceutical facility, or if we should encounter delays or difficulties in any aspect of the manufacture of STR, our clinical testing may be delayed, thereby delaying the submission of the products for regulatory approval or the market introduction and subsequent sales of the product.  Any such delay may lower our revenues and potential profitability.

 

We intend to enter into collaborations for one or more of the research, development, manufacturing, marketing and other commercialization activities relating to our STR product under development. If we are unable to secure collaborators, or if we lose collaborators, our product development and potential for profitability may suffer.  If any collaborator breaches or terminates an agreement with us, or fails to conduct its collaborative activities in a timely manner, the commercialization of our STR product under development could be slowed down or blocked completely.  Disputes may arise between NeoRx and collaborators on a variety of matters, including financial or other obligations under our agreements.  These disputes may be both expensive and time-consuming and may result in delays in the development and commercialization of our proposed STR product.

 

We face substantial competition in the development of cancer therapies and may not be able to compete successfully, and our potential products may be rendered obsolete by rapid technological change.

 

The competition for development of cancer therapies is intense.  There are numerous competitors developing products to treat the diseases for which we are seeking to develop products.  We are initially focusing our STR product candidate on the treatment of multiple myeloma.  Celgene Corp.’s thalidomide product is in development for treatment of multiple myeloma.  Other therapeutics with anti-angiogenic properties and other modes of action also are in clinical development for treatment of multiple myeloma. In addition, a number of established pharmaceutical companies, including GlaxoSmithKline, Amersham PLC, Mallinckrodt, Inc. (Tyco Healthcare) and Bristol-Myers Squibb Co., are developing proprietary technologies or have enhanced their capabilities by entering into arrangements with, or acquiring, companies with technologies applicable to the treatment of cancer.  Many of our existing or potential competitors have, or have access to, substantially greater financial, research and development, marketing and production resources than we do and may be better equipped than we are to develop,

 

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manufacture and market competing products.  Our competitors may have, or may develop and introduce, new products that would render our technology and proposed STR product less competitive, uneconomical or obsolete.

 

We also expect to face increasing competition from universities and other non-profit research organizations.  These institutions carry out a significant amount of cancer research and development.  These institutions are becoming increasingly aware of the commercial value of their findings and more active in seeking patent and other proprietary rights, as well as licensing revenues.

 

If we are unable to protect our proprietary rights, we may not be able to compete effectively, or operate profitably.

 

Our success is dependent in part on obtaining, maintaining and enforcing our patents and other proprietary rights and our ability to avoid infringing the proprietary rights of others.  Patent law relating to the scope of claims in the biotechnology field in which we operate is still evolving and, consequently, patent positions in our industry may not be as strong as in other, better-established fields.  Accordingly, the United States Patent and Trademark Office (USPTO) may not issue patents from the patent applications owned by or licensed to us.  If issued, the patents may not give us an advantage over competitors with similar technology.

 

We own more than 100 issued United States patents and have licenses to additional patents.  However, the issuance of a patent is not conclusive as to its validity or enforceability and it is uncertain how much protection, if any, will be given to our patents if we attempt to enforce them and they are challenged in court or in other proceedings, such as oppositions, which may be brought in foreign jurisdictions to challenge the validity of a patent.  A third party may challenge the validity or enforceability of a patent after its issuance by the USPTO.  It is possible that a competitor may successfully challenge our patents or that a challenge will result in limiting their coverage.  Moreover, the cost of litigation to uphold the validity of patents and to prevent infringement can be substantial.  If the outcome of litigation is adverse to us, third parties may be able to use our patented invention without payment to us.  Moreover, it is possible that competitors may infringe our patents or successfully avoid them through design innovation.  To stop these activities we may need to file a lawsuit.  These lawsuits are expensive and would consume time and other resources, even if we were successful in stopping the violation of our patent rights.  In addition, there is a risk that a court would decide that our patents are not valid and that we do not have the right to stop the other party from using the inventions.  There is also the risk that, even if the validity of our patents were upheld, a court would refuse to stop the other party on the ground that its activities do not infringe our patents.

 

In addition to the intellectual property rights described above, we rely on unpatented technology, trade secrets and confidential information.  Therefore, others may independently develop substantially equivalent information and techniques or otherwise gain access to or disclose our technology.  We may not be able to effectively protect our rights in unpatented technology, trade secrets and confidential information. We require each of our employees, consultants and advisors to execute a confidentiality agreement at the commencement of an employment or consulting relationship with us.  However, these agreements may not provide effective protection of our information or, in the event of unauthorized use or disclosure, they may not provide adequate remedies.

 

The use of our technologies could potentially conflict with the rights of others.

 

Our competitors or others may have or acquire patent rights that they could enforce against us.  If they do so, we may be required to alter our products, pay licensing fees or cease activities.  If our products conflict with patent rights of others, third parties could bring legal actions against us claiming damages and seeking to enjoin manufacturing and marketing of the affected products.  If these legal actions are successful, in addition to any potential liability for damages, we could be required to obtain a license in order to continue to manufacture or market the affected products.  We may not prevail in any legal action and a required license under the patent may not be available on acceptable terms or at all.

 

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.

 

The cost to us of any litigation or other proceedings relating to intellectual property rights, even if resolved in our favor, could be substantial.  Some of our competitors may be better able to sustain the costs of complex patent

 

19



 

litigation because they have substantially greater resources.  If there is litigation against us, we may not be able to continue our operations.  If third parties file patent applications, or are issued patents claiming technology also claimed by us in pending applications, we may be required to participate in interference proceedings in the USPTO to determine priority of invention.  We may be required to participate in interference proceedings involving our issued patents and pending applications.  We may be required to cease using the technology or license rights from prevailing third parties as a result of an unfavorable outcome in an interference proceeding.  A prevailing party in that case may not offer us a license on commercially acceptable terms or at all.

 

Product liability claims in excess of the amount of our insurance would adversely affect our financial condition.

 

The testing, manufacturing, marketing and sale of STR and any other proposed cancer therapy products that we may have under development may subject us to product liability claims.  We are insured against such risks up to a $10 million annual aggregate limit in connection with clinical trials of our products under development and intend to obtain product liability coverage in the future.  However, insurance coverage may not be available to us at an acceptable cost, if at all.  We may not be able to obtain insurance coverage that will be adequate to satisfy any liability that may arise.  Regardless of merit or eventual outcome, product liability claims may result in decreased demand for a product, injury to our reputation, withdrawal of clinical trial volunteers and loss of revenues.  As a result, regardless of whether we are insured, a product liability claim or product recall may result in losses that could be material.

 

Our use of radioactive and other hazardous materials exposes us to the risk of material environmental liabilities, and we may incur significant additional costs to comply with environmental laws in the future.

 

Our research and development and clinical manufacturing processes, as well as the manufacturing processes that may be used by our collaborators, involve the controlled use of hazardous and radioactive materials.  As a result, we are subject to foreign, federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials and wastes in connection with our use of these materials.  Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by such laws and regulations, we may be required to incur significant costs to comply with environmental and health and safety regulations in the future.  In addition, the risk of accidental contamination or injury from hazardous and radioactive materials cannot be completely eliminated.  In the event of such an accident, we could be held liable for any resulting damages, and any such liability could exceed our resources.

 

Even if we bring products to market, changes in healthcare reimbursement could adversely affect our ability to effectively price our products or obtain adequate reimbursement for sales of our products.

 

The levels of revenues and profitability of biotechnology companies may be affected by the continuing efforts of government and third-party payors to contain or reduce the costs of healthcare through various means.  For example, in certain foreign markets pricing or profitability of prescription pharmaceuticals is subject to governmental control.  In the United States, there have been, and we expect that there will continue to be, a number of federal and state proposals to implement similar governmental controls.  It is uncertain what legislative proposals will be adopted or what actions federal, state or private payors for healthcare goods and services may take in response to any healthcare reform proposals or legislation.  Even in the absence of statutory change, market forces are changing the healthcare sector.  We cannot predict the effect healthcare reforms may have on the development, testing, commercialization and marketability of our cancer therapy products.  Further, to the extent that such proposals or reforms have a material adverse effect on the business, financial condition and profitability of other companies that are prospective collaborators for certain of our potential products, our ability to commercialize our products under development may be adversely affected.  In addition, both in the United States and elsewhere, sales of prescription pharmaceuticals depend in part on the availability of reimbursement to the consumer from third-party payors, such as governmental and private insurance plans.  Third-party payors are increasingly challenging the prices charged for medical products and services.  If we succeed in bringing one or more products to market, we cannot be certain that these products will be considered cost-effective and that reimbursement to the consumer will be available or will be sufficient to allow us to sell our products on a competitive or profitable basis.

 

20



 

The loss of key employees could adversely affect our operations.

 

In July 2002, we implemented a 30% reduction in force.  In October 2002, we further reduced our work force, primarily at our Denton manufacturing facility, by an additional 13 persons, or approximately 15% of the Company’s total work force.  We currently have fewer than 75 employees.  Our success depends, to a significant extent, on the continued contributions of our principal management and scientific personnel.  The loss of the services of one or more of the principal members of our scientific and management staff could delay our STR product development activities or other programs and research and development efforts.  We do not maintain key person life insurance on any of our officers, employees or consultants.

 

Competition for qualified employees among companies in the biotechnology and biopharmaceutical industry is intense.  Our future success depends upon our ability to attract, retain and motivate highly skilled employees.  In order to commercialize our proposed products successfully, we may in the future be required to expand substantially our work force, particularly in the areas of manufacturing, clinical trials management, regulatory affairs, business development and sales and marketing.  These activities will require the addition of new personnel, including management, and the development of additional expertise by existing management personnel.

 

Our stock price is volatile and, as a result, you could lose some or all of your investment.

 

There has been a history of significant volatility in the market prices of securities of biotechnology companies, including our common stock, and it is likely that the market price of our common stock will continue to be highly volatile.  Our business and the relative prices of our common stock may be influenced by a large variety of industry factors, including:

 

                                          announcements by us or our competitors concerning acquisitions, strategic alliances, technological innovations and new commercial products;

 

                                          the availability of critical materials used in developing and manufacturing our proposed STR product;

 

                                          the progress and results of clinical trials;

 

                                          developments concerning patents, proprietary rights and potential infringement; and

 

                                          the expense and time associated with and the extent of our ultimate success in securing regulatory approvals.

 

In addition, public concern about the safety of STR and any other products we develop, comments by securities analysts, and conditions in the capital markets in general and in the life sciences capital markets specifically may have a significant effect on the market price of our common stock.  The realization of any of the risks described in this report, as well as other factors, could have a material adverse impact on the market price of our common stock and may result in a loss of some or all of your investment.

 

In the past, securities class action litigation has often been brought against companies following periods of volatility in their stock prices.  We may in the future be the targets of similar litigation.  Securities litigation could result in substantial costs and divert our management’s time and resources, which could cause our business to suffer.

 

We cannot assure you that our common stock will continue to be listed on the Nasdaq National Market, and delisting could further depress our stock price and make it more difficult for us to raise capital.

 

Our common stock is currently listed on the Nasdaq National Market.  To maintain such listing, we must continue to satisfy ongoing listing requirements, including consistently maintaining a minimum bid price for the common stock of $1.00 per share or more. Our common stock has traded below the $1.00 minimum bid requirement since July 31, 2002.  If our common stock trades below the $1.00 minimum bid requirement for a period of 30 consecutive business days or more, or if we otherwise fail to meet Nasdaq’s ongoing listing criteria, Nasdaq could initiate delisting procedures at any time.  On September 6, 2002, we received a letter from the Nasdaq Stock Market advising that we have until December 5, 2002 to regain compliance with Nasdaq National Market listing criteria.

 

21



 

Our management is currently considering various alternatives to address this situation. If Nasdaq moves to delist our common stock, we could spend material financial and management resources in an attempt to avoid delisting, which could cause our business to suffer. If we were to lose our Nasdaq National Market status, we would likely seek listing of our common stock in the over-the-counter market, which is viewed by many investors as a less liquid marketplace.  Among other things, our common stock may then constitute “penny stock,” which would place increased regulatory burden upon brokers, making them less likely to make a market in our stock.  Loss of our Nasdaq National Market status could also make it more difficult for us to raise capital or complete acquisitions and would also complicate compliance with state “blue sky” laws.

 

Certain provisions in our articles of incorporation and Washington state law could discourage a change of control.

 

Our articles of incorporation authorize our board of directors to issue up to 3,000,000 shares of preferred stock and to determine the price, rights, preference, privileges and restrictions, including voting rights, of those shares without any further vote or action by our shareholders.  The issuance of preferred stock could have the effect of delaying, deferring or preventing a change of control, even if this change would benefit our shareholders.  In addition, the issuance of preferred stock may adversely affect the market price of our common stock and the voting and other rights of the holders of our common stock.

 

We have adopted a shareholders’ rights plan, which is intended to protect the rights of shareholders by deterring coercive or unfair takeover tactics.  The board of directors declared a dividend to holders of our common stock of one preferred share purchase right for each outstanding share of common stock.  The right is exercisable ten days following the offer to purchase or acquisition of beneficial ownership of 20% of the outstanding common stock by a person or group of affiliated persons.  Each right entitles the registered holder, other than the acquiring person or group, to purchase from NeoRx one-hundredth of one share of Series A Junior Participating Preferred Stock at the price of $40, subject to adjustment.  The rights expire April 10, 2006.  In lieu of exercising the right by purchasing one one-hundredth of one share of Series A Preferred Stock, the holder of the right, other than the acquiring person or group, may purchase for $40 that number of shares of our common stock having a market value of twice that price.

 

Washington law imposes restrictions on certain transactions between a corporation and significant shareholders.  Chapter 23B.19 of the Washington Business Corporation Act prohibits a target corporation, with some exceptions, from engaging in particular significant business transactions with an acquiring person, which is defined as a person or group of persons that beneficially owns 10% or more of the voting securities of the target corporation, for a period of five years after the acquisition, unless the transaction or acquisition of shares is approved by a majority of the members of the target corporation’s board of directors prior to the acquisition.  Prohibited transactions include, among other things:

 

                                          a merger or consolidation with, disposition of assets to, or issuance or redemption of stock to or from the acquiring person;

 

                                          termination of 5% or more of the employees of the target corporation; or

 

                                          receipt by the acquiring person of any disproportionate benefit as a shareholder.

 

A corporation may not opt out of this statute.  This provision may have the effect of delaying, deterring or preventing a change in control of NeoRx or limiting future investment in NeoRx by significant shareholders and their affiliates and associates.

 

22



 

Item 3.  Quantitative and Qualitative Disclosures about Market Risk

 

The Company is exposed to the impact of interest rate changes and changes in the market values of its investments.

 

Interest Rate Risk

 

The Company’s exposure to market rate risk for changes in interest rates relates primarily to the Company’s debt securities included in its investment portfolio.  The Company does not have any derivative financial instruments.  The Company invests in debt instruments of the U.S. Government and its agencies and high-quality corporate issuers.  Investments in both fixed rate and floating rate interest earning instruments carry a degree of interest rate risk.  Fixed rate securities may have their fair market value adversely impacted due to a rise in interest rates, while floating rate securities may produce less income than expected if interest rates fall.  Due in part to these factors, the Company’s future investment income may fall short of expectations due to changes in interest rates or the Company may suffer losses in principal if forced to sell securities that have declined in market value due to changes in interest rates.  At September 30, 2002, the Company owned no government debt instruments and owned corporate debt securities in the amount of $11.3 million. The Company’s exposure to losses as a result of interest rate changes is managed through investing primarily in securities with relatively short maturities of up to three years and securities with variable interest rates.  The Company had approximately $4.2 million of corporate debt securities that had maturity dates greater than one year at September 30, 2002, all of which were variable interest rate securities.

 

Item 4.  Controls and Procedures

 

Under the supervision of and with the participation of the Company’s management, including the Company’s Chief Executive Officer and Vice President, Finance and Chief Accounting Officer, the Company has evaluated the effectiveness and design and operation of its disclosure controls and procedures within 90 days of the filing date of this quarterly report and, based on their evaluation, the Chief Executive Officer and the Vice President, Finance and Chief Accounting Officer have concluded that these disclosure controls and procedures are effective.  There were no significant changes in the Company’s internal controls or in other factors that could significantly affect those controls subsequent to the date of their evaluation.

 

23



 

PART II.

 

Item 5.  Other Information

 

Measures to reduce expenses during the third quarter of 2002 included the elimination of two senior management positions after the departures of Richard L. Anderson, formerly Senior Vice President and Chief Financial Officer, and Becky J. Bottino, formerly Senior Vice President of Operations.  The Company’s financial responsibilities will be managed by Melinda G. Kile, Vice President, Finance and Chief Accounting Officer.  Responsibilities for manufacturing will continue to be managed by Les Sabo, Vice President of Manufacturing.

 

Item 6.  Exhibits, Financial Statement Schedules and Reports on Form 8-K

 

(a)(1) Financial Statements – See Index to Financial Statements.

 

(a)(2) Financial Statement Schedules – Not Applicable.

 

(a)(3) Exhibits – See Exhibit Index filed herewith.

 

(b) Reports on Form 8-K:

 

Form 8-K dated July 24, 2002, relating to an update of the STR dosimetry study and the discontinuance of the Pretarget® program and reduction in force.

 

Form 8-K dated September 6, 2002, relating to the Company’s receipt of a letter from NASDAQ regarding noncompliance of stock listing requirements.

 

24



 

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 thereunto duly authorized.

 

 

 

 

NEORX CORPORATION

 

 

 

(Registrant)

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

/s/ MELINDA G. KILE

 

 

 

 

 

Melinda G. Kile

 

 

 

 

Vice President, Finance and Chief Accounting Officer

 

 

Date: November 14, 2002

 

25



 

CERTIFICATIONS

I, Douglass B. Given, MD, PhD, certify that:

 

1.             I have reviewed this quarterly report on Form 10-Q of NeoRx Corporation;

 

2.             Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3.             Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4.             The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

 

a)             designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

b)            evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and

 

c)             presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

 

5.             The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

 

a)             all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

 

b)            any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

 

6.             The registrant’s other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

Date:       November 14, 2002

 

 

 

 

/s/ DOUGLASS B. GIVEN

 

Douglass B. Given, MD, PhD

 

 

 

President and Chief Executive Officer

 

26



 

I, Melinda G. Kile, certify that:

 

1.             I have reviewed this quarterly report on Form 10-Q of NeoRx Corporation;

 

2.             Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;

 

3.             Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;

 

4.             The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:

 

a)             designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

b)             evaluated the effectiveness of the registrant’s disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the “Evaluation Date”); and

 

c)             presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;

 

5.             The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):

 

a)             all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant’s ability to record, process, summarize and report financial data and have identified for the registrant’s auditors any material weaknesses in internal controls; and

 

b)             any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls; and

 

6.             The registrant’s other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

Date:       November 14, 2002

 

 

 

 

/s/ MELINDA G. KILE

 

Melinda G. Kile

 

 

 

Vice President, Finance and Chief Accounting Officer

 

27



 

EXHIBIT INDEX

 

Exhibit

 

Description

 

Incorporation by
Reference to

3.1(a)

 

Restated Articles of Incorporation, dated April 29, 1996

 

*

3.1(b)

 

Articles of Amendment, dated March 31, 1997, to Restated Articles of Incorporation

 

**

3.1(c)

 

Articles of Amendment, dated August 8, 1997, to Restated Articles of Incorporation

 

XXXXX

3.2

 

Bylaws, as amended, of the registrant

 

XXXXX

10.1

 

Restated 1994 Stock Option Plan (‡)

 

10.2

 

Lease Agreement for 410 West Harrison facility, dated February 15, 1996, between NeoRx Corporation and Diamond Parking, Inc

 

#

10.3

 

Amendment No. 1, dated August 14, 2000, to Lease Agreement between NeoRx Corporation and Dina Corporation

 

X

10.4

 

1991 Stock Option Plan for Non-Employee Directors, as amended (‡)

 

=

10.5

 

1991 Restricted Stock Plan (‡)

 

******

10.6

 

Agreement, dated as of December 15, 1995

 

=====

10.7

 

Stock Option Agreement, dated July 30, 2001, between NeoRx Corporation and Douglass B. Given (‡)

 

10.8

 

Indemnification Agreement (‡)

 

#

10.9

 

Form of Key Executive Severance Agreement (‡)

 

##

10.10

 

Officer Change in Control Agreement (‡)

 

XXXXX

10.11

 

Key Executive Severance Agreement (‡)

 

XXXXX

10.12

 

License Agreement, dated June 30, 1999, between NeoRx and The Dow Chemical Company

 

_

10.13

 

Credit Facility Agreement, dated February 3, 2000, between NeoRx Corporation and Pharmaceutical Product Development, Inc.

 

__

10.14

 

Facilities Lease, dated July 24, 2000, between NeoRx Corporation and F5 Networks

 

___

10.15

 

Stock Option Agreement, dated December 19, 2000, between NeoRx Corporation and Carl S. Goldfischer (‡)

 

X

10.16

 

Stock Option Agreement, dated January 17, 2001, between NeoRx Corporation and Carl S. Goldfischer  (‡)

 

X

10.17

 

Stock Option Agreement, dated November 16, 2000, between NeoRx Corporation and Douglass Given (‡)

 

X

10.18

 

Sublicense Agreement, dated May 15, 1997, between NeoRx Corporation and Roche Molecular Biochemicals.  Certain portions of the agreement have been omitted pursuant to a grant of confidential treatment.

 

^

10.19

 

Stock Option Grant Program for Nonemployee Directors under the NeoRx Corporation 1994 Restated Stock Option Plan (‡)

 

^^

10.20

 

First Amendment to Sublease Agreement, dated March 30, 2001, between NeoRx Corporation and F5 Networks

 

^

10.21

 

Amendment No. 3 to Consulting Agreement, dated January 1, 2002, between NeoRx Corporation and Bay City Capital BD, LLC

 

&&

10.22

 

Separation Agreement, dated September 13, 2001, between NeoRx Corporation and Richard L. Anderson (‡)

 

&&

10.23

 

Form of VP Change in Control Agreements (‡)

 

&&

10.24

 

Clinical Manufacture and Supply Agreement, dated December 1, 2001, between NeoRx Corporation and MURR.  Certain portions of the agreement have been omitted pursuant to a grant of confidential treatment.

 

&&

10.25

 

Facilities Lease, dated February 15, 2002, between NeoRx Corporation and Selig Real Estate Holdings Six

 

&&

10.26

 

Form of VP Severance Agreements (‡)

 

&&

10.27

 

Lease Termination/Continuation Agreement between NeoRx Corporation and Dina Corporation

 

^^^

21

 

Subsidiaries of NeoRx Corporation

 

&&

99.1

 

Certification of Periodic Report by Chief Executive Officer

 

^^^

99.2

 

Certification of Periodic Report by Vice President, Finance and Chief Accounting Officer

 

^^^


 

&&

 

Filed as an exhibit to the Company’s Form 10-K for the fiscal year ended December 31, 2001 and incorporated herein by reference.

*

 

Filed as an exhibit to the Company’s Form 10-K for the fiscal year ended December 31, 1996 and incorporated herein by reference.

 

 

 

**

 

Filed as an exhibit to the Company’s Registration Statement on Form S-3 (Registration No. 333-25161), filed April 14, 1997 and incorporated herein by reference.

 

 

 

******

 

Filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 1991 and incorporated herein by reference.

 

 

 

=

 

Filed as an exhibit to the Company’s Registration Statement on Form S-2 (Registration No. 33-71164) effective December 13, 1993 and incorporated herein by reference.

 

 

 

=====

 

Filed as an exhibit to the Company’s Form 10-K for the fiscal year ended December 31, 1995 and incorporated herein by reference.

 

 

 

 

Filed as an exhibit to the Company’s Registration Statement on Form S-8 (Registration No. 333-71368), filed October 10, 2001 and incorporated herein by reference.

 

 

 

#

 

Filed as an exhibit to the Company’s Form 10-Q for the quarterly period ended March 31, 1996 and incorporated herein by reference.

 

 

 

##

 

Filed as an exhibit to the Company’s Form 10-Q for the quarterly period ended June 30, 1996 and incorporated herein by reference.

 

 

 

X

 

Filed as an exhibit to the Company’s Form 10-K for the fiscal year ended December 31, 2000 and incorporated herein by reference.

 

 

 

XXXXX

 

Filed as an exhibit to the Company’s Form 10-K for the fiscal year ended December 31, 1998 and incorporated herein by reference.

 

 

 

_

 

Filed as an exhibit to the Company’s Form 10-Q for the quarterly period ended September 30, 1999 and incorporated herein by reference.  Certain portions of the agreement have been omitted pursuant to a grant of confidential treatment.

 

 

 

__

 

Filed as an exhibit to the Company’s Form 10-Q for the quarterly period ended March 31, 2000 and incorporated herein by reference.  Certain portions of the agreement have been omitted pursuant to a grant of confidential treatment.

 

 

 

___

 

Filed as an exhibit to the Company’s Form 10-Q for the quarterly period ended September 30, 2000 and incorporated herein by reference.  Certain portions of the agreement have been omitted pursuant to a grant of confidential treatment.

 

 

 

 

Management contract or compensatory plan.

 

 

 

^

 

Filed as an exhibit to the Company’s Form 10-Q for the quarterly period ended March 31, 2001 and incorporated herein by reference.

 

 

 

^ ^

 

Filed as an exhibit to the Company’s Form 10-Q for the quarterly period ended June 30, 2002 and incorporated herein by reference.

 

 

 

^ ^ ^

 

Submitted herewith.

 

28