10-Q 1 a03-5153_110q.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, 2003

 

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.)

 

300 Elliott Avenue West, Suite 500, Seattle, Washington 98119-4114

(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

 

Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act. 

 

Yes

 

o

 

No

 

ý

 

As of November 7, 2003, 27,943,132 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, 2003

 

PART I
FINANCIAL INFORMATION
 
 

Item 1.

Financial Statements (Unaudited):

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2003 and December 31, 2002

 

 

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2003 and 2002

 

 

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2003 and 2002

 

 

 

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 6.

Exhibits and Reports on Form 8-K

 

 

 

Signatures

 

 

 

Exhibit Index

 

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, 2003

 

December 31, 2002

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

2,390

 

$

6,564

 

Investment securities

 

13,350

 

9,572

 

Prepaid expenses and other current assets

 

955

 

1,269

 

Total current assets

 

16,695

 

17,405

 

 

 

 

 

 

 

Facilities and equipment, net

 

8,117

 

8,509

 

Other assets, net

 

67

 

79

 

 

 

 

 

 

 

Total assets

 

$

24,879

 

$

25,993

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

653

 

$

1,024

 

Accrued liabilities

 

832

 

1,674

 

Current portion of note payable

 

348

 

512

 

Total current liabilities

 

1,833

 

3,210

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

Note payable, net of current portion

 

5,062

 

5,182

 

Asset retirement obligation

 

514

 

 

Other

 

 

25

 

Total long-term liabilities

 

5,576

 

5,207

 

 

 

 

 

 

 

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, 2003 and December 31, 2002 (entitled in liquidation to $5,300 and $5,175, respectively, at September 30, 2003 and December 31, 2002)

 

4

 

4

 

Common stock, $.02 par value, 60,000,000 shares authorized, 27,696,623 and 26,765,082 shares issued and outstanding at September 30, 2003 and December 31, 2002, respectively

 

554

 

535

 

Accumulated other comprehensive income – unrealized loss on investment securities

 

(19

)

(101

)

Additional paid-in capital

 

226,115

 

224,035

 

Accumulated deficit

 

(209,184

)

(206,897

)

  Total shareholders’ equity

 

17,470

 

17,576

 

Total liabilities and shareholders’ equity

 

$

24,879

 

$

25,993

 

 

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,

 

 

 

2003

 

2002

 

2003

 

2002

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

225

 

$

507

 

$

10,531

 

$

2,036

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

2,037

 

4,438

 

7,376

 

17,472

 

General and administrative

 

1,142

 

1,535

 

4,742

 

5,137

 

Asset impairment loss

 

 

5,658

 

 

5,658

 

Restructuring

 

 

529

 

 

529

 

Total operating expenses

 

3,179

 

12,160

 

12,118

 

28,796

 

Loss from operations

 

(2,954

)

(11,653

)

(1,587

)

(26,760

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Realized gain (loss) on sale of securities

 

(142

)

20

 

(142

)

142

 

Interest income

 

30

 

204

 

184

 

912

 

Interest expense

 

(57

)

(75

)

(177

)

(281

)

Total other income (expense)

 

(169

)

149

 

(135

)

773

 

Net loss before cumulative effect of change in accounting principle

 

(3,123

)

(11,504

)

(1,722

)

(25,987

)

Cumulative effect of change in accounting principle

 

 

 

(190

)

 

Net loss

 

(3,123

)

(11,504

)

(1,912

)

(25,987

)

Preferred stock dividends

 

(125

)

(125

)

(375

)

(375

)

Net loss applicable to common shares

 

$

(3,248

)

$

(11,629

)

$

(2,287

)

$

(26,362

)

 

 

 

 

 

 

 

 

 

 

Loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted loss per share applicable to common shares before cumulative effect of change in accounting principle

 

$

(0.12

)

$

(0.44

)

$

(0.07

)

$

(0.99

)

Cumulative effect of change in accounting principle

 

 

 

(0.01

)

 

Basic and diluted loss applicable to common shares

 

$

(0.12

)

$

(0.44

)

$

(0.08

)

$

(0.99

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

27,355

 

26,634

 

27,062

 

26,604

 

 

 

 

 

 

 

 

 

 

 

Pro forma amounts had accounting principle been applied retroactively:

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

$

(11,532

)

 

 

$

(26,070

)

Preferred stock dividends

 

 

 

(125

)

 

 

(375

)

Loss applicable to common shares

 

 

 

$

(11,657

)

 

 

$

(26,445

)

 

 

 

 

 

 

 

 

 

 

Loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

 

$

(0.44

)

 

 

$

(0.99

)

 

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,

 

 

 

2003

 

2002

 

 

 

 

 

 

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(1,912

)

$

(25,987

)

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

 

 

 

 

 

Depreciation and amortization

 

607

 

1,337

 

Gain (loss) on sale of securities

 

142

 

(142

)

Loss on disposal of equipment

 

240

 

69

 

Asset impairment loss

 

 

5,658

 

Restructuring

 

 

529

 

Cumulative effect of change in accounting principle

 

190

 

 

Accretion of asset retirement obligation liability

 

50

 

 

Common stock issued for services

 

4

 

68

 

Stock options and warrants issued for services

 

276

 

42

 

Stock-based employee compensation

 

590

 

 

Change in operating assets and liabilities:

 

 

 

 

 

Prepaid expenses and other assets

 

(60

)

(111

)

Accounts payable

 

(371

)

(693

)

Accrued liabilities

 

(909

)

(521

)

Net cash used in operating activities

 

(1,153

)

(19,751

)

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Proceeds from sales and maturities of investment securities

 

19,211

 

25,661

 

Purchases of investment securities

 

(23,049

)

(7,849

)

Facilities and equipment purchases

 

(51

)

(683

)

Proceeds from sales of equipment

 

188

 

 

Net cash (used in) provided by investing activities

 

(3,701

)

17,129

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Proceeds from stock options and warrants exercised

 

1,196

 

19

 

Receipt of note receivable principal

 

68

 

91

 

Repayment of note payable principal

 

(284

)

(175

)

Repayment of capital lease obligation

 

(50

)

(50

)

Preferred stock dividends

 

(250

)

(250

)

Net cash provided by (used in) financing activities

 

680

 

(365

)

 

 

 

 

 

 

Net decrease in cash and cash equivalents

 

(4,174

)

(2,987

)

 

 

 

 

 

 

Cash and cash equivalents:

 

 

 

 

 

Beginning of period

 

6,564

 

4,097

 

End of period

 

$

2,390

 

$

1,110

 

 

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 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, 2002.

 

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, 2003 and the results of operations and cash flows for the periods ended September 30, 2003 and 2002.

 

The results of operations for the periods ended September 30, 2003 and 2002 are not necessarily indicative of the expected operating results for the full year.

 

The Company accounts for its stock option plans for employees in accordance with the provisions of Accounting Principles Board (APB) Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations.  As such compensation expense related to employee stock options is recorded if, on the date of grant, the fair value of the underlying stock exceeds the exercise price.  The Company applies the disclosure-only requirements of SFAS No. 123, “Accounting for Stock-Based Compensation”, which allows entities to continue to apply the provisions of APB Opinion No. 25 for transactions with employees and to provide pro forma results of operations disclosures for employee stock option grants as if the fair-value based method of accounting in SFAS No. 123 had been applied to these transactions.  Stock compensation costs related to fixed employee awards with pro rata vesting are recognized on a straight-line basis over the period of benefit, generally the vesting period of the options.  For options and warrants issued to non-employees, the Company recognizes stock compensation costs utilizing the fair value methodology prescribed in SFAS No. 123 over the related period of benefit.

 

Had compensation cost for these stock option plans for employees been determined using the fair value based method of accounting under SFAS 123, “Accounting for Stock-Based Compensation,” the Company’s net loss applicable to common shares and net loss per share would have been the pro forma amounts indicated below (in thousands, except per share data):

 

 

 

Quarter ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2003

 

2002

 

2003

 

2002

 

Net loss applicable to common shares:

 

 

 

 

 

 

 

 

 

As reported

 

$

(3,248

)

$

(11,629

)

$

(2,287

)

$

(26,362

)

Add: Stock-based employee compensation expense included in reported net loss

 

 

67

 

590

 

67

 

Deduct: Stock-based employee compensation determined under fair value based method for all awards

 

(494

)

(578

)

(2,231

)

(2,475

)

Pro forma

 

$

(3,742

)

$

(12,140

)

$

(3,928

)

$

(28,770

)

Net loss per common share, basic and diluted:

 

 

 

 

 

 

 

 

 

As reported:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.12

)

$

(0.44

)

$

(0.08

)

$

(0.99

)

Pro forma:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.14

)

$

(0.46

)

$

(0.15

)

$

(1.08

)

 

6



 

The per share weighted-average fair value of stock options granted during the quarters ended and nine months ended September 30, 2003 and 2002 was $2.42, $1.95, $0.97, and $2.03, respectively, on the grant date using the Black-Scholes option pricing model with the following weighted average assumptions:

 

 

 

Quarter ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2003

 

2002

 

2003

 

2002

 

Expected dividend rate

 

0.0

%

0.0

%

0.0

%

0.0

%

Risk-free interest rate

 

2.40

%

3.83

%

2.30

%

3.83

%

Expected volatility

 

140.0

%

105.0

%

135.6

%

105.0

%

Expected life in years

 

4.00

 

4.00

 

4.00

 

4.00

 

 

 

Note 2.  Net Earnings or 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 and nine months ended September 30, 2003 and 2002 exclude the effect of stock options warrants to purchase additional shares of common stock because the share increments would not be dilutive.

 

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 not be dilutive:

 

 

 

Quarter ended
September 30,

 

Nine Months ended
September 30,

 

 

 

2003

 

2002

 

2003

 

2002

 

 

 

 

 

 

 

 

 

 

 

Common stock options

 

4,431,894

 

4,714,779

 

4,431,894

 

4,714,779

 

Weighted average exercise price per share

 

$

3.59

 

$

4.63

 

$

3.59

 

$

4.63

 

Common stock warrants

 

875,000

 

1,051,000

 

875,000

 

1,051,000

 

Weighted average exercise price per share

 

$

9.72

 

$

8.85

 

$

9.72

 

$

8.85

 

 

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 periods ended September 30, 2003 and 2002 because the effect of including such shares would not be dilutive.

 

7



 

Note 3.  Comprehensive Loss

 

The Company’s comprehensive loss for the quarters ended September 30, 2003 and 2002 was $3,100,000 and $11,608,000, respectively.  The comprehensive loss for the quarters ended September 30, 2003 and 2002 consisted of net loss of $3,123,000 and $11,504,000, respectively, and a net unrealized gain (loss) on investment securities of $23,000 and $(104,000) for the quarters ended September 30, 2003 and 2002, respectively.  The comprehensive loss for the nine months ended September 30, 2003 and 2002 was $1,830,000 and $26,533,000, respectively.  The comprehensive loss for the nine months ended September 30, 2003 and 2002 consisted of net loss of $1,912,000 and $25,987,000, respectively, and a net unrealized gain (loss) on investment securities of $82,000 and $(546,000) for the nine months ended September 30, 2003 and 2002, respectively.

 

Note 4.  Asset Retirement Obligation

 

The Company recorded a $0.2 million cumulative effect of change in accounting principle during the first nine months of 2003 as a result of the Company’s adoption of SFAS 143, Accounting for Asset Retirement Obligations.  Under SFAS 143, the Company recorded an asset and liability in the amount of $0.4 million related to estimated fair value of future decommissioning costs associated with the Denton radiopharmaceutical manufacturing facility.  This estimate will be depreciated over the seven year estimated useful life of the asset and the asset retirement obligation will be accreted over the thirty years that represents the expected time that will elapse prior to the settlement of the obligation.  The Company adopted SFAS 143 on January 1, 2003.  A reconciliation of the asset retirement obligation follows (in 000’s):

 

Asset retirement obligation calculated as of date of Denton facility purchase (April 1, 2001)

 

$

364

 

Accretion-2001

 

40

 

Balance at December 31, 2001

 

404

 

Accretion-2002

 

60

 

Balance at December 31, 2002

 

464

 

Accretion-January 1, 2003 to September 30, 2003

 

50

 

Balance at September 30, 2003

 

$

514

 

 

 

In addition, had the Company applied the provisions of SFAS 143 as of the date of acquisition of the Denton facility, and using current January 1, 2003 assumptions for interest rates and decommissioning costs, depreciation expense would have increased by $39,000, $52,000 and $39,000, respectively, for the nine months ended September 30, 2002 and the years ended December 31, 2002 and 2001.

 

Note 5.  Boston Scientific Corporation Intellectual Property Sale

 

On April 17, 2003, the Company entered into agreements with Boston Scientific Corporation relating to the sale to Boston Scientific of certain non-core NeoRx intellectual property and the grant to Boston Scientific of certain license rights.  Under the first agreement, the Company assigned to Boston Scientific certain NeoRx intellectual property in exchange for a cash payment of $9 million.  The intellectual property assigned to Boston Scientific included a portfolio of NeoRx patents and patent applications in the cardiovascular field.

 

Under a second agreement, NeoRx granted to Boston Scientific an exclusive license to use certain other NeoRx intellectual property, for which NeoRx received a one-time cash payment of $1 million.  The exclusive license grants Boston Scientific the right to use, in certain medical device fields, a separate portfolio of NeoRx patents and patent applications resulting from a collaboration with University of Cambridge investigators.

 

Note 6.  New Accounting Pronouncements

 

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.

 

8



 

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 adopted this Statement on January 1, 2003.  The cumulative effect of adopting this change in accounting principle in the first quarter of 2003 is discussed in Note 4.

 

In June 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.   The Company adopted this Statement on January 1, 2003.  Management cannot determine the impact of adopting this Statement on its consolidated financial statements, as its effects will be prospective.

 

In November 2002, the Financial Accounting Standards Board Emerging Issues Task Force issued its consensus concerning Revenue Arrangements with Multiple Deliverables (“EITF 00-21”).  EITF 00-21 addresses how to determine whether a revenue arrangement involving multiple deliverables should be divided into separate units of accounting, and, if separation is appropriate, how the arrangement consideration should be measured and allocated to the identified accounting units.  The guidance in EITF 00-21 is effective for revenue arrangements entered into in fiscal periods beginning after June 15, 2003.  The adoption of EITF 00-21 did not have a material impact on the Company’s consolidated financial statements.

 

                In May 2003, the FASB issued Statement No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, which addresses financial accounting and reporting for certain financial instruments with characteristics of both liabilities and equity and requires that those instruments be classified as liabilities in statements of financial position.  Previously many of those financial instruments were classified as equity.  The Statement is effective for financial instruments entered into or modified after May 31, 2003 and otherwise is effective at the beginning of the first interim period beginning after June 15, 2003.  The adoption of the Statement did not have a material impact on the Company’s operating results or financial position.

 

Note 7.  Liquidity

 

The Company will need to raise additional capital to fund its planned Skeletal Targeted Radiotherapy (STR™) phase III clinical trial and its future operating cash needs.  In April 2003 the Company received $10 million from the sale to Boston Scientific Corporation of certain non-core NeoRx intellectual property and the grant to Boston Scientific Corporation of certain license rights.  The Company expects that its present cash, cash equivalents, investment securities and expected interest income will be sufficient to fund its anticipated working capital and capital requirements through the third quarter of 2004.

 

During 2002, the Company discontinued all Pretarget® technology activities, reduced staffing by 67% and terminated the lease for its facilities at 410 West Harrison Street in Seattle, effective in April 2003.  PretargetÒ technology is a development platform for targeted immunotherapeutics that deliver intense doses of anti-cancer agents to tumor cells while largely sparing healthy tissues.

 

In connection with its 2001 purchase of the radiopharmaceutical manufacturing plant and other assets located in Denton, TX, the Company assumed $6,000,000 principal amount of restructured debt held by Texas State Bank, McAllen, TX.  The loan, which matures in April 2009, is secured by the assets acquired in the transaction.  During 2002 and early 2003, the Company reduced the staff at the Denton facility to four employees and operated the facility in standby mode. The Company currently is in the process of recruiting and hiring personnel and otherwise ramping up the manufacturing plant for production of clinical material for its planned STR phase III

 

9



 

clinical trial.

 

The Company may seek to raise capital through the sale of equity and/or debt securities or the establishment of other funding facilities. The Company is seeking to form a strategic partnership for STR development and commercialization.  The Company is also addressing its need for additional capital by pursuing opportunities for the licensing, sale or divestiture of certain non-core intellectual property and other assets, including its Pretarget® technology platform.  In addition, the Company is also looking for an investor or partner for its manufacturing facility who is interested in continuing the facility’s radiopharmaceutical manufacturing operations and producing the STR compound.  Under the terms of the Texas State Bank loan, the Denton facility and the assets used in the facility cannot be transferred without the written approval of the bank.  In the event that sufficient additional funds are not obtained through asset sales, licensing arrangements, 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 its STR development activities and/or further reduction of costs for facilities and administration.

 

The Company’s actual capital requirements will depend upon numerous factors, including:

 

              the rate of progress and costs of its clinical trial and research and development activities, including costs and availability of clinical materials from third-party suppliers, and the Company’s ability to manufacture STR in a timely and cost-effective manner;

 

             actions taken by the US Food and Drug Administration (FDA) and other regulatory authorities;

 

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

 

             the timing and amount of milestone or other payments the Company might receive from potential strategic partners;

 

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

 

             the Company’s degree of success in commercializing its STR product candidate or other cancer therapy product candidates;

 

             the emergence of competing technologies and products, and other adverse market developments; and

 

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

 

There can be no assurance that the Company will be able to obtain needed additional capital or enter into relationships with corporate partners on a timely basis, on favorable terms, or at all.  Conditions in the capital markets in general and the life science capital market specifically may affect the Company’s potential financing sources and opportunities for strategic partnering.

 

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

 

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.  We undertake no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this report, or to reflect the occurrence of unanticipated events.

 

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 from government grants.  Pursuant to the Securities and Exchange Commission Staff Accounting Bulletin No. 101 (SAB 101) and Emerging Issues Task Force Consensus No. 00-21, 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.  To the extent that a transaction contains multiple deliverables, the Company determines whether the multiple deliverables are separable, and, if separable, the revenue to be allocated to each deliverable based on fair value. If fair value is undeterminable for undelivered elements of the arrangement, revenue is deferred over the contract period. The revenue allocated to each deliverable is recognized following the requirements of SAB 101.

 

Quarter and nine months ended September 30, 2003 compared to quarter and nine months ended September 30, 2002
 

Revenue for the third quarter of 2003 was $0.2 million, compared to $0.5 million for the third quarter of 2002.  Revenue for the nine months ended September 30, 2003 was $10.5 million, compared to $2.0 million for the nine months ended September 30, 2002.  Revenue for the third quarter of 2003 consisted of revenue from a facilities lease agreement, while revenue for the first nine months of 2003 consisted of $10.0 million from the assignment and license to Boston Scientific Corporation of certain intellectual property and revenue from a facilities lease agreement.  Revenue for the third quarter of 2002 consisted of revenue from government grants and a facilities lease agreement.  Revenue for the nine months ended September 30, 2002 consisted of a milestone payment of $1.0 million from Angiotech Pharmaceuticals, Inc., revenue from government grants, and a facilities lease agreement.

 

Total operating expenses for the third quarter of 2003 decreased 74% to $3.2 million from $12.2 million for the third quarter of 2002 and decreased 58% to $12.1 million for the nine months ended September 30, 2003 from $28.8 million for the same period in 2002.  A significant portion of the decrease in operating expenses is due to the inclusion of a non-cash asset impairment charge of $5,658,000 in the third quarter of 2002.  Also included is a charge of $529,000 for severance 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 decreased 54% to $2.0 million for the third quarter of 2003 from $4.4 million for the third quarter of 2002 and decreased 58% to $7.4 million for the nine months ended September 30, 2003 from $17.5 million for the same time period in 2002.  The decrease in research and development expenses in 2003 is the result of significantly reduced staffing, curtailment of the Company’s PretargetÒ programs and other cost reduction measures taken in 2002 and 2003.

 

General and administrative expenses decreased 26% to $1.1 million for the third quarter of 2003 from $1.5 million for the third quarter of 2002, and decreased 8% to $4.7 million for the nine months ended September 30, 2003 from $5.1 million for the same time period in 2002.  The decrease in general and administrative costs for the third quarter ended September 30, 2003 was due primarily to reductions in facilities expense, salaries and other

 

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corporate overhead expenses.

 

Other expense for the quarter was 0.2 million and $0.1 million for the nine months ended September 30, 2003.  The expense for the three months and nine months ended September 30, 2003 results from a loss on investment securities and interest paid on the bank note secured by the Company’s Denton, Texas manufacturing facility offset by interest income earned on liquid investments.  In 2002 other income for the same time period consisted primarily of interest income and interest paid on the bank note secured by the Company’s Denton, Texas facility.

 

During the nine month period ended September 30, 2003, the Company recorded a $0.2 million cumulative effect of change in accounting principle as a result of the Company’s adoption of SFAS 143, Accounting for Asset Retirement Obligations, effective January 1, 2003.

 

Cash and investment securities as of September 30, 2003, were $15.7 million compared to $16.1 million at December 31, 2002.  NeoRx achieved an average cash expenditure rate for the third quarter of 2003 of $1.0 million per month.

 

Liquidity and capital resources
 

The Company has financed its operations primarily through the sale of equity securities, technology licensing, collaborative agreements and debt instruments.  We invest excess cash in investment securities that will be used to fund future operating costs.  Cash, cash equivalents and investment securities totaled $15,740,000 at September 30, 2003 compared to $16,136,000 at December 31, 2002.  We primarily fund current operations with our existing cash and investments.  Cash used by operating activities for the nine months ended September 30, 2003 totaled $1,153,000.  Revenues and other income sources for the third quarter of 2003 and nine months ended September 30, 2003 were not sufficient to cover operating expenses.

 

We currently maintain 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 our STR product in development.   This line of credit is available to us for the STR phase III trials subject to conditions related to the specific design thereof and to the extent that we use PPD as our Clinical Research Organization (CRO) for the phase III trial.  We may choose not to use PPD as our CRO or we may choose to use PPD, but not to utilize this line of credit, which carries an annual interest rate of 16%.

 

On November 12, 2002, we entered into an agreement with IDEC Pharmaceuticals Corporation relating to the sale to IDEC of certain non-core NeoRx intellectual property and the grant to IDEC of certain license rights.  We received $7.9 million in cash and may receive in the future royalty payments with respect to certain products. The intellectual property addressed by the agreement included a portfolio of US and international patents and certain associated technology and know-how relating to antibody-based therapeutics and ligand-linker technology.  The intellectual property rights transferred to IDEC did not include rights to our STR or Pretarget programs.  With respect to the patents involved in the sale, we retained a license for the development of certain NeoRx products.

 

On April 17, 2003, we entered into agreements with Boston Scientific Corporation relating to the sale to Boston Scientific of certain non-core NeoRx intellectual property and the grant to Boston Scientific of certain license rights.  Under the first agreement, the Company assigned to Boston Scientific certain NeoRx intellectual property in exchange for a cash payment of $9 million.  The intellectual property assigned to Boston Scientific included a portfolio of NeoRx patents and patent applications in the cardiovascular field. Under a second agreement, NeoRx granted to Boston Scientific an exclusive license to use certain other NeoRx intellectual property, for which NeoRx received a one-time cash payment of $1 million.  The exclusive license grants Boston Scientific the right to use, in certain medical device fields, a separate portfolio of NeoRx patents and patent applications resulting from our collaboration with University of Cambridge investigators.

 

In October 2003 we announced that we had reached agreement with the FDA, under the Special Protocol Assessment (SPA) process, on the design of the phase III clinical trial for STR.  We also confirmed with the FDA that a single phase III study is sufficient for registration of STR, followed by a confirmatory phase IV commitment.

 

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The phase III trial planned under the SPA will be a randomized, controlled study of STR in patients with primary refractory multiple myeloma.  The trial is expected to enroll approximately 240 evaluable patients, half on the experimental arm and half on the control arm.  Patients on the experimental arm will receive STR plus the chemotherapy drug melphalan, followed by autologous stem cell transplantation.  Patients on the control arm will receive melphalan only, followed by transplantation.  The FDA accepted complete response at six months post-transplant as a surrogate endpoint for the study.  Acceptance of a surrogate endpoint places STR on the Accelerated Approval path.  We anticipate that the STR phase III clinical trial will cost approximately $20 million, which does not include the cost of manufacturing the STR compound at our Denton facility.

 

We will need to raise additional capital to fund our planned STR phase III clinical trial and our future operating cash needs.  We expect that our present cash, cash equivalents, investment securities and expected interest income will be sufficient to fund our anticipated working capital and capital requirements through the third quarter of 2004.

 

We may seek to raise capital through the sale of equity and/or debt securities or the establishment of other funding facilities. We are seeking to form a strategic partnership for STR development and commercialization.  We may also address our need for additional capital by pursuing opportunities for the licensing, sale or divestiture of certain non-core intellectual property and other assets, including our Pretarget® technology platform.  In addition, we are also looking for an investor or partner for our manufacturing facility who is interested in continuing the facility’s radiopharmaceutical manufacturing operations and producing the STR compound.  Under the terms of the Texas State Bank loan, the Denton facility and the assets used in the facility cannot be transferred without the written approval of the bank.  In the event that sufficient additional funds are not obtained through asset sales, licensing arrangements, 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 its STR development activities and/or further reduction of costs for facilities and administration.

 

Related party transactions

 

The Company’s Vice Chairman of the Board of Directors, Dr. Frederick Craves, is a founder of Bay City Capital, LLC, also known as BCC, a merchant bank focused on the life sciences industry.  NeoRx’s Chief Executive Officer and Chairman of the Board of Directors, Jack Bowman, is on the business advisory board of BCC.  The Company and BCC entered into an agreement whereby BCC acts as the Company’s advisor for the purpose of identifying opportunities to enter into strategic alliances and provide assistance relating to structuring and negotiating such transaction. The Company paid a retainer fee of $80,000 for each calendar quarter of 2002.  The Company renewed the agreement for one additional year from January 1, 2003.  The Company pays retainer fees of $25,000 per quarter, except for the quarter ended March 31, 2003, for which it paid $26,667, plus reasonable travel and other expenses.  The agreement also includes a percentage of gross value of cash, securities, property or other consideration derived from a transaction, ranging from one to five percent, depending on the ultimate amount of consideration raised.  BCC agreed to exclude the Boston Scientific Corporation sale and assignment of intellectual property from this provision of their agreement with the Company, and, therefore, received no commission or other compensation related to the Boston Scientific transaction.

 

In connection with consulting services performed in 2003 and 2002, Dr. Paul G. Abrams, a former Chief Executive Officer of the Company, received consulting fees of approximately $25,500 and $76,600 for the quarters ended September 30, 2003 and 2002, respectively.  This agreement terminated on July 31, 2003.

 

The Company had a demand note receivable from an officer with a balance of approximately $90,700 that was recorded in other assets at March 31, 2002.  This note was paid in full on May 24, 2002.  There were no demand note receivables from related parties outstanding at September 30, 2003.

 

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 or implied by 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 since our formation in 1984.  As of September 30, 2003, we had an accumulated deficit of $209.2 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, if at all. We expect to incur additional operating losses in the future. These losses may increase significantly if we expand clinical development and commercialization efforts.

 

Our ability to achieve long-term profitability is dependent upon obtaining regulatory approvals for our STR product candidate or any other proposed products and successfully commercializing our products alone or with third parties.

 

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.  We anticipate that the planned STR phase III clinical trial will cost approximately $20 million, which does not include the cost of manufacturing the STR compound at our Denton facility.  Although we currently are focusing on our STR product candidate, we may in the future simultaneously conduct clinical trials and pre-clinical research for a number of different indications and cancer therapy products, 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 pre-clinical research.  We will need to raise additional capital:

 

            to fund operations;

 

            to continue the research and development of our STR and any other product candidates; and

 

             to commercialize our STR product candidate or any other proposed products.

 

We believe that our present cash, cash equivalents, investment securities and expected interest income will be sufficient to fund our anticipated working capital and capital requirements only through the third quarter of 2004.

 

We may seek to raise capital through the sale of equity and/or debt securities or the establishment of other funding facilities. We are seeking to form a strategic partnership for STR development and commercialization.  We may also address our need for additional capital by pursuing opportunities for the licensing, sale or divestiture of certain non-core intellectual property and other assets, including our Pretarget® technology platform.  In addition, we are also looking for an investor or partner for our manufacturing facility who is interested in continuing the facility’s radiopharmaceutical manufacturing operations and producing the STR compound.

 

The amount of additional financing we need will depend on a number of factors, including the following:

 

                  the rate of progress and costs of our clinical trial and research and development activities, including costs and availability of clinical materials from third-party suppliers, and the Company’s ability to manufacture STR in a timely and cost-effective manner;

 

                  actions taken by the FDA and other regulatory authorities;

 

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

 

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

 

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

 

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

 

                  the emergence of competing technologies and products, and other adverse market developments; and

 

                  the costs of preparing, filing, prosecuting, maintaining and enforcing patent claims and other

 

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intellectual property rights.

 

We may not be able to obtain additional financing on a timely basis, on favorable terms, or at all.  If we are unable to raise additional funds when we need them, we may be required to delay, reduce or eliminate some or all of our development programs and some or all of our clinical trials.  We also may be forced to partner with third parties to develop or commercialize products or technologies that we otherwise would have sought to develop independently.  Such relationships may not be on terms as commercially favorable to us as might otherwise be the case.  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.

 

Our current debt obligations may restrict our operating and financing flexibility and could, in an event of default, impair our cash resources and assets.

 

In connection with our 2001 purchase of the radiopharmaceutical manufacturing plant and other assets located in Denton, TX, we assumed  $6,000,000 principal amount of restructured debt held by Texas State Bank, McAllen, TX.  The assets acquired in the transaction secure the loan, which matures in April 2009.  During 2002 and early 2003, we reduced the staff at the Denton facility to four employees and operated the facility in standby mode.  We currently are in the process of recruiting and hiring personnel and otherwise ramping up the manufacturing plant for production of clinical material for our planned STR phase III clinical trial.  We are also seeking an investor or partner interested in continuing the facility’s radiopharmaceutical manufacturing operations and producing the STR compound.  Under the terms of the Texas State Bank loan, the Denton facility and the assets used in the facility cannot be transferred without the written approval of the bank.

 

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 STR product 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 depending on 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.

 

In October 2003 we announced that we had reached agreement with the FDA, under the Special Protocol Assessment (SPA) process, on the design of the phase III clinical trial for STR.  We also confirmed with the FDA that a single phase III study is sufficient for registration of STR, followed by a confirmatory phase IV commitment.  The phase III trial planned under the SPA will be a randomized, controlled study of STR in patients with primary refractory multiple myeloma.  The trial is expected to enroll approximately 240 evaluable patients, half on the experimental arm and half on the control arm.  Patients on the experimental arm will receive STR plus the chemotherapy drug melphalan, followed by autologous stem cell transplantation.  Patients on the control arm will receive melphalan only, followed by transplantation.  The FDA accepted complete response at six months post-transplant as a surrogate endpoint for the study.  Acceptance of a surrogate endpoint places STR on the Accelerated Approval path.

 

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. We will not be able to commercialize our STR product candidate 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

 

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claims necessary or desirable for product promotion.  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/or 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.

 

We expect to open the planned phase III trial for patient enrollment in the first quarter of 2004.  We anticipate that the phase III trial will take several years to complete and we do not expect to submit a New Drug Application before 2007 for the potential approval of STR by the FDA.  The actual time to initiation and completion of our STR phase III clinical trial, however, depends upon numerous factors, including:

 

                        our ability to obtain adequate additional funding;

 

                        our receipt of approvals by the FDA and other regulatory agencies and the timing thereof;

 

                        other actions by regulators;

 

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

 

                        our ability to access sufficient, reliable and affordable supplies of the STR compound for clinical studies, including third-party supplies of holmium-166, the radionuclide used in our STR product candidate, as well as other materials used in the manufacture of the STR compound;

 

                        the costs of ramping up and maintaining manufacturing operations, should we determine this to be necessary;

 

                        the extent of scheduling conflicts with participating clinicians and clinical institutions; and

 

                        our ability to identify and enroll patients who meet trial eligibility criteria.

 

We may not commence or complete our planned phase III clinical trial 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 proposed STR product.  Further, we are seeking to enter into license agreements, partnerships or other collaborative arrangements to support financing and development of our STR product candidate.  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.    If we fail to commence or complete, or experience delays in or are forced to curtail our planned clinical program, 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 proposed STR product or any other proposed products, including the following:

 

                  safety and efficacy results obtained in early human clinical trials may not be indicative of results 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. The data that we may collect from our planned phase III clinical trial may not be sufficient to support regulatory approval of our proposed STR product or any other proposed products.  The clinical trials of our proposed STR 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 would prevent us from marketing the proposed product.

 

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

 

For our STR product to be successful, we need sufficient, reliable and affordable supplies of the STR compound for clinical studies.  This requires developing and maintaining reliable and affordable third-party suppliers of commercial quantities of the radionuclide holmium-166, and the targeting agent DOTMP, used in our STR product candidate.  Sources of these materials may be limited, and we, or potential third-party suppliers of the STR compound, may be unable to obtain these materials in amounts and at prices necessary to successfully commercialize our STR product.  Timely delivery of the holmium-166 component material and of the finished STR compound is critical.  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.

 

There are, in general, relatively few sources of the holmium-166 component of our STR product. Historically, we have depended on a single source vendor, the University of Missouri Research Reactor facility group (MURR). In December 2001, we entered into a contract, under which MURR was responsible for the manufacture of holmium-166, including process qualification, quality control, packaging and shipping, from its Columbia, MO reactor facility.  That supply contract expired in December 2002.  In August 2003 we placed a purchase order with MURR for purchases of holmium-166 from November 2003 through April 2004.  Under the purchase order we will pay certain initial fixed amounts and a per unit fixed price during its term.  We are in discussions with MURR to supply holmium-166 for our planned STR phase III clinical trial.  While MURR generally has provided us materials with acceptable quality, quantity and cost in the past, it may be unable or unwilling to meet our future demands, or demands of potential third-party suppliers of our STR compound.  If MURR or an alternate supplier is unable or unwilling to provide supplies of holmium-166 at a cost and on other terms acceptable to us, the manufacture and delivery of our STR product candidate could be impaired, and we may suffer delays in, or be prevented from, initiating or completing further clinical trials of our STR product candidate.

 

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 of product components, 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 any proposed products at a cost or in quantities necessary to make them commercially viable.  We may rely on third-party contract manufacturers to produce large quantities of certain materials, potentially including the STR compound, for clinical trials and product commercialization. Third-party

 

17



 

manufacturers may not be able to meet our needs with respect to timing, quantity, quality or cost.  If we are unable to contract for a sufficient supply of needed materials or products 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 reduce our revenues and potential profitability.

 

Moreover, any potential third-party manufacturers 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 a New Drug Application (NDA) for our proposed products. 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 we, or any of our third-party manufacturers, fail to comply with these requirements, we may be subject to regulatory action.

 

Any delay or failure to restart STR manufacturing operations in Denton, Texas, or to operate the facility in a cost-effective manner and in accordance with regulatory requirements, could adversely affect our ability to proceed with our STR phase III trials on a timely and cost-effective basis.

 

In April 2001, we purchased a radiopharmaceutical manufacturing facility and certain other assets located in Denton, TX.  In addition to the manufacturing facility, we purchased existing equipment, documentation and certain processes. The facility achieved cGMP status and was issued appropriate radiation permits by the State of Texas. This radiopharmaceutical manufacturing facility assumed responsibility for all aspects of the manufacture of the STR compound, including process qualification, quality control, packaging and shipping, and production of the clinical material for the completed STR dosimetry study.  We believe that the Denton facility has the capabilities and capacity to serve as the principal manufacturing site for the STR compound for our planned phase III clinical trial and for potential commercial manufacture.  We are in the process of restarting and requalifying STR manufacturing operations at the facility to prepare for our planned STR phase III clinical trial, with the goal of having the facility operational for the production of clinical supplies of STR before we open the phase III clinical trial for patient enrollment, which we expect will occur in the first quarter of 2004.  We plan to operate the Denton facility ourselves while seeking to engage an investor or partner interested in continuing the facility’s radiopharmaceutical manufacturing operations and producing the STR compound.

 

Our decision whether to continue to utilize the Denton facility as our primary manufacturing site for the STR compound in the future will depend on a number of factors, including:

 

             actions taken by the FDA and the timing thereof;

 

             our ability to obtain adequate additional funding and the timing thereof;

 

             our ability to access sufficient, reliable and affordable third-party supplies of holmium-166;

 

             the costs of ramping up and maintaining manufacturing operations;

 

             the availability of qualified personnel;

 

             the availability and nature of strategic partnering opportunities; and

 

             the availability and cost of potential third-party suppliers of STR.

 

If in the future we decide to transition the STR production process to a third-party supplier, such third-party supplier also could require significant start-up time to qualify and implement the manufacturing process.  In either case, our ability to move forward with further STR clinical and commercial development could be adversely affected and we may incur significant additional costs in connection with manufacturing operations.  Further, there can be no assurance that manufacturing alternatives would be available on a timely or cost-effective basis.

 

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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 initially are focusing clinical development of our STR product candidate on the treatment of multiple myeloma.  Several companies, including Celgene Corp. and Millennium Pharmaceuticals, Inc., also are developing and testing therapeutics for multiple myeloma.  In May 2003 Millennium obtained FDA approval for its Velcade™ therapeutic for treatment of multiple myeloma patients who have received at least two prior therapies and demonstrated disease progression on the last therapy.  In addition, a number of established pharmaceutical companies, including GlaxoSmithKline, Novartis AG 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, 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, which carry out a significant amount of cancer research and development, 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 technologies.

 

We own approximately 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.  We may need to file lawsuits to stop these activities.  These lawsuits can be 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.  In such case, we may be required to alter our products, pay licensing fees or cease activities.  If our products conflict with

 

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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.

 

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 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.

 

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 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.  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 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 the event that we discontinue operations in facilities that have had past research and manufacturing processes where hazardous or radioactive materials have been in use, we may have significant decommissioning costs associated with the termination of operation of these facilities.  These potential decommissioning costs also may reduce the market value of the facilities and may limit our ability to sell or otherwise dispose of these facilities in a timely and cost-effective manner.  In addition, the risk of accidental contamination or injury from hazardous or 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

 

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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 proposed 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.

 

The loss of key employees could adversely affect our operations.

 

Since July 2002, we have implemented three reductions in force. Also in January 2003, we accepted the resignations of Richard Ghalie, MD, Vice President, Medical and Regulatory Affairs, and Les Sabo, Vice President, Manufacturing.  Jack L. Bowman was named Executive Chairman and became Chairman of our Board of Directors on March 11, 2003.  Douglass B. Given, MD, PhD resigned as President, Chief Executive Officer and a Director of the Company on June 30, 2003.  On that date, Mr. Bowman was named Chief Executive Officer and Karen Auditore-Hargreaves, PhD was promoted to Chief Operating Officer of the Company.  As of September 30, 2003, we had a total work force of 36 full-time employees and one part-time employee. 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 will in the future, be required to expand substantially our workforce, 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 current financial situation may make it more difficult to attract and retain key employees.

 

Our common stock listing was transferred from The Nasdaq National Market to The Nasdaq SmallCap Market; failure to maintain continued listing on Nasdaq could affect its market price and liquidity.

 

Our common stock listing was transferred from The Nasdaq National Market to The Nasdaq SmallCap Market on March 20, 2003.  We elected to seek a transfer to The Nasdaq SmallCap Market because we had been unable to regain compliance with The Nasdaq National Market minimum $1.00 bid price requirement for continued listing. By transferring to The SmallCap Market, we were afforded an extended grace period in which to satisfy the The SmallCap Market $1.00 minimum bid price requirement.  On May 6, 2003, we received notice from Nasdaq confirming that we are now in compliance with the $1.00 SmallCap minimum bid price requirement.  As a result of rule changes adopted by Nasdaq in March 2003, we will not be eligible to relist our common stock on The Nasdaq National Market unless and until our common stock maintains a minimum bid price of $5.00 per share and we otherwise comply with the initial listing requirements for The Nasdaq National Market.  Trading on the Nasdaq SmallCap Market may have a negative impact on the value of our common stock, because securities trading on the Nasdaq SmallCap Market typically are less liquid than those traded on The Nasdaq National Market.

 

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 price of our common stock may be influenced by a large variety of industry factors, including:

 

21



 

                  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, potential public concern about the safety of our proposed STR product and any other products we develop, comments by securities analysts, our ability to maintain the listing of our common stock on the Nasdaq system and conditions in the capital markets in general and in the life science capital market 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 often has been brought against companies following periods of volatility in their stock prices.  We may in the future be the target 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.

 

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.

 

22



 

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.

 

23



 

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 US 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, 2003, the Company owned $8.9 million in government debt instruments and owned corporate debt securities in the amount of $4.5 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 no corporate debt securities that had maturity dates greater than one year at September 30, 2003.

 

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, the Company has evaluated the effectiveness and design and operation of its disclosure controls and procedures as of the end of the quarter and, based on their evaluation, the Chief Executive Officer and the Vice President, Finance, have concluded that these disclosure controls and procedures are effective in ensuring that all material information required to be disclosed in the reports that the Company files or submits under the Securities Exchange Act of 1934 have been made known to them in a timely fashion.  There were no changes in the Company’s internal controls over financial reporting that occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

24



 

PART II.  OTHER INFORMATION

 

 

Item 6.  Exhibits and Reports on Form 8-K

 

 

(a) Exhibits – See Exhibit Index below.

 

(b) Reports on Form 8-K:

 

Form 8-K dated July 28, 2003, announcing the Company’s earnings for the quarter ended June 30, 2003.

 

25



 

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 13, 2003

 

 

 

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EXHIBIT INDEX

 

Exhibit

 

Description

 

 

3.1(a)

 

Restated Articles of Incorporation, dated April 29, 1996

 

(B)

3.1(b)

 

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

 

(C)

3.1(c)

 

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

 

(K)

3.2

 

Bylaws, as amended, of the registrant

 

(K)

10.1

 

Restated 1994 Stock Option Plan (‡)

 

(F)

10.2

 

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

 

(H)

10.3

 

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

 

(J)

10.4

 

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

 

(E)

10.5

 

1991 Restricted Stock Plan (‡)

 

(D)

10.6

 

Agreement, dated as of December 15, 1995

 

(F)

 

 

 

 

 

10.8

 

Indemnification Agreement (‡)

 

(H)

10.9

 

Form of Key Executive Severance Agreement (‡)

 

(I)

10.10

 

Officer Change in Control Agreement (‡)

 

(K)

10.11

 

Key Executive Severance Agreement (‡)

 

(K)

10.12

 

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

 

(L)

10.13

 

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

 

(M)

 

 

 

 

 

10.15

 

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

 

(J)

10.16

 

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

 

(J)

10.17

 

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

 

(J)

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.

 

(O)

10.19

 

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

 

(P)

 

 

 

 

 

10.21

 

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

 

(A)

10.22

 

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

 

(A)

10.23

 

Form of VP Change in Control Agreements (‡)

 

(A)

 

 

 

 

 

10.25

 

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

 

(A)

10.26

 

Form of VP Severance Agreements (‡)

 

(A)

10.27

 

Lease Termination/Continuation Agreement between NeoRx Corporation and Dina Corporation

 

(R)

10.28

 

Purchase Agreement dated as of November 12, 2002, between NeoRx Corporation and IDEC Pharmaceutical Corporation

 

(S)

 

 

 

 

 

10.30

 

Patent Assignment dated April 17, 2003 between NeoRx Corporation and SciMed Life Sciences, Inc.

 

(Q)

10.31

 

Patent License Agreement dated April 17, 2003 between NeoRx Corporation and Boston Scientific Corporation

 

(Q)

31.1

 

Certification of Chief Executive Officer pursuant to Rule 13a-14a

 

(U)

31.2

 

Certification of Principal Accounting Officer pursuant to Rule 13a-14a

 

(U)

32.1

 

Certification of Chief Executive Officer pursuant to 18 USC Section 1350

 

(U)

 

27



 

32.2

 

Certification of Principal Accounting Officer pursuant to 18 USC Section 1350

 

(U)

 

28



 


 

Management contract or compensatory plan.

 

 

 

 

 

 

(A)

 

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

 

 

 

(B)

 

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

 

 

 

(C)

 

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.

 

 

 

(D)

 

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.

 

 

 

(E)

 

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.

 

 

 

(F)

 

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

 

 

 

(H)

 

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

 

 

 

(I)

 

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

 

 

 

(J)

 

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

 

 

 

(K)

 

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

 

 

 

(L)

 

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.

 

 

 

(M)

 

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.

 

 

 

(O)

 

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

 

 

 

(P)

 

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

 

 

 

(Q)

 

Filed as an exhibit to the Company’s Form 8-K dated April 17, 2003 and incorporated herein by reference. Certain portions of the agreement have been omitted pursuant to a grant of confidential treatment.

 

 

 

(R)

 

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

 

 

 

(S)

 

Filed as an exhibit to the Company’s Current Report on Form 8-K filed as of November 27, 2002 and incorporated herein by reference.  Certain portions of the agreement have been omitted pursuant to a grant of confidential treatment.

 

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(U)

 

Filed herewith.

 

30