UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. |
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For the quarterly period ended March 31, 2004 |
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or |
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TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. |
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For the transition period from to |
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Commission File Number: 0-23556 |
NEKTAR THERAPEUTICS |
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(Exact name of registrant as specified in its charter) |
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Delaware |
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94-3134940 |
(State or other jurisdiction of |
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(IRS Employer Identification No.) |
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150 Industrial Road |
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(Address of principal executive offices) |
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650-631-3100 |
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(Registrants telephone number, including area code) |
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(Former name, former address and former fiscal year, if changed since last report) |
Indicate by check mark whether the registrant (1) has filed all reports required 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 ý No o
The number of outstanding shares of the registrants Common Stock, $0.0001 par value, was 83,534,745 as of April 30, 2004.
NEKTAR THERAPEUTICS
INDEX
PART I: |
FINANCIAL INFORMATION |
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Item 1. |
Condensed Consolidated Financial Statements unaudited: |
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Condensed Consolidated Balance Sheets March 31, 2004 and December 31, 2003 |
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Consolidated Statements of Cash Flows for the three-month periods ended March 31, 2004 and 2003 |
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Notes to Condensed Consolidated Financial Statements - unaudited |
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Managements Discussion and Analysis of Financial Condition and Results of Operations |
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Certifications |
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Forward-Looking Statements
This report includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the 1933 Act) and Section 21E of the Securities Exchange Act of 1934, as amended (the 1934 Act). All statements other than statements of historical fact are forward-looking statements for purposes of this periodic report, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations, any statements concerning proposed new products or services, any statements regarding future economic conditions or performance and any statement of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as may, will, expects, plans, anticipates, estimates, potential, or continue, or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct and actual results could differ materially from those projected or assumed in the forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including but not limited to the risk factors set forth below and for the reasons described elsewhere in this periodic report. All forward-looking statements and reasons why results may differ included in this report are made as of the date hereof and we do not intend to update any forward-looking statements except as required by law or applicable regulations.
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share information)
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March 31, 2004 |
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December 31, 2003 |
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(unaudited) |
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* |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
180,669 |
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$ |
64,050 |
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Short-term investments |
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286,741 |
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221,917 |
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Accounts receivable |
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3,563 |
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6,153 |
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Other current assets |
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18,800 |
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14,378 |
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Total current assets |
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489,773 |
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306,498 |
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Restricted investments |
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12,442 |
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Property and equipment, net |
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154,023 |
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149,388 |
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Goodwill |
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130,120 |
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130,120 |
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Other intangible assets, net |
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9,836 |
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10,963 |
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Deposits and other assets |
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3,383 |
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7,377 |
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Total assets |
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$ |
787,135 |
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$ |
616,788 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
9,362 |
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$ |
8,074 |
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Accrued research and development |
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3,486 |
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4,012 |
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Accrued general and administrative |
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2,862 |
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2,282 |
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Accrued compensation |
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7,493 |
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9,705 |
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Short-term debt |
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338 |
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288 |
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Interest payable |
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2,809 |
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2,436 |
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Capital lease obligations - current |
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1,405 |
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1,341 |
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Deferred revenue |
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21,783 |
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18,719 |
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Total current liabilities |
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49,538 |
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46,857 |
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Convertible subordinated notes and debentures |
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181,709 |
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359,988 |
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Capital lease obligations - noncurrent |
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31,070 |
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31,686 |
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Other long-term liabilities |
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11,750 |
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11,956 |
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Accrued rent |
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2,129 |
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2,110 |
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Commitments and contingencies |
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Stockholders' equity: |
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Preferred Stock, 10,000 shares authorized |
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Series A, $0.0001 par value: 3,100 shares designated; no shares issued or outstanding at March 31, 2004 and December 31, 2003. |
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Convertible Series B, $0.0001 par value: 40 shares designated; 20 and 40 shares issued and outstanding at March 31, 2004 and December 31, 2003, respectively; Liquidation preference of $19,945 and $40,000 at March 31, 2004 and December 31, 2003, respectively. |
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Common stock, $0.0001 par value; 300,000 authorized; 83,006 shares and 56,197 shares issued and outstanding at March 31, 2004 and December 31, 2003, respectively. |
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8 |
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6 |
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Capital in excess of par value |
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1,168,530 |
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778,500 |
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Deferred compensation |
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(3,718 |
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(38 |
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Accumulated other comprehensive income |
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1,354 |
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958 |
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Accumulated deficit |
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(655,235 |
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(615,235 |
) |
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Total stockholders' equity |
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510,939 |
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164,191 |
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Total liabilities and stockholders' equity |
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$ |
787,135 |
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$ |
616,788 |
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(*) The balance sheet at December 31, 2003 has been derived from the audited financial statements at that date which are included in our Form 10-K/A. as amended, for the year ended December 31, 2003 as filed with the Securities and Exchange Commission. This balance sheet does not include all the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
See accompanying notes.
2
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share information)
(unaudited)
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Three-Months Ended March 31, |
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2004 |
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2003 |
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Revenues: |
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Contract research revenue |
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$ |
21,509 |
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$ |
18,393 |
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Product sales |
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4,322 |
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7,135 |
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Total revenues |
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25,831 |
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25,528 |
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Operating costs and expenses: |
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Cost of goods sold |
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2,536 |
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4,622 |
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Research and development |
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34,020 |
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32,141 |
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General and administrative |
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4,422 |
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5,178 |
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Amortization of other intangible assets |
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981 |
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1,127 |
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Total operating costs and expenses |
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41,959 |
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43,068 |
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Loss from operations |
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(16,128 |
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(17,540 |
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Loss on extinguishment of debt |
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(9,258 |
) |
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Other income/(expense), net |
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307 |
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119 |
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Interest income |
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1,246 |
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1,624 |
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Interest expense |
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(16,035 |
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(4,152 |
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Net loss before provision for income taxes |
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(39,868 |
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(19,949 |
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Provision for income taxes |
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132 |
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Net loss |
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$ |
(40,000 |
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$ |
(19,949 |
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Basic and diluted net loss per share |
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$ |
(0.64 |
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$ |
(0.36 |
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Shares used in computing basic and diluted net loss per share |
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62,139 |
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55,601 |
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See accompanying notes.
3
NEKTAR THERAPEUTICS
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Three-Months Ended March 31, |
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2004 |
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2003 |
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Cash flows used in operating activities: |
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Net loss |
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$ |
(40,000 |
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$ |
(19,949 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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2,852 |
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3,014 |
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Amortization of other intangible assets |
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1,127 |
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1,127 |
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Amortization of debt issuance costs |
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322 |
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318 |
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Loss on extinguishment of debt |
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9,258 |
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Non-cash compensation for employee retirement plans |
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217 |
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259 |
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Non-cash compensation for employee severance |
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60 |
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Amortization of deferred compensation |
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236 |
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111 |
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Stock-based compensation for services rendered |
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185 |
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22 |
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Changes in assets and liabilities: |
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Decrease in accounts receivable, other current assets, and other assets |
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(2,337 |
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(1,808 |
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Decrease in accounts payable and other accrued liablities |
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(461 |
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(9,228 |
) |
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Increase/(decrease) in deferred revenue |
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3,133 |
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(13,771 |
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Net cash used in operating activities |
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(25,408 |
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(39,905 |
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Cash flows from investing activities: |
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Purchases of short-term investments |
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(162,383 |
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(54,733 |
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Sales of short-term investments |
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6,100 |
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13,533 |
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Maturities of short-term investments |
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92,140 |
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70,125 |
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Purchases of long-term investments |
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(28 |
) |
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Maturities of long-term investments |
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12,470 |
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Purchases of property and equipment |
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(7,487 |
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(2,331 |
) |
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Net cash provided by/(used in) investing activities |
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(59,188 |
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26,594 |
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Cash flows from financing activities: |
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Payments of loan and capital lease obligations |
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(541 |
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(354 |
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Repurchase of convertible subordinated notes |
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(460 |
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Issuance of common stock related to employee stock purchase plan |
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615 |
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Issuance of common stock related to employee stock exercises |
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5,356 |
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312 |
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Issuance of common stock for sale to the public, net of issuance costs |
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196,245 |
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Net cash provided by/(used in) financing activities |
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201,215 |
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(42 |
) |
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Net increase/(decrease) in cash and cash equivalents |
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116,619 |
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(13,353 |
) |
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Cash and cash equivalents at beginning of period |
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64,050 |
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34,879 |
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Cash and cash equivalents at end of period |
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$ |
180,669 |
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$ |
21,526 |
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See accompanying notes.
4
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
Note 1Organization and Summary of Significant Accounting Policies
Organization and Basis of Presentation
Nektar Therapeutics was originally incorporated in California in July 1990 under the name Inhale Therapeutic Systems, Inc. We were reincorporated in Delaware in 1998. On January 15, 2003 we changed our name from Inhale Therapeutic Systems, Inc. to Nektar Therapeutics.
We are working to become one of the worlds leading drug delivery products based companies by providing a portfolio of technologies and expertise that is intended to enable us and our pharmaceutical and biotechnology partners to improve drug performance throughout the drug development process. We are focused on three main technologies: Nektar Advanced PEGylation Technology, Nektar Pulmonary Technology, and Nektar Supercritical Fluids Technology.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Principles of Consolidation
Our consolidated financial statements include the financial statements of our subsidiaries: Nektar Therapeutics AL, Corporation (Nektar AL), formerly Shearwater Corporation (Shearwater); Nektar Therapeutics UK, Ltd. (Nektar UK), formerly Bradford Particle Design Ltd. (Bradford); Inhale Therapeutic Systems Deutschland Gmbh (Inhale Germany); Inhale 201 Industrial Road, L.P., a real estate partnership in San Carlos, and as of December 31, 2003, Shearwater Polymers, LLC, a real estate partnership in Alabama.
Our consolidated financial statements are denominated in U.S. dollars. Accordingly, changes in exchange rates between the applicable foreign currency and the U.S. dollar will affect the translation of each foreign subsidiarys financial results into U.S. dollars for purposes of reporting our consolidated financial results. The process by which each foreign subsidiarys financial results are translated into U.S. dollars is as follows: income statement accounts are translated at average exchange rates for the period; balance sheet asset and liability accounts are translated at end of period exchange rates; and equity accounts are translated at historical exchange rates. Translation of the balance sheet in this manner results in an accumulated other comprehensive gain/loss of the stockholders equity section. To date such cumulative translation adjustments have not been material to our consolidated financial position.
Significant Concentrations
Cash equivalents and short-term investments are financial instruments that potentially subject us to concentration of risk to the extent of the amounts recorded in the consolidated balance sheet. We limit our concentration of risk by diversifying our investment amount among a variety of industries and issuers. Our professional portfolio managers adhere to this investment policy as approved by our Board of Directors.
Our customers are primarily pharmaceutical and biotechnology companies that are typically located in the U.S. and Europe. Our accounts receivable balance contains trade receivables from product sales and collaborative research agreements. At March 31, 2004, five customers represented approximately 93% of our accounts receivable, and at March 31, 2003 four customers represented approximately 81% of our accounts receivable. We have not experienced significant credit losses from our accounts receivable or collaborative research agreements, and none are currently expected. We perform a regular review of our customers payment history and credit risks and do not require collateral from our customers.
In addition, we are dependent on our partners, vendors and contract manufacturers to provide raw materials, drugs and devices of appropriate quality and reliability and to meet applicable regulatory requirements. Consequently, in the event that supplies are delayed or interrupted for any reason, our ability to develop our products could be impaired, which could have a material adverse effect on our business, financial condition and results of operation.
5
We are dependent on Pfizer, Inc. as a significant source of our revenue. Contract research revenue from Pfizer represented 59% and 54% of our revenue for the three-month periods ended March 31, 2004 and 2003, respectively. Since Pfizer advances the costs of research at the beginning of each quarter, Pfizer is not a significant component of our accounts receivable at March 31, 2004 or 2003. The termination of this collaboration could have a material adverse effect on our financial position and results of operations.
Should the Pfizer collaboration be discontinued prior to the commercial launch of Exubera®, we will need to find alternative funding sources to replace the collaboration revenue and we will need to reassess the realizability of our capitalized assets. Additionally, we may have to reimburse our contract manufacturers for their capital outlay to the extent that they cannot re-deploy their assets. At the present time, it is not possible to estimate the loss that could occur as a result of these obligations.
Cash, Cash Equivalents and Investments
We consider all highly liquid investments with a maturity at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include demand deposits held in banks, interest bearing money market funds and repurchase agreements. All other investments are classified as short-term investments. Short-term investments consist of federal and municipal government securities, corporate bonds and commercial paper with A1 or P1 short-term ratings and A+ or better long-term ratings with remaining maturities at date of purchase of greater than 90 days and less than two years.
At March 31, 2004, all short-term investments are designated as available-for-sale and are carried at fair value, with unrealized gains and losses reported in stockholders equity as accumulated other comprehensive income/(loss). Short-term investments are adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization is included in interest income. Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities, if any, are included in other income/(expense). The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income.
Inventories
Inventories are included in other current assets on the balance sheet and consist primarily of raw materials, work-in-process and finished goods of Nektar AL. Inventories are stated at the lower of cost (first-in, first-out method) or market. Cost is computed on a currently adjusted standard basis, which approximates actual costs on a first-in, first-out basis. Inventories include a reserve of $2.7 million and $1.6 million as of March 31, 2004 and December 31, 2003, respectively. Reserves are determined using specific identification. Inventories consist of the following (in thousands):
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March 31, |
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December
31, |
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Raw material |
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$ |
5,329 |
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$ |
4,552 |
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Work-in-process |
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388 |
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433 |
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Finished goods |
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6,826 |
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3,574 |
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Total |
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$ |
12,543 |
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$ |
8,559 |
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Property and equipment are stated at cost. Major improvements are capitalized, while maintenance and repairs are expensed when incurred. Laboratory and other equipment are depreciated using the straight-line method over estimated useful lives of three to seven years. Leasehold improvements and buildings, which are subject to the terms of a build-to-suit lease, are depreciated using the straight-line method over the shorter of the estimated useful life or the remaining term of the lease.
Goodwill
On January 1, 2002, in accordance with Statement of Financial Accounting Standards (SFAS) No. 142, Goodwill and Other Intangible Assets, we stopped the periodic amortization of goodwill and adopted a new policy for measuring goodwill for impairment. No impairment of goodwill was recognized in connection with the adoption of this new policy. We currently operate as a single reporting unit and all of our goodwill is associated with the entire company. Under our new policy, goodwill is tested for impairment at least annually, or on an interim basis if an event occurs or circumstances change that would more-likely-than-not reduce the fair value below our carrying value. Goodwill is tested for impairment using a two-step approach. The first step is to compare our fair value to our carrying amount, including goodwill. If the fair value is greater than the carrying amount, goodwill is not considered impaired and the second step is not required. If the fair value is less than the carrying amount, the second step of the impairment test measures the amount
6
of the impairment loss, if any. The second step of the impairment test is to compare the implied fair value of goodwill to its carrying amount. If the carrying amount of goodwill exceeds its implied fair value, an impairment loss is recognized equal to that excess. The implied fair value of goodwill is calculated in the same manner that goodwill is calculated in a business combination, whereby the fair value is allocated to all of the assets and liabilities (including any unrecognized intangible assets) as if they had been acquired in a business combination and the fair value was the purchase price. The excess purchase price over the amounts assigned to assets and liabilities would be the implied fair value of goodwill.
We perform our annual test as of October 1st of each year, which, to date, has not resulted in an impairment charge. We will perform this test annually or more frequently if indicators of potential impairment exist.
Other Intangible Assets
Acquired technology and other intangible assets with definite useful lives are amortized on a straight-line basis over a period of five to seven years. Intangible assets are tested for impairment whenever events or changes in circumstances indicate the carrying amount of the assets may not be recoverable from future undiscounted cash flows. If impaired, asset values are adjusted to fair value. Other intangible assets include proprietary technology, intellectual property, and supplier and customer relationships acquired from third parties or in business combinations.
We periodically evaluate whether changes have occurred that would require revision of the remaining estimated useful lives of these assets or otherwise render the assets unrecoverable. If such an event occurred, we would determine whether the other intangibles are impaired. To date, no such impairment losses have been recorded.
As of March 31, 2004, we had approximately $5.7 million outstanding on a bank loan. This loan is secured by our Nektar AL Discovery Drive facility in Alabama, which, as of March 31, 2004, had a net carrying value of approximately $6.1 million. This loan originally had a variable rate of interest tied to the LIBOR index. In November 2003, we entered into an interest rate swap agreement to limit our exposure to fluctuations in U.S. interest rates. Our interest rate swap agreement effectively converts a portion of our debt to a fixed rate basis, thus reducing the impact of interest rate changes on future interest expense. The swap is designated a cash flow hedge. Under the terms of our swap arrangement, we will pay an initial effective interest rate of 5.17%. This rate is variable based on changes in the LIBOR index, but only to a maximum of 7.05%.
This swap has been accounted for as a derivative subject to SFAS No. 133, Accounting for Derivatives and Hedging Activity. Because there is still potential variability in our effective interest rate, this specific swap arrangement is not an effective hedge. Accordingly, a liability and interest expense of $0.2 million was made to record the fair value of this derivative at December 31, 2003. During the three-months ended March 31, 2004 we recorded additional liability and interest expense of $0.2 million to adjust the fair value of the derivative to its market value. We estimate the fair value of the derivative based on pricing models using current market rates. The fair value is adjusted on a quarterly basis, with an increase in interest rates generally resulting in a reduction in the liability and a decrease to interest expense, and a decrease in interest rates generally resulting in an increase to the liability and an increase in interest expense. Upon maturity of the loan, any remaining liability will be reversed.
Comprehensive Loss
Comprehensive loss is comprised of net loss and other comprehensive gain/loss. Other comprehensive loss includes unrealized gains/losses on available-for-sale securities and translation adjustments. The comprehensive loss consists of the following components (in thousands):
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Three
Months Ended |
|
||||
|
|
2004 |
|
2003 |
|
||
|
|
|
|
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|
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Net loss |
|
$ |
(40,000 |
) |
$ |
(19,949 |
) |
Changes in net unrealized gains/(losses) on available for sale securities |
|
41 |
|
(9 |
) |
||
Net unrealized gains reclassified into earnings |
|
(23 |
) |
(18 |
) |
||
Translation adjustment |
|
378 |
|
(163 |
) |
||
Comprehensive loss |
|
$ |
(39,604 |
) |
$ |
(20,139 |
) |
7
The components of accumulated other comprehensive income are as follows (in thousands):
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March 31, |
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December
31, |
|
||
Unrealized gains on available-for-sale securities |
|
$ |
268 |
|
$ |
250 |
|
Translation adjustment |
|
1,086 |
|
708 |
|
||
Total accumulated other comprehensive income |
|
$ |
1,354 |
|
$ |
958 |
|
Stock-Based Compensation
We apply the recognition and measurement principles of APB Opinion No. 25, Accounting for Stock Issued to Employees, and related Interpretations in accounting for those plans. Under this opinion, no stock-based employee compensation expense is charged for options that were granted at an exercise price that was equal to the market value of the underlying common stock on the date of grant. Pro forma information regarding net income and earnings per share is required by SFAS No. 123, as amended by SFAS No. 148, which also requires that the information be determined as if we had accounted for our employee stock options under the fair value method of that statement. The fair value for these options was estimated at the date of grant using a Black-Scholes option-pricing model with the following weighted-average assumptions:
|
|
Three-Months
Ended |
|
||
|
|
2004 |
|
2003 |
|
Risk-free interest rate |
|
3.1 |
% |
2.9 |
% |
Dividend yield |
|
0.0 |
% |
0.0 |
% |
Volatility factor |
|
0.487 |
|
0.795 |
|
Weighted average expected life |
|
5 years |
|
5 years |
|
The Black-Scholes options valuation model was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions including the expected stock price volatility. Because our employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in our opinion, the existing models do not necessarily provide a reliable single measure of the fair value of our employee, consultant, and director stock options. However, we have presented the pro forma net loss and pro forma basic and diluted net loss per common share using the assumptions noted above.
The following table illustrates the effect on net income and earnings per share if we had applied the fair value recognition provisions of SFAS No. 123, Accounting for Stock-Based Compensation, to stock-based employee compensation (in thousands, except per share information):
|
|
Three-Months
Ended |
|
||||
|
|
2004 |
|
2003 |
|
||
Net loss, as reported |
|
$ |
(40,000 |
) |
$ |
(19,949 |
) |
Add: stock-based employee compensation included in reported net loss |
|
236 |
|
111 |
|
||
Deduct: total stock-based employee compensation expense determined under fair value methods for all awards |
|
(7,478 |
) |
(10,760 |
) |
||
Pro forma net loss |
|
$ |
(47,242 |
) |
$ |
(30,598 |
) |
|
|
|
|
|
|
||
Earnings per share |
|
|
|
|
|
||
Basic and diluted, as reported |
|
$ |
(0.64 |
) |
$ |
(0.36 |
) |
Basic and diluted, pro forma |
|
$ |
(0.76 |
) |
$ |
(0.55 |
) |
Stock compensation expense for options granted to non-employees has been determined in accordance with SFAS No. 123 and Emerging Issues Task Force (EITF) No. 96-18 as the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. The fair value of options granted to non-employees is re-measured as the underlying options vest.
Revenue Recognition
Our research revenue is derived primarily from clients in the pharmaceutical and biotechnology industries and consists of reimbursement of development costs, reimbursement of certain expenses, payment for clinical supplies, and amortization of milestones. Payments received for milestones achieved are deferred and recorded as revenue ratably over the next period of continued
8
development. Contract revenue from collaborative research agreements is recorded when earned based on the performance requirements of the contract. Advance payments for research and development revenue received in excess of amounts earned are classified as deferred revenue until earned. Revenue from grants and feasibility arrangements are recognized as the related costs are incurred. Costs of contract research revenue approximate such revenue and are included in research and development expenses.
In accordance with EITF 00-21, which we adopted effective July 1, 2003, consideration received for revenue arrangements with multiple deliverables is allocated among these deliverables based on objective and reliable evidence of each deliverables fair value using available internal or third party evidence. Revenue from non-refundable upfront license fees and certain guaranteed payments where we have continuing involvement through collaborative development efforts are deferred and recognized as revenue over the period of continuing involvement.
Revenue from product sales is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable, and collectability is reasonably assured. Allowances, if any, are established for uncollectible amounts, estimated product returns, and discounts.
Research and Development
Research and development costs are expensed as incurred and include salaries, benefits, and other operating costs. We perform research and development for third parties pursuant to feasibility agreements and development and license agreements. Under these feasibility agreements, we are generally reimbursed for the cost of work performed. Feasibility agreements are designed to evaluate the applicability of our technologies to a particular molecule and therefore are generally completed in less than one year. Under our development and license agreements, products developed using our technologies are commercialized with a collaborative partner. Under these development and license agreements, we may be reimbursed for development costs, we may be entitled to milestone payments when and if certain development and/or regulatory milestones are achieved, and we may be compensated for the manufacture and supply of clinical and commercial products. We may also receive royalties on sales of commercial products. All of our research and development agreements are generally cancelable by the partner without significant financial penalty.
Net Loss Per Share
Basic net loss per share is calculated based on the weighted-average number of common shares outstanding during the periods presented, less the weighted-average shares outstanding which are subject to our right of repurchase. Diluted earnings per share would give effect to the dilutive impact of common stock equivalents which consist of convertible preferred stock and convertible subordinated debt (using the as-if converted method), and stock options and warrants (using the treasury stock method). Potentially dilutive securities have been excluded from the diluted earnings per share computations in all years presented as such securities would have an anti-dilutive effect on net loss per share due to our net loss for all periods presented. Potentially dilutive securities included the following (in thousands):
|
|
Three
Months Ended |
|
||
|
|
2004 |
|
2003 |
|
|
|
|
|
|
|
Warrants |
|
56 |
|
56 |
|
Options |
|
14,756 |
|
14,934 |
|
Convertible preferred stock |
|
875 |
|
1,755 |
|
Convertible debentures and notes |
|
3,831 |
|
6,644 |
|
|
|
|
|
|
|
Total |
|
19,518 |
|
23,389 |
|
Accounting for Income Taxes
We account for income taxes under SFAS No. 109, Accounting for Income Taxes. Under SFAS No. 109, the liability method is used in accounting for income taxes.
Note 2 - - Segment, Significant Customer, and Geographic Information
We report segments in accordance with SFAS No. 131, Disclosures About Segments of an Enterprise and Related Information. SFAS No. 131 requires the use of a management approach in identifying segments of an enterprise. We have multiple technologies, all of which are marketed to a common customer base (pharmaceutical and biotechnology companies which are typically located in the U.S. and Europe), and as such, we are organized and operate as one operating segment.
9
Our research revenue is derived primarily from clients in the pharmaceutical and biotechnology industries. Revenue from one partner, Pfizer, Inc., represented 59% and 54% of our revenue for the three-month periods ended March 31, 2004 and 2003, respectively. Product sales relate to the sale of our manufactured Advanced PEGylation Technology products by Nektar AL.
Our accounts receivable balance contains trade receivables from product sales and collaborative research agreements. At March 31, 2004, five customers represented 93% of our accounts receivable and as of March 31, 2003 four customers represented 81% of accounts receivable.
We primarily receive contract research revenue from, and provide product sales to, customers located within the United States. Revenues are from the following geographic areas (in thousands):
|
|
Three-Months
Ended |
|
||||
|
|
2004 |
|
2003 |
|
||
Contract research revenue |
|
|
|
|
|
||
United States |
|
$ |
21,394 |
|
$ |
18,119 |
|
All other countries |
|
115 |
|
274 |
|
||
Total contract research revenue |
|
$ |
21,509 |
|
$ |
18,393 |
|
|
|
|
|
|
|
||
Product sales |
|
|
|
|
|
||
United States |
|
$ |
3,168 |
|
$ |
3,603 |
|
United Kingdom |
|
203 |
|
14 |
|
||
Other European countries |
|
368 |
|
3,379 |
|
||
All other countries |
|
583 |
|
139 |
|
||
Total product sales |
|
$ |
4,322 |
|
$ |
7,135 |
|
In June, July, and October 2003, we purchased an aggregate of approximately $14.8 million face value of zero coupon U.S. treasury securities pledged for the exclusive benefit of the holders of our 3% convertible subordinated notes due June 2010. These securities were noted as restricted investments on our balance sheet and were classified as held-to-maturity. In March 2004, we converted $133.3 million of 3% convertible subordinated notes due June 2010 into 11.7 million shares of common stock. In connection with the conversion, we agreed to pay $75.00 per $1,000 of the notes to be converted, for an aggregate payment of approximately $10.0 million. This amount was paid through the sale of these held-to-maturity pledged treasury securities. As a result there were no held-to-maturity securities as of March 31, 2004. The realized gain on these held-to-maturity securities of the date of sale was approximately $26,000. The following is a summary of our operating cash, available-for-sale securities, and held-to-maturity securities as of March 31, 2004 (in thousands):
|
|
Amortized |
|
Gross |
|
Gross |
|
Fair Value |
|
||||
Cash and Available-for-Sale Securities |
|
|
|
|
|
|
|
|
|
||||
Obligations of U.S. government agencies |
|
$ |
197,763 |
|
$ |
147 |
|
$ |
(15 |
) |
$ |
197,895 |
|
U.S. corporate commercial paper |
|
108,036 |
|
164 |
|
(37 |
) |
108,163 |
|
||||
Obligations of U.S. corporations |
|
82,765 |
|
46 |
|
(35 |
) |
82,776 |
|
||||
Non U.S. corporate obligations |
|
5,405 |
|
2 |
|
(5 |
) |
5,402 |
|
||||
Repurchase agreements |
|
57,412 |
|
|
|
|
|
57,412 |
|
||||
Cash and other debt securities |
|
15,762 |
|
|
|
|
|
15,762 |
|
||||
|
|
$ |
467,143 |
|
$ |
359 |
|
$ |
(92 |
) |
$ |
467,410 |
|
|
|
|
|
|
|
|
|
|
|
||||
Amounts included in cash and cash equivalents |
|
$ |
180,669 |
|
$ |
|
|
$ |
|
|
$ |
180,669 |
|
Amounts included in short-term investments (less than one year to maturity) |
|
169,023 |
|
174 |
|
(20 |
) |
169,177 |
|
||||
Amounts included in short-term investments (one to two years to maturity) |
|
117,451 |
|
185 |
|
(72 |
) |
117,564 |
|
||||
|
|
$ |
467,143 |
|
$ |
359 |
|
$ |
(92 |
) |
$ |
467,410 |
|
10
The following is a summary of operating cash, held-to-maturity, and available-for-sale securities as of December 31, 2003 (in thousands):
|
|
Amortized |
|
Gross |
|
Gross |
|
Fair Value |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Held-to-Maturity Securities |
|
|
|
|
|
|
|
|
|
||||
U.S. treasury securities |
|
$ |
12,442 |
|
$ |
|
|
$ |
|
|
$ |
12,442 |
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and Available-for-Sale Securities |
|
|
|
|
|
|
|
|
|
||||
Obligations of U.S. government agencies |
|
$ |
138,404 |
|
$ |
231 |
|
(74 |
) |
$ |
138,561 |
|
|
U.S. corporate commercial paper |
|
115,010 |
|
118 |
|
(26 |
) |
$ |
115,102 |
|
|||
Non U.S. corporate obligations |
|
2,343 |
|
1 |
|
(1 |
) |
2,343 |
|
||||
Repurchase agreements |
|
9,083 |
|
|
|
|
|
9,083 |
|
||||
Cash and other debt securities |
|
20,878 |
|
|
|
|
|
20,878 |
|
||||
|
|
$ |
285,718 |
|
$ |
350 |
|
$ |
(101 |
) |
$ |
285,967 |
|
|
|
|
|
|
|
|
|
|
|
||||
Amounts included in cash and cash equivalents |
|
$ |
64,049 |
|
$ |
1 |
|
$ |
|
|
$ |
64,050 |
|
Amounts included in short-term investments (less than one year to maturity) |
|
205,610 |
|
330 |
|
(89 |
) |
205,851 |
|
||||
Amounts included in short-term investments (one to two years to maturity) |
|
16,059 |
|
19 |
|
(12 |
) |
16,066 |
|
||||
Amounts included in restricted investments |
|
12,442 |
|
|
|
|
|
12,442 |
|
||||
|
|
$ |
298,160 |
|
$ |
350 |
|
$ |
(101 |
) |
$ |
298,409 |
|
Note 4 - - Other Intangible Assets
The components of our other intangible assets at March 31, 2004, are as follows (in thousands, except for years):
|
|
Useful |
|
Gross |
|
Accumulated |
|
Net |
|
|||
|
|
|
|
|
|
|
|
|
|
|||
Core technology |
|
5 |
|
$ |
8,100 |
|
$ |
4,455 |
|
$ |
3,645 |
|
Developed product technology |
|
5 |
|
2,900 |
|
1,595 |
|
1,305 |
|
|||
Intellectual property |
|
5-7 |
|
7,301 |
|
4,541 |
|
2,760 |
|
|||
Supplier and customer relations |
|
5 |
|
5,140 |
|
3,014 |
|
2,126 |
|
|||
Total |
|
|
|
$ |
23,441 |
|
$ |
13,605 |
|
$ |
9,836 |
|
Amortization expense related to other intangible assets totaled $1.1 million for both of the three-month periods ended March 31, 2004 and 2003. The following table shows expected future amortization expense for other intangible assets until they are fully amortized (in thousands):
Years Ending December 31, |
|
|
|
|
Remainder of 2004 |
|
$ |
3,380 |
|
2005 |
|
4,507 |
|
|
2006 |
|
1,949 |
|
|
Total |
|
$ |
9,836 |
|
Note 5 Convertible Subordinated Debentures
In March 2004, we called for the full redemption of our outstanding 3% convertible subordinated notes due June 2010. The aggregate principal amount outstanding of the notes at the time of the call for redemption was approximately $133.3 million, all of which was converted into an aggregate of approximately 11.7 million shares of common stock prior to the redemption date. In connection with the conversion, we agreed to pay $75.00 per $1,000 of the notes to be converted, for an aggregate payment of approximately $10.0 million. This payment was recorded to interest expense. In connection with this transaction, unamortized debt issuance costs of approximately $2.3 million were reclassified to common stock issuance costs.
In February 2004, certain holders of our outstanding 3% convertible subordinated notes due June 2010 converted approximately $36.0 million in aggregate principal amount of such notes for approximately 3.2 million shares of our common stock
11
and a cash payment of approximately $3.1 million in the aggregate in privately negotiated transactions. As a result of this transaction, we recognized a loss on debt extinguishment of approximately $1.5 million in accordance with SFAS No. 84, Induced Conversions of Convertible Debt.
In January 2004, certain holders of our outstanding 3.5% convertible subordinated notes due October 2007 completed an exchange and cancellation of $9.0 million in aggregate principal amount of the notes for the issuance of 575,605 shares of our common stock in a privately negotiated transaction. As a result of this transaction, we recognized a loss on debt extinguishment of approximately $7.8 million in accordance with SFAS No. 84, Induced Conversions of Convertible Debt.
Note 6 - - Commitments and Contingencies
From time to time, we may be involved in lawsuits, claims, investigations and proceedings, consisting of intellectual property, commercial, employment and other matters, which arise in the ordinary course of business. In accordance with the SFAS No. 5, Accounting for Contingencies, we make a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. These provisions are reviewed at least quarterly and adjusted to reflect the impact of negotiations, settlements, ruling, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. However, we believe that we have valid defenses with respect to the legal matters pending against us, as well as adequate provisions for any probable and estimable losses. If any unfavorable ruling were to occur in any specific period, there exists the possibility of a material adverse impact on the results of operations of that period. We believe that, given our current liquidity and cash and investment balances, even if we receive an adverse judgment with respect to litigation that we are currently a party to, such judgment would not have a material impact on cash and investments or liquidity.
Note 7 Guarantees and Indemnifications
The following is a summary of our agreements, which we have determined are within the scope of FASB Interpretation Number (FIN) 45. The guarantees below are not subject to the initial recognition and measurement provisions of FIN No. 45 and accordingly, we have not recorded any liability for these agreements as of March 31, 2004, except as noted below.
The Church Street facility leased by our Alabama subsidiary is owned by Shearwater Polymers, LLC. We paid $0.1 million each during the three-month periods ended March 31, 2004 and 2003 as rent to Shearwater Polymers, LLC, of which Dr. J. Milton Harris is a member. Prior to March 4, 2004, Dr. Harris was one of our executive officers. Shearwater Polymers, LLC is 4% owned by Nektar AL with the remaining 96% owned by Dr. Harris. Both Nektar AL and Dr. Harris have jointly guaranteed the lease on the Nektar AL facility. We have fully consolidated this entity in our consolidated financial statements since December 31, 2003. As of March 31, 2004, principal remaining on this loan was $1.8 million. The loan bears interest of 7.22% through May 2009, with a balloon payment of $1.1 million in June 2009 and is secured by the Church Street facility, which as of March 31, 2004 has a net carrying value of $2.3 million. Our maximum exposure to loss with respect to Shearwater Polymers, LLC, at March 31, 2004 is the outstanding capital lease obligation of $1.8 million.
Indemnification of Directors, Executive Officers, Other Officers, Employees and Other Agents
As permitted under Delaware law, and as set forth in our Certificate of Incorporation and our Bylaws, we indemnify our directors, executive officers, other officers, employees, and other agents for certain events or occurrences that arose while in such capacity. The maximum potential amount of future payments we could be required to make under this indemnification is unlimited; however, we have insurance policies that may limit our exposure and may enable us to recover a portion of any future amounts paid. Assuming the applicability of coverage, the willingness of the insurer to assume coverage, and subject to certain retention, loss limits and other policy provisions, we believe any obligations under this indemnification not material. However, no assurances can be given that the covering insurers will not attempt to dispute the validity, applicability, or amount of coverage without expensive litigation against these insurers, in which case we may incur substantial liabilities as a result of these indemnification obligations.
Lease Restoration
We have several operating leases for our facilities in multiple locations. In the event that we do not exercise our option to extend the term of these leases, we guarantee certain costs to restore the property to certain conditions in place at the time of each lease. We believe the estimated fair value of these guarantees is minimal.
12
Strategic AllianceEnzon
In January 2002, we announced a broad strategic alliance with Enzon Pharmaceuticals, Inc. that included a collaboration to develop three products using our Pulmonary Technology and/or Supercritical Fluids Technology. Under the terms of the agreement, we are responsible for the development of drug formulations for the agreed upon pharmaceutical agents. We are required to self-fund a portion of these costs. As of March 31, 2004, we are required to fund $10.4 million in the coming years without reimbursement for research and development expenses. To date these costs have been included in our research and development expenses. After our funding requirement has been met, Enzon will provide research and development funding as well as milestone payments as the program progresses through clinical testing.
Manufacturing and Supply Agreement with Contract Manufacturers
In August 2000, we entered into a Manufacturing and Supply Agreement with our contract manufacturers to provide for the manufacturing of our pulmonary inhaler device for Exubera®. Under the terms of the Agreement, we may be obligated to reimburse the contract manufacturers for the actual unamortized and unrecovered portion of any equipment procured or facilities established and the interest accrued for their capital overlay in the event that Exubera® does not gain FDA approval to the extent that the contract manufacturers cannot re-deploy the assets. While such payments may be significant, at the present time, it is not possible to estimate the loss that will occur should Exubera® not be approved. We have also agreed to defend, indemnify and hold harmless the contract manufacturers from and against third party liability arising out of the agreement, including product liability and infringement of intellectual property. There is no limitation on the potential amount of future payments we could be required to make under these indemnification obligations. We have never incurred costs to defend lawsuits or settle claims related to these indemnification obligations. If any of our indemnification obligations is triggered, we may incur substantial liabilities.
Security Agreement with Pfizer, Inc.
In connection with the Collaboration, Development, and License Agreement (CDLA) dated January 18, 1995 that we entered into with Pfizer, Inc., for the development of Exubera®, we entered into a Security Agreement pursuant to which our obligations under the CDLA and certain Manufacturing and Supply Agreements related to the manufacture and supply of powdered insulin and pulmonary inhaler devices for the delivery of powdered insulin, are secured. Our default under any of these agreements triggers Pfizers rights with respect to property relating solely to, or property used or which will be used solely in connection with, the development, manufacture, use and sale of Exubera®, including proceeds from the sale or other disposition of the property.
Collaboration Agreements for Products Based on our Pulmonary Technology
As part of our collaboration agreements with our partners for the development, manufacture, and supply of products based on our Pulmonary Technology, we generally agree to defend, indemnify, and hold harmless our partners from and against third party liabilities arising out of the agreements, including product liability and infringement of intellectual property. The term of these indemnification obligations is generally perpetual any time after execution of the agreements. There is no limitation on the potential amount of future payments we could be required to make under these indemnification obligations. We have never incurred costs to defend lawsuits or settle claims related to these indemnification obligations. If any of our indemnification obligations is triggered, we may incur substantial liabilities.
License, Manufacturing and Supply Agreements for Products Based on our Advanced PEGylation Technology
As part of our license, manufacturing and supply agreements with our partners for the development and/or manufacture and supply of PEG reagents based on our Advanced PEGylation Technology, we generally agree to defend, indemnify and hold harmless our partners from and against third party liabilities arising out of the agreements, including product liability and infringement of intellectual property. The term of these indemnification obligations is generally perpetual any time after execution of the agreements. There is no limitation on the potential amount of future payments we could be required to make under these indemnification obligations. We have never incurred costs to defend lawsuits or settle claims related to these indemnification obligations. If any of our indemnification obligations is triggered, we may incur substantial liabilities.
In connection with a strategic alliance with Enzon Pharmaceuticals, Inc., we entered into a Preferred Stock Purchase Agreement in January 2002, pursuant to which we sold to Enzon and Enzon purchased from us forty thousand (40,000) shares of non-voting Series B Convertible Preferred Stock at a purchase price of one thousand dollars ($1,000) per share for an aggregate purchase price of forty million dollars ($40,000,000). A Certificate of Designation filed with the Secretary of State of Delaware sets forth the rights, privileges and preferences of the Series B Convertible Preferred Stock. Pursuant to the Certificate of Designation, the Series B Convertible Preferred Stock does not have voting rights. The Series B Convertible Preferred Stock is convertible, in whole or in part, into that number of
13
shares of our common stock (the Conversion Shares) equal to the quotient of $1,000 per share divided by the Conversion Price. The Conversion Price shall initially be equal to approximately $22.79 per share or 125% of the Closing Price and at no time can the Preferred Stock convert into shares of Common Stock at a discount to the Closing Price. The Closing Price equals $18.23 per share and was based upon the average of our closing bid prices as listed on the NASDAQ National Market for the twenty (20) trading days preceding the date of the closing of the transaction.
The Series B Convertible Preferred Stock is convertible at the option of the holder after the first anniversary of the original issuance of the Series B Convertible Preferred Stock (the Original Issue Date) or, if earlier, upon a Change in Control (as defined in the Certificate of Designation). Except with respect to an automatic conversion, the Conversion Price shall be equal to 125% of the Closing Price until the third anniversary of the Original Issue Date. Upon the third anniversary of the Original Issue Date, the Conversion Price shall be adjusted to be equal to either (i) the Closing Price, in the event that the average of the closing bid prices of our common stock as quoted on the NASDAQ National Market for the twenty (20) trading days preceding the third anniversary of the original issuance (the Future Price) is less than or equal to the Closing Price; (ii) the Future Price (as defined above) if the Future Price is greater than the Closing Price but less than 125% of the Closing Price; or (iii) 125% of the Closing Price if the Future Price is equal to or greater than 125% of the Closing Price.
During the three months ended March 31, 2004, Enzon converted an aggregate 20,055 shares of Series B Convertible Preferred Stock into an aggregate 880,085 shares of our common stock. The conversion price was $22.79 per share, which represents a conversion rate of approximately 43.88 shares of common stock for each share of Series B Convertible Preferred Stock. As of March 31, 2004 there were 19,945 shares of Series B Convertible Preferred Stock outstanding.
Note 9 Issuance of Common Stock
In March 2004, we entered into an underwriting agreement with Lehman Brothers Inc. pursuant to which we sold 9.5 million shares of our common stock at a price of $20.71 per common share for proceeds of approximately $196.2 million, net of issuance costs.
During the three months ended March 31, 2004, we issued restricted stock grants for 206,666 shares of our common stock to certain officers. The purchase price of these restricted shares is $0.01 per share, whereas the fair market value of our common stock on the dates of grant ranged between $18.46 per share and $19.54 per share. The restricted shares become fully vested over a period of 35 months. In connection with these restricted stock grants, we recorded deferred compensation of $3.9 million, which represents the difference between the fair market value of our stock on the day of grant and the purchase price of $0.01 per share. We will ratably expense the deferred compensation on a monthly basis over the vesting term of 35 months. For the three months ended March 31, 2004, we recognized expense related to these restricted stock grants of approximately $0.2 million.
In April 2004, we restated our financial statements for the year ended December 31, 2003. The restatement consists of an adjustment to reduce the gain on debt extinguishment recorded in the fourth quarter of 2003 to comply with EITF 96-19, Debtors Accounting for a Modification or Exchange of Debt Instruments. The restatement had no impact on loss from operations in the 2003 statement of operations and had no impact on net cash used in operating activities in the 2003 statement of cash flows. The revision to the gain on debt extinguishment resulted from the need to apply the more appropriate accounting principles in EITF 96-19. We originally applied APB No. 26, Early Extinguishment of Debt, in determining the amount of the gain related to convertible debt exchanges that occurred in October 2003. After further evaluation, we determined that EITF 96-19 is the more appropriate accounting principle to apply. EITF 96-19 requires that the gain be computed using the fair value of the newly issued convertible debt, resulting in a revised gain of $7.7 million compared to the amount previously reported of $26.9 million due to the newly issued convertible debt publicly trading at a substantial premium to the principal amount of the notes. As revised, we have classified the premium associated with the newly issued convertible debt of $19.2 million as capital in excess of par value in the December 31, 2003 balance sheet, following the guidance in APB No. 14, Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants. The effect of the adjustment on the year ended December 31, 2003 was to increase net loss by $19.2 million and $0.34 per share and to increase capital in excess of par by $19.2 million.
In April 2004, we called for redemption of all of our outstanding 6 ¾% convertible subordinated notes due October 2006. Holders of all but $10,000 in principal amount converted their notes prior to the redemption date, resulting in the issuance of approximately 0.5 million shares of our common stock. We redeemed the $10,000 in principal amount not converted into equity for cash in the amount of $10,000. The aggregate amount of notes converted was approximately $7.8 million.
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion contains forward-looking statements that involve risks and uncertainties. Such statements are marked with an asterisk (*). Our actual results could differ materially from those discussed here. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in this section as well as factors under the heading Risk Factors at the end of this section.
We are working to become one of the worlds leading drug delivery products based companies by providing a portfolio of technologies and expertise that will enable us and our pharmaceutical and biotechnology partners to improve drug performance throughout the drug development process. To date the revenues we have received from the sales of our products and in connection with our collaborative arrangements have been insufficient to meet our operating and other expenses and we believe this will continue to be the case for several years. To date, except for sales from six products using Nektar Advanced PEGylation Technology, we have not sold any commercial products and do not anticipate receiving significant revenue from product sales or royalties in the near future. The development of a successful product is dependent upon several factors that are outside of our control. These include, among other things, the need to obtain regulatory approval to market these products and our dependence upon our collaborative partners. As a result of these or other risks, potential products for which we have invested substantial amounts in research and development may never produce revenues or income.
We have generally been compensated for research and development expenses during initial feasibility work performed under collaborative arrangements for all three of our technologies: Nektar Advanced PEGylation Technology, Nektar Pulmonary Technology, and Nektar Supercritical Fluid Technology. In a typical Advanced PEGylation Technology collaboration, we manufacture and supply the PEG reagents and receive manufacturing revenues and possible royalties from sales of the PEGylated commercial product. Prior to commercialization of pulmonary delivery and advanced PEGylation products, we receive revenues from our partners for partial or full funding of research and development activities and progress payments upon achievement of certain developmental milestones. In a typical Pulmonary Technology collaboration, our partner will provide the active pharmaceutical ingredient (the majority of which are already approved by the U.S. Food and Drug Administration (FDA) in another delivery form), fund clinical and formulation development, obtain regulatory approvals, and market the resulting commercial product. We may manufacture and supply the drug delivery approach or drug formulation, and may receive revenues from drug manufacturing, as well as royalties from sales of most commercial products. In addition, for products using our Pulmonary Technology, we may receive revenues from the supply of our device for the product along with revenues for any applicable drug processing or filling. In addition to our partner-funded programs, we are applying our technologies independently through internal early-stage proprietary product development efforts. To achieve and sustain profitable operations, we, alone or with others, must successfully develop, obtain regulatory approval for, manufacture, introduce, market, and sell products using our drug delivery and other drug delivery systems. There can be no assurance that we can generate sufficient product or contract research revenue to become profitable or to sustain profitability.
To fund the substantial expense related to our research and development activities, we have had to raise significant amounts of capital through the sale of equity and convertible debt. Our ability to meet the repayment obligations of our outstanding convertible debt, which as of March 31, 2004 totaled approximately $181.7 million in outstanding principal, is dependent upon our ability to develop successful products without unexpected significant delay or expense. Even if we are successful in this regard, we may require additional capital to repay the debt obligations.
Because of the magnitude of the revenues and resulting gross margins we receive, we do not expect that sales of our currently marketed products will be sufficient for us to achieve profitability. Our ability to achieve profitability is dependent on the approval of and successful marketing of products with significant markets, and for which we realize relatively higher royalties.
In April 2004, we restated our financial statements for the year ended December 31, 2003. The restatement consists of an adjustment to reduce the gain on debt extinguishment recorded in the fourth quarter of 2003 to comply with Emerging Issues Task Force (EITF) 96-19, Debtors Accounting for a Modification or Exchange of Debt Instruments. The restatement had no impact on loss from operations in the statement of operations for 2003 and had no impact on net cash used in operating activities in the statement of cash flows for 2003. The revision to the gain on debt extinguishment resulted from the need to apply the more appropriate accounting principles in EITF 96-19. We originally applied Accounting Principles Board (APB) No. 26, Early Extinguishment of Debt, in determining the amount of the gain related to the October 2003 convertible debt exchanges. After further evaluation, we determined that EITF 96-19 is the more appropriate accounting principle to apply. EITF 96-19 requires that the gain be computed using the fair value of the newly issued convertible debt, resulting in a revised gain of $7.7 million compared to the amount previously reported of $26.9 million due to the newly issued convertible debt publicly trading at a substantial premium to the principal amount of the notes. As revised, we have classified the premium associated with the newly issued convertible debt of $19.2 million as capital in
15
excess of par value in the December 31, 2003 balance sheet, following the guidance in APB No. 14, Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants. The effect of the adjustment on the year ended December 31, 2003 was to increase net loss by $19.2 million and $0.34 per share and to increase capital in excess of par by $19.2 million.
In April 2004, we called for redemption of all of our outstanding 6 ¾% convertible subordinated notes due October 2006. Holders of all but $10,000 in principal amount converted their notes prior to the redemption date, resulting in the issuance of approximately 0.5 million shares of our common stock. We redeemed the $10,000 in principal amount not converted into equity for cash in the amount of $10,000. The aggregate amount of notes converted was approximately $7.8 million.
In March 2004, we entered into an underwriting agreement with Lehman Brothers Inc. pursuant to which we sold 9.5 million shares of our common stock at a price of $20.71 per common share for proceeds of approximately $196.2 million net of issuance costs.
In March 2004, we called for the full redemption of our outstanding 3% convertible subordinated notes due June 2010. The aggregate principal amount outstanding of the notes at the time of the call for redemption was $133.3 million, all of which was converted into an aggregate approximately 11.7 million shares of common stock prior to the redemption date. In connection with the conversion, we agreed to pay $75.00 per $1,000 of the notes to be converted, for an aggregate payment of approximately $10.0 million. This payment was recorded to interest expense.
In March 2004, we reported that Pfizer and Aventis announced that the European Medicines Evaluation Agency (EMEA) accepted the filing of a marketing authorization application for Exubera®. Pfizer and Aventis submitted the filing to seek approval to market Exubera for adult patients with type 1 and type 2 diabetes. The two companies have been working with the U.S. Food and Drug Administration (FDA), to determine the appropriate timing for submission of the Exubera® new drug application in the U.S. The determination of when, if ever, to file for marketing approval in the U.S. or any other market will be made by Pfizer and Aventis at their discretion.
Critical Accounting Estimates
On March 31, 2004, the Financial Accounting Standards Board (FASB) issued an exposure draft of proposed statement titled Share-Based Payment, that addresses the accounting for share-based payment transactions in which an enterprise receives employee services in exchange for (a) equity instruments of the enterprise or (b) liabilities that are based on the fair value of the enterprises equity instruments or that may be settled by the issuance of such equity instruments. The proposed statement would eliminate the ability to account for share-based compensation transactions using APB Opinion No. 25, Accounting for Stock Issued to Employees, and generally would require instead that such transactions be accounted for using a fair-value-based method. We currently apply the recognition and measurement principles of APB Opinion No. 25. Under this opinion, no stock-based employee compensation expense is charged for options that were granted at an exercise price that was equal to the market value of the underlying common stock on the date of grant. Pro forma information regarding net income and earnings per share is required to be disclosed in the footnotes to our financials statements by Statement of Financial Accounting Standards (SFAS) No. 123, as amended by SFAS No. 148, as if we had accounted for our employee stock options under the fair value method of that statement. The FASB will invite public comment regarding its proposed statement before issuing a final pronouncement, which is expected later this year. As the proposed statement currently stands, it would become effective with our fiscal quarter ended March 31, 2005. We monitor progress at the FASB and other developments with respect to the general issue of stock-based incentive compensation. In the future, should we expense the value of stock-based incentive compensation, either out of choice or due to new requirements issued by the FASB, and/or decide to alter our current employee compensation programs to provide other benefits in place of incentive stock options, we may have to recognize substantially more compensation expense. This could have a material adverse impact on our results of operations.
Three-Month Periods Ended March 31, 2004 and 2003
Revenue
Revenue for the three-month period ended March 31, 2004 was approximately $25.8 million compared to approximately $25.5 million for the three-month period ended March 31, 2003, an increase of approximately 1%. Contract research revenue included reimbursed research and development expenses as well as the amortization of deferred up-front signing and progress payments (milestone payments) received from our collaborative partners. Contract revenue increased $3.1 million during the three- month period ended March 31, 2004 compared to the three-month period ended March 31, 2003 due to increased research activity for one of our partners. Contract revenue for the three-month period ended March 31, 2004 included a $2 million termination fee paid to us by Aventis-Behring in connection with the termination of its collaboration with us, which was announced in November 2003. Contract revenues are expected to fluctuate from year to year, and future contract revenue is difficult to accurately predict. The level of contract revenues depends in part upon future success in obtaining timely completion of feasibility studies, the continuation of existing collaborations, and achievement of milestones under current and future agreements. Product sales accounted for
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approximately 17% of revenue for the three-month period ended March 31, 2004, as compared to approximately 28% for the three-month period ended March 31, 2003. Product sales decreased $2.8 million during the three-month period ended March 31, 2004 compared to the three-month period ended March 31, 2003 due primarily to re-scheduling some PEG product sales from the first quarter to later quarters in 2004, as well as lower PEG demand for some of the partner marketed products. *
Costs of Goods Sold
Cost of goods sold is associated with product sales and was approximately $2.5 million for the three-month period ended March 31, 2004 or 59% of product revenue. Cost of goods sold for three-month period ended March 31, 2003 was approximately $4.6 million or 65% of product revenue. Cost of goods sold is highly influenced by the mix of products sold and their relative stage of commercial readiness.
Research and Development Expenses
Research and development expenses are associated with three general categories: (i) collaborative agreements under which spending is reimbursed by our partners; (ii) spending attributed to internally funded programs: and (iii) commercial readiness and infrastructure costs associated with commercial operations for our drug and third-party device manufacturing. Research and development expenses were approximately $34.0 million for the three-month period ended March 31, 2004, as compared to approximately $32.1 million for the three-month period ended March 31, 2003. The approximate 6% increase for the three-month period ended March 31, 2004 as compared to the three-month period ended March 31, 2003, was primarily due to increased headcount. We expect research and development spending to continue to increase over the next few years as we attempt to increase the number of products we take through Phase I clinical testing and, in some cases, Phase II, before offering the products to our biopharmaceutical partners for commercialization. *
General and Administrative Expenses
General and administrative expenses are associated with administrative staffing, business development and marketing efforts. General and administrative expenses were approximately $4.4 million and $5.2 million for the three-month periods ended March 31, 2004 and 2003, respectively. The approximate 15% decrease for the three-month period ended March 31, 2004 as compared to the three-month period ended March 31, 2003, was primarily due to decreased headcount.
Loss on Debt Extinguishment
During the three-month period ended March 31, 2004, we recognized a loss on debt extinguishment in connection with two privately negotiated transactions to convert our outstanding convertible subordinated notes into shares of our common stock. In January 2004, certain holders of our outstanding 3.5% convertible subordinated notes due October 2007 completed an exchange and cancellation of $9.0 million in aggregate principal amount of the notes for the issuance of 575,605 shares of our common stock in a privately negotiated transaction. In February 2004, certain holders of our outstanding 3% convertible subordinated notes due June 2010 converted approximately $36.0 million in aggregate principal amount of such notes for approximately 3.2 million shares of our common stock and a cash payment of approximately $3.1 million in the aggregate in privately negotiated transactions. As a result of these transactions, we recognized losses on debt extinguishment of approximately $7.8 million and $1.5 million, respectively, in accordance with SFAS No. 84, Induced Conversions of Convertible Debt.
Interest Income
Interest income was approximately $1.2 million for the three-month period ended March 31, 2004, as compared to approximately $1.6 million for the three-month period ended March 31, 2003. The approximate $0.4 million decrease in interest income was due primarily to lower prevailing interest rates.
Interest Expense
Interest expense was approximately $16.0 million for the three-month period ended March 31, 2004, as compared to approximately $4.2 million for the three-month period ended March 31, 2003. The approximate $11.8 million increase in interest expense was due primarily to the payment of approximately $12.7 million in interest payments made to certain holders of our outstanding 3.0% convertible subordinated notes due June 2010 which completed an exchange of $169.3 million in aggregate principal amount of the notes held by such holders for the issuance of approximately 14.9 million shares of our common stock. This was partially offset by a decrease in interest expense due to the lower balance of convertible subordinated notes outstanding at March 31, 2004 as compared to March 31, 2003. We expect interest expense to decrease as a result of the decrease in the outstanding balance of our convertible subordinated notes. *
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We have financed our operations primarily through public and private placements of our debt and equity securities, revenue from development contracts, product sales and short-term research and feasibility agreements, financing of equipment acquisitions and tenant improvements, and interest income earned on our investments of cash. We do not utilize off-balance sheet financing arrangements as a source of liquidity or financing. At March 31, 2004 we had cash, cash equivalents and short-term investments of approximately $467.4 million.
|
|
As of March 31, |
|
||||
|
|
2004 |
|
2003 |
|
||
|
|
(in millions, except current ratio) |
|
||||
|
|
|
|
|
|
||
Cash, cash equivalents, and short-term investments |
|
$ |
467.4 |
|
$ |
286.0 |
|
Current ratio |
|
9.9:1 |
|
6.5:1 |
|
||
|
|
Three Months Ended March 31, |
|
||||
|
|
2004 |
|
2003 |
|
||
|
|
(in millions) |
|
||||
Cash provided by/(used in) |
|
|
|
|
|
||
Operating activities |
|
$ |
(25.4 |
) |
$ |
(39.9 |
) |
Investing activities |
|
$ |
(59.2 |
) |
$ |
26.6 |
|
Financing activities |
|
$ |
201.2 |
|
$ |
|
|
Capital expenditures (included in investing activities above) |
|
$ |
(7.5 |
) |
$ |
(2.3 |
) |
Our operations used cash of $25.4 million for the three-month period ended March 31, 2004 as compared to $39.9 million for the three-month period ended March 31, 2003. The $14.5 million decrease in cash used in operating activities was due primarily to the timing of advance payments for contract research by Pfizer ($16.9 million), the loss on debt extinguishment ($9.3 million), and changes in our liabilities ($8.8 million), offset by the increased net loss ($20.1 million).
Cash flows used by investing activities was $59.2 million for the three-month period ended March 31, 2004 as compared to cash provided by investing activities of $26.6 million for the three-month period ended March 31, 2003. Cash flows related to investing activities for the three-month periods ended March 31, 2004 and 2003 were affected primarily by the purchase, sale, and maturity of short-term investments. The balance of short-term investments as of March 31, 2004 increased by $64.8 million as compared to December 31, 2003 because much of the proceeds from the sale of our securities was invested in short-term investments. We purchased property and equipment of approximately $7.5 million and $2.3 million during the three-month periods ended March 31, 2004 and 2003, respectively. The increase in purchased property and equipment of $5.2 million was primarily due to the expansion of our manufacturing facility in Alabama.
Cash flows provided by financing activities were $201.2 million for the three-month period ended March 31, 2004 compared to $0 for the three-month period ended March 31, 2003. Cash flow provided by financing activities was primarily due to the sale of 9.5 million shares of our common stock at a price of $20.71 per common share for proceeds of approximately $196.2 million, net of issuance costs. In addition, cash received from employee exercises of stock options net of income taxes increased by approximately $5.8 million for the three-month period ended March 31, 2004 as compared to the three-month period ended March 31, 2003.
In March 2004, we called for the full redemption of our outstanding 3% convertible subordinated notes due June 2010. The aggregate principal amount outstanding of the notes at the time of the call for redemption was $133.3 million, all of which was converted into an aggregate approximately 11.7 million shares of common stock prior to the redemption date. In connection with the conversion, we agreed to pay $75.00 per $1,000 of the notes to be converted, for an aggregate payment of approximately $10.0 million. This payment was recorded to interest expense.
In February 2004, certain holders of our outstanding 3% convertible subordinated notes due June 2010 converted approximately $36.0 million in aggregate principal amount of such notes for approximately 3.2 million shares of our common stock and a cash payment of approximately $3.1 million in the aggregate in privately negotiated transactions.
As a result of the transactions related to convertible subordinated debt during the three month period ended March 31, 2004, our total contractual obligation with regard to convertible subordinated debt has decreased from $360.0 million at December 31, 2003 to $181.7 million at March 31, 2004. As of March 31, 2004, we had approximately $181.7 million outstanding convertible subordinated notes and debentures, of which, $7.8 million and $173.9 million in principal amount will mature in 2006 and 2007, respectively. As of December 31, 2003, we had approximately $360.0 million outstanding convertible subordinated notes and
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debentures, of which $7.7 million, $183.0 million and $169.3 million in principal amount would have matured in 2006, 2007 and 2010, respectively.
We may continue to seek additional capital through sales of our debt and/or equity securities, additional financing of equipment acquisitions, and tenant improvements.
Given our current cash requirements, we forecast that we will have sufficient cash to meet our net operating expense requirements for at least the next two years. We plan to continue to invest in our growth and the need for cash will be dependent upon the timing of these investments. Our capital needs will depend on many factors, including continued scientific progress in our research and development arrangements, progress with preclinical and clinical trials, the time and costs involved in obtaining regulatory approvals, the costs of developing and the rate of scaling up each manufacturing operation of our technologies, the timing and cost of our late stage clinical and early commercial production facility, the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims, the need to acquire licenses to new technologies, and the status of competitive products. Of our outstanding convertible subordinated notes and debentures as of March 31, 2004, $7.8 million, and $173.9 million will mature in 2006 and 2007, respectively. We are not likely to be able to satisfy all of these obligations through cash flow generated by our operations. To satisfy our long-term needs, we intend to seek additional funding, as necessary, from corporate partners and from the sale of securities. Because we are an early stage biotechnology company, we do not qualify to issue investment grade debt or have access to certain credit facilities. As a result, any financing we undertake will likely involve the issuance of equity, convertible debt instruments or high-yield debt to fund our working capital. To date we have been primarily dependent upon equity and convertible debt financings for capital and have incurred substantial debt as a result of our issuances of subordinated notes and debentures that are convertible into our Common Stock. Our substantial debt, the market price of our securities and the general economic climate, among other factors, could have material consequences for our financial position and could affect our sources of short-term and long-term funding. There can be no assurance that additional funds, if and when required, will be available to us on favorable terms, if at all.
* This is a forward-looking statement that involves risks and uncertainties. Our actual results could differ materially from those discussed here. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in this section as well as below under the heading Risk Factors.
There were no purchases of any class of our equity securities by us or any affiliate pursuant to any publicly announced repurchase plan.
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The following section should be read carefully in connection with evaluating our business. Any of the following factors could materially and adversely affect our business, financial position or results of operations.
If our collaborative partners that we depend on to obtain regulatory approvals and commercialization of our products are not successful, or if such collaborations fail, then our product development or commercialization of our products may be delayed or unsuccessful.
Because we are in the business of developing technology for improving drug formulations and methods for drug delivery, and licensing these technologies to companies that make and sell drugs, we do not have the people and other resources to do the following things:
synthesize active pharmaceutical ingredients to be used as medicines;
design and conduct large scale clinical studies;
prepare and file documents necessary to obtain government approval to sell a given drug product; or
market and sell our products when and if they are approved.
When we sign a collaborative development agreement or license agreement to develop a product with a drug or biotechnology company, the drug or biotechnology company agrees to do some or all of the things described above.
Reliance on collaborative relationships poses a number of risks, including:
the potential inability to control whether and the extent to which our collaborative partners will devote sufficient resources to our programs or products;
disputes which may arise in the future with respect to the ownership of rights to technology and/or intellectual property developed with collaborative partners;
disagreements with collaborative partners which could lead to delays in or termination of the research, development or commercialization of product candidates, or result in litigation or arbitration;
the potential for contracts with our collaborative partners to fail to provide significant protection or to be effectively enforced if one of these partners fails to perform. Collaborative partners have considerable discretion in electing whether to pursue the development of any additional products and may pursue alternative technologies or products either on their own or in collaboration with our competitors;
the potential for collaborative partners with marketing rights to choose to devote fewer resources to the marketing of our products than they do to products of their own development;
risks related to the ability of our collaborative partners to pay us; and
the potential for collaborative partners to terminate their agreements with us unilaterally for any or no reason.
Given these risks, there is a great deal of uncertainty regarding the success of our current and future collaborative efforts.
We have entered into collaborations in the past that have been subsequently terminated. If other collaborations are suspended or terminated, our ability to commercialize certain of our other proposed products could also be negatively impacted. If these efforts fail, our product development or commercialization of products could be delayed and our financial position and results of operations would be significantly harmed.
If Pfizer does not file an NDA for approval of Exubera® in the U.S., if the FDA does not timely approve any NDA for Exubera®, if the European Medicines Evaluation Agency (EMEA) does not timely approve a marketing authorization application for Exubera®, or if our collaboration with Pfizer is discontinued prior to the commercial launch of Exubera®, then our financial position and results of operations will be significantly harmed.
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We are developing with Pfizer an inhaleable version of insulin, Exubera®, for the treatment of Type 1 and Type 2 diabetes that will be administered using our Pulmonary Technology. Exubera® is currently in extended Phase III clinical trials. We currently depend on Pfizer as the source of a significant portion of our revenues. For the three-month periods ended March 31, 2004 and 2003, revenue from Pfizer accounted for 59% and 54% of our revenue, respectively. In March 2004, Pfizer and Aventis announced that the EMEA has accepted the filing of a marketing authorization application for Exubera®. However, there can be no assurance that Exubera® will be approved for marketing and/or commercial use in the European Union (E.U.). Delays in the filing of an Exubera® NDA will result in a delay in marketing approval in the U.S., and there can be no assurance that even if the NDA submission is filed, Exubera® will be approved for marketing and commercial use in the U.S. Among the factors that may delay the filing or approval of the NDA, the approval by the EMEA to market Exubera® in the E.U., or the commercial launch of Exubera® in the U.S. or the E.U., or that may impact a decision to proceed at all with respect to any of the foregoing, are the following:
Pfizer is currently conducting studies to generate controlled long-term safety data with respect to Exubera®, in particular its effect on lung function, and the results of the studies may impact the filing of regulatory submissions or regulatory approvals.
Pfizer and its partner, Aventis, have been working with the FDA to determine the appropriate timing for submission of the Exubera® NDA in the U.S. The results of any discussions with the FDA with respect to the requirements for and timing of the submission of an NDA may impact the filing or approval of the NDA.
We may experience difficulties with respect to the processing of the dry powder formulation of inhaleable insulin, and the filling and packaging of the inhaleable insulin powder for Exubera®. We may not be able to transfer the filling and packaging technology to Pfizer for the large-scale commercial production of Exubera®.
We, with our contract manufacturers, may experience difficulties with respect to the production of the pulmonary inhaler device for Exubera®, including the design, scale up and automation of the commercial manufacture of the pulmonary inhaler device for Exubera®, and any such difficulties may delay the filing and approval of the NDA or the approval to market in the E.U. Our contract manufacturers may also experience difficulties with respect to manufacturing the device in high volumes for commercial use.
Pfizer may elect for marketing or other reasons, to delay or not proceed with the filing of regulatory submissions for Exubera®, or if approved following any such filing, the commercial launch of Exubera®.
The determination as to whether or when an NDA is filed with respect to Exubera® will be made by Pfizer in its discretion. If the filing or approval of the NDA is substantially delayed beyond the internal estimates we have made for purposes of budgeting and resource allocation, we may not have the financial ability to continue supporting the Exubera® program or be able to meet our contractual obligations relating to the commercial launch of Exubera®. In the event of any such delay, we may also elect to divert resources away from Exubera® related activities or otherwise reduce our activities relating to the Exubera® program. Any material delay in the filing for regulatory approval or material delay in receiving regulatory approval (which in some countries includes pricing approval), or failure to receive regulatory approval for Exubera® at all, would affect our contract research revenue from Pfizer, may result in the payment by us of substantial reimbursements to the contract manufacturers of our proprietary inhaler device with respect to the capital they have deployed in support of such activity, and would significantly harm our financial position and results of operations. Furthermore, should the collaboration with Pfizer be discontinued, our financial position and results of operations may be substantially harmed.
If we fail to establish future successful collaborative relationships, then our financial results may suffer and our product development efforts may be delayed or unsuccessful.
We intend to seek future collaborative relationships with pharmaceutical and biotechnology partners to fund some of our research and development expenses and to develop and commercialize potential products. Further, we anticipate that the timing of drug development programs under existing collaborative agreements with our partners will continue to affect our revenues from such agreements. We may not be able to negotiate acceptable collaborative arrangements in the future, and any arrangements we do negotiate may not be successful. If we fail to establish additional collaborative relationships, we will be required to undertake research, development, marketing, and manufacturing of our proposed products at our own expense or discontinue or reduce these activities.
If we are unable to establish successful collaborative relationships for our early-stage proprietary product development, then our financial results may suffer and our product development efforts may be delayed or unsuccessful.
We intend to seek future collaborative relationships with pharmaceutical and biotechnology partners to fund some clinical trials and other development expenses associated with the development and commercialization of products developed through our Proprietary Products Group. We may not be able to negotiate acceptable collaborative arrangements in the future with respect to these
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products, and any arrangements we do negotiate may not be successful. If we fail to establish these collaborative relationships, we will have expended significant funds of our own in developing these products, and not get a return on our investment. We may then be required to undertake further development, marketing, and manufacturing of these products at our own expense or discontinue or reduce these activities altogether. As a result, failure to establish successful collaborative relationships for these products with pharmaceutical and biotechnology partners will cause our financial results to suffer and could delay or terminate the development of such products.
If our drug delivery technologies are not commercially feasible, then our revenues and results of operations will be impacted negatively.
We are in an early stage of development with respect to many of our products. There is a risk that our technologies will not be commercially feasible. Even if our technologies are commercially feasible, they may not be commercially accepted across a range of large and small molecule drugs. We have tested 13 drug formulations based on our Pulmonary Technology in humans. None of the products using our Pulmonary Technology has been approved for marketing; Exubera® is in Phase III in the U.S., and Pfizer and Aventis have filed a marketing authorization application for Exubera® with the EMEA; and some other products are in Phase I clinical trials. Our Advanced PEGylation Technology has been incorporated in five products that the FDA has approved for marketing and one additional product approved in Europe, and 10 others are in clinical trials. Our Supercritical Fluid Technology is also primarily in an early stage of feasibility. Our potential products require extensive research, development and preclinical and clinical testing. Our potential products also may involve lengthy regulatory reviews and require regulatory approval before they can be sold. We do not know if, and cannot provide assurance that, any of our potential products will prove to be safe and effective, accomplish the objectives that we and our collaborative partners are seeking through the use of our technologies, meet regulatory standards or continue to meet such standards if already approved. There is a risk that we, and our collaborative partners, may not be able to produce any of our potential products in commercial quantities at acceptable costs, or market them successfully. Failure to achieve commercial feasibility, demonstrate safety, achieve clinical efficacy, obtain regulatory approval or, together with partners, successfully market products will negatively impact our revenues and results of operations.
If our research and development efforts are delayed or unsuccessful, then we will experience delay or be unsuccessful in having our products commercialized, and our business will suffer.
Except for products using our Advanced PEGylation Technology that have already been approved by the FDA or other regulatory agencies, our product candidates are still in research and development, including preclinical testing and clinical trials. Preclinical testing and clinical trials are long, expensive and uncertain processes. It may take us, or our collaborators several years to complete this testing, and failure can occur at any stage in the process. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in later stage clinical trials, even after promising results in earlier trials.
Any clinical trial may fail to produce results satisfactory to us, our collaborative partners or the FDA. Preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval or commercialization. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be repeated or a program to be terminated. We typically rely on collaborative partners and third-party clinical investigators to conduct clinical trials of our products and, as a result, we may face additional delaying factors outside our control.
We do not know if any of our research and development efforts, including preclinical testing or clinical trials will adhere to our planned schedules or be completed on a timely basis or at all. Typically, there is a high rate of attrition for product candidates in preclinical and clinical trials.
If our drug delivery technologies do not satisfy certain basic feasibility requirements such as total system efficiency, then our products may not be competitive.
We may not be able to achieve the total system efficiency for products based on our Pulmonary Technology that is needed to be competitive with alternative routes of delivery or formulation technologies. We determine total system efficiency by the amount of drug loss during manufacture, in the delivery system, and in reaching the ultimate site at which the drug exhibits its activity. We would not consider a drug to be a good candidate for development and commercialization using our Pulmonary Technology if drug loss is excessive at any one stage or cumulatively in the manufacturing and delivery process.
Our ability to efficiently attach PEG polymer chains to a drug molecule is the initial screen for determining whether drug formulations using our Advanced PEGylation Technology are commercially feasible. We would not consider a drug formulation to be a good candidate for development and commercialization using our Advanced PEGylation Technology if we could not efficiently attach a PEG polymer chain to such drug without destroying or impairing the drugs activity.
For our Supercritical Fluid Technology, solubility characteristics of a drug and the solvents, which may be incorporated in the manufacturing process, provide the initial screen for whether drug formulations using this technology are commercially feasible.
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We would not consider a drug to be a good candidate for this technology if its solubility characteristics were such that the application of our technology results in very low efficiency in manufacturing of drug powders.
If our drug formulations are not stable, then we will not be able to develop or commercialize products.
We may not be able to identify and produce powdered or other formulations of drugs that retain the physical and chemical properties needed to work effectively with our inhaler devices for deep lung delivery using our Pulmonary Technology, or through other methods of drug delivery using our Advanced PEGylation or Supercritical Fluid Technology. Formulation stability is the physical and chemical stability of the drug over time and under various storage, shipping and usage conditions. Formulation stability will vary with each drug formulation and the type and amount of ingredients that are used in the formulation. Since our drug formulation technology is new and largely unproven, we do not know if our drug formulations will retain the needed physical and chemical properties and performance of the drugs. Problems with formulated drug powder stability in particular would negatively impact our ability to develop products based on our Pulmonary Technology or Supercritical Fluid Technology, or obtain regulatory approval for or market such products.
If our drug delivery technologies are not safe, then regulatory approval of our products may not be obtained, or our products may not be developed or marketed.
We, or our collaborative partners, may not be able to prove that potential products using our drug delivery technologies are safe. Our products require lengthy laboratory, animal and human testing. Many of our products are in preclinical testing or the early stage of human testing. Since many of our products are in an early stage of testing and have not completed clinical trials, we cannot be certain that these products, and our technology that developed these products, are safe or will not produce unacceptable adverse side effects. The safety of our formulations will vary with each drug and the ingredients used in our formulation. If any product is found not to be safe, the product will not be approved for marketing or commercialization.
If product liability lawsuits are brought against us, we may incur substantial liabilities.
The manufacture, testing, marketing and sale of medical products entail an inherent risk of product liability. If product liability costs exceed our liability insurance coverage, we may incur substantial liabilities. Whether or not we were ultimately successful in product liability litigation, such litigation would consume substantial amounts of our financial and managerial resources, and might result in adverse publicity, all of which would impair our business. We may not be able to maintain our clinical trial insurance or product liability insurance at an acceptable cost, if at all, and this insurance may not provide adequate coverage against potential claims or losses.
If the products using our Pulmonary Technology do not provide consistent doses of medicine, then we will not be able to develop, and our partners will not be able to obtain regulatory approval for and commercialize products.
We may not be able to provide reproducible dosing of stable formulations of drug compounds. Reproducible dosing is the ability to deliver a consistent and predictable amount of drug into the bloodstream over time both for a single patient and across patient groups. Reproducible dosing of drugs based on our Pulmonary Technology requires the development of:
an inhalation or other device that consistently delivers predictable amounts of dry powder to the deep lung;
accurate unit dose packaging of dry powder; and
moisture resistant packaging.
Since our Pulmonary Technology is still in development and is yet to be used in commercialized products, we cannot be certain that we will be able to develop reproducible dosing of any potential product. The failure to do so would mean that we would not consider such a product a good candidate for development and commercialization.
If we or our partners do not obtain regulatory approval for our products on a timely basis, then our revenues and results of operations may be affected negatively.
There is a risk that we, or our partners, will not obtain regulatory approval (which in some countries includes pricing approval) for our unapproved products on a timely basis, or at all. Our unapproved products must undergo rigorous animal and human testing and an extensive FDA mandated or equivalent foreign authorities review process. This process generally takes a number of years and requires the expenditure of substantial resources. The time required for completing such testing and obtaining such approvals is uncertain. The FDA and other U.S. and foreign regulatory agencies also have substantial discretion to terminate clinical trials, require additional testing, delay or withhold registration and marketing approval and mandate product withdrawals including recalls. The FDA has approved for marketing five products using our Advanced PEGylation Technology for specific uses in the United States. Further, another product using our Advanced PEGylation Technology has been approved in Europe. Even though our
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partners have obtained regulatory approval for some of our products, these products and our manufacturing processes are subject to continued review by the FDA and other regulatory authorities. Even if our partners receive regulatory approval of a product, the approval may limit the indicated uses for which our partners may market the product. In addition, our partners marketed products, our manufacturing facilities and we, as the manufacturer in certain instances, will be subject to continual review and periodic inspections. Later discovery from such review and inspection of previously unknown problems may result in restrictions on our partners products or on us, including withdrawal of our partners products from the market. The failure to obtain timely regulatory approval of our partners products, any product marketing limitations or a product withdrawal would negatively impact our revenues and results of operations.
In addition, we may encounter delays or rejections based upon changes in FDA regulations or policies, including policies relating to current good manufacturing practice compliance, or cGMP, during the period of product development. We may encounter similar delays in other countries.
If our technologies cannot be integrated successfully to bring products to market, then our ability to develop, and our partners ability to obtain approval or market our products, may be delayed or unsuccessful.
We may not be able to integrate all of the relevant technologies to provide complete drug delivery and formulation systems. In particular, our development of drugs based on our Pulmonary Technology relies upon the following several different but related technologies:
dry powder formulations;
dry powder processing technology;
dry powder packaging technology; and
deep lung delivery devices.
Our other technologies may face similar challenges relating to the integration of drug formulation, processing, packaging and delivery device technologies. At the same time we must:
establish collaborations with partners;
perform laboratory and pre-clinical testing of potential products; and
scale-up our manufacturing processes.
We must accomplish all of these steps without delaying any aspect of technology development. Any delay in one component of product or business development could delay our ability to develop, and our partners ability to obtain approval or market products using our delivery and formulation technologies.
If we are not able to manufacture our products in commercially feasible quantities or at commercially feasible costs, then our products will not be successfully commercialized.
Nektar Advanced PEGylation Technology and Supercritical Fluid Technology
Except for the five approved products and the one additional product approved in Europe incorporating our Advanced PEGylation Technology, all of the drug formulations which incorporate our Advanced PEGylation Technology and Supercritical Fluid Technology are in various stages of feasibility testing or human clinical trials. We are currently expanding our Advanced PEGylation Technology manufacturing capacity and anticipate having to add additional Supercritical Fluid Technology manufacturing capacity. If we are not able to scale-up to large clinical trials or commercial manufacturing for products incorporating either of these technologies in a timely manner or at a commercially reasonable cost, we risk not meeting our customers supply requirements or our contractual obligations. Our failure to solve any of these problems could delay or prevent late stage clinical testing and commercialization of our products and could negatively impact our revenues and results of operations.
Nektar Pulmonary Technology
Except for the one product incorporating our Pulmonary Technology that has been filed for approval in Europe, all of the drug formulations, which incorporate our Pulmonary Technology, are in various stages of human clinical trials or feasibility testing
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Powder Processing. We have no experience manufacturing powder products for commercial purposes. With respect to drugs based on our Pulmonary Technology, we have only performed powder processing on the scale needed for testing formulations, and for early stage and larger clinical trials. We may encounter manufacturing and control problems as we attempt to scale-up powder processing facilities. We may not be able to achieve such scale-up in a timely manner or at a commercially reasonable cost, if at all, and the powder processing system we implement may not be applicable for other drugs. Our failure to solve any of these problems could delay or prevent some late stage clinical testing and commercialization of our products and could negatively impact our revenues and results of operations.
To date, we rely primarily on two particular methods of powder processing. There is a risk that these technologies will not work with all drugs or that the cost of drug production with this processing will preclude the commercial viability of certain drugs. Additionally, there is a risk that any alternative powder processing methods we may pursue will not be commercially practical for aerosol drugs or that we will not have, or be able to acquire the rights to use, such alternative methods.
Powder Packaging. Our fine particle powders and small quantity packaging utilized for drugs based on our Pulmonary Technology require special handling. We have designed and qualified automated filling equipment for small and moderate quantity packaging of fine powders. We face significant technical challenges in scaling-up an automated filling system that can handle the small dose and particle sizes of our powders in commercial quantities. There is a risk that we will not be able to scale-up our automated filling equipment in a timely manner or at commercially reasonable costs. Any failure or delay in such scale-up would delay product development or bar commercialization of products based on our Pulmonary Technology and would negatively impact our revenues and results of operations.
There can be no assurance we will be able to manufacture products on our autofiller system in a timely manner or at a commercially reasonable cost; any delay or failure in further developing such technology would delay product development or inhibit commercialization of our products and would have a materially adverse effect on us.
Nektar Pulmonary Inhaler Device. We face many technical challenges in developing our pulmonary inhaler device to work with a broad range of drugs, to produce such devices in sufficient quantities, and to adapt the devices to different powder formulations. Our pulmonary inhaler device being used with Exubera® is still in clinical testing. Additional design and development work may be required to optimize the device for regulatory approval, field reliability, or other issues that may be important to its commercial success.
Additional design and development work may lead to a delay in regulatory approval and delay efforts to seek regulatory approval for any product that incorporates the device or the time the device could be ready for commercial launch. In addition, we are attempting to develop a smaller inhaler device, which presents particular technical challenges. There is a risk that we will not successfully achieve any of these challenges. Our failure to overcome any of these challenges would negatively impact our revenues and results of operations.
For late stage clinical trials and initial commercial production, we intend to use one or more contract manufacturers to produce our pulmonary inhaler devices. There is a risk that we will not be able to maintain arrangements with our contract manufacturers on commercially acceptable terms or at all, or effectively scale-up production of our pulmonary inhaler devices through contract manufacturers. Our failure to do so would negatively impact our revenues and results of operations. Dependence on third parties for the manufacture of our pulmonary inhaler devices and their supply chain may adversely affect our cost of goods and ability to develop and commercialize products on a timely or competitive basis. Because our manufacturing processes and those of our contract manufacturers are very complex and subject to lengthy governmental approval processes, alternative qualified production sources or capacity may not be available on a timely basis or at all. Disruptions or delays in our manufacturing processes or those of our contract manufacturers for existing or new products could result in increased costs, loss of revenues or market share, or damage to our reputation.
There is no assurance that devices designed by us and built by contract manufacturers will be approved or will meet approval requirements on a timely basis or at all, or that any of our device development will be successful or commercially viable.
If Pfizer is not able to fill the bulk drug powders for Exubera® in commercially feasible quantities, then Exubera® will not be successfully commercialized and would negatively impact our revenues and results of operations.
We have developed a high capacity automated filling unit capable of filling blisters on a production scale for moderate and large volume products using our Pulmonary Technology. The technology for the high capacity automated filling unit has been transferred to Pfizer who will have the responsibility of packaging and filling the bulk drug powders for Exubera®. There are significant technical challenges in scaling-up an automated filling system that can handle the small dose and particle sizes of our powders in commercial quantities. In addition, there is the additional risk that Pfizer has no backup manufacturing facility for this process. Any failure or delay in the manufacturing facility or process would delay product development or bar commercialization of Exubera® and would negatively impact our revenues and results of operations.
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If we are not able to manufacture our dry powder inhaler device in commercially feasible quantities or at commercially feasible costs, then our Pulmonary Technology products may not be successfully commercialized.
In addition to our inhaler device being used with Exubera®, we are developing a breath actuated compact dry powder inhaler device (DPI). We are developing the DPI device to be appropriate for the delivery of either large or small molecules for short-term use. We face many unique technical challenges in developing the DPI device to work with a broad range of drugs, producing the DPI device in sufficient quantities and adapting the DPI device to different powder formulations. Our DPI device is still in clinical testing and production scale-up work is ongoing. Further design and development will be required to obtain regulatory approval for the DPI device, enable commercial manufacturing, insure field reliability or manage other issues that may be important to its commercial success. Such additional design and development work may lead to a delay in efforts to seek regulatory approval for any product that incorporates the DPI device, or could delay the timeframe within which the device could be ready for commercial launch. There is a risk that we will not successfully achieve any of these challenges. Our failure to overcome any of these challenges would negatively impact our revenues and results of operations.
We depend on sole or exclusive suppliers for our pulmonary inhaler devices, bulk active pharmaceutical ingredients and PEG polymer chains and if such suppliers fail to supply when required, then our product development efforts may be delayed or unsuccessful and our commercial supply obligations may be compromised.
We agreed to subcontract the manufacture of our pulmonary inhaler devices used with Exubera® before commercial production. We have identified contract manufacturers that we believe have the technical capabilities and production capacity to manufacture such device and which can meet the requirements of cGMP. We are not certain that we will be able to maintain satisfactory contract manufacturing on commercially acceptable terms, if at all. Our failure to maintain ongoing commercial relationships with our existing contract manufacturers may subject us to significant reimbursement obligations upon termination of such relationships. Our dependence on third parties for the manufacture of our pulmonary inhaler devices may negatively impact our cost of goods and our ability to develop and commercialize products based on our Pulmonary Technology on a timely and competitive basis.
For the most part, we obtain the bulk active pharmaceutical ingredients we use to manufacture products using our technologies from sole or exclusive sources of supply. For example, with respect to our source of bulk insulin, we have entered into a collaborative agreement with Pfizer that has, in turn, entered into an agreement with Aventis to manufacture regular human insulin. Under the terms of their agreement, Pfizer and Aventis agreed to construct a jointly owned manufacturing plant in Frankfurt, Germany. Until needed, Pfizer will provide us with insulin from Aventiss existing plant. We have also entered into an agreement with one supplier for the supply of PEG polymer chains we use in our products that incorporate our Advanced PEGylation Technology. NOF Corporation is our sole supplier of pharmaceutical grade PEGylation materials pursuant to an agreement.
If our sole or exclusive source suppliers fail to provide either active pharmaceutical ingredients or PEGylation materials in sufficient quantities when required, our revenues and results of operations will be negatively impacted.
If the market does not accept products using our drug delivery technologies, then our revenues and results of operations will be adversely affected.
The commercial success of our potential products depends upon market acceptance by health care providers, third-party payors like health insurance companies and Medicare and patients. Our products under development use new drug delivery technologies and there is a risk that the market will not accept our potential products. Market acceptance will depend on many factors, including:
the safety and efficacy of products demonstrated in clinical trials;
favorable regulatory approval and product labeling;
the frequency of product use;
the ease of product use;
the availability of third-party reimbursement;
the availability of alternative technologies; and
the price of our products relative to alternative technologies.
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There is a risk that health care providers, patients or third-party payors will not accept products using our drug delivery and formulation technologies. If the market does not accept our potential products, our revenues and results of operations would be significantly and negatively impacted.
If our products are not cost effective, then government and private insurance plans may not pay for them and our products may not be widely accepted, which will adversely affect our revenues and results of operations.
In both domestic and foreign markets, sales of our products under development will depend in part upon the availability of reimbursement from third-party payors, such as government health administration authorities, managed care providers, private health insurers and other organizations. In addition, such third-party payors are increasingly challenging the price and cost effectiveness of medical products and services. Significant uncertainty exists as to the reimbursement status of newly approved health care products. Legislation and regulations affecting the pricing of pharmaceuticals may change before regulatory agencies approve our proposed products for marketing. Adoption of such legislation and regulations could further limit reimbursement for medical products. A government or third-party payor decision not to provide adequate coverage and reimbursements for our products would limit market acceptance of such products.
If our competitors develop and sell better drug delivery and formulation technologies, then our products or technologies may be uncompetitive or obsolete and our revenues and results of operations will be adversely affected.
We are aware of other companies engaged in developing and commercializing drug delivery and formulation technologies similar to our technologies. Some of our competitors with regard to our Pulmonary Technology include AeroGen, Inc., Alkermes, Inc., Aradigm Corporation, and MannKind. AeroGen and Aradigm are each developing liquid drug delivery systems, and Alkermes is working on a dry powder delivery system. Our competitors with regard to our Advanced PEGylation Technology include Valentis, Inc., Mountain View Pharmaceuticals, Inc. and SunBio PEG-SHOP, as well as several pharmaceutical and biotechnology companies with in-house PEGylation expertise. Some of our competitors with regard to our Supercritical Fluid Technology include Alkermes, Battelle Memorial Institute, Ethypharm SA, Ferro Corp., Lavipharm SA and RxKinetics. Some of these companies license or provide the technology to other companies, while others are developing the technology for internal use. Many of these companies have greater research and development capabilities, experience, manufacturing, marketing, financial and managerial resources than we do and represent significant competition for us. Acquisitions of or collaborations with competing drug delivery companies by large pharmaceutical or biotechnology companies could enhance our competitors financial, marketing and other resources. Accordingly, our competitors may succeed in developing competing technologies, obtaining regulatory approval for products or gaining market acceptance before us. Developments by others could make our products or technologies uncompetitive or obsolete. Our competitors may introduce products or processes competitive with or superior to our products or processes.
If any of our patents are invalid or pending patents do not issue or following issuance are deemed not valid, then we may lose key intellectual property right protection. If our products infringe on third-partys rights, then we will suffer adverse effects on our ability to develop and commercialize products as well as our revenues and results of operations.
We have filed patent applications covering certain aspects of our inhalation devices, powder processing technology, powder formulations and deep lung route of delivery for certain molecules as well as for our Advanced PEGylation and Supercritical Fluid Technology, and we plan to file additional patent applications. As of March 31, 2004, we had 686 issued U.S. and foreign patents that cover certain aspects of our technologies and we have a number of patent applications pending. There is a risk that many of the patents applied for will not issue, or that any patents that issue or have issued will not be held valid and enforceable. Enforcing our patent rights would be time consuming and costly.
Our access or our partners access to the drugs to be formulated using our technologies will affect our ability to develop and commercialize our technologies. Many drugs, including powder formulations of certain drugs that are presently under development by us, and our drug formulation technologies are subject to issued and pending U.S. and foreign patents that may be owned by competitors. We know that there are issued patents and pending patent applications relating to the formulation and delivery of large and small molecule drugs, including several for which we are developing formulations using our various technologies. This situation is highly complex, and the ability of any one company, including us, to commercialize a particular drug is unpredictable.
We intend generally to rely on the ability of our partners to provide access to the drugs that we formulate for deep lung and other forms of delivery. There is a risk that our partners will not be able to provide access to such drug candidates. Even if our partners provide such access, there is a risk that third parties will accuse, and possibly a court or a governmental agency will determine, our partners or us to be infringing a third-partys patent rights, and we will be prohibited from working with the drug or be found liable for damages that may not be subject to indemnification, or we may choose to pay such third party royalties under a license to such patent rights. Any such restriction on access to drug candidates, liability for damages or payment of royalties would negatively impact our revenues and results of operations.
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We may incur material litigation costs, which may adversely affect our business and results of operations.
From time to time, we are party to various litigation matters, including several that relate to our patent and intellectual property rights. We cannot predict with certainty the eventual outcome of any pending litigation or potential future litigation, and we might have to incur substantial expense in defending these or future lawsuits or indemnifying third parties with respect to the results of such litigation.
If earthquakes, tornadoes, hurricanes and other catastrophic events strike, our business may be negatively affected.
Our corporate headquarters, including a substantial portion of our research and development operations, are located in the San Francisco Peninsula, a region known for seismic activity. A significant natural disaster such as an earthquake could have a material adverse impact on our business, operating results, and financial condition. There are no backup facilities for some of our manufacturing operations located in the San Francisco Peninsula. Certain of our other facilities, such as our facility in Huntsville, Alabama and certain of our collaborative partners located elsewhere may also be subject to catastrophic events such as hurricanes and tornadoes, any of which could have a material adverse effect on our business, operating results, and financial condition.
Investors should be aware of industry-wide risks, which are applicable to us and may affect our revenues and results of operations.
In addition to the risks associated specifically with us described above, investors should also be aware of general risks associated with drug development and the pharmaceutical and biotechnology industries. These include, but are not limited to:
changes in and compliance with government regulations;
handling and disposal of hazardous materials;
workplace health and safety requirements;
hiring and retaining qualified people; and
insuring against product liability claims.
If we do not generate sufficient cash flow through increased revenues or raising additional capital, then we may not be able to meet our substantial debt obligations.
As of March 31, 2004, we had approximately $181.7 million in long-term convertible subordinated notes and debentures, $31.1 million in non-current capital lease obligations and $11.7 million in other long-term liabilities. Our substantial long-term indebtedness, which totaled $224.5 million as of March 31, 2004, has and will continue to impact us by:
making it more difficult to obtain additional financing; and
constraining our ability to react quickly in an unfavorable economic climate.
Currently we are not generating positive cash flow. Delay in the approval of Exubera®, or other adverse occurrences related to our product development efforts will adversely impact our ability to meet our obligations to repay the principal amounts on our convertible subordinated notes and debentures when due. In addition, if the market price of our common stock is below the related conversion price, the holders of the related outstanding convertible subordinated notes and debentures will not likely convert such securities to equity in accordance with their existing terms. If we are unable to satisfy our debt service requirements, substantial liquidity problems could result. As of March 31, 2004 we had cash, cash equivalents and short-term investments valued at approximately $467.4 million. We expect to use a substantial portion of these assets to fund our on-going operations over the next few years. As of March 31, 2004, we had approximately $181.7 million outstanding convertible subordinated notes and debentures, of which, $7.8 million and $173.9 million in principal amount will mature in 2006 and 2007, respectively. We may not generate sufficient cash from operations to repay our convertible subordinated notes and debentures or satisfy any other of these obligations when they become due and may have to raise additional funds from the sale of equity or debt securities or otherwise restructure our obligations in order to do so. There can be no assurance that any such financing or restructuring will be available to us on commercially acceptable terms, if at all.
If we cannot raise additional capital our financial condition may suffer.
Our capital needs may change as a result of numerous factors, and may result in additional funding requirements. In addition, we may choose to raise additional capital due to market conditions or strategic considerations. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of such securities could result in dilution to our stockholders.
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We have no material credit facility or other material committed sources of capital. To the extent operating and capital resources are insufficient to meet future requirements, we will have to raise additional funds to continue the development and commercialization of our technologies and products. Such funds may not be available on favorable terms, or at all. In particular, our substantial leverage may limit our ability to obtain additional financing. In addition, as an early stage biotechnology company, we do not qualify to issue investment grade debt and therefore any financing we do undertake will likely involve the issuance of equity, convertible debt instruments and/or high-yield debt. These sources of capital may not be available to us in the event we require additional financing. If adequate funds are not available on reasonable terms, we may be required to curtail operations significantly or obtain funds by entering into financing, supply or collaboration agreements on unattractive terms. Our inability to raise capital could negatively impact our business.
If we fail to manage our growth effectively, our business may suffer.
Our ability to offer commercially viable products, achieve our expansion objectives, manage our growth effectively and satisfy our commitments under our collaboration agreements depends on a variety of factors, all of which must be successfully managed. Key factors include our ability to develop products internally, enter into strategic partnerships with collaborators, attract and retain skilled employees and effectively expand our internal organization to accommodate anticipated growth including integration of any potential businesses that we may acquire. If we are unable to manage some or all of these factors effectively, our business could grow too slowly or too quickly to be successfully sustained, thereby resulting in material adverse effects on our business, financial condition and results of operations.
If we acquire additional companies, products or technologies, we may not be able to effectively integrate personnel and operations and such failure may disrupt our business and results of operations.
We have acquired companies, products and/or technologies in the past, and may continue to acquire or make investments in complementary companies, products or technologies in the future. We may not receive the anticipated benefits of these acquisitions or investments. We may face risks relating to difficult integrations of personnel, technology and operations, uncertainty whether any integration will be successful and whether earnings will be negatively affected, and potential distractions to our management with respect to these acquisitions. In addition, our earnings may suffer because of acquisition-related costs.
We expect to continue to lose money for the next few years and may not reach profitability if our products do not generate sufficient revenue.
We have never had a profitable year and, through March 31, 2004, we have an accumulated deficit of approximately $655.2 million. We expect to continue to incur substantial and potentially increasing losses over at least the next few years as we expand our research and development efforts, testing activities and manufacturing operations, and as we further expand our late stage clinical and early commercial production facilities. Most of our potential products are in the early stages of development. Except for the approved products incorporating our Advanced PEGylation Technology, we have generated no revenues from product sales. Our revenues to date have consisted primarily of payments under short-term research and feasibility agreements and development contracts.
To achieve and sustain profitable operations, we must, alone or with others, successfully develop, obtain regulatory approval for, manufacture, introduce, market and sell products using our drug delivery technologies. There is risk that we will not generate sufficient product or contract research revenue to become profitable or to sustain profitability.
Anti-takeover provisions in our charter documents and under Delaware law may make it more difficult to acquire us, even though such acquisitions may be beneficial to our stockholders.
Provisions of our certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us, even though such acquisitions may be beneficial to our stockholders. These anti-takeover provisions include:
establishment of a classified board of directors such that not all members of the board may be elected at one time;
lack of a provision for cumulative voting in the election of directors, which would otherwise allow less than a majority of stockholders to elect director candidates;
the ability of our board to authorize the issuance of blank check preferred stock to increase the number of outstanding shares and thwart a takeover attempt;
prohibition on stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of stockholders;
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establishment of advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon by stockholders at stockholder meetings; and
limitations on who may call a special meeting of stockholders.
Further, we have in place a preferred share purchase rights plan, commonly known as a poison pill. The provisions described above, our poison pill and provisions of Delaware law relating to business combinations with interested stockholders may discourage, delay or prevent a third party from acquiring us. These provisions may also discourage, delay or prevent a third party from acquiring a large portion of our securities, or initiating a tender offer or proxy contest, even if our stockholders might receive a premium for their shares in the acquisition over the then current market prices.
We expect our stock price to remain volatile.
Our stock price is volatile. In the last twelve-month period ending March 31, 2004, based on closing bid prices on The NASDAQ National Market, our stock price ranged from $6.35 to $23.24. We expect our stock price to remain volatile. A variety of factors may have a significant effect on the market price of our common stock, including:
clinical trial results or product development delays or delays in product approval or launch;
announcements by collaboration partners as to their plan or expectations related to products using our technologies;
announcement or termination of collaborative relationships by us or our competitors;
fluctuations in our operating results;
developments in patent or other proprietary rights;
announcements of technological innovations or new therapeutic products;
governmental regulation;
public concern as to the safety of drug formulations developed by us or others; and
general market conditions.
Any litigation brought against us as a result of this volatility could result in substantial costs and a diversion of our managements attention and resources, which could negatively impact our financial condition, revenues, results of operations, and the price of our common stock.
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There have been no material changes in reported market risks since December 31, 2003.
Evaluation of Disclosure Controls and Procedures. Under the supervision and with the participation of management, including our Chief Executive Officer and our Chief Financial Officer, we have, evaluated the effectiveness of the design and operation of our disclosure controls and procedures. Disclosure controls and procedures are controls and procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the 1934 Act is recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of the end of the period covered by this quarterly report.
Changes in Internal Controls. During the fiscal quarter ended March 31, 2004, there were no changes to internal control over financial reporting that have materially occurred, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on the Effectiveness of Controls. Our management, including the Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, control may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
31
From time to time, we may be involved in lawsuits, claims, investigations and proceedings, consisting of intellectual property, commercial, employment and other matters, which arise in the ordinary course of business. In accordance with SFAS No. 5, Accounting for Contingencies, we make a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss can reasonable estimate. These provisions are reviewed at least quarterly and adjusted to reflect the impact of negotiations, settlements, ruling, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. However, we believe that we have valid defenses with respect to the legal matters pending against us, as well as adequate provisions for any probable and estimable losses. If any unfavorable ruling were to occur in any specific period, there exists the possibility of a material adverse impact on the results of operations of that period. We believe that, given our current liquidity and cash, cash equivalents, and short-term investment balances, even if we receive an adverse judgment with respect to litigation that we are currently a party to, such judgment would not have a material impact on cash and investments or liquidity.
Item 2. Changes in Securities and Use of Proceeds
In March 2004, we called for the full redemption of all of our outstanding 3% convertible subordinated notes due June 2010. Holders of all the outstanding notes converted their notes prior to the redemption date, resulting in the issuance of approximately 11.7 million shares of our common stock. The total aggregate amount of notes converted was $133.3 million. We issued the shares of common stock under an exemption from the registration requirement of the 1933 Act provided by Section 3(a)(9) of the 1933 Act.
In February and March 2004, Enzon, the holder of our outstanding Series B Convertible Preferred Stock converted an aggregate 20,055 shares of such stock into an aggregate 880,085 shares of our common stock. The conversion price was $22.79 per share, which represents a conversion rate of approximately 43.88 shares of common stock for each share of Series B Convertible Preferred Stock. We issued the shares of common stock under an exemption from the registration requirement of the 1933 Act provided by Section 3(a)(9) of the 1933 Act.
In February 2004, in a limited number of privately negotiated transactions, certain holders of our outstanding 3% convertible subordinated notes due June 2010 (issued in October 2003) converted approximately $36.0 million in aggregate principal amount of such notes for shares of our common stock. The conversion price was $11.35 per share and resulted in the issuance of approximately 3.2 million shares of our common stock in the aggregate. In connection with the conversion, we agreed to make cash payments equal to $85.00 per $1,000 of the notes to be converted, for an aggregate payment of approximately $3.1 million. We issued the shares of common stock under an exemption from the registration requirement of the 1933 Act provided by Section 3(a)(9) of the 1933 Act.
In January 2004, in a privately negotiated transaction, certain holders of our outstanding 3.5% convertible subordinated notes due October 2007 completed an exchange and cancellation of $9.0 million in aggregate principal amount of the notes held by such holders, for the issuance of an aggregate of 575,605 shares of our common stock. We issued the shares of common stock under an exemption from the registration requirements of the 1933 Act provided by Section 3(a)(9) of the 1933 Act.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
We file electronically with the Securities and Exchange Commission (SEC) our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and amendments to those reports, pursuant to Section 13(a) or 15(d) of the 1934 Act. The public may read or copy any materials we file with the SEC at the SECs Public Reference Room at 450 Fifth Street, NW, Washington, DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information statements, and other information regarding issuers that file electronically with the SEC. The address of that site is http:// www.sec.gov.
You may obtain a free copy of our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K and amendments to those reports on the day of filing with the SEC on our website at http://www.nektar.com, by contacting the Investor Relations Department at our corporate offices by calling (650) 631-3100 or by sending an e-mail message to investors@nektar.com.
32
Disclosure regarding the operations of our board of director nominating committees and the means by which security holders may communicate with directors is incorporated by reference from the definitive proxy statement for our 2004 Annual Meeting of Stockholders to be filed with the SEC pursuant to Regulation 14A not later than 120 days after the end of our fiscal year ended December 31, 2003 (the Proxy Statement) under the heading Nominating and Corporate Governance Committee.
As permitted by SEC Rule 10b5-1, certain of our executive officers, directors and other employees have set up a predefined, structured stock trading program with his/her broker to sell our stock. The stock trading program allows a broker acting on behalf of the executive officer, director or other employee to trade our stock during blackout periods or while such executive officer, director or other employee may be aware of material, nonpublic information, if the trade is performed according to a pre-existing contract, instruction or plan that was established with the broker during a non-blackout period and when such executive officer, director or employee was not aware of any material, nonpublic information. Our executive officers, directors and other employees may also trade our stock outside of the stock trading programs set up under Rule 10b5-1 subject to our blackout periods and insider trading rules.
33
(a) Exhibits
Except as so indicated in Exhibit 32.1, the following exhibits are filed as part of, or incorporated by reference into, this Form 10-Q.
Exhibit |
|
|
|
Description of Documents |
|
|
|
|
|
2.1 |
|
(1) |
|
Agreement and Plan of Merger, dated June 4, 1998, by and between Inhale Therapeutic Systems, a California corporation, and Inhale Therapeutic Systems (Delaware), Inc., a Delaware corporation. |
2.2 |
|
(15) |
|
Recommended Offer, dated December 21, 2000, by Cazenove & Co. on behalf of Nektar Therapeutics for Bradford Particle Design plc. |
2.3 |
|
(20) |
|
Agreement and Plan of Merger and Reorganization, dated May 22, 2001, by and among Nektar Therapeutics, Square Acquisition Corp., Shearwater Corporation, Certain Shareholders of Shearwater Corporation and J. Milton Harris as Shareholders Agent. |
2.4 |
|
(20) |
|
Amendment to Agreement and Plan of Merger and Reorganization, dated June 21, 2001, by and among Nektar Therapeutics, Square Acquisition Corp., Shearwater Corporation, J. Milton Harris, as Shareholders Agent and a Designated Shareholder, and Puffinus, L.P. |
3.1 |
|
(1) |
|
Certificate of Incorporation of Inhale Therapeutic Systems (Delaware), Inc. |
3.2 |
|
(1) |
|
Bylaws of Nektar Therapeutics. |
3.3 |
|
(13) |
|
Certificate of Amendment of the Amended Certificate of Incorporation of Nektar Therapeutics. |
3.4 |
|
(19) |
|
Certificate of Designation of Series A Junior Participating Preferred Stock of Nektar Therapeutics. |
3.5 |
|
(24) |
|
Certificate of Designation of Series B Convertible Preferred Stock of Nektar Therapeutics. |
3.6 |
|
(28) |
|
Certificate of Ownership and Merger of Nektar Therapeutics. |
4.1 |
|
|
|
Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6. |
4.2 |
|
(2) |
|
Restated Investor Rights Agreement, dated April 29, 1993, as amended October 29, 1993, by and among Nektar Therapeutics and certain other persons named therein. |
4.3 |
|
(3) |
|
Stock Purchase Agreement, dated January 18, 1995, by and between Nektar Therapeutics and Pfizer Inc. |
4.4 |
|
(8) |
|
Form of Purchase Agreement, dated January 28, 1997, by and among Nektar Therapeutics and the individual Purchasers. |
4.5 |
|
(9) |
|
Stock Purchase Agreement, dated December 8, 1998, by and between Nektar Therapeutics and Capital Research and Management Company. |
4.6 |
|
(11) |
|
Purchase Agreement, dated October 6, 1999, by and among Nektar Therapeutics, Lehman Brothers Inc., Deutsche Bank Securities Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.7 |
|
(11) |
|
Resale Registration Rights Agreement, dated October 13, 1999, by and among Nektar Therapeutics, Lehman Brothers Inc., Deutsche Bank Securities Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.8 |
|
(11) |
|
Indenture, dated October 13, 1999, by and between Nektar Therapeutics, as Issuer, and Chase Manhattan Bank and Trust Company, National Association, as Trustee. |
4.9 |
|
(11) |
|
Form of Registration Rights Agreement by and between Nektar Therapeutics and Alliance Pharmaceutical Corp. |
4.10 |
|
(12) |
|
Purchase Agreement, dated February 2, 2000, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.11 |
|
(12) |
|
Resale Registration Rights Agreement, dated February 8, 2000, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.12 |
|
(12) |
|
Indenture, dated February 8, 2000, by and between Nektar Therapeutics, as Issuer, and Chase Manhattan Bank and Trust Company, National Association, as Trustee. |
4.13 |
|
(28) |
|
Specimen Common Stock certificate. |
4.14 |
|
(14) |
|
Specimen warrants to purchase shares of Common Stock. |
4.15 |
|
(16) |
|
Purchase Agreement, dated October 11, 2000, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.16 |
|
(16) |
|
Resale Registration Rights Agreement, dated October 17, 2000, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities, Inc., Lehman Brothers Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.17 |
|
(16) |
|
Indenture, dated October 17, 2000, by and between Nektar Therapeutics, as Issuer, and Chase Manhattan Bank and Trust Company, National Association, as Trustee. |
34
4.18 |
|
(19) |
|
Rights Agreement, dated as of June 1, 2001, by and between Nektar Therapeutics and Mellon Investor Services LLC., as Rights Agent. |
4.19 |
|
(19) |
|
Form of Right Certificate. |
4.20 |
|
(24) |
|
Preferred Stock Purchase Agreement, dated January 7, 2002, by and between Nektar Therapeutics and Enzon Pharmaceuticals, Inc. |
4.21 |
|
(27) |
|
Common Stock Purchase Agreement, dated June 7, 2002, by and between Nektar Therapeutics and AFAC Equity L.P. |
4.22 |
|
(27) |
|
Common Stock Purchase Agreement, dated July 9, 2002, by and between Nektar Therapeutics and AFAC Equity L.P. |
4.23 |
|
(26) |
|
Common Stock Purchase Agreement, dated December 6, 2002, by and between Nektar Therapeutics and AFAC Equity L.P. |
4.24 |
|
(30) |
|
Purchase Agreement, dated June 25, 2003, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc., Friedman, Billings, Ramsey & Co. Inc. and SG Cowen Securities Corporation |
4.25 |
|
(30) |
|
Resale Registration Rights Agreement, dated June 30, 2003, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc., Friedman, Billings, Ramsey & Co. Inc. and SG Cowen Securities Corporation |
4.26 |
|
(30) |
|
Indenture, dated June 30, 2003, by and between Nektar Therapeutics and J.P. Morgan Trust Company, National Association, as trustee |
4.27 |
|
(31) |
|
Indenture, dated October 9, 2003, by and between Nektar Therapeutics and J.P. Morgan Trust Company, National Association, as trustee |
4.28 |
|
(32) |
|
Resale Registration Rights Agreement, dated October 9, 2003, by and among Nektar Therapeutics and the entities named therein |
4.29 |
|
(31) |
|
Form of Convertible Subordinated Note due 2010 |
4.30 |
|
(33) |
|
First Supplemental Indenture, dated October 17, 2003, by and between Nektar Therapeutics and J.P. Morgan Trust Company, National Association, as trustee |
10.1 |
|
(6) |
|
Nektar Therapeutics 1994 Non-Employee Directors Stock Option Plan, as amended. |
10.2 |
|
(29) |
|
Nektar Therapeutics 1994 Employee Stock Purchase Plan, as amended and restated.++ |
10.3 |
|
(2) |
|
Standard Industrial Lease, dated September 17, 1992, as amended September 18, 1992, by and between Nektar Therapeutics and W.F. Batton & Co., Inc. |
10.4 |
|
(2) |
|
Addendum IV to Lease dated September 17, 1992, dated April 1, 1994, by and among Nektar Therapeutics, W.F. Batton and Marie A. Batton. |
10.5 |
|
(5) |
|
Amendment Agreement Number One to Lease dated September 17, 1992, dated October 20, 1995, by and between Nektar Therapeutics and W.F. Batton & Co., Inc. |
10.6 |
|
(5) |
|
Amendment Agreement Number Two to Lease dated September 17, 1992, dated November 15, 1995, by and among Nektar Therapeutics, W.F. Batton and Marie A. Batton, Trustees of the W.F. Batton and Marie A. Batton Trust UTA dated January 12, 1998 (Batton Trust). |
10.7 |
|
(10) |
|
Amendment Agreement Number Three to Lease dated September 17, 1992, dated February 14, 1996, by and between Nektar Therapeutics and Batton Trust. |
10.8 |
|
(10) |
|
Amendment Agreement Number Four to Lease dated September 17, 1992, dated September 15, 1996, by and between Nektar Therapeutics and Batton Trust. |
10.9 |
|
(2) |
|
Sublicense Agreement, dated September 13, 1991, by and between Nektar Therapeutics and John S. Patton.++ |
10.10 |
|
(4) |
|
Stock Purchase Agreement, dated March 1, 1996, by and between Nektar Therapeutics and Baxter World Trade Corporation. |
10.11 |
|
(7) |
|
Sublease and Lease Agreement, dated October 2, 1996, by and between Nektar Therapeutics and T.M.T. Associates L.L.C. (Landlord). |
10.12 |
|
(10) |
|
First Amendment to Sublease and Lease Agreement dated October 2, 1996, dated October 30, 1996, by and between Nektar Therapeutics and Landlord. |
10.13 |
|
(10) |
|
Letter Agreement amending Sublease and Lease Agreement dated October 2, 1996, dated April 9, 1997, by and between Nektar Therapeutics and Landlord. |
10.14 |
|
(10) |
|
Third Amendment to Sublease and Lease Agreement dated October 2, 1996, dated April 16, 1997, by and between Nektar Therapeutics and Landlord. |
10.15 |
|
(10) |
|
Fourth Amendment to Sublease and Lease Agreement dated October 2, 1996, dated November 5, 1997, by and between Nektar Therapeutics and Landlord. |
10.16 |
|
(12) |
|
Sublease, dated November 3, 1999, by and between Webvan Group, Inc., as sublessor, and Nektar Therapeutics, as sublessee. |
10.17 |
|
(14) |
|
Nektar Therapeutics 2000 Equity Incentive Plan, as amended.++ |
10.18 |
|
(14) |
|
Nektar Therapeutics Stock Option Agreement issued in accordance with Nektar Therapeutics 2000 Equity Incentive Plan, as amended.++ |
10.19 |
|
(14) |
|
Contribution Agreement made and entered into as of September 14, 2000, by and among Nektar Therapeutics, Inhale 201 Industrial Road, L.P., a California limited partnership and Bernardo Property Advisors, Inc., a California corporation. |
35
10.20 |
|
(14) |
|
Agreement of Limited Partnership of Inhale 201 Industrial Road., L.P., a California limited partnership, made and entered into September 14, 2000, by and among SCIMED PROP III, Inc., a California corporation, as general partner, 201 Industrial Partnership, a California general partnership, as limited partner and Nektar Therapeutics, as limited partner. |
10.21 |
|
(14) |
|
Build-To-Suit Lease, made and entered into as of September 14, 2000, by and between Inhale 201 Industrial Road, L.P., a California limited partnership, as Landlord, and Nektar Therapeutics, as Tenant. |
10.22 |
|
(14) |
|
Amendment to Lease, dated October 3, 2000, by and between Inhale 201 Industrial Road, L.P., a California limited partnership, as Landlord, and Nektar Therapeutics, as Tenant. |
10.23 |
|
(14) |
|
Parking Lease Agreement, entered into as of September 14, 2000, by and between Inhale 201 Industrial Road, L.P., a California limited partnership, as Landlord, and Nektar Therapeutics, as Tenant. |
10.24 |
|
(17) |
|
Nektar Therapeutics 2000 Non-Officer Equity Incentive Plan.++ |
10.25 |
|
(23) |
|
Nektar Therapeutics 2000 Non-Officer Equity Incentive Plan Stock Option Agreement (Nonstatutory Stock Option).++ |
10.26 |
|
(23) |
|
Nektar Therapeutics 2000 Non-Officer Equity Incentive Plan Stock Option Agreement (Nonstatutory (Unapproved) Stock Option). |
10.27+ |
|
(18) |
|
Manufacturing and Supply Agreement, dated August 16, 2000, by and among Nektar Therapeutics, Tech Group North America and Bespak Europe, LTD. |
10.28 |
|
(21) |
|
The Bradford Particle Design plc Approved Employee Share Option Scheme. |
10.29 |
|
(21) |
|
Form of The Bradford Particle Design plc Approved Employee Share Option Scheme Option Certificate. |
10.30 |
|
(21) |
|
The Bradford Particle Design plc Unapproved Employee Share Option Scheme. |
10.31 |
|
(21) |
|
Form of The Bradford Particle Design plc Unapproved Employee Share Option Scheme Option Certificate. |
10.32 |
|
(21) |
|
Form of Agreement Granting an Enterprise Management Incentives Option. |
10.33 |
|
(21) |
|
Agreement Granting Options, dated November 5, 1999, by and between Mr. Joseph F. Bohan and Bradford Particle Design plc. |
10.34 |
|
(21) |
|
Agreement Granting Options, dated October 27, 2000, by and between Mr. Joseph F. Bohan and Bradford Particle Design plc. |
10.35 |
|
(22) |
|
Shearwater Corporation 1996 Nonqualified Stock Option Plan. |
10.36 |
|
(22) |
|
Amendment to the 1996 Nonqualified Stock Option Plan of Shearwater Corporation, effective May 22, 1998. |
10.37 |
|
(22) |
|
Second Amendment to the 1996 Nonqualified Stock Option Plan of Shearwater Corporation, effective February 26, 2000. |
10.38 |
|
(22) |
|
Third Amendment to the 1996 Nonqualified Stock Option Plan of Shearwater Corporation, effective October 5, 2000. |
10.39 |
|
(22) |
|
Fourth Amendment to the 1996 Nonqualified Stock Option Plan of Shearwater Corporation, effective June 22, 2001. |
10.40 |
|
(22) |
|
Form of Shearwater Corporation Nonqualified Stock Option Agreement. |
10.41 |
|
(22) |
|
Form of June 2001 Amendment to Shearwater Corporation Nonqualified Stock Option Agreement. |
10.42 |
|
(25) |
|
Nektar Therapeutics 401(k) Retirement Plan.++ |
10.43 |
|
(25) |
|
Non-Standardized Adoption Agreement No. 001 for use with Nektar Therapeutics 401(k) Retirement Plan. |
10.44+ |
|
(27) |
|
Letter Agreement, dated July 31, 2002, by and between Nektar Therapeutics, and Douglas H. Altschuler.++ |
10.45 |
|
(26) |
|
Letter Agreement, dated December 29, 2001 by and between Nektar Therapeutics and Dr. Arnold J. Repta.++ |
10.46 |
|
(26) |
|
Nektar Therapeutics Severance Benefit Plan.++ |
10.47 |
|
(26) |
|
Key Employee Agreement, dated June 29, 2001, by and between Nektar Therapeutics AL, Corporation and J. Milton Harris.++ |
10.48 |
|
(34) |
|
Letter Agreement, dated January 28, 2003, by and between Nektar Therapeutics and Ajay Bansal.++ |
10.49 |
|
(34) |
|
Employee Relocation Repayment Agreement, dated April 2, 2003, by Ajay Bansal.++ |
10.50 |
|
(34) |
|
Addendum to the Offer of Employment, dated April 3, 2003, by and between Nektar Therapeutics and Ajay Bansal.++ |
31.1 |
|
(35) |
|
Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule 15d-14(a). |
31.2 |
|
(35) |
|
Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule 15d-14(a). |
32.1 |
|
(35) |
|
Section 1350 Certifications. |
+ Confidential treatment with respect to specific portions are omitted and filed separately with the SEC.
++ Management contract or compensatory plan or arrangement.
(1) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended June 30, 1998.
36
(2) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration Statement on Form S-1 (No. 33-75942), as amended.
(3) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration Statement on Form S-1 (No. 33-89502), as amended.
(4) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended March 31, 1996.
(5) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on Form 10-K for the year ended December 31, 1995.
(6) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended June 30, 1996.
(7) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended September 30, 1996.
(8) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-3 (No. 333-20787).
(9) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration Statement on Form S-3 (No. 333-68897), as amended.
(10) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended June 30, 1999.
(11) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration Statement on Form S-3 (No. 333-94161), as amended.
(12) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on Form 10-K for the year ended December 31, 1999.
(13) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended June 30, 2000.
(14) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended September 30, 2000.
(15) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on January 11, 2001.
(16) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-3 (No. 333-53678), filed on January 12, 2001.
(17) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-103040), filed on February 7, 2003.
(18) Incorporated by reference to Nektar Therapeutics Annual Report on Form 10-K, as amended, for the year ended December 31, 2000.
(19) Incorporated by reference to Nektar Therapeutics Current Report on Form 8-K, filed on June 4, 2001.
(20) Incorporated by reference to Nektar Therapeutics Current Report on Form 8-K, filed on July 10, 2001.
(21) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-55032), filed on February 6, 2001.
(22) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-67342), filed on August 10, 2001.
37
(23) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as amended.
(24) Incorporated by reference to Nektar Therapeutics Current Report on Form 8-K, filed on January 8, 2002.
(25) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-76638), filed on January 11, 2002.
(26) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on Form 10-K, as amended, for the year ended December 31, 2002.
(27) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended September 30, 2002.
(28) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on January 23, 2003.
(29) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-98321), filed on August 19, 2002.
(30) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on July 2, 2003.
(31) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on October 10, 2003.
(32) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on November 3, 2003.
(33) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on October 20, 2003.
(34) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended March 31, 2003.
(35) Filed herewith.
(b) Reports on Form 8-K for the three-month period ending March 31, 2004:
Current Report on Form 8-K, filed January 26, 2004, announcing that Nektar Therapeutics and certain holders of its 3.5% convertible subordinated notes due 2007 completed an exchange and cancellation of $9,000,000 in aggregate principal amount of the 3.5% notes, for the issuance of 575,605 shares of common stock, in a privately negotiated transaction.
Current Report on Form 8-K, filed February 2, 2004, announcing that Nektar Therapeutics issued a press release announcing results of the quarter and the year ended December 31, 2003. The information in that report, including the exhibit thereto, shall not be deemed filed for purposes of Section 18 of the 1934 Act, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the 1933 Act. The information contained therein and in the accompanying exhibit thereto shall not be incorporated by reference into any filing with the SEC made by Nektar Therapeutics, whether made before or after the date thereof, regardless of any general incorporation language in such filing.
Current Report on Form 8-K, filed March 11, 2004, announcing that Nektar Therapeutics entered into an underwriting agreement with Lehman Brothers Inc. related to the sale of 9.5 million shares of common stock of Nektar Therapeutics pursuant to an effective shelf registration statement and that Nektar Therapeutics issued a press release announcing details of redemption of 3% convertible subordinated notes due June 2010.
Current Report on Form 8-K, filed March 30, 2004, announcing that Nektar Therapeutics issued a press release announcing the completion of redemption of 3% convertible subordinated notes due June 2010.
Current Report on Form 8-K, filed April 1, 2004, announcing that Nektar Therapeutics issued a press release announcing details of redemption of 6 3/4 % convertible subordinated notes due October 2006.
38
Current Report on Form 8-K filed April 13, 2004, announcing that Nektar Therapeutics had revised its accounting for certain convertible note exchange transactions completed in October 2003 and restated its financial statements for the year ended December 31, 2003.
39
Pursuant to the requirement 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.
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By: |
/s/ AJIT S. GILL |
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Ajit S. Gill |
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Chief Executive Officer, |
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President and Director |
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Date: |
May 6, 2004 |
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By: |
/s/ AJAY BANSAL |
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Ajay Bansal |
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Chief Financial Officer and Vice |
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Date: |
May 6, 2004 |
40
Except as so indicated in Exhibit 32.1, the following exhibits are filed as part of, or incorporated by reference into, this Form 10-Q.
Exhibit |
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Description of Documents |
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2.1 |
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(1) |
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Agreement and Plan of Merger, dated June 4, 1998, by and between Inhale Therapeutic Systems, a California corporation, and Inhale Therapeutic Systems (Delaware), Inc., a Delaware corporation. |
2.2 |
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(15) |
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Recommended Offer, dated December 21, 2000, by Cazenove & Co. on behalf of Nektar Therapeutics for Bradford Particle Design plc. |
2.3 |
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(20) |
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Agreement and Plan of Merger and Reorganization, dated May 22, 2001, by and among Nektar Therapeutics, Square Acquisition Corp., Shearwater Corporation, Certain Shareholders of Shearwater Corporation and J. Milton Harris as Shareholders Agent. |
2.4 |
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(20) |
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Amendment to Agreement and Plan of Merger and Reorganization, dated June 21, 2001, by and among Nektar Therapeutics, Square Acquisition Corp., Shearwater Corporation, J. Milton Harris, as Shareholders Agent and a Designated Shareholder, and Puffinus, L.P. |
3.1 |
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(1) |
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Certificate of Incorporation of Inhale Therapeutic Systems (Delaware), Inc. |
3.2 |
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(1) |
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Bylaws of Nektar Therapeutics. |
3.3 |
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(13) |
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Certificate of Amendment of the Amended Certificate of Incorporation of Nektar Therapeutics. |
3.4 |
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(19) |
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Certificate of Designation of Series A Junior Participating Preferred Stock of Nektar Therapeutics. |
3.5 |
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(24) |
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Certificate of Designation of Series B Convertible Preferred Stock of Nektar Therapeutics. |
3.6 |
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(28) |
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Certificate of Ownership and Merger of Nektar Therapeutics. |
4.1 |
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Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6. |
4.2 |
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(2) |
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Restated Investor Rights Agreement, dated April 29, 1993, as amended October 29, 1993, by and among Nektar Therapeutics and certain other persons named therein. |
4.3 |
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(3) |
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Stock Purchase Agreement, dated January 18, 1995, by and between Nektar Therapeutics and Pfizer Inc. |
4.4 |
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(8) |
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Form of Purchase Agreement, dated January 28, 1997, by and among Nektar Therapeutics and the individual Purchasers. |
4.5 |
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(9) |
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Stock Purchase Agreement, dated December 8, 1998, by and between Nektar Therapeutics and Capital Research and Management Company. |
4.6 |
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(11) |
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Purchase Agreement, dated October 6, 1999, by and among Nektar Therapeutics, Lehman Brothers Inc., Deutsche Bank Securities Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.7 |
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(11) |
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Resale Registration Rights Agreement, dated October 13, 1999, by and among Nektar Therapeutics, Lehman Brothers Inc., Deutsche Bank Securities Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.8 |
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(11) |
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Indenture, dated October 13, 1999, by and between Nektar Therapeutics, as Issuer, and Chase Manhattan Bank and Trust Company, National Association, as Trustee. |
4.9 |
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(11) |
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Form of Registration Rights Agreement by and between Nektar Therapeutics and Alliance Pharmaceutical Corp. |
4.10 |
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(12) |
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Purchase Agreement, dated February 2, 2000, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.11 |
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(12) |
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Resale Registration Rights Agreement, dated February 8, 2000, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.12 |
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(12) |
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Indenture, dated February 8, 2000, by and between Nektar Therapeutics, as Issuer, and Chase Manhattan Bank and Trust Company, National Association, as Trustee. |
4.13 |
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(28) |
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Specimen Common Stock certificate. |
4.14 |
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(14) |
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Specimen warrants to purchase shares of Common Stock. |
4.15 |
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(16) |
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Purchase Agreement, dated October 11, 2000, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.16 |
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(16) |
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Resale Registration Rights Agreement, dated October 17, 2000, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities, Inc., Lehman Brothers Inc. and U.S. Bancorp Piper Jaffray Inc. |
4.17 |
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(16) |
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Indenture, dated October 17, 2000, by and between Nektar Therapeutics, as Issuer, and Chase Manhattan Bank and Trust Company, National Association, as Trustee. |
4.18 |
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(19) |
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Rights Agreement, dated as of June 1, 2001, by and between Nektar Therapeutics and Mellon Investor Services LLC., as Rights Agent. |
4.19 |
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(19) |
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Form of Right Certificate. |
4.20 |
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(24) |
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Preferred Stock Purchase Agreement, dated January 7, 2002, by and between Nektar Therapeutics and Enzon |
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Pharmaceuticals, Inc. |
4.21 |
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(27) |
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Common Stock Purchase Agreement, dated June 7, 2002, by and between Nektar Therapeutics and AFAC Equity L.P. |
4.22 |
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(27) |
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Common Stock Purchase Agreement, dated July 9, 2002, by and between Nektar Therapeutics and AFAC Equity L.P. |
4.23 |
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(26) |
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Common Stock Purchase Agreement, dated December 6, 2002, by and between Nektar Therapeutics and AFAC Equity L.P. |
4.24 |
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(30) |
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Purchase Agreement, dated June 25, 2003, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc., Friedman, Billings, Ramsey & Co. Inc. and SG Cowen Securities Corporation |
4.25 |
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(30) |
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Resale Registration Rights Agreement, dated June 30, 2003, by and among Nektar Therapeutics, Merrill Lynch, Pierce, Fenner & Smith Incorporated, Deutsche Bank Securities Inc., Lehman Brothers Inc., Friedman, Billings, Ramsey & Co. Inc. and SG Cowen Securities Corporation |
4.26 |
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(30) |
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Indenture, dated June 30, 2003, by and between Nektar Therapeutics and J.P. Morgan Trust Company, National Association, as trustee |
4.27 |
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(31) |
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Indenture, dated October 9, 2003, by and between Nektar Therapeutics and J.P. Morgan Trust Company, National Association, as trustee |
4.28 |
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(32) |
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Resale Registration Rights Agreement, dated October 9, 2003, by and among Nektar Therapeutics and the entities named therein |
4.29 |
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(31) |
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Form of Convertible Subordinated Note due 2010 |
4.30 |
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(33) |
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First Supplemental Indenture, dated October 17, 2003, by and between Nektar Therapeutics and J.P. Morgan Trust Company, National Association, as trustee |
10.1 |
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(6) |
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Nektar Therapeutics 1994 Non-Employee Directors Stock Option Plan, as amended. |
10.2 |
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(29) |
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Nektar Therapeutics 1994 Employee Stock Purchase Plan, as amended and restated.++ |
10.3 |
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(2) |
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Standard Industrial Lease, dated September 17, 1992, as amended September 18, 1992, by and between Nektar Therapeutics and W.F. Batton & Co., Inc. |
10.4 |
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(2) |
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Addendum IV to Lease dated September 17, 1992, dated April 1, 1994, by and among Nektar Therapeutics, W.F. Batton and Marie A. Batton. |
10.5 |
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(5) |
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Amendment Agreement Number One to Lease dated September 17, 1992, dated October 20, 1995, by and between Nektar Therapeutics and W.F. Batton & Co., Inc. |
10.6 |
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(5) |
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Amendment Agreement Number Two to Lease dated September 17, 1992, dated November 15, 1995, by and among Nektar Therapeutics, W.F. Batton and Marie A. Batton, Trustees of the W.F. Batton and Marie A. Batton Trust UTA dated January 12, 1998 (Batton Trust). |
10.7 |
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(10) |
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Amendment Agreement Number Three to Lease dated September 17, 1992, dated February 14, 1996, by and between Nektar Therapeutics and Batton Trust. |
10.8 |
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(10) |
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Amendment Agreement Number Four to Lease dated September 17, 1992, dated September 15, 1996, by and between Nektar Therapeutics and Batton Trust. |
10.9 |
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(2) |
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Sublicense Agreement, dated September 13, 1991, by and between Nektar Therapeutics and John S. Patton.++ |
10.10 |
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(4) |
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Stock Purchase Agreement, dated March 1, 1996, by and between Nektar Therapeutics and Baxter World Trade Corporation. |
10.11 |
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(7) |
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Sublease and Lease Agreement, dated October 2, 1996, by and between Nektar Therapeutics and T.M.T. Associates L.L.C. (Landlord). |
10.12 |
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(10) |
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First Amendment to Sublease and Lease Agreement dated October 2, 1996, dated October 30, 1996, by and between Nektar Therapeutics and Landlord. |
10.13 |
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(10) |
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Letter Agreement amending Sublease and Lease Agreement dated October 2, 1996, dated April 9, 1997, by and between Nektar Therapeutics and Landlord. |
10.14 |
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(10) |
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Third Amendment to Sublease and Lease Agreement dated October 2, 1996, dated April 16, 1997, by and between Nektar Therapeutics and Landlord. |
10.15 |
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(10) |
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Fourth Amendment to Sublease and Lease Agreement dated October 2, 1996, dated November 5, 1997, by and between Nektar Therapeutics and Landlord. |
10.16 |
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(12) |
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Sublease, dated November 3, 1999, by and between Webvan Group, Inc., as sublessor, and Nektar Therapeutics, as sublessee. |
10.17 |
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(14) |
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Nektar Therapeutics 2000 Equity Incentive Plan, as amended.++ |
10.18 |
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(14) |
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Nektar Therapeutics Stock Option Agreement issued in accordance with Nektar Therapeutics 2000 Equity Incentive Plan, as amended.++ |
10.19 |
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(14) |
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Contribution Agreement made and entered into as of September 14, 2000, by and among Nektar Therapeutics, Inhale 201 Industrial Road, L.P., a California limited partnership and Bernardo Property Advisors, Inc., a California corporation. |
10.20 |
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(14) |
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Agreement of Limited Partnership of Inhale 201 Industrial Road., L.P., a California limited partnership, made and entered into September 14, 2000, by and among SCIMED PROP III, Inc., a California corporation, as |
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general partner, 201 Industrial Partnership, a California general partnership, as limited partner and Nektar Therapeutics, as limited partner. |
10.21 |
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(14) |
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Build-To-Suit Lease, made and entered into as of September 14, 2000, by and between Inhale 201 Industrial Road, L.P., a California limited partnership, as Landlord, and Nektar Therapeutics, as Tenant. |
10.22 |
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(14) |
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Amendment to Lease, dated October 3, 2000, by and between Inhale 201 Industrial Road, L.P., a California limited partnership, as Landlord, and Nektar Therapeutics, as Tenant. |
10.23 |
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(14) |
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Parking Lease Agreement, entered into as of September 14, 2000, by and between Inhale 201 Industrial Road, L.P., a California limited partnership, as Landlord, and Nektar Therapeutics, as Tenant. |
10.24 |
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(17) |
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Nektar Therapeutics 2000 Non-Officer Equity Incentive Plan.++ |
10.25 |
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(23) |
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Nektar Therapeutics 2000 Non-Officer Equity Incentive Plan Stock Option Agreement (Nonstatutory Stock Option).++ |
10.26 |
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(23) |
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Nektar Therapeutics 2000 Non-Officer Equity Incentive Plan Stock Option Agreement (Nonstatutory (Unapproved) Stock Option). |
10.27+ |
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(18) |
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Manufacturing and Supply Agreement, dated August 16, 2000, by and among Nektar Therapeutics, Tech Group North America and Bespak Europe, LTD. |
10.28 |
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(21) |
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The Bradford Particle Design plc Approved Employee Share Option Scheme. |
10.29 |
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(21) |
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Form of The Bradford Particle Design plc Approved Employee Share Option Scheme Option Certificate. |
10.30 |
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(21) |
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The Bradford Particle Design plc Unapproved Employee Share Option Scheme. |
10.31 |
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(21) |
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Form of The Bradford Particle Design plc Unapproved Employee Share Option Scheme Option Certificate. |
10.32 |
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(21) |
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Form of Agreement Granting an Enterprise Management Incentives Option. |
10.33 |
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(21) |
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Agreement Granting Options, dated November 5, 1999, by and between Mr. Joseph F. Bohan and Bradford Particle Design plc. |
10.34 |
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(21) |
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Agreement Granting Options, dated October 27, 2000, by and between Mr. Joseph F. Bohan and Bradford Particle Design plc. |
10.35 |
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(22) |
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Shearwater Corporation 1996 Nonqualified Stock Option Plan. |
10.36 |
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(22) |
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Amendment to the 1996 Nonqualified Stock Option Plan of Shearwater Corporation, effective May 22, 1998. |
10.37 |
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(22) |
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Second Amendment to the 1996 Nonqualified Stock Option Plan of Shearwater Corporation, effective February 26, 2000. |
10.38 |
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(22) |
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Third Amendment to the 1996 Nonqualified Stock Option Plan of Shearwater Corporation, effective October 5, 2000. |
10.39 |
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(22) |
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Fourth Amendment to the 1996 Nonqualified Stock Option Plan of Shearwater Corporation, effective June 22, 2001. |
10.40 |
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(22) |
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Form of Shearwater Corporation Nonqualified Stock Option Agreement. |
10.41 |
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(22) |
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Form of June 2001 Amendment to Shearwater Corporation Nonqualified Stock Option Agreement. |
10.42 |
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(25) |
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Nektar Therapeutics 401(k) Retirement Plan.++ |
10.43 |
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(25) |
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Non-Standardized Adoption Agreement No. 001 for use with Nektar Therapeutics 401(k) Retirement Plan. |
10.44+ |
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(27) |
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Letter Agreement, dated July 31, 2002, by and between Nektar Therapeutics, and Douglas H. Altschuler.++ |
10.45 |
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(26) |
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Letter Agreement, dated December 29, 2001 by and between Nektar Therapeutics and Dr. Arnold J. Repta.++ |
10.46 |
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(26) |
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Nektar Therapeutics Severance Benefit Plan.++ |
10.47 |
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(26) |
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Key Employee Agreement, dated June 29, 2001, by and between Nektar Therapeutics AL, Corporation and J. Milton Harris.++ |
10.48 |
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(34) |
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Letter Agreement, dated January 28, 2003, by and between Nektar Therapeutics and Ajay Bansal.++ |
10.49 |
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(34) |
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Employee Relocation Repayment Agreement, dated April 2, 2003, by Ajay Bansal.++ |
10.50 |
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(34) |
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Addendum to the Offer of Employment, dated April 3, 2003, by and between Nektar Therapeutics and Ajay Bansal.++ |
31.1 |
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(35) |
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Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule 15d-14(a). |
31.2 |
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(35) |
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Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule 15d-14(a). |
32.1 |
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(35) |
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Section 1350 Certifications. |
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+ Confidential treatment with respect to specific portions are omitted and filed separately with the SEC.
++ Management contract or compensatory plan or arrangement.
(1) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended June 30, 1998.
(2) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration Statement on Form S-1 (No. 33-75942), as amended.
(3) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration Statement on Form S-1 (No. 33-89502), as amended.
(4) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended March 31, 1996.
(5) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on Form 10-K for the year ended December 31, 1995.
(6) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended June 30, 1996.
(7) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended September 30, 1996.
(8) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-3 (No. 333-20787).
(9) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration Statement on Form S-3 (No. 333-68897), as amended.
(10) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended June 30, 1999.
(11) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration Statement on Form S-3 (No. 333-94161), as amended.
(12) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on Form 10-K for the year ended December 31, 1999.
(13) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended June 30, 2000.
(14) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended September 30, 2000.
(15) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on January 11, 2001.
(16) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-3 (No. 333-53678), filed on January 12, 2001.
(17) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-103040), filed on February 7, 2003.
(18) Incorporated by reference to Nektar Therapeutics Annual Report on Form 10-K, as amended, for the year ended December 31, 2000.
(19) Incorporated by reference to Nektar Therapeutics Current Report on Form 8-K, filed on June 4, 2001.
(20) Incorporated by reference to Nektar Therapeutics Current Report on Form 8-K, filed on July 10, 2001.
(21) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-55032), filed on February 6, 2001.
(22) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-67342), filed on August 10, 2001.
(23) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as amended.
(24) Incorporated by reference to Nektar Therapeutics Current Report on Form 8-K, filed on January 8, 2002.
(25) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-76638), filed on January 11, 2002.
(26) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on Form 10-K, as amended, for the year ended December 31, 2002.
(27) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended September 30, 2002.
(28) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on January 23, 2003.
(29) Incorporated by reference to Nektar Therapeutics Registration Statement on Form S-8 (No. 333-98321), filed on August 19, 2002.
(30) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on July 2, 2003.
(31) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on October 10, 2003.
(32) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on November 3, 2003.
(33) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on Form 8-K, filed on October 20, 2003.
(34) Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report on Form 10-Q for the quarter ended March 31, 2003.
(35) Filed herewith.
Exhibit 31.1
CERTIFICATIONS
I, Ajit S. Gill certify that:
1. I have reviewed this quarterly report on Form 10-Q of Nektar Therapeutics;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation;
c) disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonable likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonable likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls over financial reporting.
Date: May 6, 2004 |
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/s/ AJIT S. GILL |
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Ajit S. Gill |
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Chief
Executive Officer, President |
Exhibit 31.2
CERTIFICATIONS
I, Ajay Bansal certify that:
1. I have reviewed this quarterly report on Form 10-Q of Nektar Therapeutics;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:
a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation;
c) disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonable likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function):
a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonable likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls over financial reporting.
Date: May 6, 2004 |
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/s/ AJAY BANSAL |
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Ajay Bansal |
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Chief
Financial Officer and Vice |
Exhibit 32.1
SECTION 1350 CERTIFICATIONS*
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the Exchange Act) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Ajit S. Gill, Chief Executive Officer, President and Director of Nektar Therapeutics (the Company), and Ajay Bansal, Chief Financial Officer and Vice President, Finance and Administration of the Company, each hereby certifies that, to the best of his knowledge:
1. The Companys Quarterly Report on Form 10-Q for the period ended March 31, 2004, to which this Certification is attached as Exhibit 32.1 (the Periodic Report), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
2. The information contained in the Periodic Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Periodic Report and results of operations of the Company for the period covered by the Periodic Report.
Dated: May 6, 2004 |
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/s/ AJIT S. GILL |
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/s/ AJAY BANSAL |
Ajit S. Gill |
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Ajay Bansal |
Chief Executive Officer, President and Director |
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Chief Financial Officer and Vice President, Finance and |
A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this statement required by section 906, has been provided to Nektar Therapeutics and will be retained by Nektar Therapeutics and furnished to the Securities and Exchange Commission (SEC) or its staff upon request.
* This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the SEC and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.