Filed by Bowne Pure Compliance
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 |
For the quarterly period ended March 31, 2008
or
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TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 0-24006
NEKTAR THERAPEUTICS
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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94-3134940
(IRS Employer
Identification No.) |
201 Industrial Road
San Carlos, California 94070
(Address of principal executive offices)
650-631-3100
(Registrants telephone number, including area code)
(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 to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule
12b-2 of the Exchange Act.
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the
Exchange Act). Yes o No
þ
The number of outstanding shares of the registrants Common Stock, $0.0001 par value, was
92,401,904 on April 30, 2008.
NEKTAR THERAPEUTICS
INDEX
2
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 Exchange Act). All statements other than statements of historical fact
are forward-looking statements for purposes of this Quarterly Report on Form 10-Q, including any
projections of earnings, revenue 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 statements 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 in Part II, Item 1ARisk
Factors below and for the reasons described elsewhere in this Quarterly Report on Form 10-Q. 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. Except where the context otherwise requires, in this Quarterly
Report on Form 10-Q, the Company, Nektar, we, us and our refer to Nektar Therapeutics, a
Delaware corporation, and, where appropriate, its subsidiaries.
Trademarks
All Nektar brand and product names, including, but not limited to, Nektar®,
contained in this document are trademarks, registered trademarks or service marks of Nektar
Therapeutics in the United States (U.S.) and certain other countries. This document also contains
references to trademarks, registered trademarks and service marks of other companies that are the
property of their respective owners.
3
PART I: FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements Unaudited:
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share information)
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March 31, 2008 |
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December 31, 2007 |
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Unaudited |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
36,676 |
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$ |
76,293 |
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Short-term investments |
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375,954 |
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406,060 |
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Accounts receivable, net of allowance of
$111 and $33 at March 31, 2008 and
December 31, 2007, respectively |
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14,040 |
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21,637 |
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Inventory |
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11,027 |
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12,187 |
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Other current assets |
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5,826 |
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7,106 |
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Total current assets |
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$ |
443,523 |
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$ |
523,283 |
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Property and equipment, net |
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114,381 |
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114,420 |
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Goodwill |
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78,431 |
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78,431 |
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Other intangible assets, net |
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2,444 |
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2,680 |
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Other assets |
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5,057 |
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6,289 |
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Total assets |
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$ |
643,836 |
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$ |
725,103 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,556 |
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$ |
3,589 |
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Accrued compensation |
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10,884 |
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14,680 |
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Accrued
expenses to contract manufacturers |
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8,450 |
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40,444 |
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Accrued expenses |
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12,409 |
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12,446 |
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Interest payable |
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85 |
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2,638 |
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Capital lease obligations, current portion |
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2,259 |
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2,335 |
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Deferred revenue, current portion |
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19,657 |
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19,620 |
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Other current liabilities |
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2,345 |
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2,340 |
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Total current liabilities |
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$ |
57,645 |
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$ |
98,092 |
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Convertible subordinated notes |
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315,000 |
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315,000 |
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Capital lease obligations |
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21,330 |
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21,632 |
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Deferred revenue |
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60,112 |
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61,349 |
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Other long-term liabilities |
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13,990 |
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14,591 |
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Total liabilities |
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$ |
468,077 |
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$ |
510,664 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred stock |
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Common stock, $0.0001 par value; 300,000
authorized; 92,360 shares and 92,301
shares issued and outstanding at March 31,
2008 and December 31, 2007, respectively |
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9 |
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9 |
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Capital in excess of par value |
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1,303,996 |
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1,302,541 |
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Accumulated other comprehensive income |
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2,213 |
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1,643 |
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Accumulated deficit |
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(1,130,459 |
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(1,089,754 |
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Total stockholders equity |
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175,759 |
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214,439 |
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Total liabilities and stockholders equity |
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$ |
643,836 |
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$ |
725,103 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share information)
(Unaudited)
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Three months ended |
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March 31, |
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2008 |
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2007 |
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Revenue: |
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Product sales and royalties |
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$ |
10,371 |
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$ |
73,019 |
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Contract research |
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9,621 |
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11,997 |
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Total revenue |
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19,992 |
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85,016 |
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Operating costs and expenses: |
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Cost of goods sold |
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7,227 |
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56,522 |
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Cost of idle Exubera manufacturing capacity |
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5,334 |
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Research and development |
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37,373 |
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37,492 |
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General and administrative |
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11,711 |
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16,735 |
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Amortization of other intangible assets |
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236 |
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236 |
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Total operating costs and expenses |
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61,881 |
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110,985 |
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Loss from operations |
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(41,889 |
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(25,969 |
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Non-operating income (expense): |
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Interest income |
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5,013 |
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5,473 |
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Interest expense |
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(3,918 |
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(4,933 |
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Other income (expense), net |
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302 |
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6 |
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Total non-operating income |
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1,397 |
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546 |
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Loss before provision for income taxes |
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(40,492 |
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(25,423 |
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Provision for income taxes |
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213 |
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250 |
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Net loss |
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$ |
(40,705 |
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$ |
(25,673 |
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Basic and diluted net loss per share |
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$ |
(0.44 |
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$ |
(0.28 |
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Shares used in computing basic and diluted net loss per share |
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92,330 |
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91,454 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Three months ended |
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March 31, |
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2008 |
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2007 |
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Cash flows used in operating activities: |
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Net loss |
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$ |
(40,705 |
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$ |
(25,673 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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5,917 |
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7,571 |
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Loss on disposal of assets |
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107 |
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304 |
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Amortization of gain related to sale of building |
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(219 |
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(219 |
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Stock-based compensation |
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1,084 |
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6,861 |
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Changes in assets and liabilities: |
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Decrease (increase) in trade accounts receivable |
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7,597 |
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(17,599 |
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Decrease (increase) in inventories |
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1,160 |
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(2,114 |
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Decrease (increase) in prepaids and other assets |
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2,044 |
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3,227 |
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Increase (decrease) in accounts payable |
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(2,033 |
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(3,547 |
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Increase (decrease) in accrued compensation |
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(3,932 |
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(1,635 |
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Increase (decrease) in accrued expenses to contract manufacturers |
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(31,994 |
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Increase (decrease) in accrued expenses |
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(37 |
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(2,604 |
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Increase (decrease) in interest payable |
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(2,553 |
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(2,684 |
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Increase (decrease) in deferred revenue |
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(1,200 |
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8,801 |
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Increase (decrease) in other liabilities |
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(208 |
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314 |
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Net cash used in operating activities |
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$ |
(64,972 |
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$ |
(28,997 |
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Cash flows from investing activities: |
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Purchases of investments |
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(156,092 |
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(79,411 |
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Maturities of investments |
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186,758 |
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167,696 |
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Purchases of property and equipment |
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(5,281 |
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(5,556 |
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Net cash provided by investing activities |
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$ |
25,385 |
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$ |
82,729 |
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Cash flows used in financing activities: |
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Repayments of convertible subordinated notes |
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(36,026 |
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Payments of loan and capital lease obligations |
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(411 |
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(400 |
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Issuance of common stock related to employee stock purchase plan |
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168 |
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572 |
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Issuance of common stock related to employee stock option exercises |
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203 |
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1,562 |
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Net cash used in financing activities |
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$ |
(40 |
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$ |
(34,292 |
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Effect of exchange rates on cash and cash equivalents |
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10 |
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(60 |
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Net increase (decrease) in cash and cash equivalents |
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$ |
(39,617 |
) |
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$ |
19,380 |
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Cash and cash equivalents at beginning of period |
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76,293 |
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63,760 |
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Cash and cash equivalents at end of period |
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$ |
36,676 |
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$ |
83,140 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
6
NEKTAR THERAPEUTICS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2008
(Unaudited)
Note 1Organization and Summary of Significant Accounting Policies
Organization and Basis of Presentation
We are a biopharmaceutical company headquartered in San Carlos, California and incorporated in
Delaware. Our mission is to develop breakthrough products that make a difference in patients
lives. We create differentiated, innovative products by applying our platform technologies to
established or novel medicines. Our two leading technology platforms are pulmonary technology and
PEGylation technology.
We prepared the Condensed Consolidated Financial Statements following the requirements of the
Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules,
certain footnotes or other financial information that are normally required by U.S. generally
accepted accounting principles (GAAP) can be condensed or omitted. In the opinion of management,
these financial statements include all normal and recurring adjustments that we consider necessary
for the fair presentation of our financial position and operating results.
Revenues, expenses, assets, and liabilities can vary during each quarter of the year.
Therefore, the results and trends in these interim financial statements may not be the same as
those for the full year. The information included in this quarterly report on Form 10-Q should be
read in conjunction with the consolidated financial statements and the accompanying notes to these
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2007.
Principles of Consolidation
Our condensed consolidated financial statements include the financial position, results of
operations and cash flows of our wholly-owned subsidiaries: Nektar Therapeutics AL, Corporation
(Nektar AL), Nektar Therapeutics (India) Private Limited, Nektar Therapeutics UK, Ltd. (Nektar
UK) and Aerogen, Inc. On November 30, 2007, we sold Aerogen Ireland Ltd, a subsidiary of Aerogen,
Inc. (Aerogen Ireland), and therefore Aerogen Ireland was not included in our financial position
as of December 31, 2007 or March 31, 2008 and results of operations and cash flows for the three
months ended March 31, 2008. All intercompany accounts and transactions have been eliminated in
consolidation.
Our Condensed 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. Translation gains and losses are included in
accumulated other comprehensive income in the Stockholders equity section of the Condensed
Consolidated Balance Sheet. To date, such cumulative translation adjustments have not been material
to our consolidated financial position.
Reclassifications
Certain items previously reported in specific financial statement captions have been
reclassified to conform to the current period presentation. Such reclassifications do not impact
previously reported revenues, operating loss or net loss or total assets, liabilities or
stockholders equity.
Segment Information
We operate in one business segment which focuses on applying our technology platforms to
improve the performance of established and novel medicines. We operate in one segment because our
business offerings have similar economics and other characteristics, including the nature of
products and production processes, types of customers, distribution methods and regulatory
environment. We are comprehensively managed as one business segment by our President and Chief
Executive Officer and his management team. Within our one business segment we have two components,
pulmonary technology and PEGylation technology.
Significant Concentrations
Our customers are primarily pharmaceutical and biotechnology companies that are located in the
U.S. and EU. Our accounts receivable balance contains billed and unbilled trade receivables from
product sales, royalties, and collaborative research agreements. We provide for an allowance for
doubtful accounts by reserving for specifically identified doubtful accounts. We have not
experienced significant credit losses from our accounts receivable or collaborative research
agreements and none are expected. We perform a regular review of our customers payment
histories and associated credit risk. We generally do not require collateral from our customers.
7
We are dependent on our partners, vendors and third party manufacturers to provide raw certain
materials, active pharmaceutical ingredients and pulmonary delivery devices of the appropriate
quality and reliability to meet applicable regulatory requirements. Consequently, in the event that
supplies are delayed or interrupted for any reason, our ability to develop and meet our supply
commitments could be impaired, which could have a material adverse effect on our business,
financial condition and results of operation.
Income Taxes
We account for income taxes under the liability method in accordance with
Statement of Financial Accounting Standards No. 109,
Accounting for Income Taxes (SFAS 109), and FASB Interpretation No. 48, Accounting for
Uncertainty in Income Taxes An Interpretation of FASB Statement No. 109 (FIN 48). Under this
method, deferred tax assets and liabilities are determined based on differences between financial
reporting and tax reporting bases of assets and liabilities and are measured using enacted tax
rates and laws that are expected to be in effect when the differences are expected to reverse.
Realization of deferred tax assets is dependent upon future earnings, the timing and amount of
which are uncertain. At March 31, 2008 and December 31, 2007, we have provided a full
valuation allowance against our net deferred tax assets generated by our domestic net operating
loss and we have recorded a provision for foreign income taxes payable in India at an effective
rate in India of approximately 34% for the three months ended March 31, 2008.
Recent Accounting Pronouncements
SFAS 157
On January 1, 2008, we adopted the provisions of
Statement of Financial Accounting Standards No. 157, Fair Value Measurements
(SFAS 157), for financial assets and financial liabilities. SFAS 157 defines fair value,
establishes a framework for measuring fair value in GAAP, and expands disclosures about fair value
measurements. SFAS 157 does not require any new fair value measurements, but provides guidance
on how to measure fair value by providing a fair value hierarchy used to classify the source of the
information. FASB Statement of Position No. 157-2 defers adoption of SFAS 157 for non-financial
assets and non-financial liabilities. Refer to Note 4 for fair value disclosures of cash equivalents and
available-for-sale investments.
SFAS 159
In February 2007, the FASB issued
Statement of Financial Accounting Standards No. 159, The Fair Value Option for Financial Assets and
Financial LiabilitiesIncluding an Amendment of FASB Statement No. 115 (SFAS 159). SFAS No. 159 permits
companies to choose to measure certain financial instruments and other items at fair value. This
standard is currently effective, but we have not elected to utilize the fair value option for any
of our financial assets or liabilities. We continue to account for our available-for-sale
investments utilizing Statement of Financial Accounting Standards No. 115, Accounting for Certain Investments in Debt and Equity
Securities, which requires us to mark our available-for-sale investments to fair value with
unrealized gains and losses recorded as other comprehensive income within stockholders equity.
EITF 07-3
On January 1, 2008, we adopted the provisions of the Emerging Issues Task Force (EITF)
issued EITF 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services for Use in
Future Research and Development Activities, which provides guidance on the accounting for certain
nonrefundable advance payments for goods or services that will be used or rendered for future
research and development activities. This issue focuses on these nonrefundable costs and whether
to account for them as: (a) a period expense when paid or (b) a capitalized cost until the goods
have been delivered or the related services performed. The adoption of EITF 07-3 did not have a
material impact on our financial position or results of operations.
EITF 07-1
In December 2007, the FASB ratified EITF Issue No. 07-1, Accounting for Collaborative
Arrangements, which defines collaborative arrangements and establishes reporting and disclosure
requirements for transactions between participants in a collaborative arrangement and between
participants in the arrangements and third parties. This issue is effective retrospectively to all
prior periods presented for all collaborative arrangements existing as of the effective date for
fiscal years beginning after December 15, 2008. We do not expect EITF 07-1 will have a
material impact on our financial position or results of operations.
8
Note 2Termination of Inhaled Insulin Programs
On October 18, 2007, Pfizer announced that it was exiting the Exubera business and gave notice
of termination under our collaborative development and licensing agreement. On November 9, 2007, we
entered into a termination agreement and mutual release with Pfizer in which we received a one-time
payment of $135.0 million from Pfizer in satisfaction of all outstanding contractual obligations
under our then-existing agreements relating to Exubera and our next-generation inhaled insulin
product development program, also known as NGI. On April 9, 2008, we announced that we had ceased
all negotiations with potential partners for Exubera and NGI as a result of new data analysis from
ongoing clinical trials conducted by Pfizer.
Termination of Exubera Inhaler Manufacturing and Supply Agreement
We were a party to a manufacturing and supply agreement (the Exubera Inhaler MSA) with Tech
Group North America, Inc. (Tech Group) and Bespak Europe Ltd. (Bespak) related to the
manufacture and supply of Exubera inhalers. As a result of the November 2007 Pfizer termination
described above, we concluded no further orders for supply of Exubera inhalers were
required from Tech Group and Bespak in the foreseeable future. In December 2007, we began
discussions with Tech Group and Bespak to terminate the Exubera Inhaler MSA. As of December 31,
2007, we recorded $40.4 million of accrued expenses to Bespak and Tech Group for outstanding
accounts payable and termination costs and expenses that were due and payable under the termination
provisions of the Exubera Inhaler MSA. We paid Bespak $21.8 million and Tech Group $10.6 million
related to these liabilities during the first quarter of 2008. We had a remaining termination liability of
$7.5 million payable to Tech Group as of March 31, 2008, which was paid on April 23, 2008.
Exubera Manufacturing Continuation Agreements
In connection with the termination of the Exubera Inhaler MSA, we entered into a 2008
continuation agreement with Tech Group, pursuant to which Tech Group agreed to preserve key
personnel and manufacturing facilities to support potential future Exubera inhaler manufacturing
from January through April 2008. We also entered into a letter agreement with Pfizer to retain a
limited number of Exubera manufacturing personnel at Pfizers Terre Haute, Indiana manufacturing
facility during March and April 2008. Following the termination of our inhaled insulin programs on
April 9, 2008, we have terminated these continuation agreements with Tech Group and Pfizer. For the
three months ended March 31, 2008, we incurred $3.4 million in expense related to these
continuation agreements. We will record an expense of $1.6 million in April 2008 for the final
monthly maintenance provided under these continuation agreements.
Cost of Idle Exubera Manufacturing Capacity
Cost of idle Exubera manufacturing capacity primarily includes costs payable to Tech Group and
Pfizer under our manufacturing continuation agreements discussed above and severance and
outplacement costs for our Exubera and NGI employees terminated as part of the February 2008
workforce reduction plan. Cost of idle Exubera manufacturing capacity also includes an allocation
of manufacturing costs shared between commercial operations and research and development including employee compensation and benefits, rent, and utilities. Following the
termination of our Exubera and NGI partnering efforts on April 9, 2008, we have taken all necessary
steps to cease spending associated with maintaining Exubera manufacturing capacity and any further
NGI development.
9
Note 3Cash, Cash Equivalents, and Available-For-Sale Investments
Cash, cash equivalents, and available-for-sale investments are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
March 31, 2008 |
|
|
December 31, 2007 |
|
Cash and cash equivalents |
|
$ |
36,676 |
|
|
$ |
76,293 |
|
Short-term investments (less than one year to maturity) |
|
|
375,954 |
|
|
|
406,060 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and available-for-sale investments |
|
$ |
412,630 |
|
|
$ |
482,353 |
|
|
|
|
|
|
|
|
Our portfolio of cash, cash equivalents, and available-for-sale investments includes (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
March 31, 2008 |
|
|
December 31, 2007 |
|
U.S. corporate commercial paper |
|
$ |
258,818 |
|
|
$ |
293,866 |
|
Obligations of U.S. corporations |
|
|
41,796 |
|
|
|
100,727 |
|
Obligations of U.S. government agencies |
|
|
78,331 |
|
|
|
37,333 |
|
Cash and money market funds |
|
|
33,685 |
|
|
|
50,427 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and available-for-sale investments |
|
$ |
412,630 |
|
|
$ |
482,353 |
|
|
|
|
|
|
|
|
Gross unrealized gains on the portfolio were $1.0 million and $0.5 million as of March 31,
2008 and December 31, 2007, respectively. Gross unrealized losses on the portfolio were $0.1
million as of March 31, 2008 and as of December 31, 2007. The gross unrealized losses
were primarily due to changes in interest rates on fixed income securities. We have a history of
holding our investments to maturity and we have the ability and intent to hold our debt securities
to maturity when they will be redeemed at full par value. Accordingly, we consider these unrealized
losses to be temporary and have not recorded a provision for impairment.
Note 4Fair Value
The following table represents the fair value hierarchy for our financial assets (cash
equivalents and available-for-sale investments) measured at fair value on a recurring basis as of
March 31, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted Prices in Active |
|
|
Significant Other |
|
|
Significant |
|
|
|
|
|
|
Markets for Identical Assets |
|
|
Observable Inputs |
|
|
Unobservable Inputs |
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
U.S. corporate commercial paper |
|
$ |
|
|
|
$ |
258,818 |
|
|
$ |
|
|
|
$ |
258,818 |
|
Obligations of U.S. corporations |
|
|
|
|
|
|
41,796 |
|
|
|
|
|
|
|
41,796 |
|
Obligations of U.S. government agencies |
|
|
|
|
|
|
78,331 |
|
|
|
|
|
|
|
78,331 |
|
Money market funds |
|
|
19,282 |
|
|
|
|
|
|
|
|
|
|
|
19,282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents and available-for-sale investments |
|
$ |
19,282 |
|
|
$ |
378,945 |
|
|
$ |
|
|
|
$ |
398,227 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 5Inventory
Inventory consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008 |
|
|
December 31, 2007 |
|
Raw materials |
|
$ |
8,370 |
|
|
$ |
9,522 |
|
Work-in-process |
|
|
2,069 |
|
|
|
1,749 |
|
Finished goods |
|
|
588 |
|
|
|
916 |
|
|
|
|
|
|
|
|
Inventory |
|
$ |
11,027 |
|
|
$ |
12,187 |
|
|
|
|
|
|
|
|
Inventory consists of raw materials, work-in-process and finished goods for our commercial
PEGylation business. Reserves are determined using specific identification plus an estimated
reserve for potential defective or excess inventory
based on historical experience or projected usage. Inventories are reflected net of reserves
of $5.4 million and $5.8 million as of March 31, 2008 and December 31, 2007, respectively.
10
Note 6Commitments and Contingencies
Legal Matters
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. 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 or on our cash
flows and liquidity.
Collaboration Agreements for Pulmonary Products
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 agreement. There
is no limitation on the potential amount of future payments we could be required to make under
these indemnification obligations.
To date we have not 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. Because the obligated amount under these agreements is not explicitly
stated, the overall maximum amount of the obligations cannot be reasonably estimated. No
liabilities have been recorded for these obligations on our Condensed Consolidated Balance Sheets
as of March 31, 2008 or December 31, 2007.
License, Manufacturing and Supply Agreements for Products Based on our PEGylation Technology
As part of our license, manufacturing and supply agreements with our partners for the
development or manufacture and supply of PEG reagents or intellectual property licenses based on
our 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. Because the obligated amount in these agreements is not explicitly stated,
the overall maximum amount of the obligations cannot be reasonably estimated. Historically, we have
not been obligated to make significant payments for these obligations, and no liabilities have been
recorded for these obligations in our Condensed Consolidated Balance Sheets as of March 31, 2008 or
December 31, 2007.
Other Agreements
We maintain a number
of other commercial agreements to support our business such as technology
licensing agreements, third party manufacturing agreements, consulting
agreements, and certain business development agreements. These agreements often
contain complex terms and conditions that from time to time can result in
disputes that may lead to arbitration or litigation. For example, we currently
have an ongoing dispute in arbitration related to a consulting agreement that
had a partnership success fee provision related to one of our collaboration
partner agreements. Unfavorable outcomes in these disputes could result in a
material adverse impact on our results of operations for any given period and
our financial position.
Note 7Workforce Reduction Plans
In an effort to reduce ongoing operating costs and improve our organizational structure,
efficiency and productivity, we executed a workforce reduction plan in May 2007 (the 2007 Plan).
In February 2008, we executed another workforce reduction plan (the 2008 Plan) designed to
streamline the company, consolidate corporate functions, and strengthen decision-making and
execution within our business units.
The 2007 Plan reduced our workforce by approximately 180 full-time employees, or approximately
25 percent of our regular full-time employees, and was substantially complete as of December 31,
2007. During the three months ended March 31, 2008, we made payments for severance and medical
insurance related to the 2007 Plan.
The 2008 Plan was finalized by executive management on February 8, 2008. The 2008 Plan
reduced our workforce by approximately 110 employees, or approximately 20 percent of our regular
full-time employees. We notified the employees affected by the 2008 Plan on February 11, 2008. We
estimate the 2008 Plan will cost approximately $5.7 million, comprised of cash payments for
severance, medical insurance, and outplacement services. We expect execution of the 2008 Plan will
be
complete by December 31, 2008. We have recognized $5.3 million of workforce reduction charges
related to the 2008 Plan during the three months ended March 31, 2008 and we expect to record an
additional $0.4 million during the remainder of 2008 for employees with termination dates longer
than two months from the date of notification.
11
Since May 2007, we have incurred $13.7 million related to our two workforce reduction plans,
$8.4 million related to the 2007 plan and $5.3 million related to the 2008 plan. For the three
months ended March 31, 2008, workforce reduction charges were recorded in our Condensed
Consolidated Financial Statements as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Plan |
|
|
2008 Plan |
|
|
Total |
|
Cost of goods sold, net of change in inventory |
|
$ |
|
|
|
$ |
177 |
|
|
$ |
177 |
|
Cost of idle Exubera manufacturing capacity |
|
|
|
|
|
|
1,221 |
|
|
|
1,221 |
|
Research and development expense |
|
|
24 |
|
|
|
3,314 |
|
|
|
3,338 |
|
General and administrative expense |
|
|
|
|
|
|
552 |
|
|
|
552 |
|
|
|
|
|
|
|
|
|
|
|
Total workforce reduction charges |
|
$ |
24 |
|
|
$ |
5,264 |
|
|
$ |
5,288 |
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the liabilities associated
with the 2007 Plan and 2008 Plan included in accrued compensation in our
Condensed Consolidated Balance Sheet as of March 31, 2008 and the activity during the
three-month period ended March 31, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Plan |
|
|
2008 Plan |
|
|
Total |
|
Balance at December 31, 2007 |
|
$ |
580 |
|
|
$ |
|
|
|
$ |
580 |
|
Charges |
|
|
24 |
|
|
|
5,264 |
|
|
|
5,288 |
|
Payments |
|
|
(468 |
) |
|
|
(3,409 |
) |
|
|
(3,877 |
) |
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2008 |
|
$ |
136 |
|
|
$ |
1,855 |
|
|
$ |
1,991 |
|
|
|
|
|
|
|
|
|
|
|
Note 8Stock-Based Compensation
Total stock-based compensation costs were recorded in our Condensed Consolidated Financial
Statements as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
|
March 31, |
|
|
|
2008 |
|
|
2007 |
|
Cost of goods sold, net of inventory change |
|
$ |
30 |
|
|
$ |
699 |
|
Cost of idle Exubera manufacturing capacity |
|
|
23 |
|
|
|
|
|
Research and development expense |
|
|
(32 |
) |
|
|
3,004 |
|
General and administrative expense |
|
|
1,063 |
|
|
|
2,669 |
|
|
|
|
|
|
|
|
Total stock-based compensation costs |
|
$ |
1,084 |
|
|
$ |
6,372 |
|
|
|
|
|
|
|
|
Our stock-based
compensation expense decreased by $5.3 million in the three months ended
March 31, 2008 compared to the three months ended March 31, 2007. The
decrease is attributable to fewer average unvested options outstanding and
lower fair market value of options granted in the three months ended
March 31, 2008 compared to 2007 and an increase in our estimated annual
forfeiture rates, see Black-Scholes Assumptions below.
Aggregate Unrecognized Stock-Based Compensation Expense
During the three months ended March 31, 2008, we granted 4,300,000 stock options, which
resulted in an increase in unrecognized compensation expense of $6.5 million. Aggregate total
unrecognized stock-based compensation expense is expected to be recognized as follows (in
thousands):
|
|
|
|
|
|
|
As of |
|
Fiscal Year |
|
March 31, 2008 |
|
2008 (remaining 9 months) |
|
$ |
10,727 |
|
2009 |
|
|
12,764 |
|
2010 |
|
|
9,082 |
|
2011 |
|
|
3,852 |
|
2012 and thereafter |
|
|
635 |
|
|
|
|
|
|
|
$ |
37,060 |
|
|
|
|
|
12
Black-Scholes Assumptions
The following table lists the Black-Scholes assumptions used to calculate the fair value of
employee stock option grants and ESPP purchases during the period. For the weighted average
expected life, we applied the guidance in Staff
Accounting Bulletin No. 107 that permits the initial application of a simplified method
based on the average of the vesting term and the term of the option. We based our estimate of
expected volatility for options granted on the daily historical trading data of our common stock
over the period equivalent to the expected term of the respective stock-based grant.
We utilized an
estimated annual forfeiture rate of 4.7% for executives and 7.4% for all other
employees in our calculation of stock-based compensation expense for the three
months ended March 31, 2007. We have had a significant increase in our
employee turnover incremental to our two workforce reductions in May 2007
and February 2008. As a result, we performed a qualitative and
quantitative analysis of our historical forfeitures and changed our estimated
annual forfeiture rates to 11% for stock option grants and 25% for RSU grants
for all executives and employees.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
Employee Stock |
|
|
|
|
|
|
Employee Stock |
|
|
|
|
|
|
Options |
|
|
ESPP |
|
|
Options |
|
|
ESPP |
|
Average risk-free interest rate |
|
|
2.4 |
% |
|
|
2.2 |
% |
|
|
4.6 |
% |
|
|
5.1 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility factor |
|
|
50.4 |
% |
|
|
57.3 |
% |
|
|
59.9 |
% |
|
|
37.1 |
% |
Weighted average expected life |
|
5.1 years |
|
|
0.5 years |
|
|
5.2 years |
|
|
0.5 years |
|
Summary of Stock Option Activity
The table below presents a summary of stock option activity under the 2000 Equity Incentive
Plan, the Non-Employee Directors Stock Option Plan and the 2000 Non-Officer Equity Incentive Plan
(the Option Plans) (in thousands, except for per share information):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
Options Outstanding |
|
|
Exercise |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise Price |
|
|
Price Per |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Per Share |
|
|
Share |
|
|
Life (in years) |
|
|
Value (1) |
|
Balance at December 31, 2007 |
|
|
12,212 |
|
|
$ |
0.01-61.63 |
|
|
$ |
15.62 |
|
|
|
5.20 |
|
|
$ |
643 |
|
Options granted |
|
|
4,265 |
|
|
|
6.31-7.13 |
|
|
|
6.62 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(31 |
) |
|
|
5.05-7.33 |
|
|
|
6.65 |
|
|
|
|
|
|
$ |
203 |
|
Options expired and canceled |
|
|
(1,313 |
) |
|
|
4.46-47.81 |
|
|
|
13.31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2008 |
|
|
15,133 |
|
|
$ |
0.01-61.63 |
|
|
$ |
13.23 |
|
|
|
5.54 |
|
|
$ |
2,092 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2007 |
|
|
7,023 |
|
|
|
|
|
|
|
19.15 |
|
|
|
3.64 |
|
|
$ |
584 |
|
Exercisable at March 31, 2008 |
|
|
6,897 |
|
|
|
|
|
|
|
18.86 |
|
|
|
3.12 |
|
|
$ |
658 |
|
|
|
|
(1) |
|
Aggregate Intrinsic Value represents the difference between the exercise price of the option
and the closing market price of our common stock on the exercise or period end date, as
applicable. |
The weighted average grant-date fair value of options granted during the three-months ended
March 31, 2008 and 2007 was $3.07 per share and $7.04 per share, respectively. Of the 15,133,000
options outstanding as of March 31, 2008, approximately 4,661,828, or 31%, had exercise prices
below market value.
13
Note 9Net Loss Per Share
Basic net loss per share is calculated based on the weighted-average number of common shares
outstanding during the periods presented. For all periods presented in the Condensed Consolidated
Statements of Operations, the net loss available to common stockholders is equal to the reported
net loss. Basic and diluted net loss per share are the same due to our historical net losses and
the requirement to exclude potentially dilutive securities which would have an anti-dilutive effect
on net loss per share. The weighted average of these potentially dilutive securities has been
excluded from the diluted net loss per share calculation and is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2008 |
|
|
2007 |
|
Convertible subordinated notes |
|
|
14,638 |
|
|
|
16,354 |
|
Stock options and restricted stock units |
|
|
12,333 |
|
|
|
10,739 |
|
|
|
|
|
|
|
|
Total |
|
|
26,971 |
|
|
|
27,093 |
|
|
|
|
|
|
|
|
Note 10Comprehensive Loss
Comprehensive loss is comprised of net loss and other comprehensive income and includes the
following components (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2008 |
|
|
2007 |
|
Net loss, as reported |
|
$ |
(40,705 |
) |
|
$ |
(25,673 |
) |
Change in net unrealized gains (losses) on available-for-sale investments |
|
|
560 |
|
|
|
255 |
|
Translation adjustment |
|
|
10 |
|
|
|
(14 |
) |
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(40,135 |
) |
|
$ |
(25,432 |
) |
|
|
|
|
|
|
|
The components of accumulated other comprehensive income are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008 |
|
|
December 31, 2007 |
|
Unrealized gain on available-for-sale securities |
|
$ |
988 |
|
|
$ |
428 |
|
Translation adjustment |
|
|
1,225 |
|
|
|
1,215 |
|
|
|
|
|
|
|
|
Total accumulated other comprehensive income |
|
$ |
2,213 |
|
|
$ |
1,643 |
|
|
|
|
|
|
|
|
14
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. 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 described in Part II, Item 1ARisk Factors.
Overview
We are a biopharmaceutical company that develops and enables differentiated therapeutics with
our leading PEGylation and pulmonary drug development technology platforms. Our mission is to
create differentiated, innovative products by applying our platform technologies to established or
novel medicines. By doing so, we aim to raise the standards of current patient care by improving
one or more performance parameters, including efficacy, safety or ease of use. Not including
Exubera, ten products using these technology platforms have received regulatory approval in the
U.S. or Europe. Our two technology platforms are the basis of nearly all of our partnered and
proprietary products and product candidates.
We create or enable potential breakthrough products in two ways. First, we develop products in
collaboration with pharmaceutical and biotechnology companies that seek to improve and
differentiate their products. All of the approved products today that use our technology platforms
are a result of collaborations with partners. Second, we develop our own product candidates by
applying our technologies to already approved drugs to create and develop our own differentiated,
proprietary product candidates that are designed to target serious diseases in novel ways. We
currently have two proprietary product candidates in mid-stage clinical development and a number of
other candidates in preclinical development.
Our two leading technology platforms enable improved performance of a variety of new and
existing molecules. Our PEGylation technology is a chemical process designed to enhance the
performance of most drug classes with the potential to improve solubility and stability, increase
drug half-life, reduce immune responses to an active drug and improve the efficacy or safety of a
molecule in certain instances. Our pulmonary technology makes drugs inhaleable to deliver them to
and through the lungs for local lung applications.
There are two key elements to our business strategy. First, we are developing a portfolio of
proprietary product candidates by applying our PEGylation and pulmonary technology platforms and
know-how to improving already approved drugs. Our strategy is to identify molecules that would
benefit from the application of our technologies and potentially improve one or more performance
parameters, including efficacy, safety and ease of use. Our objective is to create value by
advancing these product candidates into clinical development and then deciding on a
product-by-product basis whether we wish to continue development and commercialize on our own or
seek a partner, or pursue a combination of these approaches. Our most advanced proprietary product
candidates are NKTR-102 (PEG-irinotecan) for the treatment of solid tumors, including colorectal
cancer, and NKTR-118 (oral PEG-naloxol) for the treatment of opioid-induced bowel dysfunction, both
of which entered Phase 2 clinical development in late 2007.
Second, we have collaborations or licensing arrangements with a number of pharmaceutical and
biotechnology companies. Our partnering strategy enables us to work towards developing a larger and
more diversified pipeline of drug products and product candidates using our technologies. As we
have shifted our focus away from being a drug delivery service provider and have advanced research
and development of our proprietary product pipeline, we expect to engage in selected high value
partnerships in order to optimize revenue potential, probability of success and overall return on
investment. Our partnering options range from a comprehensive license to a co-promotion and
co-development arrangement with the structure of the partnership depending on factors such as the
cost and complexity of development, commercialization needs and therapeutic area focus.
Historically, we have depended on revenue from Pfizer Inc. related to Exubera contract
research and manufacturing. Our revenue from Pfizer, including Exubera contract research and
manufacturing revenue, was approximately $189.1 million and $139.9 million, representing 69% and
64% of revenue, for the years ended December 31, 2007 and 2006,
respectively, and nil and
$64.3 million, representing 0% and 76% of total revenue, for the three months ended March 31, 2008
and 2007, respectively.
On October 18, 2007, Pfizer announced that it was exiting the Exubera business and gave notice
of termination under our collaborative development and licensing agreement. On November 9, 2007, we
entered into a termination agreement and mutual release with Pfizer. Under the termination
agreement and mutual release, we received a one-time payment of $135.0 million in November 2007
from Pfizer in satisfaction of all outstanding contractual obligations under our then-existing
agreements relating to Exubera and our next-generation inhaled insulin product development program,
also known as NGI. All agreements between Pfizer and us related to Exubera and NGI, other than the termination agreement
and mutual release, terminated on November 9, 2007.
15
Pursuant to our termination agreement and mutual release with Pfizer, Pfizer agreed to provide
certain cooperation to assist us in securing a new marketing and development partner for Exubera
and NGI. On April 9, 2008, we announced that we had ceased all negotiations with potential partners
for Exubera and NGI as a result of new data analysis from ongoing clinical trials conducted by
Pfizer which indicated an increase in the number of new cases of lung cancer in Exubera patients
who were former smokers as compared to patients in the control group who were former smokers. We
have taken all necessary steps to cease spending associated with maintaining Exubera manufacturing
capacity and any further NGI development, including, but not limited to, terminating, in April
2008, a maintenance letter agreement with Pfizer, pursuant to which Pfizer had agreed to maintain a
group of key Pfizer manufacturing personnel in Pfizers Exubera manufacturing facility in Terre
Haute, Indiana, and a termination and 2008 continuation agreement with Tech Group North America, Inc. (Tech Group),
pursuant to which Tech Group had agreed to preserve key personnel and manufacturing facilities to
support potential future Exubera inhaler manufacturing. We incurred $3.4 million in expense for
these Pfizer and Tech Group agreements for the three months ended March 31, 2008. We will record
an expense of $1.6 million in April 2008 for the final monthly maintenance provided under these
agreements.
In an effort to reduce ongoing operating costs and improve our organizational structure,
efficiency and productivity, we executed a workforce reduction plan in May 2007. In February 2008,
we executed another workforce reduction plan designed to streamline the company, consolidate
corporate functions and strengthen decision-making and execution within our business units. The
February 2008 plan reduced our workforce by approximately 110 employees, or approximately 20
percent of our regular full-time employees. Please refer to the discussion in Workforce Reduction
Plans under Note 7 of the Notes to Condensed Consolidated Financial Statements in this Quarterly
Report on Form 10-Q for more information regarding these plans.
For the three months ended March 31, 2008, net cash used for our operating activities was
$65.0 million. For the three months ended March 31, 2008, we made the following payments, among
others: (i) $32.4 million to Bespak Europe Ltd. (Bespak) and Tech Group as payment for termination amounts
due under our Exubera inhaler manufacturing and supply agreement with those companies, all of which
was recorded as an expense in 2007, (ii) $2.6 million to Tech Group to maintain Exubera inhaler
manufacturing capacity through April 2008 and (iii) $3.9 million for severance, employee benefits and
outplacement services in connection with our workforce reduction plans. In April 2008, we paid
$7.5 million to Tech Group as the final payment due under our termination and 2008 continuation agreement,
all of which was previously recorded as an expense in 2007, and a total of $2.4 million to Pfizer
and Tech Group as the final payments under the Pfizer maintenance letter agreement and the Tech
Group continuation agreement. We do not utilize cash in operations ratably throughout the year
and we expect our cash used in operations to be significantly lower on a quarterly basis in the
remaining three quarters of 2008.
The investment required to advance our proprietary product development programs, our ability
to manage ongoing expense and the cash generated by new partnerships, if any, will be the key
drivers of our results of operations and financial position in 2008. To fund our research and
development activities, we have raised significant amounts of capital through the sale of our
equity and convertible debt securities. As of March 31, 2008, we had approximately $345.3 million
in indebtedness. Our ability to meet the repayment obligations of this debt is dependent upon our
and our partners ability to develop, obtain regulatory approvals for and successfully
commercialize products. Even if we are successful in this regard, we may require additional capital
to repay our debt obligations as they become due.
Recent Developments
Termination of Partnering Negotiations for Inhaled Insulin
As discussed above, on April 9, 2008, we announced that we had ceased all negotiations with
potential partners for Exubera and NGI.
Research and Development Activities
Our product pipeline includes both partnered products and development programs and proprietary
product development programs. We have ongoing collaborations or licensing arrangements with
numerous biotechnology and pharmaceutical companies to provide our pulmonary and PEGylation
technologies. Not including Exubera and NGI products, our technologies are currently being used in
ten products approved in the U.S. or Europe, in three partnered programs that have been filed for
with the FDA and twelve development programs in human clinical trials.
16
The length of time that a development program is in a given phase varies substantially
according to factors such as the type and intended use of the potential product, the clinical trial
design and the ability to enroll suitable patients, changing standards of care, all of which are affected by medical and
scientific developments and other variables not controlled by us or our partners. Generally, for
our partnered programs, advancement from one phase to the next and the related costs are dependent
upon factors primarily controlled by our partners.
In connection with our research and development for partnered products and development
programs, we earned $9.6 million and $12.0 million in contract research revenue for the three
months ended March 31, 2008 and 2007, respectively. The estimated completion dates and costs for
our programs are not reasonably certain. See Part II, Item 1ARisk Factors for discussion of the
risks associated with our partnered and proprietary research and development programs and the
timing and risks associated with clinical development.
Results of Operations
Three Months Ended March 31, 2008 and 2007
Revenue (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
Three months |
|
|
Three months |
|
|
Increase / |
|
|
Increase / |
|
|
|
ended |
|
|
ended |
|
|
(Decrease) 2008 |
|
|
(Decrease) 2008 |
|
|
|
March 31, 2008 |
|
|
March 31, 2007 |
|
|
vs. 2007 |
|
|
vs. 2007 |
|
Product sales and royalties |
|
$ |
10,371 |
|
|
$ |
73,019 |
|
|
$ |
(62,648 |
) |
|
|
(86 |
%) |
Contract research |
|
|
9,621 |
|
|
|
11,997 |
|
|
|
(2,376 |
) |
|
|
(20 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
19,992 |
|
|
$ |
85,016 |
|
|
$ |
(65,024 |
) |
|
|
(76 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in total revenue for the three months ended March 31, 2008, as compared to the
three months ended March 31, 2007, was primarily due to the termination of our collaborative
development and license agreement, and related agreements, with Pfizer related to Exubera and NGI.
We had no revenue from Pfizer related to Exubera or NGI for the three months ended March 31, 2008
compared to $64.3 million, or 76% of our total revenue, for the three months ended March 31, 2007.
Product sales and royalties
For the three months ended March 31, 2007, Exubera product sales and commercialization
readiness revenue from Pfizer accounted for $61.4 million of our total revenue. We had no revenue
from Pfizer related to Exubera for the three months ended March 31, 2008. Non-Exubera product sales
and royalties decreased by approximately $1.2 million, or 10%, for the three months ended March 31,
2008, compared to the three months ended March 31, 2007. The decrease in non-Exubera product sales
and royalties is primarily attributable to the November 30, 2007 sale of Aerogen Ireland Ltd., one
of our former subsidiaries that manufactured and supplied general purpose nebulizer devices, and
which
accounted for $1.2 million in revenue for the three months ended March 31, 2007. PEGylation product
sales for the three months ended March 31, 2008 was consistent with the three months ended March
31, 2007,
comprised of a decrease in product sales to UCB of $2.7 million offset by increased product sales
to Hoffman and others of $2.2 million and $0.5 million, respectively.
We had no
revenue from pulmonary product sales for the three months ended March 31, 2008.
Contract research
Contract research revenue includes reimbursed research and development expense as well as the
amortization of deferred up-front signing fees and milestone payments received from our
collaboration partners. Contract research revenue is expected to fluctuate from year to year and
therefore it is difficult to estimate future contract research revenue for any given period. The
level of contract research revenue depends in part upon the continuation of existing
collaborations, signing of new collaborations and achievement of milestones under current and
future agreements.
For the three months ended March 31, 2007, contract research revenue from Pfizer related to
Exubera accounted for $2.8 million of our total revenue. We had no contract research
revenue from Pfizer related to Exubera or NGI for the three months ended March 31, 2008. Non-Pfizer
contract research revenue increased by approximately $0.5 million, or 5%, for the three months
ended March 31, 2008, compared to the three months ended March 31, 2007. This increase is primarily
attributable to increased revenue from Bayer AG under our collaboration agreements for
ciprofloxacin inhalation
powder (CIP) and inhaled amikacin (NKTR-061), partially offset by decreases in contract
research revenue from Solvay Pharmaceuticals, Inc. and Zelos Therapeutics Inc. following notice of
termination of those collaboration agreements. The timing and future success of our product
development programs are subject to a number of risks and uncertainties. See Part II, Item 1ARisk
Factors for discussion of the risks associated with our partnered research and development
programs.
17
Cost of Goods Sold and Product Gross Margin (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
Three months |
|
|
Three months |
|
|
Increase / |
|
|
Increase / |
|
|
|
ended |
|
|
ended |
|
|
(Decrease) 2008 |
|
|
(Decrease) 2008 |
|
|
|
March 31, 2008 |
|
|
March 31, 2007 |
|
|
vs. 2007 |
|
|
vs. 2007 |
|
Cost of goods sold |
|
$ |
7,227 |
|
|
$ |
56,522 |
|
|
$ |
(49,295 |
) |
|
|
(87 |
%) |
Product gross margin |
|
$ |
3,144 |
|
|
$ |
16,497 |
|
|
$ |
(13,353 |
) |
|
|
(81 |
%) |
Product gross margin % |
|
|
30 |
% |
|
|
23 |
% |
|
|
|
|
|
|
|
|
The decrease in product gross margin for the three months ended March 31, 2008, compared to
the three months ended March 31, 2007, was primarily due to the termination of our agreements with
Pfizer related to Exubera and a decrease in PEGylation product manufacturing volumes. For the three
months ended March 31, 2007, Exubera cost of goods sold totaled $49.2 million and Exubera gross
margin totaled $12.3 million, or 20%. The increase in product gross margin percentage is
attributable to the change in product mix.
Product sales and royalties for the three months ended March 31, 2007 was comprised of 84%
Exubera product sales, 15% PEGylation product sales, and 1% royalties compared to 87% PEGylation
product sales, 13% royalties, and no Exubera product sales in the three months ended March 31,
2008.
Cost of Workforce Reduction Plans (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
Three months |
|
|
Three months |
|
|
Increase / |
|
|
Increase / |
|
|
|
ended |
|
|
ended |
|
|
(Decrease) 2008 |
|
|
(Decrease) 2008 |
|
|
|
March 31, 2008 |
|
|
March 31, 2007 |
|
|
vs. 2007 |
|
|
vs. 2007 |
|
Cost of goods sold, net of change in inventory |
|
$ |
177 |
|
|
$ |
|
|
|
$ |
177 |
|
|
|
>100 |
% |
Cost of idle Exubera manufacturing capacity |
|
|
1,221 |
|
|
|
|
|
|
|
1,221 |
|
|
|
>100 |
% |
Research and development expense |
|
|
3,338 |
|
|
|
|
|
|
|
3,338 |
|
|
|
>100 |
% |
General and administrative |
|
|
552 |
|
|
|
|
|
|
|
552 |
|
|
|
>100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of workforce reduction plans |
|
$ |
5,288 |
|
|
$ |
|
|
|
$ |
5,288 |
|
|
|
>100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Since May 2007, we have incurred $13.7 million related to our two workforce reduction plans,
$8.4 million related to the May 2007 plan and $5.3 million related to the February 2008 plan. We
estimate that the total cost of the February 2008 workforce reduction will be approximately $5.7
million, comprised of cash payments for severance, medical insurance and outplacement services.
During the remainder of 2008, we expect to record an additional $0.4 million related to the
February 2008 plan for employees with termination dates longer than two months from the date of
notification.
Cost of Idle Exubera Manufacturing Capacity (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
Three months |
|
|
Three months |
|
|
Increase / |
|
|
Increase / |
|
|
|
ended |
|
|
ended |
|
|
(Decrease) 2008 |
|
|
(Decrease) 2008 |
|
|
|
March 31, 2008 |
|
|
March 31, 2007 |
|
|
vs. 2007 |
|
|
vs. 2007 |
|
Cost of idle Exubera manufacturing capacity |
|
$ |
5,334 |
|
|
$ |
|
|
|
$ |
5,334 |
|
|
|
>100 |
% |
Cost of idle Exubera manufacturing capacity includes amounts payable to Pfizer and Tech Group
under our interim manufacturing capacity maintenance agreements, and severance, employee benefits
and outplacement costs for our Exubera commercial manufacturing employees terminated as part of the
February 2008 workforce reduction. Cost of idle Exubera manufacturing capacity also includes an
allocation of manufacturing costs shared between commercial operations and research and
development. Shared costs include employee compensation and benefits, rent, and utilities.
Since our April 9, 2008 announcement that all negotiations with potential partners for Exubera
and NGI had terminated, we terminated employees dedicated exclusively to Exubera and NGI and terminated our
interim Exubera manufacturing capacity maintenance agreements. In April 2008, we will record expense of $1.6 million for the final month
of maintenance provided under these agreements.
18
Research and Development Expense (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
Three months |
|
|
Three months |
|
|
Increase / |
|
|
Increase / |
|
|
|
ended |
|
|
ended |
|
|
(Decrease) 2008 |
|
|
(Decrease) 2008 |
|
|
|
March 31, 2008 |
|
|
March 31, 2007 |
|
|
vs. 2007 |
|
|
vs. 2007 |
|
Research and development expense |
|
$ |
37,373 |
|
|
$ |
37,492 |
|
|
$ |
(119 |
) |
|
|
<(1 |
%) |
In connection with our February 2008 workforce reduction plan, we recorded $3.3 million of
severance, employee benefits, and outplacement expenses within research and development expense for
the three months ended March 31, 2008. Additionally, we recognized a decrease in stock-based
compensation expense within research and development expense of $3.0 million for the three months
ended March 31, 2008 compared to the three months ended March 31, 2007. The decrease in
stock-based compensation expense resulted from fewer average options
outstanding and lower fair market value of options granted in the three months ended March 31, 2008
compared to 2007 and an increase in the estimated annual forfeiture rates due to higher than
anticipated turnover and related stock award cancellations.
While there was not a significant change in total research and development expense in the
three months ended March 31, 2008 compared to the three months ended March 31, 2007, there was a
change in the mix of research and development spending by program. Pulmonary research and
development expense decreased as a result of the termination of our inhaled insulin development
programs and the curtailment of our ABIP program. These decreases are offset by increased spending
on our PEGylation programs. We began Phase 2 clinical trials for NKTR-102 and NKTR-118 in December
2007, resulting in increased PEGylation research and development expense in the three months ended
March 31, 2008 compared to the three months ended March 31, 2007.
We expect research and development expense to remain at a consistent level in the remaining
three quarters of 2008.
General and Administrative Expense (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
Three months |
|
|
Three months |
|
|
Increase / |
|
|
Increase / |
|
|
|
ended |
|
|
ended |
|
|
(Decrease) 2008 |
|
|
(Decrease) 2008 |
|
|
|
March 31, 2008 |
|
|
March 31, 2007 |
|
|
vs. 2007 |
|
|
vs. 2007 |
|
General and administrative expense |
|
$ |
11,711 |
|
|
$ |
16,735 |
|
|
$ |
(5,024 |
) |
|
|
(30 |
%) |
General and administrative expense is associated with administrative staffing, business
development and marketing. The decrease in general and administrative expense for the three months
ended March 31, 2008, compared to the three months ended March 31, 2007, was primarily attributable
to personnel reductions, resulting in decreased salaries and employee benefits of $3.2 million, stock-based
compensation of $1.6 million, and a $2.0 million decrease in legal and other professional services.
These decreases were partially offset by increased severance, outplacement and employee benefit
costs for employees affected by the February 2008 workforce reduction and increased marketing costs
for NKTR-061.
Interest Income and Interest Expense (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
Three months |
|
|
Three months |
|
|
Increase / |
|
|
Increase / |
|
|
|
ended |
|
|
ended |
|
|
(Decrease) 2008 |
|
|
(Decrease) 2008 |
|
|
|
March 31, 2008 |
|
|
March 31, 2007 |
|
|
vs. 2007 |
|
|
vs. 2007 |
|
Interest Income |
|
$ |
5,013 |
|
|
$ |
5,473 |
|
|
$ |
(460 |
) |
|
|
(8 |
%) |
Interest Expense |
|
$ |
(3,918 |
) |
|
$ |
(4,933 |
) |
|
$ |
(1,015 |
) |
|
|
(21 |
%) |
The decrease in interest income for the three months ended March 31, 2008, compared to the
three months ended March 31, 2007, was primarily due to lower interest rates on our cash, cash
equivalents, and available-for-sale investments. The decrease in interest expense for the three
months ended March 31, 2008, compared to the three months ended March 31, 2007, was primarily
attributable to a lower average balance of convertible subordinated notes outstanding in the three
months ended March 31, 2008. We repaid $36.0 million of our 5% subordinated convertible notes in
February 2007 and $66.6 million of our 3.5% subordinated convertible notes in October 2007. In the
three months ended March 31, 2008, we had $315.0 million of 3.25% subordinated convertible notes
due September 2012 outstanding.
19
Liquidity and Capital Resources
We have financed our operations primarily through revenue from partner licensing and
collaboration arrangements, public and private placements of debt and equity securities and
financing of equipment acquisitions and certain tenant leasehold improvements.
We had cash, cash equivalents and investments in marketable securities of $412.6 million and
indebtedness of $345.3 million, including $315.0 million of 3.25% convertible subordinated notes,
$23.6 million in capital lease obligations and $6.8 million in other liabilities as of March 31,
2008.
Due to the recent adverse developments in the credit markets, we may experience reduced
liquidity with respect to some of our short-term investments. These investments are generally held
to maturity, which is less than one year. However, if the need arose to liquidate such securities
before maturity, we may experience losses on liquidation. To date we have not experienced any
liquidity issues with respect to these securities, but should such issues arise, we may be required
to hold some, or all, of these securities until maturity. We have the intent and ability to hold
our securities to maturity when they will be redeemed at par value. We believe that, even allowing
for potential liquidity issues with respect to these securities, our remaining cash, cash
equivalents, and short-term investments will be sufficient to meet our anticipated cash needs for
at least the next twelve months.
Cash flows used in operating activities
Net cash used for our operating activities totaled $65.0 million during the three months ended
March 31, 2008. We do not utilize cash in operations ratably throughout the year and we expect our
cash used in operations to be significantly lower on a quarterly basis in the remainder of 2008 as
compared to the three months ended March 31, 2008.
For
the three months ended March 31, 2008, cash used in operations includes payments to Bespak
and Tech Group of $32.4 million for amounts due under our termination agreements with those
companies, all of which was recorded as an expense in 2007, $2.6 million to maintain Exubera
inhaler manufacturing capacity at Tech Groups facility,
and $3.9 million for severance, employee benefits, and
outplacement services in connection with our workforce reduction plans.
For the
three-months ended March 31, 2007, net cash used in operating activities was $29.0
million.
The increase in cash used in operating activities is primarily the result of the payments made
in the three months ended March 31, 2008 discussed above, the loss of Exubera product sales, and
increased investment in clinical development programs. Partially offsetting these increases are
operating efficiencies achieved as a result of our workforce reduction plans.
Cash flows from investing activities
We purchased $5.3 million and $5.6 million of property and equipment in the three-months ended
March 31, 2008 and 2007, respectively.
Cash flows used in financing activities
We repaid nil and $36.0 million of our convertible subordinated notes in the three months
ended March 31, 2008 and 2007, respectively.
Contractual Obligations
For the three-months ended March 31, 2008, other than the contract termination payments to
Bespak and Tech Group of $24.6 million, there has not been a material change to the summary of
contractual obligations in our Annual Report on Form 10-K for the year ended December 31, 2007.
Off-Balance Sheet Arrangements
We do not utilize off-balance sheet financing arrangements as a source of liquidity or
financing.
20
Critical Accounting Policies and Recent Accounting Pronouncements
Stock-Based Compensation
We use the Black-Scholes option valuation model adjusted for the estimated historical
forfeiture rate for the respective grant to determine the estimated fair value of our stock-based
compensation arrangements on the date of the grant (grant date fair value) and expense this value
ratably over the service period of the option or performance period of the Restricted
Stock Unit award (RSU award). The Black-Scholes option pricing model requires the input of
highly subjective assumptions. Because our employee stock options have characteristics
significantly different than traded options, and because changes in the subjective input
assumptions can materially affect the fair value estimate, in managements opinion, the existing
models may not provide a reliable single measure of the fair value of our employee stock options or
common stock purchased under our employee stock purchase plan. Management continually assesses the
assumptions and methodologies used to calculate the estimated fair value of stock-based
compensation.
We utilized an
estimated annual forfeiture rate of 4.7% for executives and 7.4% for all other employees in our
calculation of stock-based compensation expense for the three months ended March 31, 2007. We
have had a significant increase in our employee turnover incremental to our two workforce
reductions in May 2007 and February 2008. As a result, we performed a qualitative and
quantitative analysis of our historical forfeitures and changed our estimated annual forfeiture
rates to 11% for stock option grants and 25% for RSU grants for all executives and employees.
Circumstances may change and additional data may become available over time, which could
result in changes to the stock-based compensation assumptions and methodologies, and which could
materially impact our fair value determination in the future.
For additional information on our critical accounting policies and recent accounting
pronouncements, please refer to the discussion in Recent Accounting Pronouncements under Note 1
of the Notes to Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q
and Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2007 on file with the
Securities and Exchange Commission.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Our market risks at March 31, 2008 have not changed significantly from those discussed in
Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2007 on file with the
Securities and Exchange Commission.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Securities Exchange Act reports is recorded, processed, summarized,
and reported within the time periods specified in the SECs rules and forms, and that such
information is accumulated and communicated to management, including our Chief Executive Officer
and Chief Financial Officer, as appropriate, to allow timely decisions regarding required financial
disclosure.
As of the end of the period covered by this report, we carried out an evaluation, under the
supervision and with the participation of our management, including our Chief Executive Officer and
Chief Financial Officer, of the effectiveness of the design and operation of our disclosure
controls and procedures pursuant to Exchange Act Rule 13a-15. Based upon, and as of the date of,
this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our
disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
We continuously seek to improve the efficiency and effectiveness of our internal controls.
This results in refinements to processes throughout the company. However, there was no change in
our internal control over financial reporting that occurred in the three months ended March 31,
2008 that has materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
Limitations on the Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, does not
expect that our disclosure controls and procedures or our internal control over financial reporting
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 errors or mistakes.
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, controls 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.
21
Approval of Non-Audit Services
In the three months ended March 31, 2008, the Audit Committee of the Board of Directors
approved no non-audit related services to be provided by Ernst & Young LLP, our independent
registered public accounting firm.
PART II: OTHER INFORMATION
Item 1. Legal Proceedings
Reference is hereby made to our disclosures in Legal Matters under Note 6 of the Notes to
Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q and the
information under the heading Legal Matters is incorporated by reference herein.
Item 1A. Risk Factors
Investors in Nektar Therapeutics should carefully consider the risks described below before
making an investment decision. The risks described below may not be the only ones relating to our
company. This description includes any material changes to and supersedes the description of the
risk factors associated with our business previously disclosed in Item 1A of our Annual Report on
Form 10-K for the twelve months ended December 31, 2007. Additional risks that we currently believe
are immaterial may also impair our business operations. Our business, results of operation,
financial condition, cash flow and future prospects and the trading price of our common stock and
our abilities to repay our convertible notes could be harmed as a result of any of these risks, and
investors may lose all or part of their investment. In assessing these risks, investors should also
refer to the other information contained or incorporated by reference in this Quarterly Report on
Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2007, including our
consolidated financial statements and related notes, and our other filings made from time to time
with the Securities and Exchange Commission (SEC).
Risks Related to Our Business
The termination of our partnership with Pfizer and the discontinuance of our efforts to find a new
marketing and development partner for Exubera and NGI will reduce our revenue significantly in 2008
as compared to 2007.
From our inception through the end of our 2007 fiscal year, we depended on Pfizer for revenue
related to Exubera contract research and manufacturing. Our total revenue from Pfizer was $189.1
million and $139.9 million, representing 69% and 64% of total revenue, for the years ended
December 31, 2007 and 2006, respectively, and nil and
$64.3 million, representing 0% and
76% of total revenue, for the three months ended March 31, 2008 and 2007, respectively. On
November 9, 2007, we entered into a termination agreement and mutual release with Pfizer, pursuant
to which Pfizer made a one-time payment of $135.0 million to us in satisfaction of all outstanding
contractual obligations under our then-existing agreements with Pfizer related to Exubera and the
next-generation inhaled insulin development program, also known as NGI. All of our agreements with
Pfizer, other than the termination agreement and mutual release, terminated as of November 9, 2007,
including our collaborative development and licensing agreement with Pfizer.
Pursuant to our termination agreement and mutual release with Pfizer, Pfizer agreed to provide
certain cooperation to assist us in securing a new marketing and development partner for Exubera
and NGI. However, on April 9, 2008, we announced that we would cease all efforts to find a new
marketing and development partner for Exubera and NGI in response to a new data analysis performed
by Pfizer from ongoing clinical trials indicating an increase in the number of new cases of lung
cancer in Exubera patients who were former smokers as compared to the control group. Prior to the
termination of our partnership with Pfizer, Pfizer had sole responsibility for all regulatory matters, distribution,
sales and marketing of Exubera and was also responsible for manufacturing and delivering bulk
insulin for powder processing, filling the insulin powder into blister packs for the Exubera
inhaler and providing the packaging for the final Exubera product. Thus, we could not have derived
any future revenue from Exubera or NGI without securing a new marketing and development partner to
assist in the manufacture of the products and provide sales, marketing and distribution services.
However, as a result of the termination of our partnership with Pfizer and the discontinuance of
our efforts to find a new partner for Exubera and NGI, we expect to derive no revenue from Pfizer
in 2008 and no future revenue from Exubera or NGI.
22
If the preclinical testing or clinical trials conducted by us or our partners are delayed or
unsuccessful, our business could be significantly harmed.
We have a number of partnered product candidates and proprietary product candidates 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
collaborative partners, several years to complete clinical trials. We have limited experience in
clinical development. Failure can occur at any stage and at any time, regardless of how successful
the results from preclinical and prior clinical testing may have been. Typically, there is a high
rate of attrition for product candidates in preclinical and clinical trials due to safety, efficacy
or other factors. Success in preclinical testing and early clinical trials does not necessarily
predict success in later clinical trials. A number of other companies in the pharmaceutical and
biotechnology industries have suffered significant setbacks in later stage clinical trials (i.e.,
Phase 2 or Phase 3 trials) due to factors such as inconclusive results and adverse medical events,
even after achieving positive results in earlier trials that were satisfactory both to them and to
reviewing regulatory agencies. If our partnered product candidates or proprietary product
candidates fail during any clinical trial stage, it could have a significant and adverse impact on
our business prospects.
The timing of the completion of clinical trials and the availability of data from those trials
can be very difficult to estimate due to many factors, including but not limited to, clinical trial
design, the rate of qualified patient enrollment, changing standards of care (alternative
treatments, patient screening testing), the time it takes to reach clinical trial end points, and
certain other medical and scientific developments that are not controlled by us or our partners.
Therefore, the completion of clinical trials and the availability of data from those trials can
take much longer than we plan.
Because our proprietary product candidates are in the early stages of development, there is a high
risk of failure, and we may never succeed in developing marketable products or generating revenue
from our proprietary product candidates.
Our efforts to apply our pulmonary technology and PEGylation technology to our proprietary
product development programs may fail. None of our proprietary product candidates have received
regulatory approval and our development efforts may not result in a commercialized product. Drug
development is an uncertain process that involves trial and error, and we may fail at numerous
stages along the way or choose to discontinue. Development of our proprietary product candidates
will require extensive time, effort and cost in preclinical testing and clinical trials and will
involve a lengthy regulatory review process before they can be marketed. In particular, successful
pre-clinical and Phase 1 clinical study results do not necessarily predict success in later stage
clinical trials. It can also be very difficult to estimate the commercial potential of early stage
product candidates due to factors such as safety and efficacy when compared to other available
treatments, including potential generic drug alternatives with similar efficacy profiles, changing
standards of care, patient and physician preferences and the availability of competitive
alternatives that may emerge either during the long drug development process or after commercial
introduction. Although NKTR-102 (PEG-irinotecan) and NKTR-118 (oral PEG-naloxol) entered Phase 2
clinical development in late 2007, because of the substantial risks and uncertainties of clinical
programs at this early stage of development, there is no assurance that either product will be
approved for marketing or, if approved, will be accepted and used by patients and physicians.
Our strategy to develop our proprietary product candidates prior to seeking partnership
arrangements may be unsuccessful and adversely impact our business, results of operations and
financial condition.
Our strategy is to fund our proprietary product development programs, including some or all of
the clinical trials, prior to partnering with pharmaceutical and biotechnology companies. While we
believe this strategy may result in improved economics for our proprietary product candidates, it
will require significant investment by us without reimbursement. For example, we may expand the
number of clinical trials for one or more of our proprietary product candidates to additional
therapeutic indications to increase the likelihood of success but such strategy can be very
expensive and may not result in a successful trial in any of the therapeutic indications due to one
or more factors. As a result, we bear an increased economic risk in the event one or more of our
proprietary product candidates does not receive regulatory approval or is not successfully
commercialized. Even if the development of a proprietary product is ultimately successful, our
increased investment could adversely impact our business, results of operations, and financial
condition prior to commercialization since we will have fewer funds available to invest in other
products and efforts.
If we are unable to establish and maintain partnerships on commercially attractive terms, our
business, results of operations and financial condition could suffer.
We intend to continue to seek partnerships with pharmaceutical and biotechnology partners to
fund some of our research and development expense and develop and commercialize product candidates.
For instance, we secured partnerships in 2007 based on our pulmonary and PEGylation technology,
namely with the execution of a co-development, license and co-promotion agreement with Bayer for
NKTR-061 and an exclusive research, development, license and manufacturing and supply agreement
with Baxter for Hemophilia B, respectively. The timing of any future partnership, as well as the
terms and conditions of the partnership, will affect our results of operation and financial
condition. If we are unable to find suitable partners or to negotiate acceptable collaborative
arrangements with respect to our existing and future product candidates or
the licensing of our technology, or if any arrangements we negotiate, or have negotiated,
include unfavorable commercial terms, our business, results of operations and financial condition
could suffer.
23
If product liability claims are brought against us, we may incur significant liabilities and suffer
damage to our reputation.
The manufacture, clinical testing, marketing and sale of medical and pharmaceutical products
involve inherent product liability risks. Although Pfizer owns the new drug application with the
FDA for Exubera and had sole responsibility for preparing prescribing information for
physicians and the Exubera patient medication guide, as well as for the sales and
marketing of Exubera, there remains a risk of product liability claims being brought against
us. Whether or not we are ultimately successful in any product liability litigation, such
litigation would consume substantial amounts of our financial and managerial resources and might
result in adverse publicity, potential decrease in demand for products based on our technology
platforms, injury to our reputation, withdrawal of clinical trial volunteers and loss of revenue,
all of which would impair our business, results of operations and financial condition. Further,
product liability claims could result in substantial judgments or settlements. Our insurance
coverage may not cover or be adequate to satisfy any liability that may arise, and we may not be able to
maintain our clinical trial insurance or product liability insurance at an acceptable cost, if at
all. If our product liability costs exceed our product liability insurance coverage, we may incur
substantial liabilities that could have a severe negative impact on our business, results of
operations and financial condition. For instance, such uninsured liabilities could deplete
financial resources that would otherwise be used to complete the development or commercialization
of our product candidates.
We expect to continue to incur substantial losses and negative cash flow from operations and may
not achieve or sustain profitability in the future.
In the three months ended March 31, 2008, we reported net losses of $40.7 million. If and when
we achieve profitability depends upon a number of factors, including the timing and recognition of
milestone payments and license fees received, the timing of revenue under collaboration agreements,
the amount of investments we make in our proprietary product candidates, the regulatory approval
and market success of our product candidates and the success of our strategy to fund our
proprietary product development programs prior to partnering with other pharmaceutical and
biotechnology companies. We may not be able to achieve and sustain profitability.
Other factors that will affect whether we achieve and sustain profitability include our
ability, alone or together with our partners, to:
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develop products utilizing our technologies, either independently or in collaboration
with other pharmaceutical or biotech companies; |
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receive necessary regulatory and marketing approvals; |
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maintain or expand manufacturing at necessary levels; |
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achieve market acceptance of our partner products; |
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receive royalties on products that have been approved, marketed or submitted for
marketing approval with regulatory authorities; and |
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maintain sufficient funds to finance our activities. |
If we do not generate sufficient cash flow through increased revenue or raising additional capital,
we may not be able to meet our substantial debt obligations.
As of March 31, 2008, we had cash, cash equivalents, short-term investments and investments in
marketable securities valued at approximately $412.6 million and approximately $345.3 million of
indebtedness, including approximately $315.0 million in convertible subordinated notes, $23.6
million in capital lease obligations and $6.8 million of other liabilities. We expect to use a
substantial portion of our cash to fund our ongoing operations over the next few years. In 2012,
$315.0 million of our 3.25% convertible subordinated notes will mature.
Our substantial indebtedness has and will continue to impact us by:
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making it more difficult to obtain additional financing; |
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constraining our ability to react quickly in an unfavorable economic climate; |
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constraining our stock price; and |
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constraining our ability to invest in our proprietary product development programs. |
24
Currently, we are not generating positive cash flow and the negative impact to our revenue of
the termination of our Exubera and NGI efforts, and corresponding expectation that we will derive
no future revenue associated with those products, may further reduce our ability to meet our debt
obligations. If we are unable to satisfy our debt service requirements, substantial liquidity
problems could result. In relation to our convertible subordinated notes, since the market price of
our common stock is significantly below the conversion price, the holders of our outstanding
convertible subordinated notes are unlikely to convert the notes to common stock in accordance with
the existing terms of the notes. If we do not generate sufficient cash from operations to repay
principal or interest on our remaining convertible subordinated notes, or satisfy any of our other
debt obligations, when due, we may have to raise additional funds from the issuance of equity or
debt securities or otherwise restructure our obligations. Any such financing or restructuring may
not be available to us on commercially acceptable terms, if at all.
If we cannot raise additional capital, our financial condition will suffer.
We have no material credit facility or other material committed sources of capital. To the
extent operating and capital resources are insufficient to meet our future capital needs, we will
have to raise additional funds from new collaboration partnerships or the capital markets to
continue the marketing and development of our technologies and proprietary products. Such funds may
not be available on favorable terms, if at all. We may be unable to obtain suitable new
collaboration partners on attractive terms and our substantial indebtedness may limit our ability
to obtain additional capital markets 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 harm our business and our stock price. To the extent that additional capital is raised
through the sale of equity or convertible debt securities, the issuance of such securities would
result in dilution to our stockholders.
Our revenue has historically depended on revenue from collaboration agreements, causing significant
fluctuation in our revenue from period to period.
Other than revenue from sales of Exubera inhalation powder and inhaler devices to Pfizer in
2007 and 2006, historically, our revenue is principally derived from collaboration agreements with
partners. Such revenue includes milestone payments and reimbursement of a portion of our research
and development expense charged to our partners pursuant to collaborative arrangements with them.
The amount of our revenue derived from collaboration agreements in any given period will depend on
a number of unpredictable factors, including our ability to find and maintain suitable partners,
the timing of the negotiation and conclusion of collaboration agreements with such partners,
whether and when we achieve milestones agreed upon with our partners, whether the partnership is
exclusive or whether we can seek other partners, the timing of regulatory approvals and the market
introduction of new products, as well as other factors.
If our partners, on which we depend to obtain regulatory approvals for and to commercialize our
partnered products, are not successful, or if such collaborations fail, the development or
commercialization of our partnered products may be delayed or unsuccessful.
When we sign a collaborative development agreement or license agreement to develop a product
candidate with a pharmaceutical or biotechnology company, the pharmaceutical or biotechnology
company is generally expected to:
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synthesize active pharmaceutical ingredients to be used in the product candidate; |
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design and conduct large scale clinical studies; |
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prepare and file documents necessary to obtain government approvals to sell a given
product candidate; and/or |
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market and sell our products when and if they are approved. |
Our reliance on collaborative relationships poses a number of risks, including risks that:
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we may be unable to control whether, and the extent to which, our partners devote
sufficient resources to the development programs or commercial efforts; |
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disputes may arise in the future with respect to the ownership of rights to
technology or intellectual property developed with partners; |
25
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disagreements with partners could lead to delays in, or termination of, the research,
development or commercialization of product candidates or to litigation or arbitration; |
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contracts with our partners may fail to provide us with significant protection, or to
be effectively enforced, in the event one of our partners fails to perform; |
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partners have considerable discretion in electing whether to pursue the development
of any additional product candidates and may pursue alternative technologies or products
either on their own or in collaboration with our competitors; |
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partners with marketing rights may choose to devote fewer resources to the marketing
of our products than they do to products of their own development; |
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the timing and level of resources that our partners dedicate to the development
program will affect the timing and amount of revenue we receive; |
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partners may be unable to pay us as expected; and |
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partners may terminate their agreements with us unilaterally for any or no reason, in
some cases with the payment of a termination fee penalty and in other cases with no
termination fee penalty. |
Given these risks, the success of our current and future partnerships are highly uncertain.
We have entered into collaborations in the past that have been subsequently terminated, such
as our collaboration with Pfizer for Exubera and NGI. If other collaborations are suspended or
terminated, our ability to commercialize certain other proposed product candidates could also be
negatively impacted. If our collaborations fail, our product development or commercialization of
product candidates could be delayed or cancelled, which would negatively impact our business,
results of operations and financial condition.
If we or our partners do not obtain regulatory approval for our product candidates on a timely
basis, if at all, or if the terms of any approval impose significant restrictions or limitations on
use, our business, results of operations and financial condition will be negatively affected.
We or our partners may not obtain regulatory approval for product candidates on a timely
basis, if at all, or the terms of any approval (which in some countries includes pricing approval)
may impose significant restrictions or limitations on use. Product candidates must undergo rigorous
animal and human testing and an extensive FDA mandated or equivalent foreign authorities review
process for safety and efficacy. This process generally takes a number of years and requires the
expenditure of substantial resources. The time required for completing testing and obtaining
approvals is uncertain, and the FDA and other U.S. and foreign regulatory agencies have substantial
discretion to terminate clinical trials, require additional testing, delay or withhold registration
and marketing approval and mandate product withdrawals, including recalls. In addition, undesirable
side effects caused by our product candidates could cause us or regulatory authorities to
interrupt, delay or halt clinical trials and could result in a more restricted label or the delay
or denial of regulatory approval by regulatory authorities.
Even if we or our partners receive regulatory approval of a product, the approval may limit
the indicated uses for which the product may be marketed. Our partnered products that have obtained
regulatory approval, and the manufacturing processes for these products, are subject to continued
review and periodic inspections by the FDA and other regulatory authorities. Discovery from such
review and inspection of previously unknown problems may result in restrictions on marketed
products or on us, including withdrawal or recall of such products from the market, suspension of
related manufacturing operations or a more restricted label. For instance, Pfizers update of the
Exubera labeling in April 2008 to include information in the warnings section for doctors and
patients regarding an imbalance of the number of new cases of lung cancer in Exubera patients who
were former smokers as compared to the control group could have significantly and negatively
impacted the market for Exubera had this product still been actively marketed. The failure to
obtain timely regulatory approval of product candidates, any product marketing limitations or a
product withdrawal would negatively impact our business, results of operations and financial
condition.
26
If we or our partners are not able to manufacture products in quantities and at costs that are
commercially feasible, our proprietary and partnered product candidates will not be successfully
commercialized.
If
we are not able to scale-up manufacturing to meet the drug or inhaler
device quantities required to support
large clinical trials or commercial manufacturing in a timely manner or at a commercially
reasonable cost, we risk not meeting our supply requirements and contractual obligations. Building
and validating large scale clinical or commercial-scale manufacturing
facilities and processes, recruiting and training qualified personnel and obtaining necessary
regulatory approvals is complex, expensive and time consuming. We also sometimes face very limited
supply of a critical raw material that can only be obtained from a single, or a limited number of,
suppliers, which could constrain our manufacturing output. In addition, in the past we have
encountered challenges in scaling up manufacturing to meet the requirements of large scale clinical
trials without making modifications to the drug formulation or device
design which has the potential to cause
significant and unanticipated delays in clinical development. Failure to manufacture products in quantities or at
costs that are commercially feasible could cause us not to meet our supply requirements,
contractual obligations or other requirements for our proprietary or
partner product candidates and, as a
result, would negatively impact our business, results of operations and financial condition.
If government and private insurance programs do not provide reimbursement for our partnered
products or proprietary products, those products will not be widely accepted, which would have a
negative impact on our business, results of operations and financial condition.
In both domestic and foreign markets, sales of our partnered and proprietary products that
have received regulatory approval will depend in part on market acceptance among physicians and
patients, pricing approvals by government authorities and the availability of reimbursement from
third-party payers, such as government health administration authorities, managed care providers,
private health insurers and other organizations. Such third-party payers are increasingly
challenging the price and cost effectiveness of medical products and services. Therefore,
significant uncertainty exists as to the pricing approvals for, and the reimbursement status of,
newly approved healthcare products. Moreover, legislation and regulations affecting the pricing of
pharmaceuticals may change before regulatory agencies approve our proposed products for marketing
and could further limit pricing approvals for, and reimbursement of, our products from government
authorities and third-party payers. A government or third-party payer decision not to approve
pricing for, or provide adequate coverage and reimbursements of, our products would limit market
acceptance of such products.
We depend on third parties to conduct the clinical trials for our proprietary product candidates
and any failure of those parties to fulfill their obligations could harm our development and
commercialization plans.
We depend on independent clinical investigators, contract research organizations and other
third-party service providers to conduct clinical trials for our proprietary product candidates.
Though we rely heavily on these parties for successful execution of our clinical trials and are
ultimately responsible for the results of their activities, many aspects of their activities are
beyond our control. For example, we are responsible for ensuring that each of our clinical trials
is conducted in accordance with the general investigational plan and protocols for the trial, but
the independent clinical investigators may prioritize other projects over ours or communicate
issues regarding our products to us in an untimely manner. Third parties may not complete
activities on schedule or may not conduct our clinical trials in accordance with regulatory
requirements or our stated protocols. The early termination of any of our clinical trial
arrangements, the failure of third parties to comply with the regulations and requirements
governing clinical trials or our reliance on results of trials that we have not directly conducted
or monitored could hinder or delay the development, approval and commercialization of our product
candidates and would adversely effect our business, results of operations and financial condition.
Our manufacturing operations and those of our contract manufacturers are subject to governmental
regulatory requirements, which, if not met, would have a material
adverse effect on our business, results of operations and financial condition.
We and our contract manufacturers are required to maintain compliance with current good
manufacturing practices (cGMP), including cGMP guidelines applicable to active pharmaceutical
ingredients, and are subject to inspections by the FDA or comparable agencies in other
jurisdictions to confirm such compliance. We anticipate periodic regulatory inspections of our drug
manufacturing facilities and the device manufacturing facilities of our contract manufacturers for
compliance with applicable regulatory requirements. Any failure to follow and document our or our
contract manufacturers adherence to such cGMP regulations or satisfy other manufacturing and
product release regulatory requirements may lead to significant delays in the availability of
products for commercial use or clinical study, result in the termination or hold on a clinical
study or delay or prevent filing or approval of marketing applications for our products. Failure to
comply with applicable regulations may also result in sanctions being imposed on us, including
fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval
of our products, delays, suspension or withdrawal of approvals, license revocation, seizures or
recalls of products, operating restrictions and criminal prosecutions, any of which could harm our
business. The results of these inspections could result in costly manufacturing changes or facility
or capital equipment upgrades to satisfy the FDA that our manufacturing and quality control
procedures are in substantial compliance with cGMP. Manufacturing delays, for us or our contract
manufacturers, pending resolution of regulatory deficiencies or suspensions would have a material
adverse effect on our business, results of operations and financial condition.
27
If any of our pending patent applications do not issue, or are deemed invalid following
issuance, we may lose valuable intellectual property protection.
The patent positions of pharmaceutical, medical device and biotechnology companies, such as
ours, are uncertain and involve complex legal and factual issues. We own over 220 U.S. and over
1,200 foreign patents and a number of patent applications pending that cover various aspects of our
technologies. We have filed patent applications, and plan to file additional patent applications,
covering various aspects of our technologies, including our pulmonary technology, both in general
and as it relates to specific molecules, our powder processing technology, our powder formulation
technology, our inhalation device technology, our PEGylation technology and certain other of our
early stage technologies. There can be no assurance that patents that have issued will be valid and
enforceable or that patents for which we apply will issue with broad coverage, if at all. The
coverage claimed in a patent application can be significantly reduced before the patent is issued
and, as a consequence, our patent applications may result in patents with narrow coverage. Since
publication of discoveries in scientific or patent literature often lag behind the date of such
discoveries, we cannot be certain that we were the first inventor of inventions covered by our
patents or patent applications. As part of the patent application process, we may have to
participate in interference proceedings declared by the U.S. Patent and Trademark Office (PTO),
which could result in substantial cost to us, even if the eventual outcome is favorable. Further,
an issued patent may undergo further proceedings to limit its scope so as not to provide meaningful
protection and any claims that have issued, or that eventually issue, may be circumvented or
otherwise invalidated. Any attempt to enforce our patents or patent application rights could be
time consuming and costly. An adverse outcome could subject us to significant liabilities to third
parties, require disputed rights to be licensed from or to third parties or require us to cease
using the technology in dispute. Even if a patent is issued and enforceable, because development
and commercialization of pharmaceutical products can be subject to substantial delays, patents may
expire early and provide only a short period of protection, if any, following commercialization of
related products.
There are many laws, regulations and judicial decisions that dictate and otherwise influence
the manner in which patent applications are filed and prosecuted and in which patents are granted
and enforced. Changes to these laws, regulations and judicial decisions are subject to influences
outside of our control and may negatively affect our business, including our ability to obtain
meaningful patent coverage or enforcement rights to any of our issued patents. New laws,
regulations and judicial decisions may be retroactive in effect, potentially reducing or
eliminating our ability to implement our patent-related strategies to these changes. Changes to
laws, regulations and judicial decisions that affect our business are often difficult or impossible
to foresee, which limits our ability to adequately adapt our patent strategies to these changes.
We rely on trade secret protection and other unpatented proprietary rights for important
proprietary technologies, and any loss of such rights could harm our business, results of
operations and financial condition.
We rely on trade secret protection for our confidential and proprietary information. No
assurance can be given that others will not independently develop substantially equivalent
confidential and proprietary information or otherwise gain access to our trade secrets or disclose
such technology, or that we can meaningfully protect our trade secrets. In addition, unpatented
proprietary rights, including trade secrets and know-how, can be difficult to protect and may lose
their value if they are independently developed by a third party or if their secrecy is lost. Any
loss of trade secret protection or other unpatented proprietary rights could harm our business,
results of operations and financial condition.
We may not be able to obtain intellectual property licenses related to the development of our
technology on a commercially reasonable basis, if at all.
Numerous pending and issued U.S. and foreign patent rights and other proprietary rights owned
by third parties relate to pharmaceutical compositions, medical devices and equipment and methods
for preparation, packaging and delivery of pharmaceutical compositions. We cannot predict with any
certainty which, if any, patent references will be considered relevant to our or our collaborative
partners technology by authorities in the various jurisdictions where such rights exist, nor can
we predict with certainty which, if any, of these rights will or may be asserted against us by
third parties. There can be no assurance that we can obtain a license to any technology that we
determine we need on reasonable terms, if at all, or that we could develop or otherwise obtain
alternate technology. If we are required to enter into a license with a third party, our potential
economic benefit for the products subject to the license will be diminished. The failure to obtain
licenses on commercially reasonable terms, or at all, if needed, would have a material adverse
effect on us.
28
Significant competition for our technology platforms, our partnered and proprietary products and
product candidates could make our technologies, products or product candidates obsolete or
uncompetitive, which would negatively impact our business, results of operations and financial
condition.
Our platform technologies and partnered and proprietary products and product candidates
compete with various pharmaceutical and biotech companies. In the PEGylation technology field, our
competitors include Dow Chemical Company, Enzon Pharmaceuticals, Inc., SunBio Corporation, Mountain
View Pharmaceuticals, Inc., Neose Technologies, Inc., NOF Corporation and Urigen Pharmaceuticals,
Inc. Several other chemical, biotechnology and pharmaceutical companies may also be developing
PEGylation technologies. Some of these companies license or provide the technology to other
companies, while others are developing the technology for internal use. Our competitors in the
pulmonary technology field include Alexza Pharmaceuticals, Inc., Alkermes, Inc., Aradigm
Corporation, 3M Company, MannKind Corporation, Microdose Technologies, Inc., SkyePharma Plc and
Vectura Group Plc.
There are several competitors for our proprietary product candidates currently in development.
For NKTR-061 (inhaled Amikacin), the current standard of care includes several approved intravenous
antibiotics for the treatment of either hospital-acquired pneumonia or ventilator-associated
pneumonia in patients on mechanical ventilators. For NKTR-118 (PEGylated naloxol), there are
currently several alternative therapies used to address opioid-induced constipation (OIC) and
opioid-induced bowel dysfunction (OBD) including over-the-counter laxatives and stool softeners
such as docusate sodium, senna and milk of magnesia. In addition, there are a number of companies
developing potential products which are in various stages of clinical development and are being
evaluated for the treatment of OIC and OBD in different patient populations, including Adolor
Corporation, GlaxoSmithKline, Progenics Pharmaceuticals, Inc., Wyeth, Mundipharma Int. Limited,
Sucampo Pharmaceuticals and Takeda Pharmaceutical Company Limited. For NKTR-102 (PEG-irinotecan),
there are a number of approved therapies for the treatment of colorectal cancer, including
Eloxatin, Camptosar, Avastin, Erbitux, Vectibux, Xeloda, Adrucil and Wellcovorin. In addition,
there are a number of drugs in various stages of preclinical and clinical development from
companies exploring cancer therapies or improved chemotherapeutic agents to potentially treat
colorectal cancer, including, but not limited to, products in development from Bristol-Myers Squibb
Company, Pfizer, GlaxoSmithKline plc, Antigenics Inc., F. Hoffman La Roche Ltd., Novartis AG, Cell
Therapeutics, Inc., Neopharm, Inc., Meditech Research Limited, Enzon Pharmaceuticals, Inc. and
others.
There can be no assurance that we or our partners will successfully develop, obtain regulatory
approvals and commercialize next-generation or new products that will successfully compete with
those of our competitors. Many of our competitors have greater financial, research and development,
marketing and sales, manufacturing and managerial capabilities. We face competition from these
companies not just in product development but also in areas such as recruiting employees, acquiring
technologies that might enhance our ability to commercialize products, establishing relationships
with certain research and academic institutions, enrolling patients in clinical trials and seeking
program partnerships and collaborations with larger pharmaceutical companies. As a result, our
competitors may succeed in developing competing technologies, obtaining regulatory approval or
gaining market acceptance for products before we do. These developments could make our products or
technologies uncompetitive or obsolete.
Our collaboration agreements with our partners contain complex commercial terms that could result
in disputes or litigation that could adversely affect our business, results of operations and
financial condition.
We currently derive, and expect to derive in the foreseeable future, all of our revenue from
collaboration agreements with biotechnology and pharmaceutical companies. These collaboration
agreements contain complex commercial terms, including:
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research and development performance and reimbursement obligations for our personnel
and other resources allocated to partnered product development programs; |
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clinical and commercial manufacturing agreements, some of which are priced on an
actual cost basis for products supplied by us to our partners with complicated cost
calculation and allocation formulas and methodologies; |
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intellectual property ownership allocation between us and our partners for
improvements and new inventions developed during the course of the partnership; |
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royalties on end product sales based on a number of complex variables, including net
sales calculations, cost of goods, geography, patent life and other financial metrics; and |
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indemnity obligations for third-party intellectual property, infringement, product
liability and certain other claims. |
From time to time, we have informal dispute resolution discussions with our partners regarding
the appropriate interpretation of the complex commercial terms contained in our collaboration
agreements. One or more disputes may arise in
the future regarding our collaborative contracts that may ultimately result in costly
litigation and unfavorable interpretation of contract terms, which would have a material adverse
impact on our business, results of operations or financial condition.
29
We could be involved in legal proceedings regarding our intellectual property rights, or those of
our partners, and may incur substantial litigation costs and liabilities that will adversely affect
our business, results of operations and financial condition.
From time to time, third parties have asserted, and may in the future assert, that we or our
partners infringe their proprietary rights. The third party often bases its assertions on a claim
that its patents cover our technology. Similar assertions of infringement could be based on future
patents that may issue to third parties. In certain of our agreements with our partners, we are
obligated to indemnify and hold harmless our partners from intellectual property infringement,
product liability and certain other claims, which could cause us to incur substantial costs if we
are called upon to defend ourselves and our partners against any claims. If a third party obtains
injunctive or other equitable relief against us or our partners, our ability, and that of our
partners, to develop or commercialize, or derive revenue from, certain products or product
candidates in the U.S. and abroad which could be effectively blocked. For instance, Hoffman-La
Roche Ltd, to which we license our proprietary PEGylation reagent for use in the manufacture of
Roches MIRCERA product, is currently the subject of a significant patent infringement lawsuit
brought by Amgen Inc. related to Roches patents for the use of MIRCERA to treat chemotherapy
anemia in the U.S. Amgen has received a favorable ruling in U.S. federal district court in the
state of Massachusetts and the parties are currently litigating the remedy phase. It is uncertain
whether Roche will be prevented from marketing and selling MIRCERA in the U.S. or whether an
economic settlement with Amgen will be concluded and approved by the court. Although we are not a
party to this lawsuit, if Roche is prevented from marketing and selling MIRCERA in the U.S., it
will have a negative impact on our revenue from our license with Roche. Third-party claims could
also result in the award of substantial damages to be paid by us or a settlement resulting in
significant payments to be made by us. For instance, a settlement might require us to enter a
license agreement under which we pay substantial royalties to a third party, diminishing our future
economic returns from the related product. For instance, on June 30, 2006, we entered into a
litigation settlement related to an intellectual property dispute with the University of Alabama in
Huntsville pursuant to which we paid $11.0 million and agreed to pay an additional $10.0 million in
equal $1.0 million installments over ten years beginning on July 1, 2007. We cannot predict with
certainty the eventual outcome of any pending or future litigation. Costs associated with such
litigation, substantial damage claims, indemnification claims or royalties paid for licenses from
third parties could have a material adverse effect on our business, results of operations and
financial condition.
Our future depends on the proper management of our current and future business operations and their
associated expenses.
Our business strategy requires us to manage our business to provide for the continued
development and potential commercialization of our proprietary and partnered product candidates.
Our strategy also calls for us to undertake increased research and development activities and to
manage an increasing number of relationships with partners and other third parties, while
simultaneously managing the expenses generated by these activities. If we are unable to manage
effectively our current operations and any growth we may experience, our business, financial
condition and results of operations may be adversely affected. Our restructuring efforts in
February 2008 resulted in a reduction of approximately 110 employees, or approximately 20 percent
of our regular full-time staff. If we are unable to effectively manage our expenses, we may find it
necessary to reduce our personnel-related costs through further reductions in our workforce, which
could harm our operations, employee morale and impair our ability to retain and recruit talent.
Furthermore, if adequate funds are not available, we may be required to obtain funds through
arrangements with partners or other sources that may require us to relinquish rights to certain of
our technologies or products that we would not otherwise relinquish.
We are dependent on our management team and key technical personnel, and the loss of any key
manager or employee may impair our ability to develop our products effectively and may harm our
business, results of operations and financial condition.
Our success largely depends on the continued services of our executive officers and other key
personnel. The loss of one or more members of our management team or other key employees could
seriously harm our business, results of operations and financial condition. The relationships that
our key managers have cultivated within our industry make us particularly dependent upon their
continued employment with us. We are also dependent on the continued services of our technical
personnel because of the highly technical nature of our products and the regulatory approval
process. Because our executive officers and key employees are not obligated to provide us with
continued services, they could terminate their employment with us at any time without penalty. We
do not have any post-employment non-competition agreements with any of our employees and do not
maintain key person life insurance policies on any of our executive officers or key employees. On
February 8, 2008, Hoyoung Huh, our Chief Operating Officer and Head of the PEGylation Business
Unit, resigned from his positions with us effective February 29, 2008. We are currently searching
for a qualified replacement for
Dr. Huh. However, we may not be able to locate or employ a replacement for Dr. Huh on
acceptable terms in the immediate future, if at all. Though our Board of Directors has appointed
Dr. Huh as a director to serve until the 2009 annual meeting of stockholders or until his successor
is duly elected and qualified, we may not benefit from his service as a director to the same extent
we benefited from his service as the Chief Operating Officer and Head of the PEGylation Business
Unit due to the varied duties of each position.
30
Because competition for highly qualified technical personnel is intense, we may not be able to
attract and retain the personnel we need to support our operations and growth.
We must attract and retain experts in the areas of clinical testing, manufacturing,
regulatory, finance, marketing and distribution and develop additional expertise in our existing
personnel. We face intense competition from other biopharmaceutical companies, research and
academic institutions and other organizations for qualified personnel. Many of the organizations
with which we compete for qualified personnel have greater resources than we have. Because
competition for skilled personnel in our industry is intense, companies such as ours sometimes
experience high attrition rates with regard to their skilled employees. Further, in making
employment decisions, job candidates often consider the value of the stock options they are to
receive in connection with their employment. Our equity incentive plan and employee benefit plans
may not be effective in motivating or retaining our employees or attracting new employees, and
significant volatility in the price of our stock may adversely affect our ability to attract or
retain qualified personnel. If we fail to attract new personnel or to retain and motivate our
current personnel, our business and future growth prospects could be severely harmed.
If earthquakes and other catastrophic events strike, our business may be harmed.
Our corporate headquarters, including a substantial portion of our research and development
and manufacturing operations for bulk powder drugs, are located in the Bay Area, a region known for
seismic activity and a potential terrorist target. In addition, we own facilities for the
manufacture of products using our PEGylation technology in Huntsville, Alabama and lease offices in
Hyderabad, India. There are no backup facilities for our manufacturing operations located in the
Bay Area and Huntsville, Alabama. In the event of an earthquake or other natural disaster or
terrorist event in any of these locations, our ability to manufacture and supply certain products
would be significantly disrupted and our business, results of operations and financial condition
would be harmed. Our collaborative partners may also be subject to catastrophic events, such as
hurricanes and tornadoes, any of which could harm our business, results of operations and financial
condition. We have not undertaken a systematic analysis of the potential consequences to our
business, results of operations and financial condition from a major earthquake or other
catastrophic event, such as a fire, power loss, terrorist activity or other disaster, and do not
have a recovery plan for such disasters. In addition, our insurance coverage may not be sufficient
to compensate us for actual losses from any interruption of our business that may occur.
We have implemented certain anti-takeover measures, which 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:
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establishment of a classified board of directors such that not all members of the
board may be elected at one time; |
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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; |
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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; |
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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 |
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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 also have a change of control severance benefits plan which provides for
certain cash severance, stock award acceleration and other benefits in the event our employees are
terminated (or, in some cases, resign for specified reasons) following an acquisition. This
severance plan could discourage a third party from acquiring us.
31
Risks Related to Our Securities
The prices of our common stock and senior convertible debt are expected to remain volatile.
Our stock price is volatile. In the three months ended March 31, 2008, based on closing bid
prices on the NASDAQ Global Select Market, our stock price ranged from $6.12 to $7.50. We expect
our stock price to remain volatile. In addition, as our convertible senior notes are convertible
into shares of our common stock, volatility or depressed prices of our common stock could have a
similar effect on the trading price of the notes. Interest rate fluctuations can also affect the
price of our convertible senior notes. A variety of factors may have a significant effect on the
market price of our common stock or notes, including:
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announcements of data from, or material developments in, our clinical trials or those
of our competitors, including safety data indicating potential risks in the use of our
proprietary or partnered product candidates, such as the inclusion of information in the
labeling regarding a data imbalance observing an increased number of lung carcinoma in
users of Exubera who were former smokers, or delays in the development, approval or launch
of our proprietary product candidates; |
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announcements of changes in governmental regulation, orders or recommendations
affecting us or our competitors, such as Pfizers update of the Exubera labeling in April
2008; |
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public concern as to the safety of drug formulations, such as Exubera, developed by
us or others; |
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product liability claims against us or our partners or litigation brought against us
by, or by us against, third parties to whom we have indemnification obligations; |
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announcements by collaboration partners as to their plans or expectations related to
products using our technologies; |
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announcements or terminations of collaborative relationships by us or our
competitors, such as Pfizers announcement late in our 2007 fiscal year that it had
terminated our partnership for Exubera and NGI; |
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developments in patent or other proprietary rights; |
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announcements of technological innovations or new therapeutic products that may
compete with our approved products or products under development; |
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hedging activities by purchasers of our convertible senior notes; |
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fluctuations in our results of operations; and |
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general market conditions. |
Our securityholders may be diluted, and the price of our securities may decrease, by the exercise
of outstanding stock options and warrants or by future issuances of securities.
We may issue additional common stock, preferred stock, restricted stock units or securities
convertible into or exchangeable for our common stock. Furthermore, substantially all shares of
common stock for which our outstanding stock options or warrants are exercisable are, once they
have been purchased, eligible for immediate sale in the public market. The issuance of additional
common stock, preferred stock, restricted stock units or securities convertible into or
exchangeable for our common stock or the exercise of stock options or warrants would dilute
existing investors and could adversely affect the price of our securities.
32
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None, including no purchases of any class of our equity securities by us or any affiliate
pursuant to any publicly announced repurchase plan in the three months ended March 31, 2008.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
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Item 6. Exhibits
Except as so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference into, this Quarterly Report on Form 10-Q.
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Exhibit |
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Description of Documents |
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10.1 |
(1) |
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Amended and Restated Compensation Plan for Non-Employee Directors. |
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10.2 |
(1) |
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Nektar Discretionary Incentive Compensation Policy. |
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31.1 |
(1) |
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Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule 15d-14(a). |
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31.2 |
(1) |
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Certification of Nektar Therapeutics principal financial officer required by Rule 13a-14(a) or Rule 15d-14(a). |
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32.1 |
(1)* |
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Section 1350 Certifications. |
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(1) |
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Filed herewith. |
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Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing. |
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SIGNATURES
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:
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/s/ John Nicholson
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John Nicholson |
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Senior Vice President and Chief Financial Officer |
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Date: May 8, 2008 |
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By:
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/s/
Jillian B. Thomsen |
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Jillian B. Thomsen |
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Vice President and Chief Accounting Officer |
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Date: May 8, 2008 |
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35
EXHIBIT INDEX
Except as so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference in, this Quarterly Report on Form 10-Q.
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Exhibit |
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Number |
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Description of Documents |
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10.1 |
(1) |
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Amended and Restated Compensation Plan for Non-Employee Directors. |
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10.2 |
(1) |
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Nektar Discretionary Incentive Compensation Policy. |
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31.1 |
(1) |
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Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule 15d-14(a). |
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31.2 |
(1) |
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Certification of Nektar Therapeutics principal financial officer required by Rule 13a-14(a) or Rule 15d-14(a). |
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32.1 |
(1)* |
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Section 1350 Certifications. |
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(1) |
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Filed herewith. |
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Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing. |
36