Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of
report (Date of earliest event reported): November 4, 2009
NEKTAR
THERAPEUTICS
(Exact
Name of Registrant as Specified in Charter)
|
|
|
|
|
|
|
Delaware
|
|
0-24006
|
|
94-3134940
|
|
(State
or Other Jurisdiction
of
Incorporation)
|
|
(Commission
File
Number)
|
|
(IRS
Employer
Identification
No.)
|
201
Industrial Road
San
Carlos, California 94070
(Address
of Principal Executive Offices and Zip Code)
Registrant’s
telephone number, including area code: (650) 631-3100
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
|
¨
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
|
¨
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
¨
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
|
¨
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
|
|
Item
2.02
|
Results
of Operations and Financial
Condition
|
On
November 4, 2009, Nektar Therapeutics issued a press release (the “Press
Release”) announcing its financial results for the third quarter ended September
30, 2009. A copy of the Press Release is furnished herewith as
Exhibit 99.1.
On
October 30, 2009, the company announced that management would hold a conference
call on November 4, 2009 to review its financial results for the third quarter
ended September 30, 2009 and provide an update on the company’s
business. On this conference call, management expects to make certain
forward-looking statements regarding certain pre-clinical and clinical
development results and progress for certain of the company’s proprietary drug
development programs, the value of the company’s pegylation and advanced polymer
chemistry technology platform, potential future revenues that may be realized in
the future under certain of the company’s collaboration agreements, and
management’s financial guidance for 2009. These forward-looking
statements involve substantial risks and uncertainties including but not limited
to: (i) the company’s proprietary drug candidates, including NKTR-118, NKTR-102
and NKTR-105, are in early to mid-stage clinical development and the risk of
failure remains high and can unexpectedly occur at any stage prior to regulatory
approval due to lack of efficacy, safety issues or other factors; (ii) the
amount and timing of future payments that may become payable to the company
under the agreement with AstraZeneca for NKTR-118 and NKTR-119 is subject to a
number of development, regulatory and commercial risks such as the risk of
failure to obtain regulatory approval for NKTR-118 and/or NKTR-119
based on safety, efficacy or other issues, the risk of a lack of government or
private insurance reimbursement limiting commercial potential, the risk of
competition from alternative competing therapies, and other important risks and
uncertainties described or referenced herein; (iii) the timing or success of the
commencement or end of clinical trials and commercial launch of new drugs may be
delayed or unsuccessful due to regulatory delays, clinical trial design, slower
than anticipated patient enrollment, drug manufacturing challenges, changing
standards of care, clinical outcomes, or delay or failure in obtaining
regulatory approval in one or more important markets; (iv) scientific
discovery of new medical breakthroughs is an inherently uncertain process and
the future success of the application of the company’s technology platforms to
potential new drug candidates is therefore very uncertain and unpredictable; (v)
clinical trials are long, expensive and uncertain processes and the risk of
failure of any drug candidate that is in clinical development and prior to
regulatory approval remains high and can occur at any stage due to efficacy,
safety or other factors; (vi) management’s financial projections for the
company’s 2009 annual revenue, cash used in operations and year-end cash
position are subject to the significant risk of unplanned revenue short-falls
and unplanned expenses, which could adversely affect the company’s actual 2009
annual financial results and end of year cash position; (vii) the company’s
patent applications for its proprietary or partner product candidates may not
issue, patents that have issued may not be enforceable, or intellectual property
licenses from third parties may be required in the future; (viii) the outcome of
any existing or future intellectual property or other litigation related to the
company’s proprietary product candidates; (ix) the market sizes and revenue
potential of the company’s proprietary and partnered product programs are based
on management’s current estimates only and actual market sizes may differ
materially; (x) the overall market size for the partnered product programs and
revenue and profit contribution potential to the company will depend upon
successful sales and marketing efforts by our partners, competition from
competing therapies (if any), government and private insurance reimbursement,
changing standards of care, commercial product profile and product pricing; (xi)
if the company is unable to establish and maintain collaboration partnerships on
attractive commercial terms, our business, results of operations and financial
condition could suffer; and (xii) certain other important risks and
uncertainties set forth in the company’s Annual Report on Form 10-K filed with
the Securities and Exchange Commission on March 6, 2009, the company’s most
recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, and
the company’s Quarterly Report on Form 10-Q for the quarter ended September 30,
2009 expected to be filed by the company on or about November 5,
2009. Actual results could differ materially from the forward-looking
statements made by management during the conference call and in the press
release attached as Exhibit 99.1 hereto. The company undertakes no
obligation to update forward-looking statements, whether as a result of new
information, future events or otherwise.
The
information in this report, including the exhibit hereto, is being furnished and
shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the liabilities
of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933,
as amended. The information contained herein and in the accompanying
exhibit shall not be incorporated by reference into any filing with the
Securities and Exchange Commission made by Nektar Therapeutics, whether
made before or after the date hereof, regardless of any general
incorporation language in such filing.
|
Item 9.01
|
Financial Statements and
Exhibits
|
|
Exhibit No.
|
Description
|
|
99.1
|
Press release titled
“Nektar Therapeutics Reports Third Quarter 2009 Financial
Results” issued on
November
4, 2009.
|
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.
| |
|
|
|
| |
|
|
| |
By:
|
|
/s/
Gil M. Labrucherie
|
| |
|
|
Gil
M. Labrucherie
|
| |
|
|
General
Counsel and Secretary
|
| |
|
|
| |
Date:
|
|
November
4, 2009
|