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): May 6, 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:
|
¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
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¨
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
2.02
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Results
of Operations and Financial
Condition
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On May 6,
2009, Nektar Therapeutics issued a press release (the “Press Release”)
announcing its financial results for the first quarter ended March 31,
2009. A copy of the Press Release is furnished herewith as
Exhibit 99.1.
On April
29, 2009, the company announced that management would hold a conference call on
May 6, 2009 to review its financial results for the quarter ended March 31, 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 technology platform, 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 preliminary Phase 2 results
for NKTR-118 presented by management on the conference call remain subject to
change based on completion of the final data gathering and analysis; (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 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 final 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 and the company’s most recent Quarterly Report on Form 10-Q to be
filed on or about May 8, 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.
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Item 9.01
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Financial
Statements and Exhibits
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Exhibit No.
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Description
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99.1
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Press
release titled “Nektar Therapeutics Reports
First Quarter 2009 Financial Results” issued on May 6,
2009.
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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/
Gil M. Labrucherie
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Gil
M. Labrucherie
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||
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General
Counsel and Secretary
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||
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Date:
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May
6, 2009
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News
Release
Nektar
Therapeutics Reports First Quarter 2009 Financial Results
SAN CARLOS, Calif., May 6,
2009 — Nektar Therapeutics (Nasdaq: NKTR) today reported its financial
results for the first quarter ended March 31, 2009.
Net loss
for the quarter ended March 31, 2009 was $31.8 million or $0.34 per share,
compared to net loss of $40.7 million or $0.44 per share in the first quarter of
2008.
Nektar
made improvements to its operating efficiencies as compared to a year ago. Total
operating costs and expenses were down 35% to $40.0 million in the first quarter
of 2009 as compared to $61.9 million in the first quarter of 2008.
“Nektar
continues to make great progress advancing our clinical pipeline and delivering
on our objectives in the first quarter of 2009,” stated Howard W. Robin,
President and Chief Executive Officer of Nektar. “Our recently reported
positive Phase 2 data for NKTR-118 provides the first clinical validation of our
advanced polymer conjugate technology with oral small molecule
drugs. With a robust clinical pipeline and a proven technology
platform, Nektar is well-positioned to enter into strategic, high-value
partnerships and capitalize on multiple new product opportunities generated by
our platform.”
Research
and development expense was $23.9 million in the first quarter of 2009 as
compared to $37.4 million for the same quarter in 2008. Included in
the $23.9 million of overall research and development spending is approximately
$13.5 million of investment in Nektar preclinical and clinical development
programs.
Revenue
for the three month period ended March 31, 2009 was $9.7 million compared to
revenue of $20.0 million in the first quarter of 2008. This decrease
in revenue is primarily the result of lower contract research and manufacturing
revenues resulting from the sale of certain of the company’s pulmonary assets to
Novartis.
Cash,
cash equivalents, and short-term investments at March 31, 2009 were $325.3
million.
Conference
Call to Discuss First Quarter 2009 Financial Results
A
conference call to review results will be held on May 6, 2009 at 2 PM Pacific
Time.
Details
are below:
Howard
Robin, president and chief executive officer, and John Nicholson, chief
financial officer, will host a conference call beginning at 5:00 p.m. Eastern
Time (ET)/2:00 p.m. Pacific Time (PT) on Wednesday, May 6, 2009.
A live
audio-only Webcast of the conference call can be accessed through a link that is
posted on the home page and Investor Relations section of the Nektar website:
http://www.nektar.com.
To access
the conference call, follow these instructions:
Dial:
888.396.2369 (U.S.); 617.847.8710 (international)
Participant
Passcode: 82263149 (Howard Robin is the host)
An audio
replay will also be available shortly after the call and will remain so through
May 20, 2009.
To access
the replay, follow these instructions:
Dial:
888-286-8010 (U.S.); 617-801-6888 (international)
Participant
Passcode: 19053055
About
Nektar
Nektar
Therapeutics is a biopharmaceutical company developing novel therapeutics based
on its PEGylation and advanced polymer conjugate technology platforms. Nektar’s
technology and drug development expertise have enabled nine approved products
for partners, which include leading biopharmaceutical companies. Nektar is also
developing a robust pipeline of its own high-value therapeutics that addresses
unmet medical needs by leveraging and expanding its technology platforms to
improve and enable molecules. For more
information on Nektar Therapeutics, please visit http://www.nektar.com.
This
press release contains forward-looking statements that reflect management’s
current views regarding the progress and potential of the company's pipeline of
proprietary drug candidates, the value and potential of the company's technology
platform, and the company’s position to enter into new strategic collaborations
with third parties. These forward-looking statements involve numerous
risks and uncertainties, including but not limited to: (i) the company's
proprietary product candidates and those of its collaboration partners are in
various stages of clinical development and the risk of failure is high and can
unexpectedly occur at any stage of development prior to regulatory approval for
numerous reasons including, without limitation, safety and efficacy findings;
(ii) the timing or success of the commencement or end of clinical trials and
commercial launch of partnered products may be delayed or unsuccessful due to
slower than anticipated patient enrollment, drug manufacturing challenges,
changing standards of care, clinical trial design, clinical outcomes, or delay
or failure in obtaining regulatory approval in one or more important markets;
(iii) 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;
(iv) the outcome of any future intellectual property or other litigation related
to the company's proprietary product candidates or complex commercial
agreements; (v) 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 (vi) 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 and
the company’s most recent Quarterly Report on Form 10-Q to be filed on or about
May 8, 2009. Actual results could differ materially from the
forward-looking statements contained in this press release. The company
undertakes no obligation to update forward-looking statements, whether as a
result of new information, future events or otherwise.
Jennifer
Ruddock, 650-631-4954
Nektar
Therapeutics
Susan
Noonan, (212) 966-3650
SAN
Group
NEKTAR
THERAPEUTICS
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands)
(unaudited)
|
March 31, 2009
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December
31, 2008(1)
|
|||||||
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ASSETS
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||||||||
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Current
assets:
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||||||||
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Cash
and cash equivalents
|
$ | 122,300 | $ | 155,584 | ||||
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Short-term
investments
|
202,999 | 223,410 | ||||||
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Accounts
receivable, net of allowance
|
5,796 | 11,161 | ||||||
|
Inventory
|
13,392 | 9,319 | ||||||
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Other
current assets
|
6,108 | 6,746 | ||||||
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Total
current assets
|
350,595 | 406,220 | ||||||
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Property
and equipment, net
|
75,020 | 73,578 | ||||||
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Goodwill
|
76,501 | 76,501 | ||||||
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Other
assets
|
3,823 | 4,237 | ||||||
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Total assets
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$ | 505,939 | $ | 560,536 | ||||
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LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
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Current
liabilities:
|
||||||||
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Accounts
payable
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$ | 2,675 | $ | 13,832 | ||||
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Accrued
compensation
|
5,437 | 11,570 | ||||||
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Accrued
clinical trial expenses
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14,982 | 17,622 | ||||||
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Accrued
expenses
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11,583 | 9,923 | ||||||
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Deferred
revenue, current portion
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8,416 | 10,010 | ||||||
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Interest
payable
|
58 | 1,805 | ||||||
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Other
current liabilities
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3,486 | 3,612 | ||||||
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Total
current liabilities
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46,637 | 68,374 | ||||||
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Convertible
subordinated notes
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214,955 | 214,955 | ||||||
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Capital
lease obligations
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19,989 | 20,347 | ||||||
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Deferred
revenue
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54,132 | 55,567 | ||||||
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Deferred
gain
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5,682 | 5,901 | ||||||
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Other
long-term liabilities
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5,270 | 5,238 | ||||||
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Total
liabilities
|
346,665 | 370,382 | ||||||
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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
|
9 | 9 | ||||||
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Capital
in excess of par value
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1,315,182 | 1,312,796 | ||||||
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Accumulated
other comprehensive income (loss)
|
(20 | ) | 1,439 | |||||
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Accumulated
deficit
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(1,155,897 | ) | (1,124,090 | ) | ||||
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Total
stockholders' equity
|
159,274 | 190,154 | ||||||
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Total
liabilities and stockholders' equity
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$ | 505,939 | $ | 560,536 | ||||
(1) The
consolidated balance sheet at December 31, 2008 has been derived from the
audited financial statements at that date but does not include all of the
information and notes required by generally accepted accounting principles in
the United States for complete financial statements. Certain 2008 amounts have
been reclassified between line items to conform with the 2009
presentation.
NEKTAR
THERAPEUTICS
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except per share information)
(unaudited)
|
Three-Months Ended March 31,
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||||||||
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2009
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2008
|
|||||||
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Revenue:
|
||||||||
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Product
sales and royalties
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$ | 6,470 | $ | 10,371 | ||||
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Collaboration
and other
|
3,241 | 9,621 | ||||||
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Total
revenue
|
9,711 | 19,992 | ||||||
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Operating
costs and expenses:
|
||||||||
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Cost
of goods sold
|
5,099 | 7,227 | ||||||
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Other
cost of revenue
|
- | 5,334 | ||||||
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Research
and development
|
23,890 | 37,373 | ||||||
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General
and administrative
|
11,020 | 11,947 | ||||||
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Total
operating costs and expenses
|
40,009 | 61,881 | ||||||
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Loss
from operations
|
(30,298 | ) | (41,889 | ) | ||||
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Non-Operating
income (expense):
|
||||||||
|
Interest
income
|
1,650 | 5,013 | ||||||
|
Interest
expense
|
(3,337 | ) | (3,918 | ) | ||||
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Other
Income
|
45 | 302 | ||||||
|
Total
non-operating income (expense)
|
(1,642 | ) | 1,397 | |||||
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Loss
before provision for income taxes
|
(31,940 | ) | (40,492 | ) | ||||
|
Provision
(benefit) for income taxes
|
(133 | ) | 213 | |||||
|
Net
income (loss)
|
$ | (31,807 | ) | $ | (40,705 | ) | ||
|
Basic
and diluted net earnings (loss) per share
|
$ | (0.34 | ) | $ | (0.44 | ) | ||
|
Shares
used in computing basic and diluted net earnings (loss) per
share
|
92,516 | 92,330 | ||||||
NEKTAR
THERAPEUTICS
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands, except per share information)
(unaudited)
|
Three-Months Ended March 31,
|
||||||||
|
2009
|
2008
|
|||||||
|
Cash
flows used in operating activities:
|
||||||||
|
Net
loss
|
$ | (31,807 | ) | $ | (40,705 | ) | ||
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
|
Depreciation
and amortization
|
3,615 | 5,917 | ||||||
|
Stock-based
compensation
|
2,325 | 1,084 | ||||||
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Other
non-cash transactions
|
115 | (112 | ) | |||||
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Changes
in assets and liabilities:
|
||||||||
|
Decrease
(increase) in trade accounts receivable
|
5,365 | 7,597 | ||||||
|
Decrease
(increase) in inventories
|
(4,073 | ) | 1,160 | |||||
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Decrease
(increase) in other assets
|
496 | 2,044 | ||||||
|
Increase
(decrease) in accounts payable
|
(8,095 | ) | (2,033 | ) | ||||
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Increase
(decrease) in accrued compensation
|
(6,133 | ) | (3,932 | ) | ||||
|
Increase
(decrease) in accrued clinical trial expenses
|
(2,640 | ) | 86 | |||||
|
Increase
(decrease) in accrued expenses to contract manufacturers
|
- | (31,994 | ) | |||||
|
Increase
(decrease) in accrued expenses
|
3,364 | (123 | ) | |||||
|
Increase
(decrease) in deferred revenue
|
(3,029 | ) | (1,200 | ) | ||||
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Increase
(decrease) in other liabilities
|
(1,897 | ) | (2,761 | ) | ||||
|
Net
cash used in operating activities
|
(42,394 | ) | (64,972 | ) | ||||
|
Cash
flows from investing activities:
|
||||||||
|
Purchases
of property and equipment
|
(5,104 | ) | (5,281 | ) | ||||
|
Purchases
of investments
|
(85,298 | ) | (156,092 | ) | ||||
|
Maturities
of investments
|
104,458 | 186,758 | ||||||
|
Transaction
costs from Novartis pulmonary asset sale
|
(4,766 | ) | - | |||||
|
Net
cash provided by investing activities
|
9,290 | 25,385 | ||||||
|
Cash
flows used in financing activities:
|
||||||||
|
Proceeds
from issuances of common stock
|
61 | 371 | ||||||
|
Payments
of loan and capital lease obligations
|
(302 | ) | (411 | ) | ||||
|
Net
cash used in financing activities
|
(241 | ) | (40 | ) | ||||
|
Effect
of exchange rates on cash and cash equivalents
|
61 | 10 | ||||||
|
Net
decrease in cash and cash equivalents
|
$ | (33,284 | ) | $ | (39,617 | ) | ||
|
Cash
and cash equivalents at beginning of period
|
$ | 155,584 | $ | 76,293 | ||||
|
Cash
and cash equivalents at end of period
|
$ | 122,300 | $ | 36,676 | ||||