|
Delaware
|
0-24006
|
94-3134940
|
||
|
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File
Number)
|
(IRS
Employer
Identification
No.)
|
|
¨
|
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
|
|
|
1.
|
Nektar’s
proprietary drug candidates, including NKTR-118, NKTR-102, Amikacin
Inhale, 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,
maufacturing challenges or other factors that can impact drug
development;
|
|
|
2.
|
The
Phase 2 results for NKTR-102 in ovarian previously announced by Nektar in
2010 remain subject to final data gathering and analysis review and
confirmation procedures and the final results for the ovarian cancer trial
may differ materially and
adversely;
|
|
|
3.
|
The
expansion of the Phase 2 study in women with platinum-resistant/refractory
ovarian cancer will necessarily change the efficacy results (e.g. overall
response rates, progression-free survival etc.) and safety observations
(i.e. frequency and severity of serious adverse events) and, as such, the
previously announced results from the Phase 2 study for ovarian cancer
remain subject to change and the final results could be materially and
adversely;
|
|
|
4.
|
Approval
of an NDA by the FDA almost always requires the sponsor to conduct Phase 3
clinical studies prior to consideration and approval of an NDA and, as a
result, review and/or approval of an NDA by the FDA based on Phase 2
results for NKTR-102 in platinum-resistant/refractory ovarian cancer prior
to completion of Phase 3 clinical studies would be unusual and is highly
unlikely;
|
|
|
5.
|
The
initial preliminary RECIST response data for the NKTR-102 clinical trial
in metastatic breast cancer reported by Nektar in a press release issued
on June 9, 2010 is subject to substantial change as the trial continues to
progress since that date and such substantial change could be material and
adverse;
|
|
|
6.
|
If
Nektar is unable to establish and maintain collaboration partnerships or
appropriate transaction structures relating to its drug candidates, such
as for NKTR-102, on attractive commercial terms, our business, results of
operations and financial condition could
suffer;
|
|
|
7.
|
The
timing of any new collaboration partnerships or other similar transactions
is difficult to predict due to availability of clinical data, the number
of potential partners that need to complete due diligence and approval
processes, and numerous other unpredictable factors that can delay, impede
or prevent significant
transactions;
|
|
|
8.
|
The
timing and/or success of the commencement or end of clinical trials,
including without limitation the anticipated Phase 3 commencement for
NKTR-118 and Amikacin Inhale, may be delayed or unsuccessful due to
regulatory delays, clinical trial design (and regulatory concurrence for
design), slower than anticipated patient enrollment, manufacturing
challenges, changing standards of care or clinical
outcomes;
|
|
|
9.
|
Scientific
discovery of new medical breakthroughs is an inherently uncertain process
and the future success of the application of Nektar’s technology platforms
to potential new drug candidates is therefore very uncertain and
unpredictable and we expect numerous research and development programs to
fail;
|
|
|
10.
|
Management’s
financial projections for 2010 revenue and year-end cash position are
subject to significant risks of unplanned revenue and/or cash short-falls
and unplanned expenses, which could adversely affect Nektar’s actual 2010
annual financial results and year-end cash
position;
|
|
|
11.
|
Nektar’s
patent applications for its proprietary or partner product candidates may
not issue, patents that have issued may not be enforceable, or additional
intellectual property licenses from third parties may be required in the
future;
|
|
|
12.
|
The
outcome of any existing or future intellectual property or other
litigation related to Nektar’s proprietary product candidates or partner
product candidates where Nektar has indemnification responsibility is
unpredictable and could have a material adverse effect on our business,
results of operations and financial
condition;
|
|
|
13.
|
The
market sizes for Nektar’s proprietary and partnered product programs are
based on management’s current estimates only and actual market sizes may
differ materially and adversely;
and
|
|
|
14.
|
Other
important risks and uncertainties set forth in Nektar’s Quarterly Report
on Form 10-Q filed with the SEC for the quarter ended June 30,
2010.
|
|
Item 9.01
|
Financial
Statements and Exhibits
|
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
release titled “Nektar Therapeutics Reports Third Quarter 2010 Financial
Results” issued by Nektar Therapeutics on November 4,
2010.
|
|
|
By:
|
/s/
Gil M. Labrucherie
|
||
|
Gil
M. Labrucherie
|
|||
|
General
Counsel and Secretary
|
|||
|
Date:
|
November
4, 2010
|
||
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
release titled “Nektar Therapeutics Reports Third Quarter 2010 Financial
Results” issued by Nektar Therapeutics on November 4,
2010.
|
|
Nektar Therapeutics Reports Third Quarter 2010 Financial Results
SAN CARLOS, Calif., Nov. 4 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the third quarter ended September 30, 2010.
Cash, cash equivalents, and short-term investments at September 30, 2010 were $303.3 million as compared to $396.2 million at December 31, 2009.
Revenue for the third quarter of 2010 increased to $37.9 million as compared to $10.2 million in the third quarter of 2009. The increase in revenue year over year is largely the result of the amortization of the $125 million milestone payment received from AstraZeneca in September 2009 under the partnership agreement for NKTR-118.
Total operating costs and expenses in the third quarter of 2010 were $44.2 million compared to $39.1 million in the third quarter 2009. The increase in total operating costs and expenses was primarily due to an increase in research and development expenses.
Research and development expenses were $27.7 million and increased by 20% in the third quarter of 2010 as compared to $23.0 million for the same quarter in 2009. General and administrative expense increased slightly to $10.2 million in the third quarter 2010 from $9.9 million in the third quarter of 2009.
“Nektar’s continued productivity in research and development has resulted in a deep pipeline of programs that range from those in preclinical research to those preparing for Phase 3,” said Howard W. Robin, President and Chief Executive Officer of Nektar. “With our Phase 2 data this year from our exciting oncology candidate, NKTR-102, and the preclinical data from our new opioid candidate, NKTR-181, we continue to demonstrate the value of Nektar’s proprietary polymer conjugate technology.”
Net loss for the third quarter ended September 30, 2010 decreased to $8.7 million or $0.09 per share as compared to a net loss of $31.0 million or $0.33 per share in the third quarter of 2009.
Conference Call to Discuss Third Quarter 2010 Financial Results
A conference call to review the financial results will be held today, Thursday, November 4, 2010 at 2 PM Pacific Time.
Details are below:
The press release and 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. The web broadcast of the conference call will be available for replay through Friday, November 19, 2010.
|
|
To access the conference call, follow these instructions: |
|
|
|
|
|
|
|
Dial: ( 800) 798-2864 (U.S.); ( 617) 614-6206 (international) |
|
|
|
Passcode: 87996589 (Nektar is the host) |
|
An audio replay will also be available shortly following the call through Friday, November 19, 2010 and can be accessed by dialing (888) 286-8010 (U.S.); or (617) 801-6888 (international) with a passcode of 55049373.
In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call.
About Nektar
Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for Nektar's oral NKTR-118 development program to treat opioid-induced constipation and its NKTR-119 development program for the treatment of pain without constipation side effects. The company has additional pain compounds in preclinical studies. In oncology, NKTR-102, a novel topoisomerase I-inhibitor, is being evaluated in Phase 2 clinical studies for the treatment of ovarian, breast and colorectal cancers. NKTR-105, a novel anti-mitotic agent, is in a Phase 1 clinical study in cancer patients with refractory solid tumors.
Nektar's technology has enabled nine approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia(R) for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS(R) for hepatitis C and Amgen's Neulasta(R) for neutropenia.
Nektar is headquartered in San Carlos, California, with additional R&D operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.
This press release contains forward-looking statements that reflect management's current views regarding the value and potential of Nektar's pipeline of drug candidates, the value and potential of Nektar's technology platform, and the value and potential of certain of Nektar's collaborations with third parties. These forward-looking statements involve numerous risks and uncertainties, including but not limited to: (i) Nektar's 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 prior to regulatory approval for numerous reasons including safety and efficacy findings even after positive findings in preclinical and clinical studies; (ii) the timing of the commencement or end of clinical trials and the successful commercial launch of our drug candidates may be delayed or unsuccessful due to slower than anticipated patient enrollment, manufacturing challenges, chan ging standards of care, regulatory delays and requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iii) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of Nektar's technology platforms to potential new drug candidates is therefore very uncertain and unpredictable and one or more research and development programs could fail; (iv) Nektar's patent applications for its proprietary or partner product candidates may not issue, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required in the future; (v) the outcome of any future intellectual property or other litigation related to Nektar's proprietary product candidates or complex commercial agreements; (vi) if Nektar is unable to establish and maintain collaboration partnerships on at tractive commercial terms (such as for NKTR-102), our business, results of operations and financial condition could suffer; and (vii) certain other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010 filed with the SEC on July 28, 2010, the Current Report on Form 8-K filed with the SEC today, and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 to be filed with the SEC on or about November 4, 2010. Actual results could differ materially from the forward-looking statements contained in this press release. Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise.
|
Nektar Investor Inquiries: |
|
|
Jennifer Ruddock/Nektar Therapeutics |
|
|
(650) 631-4954 |
|
|
|
|
|
Susan Noonan/SA Noonan Communications, LLC |
|
|
(212) 966-3650 |
|
|
|
|
|
Nektar Media Inquiries: |
|
|
Karen Bergman/BCC Partners |
|
|
(650) 575-1509 |
|
|
|
|
|
Michelle Corral/BCC Partners |
|
|
(415) 794-8662 |
|
|
NEKTAR THERAPEUTICS |
||||||
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||
|
(In thousands) |
||||||
|
(Unaudited) |
||||||
|
|
|
|
|
|||
|
ASSETS |
September 30, 2010 |
|
December 31, 2009 (1) |
|||
|
Current assets: |
|
|
|
|||
|
|
Cash and cash equivalents |
$ 12,906 |
|
$ 49,597 |
||
|
|
Short-term investments |
290,396 |
|
346,614 |
||
|
|
Accounts receivable |
5,553 |
|
4,801 |
||
|
|
Inventory |
11,460 |
|
6,471 |
||
|
|
Other current assets |
6,119 |
|
6,183 |
||
|
|
|
Total current assets |
$ 326,434 |
|
$ 413,666 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
97,686 |
|
78,263 |
|||
|
Goodwill |
76,501 |
|
76,501 |
|||
|
Other assets |
1,855 |
|
7,088 |
|||
|
|
Total assets |
$ 502,476 |
|
$ 575,518 |
||
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|||
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|||
|
|
Accounts payable |
$ 4,403 |
|
$ 3,066 |
||
|
|
Accrued compensation |
10,552 |
|
10,052 |
||
|
|
Accrued expenses |
12,352 |
|
4,354 |
||
|
|
Accrued clinical trial expenses |
12,759 |
|
14,167 |
||
|
|
Deferred revenue, current portion |
40,232 |
|
115,563 |
||
|
|
Interest payable |
58 |
|
1,805 |
||
|
|
Other current liabilities |
4,476 |
|
4,009 |
||
|
|
|
Total current liabilities |
$ 84,832 |
|
$ 153,016 |
|
|
|
|
|
|
|
|
|
|
Convertible subordinated notes |
214,955 |
|
214,955 |
|||
|
Capital lease obligations |
17,402 |
|
18,800 |
|||
|
Deferred revenue |
69,033 |
|
76,809 |
|||
|
Deferred gain |
4,371 |
|
5,027 |
|||
|
Other long-term liabilities |
4,936 |
|
4,544 |
|||
|
|
|
Total liabilities |
$ 395,529 |
|
$ 473,151 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|||
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|||
|
|
Preferred stock |
$ - |
|
$ - |
||
|
|
Common stock |
9 |
|
9 |
||
|
|
Capital in excess of par value |
1,347,800 |
|
1,327,942 |
||
|
|
Accumulated other comprehensive income |
1,105 |
|
1,025 |
||
|
|
Accumulated deficit |
(1,241,967) |
|
(1,226,609) |
||
|
|
|
Total stockholders' equity |
$ 106,947 |
|
$ 102,367 |
|
|
|
Total liabilities and stockholders' equity |
$ 502,476 |
|
$ 575,518 |
||
|
|
|
|
|
|
|
|
|
(1) The consolidated balance sheet at December 31, 2009 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. |
||||||
|
NEKTAR THERAPEUTICS |
|||||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||
|
(In thousands, except per share information) |
|||||||||
|
(Unaudited) |
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|||||
|
|
|
September 30, |
|
September 30, |
|||||
|
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
||
|
Product sales and royalties |
$ 7,230 |
|
$ 7,461 |
|
$ 21,968 |
|
$ 24,456 |
||
|
License, collaboration and other |
30,695 |
|
2,762 |
|
91,757 |
|
8,466 |
||
|
Total revenue |
37,925 |
|
10,223 |
|
113,725 |
|
32,922 |
||
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
||
|
Cost of goods sold |
6,245 |
|
6,134 |
|
15,430 |
|
22,139 |
||
|
Research and development |
27,724 |
|
23,031 |
|
76,610 |
|
70,396 |
||
|
General and administrative |
10,181 |
|
9,917 |
|
29,401 |
|
30,024 |
||
|
Total operating costs and expenses |
44,150 |
|
39,082 |
|
121,441 |
|
122,559 |
||
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
(6,225) |
|
(28,859) |
|
(7,716) |
|
(89,637) |
||
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income (expense): |
|
|
|
|
|
|
|
||
|
Interest income |
369 |
|
560 |
|
1,225 |
|
3,160 |
||
|
Interest expense |
(2,826) |
|
(2,928) |
|
(8,686) |
|
(9,213) |
||
|
Other income, net |
249 |
|
120 |
|
436 |
|
368 |
||
|
Total non-operating expense |
(2,208) |
|
(2,248) |
|
(7,025) |
|
(5,685) |
||
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision (benefit) for income taxes |
(8,433) |
|
(31,107) |
|
(14,741) |
|
(95,322) |
||
|
|
|
|
|
|
|
|
|
|
|
|
Provision (Benefit) for income taxes |
278 |
|
(140) |
|
617 |
|
(479) |
||
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ (8,711) |
|
$ (30,967) |
|
$ (15,358) |
|
$ (94,843) |
||
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ (0.09) |
|
$ (0.33) |
|
$ (0.16) |
|
$ (1.02) |
||
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding used in |
|
|
|
|
|
|
|
||
|
|
computing basic and diluted net loss per |
|
|
|
|
|
|
|
|
|
|
share |
94,213 |
|
92,789 |
|
93,972 |
|
92,621 |
|
|
NEKTAR THERAPEUTICS |
||||
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||
|
(In thousands) |
||||
|
(Unaudited) |
||||
|
|
|
|
|
|
|
|
Nine Months Ended Sept 30, |
|||
|
|
2010 |
|
2009 |
|
|
Cash flows from operating activities: |
|
|
|
|
|
Net loss |
$ (15,358) |
|
$ (94,843) |
|
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
Depreciation and amortization |
12,499 |
|
11,076 |
|
|
Stock-based compensation |
12,716 |
|
7,290 |
|
|
Deferred rent |
1,084 |
|
- - |
|
|
Other non-cash transactions |
(1,260) |
|
(124) |
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
Accounts receivable |
(752) |
|
4,505 |
|
|
Inventory |
(4,989) |
|
389 |
|
|
Other assets |
1 |
|
(1,272) |
|
|
Accounts payable |
1,755 |
|
(4,047) |
|
|
Accrued compensation |
500 |
|
(1,859) |
|
|
Accrued expenses |
4,090 |
|
(4,610) |
|
|
Accrued clinical trial expenses |
(1,408) |
|
(1,413) |
|
|
Deferred revenue |
(83,107) |
|
(2,722) |
|
|
Other liabilities |
(2,049) |
|
(2,823) |
|
|
Net cash used in operating activities |
$ (76,278) |
|
$ (90,453) |
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
Purchases of investments |
(315,160) |
|
(298,054) |
|
|
Sales of investments |
10,290 |
|
11,923 |
|
|
Maturities of investments |
360,906 |
|
266,202 |
|
|
Transaction costs from Novartis pulmonary asset sale |
- - |
|
(4,440) |
|
|
Purchases of property and equipment |
(22,160) |
|
(10,763) |
|
|
Net cash provided by investing activities |
$ 33,876 |
|
$ (35,132) |
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
Payments of loan and capital lease obligations |
(1,119) |
|
(935) |
|
|
Proceeds from issuances of common stock |
7,142 |
|
3,821 |
|
|
Net cash provided by financing activities |
$ 6,023 |
|
$ 2,886 |
|
|
Effect of exchange rates on cash and cash equivalents |
(312) |
|
(108) |
|
|
Net decrease in cash and cash equivalents |
$ (36,691) |
|
$ (122,807) |
|
|
Cash and cash equivalents at beginning of period |
49,597 |
|
155,584 |
|
|
Cash and cash equivalents at end of period |
$ 12,906 |
|
$ 32,777 |
|
CONTACT: Investor Inquiries, Jennifer Ruddock of Nektar Therapeutics, +1-650-631-4954; or Susan Noonan of SA Noonan Communications, LLC, +1-212-966-3650, or Media Inquiries, Karen Bergman, +1-650-575-1509; or Michelle Corral, +1-415-794-8662, both of BCC Partners, for Nektar Therapeutics