View:
================================================================================
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): August 2, 2004
NEKTAR THERAPEUTICS
(Exact name of Registrant as specified in its charter)
Delaware 0-23556 94-3134940
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
150 Industrial Road
San Carlos, California 94070
(Address of principal executive offices and Zip Code)
Registrant's telephone number, including area code: (650) 631-3100
================================================================================
Item 12. Results of Operations and Financial Condition
On August 2, 2004, Nektar Therapeutics issued a press release announcing results
for the quarter ended June 30, 2004. A copy of the press release is attached as
Exhibit 99.1 to this Current Report and is incorporated herein by reference.
The information in this report, including the exhibit hereto, 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.
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.
By: /s/ AJIT S. GILL
Ajit S. Gill
-----------------------------------
Chief Executive Officer,
President and Director
Date: August 2, 2004
By: /s/ AJAY BANSAL
Ajay Bansal
-----------------------------------
Chief Financial Officer and Vice
President, Finance and
Administration
Date: August 2, 2004
EXHIBIT INDEX
Exhibit No. Description
- ----------- -----------
99.1 Earnings Press Release of Nektar Therapeutics dated August 2, 2004.
Exhibit 99.1
Nektar Announces Second Quarter 2004 Results
SAN CARLOS, Calif.--(BUSINESS WIRE)--Aug. 2, 2004--Nektar
Therapeutics (Nasdaq:NKTR) announced today its financial results for
the second quarter ended June 30, 2004.
The company reported total revenue of $28.5 million for the three
months ended June 30, 2004, compared to $27.7 million for the three
months ended June 30, 2003. In the second quarter of 2004, product
revenue was $6.4 million compared to $6.5 million in the second
quarter of 2003, and contract research revenue totaled $22.1 million
compared to $21.2 million in the second quarter of 2003.
The company reported a net loss of $22.2 million or $(0.27) per
share for the three months ended June 30, 2004 compared to a net loss
of $13.0 million or $(0.23) per share for the three months ended June
30, 2003.
For the six months ended June 30, 2004, Nektar reported total
revenue of $54.4 million compared to $53.3 million for the six months
ended June 30, 2003. For the six months ended June 30, 2004, product
revenue was $10.7 million compared to $13.7 million for the six months
ended June 30, 2003, and contract research revenue totaled $43.6
million compared to $39.6 million for the six months ended June 30,
2003.
For the six months ended June 30, 2004, Nektar reported a net loss
of $62.2 million or $(0.85) per share compared to a net loss for the
six months ended June 30, 2003 of $33.0 million or $(0.59) per share.
As of June 30, 2004, the company reported cash, cash equivalents
and short-term investments totaling approximately $425.3 million
compared to $467.4 million as of March 31, 2004.
"In the second quarter we continued to see excellent progress and
growth in our product pipeline," said Ajit S. Gill, Nektar president
and chief executive officer (CEO). "First, at the annual conference of
the American Diabetes Association in June, Pfizer and Aventis
presented data from Exubera(R) (inhaled human insulin powder) clinical
trials that increase our confidence in the likelihood of Exubera
realizing its potential as a major contributor to diabetes care.
Second, Eyetech and Pfizer filed for approval of Macugen(TM)
(pegaptanib sodium injection) for age-related macular degeneration,
the leading cause of blindness for the elderly in developed countries.
Further, we expanded our pipeline by adding a new collaboration with
Pfizer to PEGylate a Pfizer product. The PEGylated version of the
undisclosed Pfizer product is already in clinical testing."
Summary of 2nd Quarter 2004 Progress
Exubera
In June, Nektar reported that Pfizer and Aventis announced results
of long-term studies showing sustained glycemic control and pulmonary
function in patients with type 2 diabetes taking Exubera. The data
were presented at the 64th Annual Scientific Sessions of the American
Diabetes conference. They included a pooled analysis of two one-year
open-label studies involving 627 patients with type 2 diabetes showing
that patients who added Exubera to their treatment regimen experienced
no clinically important effect on pulmonary function compared with
patients treated with oral agents alone. Glycemic control was
maintained in both arms. An additional analysis of 209 patients, 159
of whom were treated with Exubera for up to four years, further
supported these findings in type 1 and type 2 patients treated with
Exubera.
As reported in March 2004, the European Medicines Evaluation
Agency (EMEA) has accepted the filing of a marketing authorization
application for Exubera.
Partner Pipeline
On June 17, 2004, Eyetech Pharmaceuticals and Pfizer announced
that they have completed the filing of a New Drug Application (NDA)
with the U.S. Food and Drug Administration (FDA) for Macugen as a
treatment for wet age-related macular degeneration, the leading cause
of severe vision loss in patients older than 50 years of age in the
developed world. Macugen, which uses Nektar Advanced PEGylation
Technology, has been fast-tracked by the FDA given the significant
unmet medical need. Eyetech is also developing Macugen for diabetic
macular edema which is in Phase II clinical trials.
In a separate press release, Nektar today announced an agreement
with Pfizer under which Pfizer will use Nektar Advanced PEGylation
Technology for one of its products. The PEGylated version of this
undisclosed product is in clinical testing.
Proprietary Products Group
Nektar's Proprietary Products Group applies Nektar technologies to
create highly differentiated versions of already-approved drug
molecules. Since January 2003, the Proprietary Products Group has
advanced two products into the clinic.
Conference Call Information
Ajit S. Gill, Nektar president and CEO, will host a conference
call today for analysts and investors beginning at 2:00 p.m. Pacific
Time, to discuss further the company's performance.
Investors can access a live audio-only Webcast through a link that
will be posted on the Investor Relations section at Nektar's Web site
at http://www.nektar.com. The Web broadcast of the conference call
will be available for replay through August 16, 2004.
Analysts and investors can also access the conference call live
via telephone by dialing (888) 862-6557 (US); (630) 691-2748
(international). The passcode is Nektar and the leader is Mr. Ajit
Gill. An audio replay will be available shortly following the call
through August 16, 2004, and can be accessed by dialing (877) 213-9653
(U.S.); or (630) 652-3041 (international) with a passcode of 9483662.
In the event that any non-GAAP financial measure is discussed on the
conference call that is not described in this earnings release,
related information will be made available on the Investor Relations
page at our Web site as soon as practicable after the conclusion of
this conference call.
About Nektar
Nektar Therapeutics provides industry-leading drug delivery
technologies, expertise and manufacturing to enable the development of
high-value, differentiated therapeutics. Nektar's advanced drug
delivery capabilities are designed to enable the company's
biotechnology and pharmaceutical partners to solve drug development
challenges and realize the full potential of their therapeutics, from
developing new molecular entities to managing the life cycles of
established products.
This release contains forward-looking statements that reflect
management's current views as to Nektar's business strategy, product
and technology development plans and funding, collaborative
arrangements, clinical trials, and other future events and operations.
These forward-looking statements involve uncertainties and other risks
that are detailed in Nektar's reports and other filings with the SEC,
including its Annual Report on Form 10-K for the fiscal year ended
December 2003, as amended, and its Quarterly Report on Form 10-Q for
the quarter ended March 31, 2004. Actual results could differ
materially from these forward-looking statements.
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share information)
Three Months Ended Six Months Ended
June 30, June 30,
-------------------- -------------------
2004 2003 2004 2003
--------- --------- --------- ---------
(unaudited) (unaudited)
Revenue:
Contract research revenue 22,102 $ 21,210 $ 43,611 $ 39,603
Product sales 6,425 6,538 10,747 13,673
--------- --------- --------- ---------
Total revenue 28,527 27,748 54,358 53,276
Operating costs and
expenses:
Cost of goods sold 6,733 3,708 9,269 8,330
Research and development 36,451 32,380 70,471 64,521
General and
administrative 5,479 5,136 9,901 10,314
Amortization of other
intangible assets 981 1,127 1,962 2,254
--------- --------- --------- ---------
Total operating costs and
expenses 49,644 42,351 91,603 85,419
--------- --------- --------- ---------
Loss from operations (21,117) (14,603) (37,245) (32,143)
Gain/(loss) on extinguishment
of debt -- 4,320 (9,258) 4,320
Other income/(expense), net 124 132 431 251
Interest income 1,608 1,262 2,854 2,886
Interest expense (2,779) (4,150) (18,814) (8,302)
--------- --------- --------- ---------
Net loss before provision
for income taxes (22,164) (13,039) (62,032) (32,988)
Provision for income taxes -- -- 132 --
--------- --------- --------- ---------
Net loss $(22,164) $(13,039) $(62,164) $(32,988)
========= ========= ========= =========
Basic and diluted net loss
per common share $ (0.27) $ (0.23) $ (0.85) $ (0.59)
========= ========= ========= =========
Shares used in computing
basic and diluted net loss
per common share 83,501 55,718 72,858 55,660
========= ========= ========= =========
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
June 30, 2004 December 31, 2003
(unaudited) (1)
-------------- -----------------
ASSETS
Current assets:
Cash, cash equivalents and
short-term investments $425,271 $285,967
Other current assets 36,020 20,531
-------------- -----------------
Total current assets 461,291 306,498
Restricted investments -- 12,442
Property and equipment, net 157,615 149,388
Goodwill 130,120 130,120
Other intangible assets 8,709 10,963
Deposits and other assets 3,184 7,377
-------------- -----------------
$760,919 $616,788
============== =================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued
liabilities $22,094 $26,797
Capital lease obligations - current 1,469 1,341
Deferred revenue 21,679 18,719
-------------- -----------------
Total current liabilities 45,242 46,857
Convertible subordinated debentures 173,949 359,988
Accrued rent 2,148 2,110
Capital lease obligations - noncurrent 30,472 31,686
Other long-term liabilities 11,747 11,956
Stockholders' equity:
Preferred stock at par -- --
Common stock at par 8 6
Capital in excess of par 1,179,131 778,500
Deferred compensation (3,362) (38)
Accumulated other comprehensive
gain/(loss) (1,017) 958
Accumulated deficit (677,399) (615,235)
-------------- -----------------
Total stockholders' equity 497,361 164,191
-------------- -----------------
$760,919 $616,788
============== =================
(1) The balance sheet at December 31, 2003 has been derived from the
audited financial statements at that date but does not include all of
the information and footnotes required by accounting principles
generally accepted in the United States for complete financial
statements.
CONTACT: Nektar Therapeutics
Joyce Strand, 650-631-3138