-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OBVf8Duwzeq701ZlfO/juNbciP5xJf9YKbFsLVbNx26lWCtLeR3TapQPac4NqaZ4 VLFR1VNtipHIDdD6EbUjiA== 0001157523-05-007069.txt : 20050804 0001157523-05-007069.hdr.sgml : 20050804 20050804161900 ACCESSION NUMBER: 0001157523-05-007069 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050804 ITEM INFORMATION: Results of Operations and Financial Condition FILED AS OF DATE: 20050804 DATE AS OF CHANGE: 20050804 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEKTAR THERAPEUTICS CENTRAL INDEX KEY: 0000906709 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943134940 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24006 FILM NUMBER: 05999651 BUSINESS ADDRESS: STREET 1: 150 INDUSTRIAL RD CITY: SAN CARLOS STATE: CA ZIP: 94070 BUSINESS PHONE: 6506313100 MAIL ADDRESS: STREET 1: 150 INDUSTRIAL ROAD CITY: SAN CARLOS STATE: CA ZIP: 94070 FORMER COMPANY: FORMER CONFORMED NAME: INHALE THERAPEUTIC SYSTEMS INC DATE OF NAME CHANGE: 19980723 FORMER COMPANY: FORMER CONFORMED NAME: INHALE THERAPEUTIC SYSTEMS DATE OF NAME CHANGE: 19940303 8-K 1 a4946514.txt NEKTAR THERAPEUTICS 8-K - -------------------------------------------------------------------------------- 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 4, 2005 NEKTAR THERAPEUTICS (Exact name of Registrant as specified in its charter) Delaware 0-24006 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 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 August 4, 2005, Nektar Therapeutics issued a press release (the "Press Release") announcing results for the three-month and six-month periods ended June 30, 2005. 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 4, 2005 By: /s/ AJAY BANSAL --------------- Ajay Bansal Chief Financial Officer and Vice President, Finance and Administration Date: August 4, 2005 EXHIBIT INDEX Exhibit No. Description - ----------- ----------- 99.1 Earnings Press Release of Nektar Therapeutics dated August 4, 2005. EX-99.1 2 a4946514ex991.txt NEKTAR THERAPEUTICS EXHIBIT 99.1 Exhibit 99.1 Nektar Announces Second Quarter 2005 Results SAN CARLOS, Calif.--(BUSINESS WIRE)--Aug. 4, 2005--Nektar Therapeutics (Nasdaq:NKTR) announced today its financial results for the second quarter ended June 30, 2005. The company reported revenue of $28.6 million for the three months ended June 30, 2005, compared to $28.5 million for the three months ended June 30, 2004. In the second quarter of 2005, product and royalty revenue was $5.5 million compared to $6.4 million in 2004, and contract research revenue totaled $19.6 million compared to $22.1 million in the second quarter of 2004. Nektar also reported that in the second quarter of 2005 the company received $3.5 million from Pfizer for Exubera(R) (inhaled insulin) commercialization readiness for reimbursement of certain agreed upon operating costs related to the Exubera drug powder manufacturing facility in preparation for commercial production. Nektar reported a net loss of $26.9 million or $(0.32) per share for the three months ended June 20, 2005 compared to a net loss of $22.2 million or $(0.27) per share for the three months ended June 30, 2004. For the six months ended June 30, 2005, Nektar reported total revenue of $57.0 million compared to $54.4 million for the six months ended June 30, 2004. For the six months ended June 30, 2005, product and royalty revenue was $11.9 million compared to $10.7 million for the six months ended June 30, 2004, and contract research revenue totaled $39.1 million compared to $43.6 million for the six months ended June 30, 2004. Exubera commercialization readiness revenue totaled $6.1 million for the first six months of 2005. For the six months ended June 30, 2005, Nektar reported a net loss of $53.1 million or $(0.63) per share compared to a net loss for the six months ended June 30, 2004 of $62.2 million or $(0.85) per share. As of June 30, 2005, the company reported cash, cash equivalents and short-term investments of approximately $378.5 million compared to $401.3 million as of March 31, 2005. Summary of Progress FDA Sets Exubera Advisory Committee Date "We were pleased to note that the Food and Drug Administration (FDA) has set the date of September 8, 2005 for the Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the New Drug Application for Exubera. This is another significant announcement for this important product," said Ajit S. Gill, president and CEO of Nektar. Nektar developed the inhalers and the powdered insulin formulation for the Exubera product, a joint-development program between Pfizer Inc. and the sanofi-aventis Group. Encouraging Exubera Data Presented During Second Quarter Results from three two-year studies presented in June 2005 at the 65th Annual Scientific Sessions of the American Diabetes Association showed that Exubera, an inhaleable, short-acting, dry powder insulin, provided effective, sustained glycemic control and was well tolerated over two years in adults with type 2 diabetes. A fourth study showed that three months of Exubera therapy was well tolerated and as effective as subcutaneous (injectable) short-acting insulin in achieving tight glycemic control in adults with type 1 diabetes. Progress with Selected Partnered Products -- On July 26, 2005, UCB Pharma announced the preliminary results of two pivotal Phase III trials for Cimzia(TM), formerly CDP870, in the treatment of Crohn's disease. The trials compared Cimzia to placebo in 1,330 patients over a period of 26 weeks and data demonstrated that Cimzia was well-tolerated and met primary endpoints. Cimzia uses Nektar PEGylation Technology. -- UCB Pharma also announced that CDP791 successfully completed Phase I. Phase II trials for non-small cell lung cancer will start in the next few weeks. Another product, CDP484 is on hold after Phase I studies failed to meet the criteria to proceed. Both of these products use Nektar PEGylation Technology. -- On June 6, 2005, Roche announced new data from a year-long Phase II study that show that Roche's CERA (Continuous Erythropoietin Receptor Activator) to treat renal anemia, provided sustained and stable control of hemoglobin levels with dosing intervals up to four weeks in dialysis patients who suffer from anemia.(1) CERA uses Nektar PEGylation Technology. Conference Call Ajit S. Gill will host a conference call for analysts and investors today 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 is posted on the Investor Relations section of Nektar's website at http://www.nektar.com. The web broadcast of the conference call will be available for replay through August 18, 2005. Analysts and investors can also access the conference call live via telephone by dialing (877) 691-2551 (U.S.); (630) 691-2747 (International). The passcode is 12290907 and the host is Mr. Ajit Gill. An audio replay will be available shortly following the call through August 18, 2005 and can be accessed by dialing (877) 213-9653 (U.S.); or (630) 652-3041 (International) with a passcode of 12290907. In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, 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 enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance. This release contains forward-looking information about a product candidate which is under review by the United States Food and Drug Administration and the European Medicines Evaluation Agency that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, whether and when such regulatory authorities will approve the product candidate, their decisions regarding labeling and other matters that could affect its commercial potential as well as competitive developments. 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, developments in connection with the regulatory approval process for Exubera, including an upcoming meeting of an FDA Advisory Committee, meetings with the FDA's advisory committee 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, as amended, for the year ended December 2004 and its Quarterly Report on 10-Q for the quarter ended March 31, 2005. Actual results could differ materially from these forward-looking statements. (1) Locatellis, Francesco et al. Subcutaneous CERA (Continuous Erythropoietin Receptor Activator) Maintains Hemoglobin Concentrations With Dosing Intervals Up to 4 Weeks In Dialysis Patients. ERA-EDTA 2005. NEKTAR THERAPEUTICS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ( In thousands, except per share information) Three Months Ended Six Months Ended June 30, June 30, ------------------ ------------------ 2005 2004 2005 2004 -------- -------- -------- -------- (unaudited) (unaudited) Revenue: Contract research revenue $ 19,552 $ 22,102 $ 39,081 $ 43,611 Product sales and royalty revenue 5,470 6,425 11,862 10,747 Exubera(R) commercialization readiness revenue 3,528 - 6,101 - -------- -------- -------- -------- Total revenue 28,550 28,527 57,044 54,358 Operating costs and expenses: Cost of goods sold 5,433 6,733 10,688 9,269 Exubera(R) commercialization readiness costs 2,666 - 4,960 - Research and development 35,785 33,650 70,730 64,942 General and administrative 10,135 8,072 19,245 14,900 Amortization of other intangible assets 981 981 1,963 1,962 -------- -------- -------- -------- Total operating costs and expenses 55,000 49,436 107,586 91,073 -------- -------- -------- -------- Loss from operations (26,450) (20,909) (50,542) (36,715) Gain/(loss) on extinguishment of debt - - - (9,258) Other income/ (expense), net (118) 124 (1,403) 431 Interest income 2,512 1,608 4,784 2,854 Interest expense (2,856) (2,987) (5,916) (19,344) -------- -------- -------- -------- Net loss before provision for income taxes (26,912) (22,164) (53,077) (62,032) Provision for income taxes - - - 132 -------- -------- -------- -------- Net loss $(26,912) $(22,164) $(53,077) $(62,164) ======== ======== ======== ======== Basic and diluted net loss per common share $ (0.32) $ (0.27) $ (0.63) $ (0.85) ======== ======== ======== ======== Shares used in computing basic and diluted net loss per common share 85,040 83,501 84,875 72,858 ======== ======== ======== ======== NEKTAR THERAPEUTICS CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) June 30, December 31, 2005 2004 (unaudited) (2) ----------- ----------- ASSETS Current assets: Cash, cash equivalents and short-term investments $ 378,507 $ 418,740 Inventory 12,781 10,691 Other current assets 19,994 25,108 ---------- ---------- Total current assets 411,282 454,539 Property and equipment, net 146,371 151,247 Goodwill 129,986 130,120 Other intangible assets 4,202 6,456 Deposits and other assets 2,214 2,559 ---------- ---------- $ 694,055 $ 744,921 ========== ========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 26,372 $ 24,231 Capital lease obligations - current 408 1,532 Deferred revenue 27,764 29,890 ---------- ---------- Total current liabilities 54,544 55,653 Convertible subordinated debentures 173,949 173,949 Accrued rent 2,087 2,117 Capital lease obligations - noncurrent 20,536 23,568 Other long-term liabilities 21,615 22,292 Stockholders' equity: Preferred stock at par - - Common stock at par 9 8 Capital in excess of par 1,196,277 1,187,575 Deferred compensation (3,897) (2,764) Accumulated other comprehensive gain/(loss) (867) (356) Accumulated deficit (770,198) (717,121) ---------- ---------- Total stockholders' equity 421,324 467,342 ---------- ---------- $ 694,055 $ 744,921 ========== ========== (2) The balance sheet at December 31, 2004 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 Jennifer Ruddock, 650-631-4954 -----END PRIVACY-ENHANCED MESSAGE-----