Nektar Announces Second Quarter 2005 Results.SAN CARLOS San Carlos (săn kär`lōs), residential city (1990 pop. 26,167), San Mateo co., W Calif.; inc. 1925. The chief manufactures are plastic products, hardware, and machine parts. , Calif. -- Nektar Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. (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 in·hale v. in·haled, in·hal·ing, in·hales v.tr. 1. To draw (air or smoke, for example) into the lungs by breathing; inspire. 2. insulin) commercialization readiness for reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. of certain agreed upon Adj. 1. agreed upon - constituted or contracted by stipulation or agreement; "stipulatory obligations" stipulatory noncontroversial, uncontroversial - not likely to arouse controversy operating costs operating costs npl → gastos mpl operacionales 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of showed that Exubera, an inhaleable, short-acting, dry powder Dry Powder A slang term for cash reserves kept on hand to cover future obligations. Notes: For example, if a venture capitalist expects bad times in the IPO markets you might hear him say something like, "we want to keep enough dry powder around to keep funding our insulin, provided effective, sustained glycemic Glycemic The presence of glucose in the blood. Mentioned in: Cholesterol, High glycemic pertaining to the level of glucose in the blood. control and was well tolerated over two years in adults with type 2 diabetes type 2 diabetes n. See diabetes mellitus. . A fourth study showed that three months of Exubera therapy was well tolerated and as effective as subcutaneous subcutaneous /sub·cu·ta·ne·ous/ (sub?ku-ta´ne-us) beneath the skin. sub·cu·ta·ne·ous adj. Abbr. s.c., SQ Located, found, or placed just beneath the skin; hypodermic. (injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. ) short-acting insulin in achieving tight glycemic control in adults with type 1 diabetes type 1 diabetes n. See diabetes mellitus. . Progress with Selected Partnered Products --On July 26, 2005, UCB UCB - University of California at Berkeley Pharma announced the preliminary results of two pivotal Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials for Cimzia(TM), formerly CDP CDP (cytidine diphosphate): see cytosine. (1) (Certificate in Data Processing) An earlier award for the successful completion of an examination in hardware, software, systems analysis, programming, management and accounting, 870, in the treatment of Crohn's disease
The treatment of Crohn's disease is sequential: to treat acute disease, and then to maintain remission. Treatment initially involves the use of medications to treat any infection and to reduce inflammation. . 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 Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. 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 The erythropoietin receptor is a 66 kDa peptide and is a member of the cytokine receptor family. The receptor is tyrosine phosphorylated upon binding by erythropoietin and associates with and activates the tyrosine kinase, JAK2. Activator) to treat renal anemia, provided sustained and stable control of hemoglobin hemoglobin (hē`məglō'bĭn), respiratory protein found in the red blood cells (erythrocytes) of all vertebrates and some invertebrates. levels with dosing intervals dosing interval Therapeutics The frequency of intermittent drug administration, based on the drug's half-life. See Slow-release drug. up to four weeks in dialysis dialysis (dīăl`ĭsĭs), in chemistry, transfer of solute (dissolved solids) across a semipermeable membrane. Strictly speaking, dialysis refers only to the transfer of the solute; transfer of the solvent is called osmosis. 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 Investor relations The process by which the corporation communicates with its investors. 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 United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. 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 Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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 ERA-EDTA European Renal Association - European Dialysis and Transplant Association 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.
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