Nektar Announces Third Quarter 2005 Financial 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 (Nasdaq:NKTR): --Exubera(R) receives positive recommendations in Europe and US; 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. extends review period by 3 months; --Two proprietary products in clinic address unmet need for prevention of lung infections; --New high-value Baxter agreement to develop PEGylated therapeutic forms of blood clotting blood clotting, process by which the blood coagulates to form solid masses, or clots. In minor injuries, small oval bodies called platelets, or thrombocytes, tend to collect and form plugs in blood vessel openings. proteins; --Chiron and Nektar advance TIP to 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 ; --Aerogen acquisition broadens Nektar pulmonary leadership; --Company strengthens balance sheet. Nektar Therapeutics (Nasdaq:NKTR) announced today its financial results for the third quarter ended September 30, 2005. The Company reported total revenue of $36.4 million for the three months ended September 30, 2005 compared to $28.5 million for the three months ended September 30, 2004. In the third quarter of 2005, product and royalty revenue was $8.5 million compared to $5.0 million in the third quarter of 2004, and contract revenue totaled $23.7 million compared to $23.6 million in the third quarter of 2004. Nektar also reported that in the third quarter of 2005 the Company received $4.2 million from Pfizer for Exubera(R) (inhaled insulin) commercialization readiness for reimbursement 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 $23.8 million or $(0.28) per share for the three months ended September 30, 2005 compared to a net loss of $20.5 million or $(0.24) per share for the three months ended September 30, 2004. For the nine months ended September 30, 2005, Nektar reported total revenue of $93.4 million compared to $82.9 million for the nine months ended September 30, 2004. For the nine months ended September 30, 2005, product and royalty revenue was $20.3 million compared to $15.7 million for the nine months ended September 30, 2004, and contract research revenue totaled $62.7 million compared to $67.2 million for the nine months ended September 30, 2004. Exubera commercialization readiness totaled $10.3 million for the first nine months of 2005. For the nine months ended September 30, 2005, Nektar reported a net loss of $76.9 million or $(0.90) per share compared to a net loss for the nine months ended September 30, 2004 of $82.6 million or $(1.08) per share. As of September 30, 2005, the Company reported cash, cash equivalents and short-term investments of approximately $620.3 million compared to $378.5 million as of June 30, 2005. The cash, cash equivalents and short-term investments include the net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). from the sale of $315 million aggregate principal amount of its 3.25% convertible subordinated notes due 2012. Substantial Progress Made "This quarter Nektar achieved multiple milestones, including the recommendations for Exubera approval, announcement of two proprietary products, and new partner activities," said Ajit S. Gill, president and chief executive officer. Exubera Approval Recommended in the EU and US; FDA Extends Review Period 3 Months "The recommendations of the approval of Exubera in the US and the EU are significant milestones. The next steps for Exubera are final approvals from both regulatory agencies," said Gill. --On September 8, 2005, a US Food and Drug Administration (FDA) advisory committee panel recommended the approval of Exubera (insulin (rDNA origin) powder for oral inhalation), an inhaleable, rapid-acting powder insulin for the treatment of adults with type 1 and type 2 diabetes type 2 diabetes n. See diabetes mellitus. . While the FDA usually follows the advice of its advisory committees, it is not obligated ob·li·gate tr.v. ob·li·gat·ed, ob·li·gat·ing, ob·li·gates 1. To bind, compel, or constrain by a social, legal, or moral tie. See Synonyms at force. 2. To cause to be grateful or indebted; oblige. to do so. --On October 13, 2005, the Committee for Medicinal Products for Human Use “CHMP” redirects here. For French language Canadian radio station, see CHMP-FM. CPMP, Committee for Proprietary Medicinal Products, now CHMP Committee for Medicinal Products for Human Use (CHMP CHMP Committee for Medicinal Products for Human Use CHMP Cultural Heritage Management Plan CHMP Centrale Humanitaire Médico-Pharmaceutique CHMP Certified Hazardous Materials Practitioner (Institute of Hazardous Materials Managers) ) of the European Medicines Evaluation Agency (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) issued a positive opinion recommending approval of Exubera. The European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community is expected to act upon that recommendation early next year. --On October 28, 2005, the FDA notified Pfizer and sanofi-aventis that it is extending its original review period for Exubera by three months. Nektar pioneered the advanced pulmonary technology for Exubera, including the inhaler inhaler /in·hal·er/ (in-hal´er) 1. an apparatus for administering vapor or volatilized medications by inhalation. 2. ventilator (2). in·hal·er n. , the formulation for the powdered insulin, and the manufacturing processes for making and packaging the powdered insulin. Nektar Proprietary Products Target Local Lung Infections in Seriously Ill A patient is seriously ill when his or her illness is of such severity that there is cause for immediate concern but there is no imminent danger to life. See also very seriously ill. Patients; Aerogen Acquisition Broadens Pulmonary Leadership "Nektar announced two proprietary products that highlight how our technology and expertise can generate unique product opportunities for Nektar that will enable us to build a high-value pipeline. These new products could help reduce mortality rates from fungal and bacterial lung infections while reducing the costs of patient treatment. Because they focus on improving existing medicines, they offer a lower risk profile with potential excellent returns-on-investment compared with typical new drug development programs," said Gill. On September 29, 2005 at its Investor Day in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , Nektar disclosed two anti-infective products targeted at preventing local lung infections in seriously ill patients. --Inhaled amphotericin B amphotericin B (ăm'fətĕr`ĭsĭn), antibiotic that halts the growth of several disease-causing fungi. Discovered in 1956, it is produced by bacteria of the genus Streptomyces. product is being developed for preventing fatal pulmonary fungal infections Fungal infections Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans. in immunosuppressed Immunosuppressed A state in which the immune system is suppressed by medications during the treatment of other disorders, like cancer, or following an organ transplantation. Mentioned in: Fifth Disease patients to reduce the incidence, morbidity, mortality and high cost of treating these infections. Using a small proprietary pocket size inhaler, the company has conducted two Phase I trials and has long-term toxicity studies underway to support the planned pivotal trials. More than 150,000 patients annually in the US and Europe are at risk of developing often fatal and costly fungal infections in the lungs. Nektar's inhaleable amphotericin B potentially could be the first prophylactic prophylactic /pro·phy·lac·tic/ (pro?-fi-lak´tik) 1. tending to ward off disease; pertaining to prophylaxis. 2. an agent that tends to ward off disease. pro·phy·lac·tic n. therapy to prevent these serious infections. --Inhaled ICU ICU intensive care unit. ICU abbr. intensive care unit ICU see intensive care unit. ICU antibiotics product is being developed for the prevention of ventilator-associated pneumonia Ventilator-associated pneumonia (VAP) is a sub-type of hospital-acquired pneumonia (HAP) which occurs in people who are on mechanical ventilation through an endotracheal or tracheostomy tube for at least 48 hours. (VAP (Value Added Process) An executable program in a NetWare 2.x server. Starting with NetWare 3.x, VAPs were replaced by NLMs. See NetWare. ) in the intensive care unit (ICU). VAP is a form of hospital-acquired, or nosocomial pneumonia nosocomial pneumonia An infection of lungs–bronchoalveolar unit–in a Pt who has been hospitalized ≥ 48 hrs, and directly attributable to pathogens acquired during the hospital visit Etiology Pseudomonas spp, S aureus, Legionella , occurring in patients on mechanical ventilators. Nektar's novel drug-device system uses a nebulizer nebulizer /neb·u·liz·er/ (neb´u-li?zer) atomizer; a device for throwing a spray. neb·u·liz·er n. and Nektar proprietary adapter technology, along with a unique formulation of liquid antibiotics, to target the lungs directly with preventative doses of medicine in a ventilated ven·ti·late tr.v. ven·ti·lat·ed, ven·ti·lat·ing, ven·ti·lates 1. To admit fresh air into (a mine, for example) to replace stale or noxious air. 2. patient. More than 450,000 patients in the US are at the highest risk for this disease. A proof-of-principle study sponsored by Nektar demonstrated that aerosolized Adj. 1. aerosolized - in the form of ultramicroscopic solid or liquid particles dispersed or suspended in air or gas aerosolised gaseous - existing as or having characteristics of a gas; "steam is water is the gaseous state" antibiotics reduce the persistence of VAP after its onset by approximately half as compared to placebo. The acquisition of Aerogen, Inc., which closed on October 20, 2005, will broaden Nektar's pulmonary technology base by adding capabilities in aerosolized liquid drugs to Nektar's leadership position with inhaleable powdered drugs. Initially, Nektar will incorporate Aerogen technology into its proprietary inhaled ICU antibiotics product. Partner Pipeline Progress: New Collaboration with Baxter; Advances in the Clinic "We also saw progress in our partner pipeline. The new collaboration with Baxter exemplifies the higher value Nektar can gain through investment in early product concept work," said Gill. "The initiation of Phase III trials of tobramycin tobramycin /to·bra·my·cin/ (to?brah-mi´sin) an aminoglycoside antibiotic derived from a complex produced by Streptomyces tenebrarius, inhalation powder (TIP) by Chiron is an indication that our unique powder formulation and advanced inhaleable technologies may enable innovative therapeutics, such as TIP, to target local lung infections." --On September 29, 2005, Nektar announced an agreement with subsidiaries of Baxter International Baxter International Inc. (NYSE: BAX), is a global healthcare company with 48,000 employees and 2006 sales of US$10.4 billion. Its headquarters is in Deerfield, Illinois. Inc. to develop PEGylated therapeutic forms of blood clotting proteins for patients with hemophilia hemophilia (hē'məfĭl`ēə,–fēl`yə), genetic disease in which the clotting ability of the blood is impaired and excessive bleeding results. , in order to reduce the frequency of injections required to treat blood clotting disorders such as hemophilia A hemophilia A n. Hemophilia due to deficiency of factor VIII, characterized by prolonged clotting time, decreased formation of thromboplastin, and diminished conversion of prothrombin. . This agreement allows Nektar to capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. the internal work on PEGylated proteins to provide Baxter with a differentiated product. --On October 5, 2005, Chiron Corporation Chiron Corporation was a multinational biotechnology firm based in Emeryville, California that was acquired by Novartis International AG on April 20 2006. It had offices and facilities in eighteen countries on five continents. and Nektar announced the initiation of clinical testing in the Phase III program evaluating tobramycin inhalation powder (TIP), an investigational inhaled antibiotic. The TIP Phase III program includes two clinical trials and will evaluate the efficacy and safety of TIP in the treatment of lung infections caused by Pseudomonas aeruginosa Pseudomonas aeruginosa A normal soil inhabitant and human saprophyte that may contaminate various solutions in a hospital, causing opportunistic infection in weakened Pts Clinical Infective endocarditis in IVDAs, RTIs, UTIs, bacteremia, meningitis, 'malignant' in patients living with cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. (CF). The first trial, called ASPIRE I, is underway. Conference Call Information 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 November 17, 2005. Analysts and investors can also access the conference call live via telephone by dialing (800) 559-9370 (U.S.); (847) 619-6819 (international). The passcode is 13029999 and the host is Mr. Ajit Gill. An audio replay will be available shortly following the call through November 17, 2005 and can be accessed by dialing (877) 213-9653 (U.S.); or (630) 652-3041 (International) with a passcode of 13029999. 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 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, status of clinical trials, the potential of Nektar's collaborative partnerships to bring new products to market and produce revenue, and developments in connection with the regulatory approval process for Exubera. 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 31, 2004 and its Quarterly Report on 10-Q for the quarter ended June 30, 2005. 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 Nine Months Ended
September 30, September 30,
------------------- -------------------
2005 2004 2005 2004
--------- --------- --------- ---------
(unaudited) (unaudited)
Revenue:
Contract research revenue $ 23,657 $ 23,556 $ 62,737 $ 67,167
Product sales and royalty
revenue 8,450 4,990 20,313 15,737
Exubera(R) commercialization
readiness revenue 4,247 - 10,348 -
--------- --------- --------- ---------
Total revenue 36,354 28,546 93,398 82,904
Operating costs and expenses:
Cost of goods sold 6,125 4,477 16,813 13,746
Exubera(R) commercialization
readiness costs 3,075 - 8,035 -
Research and development 38,591 34,534 109,321 99,476
General and administrative 10,948 7,382 30,193 22,281
Amortization of other
intangible assets 982 981 2,945 2,944
--------- --------- --------- ---------
Total operating costs and
expenses 59,721 47,374 167,307 138,447
--------- --------- --------- ---------
Loss from operations (23,367) (18,828) (73,909) (55,543)
Gain/(loss) on extinguishment
of debt (303) - (303) (9,258)
Other income/ (expense), net (32) (128) (1,435) 303
Interest income 2,899 1,763 7,683 4,617
Interest expense (2,992) (3,259) (8,908) (22,603)
--------- --------- --------- ---------
Net loss before provision for
income taxes (23,795) (20,452) (76,872) (82,484)
(Provision) /benefit for
income taxes - - - (132)
--------- --------- --------- ---------
Net loss $(23,795) $(20,452) $(76,872) $(82,616)
========= ========= ========= =========
Basic and diluted net loss per
common share $ (0.28) $ (0.24) $ (0.90) $ (1.08)
========= ========= ========= =========
Shares used in computing basic
and diluted net loss per
common share 86,228 83,853 85,331 76,550
========= ========= ========= =========
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
September 30, December 31,
2005 2004
(unaudited)
------------- ------------
ASSETS
Current assets:
Cash, cash equivalents and short-term
investments $ 620,328 $ 418,740
Inventory 13,152 10,691
Other current assets 24,729 25,108
----------- -----------
Total current assets 658,209 454,539
Property and equipment, net 144,716 151,247
Goodwill 129,986 130,120
Other intangible assets 3,075 6,456
Deposits and other assets 10,924 2,559
----------- -----------
$ 946,910 $ 744,921
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 25,614 $ 24,231
Capital lease obligations - current 444 1,532
Deferred revenue 21,767 29,890
----------- -----------
Total current liabilities 47,825 55,653
Convertible subordinated debentures 417,653 173,949
Accrued rent 2,071 2,117
Capital lease obligations - noncurrent 20,419 23,568
Other long-term liabilities 24,838 22,292
Stockholders' equity:
Preferred stock at par - -
Common stock at par 9 8
Capital in excess of par 1,232,718 1,187,575
Deferred compensation (3,423) (2,764)
Accumulated other comprehensive
gain/(loss) (1,207) (356)
Accumulated deficit (793,993) (717,121)
----------- -----------
Total stockholders' equity 434,104 467,342
----------- -----------
$ 946,910 $ 744,921
=========== ===========
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