NEKTAR THERAPEUTICS (NASDAQ:NKTR) Files An 8-K Results of Operations and Financial Condition
Item2.02
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Results of Operations and Financial Condition. |
Please see the disclosure relating to the estimated cash and
investments in market securities of Nektar Therapeutics, a
Delaware corporation (the Company), set forth under Item 8.01
Other Events of this Current Report on Form 8-K, which is
incorporated by reference into this Item 2.02.
| Item8.01 | Other Events. |
On January 5, 2017, the Company announced that President and
Chief Executive Officer, Howard W. Robin, will make a
presentation at the upcoming 35th Annual J.P. Morgan Healthcare
Conference in San Francisco at the Westin St. Francis Hotel on
Tuesday, January 10, 2017, at 2:00 p.m. Pacific time.The
presentation will be accessible via a Webcast through a link
posted on the Investors, Investor Events section of the Nektar
website: http://www.nektar.com. In addition, the Company will
webcast the QA breakout session immediately following its
presentation at 2:30 p.m. Pacific Time. This Webcast will be
available for replay until February 17, 2017.
As part of the presentation, Mr.Robin intends to announce that,
based upon the Companys preliminary estimates, as of December31,
2016, the Company had cash and investments in marketable
securities of approximately $389 million.This financial
information has been prepared by and is the responsibility of the
Companys management and has not been audited by the Companys
independent registered public accounting firm. Accordingly, the
Companys independent registered public accounting firm does not
express an opinion on or provide any other form of assurance with
respect to this preliminary data. This financial information is
subject to the completion of the Companys year-end financial
closing procedures, the preparation of the Companys consolidated
financial statements, and the completion of the audit of the
Companys consolidated financial statements as of and for the year
ended December31, 2016, and the Companys actual results may
differ from these estimates.
Mr. Robin also expects to present information, including making
certain forward-looking statements, regarding the potential
future royalty revenues from the Companys partner collaboration
agreements over the next several years, pre-clinical and clinical
development results and the progress and potential for the
Companys proprietary drug development programs, the planned start
date time frames for future clinical trials of the Companys
programs (NKTR-214, NKTR-358, NKTR-255, and NKTR-102), the timing
and availability of future clinical results and regulatory
decisions of the Companys programs (NKTR-181,
ONZEALDTM, NKTR-214, NKTR-358, Ciprofloxacin Dry
Powder for Inhalation, Amikacin Inhale, and
ADYNOVATETM), the potential for submitting a New Drug
Application (NDA) on an accelerated basis to the Food and Drug
Administration (FDA) in the event there is a positive outcome
from the ongoing blinded Phase 3 clinical study for NKTR-181, and
certain other future events.This information and these
forward-looking statements involve substantial risks and
uncertainties including but not limited to:
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The Companys proprietary drug candidates and those of its collaboration partners, including NKTR-181, NKTR-214, ONZEALDTM, NKTR-358, NKTR-255, Ciprofloxacin Dry Powder for Inhalation and Amikacin Inhale, are still in clinical development and the risk of failure remains high and can unexpectedly occur at any time prior to regulatory approval due to lack of efficacy, safety issues, manufacturing challenges or other factors that can impact drug development. |
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The estimated timing of the commencement of and completion of clinical trials and the subsequent availability of clinical trial results may be delayed or unsuccessful due to additional time being required to measure certain clinical trial end points, slower than anticipated patient accrual, regulatory delays, clinical trial design (and regulatory concurrence for design), manufacturing challenges, changing standards of care or unexpected clinical outcomes. |
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The time required for obtaining regulatory decisions is uncertain and difficult to predict. The FDA and other foreign regulatory authorities have substantial discretion, at any phase of development, to terminate clinical studies, require additional clinical development or other testing, delay or withhold registration and marketing approval and mandate product withdrawals, including recalls. |
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The royalty revenue potential from the Companys collaboration partners, including the revenue from the sales of ADYNOVATE and MOVANTIK, is based on managements current estimates only (and in some cases based onthird party data that has not been independently verified by the Company) and actual royalty revenue may differ materially and adversely. The Company relies solely on our collaboration partners to market and sell these products. The Company has very little control over the timing and level of resources that our collaboration partners dedicate to commercial marketing efforts such as the amount of investment in sales and marketing personnel, general marketing campaigns, direct-to-consumer advertising, product sampling, pricing agreements and rebate strategies with government and private payers, manufacturing and supply of drug product, and other marketing and selling activities that need to be undertaken and well executed for a drug to have the potential to achieve commercial success. |
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The Companys 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. |
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The outcome of any existing or future intellectual property or other litigation related to the Companys proprietary product candidates or partner product candidates where the Company has indemnification responsibility is unpredictable and could have a material adverse effect on our business, results of operations and financial condition. |
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The market sizes for the Companys proprietary and partnered product programs are based on managements current estimates only (and in some cases based onthird party data that has not been independently verified by the Company) and actual market sizes may differ materially and adversely. |
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Other important risks and uncertainties set forth in the Companys Quarterly Report on Form 10-Q filed with the SEC on November 4, 2016 for the quarter ended September 30, 2016. |
Actual results could differ materially from the forward-looking
statements and the Company undertakes no obligation to update
forward-looking statements, whether as a result of new
information, future events or otherwise.
About NEKTAR THERAPEUTICS (NASDAQ:NKTR)
Nektar Therapeutics is a biopharmaceutical company. The Company is engaged in the development of a pipeline of drug candidates that utilize its PEGylation and advanced polymer conjugate technology platforms, which are designed to enable the development of new molecular entities that target known mechanisms of action. The Company’s pipeline consists of drug candidates for therapeutic areas, including oncology, pain, anti-infectives and immunology. The Company’s drugs include MOVANTIK (naloxegol) tablets, MOVENTIG, AdYnoVATE, NKTR-102 (next-generation topoisomerase I inhibitor), BAY41-6551 (Amikacin inhale, formerly NKTR-061), NKTR-181 (orally-available mu-opioid analgesic molecule), NKTR-102, NKTR-214 and MoVAnTiK fixed-dose combinations (opioid/naloxegol combinations). Its drugs also include Neulasta (pegfilgrastim), PEGASYS (peginterferon alfa-2a), PEG-INTRON (peginterferon alfa-2b), Somavert (pegvisomant) and Macugen (pegaptanib sodium injection). NEKTAR THERAPEUTICS (NASDAQ:NKTR) Recent Trading Information
NEKTAR THERAPEUTICS (NASDAQ:NKTR) closed its last trading session down -0.13 at 13.51 with 688,984 shares trading hands.
