Press Release

SAN FRANCISCO, May 7, 2014 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the first quarter ended March 31, 2014.

Cash and investments in marketable securities at March 31, 2014 were $309.1 million as compared to $262.0 million at December 31, 2013.  Our cash and investments in marketable securities balance at March 31, 2014 includes net proceeds of approximately $117 million from the issuance and sale of 9,775,000 shares of our common stock in a public offering in January 2014.

"Nektar is looking forward to several key milestones for our late-stage clinical drug candidates over the next six to nine months," said Howard W. Robin, President and Chief Executive Officer of Nektar. "Our partner AstraZeneca has filed for regulatory approvals for naloxegol in the U.S., Europe and Canada, with a PDUFA date in the U.S. of September 16, 2014. If approved, naloxegol will be the first once-daily oral drug to treat opioid induced constipation, a debilitating condition for chronic pain patients. Our partner Baxter is completing their Phase 3 study for BAX 855, a longer-acting PEGylated Factor VIII therapy to treat hemophilia A, and plans to file the BLA in the U.S. by the end of this year. NKTR-102, Nektar's wholly-owned Phase 3 program in advanced breast cancer, is on track for topline results in Q1 2015.  Importantly, we are equally focused on our highly promising pipeline of new pain and oncology molecules, which includes advancing NKTR-181 into Phase 3 in chronic pain patients." 

Revenue for the first quarter of 2014 was $19.8 million as compared to $23.0 million in the first quarter of 2013. Revenue included non-cash royalty revenue, related to our 2012 royalty monetization, of $5.8 million and $4.4 million in the three months ended March 31, 2014 and 2013, respectively. This non-cash royalty revenue is offset by non-cash interest expense. The decrease in revenue in the first quarter of 2014 as compared to the first quarter of 2013 is primarily due to a decrease in product sales.

Total operating costs and expenses for the first quarter of 2014 were $56.2 million as compared to $68.1 million in the first quarter of 2013.  Total operating costs and expenses decreased primarily as a result of decreased research and development (R&D) expense.

R&D expense in the first quarter of 2014 was $38.3 million as compared to $45.6 million for the first quarter of 2013.  R&D expense was lower in the first quarter of 2014 primarily because of decreased costs for the Phase 3 study of etirinotecan pegol (NKTR-102) in metastatic breast cancer, which completed enrollment in the third quarter of 2013.  Additionally, R&D expense in the first quarter of 2013 included costs related to the Phase 2 study of NKTR-181, which was completed in 2013.   The decreased R&D expense for the first quarter of 2014 was partially offset by costs for the preparation for the start of Phase 3 for NKTR-181, the ongoing Phase 1 study of NKTR-171, and the continued production of devices for the ongoing Phase 3 studies of Amikacin Inhale.

General and administrative expense was $9.9 million in the first quarter of 2014 as compared to $10.8 million in the first quarter of 2013.

Non-cash interest expense in connection with the 2012 royalty monetization was $5.4 million in the first quarter of 2014 as compared to $5.5 million in the first quarter of 2013. 

Net loss for the first quarter of 2014 was $46.2 million or $0.37 loss per share as compared to a net loss of $55.1 million or $0.48 loss per share in the first quarter of 2013.

The company also announced upcoming presentations at the following medical meetings and scientific congresses during the first half of 2014:

SMI 14th Annual Pain Therapeutics Conference, London, UK:

• Presentation Title: "NKTR-181: An Opioid for Chronic Pain with Intrinsically Low Abuse Potential", Steve Harrison
  • May 19, 2014,  5:00 p.m. British Summer Time
  • Session: How can success in analgesia be improved?

American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL:

• Abstract Title: "Etirinotecan pegol (EP, NKTR-102) in the treatment of high grade glioma (HGG): a phase 2 trial," Nagpal et al.
  • Abstract Number: 2096
  • Session Title/Track: Central Nervous System Tumors
  • Date: May 31, 2014, 1:15 p.m. - 5:00 p.m. Central Time
  • Location: S Hall A2
• Abstract Title: "Combination Immunotherapy: Synergy of a Long-Acting Engineered Cytokine (NKTR-214) and Checkpoint Inhibitors Anti-CTLA-2 or Anti-PD1 in Murine Tumor Models," Kantak et al.
  • Abstract Number: 3082
  • Session Title/Track: Developmental Therapies - Immunotherapy
  • Date: June 1, 2014, 8:00 a.m. - 11:45 a.m. Central Time
  • Location: S Hall A2

Conference Call to Discuss First Quarter 2014 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time today, Wednesday, May 7, 2014.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investor Relations section of the Nektar website: http://www.nektar.com. The web broadcast of the conference call will be available for replay through Monday, June 9, 2014.

To access the conference call, follow these instructions:

Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)    Passcode: 31565461 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, 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 (NASDAQ: NKTR) is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which has been filed for regulatory approvals in the U.S., Europe and Canada as a once- daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid. NKTR-181, a novel mu-opioid analgesic molecule for chronic pain conditions, has completed Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-171, a new sodium channel blocker being developed as an oral therapy for the treatment of peripheral neuropathic pain, is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian, colorectal, lung and brain cancers. In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia. Additional development-stage products that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a long-acting PEGylated rFVIII program, which is in Phase 3 clinical development for patients with hemophilia A.

Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia^® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS^® for hepatitis C and Amgen's Neulasta^® for neutropenia.

Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India.  Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

 

Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential regulatory approval of naloxegol; potential future regulatory filings by Baxter Healthcare for BAX 855; the timing of availability of topline overall survival data for the NKTR-102 BEACON; and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others, (i) our drug candidates and those of our collaboration partners are in various stages of clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval for numerous reasons including safety and efficacy findings even after positive findings in previous preclinical and clinical studies; (ii) the timing of the commencement or end of clinical trials and the commercial launch of our drug candidates may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iii) the United States Food and Drug Administration (FDA) is currently planning to hold an advisory committee meeting in June 2014 to discuss the cardiovascular safety and potential additional safety study requirements for the peripheral mu-opioid receptor antagonist class of drugs, including naloxegol, and the outcome of this advisory committee and the subsequent FDA review determinations for naloxegol will have a significant impact on the Company's financial position based on significant potential regulatory and launch milestone opportunities and potential repayment obligations; (iv) acceptance, review and approval decisions for new drug applications by health authorities is an uncertain and evolving process and health authorities retain significant discretion at all stages of the regulatory review and approval decision process; (v) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of our technology platform to potential new drug candidates is therefore highly uncertain and unpredictable and one or more research and development programs could fail; and (vi) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2014. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

 

 

 

 

SOURCE Nektar Therapeutics