SAN FRANCISCO, Feb. 29, 2012 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the fourth quarter and year ended December 31, 2011.
Cash, cash equivalents, and investments at December 31, 2011 were $414.9 million as compared to $315.9 million at December 31, 2010. The 2011 year-end cash balance does not include the $124.0 million payment related to the sale of Cimzia and Mircera royalties also announced today.
“In 2011, Nektar continued to demonstrate that our technology platform is capable of generating multiple new drug candidates in high value therapeutic areas such as pain, oncology and hemophilia,” said Howard W. Robin, President and Chief Executive Officer of Nektar. “In Q4, we achieved excellent results in our Phase 1 program for our new opioid molecule, NKTR-181 for chronic pain, and we are advancing it into Phase 2 this year. We also began enrollment in our Phase 3 BEACON study for NKTR-102 in metastatic breast cancer. Finally, BAX 855, a long-acting PEGylated Factor VIII therapy for hemophilia A, entered Phase 1 clinical development with our partner, Baxter.”
The company also announced today that AstraZeneca is planning regulatory filings in the US and EU in the middle of 2013 for NKTR-118 (naloxegol) in opioid-induced constipation. Naloxegol is currently in Phase 3 clinical development as a once-daily, oral tablet for the treatment of opioid-induced constipation.
Revenue for the fourth quarter of 2011 was $15.8 million. Revenue in the fourth quarter of 2011 decreased as compared to $45.3 million in the fourth quarter of 2010 primarily as a result of the completion as of December 31, 2010 of the amortization of the $125.0 million upfront payment received in 2009 from AstraZeneca for the NKTR-118 and NKTR-119 license agreement.
Total operating costs and expenses in the fourth quarter of 2011 were $50.3 million as compared to $65.9 million in the fourth quarter of 2010. Research and development expense in the fourth quarter of 2011 was $33.3 million as compared to $31.5 million for the fourth quarter in 2010. General and administrative expense was $11.5 million in the fourth quarter of 2011 as compared to $11.6 million in the fourth quarter of 2010.
Net loss for the fourth quarter ended December 31, 2011 was $37.5 million or $0.33 loss per share.
The company also announced upcoming partner events and presentations at the following medical meeting during the first and second quarters of 2012:
- Partner Event: March 26, 2012, FDA PDUFA (Prescription Drug User Fee Act) Date for MAP Pharmaceutical’s LEVADEX for acute treatment of migraine
- Partner Event: March 27, 2012, FDA PDUFA (Prescription Drug User Fee Act) Date for Affymax and Takeda’s peginesatide for renal anemia in patients with chronic kidney disease on dialysis
- IMPAKT Breast Cancer Conference, Brussels, Belgium:
Phase 2 results of NKTR-102 in metastatic breast cancer will be reviewed and the BEACON Phase 3 study design will be highlighted to members of the European breast cancer community.
- Abstract Title: “Significant antitumor activity in a randomized phase 2 study comparing 2 schedules of NKTR-102 in patients with metastatic breast cancer”, Awada A, et. al.
- Abstract/Poster Number: #249
- Session Title/Track: “New Drug Development”
- Date: May 4, 2012, Gold Hall, 16:15 17:20 pm CET
- Abstract Title: “Phase 3 study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in patients (pts) with locally recurrent or metastatic breast cancer (MBC) previously treated with an anthracycline, a taxane, and capecitabine (ATC)”, Cortes, J, et. al.
- Abstract/Poster Number: #173
- Session Title/Track: “New Drug Development”
- Date: May 4, 2012, Gold Hall, 16:15 17:20 pm CET
Conference Call to Discuss Year-end and Fourth Quarter 2011 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT) today, Wednesday, February 29, 2012.
The 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 April 1, 2012.
To access the conference call, follow these instructions:
Dial: (800) 299-0433 (U.S.); (617) 801-9712(international)
Passcode: 34860642 (Nektar Therapeutics is the host)
An audio replay will also be available shortly following the call through Sunday, April 1, 2012 and can be accessed by dialing (888) 286-8010 (U.S.); or (617) 801-6888 (international) with a passcode of 45200354.
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 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 NKTR-118, an investigational drug candidate, which is being evaluated in Phase 3 clinical studies as a once-daily, oral tablet for the treatment of opioid-induced constipation. The agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of NKTR-118 and an opioid. NKTR-181, a novel mu-opioid analgesic, has completed Phase 1 development and is being prepared for a Phase 2 study. In oncology, NKTR-102 is being evaluated in a Phase 3 clinical study for the treatment of metastatic breast cancer and Phase 2 studies for the treatment of ovarian and colorectal cancers. Nektar’s technology has enabled seven 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. Additional development stage products that leverage Nektar’s proprietary technology platform include peginesatide, for which Affymax and partner Takeda submitted an NDA to the FDA in May 2011, and Baxter‘s BAX 855, a long-acting PEGylated rFVIII program which is in Phase 1 clinical development.
Nektar is headquartered in San Francisco, California, with additional R&D 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.
