Full Press Release Details
Nektar Therapeutics Reports Fourth Quarter
and Year-End 2014 Financial Results
SAN FRANCISCO, Calif., February 24, 2015 - Nektar
Therapeutics (Nasdaq: NKTR) today reported its financial results for the fourth quarter and year ended December 31, 2014.
Cash and investments in marketable securities at December 31,
2014 were $262.8 million as compared to $262.0 million at December 31, 2013.
"Nektar begins 2015 in a very strong position with
the imminent launch of MOVANTIK in the U.S., and the E.U. launch to follow soon thereafter," said Howard W. Robin,
President and Chief Executive Officer of Nektar. "As the first approved once-daily oral PAMORA, MOVANTIK
provides a new treatment option for a common and potentially debilitating condition experienced by millions of adult patients
treated with opioids. MOVANTIK is the first oral small molecule medicine to be created using our proprietary polymer
chemistry platform and it represents a tremendous breakthrough for our technology."
"In Q4 2014, our partner Baxter announced the BLA filing
for BAX 855, a longer-acting Factor VIII therapy to treat hemophilia A and Baxter is planning for the approval and launch in late
2015," Robin continued. "Our wholly-owned late-stage clinical pipeline continues to advance as well. Enrollment
is beginning for the Phase 3 program for NKTR-181 and importantly, we will report topline results from our NKTR-102 Phase 3 study
in metastatic breast cancer in March."
Revenue for the year ended December 31, 2014 was $200.7
million as compared to $148.9 million in 2013. The revenue increase was primarily due to the recognition of $105.0 million in
milestones in September 2014 upon the approval of MOVANTIK in the U.S. Revenue for the fourth quarter of 2014 was $19.6
million as compared to $31.1 million in the fourth quarter of 2013. This change is primarily due to a decrease in
non-cash royalty revenue and license revenue. Revenue included non-cash royalty revenue, related to our 2012 royalty
monetization, of $5.2 million and $21.9 million in the fourth quarter and the full year of 2014, respectively, and $9.3
million and $22.1 million in the fourth quarter and the full year of 2013, respectively. This non-cash royalty revenue is
offset by non-cash interest expense.
Total operating costs and expenses for the year ended December
31, 2014 was $217.2 million as compared to $269.1 million in 2013. Total operating costs and expenses decreased primarily as a
result of lower research and development (R&D) expense. Total operating costs and expenses in the fourth quarter of 2014 were
$57.0 million as compared to $67.0 million in the fourth quarter of 2013.
For the year ended December 31, 2014, R&D expense was $147.7
million as compared to $190.0 million in 2013. R&D expense in the fourth quarter of 2014 was $38.5 million as compared to $48.2
million for the fourth quarter of 2013. R&D expense was lower in the fourth quarter of 2014 and the year ended December 31,
2014 as compared to the same periods in 2013 primarily because of lower costs related to the Phase 3 study of etirinotecan pegol
(NKTR-102) in metastatic breast cancer as the study progresses toward completion and the completion of our Phase 2 clinical study
for NKTR-181 in the third quarter of 2013. These decreases in R&D expense in 2014 were partially offset by costs for the ongoing
Phase 1 study of NKTR-171.
General and administrative (G&A) expense for the year ended
December 31, 2014 was $40.9 million as compared to $40.5 million in 2013. G&A expense was $12.2 million in the fourth quarter
of 2014 as compared to $9.8 million in the fourth quarter of 2013. Non-cash interest expense incurred in connection with the 2012
royalty monetization was $5.2 million and $20.9 million in the fourth quarter and year ended December 31, 2014, respectively, as
compared to $5.7 million and $22.3 million in the fourth quarter and year ended December 31, 2013, respectively.
Net loss for the year ended December 31, 2014 was $53.9 million
or $0.42 loss per share as compared to a net loss of $162.0 million or $1.40 loss per share for the year ended December 31, 2013.
Net loss for the fourth quarter of 2014 was $45.7 million or $0.35 loss per share as compared to $47.7 million or $0.41 loss per
share in the fourth quarter of 2013.
Conference Call to Discuss Fourth Quarter and Year-End 2014
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, Tuesday, February 24, 2015.
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, March 30, 2015.
To access the conference call, follow these
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 85106606 (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
Nektar Therapeutics has a robust R&D pipeline in pain,
oncology, hemophilia and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement
with AstraZeneca for MOVANTIK (naloxegol), the first FDA-approved once-daily oral peripherally-acting mu-opioid
receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with
chronic, non-cancer pain. The product is also approved in the European Union as MOVENTIG and is indicated for adult
patients with OIC who have had an inadequate response to laxatives. The AstraZeneca agreement also includes NKTR-119, an
earlier stage development program that is a co-formulation of MOVANTIK and an opioid. NKTR-181, a wholly-owned
mu-opioid analgesic molecule for chronic pain conditions, is in Phase 3 development. NKTR-171, a wholly-owned 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, NKTR-102 is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of
metastatic breast cancer. In hemophilia, BAX 855, a longer-acting PEGylated Factor VIII therapeutic is in Phase 3 development
conducted by partner Baxter. 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.
Nektar's technology has enabled nine approved products in the
U.S. or Europe through partnerships with leading biopharmaceutical companies, including AstraZeneca's MOVANTIK , 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.
MOVANTIK is a trademark and MOVENTIG is a registered
trademark of the AstraZeneca group of companies.
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 of MOVANTIK ,
regulatory and commercial plans for BAX 855, clinical plans for NKTR-181, 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
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) acceptance, review and approval decisions for new drug applications by health authorities is an uncertain and