Full Press Release Details
Nektar Therapeutics Reports Fourth Quarter
and Year-End 2015 Financial Results
SAN FRANCISCO, March 1, 2016 /PRNewswire/ - Nektar Therapeutics
(Nasdaq: NKTR) today reported its financial results for the fourth quarter and year ended December 31, 2015.
Cash and investments in marketable securities at December 31, 2015
were $308.9 million as compared to $262.8 million at December 31, 2014. Cash and investments include the net proceeds from the $250
million private placement of 7.75% Senior Secured Notes due in 2020, which was closed on October 5, 2015. A portion
of the proceeds from this secured debt financing was used to fully redeem the $125.0 million of 12% Senior Secured Notes
"Nektar begins 2016 with two new medicines launched by our
partners in the past year and multiple late-stage drug candidates advancing in the clinic," said Howard W. Robin, President
and Chief Executive Officer of Nektar. "MOVANTIK is performing very well with positive feedback from physicians and patients.
ADYNOVATE was launched in the U.S. in December 2015 and Baxalta recently submitted BLA filings in the U.S. to expand use of ADYNOVATE
to pediatric and surgical settings. The NKTR-181 Phase 3 efficacy study in patients with chronic low back pain is on track
to provide top-line results in early 2017. Finally, NKTR-214, our immuno-oncology candidate, is advancing nicely in a first-in-human
trial evaluating its safety and efficacy in patients with solid tumors. We remain on track to report initial top-line data
from the dose-escalation stage of the NKTR-214 study in the second half of 2016."
Revenue for the year ended December 31, 2015 was $230.8 million
as compared to $200.7 million in 2014. Revenue for the fourth quarter of 2015 was $39.4 million as compared to $19.6 million in
the fourth quarter of 2014. Revenue for the year ended December 31, 2015 includes the recognition of $90.0 million of
the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S., recognition
of the $40.0 million milestone payment from AstraZeneca following the first commercial sale of MOVENTIG in the EU and
recognition of the $10 million milestone payment from Baxalta for the approval and first commercial sale of ADYNOVATE in the U.S.
In addition, product sales and royalty revenue increased by $17.6 million in 2015 as compared to the same period in 2014.
Revenue also included non-cash royalty revenue, related to our 2012
royalty monetization, of $7.3 million and $22.1 million in the fourth quarter and the full year of 2015, respectively, and $5.2
million and $21.9 million in the fourth quarter and the full year of 2014, respectively. This non-cash royalty revenue is substantially
offset by non-cash interest expense, also incurred in connection with the 2012 royalty monetization. Non-cash interest expense
was $5.2 million and $20.6 million in the fourth quarter and year ended December 31, 2015, respectively, as compared to $5.2 million
and $20.9 million in the fourth quarter and year ended December 31, 2014, respectively. Total operating costs and expenses for
the year ended December 31, 2015 were $260.2 million as compared to $217.2 million in 2014. Total operating costs and expenses
increased primarily as a result of higher research and development (R&D) expense. Total operating costs and expenses in the
fourth quarter of 2015 were $68.7 million as compared to $57.0 million in the fourth quarter of 2014.
For the year ended December 31, 2015, R&D expense was $182.8
million as compared to $147.7 million in 2014. R&D expense in the fourth quarter of 2015 was $47.1 million as compared to $38.5
million for the fourth quarter of 2014. R&D expense was higher in the fourth quarter of 2015 and the year ended December 31,
2015 as compared to the same periods in 2014 primarily due to the initiation of the Phase 3 efficacy trial of NKTR-181 in chronic
low back pain and the long-term safety study for NKTR-181. R&D expense for the full year 2015 also increased as a result of
initiation of the Phase 1/2 clinical program for NKTR-214.
General and administrative (G&A) expense for the year ended
December 31, 2015 was $43.3 million as compared to $40.9 million in 2014. G&A expense for the quarter and year ended December
31, 2015 includes the expense and payment of a $3.0 million settlement of a commercial litigation matter. G&A expense
was $13.2 million in the fourth quarter of 2015 as compared to $12.2 million in the fourth quarter of 2014.
Net loss for the year ended December 31, 2015 was $81.2 million
or $0.61 loss per share as compared to a net loss of $53.9 million or $0.42 loss per share for the year ended December 31, 2014.
Net loss for the fourth quarter of 2015 was $54.1 million or $0.40 loss per share as compared to a net loss of $45.7 million or
$0.35 loss per share in the fourth quarter of 2014.
The company also announced upcoming presentations at the following
scientific congresses during the first half of 2016:
ISICEM (International Symposium on Intensive Care and Emergency
Medicine), Brussels, Belgium:
AACR Annual Meeting, New Orleans, LA:
Conference Call to Discuss Fourth Quarter and Year-End 2015 Financial
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, March 1, 2016.
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, April 4, 2016.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 50771255 (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.
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 (naloxegol) 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. In hemophilia, Nektar has a collaboration agreement with Baxalta for ADYNOVATE
[Antihemophilic Factor (Recombinant)], a longer-acting PEGylated Factor VIII therapeutic approved in the U.S. in patients
over 12 with hemophilia A. 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 , Baxalta's ADYNOVATE , 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.
ADYNOVATE is a trademark of Baxalta Inc.
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 advancement of our pipeline, potential of MOVANTIK and ADYNOVATE, target time frames for
availability of future clinical results, and the value and potential of our polymer conjugate 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) the commercial potential of a new drug at the
early stages of commercial launch, such as MOVANTIK and ADYNOVATE, is difficult to predict and will have a significant impact on
our future results of operation and financial condition; (ii) the timing of the commencement or end of clinical trials and the
commercial launch of our drug candidates and those of our partners may be delayed or unsuccessful due to regulatory delays, institutional