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Nektar Therapeutics Reports Financial Results for the Third Quarter of 2015

Key Takeaway: Therapeutics Reports Financial Results for the Third Quarter of 2015 FRANCISCO, Nov. 5, 2015 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the third quarter ended September 30, 2015. and investments in marketable securities at Sept

Full Press Release Details

Therapeutics Reports Financial Results for the Third Quarter of 2015
FRANCISCO, Nov. 5, 2015 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the third
quarter ended September 30, 2015.
and investments in marketable securities at September 30, 2015 were $267.8 million as compared to $279.7 million at June 30, 2015.
Cash and investments at September 30, 2015 include a $40.0 million milestone payment received from AstraZeneca in Q3 2015 for
the first commercial sale of MOVENTIG (naloxegol) in Germany. Cash and investments at September 30, 2015 do not
include the proceeds from the $250 million direct private placement of 7.75% Senior Secured Notes due in 2020, which was closed
on October 5, 2015. A portion of the proceeds from these new $250 million Senior Notes were used to redeem fully $125.0 million
of 12% Senior Secured Notes due in 2017.
have made great progress in advancing our pipeline this year," said Howard W. Robin, President and Chief Executive Officer
of Nektar. "MOVANTIK is performing very well with positive feedback from physicians and patients, ADYNOVATE is poised for
approval, the NKTR-181 Phase 3 SUMMIT-07 efficacy study is enrolling ahead of schedule and we are exceptionally pleased to report
that the FDA cleared the NKTR-214 IND earlier than anticipated. NKTR-214 has the potential to bring a new mechanism - direct
and selective stimulation of a patient's cancer-fighting T-cells -- to the next generation of cancer immunotherapies. We expect
to dose our first patients shortly at MD Anderson Cancer Center and Yale Cancer Center."
revenue for 2015 was $191.4 million as compared to $181.2 million in the first nine months of 2014. The increase in revenue in
the first nine months of 2015 as compared to the same period in 2014 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. and the recognition of the $40.0
million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in a major European country. In addition,
product sales and royalty revenue increased by $9.3 million in the first nine months of 2015 as compared to the same period in
2014. Revenue in the third quarter of 2015 was $60.0 million as compared to $132.9 million in the third quarter of 2014 due to
the recognition of a one-time $105 million approval milestone for MOVANTIK in the third quarter of 2014.
operating costs and expenses in the third quarter of 2015 were $59.5 million as compared to $52.6 million in the third quarter
of 2014. Year-to-date total operating costs and expenses in 2015 were $191.4 million as compared to $160.2 million for the same
period in 2014. Total operating costs and expenses increased primarily as a result of increased research and development (R&D)
and development expense in the third quarter of 2015 was $43.2 million as compared to $34.2 million in the third quarter of 2014.
Year-to-date R&D expense for 2015 was $135.7 million as compared to $109.2 million for the same period in 2014. R&D expense
was higher in the third quarter and first nine months of 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 first nine months of 2015 also increased as a result of IND-enabling and clinical study start-up activities for NKTR-214.
and administrative expense was $9.5 million in the third quarter of 2015 as compared to $9.1 million in the third quarter of 2014.
G&A expense in the first nine months of 2015 was $30.0 million as compared to $28.7 million for the same period in 2014.
loss in the third quarter of 2015 was $8.2 million or $0.06 net loss per diluted share as compared to net income of $70.6 million
or $0.53 net income per diluted share in the third quarter of 2014. Net loss in the first nine months of 2015 was $27.0 million
or $0.21 net loss per diluted share as compared to net loss of $8.2 million or $0.07 net loss per diluted share in the first nine
company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2015:
for Immunotherapy in Cancer (SITC) 30th Anniversary Annual Meeting, National Harbor, MD:
San Antonio Breast Cancer Symposium, San Antonio, TX:
Call to Discuss Third Quarter 2015 Financial Results
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,
Thursday, November 5, 2015.
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, December 7, 2015.
access the conference call, follow these instructions:
(877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 65851649 (Nektar Therapeutics is the host)
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.
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, ADYNOVATE [Antihemophilic
Factor (Recombinant)], a longer-acting PEGylated Factor VIII therapeutic has been filed for approval in the U.S. by partner Baxalta
Inc. 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.
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.
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.
is a trademark and MOVENTIG is a registered trademark of the AstraZeneca group of companies.
is a trademark of Baxalta Inc.
Note Regarding Forward-Looking Statements
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,
the enrollment status of the SUMMIT-07 efficacy study of NKTR-181, the projected time-frame for dosing the first patient in the
clinical program for NKTR-214, Baxalta's regulatory expectations for ADYNOVATE, 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, 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 review board review and approvals, 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) 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;
(iv) patents may not issue from our patent applications for our drugs (including MOVANTIK and ADYNOVATE) and drug candidates,
patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required;
and (v) the outcome of any existing or future intellectual property or other litigation related to our drugs and drug candidates
and those of our collaboration partners including MOVANTIK and ADYNOVATE. Other important risks and uncertainties set forth in
our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2015. 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.
Nektar Investor Inquiries:
Jennifer Ruddock/Nektar Therapeutics (415) 482-5585
Susie Kim/Argot Partners (212) 600-1902
Nektar Media Inquiries:
Nadia Hasan/BrewLife (212) 257-6738
NEKTAR THERAPEUTICS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
ASSETS September 30, 2015 December 31, 2014 (1)
Current assets:
Cash and cash equivalents $ 18,819 $ 12,365
Short-term investments 249,000 225,459
Accounts receivable, net 2,966 3,607
Inventory 10,352 12,952
Restricted cash - 25,000
Other current assets 5,214 8,817
Total current assets 286,351 288,200
Property, plant and equipment, net 72,532 70,368
Goodwill 76,501 76,501
Other assets 13,862 6,552
Total assets $ 449,246 $ 441,621
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 2,279 $ 2,703
Accrued compensation 12,805 5,749
Accrued clinical trial expenses 11,102 7,708
Other accrued expenses 16,561 6,418
Interest payable 3,167 6,917
Capital lease obligations, current portion 5,883 4,512
Deferred revenue, current portion 20,611 24,473
Senior secured notes, current portion 125,000 -
Other current liabilities 10,690 5,567
Total current liabilities 208,098 64,047
Senior secured notes, less current portion - 125,000
Capital lease obligations, less current portion 1,335 4,139
Liability related to sale of future royalties 121,147 120,471
Deferred revenue, less current portion 68,941 76,911
Other long-term liabilities 10,672 14,721
Total liabilities 410,193 405,289
Commitments and contingencies
Stockholders' equity:
Preferred stock - -
Common stock 13 13
Capital in excess of par value 1,854,210 1,824,195
Accumulated other comprehensive loss (1,821 ) (1,567 )
Accumulated deficit (1,813,349 ) (1,786,309 )
Total stockholders' equity 39,053 36,332
Total liabilities and stockholders' equity $ 449,246 $ 441,621
Last updated: Nov 5, 2015