SAN FRANCISCO, Nov. 3, 2016 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported its financial results
for the third quarter ended September 30,
2016.
Cash and investments in marketable securities at September 30, 2016 were $253.5 million as compared to $308.9 million at December
31, 2015. Our cash and investments in marketable securities
at September 30, 2016 do not include
net proceeds of approximately $189.1
million from the recent sale and issuance of our common
stock on October 24, 2016.
"Our pipeline is rapidly advancing with several important data
catalysts and potential approvals expected over the next several
quarters," said Howard W. Robin,
President and Chief Executive Officer of Nektar. "With the positive
clinical results from our ongoing Phase 1 study of NKTR-214, we
have now demonstrated that NKTR-214 is the
first investigational medicine in immuno-oncology that
selectively stimulates the in vivo proliferation of endogenous
tumor-killing lymphocytes within the tumor
micro-environment. In Q3, these data led to a broad
clinical collaboration with Bristol-Myers Squibb to evaluate
combination regimens with their anti-PD-1 agent in five different
tumor types and at least seven indications. Within the next
two quarters, we will have Phase 3 data for four programs: two
Bayer anti-infective programs, Ophthotech's Fovista in wet AMD, and
our own proprietary pain program, NKTR-181, in chronic low back
pain. We are also expecting a decision from the European CHMP
on conditional approval of ONZEALD by the end of Q1 2017."
Year-to-date revenue for 2016 was $128.0
million as compared to $191.4
million in the first nine months of 2015. Revenue in
2016 included recognition of $31.0
million from AstraZeneca as a result of its sublicense
of MOVENTIG® (naloxegol) to ProStrakan (Kyowa Kirin) in
Europe. In addition, product sales, royalty revenue, and
non-cash royalty revenue increased in the first nine months of 2016
compared to the first nine months of 2015. Revenue in 2015
included 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. in Q1 2015 and the $40.0 million milestone payment from AstraZeneca
following the first commercial sale of MOVENTIG in the EU in Q3
2015. Revenue in the third quarter of 2016 was $36.3 million as compared to $60.0 million in the third quarter of 2015.
Revenue included non-cash royalty revenue, related to our 2012
royalty monetization, of $7.7 million
and $22.3 million in the third
quarter and first nine months of 2016, respectively, and
$6.1 million and $14.8 million in the third quarter and first nine
months of 2015, respectively. This non-cash royalty revenue is
offset by non-cash interest expense also incurred in connection
with the 2012 royalty monetization of $4.9
million and $14.9 million in
the third quarter and first nine months of 2016, respectively and
$5.2 million and $15.4 million in the third quarter and first nine
months of 2015, respectively.
Total operating costs and expenses in the third quarter of 2016
were $69.2 million as compared to
$59.5 million in the third quarter of
2015. Year-to-date total operating costs and expenses in 2016
were $208.7 million as compared to
$191.4 million for the same period in
2015. Total operating costs and expenses increased primarily
as a result of increased research and development (R&D)
expense.
Research and development expense in the third quarter of 2016
was $52.0 million as compared to
$43.2 million in the third quarter of
2015. Year-to-date R&D expense for 2016 was $153.6 million as compared to $135.7 million for the same period in 2015.
R&D expense was higher in the third quarter and first nine
months of 2016 as compared to the same periods in 2015 primarily
due to expenses for the NKTR-181 Phase 3 studies and the initiation
of the Phase 1/2 study of NKTR-214.
General and administrative expense was $10.3 million in the third quarter of 2016 as
compared to $9.5 million in the third
quarter of 2015. G&A expense in the first nine months of
2016 was $31.5 million as compared to
$30.0 million for the same period in
2015.
Net loss in the third quarter of 2016 was $43.2 million or $0.32 loss per share as compared to $8.2 million or $0.06 loss per share in the third quarter of
2015. Net loss in the first nine months of 2016 was $111.3 million or $0.82 loss per share as compared to $27.0 million or $0.21 loss per share in the first nine months of
2015.
The company also announced upcoming presentations at the
following scientific congresses during the fourth quarter of
2016:
Society for Immunotherapy in Cancer (SITC) 31st
Anniversary Annual Meeting, National Harbor, MD:
- Oral Presentation: "A CD122-biased agonist increases
CD8+T Cells and natural killer cells in the tumor microenvironment;
making cold tumors hot with NKTR-214"
- Presenter: Dr. Adi Diab,
Assistant Professor, Department of Melanoma Medical Oncology,
Division of Cancer Medicine, The University of
Texas MD Anderson Cancer Center, Houston, Texas
- Session: New Cancer Immunotherapy Agents in
Development
- Date: Wednesday, November 9,
2016, 11:10 a.m. –
12:20 p.m. Eastern Time
- Poster 387: "A CD122-biased agonist increases CD8+T
Cells and natural killer cells in the tumor microenvironment;
making cold tumors hot with NKTR-214"
- Session: Tumor Microenvironment
- Date: Friday, November 11,
2016, 12:15 – 1:30 p.m. and
6:15 – 7:30 p.m. Eastern Time
- Poster 343: "Anti-tumor activity of NKTR-214; a
CD122-biased agonist that promotes immune cell activation in the
tumor microenvironment and lymphoid tissues"
- Session: Promoting and Measuring Anti-Tumor
Activity
- Date: Friday, November 11,
2016, 12:15 – 1:30 p.m. and
6:15 – 7:30 p.m. Eastern Time
- Poster 359: "NKTR-214, an engineered cytokine,
synergizes and improves efficacy of anti-cancer vaccination in the
treatment of established murine melanoma tumors"
- Session: Therapeutic Cancer Vaccines
- Date: Friday, November 11,
2016, 12:15 – 1:30 p.m. and
6:15 – 7:30 p.m. Eastern Time
- Poster 342: "NKTR-255: an IL-15-based therapeutic
with optimized biological activity and anti-tumor efficacy"
- Session: Promoting and Measuring Anti-Tumor
Activity
- Date: Saturday, November 12,
2016, 11:45 a.m. –
1:00 p.m. and 6:45 – 8:00 p.m. Eastern Time
EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics
Symposium, Munich,
Germany:
- Poster: "Intra-tumoral immune cell mobilization and
anti-tumor activity after treatment with the engineered cytokine
NKTR-214 in multiple preclinical mouse tumor models", Charych,
D., et al.
- Poster Session: Immunotherapy
- Date: November 30, 2016,
8:30 a.m. Central European Time
2016 San Antonio Breast Cancer Symposium, San Antonio, TX:
- Poster OT1-04-08: "Phase 3 study of
etirinotecan pegol versus treatment of physician's choice in
patients with metastatic breast cancer who have stable brain
metastases previously treated with an anthracycline, a taxane, and
capecitabine", Tripathy, D. et al.
- Poster Session: Ongoing Trials - Metastases
- Date: December 7, 2016,
5:00 p.m. – 7:00 p.m. Central Time
Conference Call to Discuss Third Quarter 2016 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, Thursday, November 3,
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 Tuesday, December 6, 2016.
To access the conference call,
follow these instructions:
Dial: (877) 881.2183 (U.S.); (970)
315.0453 (international)
Passcode: 7718800 (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 has a robust R&D pipeline and portfolio
of approved partnered medicines in oncology, pain, immunology and
other therapeutic areas. In the area of oncology, Nektar is
developing NKTR-214, an immuno-stimulatory CD122-biased agonist,
which is in Phase 1/2 clinical development for patients with solid
tumors. ONZEALD™ (etirinotecan pegol), a long-acting topoisomerase
I inhibitor, is being developed for patients with advanced breast
cancer and brain metastases and is partnered with Daiichi Sankyo in
Europe. 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. and Japan for
patients over 12 with hemophilia A. In anti-infectives, the company
has two collaborations with Bayer Healthcare, Cipro Inhale in Phase
3 for non-cystic fibrosis bronchiectasis and Amikacin Inhale in
Phase 3 for 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.
ONZEALD™ is a trademark of Nektar Therapeutics.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which
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 timing of the CHMP
decision for conditional approval of ONZEALD in Europe, the timing of the availability of
Phase 3 data for our partnered programs with Bayer and Ophthotech
and our NKTR-181 Phase 3 clinical study, the timing and potential
approval of our partnered products and the potential of our
technology and drug candidates in our 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 CHMP and FDA have
substantial discretion as to whether to grant marketing approval
for pharmaceutical products (including ONZEALD and those of our
partners) and the decisions from these regulatory authorities are
difficult to predict and these decisions have significant financial
consequences; (ii) NKTR-214 is in early-stage clinical development
and there are substantial risks that can unexpectedly occur for
numerous reasons including negative safety and efficacy findings in
the ongoing Phase 1 clinical study notwithstanding positive
findings in preclinical studies; (iii) 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 negative safety and efficacy findings
even after positive findings in previous preclinical and clinical
studies; (iv) the timing of the commencement or end of clinical
trials and the availability of clinical data 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; (v) scientific discovery of new medical breakthroughs is
an inherently uncertain process and the future success of applying
our technology platform to potential new drug candidates (such as
NKTR-181 and NKTR-214) is therefore highly uncertain and
unpredictable and one or more research and development programs
could fail; (vi) patents may not issue from our patent applications
for our drug candidates including NKTR-181 and NKTR-214, patents
that have issued may not be enforceable, or additional intellectual
property licenses from third parties may be required; and (vii)
certain other important risks and uncertainties set forth in our
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on August 4,
2016. 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.
Contact:
For Investors:
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
Jodi Sievers of Nektar
Therapeutics
415-482-5593
For Media:
Dan Budwick of Pure
Communications
973-271-6085
dan@purecommunicationsinc.com
NEKTAR
THERAPEUTICS
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
September 30,
2016
|
|
December 31,
2015
|
(1)
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
63,295
|
|
$
55,570
|
|
|
Short-term
investments
|
|
190,216
|
|
253,374
|
|
|
Accounts receivable,
net
|
|
14,249
|
|
19,947
|
|
|
Inventory
|
|
10,754
|
|
11,346
|
|
|
Other current
assets
|
|
4,008
|
|
9,814
|
|
|
|
Total current
assets
|
|
282,522
|
|
350,051
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
65,553
|
|
71,336
|
|
Goodwill
|
|
76,501
|
|
76,501
|
|
Other
assets
|
|
519
|
|
754
|
|
|
|
Total
assets
|
|
$
425,095
|
|
$
498,642
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
7,118
|
|
$
2,363
|
|
|
Accrued
compensation
|
|
15,733
|
|
5,998
|
|
|
Accrued clinical
trial expenses
|
|
10,946
|
|
8,220
|
|
|
Other accrued
expenses
|
|
6,761
|
|
4,156
|
|
|
Interest
payable
|
|
4,198
|
|
4,198
|
|
|
Capital lease
obligations, current portion
|
|
2,370
|
|
4,756
|
|
|
Liability related to
refundable upfront payment
|
|
12,500
|
|
-
|
|
|
Deferred revenue,
current portion
|
|
14,101
|
|
21,428
|
|
|
Other current
liabilities
|
|
2,578
|
|
10,127
|
|
|
|
Total current
liabilities
|
|
76,305
|
|
61,246
|
|
|
|
|
|
|
|
|
|
Senior secured notes,
net
|
|
243,004
|
|
241,699
|
|
Capital lease
obligations, less current portion
|
|
2,143
|
|
1,073
|
|
Liability related to
the sale of future royalties, net
|
|
108,893
|
|
116,029
|
|
Deferred revenue,
less current portion
|
|
57,088
|
|
62,426
|
|
Other long-term
liabilities
|
|
5,515
|
|
9,740
|
|
|
|
Total
liabilities
|
|
492,948
|
|
492,213
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficit):
|
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
|
Common
stock
|
|
13
|
|
13
|
|
|
Capital in excess of
par value
|
|
1,912,907
|
|
1,876,072
|
|
|
Accumulated other
comprehensive loss
|
|
(1,962)
|
|
(2,170)
|
|
|
Accumulated
deficit
|
|
(1,978,811)
|
|
(1,867,486)
|
|
|
|
Total stockholders'
equity (deficit)
|
|
(67,853)
|
|
6,429
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
425,095
|
|
$
498,642
|
|
(1) The consolidated
balance sheet at December 31, 2015 has been derived from the
audited financial statements at that date but does not include
all of the information and notes
required by generally accepted accounting principles in the United
States for complete financial statements.
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(In thousands, except
per share information)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
14,698
|
|
$
7,240
|
|
$
41,664
|
|
$
26,182
|
Royalty
revenue
|
|
5,573
|
|
187
|
|
13,150
|
|
1,057
|
Non-cash royalty
revenue related to sale of future royalties
|
|
7,692
|
|
6,050
|
|
22,341
|
|
14,752
|
License,
collaboration and other revenue
|
|
8,373
|
|
46,475
|
|
50,829
|
|
149,423
|
Total
revenue
|
|
36,336
|
|
59,952
|
|
127,984
|
|
191,414
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
7,033
|
|
6,760
|
|
23,611
|
|
25,738
|
Research and
development
|
|
51,951
|
|
43,229
|
|
153,569
|
|
135,652
|
General and
administrative
|
|
10,253
|
|
9,544
|
|
31,515
|
|
30,031
|
Total operating costs
and expenses
|
|
69,237
|
|
59,533
|
|
208,695
|
|
191,421
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
(32,901)
|
|
419
|
|
(80,711)
|
|
(7)
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(5,614)
|
|
(4,202)
|
|
(16,918)
|
|
(12,491)
|
Non-cash interest
expense on liability related to sale of future royalties
|
|
(4,902)
|
|
(5,226)
|
|
(14,929)
|
|
(15,428)
|
Interest income and
other income (expense), net
|
|
332
|
|
898
|
|
1,666
|
|
1,355
|
Total non-operating
expense, net
|
|
(10,184)
|
|
(8,530)
|
|
(30,181)
|
|
(26,564)
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
(43,085)
|
|
(8,111)
|
|
(110,892)
|
|
(26,571)
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
139
|
|
92
|
|
433
|
|
469
|
Net loss
|
|
$
(43,224)
|
|
$
(8,203)
|
|
$
(111,325)
|
|
$ (27,040)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.32)
|
|
$
(0.06)
|
|
$
(0.82)
|
|
$
(0.21)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing basic and diluted net loss per
share
|
|
137,094
|
|
132,631
|
|
136,415
|
|
131,882
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
2016
|
|
2015
|
Cash flows from
operating activities:
|
|
|
|
Net loss
|
$
(111,325)
|
|
$
(27,040)
|
Adjustments to
reconcile net loss to net cash (used in) provided by operating
activities:
|
|
|
|
Non-cash royalty
revenue related to sale of future royalties
|
(22,341)
|
|
(14,752)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
14,929
|
|
15,428
|
Stock-based
compensation
|
18,793
|
|
14,499
|
Depreciation and
amortization
|
11,502
|
|
9,109
|
Other non-cash
transactions
|
(2,190)
|
|
(1,448)
|
Changes in operating
assets and liabilities:
|
|
|
|
Accounts receivable,
net
|
5,698
|
|
641
|
Inventory
|
592
|
|
2,600
|
Other
assets
|
6,041
|
|
3,843
|
Accounts
payable
|
4,799
|
|
(525)
|
Accrued
compensation
|
9,735
|
|
7,056
|
Accrued clinical
trial expenses
|
2,726
|
|
3,394
|
Other accrued
expenses
|
2,386
|
|
949
|
Interest
payable
|
-
|
|
(3,750)
|
Liability related to
refundable upfront payment
|
12,500
|
|
-
|
Deferred
revenue
|
(12,665)
|
|
(11,832)
|
Other
liabilities
|
(5,793)
|
|
3,854
|
Net cash (used in)
provided by operating activities
|
(64,613)
|
|
2,026
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
Purchases of
investments
|
(142,972)
|
|
(202,870)
|
Maturities of
investments
|
201,449
|
|
155,683
|
Sales of
investments
|
4,969
|
|
23,778
|
Release of restricted
cash
|
-
|
|
25,000
|
Purchases of
property, plant and equipment
|
(3,741)
|
|
(8,722)
|
Net cash provided by
(used in) investing activities
|
59,705
|
|
(7,131)
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
Payment of capital
lease obligations
|
(5,376)
|
|
(3,798)
|
Proceeds from shares
issued under equity compensation plans
|
18,041
|
|
15,516
|
Net cash provided by
financing activities
|
12,665
|
|
11,718
|
|
|
|
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
(32)
|
|
(159)
|
Net increase in cash
and cash equivalents
|
7,725
|
|
6,454
|
Cash and cash
equivalents at beginning of period
|
55,570
|
|
12,365
|
Cash and cash
equivalents at end of period
|
$
63,295
|
|
$
18,819
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
Cash paid for
interest
|
$
15,513
|
|
$
16,095
|
|
|
|
|
|
|
|
|
|
Supplemental
schedule of non-cash investing and financing
activities
|
|
|
|
Accrued debt issuance
costs
|
$
-
|
|
$
8,503
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-financial-results-for-the-third-quarter-of-2016-300357157.html
SOURCE Nektar Therapeutics