SAN FRANCISCO, March 1, 2017 /PRNewswire/ -- Nektar Therapeutics
(Nasdaq: NKTR) today reported its financial results for the fourth
quarter and year ended December 31,
2016.
Cash and investments in marketable securities at December 31, 2016 were $389.1 million as compared to $308.9 million at December
31, 2015.
"Nektar begins 2017 in a strong position with highly promising
wholly-owned immuno-oncology and immunology clinical programs and
several important data readouts expected throughout this year,"
said Howard W. Robin, President and
Chief Executive Officer of Nektar. "Our Phase 1/2 study evaluating
NKTR-214 as a potential combination treatment regimen with Opdivo®
in collaboration with Bristol-Myers Squibb is proceeding
nicely. We plan to report initial data from the
dose-escalation part of the study in the middle of this year.
Later this month, we will have data from our Phase 3 efficacy study
of NKTR-181 in patients with chronic low back pain. Finally,
we are pleased that we will initiate a first-in-human trial
shortly for NKTR-358, our proprietary T regulatory cell stimulator,
which has the potential to become a first-in-class resolution
therapeutic for a wide range of immune disorders."
Summary of Financial Results
Revenue for the fourth quarter of 2016 was $37.5 million as compared to $39.4 million in the fourth quarter of 2015.
Revenue for the year ended December 31,
2016 was $165.4 million as
compared to $230.8 million in 2015.
Revenue in 2016 included recognition of $31.0 million from AstraZeneca as a result
of its sublicense of MOVENTIG® (naloxegol) to Kyowa Kirin in
Europe. In addition, product sales, royalty revenue, and
non-cash royalty revenue increased in 2016 compared to 2015.
Revenue in 2015 included recognition of a total of $130.0 million of milestone payments from
AstraZeneca following the first commercial sale of MOVANTIK® in the
U.S. in Q1 2015 and the first commercial sale of MOVENTIG in the EU
in Q3 2015.
Total operating costs and expenses in the fourth quarter of 2016
were $69.6 million as compared to
$68.7 million in the fourth quarter
of 2015. Total operating costs and expenses increased primarily as
a result of higher research and development (R&D)
expense. Total operating costs and expenses for the year
ended December 31, 2016 were
$278.3 million as compared to
$260.2 million in 2015.
R&D expense in the fourth quarter of 2016 was $50.2 million as compared to $47.1 million for the fourth quarter of
2015. R&D expense for the year ended December 31, 2016 was $203.8 million as compared to $182.8 million in 2015. R&D expense increased
primarily due to expenses for our NKTR-214 and NKTR-358
programs.
General and administrative (G&A) expense was $12.8 million in the fourth quarter of 2016 as
compared to $13.2 million in the
fourth quarter of 2015. G&A expense for the year ended
December 31, 2016 was $44.3 million as compared to $43.3 million in 2015.
Net loss for the fourth quarter of 2016 was $42.2 million or $0.28 loss per share as compared to a net loss of
$54.1 million or $0.40 loss per share in the fourth quarter of
2015. Net loss for the year ended December 31, 2016 was $153.5 million or $1.10 loss per share as compared to a net loss of
$81.2 million or $0.61 loss per share in 2015.
2016 and Year-to-Date Business Highlights
Nektar Wholly-Owned Programs
- In February 2017, Nektar
submitted an Investigational New Drug (IND) application to the U.S.
Food and Drug Administration (FDA) for NKTR-358, a new biologic
designed to treat autoimmune disease. Clinical trials are planned
for NKTR-358 in patients with systemic lupus erythematous (SLE) and
other indications.
- In February 2017, Nektar
announced positive data from the Phase 1 dose-escalation study of
single-agent NKTR-214 in patients with renal cell carcinoma at the
ASCO 2017 Genitourinary Cancers Symposium. Clinical benefit and
safety data presented included 40% of RCC patients experiencing
tumor reductions including one patient with a partial response and
a favorable safety and tolerability profile.
- In January 2017, Nektar announced
a new immuno-oncology candidate, NKTR-262, a small molecule agonist
that targets toll-like receptors (TLRs) found on innate immune
cells in the body. NKTR-262 is being developed as a single
intra-tumoral injection to be administered at the start of therapy
with NKTR-214. The company plans to file an IND for NKTR-262 by the
end of 2017.
- In December 2016, Nektar
initiated a pivotal human abuse liability (HAL) trial for its novel
opioid molecule NKTR-181, which is expected to complete in the
middle of 2017.
- In November 2016, Nektar
announced positive data from the Phase 1 dose-escalation study of
single-agent NKTR-214 at the Society of Immunotherapy of Cancer
Annual Meeting. Results showed encouraging anti-tumor activity
including one patient with a partial response and a favorable
safety and tolerability profile.
- In September 2016, Nektar and Bristol-Myers Squibb entered into a
clinical collaboration to develop NKTR-214 as a potential
combination treatment regimen with Bristol-Myers Squibb's
Opdivo® (nivolumab) in five tumor types and eight potential
indications. The dose-escalation part of the trial is underway with
initial data expected in the middle of 2017.
Additional Pipeline and Partner Developments
- In December 2016, Shire announced
that the U.S. Food and Drug Administration (FDA) approved
ADYNOVATE® ([Antihemophilic Factor (Recombinant), PEGylated], an
extended circulating half-life recombinant Factor VIII (rFVIII)
treatment for hemophilia A, in pediatric patients under 12 years of
age. The FDA also approved ADYNOVATE for use in surgical settings
for both adult and pediatric patients. ADYNOVATE is under
regulatory review in Europe,
Switzerland and Canada.
- In September 2016, Bayer
presented positive Phase 3 data for Ciprofloxacin DPI at the 26th
International Congress of European Respiratory Society. The RESPIRE
1 study assessed the safety and efficacy of Cipro DPI in NCFB
patients and met both primary endpoints for the every 14-day dosing
arm. The second Phase 3 trial (RESPIRE 2) completed recruitment in
September 2016 and data are expected
to be released by our partner Bayer in 2017.
- In June 2016, Nektar entered into
a partnership with Daiichi Sankyo Europe for Nektar's
investigational drug therapy, ONZEALD™ (etirinotecan pegol,
NKTR-102), which has completed a Phase 3 clinical trial (the BEACON
study) in patients with advanced breast cancer. The agreement
grants Daiichi Sankyo Europe exclusive rights to market ONZEALD in
Europe (EEA), Switzerland and Turkey. Nektar Therapeutics retained rights to
ONZEALD in the United States and
the rest of the world. Under the terms of the agreement, Nektar is
entitled to milestones and significant double-digit royalties on
net sales in Europe.
- In June 2016, Nektar submitted a
filing for a Marketing Authorization Agreement (MAA) with the
European Medicines Agency for conditional approval for ONZEALD in
patients with advanced breast cancer and brain metastases. An
opinion from the European CHMP on conditional approval of ONZEALD
is expected in the first half of 2017.
- Amikacin Inhale, our second anti-infective Phase 3 program
partnered with Bayer, which is being developed for gram-negative
pneumonia, is expected to complete in Q2 of 2017. Nektar and Bayer
expect to report topline results from this program in the middle of
2017.
Conference Call to Discuss Fourth Quarter and Year-End 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, Wednesday, March 1, 2017.
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 Investors section of the Nektar website:
http://www.nektar.com. The web broadcast of the conference call
will be available for replay through Monday,
April 3, 2017.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 75461730 (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 Investors page at the Nektar website as soon as
practical after the conclusion of the conference call.
About Nektar Therapeutics
Nektar Therapeutics is a research-based biopharmaceutical company
whose mission is to discover and develop innovative medicines to
address the unmet medical needs of patients. Our R&D pipeline
of new investigational medicines includes treatments for cancer,
auto-immune disease and chronic pain. We leverage Nektar's
proprietary and proven chemistry platform in the discovery and
design of our new therapeutic candidates. 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 registered trademark of Baxalta Incorporated, a
wholly owned, indirect subsidiary of Shire plc.
ONZEALD™ is a trademark of Nektar Therapeutics.
Opdivo® is a registered trademark of Bristol-Myers Squibb.
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
availability of Phase 3 data for our NKTR-181 efficacy study and
for our partnered programs with Bayer, the timing of the European
CHMP decision for conditional approval of ONZEALD, the timing of
the availability of data for the dose-escalation study for NKTR-214
in combination with Opdivo, the future clinical development plans
for our products (including NKTR-358 and NKTR-262), the
timing of availability of future clinical results, the timing of
planned regulatory filings, the potential of NKTR-214 in
combination with other immunotherapy agents including Bristol-Myers
Squibb's Opdivo (nivolumab), the timing of the completion of the
NKTR-181 HAL study, 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) clinical study outcomes, including the Phase 3
clinical study outcome of NKTR-181, remain very unpredictable and
it is possible that a clinical study could fail due to efficacy,
safety or other important clinical findings; (ii) 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; (iii) 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; (iv) 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; (v) 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; (vi) 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, NKTR-214
and NKTR-358) is therefore highly uncertain and unpredictable and
one or more research and development programs could fail; (vii)
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 (viii) certain
other important risks and uncertainties set forth in our Annual
Report on Form 10-K for the year ended December 31, 2016 filed with the Securities
and Exchange Commission on March 1, 2017. 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.
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
|
December 31,
2016
|
(1)
|
December 31,
2015
|
(1)
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
59,640
|
|
$
55,570
|
|
|
Short-term
investments
|
329,462
|
|
253,374
|
|
|
Accounts receivable,
net
|
15,678
|
|
19,947
|
|
|
Inventory
|
11,109
|
|
11,346
|
|
|
Other current
assets
|
10,363
|
|
9,814
|
|
|
|
Total current
assets
|
426,252
|
|
350,051
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
65,601
|
|
71,336
|
|
Goodwill
|
76,501
|
|
76,501
|
|
Other
assets
|
517
|
|
754
|
|
|
|
Total
assets
|
$
568,871
|
|
$
498,642
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
$
2,816
|
|
$
2,363
|
|
|
Accrued
compensation
|
18,280
|
|
5,998
|
|
|
Accrued clinical
trial expenses
|
7,958
|
|
8,220
|
|
|
Other accrued
expenses
|
4,711
|
|
4,156
|
|
|
Interest
payable
|
4,198
|
|
4,198
|
|
|
Capital lease
obligations, current portion
|
2,908
|
|
4,756
|
|
|
Liability related to
refundable upfront payment
|
12,500
|
|
-
|
|
|
Deferred revenue,
current portion
|
14,352
|
|
21,428
|
|
|
Other current
liabilities
|
4,499
|
|
10,127
|
|
|
|
Total current
liabilities
|
72,222
|
|
61,246
|
|
|
|
|
|
|
|
|
Senior secured notes,
net
|
243,464
|
|
241,699
|
|
Capital lease
obligations, less current portion
|
2,223
|
|
1,073
|
|
Liability related to
the sale of future royalties, net
|
105,950
|
|
116,029
|
|
Deferred revenue,
less current portion
|
51,887
|
|
62,426
|
|
Other long-term
liabilities
|
5,000
|
|
9,740
|
|
|
|
Total
liabilities
|
480,746
|
|
492,213
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
Preferred
stock
|
-
|
|
-
|
|
|
Common
stock
|
15
|
|
13
|
|
|
Capital in excess of
par value
|
2,111,483
|
|
1,876,072
|
|
|
Accumulated other
comprehensive loss
|
(2,363)
|
|
(2,170)
|
|
|
Accumulated
deficit
|
(2,021,010)
|
|
(1,867,486)
|
|
|
|
Total stockholders'
equity
|
88,125
|
|
6,429
|
|
|
Total liabilities and
stockholders' equity
|
$
568,871
|
|
$
498,642
|
|
|
|
|
|
|
|
|
|
(1) The consolidated
balance sheets at December 31, 2016 and 2015 have been derived from
the audited financial statements at those dates but do 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
December 31,
|
|
Year Ended December
31,
|
|
|
2016
|
|
2015
|
|
2016
|
(1)
|
2015
|
(1)
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Product
sales
|
$
13,690
|
|
$
13,973
|
|
$
55,354
|
|
$
40,155
|
|
Royalty
revenue
|
6,392
|
|
1,910
|
|
19,542
|
|
2,967
|
|
Non-cash
royalty revenue related to sale of future royalties
|
7,817
|
|
7,306
|
|
30,158
|
|
22,058
|
|
License,
collaboration and other revenue
|
9,553
|
|
16,181
|
|
60,382
|
|
165,604
|
|
Total
revenue
|
37,452
|
|
39,370
|
|
165,436
|
|
230,784
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
6,604
|
|
8,364
|
|
30,215
|
|
34,102
|
|
Research and
development
|
50,232
|
|
47,135
|
|
203,801
|
|
182,787
|
|
General and
administrative
|
12,760
|
|
13,235
|
|
44,275
|
|
43,266
|
|
Total operating costs
and expenses
|
69,596
|
|
68,734
|
|
278,291
|
|
260,155
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(32,144)
|
|
(29,364)
|
|
(112,855)
|
|
(29,371)
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
(5,550)
|
|
(5,791)
|
|
(22,468)
|
|
(18,282)
|
|
Non-cash
interest expense on liability related to sale of future
royalties
|
(4,783)
|
|
(5,191)
|
|
(19,712)
|
|
(20,619)
|
|
Loss on
extinguishment of debt
|
-
|
|
(14,079)
|
|
-
|
|
(14,079)
|
|
Interest
income and other income (expense), net
|
721
|
|
325
|
|
2,387
|
|
1,680
|
|
Total non-operating
expense, net
|
(9,612)
|
|
(24,736)
|
|
(39,793)
|
|
(51,300)
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
(41,756)
|
|
(54,100)
|
|
(152,648)
|
|
(80,671)
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
443
|
|
37
|
|
876
|
|
506
|
|
Net loss
|
$
(42,199)
|
|
$
(54,137)
|
|
$
(153,524)
|
|
$ (81,177)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
(0.28)
|
|
$
(0.40)
|
|
$
(1.10)
|
|
$
(0.61)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing basic and diluted net loss per
share
|
149,071
|
|
134,166
|
|
139,596
|
|
132,458
|
|
|
|
|
|
|
|
|
|
|
|
(1) The consolidated
statements of operations for the years ended December 31, 2016 and
2015 have been derived from the audited financial statements as of
those dates but do 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 CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
Year Ended December
31,
|
|
|
|
|
2016
|
(1)
|
2015
|
(1)
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
Net
loss
|
|
|
$
(153,524)
|
|
$
(81,177)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
Non-cash
royalty revenue related to sale of future royalties
|
|
|
(30,158)
|
|
(22,058)
|
|
Non-cash
interest expense on liability related to sale of future
royalties
|
|
|
19,712
|
|
20,619
|
|
Stock-based
compensation
|
|
|
25,850
|
|
19,669
|
|
Depreciation
and amortization
|
|
|
15,351
|
|
12,855
|
|
Loss from
redemption premium and incremental interest on 12% senior secured
notes
|
|
|
-
|
|
12,500
|
|
Write-off of
deferred financing costs on 12% senior secured notes
|
|
|
-
|
|
1,579
|
|
Other non-cash
transactions
|
|
|
(2,185)
|
|
(2,365)
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
Accounts
receivable, net
|
|
|
4,269
|
|
(16,340)
|
|
Inventory
|
|
|
237
|
|
1,606
|
|
Other
assets
|
|
|
(312)
|
|
(825)
|
|
Accounts
payable
|
|
|
518
|
|
(412)
|
|
Accrued
compensation
|
|
|
12,282
|
|
249
|
|
Accrued
clinical trial expenses
|
|
|
(262)
|
|
512
|
|
Other accrued
expenses
|
|
|
191
|
|
(2,278)
|
|
Interest
payable
|
|
|
-
|
|
(2,719)
|
|
Liability
related to refundable upfront payment
|
|
|
12,500
|
|
-
|
|
Deferred
revenue
|
|
|
(17,615)
|
|
(17,530)
|
|
Other
liabilities
|
|
|
(3,878)
|
|
3,032
|
|
Net cash used
in operating activities
|
|
|
(117,024)
|
|
(73,083)
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
Purchases of
investments
|
|
|
(334,659)
|
|
(297,608)
|
|
Maturities of
investments
|
|
|
253,682
|
|
226,923
|
|
Sales of
investments
|
|
|
4,969
|
|
42,544
|
|
Release of
restricted cash
|
|
|
-
|
|
25,000
|
|
Purchases of
property, plant and equipment
|
|
|
(6,392)
|
|
(11,195)
|
|
Net cash used
in investing activities
|
|
|
(82,400)
|
|
(14,336)
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
Payment of
capital lease obligations
|
|
|
(5,945)
|
|
(5,187)
|
|
Issuance of
common stock, net of issuance costs
|
|
|
189,276
|
|
-
|
|
Proceeds from
shares issued under equity compensation plans
|
|
|
20,287
|
|
32,208
|
|
Proceeds from
issuance of 7.75% senior secured notes, net of issuance
costs
|
|
|
-
|
|
241,262
|
|
Repayment of
12% senior secured notes
|
|
|
-
|
|
(125,000)
|
|
Payment of
redemption premium and incremental interest on 12% senior secured
notes
|
|
|
-
|
|
(12,500)
|
|
Net cash
provided by financing activities
|
|
|
203,618
|
|
130,783
|
|
|
|
|
|
|
|
|
Effect of
exchange rates on cash and cash equivalents
|
|
|
(124)
|
|
(159)
|
|
Net increase
in cash and cash equivalents
|
|
|
4,070
|
|
43,205
|
|
Cash and cash
equivalents at beginning of period
|
|
|
55,570
|
|
12,365
|
|
Cash and cash
equivalents at end of period
|
|
|
$
59,640
|
|
$
55,570
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
Cash paid for
interest
|
|
|
$
20,589
|
|
$
20,225
|
|
Cash paid for
income taxes
|
|
|
$
757
|
|
$
860
|
|
|
|
|
|
|
|
|
|
(1) The consolidated
statements of cash flows for the years ended December 31, 2016 and
2015 have been derived from the audited financial statements as of
those dates but do not
include all of the information and notes required by generally
accepted accounting principles in the United States for complete
financial statements.
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-fourth-quarter-and-year-end-2016-financial-results-300416315.html
SOURCE Nektar Therapeutics