SAN FRANCISCO, Nov. 6, 2014 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported its financial results
for the third quarter ended September 30,
2014.
Cash and investments in marketable securities at September 30, 2014 were $261.6 million as compared to $301.4 million at June 30,
2014.
"The recent FDA approval of MOVANTIKTM
(naloxegol) was a major milestone for Nektar," said
Howard W. Robin, President and Chief
Executive Officer of Nektar. "As the first once-daily oral PAMORA
approved in the U.S., MOVANTIK provides a new treatment option for
a common and potentially debilitating side effect 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 Q3, our
partner Baxter announced positive
topline data from the pivotal Phase 3 study of BAX 855, a
longer-acting PEGylated Factor VIII therapy to treat hemophilia
A. Our wholly-owned late-stage clinical pipeline continues to
advance as well. We plan to initiate the Phase 3 program for
NKTR-181 this quarter and importantly, we are on track to report
topline results from our NKTR-102 Phase 3 study in metastatic
breast cancer in the first quarter of 2015."
Revenue in the third quarter of 2014 was $132.9 million as compared to $60.9 million in the third quarter of 2013.
Year-to-date revenue for 2014 was $181.2
million as compared to $117.8
million in the first nine months of 2013. Revenue
increased in the third quarter and first nine months of 2014 as
compared to the same periods in 2013 primarily due to $105.0 million in milestones recognized in
September 2014 upon the approval of
MOVANTIK in the U.S., of which $70.0
million was received in November 2013. These increases
in revenue in 2014 were partially offset by a $25.0 million milestone payment recognized in
September 2013 upon the acceptance of
the MOVANTIK EMA regulatory application. Additionally,
product sales and royalty revenue decreased by $8.9 million in the third quarter and
$19.9 million for the first nine
months of 2014 as compared to the same periods in 2013.
Revenue included non-cash royalty revenue, related to our
February 2012 royalty monetization,
of $6.1 million in the third quarter
and $16.8 million year-to-date in
2014, respectively, and $4.5 million
in the third quarter and $12.7
million in the first nine months of 2013. This non-cash
royalty revenue is offset by non-cash interest expense.
Total operating costs and expenses in the third quarter of 2014
were $52.6 million as compared to
$67.4 million in the third quarter of
2013. Year-to-date total operating costs and expenses in 2014
were $160.2 million as compared to
$202.0 million for the same period in
2013. Total operating costs and expenses decreased primarily
as a result of decreased research and development (R&D)
expense, as well as decreased cost of goods sold associated with
decreased product sales.
Research and development expenses in the third quarter of 2014
were $34.2 million as compared to
$43.9 million in the third quarter of
2013. Year-to-date R&D expense for 2014 was $109.2 million as compared to $141.8 million for the same period in 2013.
R&D expense was lower in the third quarter of 2014 and
year-to-date as compared to the same periods in 2013 primarily
because of reduced activities for 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 was
$9.1 million in the third quarter of
2014 as compared to $10.6 million in
the third quarter of 2013. G&A expense in the first nine
months of 2014 was $28.7 million as
compared to $30.7 million for the
same period in 2013.
Non-cash interest expense incurred in connection with the
February 2012 royalty monetization
was $5.2 million and $15.7 million in the third quarter and first nine
months of 2014, respectively, as compared to $5.6 million and $16.6
million in the third quarter and first nine months of 2013,
respectively.
Net income in the third quarter of 2014 was $70.6 million or $0.53 net income per diluted share as compared to
net loss of $16.5 million or
$0.14 net loss per diluted share in
the third quarter of 2013. Net loss in the first nine months of
2014 was $8.2 million or $0.07 loss per diluted share as compared to net
loss of $114.4 million or
$0.99 net loss per diluted share in
the first nine months of 2013.
The company also announced an upcoming presentation at the
following scientific congress during the fourth quarter of
2014:
Society for Neuroscience, Washington, DC:
- Abstract Title: "SEO-16: an orally active opioid analgesic
with rapid onset of activity and reduced CNS side effects ",
Harrison, S., et al.
- Poster Session 244: "Opioids and Other Analgesics"
- Date: November 16, 2014,
1:00 p.m. — 5:00 p.m. Eastern
Time
26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics, Barcelona,
Spain:
- Abstract Title: "Combining the long-acting topoisomerase 1
inhibitor etirinotecan pegol with the PARP inhibitor rucaparib to
provide anti-tumor synergy without increased toxicity ", Hoch,
U., et al.
- Poster Session: "Cytotoxics"
- Date: November 19, 2014,
8:00 a.m. — 7:30 p.m. Central
European Time
AACR Tumor Immunology and Immunotherapy, Orlando, FL:
- Abstract Title: "Combining the Long-Acting Engineered
Cytokine NKTR-214 with Checkpoint Inhibitors is Synergistic and
Shows Long Lasting Anti-Tumor Immunity in Murine Tumor Models
", Kantak, S., et al.
- Poster Session A
- Date: December 2, 2014,
1:15 p.m. – 3:30 p.m. Eastern Time
2014 San Antonio Breast Cancer Symposium, San Antonio, TX:
- Poster P3-10-03: "Etirinotecan pegol target specific
pharmacodynamics (PD) biomarkers in circulating tumor cells (CTCs)
from patients in the Phase 3 BEACON study in patients with
metastatic breast cancer ", Perez, E., et al.
- Poster Session 3-10: "Treatment: Advanced Chemotherapy"
- Date: December 11, 2014,
5:00 p.m. — 7:00 p.m. Central
Time
Conference Call to Discuss Third Quarter 2014 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 6,
2014.
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,
December 8, 2014.
To access the conference call, follow these
instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453
(international)
Passcode: 25628597 (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 of potentially high-value therapeutics in pain, oncology,
hemophilia and other therapeutic areas. In the area of pain, Nektar
has an exclusive worldwide license agreement with AstraZeneca for
MOVANTIKTM, 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 AstraZeneca
agreement also includes NKTR-119, an earlier stage development
program that is a co-formulation of MOVANTIKTM and an
opioid. NKTR-181, a wholly-owned mu-opioid analgesic molecule for
chronic pain conditions, has completed Phase 2 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, etirinotecan
pegol (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 MOVANTIKTM, 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.
MOVANTIKTM is a 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™; the timing of the
initiation of the Phase 3 clinical program for NKTR-181; the
timing of availability of topline overall survival data for the
NKTR-102 Phase 3 study; 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
evolving process and health authorities retain significant
discretion at all stages of the regulatory review and approval
decision process; (iv) 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; (v)
patents may not issue from our patent applications for our drug
candidates, patents that have issued may not be enforceable, or
additional intellectual property licenses from third parties may be
required; and (vi) the outcome of any existing or future
intellectual property or other litigation related to our drug
candidates and those of our collaboration partners. Other
important risks and uncertainties set forth in our Quarterly Report
on Form 10-Q filed with the Securities and Exchange
Commission on August 1, 2014. 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
|
|
|
Andrea Rabney/Argot Partners
|
(212) 600-1494
|
|
|
|
|
Nektar Media Inquiries:
|
|
|
|
Nadia
Hasan/WCG
|
(212)
257-6738
|
NEKTAR
THERAPEUTICS
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
September 30,
2014
|
|
December 31,
2013
|
(1)
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
$
32,008
|
|
$
39,067
|
|
|
Restricted
cash
|
|
|
|
|
25,000
|
|
-
|
|
|
Short-term
investments
|
|
|
|
204,635
|
|
197,959
|
|
|
Accounts receivable,
net
|
|
|
|
46,074
|
|
2,229
|
|
|
Inventory
|
|
|
|
|
11,695
|
|
13,452
|
|
|
Other current
assets
|
|
|
|
4,708
|
|
5,175
|
|
|
|
Total current
assets
|
|
|
|
324,120
|
|
257,882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted
cash
|
|
|
|
|
-
|
|
25,000
|
|
Property and
equipment, net
|
|
|
|
69,275
|
|
66,974
|
|
Goodwill
|
|
|
|
|
|
76,501
|
|
76,501
|
|
Other
assets
|
|
|
|
|
7,006
|
|
8,170
|
|
|
Total
assets
|
|
|
|
|
$
476,902
|
|
$
434,527
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
$
5,428
|
|
$
9,115
|
|
|
Accrued
compensation
|
|
|
|
13,753
|
|
14,254
|
|
|
Accrued
expenses
|
|
|
|
7,760
|
|
6,243
|
|
|
Accrued clinical
trial expenses
|
|
|
9,643
|
|
16,905
|
|
|
Interest
payable
|
|
|
|
|
3,167
|
|
6,917
|
|
|
Deferred revenue,
current portion
|
|
|
24,626
|
|
23,664
|
|
|
Other current
liabilities
|
|
|
|
16,172
|
|
21,123
|
|
|
|
Total current
liabilities
|
|
|
|
80,549
|
|
98,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior secured
notes
|
|
|
|
125,000
|
|
125,000
|
|
Capital lease
obligations, less current portion
|
|
|
5,339
|
|
8,049
|
|
Liability related to
receipt of refundable milestone payment
|
|
-
|
|
70,000
|
|
Liability related to
sale of future royalties, less current portion
|
|
120,492
|
|
121,520
|
|
Deferred revenue,
less current portion
|
|
|
82,902
|
|
82,384
|
|
Other long-term
liabilities
|
|
|
|
15,402
|
|
19,256
|
|
|
|
Total
liabilities
|
|
|
|
429,684
|
|
524,430
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficit) :
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
|
|
-
|
|
-
|
|
|
Common
stock
|
|
|
|
|
12
|
|
11
|
|
|
Capital in excess of
par value
|
|
|
1,789,010
|
|
1,643,660
|
|
|
Accumulated other
comprehensive loss
|
|
|
(1,178)
|
|
(1,181)
|
|
|
Accumulated
deficit
|
|
|
|
(1,740,626)
|
|
(1,732,393)
|
|
|
|
Total stockholders'
equity (deficit)
|
|
|
47,218
|
|
(89,903)
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
476,902
|
|
$
434,527
|
|
|
(1) The consolidated
balance sheet at December 31, 2013 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
|
|
Nine Months
Ended
|
|
|
|
|
|
|
September
30,
|
|
September
30,
|
|
|
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
Product sales and
royalty revenue
|
$
6,172
|
|
$ 15,026
|
|
$ 17,980
|
|
$ 37,836
|
Non-cash royalty
revenue related to sale of future royalties
|
6,143
|
|
4,523
|
|
16,753
|
|
12,744
|
License,
collaboration and other revenue
|
120,556
|
|
41,360
|
|
146,422
|
|
67,195
|
Total
revenue
|
|
|
132,871
|
|
60,909
|
|
181,155
|
|
117,775
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
9,220
|
|
12,877
|
|
22,235
|
|
29,549
|
Research and
development
|
|
34,200
|
|
43,914
|
|
109,240
|
|
141,762
|
General and
administrative
|
|
9,130
|
|
10,643
|
|
28,677
|
|
30,700
|
Total operating costs
and expenses
|
52,550
|
|
67,434
|
|
160,152
|
|
202,011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
80,321
|
|
(6,525)
|
|
21,003
|
|
(84,236)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
|
|
133
|
|
116
|
|
399
|
|
639
|
Interest
expense
|
|
|
(4,391)
|
|
(4,587)
|
|
(13,412)
|
|
(13,888)
|
Non-cash interest
expense on liability related to sale of future royalties
|
(5,203)
|
|
(5,616)
|
|
(15,725)
|
|
(16,644)
|
Other income
(expense), net
|
|
(7)
|
|
262
|
|
136
|
|
385
|
Total non-operating
expense, net
|
(9,468)
|
|
(9,825)
|
|
(28,602)
|
|
(29,508)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before
provision for income taxes
|
70,853
|
|
(16,350)
|
|
(7,599)
|
|
(113,744)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
248
|
|
193
|
|
634
|
|
610
|
Net income
(loss)
|
|
|
$
70,605
|
|
$ (16,543)
|
|
$
(8,233)
|
|
$ (114,354)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
|
$
0.55
|
|
$
(0.14)
|
|
$
(0.07)
|
|
$
(0.99)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
|
$
0.53
|
|
$
(0.14)
|
|
$
(0.07)
|
|
$
(0.99)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing net income (loss) per
share
|
|
|
|
|
|
|
|
Basic
|
|
|
|
127,504
|
|
115,812
|
|
126,043
|
|
115,557
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
|
132,177
|
|
115,812
|
|
126,043
|
|
115,557
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
|
|
|
|
|
|
2014
|
|
2013
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
$ (8,233)
|
|
$ (114,354)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
Recognition of
previously received milestone payment which is no longer
refundable
|
(70,000)
|
|
-
|
Non-cash royalty
revenue related to sale of future royalties
|
|
|
|
(16,753)
|
|
(12,744)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
|
15,725
|
|
16,644
|
Stock-based
compensation
|
|
|
|
|
12,647
|
|
13,165
|
Depreciation and
amortization
|
|
|
|
|
9,733
|
|
10,882
|
Other non-cash
transactions
|
|
|
|
|
313
|
|
332
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
Accounts receivable,
net
|
|
|
|
|
|
(43,845)
|
|
1,248
|
Inventory
|
|
|
|
|
|
|
1,757
|
|
3,193
|
Other
assets
|
|
|
|
|
|
|
679
|
|
6,817
|
Accounts
payable
|
|
|
|
|
|
(3,670)
|
|
697
|
Accrued
compensation
|
|
|
|
|
|
(501)
|
|
5,137
|
Accrued
expenses
|
|
|
|
|
|
1,667
|
|
2,741
|
Accrued clinical
trial expenses
|
|
|
|
|
(7,262)
|
|
(2,261)
|
Interest
payable
|
|
|
|
|
|
(3,750)
|
|
(3,916)
|
Deferred
revenue
|
|
|
|
|
|
1,480
|
|
(14,914)
|
Other
liabilities
|
|
|
|
|
|
(7,366)
|
|
(4,825)
|
Net cash used in
operating activities
|
|
|
|
|
(117,379)
|
|
(92,158)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
Maturities of
investments
|
|
|
|
|
|
171,826
|
|
274,011
|
Purchases of
investments
|
|
|
|
|
(200,160)
|
|
(140,569)
|
Sales of
investments
|
|
|
|
|
|
21,661
|
|
-
|
Purchases of property
and equipment
|
|
|
|
|
(6,090)
|
|
(1,382)
|
Net cash
(used in) provided by investing activities
|
|
|
|
(12,763)
|
|
132,060
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
Payment of capital
lease obligations
|
|
|
|
|
(2,578)
|
|
(2,201)
|
Repayment of proceeds
from sale of future royalties
|
(7,000)
|
|
(3,000)
|
Issuance of common
stock, net of issuance costs
|
|
|
|
116,536
|
|
-
|
Proceeds from shares
issued under equity compensation plans
|
|
|
16,168
|
|
5,253
|
Net cash provided by
financing activities
|
|
|
|
|
123,126
|
|
52
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
|
|
|
(43)
|
|
20
|
Net (decrease)
increase in cash and cash equivalents
|
|
|
|
(7,059)
|
|
39,974
|
Cash and cash
equivalents at beginning of period
|
|
|
|
39,067
|
|
25,437
|
Cash and cash
equivalents at end of period
|
|
|
|
|
$ 32,008
|
|
$ 65,411
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
Cash paid for
interest
|
|
|
|
|
|
$ 16,487
|
|
$ 17,097
|
SOURCE Nektar Therapeutics