SAN FRANCISCO, Feb. 26, 2014 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported its financial results
for the fourth quarter and year ended December 31, 2013.
Cash and investments in marketable securities at December 31, 2013 were $262.0 million as compared to $302.2 million at December
31, 2012. The 2013 year-end cash balance does not include
net proceeds of $117.2 million
received from the completion of a public equity offering in
January 2014.
"2014 has the potential to be a transformative year for Nektar
as several of our highly valuable late-stage programs advance
toward approval or filing," said Howard W.
Robin, President and Chief Executive Officer of Nektar. "For
naloxegol, our partner AstraZeneca has filed for regulatory
approvals in the U.S., Europe and
Canada. Naloxegol could be the
first once-daily oral therapy approved to treat opioid-induced
constipation. The Phase 3 study for BAX 855, a longer-acting
PEGylated Factor VIII therapy, has completed enrollment and our
partner Baxter intends to file the
BLA by the end of 2014. Finally, the NKTR-102 BEACON Phase 3 study
in advanced breast cancer successfully passed its interim efficacy
analysis. Topline data from this pivotal study is expected by early
2015 and we intend to file NKTR-102 in both the U.S. and
Europe in 2015."
Revenue for the fourth quarter of 2013 was $31.1 million as compared to $21.1 million in the fourth quarter of 2012.
Revenue for the year ended December 31,
2013 was $148.9 million as
compared to $81.2 million in 2012.
Revenues included non-cash royalty revenue, related to our 2012
royalty monetization, of $9.3 million
and $22.1 million in the fourth
quarter and the full year of 2013, respectively, and $3.9 million and $10.8
million in the fourth quarter and the full year of 2012.
This non-cash royalty revenue is offset by non-cash interest
expense. The increase in revenue in the fourth quarter of
2013 as compared to the fourth quarter of 2012 is primarily due to
increased product shipments to one of our collaboration
partners. In addition, the increase in revenue in 2013 as
compared to 2012 is primarily due to a $25.0
million milestone achieved in September 2013 upon the acceptance of the
naloxegol MAA filing in Europe as
well as a $10.0 million milestone
achieved upon the initiation of Phase 3 studies for Amikacin Inhale
in April 2013.
Total operating costs and expenses in the fourth quarter of 2013
were $67.0 million as compared to
$64.5 million in the fourth quarter
of 2012. Total operating costs and expenses for the year
ended December 31, 2013 were
$269.1 million as compared to
$222.4 million in 2012. The
increase in 2013 as compared to 2012 is due primarily to increased
clinical development expenses.
Research and development expense in the fourth quarter of 2013
was $48.2 million as compared to
$46.4 million for the fourth quarter
of 2012. For the year ended December
31, 2013, R&D expense was $190.0
million as compared to $148.7
million in 2012. R&D expense was higher in the year
ended December 31, 2013 as compared
to 2012 reflecting the costs of the Phase 3 study of etirinotecan
pegol (NKTR-102) in metastatic breast cancer, the Phase 2 study of
NKTR-181, preparation for the Phase 3 study of NKTR-181, the Phase
1 study of NKTR-192, and the production of devices for the Phase 3
study of Amikacin Inhale.
General and administrative expense was $9.8 million in the fourth quarter of 2013 as
compared to $10.9 million in the
fourth quarter of 2012. G&A expense for the year ended
December 31, 2013 was $40.5 million as compared to $41.6 million in 2012.
Non-cash interest expense incurred in connection with the 2012
royalty monetization was $5.7 million
and $22.3 million in the fourth
quarter and year ended December 31,
2013, respectively, as compared to $5.4 million and $18.1
million in the fourth quarter and year ended December 31, 2012, respectively.
Net loss for the fourth quarter ended December 31, 2013 was $47.7 million or $0.41 loss per share. Net loss for the year
ended December 31, 2013 was
$162.0 million or $1.40 loss per share. Net loss for the
fourth quarter ended December 31,
2012 was $52.9 million or
$0.46 loss per share. Net loss
for the year ended December 31, 2012
was $171.9 million or $1.50 loss per share.
Conference Call to Discuss Fourth Quarter and Year-End 2013
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, February 26,
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,
March 31, 2014.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 72309374 (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 (NASDAQ: NKTR) is a biopharmaceutical
company developing novel therapeutics based on its PEGylation and
advanced polymer conjugation technology platforms. Nektar has a
robust R&D pipeline of potentially high-value therapeutics in
oncology, pain and other therapeutic areas. In the area of pain,
Nektar has an exclusive worldwide license agreement with
AstraZeneca for naloxegol (NKTR-118), an investigational drug
candidate, which has been filed for regulatory approvals in the
U.S., Europe and Canada as a once- daily, oral tablet for the
treatment of opioid-induced constipation. This agreement also
includes NKTR-119, an earlier stage development program that is a
co-formulation of naloxegol and an opioid. NKTR-181, a novel
mu-opioid analgesic molecule for chronic pain conditions, has
completed Phase 2 development in osteoarthritis patients with
chronic knee pain. NKTR-171, a 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 and is also in Phase 2 studies for the treatment of
ovarian, colorectal, lung and brain cancers. 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. Additional
development-stage products that leverage Nektar's proprietary
technology platform include Baxter's BAX 855, a long-acting PEGylated
rFVIII program, which is in Phase 3 clinical development for
patients with hemophilia A.
Nektar's technology has enabled eight approved products in the
U.S. or Europe through
partnerships with leading biopharmaceutical companies, including
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.
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
regulatory approval of naloxegol; potential future regulatory
filings by Baxter Healthcare for BAX 855; the timing of
availability of topline overall survival data for the NKTR-102
BEACON study and our plans for future regulatory filings if the
Phase 3 data is positive; 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
our 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) the
United States Food and Drug Administration (FDA) is currently
planning to hold an advisory committee meeting in 2014 to discuss
the cardiovascular safety and potential additional safety study
requirements for the peripheral mu-opioid receptor antagonist class
of drugs, including naloxegol, and the outcome of this advisory
committee and the subsequent FDA review determinations for
naloxegol will have a significant impact on the Company's financial
position based on significant potential regulatory and launch
milestone opportunities and potential repayment obligations; (iv)
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; (v) 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; and (vi) certain other important
risks and uncertainties set forth in our Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission on
November 7, 2013. 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
|
|
|
|
Susan Noonan/SA
Noonan Communications, LLC
|
|
(212)
966-3650
|
|
|
|
|
|
|
Nektar Media
Inquiries:
|
|
|
|
|
|
Brianne
Cannon/MSL
|
|
(415)
512-0770
|
|
|
|
|
|
|
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
(Unaudited)
|
ASSETS
|
December 31,
2013
|
|
December 31,
2012
|
(1)
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
39,067
|
|
$
25,437
|
|
|
Short-term
investments
|
|
197,959
|
|
251,757
|
|
|
Accounts receivable,
net
|
|
2,229
|
|
5,805
|
|
|
Inventory
|
|
13,452
|
|
18,269
|
|
|
Other current
assets
|
|
5,175
|
|
13,363
|
|
|
|
Total current
assets
|
|
257,882
|
|
314,631
|
|
|
|
|
|
|
|
|
|
Restricted
cash
|
|
|
25,000
|
|
25,000
|
|
Property and
equipment, net
|
|
66,974
|
|
72,215
|
|
Goodwill
|
|
|
76,501
|
|
76,501
|
|
Other
assets
|
|
|
8,170
|
|
9,443
|
|
|
Total
assets
|
|
|
$
434,527
|
|
$
497,790
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
9,115
|
|
$
2,863
|
|
|
Accrued
compensation
|
|
14,254
|
|
8,773
|
|
|
Accrued
expenses
|
|
6,243
|
|
8,008
|
|
|
Accrued clinical
trial expenses
|
|
16,905
|
|
17,500
|
|
|
Deferred revenue,
current portion
|
|
23,664
|
|
21,896
|
|
|
Interest
payable
|
|
6,917
|
|
7,083
|
|
|
Liability related to
sale of future royalties, current portion
|
|
7,000
|
|
3,000
|
|
|
Other current
liabilities
|
|
14,123
|
|
9,414
|
|
|
|
Total current
liabilities
|
|
98,221
|
|
78,537
|
|
|
|
|
|
|
|
|
|
Senior secured
notes
|
|
125,000
|
|
125,000
|
|
Capital lease
obligations, less current portion
|
|
8,049
|
|
11,607
|
|
Liability related to
receipt of refundable milestone payment
|
|
70,000
|
|
-
|
|
Liability related to
sale of future royalties, less current portion
|
|
121,520
|
|
128,266
|
|
Deferred revenue,
less current portion
|
|
82,384
|
|
96,551
|
|
Other long-term
liabilities
|
|
19,256
|
|
10,811
|
|
|
|
Total
liabilities
|
|
524,430
|
|
450,772
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficit) :
|
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
|
Common
stock
|
|
11
|
|
11
|
|
|
Capital in excess of
par value
|
|
1,643,660
|
|
1,617,744
|
|
|
Accumulated other
comprehensive loss
|
|
(1,181)
|
|
(357)
|
|
|
Accumulated
deficit
|
|
(1,732,393)
|
|
(1,570,380)
|
|
|
|
Total stockholders'
equity (deficit)
|
|
(89,903)
|
|
47,018
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
434,527
|
|
$
497,790
|
|
|
|
|
|
|
|
|
|
(1) The consolidated
balance sheet at December 31, 2012 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
|
|
Twelve Months
Ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
8,040
|
|
$
10,405
|
|
$
44,846
|
|
$
35,399
|
Royalty
revenue
|
|
118
|
|
908
|
|
1,148
|
|
4,874
|
Non-cash royalty
revenue related to sale of future royalties
|
|
9,311
|
|
3,896
|
|
22,055
|
|
10,791
|
License, collaboration
and other revenue
|
|
13,677
|
|
5,937
|
|
80,872
|
|
30,127
|
Total
revenue
|
|
31,146
|
|
21,146
|
|
148,921
|
|
81,191
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
8,960
|
|
7,290
|
|
38,509
|
|
30,428
|
Research and
development
|
|
48,248
|
|
46,373
|
|
190,010
|
|
148,675
|
General and
administrative
|
|
9,832
|
|
10,864
|
|
40,532
|
|
41,614
|
Impairment of
long-lived assets
|
|
-
|
|
-
|
|
-
|
|
1,675
|
Total operating costs
and expenses
|
|
67,040
|
|
64,527
|
|
269,051
|
|
222,392
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(35,894)
|
|
(43,381)
|
|
(120,130)
|
|
(141,201)
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
93
|
|
450
|
|
732
|
|
2,315
|
Interest
expense
|
|
(4,565)
|
|
(4,682)
|
|
(18,453)
|
|
(15,489)
|
Non-cash interest
expense on liability related to sale of future royalties
|
|
(5,665)
|
|
(5,416)
|
|
(22,309)
|
|
(18,057)
|
Other income
(expense), net
|
|
7
|
|
70
|
|
392
|
|
983
|
Total non-operating
expense, net
|
|
(10,130)
|
|
(9,578)
|
|
(39,638)
|
|
(30,248)
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
(46,024)
|
|
(52,959)
|
|
(159,768)
|
|
(171,449)
|
|
|
|
|
|
|
|
|
|
Provision (benefit)
for income taxes
|
|
1,635
|
|
(33)
|
|
2,245
|
|
406
|
Net loss
|
|
$
(47,659)
|
|
$
(52,926)
|
|
$
(162,013)
|
|
$
(171,855)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.41)
|
|
$
(0.46)
|
|
$
(1.40)
|
|
$
(1.50)
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing basic and diluted net loss per
share
|
|
116,259
|
|
115,179
|
|
115,732
|
|
114,820
|
|
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
Twelve Months Ended
December 31,
|
|
|
|
|
|
|
|
2013
|
|
2012
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
$
(162,013)
|
|
$
(171,855)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
Non-cash royalty
revenue related to sale of future royalties
|
(22,055)
|
|
(10,791)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
22,309
|
|
18,057
|
Stock-based
compensation
|
|
|
|
|
17,708
|
|
16,199
|
Depreciation and
amortization
|
|
|
|
|
14,275
|
|
14,508
|
Impairment of
long-lived assets
|
|
|
|
|
-
|
|
1,675
|
Other non-cash
transactions
|
|
|
|
|
664
|
|
845
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
Accounts receivable,
net
|
|
|
|
|
3,576
|
|
(867)
|
Inventory
|
|
|
|
|
|
4,817
|
|
(5,613)
|
Other
assets
|
|
|
|
|
6,423
|
|
6,031
|
Accounts
payable
|
|
|
|
|
6,199
|
|
(122)
|
Accrued
compensation
|
|
|
|
|
5,481
|
|
(4,034)
|
Accrued
expenses
|
|
|
|
|
(1,915)
|
|
1,495
|
Accrued clinical
trial expenses
|
|
|
|
|
(595)
|
|
5,547
|
Deferred
revenue
|
|
|
|
|
(12,399)
|
|
(9,384)
|
Interest
payable
|
|
|
|
|
(166)
|
|
5,278
|
Liability related to
receipt of refundable milestone payment
|
70,000
|
|
-
|
Other
liabilities
|
|
|
|
|
9,164
|
|
3,275
|
Net cash used
in operating activities
|
|
|
|
|
(38,527)
|
|
(129,756)
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
Maturities of
investments
|
|
|
|
|
319,181
|
|
307,887
|
Purchases of
investments
|
|
|
|
|
(268,068)
|
|
(164,662)
|
Sales of
investments
|
|
|
|
|
2,887
|
|
5,378
|
Restricted
cash
|
|
|
|
|
-
|
|
(25,000)
|
Purchases of property
and equipment
|
|
|
|
|
(4,091)
|
|
(10,583)
|
Net cash
provided by investing activities
|
|
|
|
|
49,909
|
|
113,020
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
Payment of capital
lease obligations
|
|
|
|
|
(2,992)
|
|
(2,437)
|
(Repayment of)
proceeds from sale of future royalties, net of $4.4 million of
transaction costs in 2012
|
(3,000)
|
|
119,588
|
Proceeds from
issuance of senior secured notes, net of $4.5 million of issuance
costs
|
-
|
|
77,940
|
Repayment of
convertible subordinated notes
|
|
|
|
|
-
|
|
(172,407)
|
Proceeds from shares
issued under equity compensation plans
|
8,208
|
|
4,117
|
Net cash
provided by financing activities
|
|
|
|
|
2,216
|
|
26,801
|
|
|
|
|
|
|
|
|
|
|
Effect of
exchange rates on cash and cash equivalents
|
32
|
|
60
|
Net increase
in cash and cash equivalents
|
|
|
|
|
13,630
|
|
10,125
|
Cash and cash
equivalents at beginning of period
|
|
|
|
|
25,437
|
|
15,312
|
Cash and cash
equivalents at end of period
|
|
|
|
|
$
39,067
|
|
$
25,437
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
Cash paid for
interest
|
|
|
|
|
$
17,590
|
|
$
9,620
|
Cash paid for
income taxes
|
|
|
|
|
$
1,014
|
|
$
1,021
|
Retirement of
convertible subordinated notes in exchange for senior secured
notes
|
$
-
|
|
$
42,548
|
|
SOURCE Nektar Therapeutics