SAN FRANCISCO, May 7, 2014 /PRNewswire/ -- Nektar Therapeutics
(Nasdaq: NKTR) today reported its financial results for the first
quarter ended March 31, 2014.
Cash and investments in marketable securities at March 31, 2014 were $309.1
million as compared to $262.0
million at December 31,
2013. Our cash and investments in marketable securities
balance at March 31, 2014 includes
net proceeds of approximately $117
million from the issuance and sale of 9,775,000 shares of
our common stock in a public offering in January 2014.
"Nektar is looking forward to several key milestones for our
late-stage clinical drug candidates over the next six to nine
months," said Howard W. Robin,
President and Chief Executive Officer of Nektar. "Our partner
AstraZeneca has filed for regulatory approvals for naloxegol in the
U.S., Europe and Canada, with a PDUFA date in the U.S. of
September 16, 2014. If approved,
naloxegol will be the first once-daily oral drug to treat opioid
induced constipation, a debilitating condition for chronic pain
patients. Our partner Baxter is
completing their Phase 3 study for BAX 855, a longer-acting
PEGylated Factor VIII therapy to treat hemophilia A, and plans to
file the BLA in the U.S. by the end of this year. NKTR-102,
Nektar's wholly-owned Phase 3 program in advanced breast cancer, is
on track for topline results in Q1 2015. Importantly, we are
equally focused on our highly promising pipeline of new pain and
oncology molecules, which includes advancing NKTR-181 into Phase 3
in chronic pain patients."
Revenue for the first quarter of 2014 was $19.8 million as compared to $23.0 million in the first quarter of 2013.
Revenue included non-cash royalty revenue, related to our 2012
royalty monetization, of $5.8 million
and $4.4 million in the three months
ended March 31, 2014 and 2013,
respectively. This non-cash royalty revenue is offset by non-cash
interest expense. The decrease in revenue in the first quarter of
2014 as compared to the first quarter of 2013 is primarily due to a
decrease in product sales.
Total operating costs and expenses for the first quarter of 2014
were $56.2 million as compared to
$68.1 million in the first quarter of
2013. Total operating costs and expenses decreased primarily
as a result of decreased research and development (R&D)
expense.
R&D expense in the first quarter of 2014 was $38.3 million as compared to $45.6 million for the first quarter of
2013. R&D expense was lower in the first quarter of 2014
primarily because of decreased costs for the Phase 3 study of
etirinotecan pegol (NKTR-102) in metastatic breast cancer, which
completed enrollment in the third quarter of 2013.
Additionally, R&D expense in the first quarter of 2013 included
costs related to the Phase 2 study of NKTR-181, which was completed
in 2013. The decreased R&D expense for the first
quarter of 2014 was partially offset by costs for the preparation
for the start of Phase 3 for NKTR-181, the ongoing Phase 1 study of
NKTR-171, and the continued production of devices for the ongoing
Phase 3 studies of Amikacin Inhale.
General and administrative expense was $9.9 million in the first quarter of 2014 as
compared to $10.8 million in the
first quarter of 2013.
Non-cash interest expense in connection with the 2012 royalty
monetization was $5.4 million in the
first quarter of 2014 as compared to $5.5
million in the first quarter of 2013.
Net loss for the first quarter of 2014 was $46.2 million or $0.37 loss per share as compared to a net loss of
$55.1 million or $0.48 loss per share in the first quarter of
2013.
The company also announced upcoming presentations at the
following medical meetings and scientific congresses during the
first half of 2014:
SMI 14th Annual Pain Therapeutics Conference, London, UK:
- Presentation Title: "NKTR-181: An Opioid for Chronic Pain
with Intrinsically Low Abuse Potential", Steve Harrison
- May 19, 2014, 5:00 p.m. British Summer Time
- Session: How can success in analgesia be improved?
American Society of Clinical Oncology (ASCO) Annual Meeting,
Chicago, IL:
- Abstract Title: "Etirinotecan pegol (EP, NKTR-102) in the
treatment of high grade glioma (HGG): a phase 2 trial," Nagpal
et al.
- Abstract Number: 2096
- Session Title/Track: Central Nervous System Tumors
- Date: May 31, 2014, 1:15 p.m. – 5:00 p.m.
Central Time
- Location: S Hall A2
- Abstract Title: "Combination Immunotherapy: Synergy of a
Long-Acting Engineered Cytokine (NKTR-214) and Checkpoint
Inhibitors Anti-CTLA-2 or Anti-PD1 in Murine Tumor Models,"
Kantak et al.
- Abstract Number: 3082
- Session Title/Track: Developmental Therapies -
Immunotherapy
- Date: June 1, 2014, 8:00 a.m. – 11:45 a.m.
Central Time
- Location: S Hall A2
Conference Call to Discuss First 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, Wednesday, May 7, 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,
June 9, 2014.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453
(international) Passcode: 31565461 (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; 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
June 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 Annual Report on Form 10-K
filed with the Securities and Exchange Commission on February 27, 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
|
|
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
|
|
March 31,
2014
|
|
December 31,
2013
|
(1)
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
$
32,443
|
|
$
39,067
|
|
|
Short-term
investments
|
|
|
|
251,628
|
|
197,959
|
|
|
Accounts
receivable
|
|
|
|
1,855
|
|
2,229
|
|
|
Inventory
|
|
|
|
|
12,872
|
|
13,452
|
|
|
Other current
assets
|
|
|
|
5,972
|
|
5,175
|
|
|
|
Total current
assets
|
|
|
|
304,770
|
|
257,882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted
cash
|
|
|
|
|
25,000
|
|
25,000
|
|
Property and
equipment, net
|
|
|
|
72,968
|
|
66,974
|
|
Goodwill
|
|
|
|
|
|
76,501
|
|
76,501
|
|
Other
assets
|
|
|
|
|
7,774
|
|
8,170
|
|
|
Total
assets
|
|
|
|
|
$
487,013
|
|
$
434,527
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
$
3,064
|
|
$
9,115
|
|
|
Accrued
compensation
|
|
|
|
9,427
|
|
14,254
|
|
|
Accrued
expenses
|
|
|
|
6,821
|
|
6,243
|
|
|
Accrued clinical
trial expenses
|
|
|
13,726
|
|
16,905
|
|
|
Interest
payable
|
|
|
|
|
3,167
|
|
6,917
|
|
|
Deferred revenue,
current portion
|
|
|
23,542
|
|
23,664
|
|
|
Liability related to
sale of future royalties, current portion
|
|
-
|
|
7,000
|
|
|
Other current
liabilities
|
|
|
|
19,566
|
|
14,123
|
|
|
|
Total current
liabilities
|
|
|
|
79,313
|
|
98,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior secured
notes
|
|
|
|
125,000
|
|
125,000
|
|
Capital lease
obligations, less current portion
|
|
|
7,050
|
|
8,049
|
|
Liability related to
receipt of refundable milestone payment
|
|
70,000
|
|
70,000
|
|
Liability related to
sale of future royalties, less current portion
|
|
121,134
|
|
121,520
|
|
Deferred revenue,
less current portion
|
|
|
76,549
|
|
82,384
|
|
Other long-term
liabilities
|
|
|
|
17,776
|
|
19,256
|
|
|
|
Total
liabilities
|
|
|
|
496,822
|
|
524,430
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficit):
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
|
|
-
|
|
-
|
|
|
Common
stock
|
|
|
|
|
12
|
|
11
|
|
|
Capital in excess of
par value
|
|
|
1,769,713
|
|
1,643,660
|
|
|
Accumulated other
comprehensive loss
|
|
|
(940)
|
|
(1,181)
|
|
|
Accumulated
deficit
|
|
|
|
(1,778,594)
|
|
(1,732,393)
|
|
|
|
Total stockholders'
equity (deficit)
|
|
|
(9,809)
|
|
(89,903)
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
487,013
|
|
$
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
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
|
|
|
|
|
|
|
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
Product
sales and royalty revenue
|
|
|
$
5,917
|
|
$
12,135
|
|
|
Non-cash
royalty revenue related to sale of future royalties
|
|
5,773
|
|
4,393
|
|
|
License,
collaboration and other revenue
|
|
|
8,081
|
|
6,476
|
|
|
Total
revenue
|
|
|
|
|
19,771
|
|
23,004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of
goods sold
|
|
|
|
7,907
|
|
11,661
|
|
|
Research
and development
|
|
|
|
38,338
|
|
45,618
|
|
|
General
and administrative
|
|
|
|
9,928
|
|
10,829
|
|
|
Total operating costs
and expenses
|
|
|
56,173
|
|
68,108
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
(36,402)
|
|
(45,104)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
|
|
|
|
134
|
|
314
|
|
|
Interest
expense
|
|
|
|
|
(4,533)
|
|
(4,645)
|
|
|
Non-cash
interest expense on liability related to sale of future
royalties
|
|
(5,387)
|
|
(5,543)
|
|
|
Other
income (expense), net
|
|
|
|
178
|
|
127
|
|
|
Total non-operating
expense, net
|
|
|
(9,608)
|
|
(9,747)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
|
(46,010)
|
|
(54,851)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
|
191
|
|
212
|
|
|
Net loss
|
|
|
|
|
|
$
(46,201)
|
|
$
(55,063)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
$
(0.37)
|
|
$
(0.48)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing basic and diluted net loss per
share
|
|
123,543
|
|
115,309
|
|
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
|
|
|
|
|
2014
|
|
2013
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
Net
loss
|
|
|
|
|
|
|
|
$
(46,201)
|
|
$
(55,063)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
Non-cash royalty
revenue related to sale of future royalties
|
|
|
|
(5,773)
|
|
(4,393)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
|
5,387
|
|
5,543
|
Stock-based
compensation
|
|
|
|
|
4,361
|
|
4,245
|
Depreciation and
amortization
|
|
|
|
|
3,264
|
|
3,628
|
Other non-cash
transactions
|
|
|
|
|
777
|
|
139
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
|
|
|
374
|
|
2,158
|
Inventory
|
|
|
|
|
|
|
580
|
|
(112)
|
Other
assets
|
|
|
|
|
|
|
(718)
|
|
3,844
|
Accounts
payable
|
|
|
|
|
|
(6,126)
|
|
1,355
|
Accrued
compensation
|
|
|
|
|
|
(4,827)
|
|
179
|
Accrued
expenses
|
|
|
|
|
|
693
|
|
(1,130)
|
Accrued clinical
trial expenses
|
|
|
|
|
(3,179)
|
|
6,532
|
Interest
payable
|
|
|
|
|
|
(3,750)
|
|
(3,916)
|
Deferred
revenue
|
|
|
|
|
|
(5,957)
|
|
2,710
|
Other
liabilities
|
|
|
|
|
|
(1,195)
|
|
(3,830)
|
Net cash used in
operating activities
|
|
|
|
|
(62,290)
|
|
(38,111)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
Maturities of
investments
|
|
|
|
|
|
56,972
|
|
100,338
|
Purchases of
investments
|
|
|
|
|
(110,661)
|
|
(56,336)
|
Purchases of property
and equipment
|
|
|
|
|
(4,524)
|
|
(316)
|
Net cash (used in)
provided by investing activities
|
|
|
|
(58,213)
|
|
43,686
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
Payment of capital
lease obligations
|
|
|
|
|
(825)
|
|
(692)
|
Repayment of proceeds
from sale of future royalties
|
(7,000)
|
|
(3,000)
|
Proceeds from
issuance of common stock, net of issuance costs
|
|
|
|
116,619
|
|
-
|
Proceeds from shares
issued under equity compensation plans
|
|
|
|
5,074
|
|
1,218
|
Net cash provided by
(used in) financing activities
|
|
|
|
113,868
|
|
(2,474)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
|
|
|
11
|
|
(7)
|
Net (decrease)
increase in cash and cash equivalents
|
|
|
|
(6,624)
|
|
3,094
|
Cash and cash
equivalents at beginning of period
|
|
|
|
39,067
|
|
25,437
|
Cash and cash
equivalents at end of period
|
|
|
|
|
$
32,443
|
|
$
28,531
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
Cash paid for
interest
|
|
|
|
|
|
$
7,961
|
|
$
8,250
|
SOURCE Nektar Therapeutics