SAN FRANCISCO, March 1, 2016 /PRNewswire/ -- Nektar Therapeutics
(Nasdaq: NKTR) today reported its financial results for the fourth
quarter and year ended December 31,
2015.
Cash and investments in marketable securities at December 31, 2015 were $308.9 million as compared to $262.8 million at December
31, 2014. Cash and investments include the net proceeds from
the $250 million private placement of 7.75% Senior
Secured Notes due in 2020, which was closed on October 5,
2015. A portion of the proceeds from this secured debt
financing was used to fully redeem the $125.0 million of
12% Senior Secured Notes due in 2017.
"Nektar begins 2016 with two new medicines launched by our
partners in the past year and multiple late-stage drug candidates
advancing in the clinic," said Howard W.
Robin, President and Chief Executive Officer of Nektar.
"MOVANTIK is performing very well with positive feedback from
physicians and patients. ADYNOVATE was launched in the U.S. in
December 2015 and Baxalta recently
submitted BLA filings in the U.S. to expand use of ADYNOVATE to
pediatric and surgical settings. The NKTR-181 Phase 3
efficacy study in patients with chronic low back pain is on track
to provide top-line results in early 2017. Finally, NKTR-214, our
immuno-oncology candidate, is advancing nicely in a
first-in-human trial evaluating its safety and efficacy in patients
with solid tumors. We remain on track to report initial
top-line data from the dose-escalation stage of the NKTR-214 study
in the second half of 2016."
Revenue for the year ended December 31,
2015 was $230.8 million as
compared to $200.7 million in 2014.
Revenue for the fourth quarter of 2015 was $39.4 million as compared to $19.6 million in the fourth quarter of 2014.
Revenue for the year ended December 31,
2015 includes the 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.,
recognition of the $40.0 million milestone payment from
AstraZeneca following the first commercial sale of MOVENTIG in the
EU and recognition of the $10 million
milestone payment from Baxalta for the approval and first
commercial sale of ADYNOVATE in the U.S. In addition, product sales
and royalty revenue increased by $17.6 million in 2015 as
compared to the same period in 2014.
Revenue also included non-cash royalty revenue, related to our
2012 royalty monetization, of $7.3
million and $22.1 million in
the fourth quarter and the full year of 2015, respectively, and
$5.2 million and $21.9 million in the fourth quarter and the full
year of 2014, respectively. This non-cash royalty revenue is
substantially offset by non-cash interest expense, also incurred in
connection with the 2012 royalty monetization. Non-cash interest
expense was $5.2 million and
$20.6 million in the fourth quarter
and year ended December 31, 2015,
respectively, as compared to $5.2
million and $20.9 million in
the fourth quarter and year ended December
31, 2014, respectively. Total operating costs and expenses
for the year ended December 31, 2015
were $260.2 million as compared to
$217.2 million in 2014. Total
operating costs and expenses increased primarily as a result of
higher research and development (R&D) expense. Total operating
costs and expenses in the fourth quarter of 2015 were $68.7 million as compared to $57.0 million in the fourth quarter of 2014.
For the year ended December 31,
2015, R&D expense was $182.8
million as compared to $147.7
million in 2014. R&D expense in the fourth quarter of
2015 was $47.1 million as compared to
$38.5 million for the fourth quarter
of 2014. R&D expense was higher in the fourth quarter of 2015
and the year ended December 31, 2015
as compared to the same periods in 2014 primarily due to the
initiation of the Phase 3 efficacy trial of NKTR-181 in chronic low
back pain and the long-term safety study for NKTR-181. R&D
expense for the full year 2015 also increased as a result of
initiation of the Phase 1/2 clinical program for NKTR-214.
General and administrative (G&A) expense for the year ended
December 31, 2015 was $43.3 million as compared to $40.9 million in 2014. G&A expense for the
quarter and year ended December 31,
2015 includes the expense and payment of a $3.0 million settlement of a commercial
litigation matter. G&A expense was $13.2 million in the fourth quarter of 2015 as
compared to $12.2 million in the
fourth quarter of 2014.
Net loss for the year ended December 31,
2015 was $81.2 million or
$0.61 loss per share as compared to a
net loss of $53.9 million or
$0.42 loss per share for the year
ended December 31, 2014. Net loss for
the fourth quarter of 2015 was $54.1
million or $0.40 loss per
share as compared to a net loss of $45.7
million or $0.35 loss per
share in the fourth quarter of 2014.
The company also announced upcoming presentations at the
following scientific congresses during the first half of
2016:
ISICEM (International Symposium on Intensive Care and
Emergency Medicine), Brussels,
Belgium:
- Abstract Title: "In vitro evaluation of Amikacin Inhale
and other commercial nebulizers in mechanical ventilator",
Challoner, P., et al.
AACR Annual Meeting, New Orleans, LA:
- Abstract 558: "Durable antitumor activity of the
CD122-biased immunostimulatory cytokine NKTR-214 combined with
immune checkpoint blockade", Langowski, J., et al.
- Poster Session: Immune Modulating Agents 1
- Date: April 17, 2016, 1:00 p.m. - 5:00 p.m.
Central Time
Conference Call to Discuss Fourth Quarter and Year-End 2015
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, Tuesday, March 1, 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 Monday,
April 4, 2016.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 50771255 (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 in pain,
oncology, hemophilia and other therapeutic areas. 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. in patients over 12 with hemophilia
A. 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
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.
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 advancement of our pipeline, potential of
MOVANTIK and ADYNOVATE, target time frames for availability of
future clinical results, and the value and potential of our polymer
conjugate 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) the commercial potential of a new drug at the
early stages of commercial launch, such as MOVANTIK and ADYNOVATE,
is difficult to predict and will have a significant impact on our
future results of operation and financial condition; (ii) the
timing of the commencement or end of clinical trials and the
commercial launch of our drug candidates and those of our partners
may be delayed or unsuccessful due to regulatory delays,
institutional review board review and approvals, 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) 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; (iv)
patents may not issue from our patent applications for our drugs
(including MOVANTIK and ADYNOVATE) and drug candidates, patents
that have issued may not be enforceable, or additional intellectual
property licenses from third parties may be required; and (v) the
outcome of any existing or future intellectual property or other
litigation related to our drugs and drug candidates and those of
our collaboration partners including MOVANTIK and ADYNOVATE.
Other important risks and uncertainties set forth in our Annual
Report on Form 10-K for the year ended December 31, 2015 filed with
the Securities and Exchange Commission on February 29, 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 and Media:
Jennifer Ruddock of Nektar Therapeutics
415-482-5585
Jodi Sievers of Nektar Therapeutics
415-482-5593
NEKTAR
THERAPEUTICS
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
ASSETS
|
December 31,
2015
|
(1)
|
December 31,
2014
|
(1)
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
$
55,570
|
|
$
12,365
|
|
|
Short-term
investments
|
253,374
|
|
225,459
|
|
|
Accounts receivable,
net
|
19,947
|
|
3,607
|
|
|
Inventory
|
11,346
|
|
12,952
|
|
|
Restricted
cash
|
-
|
|
25,000
|
|
|
Other current
assets
|
9,814
|
|
8,817
|
|
|
|
Total current
assets
|
350,051
|
|
288,200
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
71,336
|
|
70,368
|
|
Goodwill
|
|
76,501
|
|
76,501
|
|
Other
assets
|
4,173
|
|
6,552
|
|
|
Total
assets
|
$
502,061
|
|
$
441,621
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
$
2,363
|
|
$
2,703
|
|
|
Accrued
compensation
|
5,998
|
|
5,749
|
|
|
Accrued clinical
trial expenses
|
8,220
|
|
7,708
|
|
|
Other accrued
expenses
|
4,156
|
|
6,418
|
|
|
Interest
payable
|
4,198
|
|
6,917
|
|
|
Capital lease
obligations, current portion
|
4,756
|
|
4,512
|
|
|
Deferred revenue,
current portion
|
21,428
|
|
24,473
|
|
|
Other current
liabilities
|
10,127
|
|
5,567
|
|
|
|
Total current
liabilities
|
61,246
|
|
64,047
|
|
|
|
|
|
|
|
|
Senior secured notes,
net
|
242,115
|
|
125,000
|
|
Capital lease
obligations, less current portion
|
1,073
|
|
4,139
|
|
Liability related to
the sale of future royalties
|
119,032
|
|
120,471
|
|
Deferred revenue,
less current portion
|
62,426
|
|
76,911
|
|
Other long-term
liabilities
|
9,740
|
|
14,721
|
|
|
|
Total
liabilities
|
495,632
|
|
405,289
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
:
|
|
|
|
|
|
Preferred
stock
|
-
|
|
-
|
|
|
Common
stock
|
13
|
|
13
|
|
|
Capital in excess of
par value
|
1,876,072
|
|
1,824,195
|
|
|
Accumulated other
comprehensive loss
|
(2,170)
|
|
(1,567)
|
|
|
Accumulated
deficit
|
(1,867,486)
|
|
(1,786,309)
|
|
|
|
Total stockholders'
equity
|
6,429
|
|
36,332
|
|
|
Total liabilities and
stockholders' equity
|
$
502,061
|
|
$
441,621
|
|
|
(1) The consolidated
balance sheets at December 31, 2015 and 2014 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 OPERATIONS
|
|
(In thousands, except
per share information)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Year Ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2015
|
|
2014
|
|
2015
|
(1)
|
2014
|
(1)
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Product
sales
|
$ 13,973
|
|
$ 7,460
|
|
$ 40,155
|
|
$ 25,152
|
|
Royalty
revenue
|
1,910
|
|
41
|
|
2,967
|
|
329
|
|
Non-cash royalty
revenue related to sale of future royalties
|
7,306
|
|
5,184
|
|
22,058
|
|
21,937
|
|
License,
collaboration and other revenue
|
16,181
|
|
6,866
|
|
165,604
|
|
153,289
|
|
Total
revenue
|
39,370
|
|
19,551
|
|
230,784
|
|
200,707
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
8,364
|
|
6,298
|
|
34,102
|
|
28,533
|
|
Research and
development
|
47,135
|
|
38,494
|
|
182,787
|
|
147,734
|
|
General and
administrative
|
13,235
|
|
12,247
|
|
43,266
|
|
40,925
|
|
Total operating costs
and expenses
|
68,734
|
|
57,039
|
|
260,155
|
|
217,192
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(29,364)
|
|
(37,488)
|
|
(29,371)
|
|
(16,485)
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
(5,791)
|
|
(4,456)
|
|
(18,282)
|
|
(17,869)
|
|
Non-cash interest
expense on liability related to sale of future royalties
|
(5,191)
|
|
(5,163)
|
|
(20,619)
|
|
(20,888)
|
|
Loss on
extinguishment of debt
|
(14,079)
|
|
-
|
|
(14,079)
|
|
-
|
|
Interest income and
other income (expense), net
|
325
|
|
278
|
|
1,680
|
|
814
|
|
Total non-operating
expense, net
|
(24,736)
|
|
(9,341)
|
|
(51,300)
|
|
(37,943)
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
(benefit) for income taxes
|
(54,100)
|
|
(46,829)
|
|
(80,671)
|
|
(54,428)
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit)
for income taxes
|
37
|
|
(1,146)
|
|
506
|
|
(512)
|
|
Net loss
|
$ (54,137)
|
|
$ (45,683)
|
|
$ (81,177)
|
|
$ (53,916)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$ (0.40)
|
|
$ (0.35)
|
|
$ (0.61)
|
|
$ (0.42)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing basic and diluted net loss per
share
|
134,166
|
|
129,334
|
|
132,458
|
|
126,873
|
|
|
(1) The consolidated
statements of operations for the years ended December 31, 2015 and
2014 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,
|
|
|
2015
|
(1)
|
2014
|
(1)
|
Cash flows from
operating activities:
|
|
|
|
|
Net
loss
|
$(81,177)
|
|
$ (53,916)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
Non-cash royalty
revenue related to sale of future royalties
|
(22,058)
|
|
(21,937)
|
|
Non-cash interest
expense on liability related to sale of future
royalties
|
20,619
|
|
20,888
|
|
Stock-based
compensation
|
19,669
|
|
17,017
|
|
Depreciation and
amortization
|
12,855
|
|
12,927
|
|
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
|
(2,365)
|
|
(560)
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
Accounts receivable,
net
|
(16,340)
|
|
(1,378)
|
|
Inventory
|
1,606
|
|
500
|
|
Other
assets
|
(825)
|
|
(3,294)
|
|
Accounts
payable
|
(412)
|
|
(6,359)
|
|
Accrued
compensation
|
249
|
|
(8,505)
|
|
Accrued clinical
trial expenses
|
512
|
|
(9,197)
|
|
Other accrued
expenses
|
(2,278)
|
|
273
|
|
Interest
payable
|
(2,719)
|
|
-
|
|
Deferred
revenue
|
(17,530)
|
|
(4,664)
|
|
Liability related to
receipt of refundable milestone payment
|
-
|
|
(70,000)
|
|
Other
liabilities
|
3,032
|
|
(13,801)
|
|
Net cash used in
operating activities
|
(73,083)
|
|
(142,006)
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
Purchases of
investments
|
(297,608)
|
|
(297,251)
|
|
Maturities of
investments
|
226,923
|
|
247,995
|
|
Sales of
investments
|
42,544
|
|
21,661
|
|
Release of restricted
cash
|
25,000
|
|
-
|
|
Purchases of
property, plant and equipment
|
(11,195)
|
|
(9,976)
|
|
Net cash used in
investing activities
|
(14,336)
|
|
(37,571)
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
Payment of capital
lease obligations
|
(5,187)
|
|
(3,536)
|
|
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)
|
|
-
|
|
Repayment of proceeds
from sale of future royalties
|
-
|
|
(7,000)
|
|
Issuance of common
stock, net of issuance costs
|
-
|
|
116,536
|
|
Proceeds from shares
issued under equity compensation plans
|
32,208
|
|
46,984
|
|
Net cash provided by
financing activities
|
130,783
|
|
152,984
|
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
(159)
|
|
(109)
|
|
Net increase
(decrease) in cash and cash equivalents
|
43,205
|
|
(26,702)
|
|
Cash and cash
equivalents at beginning of year
|
12,365
|
|
39,067
|
|
Cash and cash
equivalents at end of year
|
$ 55,570
|
|
$ 12,365
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
Cash paid for
interest
|
$ 20,225
|
|
$ 17,445
|
|
Cash paid for income
taxes
|
$ 860
|
|
$ 964
|
|
|
|
|
|
|
Supplemental
schedule of non-cash investing and financing
activities:
|
|
|
|
|
Property and
equipment acquired through capital leases and other
financing
|
$ 93
|
|
$ 5,231
|
|
|
(1) The consolidated
statements of cash flows for the years ended December 31, 2015 and
2014 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-2015-financial-results-300228925.html
SOURCE Nektar Therapeutics