SAN FRANCISCO, May 3, 2016 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported its financial results
for the first quarter ended March 31,
2016.
Cash and investments in marketable securities at March 31, 2016 were $288.3
million as compared to $308.9
million at December 31, 2015.
This balance at March 31, 2016 does
not include $28.0 million received
from AstraZeneca in April of 2016 for the sublicense of MOVENTIG™
to ProStrakan in Europe.
"I am very pleased with the progress of both our proprietary
pipeline and partner programs," said Howard
W. Robin, President and Chief Executive Officer of Nektar.
"MOVANTIK® has performed well in its first year with positive
feedback from physicians and patients. ADYNOVATE™, which was
launched in the U.S. in December 2015 by
Baxalta, recently received approval in Japan and has now been filed for approval in
Europe. 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 in its first-in-human trial evaluating its safety
and efficacy in cancer patients with solid tumors. We expect
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 first quarter of 2016 was $58.9 million as compared to $108.8 million in the first quarter of 2015.
Revenue for the first quarter of 2016 includes the recognition of
$28.0 million received from
AstraZeneca in April of 2016 for the sublicense of MOVENTIG to
ProStrakan in Europe which
occurred in the first quarter. Revenue in the first quarter
of 2015 was higher primarily because of the one-time recognition of
$90 million related to the U.S.
commercial launch of MOVANTIK™. Product sales and royalty
revenue increased to $18.2 million in
the first quarter of 2016 as compared to $8.1 million in the first quarter of 2015.
Revenue also included non-cash royalty revenue, related to our
2012 royalty monetization, of $6.5
million and $4.0 million for
the three months ended March 31, 2016
and 2015, respectively. This non-cash royalty revenue is partially
offset by non-cash interest expense also incurred in connection
with the 2012 royalty monetization. Non-cash interest expense was
$5.0 million in the first quarter
2016 as compared to $5.1 million in
the first quarter 2015.
Total operating costs and expenses for the first quarter of 2016
were $68.4 million as compared to
$65.8 million in the first quarter of
2015. Total operating costs and expenses increased primarily as a
result of higher research and development (R&D) expense in the
first quarter of 2016. R&D expense in the first quarter
of 2016 was $49.3 million as compared
to $47.0 million for the first
quarter of 2015 and was higher in the first quarter of 2016
primarily due to expenses for the NKTR-181 Phase 3 studies and for
initiation of the Phase 1/2 study of NKTR-214.
General and administrative expense was $10.2 million in the first quarter of 2016 as
compared to $10.3 million in the
first quarter of 2015.
In Q1 2016, net loss was $19.5
million, or $0.14 loss per
share as compared to net income of $33.8
million, or $0.26 basic
earnings per share in the first quarter of 2015. This
decrease is primarily because of the one-time recognition of
$90 million related to the U.S.
commercial launch of MOVANTIK™ in the first quarter of 2015.
The company also announced upcoming presentations at the
following scientific congresses during the first half of
2016:
SMI 16th Annual Pain Therapeutics Conference,
London, England:
- Abstract Title: "NKTR-181, A Novel Mu-Opioid Analgesic
Designed for Inherent Low Abuse Liability" presented by
Stephen Doberstein, Ph.D.
- Session: Opioid Dependence
- Date: May 24, 2016
ASCO Annual Meeting, Chicago, IL:
- Abstract 11545: "Immune Memory in Nonclinical Models after
Treatment with NKTR-214, an Engineered Cytokine Biased Towards
Expansion of CD8+ T Cells in Tumor", D. Charych, et al.
- Poster Session: Tumor Biology
- Date: June 6, 2016, 1:00 p.m. – 4:30 p.m.
Central Time
Conference Call to Discuss First Quarter 2016 Financial
Results
Nektar management will host a conference call to review the
results beginning at 4:30 p.m. Eastern
Time/1:30 p.m. Pacific Time
today, Tuesday, May 3, 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 Friday,
June 3, 2016.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 96031147 (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, the 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:
Jennifer Ruddock of Nektar Therapeutics
415-482-5585
Jodi Sievers of Nektar Therapeutics
415-482-5593
For Media:
Dan Budwick of Pure Communications, Inc.
(973) 271-6085
dan@purecommunicationsinc.com
NEKTAR
THERAPEUTICS
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
March 31,
2016
|
|
December 31,
2015
|
(1)
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
72,549
|
|
$
55,570
|
|
|
Short-term
investments
|
|
215,776
|
|
253,374
|
|
|
Accounts receivable,
net
|
|
39,677
|
|
19,947
|
|
|
Inventory
|
|
11,250
|
|
11,346
|
|
|
Other current
assets
|
|
5,593
|
|
9,814
|
|
|
|
Total current
assets
|
|
344,845
|
|
350,051
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
69,852
|
|
71,336
|
|
Goodwill
|
|
76,501
|
|
76,501
|
|
Other
assets
|
|
681
|
|
754
|
|
|
|
Total
assets
|
|
$
491,879
|
|
$
498,642
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
2,349
|
|
$
2,363
|
|
|
Accrued
compensation
|
|
10,044
|
|
5,998
|
|
|
Accrued clinical
trial expenses
|
|
10,596
|
|
8,220
|
|
|
Other accrued
expenses
|
|
6,284
|
|
4,156
|
|
|
Interest
payable
|
|
4,144
|
|
4,198
|
|
|
Capital lease
obligations, current portion
|
|
4,782
|
|
4,756
|
|
|
Deferred revenue,
current portion
|
|
17,240
|
|
21,428
|
|
|
Other current
liabilities
|
|
10,506
|
|
10,127
|
|
|
|
Total current
liabilities
|
|
65,945
|
|
61,246
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior secured notes,
net
|
|
242,130
|
|
241,699
|
|
Capital lease
obligations, less current portion
|
|
3,325
|
|
1,073
|
|
Liability related to
sale of future royalties, net
|
|
114,631
|
|
116,029
|
|
Deferred revenue,
less current portion
|
|
59,587
|
|
62,426
|
|
Other long-term
liabilities
|
|
6,536
|
|
9,740
|
|
|
|
Total
liabilities
|
|
492,154
|
|
492,213
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
(deficit):
|
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
|
Common
stock
|
|
13
|
|
13
|
|
|
Capital in excess of
par value
|
|
1,888,531
|
|
1,876,072
|
|
|
Accumulated other
comprehensive loss
|
|
(1,835)
|
|
(2,170)
|
|
|
Accumulated
deficit
|
|
(1,886,984)
|
|
(1,867,486)
|
|
|
|
Total stockholders'
equity (deficit)
|
|
(275)
|
|
6,429
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
491,879
|
|
$
498,642
|
|
|
(1) The consolidated
balance sheet at December 31, 2015 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,
|
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
Product sales
|
|
$
14,099
|
|
$
7,974
|
Royalty revenue
|
|
4,061
|
|
125
|
Non-cash royalty revenue related to sale of future
royalties
|
|
6,535
|
|
3,962
|
License, collaboration and other revenue
|
|
34,187
|
|
96,740
|
Total
revenue
|
|
58,882
|
|
108,801
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
Cost of goods sold
|
|
8,870
|
|
8,444
|
Research and development
|
|
49,268
|
|
47,011
|
General and administrative
|
|
10,228
|
|
10,303
|
Total operating costs
and expenses
|
|
68,366
|
|
65,758
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
(9,484)
|
|
43,043
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
Interest expense
|
|
(5,677)
|
|
(4,171)
|
Non-cash interest expense on liability related to sale of future
royalties
|
|
(5,045)
|
|
(5,050)
|
Interest income and other income (expense), net
|
|
875
|
|
211
|
Total non-operating
expense, net
|
|
(9,847)
|
|
(9,010)
|
|
|
|
|
|
|
Income (loss) before
provision for income taxes
|
|
(19,331)
|
|
34,033
|
|
|
|
|
|
|
Provision for income
taxes
|
|
167
|
|
213
|
Net income
(loss)
|
|
$
(19,498)
|
|
$
33,820
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
Basic
|
|
$
(0.14)
|
|
$
0.26
|
|
|
|
|
|
|
Diluted
|
|
$
(0.14)
|
|
$
0.25
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing net income (loss) per
share:
|
|
|
|
|
Basic
|
|
135,793
|
|
131,359
|
|
|
|
|
|
|
Diluted
|
|
135,793
|
|
135,667
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2016
|
|
2015
|
Cash flows from
operating activities:
|
|
|
|
|
Net income
(loss)
|
|
$ (19,498)
|
|
$ 33,820
|
Adjustments to
reconcile net income (loss) to net cash (used in) provided by
operating activities:
|
|
|
|
|
Non-cash royalty
revenue related to sale of future royalties
|
|
(6,535)
|
|
(3,962)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
|
5,045
|
|
5,050
|
Stock-based
compensation
|
|
6,363
|
|
5,177
|
Depreciation and
amortization
|
|
3,715
|
|
2,973
|
Other non-cash
transactions
|
|
(617)
|
|
(938)
|
Changes in operating
assets and liabilities:
|
|
|
|
|
Accounts receivable,
net
|
|
(19,730)
|
|
722
|
Inventory
|
|
96
|
|
441
|
Other
assets
|
|
4,294
|
|
2,809
|
Accounts
payable
|
|
(34)
|
|
2,241
|
Accrued
compensation
|
|
4,046
|
|
3,607
|
Accrued clinical
trial expenses
|
|
2,376
|
|
1,039
|
Other accrued
expenses
|
|
2,176
|
|
1,811
|
Interest
payable
|
|
(54)
|
|
(3,750)
|
Deferred
revenue
|
|
(7,027)
|
|
1,993
|
Other
liabilities
|
|
1,736
|
|
10,279
|
Net cash (used in)
provided by operating activities
|
|
(23,648)
|
|
63,312
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
Purchases of
investments
|
|
(31,452)
|
|
(24,432)
|
Maturities of
investments
|
|
69,377
|
|
73,434
|
Sales of
investments
|
|
-
|
|
5,215
|
Purchases of
property, plant and equipment
|
|
(1,679)
|
|
(1,059)
|
Net cash provided by
investing activities
|
|
36,246
|
|
53,158
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
Payment of capital
lease obligations
|
|
(1,723)
|
|
(1,098)
|
Proceeds from shares
issued under equity compensation plans
|
|
6,096
|
|
1,685
|
Net cash provided by
financing activities
|
|
4,373
|
|
587
|
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
|
8
|
|
30
|
Net increase in cash
and cash equivalents
|
|
16,979
|
|
117,087
|
Cash and cash
equivalents at beginning of period
|
|
55,570
|
|
12,365
|
Cash and cash
equivalents at end of period
|
|
$ 72,549
|
|
$ 129,452
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
Cash paid for
interest
|
|
$ 5,244
|
|
$ 7,855
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-financial-results-for-the-first-quarter-of-2016-300262015.html
SOURCE Nektar Therapeutics