SAN FRANCISCO, April 30, 2015 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported its financial results
for the first quarter ended March 31,
2015.
Cash and investments in marketable securities at March 31, 2015 were $325.8
million as compared to $262.8
million at December 31, 2014.
Our cash and investments in marketable securities at March 31, 2015 includes a $100.0 million milestone payment received from
AstraZeneca in Q1 2015 for the first commercial sale of
Movantik™(naloxegol) in the U.S.
"The recent U.S. launch of Movantik by AstraZeneca is
progressing well and this first-in-class medicine to treat OIC is
now being made available in several European countries," said
Howard W. Robin, President and Chief
Executive Officer of Nektar. "In the first quarter, we
initiated enrollment for the SUMMIT-07 efficacy study of NKTR-181
in patients with chronic low back pain. We are also
finalizing preparations for our new cancer immunotherapy, NKTR-214,
to enter clinical studies this year. With the recent launch
of Movantik and the anticipated approval of BAX 855 in Q4, we are
beginning to see important new medicines emerging from our
late-stage pipeline that should drive Nektar's near-term
revenue. Importantly, we have three additional partnered drug
candidates in Phase 3 which are expected to have data readouts in
2016 and should continue to build our revenue base in the
future."
Revenue for the first quarter of 2015 was $108.8 million as compared to $19.8 million in the first quarter of 2014. The
increase in revenue in the first quarter of 2015 as compared to the
first quarter of 2014 is due to 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.
Revenue also included non-cash royalty revenue, related to our 2012
royalty monetization, of $4.0 million
and $5.8 million in the three months
ended March 31, 2015 and 2014,
respectively. This non-cash royalty revenue is offset by non-cash
interest expense.
Total operating costs and expenses for the first quarter of 2015
were $65.8 million as compared to
$56.2 million in the first quarter of
2014. Total operating costs and expenses increased primarily
as a result of increased research and development (R&D)
expense.
R&D expense in the first quarter of 2015 was $47.0 million as compared to $38.3 million for the first quarter of
2014. R&D expense was higher in the first quarter of 2015
primarily due to the initiation of the Phase 3 efficacy study of
NKTR-181 in patients with chronic low back pain.
Additionally, R&D expense in the first quarter of 2015 included
costs related to the continued production of devices for the
ongoing Phase 3 studies of Amikacin Inhale, the ongoing Phase 3
study of NKTR-102 in breast cancer, the ongoing Phase 1 study of
NKTR-171, and IND enabling activities for NKTR-214 which will enter
the clinic in 2015.
General and administrative expense was $10.3 million in the first quarter of 2015 as
compared to $9.9 million in the first
quarter of 2014.
In Q1 2015, net income was $33.8
million, or $0.26 basic
earnings per share. This compared to a net loss of
$46.2 million or ($0.37) basic loss per share in Q1 2014.
Corporate Highlights
- Movantik launched in the U.S. on March
31, 2015 for the treatment of opioid-induced constipation
(OIC) in adult patients with chronic, non-cancer pain. First
commercial sale triggered $100
million milestone payment to Nektar by partner
AstraZeneca.
- New drug application submitted for BAX 855 to Japan's Ministry of Health, on April 16, 2015.
- BAX 855 pediatric study completed enrollment. Data from the
study will support post-approval label expansion by Baxter in the U.S. for previously treated
pediatric patients and European regulatory submission in 2016.
- NKTR-181 Phase 3 SUMMIT-07 study in opioid naïve patients with
chronic low back pain began enrollment in February 2015.
- Data from the Phase 3 BEACON study of NKTR-102 in metastatic
breast cancer selected for oral abstract presentation at the 2015
ASCO Annual Meeting in Chicago.
Presentation Details:
Abstract #1001: "Phase III trial of etirinotecan pegol (EP)
versus Treatment of Physician's Choice (TPC) in patients (pts) with
advanced breast cancer (aBC) whose disease has progressed following
anthracycline (A), taxane (T) and capecitabine (C): The BEACON
study.", Perez, E., et al.
Oral Abstract Session: "Breast
Cancer—Triple-Negative/Cytotoxics/Local Therapy"
Date: June 1, 2015, 3:12 p.m. — 3:24 p.m.
Central Time
Conference Call to Discuss First Quarter 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, Thursday, April 30, 2015.
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 1, 2015.
To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 33513793 (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® 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. 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
hemophilia, BAX 855, a longer-acting PEGylated Factor VIII
therapeutic is in Phase 3 development conducted by partner
Baxter. A BLA for BAX 855 was
filed by Baxter to the US FDA in
December, 2014 and is currently under review. 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™, 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.
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 (naloxegol), BAX 855, the
future revenue potential from our collaboration partnerships, the
timing of availability of future clinical trial data from our
collaboration partners, the timing of the expected start date of
the clinical program for NKTR-214, 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, is difficult
to predict and will have a significant impact on our future results
of operation and financial condition; (ii) 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; (iii) patents may not issue from our patent
applications for our drugs (including MOVANTIK and BAX 855) and
drug candidates, patents that have issued may not be enforceable,
or additional intellectual property licenses from third parties may
be required; and (iv) 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 BAX 855. Other important risks and uncertainties
set forth in our Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on February 26, 2015 and our Current Report on Form
8-K filed with the SEC on March 17,
2015. 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:
Investors
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
Media
Nadia Hasan of WCG
212-257-6738
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
March 31,
2015
|
|
December 31,
2014
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
$
129,452
|
|
$
12,365
|
|
Restricted
cash
|
|
|
|
25,000
|
|
25,000
|
|
Short-term
investments
|
|
|
|
171,353
|
|
225,459
|
|
Accounts receivable,
net
|
|
|
|
2,885
|
|
3,607
|
|
Inventory
|
|
|
|
|
12,511
|
|
12,952
|
|
Other current
assets
|
|
|
|
6,092
|
|
8,817
|
|
|
Total current
assets
|
|
|
|
347,293
|
|
288,200
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
|
69,267
|
|
70,368
|
Goodwill
|
|
|
|
|
|
76,501
|
|
76,501
|
Other
assets
|
|
|
|
|
6,151
|
|
6,552
|
|
Total
assets
|
|
|
|
|
$
499,212
|
|
$
441,621
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
$
5,024
|
|
$
2,703
|
|
Accrued
compensation
|
|
|
|
9,356
|
|
5,749
|
|
Accrued
expenses
|
|
|
|
8,245
|
|
6,418
|
|
Accrued clinical
trial expenses
|
|
|
8,747
|
|
7,708
|
|
Interest
payable
|
|
|
|
|
3,167
|
|
6,917
|
|
Capital lease
obligations, current portion
|
|
|
5,412
|
|
4,512
|
|
Deferred revenue,
current portion
|
|
|
24,959
|
|
24,473
|
|
Other current
liabilities
|
|
|
|
10,534
|
|
5,567
|
|
|
Total current
liabilities
|
|
|
|
75,444
|
|
64,047
|
|
|
|
|
|
|
|
|
|
|
|
Senior secured
notes
|
|
|
|
125,000
|
|
125,000
|
Capital lease
obligations, less current portion
|
|
|
4,386
|
|
4,139
|
Liability related to
sale of future royalties
|
|
|
121,558
|
|
120,471
|
Deferred revenue,
less current portion
|
|
|
78,418
|
|
76,911
|
Other long-term
liabilities
|
|
|
|
17,101
|
|
14,721
|
|
|
Total
liabilities
|
|
|
|
421,907
|
|
405,289
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
|
|
-
|
|
-
|
|
Common
stock
|
|
|
|
|
13
|
|
13
|
|
Capital in excess of
par value
|
|
|
1,831,057
|
|
1,824,195
|
|
Accumulated other
comprehensive loss
|
|
|
(1,276)
|
|
(1,567)
|
|
Accumulated
deficit
|
|
|
|
(1,752,489)
|
|
(1,786,309)
|
|
|
Total stockholders'
equity
|
|
|
77,305
|
|
36,332
|
|
Total liabilities and
stockholders' equity
|
|
|
$
499,212
|
|
$
441,621
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
The consolidated
balance sheet at December 31, 2014 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,
|
|
|
2015
|
|
2014
|
|
|
|
|
|
Revenue:
|
|
|
|
|
Product sales and royalty
revenue
|
|
$
8,099
|
|
$
5,917
|
Non-cash royalty revenue
related to sale of future royalties
|
|
3,962
|
|
5,773
|
License, collaboration
and other revenue
|
|
96,740
|
|
8,081
|
Total
revenue
|
|
108,801
|
|
19,771
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
Cost of goods
sold
|
|
8,444
|
|
7,907
|
Research and
development
|
|
47,011
|
|
38,338
|
General and
administrative
|
|
10,303
|
|
9,928
|
Total operating costs
and expenses
|
|
65,758
|
|
56,173
|
|
|
|
|
|
Income (loss) from
operations
|
|
43,043
|
|
(36,402)
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
Interest
expense
|
|
(4,171)
|
|
(4,533)
|
Non-cash interest
expense on liability related to sale of future royalties
|
|
(5,050)
|
|
(5,387)
|
Interest income and
other income (expense), net
|
|
211
|
|
312
|
Total non-operating
expense, net
|
|
(9,010)
|
|
(9,608)
|
|
|
|
|
|
Income (loss) before
provision for income taxes
|
|
34,033
|
|
(46,010)
|
|
|
|
|
|
Provision for income
taxes
|
|
213
|
|
191
|
Net income
(loss)
|
|
$
33,820
|
|
$
(46,201)
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
Basic
|
|
$
0.26
|
|
$
(0.37)
|
|
|
|
|
|
Diluted
|
|
$
0.25
|
|
$
(0.37)
|
|
|
|
|
|
Weighted average
shares outstanding used in computing net income (loss) per
share:
|
|
|
|
|
Basic
|
|
131,359
|
|
123,543
|
|
|
|
|
|
Diluted
|
|
135,667
|
|
123,543
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
2014
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
Net income
(loss)
|
|
|
|
|
|
|
$
33,820
|
|
$
(46,201)
|
Adjustments to
reconcile net income (loss) to net cash provided by (used in)
operating activities:
|
|
|
|
|
Non-cash royalty
revenue related to sale of future royalties
|
|
|
|
(3,962)
|
|
(5,773)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
|
5,050
|
|
5,387
|
Stock-based
compensation
|
|
|
|
|
5,177
|
|
4,361
|
Depreciation and
amortization
|
|
|
|
|
2,973
|
|
3,264
|
Other non-cash
transactions
|
|
|
|
|
(938)
|
|
777
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
Accounts receivable,
net
|
|
|
|
|
|
722
|
|
374
|
Inventory
|
|
|
|
|
|
|
441
|
|
580
|
Other
assets
|
|
|
|
|
|
|
2,809
|
|
(718)
|
Accounts
payable
|
|
|
|
|
|
2,241
|
|
(6,126)
|
Accrued
compensation
|
|
|
|
|
|
3,607
|
|
(4,827)
|
Accrued
expenses
|
|
|
|
|
|
1,811
|
|
693
|
Accrued clinical
trial expenses
|
|
|
|
|
1,039
|
|
(3,179)
|
Interest
payable
|
|
|
|
|
|
(3,750)
|
|
(3,750)
|
Deferred
revenue
|
|
|
|
|
|
1,993
|
|
(5,957)
|
Other
liabilities
|
|
|
|
|
|
10,279
|
|
(1,195)
|
Net cash provided by
(used in) operating activities
|
|
|
|
63,312
|
|
(62,290)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
Maturities of
investments
|
|
|
|
|
|
73,434
|
|
56,972
|
Purchases of
investments
|
|
|
|
|
(24,432)
|
|
(110,661)
|
Sale of
investments
|
|
|
|
|
|
5,215
|
|
-
|
Purchases of property
and equipment
|
|
|
|
|
(1,059)
|
|
(4,524)
|
Net cash provided by
(used in) investing activities
|
|
|
|
53,158
|
|
(58,213)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
Payment of capital
lease obligations
|
|
|
|
|
(1,098)
|
|
(825)
|
Repayment of proceeds
from sale of future royalties
|
|
|
|
-
|
|
(7,000)
|
Issuance of common
stock, net of issuance costs
|
|
|
|
-
|
|
116,619
|
Proceeds from shares
issued under equity compensation plans
|
|
|
|
1,685
|
|
5,074
|
Net cash provided by
financing activities
|
|
|
|
|
587
|
|
113,868
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
|
|
|
30
|
|
11
|
Net increase
(decrease) in cash and cash equivalents
|
|
|
|
117,087
|
|
(6,624)
|
Cash and cash
equivalents at beginning of period
|
|
|
|
12,365
|
|
39,067
|
Cash and cash
equivalents at end of period
|
|
|
|
|
$
129,452
|
|
$
32,443
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
Cash paid for
interest
|
|
|
|
|
|
$
7,855
|
|
$
7,961
|
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-2015-300075512.html
SOURCE Nektar Therapeutics