SAN FRANCISCO, May 9, 2017 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported its financial
results for the first quarter ended March 31, 2017.
Cash and investments in marketable securities at March 31,
2017 were $362.0 million as compared to $389.1
million at December 31, 2016.
"I am very pleased with our continued success in advancing the
Nektar pipeline, driven by our expanding research in
immuno-oncology and immunology that continues to generate highly
valuable new clinical candidates," said Howard W. Robin, President and Chief Executive
Officer of Nektar. "In March, we announced overwhelmingly positive
efficacy and safety results from our Phase 3 study of NKTR-181 in
patients with chronic low back pain. Our Phase 1/2 study evaluating
NKTR-214 as a combination regimen with Opdivo® in collaboration
with Bristol-Myers Squibb is advancing and we look forward to
reporting initial data from the first patients in this trial at
ASCO. In Q1, we also initiated a first-in-human trial for
NKTR-358, our proprietary Treg stimulator, which has the potential
to become a first-in-class resolution therapeutic for a wide range
of immune-mediated disorders. We plan to report the results from
this trial at a medical meeting in the second half of 2017."
Revenue for the first quarter of 2017 was $24.7
million as compared to $58.9 million in the first
quarter of 2016. Revenue in the first quarter of 2016 was higher
primarily because of the recognition of $28.0
million received from AstraZeneca for the sublicense of
MOVENTIG® to Kirin in Europe. In
addition, product sales were $4.8
million in the first quarter of 2017 as compared to
$14.1 million in the first quarter of
2016.
Total operating costs and expenses for the first quarter of 2017
were $79.2 million as compared to $68.4
million in the first quarter of 2016. Total operating costs
and expenses increased primarily as a result of higher research and
development (R&D) expense in the first quarter of 2017.
R&D expense in the first quarter of 2017 was $61.1
million as compared to $49.3 million for the first
quarter of 2016 and was higher in the first quarter of 2017
primarily due to expenses for our NKTR-214 and NKTR-358
programs.
General and administrative expense was $12.0
million in the first quarter of 2017 as compared to $10.2
million in the first quarter of 2016.
In the first quarter of 2017, net loss was $63.9 million,
or $0.42 loss per share as compared to net loss
of $19.5 million, or $0.14 loss per share in the
first quarter of 2016. The loss was higher year over year
primarily because of the recognition of $28.0
million received from AstraZeneca for the sublicense of
MOVENTIG® to Kirin in Europe in the first
quarter of 2016.
The company also announced upcoming presentations at the
following scientific congresses during the second quarter of
2017:
Oxford Global 2nd Annual Advances in Immuno-Oncology
Congress, London, UK
Oral Presentation: "NKTR-255: Accessing The Immunotherapeutic
Potential of IL-15"
Presenter: Jonathan Zalevsky,
Ph.D.
Session: Pre-clinical Immuno-Oncology
Date and Time: May 15, 2017 – 2:20 p.m.
- 2:50 p.m. BST
SMI 16th Annual Pain Therapeutics Conference, London, UK
Key Note Address: "NKTR-181: Separating Analgesia from
Euphoria in a Novel Opioid Agonist for Chronic Pain"
Presenter: Stephen Doberstein,
Ph.D.
Session: Opioid Addiction
Date and Time: May 23, 2017 – 9:50 a.m.
- 10:30 a.m. BST
2017 American Society of Clinical Oncology (ASCO) Annual
Meeting, Chicago, IL
Abstract 2545/Poster 37: "Effect of a novel
IL-2 cytokine immune agonist (NKTR-214) on proliferating CD8+T
cells and PD-1 expression on immune cells in the tumor
microenvironment in patients with prior checkpoint therapy."
Bernatchez, C., et al.
Poster Session: Developmental Therapeutics—Clinical Pharmacology
and Experimental Therapeutics
Date and Time: June 5, 2017 –
8:00 a.m. - 11:30 a.m. CDT
Location: Hall A
Abstract TPS1120/Poster 105a: "ATTAIN: Phase 3 study of
etirinotecan pegol (EP) vs treatment of physician's choice (TPC) in
patients (pts) with metastatic breast cancer (MBC) who have stable
brain metastases (BM) previously treated with an anthracycline, a
taxane, and capecitabine (ATC)." Tripathy, D., et al.
Poster session: Breast Cancer – Metastatic
Date and Time: June 4, 2017 –
8:00 a.m. - 11:30 a.m. CDT
Location: Hall A
Abstract e14040: "A phase 1/2 study of a novel IL-2 cytokine,
NKTR-214, and nivolumab in patients with select locally advanced or
metastatic solid tumors." Diab, A., et al.
Publication abstract to be included online in the 2017 ASCO
Annual Meeting Proceedings, a Journal of Clinical
Oncology supplement.
2017 International Conference on Opioids (ICOO 2017),
Boston, MA
Poster 31: "NKTR-181 Produces Full CNS µ-Opioid Agonism
With Significantly Lower Abuse Potential": Odinecs, A., et
al.
Poster session: Session 2
Date and Time: Monday, June 12,
2017 – 8:00 a.m. - 6:00 p.m.
EDT
Inaugural Immuno-Oncology Targets Conference, Boston, MA
Oral Presentation: "NKTR-214 Plus NKTR-262, a
Scientifically-Guided Rational Combination Approach for Immune
Oncology"
Presenter: Jonathan Zalevsky,
Ph.D.
Session: Rational Combination Immunotherapy
Date and Time: June 15, 2017 – 12:00
p.m. EDT
Nektar Analyst & Investor Event at the 2017 ASCO Annual
Meeting, Chicago, IL
Nektar will host an analyst and investor event with clinical
investigators during the 2017 American Society of Clinical
Oncology (ASCO) Meeting in Chicago. The program will include
a presentation and discussion of updated clinical data for the
company's CD122-biased agonist, NKTR-214. Data from two
studies of NKTR-214 will be reviewed at the event, including the
Phase 1 dose-escalation study of NKTR-214 in combination with
nivolumab in patients with melanoma, renal cell carcinoma and
non-small cell lung cancer (PIVOT-02); and the Phase 1 study of
monotherapy NKTR-214 in patients with advanced solid tumors
(EXCEL).
Presenters will include Dr. Adi Diab, Assistant Professor,
Melanoma Medical Oncology at the University of Texas MD
Anderson Cancer Center, Dr. Nizar Tannir, Professor,
Genitourinary Medical Oncology at the University of Texas MD
Anderson Cancer Center and Dr. Michael Hurwitz, Assistant
Professor of Medicine (Medical Oncology) at Yale Cancer
Center.
Date and Time: June 3, 2017 –
6:00 p.m. CDT
Webcast Link: http://edge.media-server.com/m/p/guf8mqwk.
Conference Call to Discuss First Quarter 2017 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, May 9, 2017.
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 Investors section of the Nektar website:
http://www.nektar.com. The web broadcast of the conference call
will be available for replay through June 12, 2017.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 8518262 (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 Investors page at the Nektar website as
soon as practical after the conclusion of the conference call.
About Nektar
Nektar Therapeutics is a research-based biopharmaceutical
company whose mission is to discover and develop innovative
medicines to address the unmet medical needs of patients. Our
R&D pipeline of new investigational medicines includes
treatments for cancer, auto-immune disease and chronic pain. We
leverage Nektar's proprietary and proven chemistry platform in the
discovery and design of our new therapeutic candidates. 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 uncertain or forward-looking
statements which 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 therapeutic benefits of NKTR-181, the risks of opioid
abuse resulting from pain medicines, future development plans for
NKTR-181, the availability of data for NKTR-214 in combination with
Opdivo, clinical development plans for our products
(including NKTR-358), availability of future clinical results,
the timing of planned regulatory filings, the potential of NKTR-214
in combination with other immunotherapy agents, and the potential
of our 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 and 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 and you should not rely on such
statements. Important factors that could cause our actual results
to differ materially from those indicated in the forward-looking
statements include: (i) clinical study outcomes remain very
unpredictable and it is possible that a clinical study could fail;
(ii) the regulatory pathway to review and approve NKTR-181 for use
in patients is subject to substantial uncertainty; (iii)
regulations concerning access to opioid-based pharmaceuticals are
strict and there is no guarantee which scheduling category will
apply to NKTR-181 if regulatory approval is achieved; (iv) the CHMP
and FDA have substantial discretion as to whether to grant
marketing approval for pharmaceutical products; (v) 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 negative safety and efficacy
findings even after positive findings in previous preclinical and
clinical studies; (vi) the commencement or end of clinical trials
and the availability of clinical data may be delayed or
unsuccessful; (vii) patents may not issue from our patent
applications for our drug candidates, patents that have issued may
not be enforceable, or additional intellectual property licenses
from third parties may be required; and (viii) certain other
important risks and uncertainties set forth in our Annual Report on
Form 10-K for the year ended December 31, 2016 filed with
the Securities and Exchange Commission on March 1,
2017. 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.
Contact:
For Investors:
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
|
|
March 31,
2017
|
|
December 31, 2016
(1)
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
23,480
|
|
$
59,640
|
|
Short-term
investments
|
|
335,043
|
|
329,462
|
|
Accounts receivable,
net
|
|
1,565
|
|
15,678
|
|
Inventory
|
|
13,016
|
|
11,109
|
|
Other current
assets
|
|
7,881
|
|
10,063
|
|
|
Total current
assets
|
|
380,985
|
|
425,952
|
|
|
|
|
|
|
|
Long-term
investments
|
|
3,493
|
|
-
|
Property, plant and
equipment, net
|
|
66,642
|
|
65,601
|
Goodwill
|
|
76,501
|
|
76,501
|
Other
assets
|
|
865
|
|
817
|
|
|
Total
assets
|
|
$
528,486
|
|
$
568,871
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
6,951
|
|
$
2,816
|
|
Accrued
compensation
|
|
11,463
|
|
18,280
|
|
Accrued clinical
trial expenses
|
|
7,443
|
|
7,958
|
|
Other accrued
expenses
|
|
6,576
|
|
4,711
|
|
Interest
payable
|
|
4,090
|
|
4,198
|
|
Capital lease
obligations, current portion
|
|
2,909
|
|
2,908
|
|
Liability related to
refundable upfront payment
|
|
12,500
|
|
12,500
|
|
Deferred revenue,
current portion
|
|
24,192
|
|
14,352
|
|
Other current
liabilities
|
|
2,391
|
|
4,499
|
|
|
Total current
liabilities
|
|
78,515
|
|
72,222
|
|
|
|
|
|
|
|
Senior secured notes,
net
|
|
243,900
|
|
243,464
|
Capital lease
obligations, less current portion
|
|
1,609
|
|
2,223
|
Liability related to
sale of future royalties, net
|
|
103,931
|
|
105,950
|
Deferred revenue,
less current portion
|
|
51,666
|
|
51,887
|
Other long-term
liabilities
|
|
4,116
|
|
5,000
|
|
|
Total
liabilities
|
|
483,737
|
|
480,746
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
Common
stock
|
|
15
|
|
15
|
|
Capital in excess of
par value
|
|
2,131,698
|
|
2,111,483
|
|
Accumulated other
comprehensive loss
|
|
(1,849)
|
|
(2,363)
|
|
Accumulated
deficit
|
|
(2,085,115)
|
|
(2,021,010)
|
|
|
Total stockholders'
equity
|
|
44,749
|
|
88,125
|
|
Total liabilities and
stockholders' equity
|
|
$
528,486
|
|
$
568,871
|
|
(1) The consolidated
balance sheet at December 31, 2016 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,
|
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
Product
sales
|
|
$
4,756
|
|
$
14,099
|
Royalty
revenue
|
|
7,217
|
|
4,061
|
Non-cash royalty
revenue related to sale of future royalties
|
|
6,663
|
|
6,535
|
License,
collaboration and other revenue
|
|
6,092
|
|
34,187
|
Total
revenue
|
|
24,728
|
|
58,882
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
Cost of goods
sold
|
|
6,131
|
|
8,870
|
Research and
development
|
|
61,058
|
|
49,268
|
General and
administrative
|
|
11,976
|
|
10,228
|
Total operating costs
and expenses
|
|
79,165
|
|
68,366
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(54,437)
|
|
(9,484)
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
Interest
expense
|
|
(5,402)
|
|
(5,677)
|
Non-cash interest
expense on liability related to sale of future royalties
|
|
(4,552)
|
|
(5,045)
|
Interest income and
other income (expense), net
|
|
658
|
|
875
|
Total non-operating
expense, net
|
|
(9,296)
|
|
(9,847)
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
(63,733)
|
|
(19,331)
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
133
|
|
167
|
Net loss
|
|
$
(63,866)
|
|
$
(19,498)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.42)
|
|
$
(0.14)
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing basic and diluted net loss per
share
|
|
153,666
|
|
135,793
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
2017
|
|
2016
|
Cash flows from
operating activities:
|
|
|
|
|
Net loss
|
|
$
(63,866)
|
|
$
(19,498)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
Non-cash royalty revenue related to
sale of future royalties
|
|
(6,663)
|
|
(6,535)
|
Non-cash interest expense on
liability related to sale of future
royalties
|
|
4,552
|
|
5,045
|
Stock-based
compensation
|
|
8,184
|
|
6,363
|
Depreciation and
amortization
|
|
4,033
|
|
3,715
|
Other non-cash
transactions
|
|
(731)
|
|
(617)
|
Changes in operating
assets and liabilities:
|
|
|
|
|
Accounts receivable,
net
|
|
14,113
|
|
(19,730)
|
Inventory
|
|
(1,907)
|
|
96
|
Other
assets
|
|
2,134
|
|
4,294
|
Accounts
payable
|
|
4,117
|
|
(34)
|
Accrued
compensation
|
|
(6,817)
|
|
4,046
|
Accrued clinical
trial expenses
|
|
(515)
|
|
2,376
|
Other accrued
expenses
|
|
1,798
|
|
2,176
|
Interest
payable
|
|
(108)
|
|
(54)
|
Deferred
revenue
|
|
9,619
|
|
(7,027)
|
Other
liabilities
|
|
(2,509)
|
|
1,736
|
Net cash used in
operating activities
|
|
(34,566)
|
|
(23,648)
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
Purchases of
investments
|
|
(75,857)
|
|
(31,452)
|
Maturities of
investments
|
|
58,053
|
|
69,377
|
Sales of
investments
|
|
8,823
|
|
-
|
Purchases of
property, plant and equipment
|
|
(4,089)
|
|
(1,679)
|
Net cash (used in)
provided by investing activities
|
|
(13,070)
|
|
36,246
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
Payment of capital
lease obligations
|
|
(613)
|
|
(1,723)
|
Proceeds from shares
issued under equity compensation plans
|
|
11,792
|
|
6,096
|
Net cash provided by
financing activities
|
|
11,179
|
|
4,373
|
|
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
|
297
|
|
8
|
Net (decrease)
increase in cash and cash equivalents
|
|
(36,160)
|
|
16,979
|
Cash and cash
equivalents at beginning of period
|
|
59,640
|
|
55,570
|
Cash and cash
equivalents at end of period
|
|
$
23,480
|
|
$
72,549
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
Cash paid for
interest
|
|
$
5,067
|
|
$
5,244
|
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SOURCE Nektar Therapeutics