SAN FRANCISCO, Feb. 27, 2020 /PRNewswire/ -- Nektar Therapeutics
(Nasdaq: NKTR) today reported financial results for the fourth
quarter and full year ended December 31,
2019.
Cash and investments in marketable securities at December 31, 2019 were approximately $1.6 billion as compared to $1.9 billion at December
31, 2018.
"Nektar's progress over the past year has established a strong
foundation for growth, with a robust portfolio of clinical-stage
immuno-oncology and immunology candidates addressing multiple
therapeutic areas," said Howard W.
Robin, President and CEO of Nektar. "Our amended joint
development plan with Bristol-Myers Squibb for bempegaldesleukin in
combination with Opdivo expands the active registrational program
for the doublet to five indications, including new Phase 3 studies
in the adjuvant melanoma setting and muscle invasive bladder
cancer. It also provides a path forward in first-line lung cancer
and enhances our ability to pursue new combinations in additional
indications."
Mr. Robin continued, "We also advanced NKTR-255, a novel IL-15
agonist that stimulates NK cells and memory T cells, into the
clinic in combination with ADCC therapies. With NKTR-358, we have
an opportunity to address the underlying immune imbalance
associated with multiple autoimmune and chronic inflammatory
diseases. Our partner Eli Lilly is on track to initiate a Phase 2
study in lupus, advance ongoing Phase 1b clinical trials in psoriasis and atopic
dermatitis, and start an additional Phase 2 study in a new
autoimmune indication this year."
Summary of Financial Results
Revenue in the fourth quarter of 2019 was $33.9 million as compared to $39.8 million in the fourth quarter of 2018.
Revenue for the year ended December 31,
2019 was $114.6 million as
compared to $1.2 billion in 2018 and
was lower primarily due to the recognition of $1.06 billion of license revenue from the
Bristol-Myers Squibb collaboration agreement in the second quarter
of 2018.
Total operating costs and expenses in the fourth quarter of 2019
were $143.5 million as compared to
$140.1 million in the fourth quarter
of 2018. Total operating costs and expenses for 2019 were
$554.7 million as compared to
$505.4 million in 2018. Total
operating costs and expenses increased primarily as a result of
increases in research and development (R&D) expense and general
and administrative (G&A) expense.
R&D expense in the fourth quarter of 2019 was $110.4 million as compared to $108.9 million for the fourth quarter of 2018.
R&D expense for the year ended December
31, 2019 was $434.6 million as
compared to $399.5 million in 2018.
R&D expense was higher in 2019 as compared to 2018 primarily
because of the continued clinical development of bempegaldesleukin,
including the registrational studies in melanoma, bladder cancer
and renal cell carcinoma, and manufacture of Phase 2 drug supply
for NKTR-358, which were partially offset by lower
bempegaldesleukin and NKTR-181 manufacturing costs.
G&A expense was $27.1 million
in the fourth quarter of 2019 as compared to $23.8 million in the fourth quarter of 2018.
G&A expense for 2019 was $98.7
million as compared to $81.4
million in 2018. G&A expense was higher in the fourth
quarter and full year 2019 as compared to the same periods in 2018
primarily due to non-cash stock based compensation expense, limited
commercialization readiness activities for NKTR-181, as well as
other costs related to personnel, facilities and outside
services.
Net loss for the fourth quarter of 2019 was $112.2 million or $0.64 basic and diluted loss per share as
compared to a net loss of $98.2
million or $0.57 basic and
diluted loss per share in the fourth quarter of 2018. Net loss for
the year ended December 31, 2019 was
$440.7 million or $2.52 diluted loss per share as compared to net
income of $681.3 million or
$3.78 diluted earnings per share in
2018.
2019 and Year-to-Date Business Highlights:
- In February 2020, Nektar
announced the publication of preclinical bempegaldesleukin
data in two manuscripts in Nature Communications
showing how bempegaldesleukin works synergistically with multiple
immune-based therapies to enhance T-cell-mediated tumor
control.
- In January 2020, Nektar and Bristol-Myers Squibb announced a new
joint development plan that expands the ongoing registrational
program for bempegaldesleukin plus Opdivo (nivolumab) from three
ongoing registrational trials in first-line metastatic melanoma,
first-line cisplatin-ineligible metastatic urothelial cancer and
first-line metastatic renal cell carcinoma (RCC) to include two
additional registrational trials in adjuvant melanoma and
muscle-invasive bladder cancer. In addition, a Phase 1/2 study will
be initiated to evaluate bempegaldesleukin plus nivolumab in
combination with axitinib in first-line RCC in order to support a
future registrational trial. Bristol-Myers
Squibb will also independently conduct and fund a Phase 1/2
study in first-line non-small-cell lung cancer with
bempegaldesleukin and nivolumab.
- In January 2020, Nektar made the
strategic business decision to withdraw its New Drug Application
(NDA) for NKTR-181, an investigational medicine in development for
chronic pain and make no further investment into the program.
- In December 2019, Nektar
presented results from preclinical studies of NKTR-255, its IL-15
agonist, at the 61st American Society of Hematology Annual Meeting
highlighting the candidate's potential in the treatment of
hematological malignancies by restoring both NK cell and memory CD8
T cell compartments in patients.
- In November 2019, Nektar
presented updated results from the first-in-human Phase 1a study of
NKTR-358 at the 2019 Annual Meeting of the American College of
Rheumatology supporting development of the candidate as a
first-in-class T regulatory cell stimulator for the treatment of
autoimmune and other chronic inflammatory conditions.
- In November 2019, Nektar
presented new data from the Stage IV front-line melanoma cohort in
the PIVOT-02 study at the 2019 Society for Immunotherapy of Cancer
Annual Meeting. At a median time of follow-up of 18.6 months,
median progression free survival had not yet been reached.
- In October 2019, Nektar announced
that its partner Eli Lilly initiated two Phase 1b studies of NKTR-358, one in patients with
psoriasis and one in patients with atopic dermatitis.
- In October 2019, Nektar announced
the initiation of a first-in-human, Phase 1 clinical study
evaluating NKTR-255 as monotherapy for patients with relapsed or
refractory non-Hodgkin lymphoma or multiple myeloma.
- In September 2019, Nektar
presented clinical data from its PIVOT-02 study for
bempegaldesleukin in combination with Opdivo (nivolumab) at the
2019 CRI-CIMT-EATI-AACR International Cancer Immunotherapy
Conference demonstrating the promising clinical activity of the
combination in patients with advanced or metastatic triple-negative
breast cancer, particularly in patients with PD-L1 negative
baseline tumors.
- In August 2019, the U.S. Food and
Drug Administration (FDA) granted Breakthrough Therapy Designation
for bempegaldesleukin in combination with Opdivo (nivolumab) for
the treatment of patients with previously untreated unresectable or
metastatic melanoma.
- In June 2019, Nektar presented
biomarker and clinical data from the ongoing PIVOT-02 study for
bempegaldesleukin in combination with Opdivo (nivolumab) at the
2019 ASCO Annual Meeting. Clinical data presented included 12-month
follow-up for the Stage IV first-line melanoma patient cohort and
showed a deepening and durability of response over time.
- In April 2019, Nektar presented
positive preclinical data on its immuno-oncology pipeline
candidates, bempegaldesleukin and NKTR-255, at the 2019 AACR Annual
Meeting.
- In March 2019, Nektar presented
preliminary immune activation, safety and clinical activity data
from the ongoing dose-escalation stage of the REVEAL study at the
2019 ASCO-SITC Meeting. The REVEAL Phase 1/2 study is evaluating
the safety and efficacy of NKTR-262, a novel TLR agonist, in
combination with bempegaldesleukin.
- In February 2019, Nektar
presented clinical data from first-line Stage IV urothelial
carcinoma patients enrolled in the PIVOT-02 study of
bempegaldesleukin with Opdivo (nivolumab) at the 2019 ASCO
Genitourinary Cancers Symposium.
The company also announced upcoming presentations at the
following scientific congresses:
Society of Toxicology (SOT) 59th Annual Meeting,
Anaheim, CA
- Presentation: "Bempegaldesleukin (NKTR-214), a novel
IL-2 based immunotherapy, demonstrates superior nonclinical safety
compared to that reported for recombinant human IL-2 (rhIL-2)",
Leung, S., et al.
-
- Session: Safety Assessment: Pharmaceutical—Drug
Development
- Date: Wednesday, March 18th,
10:45 a.m. – 12:30 p.m.
- Presentation: "Toxicology Species Selection for
Preclinical Safety Assessment of TLR7/8 Prodrug Agonist",
Gunther, J., et al.
-
- Session: Safety Assessment: Pharmaceutical—Drug
Development
- Date: Wednesday, March 18th,
10:45 a.m. – 12:30 p.m.
American Chemical Society National Meeting
- Presentation: "NKTR-262: Discovery of a novel
TLR 7/8 agonist prodrug that demonstrates synergistic anti-tumor
effect in combination with NKTR-214, a CD-122 preferential IL-2
pathway agonist", Anand, N., et al.
-
- Session: MEDI: Tissue Specific Delivery: TLR
Agonists
- Date: Tuesday, March
24th, 10:10 a.m. –
10:45 a.m.
Conference Call to Discuss Fourth Quarter and Year-End 2019
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, Thursday, February 27,
2020.
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:
https://ir.nektar.com/. The web broadcast of the conference call
will be available for replay through March
27, 2020.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453
(international)
Passcode: 2507828 (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
biopharmaceutical company with a robust, wholly-owned R&D
pipeline of investigational medicines in oncology and immunology as
well as a portfolio of approved partnered medicines. 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 which can be identified by words such
as: "may," "design," "potential" and similar references to future
periods. Examples of forward-looking statements include, among
others, statements we make regarding the therapeutic potential of,
and future development plans for, bempegaldesleukin, NKTR-358 and
NKTR-255, and the timing of the initiation of clinical studies for
our drug candidates. 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 statements regarding the
therapeutic potential of bempegaldesleukin, NKTR-358 and NKTR-255
are based on preclinical and clinical findings and observations and
are subject to change as research and development continue; (ii)
bempegaldesleukin, NKTR-358 and NKTR-255 are an investigational
agents and continued research and development for these drug
candidates is subject to substantial risks, including negative
safety and efficacy findings in ongoing clinical studies
(notwithstanding positive findings in earlier preclinical and
clinical studies); (iii) bempegaldesleukin, NKTR-358 and NKTR-255
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; (iv) the timing of the commencement or end of
clinical trials and the availability of clinical data 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; (v) 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 (vi) certain other
important risks and uncertainties set forth in our Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on
November 7, 2019. 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:
Vivian Wu
of Nektar Therapeutics
628-895-0661
For Media:
Dan Budwick
of 1AB
973-271-6085
dan@1abmedia.com
NEKTAR
THERAPEUTICS
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(In
thousands)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
ASSETS
|
December 31,
2019
|
|
December 31,
2018
|
(1)
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
96,363
|
|
$
194,905
|
|
|
Short-term
investments
|
1,228,499
|
|
1,140,445
|
|
|
Accounts
receivable
|
36,802
|
|
43,213
|
|
|
Inventory
|
12,665
|
|
11,381
|
|
|
Advance payments to
contract manufacturers
|
31,834
|
|
26,450
|
|
|
Other current
assets
|
15,387
|
|
21,293
|
|
|
|
Total current
assets
|
1,421,550
|
|
1,437,687
|
|
|
|
|
|
|
|
|
Long-term
investments
|
279,119
|
|
582,889
|
|
Property, plant and
equipment, net
|
64,999
|
|
48,851
|
|
Operating lease
right-of-use assets
|
134,177
|
|
-
|
|
Goodwill
|
|
76,501
|
|
76,501
|
|
Other
assets
|
|
1,010
|
|
4,244
|
|
|
|
Total
assets
|
$
1,977,356
|
|
$
2,150,172
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
$
19,234
|
|
$
5,854
|
|
|
Accrued
compensation
|
11,467
|
|
9,937
|
|
|
Accrued clinical
trial expenses
|
32,626
|
|
14,700
|
|
|
Accrued contract
manufacturing expenses
|
7,304
|
|
23,841
|
|
|
Other accrued
expenses
|
11,414
|
|
9,087
|
|
|
Senior secured notes,
net
|
248,693
|
|
-
|
|
|
Interest
payable
|
4,198
|
|
4,198
|
|
|
Lease liability,
current portion
|
12,516
|
|
-
|
|
|
Deferred revenue,
current portion
|
5,517
|
|
13,892
|
|
|
Other current
liabilities
|
924
|
|
493
|
|
|
|
Total current
liabilities
|
353,893
|
|
82,002
|
|
|
|
|
|
|
|
|
Senior secured notes,
net
|
-
|
|
246,950
|
|
Lease liability, less
current portion
|
142,730
|
|
-
|
|
Liability related to
the sale of future royalties, net
|
72,020
|
|
82,911
|
|
Deferred revenue,
less current portion
|
2,554
|
|
10,744
|
|
Other long-term
liabilities
|
768
|
|
9,990
|
|
|
|
Total
liabilities
|
571,965
|
|
432,597
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
Preferred
stock
|
-
|
|
-
|
|
|
Common
stock
|
17
|
|
17
|
|
|
Capital in excess of
par value
|
3,271,097
|
|
3,147,925
|
|
|
Accumulated other
comprehensive loss
|
(1,005)
|
|
(6,316)
|
|
|
Accumulated
deficit
|
(1,864,718)
|
|
(1,424,051)
|
|
|
|
Total stockholders'
equity
|
1,405,391
|
|
1,717,575
|
|
|
Total liabilities and
stockholders' equity
|
$
1,977,356
|
|
$
2,150,172
|
|
|
|
|
|
|
|
|
|
(1) The consolidated
balance sheet at December 31, 2018 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
December 31,
|
|
Year Ended December
31,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
Product
sales
|
$
5,815
|
|
$
4,360
|
|
$
20,117
|
|
$
20,774
|
Royalty
revenue
|
12,214
|
|
12,078
|
|
41,222
|
|
41,976
|
Non-cash
royalty revenue related to sale of future royalties
|
8,718
|
|
8,971
|
|
36,303
|
|
33,308
|
License,
collaboration and other revenue
|
7,115
|
|
14,417
|
|
16,975
|
|
1,097,265
|
Total
revenue
|
33,862
|
|
39,826
|
|
114,617
|
|
1,193,323
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of goods
sold
|
5,989
|
|
7,461
|
|
21,374
|
|
24,412
|
Research and
development
|
110,369
|
|
108,883
|
|
434,566
|
|
399,536
|
General and
administrative
|
27,142
|
|
23,777
|
|
98,712
|
|
81,443
|
Total operating costs
and expenses
|
143,500
|
|
140,121
|
|
554,652
|
|
505,391
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
(109,638)
|
|
(100,295)
|
|
(440,035)
|
|
687,932
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(5,428)
|
|
(5,415)
|
|
(21,310)
|
|
(21,582)
|
Non-cash
interest expense on liability related to sale of future
royalties
|
(7,191)
|
|
(6,388)
|
|
(25,044)
|
|
(21,196)
|
Interest
income and other income (expense), net
|
10,371
|
|
12,048
|
|
46,335
|
|
37,571
|
Total non-operating
income (expense), net
|
(2,248)
|
|
245
|
|
(19)
|
|
(5,207)
|
|
|
|
|
|
|
|
|
Income (loss) before
provision for income taxes
|
(111,886)
|
|
(100,050)
|
|
(440,054)
|
|
682,725
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
278
|
|
(1,838)
|
|
613
|
|
1,412
|
Net income
(loss)
|
$
(112,164)
|
|
$
(98,212)
|
|
$(440,667)
|
|
$ 681,313
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
Basic
|
$
(0.64)
|
|
$
(0.57)
|
|
$
(2.52)
|
|
$
4.02
|
Diluted
|
$
(0.64)
|
|
$
(0.57)
|
|
$
(2.52)
|
|
$
3.78
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing net income (loss) per
share:
|
|
|
|
|
|
|
|
Basic
|
176,130
|
|
173,271
|
|
174,993
|
|
169,600
|
Diluted
|
176,130
|
|
173,271
|
|
174,993
|
|
180,119
|
|
|
|
|
|
|
|
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Year Ended December
31,
|
|
|
|
|
|
|
|
|
|
|
2019
|
|
2018
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
Net income
(loss)
|
|
|
|
|
|
|
$
(440,667)
|
|
$
681,313
|
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
|
|
|
|
(36,303)
|
|
(33,308)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
|
25,044
|
|
21,196
|
Stock-based
compensation
|
|
|
|
|
99,795
|
|
88,101
|
Depreciation and
amortization
|
|
|
|
|
13,156
|
|
10,870
|
Accretion of
discounts, net and other non-cash transactions
|
|
|
|
(11,394)
|
|
(10,952)
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
|
|
|
6,411
|
|
(25,505)
|
Inventory
|
|
|
|
|
|
|
(1,284)
|
|
(655)
|
Operating lease
right-of-use assets, net of operating lease liabilities
|
|
|
13,090
|
|
-
|
Other
assets
|
|
|
|
|
|
|
1,190
|
|
(31,652)
|
Accounts
payable
|
|
|
|
|
|
12,967
|
|
971
|
Accrued
compensation
|
|
|
|
|
|
1,530
|
|
1,674
|
Other accrued
expenses
|
|
|
|
|
|
3,816
|
|
27,947
|
Deferred
revenue
|
|
|
|
|
|
(16,565)
|
|
(15,331)
|
Other
liabilities
|
|
|
|
|
|
533
|
|
3,545
|
Net cash provided by
(used in) operating activities
|
|
|
|
(328,681)
|
|
718,214
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
Purchases of
investments
|
|
|
|
|
(1,380,865)
|
|
(2,271,250)
|
Maturities of
investments
|
|
|
|
|
|
1,614,036
|
|
890,957
|
Sales of
investments
|
|
|
|
|
|
-
|
|
11,963
|
Purchases of
property, plant and equipment
|
|
|
|
|
(26,285)
|
|
(14,239)
|
Sales of property and
plant
|
|
|
|
|
-
|
|
2,633
|
Net cash provided by
(used in) investing activities
|
|
|
|
206,886
|
|
(1,379,936)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
Payment of capital
lease obligations
|
|
|
|
|
-
|
|
-
|
Proceeds from shares
issued under equity compensation plans
|
|
|
|
23,355
|
|
61,735
|
Issuance of common
stock to Bristol-Myers Squibb
|
|
|
|
-
|
|
790,231
|
Net cash
provided by financing activities
|
|
|
|
|
23,355
|
|
851,966
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of
exchange rates on cash and cash equivalents
|
|
|
|
(102)
|
|
(101)
|
Net increase
(decrease) in cash and cash equivalents
|
|
|
|
(98,542)
|
|
190,143
|
Cash and cash
equivalents at beginning of year
|
|
|
|
|
194,905
|
|
4,762
|
Cash and cash
equivalents at end of year
|
|
|
|
|
$
96,363
|
|
$
194,905
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
Cash paid for
interest
|
|
|
|
|
|
$
19,199
|
|
$
19,471
|
Cash paid for
income taxes
|
|
|
|
|
|
$
555
|
|
$
618
|
Right-of-use
assets recognized in exchange for operating lease
liabilities
|
|
$
57,691
|
|
$
-
|
View original
content:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-fourth-quarter-and-year-end-2019-financial-results-301013013.html
SOURCE Nektar Therapeutics