SAN FRANCISCO, May 8, 2019 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported its financial results
for the first quarter ended March 31,
2019.
Cash and investments in marketable securities at March 31, 2019 were approximately $1.8 billion as compared to $1.9 billion at December
31, 2018.
"Nektar continues to advance our immuno-oncology and immunology
pipeline with clinical trials initiating for multiple drug
candidates across multiple indications," said Howard W. Robin,
President and CEO of Nektar. "We are working with our partner,
Bristol-Myers Squibb, to execute on our broad joint development
program for bempegaldesleukin in combination with nivolumab, with
registrational trials in melanoma, RCC, urothelial and non-small
cell lung cancer underway and additional trials planned to begin in
the coming months."
"NKTR-181 is under review with the FDA and we are planning for a
potential launch later this year," continued Robin. "With respect
to NKTR-358, we will report the first data for this exciting drug
candidate in an oral presentation at the EULAR Congress in June and
our multiple-ascending dose trial in lupus patients is continuing.
With our partner Lilly, we continue to advance development of
NKTR-358 with two new Phase 1b
studies in additional auto-immune disorders planned to start in
2019. We are also completing our IND-enabling activities for our
next immuno-oncology candidate, NKTR-255, which activates the IL-15
pathway."
Revenue in the first quarter of 2019 was $28.2 million as compared to $38.0 million in the first quarter of 2018.
Revenue in the first quarter of 2019 was lower primarily due to the
recognition of $10.0 million received
in the first quarter of 2018 from Takeda for the approval of
Adynovi® in Europe.
Total operating costs and expenses in the first quarter of 2019
were $148.9 million as compared to
$124.8 million in the first quarter
of 2018. 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 2019 was $118.5 million as compared to $99.4 million for the first quarter of 2018.
R&D expense was higher in the first quarter of 2019 as compared
to the same period in 2018 primarily because of expenses for our
pipeline programs, including the continued development of
bempegaldesleukin in Phase 2 and registrational studies and related
manufacturing costs, costs related to Phase 1 clinical studies of
NKTR-358 and IND-enabling activities for NKTR-255.
General and administrative expense was $25.0 million in the first quarter of 2019 as
compared to $18.7 million in the
first quarter of 2018 and increased primarily due to costs related
to commercialization readiness activities for NKTR-181 and
increased non-cash stock-based compensation.
In the first quarter of 2019, net loss was $118.5 million, or $0.68 loss per share as compared to net loss of
$95.8 million, or $0.60 loss per share in the first quarter of
2018.
2019 Business Highlights
- In April, Nektar presented positive preclinical data on its
immuno-oncology pipeline candidates, bempegaldesleukin and
NKTR-255, an IL-15 receptor agonist, at the 2019 AACR Annual
Meeting.
- In March, 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, Nektar presented clinical data from first-line
Stage IV urothelial carcinoma patients enrolled in the PIVOT-02
study of bempegaldesleukin with nivolumab at the 2019 ASCO
Genitourinary Cancers Symposium.
The company also announced upcoming presentations at the
following scientific congresses during the second quarter of
2019:
4th Drug Discovery Nexus, Boston, MA:
- Presentation: "Harnessing cytokines to develop immune
therapeutic agents"
-
- Presenter: Loui Madakamutil, Ph.D., Nektar
Therapeutics
- Date: Friday, May 17,
2019, 9:30 a.m. Eastern Daylight
Time
4th Annual Advances in Immuno-Oncology Congress
2019, London, U.K.:
- Presentation: "Bempegaldesleukin
(NKTR-214): Targeting the IL-2 Pathway for Immuno-Oncology
Applications"
-
- Presenter: Jonathan
Zalevsky, Ph.D., Nektar Therapeutics
- Session: Immuno-Oncology Therapeutic Approaches,
Clinical Research & Clinical Trials
- Date: Tuesday, May 21,
2019, 16:30 British Summer Time
American Society for Clinical Oncology (ASCO) 2019 Annual
Meeting, Chicago, IL:
- Oral Abstract # 11010: "Pilot study of
bempegaldesleukin (NKTR-214) and nivolumab in patients with
sarcomas"
-
- Presenter: Sandra
D'Angelo, M.D., Memorial Sloan-Kettering Cancer Center
- Session: Clinical Science Symposium: Emerging
Combinations in Sarcoma Immunotherapy
- Date: Monday, June 3,
2019, 11:30 a.m. - 1:00 p.m. Central
Daylight Time
- Poster #228/Abstract # 2584: "Overcoming
genetically-based resistance mechanisms to PD-1 blockade",
Torrejon, D., et al.
-
- Session: Developmental Immunotherapy and Tumor
Immunobiology
- Date: Saturday, June 1,
2019, 8:00 a.m. - 11:00 a.m. Central
Daylight Time
- Poster #267/Abstract # 2623: "Baseline tumor immune
signatures associated with response to bempegaldesleukin (NKTR-214)
and nivolumab", Hurwitz, M., et al.
-
- Session: Developmental Immunotherapy and Tumor
Immunobiology
- Date: Saturday, June 1,
2019, 8:00 a.m. - 11:00 a.m. Central
Daylight Time
- Poster #416b/Abstract # TPS4595: "A phase III
randomized open label study comparing bempegaldesleukin (NKTR-214)
plus nivolumab to sunitinib or cabozantinib (investigator's choice)
in patients with previously untreated advanced renal cell
carcinoma", Tannir, N., et al.
-
- Session: Genitourinary (Nonprostate) Cancer
- Date: Monday, June 3,
2019, 1:15 p.m. - 4:15 p.m. Central
Daylight Time
- Poster 168b/Abstract #
TPS9601: "A phase III, randomized, open-label study of
bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO
monotherapy in patients (pts) with previously untreated,
unresectable or metastatic melanoma (MEL)", Khushalani, N., et
al.
-
- Session: Melanoma/Skin Cancers
- Date: Monday, June 3,
2019, 1:15 p.m. - 4:15 p.m. Central
Daylight Time
Pharmaceutical & Bioscience Society Symposium: Advances
in Immuno-Oncology, Foster City,
CA:
- Presentation: "Bempegaldesleukin (NKTR-214), a
first-in-class, CD122-preferential IL-2 pathway agonist"
-
- Presenter: Willem
Overwijk, Ph.D., Nektar Therapeutics
- Date: Tuesday, June 11,
2019, 8:45 a.m. Pacific Daylight
Time
24th Congress of European Hematology Association (EHA),
Amsterdam, Netherlands:
- Abstract # PS1208: " Effects Of NKTR-255, A
Polymer Conjugated Human IL-15, on Efficacy of CD19 CAR T Cell
Immunotherapy in a Preclinical Lymphoma Model"
-
- Presenter: Cassie K.
Chou, M.D., Ph.D., Fred Hutchinson Cancer Research
Center
- Session: Gene therapy, cellular immunotherapy and
vaccination – Biology & Transitional Research
- Date: Saturday, June 15,
2019, 17:30 – 19:00 Central European Summer Time
- Poster Pitch: Saturday, June 15,
2019, 16:30 – 16:45 Central European Summer Time
- Location: Hall G106
Annual European Congress of Rheumatology (EULAR) 2019,
Madrid, Spain:
- Abstract # OP0195: "Selective Expansion of Regulatory
T-Cells in Humans by a Novel IL-2 Conjugate T-reg Stimulator,
NKTR-358, Being Developed for the Treatment of Autoimmune
Diseases"
-
- Presenter: Brian Kotzin,
M.D., Nektar Therapeutics
- Session: Genetics, epigenetics and immunity
- Date: Thursday, June 13,
2019, 11:15 Central European Summer Time
Conference Call to Discuss First Quarter 2019 Financial
Results
Nektar management will host a conference call to
review the results beginning at 5:00 p.m.
Eastern Daylight Time/2:00 p.m.
Pacific Daylight Time, Wednesday, May
8, 2019.
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 Monday,
June 10, 2019.
To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970)
315-0453 (international)
Passcode: 8249707 (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,
development stage 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,
autoimmune disease and chronic pain. We leverage our 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 Nektar and its drug development programs and
capabilities may be found online at 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: "advance," "planned," "preparing," "potential," "continue,"
"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 and future
development plans for our investigational products [including
bempegaldesleukin ("bempeg"), NKTR-181, NKTR-358, NKTR-262 and
NKTR-255], the timing of a potential launch for NKTR-181, and the
results of clinical trials. 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) the timing
of the commencement or end of clinical studies 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, and
enrollment competition; (ii) the timing and probability of
regulatory approval, if any, for NKTR-181 is uncertain and
difficult to predict; (iii) scientific discovery of new medical
breakthroughs is an inherently uncertain process and the future
success of applying our technology platform to drug candidates
[such as bempegaldesleukin ("bempeg"), NKTR-262, NKTR-358, and
NKTR-255] is therefore highly uncertain and unpredictable and one
or more of these programs may fail; (iv) 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 (v) certain other
important risks and uncertainties set forth in Nektar's
Annual Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and
Exchange Commission on March 1, 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.
Adynovi is a registered trademark of Baxalta Incorporated.
Contact:
For Investors:
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
For Media:
Jodi Sievers of Nektar
Therapeutics
415-482-5593
Dan Budwick of 1AB
973-271-6085
dan@1abmedia.com
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
ASSETS
|
|
March 31,
2019
|
|
December 31,
2018
|
(1)
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
106,752
|
|
$
194,905
|
|
|
Short-term
investments
|
|
1,281,913
|
|
1,140,445
|
|
|
Accounts
receivable
|
|
42,894
|
|
43,213
|
|
|
Inventory
|
|
11,778
|
|
11,381
|
|
|
Advance payments to
contract manufacturers
|
|
27,425
|
|
26,450
|
|
|
Other current
assets
|
|
19,352
|
|
21,293
|
|
|
|
Total current
assets
|
|
1,490,114
|
|
1,437,687
|
|
|
|
|
|
|
|
|
|
Long-term
investments
|
|
455,867
|
|
582,889
|
|
Property, plant and
equipment, net
|
|
58,158
|
|
48,851
|
|
Operating lease
right-of-use assets
|
|
83,475
|
|
-
|
|
Goodwill
|
|
76,501
|
|
76,501
|
|
Other
assets
|
|
2,367
|
|
4,244
|
|
|
|
Total
assets
|
|
$
2,166,482
|
|
$
2,150,172
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
11,012
|
|
$
5,854
|
|
|
Accrued
compensation
|
|
18,371
|
|
9,937
|
|
|
Accrued contract
manufacturing expenses
|
|
21,384
|
|
23,841
|
|
|
Accrued clinical
trial expenses
|
|
17,496
|
|
14,700
|
|
|
Other accrued
expenses
|
|
14,624
|
|
9,580
|
|
|
Interest
payable
|
|
4,090
|
|
4,198
|
|
|
Operating lease
liabilities, current portion
|
|
1,649
|
|
-
|
|
|
Deferred revenue,
current portion
|
|
11,092
|
|
13,892
|
|
|
|
Total current
liabilities
|
|
99,718
|
|
82,002
|
|
|
|
|
|
|
|
|
|
Senior secured notes,
net
|
|
247,386
|
|
246,950
|
|
Operating lease
liabilities, less current portion
|
|
95,024
|
|
-
|
|
Liability related to
the sale of future royalties, net
|
|
80,837
|
|
82,911
|
|
Deferred revenue,
less current portion
|
|
9,340
|
|
10,744
|
|
Other long-term
liabilities
|
|
666
|
|
9,990
|
|
|
|
Total
liabilities
|
|
532,971
|
|
432,597
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
|
Common
stock
|
|
17
|
|
17
|
|
|
Capital in excess of
par value
|
|
3,178,773
|
|
3,147,925
|
|
|
Accumulated other
comprehensive loss
|
|
(2,716)
|
|
(6,316)
|
|
|
Accumulated
deficit
|
|
(1,542,563)
|
|
(1,424,051)
|
|
|
|
Total stockholders'
equity
|
|
1,633,511
|
|
1,717,575
|
|
|
Total liabilities and
stockholders' equity
|
|
$
2,166,482
|
|
$
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
March 31,
|
|
|
2019
|
|
2018
|
|
|
|
|
|
Revenue:
|
|
|
|
|
Product
sales
|
|
$
4,398
|
|
$
6,295
|
Royalty
revenue
|
|
11,390
|
|
11,076
|
Non-cash
royalty revenue related to sale of future royalties
|
|
8,230
|
|
6,920
|
License,
collaboration and other revenue
|
|
4,204
|
|
13,727
|
Total
revenue
|
|
28,222
|
|
38,018
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
Cost of
goods sold
|
|
5,440
|
|
6,646
|
Research
and development
|
|
118,463
|
|
99,424
|
General
and administrative
|
|
25,006
|
|
18,687
|
Total operating costs
and expenses
|
|
148,909
|
|
124,757
|
|
|
|
|
|
Loss from
operations
|
|
(120,687)
|
|
(86,739)
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
Interest
expense
|
|
(5,226)
|
|
(5,340)
|
Non-cash
interest expense on liability related to sale of future
royalties
|
|
(6,065)
|
|
(5,019)
|
Interest
income and other income (expense), net
|
|
12,483
|
|
1,571
|
Total non-operating
income (expense), net
|
|
1,192
|
|
(8,788)
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
(119,495)
|
|
(95,527)
|
|
|
|
|
|
Provision (benefit)
for income taxes
|
|
(983)
|
|
265
|
Net loss
|
|
$
(118,512)
|
|
$
(95,792)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.68)
|
|
$
(0.60)
|
|
|
|
|
|
Weighted average
shares outstanding used in computing basic and diluted net loss per
share
|
|
173,859
|
|
160,884
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
Three Months Ended
March 31,
|
|
|
2019
|
|
2018
|
Cash flows from
operating activities:
|
|
|
|
|
Net
loss
|
|
$
(118,512)
|
|
$
(95,792)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
Non-cash royalty revenue related to sale of future
royalties
|
|
(8,230)
|
|
(6,920)
|
Non-cash interest expense on liability related to sale of future
royalties
|
|
6,065
|
|
5,019
|
Stock-based compensation
|
|
25,385
|
|
19,949
|
Depreciation and amortization
|
|
3,077
|
|
2,541
|
Accretion of discounts, net and other non-cash
transactions
|
|
(4,303)
|
|
(370)
|
Changes in
operating assets and liabilities:
|
|
|
|
|
Accounts receivable
|
|
319
|
|
151
|
Inventory
|
|
(397)
|
|
51
|
Other assets
|
|
4,209
|
|
1,853
|
Accounts payable
|
|
5,156
|
|
6,492
|
Accrued compensation
|
|
8,434
|
|
6,867
|
Other accrued expenses
|
|
774
|
|
10,826
|
Deferred revenue
|
|
(4,204)
|
|
(3,678)
|
Other liabilities
|
|
1,332
|
|
545
|
Net cash used
in operating activities
|
|
(80,895)
|
|
(52,466)
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
Purchases of investments
|
|
(368,739)
|
|
-
|
Maturities of investments
|
|
362,249
|
|
37,232
|
Sales of investments
|
|
-
|
|
11,963
|
Purchases of property, plant and equipment
|
|
(5,648)
|
|
(985)
|
Net cash
provided by (used in) investing activities
|
|
(12,138)
|
|
48,210
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
Proceeds from shares issued under equity compensation
plans
|
|
4,894
|
|
34,352
|
Net cash
provided by financing activities
|
|
4,894
|
|
34,352
|
|
|
|
|
|
Effect of
exchange rates on cash and cash equivalents
|
|
(14)
|
|
(53)
|
Net increase
(decrease) in cash and cash equivalents
|
|
(88,153)
|
|
30,043
|
Cash and cash
equivalents at beginning of period
|
|
194,905
|
|
4,762
|
Cash and cash
equivalents at end of period
|
|
$
106,752
|
|
$
34,805
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
Cash paid for
interest
|
|
$
4,805
|
|
$
4,952
|
View original
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SOURCE Nektar Therapeutics