SAN
FRANCISCO, Aug. 8, 2023 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported financial results for
the second quarter ended June 30,
2023.
Cash and investments in marketable securities at June 30, 2023, were $409.4
million as compared to $505.0
million at December 31, 2022.
Nektar's cash and marketable securities are expected to support
strategic development activities and operations into at least the
middle of 2026.
"With new and corrected strong clinical data for REZPEG, we
look forward to initiating a Phase 2b
study of rezpegaldesleukin in patients with atopic dermatitis and
achieving our objective to have initial data from this study in the
first half of 2025," said Howard W.
Robin, President and CEO of Nektar. "We also are working to
advance our next pipeline candidates in immunology with an IND
filing in 2024. And finally, we are continuing our Phase 2 studies
of NKTR-255 in liquid and solid tumors as we evaluate strategic
partnership pathways."
Summary of Financial Results
Revenue in the second quarter of 2023 was $20.5 million as compared to $21.6 million in the second quarter of 2022.
Revenue for the first half of 2023 was $42.1
million as compared to $46.4
million in the first half of 2022.
Total operating costs and expenses in the second quarter of 2023
were $71.1 million as compared to
$174.4 million in the second quarter
of 2022. Total operating costs and expenses in the first half of
2023 were $227.4 million as compared
to $315.8 million in the first half
of 2022. Operating costs and expenses for both the second quarter
and first half of 2023 decreased due to decreases in research and
development expense, general and administrative expense and
restructuring, impairment and costs of terminated program. For the
first half of 2023, these decreases were partially offset by
$76.5 million in non-cash goodwill
impairment and $26.5 million in other
non-cash impairment charges primarily related to lease assets.
R&D expense in the second quarter of 2023 was $29.7 million as compared to $42.7 million for the second quarter of 2022. For
the first half of 2023, R&D expense was $60.2 million as compared to $150.0 million in the first half of 2022. R&D
expense decreased for both the second quarter and first half of
2023 due to due to the wind down of the bempegaldesleukin
program.
G&A expense was $17.9 million
in the second quarter of 2023 as compared to $20.5 million in the second quarter of 2022. For
the first half of 2023, G&A expense was $39.0 million as compared to $47.9 million in the first half of 2022. G&A
expense decreased for both the second quarter and first half of
2023 due to the wind down of the bempegaldesleukin program.
Restructuring, impairment and costs of terminated program were
$16.6 million in the second quarter
of 2023 as compared to $106.0 million
in the second quarter of 2022. The amount for the second quarter of
2023 includes $13.3 million in
non-cash lease impairment charges, $1.9
million in severance, and $1.4
million for the wind down of the bempegaldesleukin program.
The amount for the second quarter of 2022 includes $57.3 million in non-cash lease and equipment
impairment charges, $27.8 million in
severance and $20.4 million for the
wind down of the bempegaldesleukin program.
For the first half of 2023, restructuring, impairment and costs
of terminated program were $37.7
million. This amount includes $26.5
million in non-cash lease and equipment impairment charges,
$7.4 million in severance and
$3.0 million for the wind down of
the bempegaldesleukin program. The amounts for the first half
of 2022 are consistent with the amounts for the second quarter of
2022.
Net loss for the second quarter of 2023 was $51.1 million or $0.27 basic and diluted loss per share as
compared to a net loss of $159.1
million or $0.85 basic and
diluted loss per share in the second quarter of 2022. Net loss in
the first half of 2023 was $188.1
million or $0.99 basic and
diluted loss per share as compared to a net loss of $249.5 million or $1.34 basic and diluted loss per share in the
first half of 2022. Excluding the $103.0
million in non-cash goodwill and other impairment charges,
net loss, on a non-GAAP basis for the first half of 2023 was
$85.1 million or $0.45 basic and diluted loss per share.
Second Quarter 2023 and Recent Business Updates
- Nektar announced promising new and corrected rezpegaldesleukin
efficacy data which were previously reported in 2022 and
inaccurately calculated by former collaborator Eli Lilly &
Co.
- Nektar continues to execute on several cost reduction
initiatives as announced in its strategic reprioritization and cost
restructuring plan in April
2023.
- Nektar continues to evaluate strategic partnership options for
NKTR-255, the Company's lead oncology asset, while the Phase 2
study of NKTR-255 in combination with cell therapies and the Phase
2 JAVELIN Bladder Medley Study with partner Merck KGaA
progress.
Conference Call to Discuss Second Quarter 2023 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,
August 8, 2023.
This press release and 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://ir.nektar.com/.
The web broadcast of the conference call will be available for
replay through September 8, 2023.
To access the conference call, please pre-register at Nektar
Earnings Call Registration. All registrants will receive dial-in
information and a PIN allowing them to access the live call.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a
robust, wholly owned R&D pipeline of investigational medicines
in immunology and oncology as well as a portfolio of approved
partnered medicines. Nektar is headquartered in San Francisco, California, with additional
manufacturing operations in Huntsville,
Alabama. 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: "will," "may," "advance,"
"support," "develop," "provide," "expect," "aim," "potential" and
similar references to future periods. Examples of forward-looking
statements include, among others, statements regarding the
therapeutic potential of, and future development plans for
rezpegaldesleukin, NKTR-255 and our other drug candidates in
research programs, the prospects and plans for our collaborations
with other companies, the timing of the initiation of clinical
studies and the data readouts for our drug candidates, and
our expected working capital and cash runway. 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
rezpegaldesleukin, NKTR-255 and our other drug candidates are based
on preclinical and clinical findings and observations and are
subject to change as research and development continue; (ii)
rezpegaldesleukin, NKTR-255 and our other drug candidates are
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) rezpegaldesleukin, NKTR-255 and our other
drug candidates 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 challenges caused by the COVID-19
pandemic, 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)
we may not achieve the expected cost savings we expect from our
2022 corporate restructuring and reorganization plan or our 2023
cost restructuring plan and we may undertake additional
restructuring and cost-saving activities in the future, (vi)
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 (vii) certain other important risks and uncertainties
set forth in our Annual Report on Form 10-Q filed with the
Securities and Exchange Commission on May
10, 2023. 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:
David Rosen of Argot Partners
(212) 600-1902
david.rosen@argotpartners.com
NEKTAR THERAPEUTICS
|
CONDENSED CONSOLIDATED BALANCE
SHEETS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
ASSETS
|
June 30,
2023
|
|
December 31,
2022
|
(1)
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
50,728
|
|
$
88,227
|
|
|
Short-term
investments
|
|
358,704
|
|
416,750
|
|
|
Accounts
receivable
|
|
1,335
|
|
5,981
|
|
|
Inventory,
net
|
|
20,689
|
|
19,202
|
|
|
Other current
assets
|
|
9,602
|
|
15,808
|
|
|
|
Total current
assets
|
|
441,058
|
|
545,968
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
22,554
|
|
32,451
|
|
Operating lease
right-of-use assets
|
|
29,015
|
|
53,435
|
|
Goodwill
|
|
-
|
|
76,501
|
|
Other assets
|
|
1,652
|
|
2,245
|
|
|
|
Total assets
|
|
$
494,279
|
|
$
710,600
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
2,619
|
|
$
12,980
|
|
|
Accrued
expenses
|
|
29,142
|
|
36,557
|
|
|
Operating lease
liabilities, current portion
|
|
18,933
|
|
18,667
|
|
|
|
Total current
liabilities
|
|
50,694
|
|
68,204
|
|
|
|
|
|
|
|
|
|
Operating lease
liabilities, less current portion
|
|
105,817
|
|
112,829
|
|
Liabilities related to
the sales of future royalties, net
|
|
135,659
|
|
155,378
|
|
Other long-term
liabilities
|
|
5,151
|
|
7,551
|
|
|
|
Total
liabilities
|
|
297,321
|
|
343,962
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
|
Common stock
|
|
19
|
|
19
|
|
|
Capital in excess of
par value
|
|
3,592,722
|
|
3,574,719
|
|
|
Accumulated other
comprehensive loss
|
|
(6,450)
|
|
(6,907)
|
|
|
Accumulated
deficit
|
|
(3,389,333)
|
|
(3,201,193)
|
|
|
|
Total stockholders'
equity
|
|
196,958
|
|
366,638
|
|
|
Total liabilities and
stockholders' equity
|
|
$
494,279
|
|
$
710,600
|
|
|
|
|
|
|
|
|
|
(1) The consolidated
balance sheet at December 31, 2022 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
June 30,
|
|
Six months ended June
30,
|
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
4,658
|
|
$
5,312
|
|
$
9,376
|
|
$
11,000
|
|
Non-cash royalty
revenue related to the sales of future royalties
|
|
15,832
|
|
16,264
|
|
32,693
|
|
33,825
|
|
License, collaboration
and other revenue
|
|
9
|
|
9
|
|
24
|
|
1,582
|
Total
revenue
|
|
20,499
|
|
21,585
|
|
42,093
|
|
46,407
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
6,994
|
|
5,115
|
|
14,054
|
|
10,430
|
|
Research and
development
|
|
29,681
|
|
42,740
|
|
60,150
|
|
149,993
|
|
General and
administrative
|
|
17,869
|
|
20,521
|
|
38,950
|
|
47,860
|
|
Restructuring,
impairment, and costs of terminated program
|
|
16,554
|
|
106,045
|
|
37,747
|
|
107,520
|
|
Impairment of
goodwill
|
|
-
|
|
-
|
|
76,501
|
|
-
|
Total operating costs
and expenses
|
|
71,098
|
|
174,421
|
|
227,402
|
|
315,803
|
|
Loss from
operations
|
|
(50,599)
|
|
(152,836)
|
|
(185,309)
|
|
(269,396)
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
|
Change in fair value of
development derivative liability
|
|
-
|
|
-
|
|
-
|
|
33,427
|
|
Non-cash interest
expense on liabilities related to the sales of future
royalties
|
|
(6,152)
|
|
(7,228)
|
|
(12,557)
|
|
(14,757)
|
|
Interest income and
other income (expense), net
|
|
5,582
|
|
1,096
|
|
9,616
|
|
1,491
|
Total non-operating
income (expense), net
|
|
(570)
|
|
(6,132)
|
|
(2,941)
|
|
20,161
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
(51,169)
|
|
(158,968)
|
|
(188,250)
|
|
(249,235)
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for
income taxes
|
|
(47)
|
|
100
|
|
(110)
|
|
226
|
Net loss
|
|
$
(51,122)
|
|
$
(159,068)
|
|
$
(188,140)
|
|
$
(249,461)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.27)
|
|
$
(0.85)
|
|
$
(0.99)
|
|
$
(1.34)
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing basic and diluted net loss
per share
|
|
189,656
|
|
186,800
|
|
189,268
|
|
186,323
|
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SOURCE Nektar Therapeutics