SAN
FRANCISCO, March 4, 2024 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported financial results for
the fourth quarter and full year ended December 31, 2023.
Cash and investments in marketable securities at
December 31, 2023, were $329.4 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 the third quarter of 2026.
"We believe that the progress that we have made
in the past nine months puts Nektar in a strong position to
advance our highly promising immunology and inflammation pipeline
programs," said Howard W. Robin,
President and CEO of Nektar. "We are looking forward to multiple
potential value-creating data readouts for REZPEG in the first half
of 2025 in both atopic dermatitis and alopecia areata. As we build
our pipeline in immunology, we are also conducting IND-enabling
studies for NKTR-0165, our novel agonist antibody targeting
TNFR2."
Summary of Financial Results
Revenue in the fourth quarter of 2023 was
$23.9 million as compared to
$22.0 million in the fourth quarter
of 2022. Revenue for the year ended December
31, 2023 was $90.1 million as
compared to $92.1 million in
2022.
Total operating costs and expenses in the fourth
quarter of 2023 were $57.4 million as
compared to $74.5 million in the
fourth quarter of 2022. Total operating costs and expenses for the
full year 2023 were $353.8 million as
compared to $468.2 million in 2022.
Operating costs and expenses for both the fourth quarter and the
full year 2023 decreased as compared to 2022 primarily due to
decreases in research and development expenses, general and
administrative expense and restructuring, impairment and costs of
terminated program, partially offset by $76.5 million in non-cash goodwill impairment
recorded in the first quarter of 2023.
R&D expense in the fourth quarter of 2023 was
$29.9 million as compared to
$34.7 million for the fourth quarter
of 2022. R&D expense for the year ended December 31, 2023 was $114.2 million as compared to $218.3 million in 2022. R&D expense decreased
for full year 2023 primarily due to the wind down of the
bempegaldesleukin program.
G&A expense was $17.3
million in the fourth quarter of 2023 and $21.9 million in the fourth quarter of 2022.
G&A expense for the full year 2023 was $77.4 million as compared to $92.3 million in 2022. G&A expense decreased
for the full year 2023 primarily due to the wind down of the
bempegaldesleukin program.
Restructuring, impairment and other costs of the
terminated program were $2.9 million
in the fourth quarter of 2023 and $52.0
million in the full year 2023, as compared to $11.6 million in the fourth quarter of 2022 and
$135.9 million in the full year 2022.
The full year 2023 amount includes $7.9
million in severance expense, $35.3
million in non-cash lease impairment charges, $5.5 million for clinical trial and related
employee compensation costs for the wind down of
the bempegaldesleukin program, and $3.3
million in other restructuring costs. The full year 2022
amount includes $30.9 million in
severance expense, $65.8 million in
non-cash lease impairment charges, $31.7
million for clinical trial and related employee compensation
costs for the wind down of the bempegaldesleukin program, as
well as $7.5 million in other
restructuring costs.
Net loss for the fourth quarter of 2023 was
$42.1 million or $0.22 basic and diluted loss per share as
compared to a net loss of $59.7
million or $0.32 basic and
diluted loss per share in the fourth quarter of 2022. Net loss for
the year ended December 31, 2023 was
$276.1 million or $1.45 basic and diluted loss per share as
compared to a net loss of $368.2
million or $1.97 basic and
diluted loss per share in 2022. Excluding the $111.8 million in non-cash goodwill and other
impairment charges, net loss, on a non-GAAP basis, for the full
year 2023 was $164.3 million or
$0.86 basic and diluted loss per
share.
2023 and Recent Business Highlights
- In March 2024, we entered into a
securities purchase agreement with TCG Crossover Fund, an
institutional accredited investor, to sell securities in a private
placement financing for gross proceeds of approximately
$30 million, before deducting
expenses.
- In December 2023, Nektar's collaborators from the Cairo
Laboratory at New York Medical College
presented preclinical data on NKTR-255 in combination with
obinutuzumab at the 65th American Society of Hematology (ASH)
Annual Meeting. NKTR-255 significantly enhanced the cytotoxicity of
expanded Natural Killer (NK) cells when combined with obinutuzumab
against rituximab-resistant Burkitt lymphoma (BL) cells in vitro
and significantly improved the survival of mice xenografted with
Raji-4RH compared to controls.
- In October 2023, Nektar initiated
a Phase 2b study of rezpegaldesleukin
in patients with moderate-to-severe atopic dermatitis. The Company
expects initial data from the study in the first half of 2025.
- In October 2023, Nektar presented
data from the Phase 1b study of
rezpegaldesleukin in patients with atopic dermatitis (AD) in
an oral session at the 2023 European Academy of Dermatology
and Venereology (EADV) Congress. Patients with
moderate-to-severe AD that were treated with rezpegaldesleukin
showed dose-dependent improvements in Eczema Area and Severity
Index (EASI), Validated Investigator Global Assessment (vIGA), Body
Surface Area (BSA), and Itch Numeric Rating Scale (NRS) over 12
weeks of treatment compared to placebo, which were sustained
post-treatment over an additional 36 weeks.
- In September 2023, Nektar
announced a clinical study collaboration with AbelZeta Pharma,
Inc. (formerly Cellular Biomedicine Group Inc.) to evaluate
NKTR-255 in combination with C-TIL051 in advanced non-small cell
lung cancer (NSCLC) patients that are relapsed or refractory to
anti-PD-1 therapy. Under the collaboration, AbelZeta will add
NKTR-255 to its ongoing Phase 1 clinical trial being conducted at
Duke Cancer Institute. Enrollment for this trial is ongoing.
- In August 2023, Nektar announced promising new and
corrected rezpegaldesleukin efficacy data which were previously
reported in 2022 and inaccurately calculated by former collaborator
Eli Lilly and Company. Nektar regained the full rights to
rezpegaldesleukin from Eli Lilly in April
2023.
- In April 2023, Nektar announced a
strategic reprioritization and cost restructuring plan in order to
enable a new focus of its pipeline on immunology and inflammation
programs.
Conference Call to Discuss Fourth Quarter and
Year-End 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, March 4, 2024.
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 April
5, 2024.
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 biotechnology 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 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: "expect,"
"believe," "design," "plan," "will," "develop," "advance" 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 and NKTR-0165, and expectations for how long our
cash and marketable securities will support our development
activities and operations. 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 and NKTR-0165 are based
on preclinical and clinical findings and observations and are
subject to change as research and development continue; (ii)
rezpegaldesleukin and NKTR-0165 are investigational agents and
continued research and development for these drug candidates is
subject to substantial risks, including negative safety and
efficacy findings in future studies (notwithstanding positive
findings in earlier preclinical and clinical studies); (iii)
NKTR-0165 is in preclinical development and rezpegaldesleukin is in
clinical development, and the risk of failure is high for drug
candidates at this stage of development 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 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
prior corporate restructuring and reorganization plans 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 Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission on
November 8, 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
|
|
December 31,
2023
|
|
December 31, 2022
(1)
|
Current
assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
35,277
|
|
$
88,227
|
|
Short-term
investments
|
|
|
|
|
|
268,339
|
|
416,750
|
|
Accounts
receivable
|
|
|
|
|
|
1,205
|
|
5,981
|
|
Inventory
|
|
|
|
|
|
16,101
|
|
19,202
|
|
Other current
assets
|
|
|
|
|
|
9,779
|
|
15,808
|
|
|
Total current
assets
|
|
|
|
|
|
330,701
|
|
545,968
|
|
|
|
|
|
|
|
|
|
|
|
Long-term
investments
|
|
|
|
|
|
25,825
|
|
-
|
Property, plant and
equipment, net
|
|
|
|
|
|
18,856
|
|
32,451
|
Operating lease
right-of-use assets
|
|
|
|
|
|
18,007
|
|
53,435
|
Goodwill
|
|
|
|
|
|
-
|
|
76,501
|
Other assets
|
|
|
|
|
|
4,644
|
|
2,245
|
|
|
Total assets
|
|
|
|
|
|
$
398,033
|
|
$
710,600
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
|
|
|
9,848
|
|
12,980
|
|
Accrued
expenses
|
|
|
|
|
|
22,162
|
|
36,557
|
|
Operating lease
liabilities, current portion
|
|
|
|
|
19,259
|
|
18,667
|
|
|
Total current
liabilities
|
|
|
|
|
|
51,269
|
|
68,204
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
liabilities, less current portion
|
|
|
|
98,517
|
|
112,829
|
Liabilities related to
the sales of future royalties, net
|
|
|
|
112,625
|
|
155,378
|
Other long-term
liabilities
|
|
|
|
|
|
4,635
|
|
7,551
|
|
|
Total
liabilities
|
|
|
|
|
|
267,046
|
|
343,962
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
|
|
|
-
|
|
-
|
|
Common stock
|
|
|
|
|
|
19
|
|
19
|
|
Capital in excess of
par value
|
|
|
|
|
|
3,608,137
|
|
3,574,719
|
|
Accumulated other
comprehensive income (loss)
|
|
|
|
80
|
|
(6,907)
|
|
Accumulated
deficit
|
|
|
|
|
|
(3,477,249)
|
|
(3,201,193)
|
|
|
Total stockholders'
equity
|
|
|
|
|
|
130,987
|
|
366,638
|
|
Total liabilities and
stockholders' equity
|
|
|
|
|
$
398,033
|
|
$
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
December 31,
|
|
Year ended December
31,
|
|
|
|
|
|
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
|
|
|
|
$
5,483
|
|
$
4,379
|
|
$
20,681
|
|
$
20,348
|
|
Non-cash royalty
revenue related to the sales of future royalties
|
|
|
18,061
|
|
17,627
|
|
68,921
|
|
69,794
|
|
License, collaboration
and other revenue
|
|
|
|
|
341
|
|
17
|
|
520
|
|
1,913
|
Total
revenue
|
|
|
|
|
|
23,885
|
|
22,023
|
|
90,122
|
|
92,055
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
|
|
7,283
|
|
6,233
|
|
33,768
|
|
21,635
|
|
Research and
development
|
|
|
|
|
|
29,942
|
|
34,740
|
|
114,162
|
|
218,323
|
|
General and
administrative
|
|
|
|
|
|
17,320
|
|
21,939
|
|
77,417
|
|
92,333
|
|
Restructuring,
impairment and costs of terminated program
|
|
|
2,851
|
|
11,580
|
|
51,958
|
|
135,930
|
|
Impairment of
goodwill
|
|
|
|
|
|
|
|
|
|
76,501
|
|
-
|
Total operating costs
and expenses
|
|
|
|
|
|
57,396
|
|
74,492
|
|
353,806
|
|
468,221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
|
|
(33,511)
|
|
(52,469)
|
|
(263,684)
|
|
(376,166)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
(6,867)
|
|
(7,201)
|
|
(25,334)
|
|
(28,911)
|
|
Interest
income
|
|
|
|
|
|
4,617
|
|
3,346
|
|
19,009
|
|
6,783
|
|
Other income (expense),
net
|
|
|
|
|
|
(6,347)
|
|
(220)
|
|
(6,247)
|
|
(116)
|
Total non-operating
income (expense), net
|
|
|
|
|
(8,597)
|
|
(4,075)
|
|
(12,572)
|
|
11,183
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
|
|
|
(42,108)
|
|
(56,544)
|
|
(276,256)
|
|
(364,983)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision (benefit) for
income taxes
|
|
|
|
|
|
(29)
|
|
3,144
|
|
(200)
|
|
3,215
|
Net loss
|
|
|
|
|
|
$
(42,079)
|
|
$
(59,688)
|
|
$
(276,056)
|
|
$
(368,198)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
|
|
$
(0.22)
|
|
$
(0.32)
|
|
$
(1.45)
|
|
$
(1.97)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing basic and diluted net loss per
share
|
|
191,040
|
|
188,237
|
|
190,001
|
|
187,138
|
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SOURCE Nektar Therapeutics