SAN
FRANCISCO, May 9, 2023 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported financial results for
the first quarter ended March 31,
2023.
Cash and investments in marketable securities at March 31, 2023, were $456.8 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 Nektar regaining full rights to rezpegaldesleukin, we are
already making progress towards initiating a Phase 2b study in atopic dermatitis," said Howard W. Robin, President and CEO of Nektar.
"We are confident that our focus on immunology is the best path
forward to bring important potential therapies to patients and
create shareholder value. Based on feedback from key opinion
leaders in atopic dermatitis, we are enthusiastic about the future
prospects for rezpegaldesleukin in a significant and growing
biologic treatment landscape. Finally, we are working diligently to
advance our immunology research pipeline with the goal of advancing
a new IND candidate next year."
Summary of Financial Results
Revenue in the first quarter of 2023 was $21.6 million as compared to $24.8 million in the first quarter of 2022.
Total operating costs and expenses in the first quarter of 2023
were $156.3 million as compared to
$141.4 million in the first quarter
of 2022. Operating costs and expenses for the first quarter include
$76.5 million in non-cash goodwill
impairment, $13.2 million in other
non-cash impairment charges primarily related to lease assets, and
$8.0 million in other restructuring
costs, offset by decreases in R&D and G&A expenses.
R&D expense in the first quarter of 2023 was $30.5 million as compared to $107.3 million for the first quarter of 2022.
R&D expense decreased primarily due to the wind down of the
bempegaldesleukin program.
G&A expense was $21.1 million
in the first quarter of 2023 as compared to $27.3 million in the first quarter of 2022.
G&A expense decreased primarily due to the wind down of the
bempegaldesleukin program.
Restructuring, impairment and costs of the terminated program
were $21.2 million in the first
quarter of 2023 as compared to $1.5
million in the first quarter of 2022. The amount for the
first quarter of 2023 includes $13.2
million in non-cash lease and equipment impairment charges,
$5.5 million in severance, and
$2.5 million in other costs.
Net loss for the first quarter of 2023 was $137.0 million or $0.73 basic and diluted loss per share as
compared to a net loss of $90.4
million or $0.49 basic and
diluted loss per share in the first quarter of 2022. Excluding the
$89.7 million in non-cash goodwill
and other impairment charges, net loss, on a non-GAAP basis, for
the first quarter of 2023 was $47.3
million or $0.25 basic and
diluted loss per share.
First Quarter 2023 and Recent Business Updates
- On April 27, 2023, Nektar
announced that it will be regaining the full rights to
rezpegaldesleukin from Eli Lilly and Company. Nektar plans to move
forward with rezpegaldesleukin and will initiate a Phase
2b study in patients with
moderate-to-severe atopic dermatitis in 2023. The company will also
explore other auto-immune indications for the development plan for
rezpegaldesleukin.
- On April 17, 2023, Nektar
announced a strategic reprioritization and cost restructuring plan
that includes a new pipeline focus on immunology, as well as
several cost reduction initiatives.
Conference Call to Discuss First 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,
May 9, 2023.
The 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 June 4, 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," "progress," "expect," "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 and our other drug candidates in research
programs, the timing for filing a new IND, our expectations
regarding our 2023 cost restructuring plan, 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 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 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 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 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 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-K
filed with the Securities and Exchange Commission on February 28, 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
|
|
March 31,
2023
|
|
December 31,
2022(1)
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
76,955
|
|
$
88,227
|
|
|
Short-term
investments
|
|
379,872
|
|
416,750
|
|
|
Accounts
receivable
|
|
2,995
|
|
5,981
|
|
|
Inventory,
net
|
|
20,235
|
|
19,202
|
|
|
Other current
assets
|
|
11,009
|
|
15,808
|
|
|
|
Total current
assets
|
|
491,066
|
|
545,968
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
27,084
|
|
32,451
|
|
Operating lease
right-of-use assets
|
|
42,187
|
|
53,435
|
|
Goodwill
|
|
-
|
|
76,501
|
|
Other assets
|
|
1,406
|
|
2,245
|
|
|
|
Total assets
|
|
$
561,743
|
|
$
710,600
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
3,696
|
|
12,980
|
|
|
Accrued
expenses
|
|
37,410
|
|
36,557
|
|
|
Operating lease
liabilities, current portion
|
|
18,773
|
|
18,667
|
|
|
|
Total current
liabilities
|
|
59,879
|
|
68,204
|
|
|
|
|
|
|
|
|
|
Operating lease
liabilities, less current portion
|
|
109,389
|
|
112,829
|
|
Liabilities related to
the sales of future royalties, net
|
|
145,131
|
|
155,378
|
|
Other long-term
liabilities
|
|
6,479
|
|
7,551
|
|
|
|
Total
liabilities
|
|
320,878
|
|
343,962
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
|
Common stock
|
|
19
|
|
19
|
|
|
Capital in excess of
par value
|
|
3,584,738
|
|
3,574,719
|
|
|
Accumulated other
comprehensive loss
|
|
(5,681)
|
|
(6,907)
|
|
|
Accumulated
deficit
|
|
(3,338,211)
|
|
(3,201,193)
|
|
|
|
Total stockholders'
equity
|
|
240,865
|
|
366,638
|
|
|
Total liabilities and
stockholders' equity
|
|
$
561,743
|
|
$
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
March 31,
|
|
|
|
2023
|
|
2022
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
Product
sales
|
|
$
4,718
|
|
$
5,688
|
|
Non-cash royalty
revenue related to the sales of future royalties
|
|
16,861
|
|
17,561
|
|
License, collaboration
and other revenue
|
|
15
|
|
1,573
|
Total
revenue
|
|
21,594
|
|
24,822
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
Cost of goods
sold
|
|
7,060
|
|
5,315
|
|
Research and
development
|
|
30,469
|
|
107,253
|
|
General and
administrative
|
|
21,081
|
|
27,339
|
|
Restructuring,
impairment, and costs of terminated program
|
|
21,193
|
|
1,475
|
|
Impairment of
goodwill
|
|
76,501
|
|
-
|
Total operating costs
and expenses
|
|
156,304
|
|
141,382
|
|
Loss from
operations
|
|
(134,710)
|
|
(116,560)
|
|
|
|
|
|
|
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
|
|
(6,405)
|
|
(7,529)
|
|
Interest income and
other income (expense), net
|
|
4,034
|
|
395
|
Total non-operating
income (expense), net
|
|
(2,371)
|
|
26,293
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
(137,081)
|
|
(90,267)
|
|
|
|
|
|
|
Provision for income
taxes
|
|
(63)
|
|
126
|
Net loss
|
|
$
(137,018)
|
|
$
(90,393)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.73)
|
|
$
(0.49)
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing basic and diluted net loss per
share
|
|
188,875
|
|
185,848
|
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SOURCE Nektar Therapeutics