SAN FRANCISCO, May 6, 2021 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported financial results
for the first quarter ended March 31,
2021.
Cash and investments in marketable securities at March 31,
2021 were approximately $1.1 billion as compared to $1.2
billion at December 31, 2020.
"We continue to build momentum with our clinical pipeline of
novel cytokine therapeutics," said Howard
W. Robin, President and CEO of Nektar. "We have a robust
development program for bempegaldesleukin focused on pursuing large
front-line and adjuvant tumor settings. Our five registrational
studies underway in melanoma, renal cell carcinoma, and bladder
cancer are progressing as planned. In February, we added a sixth
registrational study for bempegaldesleukin plus pembrolizumab in
head and neck cancer, which we expect to initiate later this year.
In addition, we remain on track to report the first data for our
PROPEL study evaluating bempegaldesleukin plus pembrolizumab in
patients with metastatic non-small cell lung cancer in the second
half of 2021."
"For our second cytokine program in oncology, NKTR-255, our
initial efforts include two Phase 1 clinical studies in combination
with ADCC antibodies, one in hematological malignancies and one in
solid tumors, and we look forward to sharing data from these
studies in Q4 of this year," continued Mr. Robin.
"Finally, as part of the broad development program for NKTR-358,
our T regulatory cell IL-2 agent, our partner Eli Lilly is
conducting Phase 2 studies in both lupus and ulcerative colitis and
plans to initiate additional Phase 2 studies in two different
immune-mediated diseases over the next 9-12 months."
Summary of Financial Results
Revenue in the first quarter of 2021 was $23.6 million as
compared to $50.6 million in the first quarter of 2020.
The decrease was due primarily to the recognition of the
$25.0 million milestone payment from
Bristol-Myers Squibb related to the initiation of the
registrational trial of bempegaldesleukin plus
Opdivo® in muscle-invasive bladder cancer in the
first quarter of 2020.
Total operating costs and expenses in the first quarter of 2021
were $133.0 million as compared
to $184.2 million in the first quarter of 2020. Operating
costs and expenses decreased primarily as a result of $45.2
million in impairment charges in the first quarter of 2020
resulting from the discontinuation of the NKTR-181 program and a
decrease in R&D expense.
R&D expense in the first quarter of 2021 was $95.6 million as compared to $109.0 million for the first quarter of
2020. R&D expense decreased primarily due to a decrease in
manufacturing costs for bempegaldesleukin.
G&A expense was $31.7 million
in the first quarter of 2021 and $26.2 million in the
first quarter of 2020. G&A expense increased primarily due to
an increase in pre-commercial costs for bempegaldesleukin.
Net loss for the first quarter of 2021 was $123.0 million
or $0.68 basic and diluted loss per
share as compared to a net loss of $138.7
million or $0.78 basic and diluted loss per share in the
first quarter of 2020.
First Quarter 2021 and Recent Business Highlights:
- In February 2021, Nektar
announced a clinical trial collaboration and supply agreement with
Merck for a Phase 2/3 study of bempegaldesleukin, Nektar's
investigational IL-2 pathway agent, in combination with Merck's
KEYTRUDA® (pembrolizumab) for first-line treatment of
patients with metastatic or unresectable recurrent squamous cell
carcinoma of the head and neck (SCCHN) whose tumors express PD-L1.
The study is planned to start in the second half of 2021.
- In February 2021, Nektar
announced a financing and co-development collaboration with SFJ
Pharmaceuticals® for the development of
bempegaldesleukin plus pembrolizumab in SCCHN. SFJ has agreed to
fund up to $150 million to support
the planned Phase 2/3 study and manage clinical trial operations
for the study. In return, Nektar agrees to pay SFJ success-based
annual milestone payments over a period of seven to eight years
which are contingent upon receipt of certain U.S. regulatory
approvals for specified indications for bempegaldesleukin, and will
begin following completion of the SCCHN study, which is projected
to be completed in 2024.
Conference Call to Discuss First Quarter 2021 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, May 6, 2021.
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 June 6,
2021.
To access the conference call, follow these instructions:
Dial: (877) 881-2183
(U.S.); (970) 315-0453 (International)
Conference ID: 9233368 (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, immunology, and virology 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," "plan," "expect," "project" 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 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 Annual Report on Form 10-K filed with the
Securities and Exchange Commission on February 26, 2021. 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
|
March 31,
2021
|
|
December 31, 2020
1
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
150,164
|
|
$
|
198,955
|
Short-term
investments
|
887,152
|
|
862,941
|
Accounts
receivable
|
29,156
|
|
38,889
|
Inventory
|
16,808
|
|
15,292
|
Other current
assets
|
15,771
|
|
21,928
|
Total
current assets
|
1,099,051
|
|
1,138,005
|
|
|
|
|
Long-term
investments
|
96,093
|
|
136,662
|
Property, plant and
equipment, net
|
58,510
|
|
59,662
|
Operating lease
right-of-use assets
|
124,971
|
|
126,476
|
Goodwill
|
76,501
|
|
76,501
|
Other
assets
|
1,435
|
|
1,461
|
Total
assets
|
$1,456,561
|
|
$1,538,767
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
22,434
|
|
22,139
|
Accrued
compensation
|
23,513
|
|
14,532
|
Accrued clinical trial
expenses
|
41,028
|
|
44,207
|
Accrued contract
manufacturing expenses
|
6,057
|
|
11,310
|
Other accrued
expenses
|
14,833
|
|
9,676
|
Operating lease
liabilities, current portion
|
15,768
|
|
13,915
|
Total
current liabilities
|
123,633
|
|
115,779
|
|
|
|
|
Operating lease
liabilities, less current portion
|
134,556
|
|
136,373
|
Development
derivative liability
|
4,597
|
|
-
|
Liability related to
the sale of future royalties, net
|
195,139
|
|
200,340
|
Other long-term
liabilities
|
4,130
|
|
8,980
|
Total
liabilities
|
462,055
|
|
461,472
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Preferred
stock
|
-
|
|
-
|
Common stock
|
18
|
|
18
|
Capital in excess of
par value
|
3,429,734
|
|
3,388,730
|
Accumulated other
comprehensive loss
|
(3,121)
|
|
(2,295)
|
Accumulated
deficit
|
(2,432,125)
|
|
(2,309,158)
|
Total
stockholders' equity
|
994,506
|
|
1,077,295
|
Total liabilities and
stockholders' equity
|
$1,456,561
|
|
$1,538,767
|
|
|
(1)
|
The consolidated
balance sheet at December 31, 2020 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,
|
|
|
|
|
|
|
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
Product
sales
|
|
|
|
|
|
|
$
|
4,795
|
|
$
|
3,444
|
Royalty
revenue
|
|
|
|
|
|
|
-
|
|
9,719
|
Non-cash royalty
revenue related to sale of future royalties
|
|
|
|
|
|
|
18,798
|
|
9,895
|
License, collaboration
and other revenue
|
|
|
|
|
|
|
54
|
|
27,515
|
Total
revenue
|
|
|
|
|
23,647
|
|
50,573
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
|
5,756
|
|
3,811
|
Research and
development
|
|
|
|
95,604
|
|
108,987
|
General and
administrative
|
|
|
|
31,679
|
|
26,217
|
Impairment of assets
and other costs for terminated program
|
|
-
|
|
45,189
|
Total operating costs
and expenses
|
|
|
133,039
|
|
184,204
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
|
(109,392)
|
|
(133,631)
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
|
|
Non-cash interest
expense on liability related to sale of future royalties
|
|
(13,296)
|
|
(6,968)
|
Change in fair value of
development derivative liability
|
|
|
(1,599)
|
|
-
|
Interest income and
other income (expense), net
|
|
|
1,412
|
|
8,352
|
Interest
expense
|
|
|
|
-
|
|
(6,204)
|
Total non-operating
income (expense), net
|
|
|
(13,483)
|
|
(4,820)
|
|
|
|
|
|
|
|
|
|
|
|
Loss before provision
for income taxes
|
|
|
(122,875)
|
|
(138,451)
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
|
92
|
|
200
|
Net loss
|
|
|
|
|
|
$
|
(122,967)
|
|
$
|
(138,651)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
$
|
(0.68)
|
|
$
|
(0.78)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing basic and diluted net loss per
share
|
|
181,370
|
|
177,185
|
NEKTAR
THERAPEUTICS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
|
|
|
|
2021
|
|
2020
|
Cash flows from
operating activities:
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
$
|
(122,967)
|
|
$
|
(138,651)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
Non-cash royalty
revenue related to sale of future royalties
|
|
|
(18,798)
|
|
(9,895)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
|
13,296
|
|
6,968
|
Change in fair value of
development derivative liability
|
|
|
1,599
|
|
-
|
Non-cash research and
development expense
|
|
|
2,248
|
|
-
|
Stock-based
compensation
|
|
|
|
23,898
|
|
25,236
|
Depreciation and
amortization
|
|
|
3,543
|
|
4,502
|
Impairment of advance
payments to contract manufacturers and equipment for terminated
program
|
|
-
|
|
20,351
|
Amortization of
premiums (discounts), net and other non-cash
transactions
|
|
2,345
|
|
(1,289)
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
Accounts
receivable
|
|
|
|
9,733
|
|
(5,229)
|
Inventory
|
|
|
|
|
(1,516)
|
|
(1,655)
|
Operating leases,
net
|
|
|
|
1,541
|
|
2,940
|
Other
assets
|
|
|
|
|
6,183
|
|
1,067
|
Accounts
payable
|
|
|
|
779
|
|
2,687
|
Accrued
compensation
|
|
|
|
8,981
|
|
9,920
|
Other accrued
expenses
|
|
|
|
(7,345)
|
|
7,483
|
Deferred
revenue
|
|
|
|
(605)
|
|
(2,510)
|
Net cash used in
operating activities
|
|
|
(77,085)
|
|
(78,075)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
Purchases of
investments
|
|
|
|
(295,314)
|
|
(241,068)
|
Maturities of
investments
|
|
|
|
303,612
|
|
439,735
|
Sales of
investments
|
|
|
|
5,036
|
|
-
|
Purchases of property,
plant and equipment
|
|
|
(2,876)
|
|
(900)
|
Net cash provided by
investing activities
|
|
|
|
|
|
|
|
10,458
|
|
197,767
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
Proceeds from shares
issued under equity compensation plans
|
|
17,106
|
|
11,077
|
Cash receipts from
development derivative liability
|
|
|
750
|
|
-
|
Net cash provided by
financing activities
|
|
|
17,856
|
|
11,077
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
|
|
(20)
|
|
(97)
|
Net increase
(decrease) in cash and cash equivalents
|
|
|
(48,791)
|
|
130,672
|
Cash and cash
equivalents at beginning of period
|
|
|
198,955
|
|
96,363
|
Cash and cash
equivalents at end of period
|
|
|
$
|
150,164
|
|
$
|
227,035
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
Cash paid for
interest
|
|
|
|
$
|
-
|
|
$
|
4,951
|
Operating lease
right-of-use asset recognized in exchange for lease
liabilities
|
|
$
|
1,057
|
|
$
|
2,133
|
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SOURCE Nektar Therapeutics