SAN FRANCISCO, Aug. 8, 2018 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today reported its financial
results for the second quarter ended June
30, 2018.
Cash and investments in marketable securities at June 30,
2018 were $2.1 billion as compared to $353.2
million at December 31, 2017. This includes the
$1.0 billion upfront payment and
$850.0 million share purchase
proceeds received on April 3, 2018,
as a result of our Bristol-Myers Squibb collaboration for the
global development and commercialization of NKTR-214.
"Over the past few months, we have reported significant progress
across all areas of our pipeline, with notable milestones for our
immuno-oncology, immunology and pain programs," said Howard W. Robin, President and CEO of Nektar.
"Together with Bristol-Myers Squibb, we plan to initiate 20
registrational studies in nine tumor settings under our joint
development plan with the first wave of studies in melanoma, renal
cell carcinoma, and urothelial cancers starting this year. We
initiated our first study of NKTR-358 in patients with lupus with
our partner Eli Lilly. And importantly, we recently achieved
a significant milestone for our pain program, with the FDA's
acceptance of the NDA filing for NKTR-181, a first-in-class opioid
analgesic."
Revenue in the second quarter of 2018 was $1.088
billion as compared to $34.6 million in the second
quarter of 2017. Year-to-date revenue for 2018 was $1.126
billion as compared to $59.3 million in the first half of
2017. Revenue was higher in the second quarter and first half of
2018 as compared to the same periods in 2017 primarily because of
the recognition of $1.06 billion of
license revenue from the Bristol-Myers Squibb collaboration
agreement.
Total operating costs and expenses in the second quarter of 2018
were $114.1 million as compared to $85.2 million in the second quarter of 2017.
Total operating costs and expenses in the first half of 2018
were $238.9 million as compared to $164.4
million in the first half of 2017. Total operating costs and
expenses increased primarily as a result of increased research and
development (R&D) expense.
R&D expense in the second quarter of 2018 was $88.3 million as compared to $60.3
million in the second quarter of 2017. For the first
half of 2018, R&D expense was $187.8 million as
compared to $121.3 million in the first half of 2017.
R&D expense was higher in the second quarter and first half of
2018 as compared to the same periods in 2017 primarily because of
expenses for our pipeline programs, including the continued
development of NKTR-214 in Phase 1/2 studies and Phase 3
preparatory activities, costs related to the NKTR-181 New Drug
Application and NKTR-181 pre-commercial manufacturing, Phase 1
clinical studies of NKTR-358, initiation of the Phase 1 study of
NKTR-262 in combination with NKTR-214 and IND-enabling activities
for NKTR-255.
General and administrative (G&A) expense was $20.3
million in the second quarter of 2018 as compared
to $16.0 million in the second quarter of
2017. G&A expense in the first half of 2018
was $38.9 million as compared to $28.0
million in the first half of 2017. G&A expense was
higher in the second quarter and first half of 2018 as compared to
the same periods in 2017 primarily due to an increase in non-cash
stock based compensation expense.
Net income in the second quarter of 2018 was $971.5
million or $5.33 diluted earnings per share as compared
to a net loss of $59.9 million or $0.39 basic
and diluted loss per share in the second quarter of 2017. Net
income in the first half of 2018 was $875.7
million or $4.91 diluted earnings per share as compared
to a net loss of $123.7 million or $0.80 basic
and diluted loss per share in the first half of 2017.
Second Quarter 2018 and Recent Business Highlights
- In July, the U.S. Food and Drug Administration filed and
accepted a New Drug Application (NDA) for NKTR-181, a
first-in-class opioid analgesic, to treat chronic low back pain in
adult patients new to opioid therapy. The NDA has been assigned a
PDUFA (Prescription Drug User Fee Act) target action date of
May 29, 2019 by the FDA.
- In June, Nektar presented data for NKTR-181 at the 80th Annual
Scientific Meeting of the College on Problems of Drug Dependence.
The data show that NKTR-181 consistently demonstrates low abuse
potential.
- In June, Nektar presented data from the Phase 1 dose escalation
and preliminary data from the Phase 2 dose expansion phase of the
ongoing PIVOT study for NKTR-214 in combination with Opdivo
(nivolumab) at the 2018 ASCO Annual Meeting. This data showed that
pre-specified efficacy criteria were achieved in three tumor types:
first-line melanoma, first-line renal cell carcinoma and first-line
urothelial cancer. Nektar and Bristol-Myers
Squibb expect to initiate a Phase 3 registrational trial in
first-line advanced melanoma patients in Q3 2018, and pivotal
studies are also being designed in renal cell carcinoma and
urothelial cancer.
- In May, Nektar announced a clinical collaboration with Syndax
Pharmaceuticals to evaluate NKTR-214 in combination with
entinostat, an oral, small molecule Class 1 specific HDAC
inhibitor, in patients with metastatic melanoma who have previously
progressed on treatment with an anti-PD-1 agent.
- In May, Nektar began dosing patients with systemic lupus
erythematosus in a Phase 1b multiple
ascending dose study of NKTR-358, a first-in-class regulatory T
cell stimulator, designed to correct the underlying immune system
dysfunction found in patients with immune disorders.
The company also announced the following upcoming presentations
during the second half of 2018:
American Chemical Society Annual Meeting, Boston, MA:
- Oral Presentation: "Confronting the Opioid Epidemic:
Novel Treatments for Chronic Pain"
-
- Presenter: Stephen
Doberstein, Ph.D., Nektar Therapeutics
- Date: Monday, August, 20, 2018, 1:35 p.m. - 2:05 p.m., Eastern Daylight Time
SMI Immuno-Oncology Conference, London, UK:
- Oral Presentation: "Enhanced cancer vaccine
effectiveness with NKTR-214, a CD122-biased cytokine"
-
- Presenter: Loui Marakamutil, Ph.D., Nektar
Therapeutics
- Date: September 26, 2018,
11:00 a.m., British Summer Time
Ninth American Conference on Pharmacometrics, San Diego, CA:
- Poster: "NKTR-255 Exhibits Target Mediated Drug
Disposition and Stimulates Proliferation of Cytotoxic Immune Cells
in Cyonomolgous Monkeys", Bhasi, K., et al.
-
ESMO 2018 Congress, Munich,
Germany:
- Poster 362TiP: "ATTAIN: Phase 3 study of etirinotecan
pegol (EP) vs treatment of physician's choice (TPC) in patients
(pts) with metastatic breast cancer (MBC) who have stable brain
metastases (BM) previously treated with an anthracycline, a taxane,
and capecitabine (ATC).", Tripathy, D., et al.
-
- Date: October 22, 2018,
12:45-13:45 p.m. Central European
Summer Time
- Poster 446TiP: "REVEAL: A phase 1/2, open-label,
multicenter, dose escalation and dose expansion study of NKTR-262
[TLR 7/8 agonist] plus NKTR-214 [CD122-biased agonist] with or
without nivolumab (nivo) in patients (pts) with locally advanced or
metastatic solid tumor malignancies.", Diab, A., et al.
-
- Date: October 22, 2018,
12:45-13:45 p.m. Central European
Summer Time
Conference Call to Discuss Second Quarter 2018 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 today, Wednesday, August 8,
2018.
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:
http://ir.nektar.com/. The web broadcast of the
conference call will be available for replay through Monday, September 10, 2018.
To access the conference call,
follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 7099844 (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 Therapeutics
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,
auto-immune disease and chronic pain. We leverage Nektar's
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 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 uncertain or forward-looking
statements which can be identified by words such as: "expect,"
"may," "will," "design," "develop," 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
products (including NKTR‑214, NKTR-181, NKTR-358,
NKTR-262 and NKTR-255) and the initiation of Phase 3 registrational
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) clinical study
outcomes remain very unpredictable and it is possible that a
clinical study could fail even after positive interim data is
observed; (ii) the data package required for approval of an NDA to
the FDA is very uncertain and difficult to predict due to broad FDA
regulatory discretion, and changing FDA regulatory guidelines;
(iii) regulations concerning and controlling access to opioid-based
pharmaceuticals are strict and it is difficult to predict which
scheduling category will apply to NKTR-181 if regulatory approval
is achieved; (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 our Annual Report on Form 10-Q
filed with the Securities and Exchange Commission on May 10, 2018. 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.
Contacts:
For Investors:
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
Jodi Sievers of Nektar
Therapeutics
415-482-5593
For Media:
Dan Budwick of 1AB
973-271-6085
dan@1abmedia.com
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(In
thousands)
|
(Unaudited)
|
|
ASSETS
|
|
June 30,
2018
|
|
December 31,
2017
|
(1)
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
911,125
|
|
$
4,762
|
|
|
Short-term
investments
|
|
912,683
|
|
291,370
|
|
|
Accounts receivable,
net
|
|
35,315
|
|
5,014
|
|
|
Inventory
|
|
11,884
|
|
10,726
|
|
|
Other current
assets
|
|
34,940
|
|
14,948
|
|
|
|
Total current
assets
|
|
1,905,947
|
|
326,820
|
|
|
|
|
|
|
|
Long-term
investments
|
|
282,277
|
|
57,088
|
|
Property, plant and
equipment, net
|
|
45,000
|
|
47,463
|
|
Goodwill
|
|
76,501
|
|
76,501
|
|
Other
assets
|
|
3,362
|
|
994
|
|
|
|
Total
assets
|
|
$
2,313,087
|
|
$
508,866
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
10,674
|
|
$
4,782
|
|
|
Accrued
compensation
|
|
18,980
|
|
8,263
|
|
|
Accrued clinical
trial expenses
|
|
20,028
|
|
9,461
|
|
|
Other accrued
expenses
|
|
14,993
|
|
10,064
|
|
|
Interest
payable
|
|
4,144
|
|
4,198
|
|
|
Deferred revenue,
current portion
|
|
17,988
|
|
18,949
|
|
|
Other current
liabilities
|
|
10,090
|
|
446
|
|
|
|
Total current
liabilities
|
|
96,897
|
|
56,163
|
|
|
|
|
|
|
|
Senior secured notes,
net
|
|
246,078
|
|
245,207
|
|
Liability related to
the sale of future royalties, net
|
|
88,867
|
|
94,655
|
|
Deferred revenue,
less current portion
|
|
13,780
|
|
19,021
|
|
Other long-term
liabilities
|
|
7,051
|
|
5,992
|
|
|
|
Total
liabilities
|
|
452,673
|
|
421,038
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
Preferred
stock
|
|
-
|
|
-
|
|
|
Common
stock
|
|
17
|
|
15
|
|
|
Capital in excess of
par value
|
|
3,094,095
|
|
2,207,865
|
|
|
Accumulated other
comprehensive loss
|
|
(4,002)
|
|
(2,111)
|
|
|
Accumulated
deficit
|
|
(1,229,696)
|
|
(2,117,941)
|
|
|
|
Total stockholders'
equity
|
|
1,860,414
|
|
87,828
|
|
|
Total liabilities and
stockholders' equity
|
|
$
2,313,087
|
|
$
508,866
|
|
|
(1) The consolidated
balance sheet at December 31, 2017 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,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Product
sales
|
|
$
5,863
|
|
$
15,693
|
|
$
12,158
|
|
$
20,449
|
Royalty
revenue
|
|
8,563
|
|
7,434
|
|
19,639
|
|
14,651
|
Non-cash
royalty revenue related to sale of future royalties
|
|
9,045
|
|
6,638
|
|
15,965
|
|
13,301
|
License,
collaboration and other revenue
|
|
1,064,246
|
|
4,824
|
|
1,077,973
|
|
10,916
|
Total
revenue
|
|
1,087,717
|
|
34,589
|
|
1,125,735
|
|
59,317
|
|
|
|
|
|
|
|
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of
goods sold
|
|
5,522
|
|
8,989
|
|
12,168
|
|
15,120
|
Research
and development
|
|
88,334
|
|
60,260
|
|
187,758
|
|
121,318
|
General
and administrative
|
|
20,261
|
|
15,996
|
|
38,948
|
|
27,972
|
Total operating costs
and expenses
|
|
114,117
|
|
85,245
|
|
238,874
|
|
164,410
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
973,600
|
|
(50,656)
|
|
886,861
|
|
(105,093)
|
|
|
|
|
|
|
|
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
(5,385)
|
|
(5,510)
|
|
(10,725)
|
|
(10,912)
|
Non-cash
interest expense on liability related to sale of future
royalties
|
|
(4,975)
|
|
(4,512)
|
|
(9,994)
|
|
(9,064)
|
Interest
income and other income (expense), net
|
|
12,105
|
|
906
|
|
13,676
|
|
1,564
|
Total non-operating
income (expense), net
|
|
1,745
|
|
(9,116)
|
|
(7,043)
|
|
(18,412)
|
|
|
|
|
|
|
|
|
|
Income (loss) before
provision for income taxes
|
|
975,345
|
|
(59,772)
|
|
879,818
|
|
(123,505)
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
3,885
|
|
99
|
|
4,150
|
|
232
|
Net income
(loss)
|
|
$
971,460
|
|
$
(59,871)
|
|
$
875,668
|
|
$
(123,737)
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
5.67
|
|
$
(0.39)
|
|
$
5.27
|
|
$
(0.80)
|
Diluted
|
|
$
5.33
|
|
$
(0.39)
|
|
$
4.91
|
|
$
(0.80)
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding used in computing net income (loss) per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
171,378
|
|
155,352
|
|
166,160
|
|
154,514
|
Diluted
|
|
182,291
|
|
155,352
|
|
178,281
|
|
154,514
|
NEKTAR
THERAPEUTICS
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(In
thousands)
|
(Unaudited)
|
|
|
|
Six Months Ended June
30,
|
|
|
2018
|
|
2017
|
Cash flows from
operating activities:
|
|
|
|
|
Net income
(loss)
|
|
$
875,668
|
|
$
(123,737)
|
Adjustments to
reconcile net income (loss) to net cash provided by
(used in) operating
activities:
|
|
Non-cash royalty
revenue related to sale of future royalties
|
|
(15,965)
|
|
(13,301)
|
Non-cash interest
expense on liability related to sale of future
royalties
|
|
9,994
|
|
9,064
|
Stock-based
compensation
|
|
40,608
|
|
16,283
|
Depreciation and
amortization
|
|
5,115
|
|
8,287
|
Other non-cash
transactions
|
|
(3,991)
|
|
(1,089)
|
Changes in operating
assets and liabilities:
|
|
|
|
|
Accounts receivable,
net
|
|
(19,557)
|
|
11,564
|
Inventory
|
|
(1,158)
|
|
101
|
Other
assets
|
|
(14,282)
|
|
2,280
|
Accounts
payable
|
|
5,791
|
|
3,221
|
Accrued
compensation
|
|
10,717
|
|
(3,934)
|
Accrued clinical
trial expenses
|
|
10,567
|
|
(1,275)
|
Other accrued
expenses
|
|
4,904
|
|
2,388
|
Interest
payable
|
|
(54)
|
|
(54)
|
Deferred
revenue
|
|
(6,249)
|
|
(3,887)
|
Other
liabilities
|
|
5,068
|
|
1,000
|
Net cash provided by
(used in) operating activities
|
|
907,176
|
|
(93,089)
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
Purchases of
investments
|
|
(989,850)
|
|
(121,135)
|
Maturities of
investments
|
|
132,779
|
|
147,558
|
Sales of
investments
|
|
11,963
|
|
8,823
|
Purchases of
property, plant and equipment
|
|
(3,730)
|
|
(6,344)
|
Sales of property,
plant and equipment
|
|
2,633
|
|
-
|
Net cash (used in)
provided by investing activities
|
|
(846,205)
|
|
28,902
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
Payment of capital
lease obligations
|
|
-
|
|
(1,369)
|
Issuance of common
stock
|
|
790,231
|
|
-
|
Proceeds from shares
issued under equity compensation plans
|
|
55,208
|
|
22,016
|
Net cash provided by
financing activities
|
|
845,439
|
|
20,647
|
|
|
|
|
|
Effect of exchange
rates on cash and cash equivalents
|
|
(47)
|
|
49
|
Net increase
(decrease) in cash and cash equivalents
|
|
906,363
|
|
(43,491)
|
Cash and cash
equivalents at beginning of period
|
|
4,762
|
|
59,640
|
Cash and cash
equivalents at end of period
|
|
$
911,125
|
|
$
16,149
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
Cash paid
for interest
|
|
$
9,795
|
|
$
10,010
|
View original
content:http://www.prnewswire.com/news-releases/nektar-therapeutics-reports-financial-results-for-the-second-quarter-of-2018-300694282.html
SOURCE Nektar Therapeutics