8-K

NEKTAR THERAPEUTICS (NKTR)

8-K 2021-05-06 For: 2021-05-06
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Added on April 04, 2026

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 8-K


CURRENT REPORT

Pursuant to Section 13 or 15(d) of theSecurities Exchange Act of 1934

Date of report (Date of earliest event reported):

May 6, 2021


NEKTAR THERAPEUTICS

(Exact Name of Registrant as Specified in Charter)

Delaware 0-24006 94-3134940
(State or Other Jurisdictionof Incorporation) (Commission File Number) (IRS EmployerIdentification No.)

455 Mission Bay Boulevard South

San Francisco, California 94158

(Address of Principal Executive Offices andZip Code)

Registrant’s telephone number, including area code: (415) 482-5300

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant<br>to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to<br>Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications<br>pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications<br>pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:


Title of each class Trading symbol(s) Name of each exchange on whichregistered
Common Stock, $0.0001 par value NKTR NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐


Item 2.02 Results of Operations and Financial Condition.

On May 6, 2021, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press release (the “Press Release”) announcing its financial results for the quarter ended March 31, 2021. A copy of the Press Release is furnished herewith as Exhibit 99.1.

On April 27, 2021, Nektar announced that it would hold a Webcast conference call on May 6, 2021 to review its financial results for the quarter ended March 31, 2021. This conference call is accessible through a link that is posted on the home page and Investors section of the Nektar website: http://ir.nektar.com.

The information in this report, including the exhibit hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by Nektar Therapeutics, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

Exhibit No. Description
99.1 Press release titled “Nektar Therapeutics Reports First Quarter 2021 Financial Results” issued by Nektar Therapeutics on May 6, 2021.
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SIGNATURES

Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

By: /s/ Mark A. Wilson
Mark A. Wilson
General Counsel and Secretary
Date: May 6, 2021

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Exhibit 99.1

NektarTherapeutics Reports First Quarter 2021 Financial Results

SAN FRANCISCO, May 6, 2021 -- 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.”

Summaryof 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.

FirstQuarter 2021 and Recent Business Highlights:

In<br> February 2021, Nektar announced a clinical trial collaboration and supply agreement with<br> Merck for a Phase 2/3 study of bempegaldesleukin, Nektar’s investigational IL-2 pathway<br> agent, in combination with Merck’s KEYTRUDA^®^ (pembrolizumab) for first-line<br> treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of<br> the head and neck (SCCHN) whose tumors express PD-L1. The study is planned to start in the<br> second half of 2021.
In<br> 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<br> to fund up to $150 million to support the planned Phase 2/3 study and manage clinical<br> trial operations for the study. In return, Nektar agrees to pay SFJ success-based annual<br> milestone payments over a period of seven to eight years which are contingent upon receipt<br> of certain U.S. regulatory approvals for specified indications for bempegaldesleukin, and<br> will begin following completion of the SCCHN study, which is projected to be completed in<br> 2024.
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ConferenceCall 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.

AboutNektar

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.

CautionaryNote 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. Examplesof forward-looking statements include, among others, statements we make regarding the therapeutic potential of, and future developmentplans for, bempegaldesleukin, NKTR-358 and NKTR-255, and the timing of the initiation of clinical studies for our drug candidates. Forward-lookingstatements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectationsand assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and otherfuture conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changesin circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materiallyfrom those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Importantfactors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, amongothers: (i) our statements regarding the therapeutic potential of bempegaldesleukin, NKTR-358 and NKTR-255 are based on preclinicaland clinical findings and observations and are subject to change as research and development continue; (ii) bempegaldesleukin, NKTR-358and 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 preclinicaland clinical studies); (iii) bempegaldesleukin, NKTR-358 and NKTR-255 are in various stages of clinical development and the risk of failureis high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinicaltrials and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patientenrollment, 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 maynot issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectualproperty licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our AnnualReport on Form 10-K filed with the Securities and Exchange Commission on February 26, 2021. Any forward-looking statement made by usin 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 undertakeno obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a resultof 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

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NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value)

(Unaudited)


March 31, 2021 December 31, 2020^(1)^
ASSETS
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
Liabilities related to the sales 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

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^(1)^ The consolidated balance sheet at December 31, 2020 has been derived<br>from the audited financial statements at that date but does not include all of the information and notes required by generally accepted<br>accounting principles in the United States for complete financial statements.
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NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share information)

(Unaudited)


Three months ended <br> 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
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NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)


Three months ended<br><br>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 foreign 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 disclosures 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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