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Washington, D.C. 20549





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


Date of report (Date of earliest event reported): February 28, 2022



(Exact Name of Registrant as Specified in Charter)


Delaware   0-24006   94-3134940
(State or Other Jurisdiction
of Incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)


455 Mission Bay Boulevard South

San Francisco, California 94158

(Address of Principal Executive Offices and Zip 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 to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Securities registered pursuant to Section 12(b) of the Act:


Title of each class   Trading symbol(s)   Name of each exchange on which registered
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 February 28, 2022, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press release (the “Press Release”) announcing its financial results for the quarter and year ended December 31, 2021. A copy of the Press Release is furnished herewith as Exhibit 99.1.


On February 17, 2022, Nektar announced that it would hold a Webcast conference call on February 28, 2022 to review its financial results for the quarter and year ended December 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, whether made before or after the date hereof, regardless of any general incorporation language in such filing.


Item 9.01 Financial Statements and Exhibits.


(d) Exhibits.


Exhibit No.   Description 
99.1   Press release titled “Nektar Therapeutics Reports Fourth Quarter and Year-End 2021 Financial Results” issued by Nektar Therapeutics on February 28, 2022.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).







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


Date: February 28, 2022 By: /s/ Mark A. Wilson
    Mark A. Wilson
    General Counsel and Secretary






Exhibit 99.1



Nektar Therapeutics Reports Fourth Quarter and Year-End 2021 Financial Results


SAN FRANCISCO, Feb. 28, 2022 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the fourth quarter and full year ended December 31, 2021.


Cash and investments in marketable securities at December 31, 2021 were approximately $0.8 billion as compared to $1.2 billion at December 31, 2020.


“We are pleased with the significant progress that Nektar has made advancing our clinical pipeline in 2021 in the areas of solid tumors, liquid tumors and auto-immune disorders,” said Howard W. Robin, President and CEO of Nektar. “In the first half of 2022, we expect topline results from three of our six registrational trials evaluating bempegaldesleukin in combination with a checkpoint inhibitor in melanoma, renal cell carcinoma and bladder cancer. We look forward to collaborating with our partner Bristol Myers to support timely potential regulatory filings for the first three studies and to complete preparations to support a potential commercial launch.”


Mr. Robin continued, “Our second oncology cytokine program, NKTR-255, a full IL-15 agonist, is being combined with multiple mechanisms in both solid tumors and hematological malignancies and we are excited that Merck KGaA and Pfizer will evaluate the combination of NKTR-255 with avelumab in the JAVELIN Bladder Medley, which is expected to start in the first half of 2022.  Eli Lilly and Nektar also made significant progress in 2021 and we now have NKTR-358 in a broad set of clinical trials, including Phase 2 studies in lupus and ulcerative colitis with another planned in atopic dermatitis and a fourth planned in another auto-immune indication. In December of 2021, Lilly presented the first proof-of-concept data for NKTR-358 in atopic dermatitis which showed sustained disease control for at least 6 months after last treatment dose and highlighted the potential for this T regulatory cell stimulating agent to differentiate from standard of care.” 


Summary of Financial Results


Revenue in the fourth quarter of 2021 was $25.0 million as compared to $23.5 million in the fourth quarter of 2020. Revenue for the year ended December 31, 2021 was $101.9 million as compared to $152.9 million in 2020 and was lower due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb for the initiation of registrational trials of bempegaldesleukin plus Opdivo® in adjuvant melanoma and muscle invasive bladder cancer in 2020. 


Total operating costs and expenses in the fourth quarter of 2021 were $137.9 million as compared to $134.2 million in the fourth quarter of 2020. The increase was due to an increase in G&A expense. Total operating costs and expenses for the full year 2021 were $548.0 million as compared to $578.0 million in 2020. Operating costs and expenses for the full year 2021 decreased as compared to 2020 primarily due to the recording of $45.2 million impairment charge in 2020 resulting from the discontinuation of the NKTR-181 program. 


R&D expense in the fourth quarter of 2021 was $99.6 million as compared to $102.7 million for the fourth quarter of 2020. R&D expense for the year ended December 31, 2021 was $400.3 million as compared to $408.7 million in 2020. 





G&A expense was $32.1 million in the fourth quarter of 2021 and $27.1 million in the fourth quarter of 2020. G&A expense for the full year 2021 was $122.8 million compared to $104.7 million in 2020. G&A expense increased primarily due to an increase in pre-commercial costs for bempegaldesleukin.


Net loss for the fourth quarter of 2021 was $145.6 million or $0.79 basic and diluted loss per share as compared to a net loss of $117.2 million or $0.65 basic and diluted loss per share in the fourth quarter of 2020. Net loss for the year ended December 31, 2021 was $523.8 million or $2.86 basic and diluted loss per share as compared to a net loss of $444.4 million or $2.49 basic and diluted loss per share in 2020.


2021 Business Highlights:


In December 2021, Nektar announced Phase 1b proof-of-concept data for NKTR-358, a novel T regulatory cell stimulator, in patients with moderate-to-severe atopic dermatitis. The data demonstrate the potential for NKTR-358 to differentiate from standard of care and supports Eli Lilly’s planned Phase 2 study in this indication.


In December 2021, Nektar presented data from the dose-escalation portion of its ongoing Phase 1 study of NKTR-255 in patients with relapsed/refractory hematologic malignancies at the 63rd American Society of Hematology (ASH) Annual Meeting. The data supports the development of NKTR-255 in combination with anticancer agents that induce antibody dependent cellular toxicity as well as CAR-T therapies.


In November 2021, Nektar presented clinical data from the ongoing PROPEL study evaluating bempegaldesleukin plus KEYTRUDA® (pembrolizumab) in patients with non-small cell lung cancer at the 2021 European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress.


In November 2021, Nektar presented initial clinical results from the Phase 1/2 study of NKTR-255 in combination with cetuximab in solid tumors in a late-breaking abstract at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The data showed early evidence of clinical benefit in the first patients treated in the dose-escalation portion of the study.


In October 2021, Bristol-Myers Squibb and Nektar completed enrollment in the Phase 3 first-line metastatic melanoma study evaluating bempegaldesleukin combined with Opdivo® versus Opdivo® in 760 patients with previously untreated, unresectable or metastatic melanoma.


In September 2021, Nektar entered into a new oncology clinical collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the maintenance regimen of NKTR-255 in combination with avelumab, a PD-L1 inhibitor, in patients with locally advanced or metastatic urothelial carcinoma (UC) in the Phase II JAVELIN Bladder Medley study. The study is expected to begin enrolling patients in the second quarter of 2022.


In July 2021, data from the Phase 2 study of bempegaldesleukin combined with Opdivo® was published in the Journal of Clinical Oncology, highlighting the encouraging safety and efficacy data in patients with first-line metastatic melanoma.


In May 2021, Nektar announced the publication of preclinical data in the Journal of Translational Autoimmunity describing NKTR-358 as a first-in-class, composition of stable PEG conjugates of native IL-2 designed to selectively stimulate T regulatory cell function.


In May 2021, Nektar announced its first publication of preclinical data highlighting anti-tumor properties of IL-15 agonist, NKTR-255, in the Journal for ImmunoTherapy of Cancer.





In February 2021, Nektar announced a clinical trial collaboration and supply agreement with Merck for a Phase 2/3 study of bempegaldesleukin in combination with 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.


In February 2021, Nektar announced a financing and co-development collaboration with SFJ Pharmaceuticals® for the development of bempegaldesleukin plus KEYTRUDA® (pembrolizumab) in SCCHN. SFJ agreed to fund up to $150 million to support the planned Phase 2/3 study and to manage clinical trial operations for the study. In return, Nektar agreed 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.


Conference Call to Discuss Fourth Quarter and Year-End 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, Monday, February 28, 2022.


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 March 28, 2022.


To access the conference call, follow these instructions:


Dial: (877) 881-2183 (U.S.); (970) 315-0453 (International)
Conference ID: 8890486 (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 this press release, or explained on the conference call, related information will be made available on the Investors section of 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: “will,” “may,” “design,” “potential,” “initiate,” “plan,” “advance” 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, the prospects and plans for our collaborations with other companies, and the timing of the initiation of clinical studies and the data readouts 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 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.




For Investors:
Vivian Wu of Nektar Therapeutics


For Media:
Dan Budwick of 1AB







(In thousands)



ASSETS  December 31,
   December 31,
Current assets:        
Cash and cash equivalents  $25,218   $198,955 
Short-term investments   708,737    862,941 
Accounts receivable   22,492    38,889 
Inventory   15,801    15,292 
Other current assets   23,333    21,928 
Total current assets   795,581    1,138,005 
Long-term investments   64,828    136,662 
Property, plant and equipment, net   60,510    59,662 
Operating lease right-of-use assets   117,025    126,476 
Goodwill   76,501    76,501 
Other assets   2,744    1,461 
Total assets  $1,117,189   $1,538,767 
Current liabilities:          
Accounts payable   9,747    22,139 
Accrued compensation   15,735    14,532 
Accrued clinical trial expenses   26,809    44,207 
Other accrued expenses   15,468    20,986 
Operating lease liabilities, current portion   17,441    13,915 
Total current liabilities   85,200    115,779 
Operating lease liabilities, less current portion   125,736    136,373 
Development derivative liability   27,726    - 
Liabilities related to the sales of future royalties, net   195,427    200,340 
Other long-term liabilities   3,592    8,980 
Total liabilities   437,681    461,472 
Commitments and contingencies          
Stockholders' equity:          
Preferred stock   -    - 
Common stock   19    18 
Capital in excess of par value   3,516,641    3,388,730 
Accumulated other comprehensive loss   (4,157)   (2,295)
Accumulated deficit   (2,832,995)   (2,309,158)
Total stockholders' equity   679,508    1,077,295 
Total liabilities and stockholders' equity  $1,117,189   $1,538,767 


(1)The consolidated balance sheet at December 31, 2021 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.







(In thousands, except per share information)



   Three months ended
December 31,
   Year ended December 31, 
   2021   2020   2021   2020 
Product sales  $5,890   $2,884   $23,725   $17,504 
Royalty revenue   -    (412)   -    30,999 
Non-cash royalty revenue related to the sales of future royalties   19,079    20,562    77,746    48,563 
License, collaboration and other revenue   40    428    436    55,849 
Total revenue   25,009    23,462    101,907    152,915 
Operating costs and expenses:                    
Cost of goods sold   6,163    4,323    24,897    19,477 
Research and development   99,614    102,724    400,269    408,678 
General and administrative   32,142    27,136    122,844    104,682 
Impairment of assets and other costs for terminated program   -    -    -    45,189 
Total operating costs and expenses   137,919    134,183    548,010    578,026 
Loss from operations   (112,910)   (110,721)   (446,103)   (425,111)
Non-operating income (expense):                    
Change in fair value of development derivative liability   (383)   -    (8,023)   - 
Non-cash interest expense on liabilities related to the sales of future royalties   (8,127)   (8,183)   (47,313)   (30,267)
Loss on revaluation of liability related to the sale of future royalties   (24,410)   -    (24,410)   - 
Interest income and other income (expense), net   181    1,829    2,569    18,282 
Interest expense   -    -    -    (6,851)
Total non-operating expense, net   (32,739)   (6,354)   (77,177)   (18,836)
Loss before provision for income taxes   (145,649)   (117,075)   (523,280)   (443,947)
Provision for income taxes   (4)   128    557    493 
Net loss  $(145,645)  $(117,203)  $(523,837)  $(444,440)
Basic and diluted net loss per share  $(0.79)  $(0.65)  $(2.86)  $(2.49)
Weighted average shares outstanding used in computing basic and diluted net loss per share   184,964    179,684    183,298    178,581 







(In thousands)



   Year ended December 31, 
   2021   2020 
Cash flows from operating activities:        
Net loss  $(523,837)  $(444,440)
Adjustments to reconcile net loss to net cash used in operating activities:          
Non-cash royalty revenue related to the sales of future royalties   (77,746)   (48,563)
Non-cash interest expense on liabilities related to the sales of future royalties   47,313    30,267 
Loss on revaluation of liability related to the sale of future royalties   24,410    - 
Change in fair value of development derivative liability   8,023    - 
Non-cash research and development expense   16,703    - 
Stock-based compensation   94,674    94,261 
Depreciation and amortization   14,146    14,182 
Impairment of advance payments to contract manufacturers and equipment for terminated program   -    20,351 
Amortization of premiums (discounts), net and other non-cash transactions   6,730    3,943 
Changes in operating assets and liabilities:          
Accounts receivable   12,397    1,913 
Inventory   (509)   (2,627)
Operating leases, net   2,340    2,743 
Other assets   (2,688)   4,476 
Accounts payable   (11,690)   2,382 
Accrued compensation   1,203    4,697 
Other accrued expenses   (23,524)   8,644 
Deferred revenue   (605)   (5,516)
Net cash used in operating activities   (412,660)   (313,287)
Cash flows from investing activities:          
Purchases of investments   (960,689)   (987,533)
Maturities of investments   1,166,951    1,449,304 
Sales of investments   11,504    41,700 
Purchases of property, plant and equipment   (14,989)   (7,258)
Net cash provided by investing activities   202,777    496,213 
Cash flows from financing activities:          
Proceeds from sale of future royalties, net of $3.8 million of transaction costs   -    146,250 
Repayment of senior notes   -    (250,000)
Cash receipts from development derivative liability   3,000    - 
Proceeds from shares issued under equity compensation plans   33,238    23,396 
Net cash provided by (used in) financing activities   36,238    (80,354)
Effect of foreign exchange rates on cash and cash equivalents   (92)   20 
Net increase (decrease) in cash and cash equivalents   (173,737)   102,592 
Cash and cash equivalents at beginning of year   198,955    96,363 
Cash and cash equivalents at end of year  $25,218   $198,955 
Supplemental disclosure of cash flow information:          
Cash paid for interest  $-   $9,742 
Cash paid for income taxes  $325   $539 
Operating lease right-of-use assets recognized in exchange for lease liabilities  $1,057   $2,133 
Accounts receivable recognized in exchange for long-term liabilities  $-   $4,000