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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): May 6, 2021



(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
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.







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






Exhibit 99.1




Nektar Therapeutics 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.”


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.




For Investors:

Vivian Wu of Nektar Therapeutics



For Media:

Dan Budwick of 1AB









(In thousands, except par value)



   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 
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 


(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.






(In thousands, except per share information)



   Three months ended
March 31,
   2021   2020 
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 







(In thousands)



   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 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