SECURITIES AND EXCHANGE COMMISSION
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Item 2.02 Results of Operations and Financial Condition.
On February 28, 2023, 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, 2022. A copy of the Press Release is furnished herewith as Exhibit 99.1.
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. 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.
|99.1||Press release titled “Nektar Therapeutics Reports Fourth Quarter and Year-End 2022 Financial Results”|
|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, 2023||By:||/s/ Mark A. Wilson|
|Mark A. Wilson|
|Chief Legal Officer and Secretary|
Nektar Therapeutics Reports Fourth Quarter and Year-End 2022 Financial Results
SAN FRANCISCO, Feb. 28, 2023 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the fourth quarter and full year ended December 31, 2022.
Cash and investments in marketable securities at December 31, 2022, were approximately $505.0 million as compared to $798.8 million at December 31, 2021.
"We are committed to ensuring that our existing cash can support a runway through at least the middle of 2025," said Howard W. Robin, President and CEO of Nektar. "This will enable us to advance our current pipeline to reach value-enhancing milestones. As a result, and as we stated on our analyst call last week, we will be making additional changes at Nektar to significantly reduce operating costs to meet that commitment."
Summary of Financial Results
Revenue in the fourth quarter of 2022 was $22.0 million as compared to $25.0 million in the fourth quarter of 2021. Revenue for the year ended December 31, 2022 was $92.1 million as compared to $101.9 million in 2021. Revenue for 2022 was lower compared to 2021, driven by a decrease in non-cash royalty revenue.
Total operating costs and expenses in the fourth quarter of 2022 were $74.5 million as compared to $137.9 million in the fourth quarter of 2021. Total operating costs and expenses for the full year 2022 were $468.2 million as compared to $548.0 million in 2021. Operating costs and expenses for both the fourth quarter and the full year 2022 decreased as compared to 2021 primarily due to the wind down of the bempegaldesleukin program, partially offset by severance expense and non-cash lease and equipment impairment charges.
R&D expense in the fourth quarter of 2022 was $34.7 million as compared to $99.6 million for the fourth quarter of 2021. R&D expense for the year ended December 31, 2022 was $218.3 million as compared to $400.3 million in 2021. R&D expense decreased for both the fourth quarter and full year 2022 primarily due to the wind down of the bempegaldesleukin program. The clinical trial and related employee compensation costs for the wind down of the bempegaldesleukin program are reported in restructuring, impairment and other costs of terminated program, discussed below.
G&A expense was $21.9 million in the fourth quarter of 2022 and $32.1 million in the fourth quarter of 2021. G&A expense for the full year 2022 was $92.3 million as compared to $122.8 million in 2021. G&A expense decreased for both the fourth quarter and full year 2022 primarily due to the wind down of the bempegaldesleukin program.
Restructuring, impairment and other costs of the terminated program were $11.6 million in the fourth quarter of 2022 and $135.9 million in the full year 2022. The full year 2022 amount includes $65.8 million in non-cash lease and equipment impairment charges, $30.9 million in employee severance expense and $31.7 million for clinical trial and related employee compensation costs for the wind down of the bempegaldesleukin program, as well as $7.5 million in other restructuring costs.
Net loss for the fourth quarter of 2022 was $59.7 million or $0.32 basic and diluted loss per share as compared to a net loss of $145.6 million or $0.79 basic and diluted loss per share in the fourth quarter of 2021. Net loss for the year ended December 31, 2022 was $368.2 million or $1.97 basic and diluted loss per share as compared to a net loss of $523.8 million or $2.86 basic and diluted loss per share in 2021.
On February 23, 2023, Nektar announced topline data from a Phase 2 study of rezpegaldesleukin in adults with moderately-to-severely active systemic lupus erythematosus (SLE) (https://ir.nektar.com/news-releases/news-release-details/nektar-therapeutics-announces-phase-2-topline-data) and conducted a call with analysts and investors.
As a result of this call, Nektar will not host its regular quarterly financial results conference call for the fourth quarter and year-end 2022. Nektar's Form 10-K for the year ended December 31, 2022 was filed on February 28, 2023.
About Nektar Therapeutics
Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology and immunology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama. 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," "advance," "support," "develop," "provide" 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 rezpegaldesleukin (formerly NKTR-358), NKTR-255 and our other drug candidates in research programs, the prospects and plans for our collaborations with other companies, the timing of the initiation of clinical studies and the data readouts for our drug candidates, our expectations (including our expected charges and cost savings) following our 2022 corporate restructuring and reorganization plan and workforce reduction, and our expected working capital and cash runway. 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 rezpegaldesleukin, NKTR-255 and our other drug candidates are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-255 and our other drug candidates 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) rezpegaldesleukin, NKTR-255 and our other drug candidates 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 challenges caused by the COVID-19 pandemic, 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) we may not achieve the expected cost savings we expect from our 2022 corporate restructuring and reorganization plan and we may undertake additional restructuring and cost-saving activities in the future, (vi) 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 (vii) 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 28, 2023. 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.
Vivian Wu of Nektar Therapeutics
David Rosen of Argot Partners
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|ASSETS||December 31, 2022||December 31, 2021||(1)|
|Cash and cash equivalents||$||88,227||$||25,218|
|Other current assets||15,808||23,333|
|Total current assets||545,968||795,581|
|Property, plant and equipment, net||32,451||60,510|
|Operating lease right-of-use assets||53,435||117,025|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued clinical trial expenses||12,262||26,809|
|Other accrued expenses||14,713||15,468|
|Operating lease liabilities, current portion||18,667||17,441|
|Total current liabilities||68,204||85,200|
|Operating lease liabilities, less current portion||112,829||125,736|
|Development derivative liability||-||27,726|
|Liabilities related to the sales of future royalties, net||155,378||195,427|
|Other long-term liabilities||7,551||3,592|
|Commitments and contingencies|
|Capital in excess of par value||3,574,719||3,516,641|
|Accumulated other comprehensive loss||(6,907||)||(4,157||)|
|Total stockholders' equity||366,638||679,508|
|Total liabilities and stockholders' equity||$||710,600||$||1,117,189|
(1) The consolidated balance sheet at December 31, 2022 has been derived from the audited financial statements at that date but does not include all of the information and notes required by generally accepted accounting principles in the United States for complete financial statements.
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share information)|
|Three months ended December 31,||Year ended December 31,|
|Non-cash royalty revenue related to the sales of future royalties||17,627||19,079||69,794||77,746|
|License, collaboration and other revenue||17||40||1,913||436|
|Operating costs and expenses:|
|Cost of goods sold||6,233||6,163||21,635||24,897|
|Research and development||34,740||99,614||218,323||400,269|
|General and administrative||21,939||32,142||92,333||122,844|
|Restructuring, impairment and other costs of terminated program||11,580||-||135,930||-|
|Total operating costs and expenses||74,492||137,919||468,221||548,010|
|Loss from operations||(52,469||)||(112,910||)||(376,166||)||(446,103||)|
|Non-operating income (expense):|
|Change in fair value of development derivative liability||-||(383||)||33,427||(8,023||)|
|Non-cash interest expense on liabilities related to the sales of future royalties||(7,201||)||(8,127||)||(28,911||)||(47,313||)|
|Loss on revaluation of liability related to the sale of future royalties||-||(24,410||)||-||(24,410||)|
|Interest income and other income (expense), net||3,126||181||6,667||2,569|
|Total non-operating income (expense), net||(4,075||)||(32,739||)||11,183||(77,177||)|
|Loss before provision for income taxes||(56,544||)||(145,649||)||(364,983||)||(523,280||)|
|Provision for income taxes||3,144||(4||)||3,215||557|
|Basic and diluted net loss per share||$||(0.32||)||$||(0.79||)||$||(1.97||)||$||(2.86||)|
|Weighted average shares outstanding used in computing basic and diluted net loss per share||188,237||184,964||187,138||183,298|
|CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS|
|Year ended December 31,|
|Cash flows from operating activities:|
|Adjustments to reconcile net loss to net cash used in operating activities:|
|Non-cash royalty revenue related to the sales of future royalties||(69,794||)||(77,746||)|
|Non-cash interest expense on liabilities related to the sales of future royalties||28,911||47,313|
|Loss on revaluation of liability related to the sale of future royalties||-||24,410|
|Change in fair value of development derivative liability||(33,427||)||8,023|
|Non-cash research and development expense||4,951||16,703|
|Depreciation and amortization||13,030||14,146|
|Deferred income tax expense||2,708||(102||)|
|Impairment of right-of-use asset and property, plant and equipment||65,761||-|
|(Gain) loss on sale or disposal of property, plant and equipment, net||(3,326||)||-|
|Amortization of premiums (discounts), net and other non-cash transactions||(2,435||)||6,730|
|Changes in operating assets and liabilities:|
|Operating leases, net||(2,680||)||2,340|
|Other accrued expenses||(12,734||)||(23,524||)|
|Net cash used in operating activities||(304,007||)||(412,660||)|
|Cash flows from investing activities:|
|Purchases of investments||(467,914||)||(960,689||)|
|Maturities of investments||826,229||1,166,951|
|Sales of investments||-||11,504|
|Purchases of property, plant and equipment||(5,676||)||(14,989||)|
|Sales of property, plant and equipment||13,196||-|
|Net cash provided by investing activities||365,835||202,777|
|Cash flows from financing activities:|
|Proceeds from sale of future royalties, net of $3.8 million of transaction costs||-||-|
|Repayment of senior notes||-||-|
|Cash receipts from development derivative liability||750||3,000|
|Proceeds from shares issued under equity compensation plans||758||33,238|
|Net cash provided by (used in) financing activities||1,508||36,238|
|Effect of foreign exchange rates on cash and cash equivalents||(327||)||(92||)|
|Net increase (decrease) in cash and cash equivalents||63,009||(173,737||)|
|Cash and cash equivalents at beginning of year||25,218||198,955|
|Cash and cash equivalents at end of year||$||88,227||$||25,218|
|Supplemental disclosure of cash flow information:|
|Cash paid for income taxes||$||272||$||325|
|Operating lease right-of-use assets recognized in exchange for lease liabilities||$||-||$||1,057|