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Astria Therapeutics

Nektar Therapeutics Reports Fourth Quarter and Year-End 2023 Financial Results

March 04, 2024 | Last Trade: US$1.70 0.05 -2.86

SAN FRANCISCO, March 4, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Cash and investments in marketable securities at December 31, 2023, were $329.4 million as compared to $505.0 million at December 31, 2022. Nektar's cash and marketable securities are expected to support strategic development activities and operations into the third quarter of 2026.

"We believe that the progress that we have made in the past nine months puts Nektar in a strong position to advance our highly promising immunology and inflammation pipeline programs," said Howard W. Robin, President and CEO of Nektar. "We are looking forward to multiple potential value-creating data readouts for REZPEG in the first half of 2025 in both atopic dermatitis and alopecia areata. As we build our pipeline in immunology, we are also conducting IND-enabling studies for NKTR-0165, our novel agonist antibody targeting TNFR2."

Summary of Financial Results

Revenue in the fourth quarter of 2023 was $23.9 million as compared to $22.0 million in the fourth quarter of 2022. Revenue for the year ended December 31, 2023 was $90.1 million as compared to $92.1 million in 2022.

Total operating costs and expenses in the fourth quarter of 2023 were $57.4 million as compared to $74.5 million in the fourth quarter of 2022. Total operating costs and expenses for the full year 2023 were $353.8 million as compared to $468.2 million in 2022. Operating costs and expenses for both the fourth quarter and the full year 2023 decreased as compared to 2022 primarily due to decreases in research and development expenses, general and administrative expense and restructuring, impairment and costs of terminated program, partially offset by $76.5 million in non-cash goodwill impairment recorded in the first quarter of 2023.

R&D expense in the fourth quarter of 2023 was $29.9 million as compared to $34.7 million for the fourth quarter of 2022. R&D expense for the year ended December 31, 2023 was $114.2 million as compared to $218.3 million in 2022. R&D expense decreased for full year 2023 primarily due to the wind down of the bempegaldesleukin program.

G&A expense was $17.3 million in the fourth quarter of 2023 and $21.9 million in the fourth quarter of 2022. G&A expense for the full year 2023 was $77.4 million as compared to $92.3 million in 2022. G&A expense decreased for the full year 2023 primarily due to the wind down of the bempegaldesleukin program.

Restructuring, impairment and other costs of the terminated program were $2.9 million in the fourth quarter of 2023 and $52.0 million in the full year 2023, as compared to $11.6 million in the fourth quarter of 2022 and $135.9 million in the full year 2022. The full year 2023 amount includes $7.9 million in severance expense, $35.3 million in non-cash lease impairment charges, $5.5 million for clinical trial and related employee compensation costs for the wind down of the bempegaldesleukin program, and $3.3 million in other restructuring costs. The full year 2022 amount includes $30.9 million in severance expense, $65.8 million in non-cash lease impairment charges, $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 2023 was $42.1 million or $0.22 basic and diluted loss per share as compared to a net loss of $59.7 million or $0.32 basic and diluted loss per share in the fourth quarter of 2022. Net loss for the year ended December 31, 2023 was $276.1 million or $1.45 basic and diluted loss per share as compared to a net loss of $368.2 million or $1.97 basic and diluted loss per share in 2022. Excluding the $111.8 million in non-cash goodwill and other impairment charges, net loss, on a non-GAAP basis, for the full year 2023 was $164.3 million or $0.86 basic and diluted loss per share.

2023 and Recent Business Highlights

  • In March 2024, we entered into a securities purchase agreement with TCG Crossover Fund, an institutional accredited investor, to sell securities in a private placement financing for gross proceeds of approximately $30 million, before deducting expenses.
  • In December 2023, Nektar's collaborators from the Cairo Laboratory at New York Medical College presented preclinical data on NKTR-255 in combination with obinutuzumab at the 65th American Society of Hematology (ASH) Annual Meeting. NKTR-255 significantly enhanced the cytotoxicity of expanded Natural Killer (NK) cells when combined with obinutuzumab against rituximab-resistant Burkitt lymphoma (BL) cells in vitro and significantly improved the survival of mice xenografted with Raji-4RH compared to controls.
  • In October 2023, Nektar initiated a Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis. The Company expects initial data from the study in the first half of 2025.
  • In October 2023, Nektar presented data from the Phase 1b study of rezpegaldesleukin in patients with atopic dermatitis (AD) in an oral session at the 2023 European Academy of Dermatology and Venereology (EADV) Congress. Patients with moderate-to-severe AD that were treated with rezpegaldesleukin showed dose-dependent improvements in Eczema Area and Severity Index (EASI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA), and Itch Numeric Rating Scale (NRS) over 12 weeks of treatment compared to placebo, which were sustained post-treatment over an additional 36 weeks.
  • In September 2023, Nektar announced a clinical study collaboration with AbelZeta Pharma, Inc. (formerly Cellular Biomedicine Group Inc.) to evaluate NKTR-255 in combination with C-TIL051 in advanced non-small cell lung cancer (NSCLC) patients that are relapsed or refractory to anti-PD-1 therapy. Under the collaboration, AbelZeta will add NKTR-255 to its ongoing Phase 1 clinical trial being conducted at Duke Cancer Institute. Enrollment for this trial is ongoing.
  • In August 2023, Nektar announced promising new and corrected rezpegaldesleukin efficacy data which were previously reported in 2022 and inaccurately calculated by former collaborator Eli Lilly and Company. Nektar regained the full rights to rezpegaldesleukin from Eli Lilly in April 2023.
  • In April 2023, Nektar announced a strategic reprioritization and cost restructuring plan in order to enable a new focus of its pipeline on immunology and inflammation programs.

Conference Call to Discuss Fourth Quarter and Year-End 2023 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, March 4, 2024.

This press release and 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 April 5, 2024.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

About Nektar Therapeutics

Nektar Therapeutics is a biotechnology company with a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology 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: "expect," "believe," "design," "plan," "will," "develop," "advance" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for, rezpegaldesleukin and NKTR-0165, and expectations for how long our cash and marketable securities will support our development activities and operations. 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 and NKTR-0165 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin and NKTR-0165 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) NKTR-0165 is in preclinical development and rezpegaldesleukin is in clinical development, and the risk of failure is high for drug candidates at this stage of development 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 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 prior corporate restructuring and reorganization plans 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 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.

Contact:

For Investors:
Vivian Wu of Nektar Therapeutics
(628) 895-0661

For Media:
David Rosen of Argot Partners
(212) 600-1902
This email address is being protected from spambots. You need JavaScript enabled to view it. 

NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

           

ASSETS

 

December 31, 2023

 

December 31, 2022 (1)

Current assets:

        
 

Cash and cash equivalents

     

$                   35,277

 

$                   88,227

 

Short-term investments

     

268,339

 

416,750

 

Accounts receivable

     

1,205

 

5,981

 

Inventory

     

16,101

 

19,202

 

Other current assets

     

9,779

 

15,808

  

Total current assets

     

330,701

 

545,968

           

Long-term investments

     

25,825

 

-

Property, plant and equipment, net

     

18,856

 

32,451

Operating lease right-of-use assets

     

18,007

 

53,435

Goodwill

     

-

 

76,501

Other assets

     

4,644

 

2,245

  

Total assets

     

$                 398,033

 

$                 710,600

           

LIABILITIES AND STOCKHOLDERS' EQUITY

    
           

Current liabilities:

        
 

Accounts payable

     

9,848

 

12,980

 

Accrued expenses

     

22,162

 

36,557

 

Operating lease liabilities, current portion

    

19,259

 

18,667

  

Total current liabilities

     

51,269

 

68,204

           

Operating lease liabilities, less current portion

   

98,517

 

112,829

Liabilities related to the sales of future royalties, net

   

112,625

 

155,378

Other long-term liabilities

     

4,635

 

7,551

  

Total liabilities

     

267,046

 

343,962

           

Commitments and contingencies

        
           

Stockholders' equity:

        
 

Preferred stock

     

-

 

-

 

Common stock

     

19

 

19

 

Capital in excess of par value

     

3,608,137

 

3,574,719

 

Accumulated other comprehensive income (loss)

   

80

 

(6,907)

 

Accumulated deficit

     

(3,477,249)

 

(3,201,193)

  

Total stockholders' equity

     

130,987

 

366,638

 

Total liabilities and stockholders' equity

    

$                 398,033

 

$                 710,600

           

(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.

NEKTAR THERAPEUTICS

    

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    

(In thousands, except per share information)

    

(Unaudited)

    
               
        

Three months ended December 31,

 

Year ended December 31,

        

2023

 

2022

 

2023

 

2022

               

Revenue:

            
 

Product sales

     

$                     5,483

 

$                     4,379

 

$            20,681

 

$                   20,348

 

Non-cash royalty revenue related to the sales of future royalties

  

18,061

 

17,627

 

68,921

 

69,794

 

License, collaboration and other revenue

    

341

 

17

 

520

 

1,913

Total revenue

     

23,885

 

22,023

 

90,122

 

92,055

               

Operating costs and expenses:

            
 

Cost of goods sold

     

7,283

 

6,233

 

33,768

 

21,635

 

Research and development

     

29,942

 

34,740

 

114,162

 

218,323

 

General and administrative

     

17,320

 

21,939

 

77,417

 

92,333

 

Restructuring, impairment and costs of terminated program

  

2,851

 

11,580

 

51,958

 

135,930

 

Impairment of goodwill

         

76,501

 

-

Total operating costs and expenses

     

57,396

 

74,492

 

353,806

 

468,221

               
 

Loss from operations

     

(33,511)

 

(52,469)

 

(263,684)

 

(376,166)

               

Non-operating income (expense):

            
 

Change in fair value of development derivative liability

   

-

 

-

 

-

 

33,427

 

Non-cash interest expense on liabilities related to the sales of future royalties

 

(6,867)

 

(7,201)

 

(25,334)

 

(28,911)

 

Interest income

     

4,617

 

3,346

 

19,009

 

6,783

 

Other income (expense), net

     

(6,347)

 

(220)

 

(6,247)

 

(116)

Total non-operating income (expense), net

    

(8,597)

 

(4,075)

 

(12,572)

 

11,183

               

Loss before provision for income taxes

    

(42,108)

 

(56,544)

 

(276,256)

 

(364,983)

               

Provision (benefit) for income taxes

     

(29)

 

3,144

 

(200)

 

3,215

Net loss

     

$                 (42,079)

 

$                  (59,688)

 

$         (276,056)

 

$                (368,198)

               
               

Basic and diluted net loss per share

    

$                     (0.22)

 

$                      (0.32)

 

$               (1.45)

 

$                      (1.97)

               

Weighted average shares outstanding used in computing basic and diluted net loss per
share

 

191,040

 

188,237

 

190,001

 

187,138

Astria Therapeutics

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