UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

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

 

Date of report (Date of earliest event reported): November 5, 2015

 

NEKTAR THERAPEUTICS

(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))

 

 

 

Item 2.02Results of Operations and Financial Condition.

 

On November 5, 2015, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press release (the “Press Release”) announcing its financial results for the quarter ended September 30, 2015. A copy of the Press Release is furnished herewith as Exhibit 99.1.

 

On October 29, 2015, Nektar announced that it would hold a Webcast conference call on November 5, 2015 to review financial results for the quarter ended September 30, 2015. This conference call is accessible through a link that is posted on the home page and Investor Relations section of the Nektar website: http://www.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 Financial Results for the Third Quarter of 2015” issued by Nektar Therapeutics on November 5, 2015.

 

 

 

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/ Gil M. Labrucherie
    Gil M. Labrucherie
    General Counsel and Secretary
     
  Date: November 5, 2015

 

 

 

EXHIBIT INDEX

 

Exhibit
No.
  Description
   
99.1   Press release titled “Nektar Therapeutics Reports Financial Results for the Third Quarter of 2015” issued by Nektar Therapeutics on November 5, 2015.

 

 

 



Exhibit 99.1

 

Nektar Therapeutics Reports Financial Results for the Third Quarter of 2015

SAN FRANCISCO, Nov. 5, 2015 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the third quarter ended September 30, 2015.

Cash and investments in marketable securities at September 30, 2015 were $267.8 million as compared to $279.7 million at June 30, 2015. Cash and investments at September 30, 2015 include a $40.0 million milestone payment received from AstraZeneca in Q3 2015 for the first commercial sale of MOVENTIG® (naloxegol) in Germany. Cash and investments at September 30, 2015 do not include the proceeds from the $250 million direct private placement of 7.75% Senior Secured Notes due in 2020, which was closed on October 5, 2015. A portion of the proceeds from these new $250 million Senior Notes were used to redeem fully $125.0 million of 12% Senior Secured Notes due in 2017.

"We have made great progress in advancing our pipeline this year," said Howard W. Robin, President and Chief Executive Officer of Nektar. "MOVANTIK is performing very well with positive feedback from physicians and patients, ADYNOVATE is poised for approval, the NKTR-181 Phase 3 SUMMIT-07 efficacy study is enrolling ahead of schedule and we are exceptionally pleased to report that the FDA cleared the NKTR-214 IND earlier than anticipated. NKTR-214 has the potential to bring a new mechanism – direct and selective stimulation of a patient's cancer-fighting T-cells -- to the next generation of cancer immunotherapies. We expect to dose our first patients shortly at MD Anderson Cancer Center and Yale Cancer Center."

Year-to-date revenue for 2015 was $191.4 million as compared to $181.2 million in the first nine months of 2014. The increase in revenue in the first nine months of 2015 as compared to the same period in 2014 includes the recognition of $90.0 million of the $100.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in the U.S. and the recognition of the $40.0 million milestone payment from AstraZeneca following the first commercial sale of MOVANTIK in a major European country. In addition, product sales and royalty revenue increased by $9.3 million in the first nine months of 2015 as compared to the same period in 2014. Revenue in the third quarter of 2015 was $60.0 million as compared to $132.9 million in the third quarter of 2014 due to the recognition of a one-time $105 million approval milestone for MOVANTIK in the third quarter of 2014.

Total operating costs and expenses in the third quarter of 2015 were $59.5 million as compared to $52.6 million in the third quarter of 2014. Year-to-date total operating costs and expenses in 2015 were $191.4 million as compared to $160.2 million for the same period in 2014. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2015 was $43.2 million as compared to $34.2 million in the third quarter of 2014. Year-to-date R&D expense for 2015 was $135.7 million as compared to $109.2 million for the same period in 2014. R&D expense was higher in the third quarter and first nine months of 2015 as compared to the same periods in 2014 primarily due to the initiation of the Phase 3 efficacy trial of NKTR-181 in chronic low back pain and the long-term safety study for NKTR-181. R&D expense for the first nine months of 2015 also increased as a result of IND-enabling and clinical study start-up activities for NKTR-214.

General and administrative expense was $9.5 million in the third quarter of 2015 as compared to $9.1 million in the third quarter of 2014. G&A expense in the first nine months of 2015 was $30.0 million as compared to $28.7 million for the same period in 2014.

Net loss in the third quarter of 2015 was $8.2 million or $0.06 net loss per diluted share as compared to net income of $70.6 million or $0.53 net income per diluted share in the third quarter of 2014. Net loss in the first nine months of 2015 was $27.0 million or $0.21 net loss per diluted share as compared to net loss of $8.2 million or $0.07 net loss per diluted share in the first nine months of 2014.

 

 

The company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2015:

Society for Immunotherapy in Cancer (SITC) 30th Anniversary Annual Meeting, National Harbor, MD:

Abstract Title: "Synergistic antitumor activity of the CD122-biased immunostimulatory cytokine NKTR-214 when combined with anti-PD-1 in murine tumor models", Hoch, U., et al.
oDate: November 6, 2015, 12:45 p.m. — 2:00 p.m. Eastern Time

2015 San Antonio Breast Cancer Symposium, San Antonio, TX:

Poster P1-13-02: "Early change in topoisomerase 1 (Top1) positive circulating tumor cells (CTCs) is associated with overall survival (OS) in patients with advanced breast cancer after treatment with etirinotecan pegol", Rugo, H., et al.
oPoster Session: Advanced Chemotherapy
oDate: December 9, 2015, 5:00 p.m. – 7:00 p.m. Central Time
Poster P4-11-08: "Impact of treatment on quality of life (QOL) in the BEACON study, a randomized phase III trial of etirinotecan pegol (EP) versus Treatment of Physician's Choice (TPC) in patients (pts) with advanced breast cancer (aBC) whose disease has progressed following treatment with an Anthracycline, a Taxane and Capecitabine", Cortes, J., et al.
oPoster Session: "Psychosocial, Quality of Life, and Educational Aspects: Psychosocial, QOL, and Educational Aspects -- Other"
oDate: December 11, 2015, 7:30 a.m. — 9:00 a.m. Central Time

Conference Call to Discuss Third Quarter 2015 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 today, Thursday, November 5, 2015.

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 Investor Relations section of the Nektar website: http://www.nektar.com. The web broadcast of the conference call will be available for replay through Monday, December 7, 2015.

To access the conference call, follow these instructions:

Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 65851649 (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 Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call.

About Nektar

Nektar Therapeutics has a robust R&D pipeline in pain, oncology, hemophilia and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for MOVANTIK™ (naloxegol), the first FDA-approved once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. The product is also approved in the European Union as MOVENTIG® (naloxegol) and is indicated for adult patients with OIC who have had an inadequate response to laxatives. The AstraZeneca agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of MOVANTIK and an opioid. NKTR-181, a wholly-owned mu-opioid analgesic molecule for chronic pain conditions, is in Phase 3 development. In hemophilia, ADYNOVATE™ [Antihemophilic Factor (Recombinant)], a longer-acting PEGylated Factor VIII therapeutic has been filed for approval in the U.S. by partner Baxalta Inc. In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia.

 

 

Nektar's technology has enabled nine approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including AstraZeneca's MOVANTIK™, UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia.

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.

MOVANTIK™ is a trademark and MOVENTIG® is a registered trademark of the AstraZeneca group of companies.

ADYNOVATE is a trademark of Baxalta Inc.

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential of MOVANTIK, the enrollment status of the SUMMIT-07 efficacy study of NKTR-181, the projected time-frame for dosing the first patient in the clinical program for NKTR-214, Baxalta's regulatory expectations for ADYNOVATE, and the value and potential of our polymer conjugate technology and research and development pipeline. 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) the commercial potential of a new drug at the early stages of commercial launch, such as MOVANTIK, is difficult to predict and will have a significant impact on our future results of operation and financial condition; (ii) the timing of the commencement or end of clinical trials and the commercial launch of our drug candidates and those of our partners may be delayed or unsuccessful due to regulatory delays, institutional review board review and approvals, 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; (iii) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of our technology platform to potential new drug candidates is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (iv) patents may not issue from our patent applications for our drugs (including MOVANTIK and ADYNOVATE) and drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (v) the outcome of any existing or future intellectual property or other litigation related to our drugs and drug candidates and those of our collaboration partners including MOVANTIK and ADYNOVATE. Other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2015. 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.

Nektar Investor Inquiries:  
Jennifer Ruddock/Nektar Therapeutics (415) 482-5585
Susie Kim/Argot Partners (212) 600-1902
Nektar Media Inquiries:  
Nadia Hasan/BrewLife (212) 257-6738

 

 

 

 

NEKTAR THERAPEUTICS

 
CONDENSED CONSOLIDATED BALANCE SHEETS  
(In thousands)  
(Unaudited)  

   

           
ASSETS   September 30, 2015    December 31,
2014
(1)
Current assets:          
Cash and cash equivalents  $18,819   $12,365 
Short-term investments   249,000    225,459 
Accounts receivable, net   2,966    3,607 
Inventory   10,352    12,952 
Restricted cash   —      25,000 
Other current assets   5,214    8,817 
Total current assets   286,351    288,200 
           
Property, plant and equipment, net   72,532    70,368 
Goodwill   76,501    76,501 
Other assets   13,862    6,552 
Total assets  $449,246   $441,621 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
           
Current liabilities:          
Accounts payable  $2,279   $2,703 
Accrued compensation   12,805    5,749 
Accrued clinical trial expenses   11,102    7,708 
Other accrued expenses   16,561    6,418 
Interest payable   3,167    6,917 
Capital lease obligations, current portion   5,883    4,512 
Deferred revenue, current portion   20,611    24,473 
Senior secured notes, current portion   125,000    —   
Other current liabilities   10,690    5,567 
Total current liabilities   208,098    64,047 
           
Senior secured notes, less current portion   —      125,000 
Capital lease obligations, less current portion   1,335    4,139 
Liability related to sale of future royalties   121,147    120,471 
Deferred revenue, less current portion   68,941    76,911 
Other long-term liabilities   10,672    14,721 
Total liabilities   410,193    405,289 
           
Commitments and contingencies          
           
Stockholders' equity:          
Preferred stock   —      —   
Common stock   13    13 
Capital in excess of par value   1,854,210    1,824,195 
Accumulated other comprehensive loss   (1,821)   (1,567)
Accumulated deficit   (1,813,349)   (1,786,309)
Total stockholders' equity   39,053    36,332 
Total liabilities and stockholders' equity  $449,246   $441,621 
           

  

 
(1) The consolidated balance sheet at December 31, 2014 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  Nine Months Ended
   September 30,  September 30,
   2015  2014  2015  2014
             
             
Revenue:                    
Product sales and royalty revenue  $7,427   $6,172   $27,239   $17,980 
Non-cash royalty revenue related to sale of future royalties   6,050    6,143    14,752    16,753 
License, collaboration and other revenue   46,475    120,556    149,423    146,422 
Total revenue   59,952    132,871    191,414    181,155 
                     
Operating costs and expenses:                    
Cost of goods sold   6,760    9,220    25,738    22,235 
Research and development   43,229    34,200    135,652    109,240 
General and administrative   9,544    9,130    30,031    28,677 
Total operating costs and expenses   59,533    52,550    191,421    160,152 
                     
Income (loss) from operations   419    80,321    (7)   21,003 
                     
Non-operating income (expense):                    
Interest expense   (4,202)   (4,391)   (12,491)   (13,412)
Non-cash interest expense on liability related to sale of future royalties   (5,226)   (5,203)   (15,428)   (15,725)
Interest income and other income (expense), net   898    126    1,355    535 
Total non-operating expense, net   (8,530)   (9,468)   (26,564)   (28,602)
                     
Income (loss) before provision for income taxes   (8,111)   70,853    (26,571)   (7,599)
                     
Provision for income taxes   92    248    469    634 
Net income (loss)  $(8,203)  $70,605   $(27,040)  $(8,233)
                     
Net income (loss) per share:                    
Basic  $(0.06)  $0.55   $(0.21)  $(0.07)
                     
Diluted  $(0.06)  $0.53   $(0.21)  $(0.07)
                     
Weighted average shares outstanding used in computing net income (loss) per share                    
Basic   132,631    127,504    131,882    126,043 
                     
Diluted   132,631    132,177    131,882    126,043 
                     

 

 

 

 

NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)

 

   Nine Months Ended September 30,
   2015  2014
Cash flows from operating activities:          
Net loss  $(27,040)  $(8,233)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:          
Non-cash royalty revenue related to sale of future royalties   (14,752)   (16,753)
Non-cash interest expense on liability related to sale of future royalties   15,428    15,725 
Stock-based compensation   14,499    12,647 
Depreciation and amortization   9,109    9,733 
Other non-cash transactions   (1,448)   313 
Changes in operating assets and liabilities:          
Accounts receivable, net   641    (43,845)
Inventory   2,600    1,757 
Other assets   3,843    679 
Accounts payable   (525)   (3,670)
Accrued compensation   7,056    (501)
Accrued clinical trial expenses   3,394    (7,262)
Other accrued expenses   949    1,667 
Interest payable   (3,750)   (3,750)
Deferred revenue   (11,832)   1,480 
Liability related to receipt of refundable milestone payment   —      (70,000)
Other liabilities   3,854    (7,366)
Net cash provided by (used in) operating activities   2,026    (117,379)
           
Cash flows from investing activities:          
Maturities of investments   155,683    171,826 
Purchases of investments   (202,870)   (200,160)
Sales of investments   23,778    21,661 
Release of restricted cash   25,000    —   
Purchases of property, plant and equipment   (8,722)   (6,090)
Net cash used in investing activities   (7,131)   (12,763)
           
Cash flows from financing activities:          
Payment of capital lease obligations   (3,798)   (2,578)
Repayment of proceeds from sale of future royalties   —      (7,000)
Issuance of common stock, net of issuance costs   —      116,536 
Proceeds from shares issued under equity compensation plans   15,516    16,168 
Net cash provided by financing activities   11,718    123,126 
           
Effect of exchange rates on cash and cash equivalents   (159)   (43)
Net increase (decrease) in cash and cash equivalents   6,454    (7,059)
Cash and cash equivalents at beginning of period   12,365    39,067 
Cash and cash equivalents at end of period  $18,819   $32,008 
           
Supplemental disclosure of cash flow information:          
Cash paid for interest  $16,095   $16,487 
           
Supplemental schedule of non-cash investing and financing activities:          
Accrued debt issuance costs  $8,503   $—   
           

 


 

 

 

 

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