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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): May 10, 2018 

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))

 

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 10, 2018, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press release (the “Press Release”) announcing its financial results for the quarter ended March 31, 2018. A copy of the Press Release is furnished herewith as Exhibit 99.1.

 

On May 3, 2018, Nektar announced that it would hold a Webcast conference call on May 10, 2018 to review its financial results for the quarter ended March 31, 2018. This conference call is accessible through a link that is posted on the home page and Investors 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 First Quarter of 2018” issued by Nektar Therapeutics on May 10, 2018.

 

 

 

 

 

 

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/ Mark A. Wilson
                  Mark A. Wilson
        General Counsel and Secretary
     
Date: May 10, 2018

 

   

 

 

 

 

Exhibit 99.1

 

Nektar Therapeutics Reports Financial Results for the First Quarter of 2018

SAN FRANCISCO, May 10, 2018 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the first quarter ended March 31, 2018.

Cash and investments in marketable securities at March 31, 2018 were $333.8 million as compared to $353.2 million at December 31, 2017. This does not include the $1.0 billion upfront payment and $850.0 million share purchase proceeds received on April 3, 2018, as a result of our new Bristol-Myers Squibb collaboration.

"Nektar begins 2018 in a very strong position with a major collaboration with Bristol-Myers Squibb for NKTR-214 and key advancements in our immuno-oncology and immunology pipeline," said Howard W. Robin, President and CEO of Nektar. "The PIVOT study of NKTR-214 in combination with nivolumab continues to enroll patients and we are exceptionally pleased that the preliminary data from PIVOT was accepted for an oral presentation at this year's ASCO Meeting. We initiated two new clinical studies this quarter, the first with our novel I-O combination of NKTR-262 and NKTR-214 and the second with our autoimmune disease candidate, NKTR-358. Based on positive preclinical results, we entered into a clinical collaboration with Takeda to evaluate NKTR-214 with their TAK-659, a SYK/FLT inhibitor. Finally, in the area of pain, we plan to submit our NDA filing for NKTR-181 this month."

Revenue in the first quarter of 2018 was $38.0 million as compared to $24.7 million in the first quarter of 2017. Revenue in the first quarter of 2018 was higher primarily because of the recognition of $10.0 million received from Shire for the approval of Adynovi in Europe.

Total operating costs and expenses in the first quarter of 2018 were $124.8 million as compared to $79.2 million in the first quarter of 2017.  Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the first quarter of 2018 was $99.4 million as compared to $61.1 million for the first quarter of 2017. R&D expense was higher in the first quarter 2018 as compared to the same period in 2017 primarily because of expenses for our pipeline programs, including the completion of Phase 3 clinical studies for NKTR-181, Phase 1/2 clinical studies of NKTR-214 and NKTR-358, initiation of the Phase 1 study of NKTR-262 in combination with NKTR-214 and IND-enabling activities for NKTR-255.

General and administrative expense was $18.7 million in the first quarter of 2018 as compared to $12.0 million in the first quarter of 2017 and increased primarily due to increased stock based compensation.

In the first quarter of 2018, net loss was $95.8 million, or $0.60 loss per share as compared to net loss of $63.9 million, or $0.42 loss per share in the first quarter of 2017. 

2018 Business Highlights

 

 

The company also announced upcoming presentations at the following scientific congresses during the second quarter of 2018:

Treg Directed Therapy for Autoimmune Disorders Meeting, Boston, MA: 

3rd Annual Advances in Immuno-Oncology Congress, London, U.K.:

American Society for Clinical Oncology (ASCO) 2018 Annual Meeting, Chicago, IL:

 

 

 

College on Problems of Drug Dependence 80th Annual Scientific Meeting (2018), San Diego, CA:

Conference Call to Discuss First Quarter 2018 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 10, 2018.

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: http://ir.nektar.com/index.cfm. The web broadcast of the conference call will be available for replay through Monday, June 11, 2018.

To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)    
Passcode: 2379326 (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 research-based development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. 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 uncertain or forward-looking statements which can be identified by words such as: "expect," "plan," "may," "will," "design," "develop," "enable" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential therapeutic benefits of and future development plans for our products (including NKTR-214, NKTR-181, NKTR-358, NKTR-262 and NKTR-255) and the timing for filing a new drug application, "NDA".  Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions and 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 and you should not rely on such statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include: (i) clinical study outcomes remain very unpredictable and it is possible that a clinical study could fail even after positive interim data is observed; (ii) the data package required for filing and approval of an NDA to the FDA is very uncertain and difficult to predict due to broad FDA regulatory discretion, and changing FDA regulatory guidelines; (iii) regulations concerning and controlling access to opioid-based pharmaceuticals are strict and it is difficult to predict which scheduling category will apply to NKTR-181 if regulatory approval is achieved; (iv) 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 (v) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2018.  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.

 

 

 

Contact:

For Investors:

Jennifer Ruddock of Nektar Therapeutics
415-482-5585

Jodi Sievers of Nektar Therapeutics
415-482-5593

For Media:

Dan Budwick of 1AB
973-271-6085
dan@1abmedia.com

 

 

 

 

NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

ASSETS  March 31, 2018   December 31, 2017(1) 
Current assets:          
Cash and cash equivalents  $34,805   $4,762 
Short-term investments   261,854    291,370 
Accounts receivable, net   15,607    5,014 
Inventory   10,675    10,726 
Other current assets   13,074    14,948 
Total current assets   336,015    326,820 
           
Long-term investments   37,157    57,088 
Property, plant and equipment, net   46,328    47,463 
Goodwill   76,501    76,501 
Other assets   789    994 
Total assets  $496,790   $508,866 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $11,375   $4,782 
Accrued compensation   15,130    8,263 
Accrued clinical trial expenses   19,790    9,461 
Other accrued expenses   10,676    10,064 
Interest payable   4,090    4,198 
Deferred revenue, current portion   19,531    18,949 
Other current liabilities   105    446 
Total current liabilities   80,697    56,163 
           
Senior secured notes, net   245,643    245,207 
Liability related to sale of future royalties, net   92,846    94,655 
Deferred revenue, less current portion   12,808    19,021 
Other long-term liabilities   6,513    5,992 
Total liabilities   438,507    421,038 
           
Commitments and contingencies          
           
Stockholders’ equity:          
Preferred stock   —    — 
Common stock   16    15 
Capital in excess of par value   2,262,219    2,207,865 
Accumulated other comprehensive loss   (2,796)   (2,111)
Accumulated deficit   (2,201,156)   (2,117,941)
Total stockholders’ equity   58,283    87,828 
Total liabilities and stockholders’ equity  $496,790   $508,866 

 

(1) The consolidated balance sheet at December 31, 2017 has been derived from the audited financial statements at that date but does not include all

 

 

 

 

NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share information)

(Unaudited)

 

   Three Months Ended March 31, 
   2018   2017 
         
Revenue:          
Product sales  $6,295   $4,756 
Royalty revenue   11,076    7,217 
Non-cash royalty revenue related to sale of future royalties   6,920    6,663 
License, collaboration and other revenue   13,727    6,092 
Total revenue   38,018    24,728 
           
Operating costs and expenses:          
Cost of goods sold   6,646    6,131 
Research and development   99,424    61,058 
General and administrative   18,687    11,976 
Total operating costs and expenses   124,757    79,165 
           
Loss from operations   (86,739)   (54,437)
           
Non-operating income (expense):          
Interest expense   (5,340)   (5,402)
Non-cash interest expense on liability related to sale of future royalties   (5,019)   (4,552)
Interest income and other income (expense), net   1,571    658 
Total non-operating expense, net   (8,788)   (9,296)
           
Loss before provision for income taxes   (95,527)   (63,733)
           
Provision for income taxes   265    133 
Net loss  $(95,792)  $(63,866)
           
Basic and diluted net loss per share  $(0.60)  $(0.42)
           
Weighted average shares outstanding used in computing basic and diluted net loss per share   160,884    153,666 

 

 

 

 

NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

   Three Months Ended March 31, 
   2018   2017 
Cash flows from operating activities:          
Net loss  $(95,792)  $(63,866)
Adjustments to reconcile net loss to net cash used in operating activities:          
Non-cash royalty revenue related to sale of future royalties   (6,920)   (6,663)
Non-cash interest expense on liability related to sale of future royalties   5,019    4,552 
Stock-based compensation   19,949    8,184 
Depreciation and amortization   2,541    4,033 
Other non-cash transactions   (370)   (731)
Changes in operating assets and liabilities:          
Accounts receivable, net   151    14,113 
Inventory   51    (1,907)
Other assets   1,853    2,134 
Accounts payable   6,492    4,117 
Accrued compensation   6,867    (6,817)
Accrued clinical trial expenses   10,329    (515)
Other accrued expenses   605    1,798 
Interest payable   (108)   (108)
Deferred revenue   (3,678)   9,619 
Other liabilities   545    (2,509)
Net cash used in operating activities   (52,466)   (34,566)
           
Cash flows from investing activities:          
Purchases of investments   —    (75,857)
Maturities of investments   37,232    58,053 
Sales of investments   11,963    8,823 
Purchases of property, plant and equipment   (985)   (4,089)
Net cash provided by (used in) investing activities   48,210    (13,070)
           
Cash flows from financing activities:          
Payment of capital lease obligations   —    (613)
Proceeds from shares issued under equity compensation plans   34,352    11,792 
Net cash provided by financing activities   34,352    11,179 
           
Effect of exchange rates on cash and cash equivalents   (53)   297 
Net increase (decrease) in cash and cash equivalents   30,043    (36,160)
Cash and cash equivalents at beginning of period   4,762    59,640 
Cash and cash equivalents at end of period  $34,805   $23,480 
           
Supplemental disclosure of cash flow information:          
Cash paid for interest  $4,952   $5,067