EX-99.1 2 s105445_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

Nektar Therapeutics Reports Fourth Quarter and Year-End 2016 Financial Results

 

SAN FRANCISCO, March 1, 2017 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the fourth quarter and year ended December 31, 2016.

 

Cash and investments in marketable securities at December 31, 2016 were $389.1 million as compared to $308.9 million at December 31, 2015.

 

“Nektar begins 2017 in a strong position with highly promising wholly-owned immuno-oncology and immunology clinical programs and several important data readouts expected throughout this year,” said Howard W. Robin, President and Chief Executive Officer of Nektar. “Our Phase 1/2 study evaluating NKTR-214 as a potential combination treatment regimen with Opdivo® in collaboration with Bristol-Myers Squibb is proceeding nicely. We plan to report initial data from the dose-escalation part of the study in the middle of this year.  Later this month, we will have data from our Phase 3 efficacy study of NKTR-181 in patients with chronic low back pain.  Finally, we are pleased that we will initiate a first-in-human trial shortly for NKTR-358, our proprietary T regulatory cell stimulator, which has the potential to become a first-in-class resolution therapeutic for a wide range of immune disorders.”

 

Summary of Financial Results

 

Revenue for the fourth quarter of 2016 was $37.5 million as compared to $39.4 million in the fourth quarter of 2015.

 

Revenue for the year ended December 31, 2016 was $165.4 million as compared to $230.8 million in 2015. Revenue in 2016 included recognition of $31.0 million from AstraZeneca as a result of its sublicense of MOVENTIG® (naloxegol) to Kyowa Kirin in Europe.  In addition, product sales, royalty revenue, and non-cash royalty revenue increased in 2016 compared to 2015.  Revenue in 2015 included recognition of a total of $130.0 million of milestone payments from AstraZeneca following the first commercial sale of MOVANTIK® in the U.S. in Q1 2015 and the first commercial sale of MOVENTIG in the EU in Q3 2015. 

 

Total operating costs and expenses in the fourth quarter of 2016 were $69.6 million as compared to $68.7 million in the fourth quarter of 2015. Total operating costs and expenses increased primarily as a result of higher research and development (R&D) expense.  Total operating costs and expenses for the year ended December 31, 2016 were $278.3 million as compared to $260.2 million in 2015.

 

R&D expense in the fourth quarter of 2016 was $50.2 million as compared to $47.1 million for the fourth quarter of 2015.  R&D expense for the year ended December 31, 2016 was $203.8 million as compared to $182.8 million in 2015. R&D expense increased primarily due to expenses for our NKTR-214 and NKTR-358 programs.

 

General and administrative (G&A) expense was $12.8 million in the fourth quarter of 2016 as compared to $13.2 million in the fourth quarter of 2015.  G&A expense for the year ended December 31, 2016 was $44.3 million as compared to $43.3 million in 2015.

 

Net loss for the fourth quarter of 2016 was $42.2 million or $0.28 loss per share as compared to a net loss of $54.1 million or $0.40 loss per share in the fourth quarter of 2015.  Net loss for the year ended December 31, 2016 was $153.5 million or $1.10 loss per share as compared to a net loss of $81.2 million or $0.61 loss per share in 2015.

 

2016 and Year-to-Date Business Highlights

 

Nektar Wholly-Owned Programs

 

·In February 2017, Nektar submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-358, a new biologic designed to treat autoimmune disease. Clinical trials are planned for NKTR-358 in patients with systemic lupus erythematous (SLE) and other indications.
·In February 2017, Nektar announced positive data from the Phase 1 dose-escalation study of single-agent NKTR-214 in patients with renal cell carcinoma at the ASCO 2017 Genitourinary Cancers Symposium. Clinical benefit and safety data presented included 40% of RCC patients experiencing tumor reductions including one patient with a partial response and a favorable safety and tolerability profile.
·In January 2017, Nektar announced a new immuno-oncology candidate, NKTR-262, a small molecule agonist that targets toll-like receptors (TLRs) found on innate immune cells in the body. NKTR-262 is being developed as a single intra-tumoral injection to be administered at the start of therapy with NKTR-214. The company plans to file an IND for NKTR-262 by the end of 2017.
·In December 2016, Nektar initiated a pivotal human abuse liability (HAL) trial for its novel opioid molecule NKTR-181, which is expected to complete in the middle of 2017.

 

 

 

·In November 2016, Nektar announced positive data from the Phase 1 dose-escalation study of single-agent NKTR-214 at the Society of Immunotherapy of Cancer Annual Meeting. Results showed encouraging anti-tumor activity including one patient with a partial response and a favorable safety and tolerability profile.
·In September 2016, Nektar and Bristol-Myers Squibb entered into a clinical collaboration to develop NKTR-214 as a potential combination treatment regimen with Bristol-Myers Squibb’s Opdivo® (nivolumab) in five tumor types and eight potential indications. The dose-escalation part of the trial is underway with initial data expected in the middle of 2017.

 

Additional Pipeline and Partner Developments

 

·In December 2016, Shire announced that the U.S. Food and Drug Administration (FDA) approved ADYNOVATE® ([Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. The FDA also approved ADYNOVATE for use in surgical settings for both adult and pediatric patients. ADYNOVATE is under regulatory review in Europe, Switzerland and Canada.
·In September 2016, Bayer presented positive Phase 3 data for Ciprofloxacin DPI at the 26th International Congress of European Respiratory Society. The RESPIRE 1 study assessed the safety and efficacy of Cipro DPI in NCFB patients and met both primary endpoints for the every 14-day dosing arm. The second Phase 3 trial (RESPIRE 2) completed recruitment in September 2016 and data are expected to be released by our partner Bayer in 2017.
·In June 2016, Nektar entered into a partnership with Daiichi Sankyo Europe for Nektar’s investigational drug therapy, ONZEALD™ (etirinotecan pegol, NKTR-102), which has completed a Phase 3 clinical trial (the BEACON study) in patients with advanced breast cancer. The agreement grants Daiichi Sankyo Europe exclusive rights to market ONZEALD in Europe (EEA), Switzerland and Turkey. Nektar Therapeutics retained rights to ONZEALD in the United States and the rest of the world. Under the terms of the agreement, Nektar is entitled to milestones and significant double-digit royalties on net sales in Europe.
·In June 2016, Nektar submitted a filing for a Marketing Authorization Agreement (MAA) with the European Medicines Agency for conditional approval for ONZEALD in patients with advanced breast cancer and brain metastases. An opinion from the European CHMP on conditional approval of ONZEALD is expected in the first half of 2017.
·Amikacin Inhale, our second anti-infective Phase 3 program partnered with Bayer, which is being developed for gram-negative pneumonia, is expected to complete in Q2 of 2017. Nektar and Bayer expect to report topline results from this program in the middle of 2017.

 

Conference Call to Discuss Fourth Quarter and Year-End 2016 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, Wednesday, March 1, 2017.

 

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://www.nektar.com. The web broadcast of the conference call will be available for replay through Monday, April 3, 2017.

 

To access the conference call, follow these instructions:

 

Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 75461730 (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 Therapeutics
Nektar Therapeutics is a research-based 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.

 

 

 

MOVANTIK™ is a trademark and MOVENTIG® is a registered trademark of the AstraZeneca group of companies.
ADYNOVATE® is a registered trademark of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc.
ONZEALD™ is a trademark of Nektar Therapeutics.
Opdivo® is a registered trademark of Bristol-Myers Squibb.

 

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which 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 timing of the availability of Phase 3 data for our NKTR-181 efficacy study and for our partnered programs with Bayer, the timing of the European CHMP decision for conditional approval of ONZEALD, the timing of the availability of data for the dose-escalation study for NKTR-214 in combination with Opdivo, the future clinical development plans for our products (including NKTR-358 and NKTR-262), the timing of availability of future clinical results, the timing of planned regulatory filings, the potential of NKTR-214 in combination with other immunotherapy agents including Bristol-Myers Squibb’s Opdivo (nivolumab), the timing of the completion of the NKTR-181 HAL study, and the potential of our technology and drug candidates in our 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) clinical study outcomes, including the Phase 3 clinical study outcome of NKTR-181, remain very unpredictable and it is possible that a clinical study could fail due to efficacy, safety or other important clinical findings; (ii) the CHMP and FDA have substantial discretion as to whether to grant marketing approval for pharmaceutical products (including ONZEALD and those of our partners) and the decisions from these regulatory authorities are difficult to predict and these decisions have significant financial consequences; (iii) NKTR-214 is in early-stage clinical development and there are substantial risks that can unexpectedly occur for numerous reasons including negative safety and efficacy findings in the ongoing Phase 1 clinical study notwithstanding positive findings in preclinical studies; (iv) our drug candidates and those of our collaboration partners 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 for numerous reasons including negative safety and efficacy findings even after positive findings in previous preclinical and clinical studies; (v) 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; (vi) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-181, NKTR-214 and NKTR-358) is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (vii) patents may not issue from our patent applications for our drug candidates including NKTR-181 and NKTR-214, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (viii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K for the year ended December 31, 2016 filed with the Securities and Exchange Commission on March 1, 2017. 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: 
Jennifer Ruddock of Nektar Therapeutics
415-482-5585

 

Jodi Sievers of Nektar Therapeutics
415-482-5593

 

For Media: 
Dan Budwick of Pure Communications
973-271-6085
dan@purecommunicationsinc.com

 

 

 

NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

   December 31, 2016 (1)   December 31, 2015 (1) 
ASSETS          
Current assets:          
Cash and cash equivalents  $59,640   $55,570 
Short-term investments   329,462    253,374 
Accounts receivable, net   15,678    19,947 
Inventory   11,109    11,346 
Other current assets   10,363    9,814 
Total current assets   426,252    350,051 
           
Property, plant and equipment, net   65,601    71,336 
Goodwill   76,501    76,501 
Other assets   517    754 
Total assets  $568,871   $498,642 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $2,816   $2,363 
Accrued compensation   18,280    5,998 
Accrued clinical trial expenses   7,958    8,220 
Other accrued expenses   4,711    4,156 
Interest payable   4,198    4,198 
Capital lease obligations, current portion   2,908    4,756 
Liability related to refundable upfront payment   12,500    - 
Deferred revenue, current portion   14,352    21,428 
Other current liabilities   4,499    10,127 
Total current liabilities   72,222    61,246 
           
Senior secured notes, net   243,464    241,699 
Capital lease obligations, less current portion   2,223    1,073 
Liability related to the sale of future royalties, net   105,950    116,029 
Deferred revenue, less current portion   51,887    62,426 
Other long-term liabilities   5,000    9,740 
Total liabilities   480,746    492,213 
           
Commitments and contingencies          
           
Stockholders’ equity:          
Preferred stock   -    - 
Common stock   15    13 
Capital in excess of par value   2,111,483    1,876,072 
Accumulated other comprehensive loss   (2,363)   (2,170)
Accumulated deficit   (2,021,010)   (1,867,486)
Total stockholders’ equity   88,125    6,429 
Total liabilities and stockholders’ equity  $568,871   $498,642 

 

(1) The consolidated balance sheets at December 31, 2016 and 2015 have been derived from the audited financial statements at those dates but do 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, 
   2016   2015   2016 (1)   2015 (1) 
                 
Revenue:                    
Product sales  $13,690   $13,973   $55,354   $40,155 
Royalty revenue   6,392    1,910    19,542    2,967 
Non-cash royalty revenue related to sale of future royalties   7,817    7,306    30,158    22,058 
License, collaboration and other revenue   9,553    16,181    60,382    165,604 
Total revenue   37,452    39,370    165,436    230,784 
                     
Operating costs and expenses:                    
Cost of goods sold   6,604    8,364    30,215    34,102 
Research and development   50,232    47,135    203,801    182,787 
General and administrative   12,760    13,235    44,275    43,266 
Total operating costs and expenses   69,596    68,734    278,291    260,155 
                     
Loss from operations   (32,144)   (29,364)   (112,855)   (29,371)
                     
Non-operating income (expense):                    
Interest expense   (5,550)   (5,791)   (22,468)   (18,282)
Non-cash interest expense on liability related to sale of future royalties   (4,783)   (5,191)   (19,712)   (20,619)
Loss on extinguishment of debt   -    (14,079)   -    (14,079)
Interest income and other income (expense), net   721    325    2,387    1,680 
Total non-operating expense, net   (9,612)   (24,736)   (39,793)   (51,300)
                     
Loss before provision for income taxes   (41,756)   (54,100)   (152,648)   (80,671)
                     
Provision for income taxes   443    37    876    506 
Net loss  $(42,199)  $(54,137)  $(153,524)  $(81,177)
                     
Basic and diluted net loss per share  $(0.28)  $(0.40)  $(1.10)  $(0.61)
                     
Weighted average shares outstanding used in computing basic and diluted net loss per share   149,071    134,166    139,596    132,458 

 

(1) The consolidated statements of operations for the years ended December 31, 2016 and 2015 have been derived from the audited financial statements as of those dates but do 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 CASH FLOWS

(In thousands)

(Unaudited)

 

   Year Ended December 31, 
   2016 (1)   2015 (1) 
Cash flows from operating activities:          
Net loss  $(153,524)  $(81,177)
Adjustments to reconcile net loss to net cash used in operating activities:          
Non-cash royalty revenue related to sale of future royalties   (30,158)   (22,058)
Non-cash interest expense on liability related to sale of future royalties   19,712    20,619 
Stock-based compensation   25,850    19,669 
Depreciation and amortization   15,351    12,855 
Loss from redemption premium and incremental interest on 12% senior secured notes   -    12,500 
Write-off of deferred financing costs on 12% senior secured notes   -    1,579 
Other non-cash transactions   (2,185)   (2,365)
Changes in operating assets and liabilities:          
Accounts receivable, net   4,269    (16,340)
Inventory   237    1,606 
Other assets   (312)   (825)
Accounts payable   518    (412)
Accrued compensation   12,282    249 
Accrued clinical trial expenses   (262)   512 
Other accrued expenses   191    (2,278)
Interest payable   -    (2,719)
Liability related to refundable upfront payment   12,500    - 
Deferred revenue   (17,615)   (17,530)
Other liabilities   (3,878)   3,032 
Net cash used in operating activities   (117,024)   (73,083)
           
Cash flows from investing activities:          
Purchases of investments   (334,659)   (297,608)
Maturities of investments   253,682    226,923 
Sales of investments   4,969    42,544 
Release of restricted cash   -    25,000 
Purchases of property, plant and equipment   (6,392)   (11,195)
Net cash used in investing activities   (82,400)   (14,336)
           
Cash flows from financing activities:          
Payment of capital lease obligations   (5,945)   (5,187)
Issuance of common stock, net of issuance costs   189,276    - 
Proceeds from shares issued under equity compensation plans   20,287    32,208 
Proceeds from issuance of 7.75% senior secured notes, net of issuance costs   -    241,262 
Repayment of 12% senior secured notes   -    (125,000)
Payment of redemption premium and incremental interest on 12% senior secured notes   -    (12,500)
Net cash provided by financing activities   203,618    130,783 
           
Effect of exchange rates on cash and cash equivalents   (124)   (159)
Net increase in cash and cash equivalents   4,070    43,205 
Cash and cash equivalents at beginning of period   55,570    12,365 
Cash and cash equivalents at end of period  $59,640   $55,570 
           
Supplemental disclosure of cash flow information:          
Cash paid for interest  $20,589   $20,225 
Cash paid for income taxes  $757   $860 

 

(1) The consolidated statements of cash flows for the years ended December 31, 2016 and 2015 have been derived from the audited financial statements as of those dates but do not include all of the information and notes required by generally accepted accounting principles in the United States for complete financial statements.