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): March 1, 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 March 1, 2018, 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, 2017. A copy of the Press Release is furnished herewith as Exhibit 99.1.

 

On February 21, 2018, Nektar announced that it would hold a Webcast conference call on March 1, 2018 to review its financial results for the quarter and year ended December 31, 2017. 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 Fourth Quarter and Year-End 2017 Financial Results” issued by Nektar Therapeutics on March 1, 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: March 1, 2018

 

 

Exhibit 99.1 

 

Nektar Therapeutics Reports Fourth Quarter and Year-End 2017 Financial Results

 

SAN FRANCISCO, March 1, 2018 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the fourth quarter and year ended December 31, 2017.

 

Cash and investments in marketable securities at December 31, 2017 were $353.2 million as compared to $389.1 million at December 31, 2016. This does not include $1.85 billion in upfront payments from the new Bristol-Myers Squibb collaboration, which was announced on February 14, 2018.

 

“This past year was truly transformational for Nektar as we achieved a number of successes with Nektar medicines across our three key therapeutic areas of immuno-oncology, immunology and pain,” said Howard W. Robin, President and Chief Executive Officer of Nektar. “In the area of pain, we completed a successful Phase 3 program for NKTR-181 in over 2,100 patients and healthy volunteers that will comprise our NDA submission in the second quarter of this year. In immunology, we entered into a major partnership with Eli Lilly for NKTR-358, a potential first-in-class T regulatory resolution therapeutic, which will be developed to treat a broad range of auto-immune disorders. Finally, in immuno-oncology, the clinical success we achieved with NKTR-214 led to a groundbreaking collaboration with Bristol-Myers Squibb that now enables us to broadly and rapidly advance NKTR-214 into over 20 registrational trials in up to 15,000 patients.”

 

Summary of Financial Results

 

Revenue for the fourth quarter of 2017 was $95.5 million as compared to $37.5 million in the fourth quarter of 2016. Revenue in the fourth quarter of 2017 included a total of $60.0 million of non-recurring revenue related to a new sublicense agreement, a contract settlement agreement and the recognition of deferred revenue from several collaboration agreements.

 

Revenue for the year ended December 31, 2017 was $307.7 million as compared to $165.4 million in 2016. Revenue in 2017 included recognition of $130.1 million of the $150.0 million upfront payment from Nektar’s collaboration with Eli Lilly & Company for the development and commercialization of NKTR-358.

 

Total operating costs and expenses in the fourth quarter of 2017 were $119.5 million as compared to $69.6 million in the fourth quarter of 2016. 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, 2017 were $367.4 million as compared to $278.3 million in 2016.

 

R&D expense in the fourth quarter of 2017 was $81.4 million as compared to $50.2 million for the fourth quarter of 2016. R&D expense for the year ended December 31, 2017 was $268.5 million as compared to $203.8 million in 2016. R&D expense was higher in 2017 as compared to 2016 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, and IND-enabling activities for NKTR-262 and NKTR-255.

 

General and administrative (G&A) expense was $12.3 million in the fourth quarter of 2017 as compared to $12.8 million in the fourth quarter of 2016. G&A expense for the year ended December 31, 2017 was $52.4 million as compared to $44.3 million in 2016.

 

Net loss for the fourth quarter of 2017 was $33.8 million or $0.21 loss per share as compared to a net loss of $42.2 million or $0.28 loss per share in the fourth quarter of 2016. Net loss for the year ended December 31, 2017 was $96.7 million or $0.62 loss per share as compared to a net loss of $153.5 million or $1.10 loss per share in 2016.

 

 

 

 

2017 and Year-to-Date Business Highlights

 

In February 2018, Nektar and Bristol-Myers Squibb entered into a global development and commercialization agreement to evaluate the full potential of NKTR-214 plus Opdivo® (nivolumab) in more than 20 indications in 9 tumor types including melanoma, renal cell carcinoma, non-small cell lung cancer, bladder and triple negative breast cancer. The first pivotal studies in melanoma and renal cell carcinoma are expected to be initiated in mid-2018.

In December 2017, Nektar submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-262, a small molecule agonist that targets toll-like receptors (TLRs) found on innate immune cells in the body. The REVEAL Phase 1/2 study will evaluate the safety, tolerability and anti-tumor effect of NKTR-262, administered in combination with NKTR-214 (doublet) and in combination with NKTR-214 and nivolumab (triplet), in patients with locally advanced or metastatic cancers. The company plans to enroll the first patients in the REVEAL study in March of 2018.

In November 2017, Nektar announced positive data from the dose-escalation stage of the PIVOT-02 study of NKTR-214 in combination with Opdivo at the 2017 SITC conference. Results showed compelling response rates and favorable safety data in both PD-L1 negative and PD-L1 positive patients with melanoma, renal cell carcinoma and non-small cell lung cancer.

In September 2017, Nektar initiated the PROPEL clinical study to evaluate the efficacy and safety of NKTR-214 in combination with approved checkpoint inhibitors, TECENTRIQ®(atezolizumab) and KEYTRUDA® (pembrolizumab) in patients with bladder and non-small cell lung cancer. Data from the PROPEL study is expected in the second half of 2018.

In July 2017, Nektar and Eli Lilly announced a strategic collaboration to develop and commercialize NKTR-358, a potential first-in-class resolution therapeutic, that addresses an underlying immune system imbalance in patients with auto-immune conditions. A Phase 1 singe-ascending dose study is underway and a Phase 1/2 multiple-ascending dose study of NKTR-358 in patients with lupus is planned to begin in the second quarter of 2018.

In July 2017, Nektar announced positive results from a Human Abuse Potential (HAP) study of NKTR-181, a first-in-class opioid analgesic.

In May 2017, Nektar announced a new research collaboration with Takeda to explore the combination of NKTR-214 with five oncology compounds from Takeda’s cancer portfolio including a SYK-inhibitor and a proteasome inhibitor.

In March 2017, Nektar announced positive results from the SUMMIT-07 Phase 3 efficacy study of NKTR-181 in over 600 patients with chronic low back pain. The primary efficacy endpoint of the study demonstrated significantly improved chronic back pain relief with NKTR-181 compared to placebo (p=0.0019). Key secondary endpoints of the study also achieved high statistical significance. The study demonstrated that NKTR-181 had a favorable safety profile and was well tolerated.

 

The company also announced upcoming presentations at the following scientific congresses during the first half of 2018:

 

American Association for Cancer Research (AACR) Annual Meeting 2018, Chicago, IL:

 

Abstract 3755/Poster 5: Comprehensive antitumor immune activation by a novel TLR7/8 targeting agent NKTR-262 combined with CD122-biased immunostimulatory cytokine NKTR-214”, Kivimae, S., et al.

Session: Immunology: Immunomodulatory Agents and Interventions 1

Session Date and Time: Tuesday, April 17, 2018, 8:00 a.m. - 12:00 p.m. Central Time

Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Abstract 2755/Poster 17: “NKTR-262: Prodrug pharmacokinetics in mice, rats, and dogs”, Lee, M., et al.

Session: Immunology: Immune Mechanisms Invoked by Therapies 1

Session Date and Time: Monday, April 16, 2018, 1:00 p.m. - 5:00 p.m. Central Time

Location: McCormick Place South, Exhibit Hall A, Poster Section 33

Abstract 123/Poster 13: “Enhanced anti-tumor activity of the combination of entinostat and NKTR-214 in renal and colon cancer tumor models”, Wang, L., et al.

Session: Tumor Biology: Role of the Innate Immune System in Tumorigenesis

Session Date and Time: Sunday, April 15, 2018, 1:00 p.m. - 5:00 p.m. Central Time

Location: McCormick Place South, Exhibit Hall A, Poster Section 5

Abstract 3566/Poster 4: “Enhanced expansion and tumor targeting of adoptively transferred T cells with NKTR-214”, Parisi, G., et al.

Session: Clinical Research: Adoptive Cell Therapy 3

Session Date and Time: Tuesday, April 17, 2018, 8:00 a.m. - 12:00 p.m. Central Time

Location: McCormick Place South, Exhibit Hall A, Poster Section 24

 

 

 

 

Antigen-Specific Immune Tolerance Drug Development Summit 2018, Boston, MA:

 

Preclinical Data Presentation: “NKTR-358: A Selective Regulatory T Cell Inducing Agent for the Treatment of Autoimmune and Inflammatory Diseases”

Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics

Date and Time: Wednesday, April 25, 2018, 4:20 p.m. Eastern Time

 

American Academy of Pain Medicine 34th Annual Meeting, Vancouver, BC:

 

Poster: “Efficacy, safety, and tolerability of NKTR-181 in patients with moderate to severe chronic low-back pain: A Phase 3 study”

Presenter: John Markman, M.D., University of Rochester Medical Center

Session: Poster Session 2

Date and Time: Friday, April 27, 2018, 6:00 p.m. Pacific Time

Poster: “Measuring withdrawal in a phase 3 study of a new analgesic, NKTR-181, in subjects with moderate-to-severe chronic low-back pain”

Presenter: Jack Henningfield, Ph.D., Pinney Associates

Session: Poster Session 2

Date: Friday, April 27, 2018, 6:00 p.m. Pacific Time

 

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

 

Preclinical Data Presentation: “NKTR-358: An IL-2 Pathway Agonist that Selectively Expands and Activates Regulatory T cells for the Treatment of Allergy and Autoimmune Disease”

Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics

Session: Enhanced Treg-based therapy with the use of IL-2

Date and Time:  Wednesday, May 23, 2018, 3:40 p.m. Eastern Time

 

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

 

Presentation: “Accessing The Potential Of An Immunotherapeutic Agent”

Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics

Session: Translational Immuno-Oncology

Date and Time:  Thursday, May 24, 2018, 5:40 p.m. London Time

 

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

 

Oral Presentation: “Neuropharmacodynamic Profile of NKTR-181: Correlation to Low Abuse Potential”

Presenter: Laurie VanderVeen, Ph.D., Nektar Therapeutics

Session: Preclinical Opioid

Date and Time: Tuesday, June 12, 2018, 10:15 a.m. - 10:30 a.m. Pacific Time

 

Oral Presentation: “Assessment of Drug Abuse-Related Events with MADDERS in SUMMIT-07: A Phase-3 Study of NKTR-181 in Patients With Moderate to Severe Chronic Low-Back Pain”

Presenter: Ryan K. Lanier, Ph.D., Analgesic Solutions

Session: Pain

Date and Time: Wednesday, June 13, 2018, 1:30 p.m. - 1:45 p.m. Pacific Time

 

 

 

 

Conference Call to Discuss Fourth Quarter and Year-End 2017 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, March 1, 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/. The web broadcast of the conference call will be available for replay through Monday, April 2, 2018.

 

To access the conference call, follow these instructions:

 

Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 6299239 (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.

 


Opdivo® is a registered trademark of Bristol-Myers Squibb, TECENTRIQ® is a registered trademark of Roche and KEYTRUDA® is a registered trademark of Merck.

 

Cautionary Note Regarding Forward-Looking Statements
This press release contains uncertain or forward-looking statements which can be identified by words such as: “could,” “plan,” “expect,” “prepare,” “may,” “will” 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), the potential impact of NKTR-181 with respect to the opioid abuse epidemic, the timing and strategy for regulatory filings (including the timing and strategy for filing a new drug application, “NDA”), and the results of clinical trials. 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 regulatory pathway to review and approve pharmaceutical products is subject to substantial uncertainty; (iii) 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; (iv) the final outcomes and conclusions from sponsor meetings with FDA are subject to substantial FDA discretion associated with issuing final meeting minutes and outcomes; (v) 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; (vi) the timing of regulatory approval for the recently announced strategic collaboration agreement with Bristol-Myers Squibb is uncertain; (vii) 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 (viii) 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:
Jennifer Paganelli
347-658-8290
jpaganelli@purecommunications.com

 

 

 

 

NEKTAR THERAPEUTICS 

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

ASSETS  December 31, 2017(1)   December 31, 2016(1) 
Current assets:          
Cash and cash equivalents  $4,762   $59,640 
Short-term investments   291,370    329,462 
Accounts receivable, net   5,014    15,678 
Inventory   10,726    11,109 
Other current assets   14,948    10,063 
Total current assets   326,820    425,952 
           
Long-term investments   57,088     
Property, plant and equipment, net   47,463    65,601 
Goodwill   76,501    76,501 
Other assets   994    817 
Total assets  $508,866   $568,871 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $4,782   $2,816 
Accrued compensation   8,263    18,280 
Accrued clinical trial expenses   9,461    7,958 
Other accrued expenses   10,064    4,711 
Interest payable   4,198    4,198 
Liability related to refundable upfront payment       12,500 
Deferred revenue, current portion   18,949    14,352 
Other current liabilities   446    7,407 
Total current liabilities   56,163    72,222 
           
Senior secured notes, net   245,207    243,464 
Liability related to the sale of future royalties, net   94,655    105,950 
Deferred revenue, less current portion   19,021    51,887 
Other long-term liabilities   5,992    7,223 
Total liabilities   421,038    480,746 
Commitments and contingencies          
           
Stockholders’ equity:          
Preferred stock        
Common stock   15    15 
Capital in excess of par value   2,207,865    2,111,483 
Accumulated other comprehensive loss   (2,111)   (2,363)
Accumulated deficit   (2,117,941)   (2,021,010)
Total stockholders’ equity   87,828    88,125 
Total liabilities and stockholders’ equity  $508,866   $568,871 

  

(1) The consolidated balance sheets at December 31, 2017 and 2016 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, 
   2017   2016   2017(1)   2016(1) 
                     
Revenue:                    
Product sales  $7,791   $13,690   $32,688   $55,354 
Royalty revenue   9,574    6,392    33,527    19,542 
Non-cash royalty revenue related to sale of future royalties   9,164    7,817    30,531    30,158 
License, collaboration and other revenue   68,937    9,553    210,965    60,382 
Total revenue   95,466    37,452    307,711    165,436 
                     
Operating costs and expenses:                    
Cost of goods sold   9,753    6,604    30,547    30,215 
Research and development   81,429    50,232    268,461    203,801 
General and administrative   12,337    12,760    52,364    44,275 
Impairment of equipment and other costs for terminated program   15,981        15,981     
Total operating costs and expenses   119,500    69,596    367,353    278,291 
                     
Loss from operations   (24,034)   (32,144)   (59,642)   (112,855)
                     
Non-operating income (expense):                    
Interest expense   (5,633)   (5,550)   (22,085)   (22,468)
Non-cash interest expense on liability related to sale of future royalties   (5,334)   (4,783)   (18,869)   (19,712)
Interest income and other income (expense), net   1,357    721    4,520    2,387 
Total non-operating expense, net   (9,610)   (9,612)   (36,434)   (39,793)
                     
Loss before provision for income taxes   (33,644)   (41,756)   (96,076)   (152,648)
Provision for income taxes   182    443    616    876 
Net loss  $(33,826)  $(42,199)  $(96,692)  $(153,524)
                     
Basic and diluted net loss per share  $(0.21)  $(0.28)  $(0.62)  $(1.10)
                     
Weighted average shares outstanding used in computing basic and diluted net loss per share   158,324    149,071    155,953    139,596 

 

(1) The consolidated statements of operations for the years ended December 31, 2017 and 2016 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, 
   2017(1)   2016(1) 
Cash flows from operating activities:          
Net loss  $(96,692)  $(153,524)
Adjustments to reconcile net loss to net cash used in operating activities:          
Non-cash royalty revenue related to sale of future royalties   (30,531)   (30,158)
Non-cash interest expense on liability related to sale of future royalties   18,869    19,712 
Stock-based compensation   36,615    25,850 
Depreciation and amortization   14,741    15,351 
Impairment of equipment from terminated program   15,081     
Other non-cash transactions   (881)   (2,185)
Changes in operating assets and liabilities:          
Accounts receivable, net   10,664    4,269 
Inventory   383    237 
Other assets   (4,800)   (312)
Accounts payable   2,074    518 
Accrued compensation   (10,017)   12,282 
Accrued clinical trial expenses   1,503    (262)
Other accrued expenses   5,774    191 
Liability related to refundable upfront payment   (12,500)   12,500 
Deferred revenue   (28,269)   (17,615)
Other liabilities   (2,428)   (3,878)
Net cash used in operating activities   (80,414)   (117,024)
           
Cash flows from investing activities:          
Purchases of investments   (404,425)   (334,659)
Maturities of investments   347,743    253,682 
Sales of investments   37,549    4,969 
Purchases of property, plant and equipment   (9,676)   (6,392)
Net cash used in investing activities   (28,809)   (82,400)
           
Cash flows from financing activities:          
Payment of capital lease obligations   (5,131)   (5,945)
Proceeds from shares issued under equity compensation plans   59,522    20,287 
Issuance of common stock, net of issuance costs       189,276 
Net cash provided by financing activities   54,391    203,618 
           
Effect of exchange rates on cash and cash equivalents   (46)   (124)
Net increase (decrease) in cash and cash equivalents   (54,878)   4,070 
Cash and cash equivalents at beginning of year   59,640    55,570 
Cash and cash equivalents at end of year  $4,762   $59,640 
           
Supplemental disclosure of cash flow information:          
Cash paid for interest  $20,116   $20,589 
Cash paid for income taxes  $556   $757 

 

(1) The consolidated statements of cash flows for the years ended December 31, 2017 and 2016 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.