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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): November 6, 2019

 

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))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading symbol(s)   Name of each exchange on which registered
Common Stock, $0.0001 par value   NKTR   NASDAQ Global Select Market

 

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 November 6, 2019, Nektar Therapeutics, a Delaware corporation (“Nektar”), issued a press release (the “Press Release”) announcing its financial results for the quarter ended September 30, 2019. A copy of the Press Release is furnished herewith as Exhibit 99.1.

 

On October 30, 2019, Nektar announced that it would hold a Webcast conference call on November 6, 2019 to review its financial results for the quarter ended September 30, 2019. This conference call is accessible through a link that is posted on the home page and Investors section of the Nektar website: http://ir.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 2019” issued by Nektar Therapeutics on November 6, 2019.

 

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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: November 6, 2019

 

 

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Exhibit 99.1

 

 

Nektar Therapeutics Reports Financial Results

for the Third Quarter of 2019

 

SAN FRANCISCO, November 6, 2019 – Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the third quarter ended September 30, 2019.

 

Cash and investments in marketable securities at September 30, 2019 were approximately $1.7 billion as compared to $1.9 billion at December 31, 2018.

 

“We continue to make steady progress with our diverse portfolio of immuno-oncology and immunology programs,” said Howard W. Robin, President and CEO of Nektar. “With our partner Bristol-Myers Squibb, we are conducting registrational trials evaluating the combination of bempegaldesleukin with nivolumab in melanoma, urothelial cancer and renal cell carcinoma. We are also working collaboratively with BMS to finalize the next set of registrational studies. This weekend at the SITC Annual Meeting, we are excited to present an 18-month follow-up for patients with metastatic melanoma enrolled in our PIVOT-02 study. This follows the recent announcement of our Breakthrough Therapy Designation for the doublet which was granted by FDA in August for patients with previously untreated metastatic melanoma.  For NKTR-358, we now have three separate Phase 1b clinical trials ongoing in lupus, psoriasis and atopic dermatitis with our partner Eli Lilly, with plans to add an additional autoimmune indication to the development program in 2020.  And importantly, we initiated our first clinical trial for NKTR-255, our novel IL-15 agonist, in patients with non-Hodgkin lymphoma and multiple myeloma.”

 

Revenue in the third quarter of 2019 was $29.2 million as compared to $27.8 million in the third quarter of 2018. Year-to-date revenue for 2019 was $80.8 million as compared to $1.15 billion in the first nine months of 2018. Revenue was higher in the third quarter of 2019 as compared to the same period in 2018 primarily due to non-cash royalty revenue and an increase in product sales. Revenue was lower in the first nine months of 2019 as compared to the same period in 2018 primarily because of the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement in the second quarter of 2018.

 

Total operating costs and expenses in the third quarter of 2019 were $128.0 million as compared to $126.4 million in the third quarter of 2018. Total operating costs and expenses in the first nine months of 2019 were $411.2 million as compared to $365.3 million in the same period of 2018. Total operating costs and expenses increased marginally in the third quarter of 2019 as compared to the third quarter of 2018 due to a decrease in research and development (R&D) expense, offset by an increase in general and administrative (G&A) expense. Total operating costs and expenses increased in the first nine months of 2019 as compared to the same period in 2018 due to increases in both R&D and G&A expense.

 

 

 

 

R&D expense in the third quarter of 2019 was $99.0 million as compared to $102.9 million for the third quarter of 2018. For the first nine months of 2019, R&D expense was $324.2 million as compared to $290.7 million in the first nine months of 2018. R&D expense was lower in the third quarter of 2019 as compared to the same period in 2018 due to decreased expense for the bempegaldesleukin program. R&D expense was higher in the first nine months as compared to the same period in 2018 primarily because of expenses for our pipeline programs, including the continued development of bempegaldesleukin in Phase 2 and registrational studies and related manufacturing costs, costs related to Phase 1 clinical studies of NKTR-358 and IND-enabling activities for NKTR-255.

 

G&A expense was $24.0 million in the third quarter of 2019 as compared to $18.7 million in the third quarter of 2018. G&A expense in the first nine months of 2019 was $71.6 million as compared to $57.7 million in the first nine months of 2018. G&A expense was higher in the third quarter and first nine months of 2019 as compared to the same periods in 2018 due to costs related to commercialization readiness activities for NKTR-181 and bempegaldesleukin, and increased non-cash stock-based compensation.

 

Net loss in the third quarter of 2019 was $98.8 million or $0.56 basic and diluted loss per share as compared to net loss of $96.1 million or $0.56 basic and diluted loss per share in the third quarter of 2018. Net loss in the first nine months of 2019 was $327.2 million or $1.87 basic and diluted loss per share as compared to net income of $779.5 million or $4.34 diluted income per share in the first nine months of 2018.

 

Third Quarter 2019 and Recent Business Highlights

 

·In September, Nektar presented clinical data from its PIVOT-02 study for bempegaldesleukin in combination with Opdivo (nivolumab) at the 2019 CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference demonstrating the promising clinical activity of the combination in patients with advanced or metastatic triple-negative breast cancer, particularly in patients with PD-L1 negative baseline tumors.

 

·In October, Nektar announced that its partner Eli Lilly initiated two Phase 1b studies of NKTR-358, a novel T regulatory (Treg) cell stimulator, one in patients with psoriasis and one in patients with atopic dermatitis. NKTR-358 is designed to treat autoimmune and inflammatory conditions by correcting the immune system imbalance that results from reduced numbers and impaired function of immune regulating Treg cells.

 

·In October, Nektar announced the initiation of a first-in-human, Phase 1 clinical study evaluating NKTR-255, an interleukin-15 (IL-15) receptor agonist, as monotherapy for patients with relapsed or refractory non-Hodgkin lymphoma or multiple myeloma (MM). The study will also combine NKTR-255 with multiple targeted antibodies that function through an antibody-dependent cell-mediated cytotoxicity mechanism to evaluate the safety and efficacy in adults with relapsed or refractory MM.

 

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The company also announced upcoming presentations at the following scientific congresses:

 

2019 Society for Immunotherapy and Cancer (SITC) Annual Meeting, National Harbor, MD:

·Oral Presentation: “Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the phase 1/2 PIVOT-02 study”
oPresenter: Dr. Adi Diab, MD Anderson Cancer Center
oSession: Concurrent Session 310: Combination Phase 1-2 Clinical Trials
oDate: Saturday, November 9, 2019, 5:15 p.m. – 5:30 p.m. Eastern Standard Time

 

·Poster: “NKTR-255, a polymer-conjugated IL-15 receptor agonist, enhances efficacy of therapeutic monoclonal antibodies with ADCC activity in solid tumor models”, Kivimäe, S., et al.
oSession Date and Time: Friday, November 8, 2019, 7:00 a.m. - 8:00 p.m. Eastern Standard Time

 

·Poster: “Bempegaldesleukin in combination with local radiation and systemic checkpoint blockade induces a robust systemic anti-tumor immunity”, Pieper, A., et al.
oSession Date and Time: Friday, November 8, 2019, 7:00 a.m. - 8:00 p.m. Eastern Standard Time

 

·Poster: “Characterization and comparison of NKTR-255, a polymer-conjugated IL-15 versus IL-15 superagonist”, Miyazaki, T., et al.
oSession Date and Time: Saturday, November 9, 2019, 7:00 a.m. - 8:00 p.m. Eastern Standard Time

 

·Trials in Progress Poster: “A multicenter, open-label, exploratory platform study to evaluate biomarkers and immunotherapy combinations for the treatment of patients with metastatic castration-resistant prostate cancer (PORTER)”, Nissola, L., et al.
oSession Date and Time: Friday, November 8, 2019, 7:00 a.m. - 8:00 p.m. Eastern Standard Time

 

ACR 2019 American College of Rheumatology Annual Meeting, Atlanta, GA:

·Poster: “Selective induction of functional regulatory T-cells in healthy volunteers by NKTR-358, a novel IL-2 conjugate Treg stimulator, in development for the treatment of autoimmune diseases”, Fanton, C., et al.
oSession: T Cell Biology & Targets in Autoimmune & Inflammatory Disease Poster
oDate: Sunday, November 10, 2019, 9:00 a.m. – 11:00 a.m. Eastern Standard Time

 

The Promise of Interleukin-2 Therapy 2019, Paris, France:

·Presentation: “NKTR-358: A polymer-conjugated IL-2 that drives the selective expansion of endogenous Tregs for the treatment of autoimmune diseases”
oPresenter: Christine Fanton, Ph.D., Nektar Therapeutics
oSession: Session V.a – Novel IL-2s
oDate: Friday, November 15, 2019, 2:00 p.m. Central European Time

 

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·Presentation:Bempegaldesleukin: A polymer-conjugated IL-2 prodrug for multiple immune oncology applications”
oPresenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
oSession: Session VI – IL-2 in cancer therapy
oDate: Friday, November 15, 2019, 4:30 p.m. Central European Time

 

11th Annual PEGs Europe, Lisbon, Portugal:

·Presentation: “TLR Agonist NKTR-262 Immunotherapy Combination with Bempegaldesleukin (NKTR-214) Harnessing Innate and Adaptive Immune System for the Treatment of Solid Tumors”
oPresenter: Saul Kivimäe, Ph.D., Nektar Therapeutics
oSession: Reprogramming the Microenvironment/The Innate Immune System/Glyco-immune Checkpoints
oDate: Tuesday, November 19, 2019, 5:30 p.m. Western European Time

 

·Presentation: “NKTR-255: A Polymer-Conjugated IL-15 that Enhances CAR T Efficacy in Murine Models”
oPresenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
oSession: TILs and Gamma Delta Therapy
oDate: Thursday, November 21, 2019, 11:15 a.m. Western European Time

 

 

Melanoma Bridge 2019, Naples, Italy:

·Presentation: “Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the phase 1/2 PIVOT-02 study”- [Encore Presentation]
oPresenter: Igor Puzanov, M.D., Roswell Park Comprehensive Cancer Center, Melanoma Bridge Co-chair
oSession: Emergent Strategies Session
oDate: Saturday, December 7, 2019, 12:00 p.m. – 12:15 p.m. Central European Time

 

61st American Society of Hematology (ASH) Annual Meeting & Exposition, Orlando, FL:

·Poster: "Combination of NKTR-255, a Polymer Conjugated Human IL-15, with CD19 CAR T Cell Immunotherapy in a Preclinical Lymphoma Model", Chou, C., et al.
oSession: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
oDate: Sunday, December 8, 2019, 6:00 p.m. - 8:00 p.m. Eastern Standard Time

·Poster: "Restoring Innate and Adaptive Immune Repertoire in Multiple Myeloma for Therapeutic Application", Fernandez, R., et al.
oSession: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, Excluding Therapy: Poster III
oDate: Monday, December 9, 2019, 6:00 p.m. - 8:00 p.m. Eastern Standard Time

 

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·Trials in Progress Poster: “A Phase 1, Open-Label, Multi-Center, Dose Escalation and Dose Expansion Study of NKTR-255 As a Single Agent in Relapsed or Refractory Hematologic Malignancies and in Combination with Daratumumab As a Salvage Regimen for Multiple Myeloma”, Shah, N. et al.
oSession: 704. Immunotherapies: Poster III
oDate: Monday, December 9, 2019, 6:00 p.m. - 8:00 p.m. Eastern Standard Time

Conference Call to Discuss First Quarter 2019 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Standard Time/2:00 p.m. Pacific Standard Time, Wednesday, November 6, 2019.

 

This press release and a 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: https://ir.nektar.com/. The web broadcast of the conference call will be available for replay through Monday, December 9, 2019.

 

To access the conference call, follow these instructions:

 

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)

Conference ID: 3079832 (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, autoimmune 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.

 

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Cautionary Note Regarding Forward-Looking Statements

This press release contains uncertain or forward-looking statements which can be identified by words such as: "advance," "plan," "finalizing," "design," "evaluate," "promise," "potential," "continue," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the finalization of a joint development plan to study bempegaldesleukin ("bempeg"), the potential therapeutic benefits of our investigational products (including bempeg, NKTR-358 and NKTR-255) and future plans to clinically study our investigational products in one or more particular indications, 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) the timing of the commencement or end of clinical studies 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, delays caused by our collaboration partners, and enrollment competition; (ii) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying our technology platform to drug candidates (such as bempeg, NKTR-358, and NKTR-255) is therefore highly uncertain and unpredictable and one or more of these programs may fail; (iii) 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 (iv) certain other important risks and uncertainties set forth in Nektar's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2019. 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

 

For Media:

Jodi Sievers of Nektar Therapeutics

415-482-5593

 

Dan Budwick of 1AB

973-271-6085

dan@1abmedia.com

 

 

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NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

  September 30,
2019
   December 31,
2018(1)
 
ASSETS        
Current assets:        
Cash and cash equivalents  $81,224   $194,905 
Short-term investments   1,414,448    1,140,445 
Accounts receivable   41,205    43,213 
Inventory   13,720    11,381 
Advance payments to contract manufacturers   13,015    26,450 
Other current assets   15,212    21,293 
Total current assets   1,578,824    1,437,687 
           
Long-term investments   231,082    582,889 
Property, plant and equipment, net   64,614    48,851 
Operating lease right-of-use assets   134,888    - 
Goodwill   76,501    76,501 
Other assets   2,385    4,244 
Total assets  $2,088,294   $2,150,172 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
Current liabilities:          
Accounts payable  $21,963   $5,854 
Accrued compensation   23,101    9,937 
Accrued clinical trial expenses   38,338    14,700 
Accrued contract manufacturing expenses   8,646    23,841 
Other accrued expenses   11,394    9,580 
Interest payable   4,198    4,198 
Operating lease liabilities, current portion   9,318    - 
Deferred revenue, current portion   8,392    13,892 
Total current liabilities   125,350    82,002 
           
Senior secured notes, net   248,257    246,950 
Operating lease liabilities, less current portion   145,099    - 
Liability related to the sale of future royalties, net   73,455    82,911 
Deferred revenue, less current portion   6,779    10,744 
Other long-term liabilities   643    9,990 
Total liabilities   599,583    432,597 
           
Commitments and contingencies          
           
Stockholders’ equity:          
Preferred stock   -    - 
Common stock   17    17 
Capital in excess of par value   3,241,160    3,147,925 
Accumulated other comprehensive loss   (1,186)   (6,316)
Accumulated deficit   (1,751,280)   (1,424,051)
Total stockholders’ equity   1,488,711    1,717,575 
Total liabilities and stockholders’ equity  $2,088,294   $2,150,172 

 

(1)The consolidated balance sheet at December 31, 2018 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.

  

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NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share information)

(Unaudited)

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2019   2018   2019   2018 
                 
Revenue:                
Product sales  $5,558   $4,256   $14,302   $16,414 
Royalty revenue   10,275    10,259    29,008    29,898 
Non-cash royalty revenue related to sale of future royalties   10,264    8,372    27,585    24,337 
License, collaboration and other revenue   3,121    4,875    9,860    1,082,848 
Total revenue   29,218    27,762    80,755    1,153,497 
                     
Operating costs and expenses:                    
Cost of goods sold   4,927    4,783    15,385    16,951 
Research and development   99,048    102,895    324,197    290,653 
General and administrative   23,983    18,718    71,570    57,666 
Total operating costs and expenses   127,958    126,396    411,152    365,270 
                     
Income (loss) from operations   (98,740)   (98,634)   (330,397)   788,227 
                     
Non-operating income (expense):                    
Interest expense   (5,425)   (5,442)   (15,882)   (16,167)
Non-cash interest expense on liability related to sale of future royalties   (5,813)   (4,814)   (17,853)   (14,808)
Interest income and other income (expense), net   11,492    11,847    35,964    25,523 
Total non-operating income (expense), net   254    1,591    2,229    (5,452)
                     
Income (loss) before provision for income taxes   (98,486)   (97,043)   (328,168)   782,775 
                     
Provision (benefit) for income taxes   322    (900)   (939)   3,250 
Net income (loss)  $(98,808)  $(96,143)  $(327,229)  $779,525 
                     
Net income (loss) per share:                    
Basic  $(0.56)  $(0.56)  $(1.87)  $4.63 
Diluted  $(0.56)  $(0.56)  $(1.87)  $4.34 
                     
Weighted average shares outstanding used in computing net income (loss) per share:                    
Basic   175,402    172,698    174,609    168,363 
Diluted   175,402    172,698    174,609    179,619 

  

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NEKTAR THERAPEUTICS

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

   Nine Months Ended
September 30,
 
   2019   2018 
Cash flows from operating activities:        
Net income (loss)  $(327,229)  $779,525 
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:          
Non-cash royalty revenue related to sale of future royalties   (27,585)   (24,337)
Non-cash interest expense on liability related to sale of future royalties   17,853    14,808 
Stock-based compensation   74,787    63,895 
Depreciation and amortization   9,582    7,799 
Accretion of discounts, net and other non-cash transactions   (10,421)   (8,136)
Changes in operating assets and liabilities:          
Accounts receivable   2,008    (16,179)
Inventory   (2,339)   (2,570)
Other assets   18,127    (22,087)
Accounts payable   16,109    2,611 
Accrued compensation   13,164    19,659 
Other accrued expenses   10,019    26,603 
Deferred revenue   (9,465)   (10,931)
Other liabilities   11,932    5,104 
Net cash provided by (used in) operating activities   (203,458)   835,764 
           
Cash flows from investing activities:          
Purchases of investments   (1,028,883)   (1,944,178)
Maturities of investments   1,122,902    467,658 
Sales of investments   -    11,963 
Purchases of property, plant and equipment   (22,614)   (5,552)
Sales of property, plant and equipment   -    2,633 
Net cash provided by (used in) investing activities   71,405    (1,467,476)
           
Cash flows from financing activities:          
Issuance of common stock   -    790,231 
Proceeds from shares issued under equity compensation plans   18,449    59,067 
Net cash provided by financing activities   18,449    849,298 
           
Effect of exchange rates on cash and cash equivalents   (77)   (87)
Net increase (decrease) in cash and cash equivalents   (113,681)   217,499 
Cash and cash equivalents at beginning of period   194,905    4,762 
Cash and cash equivalents at end of period  $81,224   $222,261 
           
Supplemental disclosure of cash flow information:          
Cash paid for interest  $14,229   $14,701 

 

 

 

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