Nektar Therapeutics Reports Financial Results for the Third Quarter of 2017

Cash and investments in marketable securities at September 30, 2017 were $412.2M as compared to $389.1M at December 31, 2016.

 
[07-November-2017]
 
 

SAN FRANCISCO, Nov. 7, 2017 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported its financial results for the third quarter ended September 30, 2017.

Cash and investments in marketable securities at September 30, 2017 were $412.2 million as compared to $389.1 million at December 31, 2016. The cash balance includes the $150.0 million upfront payment from Nektar's collaboration with Eli Lilly & Company for the development and commercialization of NKTR-358.

"Nektar's immuno-oncology portfolio continues to expand as we add novel drug candidates to our growing pipeline," said Howard W. Robin, President and CEO of Nektar. "NKTR-214 is the first I-O agent to both increase tumor-infiltrating lymphocytes (TILs) and increase PD-1 expression on human immune cells, which uniquely complements checkpoint inhibition and other anti-cancer mechanisms. As the majority of cancer patients have tumors that do not express PD-L1 and these patients receive limited benefit from treatment with checkpoint inhibitors, the potential of NKTR-214 to help patients is significant. Finally, based on recent positive conversations with the agency regarding our regulatory plans for NKTR-181, we are now planning to submit an NDA for NKTR-181 by April 2018 with our data package of over 2,100 patients and healthy volunteers."

Revenue in the third quarter of 2017 was $152.9 million as compared to $36.3 million in the third quarter of 2016. Year-to-date revenue for 2017 was $212.2 million as compared to $128.0 million in the first nine months of 2016. Revenue in 2017 included recognition of $127.6 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 third quarter of 2017 were $83.4 million as compared to $69.2 million in the third quarter of 2016. Year-to-date total operating costs and expenses in 2017 were $247.9 million as compared to $208.7 million for the same period in 2016. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2017 was $65.7 million as compared to $52.0 million in the third quarter of 2016. Year-to-date R&D expense for 2017 was $187.0 million as compared to $153.6 million for the same period in 2016. R&D expense was higher in the third quarter and first nine months of 2017 as compared to the same periods in 2016 primarily because of expenses for our pipeline programs, including 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 expense was $12.1 million in the third quarter of 2017 as compared to $10.3 million in the third quarter of 2016. G&A expense in the first nine months of 2017 was $40.0 million as compared to $31.5 million for the same period in 2016. G&A expense in the first nine months of 2017 includes a $3.3 million charge for a litigation settlement related to a cross-license agreement.

Net income in the third quarter of 2017 was $60.9 million or $0.39 basic income per share as compared to net loss of $43.2 million or $0.32 basic loss per share in the third quarter of 2016. Net loss in the first nine months of 2017 was $62.9 million or $0.41 basic loss per share as compared to $111.3 million or $0.82 basic loss per share in the first nine months of 2016.

The company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2017:

Society for Immunotherapy in Cancer (SITC) 32nd Annual Meeting, National Harbor, MD:

Oral Presentation: "PIVOT-02: Preliminary safety, efficacy and biomarker results from the Phase 1/2 study of CD-122-biased agonist NKTR-214 plus nivolumab in patients with locally advanced/metastatic solid tumors"
Presenter: Dr. Adi Diab, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: Clinical Trials: Novel Combinations
Date: Saturday, November 11, 2017, 5:00 p.m. Eastern Time

Poster #P77: "The Novel IL-2 Cytokine Immune Agonist NKTR-214 Harnesses the Adaptive and Innate Immune System for the Treatment of Solid Cancers"
Presenter: Salah Eddine Bentebibel, University of Texas MD Anderson Cancer Center
Session: Biomarkers and Immune Monitoring
Date: Friday, November 10, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P140: "NKTR-214 enhances anti-tumor T-cell immune responses induced by checkpoint blockade or vaccination"
Presenter: Meenu Sharma, University of Texas MD Anderson Cancer Center
Session: Cancer Vaccines
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P274: "Combination of NKTR-214 and radiotherapy (RT) to reverse anergy and expand tumor-specific CD8 T-Cells"
Presenter: Joshua Walker, Oregon Health & Science University
Session: Combination Therapy
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P275: "Harnessing the innate and adaptive immune system to eradicate treated and distant untreated solid tumors"
Presenter: Saul Kivimae, Nektar Therapeutics
Session: Combination Therapy
Date: Friday, November 10, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P332: "Pre-clinical efficacy and tolerability of NKTR-255, a polymer-conjugated IL-15 for immuno-oncology"
Presenter: Peiwen Kuo, Nektar Therapeutics
Session: Combination Therapy
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Poster #434: "Great Apes Adenoviral vaccine encoding neoantigens synergizes with immunomodulators to cure established tumors in mice"
Presenter: Anna Morena D'Alise, Nouscom srl
Session: Personalized Vaccines and Technologies/Personalized Medicines
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

American College of Neuropsychopharmacology 56th Annual Meeting, Palm Springs, CA:

Poster #T166: "Abuse potential of NKTR-181 in recreational opioid users: results from a randomized, double-blind crossover oral study"
Presenter: Snow Ge, Nektar Therapeutics
Session: Poster Session II
Date: Tuesday, December 5, 2017, 5:30-7:30 p.m. Pacific Time

Conference Call to Discuss Third Quarter 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, Tuesday, November 7, 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://ir.nektar.com/index.cfm. The web broadcast of the conference call will be available for replay through Monday, December 11, 2017.

To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 4677348 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call.

About Nektar
Nektar Therapeutics 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: "could," "plan," "expect," "should," "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-181, NKTR-358, NKTR-214, 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 meetings with representatives of the Food and Drug Administration (FDA) and other governmental officials, 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, established guidance and precedent (e.g., the practice of typically requiring two placebo-controlled pivotal studies to support NDA approvals for drugs like NKTR-181), 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 is difficult to predict which scheduling category will apply to NKTR-181 if regulatory approval is achieved; (vi) 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 (vii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 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.

Contact:
For Investors:
Jennifer Ruddock of Nektar Therapeutics
415-482-5585
Jodi Sievers of Nektar Therapeutics
415-482-5593

                                                      NEKTAR THERAPEUTICS

                                             CONDENSED CONSOLIDATED BALANCE SHEETS

                                                        (In thousands)

                                                          (Unaudited)


                       ASSETS                      September 30, 2017                    December 31, 2016              (1)
                                                   ------------------                    -----------------

    Current assets:

                Cash and cash
                equivalents                                                      $37,967                        $59,640

                Short-term
                investments                                                      314,600                        329,462

                Accounts
                receivable, net                                                    3,314                         15,678

               Inventory                                                          13,654                         11,109

                Other current
                assets                                                            13,260                         10,063


               Total current assets                                              382,795                        425,952


    Long-term investments                                                      59,596                              -

    Property, plant and equipment, net                                         62,396                         65,601

    Goodwill                                                                   76,501                         76,501

    Other assets                                                                  767                            817
                                                                                  ---                            ---

               Total assets                                                     $582,055                       $568,871
                                                                                ========                       ========


        LIABILITIES AND STOCKHOLDERS' EQUITY


    Current liabilities:

               Accounts payable                                                   $8,563                         $2,816

                Accrued
                compensation                                                      19,088                         18,280

                Accrued clinical
                trial expenses                                                     7,000                          7,958

                Other accrued
                expenses                                                           9,302                          4,711

               Interest payable                                                    4,198                          4,198

                Capital lease
                obligations,
                current portion                                                    2,482                          2,908

                Liability
                related to
                refundable
                upfront payment                                                   12,500                         12,500

                Deferred
                revenue,
                current portion                                                   25,491                         14,352

                Other current
                liabilities                                                        3,920                          4,499


               Total current liabilities                                          92,544                         72,222


    Senior secured notes, net                                                 244,771                        243,464

    Liability related to the sale of future
     royalties, net                                                            98,394                        105,950

    Deferred revenue, less current portion                                     56,225                         51,887

    Other long-term liabilities                                                 5,959                          7,223
                                                                                -----                          -----

               Total liabilities                                                 497,893                        480,746


    Commitments and contingencies


    Stockholders' equity:

               Preferred stock                                                         -                             -

               Common stock                                                           15                             15

                Capital in
                excess of par
                value                                                          2,170,169                      2,111,483

                Accumulated
                other
                comprehensive
                loss                                                             (1,907)                       (2,363)

                Accumulated
                deficit                                                      (2,084,115)                   (2,021,010)


               Total stockholders' equity                                         84,162                         88,125

                Total
                liabilities and
                stockholders'
                equity                                                          $582,055                       $568,871

    (1) The consolidated balance
     sheet at December 31, 2016 has
     been derived from the audited
     financial statements at that
     date but does not include all
     of the information and notes
     required by generally accepted
     accounting principles in the
     United States for complete
     financial statements.
 

 

                                                                                               NEKTAR THERAPEUTICS

                                                                                 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

                                                                                   (In thousands, except per share information)

                                                                                                   (Unaudited)


                                                   Three Months Ended September 30,                                  Nine Months Ended September
                                                                                                                                30,
                                                         --------------------------------                        ---------------------------

                                                                                     2017                                                           2016          2017            2016
                                                                                     ----                                                           ----          ----            ----


    Revenue:

                  Product sales                                                      $4,448                                                        $14,698       $24,897         $41,664

                 Royalty revenue                                                      9,302                                                          5,573        23,953          13,150

                  Non-cash royalty revenue related
                  to sale of future royalties                                         8,066                                                          7,692        21,367          22,341

                  License, collaboration and other
                  revenue                                                           131,112                                                          8,373       142,028          50,829


    Total revenue                                                                152,928                                                         36,336       212,245         127,984


    Operating costs and expenses:

                  Cost of goods sold                                                  5,674                                                          7,033        20,794          23,611

                 Research and development                                            65,714                                                         51,951       187,032         153,569

                 General and administrative                                          12,055                                                         10,253        40,027          31,515

    Total operating costs and expenses                                            83,443                                                         69,237       247,853         208,695
                                                                                  ------                                                         ------       -------         -------


    Income (loss) from operations                                                 69,485                                                       (32,901)     (35,608)       (80,711)


    Non-operating income (expense):

                  Interest expense                                                  (5,540)                                                       (5,614)     (16,452)       (16,918)

                  Non-cash interest expense on
                  liability related to sale of
                  future royalties                                                  (4,471)                                                       (4,902)     (13,535)       (14,929)

                  Interest income and other income
                  (expense), net                                                      1,599                                                            332         3,163           1,666


    Total non-operating expense, net                                             (8,412)                                                      (10,184)     (26,824)       (30,181)


    Income (loss) before provision for
     income taxes                                                                 61,073                                                       (43,085)     (62,432)      (110,892)


    Provision for income taxes                                                       202                                                            139           434             433
                                                                                     ---                                                            ---           ---             ---

    Net income (loss)                                                            $60,871                                                      $(43,224)    $(62,866)     $(111,325)
                                                                                 =======                                                       ========      ========       =========


    Net income (loss) per share:

                 Basic                                                                $0.39                                                        $(0.32)      $(0.41)        $(0.82)


                 Diluted                                                              $0.37                                                        $(0.32)      $(0.41)        $(0.82)



    Weighted average shares outstanding
     used in computing net income (loss)
     per share:

                 Basic                                                              156,411                                                        137,094       155,153         136,415


                 Diluted                                                            162,641                                                        137,094       155,153         136,415

 

                                                        NEKTAR THERAPEUTICS

                                          CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

                                                           (In thousands)

                                                            (Unaudited)

                                                                                              Nine Months Ended September 30,
                                                                                              -------------------------------

                                                                                                             2017                    2016
                                                                                                             ----                    ----

    Cash flows from operating activities:

                                                          Net loss                                      $(62,866)             $(111,325)

                                                         Adjustments to
                                                          reconcile net loss
                                                          to net cash used in
                                                          operating
                                                          activities:

                                                          Non-cash royalty revenue related to
                                                          sale of future royalties                       (21,367)               (22,341)

                                                          Non-cash interest expense on
                                                          liability related to sale of future
                                                          royalties                                        13,535                  14,929

                                                         Stock-based compensation                          25,118                  18,793

                                                         Depreciation and amortization                     12,081                  11,502

                                                         Other non-cash transactions                      (1,370)                (2,190)

                                                          Changes in operating
                                                          assets and
                                                          liabilities:

                                                         Accounts receivable, net                          12,364                   5,698

                                                         Inventory                                        (2,545)                    592

                                                         Other assets                                     (2,036)                  6,041

                                                         Accounts payable                                   5,729                   4,799

                                                         Accrued compensation                                 808                   9,735

                                                         Accrued clinical trial expenses                    (958)                  2,726

                                                         Other accrued expenses                             4,971                   2,386

                                                          Liability related to refundable
                                                          upfront payment                                       -                 12,500

                                                         Deferred revenue                                  15,477                (12,665)

                                                         Other liabilities                                  1,046                 (5,793)
                                                                                                            -----                  ------

                                                          Net cash used in
                                                          operating activities                               (13)               (64,613)


    Cash flows from investing activities:

                                                         Purchases of investments                       (314,439)              (142,972)

                                                         Maturities of investments                        261,112                 201,449

                                                         Sales of investments                               8,823                   4,969

                                                          Purchases of property, plant and
                                                          equipment                                       (7,283)                (3,741)
                                                                                                           ------                  ------

                                                          Net cash (used in)
                                                          provided by
                                                          investing activities                           (51,787)                 59,705


    Cash flows from financing activities:

                                                         Payment of capital lease obligations             (2,159)                (5,376)

                                                          Proceeds from shares issued under
                                                          equity compensation plans                        32,275                  18,041
                                                                                                           ------                  ------

                                                          Net cash provided by
                                                          financing activities                             30,116                  12,665


                                                          Effect of exchange
                                                          rates on cash and
                                                          cash equivalents                                     11                    (32)


                                                          Net (decrease)
                                                          increase in cash and
                                                          cash equivalents                               (21,673)                  7,725

                                                          Cash and cash
                                                          equivalents at
                                                          beginning of period                              59,640                  55,570

                                                          Cash and cash
                                                          equivalents at end
                                                          of period                                       $37,967                 $63,295



    Supplemental disclosure of cash flow information:

                                                          Cash paid for
                                                          interest                                        $14,989                 $15,513

 

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SOURCE Nektar Therapeutics

 
 
Company Codes: NASDAQ-NMS:NKTR
 
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