NVCR NovoCure Limited

75.69
-0.44  -1%
Previous Close 76.13
Open 75.94
52 Week Low 53.4
52 Week High 98.8412
Market Cap $7,651,586,116
Shares 101,091,110
Float 87,523,123
Enterprise Value $7,398,294,250
Volume 517,463
Av. Daily Volume 1,024,961
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Upcoming Catalysts

Drug Stage Catalyst Date
Tumor Treating Fields (TTFields) - HEPANOVA
Liver cancer
Phase 2
Phase 2
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
EF-31
Gastric cancer
Phase 2
Phase 2
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Tumor Treating Fields (TTFields) LUNAR
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Tumor Treating Fields (TTFields) - INNOVATE-3
Ovarian cancer
Phase 3
Phase 3
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Tumor Treating Fields (TTFields) - PANOVA 3
Pancreatic cancer
Phase 3
Phase 3
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EF-33
Recurrent glioblastoma
Phase 2
Phase 2
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Tumor Treating Fields (TTFields) METIS
Brain Metastases Originating from Non-Small Cell Lung Cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Tumor Treating Fields and Keytruda
Non-Small Cell Lung Cancer
Phase 2
Phase 2
Phase 2 trial planned for 2H 2020.
Tumor Treating Fields (TTFields) STELLAR
Mesothelioma
Phase 2
Phase 2
Phase 2 abstract September 5, 2018 noted 6.1 months improvement in OS compared with control.

Latest News

  1. Wilco Groenhuysen appointed to an expanded Chief Operating Officer role

    Ashley Cordova promoted to Chief Financial Officer

    Frank Leonard promoted to Chief Development Officer

    Novocure (NASDAQ:NVCR) today announced an expansion of its Executive Leadership Team, effective Sept. 1, 2020, intended to further solidify executive leadership in preparation for an anticipated period of significant innovation and growth and to recognize the proven senior management experience of key Novocure leaders.

    After eight years of service as Chief Financial Officer, Wilco Groenhuysen has been appointed to an expanded Chief Operating Officer role responsible for the general and administrative management of the company. He will also assume responsibility…

    Wilco Groenhuysen appointed to an expanded Chief Operating Officer role

    Ashley Cordova promoted to Chief Financial Officer

    Frank Leonard promoted to Chief Development Officer

    Novocure (NASDAQ:NVCR) today announced an expansion of its Executive Leadership Team, effective Sept. 1, 2020, intended to further solidify executive leadership in preparation for an anticipated period of significant innovation and growth and to recognize the proven senior management experience of key Novocure leaders.

    After eight years of service as Chief Financial Officer, Wilco Groenhuysen has been appointed to an expanded Chief Operating Officer role responsible for the general and administrative management of the company. He will also assume responsibility for the strategic and operational leadership of Novocure's supply chain, warehousing and distribution, quality assurance and information technology operations. Mr. Groenhuysen is tasked to ensure organizational readiness in anticipation of the completion of four Phase 3 clinical trials over the next few years.

    Ashley Cordova has been promoted to Chief Financial Officer and will assume responsibility for the oversight of Novocure's global financial operations, including financial reporting, financial planning and analysis, treasury, tax, and investor relations. In her new role, Ms. Cordova will report directly to Asaf Danziger, Novocure's CEO.

    With more than 15 years of experience in financial operations, Ms. Cordova has played a key role in leading multiple financial functions for Novocure with increasing responsibilities since she joined as Director of Global Treasury in 2014. Most recently, she served as Senior Vice President with responsibility for financial planning and analysis, treasury, investor relations and corporate communications. Prior to joining Novocure, Ms. Cordova served in various financial roles at Pfizer and Zoetis. Ms. Cordova graduated with a bachelor's degree in Music and Business from Furman University, and earned her international MBA from the University of South Carolina.

    Frank Leonard has been promoted to Chief Development Officer, a newly created executive role with responsibility for engineering, product development, business development, and the overall strategic and operational leadership of Novocure's innovation platforms. In his new role, Mr. Leonard will report directly to Mr. Danziger.

    Mr. Leonard joined Novocure in 2010 to help prepare the company for the commercial launch of Optune®. In this role, he established Novocure's health policy and business development groups, and additionally led various finance functions. Prior to joining Novocure, Mr. Leonard was a venture capital investor focused on high-impact medical technologies. Mr. Leonard holds an A.B. from Harvard and an M.A. from the London School of Economics and Political Science.

    "Novocure's track record of innovation and financial performance is a testament to the strength of our leaders and the focus and drive of all of our employees," said William Doyle, Novocure's Executive Chairman, and Mr. Danziger. "We are confident that Wilco's expanded role and the addition of Ashley and Frank to the Executive Leadership Team places Novocure in the best possible position to prepare for the future."

    After 10 years of service as Chief Operating Officer and 14 years after signing on as Novocure's first U.S. employee, Mike Ambrogi will transition to become Senior Technology Fellow. Mr. Ambrogi joined Novocure with a background in technology development. This newly created position allows Mr. Ambrogi the freedom to focus exclusively on the development of high-impact technologies to further Novocure's mission.

    About Novocure

    Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure's commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the treatment of adult patients with malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer and gastric cancer.

    Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

    Forward-Looking Statements

    In addition to historical facts or statements of current condition, this annual report may contain forward-looking statements. Forward-looking statements provide Novocure's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, innovation, growth, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 27, 2020 and its Quarterly Report on Form 10-Q filed on April 30, 2020 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

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  2. Quarterly net revenues of $115.9 million, representing 34 percent growth versus the second quarter 2019 and 14 percent growth versus the first quarter 2020

    Financial strength allows for continued investments in clinical and product innovation

    Novocure (NASDAQ:NVCR) today reported financial results for the quarter ended June 30, 2020, highlighting revenue growth and financial strength as well as the advancement of the company's clinical and product development programs. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields.

    Second quarter 2020 highlights include:

     

    Three months ended
    June 30,

    Quarterly net revenues of $115.9 million, representing 34 percent growth versus the second quarter 2019 and 14 percent growth versus the first quarter 2020

    Financial strength allows for continued investments in clinical and product innovation

    Novocure (NASDAQ:NVCR) today reported financial results for the quarter ended June 30, 2020, highlighting revenue growth and financial strength as well as the advancement of the company's clinical and product development programs. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields.

    Second quarter 2020 highlights include:

     

    Three months ended

    June 30,

     

    Six months ended

    June 30,

     

    2020

     

    2019

     

    % Change

     

    2020

     

    2019

     

    % Change

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Financial, in millions

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net revenues

    $

    115.9

     

    $

    86.7

     

    34

    %

     

    $

    217.8

     

    $

    160.0

     

    36

    %

    Gross profit

    $

    90.5

     

    $

    65.6

     

    38

    %

     

    $

    167.8

     

    $

    119.1

     

    41

    %

    Net income (loss)

    $

    1.7

     

    $

    (1.3

    )

    -

     

     

    $

    5.6

     

    $

    (13.4

    )

    -

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Cash, cash equivalents and short-term investments at end of period

    $

    346.7

     

    $

    284.6

     

    22

    %

     

    $

    346.7

     

    $

    284.6

     

    22

    %

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Non-financial

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Active patients at period end(1)

     

    3,278

     

     

    2,726

     

    20

    %

     

     

    3,278

     

     

    2,726

     

    20

    %

    Prescriptions received in period(2)

     

    1,422

     

     

    1,362

     

    4

    %

     

     

    2,831

     

     

    2,672

     

    6

    %

    (1)

     

    An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

         

    (2)

     

    A "prescription received" is a commercial order for Optune or Optune Lua that is received from a physician certified to treat patients for a patient not previously on Optune or Optune Lua. Orders to renew or extend treatment are not included in this total.

    "Our track record of execution extended into the second quarter 2020 with sustained commercial momentum driving strong financial performance that allowed us to fund increased investments supporting the advancement of Tumor Treating Fields' science and technology," said William Doyle, Novocure's Executive Chairman. "There were several notable achievements since our last earnings call, including last patient enrollment in the HEPANOVA trial, announcement of a clinical collaboration with MSD (a tradename of Merck & Co., Inc., through a subsidiary) in first-line non-small cell lung cancer, and launch of the EF-33 trial to study Tumor Treating Fields delivered with a high-intensity array in recurrent GBM, and we remain determined to advance our strategic priorities to unlock the long-term potential of our proprietary platform."

    "We further strengthened our foundation for growth in Q2," added Asaf Danziger, Novocure's Chief Executive Officer. "Our GBM business delivered a record $116 million in global net revenues, we reported positive EPS of $0.02, and Optune received regulatory approval for the treatment of GBM in China. With nearly 3,300 active patients on therapy at the end of the quarter, we added to the more than 16,000 patients treated to-date, globally. We remain confident in our team, our strategy and in the potential of our therapy to extend survival in some of the most aggressive forms of cancer."

    Second quarter 2020 operating statistics and financial update

    For the quarter ended June 30, 2020, net revenues were $115.9 million, representing 34% growth compared to the second quarter 2019.

    • In the United States, net revenues totaled $81.2 million in the quarter ended June 30, 2020, representing 38% growth compared to the same period in 2019.
    • In Germany and other EMEA markets, net revenues totaled $25.4 million in the quarter ended June 30, 2020, representing 13% growth compared to the same period in 2019.
    • In Japan, net revenues totaled $7.2 million in the quarter ended June 30, 2020, representing 72% growth compared to the same period in 2019.
    • In Greater China, net revenues totaled $2.1 million in the quarter ended June 30, 2020, representing 97% growth compared to the same period in 2019.

    There were 3,278 active patients at June 30, 2020, representing 20% growth compared to June 30, 2019, and six percent growth compared to March 31, 2020.

    • In the United States, there were 2,143 active patients at June 30, 2020, representing 16% growth compared to June 30, 2019.
    • In Germany and other EMEA markets, there were 900 active patients at June 30, 2020, representing 22% growth compared to June 30, 2019.
    • In Japan, there were 235 active patients at June 30, 2020, representing 64% growth compared to June 30, 2019.

    Additionally, 1,422 prescriptions were received in the quarter ended June 30, 2020, representing four percent growth compared to the same period in 2019, and one percent growth compared to the quarter ended March 31, 2020. In the quarter ended June 30, 2020, 1,156 Optune prescriptions were written for patients with newly diagnosed glioblastoma.

    • In the United States, 968 prescriptions were received in the quarter ended June 30, 2020, representing a two percent decrease compared to the same period in 2019.
    • In Germany and other EMEA markets, 369 prescriptions were received in the quarter ended June 30, 2020, representing 23% growth compared to the same period in 2019.
    • In Japan, 85 prescriptions were received in the quarter ended June 30, 2020, representing 15% growth compared to the same period in 2019.

    For the three months ended June 30, 2020, cost of revenues was $25.5 million compared to $21.1 million for the same period in 2019, representing an increase of 21%. The increase was primarily due to the cost of shipping transducer arrays to a higher volume of commercial patients, partially offset by benefits of ongoing efficiency initiatives and scale. Gross margin was 78% for the three months ended June 30, 2020 and 76% for the three months ended June 30, 2019.

    Research, development and clinical trials expenses for the three months ended June 30, 2020, were $29.9 million compared to $19.5 million for the same period in 2019, representing an increase of 54%. This was primarily due to an increase in clinical trial and personnel expenses for our phase 3 pivotal and phase 4 post-marketing trials, an increase in development and personnel expenses to support our product development programs, increased investments in preclinical research and the expansion of our medical affairs activities.

    Sales and marketing expenses for the three months ended June 30, 2020, were $28.5 million compared to $23.7 million for the same period in 2019, representing an increase of 20%. This was primarily due to an increase in personnel costs to support our growing commercial business and reimbursement efforts and an increase in marketing expenses related to the launch of Optune Lua for malignant pleural mesothelioma.

    General and administrative expenses for the three months ended June 30, 2020 were $25.4 million compared to $21.2 million for the same period in 2019, representing an increase of 20%. This was primarily due to an increase in personnel costs, insurance premiums and professional services.

    Net income for the three months ended June 30, 2020 was $1.7 million compared to a net loss of $1.3 million for the same period in 2019.

    At June 30, 2020, we had $196.8 million in cash and cash equivalents and $149.9 million in short-term investments, for a total balance of $346.7 million in cash, cash equivalents and short-term investments. This represents an increase of $15.4 million in cash and investments since March 31, 2020.

    Second quarter 2020 non-U.S. GAAP measures

    We also measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.

    Adjusted EBITDA was $28.0 million for the three months ended June 30, 2020, an increase of $10.9 million, or 64%, from $17.1 million for the three months ended June 30, 2019. This improvement in fundamental financial performance was driven by net revenue growth coupled with an ongoing commitment to disciplined management of expenses.

    Anticipated clinical milestones

    • Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2021)
    • Data from phase 2 pilot EF-31 trial in gastric cancer (2021)
    • Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
    • Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
    • Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2021)
    • Data from phase 3 pivotal METIS trial in brain metastases (2022)
    • Data from phase 2 pilot EF-33 trial with high-intensity arrays in recurrent glioblastoma (2022)
    • Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2023)
    • Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2023)
    • Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2023)

    Conference call details

    Novocure will host a conference call and webcast to discuss second quarter 2020 financial results at 8 a.m. EDT today, Thursday, July 30, 2020. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1484689.

    The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure's website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

    About Novocure

    Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure's commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the treatment of adult patients with malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer, gastric cancer and glioblastoma.

    Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

    Forward-Looking Statements

    In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 27, 2020 and its Quarterly Report on Form 10-Q filed on April 30, 2020 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

    Consolidated Statements of Operations

    USD in thousands (except share and per share data)

     

     

    Three months ended June 30,

     

    Six months ended June 30,

     

    Year ended

    December 31,

     

    2020

     

    2019

     

    2020

     

    2019

     

    2019

     

    Unaudited

     

    Unaudited

     

    Audited

    Net revenues

    $

    115,925

     

     

    $

    86,713

     

     

    $

    217,753

     

     

    $

    160,022

     

     

    $

    351,318

     

    Cost of revenues

    25,474

     

     

    21,106

     

     

    49,970

     

     

    40,920

     

     

    88,606

     

    Gross profit

    90,451

     

     

    65,607

     

     

    167,783

     

     

    119,102

     

     

    262,712

     

     

     

     

     

     

     

     

     

     

     

    Operating costs and expenses:

     

     

     

     

     

     

     

     

     

    Research, development and clinical trials

    29,918

     

     

    19,454

     

     

    55,190

     

     

    36,496

     

     

    79,003

     

    Sales and marketing

    28,461

     

     

    23,708

     

     

    57,294

     

     

    46,041

     

     

    96,675

     

    General and administrative

    25,404

     

     

    21,249

     

     

    52,012

     

     

    41,487

     

     

    87,948

     

    Total operating costs and expenses

    83,783

     

     

    64,411

     

     

    164,496

     

     

    124,024

     

     

    263,626

     

     

     

     

     

     

     

     

     

     

     

    Operating income (loss)

    6,668

     

     

    1,196

     

     

    3,287

     

     

    (4,922

    )

     

    (914

    )

    Financial expenses (income), net

    2,617

     

     

    1,239

     

     

    5,049

     

     

    3,610

     

     

    7,910

     

     

     

     

     

     

     

     

     

     

     

    Income (loss) before income tax

    4,051

     

     

    (43

    )

     

    (1,762

    )

     

    (8,532

    )

     

    (8,824

    )

    Income tax

    2,396

     

     

    1,227

     

     

    (7,369

    )

     

    4,888

     

     

    (1,594

    )

    Net income (loss)

    $

    1,655

     

     

    $

    (1,270

    )

     

    $

    5,607

     

     

    $

    (13,420

    )

     

    $

    (7,230

    )

     

     

     

     

     

     

     

     

     

     

    Basic net income (loss) per ordinary share

    $

    0.02

     

     

    $

    (0.01

    )

     

    $

    0.06

     

     

    $

    (0.14

    )

     

    $

    (0.07

    )

    Weighted average number of ordinary shares used in computing basic net income (loss) per share

    100,718,893

     

     

    96,356,317

     

     

    100,298,230

     

     

    95,583,802

     

     

    97,237,549

     

     

     

     

     

     

     

     

     

     

     

    Diluted net income (loss) per ordinary share

    $

    0.02

     

     

    $

    (0.01

    )

     

    $

    0.05

     

     

    $

    (0.14

    )

     

    $

    (0.07

    )

    Weighted average number of ordinary shares used in computing diluted net income (loss) per share

    107,647,802

     

     

    96,356,317

     

     

    107,897,907

     

     

    95,583,802

     

     

    97,237,549

     

    Consolidated Balance Sheets

    USD in thousands (except share data)

     

     

    June 30,

    2020

     

    December 31,

    2019

     

    Unaudited

     

    Audited

    ASSETS

     

     

     

    CURRENT ASSETS:

     

     

     

    Cash and cash equivalents

    $

    196,784

     

     

    $

    177,321

     

    Short-term investments

    149,930

     

     

    148,769

     

    Restricted cash

    801

     

     

    2,095

     

    Trade receivables

    76,026

     

     

    58,859

     

    Receivables and prepaid expenses

    38,104

     

     

    29,202

     

    Inventories

    26,136

     

     

    23,701

     

    Total current assets

    487,781

     

     

    439,947

     

    LONG-TERM ASSETS:

     

     

     

    Property and equipment, net

    10,530

     

     

    9,342

     

    Field equipment, net

    8,339

     

     

    7,684

     

    Right-of-use assets, net

    17,429

     

     

    17,571

     

    Other long-term assets

    4,860

     

     

    4,904

     

    Total long-term assets

    41,158

     

     

    39,501

     

    TOTAL ASSETS

    $

    528,939

     

     

    $

    479,448

     

     

     

     

     

    Consolidated Balance Sheets

    USD in thousands (except share data)

     

     

    June 30,

    2020

     

    December 31,

    2019

     

    Unaudited

     

    Audited

    LIABILITIES AND SHAREHOLDERS' EQUITY

     

     

     

    CURRENT LIABILITIES:

     

     

     

    Trade payables

    $

    38,506

     

     

    $

    36,925

     

    Other payables, lease liabilities and accrued expenses

    46,615

     

     

    49,386

     

    Total current liabilities

    85,121

     

     

    86,311

     

    LONG-TERM LIABILITIES:

     

     

     

    Long-term loan, net of discount and issuance costs

    149,507

     

     

    149,424

     

    Deferred revenue

    8,022

     

     

    7,807

     

    Long-term leases

    13,668

     

     

    14,140

     

    Employee benefits

    4,626

     

     

    3,754

     

    Other long-term liabilities

    173

     

     

    222

     

    Total long-term liabilities

    175,996

     

     

    175,347

     

    TOTAL LIABILITIES

    261,117

     

     

    261,658

     

     

     

     

     

    COMMITMENTS AND CONTINGENCIES

     

     

     

     

     

     

     

    SHAREHOLDERS' EQUITY:

     

     

     

    Share capital -

     

     

     

    Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 101,020,721 shares and 99,528,435 shares at June 30, 2020 (unaudited) and December 31, 2019, respectively

     

     

     

    Additional paid-in capital

    916,632

     

     

    871,442

     

    Accumulated other comprehensive income (loss)

    (3,532

    )

     

    (2,767

    )

    Retained earnings (accumulated deficit)

    (645,278

    )

     

    (650,885

    )

    TOTAL SHAREHOLDERS' EQUITY

    267,822

     

     

    217,790

     

    TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

    $

    528,939

     

     

    $

    479,448

     

    Non-U.S. GAAP financial measures reconciliation

    USD in thousands

     

     

    Three months ended June 30,

     

    Six months ended June 30,

     

    2020

     

    2019

     

    % Change

     

    2020

     

    2019

     

    % Change

    Net income (loss)

    $

    1,655

     

     

    $

    (1,270

    )

     

    (230

    )%

    $

    5,607

     

     

    $

    (13,420

    )

     

    (142

    )%

     

    Add: Income tax

    2,396

     

     

    1,227

     

     

    95

    %

    (7,369

    )

     

    4,888

     

     

    (251

    )%

     

    Add: Financial income (expenses), net

    2,617

     

     

    1,239

     

     

    111

    %

    5,049

     

     

    3,610

     

     

    40

    %

     

    Add: Depreciation and amortization

    2,601

     

     

    2,132

     

     

    22

    %

    4,489

     

     

    4,061

     

     

    11

    %

     

    EBITDA

    $

    9,269

     

     

    $

    3,228

     

     

    179

    %

    $

    7,776

     

     

    $

    (861

    )

     

    (1,003

    )%

     

    Add: Share-based compensation

    18,770

     

     

    13,732

     

     

    37

    %

    35,327

     

     

    23,381

     

     

    51

    %

     

    Adjusted EBITDA

    $

    28,039

     

     

    $

    17,060

     

     

    64

    %

    $

    43,103

     

     

    $

    22,520

     

     

    91

    %

     

     

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  3. Novocure (NASDAQ:NVCR) announced today the recipients of the AACR-Novocure Grants for Tumor Treating Fields Research program. The program represents a joint effort between Novocure and the American Association for Cancer Research (AACR) to promote and support innovative research on Tumor Treating Fields. The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer.

    Such collaborations help to deepen the understanding of the mechanism of action and to accelerate the development of new treatment strategies. Extensive preclinical and clinical evidence provides the foundation upon which Novocure executes its strategy to advance Tumor Treating Fields through additional clinical research studies…

    Novocure (NASDAQ:NVCR) announced today the recipients of the AACR-Novocure Grants for Tumor Treating Fields Research program. The program represents a joint effort between Novocure and the American Association for Cancer Research (AACR) to promote and support innovative research on Tumor Treating Fields. The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer.

    Such collaborations help to deepen the understanding of the mechanism of action and to accelerate the development of new treatment strategies. Extensive preclinical and clinical evidence provides the foundation upon which Novocure executes its strategy to advance Tumor Treating Fields through additional clinical research studies across multiple solid tumor types.

    "Congratulations to the recipients of the AACR-Novocure Grants for Tumor Treating Fields Research," said Asaf Danziger, Novocure's Chief Executive Officer. "We value our ongoing partnership with the AACR as we continue to deepen our understanding of the mechanism of action of Tumor Treating Fields. We look forward to learning the outcomes of the impressive research planned by our grant recipients."

    "The AACR is thrilled to welcome its newest class of grant recipients, including the recipients of the AACR-Novocure Grants for Tumor Treating Fields," said Mitch Stoller, the AACR's Chief Philanthropic Officer. "Our continued partnership with Novocure has played a pivotal role in providing crucially needed resources to scientists on the leading edge of discovery. The innovative research supported by these grants will contribute to our understanding of Tumor Treating Fields, and may lead to the identification of new and exciting applications for this emerging technology."

    2020 AACR-Novocure Career Development Awards for Tumor Treating Fields Research

    • Narasimha Kumar Karanam, Ph.D., University of Texas Southwestern Medical Center

      "Harnessing E2F-Rb-CDK4/6 axis for novel combination therapy with TTFields"
    • Chirag B. Patel, M.D., Ph.D., Stanford University

      "Increasing glioblastoma cell membrane permeability with TTFields"

    2020 AACR-Novocure Tumor Treating Fields Research Grants

    • Carsten Hagemann, Ph.D., Universitätsklinikum Würzburg, Germany

      "Overcoming the blood brain barrier drug delivery hurdle with TTFields"
    • Sandeep Mittal, M.D., FRCSC, FACS, Virginia Polytechnic Institute

      "Epigenetic modifications induced by TTFields in patient-derived GBM cells"
    • Debabrata Saha, Ph.D., University of Texas Southwestern Medical Center

      "Evaluating efficacy of TTFields and radiotherapy in preclinical tumor model"
    • David D. Tran, M.D., Ph.D., University of Florida College of Medicine

      "Molecular mechanism of resistance to Tumor Treating Fields in glioblastoma"
    • Christopher Douglas Willey, M.D., Ph.D., University of Alabama at Birmingham

      "Exploring Novo-TTF in advanced patient derived GBM models with multi-omics"

    About Novocure

    Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure's commercialized products are approved for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and liver cancer.

    Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

    About the AACR

    Founded in 1907, the American Association for Cancer Research (AACR) is the world's first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes more than 47,000 laboratory, translational, and clinical researchers; population scientists; other health care professionals; and patient advocates residing in 120 countries. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis, and treatment of cancer by annually convening more than 30 conferences and educational workshops, the largest of which is the AACR Annual Meeting with more than 22,500 attendees. In addition, the AACR publishes eight prestigious, peer-reviewed scientific journals and a magazine for cancer survivors, patients, and their caregivers. The AACR funds meritorious research directly as well as in cooperation with numerous cancer organizations. As the Scientific Partner of Stand Up To Cancer, the AACR provides expert peer review, grants administration, and scientific oversight of team science and individual investigator grants in cancer research that have the potential for near-term patient benefit. The AACR actively communicates with legislators and other policymakers about the value of cancer research and related biomedical science in saving lives from cancer. For more information about the AACR, visit www.AACR.org.

    Forward-Looking Statements

    In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Quarterly Report on Form 10-Q filed on July 25, 2019, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

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  4. EF-33 will test the potential incremental survival benefit of Tumor Treating Fields delivered using high-intensity arrays in patients with recurrent glioblastoma

    Novocure (NASDAQ:NVCR) announced today that the first patient has been enrolled in its EF-33 phase 2 pilot trial of Tumor Treating Fields delivered utilizing high-intensity arrays in patients with recurrent glioblastoma (GBM). Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division.

    Tumor Treating Fields survival benefit has shown a positive correlation with electric field intensity. The Optune® system currently delivers Tumor Treating Fields therapy for the treatment of GBM using four transducer arrays with nine…

    EF-33 will test the potential incremental survival benefit of Tumor Treating Fields delivered using high-intensity arrays in patients with recurrent glioblastoma

    Novocure (NASDAQ:NVCR) announced today that the first patient has been enrolled in its EF-33 phase 2 pilot trial of Tumor Treating Fields delivered utilizing high-intensity arrays in patients with recurrent glioblastoma (GBM). Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division.

    Tumor Treating Fields survival benefit has shown a positive correlation with electric field intensity. The Optune® system currently delivers Tumor Treating Fields therapy for the treatment of GBM using four transducer arrays with nine ceramic discs each. To increase field intensity, Novocure designed high-intensity arrays with 14 ceramic discs each for use in the EF-33 study. Increasing the surface area of the array is expected to enable delivery of higher field intensities while maintaining the treatment's safety profile.

    "Building upon a foundation of compelling preclinical and clinical evidence, we continue to expand our product development programs to support our mission to extend survival in some of the most aggressive forms of cancer," said William Doyle, Novocure's Executive Chairman. "We believe we have a considerable opportunity to improve Tumor Treating Fields delivery systems through product innovation and are very pleased to bring the first high-intensity arrays to the clinic. We look forward to sharing data from these programs in future quarters."

    EF-33 is an open-label, single-arm clinical trial to study if Optune delivered at 200 kHz to the brain using high-intensity arrays in the treatment of recurrent GBM significantly improves the clinical outcomes of patients compared to using standard transducer arrays. The study will enroll 25 patients with a minimum follow-up of six months. Patients will remain on Optune until disease progression. The primary endpoint of EF-33 is progression free survival. Secondary endpoints include overall survival, progression free survival rate at six months, overall survival rate at one year and two years, overall radiological response, and severity and frequency of adverse events. All comparisons will be made against historical control data from Novocure's EF-11 study. Final data from the study is expected in 2022, at which point Novocure will determine the appropriate regulatory pathway for potential commercial use.

    About Optune

    Optune is a noninvasive, antimitotic cancer treatment for GBM. Optune delivers Tumor Treating Fields to the region of the tumor.

    Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

    Approved Indications (U.S.)

    Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

    Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.

    For the treatment of recurrent GBM, Optune is indicated following histologically- or radiologically-confirmed recurrence in the supratentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

    Important Safety Information

    Contraindications

    Do not use Optune in patients with GBM with an implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

    Use of Optune for GBM together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

    Do not use Optune for GBM in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with Optune may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

    Warnings and Precautions

    Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure®.

    The most common (≥10%) adverse events involving Optune in combination with chemotherapy in patients with GBM were thrombocytopenia, nausea, constipation, vomiting, fatigue, convulsions, and depression.

    The most common (≥10%) adverse events related to Optune treatment alone in patients with GBM were medical device site reaction and headache. Other less common adverse reactions were malaise, muscle twitching, and falls related to carrying the device.

    If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with Optune treatment.

    Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.

    About Novocure

    Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure's commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the treatment of adult patients with malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer and gastric cancer.

    Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

    Forward-Looking Statements

    In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 27, 2020 and its Quarterly Report on Form 10-Q filed on April 30, 2020 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

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  5. Novocure (NASDAQ:NVCR) today announced it has entered into a clinical trial collaboration agreement with MSD (a tradename of Merck & Co., Inc.), through a subsidiary, to develop Tumor Treating Fields together with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for treatment of non-small cell lung cancer (NSCLC). Novocure's Tumor Treating Fields use electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die.

    The two companies plan to conduct a phase 2 pilot study of Tumor Treating Fields concomitant with KEYTRUDA for first-line treatment of intrathoracic advanced or metastatic, PD-L1 positive NSCLC. The study is designed to enroll approximately 66 patients in the United…

    Novocure (NASDAQ:NVCR) today announced it has entered into a clinical trial collaboration agreement with MSD (a tradename of Merck & Co., Inc.), through a subsidiary, to develop Tumor Treating Fields together with MSD's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for treatment of non-small cell lung cancer (NSCLC). Novocure's Tumor Treating Fields use electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die.

    The two companies plan to conduct a phase 2 pilot study of Tumor Treating Fields concomitant with KEYTRUDA for first-line treatment of intrathoracic advanced or metastatic, PD-L1 positive NSCLC. The study is designed to enroll approximately 66 patients in the United States and is expected to begin in the second half of 2020. Objective response rate (ORR) is the primary endpoint of the study. Secondary endpoints include overall survival, progression free survival (PFS), PFS at six months, one-year survival rate, duration of response, disease control rate at 18 weeks and safety.

    "We are very pleased to collaborate with MSD, a global leader in oncology, in this important combination study as we strive to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields," said William Doyle, Novocure's Executive Chairman. "Multiple preclinical studies suggest that the use of Tumor Treating Fields together with anti-PD-1 therapy can potentially augment the immune response resulting in improved tumor control. We look forward to generating clinical data demonstrating the effect of Tumor Treating Fields concurrent with KEYTRUDA in first-line NSCLC."

    About Lung Cancer

    Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die from lung cancer than from colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85 percent of all cases. The five-year survival rate for patients diagnosed in the U.S. with NSCLC is approximately 24 percent.

    About Tumor Treating Fields

    Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the U.S. for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

    Use of Tumor Treating Fields for the treatment of NSCLC is investigational only.

    KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

    About Novocure

    Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure's commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the treatment of adult patients with malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer, liver cancer and gastric cancer.

    Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

    Forward-Looking Statements

    In addition to historical facts or statements of current condition, this annual report may contain forward-looking statements. Forward-looking statements provide Novocure's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Novocure's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 27, 2020 and its Quarterly Report on Form 10-Q filed on April 30, 2020 with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

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