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novocure(NVCR) - 2024 Q2 - Quarterly Results
2024-07-25 11:01
"The second quarter was a period of consistent execution at Novocure," said Asaf Danziger, Novocure's Chief Executive Officer. "We began the year with three key objectives – grow our commercial business in glioblastoma, launch our next indication in non-small cell lung cancer, and deliver on the promise of our clinical and product development pipeline. I am pleased to share we have made significant progress on all fronts this quarter.""The second quarter was a period of consistent execution at Novocure," sa ...
NovoCure (NVCR) Reports Q1 Loss, Tops Revenue Estimates
Zacks Investment Research· 2024-05-02 13:31
NovoCure (NVCR) came out with a quarterly loss of $0.36 per share versus the Zacks Consensus Estimate of a loss of $0.43. This compares to loss of $0.50 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 16.28%. A quarter ago, it was expected that this oncology drug developer would post a loss of $0.53 per share when it actually produced a loss of $0.45, delivering a surprise of 15.09%.Over the last four quarters, the company has ...
novocure(NVCR) - 2024 Q1 - Quarterly Report
2024-05-02 11:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________________________ FORM 10-Q (Exact Name of Registrant as Specified in Its Charter) For the quarterly period ended March 31, 2024 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organization) Identification No.) or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Jersey 98-1057807 For the transition period from to Commission File Number 001- ...
novocure(NVCR) - 2024 Q1 - Quarterly Results
2024-05-02 11:01
Exhibit 99.1 Novocure Reports First Quarter 2024 Financial Results Quarterly net revenues of $139 million, up 13% year-over-year, with 3,845 active patients on therapy as of March 31, 2024 Phase 3 METIS trial in brain metastases from non-small cell lung cancer met primary endpoint and will be presented as late-breaking abstract at ASCO 2024 LUNAR PMA application for TTFields in NSCLC Day 100 FDA meeting complete Root, Switzerland – Novocure (NASDAQ: NVCR) today reported financial results for the quarter end ...
novocure(NVCR) - 2023 Q4 - Earnings Call Presentation
2024-02-22 13:18
q4 2023 selected financial highlights patientforward® @ 2024 Novocure GmbH 9 novocure® Optune Lua® and Optune Gio® indications for use and important safety information novocure® | --- | --- | --- | --- | |----------------------------------------------|-------|-------|-------| | | | | | | | | | | | | | | | | Novocure | | | | | Q4 2023 Earnings Thursday, February 22, 2024 | | | | forward-looking statements ln addition to historical facts or statements of current condition, this presentation may contain forwar ...
novocure(NVCR) - 2023 Q4 - Annual Report
2024-02-22 12:05
Part I [Business](index=8&type=section&id=Item%201.%20Business) NovoCure is an oncology company focused on its TTFields platform for GBM and MPM, with a robust pipeline and pending FDA decision for NSCLC [Overview and Technology](index=8&type=section&id=Overview%20and%20Technology) NovoCure's TTFields technology uses electric fields to disrupt cancer cell division, delivered via portable devices - The company's proprietary **TTFields technology** disrupts cancer cell mitosis by applying specific frequency electric fields, a mechanism believed to be broadly applicable to solid tumors[22](index=22&type=chunk)[23](index=23&type=chunk)[32](index=32&type=chunk) - Key commercial products are **Optune Gio** (for GBM) and **Optune Lua** (for MPM), delivered via a portable device. The company is actively developing next-generation arrays and a third-generation device to optimize therapy[22](index=22&type=chunk)[35](index=35&type=chunk)[37](index=37&type=chunk) - In December 2023, NovoCure filed a **PMA application** with the FDA for **TTFields therapy in non-small cell lung cancer (NSCLC)**, which was accepted in January 2024, with a decision anticipated in the **second half of 2024**[24](index=24&type=chunk) [Commercial Business and Reimbursement](index=10&type=section&id=Commercial%20Business%20and%20Reimbursement) Commercial operations focus on Optune Gio and Optune Lua, with direct-to-patient distribution and established reimbursement Estimated Annual Addressable Patient Population for Optune Gio (GBM) | Region | Diagnosed with GBM (or progressing tumors) | Candidates for Optune Gio Treatment | | :--- | :--- | :--- | | U.S. | ~15,000 | ~8,200 | | Germany | ~4,600 | ~2,500 | | Japan | ~2,200 | ~1,200 | - The company operates a **direct-to-patient distribution model** (except in Japan) and employs **126 sales force colleagues** globally as of December 31, 2023[56](index=56&type=chunk)[57](index=57&type=chunk) - As of December 31, 2023, national reimbursement for Optune Gio is secured in **seven countries**, and in the U.S., a **substantial majority of private health insurance plans** and the **Medicare fee-for-service program** provide coverage for newly diagnosed GBM[61](index=61&type=chunk)[62](index=62&type=chunk) [Development Pipeline](index=13&type=section&id=Development%20Pipeline) The development pipeline expands TTFields therapy to solid tumors, with key late-stage trials in NSCLC, pancreatic cancer, and GBM Key Phase 3 Clinical Trial Status and Anticipated Data | Trial Name | Indication | Status | Anticipated Top-Line Data | | :--- | :--- | :--- | :--- | | LUNAR | 2nd Line NSCLC | Positive results presented | N/A (PMA submitted) | | METIS | Brain Metastases from NSCLC | Final patient enrolled (Mar 2023) | Q1 2024 | | PANOVA-3 | Pancreatic Cancer | Final patient enrolled (Feb 2023) | Q4 2024 | | TRIDENT | Newly Diagnosed GBM | Final patient enrolled (Jan 2024) | 2026 | - The **Phase 3 LUNAR study** in NSCLC met its **primary endpoint**, showing a statistically significant **3-month improvement** in median overall survival (**13.2 months vs. 9.9 months**) for patients receiving TTFields plus standard therapies[76](index=76&type=chunk) - The **Phase 3 INNOVATE-3 trial** for platinum-resistant ovarian cancer **did not meet its primary endpoint** of overall survival, with results announced in August 2023[99](index=99&type=chunk) [Operations and Human Capital](index=18&type=section&id=Operations%20and%20Human%20Capital) NovoCure outsources manufacturing, maintains a robust IP portfolio, and reduced its workforce by 13% to optimize operations - The company **outsources all manufacturing** and is developing **second sources** for critical components to mitigate supply chain risk[101](index=101&type=chunk)[102](index=102&type=chunk) - The intellectual property portfolio includes **hundreds of issued patents** with expected U.S. expiration dates between **2024 and 2041**[103](index=103&type=chunk) - In November 2023, the company reduced its headcount by approximately **200 employees (13%)** to strengthen and optimize business operations for future growth[151](index=151&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company faces risks from product reliance, market acceptance, reimbursement, operating losses, supply chain, competition, regulation, and IP - The business **heavily depends on Optune Gio (for GBM) and Optune Lua (for MPM)**, and its prospects will be materially harmed if it cannot increase sales or successfully commercialize products for additional indications[157](index=157&type=chunk)[158](index=158&type=chunk) - The company has a **history of substantial operating losses** and may **not achieve sustainable profitability**, as expenses for commercialization and R&D are expected to increase[162](index=162&type=chunk) - **Failure to secure and maintain adequate coverage and reimbursement** from third-party payers, including Medicare, could adversely affect product acceptance and revenues[175](index=175&type=chunk)[187](index=187&type=chunk) - **Dependence on single-source suppliers** for some components creates risk of shipment delays and business disruption if these suppliers fail to deliver[196](index=196&type=chunk) - Several **early patents began expiring in 2021**, which could adversely affect the company's ability to protect its products and may allow competitors to develop competing therapies[271](index=271&type=chunk)[272](index=272&type=chunk) [Cybersecurity](index=56&type=section&id=Item%201C.%20Cybersecurity) NovoCure manages cybersecurity risks through technology, ISO certifications, Board oversight, and compliance with HIPAA and GDPR - The company's cybersecurity risk management is overseen by the **Board's Audit Committee**, which receives updates **at least quarterly**[297](index=297&type=chunk) - NovoCure holds **ISO 13485** (quality management for medical devices) and **ISO 27001** (information security) **certifications**, which require **annual independent audits**[296](index=296&type=chunk) - The company complies with major data privacy laws in its operating jurisdictions, including **HIPAA** in the U.S. and **GDPR** in the EU[298](index=298&type=chunk) [Properties](index=56&type=section&id=Item%202.%20Properties) NovoCure's primary facilities are leased in Switzerland, the U.S., and Israel, with a new U.S. flagship under construction - The company's main global facilities in Switzerland, the U.S., and Israel are **leased**[299](index=299&type=chunk) - A property was **acquired in Portsmouth, New Hampshire**, in December 2021, with construction for a **new U.S. flagship location** expected to be **completed in 2024**[300](index=300&type=chunk) [Legal Proceedings](index=57&type=section&id=Item%203.%20Legal%20Proceedings) A class action lawsuit was filed in June 2023 against NovoCure and executives regarding LUNAR trial results, which the company will defend - A **putative class action lawsuit** was filed in **June 2023** against the company and its executives concerning public statements about the **phase 3 LUNAR clinical trial results**[301](index=301&type=chunk) - The company believes the action is **without merit** and plans to **defend the lawsuit vigorously**[301](index=301&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=59&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) NovoCure's ordinary shares trade on NASDAQ under 'NVCR'; no dividends have been paid, and equity compensation plan data is provided - The company's ordinary shares are traded on the **NASDAQ Global Select Market** under the symbol **NVCR**[315](index=315&type=chunk) - The company has **not paid any dividends** since its inception and does not plan to in the foreseeable future[316](index=316&type=chunk) Equity Compensation Plan Information (as of Dec 31, 2023) | Plan Category | Number of Securities to be Issued Upon Exercise | Weighted Average Exercise Price | Number of Securities Remaining Available for Future Issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by shareholders | 14,352,573 | $23.84 | 28,632,049 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=61&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2023, net revenues decreased **5%** to **$509.3 million**, resulting in a **$207.0 million** net loss due to lower revenues and higher operating expenses [Results of Operations](index=65&type=section&id=Results%20of%20Operations) In 2023, net revenues fell **5%** to **$509.3 million**, gross margin declined to **75%**, and operating expenses rose **20%**, resulting in a **$207.0 million** net loss Consolidated Statements of Operations Data (in thousands) | | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Net revenues | $509,338 | $537,840 | $535,031 | | Gross profit | $381,058 | $422,973 | $420,154 | | Total operating costs and expenses | $613,928 | $512,496 | $464,487 | | Operating income (loss) | $(232,870) | $(89,523) | $(44,333) | | Net income (loss) | $(207,043) | $(92,534) | $(58,351) | | Basic and diluted net income (loss) per share | $(1.95) | $(0.88) | $(0.56) | - Net revenues decreased by **5%** in 2023, primarily due to a **$48.4 million** reduction in collections from denied or appealed claims in the U.S[359](index=359&type=chunk) - Sales and marketing expenses increased by **31%** to **$226.8 million**, largely due to costs for geographic expansion and pre-launch activities for the anticipated NSCLC indication[367](index=367&type=chunk) [Key Performance Indicators](index=65&type=section&id=Key%20Performance%20Indicators) Active patients on therapy increased to **3,755** in 2023, driven by international growth, and total prescriptions rose to **6,083** Commercial Operating Statistics | Metric | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | **Active patients at period end** | | | | | United States | 2,162 | 2,164 | 2,259 | | International markets - Total | 1,593 | 1,266 | 1,328 | | **Total** | **3,755** | **3,430** | **3,587** | | **Prescriptions received in period** | | | | | United States | 3,912 | 3,790 | 3,770 | | International markets - Total | 2,171 | 1,739 | 1,892 | | **Total** | **6,083** | **5,529** | **5,662** | [Liquidity and Capital Resources](index=68&type=section&id=Liquidity%20and%20Capital%20Resources) Cash and investments totaled **$910.6 million** at year-end 2023, a **$58.8 million** decrease due to operating losses, but capital is sufficient for 12 months - The company's cash, cash equivalents, and short-term investments totaled **$910.6 million** at year-end 2023, down from **$969.4 million** at year-end 2022[375](index=375&type=chunk) Summary of Cash Flows (in thousands) | | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $(73,336) | $30,788 | $82,756 | | Net cash provided by (used in) investing activities | $184,148 | $(139,957) | $(144,834) | | Net cash provided by (used in) financing activities | $15,787 | $15,491 | $25,702 | - The company holds **$575 million** of 0% Convertible Senior Notes due in 2025. In February 2023, the company terminated its **$150 million** senior secured revolving credit facility, under which no balance was outstanding[387](index=387&type=chunk)[392](index=392&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=72&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks are interest rate sensitivity on investments and foreign currency exchange risk, with no current hedging for currency exposure - The primary market risks are interest rate sensitivity on its **$910.6 million** investment portfolio and foreign currency exchange risk from global operations[408](index=408&type=chunk)[409](index=409&type=chunk) - Due to the short-term nature of its investments, a hypothetical **10%** change in market interest rates is not expected to materially impact financial results[410](index=410&type=chunk) - The company does not currently hedge its foreign currency exchange risk[411](index=411&type=chunk) [Financial Statements and Supplementary Data](index=74&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents audited consolidated financial statements and the independent auditor's unqualified opinion, with revenue recognition as a critical audit matter Consolidated Balance Sheet Highlights (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | **$1,146,129** | **$1,191,648** | | Cash, cash equivalents & short-term investments | $910,616 | $969,425 | | **Total Liabilities** | **$783,633** | **$750,478** | | Long-term debt, net | $568,822 | $565,509 | | **Total Shareholders' Equity** | **$362,496** | **$441,170** | - The independent auditor, Kost Forer Gabbay & Kasierer, issued an **unqualified opinion** on the financial statements and internal controls over financial reporting[414](index=414&type=chunk)[425](index=425&type=chunk) - The auditor identified revenue recognition, specifically the measurement of variable consideration from implicit price concessions, as a **critical audit matter** due to the challenging judgment and subjective management assumptions involved[418](index=418&type=chunk)[420](index=420&type=chunk)[421](index=421&type=chunk) [Controls and Procedures](index=111&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with an unqualified auditor's opinion - Management concluded that both disclosure controls and procedures and internal control over financial reporting were **effective** as of December 31, 2023[595](index=595&type=chunk)[597](index=597&type=chunk) - The independent registered public accounting firm provided an **unqualified attestation report** on the effectiveness of the company's internal control over financial reporting[598](index=598&type=chunk) Part III [Directors, Executive Compensation, and Corporate Governance](index=113&type=section&id=Items%2010-14) Information for Items 10-14, including directors, executive compensation, and corporate governance, is incorporated by reference from the 2024 proxy statement - Information regarding directors, executive officers, corporate governance, executive compensation, security ownership, related party transactions, and principal accountant fees is **incorporated by reference** from the forthcoming 2024 proxy statement[605](index=605&type=chunk)[606](index=606&type=chunk)[607](index=607&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=114&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists financial statements, schedules, and exhibits filed with the 10-K, including governance documents, material contracts, and certifications - This section provides a **comprehensive list of all exhibits** filed with the 10-K, including governance documents, material contracts (such as the Zai Lab agreement and debt indentures), and executive compensation plans[621](index=621&type=chunk)[622](index=622&type=chunk)[623](index=623&type=chunk) - **Certifications** by the Principal Executive Officer and Principal Financial Officer as required by the **Sarbanes-Oxley Act** are included as exhibits[624](index=624&type=chunk)
novocure(NVCR) - 2023 Q3 - Earnings Call Presentation
2023-10-26 15:17
patientforward HR, hazard ratio; ICI, immune checkpoint inhibitor; TTFields, Turnor Treating Fields; © 2023 Novocure GmbH phase 3 LUNAR trial met primary overall survival endpoint Overall survival (ITT population) 1.0 1.0 · 0.9 0.9 13.2 9.9 18.5 Median OS (months) MedianOS (months) 10.8 0.8 0.8 Log-rank P-value 0.035 0.03 Log-rank P-value HR (95% CI) HR (95% CI) 0.74 (0.56-0.98) 0.63 (0.41-0.96) 0.7 0.7 7% (2-15) 3-year survival (95% Cl) 18% (11-27) 3-year survival (95% Cl) 27% (15-42) 9% (3-21) bability of ...
novocure(NVCR) - 2023 Q3 - Quarterly Report
2023-10-26 11:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37565 NovoCure Limited Washington, D.C. 20549 _______________________________________________________ (Exact Name of Registrant as Specified in Its ...
novocure(NVCR) - 2023 Q2 - Quarterly Report
2023-07-27 11:02
For the quarterly period ended June 30, 2023 Washington, D.C. 20549 _______________________________________________________ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37565 NovoCure Limited (Exact Name of Registrant as Specified in Its Char ...
novocure(NVCR) - 2023 Q1 - Quarterly Report
2023-05-04 11:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________________________________________ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-37565 NovoCure Limited (Exact Name of Registrant as Specified in Its Cha ...