Novocure (NVCR) overview. updated August 2018

Transcription

1 Novocure (NVCR) overview updated August 2018

2 forward-looking statements This presentation contains certain forward-looking statements with respect to the business of Novocure and certain of its plans and objectives, including with respect to the development and commercialization of its lead product candidate, Optune, for a number of oncology indications. These forward-looking statements can be identified in this presentation by the fact that they do not relate only to historical or current facts. Forward-looking statements often use words expect, intend, anticipate, plan, may, should, would, could or other words of similar meaning. These statements are based on assumptions and assessments made by Novocure in light of industry experience and perception of historical trends, current conditions, expected future developments and other appropriate factors. By their nature, forward-looking statements involve risk and uncertainty, and Novocure's performance and financial results could differ materially from those expressed or implied 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 Annual Report on Form 10-K filed on February 22, 2018, or in subsequent quarterly filings with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this presentation. Novocure assumes no obligation to update or correct the information contained in this presentation, whether as a result of new information, future events or otherwise, except to the extent legally required. The statements contained in this presentation are made as at the date of this presentation, unless some other time is specified in relation to them, and service of this presentation shall not give rise to any implication that there has been no change in the facts set out in this presentation since such date. Nothing contained in this presentation shall be deemed to be a forecast, projection or estimate of the future financial performance of Novocure, except where expressly stated. As of the date of this presentation, Optune is only FDA-approved for the treatment of adults with supratentorial glioblastoma, or GBM, and its approval for other indications is not certain. Novocure can provide no assurances regarding market acceptance of Optune or its successful commercialization, and can provide no assurances regarding the company s results of operations or financial condition in the future. This presentation is for informational purposes only and may not be relied upon in connection with the purchase or sale of any security. Novocure

3 Optune indications for use and important safety information INDICATIONS 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. CONTRAINDICATIONS Do not use Optune in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. 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. Do not use Optune in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure. Novocure

4 Optune indications for use and important safety information WARNINGS AND PRECAUTIONS Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure (the device manufacturer). 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. The most common ( 10%) adverse events involving Optune in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression. The most common ( 10%) adverse events seen with Optune monotherapy were medical device site reaction and headache. The following adverse reactions were considered related to Optune when used as monotherapy: medical device site reaction, headache, malaise, muscle twitching, fall and skin ulcer. Use of Optune in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune in these patients could lead to tissue damage or lower the chance of Optune being effective. If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune treatment. Novocure

5 a global oncology company with a proprietary platform GROWING COMMERCIAL BUSINESS More than 2,100 patients on therapy 14 consecutive quarters of patient growth $217 million trailing twelve month revenues Information above as of June 30, 2018 SIGNIFICANT UPSIDE POTENTIAL Increase adoption and average reimbursement in GBM Advance clinical pipeline in five additional solid tumor indications Novocure

6 we can leverage physics to fight cancer AN ELECTRIC FIELD EXERTS FORCES ON CHARGED OBJECTS TUMOR TREATING FIELDS USES ELECTRIC FIELDS TO DISRUPT CELL DIVISION MISALIGNED TUBULINS INTERFERE WITH FORMATION OF MITOTIC SPINDLE ALTERNATING ELECTRIC FIELDS DISRUPT CANCER CELL DIVISION MISALIGNED SEPTINS INTERFERE WITH FORMATION OF CONTRACTILE RING TUMOR TREATING FIELDS DESCRIBES ELECTRIC FIELDS THAT ALTERNATE 100,000 TO 300,000 TIMES PER SECOND TO TARGET CANCER CELLS CANCER CELL DEATH Novocure

7 single therapy provides multiple opportunities in solid tumor cancers CANCERS OF THE CENTRAL NERVOUS SYSTEM CANCERS OF THE CHEST CANCERS OF THE ABDOMEN OTHER Glioblastoma Brain metastases from non-small cell lung cancer Brain metastases from breast cancer Brain metastases from melanoma Ependymoma Medulloblastoma Meningioma Mesothelioma Non-small cell lung cancer Small cell lung cancer Pancreatic cancer Ovarian cancer Liver cancer Renal cell adenocarcinoma Cervical cancer Colorectal carcinoma Gastric adenocarcinoma Urinary transitional cell carcinoma Breast cancer Malignant melanoma PRE-CLINICAL EVIDENCE FIRST IN HUMAN EVIDENCE CLINICAL EVIDENCE FDA APPROVAL Novocure

8 the Optune system ELECTRIC FIELD GENERATOR The portable field generator can be carried with you to generate Tumor Treating Fields as you go about your day. TRANSDUCER ARRAY Sterile, single-use transducer arrays are connected to the electric field generator to deliver therapy. Transducer arrays should be changed at least 2 times per week (every 4 days at most). Steve is an Optune user Novocure

9 In newly diagnosed GBM, Optune plus temozolomide provided an unprecedented long-term survival benefit In Newly diagnosed GBM, Survival with Optune plus TMZ versus TMZ alone was significantly better at the 2- and 5-year landmark analyses Median overall survival in ITT population significantly extended by nearly 5 months (p<0.001) Optune plus TMZ also significantly improved PFS versus TMZ alone GBM, glioblastoma; TMZ, temozolomide; PFS, progression-free survival; ITT, intent-to-treat 1. Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23): Taphoorn MJB, Dirven L, Kanner AA, et al. Influence of treatment with tumor-treating fields on health-related quality of life of patients with newly diagnosed glioblastoma: a secondary analysis of a randomized-clinical trial. JAMA Oncol 2018;4(4) Novocure

10 more time on Optune predicted increased significant survival benefit 86% of patients received a survival benefit from Optune because they used it more than half the time (n=388/450) Based on amount of time Optune was turned on and providing therapy over the course of a month. This data reflects the average patient usage of Optune for the first 6 months of treatment (months 1-6). Approximation, based on monthly usage. vs TMZ alone. TMZ, temozolomide Ram Z, Kim CY, Nicholas GA and Toms S on behalf of EF-14 investigators. Compliance and treatment duration predict survival in a phase 3 EF-14 trial of Tumor Treating Fields with temozolomide in patients with newly diagnosed glioblastoma. Presented at: 2017 Society for Neuro Oncology; November 16-19, 2017; San Francisco, CA. Oral presentation ACTR-27. Novocure

11 five-year survival analysis in most compliant patients (>90%) 1 100% 90% 80% 86% Optune > 90% compliance + temozolomide (n=43) temozolomide alone (n=229) Survival rate (%) 70% 60% 50% 40% 30% 20% 65% 55% 31% 29% 29% 29% 10% 16% 0% 8% 5% Year from randomization 1. Ram Z, Kim CY, Nicholas GA and Toms S on behalf of EF-14 investigators. Compliance and treatment duration predict survival in a phase 3 EF-14 trial of Tumor Treating Fields with temozolomide in patients with newly diagnosed glioblastoma. Presented at: 2017 Society for Neuro Oncology; November 16-19, 2017; San Francisco, CA. Oral presentation ACTR-27. Novocure

12 established commercial operations in six markets across three regions UNITED STATES 9,300 eligible patient population UNITED STATES 30% estimated penetration EMEA 20% estimated penetration EMEA 3,450 eligible patient population JAPAN 1,100 eligible patient population JAPAN 10% estimated penetration Information above as of June 30, 2018 Considers currently active markets: Germany, Switzerland, Austria and Israel Novocure

13 continued growth in active patients active patients at period end ,169 2,009 1,834 1,683 1,460 1,266 1, Q Q Q Q Q Q Q Q Q Q Q Q Q Q CONSECUTIVE QUARTERS OF ACTIVE PATIENT GROWTH SINCE INITIAL PRESENTATION OF EF-14 DATA 8,000+ PATIENTS TREATED TO DATE GLOBALLY U.S. active patients EMEA active patients Japan active patients Novocure

14 direct-to-patient distribution model PHYSICIAN SENDS PHYSICIAN OR NOVOCURE NOVOCURE NOVOCURE BILLS PHYSICIAN SEES PRESCRIPTION NOVOCURE USES DELIVERS OPTUNE PROVIDES 24/7 THIRD-PARTY PATIENT FOR ORDER TO NOVOCURE NOVOTAL SYSTEM TO CREATE ARRAY PLACEMENT MAP AND TRAINS PATIENT/FAMILY TECH SUPPORT AND SUPPLIES TRANSDUCER PAYER AND PATIENT FOR EACH MONTH OF REGULAR COMPLIANCE MONITORING AND ARRAYS THERAPY FOLLOW-UP APPOINTMENTS NOVOCURE Novocure distributes product through hospitals in Japan. Subject to patient assistance programs. Novocure

15 record quarterly revenue of $61.5 million global net revenues (USD in thousands) $70,000 $60,000 $50,000 $40,000 $30,000 $30,242 $34,880 $38,376 $50,109 60% $53,661 $52,125 $61,514 YEAR-OVER-YEAR REVENUE GROWTH Q VS. Q $20,000 $10,000 $5,208 $6,543 $8,953 $12,383 $13,053 $17,919 $21,674 $217 $0 Q Q Q Q Q Q Q Q Q Q Q Q Q Q $33,087 $82,888 $177,026 FY 2015 FY 2016 FY 2017 U.S. net revenues EMEA net revenues Japan net revenues MILLION TRAILING TWELVE MONTH REVENUES Novocure

16 multiple levers for revenue growth in GBM OPPORTUNITY TO INCREASE GBM PENETRATION Category 1 NCCN guidelines recommendation Steady growth in prescriptions for newly diagnosed GBM OPPORTUNITY TO INCREASE NET REVENUES REALIZATION Step-function improvements with national reimbursements, e.g. Medicare Incremental improvements with ongoing market access initiatives OPPORTUNITY TO STRATEGICALLY EXPAND INTO ADDITIONAL MARKETS OVER TIME Current commercial efforts focused on six markets Ability to leverage established organization across three regions Novocure

17 advancing clinical pipeline PHASE II PILOT PHASE III PIVOTAL IN REGISTRATION MILESTONES Brain metastases METIS trial last patient in 2019 with final data collection in 2020 Non-small cell lung cancer LUNAR trial last patient in 2019 with final data collection in 2021 Pancreatic cancer PANOVA 3 trial last patient in 2020 with final data collection in 2022 Ovarian cancer phase three pivotal trial open in 2H 2018 Mesothelioma STELLAR trial data presentation in 2H 2018 Liver cancer HEPANOVA trial first patient in 2H 2018 Trial ongoing Trial complete Novocure

18 completed pilot STELLAR trial in mesothelioma A pilot, non-randomized, open-label study of Tumor Treating Fields (150 khz) concomitant with pemetrexed and cisplatin or carboplatin in patients with previously untreated malignant pleural mesothelioma 80 patients with comparison to historical controls Data will be presented at the 19 th World Conference on Lung Cancer in Toronto on September 25, 2018 Sample size was based the on ability to detect an increase in median overall survival of 5.5 months Pre-submission package for Humanitarian Device Exemption (HDE) application submitted to the FDA in Q EFFICACY ENDPOINTS FOR FIRST 42 PATIENTS WITH AVERAGE FOLLOW-UP OF 11.5 MONTHS TTFIELDS WITH PEMETREXED AND CISPLATIN OR CARBOPLATIN 1 PEMETREXED AND CISPLATIN-ALONE HISTORICAL RESULTS 2 Median PFS 7.3 months 5.7 months Median OS Not yet reached 12.1 months One-year survival rate 79.7% 50.3% Novocure, Ltd. Safety and Efficacy of TTFields (150 khz) Concomitant With Pemetrexed and Cisplatin or Carboplatin in Malignant Pleural Mesothelioma (STELLAR) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US) [cited 2018 May]. Available from: NLM Identifier: NCT Cerasoli, G.L. International Association for the Study of Lung Cancer. OA22.01 STELLAR Interim Results of a Phase 2 Trial of TTFields with Chemotherapy for First Line Treatment of Malignant Mesothelioma. Oral Session: Novel Trials and Biomarkers in Malignant Pleural Mesothelioma. Wednesday, Dec. 7, 2016, 2:20 p.m. CET 2. Vogelzang N.J., Rusthoven J.J., Symanowski J., et al. Phase III Study of Pemetrexed in Combination With Cisplatin Versus Cisplatin Alone in Patients With Malignant Pleural Mesothelioma J Clin Oncol Jul 15;21(14): doi: /JCO Novocure

19 completed pilot PANOVA trial in pancreatic cancer A pilot, double arm, non-randomized, open-label study of Tumor Treating Fields (150 khz) concomitant with gemcitabine and nab-paclitaxel for front-line treatment of pancreatic adenocarcinoma 40 patients (2 cohorts of 20 patients) with comparison to historical controls Data was presented at the ASCO 2016 Gastrointestinal Cancers Symposium in January 2016 and at the 107 th Annual Meeting of the American Association of Cancer Research in April 2017 EFFICACY ENDPOINTS FOR SECOND COHORT TTFIELDS WITH NAB-PACLITAXEL + GEMCITABINE 1 NAB-PACLITAXEL + GEMCITABINE HISTORICAL RESULTS 2 Median PFS 12.7 months 5.5 months Median OS Not yet reached 8.5 months One-year survival rate 72% 35% Partial response rate 40% 23% Stable disease 47% 27% Novocure, Ltd. Safety Feasibility and Effect of TTFields (150 khz) Concomitant With Gemcitabine or Concomitant With Gemcitabine Plus Nab-paclitaxel for Front-line Therapy of Advanced Pancreatic Adenocarcinoma (PANOVA) In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US) [cited 2018 May]. Available from: NLM Identifier: NCT Benavides M. et.al. PANOVA: A phase II study of TTFields (150kHz) concomitant with standard chemotherapy for front line therapy of advanced pancreatic adenocarcinoma In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Abstract CT Von Hoff D.D., Ervin T., Arena F.P., et al. Increased Survival in Pancreatic Cancer with nab-paclitaxel plus Gemcitabine. N Engl J Med Oct 31;369(18): doi: /NEJMoa Novocure

20 robust intellectual property portfolio INTELLECTUAL PROPERTY As of December 31, 2017 over 140 issued patents globally with expected expiration dates as late as 2035 Numerous patents pending worldwide LAYERED PATENT STRATEGY Hold fundamental IP for the use of alternating electric fields in oncology Platform technology, tools and multiple applications covered, including mechanism of action, use of alternating electric fields in combination with chemotherapy and delivery of alternating electric fields through transducer arrays Continue to file patent applications globally as we enhance our technology and applications PMA PATHWAY A BARRIER TO COMPETITION Optune classified as class III, life-sustaining device requiring PMA Anticipate any competitor device would require clinical trials and extensive data Novocure

21 q selected financial highlights U.S. DOLLARS IN THOUSANDS Q Q % CHANGE Q YTD Q YTD % CHANGE Net revenues $ 61,514 $ 38,376 60% $ 113,639 $ 73,256 55% Cost of revenues 19,833 13,152 51% 38,071 24,816 53% Gross profit 41,681 25,224 65% 75,568 48,440 56% Research, development and clinical trials 11,362 9,371 21% 22,466 18,782 20% Sales and marketing 19,196 16,360 17% 37,331 31,116 20% General and administrative 18,208 15,023 21% 35,533 27,445 29% Total operating costs and expenses 48,766 40,754 20% 95,330 77,343 23% Operating income (loss) (7,085) (15,530) 54% (19,762) (28,903) 32% Financial expenses, net 2,860 2,183 31% 7,713 4,629 67% Income (loss) before income taxes (9,945) (17,713) 44% (27,475) (33,532) 18% Income taxes 5,565 3,461 61% 8,759 5,687 54% Net income (loss) $ (15,510 ) $ (21,174 ) 27% $ (36,234 ) $ (39,219 ) 8% Cash and cash equivalents $ 114,456 $ 80,190 $ 114,456 $ 80,190 Short-term investments 104, , , ,186 Novocure

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