Sep 29, 2025 4:30 PM Eastern Daylight Time Novocure to Present Final Results from the Pivotal Phase 3 METIS Trial of its Tumor Treating Fields (TTFields) Therapy for Brain Metastases from Non- Small Cell Lung Cancer at 2025 ASTRO Annual Meeting Share METIS trial achieved its primary endpoint, showing a statistically significant delay in time to intracranial progression in patients receiving TTFields therapy and best supportive care following stereotactic radiation of the metastases Results from the METIS tr ...

Core Insights - NovoCure's mission is to extend survival in aggressive cancer forms through Tumor Treating Fields technology [2] - The company is transitioning from a single indication focus, primarily on GBM, which generates $600 million in revenue, to a multi-indication platform [3] - By the end of 2026, NovoCure aims to have four products, creating a diversified revenue stream and a clear path to profitability [3]

Summary of Novocure FY Conference Call - September 10, 2025 Company Overview - **Company**: Novocure (NasdaqGS: NVCR) - **Industry**: Oncology, specifically focused on Tumor Treating Fields technology Core Points and Arguments 1. **Mission and Focus**: Novocure aims to extend survival in aggressive cancers through Tumor Treating Fields, transitioning from a single indication (GBM) to a multi-indication platform with expected revenues of $600 million from GBM alone [2][18]. 2. **Product Pipeline**: By the end of 2026, Novocure anticipates having four products, including: - Optune for non-small cell lung cancer (NSCLC) - A product for pancreatic cancer - A product for brain metastases from NSCLC [6][26]. 3. **GBM as a Foundation**: GBM serves as a stable revenue source with mid-single-digit growth, providing cash flow to support future investments [5][11]. 4. **Market Strategy**: The company plans to leverage its experience in GBM to enhance the launch of new products, focusing on education and market penetration strategies [6][30]. 5. **Clinical Trials**: Upcoming trials, such as the Trident trial, aim to explore the potential for improved survival by starting treatment earlier in the patient journey [10][15]. The KEYNOTE D58 trial will investigate the combination of Tumor Treating Fields with immunotherapy [17]. 6. **Challenges in NSCLC Launch**: The launch of Optune for NSCLC has faced challenges due to a competitive landscape and the need for extensive education in a device-based approach [19][20]. 7. **Geographic Expansion**: Japan is identified as a key market for future growth, with expectations for approval and reimbursement in the near term [21][22]. 8. **Path to Profitability**: Novocure is committed to achieving profitability through top-line growth and has a strong cash position of over $900 million, which supports its operational needs [35][38]. Important but Overlooked Content 1. **Reimbursement Dynamics**: The reimbursement process in the U.S. is primarily dependent on Medicare, which constitutes 75% of the payer population. The company is optimistic about future reimbursement discussions [22]. 2. **Luminar 4 Trial Suspension**: The Luminar 4 trial was suspended to pivot towards real-world evidence, reflecting a strategic decision to maintain cash flow while addressing relevant scientific questions [24][25]. 3. **Device Education**: The importance of educating prescribers about the device's functionality has been emphasized as a key learning from the NSCLC launch, indicating a shift in marketing strategy [30][31]. 4. **Market Perception**: There is a noted disconnect between the company's fundamentals and its current valuation, attributed to confidence issues rather than operational performance [40][41]. Conclusion - Novocure is transitioning into a multi-indication platform with a strong foundation in GBM, aiming for significant growth through new product launches and strategic market expansions. The company is focused on achieving profitability while navigating challenges in competitive markets and reimbursement landscapes.

Summary of Novocure's Conference Call Company Overview - **Company**: Novocure - **Technology**: Tumor Treating Fields (TTFields) technology, which uses electric fields to disrupt cancer cell division and stimulate immune responses [2][3] Core Points and Arguments - **Mission**: Novocure aims to extend survival for patients with aggressive cancers through the commercialization of TTFields [2] - **Current Revenue**: The company generates approximately $600 million in net revenues annually from its GBM (glioblastoma) business, which has been operational for nearly 10 years [4] - **Growth Rate**: GBM business is classified as a mid-single-digit growth engine, with active patient growth between 6% and 12% over the last nine quarters [6] - **Expansion Plans**: Novocure is preparing to launch three additional indications: lung cancer, pancreatic cancer, and brain metastases, expected by the end of next year [4][6] Market Dynamics - **Lung Cancer Launch**: The launch of the lung cancer indication has faced challenges due to high competition and the need for medical education in a drug-dominated market [9][10] - **Pancreatic Cancer Opportunity**: The pancreatic cancer indication is anticipated to provide significant growth, with an estimated market size of about 16,000 patients in the U.S., which is double the GBM incidence [22] - **International Expansion**: Novocure has launched in the U.S. and Germany, with plans to enter the Japanese market, which presents a larger opportunity for future indications [16][17] Clinical Insights - **PINOVA-4 Trial**: The trial for pancreatic cancer has shown a two-month extension in overall survival and a six-month extension in pain-free survival, generating significant interest from the medical community [19][20] - **Combination Therapies**: Novocure is exploring combinations of TTFields with immune checkpoint inhibitors, showing potential for enhanced efficacy in previously resistant tumor microenvironments [30][31] Product Development - **Device Innovations**: Novocure is working on next-generation arrays to improve patient experience and device efficacy, with plans for torso versions of the arrays [32][34] - **Regulatory Submissions**: The company has submitted a PMA for pancreatic cancer and is preparing for a modular submission for brain metastases, with expected launches in the second half of next year [38] Upcoming Milestones - **Catalyst Events**: Key upcoming milestones include: - Approval of non-small cell lung cancer in Japan - Readout of the PINOVA-4 trial in early 2024 - Launch preparations for pancreatic cancer and brain metastases indications [40][41] Additional Considerations - **Market Education**: The company emphasizes the importance of educating the medical community to facilitate the adoption of its device-based therapies in a predominantly drug-focused oncology landscape [10][13] - **Financial Leverage**: Novocure has a well-established commercial infrastructure that allows for leveraging existing resources to support new product launches [14][27] This summary encapsulates the key points discussed during the conference call, highlighting Novocure's strategic direction, market opportunities, and clinical advancements.

Financial Data and Key Metrics Changes - The company is experiencing mid single-digit growth in the GBM business, which serves as a foundation for launching three new indications by the end of next year [73][80] - The company anticipates reaching EBITDA positive at sales of $700 million, with a belief that they will achieve this quicker than market expectations [74][76] - The company has over $900 million on the balance sheet and expects to exit the year with more than $400 million after paying off a convertible note [77] Business Line Data and Key Metrics Changes - GBM prescriptions have slightly declined, but active patients have grown, indicating a strategic focus on fillable prescriptions [10][12] - The launch of non-small cell lung cancer (NSCLC) is behind expectations, with the company acknowledging the challenges in the competitive landscape [14][16] - The pancreatic cancer indication is expected to have a regulatory decision in 2026, with strong community response and meaningful data [36][40] Market Data and Key Metrics Changes - The company is focusing on a multi-indication strategy, with four indications expected to be in the market by the end of next year [6][14] - The competitive landscape for lung cancer is described as highly competitive and rapidly evolving, impacting the launch trajectory [15][22] - The company sees a significant unmet need in the post-platinum setting for lung cancer, which they believe will drive future growth [21][29] Company Strategy and Development Direction - The company is committed to a multi-indication platform and profitability, leveraging established commercial infrastructure [6][7] - There is a clear path to profitability, with a focus on executing their strategy and demonstrating value to investors [9][73] - The company is open to partnerships and collaborations to enhance the use of Tumor Treating Fields in combination with other treatments [100][101] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that investor confidence is currently low, but they believe the fundamentals are strong [9][8] - The company is focused on education and awareness in the medical oncology community, particularly for the lung cancer indication [18][22] - Management expresses confidence in the future growth potential across multiple indications, despite current challenges [20][63] Other Important Information - The TRIDENT trial, which will read out in the first half of next year, has the potential to materially accelerate GBM growth if positive [88][90] - The company is preparing for the launch of Brain METs, with a successful trial showing significant results [65][68] - The pancreatic cancer indication is viewed as a high unmet need, with the potential for significant market impact [40][63] Q&A Session Summary Question: What do you think investors are missing? - Management believes investors are underappreciating the solid foundation in GBM, the established commercial platform, and the clear path to profitability [9][8] Question: Why are GBM prescriptions declining? - The decline is intentional as the focus is on ensuring prescriptions are fillable and lead to active patients [10][12] Question: What lessons have been learned from the lung cancer launch? - The education of the device in the medical oncology community is more challenging than anticipated, and adjustments have been made to marketing strategies [18][19] Question: How should we think about the lung cancer opportunity going forward? - Management acknowledges that while the opportunity is real, the growth trajectory is slower than expected [22][24] Question: What is the status of the pancreatic cancer filing? - The filing is expected to lead to a regulatory decision in 2026, with strong community interest and meaningful data [36][40] Question: How does the company view potential peak sales for pancreatic cancer? - Management believes pancreatic cancer could have a similar penetration to GBM, given the high unmet need [46][50] Question: What is the company's cash position and outlook for breakeven? - The company is confident in its cash position and believes it has sufficient funds to reach breakeven [76][77]

Company Overview - NovoCure Limited (NVCR) submitted a premarket approval (PMA) application to the FDA for Tumor Treating Fields (TTFields) therapy aimed at treating locally advanced pancreatic cancer, with a decision expected in the second half of 2026 [1][9] - The PMA submission is a significant milestone for NovoCure, likely enhancing its position in the global oncology market [2] Financial Performance - NovoCure currently has a market capitalization of $1.33 billion and a price-to-sales (P/S) ratio of 2.1, which is lower than the industry average of 5.8 [4] - In the last reported quarter, NVCR achieved an earnings surprise of 7.7% [4] - The company reported a 5.6% year-over-year increase in total net revenues for the second quarter of 2025, driven by active patient growth [8] Clinical Development - The PMA application is supported by the PANOVA-3 trial, which assessed TTFields therapy in combination with gemcitabine and nab-paclitaxel as a first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma [5] - The PMA for pancreatic cancer is submitted as a supplement to the existing PMA for Optune Lua, which is currently indicated for non-small cell lung cancer [6] Market Potential - The global pancreatic cancer treatment market is projected to grow from $2.92 billion in 2024 to $5.84 billion by 2030, at a compound annual growth rate (CAGR) of 12.3% [7] - Factors such as the rise in lifestyle-related diseases and an aging population are expected to drive market growth, presenting significant opportunities for NovoCure [7] Stock Performance - Following the announcement of the PMA submission, NVCR shares declined by nearly 1.3% [3] - Over the past year, NVCR's stock has decreased by 33.2%, compared to a 14% decline in the industry and a 13.8% gain in the S&P 500 [10]

Company Overview - Novocure Limited (NASDAQ: NVCR) develops wearable devices that generate Tumor Treating Fields (TTFields) for the treatment of aggressive cancers [1] - The company has approved devices such as Optune and Optune Gio specifically for treating glioblastoma (GBM) [1] Product Details - Optune Lua is another device developed by Novocure, aimed at assisting in cancer treatment [1]

Core Points - Novo Nordisk's stock has dropped 21% following a reduction in full-year guidance, overshadowing the appointment of a new CEO [1][2] - The company has lowered its sales growth forecast from 13%-21% to 8%-14% and its operating profit guidance from 16%-24% to 10%-16% [3] - Weaker U.S. sales of its weight loss drugs, Wegovy and Ozempic, were cited as a reason for the guidance cut [4] Company Leadership - Novo Nordisk appointed Mike Doustdar as the new CEO, effective August 7, following the unexpected removal of the previous CEO, Lars Fruergaard Jørgensen [2] - The board chairman expressed optimism about the leadership change, but investor sentiment was negatively impacted by the guidance cut [2] Financial Outlook - The company is facing significant competition from compounded versions of its drugs, but this threat is expected to diminish as the FDA restricts their sales [5] - Novo Nordisk's stock is currently trading at one of its lowest price-to-earnings ratios in nearly 30 years, presenting a potential investment opportunity [5]

Core Insights - NovoCure reported revenue of $158.81 million for the quarter ended June 2025, reflecting a year-over-year increase of 5.6% [1] - The company's EPS was -$0.36, a slight decline from -$0.31 in the same quarter last year [1] - Revenue exceeded the Zacks Consensus Estimate of $153.83 million by 3.24%, while EPS also surpassed expectations by 7.69% [1] Financial Performance - The reported revenue of $158.81 million indicates a positive trend compared to the previous year [1] - EPS of -$0.36 shows a deterioration in earnings performance compared to the prior year's -$0.31 [1] - The company achieved a revenue surprise of +3.24% and an EPS surprise of +7.69% against analyst estimates [1] Geographic Revenue Breakdown - Revenue from Greater China was $4.59 million, exceeding the average estimate of $3.7 million [4] - Revenue from Japan reached $9.48 million, surpassing the average estimate of $8.54 million [4] - Revenue from the United States was $94.26 million, slightly above the average estimate of $93.78 million [4] Stock Performance - NovoCure's shares have declined by 4.7% over the past month, contrasting with a 5.7% increase in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Core Viewpoint - Novocure's fiscal Q2 2025 results showed a 6% increase in revenue year-over-year, exceeding Wall Street expectations, while the company continues to develop noninvasive treatments for solid-tumor cancers [3][5]. Financial Performance - Revenue for Q2 2025 was $158.8 million, compared to $150.4 million in Q2 2024, marking a 6% increase [2]. - Earnings per share for Q2 2025 were -$0.36, slightly worse than -$0.31 in Q2 2024, but still beating expectations [2]. - Gross margin decreased to 74% from 77%, a decline of 300 basis points attributed to new product rollout costs [2][4]. - Total active patients increased from 3,963 in Q2 2024 to 4,331 in Q2 2025, a growth of 9% [2]. Product Development and Market Strategy - Revenue from the Optune Lua lung cancer treatment was $2.4 million, following its U.S. approval last fall [3]. - The company plans to seek FDA premarket approval for treatments targeting pancreatic and brain cancers by the end of the year, with trial data expected in the first half of 2026 [6]. Market Reaction - The market response to the results was muted, with Novocure's stock up about 2% in premarket trading, indicating that the results were largely in line with expectations [5]. Long-term Outlook - Despite the current progress, Novocure's stock has seen a significant decline of over 92% from its 2021 high due to previous disappointing trial results, highlighting the inherent risks in biotech investments [7].