Core Viewpoint - Gilead Sciences announced that its breast cancer drug Trodelvy did not achieve the primary endpoint in a late-stage clinical trial [1] Company Summary - Gilead Sciences is facing a setback with its breast cancer treatment Trodelvy, as the drug failed to meet the main goal in a significant study [1]

Core Insights - Gilead Sciences showcased multiple products at the 8th China International Import Expo, including two Asia debut products: long-acting HIV pre-exposure prophylaxis drug Lenacapavir and a new drug for primary biliary cholangitis (PBC) named Seladelpar [1][2] Group 1: Lenacapavir - Lenacapavir is a globally first-of-its-kind long-acting HIV capsid inhibitor that requires administration only twice a year, demonstrating over 99.9% effectiveness in preventing HIV based on global Phase III clinical studies [1] - Lenacapavir has received several prestigious recognitions, including being ranked first in Science magazine's "Top 10 Scientific Breakthroughs of 2024" and being included in Time magazine's "Best Inventions of 2025" [1] - The drug was approved for HIV pre-exposure prophylaxis in Hainan Boao Lecheng International Medical Tourism Pilot Zone in late June, almost simultaneously with the approval from the U.S. FDA [1] Group 2: Seladelpar - Seladelpar is an innovative drug targeting patients with primary biliary cholangitis, a chronic autoimmune liver disease recognized as a "silent killer" and included in the National Health Commission's list of rare diseases in 2023 [2] - The drug is the first global therapy that can improve biochemical indicators in PBC patients while alleviating itching symptoms, which significantly impact the quality of life [2] - Seladelpar was approved in August under Beijing's clinical urgent import policy, marking a significant step in addressing the needs of PBC patients [2] Group 3: Gilead's Market Presence - Gilead Sciences has launched 13 global innovative drugs in China over the past eight years, benefiting approximately 1.8 million patients [2] - At the expo, Gilead plans to deepen collaborations with various parties to enhance the accessibility of innovative drugs and promote standardized diagnosis and treatment [2]

Core Viewpoint - The China International Import Expo (CIIE) is significantly accelerating the speed at which innovative drugs enter the Chinese market, transforming the landscape for multinational pharmaceutical companies and benefiting countless patients [3][8]. Group 1: Innovative Drug Launches - A groundbreaking drug for delaying the progression of type 1 diabetes, Trelagliptin, made its Asian debut at the CIIE and received approval for market entry in September [10]. - Sanofi's innovative cardiovascular drugs and Gilead Sciences' long-acting HIV prevention drug, Lenacapavir, were showcased at the CIIE, indicating a trend of faster access to top-tier medications for Chinese patients [6][18]. - The "CIIE speed" is exemplified by Sanofi's drug Dupixent, which received approval in China ahead of the U.S. FDA, showcasing a record time for innovative drugs to benefit Chinese patients [11]. Group 2: Market Strategy and Investment - Multinational pharmaceutical companies are shifting from merely introducing products to deeper, full-industry chain strategies in China, with Sanofi establishing China as an independent strategic market unit [20][22]. - Novartis has conducted over 100 clinical trials in China and aims for 90% of new drug registrations to align with global timelines within the next two years [28]. - Gilead Sciences is focusing on synchronizing its research and development projects in China with global efforts, emphasizing the importance of the Chinese market [23][26]. Group 3: CIIE's Spillover Effect - The CIIE is not only expediting drug launches but also creating a "spillover effect" that enhances the overall healthcare landscape in China, allowing for broader access to innovative treatments [15][17]. - Since its inception, Novartis has had over 40 innovative drugs and indications approved in China, accounting for 40% of its total approvals in the country since 1987 [15]. - The CIIE serves as a high-level open platform that fosters consensus, innovation, and collaboration among pharmaceutical companies, ultimately changing the lives of Chinese patients [17].

Financial Data and Key Metrics Changes - Total operating loss from continuing operations for the first nine months of 2025 amounted to EUR 462.2 million, compared to an operating loss of EUR 125.6 million for the same period in 2024 [24] - Net other financial income for the first nine months of 2025 was EUR 30.4 million, down from EUR 71.7 million in the same period of 2024 [25] - Cash and cash equivalents and current financial investments totaled EUR 3.05 billion on September 30, 2025, compared to EUR 3.32 billion on December 31, 2024 [26] Business Line Data and Key Metrics Changes - The company intends to wind down the self-therapy business due to significant ongoing investment requirements and lack of viable acquisition proposals [6][7] - The remaining organization will focus on transformational business development and maintaining a dedicated presence at headquarters in Mechelen, Belgium [10] Market Data and Key Metrics Changes - The cash balance of approximately EUR 3 billion represents about EUR 46 per share, generating significant interest income [12] - The company expects to receive tax receivables of approximately EUR 20 million to EUR 35 million per year over the next three years [13] Company Strategy and Development Direction - The company is undergoing a transformation, focusing on business development and rebuilding its pipeline after the decision to wind down the self-therapy business [4][5] - The strategy includes identifying and executing on opportunities that can enhance the standard of care in various diseases, particularly in partnership with Gilead [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, emphasizing the importance of a disciplined approach to business development and the potential for significant value creation [28] - The company anticipates being cash flow neutral to positive by the end of 2026, excluding any business development activities [27] Other Important Information - The company has welcomed four new board members to enhance its leadership team [9] - The wind-down process is expected to conclude in the first quarter of 2026, with consultations ongoing with works councils in Belgium and the Netherlands [11] Q&A Session Summary Question: What assumptions are behind the expectation of achieving cash flow neutral status by year-end 2026? - The assumptions include interest income based on forward rates, tax credits, and the completion of the wind-down process [30] Question: What types of opportunities are in the deal funnel? - The focus is on clinically de-risked mid to late-stage opportunities, particularly in oncology and immunology, with a preference for collaboration with Gilead [31][32] Question: How does the company balance being conservative with pursuing business development? - The company aims to leverage its cash balance and existing assets while ensuring any new opportunities create a positive return [33] Question: What expectations does the company have for Gilead's contribution to the deal process? - Gilead is expected to provide expertise in diligence and potentially contribute capital for development [35] Question: What is the timeline for the wind-down process of the cell therapy business? - The wind-down process is expected to be concluded in Q1 2026, with the company open to viable proposals during this time [44] Question: Will potential transactions bring in R&D capabilities? - The company is flexible regarding R&D capabilities, considering both acquiring teams and funding external parties [50]

Core Insights - The cell and gene therapy (CGT) sector is experiencing a dichotomy, with major pharmaceutical companies entering the CAR-T therapy space while others are exiting, indicating a complex market landscape [1][2][10]. Group 1: Market Dynamics - The CGT market has seen rapid growth, with 46 CGT products approved by the FDA and approximately 3,600 active INDs [2]. - Despite the approval of over 10 CAR-T therapies globally, only a few have achieved blockbuster status, with Gilead's Yescarta showing a sales growth of only 4.81% in 2024 [3][4]. - The commercial performance of most CAR-T therapies has been disappointing, with high costs and market access issues limiting their success [6][9]. Group 2: Economic Challenges - The CGT sector faces significant economic challenges, including high R&D costs (estimated at $1.7 to $2.3 billion for CGT drugs compared to $1.25 to $1.48 billion for traditional drugs) and high production costs due to the personalized nature of treatments [11][12]. - The pricing of CAR-T therapies is exorbitant, with Carvykti priced over $500,000 in the U.S. and similar high costs in China, which restricts market accessibility [8][13]. Group 3: Industry Exits - Major multinational corporations (MNCs) like Takeda and Novo Nordisk have announced exits from the CGT space, indicating a shift in focus from technology-driven enthusiasm to financial viability [10][11]. - The industry's narrative has shifted from a focus on unique treatment mechanisms to a more pragmatic assessment of economic returns, highlighting the unsustainable nature of current CGT investments [11]. Group 4: Path to Recovery - The CGT industry is exploring various strategies to overcome its challenges, including the development of off-the-shelf CAR-T therapies to reduce costs and improve accessibility [14]. - Expanding the indications for CGT drugs to target larger patient populations is seen as a potential avenue for growth, similar to how Novartis expanded the application of siRNA therapies [17]. - The shift towards in vivo CAR-T therapies aims to simplify processes and reduce costs significantly, with predictions suggesting treatment costs could drop by an order of magnitude [18]. Group 5: Future Directions - The future of the CGT sector hinges on technological advancements that enhance accessibility, with a focus on universal CAR-T, in vivo therapies, and next-generation delivery technologies [19]. - The strategic movements of MNCs signal a paradigm shift in the industry, emphasizing the need to convert cutting-edge technology into sustainable business models for long-term success [19].

Group 1 - Gilead Sciences showcased 13 innovative drugs at the China International Import Expo, emphasizing their commitment to creating a healthier world [1] - The long-acting HIV pre-exposure prophylaxis drug, Lenacapavir, is the first of its kind approved globally, requiring administration only twice a year, and has recently been applied in China [1] - The expo featured numerous cutting-edge medical technologies, including Siemens Healthineers' photon-counting CT and Medtronic's first rechargeable closed-loop spinal cord stimulation system [1] Group 2 - This year's expo saw an increase in reception and negotiation spaces for pharmaceutical companies, indicating a growing emphasis on business interactions [2] - A centralized signing hall was established for procurement activities, with nearly 200 buyers from central enterprises and health authorities expected to engage in over 70 signing events [2] - The overall theme of the expo is focused on collaboration to create a healthier world through new products, technologies, and services [3]

Core Insights - The China International Import Expo (CIIE) serves as a significant platform for global companies to showcase their innovations and engage with key decision-makers in the Chinese pharmaceutical market [1][2][3] - Gilead Sciences has experienced the benefits of the CIIE, particularly in accelerating the approval and market entry of innovative therapies in China [1][2][3] Policy and Regulatory Environment - China's continuous policy reforms in drug approval processes have created a favorable environment for innovative drugs, enhancing the attractiveness of the Chinese market for multinational pharmaceutical companies [1][2] - The establishment of expedited approval channels for breakthrough therapies and conditional approvals has significantly reduced the time for innovative drugs to enter the Chinese market [2][3] Market Dynamics and Opportunities - The CIIE has become a "policy windfall" and "information hub" for new drugs entering China, allowing companies to effectively communicate with regulatory bodies and enhance product recognition among healthcare professionals and patients [2][3] - Gilead's innovative drugs, such as Lenacapavir and Seladelpar, have demonstrated rapid approval and market entry following their showcases at the CIIE, highlighting the event's role in expediting access to new treatments [3][4][7] Collaboration and Local Partnerships - Gilead is actively pursuing collaborations with local pharmaceutical companies and healthcare platforms to strengthen its supply chain and enhance product accessibility in China [9][10] - The company is also focusing on educational initiatives to reduce stigma around diseases like HIV, thereby fostering a more informed patient population and improving market conditions [9][10] Future Directions - Gilead plans to continue its focus on both treatment and prevention in the HIV space, exploring innovative dosing regimens to improve patient adherence [8][9] - The company is engaged in multiple clinical studies globally, with a significant emphasis on advancing HIV treatment and prevention strategies [8][11] - Gilead's ongoing partnerships and collaborations with local innovators reflect a broader trend of multinational companies seeking to capitalize on China's growing pharmaceutical market [12]

Group 1: Gilead Sciences Inc - Gilead Sciences reported a revenue of $6.4 billion for the last quarter, reflecting a 5% increase year-over-year [1] - The company’s antiviral drug sales, particularly for HIV and COVID-19 treatments, contributed significantly to the revenue growth [1] - Gilead's pipeline includes promising candidates for oncology and inflammatory diseases, which may enhance future growth prospects [1] Group 2: Applied Materials Inc - Applied Materials achieved a revenue of $6.2 billion, marking a 10% increase compared to the previous year [1] - The semiconductor equipment segment showed strong demand, driven by advancements in AI and 5G technologies [1] - The company anticipates continued growth in the semiconductor market, supported by increased capital expenditures from major customers [1] Group 3: Salesforce Inc - Salesforce reported a revenue of $7.4 billion, up 14% year-over-year, driven by strong demand for its cloud-based solutions [1] - The company’s focus on expanding its product offerings and enhancing customer experience has led to increased customer retention [1] - Salesforce is investing in AI capabilities to further enhance its platform, which is expected to drive future growth [1]

Group 1 - The eighth China International Import Expo opened on November 5, showcasing Gilead's commitment to creating a healthier world with a 500 square meter exhibition space [1] - Gilead presented two Asia debut products: long-acting HIV pre-exposure prophylaxis drug Lenacapavir and a new drug for primary biliary cholangitis (PBC) Seladelpar, along with 13 innovative drugs launched in China [1] - Gilead's global vice president and general manager for China, Jin Fangqian, emphasized the company's accelerated development in China, highlighting the transformation of several "Expo babies" from exhibits to commercial products [1] Group 2 - Gilead plans to sign nearly ten cooperation projects at the expo to enhance the accessibility of innovative drugs and promote standardized diagnosis and treatment [2] - Jin Fangqian expressed confidence in Gilead's long-term development in China, citing the country's efforts in expanding openness, strengthening intellectual property protection, and optimizing the business environment [2] - The company aims to support the high-quality development of China's healthcare sector and contribute to the "Healthy China 2030" goal [2]

Group 1 - Gilead Sciences showcased its innovative drug, Lenacapavir, which is the world's first long-acting HIV pre-exposure prophylaxis approved for administration twice a year, recently launched in China [1] - The exhibition highlighted 13 innovative drugs launched by Gilead in China, emphasizing the company's commitment to improving drug accessibility and promoting health equity [1] - The event featured various cutting-edge medical technologies, including Siemens Healthineers' photon-counting CT and Medtronic's first-ever rechargeable closed-loop spinal cord stimulation system [1][2] Group 2 - This year's exhibition saw an increase in reception and negotiation spaces for pharmaceutical companies, indicating a growing emphasis on business interactions [2] - A centralized signing hall was established for nearly 200 buyers from central enterprises and health authorities to engage in over 70 signing activities with exhibitors [2] - The overarching theme of the event was to collaboratively "create a healthier world," showcasing new products, technologies, and services [3]