Group 1 - The marketplace channel Haggerston BioHealth offers exclusive stock tips focused on Pharma, Biotech, and Healthcare, providing access to investment bank-grade financial models and research [1] - The group caters to both novice and experienced biotech investors, offering insights on catalysts, buy and sell ratings, product sales forecasts, and integrated financial statements [2] - Edmund Ingham, a biotech consultant with over 5 years of experience, leads the Haggerston BioHealth investing group and has compiled detailed reports on over 1,000 companies [2]

This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as 'believes', 'expects', 'anticipates', 'projects', 'intends', 'should', 'seeks', 'estimates', 'future' or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: Thom ...

Core Insights - Roche Holding AG reported better-than-expected results for 2024, with total sales of $68.7 billion, surpassing the Zacks Consensus Estimate of $68 billion, and earnings per American Depositary Receipt of $2.67, exceeding the estimate of $2.56 [1][2] Sales Performance - Total sales grew 7% year over year at constant exchange rates (CER) to CHF 60.5 billion, driven by strong demand for drugs and diagnostics [1] - The Pharmaceuticals Division saw an 8% increase in sales to CHF 46.2 billion, fueled by demand for key drugs such as Vabysmo, Phesgo, Ocrevus, and Hemlibra [3] - The Diagnostics Division's sales rose 4% year over year to CHF 14.3 billion, with a notable drop in COVID-19-related product sales [4] Key Drug Performance - The top four growth drivers—Vabysmo, Phesgo, Ocrevus, and Hemlibra—achieved total sales of CHF 16.9 billion, an increase of CHF 3.3 billion from 2023 [7] - Vabysmo sales surged 68% to CHF 3.9 billion, while Ocrevus generated sales of $6.7 billion, up 9% [7] - Hemlibra sales increased 12% year over year to CHF 4.5 billion [7] Financial Metrics - Core operating profit grew 14%, attributed to higher sales, improved gross margin, and effective cost management [11] - Roche expects total sales to grow in the mid-single-digit range (at CER) in 2025, with core earnings per share anticipated to grow in the high single-digit range [12] Pipeline Developments - Roche acquired Poseida Therapeutics for $9.00 per share, with potential additional payments [13] - The FDA accepted a supplemental Biologics License Application for Columvi for DLBCL, while the phase IIb study of prasinezumab missed its primary endpoint [14][16] Market Position - Roche's shares have risen 10.6% year to date, contrasting with a 1.2% decline in the industry [5] - The company launched two new drugs in 2024—Itovebi for breast cancer and PiaSky for a serious blood disorder [18]

Core Points - Roche announced the appointment of Wafaa Mamilli as Chief Digital Technology Officer (CDTO), effective February 10, 2025, reporting to CEO Thomas Schinecker [1][2] - The role of CDTO is created to focus on digital transformation and artificial intelligence, separating it from the Chief Financial Officer (CFO) responsibilities held by Alan Hippe [2] - Mamilli previously served as Chief Digital & Technology Officer at Zoetis and has over 20 years of experience at Eli Lilly, where she was the global chief information officer [3] Company Overview - Roche, founded in 1896 in Basel, Switzerland, is the world's largest biotechnology company and a leader in in-vitro diagnostics, focusing on scientific excellence to develop medicines and diagnostics [5][6] - The company is committed to sustainability and aims to achieve net zero by 2045, aligning with the Science Based Targets initiative [6] - Genentech, a wholly owned member of the Roche Group, plays a significant role in the company's operations in the United States [6]

Core Insights - Roche announced positive topline results from the phase III INAVO120 study, demonstrating that the Itovebi-based regimen significantly improves overall survival (OS) for patients with advanced PIK3CA-mutated, hormone receptor-positive, HER2-negative breast cancer compared to standard treatments [1][2][7] Group 1: Study Results - The INAVO120 study met its key secondary endpoint, showing a statistically significant OS benefit with the Itovebi-based regimen, which reduced the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone [2][7] - The primary analysis indicated that the Itovebi-based regimen more than doubled progression-free survival, with a median of 15.0 months versus 7.3 months for the control group [2][7] - The study included 325 patients, with the primary endpoint being progression-free survival, and secondary endpoints including overall survival and objective response rate [8] Group 2: Regulatory Approval and Future Studies - The U.S. FDA approved the Itovebi-based regimen in October 2024 for treating adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer [3] - Roche is conducting four additional phase III clinical studies to further investigate Itovebi in various combinations for PIK3CA-mutated breast cancer [4][8] - The full results from the OS analysis will be presented at an upcoming medical meeting, indicating ongoing commitment to transparency and scientific communication [2][7] Group 3: Product Information - Itovebi is an oral, targeted treatment designed to provide durable disease control and improved outcomes for patients with PIK3CA-mutated breast cancer, addressing a significant unmet need in this patient population [5][9] - The drug is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform, which is crucial for targeting the underlying mutation in these cancers [5][9] Group 4: Company Background - Roche has over 30 years of experience in advancing breast cancer research, aiming to improve treatment outcomes for various subtypes, including hormone receptor-positive breast cancer, which accounts for approximately 70% of all breast cancer cases [10][9] - The company is committed to personalized healthcare and aims to transform healthcare delivery through innovative medicines and diagnostics [11][12]

EMBARK Trial Results - Positive topline results from year two of the EMBARK trial show statistically significant and clinically meaningful improvements in motor function measures (NSAA, TTR, 10MWR) for individuals treated with Elevidys compared to an external control group [1] - Functional differences between Elevidys-treated individuals and the external control group increased between one and two years after treatment, demonstrating sustained benefits [1][6] - Detailed year two results will be shared at an upcoming medical meeting and discussed with health authorities [2] Functional Improvements - Individuals treated in part one of EMBARK (n=63) showed sustained improvements in NSAA (+2.88 points, P<0.0001), TTR (-2.06 seconds, P<0.0033), and 10MWR (-1.36 seconds, P<0.0028) two years after treatment [4] - The crossover treated group (n=59) experienced similar improvements 52 weeks after treatment, despite being one year older than those treated in part one [4] - Muscle biopsies from a subset of patients showed consistent and sustained expression of micro-dystrophin 64 weeks after dosing, with minimal progression in underlying muscle pathology [7] Safety and Regulatory Status - No new safety signals were observed, reinforcing the consistent and manageable safety profile of Elevidys [6][8] - Elevidys is approved for individuals aged four years and older in the US, UAE, Qatar, Kuwait, Bahrain, and Oman, and for ambulatory individuals aged four through seven years in Brazil and Israel [9] - Regulatory filings have been submitted to the EMA and authorities in Japan, Switzerland, Singapore, Hong Kong, and Saudi Arabia [9] Clinical Development Program - EMBARK is a multinational, phase III, randomised, double-blind, two-part crossover, placebo-controlled study assessing the safety and efficacy of Elevidys in ambulatory boys aged four to seven years [12] - The clinical development program includes multiple studies evaluating the safety, efficacy, and long-term effects of Elevidys in various age groups and disease stages [13] About Elevidys and Duchenne Muscular Dystrophy - Elevidys is the first approved disease-modifying gene therapy for Duchenne, designed to address the underlying cause through targeted skeletal, respiratory, and cardiac muscle expression of shortened dystrophin [16] - Duchenne is a rare, genetic, muscle-wasting disease affecting approximately 1 in 5,000 boys worldwide, leading to loss of mobility, respiratory and cardiac function, and a mean life expectancy of 28 years [17][18] Roche's Neuroscience Focus - Neuroscience is a major focus of Roche's research and development, with a goal to develop new treatments for chronic and potentially devastating diseases [19] - Roche is investigating more than a dozen medicines for neurological disorders, including Duchenne muscular dystrophy, multiple sclerosis, and Alzheimer's disease [20]

Core Insights - The B-cell depletion therapy sector is primarily dominated by major pharmaceutical companies like Roche, with a noted decline in new companies filing patents in recent years [1][6] - Key players in the B-cell depletion therapy market include Gilead Sciences, Bristol-Myers Squibb (BMS), Roche, and Regeneron, which have strong innovation portfolios [2][6] - The drug landscape is focused on oncology and immunology therapies, with significant contributions from Bristol-Myers Squibb and Novartis in drug development [3][6] Competitive Insights - Over 50 major pharmaceutical companies are involved in B-cell depletion therapy, with leaders such as Gilead Sciences, BMS, Roche, and Regeneron driving innovation [6] - Startups like Abelzeta, Nanjing IASO, and Ossianix are recognized for their innovation impact in the B-cell depletion sector [2][6] - The University of Texas MD Anderson Cancer Center leads in clinical trials related to B-cell depletion therapy, particularly in immunology [3][6] Market Insights - The B-cell depletion therapy market has seen 622 deals totaling US$262 billion, with Ireland and the United States being significant players in deal volume and value [6] - The focus of clinical trials is primarily on immunology, with Diffuse Large B-Cell Lymphoma being the top indication [3][6] - Emerging therapies, such as CAR T cells targeting CD19, show potential for deeper B-cell depletion compared to traditional treatments [4][6] Innovation Insights - The report provides a comprehensive overview of patents, drugs, clinical trials, and deals data in the B-cell depletion therapy landscape [4][6] - New indications being explored include neurological diseases, autoimmune diseases, and orphan diseases, indicating a broadening scope of research and development [6] - The report highlights the importance of strategic partnerships and early acquisitions in driving innovation within the sector [6]

Core Message - Roche has received FDA 510(k) clearance for its VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail, a highly sensitive test designed to differentiate B-cell malignancies from normal immune responses, facilitating faster treatment access [4][6][8] Product Details - The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is the first clinically approved ISH test capable of assessing the full spectrum of B-cell lymphoma subtypes [6] - The test can evaluate over 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide, reducing the need for multiple samples and follow-up tests [8] - It is designed to detect kappa and lambda immunoglobulin light chains in formalin-fixed paraffin-embedded human hematolymphoid specimens [10] - The assay aids in diagnosing mature B-cell lymphomas and plasma cell neoplasms, particularly when biopsy results are inconclusive [11] Market and Industry Context - B-cell lymphoma accounts for approximately 85% of non-Hodgkin lymphoma (NHL) cases, which is one of the most common cancers in the US, representing about 4% of all cancer cases and causing over 80,000 deaths annually [6][7] - The test is a significant addition to Roche's hematopathology portfolio, which includes more than 65 biomarkers [9] Company Background - Roche, founded in 1896, is the world's largest biotechnology company and a global leader in in-vitro diagnostics [12] - The company is committed to sustainability, aiming for net zero by 2045 through initiatives like the Science Based Targets and Sustainable Markets Initiative [13]

Roche Digital Pathology Dx System - Roche Digital Pathology Dx system has received an additional 510(k) clearance from the FDA, now including the VENTANA DP 600 slide scanner alongside the previously cleared VENTANA DP 200 slide scanner, digital pathology workflow software, and a display [1] - The VENTANA DP 600 slide scanner has 40 times the capacity of the VENTANA DP 200 and uses the same scanning technology, providing consistent, high-quality images for pathologists [2] - The system aids pathologists in reviewing and interpreting digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue for clinical diagnosis [3] - The VENTANA DP 600 produces excellent image quality of stained histology slides from patient tissue samples, enhancing diagnostic accuracy, consistency, and speed through high-resolution images and advanced analysis tools [8] Roche's Leadership in Digital Pathology - Roche is the leading provider of pathology lab solutions, offering an end-to-end digital pathology solution from tissue staining to producing high-quality digital images for reliable AI-based image analysis [4] - The company is moving traditionally research-oriented tools into routine clinical practice, driven by the acceleration of immunotherapy and the development of more complex assays [4] - Roche is committed to investing in and shaping the future of pathology, focusing on improving healthcare efficiency and patient care through digital transformation [2][4] Roche's Corporate Background - Founded in 1896 in Basel, Switzerland, Roche is the world's largest biotechnology company and a global leader in in-vitro diagnostics [5] - The company combines strengths in Diagnostics and Pharma with data insights from clinical practice to deliver personalised healthcare [5] - Roche is committed to sustainability, aiming to achieve net zero by 2045 through initiatives like the Science Based Targets and the Sustainable Markets Initiative [6] - Genentech in the United States is a wholly owned member of the Roche Group, and Roche is the majority shareholder in Chugai Pharmaceutical, Japan [6]

Company Overview - Proactive is a financial news and online broadcast company that provides fast, accessible, and actionable business and finance news to a global investment audience [1] - The company has a global presence with bureaus and studios in key finance and investment hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [2] Industry Coverage - The company delivers news and unique insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] - Proactive has reported on energy companies during global crises, aviation and airlines as the sector recovers from the pandemic, and economic, social, and governance issues [1] Technology and Content Production - Proactive is a forward-looking company that adopts technology to enhance workflows and content creation [4] - The company occasionally uses automation and software tools, including generative AI, but all content is ultimately edited and authored by humans to ensure quality and adherence to best practices in content production and SEO [5] - The content creators at Proactive possess decades of valuable expertise and experience, which is complemented by the use of technology [4]