Financial Performance and Losses - The company has incurred net losses since inception and expects to continue incurring losses for the foreseeable future, indicating a risk of never achieving profitability[31]. - The company reported net losses of $79.0 million for the year ended December 31, 2023, and $62.5 million for the year ended December 31, 2024, with an accumulated deficit of $440.3 million as of December 31, 2024[179]. - The company expects to continue incurring net losses as it invests in research and development, particularly for the SOPHiA DDM Platform, and expanding marketing efforts to drive new customer adoption[180]. - The company may need to raise additional capital to fund operations and further develop its SOPHiA DDM Platform, with potential dilution of shareholder ownership if raised through equity[182]. - The company has incurred substantial cash expenditures since inception, indicating a capital-intensive research and development process[182]. - The company anticipates fluctuations in operating results, which may not meet investor expectations, potentially affecting share price[188]. - The company is focused on reducing costs to achieve sustainable gross margins, but faces challenges from rising operational costs and the need for increased capacity[190]. Market and Competitive Landscape - The SOPHiA DDM Platform offers a broad range of genomics applications across various disease areas, but expanding features and applications poses significant risks and challenges[28]. - The company faces competition from many sources, some with greater financial resources, which may hinder its ability to compete successfully[26]. - The company faces competition from established healthcare technology companies with greater financial resources and market share, which may hinder its ability to compete effectively[79]. - The company faces challenges in penetrating existing markets and expanding into new ones, which could adversely affect revenues and operations[48]. - The commercial success of the SOPHiA DDM Platform relies on significant market acceptance, which is uncertain and influenced by various factors[44]. - Market acceptance depends on the safety, accuracy, ease of use, and perceived advantages of the SOPHiA DDM Platform compared to competitors[45]. - Estimates of the addressable market for the SOPHiA DDM Platform may be smaller than anticipated, impacting business and financial results[49]. Regulatory and Compliance Risks - There is uncertainty regarding the coverage and reimbursement status of newly developed applications and products, which could limit the commercial potential of the SOPHiA DDM Platform[26]. - The company intends to seek regulatory clearance for its applications and products as IVD applications, but the approval process is expensive, time-consuming, and uncertain[101]. - Regulatory authorities have substantial discretion in the clearance and approval process, which may delay or prevent the launch of applications and products[103]. - The company may incur significant additional costs if required to conduct further studies for regulatory approval[103]. - Failure to comply with FDA regulations could result in enforcement actions, including product recalls and revocation of marketing authorization[104]. - The company is subject to various risks associated with international operations, including economic instability and regulatory compliance challenges, which could impact future expansion and revenue[100]. - The FDA's final rule on LDTs, effective by May 6, 2028, will require premarket review, increasing commercialization costs and potentially reducing demand for RUO applications and products[105]. - The evolving regulatory landscape for AI/ML technologies may impose additional compliance costs on the company[110]. - The company must navigate varying regulatory requirements across jurisdictions, which could delay product introductions[115]. - Noncompliance with privacy policies could lead to significant liability and reputational harm[123]. - The company faces significant legal and compliance risks related to various federal healthcare laws, including the Anti-Kickback Statute and the Stark Law, which could lead to substantial penalties and operational disruptions[126]. - Compliance with healthcare regulations is costly, and any violations could result in administrative, civil, or criminal penalties, potentially harming the company's financial condition and operations[127]. Cybersecurity and Data Privacy - The company faces risks related to cybersecurity and data privacy breaches, which could result in additional costs and harm to its brand[26]. - Cybersecurity breaches could result in significant liabilities and harm to the company's brand, affecting revenue and customer retention[85]. - The company is increasingly dependent on information technology, which raises the risk of cybersecurity incidents, including deliberate attacks and unauthorized access to systems[86]. - Cybersecurity threats could disrupt operations, compromise data integrity, and lead to significant business disruptions if not effectively managed[88]. - The company carries cybersecurity insurance, but there is no assurance that potential losses will be covered or will not exceed policy limits[88]. Operational Dependencies and Risks - The company is highly dependent on its senior management team and qualified personnel, and failure to retain or attract such personnel could harm its business[26]. - The company must maintain and continuously improve the performance, security, and reliability of its platform, as poor performance could adversely impact customer satisfaction and revenue[30]. - The company is expanding its sales and marketing capabilities, but challenges in recruiting and training personnel may hinder revenue growth[40]. - The company relies on strategic relationships with third-party providers, and failure to maintain these relationships could impact revenue growth[42]. - The company relies on third-party manufacturers for the supply and production of its products, which may expose it to risks if agreements are terminated or not renewed[68]. - The company is dependent on third-party service providers for hosting its SOPHiA DDM Platform, and interruptions could lead to lengthy service disruptions and additional expenses[65]. - The performance of third-party distributors is crucial, and any disruption in these relationships could materially affect operations[63]. - The company relies on third parties for conducting multimodal clinical studies, and failures in these studies could impact regulatory submissions and commercial activities[71]. - The company faces risks related to shipping and warehousing providers, which could affect timely product delivery and operational costs[73]. Intellectual Property and Legal Risks - The company’s ability to protect its intellectual property is uncertain, with potential challenges in obtaining and maintaining patents that could allow competitors to develop similar products[135]. - The patent application process is complex and may not yield the desired protection, impacting the company's competitive advantage in the market[139]. - The company may face challenges in patent rights, as others may have filed similar patent applications that could affect its ability to commercialize technology[140]. - The issuance of patents does not guarantee their validity or enforceability, and the company may be involved in legal proceedings that could limit its patent rights[142]. - The company may be subject to third-party claims of patent infringement, which could adversely affect its operations and financial condition[149]. - The biotechnology industry is prone to extensive litigation regarding patents, increasing the risk of needing licenses from organizations that may refuse reasonable terms[152]. - Legal disputes over intellectual property could result in significant costs and distract management from core responsibilities, impacting overall productivity[145]. - The company relies on licenses from third parties, such as Normandie Valorisation, for certain products, and termination of these agreements could adversely affect its ability to commercialize those products[155]. - Future license agreements may impose significant royalty obligations, which could impact the company's profitability if it fails to develop and commercialize successful applications and products[156]. - Disputes over royalty payments and obligations under license agreements could lead to increased financial liabilities and distract management from core business activities[158]. Corporate Governance and Structure - SOPHiA GENETICS SA was incorporated on March 18, 2011, as a Swiss stock corporation[224]. - The company is classified as a foreign private issuer, exempt from certain U.S. domestic public company regulations[216]. - SOPHiA GENETICS may lose its foreign private issuer status by June 30, 2025, requiring compliance with more extensive U.S. reporting requirements[219]. - The company is currently an emerging growth company, allowing it to benefit from reduced reporting obligations[220]. - If the market value of its ordinary shares held by non-affiliates exceeds $700 million or total annual gross revenues reach $1.235 billion, it will lose its emerging growth company status[221]. - The company holds a substantial amount of cash, which may affect its classification as a passive foreign investment company (PFIC)[214]. - There is uncertainty regarding the enforceability of U.S. court judgments in Switzerland, which may impact investor rights[210]. - The company's articles of association contain anti-takeover provisions that could deter beneficial acquisitions[212]. - SOPHiA GENETICS is subject to different corporate governance standards compared to U.S. domestic companies listed on Nasdaq[218]. - The company may incur significant legal and compliance costs if it loses its foreign private issuer status[219].

Revenue and Growth - Revenue in 2024 was softer than expected, but the company laid a strong foundation for future success through new product launches and a record number of new customers[11]. - The company signed a record 92 new core genomics customers in 2024, including top institutions like Mount Sinai and Mayo Clinic, contributing to a 23% growth in clinical revenue in the US[14][15]. - The company impacted 352,000 patients in 2024, contributing to a total of over 1.9 million patients since inception[28]. - The number of active customers grew from 182 to over 810 from December 31, 2016, to December 31, 2024, with genomic profiles analyzed increasing from approximately 80,000 to about 1,900,000[158]. Financial Performance - Adjusted gross margin improved to 72.8% in 2024, an increase of 60 basis points year-over-year, while adjusted operating loss improved by 20%[26]. - The company expects to approach adjusted EBITDA breakeven by the end of 2026 and achieve positive adjusted EBITDA in the second half of 2027[27]. - Approximately 70% of revenue from clinical customers in 2024 was generated from oncology applications, while 30% came from other disease areas[73]. - The revenue churn rate for customers accessing the platform through dry lab and bundle access models is 4% for the year ending December 31, 2024[163]. Product and Service Offerings - The new liquid biopsy offering, MSK-ACCESS, was adopted by 34 customers across 20 countries within 10 months of its launch[19]. - The company launched SOPHiA UNITY, a data-driven consortium aimed at advancing cancer research and drug development[21]. - SOPHiA CarePath, launched in 2022, integrates data across multiple modalities, enhancing the monitoring of cancer patients and tumor progression[63]. - The SOPHiA DDM Platform supports multimodal data analytics, integrating clinical, biological, genomics, and radiomics data, with plans to include additional modalities like digital pathology and proteomics[91]. Market Opportunities - The total addressable market for current commercial clinical applications is estimated to be approximately $25 billion, while for biopharma applications it is around $15 billion[45]. - The total addressable market opportunity for clinical and biopharma applications is estimated at $40 billion globally in 2024, with approximately $9 billion in the United States[130]. - The total addressable global clinical market opportunity for current offerings is estimated at $25 billion in 2024, with oncology being the largest market segment[133]. - The total addressable biopharma opportunity for current offerings is estimated at $15 billion in 2024, covering Discovery, Development, and Deployment segments[139]. Technology and Innovation - The SOPHiA DDM Platform is designed to grow a global collective intelligence by analyzing pseudonymized data and sharing insights among customers[44]. - The platform is capable of generating approximately 30,000 new genomic profiles monthly, indicating a robust growth in data capture[64]. - The company has developed AI/ML-powered segmentation algorithms for radiomics, capable of analyzing data from various imaging technologies, including CT and MRI[95]. - The platform's architecture allows for flexible and scalable data analysis, supporting multiple data modalities and regional data warehouses[66]. Partnerships and Collaborations - A partnership with NVIDIA aims to improve the speed and efficiency of healthcare data analysis, potentially delivering insights up to 10 times faster[23]. - The company collaborates with 11 laboratories across 9 countries to provide integrated access services for the SOPHiA DDM Platform as of December 31, 2024[177]. - The company has ongoing R&D projects with major cloud providers, including Microsoft Azure, Amazon Web Services, and Google Cloud Platform, enhancing flexibility and managing vendor risks[175]. Sales and Marketing Strategy - The direct sales team consists of over 96 field-based representatives with a presence in 58 countries, supplemented by distributor partners in 46 countries[46]. - The company employs a "land and expand" model to increase utilization within its clinical customer base, facilitating the deployment of additional testing solutions[166]. - The company has shifted its sales strategy to target smaller, repeatable business opportunities to expedite the sales cycle in biopharma services[173]. Regulatory and Intellectual Property - The company aims to pursue additional IVD status and FDA approval for specific solutions in the future[73]. - The company has 8 issued U.S. patents and 32 pending U.S. patent applications as of December 31, 2024, with foreign patents and applications in multiple jurisdictions[184]. - The company owns 11 registered U.S. trademarks and approximately 134 registered foreign trademarks as of December 31, 2024, aimed at protecting its brand and products[189]. - The company’s intellectual property strategy includes a combination of patents, trademarks, and trade secrets to protect its technology and competitive position[181]. Customer Engagement and Satisfaction - The Net Promoter Score reached 67, with 58% of customers using two or more applications, up from 56% the previous year[17]. - Regular platform updates occur approximately every three weeks, providing new content and improvements to existing applications[159]. - The platform's ease of use and decentralized nature facilitate rapid knowledge generation and variant discovery among users[87].

Core Insights - SOPHiA GENETICS reported financial results for Q4 and FY 2024, highlighting a record number of analyses and new customer acquisitions despite challenges in the BioPharma sector [2][6][20] Financial Highlights - Q4 2024 revenue was $17.7 million, a 4% increase year-over-year, and FY 2024 revenue reached $65.2 million, also up 4% year-over-year [6][22] - Gross margin for Q4 2024 was 68.2% on a reported basis and 74.2% on an adjusted basis, compared to 69.8% and 73.4% in the prior year [6][32] - Operating loss for Q4 2024 was $17.4 million, improving by 8% year-over-year, while FY 2024 operating loss was $66.6 million, improving by 11% year-over-year [6][22] Business Highlights - The company performed a record 352,000 analyses in FY 2024, representing an 11% year-over-year volume growth [7] - SOPHiA GENETICS expanded its customer base to 472 core genomics customers by the end of FY 2024, up from 450 at the end of Q4 2023 [7] - The company signed a record 92 new customers in FY 2024, including 31 in Q4 2024, who will implement SOPHiA DDM™ and begin generating revenue [7] Product Development and Market Expansion - The launch of the Liquid Biopsy application MSK-ACCESS® in Q2 2024 attracted 34 customers, with 15 implementations completed by the end of FY 2024 [7][10] - The company entered into a collaboration with Genesis Healthcare Co. in Japan to enhance access to genomic testing and support BioPharma companies [7] - SOPHiA GENETICS is focused on operational excellence, with an adjusted operating loss improvement of 23% year-over-year in Q4 2024 [10] 2025 Financial Outlook - The company expects full-year revenue between $72 million and $76 million, representing growth of approximately 10% to 17% compared to FY 2024 [10] - Adjusted EBITDA loss is projected to be between $35 million and $39 million, compared to $40.2 million in FY 2024 [10]

Core Insights - SOPHiA GENETICS has achieved a significant milestone in the global adoption of its cancer testing applications, with 37 institutions adopting the MSK-ACCESS® and MSK-IMPACT® applications powered by SOPHiA DDM™ [1][5][8] Group 1: Adoption and Impact - 34 out of the 37 institutions have adopted the MSK-ACCESS® application within 10 months of its launch, enabling decentralized Liquid Biopsy testing [5] - The decentralized deployment allows institutions to provide less-invasive genomic testing options, resulting in lower costs and faster turnaround times while retaining control over patient data [5] - Notable institutions adopting these applications include Heidelberg University Hospital, Biopticka Laboratory, and Jewish General Hospital [6][7] Group 2: Collaborations and Future Prospects - SOPHiA GENETICS partnered with Memorial Sloan Kettering Cancer Center in 2023 to enhance cancer testing capabilities globally [8] - A definitive partnership with AstraZeneca was announced in October 2024 to accelerate the deployment of MSK-ACCESS® [8] - These collaborations aim to transform cancer research by leveraging real-world data and advanced technology [8] Group 3: Expert Endorsements - Professor Umberto Malapelle from the University Federico II of Naples supports the new applications for cancer research, highlighting the collaborative potential of SOPHiA GENETICS [2][3] - Ross Muken, President of SOPHiA GENETICS, emphasized the importance of bringing advanced technology to global organizations for improved healthcare [4]

BOSTON and ROLLE, Switzerland, Feb. 18, 2025 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and a leader in data-driven medicine, today announced it will release its financial results for the fourth quarter and full year 2024 before U.S. markets open on Tuesday, March 4, 2025. On that day, SOPHiA GENETICS will host a conference call to discuss its financial results as well as business outlook beginning at 8:00 a.m. (08:00) EDT / 2:00 p.m. (14:00) CET.The call will be webcast ...

The cutting-edge OncoPortal™ Mutation Tracker add-on module enables precision monitoring of evolving genomic cancer drivers BOSTON, MA and ROLLE, Switzerland, Jan. 28, 2025 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, has unveiled the OncoPortal™ Mutation Tracker — a longitudinal MRD tracking tool designed for disease monitoring in the context of oncology. This innovation underscores SOPHiA GENETICS' commitment to a ...

Financial Data and Key Metrics - Q3 2024 revenue was $15.9 million, a 2.5% YoY decline, primarily due to a $2 million drop in biopharma revenue [21] - Adjusted gross margin improved to 73.1% in Q3 2024, up 60 basis points YoY, despite revenue softness [24] - Operating loss improved by 7% YoY to $15.4 million, with adjusted operating loss improving by 10% to $10.6 million [26] - Cash burn decreased by 39% YoY to $9.6 million, with cash and cash equivalents at $95.8 million as of September 30, 2024 [27] - Full-year 2024 revenue guidance reaffirmed at $65-67 million, representing 4-7% YoY growth [28] Business Line Performance - Clinical analysis volume grew 16% YoY (17% excluding COVID-related volumes) to 91,000 analyses in Q3 2024 [8] - Biopharma revenue declined materially in Q3, but the pipeline remains healthy, suggesting a recovery in 2025 [9] - Hemon testing and rare/inherited disease portfolio grew 26% and 29% YoY, respectively [20] - MSK-ACCESS adoption reached 18 customers across 5 continents, with 5 already in routine usage [13][14] Market Performance - North America and Asia Pacific grew approximately 30% YoY, while EMEA returned to company average growth [20] - Latin America faced challenges due to the churn of a large account, partially offsetting growth in other regions [21] - Spain remained weak due to reimbursement dynamics in the solid tumor market, with softness expected to persist into 2025 [20] Strategy and Industry Competition - The company is focused on decentralized testing through MSK-ACCESS and MSK-IMPACT, enabling hospitals to conduct liquid biopsy and solid tumor testing in-house [12][14] - Biopharma partnerships, such as with AstraZeneca, are leveraging SOPHiA's network for drug deployment and market access [15] - The company is positioning itself as a leader in data-driven medicine, with a strong focus on oncology and rare diseases [30] Management Commentary on Operating Environment and Future Outlook - Management remains confident in the path to profitability, with strong cost management and operational leverage [26] - The company expects a reacceleration of growth in 2025, driven by clinical volume recovery and biopharma momentum [9][42] - Cancer rates are increasing globally, and the company is well-positioned to capitalize on the growing demand for data-driven diagnostics and therapies [30] Other Important Information - Ross Muken was promoted to Company President, overseeing global business operations [17] - George Cardoza joined as CFO, bringing extensive financial and scaling expertise [18] - The company is presenting at the Guggenheim Healthcare Conference in Boston [31] Q&A Session Summary Question: MSK-ACCESS and MSK-IMPACT Growth Potential - MSK-ACCESS has been adopted by 18 customers globally, with 5 already in routine usage, and is expected to contribute materially to growth in 2025 [34][37] - MSK-IMPACT, launched in October, is expected to complement MSK-ACCESS, with strong demand anticipated [35] - Biopharma interest in decentralized testing is growing, providing additional growth opportunities [39] Question: 2025 Growth Acceleration - The company is confident in reaccelerating growth in 2025, driven by clinical volume recovery and biopharma momentum [41][42] - MSK-based products and new customer onboarding are expected to be key growth drivers [42] Question: Pricing Trends - Pricing pressure in Europe, particularly in Spain, has stabilized in France and Italy, with overall pricing expected to improve in 2025 [45][46] - Newer products with higher ASPs are expected to drive overall pricing improvements [46] Question: Biopharma Recovery - Biopharma revenue is expected to stabilize and improve in 2025, with a focus on post-approval activities and market access [50][53] - The company has a strong pipeline and is well-positioned to capitalize on biopharma demand for decentralized testing [53] Question: Clinical Volume Growth - Clinical volume growth remains strong, with North America and Asia Pacific leading the way [65] - The company is not seeing a market slowdown in clinical sequencing volumes, with robust demand for complex tests like liquid biopsy and MRD [67] Question: Biopharma Spending Dynamics - Biopharma budget constraints have impacted pre-approval activities, but the company is refocusing on post-approval activities to drive growth [70]

Exhibit 99.1 Index to Consolidated Financial Statements Table of Contents | | Unaudited Interim Condensed Consolidated Financial Statements | F-2 | | --- | --- | --- | | – | Unaudited Interim Condensed Consolidated Statements of Loss | F-3 | | – | Unaudited Interim Condensed Consolidated Statements of Comprehensive Loss | F-4 | | – | Unaudited Interim Condensed Consolidated Balance Sheets | F-5 | | – | Unaudited Interim Condensed Consolidated Statements of Changes in Equity | F-6 | | – | Unaudited Interim C ...

BOSTON and ROLLE, Switzerland, Nov. 5, 2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and leader in data-driven medicine, today announced that Ross Muken, previously Chief Financial Officer ("CFO") and Chief Operating Officer ("COO"), has been promoted to company President, effective November 5, 2024. George Cardoza has been appointed as the company's new CFO. Ross Muken George Cardoza In the newly created role of company President, Ross Muken will oversee SOPHiA ...

Clinical growth reaccelerates with record analysis volume; Cash burn improves 39%BOSTON and ROLLE, Switzerland, Nov. 5, 2024 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and leader in data-driven medicine, today reported financial results for the third quarter ended September 30, 2024.Third Quarter 2024 Financial Results Revenue was $15.9 million, down 2.8% year-over-year Gross margins were 67.2% on a reported basis and 73.1% on an adjusted basis, compared to 69.1% and 72. ...