Company Performance - SOPHiA GENETICS reported a quarterly loss of $0.26 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.21, representing an earnings surprise of -23.81% [1] - The company posted revenues of $17.78 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 7.30% and showing an increase from $15.78 million in the same quarter last year [2] - Over the last four quarters, SOPHiA GENETICS has surpassed consensus EPS estimates two times and topped consensus revenue estimates twice [2] Market Outlook - SOPHiA GENETICS shares have increased by approximately 2.3% since the beginning of the year, contrasting with the S&P 500's decline of -3.9% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is -$0.20 on revenues of $17.85 million, and for the current fiscal year, it is -$0.80 on revenues of $74.18 million [7] Industry Context - The Medical Info Systems industry, to which SOPHiA GENETICS belongs, is currently ranked in the top 28% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5] - The estimate revisions trend for SOPHiA GENETICS is currently favorable, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6]

SOPHiA GENETICS (SOPH) Q1 2025 Earnings Call May 06, 2025 08:00 AM ET Speaker0 Good morning, ladies and gentlemen, and welcome to the Sofia Genetics q one twenty twenty five earnings call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call, you require immediate assistance, please press 0 for the operator. This call is being recorded on Tuesday, 05/06/2025. I would now like to turn the conference over ...

Company Overview The AI Platform for Precision Medicine May 6, 2025 Cautionary notices This presentation contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, products and technology, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking state ...

BOSTON and ROLLE, Switzerland, May 6, 2025 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and leader in data-driven medicine, today reported financial results for the first quarter ended March 31, 2025.First Quarter 2025 Financial Results Revenue was $17.8 million, up 13% year-over-year or 15% on a constant currency basis Gross margin was 68.7% on a reported basis and 75.7% on an adjusted basis, up from 65.9% and 70.5% in the prior year period, respectively IFRS net loss inc ...

Financial Data and Key Metrics Changes - Total revenue for 2024 was $65.2 million, representing a year-over-year growth of 4% [50] - Adjusted gross margin improved to 72.8%, up 60 basis points from the previous year [55] - Adjusted operating loss for 2024 was $44.8 million, improving by 20% year-over-year [56] - Total cash burn for 2024 was $58 million, up 5% from the previous year [57] Business Line Data and Key Metrics Changes - Clinical revenue grew 23% in the U.S. in 2024, with analysis volume increasing by 26% [16] - The company signed a record 92 new core genomic customers in 2024, with 35 new customers implemented in Q4 alone [13][14] - Hematology was the top-performing application in 2024, followed by Solid Tumors and rare disease applications [29] Market Data and Key Metrics Changes - North America and Asia Pacific saw significant growth, with volume growth of 33% and 40% year-over-year, respectively [27] - Latin America experienced a decline due to the acquisition of a top customer, but the company has since regained this business [28] Company Strategy and Development Direction - The company aims to expedite implementation times for new customers and expand usage across accounts as a key growth driver [12] - Focus on growing new applications, MSK-ACCESS and MSK-IMPACT, which are expected to significantly impact clinical and BioPharma businesses [20][21] - Continued investment in product upgrades and launches, including Enhanced Exomes and improvements to Liquid Biopsy offerings [31][33] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the BioPharma sector due to tightened budgets but expressed optimism for recovery [8][76] - The company expects to report full-year revenue between $72 million and $76 million for 2025, representing 10% to 17% growth [59] - Management is confident in achieving adjusted EBITDA breakeven by the end of 2026 [67] Other Important Information - The company analyzed a record 352,000 patients on SOPHiA DDM in 2024, benefiting from a global reach of nearly 800 healthcare institutions [10] - The company has access to an additional $35 million of capital through a financing line with Perceptive Advisors [67] Q&A Session Summary Question: What are you seeing in terms of BioPharma funding and recovery trends? - Management noted that the BioPharma environment has been challenging, but they are seeing improved momentum in the pipeline and activity rates with pharma [75][80] Question: What indicators give you line of sight into customer volumes? - Management highlighted the backlog of signed contracts and the strong expansion of existing accounts as indicators of future customer volumes [87][89] Question: What is embedded in your ASP assumptions for 2025? - Management indicated that while volume growth is expected to be strong, ASPs may be impacted by the loss of certain pharma-linked business, but new products are expected to help pull ASPs back up [100][101]

SOPHiA GENETICS SA (SOPH) came out with a quarterly loss of $0.23 per share versus the Zacks Consensus Estimate of a loss of $0.24. This compares to loss of $0.37 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 4.17%. A quarter ago, it was expected that this company would post a loss of $0.24 per share when it actually produced a loss of $0.28, delivering a surprise of -16.67%.Over the last four quarters, the company has surpa ...

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].

SOPHiA GENETICS 2024 Annual Report TABLE OF CONTENTS | | 1 | | --- | --- | | Business Update | 6 | | Financial Review | 53 | | Corporate Governance | 77 | | Report of the Statutory Auditor on the Consolidated Financial Statements for the Year | 91 | | Ended December 31, 2024 | | | Consolidated Financial Statements of SOPHiA GENETICS SA for the year ended | 98 | | December 31, 2024 | | | Report of the Statutory Auditor on the Statutory Financial Statements of SOPHiA | 157 | | GENETICS SA for the Year ended D ...

BOSTON and ROLLE, Switzerland, March 4, 2025 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and leader in data-driven medicine, today reported financial results for its fourth quarter and fiscal year ended December 31, 2024.Fourth Quarter 2024 Financial Highlights Revenue was $17.7 million, up 4% year-over-year or 6% on a constant currency basis excluding COVID-19-related revenue  Gross margin was 68.2% on a reported basis and 74.2% on an adjusted basis, compared to 69.8% an ...

SOPHiA GENETICS enables institutions across the globe to launch world-class oncology testingBOSTON, MA and ROLLE, Switzerland, Feb. 24, 2025 /PRNewswire/ -- SOPHiA GENETICS (Nasdaq: SOPH), a pioneer in AI healthcare technology and a leader in data-driven medicine, announced a new milestone in the global adoption of its groundbreaking cancer testing applications MSK-ACCESS® powered with SOPHiA DDM™ and MSK-IMPACT® powered with SOPHiA DDM™. Thirty-seven prominent institutions, including top researchers and ke ...