Core Insights - The growth of testing services by 23% was attributed to the resumption of surveillance protocols in kidney centers and increased for-cause utilization [1] - The solution selling strategy that integrated digital and pharmacy offerings led to a 47% year-over-year growth in Patient and Digital Solutions [1] - Revenue Cycle Management (RCM) evolved from stabilization to a core strength, achieving over a 60% reduction in claim rejection rates through automation and AI [1] - The Lab Products segment gained from a global shift towards NGS-based HLA typing, where the company holds a leading position [1] - Strategic investments in infrastructure, particularly the Epic Aura integration, aim to minimize clinical friction and enhance electronic order data quality [1] - Clinical evidence generation is crucial for adoption, as shown by SHORE registry data that highlights HeartCare's prognostic value beyond traditional biopsy [1] - The management's disciplined capital allocation strategy includes returning capital through share repurchases while maintaining a debt-free balance sheet with $200 million in cash [1]

Core Insights - Exagen Inc. will release its financial results for Q4 2025 on March 10, 2026, before market opening [1] - The conference call to discuss the results will be hosted by the CEO and CFO at 8:30 a.m. ET [1] Company Overview - Exagen Inc. is a leading provider of autoimmune diagnostics, focused on transforming care for patients with chronic autoimmune conditions [2] - The company's flagship product, AVISE CTD, aids in the early and accurate diagnosis of complex autoimmune diseases such as lupus and rheumatoid arthritis [2] - Exagen operates a CLIA-certified, CAP-accredited laboratory specializing in rheumatic disease testing, providing precise and timely results [2] - The company emphasizes research, innovation, education, and patient-centered care to address challenges in autoimmune disease management [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示不會就因本公告全部或任何部分內容而產生或因 依賴該等內容而引致的任何損失承擔任何責任。 Mirxes Holding Company Limited （ 於 開 曼 群 島 註 冊 成 立 的 有 限 責 任 公 司 ） （股份代號：2629） 自願性公告 完成CADENCE CRC的入組程序 本公告乃由Mirxes Holding Company Limited（「本公司」，連同其附屬公司統稱「本 集團」）自願刊發，旨在知會本公司股東及潛在投資者有關本集團的最新業務 發展。 完成CADENCE CRC的入組程序 本 公 司 董 事（「董 事」）會（「董事會」）宣 佈，本 公 司 已 完 成CADENCE (CAncer Detected Early caN be CurEd) CRC的入組程序，CADENCE CRC是一項大型前瞻性 臨床研究，旨在驗證其血液檢測於平均風險及高風險成人群體中篩查結直腸 癌（「結直腸癌」）的有效性。 – 1 – CADENCE CRC中評估的血液檢測由本公司專 ...

Group 1 - CareDx, Inc. (CDNA) reported preliminary fourth quarter revenue of approximately $108 million, an increase of 25% year-over-year [1] - Testing services revenue for the fourth quarter was approximately $78 million, reflecting a 23% increase [1] - Testing services volume reached approximately 53,000, marking a 17% increase [1] Group 2 - Preliminary revenue for 2025 was approximately $380 million, an increase of 14% year-over-year [2] - Testing services revenue for 2025 was approximately $274 million, an increase of 10% [2] - Testing services volume for 2025 was approximately 200,000, an increase of 14% [2]

Core Insights - Exagen Inc. reported preliminary unaudited financial results for Q4 and the full year 2025, indicating strong revenue growth and operational progress [1][2]. Financial Performance - Total revenue for Q4 2025 is projected to be between $16 million and $17 million, while total revenue for the full year is expected to be between $66 million and $67 million [2]. - Year-over-year revenue growth for Q4 is estimated at 17% to 24%, and for the full year, growth is projected at 19% to 20% [2]. - The AVISE CTD test volume is expected to be between 136,000 and 137,000, with a trailing 12-month average selling price (ASP) of $441 to $445 [2]. - Year-end cash and cash equivalents are reported at $32 million, reflecting a $10 million increase from 2024 [4]. Operational Highlights - The company has made significant advancements in its commercial, scientific, and operational teams, leading to the launch of enhancements to the AVISE platform [2]. - The AVISE CTD ASP has expanded by at least $30 compared to 2024, and test volume has grown by at least 13,000, marking an 11% increase over the previous year [4]. Strategic Focus - Exagen aims to transform care for patients with autoimmune diseases through innovative testing solutions, enhancing decision-making and clinical outcomes [5]. - The company is committed to investing in innovation and advancing its strategy to improve the standard of care in autoimmune disease management [2].

Core Viewpoint - CareDx, Inc. faces uncertainty due to proposed reimbursement changes that threaten its core testing business, impacting near-term growth, while the company's expanding transplant solutions platform positions it for long-term opportunities in an $8 billion market [1][5]. Company Overview - CareDx is a provider of solutions for transplant centers, offering lab tests, transplant management services, digital administration, and pharma services, targeting a total addressable market (TAM) of $8 billion [3]. Financial Performance - In the second quarter, CareDx reported adjusted earnings of 10 cents, missing the consensus estimate of 12 cents, with sales of $86.68 million, also below the consensus of $90.56 million [4]. - The company narrowed its fiscal 2025 sales guidance from $365 million-$375 million to $367 million-$373 million, compared to the consensus of $370.79 million [4]. Analyst Insights - Analyst Andrew F. Brackmann views CareDx as a deeply undervalued company with a powerful platform, despite ongoing reimbursement challenges that raise questions about its future [2][5]. - Brackmann initiated coverage with a Market Perform rating, noting that shares trade at a 67% discount to peers based on a 2026 revenue multiple and discounted cash flow analysis suggesting a fair value closer to $20 per share [6]. Market Dynamics - The proposed local coverage decision affecting CareDx's testing services, which account for about 75% of revenue, may create modest revenue headwinds, leaving near-term forecasts unclear [5]. - CareDx has faced challenges including reimbursement issues, patent disputes, regulatory probes, and leadership changes, with potential downside from the draft LCD appearing priced in [7]. Stock Performance - CareDx's stock is currently trading higher by 1.02% to $12.88, reflecting some market optimism despite the uncertainties [8].

Financial Data and Key Metrics Changes - CareDx reported quarterly revenue of $84.7 million, an 18% increase year over year, with adjusted EBITDA of $4.6 million [11][31][39] - The company ended the quarter with a cash balance of $231 million and no debt [11][39] - Non-GAAP gross margin improved to 68.5%, up 150 basis points year over year [34][35] Business Line Data and Key Metrics Changes - Testing services revenue was $61.9 million, up 15% year over year, with approximately 47,100 tests delivered, a 12% increase from the prior year [11][32] - Patient and Digital Solutions revenue reached $12 million, representing a 24% year over year growth [29][33] - Lab products revenue was $10.8 million, up 26% year over year, driven by sales of AlloSeq TX kits [29][33] Market Data and Key Metrics Changes - CareDx added 3.5 million new covered lives for AlloMap Heart and 15.5 million for AlloSure testing in the first quarter [14] - The company launched two expanded indications for AlloSure, targeting pediatric heart transplant patients and simultaneous pancreas-kidney transplant patients [12][13] Company Strategy and Development Direction - CareDx aims to achieve $365 million to $375 million in revenue for 2025, with a long-range plan of reaching $500 million in revenue by 2027 [11][39] - The company is focusing on expanding its testing services and enhancing market access strategies through published evidence and payer network integration [10][14][29] Management's Comments on Operating Environment and Future Outlook - Management noted a positive trend in surveillance testing volumes, particularly in kidney testing, and expects continued growth in the coming quarters [46][52] - The company anticipates a significant uptick in transplant procedures in the second half of the year due to the initiation of the IOTA program [84] Other Important Information - CareDx is integrating Epic Aura to streamline the ordering process for healthcare providers, with a full launch expected by the end of the year [29][61] - The company reached an agreement to resolve a securities class action litigation for $20.25 million, with expected coverage from insurers [38] Q&A Session Summary Question: Signs of volume returning in surveillance testing - Management confirmed that they are seeing signs of volume returning, particularly in kidney testing, and expect continued growth [46][47] Question: Higher than expected R&D and SG&A expenses - Management explained that the increase in operating expenses was primarily due to investments in sales and marketing, with a focus on maintaining a tight control on overall expenses [48][49] Question: Progress on surveillance volumes and protocols - Management indicated that they are making progress on surveillance testing protocols and expect growth in Q2 [51][52] Question: Impact of new CPT code on coverage and ASP - Management highlighted that the new AlloSure specific code will facilitate better payer contracts and improve ASP per test [85] Question: Incremental benefit from transplant pharmacy on testing services revenue - Management noted that the synergy between patient solutions and testing services is strong, leading to greater engagement and protocol adoption [88][90] Question: Competitive developments in the space - Management expressed confidence in CareDx's market leadership and does not anticipate competitive announcements impacting guidance [97][98]

Financial Data and Key Metrics Changes - The company reported quarterly revenue of $84.7 million, an increase of 18% year over year, with adjusted EBITDA of $4.6 million, compared to an adjusted EBITDA loss of $1.9 million in Q1 2024 [9][31][35] - The cash balance at the end of the quarter was $231 million, with no debt, reflecting a $15 million increase from $216 million at the end of Q1 2024 [9][35] - Non-GAAP gross margin improved to 68.5%, up 150 basis points year over year, driven by ASP expansion [30][31] Business Line Data and Key Metrics Changes - Testing services revenue was $61.9 million, up 15% year over year, with approximately 47,100 tests delivered, a 12% increase from the prior year [9][29] - Patient and Digital Solutions revenue reached $12 million, representing a 24% year over year growth, while products revenue was $10.8 million, up 26% year over year [26][30] - Adjusted testing services revenue was $63 million, up 26% year over year on a comparable basis, excluding $1.1 million in write-offs for aged receivables [30] Market Data and Key Metrics Changes - The company added 3.5 million new covered lives for AlloMap Heart and 15.5 million new covered lives for AlloSure testing in the first quarter [12] - The launch of two expanded indications for AlloSure testing is expected to enhance market penetration, particularly in pediatric heart transplant patients and simultaneous pancreas-kidney transplant patients [10][11] Company Strategy and Development Direction - The company is focused on expanding its testing services and market access strategies, with a long-range plan to achieve $500 million in revenue and 20% adjusted EBITDA by 2027 [9] - A significant initiative to integrate Epic Aura aims to streamline the ordering process for healthcare providers, enhancing operational efficiency [25][26] - The company is investing in sales and marketing to accelerate growth, with a disciplined approach to managing G&A and legal expenses [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the gradual return of surveillance testing volumes, particularly in kidney testing, and expects continued growth in Q2 [44][50] - The company anticipates a significant uptick in transplant procedures in the second half of the year, driven by the initiation of the IOTA program [78] - Management reiterated guidance for 2025 revenue of $365 million to $375 million, with expectations of mid-teens growth in testing volumes [36][37] Other Important Information - The company reached an agreement to resolve a securities class action litigation for $20.25 million, with expected coverage of approximately $14.9 million from D&O insurers [34] - The company is enhancing its revenue cycle management processes to improve billing and collections, which is expected to drive ASP increases over the next six to eight quarters [66] Q&A Session Summary Question: Signs of volume returning for surveillance testing - Management confirmed that they are seeing signs of volume returning, particularly in kidney testing, and progress has been made on surveillance testing protocols [44] Question: Higher than expected R&D and SG&A expenses - Management noted that the increase in operating expenses was primarily driven by investments in sales and marketing, with a focus on maintaining a tight control on overall expenses [45] Question: Additional color on surveillance volumes and protocols - Management emphasized that while they are making progress, they expect to see growth in Q2, with centers responding positively to the reinitiation of surveillance [50] Question: Impact of new LCDs for transplant testing - Management believes that the growing body of evidence supporting surveillance testing will solidify their position for coverage, although no specific timing for new LCDs was provided [51] Question: Feedback on Epic integration - Management indicated that the integration is ahead of schedule, with a full launch expected by the end of Q2, which is anticipated to reduce friction for healthcare providers [54][60] Question: Incremental benefit from transplant pharmacy on testing services revenue - Management highlighted that the synergy between patient solutions and testing services is strong, leading to greater access and engagement with customers [82]

Financial Data and Key Metrics Changes - CareDx reported Q4 2024 revenue of $86.6 million, a 32% increase year-over-year, and full-year revenue of $334 million, up 19% year-over-year [10][36] - Adjusted EBITDA for Q4 was $9.8 million, with a full-year adjusted EBITDA of $27.8 million, compared to an adjusted EBITDA loss of $38 million in 2023 [10][42] - The company ended the year with a cash balance of $261 million and no debt, generating $22 million in cash from operations in Q4 [10][44] Business Line Data and Key Metrics Changes - Testing Services revenue was $63.8 million in Q4, up 37% year-over-year, with approximately 45,500 tests delivered, a 14% increase from the prior year [12][13] - Patient and Digital Solutions revenue reached approximately $11.4 million in Q4, representing an 18% year-over-year growth [15] - Lab Products revenue was $11.4 million, showing a 23% year-over-year growth, driven by sales of AlloSeq Tx NGS-based HLA typing kits [17] Market Data and Key Metrics Changes - CareDx expanded AlloMap Heart coverage to 21 million commercial lives and added 12.2 million new commercial covered lives for AlloSure in Q4 [14] - For the full year 2024, the company added or expanded coverage for 28 million lives for AlloMap Heart and 36 million new commercial covered lives for AlloSure [14] Company Strategy and Development Direction - CareDx aims for long-term profitable growth, targeting $370 million in revenue for 2025 and $500 million by 2027, with a focus on operational excellence and evidence generation to expand payer coverage [10][20] - The company plans to launch several new products in 2025, including AlloSure Heart for pediatric patients and AlloSure Kidney for simultaneous pancreas and kidney transplant patients [26] Management's Comments on Operating Environment and Future Outlook - Management highlighted 2024 as a transformational year and expressed confidence in achieving significant milestones in 2025, particularly in expanding testing services and payer coverage [20][22] - The company anticipates continued adoption of surveillance testing and expects to see a ramp-up in testing volumes as transplant centers implement new protocols [76][112] Other Important Information - The company reported a reversal of a $96 million liability related to patent litigation, resulting in a positive GAAP net income of approximately $52.5 million for 2024 [42] - CareDx has authorized a share buyback program of up to $50 million over two years, following a previous buyback of approximately $29 million [44] Q&A Session Summary Question: Can you talk about efforts in converting existing accounts with less than 3 solutions to 3 or more solutions? - Management emphasized the focus on synergistic solutions and the importance of the XynQAPI product for quality reporting, which is expected to drive growth in testing services [56] Question: What is the path forward regarding litigation after the reversal of the $96 million verdict? - Management indicated that the litigation may be appealed but emphasized the importance of capital allocation towards growth opportunities and share buybacks if no strategic investments are identified [66] Question: Can you clarify how much revenue from prior period collections impacted Q4 and 2025 guidance? - Q4 revenue included about $2.2 million from prior period collections, with a total of $17 million recognized throughout 2024, but no contribution from these collections is included in the 2025 guidance [72][73] Question: How much of the mid-teens volume growth in 2025 is expected from increased surveillance testing? - Management believes surveillance testing will significantly contribute to volume growth, with ongoing discussions with transplant centers to implement protocols [75][112] Question: What opportunities exist to improve revenue capture through the billing organization? - Management discussed the restructuring of the billing team and the implementation of improved processes to enhance cash collection and billing efficiency [87][91]

Financial Data and Key Metrics Changes - CareDx reported quarterly revenue of $86.6 million for Q4 2024, representing a 32% year-over-year increase [10] - Full year 2024 revenue reached $334 million, up 19% year-over-year, exceeding the high end of guidance [36] - Adjusted EBITDA for Q4 was $9.8 million, with a full year adjusted EBITDA of $27.8 million, a significant improvement from a loss of $38 million in 2023 [10][42] - The company ended the year with a cash balance of $261 million and no debt, generating $22 million in cash from operations in Q4 [10][44] Business Line Data and Key Metrics Changes - Testing Services revenue for Q4 was $63.8 million, up 37% year-over-year, with approximately 45,500 tests delivered, marking a 14% increase [12][13] - Patient and Digital Solutions revenue was approximately $11.4 million in Q4, representing an 18% year-over-year growth [15] - Lab Products revenue also reached $11.4 million, showing a 23% year-over-year increase, driven by sales of AlloSeq Tx NGS-based HLA typing kits [17] Market Data and Key Metrics Changes - CareDx expanded payer coverage significantly, adding or expanding coverage for 28 million lives for AlloMap Heart and 36 million lives for AlloSure in 2024 [14] - Approximately 5% of CareDx's revenue comes from outside the U.S., with significant potential for growth in the European market [19] Company Strategy and Development Direction - The company aims for long-term profitable growth, targeting $370 million in revenue for 2025 and $500 million by 2027, with a focus on operational excellence and scaling business profitably [10][48] - Key growth drivers include a go-to-market strategy to provide comprehensive solutions to transplant centers, evidence generation to expand payer coverage, and operational excellence to improve efficiency [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving significant milestones in 2025, particularly with the anticipated implementation of the IOTA program for kidney transplant centers [23][24] - The company is focused on enhancing patient adherence to immunosuppressants through a medication therapy management program launching in 2025 [26] Other Important Information - The company has initiated a share buyback program of up to $50 million over two years, reflecting confidence in its financial position [44] - A significant legal victory reversed a prior $96 million verdict, positively impacting the company's financial statements for 2024 [42] Q&A Session Summary Question: Can you discuss efforts in converting existing accounts with fewer than three solutions to three or more solutions? - Management highlighted the focus on the XynQAPI product for quality reporting and the launch of a medication therapy management program to assist patients with drug interactions, which will drive the use of AlloSure [56] Question: What is the path forward regarding litigation after the reversal of the $96 million verdict? - Management indicated that while an appeal is likely, the reversal allows for strategic capital allocation, including reinvestment in growth opportunities and share buybacks [66] Question: Can you clarify the impact of prior period collections on Q4 revenue and guidance for 2025? - Q4 revenue included approximately $2.2 million from prior period collections, with no contributions from these one-time tests included in the 2025 guidance [72][73] Question: How much of the mid-teens volume growth in 2025 is expected from increased surveillance testing? - Management believes surveillance testing will significantly contribute to mid-teens volume growth, with ongoing discussions to turn on protocols at transplant centers [75] Question: What opportunities exist to improve revenue capture through the billing organization? - The company is focused on enhancing billing processes and systems to improve cash collection, with a new leader in place to drive these initiatives [87][90] Question: Can you remind us of the objectives of the KOAR study? - The KOAR study is a prospective multicenter study evaluating the efficacy of AlloSure Kidney to detect rejection, which is crucial for payer acceptance and product adoption [96]