SEATTLE, April 10, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced it will report financial results for the first quarter 2025 after market close on Thursday, May 1, 2025. Company management will webcast a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. Live au ...

SEATTLE, April 08, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (NASDAQ:ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses diagnostic technologies through its Molecular Diagnostic Services Program (MolDX), has expanded coverage of clonoSEQ® to include single time point testing to monit ...

Core Viewpoint - Adaptive Biotechnologies has launched an enhanced version of its clonoSEQ assay for measurable residual disease (MRD) detection in diffuse large B-cell lymphoma (DLBCL), which is now approved for clinical use in New York State and covered by Medicare [1][4]. Group 1: Product Enhancements - The enhanced clonoSEQ assay features an optimized DNA extraction methodology and maximizes sample input, resulting in a 7-fold increase in sensitivity [2]. - The assay maintains its proprietary approach by reading the full immune receptor sequence of malignant B cells, which improves sensitivity while preserving specificity, thus minimizing the risk of overtreatment due to false positives [2][4]. Group 2: Clinical Impact - The enhanced assay was previously available for research use and is being incorporated into biopharma-sponsored and investigator-initiated trials, with data indicating that MRD negativity post-cycle six is highly prognostic of progression-free survival [3][6]. - The assay has been used to manage and inform patient care for over 2,800 DLBCL patients, with more than 640 providers utilizing it in 2024 alone [4]. Group 3: Market Context - DLBCL is the most common form of non-Hodgkin lymphoma in the U.S., accounting for about 1 in 3 NHL patients, with over 18,000 new diagnoses each year [5]. - Approximately 30-40% of DLBCL patients experience relapse, primarily within the first two years, highlighting the importance of MRD testing for assessing treatment response and adjusting treatment plans [5][6]. Group 4: Regulatory and Clinical Guidelines - The New York State Department of Health has approved the enhanced clonoSEQ ctDNA assay for MRD detection in DLBCL, aligning with updated National Comprehensive Cancer Network (NCCN) guidelines recommending ctDNA testing for MRD assessment in PET-positive DLBCL patients [4].

Revenue and Financial Performance - In 2024, the company's revenue was $179.0 million, a 5.0% increase from $170.3 million in 2023, primarily driven by the MRD business[23]. - The MRD business generated $145.5 million in revenue in 2024, representing a 42% growth from 2023, which included $12.5 million in milestone revenue[28]. - Operating expenses were reduced to $341.5 million in 2024 from $397.3 million in 2023, reflecting ongoing operational streamlining[23]. - For the year ended December 31, 2024, the company incurred a net loss of $159.6 million, compared to $225.3 million in 2023 and $200.4 million in 2022, with an accumulated deficit of $1.3 billion[169]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $256.0 million[23]. - The company expects to continue incurring significant expenses and operating losses as it invests in the development of products and services utilizing its immune medicine platform[169]. Product Development and Clinical Trials - The clonoSEQ assay is utilized in over 170 active trials by more than 40 biopharmaceutical partners, with 85 trials using MRD as a clinical endpoint[28]. - A phase 3 study showed that the MRD negativity rate at 10⁻⁵ was significantly higher with D-VRd (60.9%) compared to VRd (39.4%) in newly diagnosed MM patients[45]. - The company aims to expand clonoSEQ's clinical utility in NHL, which represents approximately 50% of newly diagnosed lymphoid malignancies in the U.S.[51]. - The company is developing TCR-based cell therapies under the Genentech Agreement, but has limited experience in commercialization, which may hinder future success[197]. - The company is developing a pipeline of immune-based diagnostics and therapeutics, including TCR-based cellular therapies in oncology and antibodies in autoimmunity, but significant additional research and development, validations, and clinical trials are required before achieving commercially viable products[204]. Regulatory and Compliance - The company must comply with HIPAA and HITECH regulations, which govern the privacy and security of protected health information[127]. - The IVDR requires systematic post-market surveillance and performance evaluations to enhance health and safety[115]. - The FDA's final rule on May 6, 2024, amended the definition of IVDs, requiring compliance with medical device regulatory requirements starting May 6, 2025[125]. - The company is subject to various federal and state fraud and abuse laws, including the Anti-Kickback Statute, which imposes severe penalties for violations[137]. - The company holds required licenses for Maryland, Rhode Island, Pennsylvania, New York, and California, ensuring compliance with state regulations[120]. Strategic Partnerships and Collaborations - The company entered a multi-year exclusive strategic collaboration with NeoGenomics to integrate clonoSEQ with their offerings in complex blood cancers[52]. - The company received a $300 million upfront payment from Genentech and a $10 million milestone payment for FDA IND acceptance of the first cell therapy product candidate[71]. - The company is developing therapeutic product candidates under a collaboration agreement with Genentech, leveraging its platform to identify TCRs for personalized cellular therapeutic products[180]. - The company is exposed to risks associated with the Genentech Agreement, including Genentech's sole control over clinical development and commercialization[193]. Market and Competitive Landscape - The company faces substantial competition in the biotechnology and pharmaceutical industries, with many competitors having greater financial resources and expertise[105]. - The company’s diagnostic revenue is dependent on achieving broad coverage and reimbursement for its clonoSEQ tests from both private and government payors[174]. - The company anticipates ongoing proposals at federal and state levels aimed at reducing healthcare costs and expanding individual healthcare benefits, which could impact demand for its products[152]. Innovation and Intellectual Property - The company has filed 847 patent applications, with 416 active patents as of December 31, 2024, covering improvements in sequencing methods and adaptive immune receptors[72]. - The patent portfolio includes 124 applications from the Sequenta Acquisition, with 62 patents granted, focusing on T cell-based immune responses using NGS[89]. - The company has developed a therapeutic antibody discovery process called TruAB, with pending patent applications across 11 patent families targeting various conditions[95]. Workforce and Organizational Culture - As of December 31, 2024, the company had 619 full-time employees, with 94 holding medical or doctoral degrees[160]. - The company was recognized as one of Washington State's Best Places to Work from 2018 to 2022 and received national certification as a Great Place to Work in 2021 and 2022[161]. - The company has reduced its workforce last year as part of restructuring plans, indicating potential challenges in scaling operations to meet future demand[212]. Risks and Challenges - The company faces complex reimbursement and billing requirements from various payors, including Medicare and Medicaid, which may lead to reduced payments[155]. - The company may face significant costs and delays if it needs to transition to alternative suppliers or equipment due to reliance on single suppliers[186]. - The company may abandon current or future products if they are deemed unlikely to succeed, which could impair growth potential[183]. - The company faces a high rate of failure in therapeutic product development as it progresses through clinical trials, which could significantly impact its financial condition and prospects[205].

Core Viewpoint - Adaptive Biotechnologies (ADPT) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - For the fiscal year ending December 2025, Adaptive Biotechnologies is expected to earn -$0.91 per share, representing a 15.7% change from the previous year's reported number [8]. - Over the past three months, the Zacks Consensus Estimate for Adaptive Biotechnologies has increased by 2.7% [8]. Investment Implications - The upgrade to Zacks Rank 2 positions Adaptive Biotechnologies in the top 20% of Zacks-covered stocks, suggesting potential for higher stock prices in the near term due to improved earnings outlook [10]. - Rising earnings estimates and the corresponding rating upgrade imply an enhancement in the company's underlying business, which could lead to increased investor interest and stock appreciation [5].

Financial Data and Key Metrics Changes - In Q4 2024, total revenue was $47.5 million, with MRD contributing 85% and immune medicine 15%, representing a 4% growth year-over-year [31] - MRD revenue reached $40.1 million, up 31% from the previous year, while immune medicine revenue was $7.3 million, down 51% [32] - Full year 2024 revenue was $179 million, a 5% increase year-over-year, with MRD revenue at $145.5 million, up 42% [33] - Adjusted EBITDA loss for Q4 was $16.4 million, an improvement from $24.7 million in Q4 2023, and for the full year, the loss was $80.4 million compared to $116.4 million in 2023 [36] Business Line Data and Key Metrics Changes - In MRD, clinical testing revenue grew 40% year-over-year, with clonoSEQ test volume increasing 34% to 20,945 tests delivered in Q4 [11][12] - The average selling price (ASP) for clonoSEQ tests was $1,117, a 7% increase from fiscal year 2023 [15] - The MRD Pharma business saw a revenue growth of 44% versus 2023, including $12.5 million in regulatory milestone revenue [18] Market Data and Key Metrics Changes - Blood-based MRD testing grew 55%, contributing 41% of MRD tests in the U.S. [13] - The number of ordering healthcare providers increased by 30%, exceeding 3,000 [14] - The company completed integrations with 19 accounts, representing about 20% of ordering volume in 2024 [14] Company Strategy and Development Direction - The company aims to drive top-line growth in 2025 by expanding blood-based testing to contribute over 45% of total MRD volume and increasing ASP to an average of $1,300 per test [22] - Strategic priorities include integrating additional EPIC accounts and launching OncoEMR integration with Flatiron [22] - The immune medicine business focuses on developing TCR-based cell therapies and antibody therapeutic candidates for autoimmune diseases [24][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving adjusted EBITDA positivity in the second half of 2025, driven by improved revenue and operating efficiencies [45] - The company highlighted a strong cash position of $256 million, enabling continued growth and execution of strategic goals [38][44] - Management noted the importance of the NeoGenomics partnership for future growth, although material contributions are not expected until 2026 and 2027 [64] Other Important Information - The company completed restructuring initiatives, resulting in a 40% reduction in cash burn from 2023 [11] - The company anticipates full-year operating expenses to be between $340 million and $350 million, reflecting similar levels as in 2024 [41] Q&A Session Summary Question: What are the underlying assumptions for the MRD business guidance? - Management discussed the impact of the new gap fill rate for Medicare and the importance of recontracting with payers to drive ASP [50][52] Question: Can you elaborate on the NeoGenomics partnership and its expected contributions? - Management indicated that the partnership would take about four months to implement, with material volume contributions expected in 2026 and 2027 [62][64] Question: What is the expected volume growth progression throughout the year? - Management suggested a linear progression in volume growth, with potential upside from EPIC and Flatiron integrations [68] Question: How is the company addressing the ASP for 2025? - Management outlined several drivers for ASP, including the full-year impact of the gap fill rate and improved revenue cycle management [50][52] Question: What is the status of the MRD pipeline and upcoming indications? - Management confirmed that mantle cell lymphoma is the most recent Medicare-covered indication, with plans to seek coverage for T-cell ALL and advanced stages of cutaneous T-cell lymphoma [78][79]

Core Insights - Adaptive Biotechnologies reported revenue of $47.46 million for the quarter ended December 2024, marking a year-over-year increase of 3.7% [1] - The company's EPS for the same period was -$0.23, an improvement from -$0.30 a year ago [1] - The reported revenue exceeded the Zacks Consensus Estimate of $46.43 million by 2.23%, and the EPS also surpassed the consensus estimate of -$0.26 by 11.54% [1] Performance Metrics - The ClonoSEQ test volume was reported at 20,945, which was below the average estimate of 22,150 by three analysts [4] - Total Minimal Residual Disease (MRD) revenues were $40.15 million, exceeding the average estimate of $38.24 million by three analysts, representing a significant year-over-year increase of 30.4% [4] - Total Immune Medicine revenues were reported at $7.31 million, which fell short of the average estimate of $7.90 million and indicated a year-over-year decline of 51.3% [4] Stock Performance - Shares of Adaptive Biotechnologies have increased by 18.9% over the past month, outperforming the Zacks S&P 500 composite, which saw a change of 4.2% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Group 1 - Adaptive Biotechnologies reported a quarterly loss of $0.23 per share, better than the Zacks Consensus Estimate of a loss of $0.26, and improved from a loss of $0.30 per share a year ago, representing an earnings surprise of 11.54% [1] - The company posted revenues of $47.46 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 2.23% and showing an increase from $45.78 million year-over-year [2] - Adaptive Biotechnologies has outperformed the S&P 500, with shares up about 28.1% since the beginning of the year compared to the S&P 500's gain of 3.1% [3] Group 2 - The earnings outlook for Adaptive Biotechnologies is mixed, with the current consensus EPS estimate for the coming quarter at -$0.26 on revenues of $46.59 million, and -$0.92 on revenues of $210.4 million for the current fiscal year [7] - The Medical - Biomedical and Genetics industry, to which Adaptive Biotechnologies belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8]

Revenue Performance - Revenue for Q4 2024 was $47.5 million, a 4% increase year-over-year, while full year revenue reached $179.0 million, up 5% from the previous year[3][8]. - The MRD business generated $40.1 million in Q4 2024, reflecting a 31% increase compared to Q4 2023, and $145.5 million for the full year, a 42% increase from 2023[4][8]. - Revenue for the year ended December 31, 2024, was $178,957 million, compared to $170,276 million in 2023, reflecting a growth of approximately 5.0%[28]. - Revenue from the MRD segment for the year ended December 31, 2024, was $145,529 million, up from $102,739 million in 2023, representing a growth of approximately 41.5%[28]. Operating Expenses - Operating expenses for Q4 2024 were $81.3 million, a 30% decrease from $116.9 million in Q4 2023, excluding a $25.4 million lease impairment charge[5]. - Operating expenses for the year ended December 31, 2024, totaled $341,506 million, compared to $397,311 million in 2023, a decrease of approximately 14.1%[28]. - Share-based compensation expense for the year ended December 31, 2024, was $53,610 million, down from $62,908 million in 2023, a decrease of about 14.8%[28]. Profitability and Loss - Net loss for Q4 2024 was $33.7 million, significantly reduced from $69.5 million in the same period of 2023[6]. - Adjusted EBITDA for Q4 2024 was a loss of $16.4 million, an improvement from a loss of $24.7 million in Q4 2023[7]. - Net loss attributable to Adaptive Biotechnologies Corporation improved from $(225,250) million in 2023 to $(159,492) million in 2024, a reduction of about 29.2%[26]. - Adjusted EBITDA for the year ended December 31, 2024, was $(80,371) million, an improvement from $(116,413) million in 2023, indicating a reduction of about 30.9%[28]. Cash and Assets - Cash, cash equivalents, and marketable securities totaled $256.0 million as of December 31, 2024[10]. - Cash and cash equivalents decreased from $65,064 million in 2023 to $47,920 million in 2024, a decline of about 26.4%[25]. - Total assets decreased from $661,134 million in 2023 to $539,376 million in 2024, a decline of approximately 18.4%[25]. - Total shareholders' equity decreased from $308,278 million in 2023 to $202,485 million in 2024, a decline of approximately 34.3%[25]. Future Projections - The company expects full year 2025 MRD revenue to be between $175 million and $185 million, with total operating expenses projected between $340 million and $350 million[11]. Strategic Developments - The FDA's advisory committee voted unanimously to support the use of MRD as a primary endpoint for accelerated approval of new therapies for multiple myeloma[3]. - An exclusive strategic partnership was signed with NeoGenomics to cross-promote clonoSEQ tests alongside NeoGenomics' services[3]. Test Volume - clonoSEQ test volume increased by 34% in Q4 2024, delivering 20,945 tests, and ended the year with 76,105 tests delivered, a 35% increase from 2023[3].

Core Insights - Adaptive Biotechnologies reported strong execution in 2024, with significant growth in its Minimal Residual Disease (MRD) business and advancements in Immune Medicine programs [2][4] - The company aims to achieve profitability in its MRD business and advance its therapeutics pipeline while maintaining a durable cash position for sustainable growth [2] Financial Performance - Fourth quarter 2024 revenue was $47.5 million, a 4% increase from the same quarter in the previous year [4] - MRD revenue for the fourth quarter was $40.1 million, reflecting a 31% increase year-over-year, while Immune Medicine revenue decreased by 51% to $7.3 million [4][9] - For the full year 2024, total revenue was $179.0 million, a 5% increase from 2023, with MRD revenue at $145.5 million (42% increase) and Immune Medicine revenue at $33.4 million (51% decrease) [9][11] Operating Expenses - Operating expenses for Q4 2024 were $81.3 million, down 30% from $116.9 million in Q4 2023, excluding a $25.4 million lease impairment charge [5] - For the full year 2024, operating expenses totaled $341.5 million, a 14% decrease from $397.3 million in 2023 [10] Net Loss and Adjusted EBITDA - The net loss for Q4 2024 was $33.7 million, significantly reduced from $69.5 million in Q4 2023 [6] - Adjusted EBITDA for Q4 2024 was a loss of $16.4 million, an improvement from a loss of $24.7 million in the same quarter of the previous year [7] Key Business Highlights - clonoSEQ test volume increased by 34% to 20,945 tests delivered in Q4 2024, ending the year with 76,105 tests delivered, a 35% increase from 2023 [8] - The company received an updated Medicare Clinical Laboratory Fee Schedule for clonoSEQ, increasing the reimbursement rate by 17% to $2,007 per test [8] - The FDA's Oncologic Drug Advisory Committee voted unanimously in favor of using MRD as a primary endpoint for accelerated approval of new therapies for multiple myeloma [8] - An exclusive strategic partnership was signed with NeoGenomics to cross-promote clonoSEQ tests alongside NeoGenomics' services [8] 2025 Financial Guidance - The company expects full-year revenue for the MRD business to be between $175 million and $185 million, with total operating expenses projected between $340 million and $350 million [12]