Exact Sciences(EXAS) - 2023 Q4 - Earnings Call Transcript

Financial Data and Key Metrics - Q4 2023 revenue grew 17% YoY to $647 million, with core revenue growth of 18$487 million, driven by Cologuard adoption, with 172,000 healthcare providers ordering Cologuard, an all-time high [7] - Precision Oncology revenue grew 12% to $160 million, with Oncotype DX international growth of 48$50 million, and adjusted EBITDA improved by $45 million to$50 million [7] - Free cash flow turned positive at $35 million, an improvement of$55 million YoY [7] - Cash and securities at year-end totaled $778 million [7] Business Line Performance - Screening revenue is expected to be between$460 million and $470 million in Q1 2024, and between$2.155 billion and $2.175 billion for the full year [8] - Precision Oncology revenue is expected to be between$155 million and $160 million in Q1 2024, and between$655 million and $675 million for the full year [8] - Cologuard brand awareness reached an all-time high of 89$30 million in growth in 2024 [54] - The company expects strong double-digit growth internationally for Oncotype DX, with Japan being a significant market [10] Strategic Direction and Industry Competition - The company is focused on embedding Cologuard as a standard of care, increasing Oncotype DX adoption internationally, advancing pipeline programs, and deepening relationships with health systems [6] - The company is investing in new digital and TV campaigns for Cologuard, improving patient and physician experience, and advancing the MRD program [10] - The company is developing next-generation Cologuard, which is expected to raise the performance bar in noninvasive screening and be available to patients in 2025 [14] - The company is advancing its MRD program, with plans to share data supporting reimbursement in colon cancer and integrating OncoDetect with technology licensed from the Broad Institute [15] Management Commentary on Operating Environment and Future Outlook - The company expects total revenue between $615 million and$630 million for Q1 2024 and between $2.81 billion and$2.85 billion for the full year, implying 13% core revenue growth [8] - Adjusted EBITDA is expected to be between $325 million and$350 million for the year, with CapEx around 150 million [8] - The company is optimistic about the future, with a strong pipeline of new tests and a focus on reaching more patients through innovative campaigns and partnerships [11][12] Other Important Information - The company submitted its premarket approval application for next-generation Cologuard to the FDA in December 2023 and expects to make the test available in 2025 [14] - The company plans to announce top-line results from the BLUE-C study for its colon cancer blood test in 2024 [14] Q&A Session Summary Question: Unpack the 20 million headwind in Precision Oncology and OpEx and gross margin guidance for 2024 [17] - The 20 million headwind is due to contracts rolling off as labs transition whole exome sequencing and prostate cancer testing in-house, with the impact more pronounced in Q1 [18] - The company expects continued gross margin expansion and OpEx leverage, particularly in G&A, with investments in lab automation driving efficiency [18] Question: Phasing of screening revenue and CEO's stock options [20] - Q1 screening revenue is expected to be down sequentially due to seasonal trends, with 22% of full-year revenue expected in Q1 [23] - The CEO plans to exercise and hold stock options expiring this week, selling only enough to cover costs and taxes [21] Question: Screening revenue growth and competition from blood-based tests [25] - The company expects 16% screening revenue growth in 2024, driven by rescreens and first-time users, with double-digit growth in the 50-plus age group [26] - The company believes the USPSTF guidelines, which focus on life years gained and unnecessary colonoscopies, set a high bar for blood-based tests to achieve widespread adoption [28] Question: Growth in the 45-49 age segment and blood-based competition [30] - The 45-49 age segment now accounts for nearly 20% of screening revenue and is a significant growth driver [32] - The company believes blood-based tests face biological barriers, with high false-positive rates and insufficient precancer detection, making it difficult to meet USPSTF guidelines [31] Question: Life years gained and adjusted EBITDA margin guidance [36] - Cologuard has the best ratio of life years gained to unnecessary colonoscopies among screening tests, with blood-based tests falling short due to lower sensitivity for precancerous polyps [37] - The company expects 300 basis points of adjusted EBITDA margin expansion in 2024, with continued leverage across all major OpEx lines [38] Question: USPSTF process and timeline for blood-based tests [43] - The company is confident in meeting USPSTF data submission deadlines, with the next guideline update expected by 2026 [45] Question: Health system partnerships and competition [47] - The company's partnerships with health systems are based on value creation, including product offerings, customer support, and technology platforms, rather than contractual barriers [48][49] Question: Oncotype DX international growth and path to 1 billion in Precision Oncology revenue [52] - Japan is expected to contribute $30 million in growth in 2024, with the international business approaching$200 million in annual revenue [54] - The company aims to grow Oncotype DX to $600 million and the broader Precision Oncology business to$1 billion through market penetration, new product launches, and pipeline expansion [54] Question: MRD expectations and investment priorities [56] - The company plans to share data supporting Medicare reimbursement for MRD in colon cancer and expects to commercialize OncoDetect in late 2024 or early 2025 [57] - MRD is one of the company's top three investment areas, alongside colon cancer screening and multi-cancer early detection [59] Question: Multi-cancer early detection (MCAD) investment and progress [61] - The company has scaled back investment in MCAD due to uncertainty around Medicare reimbursement but remains committed to the long-term potential of the technology [62] Question: BLUE-C blood test expectations and positioning [65] - The company expects its blood test to receive a best second-line screening claim from the FDA, targeting patients who refuse frontline tests like Cologuard and colonoscopy [66] Question: MRD reimbursement and gross margin impact [69] - The company is generating data to support Medicare reimbursement for MRD in colon cancer, with breast cancer reimbursement expected in 2025 [70] - New products, including Cologuard 2, are expected to drive gross margin improvement, with temporary pressure from products lacking full reimbursement [71] Question: Cologuard 2.0 pricing and BLUE-C study publication [74] - The company expects to create value with Cologuard 2 through reduced false positives and cost savings but has not provided specific pricing guidance [75] - The BLUE-C study is expected to be published in the near term [75] Question: Rescreen hit rate and timing [77] - The rescreen success rate is below 55% but improving, with a long-term goal of 70% [78] - The median time to rescreen is approximately 3.5 years, with some spillover into the following year [78] Question: OncoLiquid data and commercial launch timing [80] - The company is working on validating OncoLiquid and plans to submit for Medicare reimbursement this year [83] Question: Advanced adenoma detection bar for first-line tests [81] - The company believes the FDA may set a minimum bar for advanced adenoma detection around 20%, based on the performance of the FIT test [82]