Exact Sciences(EXAS)

Search documents
Exact Sciences(EXAS) - 2023 Q3 - Earnings Call Transcript
2023-11-02 00:28
Exact Sciences Corporation (NASDAQ:EXAS) Q3 2023 Earnings Conference Call November 1, 2023 5:00 PM ET Company Participants Kevin Conroy - Chairman, Chief Executive Officer Jeff Elliott - Chief Financial Officer Everett Cunningham - Chief Commercial Officer Erik Holznecht - Manager, Investor Relations Conference Call Participants Catherine Schulte - Baird Brandon Couillard - Jefferies Derik de Bruin - Bank of America Dan Brennan - TD Cowen Andrew Brackmann - William Blair Vijay Kumar - Evercore ISI Matt Syke ...
Exact Sciences(EXAS) - 2023 Q3 - Quarterly Report
2023-10-31 16:00
Revenue Performance - Revenue for the three months ended September 30, 2023, reached $628 million, a 20% increase compared to the same period in 2022[191] - Total revenue for the three months ended September 30, 2023, was $628.3 million, an increase of $105.3 million (20.1%) compared to $523.1 million in the same period of 2022[205] - Screening revenue increased to $472.0 million for the three months ended September 30, 2023, up $111.3 million (30.8%) from $360.8 million in 2022, driven by higher completed Cologuard tests[205] - Precision Oncology revenue rose to $156.3 million, a $4.9 million (3.2%) increase from $151.4 million in the prior year, attributed to more completed Oncotype DX tests[205] - COVID-19 testing revenue dropped to $0 million from $10.9 million, reflecting reduced demand as the pandemic subsides[205] Cash Flow and Financial Position - Positive cash provided by operating activities was $24 million for the three months ended September 30, 2023, an improvement of $65 million year-over-year[191] - Net cash provided by operating activities for the nine months ended September 30, 2023 was $86.6 million, compared to a cash used of $275.6 million for the same period in 2022[227] - As of September 30, 2023, the company had approximately $594.6 million in unrestricted cash and cash equivalents and approximately $139.8 million in marketable securities[225] - The company has an accumulated deficit of approximately $3.42 billion as of September 30, 2023[203] - The outstanding aggregate principal of all convertible notes was $2.34 billion as of September 30, 2023[233] Expenses and Investments - Research and development expenses for the three months ended September 30, 2023, totaled $111.4 million, an increase of $20.6 million (22.7%) from $90.8 million in 2022[211] - General and administrative expenses increased to $217.4 million for the three months ended September 30, 2023, up $25.4 million (13.2%) from $192.0 million in 2022[215] - The company anticipates that research and development expenses will continue to rise as it invests in advancing new tests[210] Operational Efficiency - Cost of sales as a percentage of revenue decreased to 27% for the three months ended September 30, 2023, compared to 28% in the same period of 2022, due to improved efficiency[209] - Amortization of acquired intangible assets decreased to $23.0 million for the three months ended September 30, 2023, compared to $23.5 million in the same period of 2022[215] Strategic Initiatives - Exact Sciences has delivered over 1 million test results, including a record number of Cologuard and Oncotype DX results[191] - The company plans to complete submission for FDA approval of the next-generation Cologuard test by the end of 2023[195] - Exact Sciences aims to develop a multi-cancer early detection test, Cancerguard, with a mean sensitivity of 61% and mean specificity of 98.2% for detecting cancer signals from 15 organ sites[195] - Exact Sciences is focused on improving customer relations and enhancing digital tools for providers and patients[199] - The company is integrating Resolution Bioscience and its liquid therapy selection test into its foundation[191] - Exact Sciences is committed to expanding its business by testing more people, aiming for sustainable profits and increased shareholder value[201] Other Financial Metrics - Other operating income was $72.0 million for the three and nine months ended September 30, 2023, compared to a loss of $13.2 million for the same periods in 2022[217] - Net investment income was $2.1 million for the three months ended September 30, 2023, compared to a net investment loss of $8.6 million for the same period in 2022[218] - Interest expense increased to $7.9 million for the three months ended September 30, 2023, compared to $5.2 million for the same period in 2022[219] - Income tax expense was $0.2 million for the three months ended September 30, 2023, compared to a benefit of $3.1 million for the same period in 2022[220] Risk Management - The company maintains significant amounts of cash, cash equivalents, restricted cash, and marketable securities at financial institutions that exceed federally insured limits, posing a risk of potential losses on these deposits[240] - The company had open foreign currency forward contracts with notional amounts of $33.3 million as of September 30, 2023, to mitigate foreign exchange rate exposure[243] - Substantially all of the company's revenues are recognized in U.S. dollars, minimizing material gains and losses from foreign currency translation[242] - The company does not utilize interest rate hedging agreements or other interest rate derivative instruments, which may expose it to interest rate risk[240] - A hypothetical 100 basis point decrease in market interest rates would result in immaterial potential losses in future earnings and cash flows[240] - The company is subject to risks from changes in foreign currency exchange rates, which could affect financial results due to international activities[242] - The company invests cash and marketable securities in high-quality, highly liquid investments, maintaining safety and liquidity[239] - All significant interest-bearing liabilities, except for variable rate debt, bear fixed interest rates, which may lead to higher future interest payments if market rates change[241] - The company has established investment guidelines for diversification and maturities to manage credit exposure and maintain liquidity[239]
Exact Sciences(EXAS) - 2023 Q2 - Earnings Call Transcript
2023-08-02 01:20
Financial Data and Key Metrics - Q2 2023 revenue grew 19% YoY to $622 million, with core revenue (excluding COVID testing, prostate business sale, and FX) up 24% to $617 million [8] - Screening revenue increased 31% to $463 million, driven by broad-based momentum in Cologuard adoption [8] - Precision Oncology revenue grew 2% to $157 million (7% excluding prostate business sale and FX) [9] - COVID testing revenue declined 84% to $2 million, and the company discontinued COVID testing in July [9][10] - GAAP gross margin was 71%, while non-GAAP gross margin (excluding amortization of acquired intangibles) was 75% [9] - Adjusted EBITDA improved by $113 million YoY to $67 million, driven by better-than-expected revenue, gross margin, and operating expense discipline [10] - Free cash flow improved by $190 million YoY to $66 million, with cash and securities totaling $776 million at quarter-end [10] Business Line Performance - Cologuard adoption continues to grow, with over 9,000 new healthcare professionals ordering the test in Q2 and more than 321,000 since launch [9] - Approximately 75% of US primary care physicians have ordered Cologuard, with 10% penetration among eligible patients [23][24] - The company implemented 40 new electronic connections with large US health systems in 2023, bringing the total to nearly 300 [8] - Precision Oncology growth was driven by a 26% increase in international revenue, with Oncotype DX Breast test securing reimbursement in Japan [14][62] Market Performance - The US market remains the primary driver, with significant opportunities in colorectal cancer screening, as 60 million Americans are not up-to-date with screening [13] - Japan represents a major opportunity for Oncotype DX, with 90,000 women diagnosed with breast cancer annually, half of whom are eligible for the test [14] - The company is focusing on molecular residual disease (MRD) and multi-cancer early detection as key growth areas, with collaborations with the Broad Institute and Baylor Scott & White [6][15] Strategic Direction and Industry Competition - The company is advancing next-generation Cologuard, which achieved a 30% improvement in specificity and enhanced sensitivity for cancer and pre-cancer detection [12] - FDA submission for next-gen Cologuard is expected by year-end, with potential approval in early 2025 [13] - The company is investing in MRD and multi-cancer early detection platforms, with partial results from the ASCEND 2 trial expected in fall 2023 [16] - The company raised full-year revenue guidance by $54 million and adjusted EBITDA guidance by $63 million, reflecting strong execution and market opportunities [7][11] Management Commentary on Operating Environment and Future Outlook - Management highlighted the company's commitment to eradicating cancer through innovative diagnostics and strong commercial execution [5][6] - The company expects long-term double-digit revenue growth and margin improvement, supported by its scalable platform [7][11] - Management emphasized the importance of next-gen Cologuard in reducing false positives and improving screening outcomes, which will drive future growth [12][13] Other Important Information - The company is working on a blood-based CRC test, with data expected by mid-2024, targeting patients who refuse frontline screening tests [79][80] - The care gap program, which targets hard-to-screen patients, is a key initiative to improve screening rates and strengthen relationships with payers and health systems [52][53] Q&A Session Summary Question: OpEx trends and Cologuard 2.0 impact [18] - OpEx is expected to increase in the mid-single-digit range for the year, with accelerated investments in MRD and hiring in H2 [19][20] - Cologuard 2.0 will target physicians who previously objected to the false positive rate, leveraging data and analytics for targeted outreach [21] Question: Strategy for deepening Cologuard penetration [22] - The company focuses on increasing frequency and consistency of messaging to drive higher Cologuard orders, despite 75% of primary care physicians already ordering the test [23][24] Question: Profitability and G&A leverage [25] - Adjusted EBITDA margins are improving, with a $320 million YoY improvement expected for 2023 [26] - G&A growth was 2% excluding one-time items, with further leverage expected over time [27] Question: Cologuard drivers and rescreen trends [28] - Rescreens are a key driver, with a temporary headwind from COVID-related declines in 2020 orders, but growth is expected to rebound in 2024 [29][30] - The 45-49 age group now accounts for nearly 20% of Cologuard revenue, driven by guideline changes [31] Question: Oncotype DX in Japan and cash collections [34] - Oncotype DX in Japan is expected to contribute $25-30 million annually, with a small impact in 2023 [35] - Improved cash collections contributed over $10 million in H1, with $5 million expected in H2 [36][37] Question: Seasonality and Q3 guidance [38] - Q3 screening revenue is expected to be flat due to COVID-related rescreen headwinds, but full-year growth remains strong at 28% [41][42] Question: MRD Oncodetect launch timing [43] - The MRD test is expected to launch in late Q4 2023, with Medicare coverage likely by mid-2025 [44] Question: Next-gen Cologuard timeline [45] - FDA submission for next-gen Cologuard is expected by year-end, with approval likely in 9-12 months [47] Question: Gross margin trends and Cologuard 2.0 cost savings [48] - Full-year gross margin guidance is raised to 73.5%-74%, with Cologuard 2.0 expected to reduce costs by at least 5% [49][51] Question: Health system electronic connections [54] - Electronic ordering accounts for 65% of Cologuard orders, with plans to connect 60 more health systems in H2 [55][57] Question: Physician feedback on next-gen Cologuard [58] - Early feedback from KOLs and payers on next-gen Cologuard is positive, with expectations of smooth adoption and reimbursement [59][60] Question: Precision Oncology revenue breakdown [61] - International Precision Oncology revenue grew 26% in Q2, with strong momentum in the global breast franchise [62] Question: MRD technology and Broad Institute collaboration [65] - The Broad Institute's MAESTRO technology will enhance the next-gen MRD test, improving sensitivity and specificity [66] Question: Health system backlog and screening capacity [67] - Health systems are partnering with the company to address colonoscopy backlogs and improve screening rates [68][70] Question: Margin profile and COVID rescreen headwind [71] - The $50 million COVID rescreen headwind is temporary, with margins expected to improve as the headwind lifts in 2024 [72] Question: International expansion learnings [73] - The company is leveraging its US experience to explore opportunities for Cologuard in international markets, particularly Europe [74][75] Question: Cologuard blood test timeline [78] - Data for the CRC blood test is expected by mid-2024, targeting patients who refuse frontline screening tests [79][80]
Exact Sciences(EXAS) - 2023 Q2 - Earnings Call Presentation
2023-08-01 22:37
We aim to eradicate cancer with tests that help prevent it, detect it earlier, and guide treatment. Second-quarter 2023 earnings call August 1, 2023 EXACT SCIENCES 1 Safe harbor and non-GAAP disclosures This presentation contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject t ...
Exact Sciences(EXAS) - 2023 Q2 - Quarterly Report
2023-07-31 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-35092 EXACT SCIENCES CORPORATION (Exact name of registrant as specified in its charter) (Address of principal executive offices) (Zip Code) (608) 535-8815 ...
Exact Sciences(EXAS) - 2023 Q1 - Earnings Call Presentation
2023-05-09 23:56
We aim to eradicate cancer with tests that help prevent it, detect it earlier, and guide treatment. First quarter 2023 earnings call May 9, 2023 EXACT SCIENCES Safe harbor and non-GAAP disclosures This presentation contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject t ...
Exact Sciences(EXAS) - 2023 Q1 - Earnings Call Transcript
2023-05-09 23:56
Exact Sciences Corporation (NASDAQ:EXAS) Q1 2023 Earnings Conference Call May 9, 2023 5:00 PM ET Company Participants Megan Jones - IR Kevin Conroy - Chairman & CEO Jeffrey Elliott - CFO & COO Everett Cunningham - Chief Commercial Officer Conference Call Participants Brandon Couillard - Jefferies Catherine Schulte - Baird Vijay Kumar - Evercore ISI Andrew Brackmann - William Blair Jack Meehan - Nephron Research Daniel Arias - Stifel Derik De Bruin - Bank of America Matt Sykes - Goldman Sachs Dan Brennan - C ...
Exact Sciences(EXAS) - 2023 Q1 - Quarterly Report
2023-05-08 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-35092 EXACT SCIENCES CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Del ...
Exact Sciences(EXAS) - 2022 Q4 - Earnings Call Transcript
2023-02-22 02:07
Exact Sciences Corporation (NASDAQ:EXAS) Q4 2022 Earnings Conference Call February 21, 2023 5:00 PM ET Company Participants Megan Jones - Investor Relations Kevin Conroy - Chairman and Chief Executive Officer Jeff Elliott - Chief Financial Officer and Chief Operating Officer Everett Cunningham - Chief Commercial Officer Conference Call Participants Derik De Bruin - Bank of America Andrew Brackmann - William Blair Dan Brennan - Cowen Vijay Kumar - Evercore ISI Catherine Schulte - Baird Brandon Couillard - Je ...
Exact Sciences(EXAS) - 2022 Q4 - Earnings Call Presentation
2023-02-22 02:02
Making earlier cancer detection a routine part of medical care Fourth quarter 2022 earnings call February 21, 2023 EXACT SCIENCES 1 Safe harbor and non-GAAP disclosures This pre ...