On November 5, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the Company generated revenue of $709 million for the third quarter ended September 30, 2024, compared to $628 million for the same period of 2023 (Press release, Exact Sciences, NOV 5, 2024, View Source [SID1234647724]).

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"The Exact Sciences’ team is helping eradicate cancer while strengthening our platform and growing our business efficiently," said Kevin Conroy, chairman and CEO. "During the third quarter, we delivered test results to more patients than ever before, improved profitability, and achieved key milestones in our pipeline of innovative cancer diagnostics. While we have made progress, our execution during the third quarter and updated outlook for the full year don’t reflect our full potential. We plan to accelerate growth in 2025, and our long-term outlook remains strong."

Third-quarter 2024 financial results

For the three-month period ended September 30, 2024, as compared to the same period of 2023 (where applicable):

Total revenue was $709 million, an increase of 13 percent on a reported and core revenue basis
Screening revenue was $545 million, an increase of 15 percent
Precision Oncology revenue was $164 million, an increase of 5 percent on a reported and core revenue basis
Gross margin including amortization of acquired intangible assets was 69 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 72 percent
Other operating income was $3 million compared to $72 million, which included a gain related to the sale of the Oncotype DX Genomic Prostate Score Test in third-quarter 2023
Net loss was $38 million, or $0.21 per basic and diluted share, a reduction of $39 million, or $0.21 per basic and diluted share
Adjusted EBITDA was $99 million an increase of $42 million, and adjusted EBITDA margin was 14 percent, an increase of 500 basis points
Operating cash flow was $139 million and free cash flow was $113 million, increases of $114 million and $113 million, respectively
Cash, cash equivalents, and marketable securities were $1.02 billion at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX and therapy selection tests.

Platform and pipeline advancements

The Company’s ExactNexus technology platform allows Exact Sciences to connect electronically with patients, health systems, healthcare professionals, and payers. The digital tools and data embedded within the ExactNexus platform enable personalized customer experiences, creating a streamlined process for accessing information, enhancing patient engagement, and improving health outcomes. This approach contributed to strong growth in Cologuard test utilization among rescreen patients and within care gap programs during the third quarter.

Exact Sciences received FDA approval for the Cologuard Plus test, its next-generation Cologuard test. The Cologuard Plus test detects cancers and precancerous polyps with even greater sensitivity than the Cologuard test while reducing false positives by more than 30 percent. This advancement enhances the Company’s screening capabilities and reinforces its commitment to delivering high-quality, non-invasive options for patients. With the Cologuard Plus test, the Company expects to secure a higher price through an established Medicare pathway.

In the third quarter, the Company also presented data for its blood-based colorectal cancer screening test, showcasing a sensitivity of 88% for colorectal cancer and 31% for advanced precancerous lesions at 90% specificity. These results show the potential of the Company’s novel marker panel to detect advanced precancerous lesions and cancers at an attractive cost profile. This innovation is expected to provide average-risk patients with another screening option, reinforcing the power of the Company’s unique scientific approach.

Exact Sciences secured acceptance from a peer-reviewed journal for its first publication on the Oncodetect test, its molecular residual disease and recurrence monitoring test. These data are currently under embargo and are expected to be shared in January 2025. With nearly 6 million cancer survivors in the U.S. who could benefit from residual and recurrent disease testing, the need is urgent – yet less than 5% are currently receiving the vital testing today. This recognition highlights the scientific rigor behind the product and positions the Oncodetect test as a leading solution for monitoring residual disease and cancer recurrence.

The Company also shared evidence supporting its blood-based multi-cancer screening test, assessing organ-specific performance of methylation and protein biomarkers in a prospectively collected cohort of samples from its ASCEND 2 study. The analysis indicated an overall sensitivity of 55% in cancers without standard-of-care screening options (excluding lung), and 64% in the six most aggressive cancers with the shortest survival rates, with a specificity of 98.5%. These findings highlight the potential clinical value of using multiple biomarkers to detect various cancer types, including the most aggressive and those without recommended screening options.

2024 outlook

The Company has updated its full-year 2024 revenue and adjusted EBITDA guidance:

Prior guidance

November 5 update

Total revenue

$2.810 – $2.850 billion

$2.730 – $2.750 billion

Screening

$2.155 – $2.175 billion

$2.080 – $2.095 billion

Precision Oncology

$655 – $675 million

$650 – $655 million

Adjusted EBITDA

$335 – $355 million

$310 – $320 million

Third-quarter 2024 conference call & webcast

Company management will host a conference call and webcast on Tuesday, November 5, 2024, at 5 p.m. ET to discuss third-quarter 2024 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608. A replay of the webcast will be available at exactsciences.com. The webcast, conference call, and replay are open to all interested parties.