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Exact Sciences Preps for New Assay Launches Buoyed by Continued Growth for Legacy Tests


NEW YORK – Exact Sciences is gearing up for the launch of a new slate of assays over the next few years including a new iteration of its well-established stool-based colorectal cancer screening test Cologuard, a complementary blood-based assay, and a test for minimal residual disease detection.

Exact CEO Kevin Conroy discussed these new assays during a Wednesday call recapping the firm's fourth quarter financial results, which included year-over-year revenue growth of 17 percent and, Conroy said, "set the tone for an impactful year ahead."

Conroy said during the call that Exact submitted its premarket approval application for the second generation of Cologuard to the US Food and Drug Administration in December and expects to make the test available to patients in 2025.

The submission is supported by data from the company's BLUE-C trial, which Exact previewed last year, demonstrating 94 percent sensitivity for detecting cancers, 93 percent sensitivity for detecting curable-stage cancers, 43 percent sensitivity for advanced precancerous lesions, and 91 percent specificity, up from 87 percent specificity seen in the FDA registrational trial for the initial version of Cologuard.

According to Conroy, most study participants in BLUE-C also provided a sample for the company to use in evaluating the blood-based colon cancer screening test it has been developing alongside the second-generation Cologuard. The company has been relatively quiet about progress on that assay in the past, but Conroy said that Exact will announce top-line results from that analysis this year.

Exact has maintained that blood-based colorectal cancer screening will most likely be embraced by regulators and payors as a second-line screening option for patients that refuse frontline tests. 

"We know who the patients are that refuse high-quality tests like Cologuard and colonoscopy," he said, "and when they refuse those tests, there's an opportunity for us to help those patients at least get screened."

"One of the things that's competitively unique about our approach is just the cost structure," he added. "It's a test that's built on a supercharged PCR platform. And that provides a cost structure that we believe will be best in class and provide real value to the health system and to those patients that get tested."

The company also expects to share data from several studies on its minimal residual disease test, OncoDetect, over the next 12 months, including data that Conroy said will support reimbursement for the assay in colon cancer.

Brian Baranick, Exact's general manager of precision oncology, added that the company is already having discussions with customers about MRD. "We're working very closely in the business unit and the commercial team … and very much look forward to introducing that test into the commercial team later this year or very early next year," he said.

Other work going on in the background includes preparation to integrate MRD testing into Exact's evolving IT platform, which Baranick said could give the firm a competitive advantage in terms of clinical implementation, especially in the context of long-term monitoring.

Exact CFO Jeff Elliott added that while the company does not expect a material revenue contribution from MRD testing until next year, it views it as one of its biggest pipeline opportunities.

Although it doesn't expect to seek reimbursement in other cancer types this year, Exact is also building data for OncoDetect in other tumors like breast cancer.

Baranick said that with the firm's licensing of the Broad Institute's whole-genome MAESTRO technology, Exact believes it can overcome some of the challenges of implementing MRD in breast cancer, which includes tumor subtypes that are known to shed much less DNA into the blood.

Q4 and FY2023 financial results

Exact's fourth quarter revenues grew 17 percent year over year to $646.9 million from $553.0 million in the same period of 2022, beating the consensus Wall Street estimate of $638.8 million.

The firm's screening revenue was $486.7 million during the quarter, an increase of 21 percent from $403.5 million in Q4 of the previous year. Its precision oncology revenue was up 12 percent at $160.2 million from $143.4 million.

Exact's Q4 net loss was $49.8 million, or $.27 per share, compared to a net loss of $127.7 million, or $.72 per share, in the same period of 2022. Analysts, on average, had expected a larger loss of $.46 per share.

The firm's quarterly R&D expenses rose about 22 percent to $114.9 million from $94.3 million. Its SG&A spending was $411.1 million in Q4, up slightly from $404.1 million in Q4 2022.

During the earnings call, Exact Sciences CFO Jeff Elliott said that the number of physicians ordering Cologuard reached an all-time high during the quarter at 172,000.

For full-year 2023, Exact's revenues were $2.50 billion in total, an increase of 20 percent from $2.08 billion in 2022 and beating the consensus Wall Street estimate of $2.49 billion.

This included screening revenue of $1.86 billion, up 32 percent from $1.42 billion, and precision oncology revenue of $629.1 million, up about 5 percent from $601.5 million.

The company's full-year net loss was $204.1 million, or $1.13 per share, compared to $623.5 million, or $3.54 per share, in the prior year. Analysts' average estimate for full-year loss was $1.35 per share.

Exact ended the quarter with cash and cash equivalents of $605.4 million and marketable securities totaling $172.3 million.

For the upcoming year, Exact said it anticipates revenue of $2.81 billion to $2.85 billion, assuming screening revenue between $2.16 billion and $2.18 billion and precision oncology revenue of $655 million to $675 million.