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Exact Sciences Q4 Revenues up 2 Percent; Non-COVID-19 Revenues Rise 16 Percent

NEW YORK – Exact Sciences reported after the close of the market on Tuesday that its fourth quarter revenues were up 2 percent year over year, in line with preliminary results announced last month.

For the three months ended Dec. 31, 2021, Madison, Wisconsin-based Exact reported revenues of $473.8 million compared to $466.3 million a year earlier, and beating the average Wall Street estimate of $449 million.

Excluding the company's COVID-19 testing revenues, which dropped 52 percent to $47.1 million, Exact's Q4 revenue increased 16 percent. Screening revenues, which include laboratory service revenue from Cologuard tests and revenue from Biomatrica products, rose 11 percent to $277.7 million in Q4, while precision oncology revenues, including laboratory service revenue from global Oncotype testing and Oncomap therapy selection products, were up 27 percent at $149 million.

The firm attributed its screening revenue growth to more Cologuard rescreens, growing use of the test in the 45-49 age group, expansion of its primary care sales team, and increased in-person sales calls.

"Cologuard and Oncotype DX are off to a great start in 2022, with strong momentum from the fourth quarter carrying over to the new year," Exact CEO and chairman Kevin Conroy said in a statement. "We have a team of talented people dedicated to defeating cancer. You'll see the results of their dedication this year as we test more patients and share evidence supporting our pipeline of innovative tests across the cancer continuum," he added.

Exact reported a Q4 net loss of $220.6 million or $1.28 per share, compared to $418.3 million or $2.67 per share, in the year-ago period. Analysts had expected a lower loss of $1.04 per share.

The company's R&D costs for the quarter dropped more than 80 percent to $88.5 million from $446.4 million in Q4 2020. Its SG&A expenses rose about 49 percent to $463.7 million from $311.9 million.

For full-year 2021, the company's revenues rose 19 percent to $1.77 billion from $1.49 billion in 2020, exceeding the Wall Street estimate of $1.74 billion.

On a call discussing the company's financial results, Conroy specified that Exact saw "more than $100 million in revenue from patients being rescreened with Cologuard [and] more than $40 million from patients in the 45 to 49 age group," both key drivers for Exact to continue revenue growth for its core assay as it expands its pipeline.

He added that recent moves, including the acquisition of hereditary genetics firm PreventionGenetics, are helping the firm cement a presence across the continuum of cancer care, with a new inroad in hereditary mutation testing.

"We provide Oncocyte Dx testing to more than 70 percent of all women diagnosed with ER-positive HER2-negative early-stage breast cancer each year in the US [but] oncologists order hereditary testing only 40 percent of the time," Conroy said. "Offering a hereditary cancer and Oncotype DX test for all of them could provide the whole picture necessary to understand and treat their cancer."

He reiterated that Exact intends to announce top-line results within the next 18 months from its prospective study to support US Food and Drug Administration submission for its next-generation version of Cologuard and blood-based colon cancer screening test.

Conroy also said the company is gearing up to present multi-center feasibility and validation data and information about the finalized design of its planned multi-cancer detection test. It will then begin a prospective study, but intends to launch a lab-developed test in the interim as it works to gain FDA approval and insurance reimbursement.

Exact's net loss for the year dropped to $595.6 million, or $3.48 per share, from $823.6 million, or $5.45 per share, in 2020. Analysts had expected a loss of $3.09 per share for the year.

The company's R&D costs for the year dropped about 30 percent to $385.6 million from $554.1 million in the same period last year, and its SG&A expenses rose 55 percent to $1.66 billion from $1.07 billion.

Exact ended the year with $315.5 million in cash and cash equivalents and $715 million in marketable securities.

Providing an outlook for 2022, the company said it anticipates revenue of $1.97 billion to $2.03 billion. This assumes screening revenues between $1.34 billion and 1.37 billion, at least $40 million of which should come from testing by PreventionGenetics.

Alongside that, the firm expects precision oncology revenue of $595 million to $610 million, and COVID-19 testing revenue between $40 million and $50 million during the year.

Exact's shares were down about 9 percent to $66.99 in Wednesday morning trading on the Nasdaq.