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Exact Sciences Q4 Revenues Up 107 Percent

NEW YORK – Exact Sciences reported after the close of the market on Tuesday that its fourth quarter revenues rose 107 percent year over year, thanks to a 63 percent increase in testing volumes for its Cologuard colorectal cancer screening test.

For the three months ended Dec. 31, 2019, the Madison, Wisconsin-based molecular diagnostics company reported revenues of $295.6 million, up from $143.0 million a year earlier, and beating the average Wall Street estimate of $283.1 million.

Screening revenues rose 60 percent year over year to $229.4 million, and precision oncology revenues — tied to the acquisition of Genomic Health, which closed Nov. 8, 2019 — were $66.2 million for the period of Nov. 8, 2019 through Dec. 31, 2019. Assuming Genomic Health was a standalone entity, precision oncology proforma revenues for the full fourth quarter would have been $119 million, an increase of 14 percent from proforma 2018 revenues, the company said.

"The Exact Sciences team delivered another strong quarter to end a transformative year for the company," Exact Chairman and CEO Kevin Conroy said in a statement. "The strong foundation we've built for Cologuard and Oncotype DX and the capabilities of our combined team position us well to continue to grow our core business and deliver more innovative cancer tests to people in need."

The number of people screened with Cologuard during the quarter rose to 477,000. Test volume for Genomic Health's Oncotype DX for the full fourth quarter was 41,000, a year-over-year increase of 14 percent. The average Cologuard recognized revenue per test was $481 in Q4, and the average cost per test to the company improved $6 to $123. On a conference call with analysts following the release of the earnings, Exact CFO Jeff Elliott noted that the company continues to expect that it will reach a revenue-per-test of $500 and is confident in reaching its long-term cost-per-test goal of $100.

In January, the company reported preliminary Q4 revenues of $294 million to $296 million, well above its previously stated estimate of $232.8 million and the then-consensus Wall Street estimate of $253.1 million. Exact also said that it expected to report Q4 screening revenue between $229 million and $230 million, a 61 percent year-over-year increase, and precision oncology revenues of $65 million to $66 million.

On the call, Conroy provided an update on the liver cancer test the company is developing in conjunction with the Mayo Clinic. He said Exact is planning to make that test available in the second half of 2020, and that it could eventually reach 3 million patients, or an addressable market worth $1.5 billion.

Conroy also disclosed that Exact has acquired two companies: Paradigm Diagnostics, which currently sells an NGS-based cancer diagnostic test that aids in therapy selection; and Viomics, a molecular diagnostics company that specializes in biomarker selection for cancer diagnostics.

The acquisitions will expand Exact's expertise in cancer diagnostics, Conroy said. He noted that Paradigm's test has deep DNA sequencing capabilities that is differentiated from other therapy selection tests on the market. The test is currently tissue-based, but Exact is making plans to convert it to liquid biopsy, he added. Conroy also said that Exact has a pre-existing relationship with Viomics, which has delivered biomarkers that are in products Exact plans to sell in the future.

The company declined to disclose the purchase prices for the acquisitions, and Conroy said Exact wouldn't be giving a timeline for the completion of the conversion of Paradigm's test from tissue to liquid biopsy.

Exact reported Q4 net income of $77.9 million, or $.54 per share, compared to a net loss of $54.0 million, or $.44 per share, in the year-ago period. Analysts had expected a loss of $.35 per share. The company received an income tax benefit of $184.6 million due to a change in the deferred tax asset valuation allowance resulting from the combination with Genomic Health in Q4.

The company's R&D costs for the quarter rose 109 percent to $43.2 million from $20.7 million in Q4 2018, and its SG&A expenses rose 99 percent to $264.3 million from $133.1 million.

For full-year 2019, Exact reported revenues of $876.3 million, up 93 percent from $454.5 million in 2018, and beating the average Wall Street estimate of $863.7 million.

For full-year 2019, the company had expected total revenues of $874.5 million to $876.5 million, including precision oncology revenues of $65 million to $66 million for the period of Nov. 8, 2019 through Dec. 31, 2019.

Exact's 2019 net loss narrowed to $84.0 million, or $.64 per share, from a net loss of $175.1 million, or $1.43 per share, in the year-ago period. Analysts had expected a loss of $1.63 per share for the year.

The company's R&D costs for the year rose 108 percent to $139.7 million from $67.3 million in 2018, and its SG&A expenses rose 73 percent to $737.7 million from $427.4 million.

Exact ended the year with $177.3 million in cash and cash equivalents, and $146.4 million in marketable securities.

For full-year 2020, Exact expects revenues of $1.61 billion to $1.65 billion, including screening revenues of $1.13 billion to $1.15 billion and precision oncology revenues of $485 million to $495 million. On average, analysts expect revenues of $1.59 billion for the year.

In the first quarter, Elliott said the company is expecting revenues of $349 million to $359 million, with screening revenues of $230 million to $235 million and precision oncology revenues of about $119 million to $124 million. Analysts are expecting revenues of $350.3 million for Q1.

Elliott noted that there are several growth drivers for Cologuard in 2020, including about 200,000 more patients due for rescreening in 2020 than were due for rescreening in 2019. Exact expects that Q1 will make up about 20 percent of Cologuard revenues for the year, he added. However, the company will not be providing any specific Cologuard or Oncotype DX metrics in earnings reports going forward.

Elliott also said that the acquisitions of Viomics and Paradigm would not materially affect 2020 revenues. The deal with Viomics is an R&D partnership, he said, and even though Paradigm has a test on the market, those sales are unlikely to make a significant impact on revenues in 2020.

Exact's shares fell more than 1 percent to $93.50 in Wednesday morning pre-market trading on the Nasdaq.

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