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Oncocyte Reports Sevenfold Increase in Q4 Revenues on Strong DetermaRx Growth

NEW YORK – Oncocyte reported after the close of market Thursday that its fourth quarter and 2021 revenues rose sevenfold and sixfold, respectively, over their prior-year periods.

The Irvine, California-based company brought in total revenues of $3.6 million for the three months ending Dec. 31, 2021, compared to $503,000 for the fourth quarter of 2020 and in line with the consensus analyst estimate.

During a conference call recapping earnings, Oncocyte CEO Ronald Andrews attributed the growth to a variety of factors, including onboarding more physicians and an uptick in surgeries as the COVID-19 pandemic began to ebb, and launching DetermaRx, the firm's lung cancer test, in China through partner Burning Rock, triggering a milestone payment.

Oncocyte currently derives its revenues from sales of DetermaRx, which commercially launched in 2020, as well as pharma services generated by its wholly owned subsidiary Insight Genetics, which it acquired at the beginning of 2020.

DetermaRx revenues and test volumes grew 104 percent and 54 percent, respectively, in Q4, the company said.

Oncocyte's Q4 net loss amounted to $35.9 million, or $.39 per share, compared to a net loss of $6.3 million, or $.09 per share a year ago. On average, analysts were expecting a loss per share of $.13.

Oncocyte's Q4 R&D expenses rose 156 percent to $4.6 million from $1.8 million a year ago, while SG&A spending rose 40 percent to $7.4 million from $5.3 million.

In 2021, Oncocyte logged total revenues of $7.7 million compared to $1.2 million a year ago.

Net loss for 2021 was $64.1 million, or $.72 per share, compared to $29.9 million, or $.46 per share, in 2020. On average, analysts were expecting a loss per share of $.45 for 2021.

The firm's full-year R&D expenses rose 39 percent to $13.6 million from $9.8 million, while its SG&A spending jumped 44 percent to $33.5 million from $23.3 million.

Oncocyte finished the year with $35.6 million in cash and cash equivalents.

The increase in R&D expense in 2021 was related to "increased headcount and investment in clinical trials," Oncocyte CFO Mitch Levine said during the call.

Levine also attributed increased expenditures to professional and legal fees paid over the year, as well as to acquisition and other business-related costs.

Oncocyte acquired Chronix Biomedical last year to expand into the organ transplant market.

"We gained a powerful test for transplant rejection monitoring called Therasure," Andrews said.

He also mentioned that following a blanket coverage decision for Therasure from CMS, the firm has allocated a small team to set up a transplant monitoring business and to quickly perform tech transfer and validation of the test from Oncocyte's Nashville, Tennessee, CLIA lab.

"We remain on track to complete the work and have our lab-developed tests completed for commercialization by the end of March," Andrews said, adding that platform partnership discussions related to Therasure are taking place.

Oncocyte also launched its research-use-only immunotherapy response test, DetermaIO, late last year as part of an early-access program for non-small cell lung cancer and early-stage triple negative breast cancer. Andrews said that the firm now has seven early adopter sites up and running.

"We will exit 2022 with all major products launched," he stated, "at least two with high value reimbursement and gaining revenue traction, and two more with reimbursement dossiers submitted awaiting" approval from the Centers for Medicare and Medicaid Services.

In morning trading on the Nasdaq, shares of Oncocyte were up more than 7 percent at $1.50.