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Luminex Q4 Revenues Rise 23 Percent; FDA Deprioritizes EUA Submission for COVID-19 Test

NEW YORK – Luminex reported after the close of the market on Monday that its fourth quarter revenues rose 23 percent year over year, in line with preliminary estimates announced in January.

For the three months ended Dec. 31, 2020, the Austin, Texas-based diagnostics company reported revenues of $111.4 million compared to $90.5 million in Q4 2020, and beating analysts' average estimate for revenues of $104.6 million.

Luminex said its Q4 system revenues were $23.8 million, up 14 percent year over year from $20.8 million, while consumable revenues were $13.0 million, up 11 percent year over year from $11.7 million. Its royalty revenues were $13.9 million, up 2 percent year over year from $13.6 million. Assay revenues were $51.3 million, up 41 percent year over year from $36.4 million. Service revenues were $6.3 million, up 11 percent year over year from $5.7 million, and other revenues were $3.1 million, an increase of 29 percent from $2.4 million in the prior-year quarter. 

"We delivered record revenue growth, profitability, and cash flow during 2020 and positioned ourselves well for continued growth in 2021 and for the foreseeable future thereafter," Nachum Shamir, the firm's president and CEO, said in a statement.

"During 2020, we had a strong tailwind from MDx revenue," Shamir said on a conference call to discuss the firm's financial results. "While we had initial pressure on our license revenue, we recovered very nicely during the third and fourth quarters."

Though a submission to obtain Emergency Use Authorization for its NxTag RPP syndromic respiratory panel remains on track, "the status is more puzzling" regarding an EUA submission for its Verigene I COVID-19 standalone assay, Shamir said.

Last Thursday, the US Food and Drug Administration notified Luminex that it is deprioritizing the firm's EUA submission for the Verigene I assay. That came as a surprise to Luminex because it expected to soon receive EUA, Shamir said.

Instead, the agency told the company that it is focusing on EUAs for at-home and point-of-care tests for SARS-CoV-2 to increase accessibility to testing, Shamir added.

However, Luminex is reviewing options to challenge the decision to deprioritize the Verigene I assay, because the firm believes "getting this product in the hands of the hundreds of customers who have requested it will rapidly increasing accessibility," Shamir said. "Still, at this point, we cannot say whether we will be successful in reversing this decision."

The firm continues to plan to submit additional EUA applications to the FDA during this quarter, he said.

In Q4 2020, its flow cytometry revenue growth was flat year over year at $12 million, and its licensed technologies group revenue increased 4 percent year over year to $40 million from $38.6 million in Q4 2019.

The firm's molecular diagnostics revenues rose 49 percent year over year to $57.8 million from $38.8 million in Q4 2019.

Luminex reported Q4 2020 net income of $239,000, or $.01 per share, compared to $3.4 million, or $.07 per share, in Q4 2019. Analysts, on average, had estimated a profit of $.13 per share.

The company's R&D spending increased 7 percent to $13.8 million from $12.9 million in the year-ago quarter, while its Q4 SG&A expenses increased 19 percent to $37.2 million from $31.1 million in Q4 2019.

For full-year 2020, Luminex reported revenues of $417.4 million, up 25 percent year over year from $334.6 million, beating analysts' average estimate of $410.6 million. The company reported molecular diagnostics revenues of $227.8 million, up 66 percent from $137 million in 2019. It sold or inked contracts for 449 sample-to-answer systems for the year, with a significant number under reagent rental agreements, up nearly 120 percent year over year.

Further, for full-year 2020, the company reported $146.7 million in Licensed Technologies Group revenues, down 2 percent compared to $149 million in 2019. Luminex posted full-year 2020 Flow Cytometry revenues of $35.8 million, down 20 percent from $45 million in 2019.

For full-year 2020, its system revenues were $70.8 million, up 1 percent year over year from $70.3 million. Consumable revenues were $48.9 million, up 1 percent year over year from $48.5 million. Luminex posted $48.9 million in royalty revenues, down 9 percent from $53.6 million in the prior year. Assay revenues were $211.9 million, up 60 percent from $132 million in the prior year. Service revenues were $23.3 million, up 4 percent year over year from $22.4 million. Other revenues were $13.6 million, an increase of 74 percent from $7.8 million in the prior year.

Luminex reported full-year 2020 net income of $15.2 million, or $.32 per share, compared to a loss of $3.8 million, or $.09 per share, in 2019.

Its R&D expenses for the year rose 4 percent to $53.7 million from $56.2 million in 2019, while its SG&A expenses rose 10 percent to $140.2 million from $127.2 million in 2019.

Luminex ended the year with $309.4 million in cash and cash equivalents.

Luminex reaffirmed its 2021 revenue guidance of approximately $480 million, which would represent a 15 percent increase compared to full-year 2020 revenues. The firm said it anticipates that revenue growth in 2021 will be primarily driven by significant expansion of its Aries assay sales resulting from the completion of a manufacturing line expansion, an expanded customer base, and new product launches.

Before the release of the Q4 financial results, analysts, on average, estimated that Luminex will book revenues of $474.4 million in 2021.

Shamir said during the conference call that in 2020 Luminex expanded its manufacturing capability, leading to a fourfold increase in production capacity for Aries systems and assays. That and planned new product launches support its 2021 growth expectations, he said, adding, "We are also investing in additional expansion of our facilities to accommodate future growth."

Luminex on Monday announced that its board declared a cash dividend for the first quarter of 2021 of $.10 per share of common stock, payable on April 15 to stockholders of record on March 25.

Luminex shares were down more than 6 percent to $28.05 in early Tuesday morning trading on the Nasdaq.

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