NEW YORK ─ Luminex said after the close of the market on Tuesday that its second-quarter revenues rose 32 percent year over year, driven by COVID-19-related sales, in line with preliminary revenues reported in July.
For the three months ended June 30, the diagnostics firm reported Q2 revenues of $109.5 million compared to $83.1 million for the prior-year quarter, beating analysts' average estimate of $107.3 million.
The firm reported Q2 systems revenues of $15.5 million, down 16 percent year over year from $18.6 million. Its consumables revenues were $11.3 million, down 11 percent from $12.7 million in Q2 2019. Royalty revenues were $12.1 million, down 5 percent year over year from $12.8 million; assay revenues were $61.2 million, up 95 percent year over year from $31.4 million; service revenues were $5.5 million, down 8 percent year over year from $6 million; and all other revenues were $3.9 million, up 160 percent year over year from $1.5 million.
Austin, Texas-based Luminex posted Q2 molecular diagnostics revenues of $64.9 million, up more than 100 percent compared to Q2 2019. The firm said it either sold or signed contracts for the sale of 162 sample-to-answer systems in the second quarter, most of which were Aries Systems.
The company added in a statement that its Q2 Licensed Technologies Group revenues were $35.2 million, down 4 percent compared to Q2 2019, and that it "continues to be significantly impacted by the slowdown in academic research due to COVID-19."
"In line with our mission, we quickly developed multiple COVID-19 products that work with many of our existing systems, providing flexible testing solutions to the facilities that need them and the healthcare workers and patients that are dependent upon them," Nachum Shamir, Luminex president and CEO, said in a statement. "As a result of the increased demand for our products following the outbreak, we delivered record revenue, the most profitable quarter in the history of our company, and a significant amount of cash flow."
Shamir added that revenue growth in its "molecular diagnostics franchise drove record sample-to-answer system placements, assay sales, and revenue."
Still, the company "experienced COVID-19 headwinds that negatively impacted" its clinical tools and life science revenue streams, Shamir said.
"We have launched several new testing solutions directly targeting the COVID pandemic and anticipate launching several more in the near term," Shamir said on a conference call to discuss the firm's financial results. "At the same time, we continue to invest in developing our core technologies, including our Verigene portfolio, our Xmap technology, and our flow cytometry offering."
Luminex recently submitted two tests for US Food and Drug Administration Emergency Use Authorization ─ a NxTag RPP-plus SARS-CoV-2 consolidated panel and a stand-alone assay with its Verigene I instrument. It plans a submission soon for EUA for a next-generation Verigene II respiratory assay with a SARS-CoV-2 target.
Luminex reported net income in Q2 of $12.5 million, or $.27 per share, compared to a net loss of $4.9 million, or $.11 per share, a year earlier, beating analysts' average estimate of $.08 per share.
The company's Q2 R&D costs were $13.9 million, down 7 percent from $15.0 million in Q2 2019, and its SG&A costs were $34.2 million, up 3 percent from $33.1 million.
The company ended the quarter with $291.7 million in cash and cash equivalents.
Luminex anticipates third quarter 2020 revenues will be more than $100 million with growth in excess of 26 percent over Q3 2019, and it expects its full-year 2020 revenue will be $415 million, or more.
The firm said it anticipates providing updated full-year guidance in conjunction with its third-quarter earnings release.
Prior to the release of Luminex's earnings, analysts on average expected $89.5 million in Q3 revenues and $387 million in full-year 2020 revenues.
The firm noted that it recently received FDA EUA for a COVID-19 antibody test and for its Aries SARS-CoV-2 molecular assay.
Shamir noted on the conference call that in June the company received a warning letter from the FDA that stemmed from inspections at its facilities in February and pertained to FDA requirements for its Verigene SP instrument.
The FDA noted in its warning letter that a medical device report was filed after a patient died. A malfunction had been reported that resulted in a delay of therapy due to false-negative results of the firm's assays using the Verigene SP instrument, the FDA wrote.
"We obviously took this warning letter seriously and provided our responses and additional data to the FDA within the allowed 15 working days," Shamir said. "As a reminder, the warning letter did not restrict the manufacturing, production, or shipment of any of the company's products [and] didn't require the withdrawal of any products from the marketplace. However, we are taking significant action to address certain issues addressed in the warning letter and are currently waiting for any further response or comment from the FDA."
Separately on Tuesday, Luminex announced the retirement of G. Walter Loewenbaum, chairman of its board of directors. Shamir will serve as its new chairman of the board, and Edward Ogunro will become its lead independent director.
Luminex shares were up more than 3 percent to $40.72 in Wednesday morning trading on the Nasdaq.