NEW YORK ─ DiaSorin on Wednesday cautioned that its 2022 revenues are likely to decline slightly year over year due to an anticipated decline in COVID-19 testing as it looks toward its base business and Luminex subsidiary for revenue growth.
After its 2021 revenues increased 41 percent compared to 2020, the Saluggia, Italy-based-firm said it anticipates a 2 percent year-over-year drop in overall revenue growth in 2022, driven in part by a possible 61 percent decline in COVID-19 revenues.
At current exchange rates, DiaSorin's 2021 COVID-19 revenues rose more than threefold year over year to €378 million, but the firm expects revenues to decline to €150 million this year, DiaSorin CFO Piergiorgio Pedron said on a conference call Wednesday to discuss the financial results.
The firm's fourth quarter COVID-19 revenue growth was flat at €102 million compared to €101 million in Q4 2020, he noted, with €70 million to €75 million booked for immunoassay testing and the rest for molecular testing.
DiaSorin CEO Carlo Rosa added that recent demand for the firm's SARS-CoV-2 tests peaked during the Omicron wave in December and January but declined sharply in recent weeks. Looking ahead, the firm is adopting a "wait and see" approach and seeking a better understanding of the likely demand for its tests, he said.
Throughout 2021, DiaSorin's COVID-19 revenues and volumes have fluctuated with the emergence and departure of various pandemic waves.
The firm is seeing geographical differences in demand for its systems and SARS-CoV-2 tests. In Europe, its SARS-CoV-2 tests are frequently used for hospital admissions and confirmatory testing following positive antigen test results, while in the US its systems are among the primary testing platforms in midsized hospitals where, Rosa noted, they are more sensitive to shifts in demand during pandemic waves.
Removing the effect of an expected decline in 2022 COVID-19 revenues, DiaSorin expects its full-year 2022 revenues to grow 24 percent at constant exchange rates, driven by strength in its base business and the potential of Luminex products, Rosa said.
In 2021, DiaSorin saw a record year for new installations of its Liaison XL fully automated chemiluminescence analyzer, placing more than 550 systems and seeing strong growth in the US where a hospital placement strategy initiated two years ago is paying dividends, Rosa said.
Excluding COVID-19 testing, DiaSorin's immunodiagnostic testing product revenues rose 12 percent year over year in the recently completed quarter. Chemiluminescent immunoassay testing for applications other than vitamin D grew 19 percent while CLIA vitamin D testing remained flat compared to Q4 2020.
Overall, in Q4, CLIA testing grew double digits in all geographies outside China where DiaSorin is facing pricing pressures as it competes for new business with local testing companies, he said.
Additionally, DiaSorin recently launched the fully automated, chemiluminescent immunoassay MeMed BV test in Europe, and applied in mid-December for US Food and Drug Administration clearance. The test uses host-response data to enable physicians to differentiate between bacterial and viral infections, and DiaSorin obtained the rights to commercialize the assay and make it available on its Liaison XL and Liaison XS platforms in September 2020.
Rosa noted that the test expands DiaSorin's infectious disease menu and can run on its growing installed base of hospital-based analyzers.
DiaSorin partnered with Qiagen to develop the assay for its Liaison XS benchtop platform. In the US especially, where DiaSorin has signed Labcorp as a customer and there is ample runway for adoption, the firm expects to soon see additional traction, Rosa said.
The new Luminex business, which DiaSorin acquired for $1.8 billion in the second quarter of 2021, also has the potential to drive strong revenue growth for DiaSorin, Rosa said. The Austin, Texas-based business contributed €104 million to DiaSorin's revenues in the recently completed quarter, with orders coming mainly for molecular diagnostic products.
The Luminex Licensed Technologies Partner (LTP) business, in particular, is expected to be a strong contributor to DiaSorin's margin and top-line growth. The LTP business, primarily driven by sales to strategic partners for research or IVD kits, grew 20 percent year over year in Q4, Rosa said, adding that recent LTP revenue growth was driven in part by the launch of Luminex xMap Intelliflex multiplex platform, which leverages advanced imaging flow cytometry.
Meanwhile, the Luminex multiplex diagnostic testing business is "relatively stable" overall, mainly driven by placements of its Verigene I system and tests, but demand for the Verigene respiratory panel fluctuates with COVID-19 testing demand, Rosa said.
DiaSorin continues to update panels on Verigene I and recently launched an updated gastrointestinal panel for the European market.
The firm is also validating a manufacturing line in Chicago for the Verigene II benchtop molecular diagnostic system, which would offer rapid, sample-to-result detection. It is developing a gastrointestinal panel and three blood-based panels — Gram positive, Gram negative, and yeast — for the Verigene II system, and it anticipates kicking off clinical studies in advance of an In Vitro Diagnostic Regulation submission for approval in Europe in the second half of 2022.
"We expect to start initial placements in Europe for customer usability in the early fall," Rosa said, adding that some of the panels could be available in the US with FDA clearance in 2023.
At the same time, DiaSorin continues to take corrective actions to mitigate issues related to Verigene I for which Luminex had received an FDA warning letter in 2020.
"I’m comfortable that within 18 months that issue is going to be completely resolved," Rosa said, adding that it is not preventing Luminex from submitting applications to the agency for clearance of its tests and systems.