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Roche Dx Revenues Down 6 Percent in Q1 on Lower COVID Test Sales as Base Business Rises

This story has been updated with comments from Roche's Q1 earnings call.

NEW YORK – Roche on Wednesday reported its diagnostics sales in the first quarter fell 6 percent year over year to CHF 3.48 billion ($3.80 billion) from CHF 3.71 billion in the year-ago quarter.

At constant exchange rates, however, diagnostics sales rose 2 percent year over year, the Basel, Switzerland-based firm said. The base business, meantime, grew 8 percent, offset by declining revenues from COVID-19 testing, which dropped 67 percent to CHF 100 million from CHF 300 million in the year-ago period.

The company said the performance of its base business was driven by demand for its immunodiagnostic products, clinical chemistry tests, and advanced staining solutions. Revenues from immunodiagnostics, which include cardiac, oncology, and thyroid tests, were up 10 percent year over year. Clinical chemistry revenues were up 8 percent, while advanced oncology staining products were up 12 percent, and companion diagnostics were up 47 percent.

Point-of-care immunodiagnostics revenue was down 68 percent while point-of-care molecular revenue was up 4 percent. Roche's blood screening business was up 11 percent, and its virology base business was up 9 percent. Diabetes care revenue was down 12 percent.

Within diagnostics, core lab revenues, which comprised 55 percent of total diagnostics sales, were flat at CHF 1.93 billion. Molecular lab sales fell 9 percent to CHF 620 million from CHF 683 million in 2023 and contributed 18 percent of total diagnostics sales. Sales in the pathology lab segment grew 10 percent to CHF 363 million from CHF 329 million in 2023 and accounted for 10 percent of total diagnostics sales.

Roche's near-patient care business, which accounted for 16 percent of diagnostics sales, fell 26 percent to CHF 570 million from CHF 774 million last year. Near-patient care is a new segment created by the combination of the company's point-of-care testing and diabetes businesses.

Although the declining demand for COVID-19 tests has had a significant impact on Roche, the firm is continuing to focus on recent and upcoming non-COVID-19 product launches in its diagnostics division, with CEO Thomas Schinecker saying during a conference call following release of the firm's Q1 results that 2024 is "a very important launch year for diagnostics."

He highlighted as significant developments during the quarter the US Food and Drug Administration's approval of the company's Cobas Malaria test as well as its receipt of FDA breakthrough device designation for its Elecsys PTau217 plasma biomarker test for Alzheimer's disease.

Matt Sause, CEO Roche Diagnostics, noted during the call that the company had seen "very good development" of its instrument install base throughout 2023.

Roche's new Cobas pro and pure systems grew 77 percent in 2023, driving a 3 percent uptick in its serum work area placements. Placement of its Cobas 5800, 6800, and 8800 molecular systems grew 20 percent, driven by sales of the Cobas 5800. The firm's molecular point-of-care Cobas Liat system grew by 6 percent over the course of 2023.

In pathology, Sause noted that the company's "main workhorse" systems, the BenchMark Ultra and Benchmark UltraPlus grew 10 percent while its HE600 system grew 12 percent. Placements of its DP200 and DP600 digital pathology systems grew 29 percent, indicating the strength of that business, Sause said.

Sause also provided an update on Roche's work in blood-based Alzheimer's testing, noting that the company expected to submit US and EU regulatory filings in 2025 for its blood-based rule-out test measuring phosphorylated-tau 181 (p-tau 181) and APOE4 and in 2026 for its p-tau 217 blood test for ruling in Alzheimer's disease.

Overall, Roche posted CHF 14.40 billion in sales in the quarter, down 6 percent from CHF 15.32 billion in Q1 2023. At constant exchange rates, sales rose 2 percent year over year. Excluding the effect of lower demand for COVID-19 tests, sales grew 7 percent, the company said in a statement. It added that "going forward there will be no further material impact of COVID-19 sales decline."

The pharmaceutical division had CHF 10.92 billion in Q1 sales, down 6 percent from CHF 11.61 billion in Q1 2023. At constant exchange rates, sales rose 2 percent year over year.

Roche confirmed its full-year outlook with sales expected to increase in the mid-single digit percent range at constant exchange rates. The firm added that EPS for full-year 2024 is expected to be in line with the sales increase.