NEW YORK – Roche on Wednesday reported essentially flat year-over-year sales for its diagnostics division in the first quarter of 2020, despite a sharp uptick in its molecular diagnostics sales.
Roche as a whole, including both its pharmaceutical and diagnostics divisions, had CHF 15.14 billion ($15.65 billion) in sales in the quarter, up 7 percent from CHF 14.83 billion in Q1 of 2019.
The Swiss company's diagnostics division reported sales of CHF 2.88 billion for Q1, down slightly compared to sales of CHF 2.90 billion in the year-ago quarter. At constant exchange rates, diagnostics sales increased 5 percent year over year. The pharmaceutical division had CHF 12.26 billion in Q1 sales, up 3 percent (7 percent at constant exchange rates) from CHF 11.93 billion in Q1 of 2019. Â
In diagnostics, revenues for the centralized and point-of-care solutions business, which contributed 55 percent to diagnostics sales, decreased 6 percent (1 percent at constant exchange rates) to CHF 1.57 billion from CHF 1.68 billion. The immunodiagnostics business declined 4 percent, due to strong impacts from the COVID-19 pandemic in China. Point-of-care testing, however, grew 8 percent due to emergency testing, including blood gas analysis. Clinical chemistry sales were flat.
Molecular diagnostics revenues, which contributed 21 percent to overall diagnostics sales, grew 22 percent (29 percent at constant exchange rates) to CHF 614 million from CHF 502 million. The unit was the largest contributor to diagnostics sales growth in the quarter. Sales in cervical cancer and microbiology grew 17 percent, and sales in blood screening grew 6 percent. Growth in the molecular diagnostics business was driven by qPCR, virology, cervical cancer diagnosis, blood screening, and sequencing. Throughout the quarter, Roche significantly increased production capacity for SARS-CoV-2 testing, including products running on MagNA Pure and LightCycler instruments, it said. Routine testing in virology decreased due to the shift in resources to SARS-CoV-2 testing.
Molecular diagnostics growth was specifically driven by point-of-care flu testing and SARS-CoV-2 molecular testing, Roche Diagnostics CEO Thomas Schinecker said on a conference call to discuss the financial results.
In March, Roche received Emergency Use Authorization from the US Food and Drug Administration for its molecular Cobas SARS-CoV-2 test, which runs on the Cobas 6800/8800 systems. The Cobas 6800 system can return 1,440 results in 24 hours and the 8800 system can return 4,128 results in 24 hours. Roche's current production capacity for COVID-19 testing is 15 million tests per month, Schinecker said.
Also in March, Roche received clearance for its Elecsys BRAHMS PCT electrochemiluminescence immunoassay to measure procalcitonin levels in serum and plasma, as well as 510(k) clearance for its Tina-quant Hemoglobin A1cDx Gen.3 assay to diagnose diabetes and detect patients who may be at risk of developing diabetes.
Diabetes care revenues, which contributed 15 percent to sales, shrank 9 percent (2 percent at constant exchange rates) to CHF 425 million from CHF 465 million, largely due to price pressure for blood glucose monitoring products in Europe, the company said. Blood glucose monitoring sales, which make up the majority of the diabetes care business, decreased 2 percent.
Tissue diagnostics revenues, which contributed 9 percent to sales, grew 8 percent (12 percent at current exchange rates) to CHF 270 million from CHF 251 million. Advanced staining sales, which drove sales growth in the business, grew 11 percent, primary staining sales grew 3 percent, and companion diagnostics sales increased 30 percent. Revenues from the tissue diagnostics segment weren't impacted by SARS-CoV-2, Schinecker said.
This week, the company announced approval from the FDA for its Cobas HPV test to be used with the Cobas 6800/8800 systems. Earlier in the quarter, the CINtec Plus Cytology test for women with human papillomavirus at risk for cervical cancer was also approved by the FDA.
Roche noted that a SARS-CoV-2 serology test to detect antibodies is in late stage development and it expects to have the test available by early May for companies accepting the CE mark. The firm added that it is actively working with the FDA for EUA for the test.
Schinecker said on the conference call that data on the serology test's specificity should be finalized by the end of this week. Roche CEO Severin Schwan added the Elecsys antibody test would run on the Cobas E platform, which has an installed based of more than 40,000 systems. "Unlike in the molecular testing setting we are very confident that we can really go into broader testing for broader parts of the population with the antibody test," Schwan said.
Schwan noted that Roche would focus on ramping up manufacturing capacity for both SARS-CoV-2 molecular testing and antibody testing. Schinecker added that Roche is looking to provide antibody testing in the high double-digit millions in June and that there was high interest in antibody testing from governments around the world.
Schinecker also said on the call that if Roche launched a point-of-care test for SARS-CoV-2, it would be a multiplex assay with influenza and SARS-CoV-2,
He said Roche was experiencing an extremely high demand for tests and systems, including the high-throughput Cobas 6800/8800 instruments, and noted the company has been contacted by governments looking to prepare for future waves of the COVID-19 pandemic or other pandemics.
In contrast to many other companies, which have largely withdrawn 2020 financial guidance, Roche confirmed its full-year outlook of growth in the low- to mid-single digit range.