Roche Reports Strong Q3 Diagnostics Growth Driven by Immunodiagnostics and New FDA Approvals

〢Roche was founded in 1896,As a pioneer in the global pharmaceutical and diagnostics sectors, Roche’s pharmaceutical and diagnostics businesses constitute the cornerstone of the Roche empire.

Meanwhile, Roche is also the world’s largest biotechnology company, with a diverse portfolio of patented pharmaceuticals and diagnostic technologies in oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders. In the diagnostics sector, Roche Diagnostics has long maintained its position as the global leader.

Overall, from January to September 2019, the Roche Group achieved robust sales growth, with the Pharmaceuticals Division growing by 12% and the Diagnostics Division by 4%.

January–September 2019, Roche Diagnostics Division:

〢Total revenue of CHF 9,507 million, equivalent to USD 9,576.40 million;

〢Accounting for 20.6% of the Roche Group's total sales;

〢4% year-over-year growth

The growth in the diagnostics business was primarily driven by the approval of new therapeutic and diagnostic tests within the immunoassay portfolio in the third quarter.

Roche’s Diagnostics Division provides detailed revenue disclosure by segment: Point-of-Care Solutions, Molecular Diagnostics, Diabetes Care, and Tissue Diagnostics. Among these, immunoassay once again emerged as the largest contributor to sales growth within the Diagnostics Division. Specifically:

〢Centralized and Point-of-Care SolutionsRevenue: CHF 5,766; converted to USD 5,806.36 million.Accounting for 60.6% of diagnostic sales; a year-on-year increase of 5%;

〢Molecular Diagnostics BusinessRevenue of CHF 1,547 million; converted to USD 1,557.829 million. Accounting for 16.3% of diagnostic business sales; a year-on-year increase of 7%;

Driven primarily by the recent FDA approval of COBAS PRO, which meets demands for high efficiency and improved turnaround time, the molecular diagnostics business grew by 7%, fueled by blood screening, sequencing sample preparation, and microbiology.

〢Diabetes Care BusinessRevenue of CHF 1,395 million; converted to USD 1,404.765 million. Accounting for 14.7% of diagnostic business sales; a year-on-year increase of 2%;

〢Tissue Diagnostics BusinessRevenue of CHF 799 million; converted to USD 804.593 million. Accounting for 8.4% of diagnostic business sales; year-on-year growth of 0%;

From the perspective of specific regions globally:

●Europe, Middle East and Africa:The region that contributed the most to Roche Diagnostics' Q3 revenue generated CHF 3,617 million, equivalent to USD 3,642.319 million. This accounted for 38% of diagnostic sales, representing a 3% year-on-year increase.

●Asia-Pacific Region:Q3 revenue amounted to CHF 2,550 million, equivalent to USD 2,567.85 million. This accounted for 26.8% of diagnostic sales, representing a 9% year-on-year increase.

● North America:Q3 RevenueCHF 2,366 million, equivalent to USD 2,382.562 million. Accounting for 24.9% of diagnostic sales, a year-on-year decrease of 1%.

● Latin America:Revenue Generated in Q3CHF 615 million was converted to USD 619.305 million. This accounted for 6.6% of diagnostic sales, representing a 9% year-on-year increase.

● Japan:Q3 Revenue: $329 MillionSwiss francs, converted to USD 331.30 million.Accounting for 3.8% of diagnostic sales%, a year-on-year increase of 3%.

According to the financial report disclosed by Roche, in Q3FDA Approves Roche Diagnostics’ cobas pro Integrated Solutions, a Next-Generation Serum Work Area (Clinical Chemistry and Immunochemistry) Laboratory Solution Designed to Optimize Laboratory Operations.

▷ COBASS is a professional integrated solution,Enable laboratories to run tests faster on fewer devices, automate manual tasks, and deliver results more rapidly to support treatment decisions.

This shift helps physicians provide evidence-based diagnostic and treatment decisions for all patients, with greater cost-effectiveness and speed.

▷ Additionally, the FDA approved the Cobas Babesia whole blood test for use on the COBAS 6800/8800 individual donor screening system.This marks the first time Roche has commercially offered a whole-blood test for donor screening, in compliance with the U.S. Food and Drug Administration (FDA)’s updated industry guidance recommending Babesia screening and testing to reduce the risk of transfusion-transmitted infection with this parasite.

Screening and testing for Babesia are recommended to reduce the risk of transfusion-transmitted infection. Roche has launched the COBAS EBV and BKV tests for transplant patients on the COBAS 600/8800 systems in countries accepting CE marking.

Immunocompromised transplant recipients are at risk of serious complications when infected with Epstein-Barr virus or BK virus (BKV is a member of the human polyomavirus family). With new tests, healthcare professionals can now identify which transplant patients are at risk of further complications due to reactivation of these viruses.

▷The global access program has expanded beyond HIV to include Mycobacterium tuberculosis (MTB), hepatitis B and C (HBV and HCV), and human papillomavirus (HPV) in low- and middle-income countries, where the disease burden is highest.In other words, in the field of infectious diseases, Roche’s business scope continues to expand and penetrate into middle- and low-income countries.