On April 22, 2020 Hoffmann-La Roche Reported that (Press release, Hoffmann-La Roche, APR 22, 2020, View Source [SID1234556489])
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Impact of the COVID-19 pandemic
Volatility in some markets has limited impact on business performance in the first quarter
Global supply chain for medicines and tests remain intact
FDA issued Emergency Use Authorization for the cobas SARS-CoV-2 test (coronavirus) for detection of infection with the virus; test also available in markets accepting the CE mark
Production capacity for cobas SARS-CoV-2 test ramped up massively
Clinical phase III study to evaluate the safety and efficacy of Actemra/RoActemra in severe COVID-19 pneumonia ongoing in several countries. Results are expected in early summer. Rapid increase of production capacity for Actemra/RoActemra
Anti-SARS-CoV-2 serology test to detect antibodies in people exposed to SARS-CoV-2 in late stage development with availability aimed for early May. Monthly production is ramped up to high double-digit million tests by June with further scale up as fast as possible.
Commenting on the Group’s performance in the first quarter, Roche CEO Severin Schwan said: "The global coronavirus pandemic outbreak during the first quarter poses an unprecedented challenge in particular for healthcare systems worldwide. Roche made important contributions to the fight against COVID-19. In close collaboration with authorities we were able to make our cobas SARS-CoV-2 test available and to initiate a global phase III study of Actemra/RoActemra in COVID-19 pneumonia in record time. With healthcare needs remaining high, Roche’s business has so far proved to be resilient in this difficult environment. The uptake of our recently introduced medicines continues to be strong. Based on our current assessment, we confirm the outlook for the full-year."
Outlook confirmed for 2020
Based on the current assessment of the COVID-19 impact sales are expected to grow in the low- to mid-single digit range, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to increase its dividend in Swiss francs further.
Group sales
In the first three months of the year, Group sales rose 7% to CHF 15.1 billion. Sales in the Pharmaceuticals Division increased 7% to CHF 12.3 billion. Key growth drivers were the cancer medicine Tecentriq, the haemophilia medicine Hemlibra, the multiple sclerosis medicine Ocrevus and the breast cancer medicine Perjeta. The strong uptake of newly introduced medicines generated sales of CHF 4.6 billion, including a growth of CHF 1.6 billion at constant exchange rates over 2019, more than offsetting the impact of the competition from biosimilars (CHF 857 million at constant exchange rates).2
In the US, the sales growth (+3%) was predominantly generated by recently launched medicines such as Ocrevus, Hemlibra and Tecentriq, partially offset by the competition from biosimilars.
In Europe, sales increased (+14%) as the strong demand for Tecentriq, Ocrevus, Perjeta, Hemlibra, Actemra/RoActemra and Kadcyla, was able to offset the impact of lower sales of Herceptin (-32%) and MabThera/Rituxan (-24%). The first biosimilar versions of Avastin are expected later this year.
In the International region, sales increased 16%, the main contributors were Perjeta, Ocrevus, Tamiflu and Alecensa. In China, the strong uptake of recently launched medicines Perjeta and Alecensa and higher sales of established products including Tamiflu and Rocephin offset the National Reimbursement Drug List price cut and COVID-19 impact for Herceptin, Avastin and MabThera/Rituxan.
Growth in Japan (+3%) was also driven by recently launched products Hemlibra, Tecentriq and Perjeta, despite considerable competition from biosimilars.
Diagnostics Division sales increased 5% to CHF 2.9 billion. The business area Molecular Diagnostics (+29%) was the main growth contributor, driven by molecular testing. Growth was reported in North America (+12%), EMEA3 (+7%), Latin America (+20%) and Japan (+14%). In the Asia-Pacific region (-11%) sales were strongly impacted by the COVID-19 pandemic shutdown in China. Overall, demand in North America, Europe and Latin America was less affected by COVID-19 in the first quarter due to the later onset of the pandemic in these regions. Routine testing decreased due to a decline in regular health checks while emergency and COVID-19 testing strongly increased.
Regulatory achievements in the first quarter
Regulators around the globe granted approvals for new Roche medicines, line extensions of existing medicines and new tests.
In China the National Medical Products Administration (NMPA) approved Tecentriq in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
The European Commission approved Polivy in combination with bendamustine and MabThera/Rituxan, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for a haematopoietic stem cell transplant.
The Commission also approved Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.