[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong growth in the first nine months – outlook for 2021 raised
Basel, 20 October 2021
- Group sales up 8%1 at constant exchange rates (CER); 6% in Swiss francs
- Pharmaceuticals Division sales grow 5% in the third quarter and are now in line with the prior year for the first nine months; continued strong growth of newly launched medicines
- Diagnostics Division sales grow 18% in the third quarter and 39% in the first nine months due to high demand for COVID-19 tests, a strong recovery in the base business and the newly launched diagnostics platforms
- Highlights in the third quarter:
- FDA approves cancer immunotherapy Tecentriq (early-stage lung cancer) and grants Priority Review for eye medicine faricimab
- Positive study results for Polivy (blood cancer) and Ronapreve (COVID-19)
- FDA grants Breakthrough Therapy Designation to gantenerumab (Alzheimer’s disease);final study results expected in second half of 2022
- Share purchase agreement with long-term partner TIB Molbiol to expand molecular diagnostics portfolio
- Outlook raised
Sales | CHF millions | As % of sales | % change | |||
January–September 2021 | 2021 | 2020 | 2021 | 2020 | CER | CHF |
Group sales | 46,684 | 43,979 | 100.0 | 100.0 | 8 | 6 |
Pharmaceuticals Division | 33,379 | 34,317 | 71.5 | 78.0 | 0 | -3 |
United States | 16,707 | 18,389 | 35.8 | 41.8 | -5 | -9 |
Europe | 6,610 | 6,268 | 14.2 | 14.3 | 3 | 5 |
Japan | 3,186 | 2,802 | 6.8 | 6.4 | 20 | 14 |
International* | 6,876 | 6,858 | 14.7 | 15.5 | 2 | 0 |
Diagnostics Division | 13,305 | 9,662 | 28.5 | 22.0 | 39 | 38 |
*Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, others
CEO Severin Schwan on the results: “The demand for coronavirus tests remained high in the third quarter due to the Delta variant. Together with the recently launched medicines and diagnostics platforms they contributed to the strong sales growth. We also made significant progress in our product pipeline in the third quarter, including with Polivy, the first medicine in 20 years to significantly improve outcomes in a form of aggressive blood cancer. Based on the results achieved so far, we are raising our outlook for the full year.”
Outlook raised for 2021
Sales are now expected to grow in the mid-single digit range, at constant exchange rates (before: in the low to mid-single digit range). 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 results
Group sales increased by 8% (6% in CHF) to CHF 46.7 billion in the first nine months of the year.
Pharmaceuticals Division sales remained stable at CHF 33.4 billion. Since summer there have been signs of recovery from the COVID-19 pandemic and the biosimilar impact is slowing down as expected (Pharma sales: -9% in the first quarter, +4% in the second quarter and +5% in the third quarter).
In the United States, sales declined by 5% over the first nine months, with stable year-on-year sales since the summer.
Competition from biosimilars for the established cancer medicines MabThera/Rituxan, Avastin and Herceptin led to an overall decline, partly offset by sales of Actemra/RoActemra, Hemlibra, Ocrevus and Tecentriq, as well as for Evrysdi (spinal muscular atrophy) and Phesgo (breast cancer), which were launched only last year.
Sales in Europe increased by 3%. Sales growth of new medicines (Ronapreve, Ocrevus, Hemlibra and Kadcyla) more than offset the impact of biosimilars.
In Japan, sales increased by 20%. Growth was driven by the new medicines Ronapreve, Tecentriq, Enspryng and Hemlibra. This more than offset the impact of biosimilars and government price cuts.
Sales in the International region grew 2%, driven by strong demand for Perjeta and Ronapreve. Sales growth in China (+2%) resulted from continued strong uptake of Perjeta, Alecensa and other innovative cancer medicines.
The Diagnostics Division achieved strong sales growth of 39% to CHF 13.3 billion in the first nine months. Growth was 18% in the third quarter compared to the already very strong third quarter last year. Demand for COVID-19 testing remained high in the third quarter, driven primarily by the Delta variant. As a result, Roche’s industry-leading portfolio of COVID-19 tests again contributed significantly to the division’s overall sales growth.
The base business, still heavily impacted by the pandemic in 2020, showed strong growth in the first nine months of 2021: after a significant recovery in the first half of the year (+17% in the first quarter, 31% in the second quarter), strong growth of 11% was also achieved in the third quarter.
Sales grew strongly in all regions: Europe, Middle East and Africa +54%, Asia-Pacific +35%, North America +18% and Latin America +63%.
In September Roche signed a definitive share purchase agreement with TIB Molbiol. Roche and TIB Molbiol have been working together for more than 20 years on tests and reagents for pathogens such as SARS, anthrax, MERS, the novel H1N1 swine flu virus and, most recently, the SARS-CoV-2 virus and its variants. This acquisition will add a range of infectious disease tests to Roche’s broad portfolio of molecular diagnostic solutions.
Pharmaceuticals: strong pipeline
Roche now has 17 new compounds in late-stage development or registration, which is a new all-time high, and almost an 80% increase over the last decade. Thanks to innovative new approaches, Roche was able to reduce the drug filing process from on average 26 to just 13 weeks.
In the third quarter, Roche achieved a number of regulatory milestones:
After the FDA granted Priority Review to Tecentriq in August, approval was already granted in October: Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of certain people with early-stage non-small cell lung cancer (NSCLC). It has the potential to significantly reduce risk of cancer recurrence, after more than a decade with limited treatment advances in this setting.
In September, Roche was granted another Priority Review by the FDA: for its eye medicine faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). If approved, faricimab would be the first in a new class of eye medicines targeting two key pathways that drive retinal disorders, with the potential to offer durable vision outcomes with fewer eye injections than the current standard of care.
Also in September, the European Medicines Agency (EMA) recommended the approval of RET inhibitor Gavreto as monotherapy for patients with advanced RET-fusion positive NSCLC. RET alterations are key disease drivers in many cancer types, including NSCLC and multiple types of thyroid cancer.
In October, the EMA approved a new, shorter 90-minute Gazyva/Gazyvaro infusion, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma; the regular rate of infusion can take three to four hours.
Furthermore, the FDA granted two additional Breakthrough Therapy Designations (BTD):
- for Venclexta/Venclyxto combination therapy for the treatment of adult patients with myelodysplastic syndromes, a rare form of blood cancer. This marks the sixth BTD for Venclexta/Venclyxto.
- for gantenerumab for the treatment of people with Alzheimer’s disease (AD). Gantenerumab would be the first subcutaneous drug for AD treatment that could also be administered at home. The pivotal trials are expected to be completed in the second half of 2022. This is the 39th BTD for Roche.
In the third quarter, Roche also announced several key development milestones in neuroscience, ophthalmology, oncology and COVID-19:
Neuroscience is a major research focus at Roche. The company is investigating more than a dozen medicines for neurological disorders, including rare neuromuscular disorders, such as spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD).
SMA is the leading genetic cause of death in babies. In September, new data showed that pre-symptomatic babies with SMA treated with Evrysdi maintained the ability to swallow. Evrysdi thus demonstrated consistent clinically meaningful efficacy in adults, children, and babies two months and older.
DMD is a rare progressive neuromuscular disease caused by mutations in the DMD gene. Longevity is limited due to cardiac and/or respiratory failure. Also in September, new data supported the efficacy, safety and durability of gene therapy SRP-9001 in the treatment of DMD.
In October, Roche presented new data for Ocrevus (multiple sclerosis; MS) and Enspryng (neuromyelitis optica spectrum disorder; NMOSD). The longer-term efficacy and safety data for both medicines reinforce the impact of Ocrevus in significantly slowing disease progression in MS and of Enspryng in significantly reducing relapses in NMOSD.
Among the highlights in oncology were the highly promising phase III study results for first-line Polivy combination therapy in an aggressive form of blood cancer (previously untreated diffuse large B-cell lymphoma, DLBCL). This Polivy regimen is the first therapy in two decades to improve progression-free survival in DLBCL compared to the standard of care. Since 40% of people with DLBCL relapse after initial therapy, achieving meaningful treatment effects in the front-line setting has the potential to be transformative.
Another highlight were the new encouraging phase II data from an interim analysis on giredestrant in hormone receptor (HR)-positive and HER2-negative early breast cancer. Giredestrant is a next-generation selective oestrogen receptor degrader (SERD). Because it is taken orally, it has the potential to transform the treatment experience for patients by offering greater convenience and a less painful option compared to therapies administered via intramuscular injection.
Cancer of unknown origin (CUP) is still a devastating diagnosis. In CUPs, doctors are unable to identify the location of the primary tumour and can only find metastases, which makes treatment difficult. In September, Roche published initial results of a phase II study (CUPISCO), which emphasised the importance of genomic profiling for patients with CUP and how it may help to inform a more personalised treatment plan in the future.
COVID-19 has now led to almost 4.9 million deaths, mostly involving hospitalised patients. While vaccines are mostly effective in preventing hospitalisation, there is still a high medical need for all those who have not or could not receive a vaccination so far.
In September, Roche published positive data from a phase II/III study on Ronapreve in patients hospitalised with COVID-19. The trial showed that the antibody combination (co-developed with Regeneron) significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response of their own. These data add to previous findings that support the potential of Ronapreve in hospitalised patients, which may also help to ease pressure on healthcare systems.
In addition, the World Health Organization recently issued guidance regarding the use of Ronapreve for the treatment of certain patients with COVID-19. So far, Ronapreve has been made available to patients in more than 40 countries via bilateral purchase agreements across many geographies and economies, including lower middle-income countries.
The study on AT-527 did not meet its primary endpoint. Final data from the full phase II study will be submitted to a peer-reviewed publication. Roche and its partner Atea will continue to analyse available and incoming data from the trial to generate evidence and provide a more complete picture of AT-527 in COVID-19.
Pharmaceuticals: major clinical studies and regulatory milestones up to mid-October 2021
Compound | Indication | Milestone | |
Regulatory | Xofluza | Influenza: healthy people; high-risk people; post exposure | EU approval |
Evrysdi | Spinal muscular atrophy (SMA) type 1/2/3 | EU approval | |
faricimab | Diabetic macular oedema/neovascular age-related macular degeneration (nAMD) | US/EU joint filing | |
Tecentriq | First-line PD-L1+ non-small cell lung cancer (NSCLC) | EU approval | |
Venclexta/Venclyxto + azacitidine | Acute myeloid leukaemia | EU approval | |
Ronapreve | SARS-CoV-2 | EU approval | |
Port Delivery System with ranibizumab | nAMD (continuous delivery) | US/EU filing; US approval | |
Venclexta/Venclyxto combination therapy | Myelodysplastic syndromes | Breakthrough Therapy Designation (BTD) | |
gantenerumab | Alzheimer’s disease | BTD | |
Phase III / pivotal readouts | faricimab | nAMD | Phase III TENAYA/LUCERNE |
Ronapreve | SARS-CoV-2 outpatient | Phase III study 2067 | |
Ronapreve | SARS-CoV-2 post-exposure prophylaxis | Phase III study 2069 | |
Tecentriq | Adjuvant NSCLC | Phase III IMpower010 | |
Evrysdi | SMA type 1/2/3 switching study | Phase II JEWELFISH | |
mosunetuzumab | 3L+ follicular lymphoma | Phase Ib GO29781 | |
Polivy + R-CHP | First-line diffuse large B-cell lymphoma (DLBCL) | Phase III POLARIX | |
glofitamab | 3L+ DLBCL | Phase Ib NP30179 | |
Tecentriq + chemo | Adjuvant squamous cell carcinoma of head and neck (SCCHN) | Phase III IMvoke010 |
Diagnostics: key launches in virology and oncology
Whether for infectious diseases (such as COVID-19), cancer or other serious health threats, prevention and early detection are key and depend on high-quality diagnostics. The division launched several innovative solutions in the third quarter.
One of the highlights was the launch of three molecular PCR diagnostic test panels to simultaneously detect and differentiate common respiratory pathogens such as influenza, out of one patient sample. Syndromic panels are a flexible testing option to look at 15 or more pathogens. It enables clear diagnosis in one test and ability to pair to the right antibiotic without exposing patients to antibiotics they may not respond to. With this multimodal testing infrastructure offering, Roche allows for fit-for-purpose diagnostic testing needs for the patient and avoids antibiotic misuse.
Roche is also investing heavily in the digitalisation of healthcare data. To enhance collaboration, Roche has opened access to its pathology imaging tools. The Roche Digital Pathology Open Environment allows software developers globally to distribute their digital products through Roche’s uPath software, offering a broader set of diagnostics tools for pathologists and ultimately, benefiting patients.
In addition, the Elecsys GAAD Algorithm received the CE mark. This algorithm is used to aid in the diagnosis of early stage hepatocellular carcinoma (HCC) and is an important step towards clinical algorithms supporting clinicians to make earlier treatment decisions to facilitate better clinical outcomes for patients.
Pharmaceuticals sales
Sales | CHF millions | As % of sales | % change | |||
January–September 2021 | 2021 | 2020 | 2021 | 2020 | CER | CHF |
Pharmaceuticals Division | 33,379 | 34,317 | 100.0 | 100.0 | 0 | -3 |
United States | 16,707 | 18,389 |
By: GlobeNewswire
- 20 Oct 2021
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