Basel, 22 July 2021
- Group gross sales up 8%1 at fixed change charges (CER); 5% in Swiss francs
- Prescribed drugs Division gross sales decline 3%; gross sales develop 4% within the second quarter, following a first-quarter lower of 9%; newly launched medicines (+30%) compensate for the continued influence from biosimilars
- Diagnostics Division gross sales develop 51% attributable to excessive demand for COVID-19 checks and powerful momentum in routine testing
- IFRS web earnings will increase by 2% (-3% in Swiss francs), whereas core earnings per share up 6%
- Highlights within the second quarter:
- Pipeline: Optimistic examine outcomes for immunotherapy Tecentriq in early lung most cancers; encouraging knowledge strengthen Roche’s portfolio in neurosciences and hard-to-treat blood cancers
- EU approvals: Tecentriq (particular kind of metastatic non-small cell lung most cancers), Venclyxto-based combos (acute myeloid leukaemia) and Enspryng (neuromyelitis optica spectrum dysfunction, a uncommon autoimmune illness of the CNS)
- GenMark Diagnostics: Acquisition, accomplished in April, broadens Roche’s molecular lab portfolio and reinforces our dedication to combat infectious illnesses and antibiotic resistance
- COVID-19: Extra optimistic examine outcomes for antibody mixture Ronapreve (co-developed with Regeneron) and AT-527 (co-developed with Atea); Japan turns into first nation to approve Ronapreve for the therapy of gentle to average COVID-19; FDA Emergency Use Authorization for Actemra/RoActemra; launch of additional checks reinforces Roche’s place as a world chief in COVID-19 diagnostics
- Outlook for 2021 confirmed
|Key figures||CHF hundreds of thousands||% change|
|January – June 2021||2021||2020||At CER1||In CHF|
|Group gross sales||30,713||29,281||8||5|
|Prescribed drugs Division||21,671||23,202||-3||-7|
|Core working revenue||11,652||11,766||4||-1|
|Core EPS – diluted (CHF)||10.56||10.44||6||1|
|IFRS web earnings||8,216||8,465||2||-3|
Commenting on the Group’s efficiency within the first six months, Roche CEO Severin Schwan stated: “Now we have achieved good leads to the primary half, primarily because of the demand for our new medicines and COVID-19 checks. The Pharma Division started to develop once more within the second quarter. The bottom diagnostics enterprise exhibits sturdy momentum. As anticipated, demand for COVID-19 checks peaked within the second quarter. I’m notably excited concerning the important progress we made in our product pipeline, together with very promising examine outcomes for Tecentriq in early-stage lung most cancers, in addition to extra optimistic knowledge for Evrysdi in spinal muscular atrophy and for COVID-19 medicines. Primarily based on the great outcomes of the primary half of 2021, we affirm the outlook for the total yr.”
Outlook confirmed for 2021
Regardless of the continued sturdy influence of biosimilars, gross sales are anticipated to develop within the low- to mid-single digit vary, at fixed change charges. Core earnings per share are focused to develop broadly in keeping with gross sales, at fixed change charges. Roche expects to extend its dividend in Swiss francs additional.
Within the first half of the yr, Group gross sales rose 8% (5% in CHF) to CHF 31 billion. IFRS web earnings elevated 2% (-3% in CHF), whereas core earnings per share up by 6%. The appreciation of the Swiss franc towards most currencies had a destructive influence on the outcomes expressed in Swiss francs in comparison with fixed change charges.
Gross sales within the Prescribed drugs Division have been CHF 22 billion, a lower of three%. Nevertheless, whereas gross sales within the first quarter have been nonetheless strongly affected by COVID-19 (-9%), the second quarter confirmed indicators of restoration in some areas (+4%). The continuing influence from biosimilars, notably within the US, resulted in a gross sales lower of CHF 2.8 billion.
The brand new medicines (launched since 20122) continued their sturdy progress (+30%, or +CHF 2.6 billion). Within the first six months, they generated gross sales of over CHF 11 billion, thus already contributing greater than 50% to the division’s complete gross sales.
Within the United States, gross sales decreased by 8%, as a result of launches of biosimilars for the most cancers medicines MabThera/Rituxan, Avastin and Herceptin (mixed -49% or CHF 1.7 billion) and the pandemic. This decline was partially compensated for by the brand new medicines – primarily Ocrevus (a number of sclerosis), Hemlibra (haemophilia), Evrysdi (spinal muscular atrophy) and Tecentriq (most cancers immunotherapy). Right here too, enterprise is displaying indicators of restoration: after -14% within the first quarter, gross sales within the second quarter have been secure, i.e. on the earlier yr’s stage.
Gross sales in Europe grew by 4%, with new product gross sales greater than compensating for the influence from biosimilars and the pandemic. Ronapreve, the antibody mixture towards COVID-19, was the important thing progress driver, primarily in Germany, Italy and France.
In Japan, gross sales have been secure. Development of lately launched medicines, similar to Tecentriq and Enspryng, was offset by the influence from biosimilars and authorities value cuts.
Gross sales within the Worldwide area grew by 2%. Development in China (+3%) was primarily attributable to sturdy gross sales of Perjeta, Alecensa, Tecentriq and Herceptin, partly offset by biosimilar competitors for Avastin and MabThera/Rituxan. Excluding China, gross sales elevated by 1%, primarily attributable to orders for Ronapreve in India, once more partially offset by the influence from biosimilars, primarily in Canada and Brazil.
The Diagnostics Division achieved very sturdy gross sales progress of 51% to CHF 9 billion. The bottom enterprise (i.e. routine diagnostics), which was closely impacted by the pandemic in 2020, grew strongly: +17% within the first quarter and +31% within the second quarter. Roche’s industry-leading portfolio of COVID-19 checks contributed complete gross sales of CHF 2.5 billion (CHF 0.7 billion in 2020); the demand for COVID-19 checks is prone to lower within the second half of 2021.
The division recorded excessive gross sales progress in all areas: Europe, Center East and Africa +70%, Asia-Pacific +44%, North America +25% and Latin America +77%.
In April, Roche acquired the US firm GenMark Diagnostics for USD 1.9 billion. GenMark’s novel expertise detects a variety of pathogens from a single affected person pattern. It broadens Roche’s molecular lab portfolio, and reinforces our dedication to assist management infectious illnesses and antibiotic resistance.
Roche’s response to the COVID-19 pandemic
Even with the supply of vaccines and declines in deaths from COVID-19 in numerous components of the world, extra therapy choices are nonetheless wanted. Within the second quarter, Roche and/or its companions shared optimistic information:
- Antibody mixture Ronapreve (co-developed with Regeneron): Preliminary section III knowledge from a College of Oxford-led trial demonstrated that the antibody mixture casirivimab/imdevimab lowered the chance of dying when given to sufferers hospitalised with extreme COVID-19 who had not mounted a pure antibody response of their very own. In July, Japan turned the primary nation to approve Ronapreve for the therapy of sufferers with gentle to average COVID-19.
- AT-527 (co-developed with Atea): Interim outcomes from a section II trial indicated speedy and sustained antiviral exercise towards SARS-CoV-2 in hospitalised COVID-19 sufferers. AT-527 continues to be evaluated for the therapy and prevention of COVID-19.
- Actemra/RoActemra:3 Roche’s intravenous anti-inflammation drugs acquired FDA Emergency Use Authorization (EUA) for the therapy of extreme COVID-19 in hospitalised adults and kids.
- Manufacturing: Roche is presently ramping up its manufacturing capability for AT-527, which requires a posh manufacturing course of, as a lot as potential. For Actemra, Roche has already elevated its personal manufacturing capability considerably and has been working with exterior producers on transferring its applied sciences to extend the worldwide provide additional.
Roche has additionally bolstered its place as a world-leading provider of COVID-19 diagnostics. In June, the SARS-CoV-2 Antigen Self Take a look at Nasal obtained the CE mark,4 and the cobas SARS-CoV-2 Nucleic acid take a look at to be used on the cobas Liat System was granted first FDA EUA for PCR testing of each symptomatic and asymptomatic people on the level of care (with outcomes inside 20 minutes).
Prescribed drugs: main approvals; optimistic knowledge in neuroscience and oncology
Along with all of the efforts within the combat towards the pandemic, Roche has continued to develop progressive medicines for different critical illnesses. Within the second quarter, Roche reported numerous regulatory achievements:
In Might, the European Fee permitted Venclyxto5-based combos for adults with newly recognized acute myeloid leukaemia (AML) who’re ineligible for intensive chemotherapy, and Tecentriq as a first-line monotherapy therapy for individuals with a selected kind of metastatic non-small cell lung most cancers.
In June, the FDA granted precedence evaluation for Roche’s Port Supply System (PDS) with ranibizumab for the therapy of neovascular or “moist” age-related macular degeneration. If permitted, it might be the primary and solely eye implant with steady drug supply – an alternative choice to frequent eye injections.
Additionally in June, the European Fee permitted Enspryng as the primary and solely at-home subcutaneous therapy for neuromyelitis optica spectrum dysfunction (NMOSD) for each adults and adolescents. NMOSD is a uncommon autoimmune illness of the central nervous system that may trigger everlasting blindness, muscle weak spot and paralysis.
Moreover, Roche offered optimistic knowledge in neurosciences and oncology:
Roche’s knowledge throughout its rising neuroscience portfolio, offered at a number of medical congresses, demonstrates our continued dedication to growing breakthrough medicines for difficult neurological situations. New knowledge for Enspryng (NMOSD) and Evrysdi (spinal muscular atrophy, SMA) bolstered the efficacy and security profile of each medicines, together with early, very encouraging trial outcomes for Evrysdi in pre-symptomatic infants underneath two months of age. Knowledge for Ocrevus (relapsing and first progressive a number of sclerosis, MS) confirmed constant profit on slowing illness development in each types of MS.
As well as, Roche offered new knowledge from 19 permitted and investigational medicines throughout 20 most cancers varieties on the American Society of Scientific Oncology congress. One of many highlights was the extremely promising immunotherapy knowledge in early lung most cancers. It confirmed that Tecentriq improved disease-free survival in individuals with resectable early-stage non-small cell lung most cancers in comparison with greatest supportive care – a primary in most cancers immunotherapy.
The most recent advances with immunotherapies in non-Hodgkin lymphoma have been additionally encouraging: knowledge from the rising T-cell partaking bispecific antibodies, mosunetuzumab and glofitamab, and the antibody-drug conjugate, Polivy, present the potential of those novel immunotherapeutic approaches for individuals with numerous sorts of blood most cancers.
The outlook of Roche’s haematology franchise was strengthened additional with new knowledge from three pivotal section III research. These knowledge, offered on the annual haematology congress EHA, bolstered the efficacy of Venclexta/Venclyxto combos in hard-to-treat blood cancers.
Prescribed drugs: main scientific and regulatory information stream as much as mid-July 2021
|Xofluza||Influenza: Wholesome individuals; high-risk individuals; submit publicity||EU approval|
|Evrysdi||Spinal muscular atrophy (SMA) kind 1/2/3||EU approval|
|faricimab||Diabetic macular oedema/neovascular age-related macular degeneration (nAMD)||US/EU joint submitting|
|Tecentriq||First-line PDL1+ non-small cell lung most cancers (NSCLC)||EU approval|
|Venclexta + azacitidine||Acute myeloid leukaemia||EU approval|
| Section III / pivotal readouts
|faricimab||nAMD||Ph III TENAYA/LUCERNE|
|casirivimab/imdevimab||SARS-CoV-2 outpatient||Ph III examine 2067|
|casirivimab/imdevimab||SARS-CoV-2 post-exposure prophylaxis||Ph III examine 2069|
|Tecentriq||Adjuvant NSCLC||Ph III IMpower010|
|Evrysdi||SMA kind 1/2/3 switching examine||Ph II JEWELFISH|
Diagnostics: vital launches in cardiovascular and oncology
Offering correct and well timed testing has by no means been extra very important. Roche continues to speculate closely in diagnostic innovation to assist meet the altering calls for of healthcare programs past COVID-19.
In April, Roche launched new methods (declare extensions) to make use of their cardiovascular checks, empowering clinicians to enhance screening, prognosis and therapy of hundreds of thousands of individuals. These gold customary biomarkers have confirmed to achieve success in supporting heart problems administration and might help clinicians diagnose coronary heart assaults (Troponin T) and handle coronary heart failure extra successfully (NT-proBNP).
Additionally in April, Roche acquired US approval for the primary companion diagnostic, VENTANA MMR RxDx Panel, to establish most cancers sufferers greatest suited to therapy with a selected GSK immunotherapy.
Prescribed drugs gross sales
|Gross sales||CHF hundreds of thousands||As % of gross sales||% change|
|January – June 2021||2021||2020||2021||2020||At CER||In CHF|
|Prescribed drugs Division||21,671||23,202||100.0||100.0||-3||-7|
|*Asia–Pacific, EEMEA (Japanese Europe, Center East and Africa), Latin America, Canada, others|
| High-selling prescription drugs
|* Asia–Pacific, EEMEA (Japanese Europe, Center East and Africa), Latin America, Canada, others|
Prescribed drugs: established merchandise
Avastin (CHF 1.6 billion -40%). Superior colorectal, breast, lung, kidney, cervical and ovarian most cancers, relapsed glioblastoma (a sort of mind tumour) and liver most cancers together with Tecentriq. Gross sales have been strongly impacted by the launch of biosimilars, primarily within the US and Europe.
Actemra/RoActemra (CHF 1.6 billion, +17%). Rheumatoid arthritis, types of juvenile idiopathic arthritis and large cell arteritis in addition to CAR T cell-induced extreme or life-threatening cytokine launch syndrome. Development was pushed by the truth that numerous nations included this drugs of their therapy pointers for extreme COVID-19-associated pneumonia. The Worldwide area and Europe have been the key contributors to this gross sales improve.
Herceptin (CHF 1.4 billion, -35%). HER2-positive breast most cancers and HER2-positive metastatic gastric most cancers. Gross sales lower was primarily attributable to biosimilar launches within the US and Europe.
MabThera/Rituxan (CHF 1.4 billion, -41%). Types of blood most cancers, rheumatoid arthritis and sure sorts of vasculitis. Gross sales have been decrease as a result of biosimilar erosion in addition to COVID-19 pandemic restrictions.
Xolair (CHF 887 million, -1%, US solely). Persistent idiopathic urticaria and allergic bronchial asthma. Gross sales progress within the power idiopathic urticaria indication was offset by competitors within the allergic bronchial asthma indication. Xolair stays the market chief within the bigger allergic bronchial asthma indication.
Lucentis (CHF 665 million, -3%, US solely). Eye situations, together with ‘moist’ age-related macular degeneration. Gross sales decreased, primarily based on the continued influence of the COVID-19 pandemic (sufferers delaying therapy).
Prescribed drugs: medicines launched since 2012
Ocrevus (first permitted in 2017; CHF 2.4 billion, +23%). Relapsing and first progressive types of a number of sclerosis; 2-hour solely infusion. The demand for this therapy in each indications remained sturdy, whereas the pandemic nonetheless had a sure destructive influence. Within the US, progress was pushed each by new and returning sufferers, with the next proportion of gross sales coming from returning sufferers.
Perjeta (first permitted in 2012; CHF 2 billion, +5%). HER2-positive breast most cancers. Gross sales elevated principally as a result of excessive demand in China in each early and metastatic breast most cancers settings.
Tecentriq (first permitted in 2016; CHF 1.6 billion, +29%). Most cancers immunotherapy for numerous sorts of most cancers (both alone or in combos), e.g. sure sorts of lung, bladder, breast and liver most cancers. Gross sales progress in all areas, notably Japan, primarily as a result of progress within the therapy of hepatocellular carcinoma (HCC). Within the US, gross sales have been increased pushed by the brand new indications for first-line non-small cell lung most cancers (NSCLC) and HCC.
Hemlibra (first permitted in 2017; CHF 1.4 billion, +45%). Haemophilia A with and with out issue VIII inhibitors; solely prophylactic therapy that may be administered subcutaneously as soon as weekly, each two or each 4 weeks. Gross sales continued to indicate a robust uptake, particularly within the US and Europe.
Kadcyla (first permitted in 2013; CHF 959 million, +19%). HER2-positive breast most cancers. Gross sales progress was pushed by Kadcyla’s utilization within the early breast most cancers setting. Gross sales benefited from sufferers switching to the brand new customary of therapy.
Alecensa (first permitted in 2015; CHF 631 million, +20%). ALK-positive non-small cell lung most cancers. The worldwide uptake continued with gross sales progress throughout all areas; the Worldwide Area and Europe have been the principle drivers.
Ronapreve (first permitted in 2021; FDA EUA in 2020 for Regeneron; CHF 595 million*). Antibody mixture casirivimab/imdevimab for the therapy of lately recognized high-risk sufferers with gentle to average COVID-19. Roche and Regeneron are collaborating on growing and manufacturing the drugs; Roche is chargeable for distribution in Europe and different nations exterior the US. There was a robust uptake, primarily in Germany, India, Italy and France.
Esbriet (first permitted in 2014; CHF 526 million, -3%). Idiopathic pulmonary fibrosis (IPF).
Gazyva/Gazyvaro (first permitted in 2013; CHF 324 million, +8%). Persistent lymphocytic leukaemia, rituximab-refractory follicular lymphoma and beforehand untreated superior follicular lymphoma.
Evrysdi (first permitted in 2020; CHF 243 million*). Spinal muscular atrophy (SMA) in adults and kids two months of age and older. Evrysdi helps infants to outlive with out everlasting air flow; the primary and solely drugs for SMA that may be taken at house. The brand new SMA drugs continued to indicate a robust uptake, primarily within the US and Russia.
Erivedge (first permitted in 2012; CHF 127 million, -9%). Superior basal cell carcinoma.
Phesgo (first permitted in 2020; CHF 96 million*). Early and metastatic HER2-positive breast most cancers (fixed-dose mixture of Perjeta and Herceptin for subcutaneous injection). Presents quicker administration in simply minutes, in comparison with hours with customary intravenous administration.
Polivy (first permitted in 2019; CHF 94 million, +17%). Relapsed or refractory diffuse massive B-cell lymphoma; a part of mixture remedy; a fixed-duration therapy choice for individuals with this aggressive type of lymphoma.
Enspryng (first permitted in 2020; CHF 39 million*). Uncommon autoimmune illness of the central nervous system (neuromyelitis optica spectrum dysfunction; NMOSD); first subcutaneous NMOSD therapy that may be self-administered at house. The drugs continues to indicate a superb uptake, regardless of COVID-19 restrictions having some influence on potential new sufferers.
Rozlytrek (first permitted in 2019; CHF 22 million, +182%). Particular type of non-small cell lung most cancers (NSCLC); stable tumours expressing a selected gene fusion; ROS1-positive, superior NSCLC.
Diagnostics gross sales
|Gross sales||CHF hundreds of thousands||As % of gross sales||% change|
|January – June 2021||2021||2020||2021||2020||At CER||In CHF|
|Level of Care||1,616||360||17.9||5.9||349||349|
|Europe, Center East, Africa||4,144||2,408||45.8||39.5||70||72|
Core Lab. Focuses on central labs; offers diagnostics options within the areas of immunoassays, scientific chemistry and customized biotech. Gross sales elevated by 34%, as a result of ongoing restoration of routine testing in all areas (with the most important contribution coming from Asia-Pacific) and COVID-19-related testing. Its immunodiagnostics enterprise grew 40%.
Molecular Lab. Focuses on molecular labs; offers diagnostics options for the detection and monitoring of pathogens, donor screening, sexual well being and genomics. Gross sales grew by 45% led by COVID-19 testing, such because the high-throughput PCR checks. Its virology enterprise grew 60%. Gross sales have been increased in all areas, led by the EMEA area and North America.
Level of Care. Focuses on diagnostics options on the level of care, e.g. in emergency rooms, medical practices or instantly with sufferers; consists of SARS-CoV-2 speedy checks, blood gasoline and electrolyte checks. Important gross sales progress of 349%; the SARS-CoV-2 Speedy Antigen take a look at was the principle progress driver, particularly within the EMEA area.
Diabetes Care. Focuses on built-in personalised diabetes administration for individuals with diabetes and healthcare professionals. Gross sales elevated by 10%, pushed by its blood glucose monitoring enterprise (such because the Accu-Chek Information system).
Pathology Lab. Focuses on pathology labs; offers diagnostics options for tissue biopsies and companion diagnostics. Gross sales elevated by 20%. This was primarily attributable to progress within the superior staining and within the companion diagnostics companies.
Roche is a world pioneer in prescription drugs and diagnostics centered on advancing science to enhance individuals’s lives. The mixed strengths of prescription drugs and diagnostics, in addition to rising capabilities within the space of data-driven medical insights assist Roche ship really personalised healthcare. Roche is working with companions throughout the healthcare sector to supply the most effective look after every individual.
Roche is the world’s largest biotech firm, with really differentiated medicines in oncology, immunology, infectious illnesses, ophthalmology and illnesses of the central nervous system. Roche can also be the world chief in in vitro diagnostics and tissue-based most cancers diagnostics, and a frontrunner in diabetes administration. Lately, Roche has invested in genomic profiling and real-world knowledge partnerships and has develop into an industry-leading associate for medical insights.
Based in 1896, Roche continues to seek for higher methods to forestall, diagnose and deal with illnesses and make a sustainable contribution to society. The corporate additionally goals to enhance affected person entry to medical improvements by working with all related stakeholders. Greater than thirty medicines developed by Roche are included within the World Well being Group Mannequin Lists of Important Medicines, amongst them life-saving antibiotics, antimalarials and most cancers medicines. Furthermore, for the twelfth consecutive yr, Roche has been recognised as probably the most sustainable corporations within the Prescribed drugs Business by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is energetic in over 100 nations and in 2020 employed greater than 100,000 individuals worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted gross sales of CHF 58.3 billion. Genentech, in the USA, is a completely owned member of the Roche Group. Roche is almost all shareholder in Chugai Pharmaceutical, Japan. For extra data, please go to www.roche.com.
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Cautionary assertion concerning forward-looking statements
This doc incorporates sure forward-looking statements. These forward-looking statements could also be recognized by phrases similar to
‘believes’, ‘expects’, ‘anticipates’, ‘tasks’, ‘intends’, ‘ought to’, ‘seeks’, ‘estimates’, ‘future’ or comparable expressions or by dialogue of,
amongst different issues, technique, targets, plans or intentions. Numerous elements might trigger precise outcomes to vary materially sooner or later from
these mirrored in forward-looking statements contained on this Annual Report, similar to: (1) pricing and product initiatives of
rivals; (2) legislative and regulatory developments and financial situations; (3) delay or lack of ability in acquiring regulatory
approvals or bringing merchandise to market; (4) fluctuations in foreign money change charges and basic monetary market situations; (5)
uncertainties within the discovery, improvement or advertising of recent merchandise or new makes use of of present merchandise, together with with out
limitation destructive outcomes of scientific trials or analysis tasks, surprising uncomfortable side effects of pipeline or marketed merchandise; (6)
elevated authorities pricing pressures; (7) interruptions in manufacturing; (8) lack of or lack of ability to acquire satisfactory safety for
mental property rights; (9) litigation; (10) lack of key executives or different staff; and (11) adversarial publicity and information
protection. The assertion concerning earnings per share progress is just not a revenue forecast and shouldn’t be interpreted to imply that
Roche’s earnings or earnings per share for 2020 or any subsequent interval will essentially match or exceed the historic revealed
earnings or earnings per share of Roche
 Until in any other case said, all progress charges and comparisons to prior yr on this doc are at fixed change charges (CER: common 2020) and all complete figures quoted are reported in CHF.
 Launched since 2012: Erivedge, Perjeta, Kadcyla, Gazyva/Gazyvaro, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi and Ronapreve (casirivimab/imdevimab).
 Actemra/RoActemra is presently not permitted for this use.
 An early model has already been obtainable in numerous European nations since February 2021 (native particular approval pathways).
 Venclexta/Venclexto is being developed by AbbVie and Roche.
* lately launched, no progress figures obtainable
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