Factor VIII(Intas Biopharmaceuticals Ltd.)

Basel, 2 February 2023 Group sales grow by 2%1 at constant exchange rates (CER) and 1% in Swiss francs, despite lower COVID-19-related sales in both divisionsPharmaceuticals Division sales increase by 2%; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19) Diagnostics Division sales grow by 3%; ongoing strong momentum in base business (+7%) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the yearHighlights in the fourth quarter of 2022 (incl. January 2023): US approvals of Lunsumio (follicular lymphoma), Tecentriq (advanced rare sarcoma) and Actemra/RoActemra (COVID-19)US priority review of glofitamab (aggressive form of blood cancer) Positive phase III data for Vabysmo (serious retinal vascular condition) and for Tecentriq plus Avastin (early-stage liver cancer)Priority review for crovalimab (rare blood disease) in ChinaNew study proves high medical value of Elecsys NT-proBNP heart test US approval for Alzheimer’s tests; US Emergency Use Authorization for mpox virus test Core earnings per share rise by 5% (+2% in CHF)IFRS net income amounts to CHF 13.5 billion (-6%; -9% in CHF)Board proposes dividend increase to CHF 9.50. If approved by shareholders, this would be the 36th consecutive dividend increase. Outlook for 2023Due to the sharp decline in sales of COVID-19 products of roughly CHF 5 billion, Roche expects a decrease in Group sales in the low single digit range (at constant exchange rates). Excluding this COVID-19 sales decline, Roche anticipates solid underlying sales growth in both divisions. Core earnings per share are targeted to develop broadly in line with sales decline (at constant exchange rates). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–December 2022 2022 2021 At CER1 In CHF Group sales 63,281 62,801 2 1 Pharmaceuticals Division 45,551 45,041 2 1 Diagnostics Division 17,730 17,760 3 0 Core operating profit 22,173 21,897 3 1 Core EPS – diluted (CHF) 20.30 19.81 5 2 IFRS net income 13,531 14,935 -6 -9 Roche CEO Severin Schwan: “We achieved good results in 2022, even though the demand for COVID-19 products declined, as expected. The diagnostics base business and our newer medicines continued their strong growth. While we had pipeline setbacks in 2022, I am particularly pleased that we brought two new medicines to patients: Vabysmo for certain severe eye diseases and Lunsumio for a currently incurable form of blood cancer. For the current year we expect solid underlying growth in both divisions, which will largely compensate for the further significant drop in sales of roughly CHF 5 billion in COVID-19 products.” Group resultsIn 2022, Roche achieved sales growth of 2% (+1% in CHF) to CHF 63.3 billion. Core operating profit increased by 3% (+1% in CHF), reflecting the good underlying business performance. IFRS net income was CHF 13.5 billion, a decrease of 6% compared to the previous year. This was due to higher impairment of intangible assets and higher interest costs and income taxes. Core earnings per share increased by 5% (+2% in CHF). This includes the positive impact of the repurchase of Roche shares held by Novartis. Sales in the Pharmaceuticals Division increased by 2% to CHF 45.6 billion. Newer medicines to treat severe diseases continued their strong growth. Vabysmo, an eye medicine launched at the beginning of 2022, is already one of the top five growth drivers. This medicine, together with Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Evrysdi (spinal muscular atrophy) and Tecentriq (cancer), generated additional sales totalling CHF 3.2 billion. Sales of COVID-19 medicines were generally lower (with a decline of roughly CHF 0.5 billion): the drop in sales of Actemra/RoActemra (severe COVID-19 pneumonia) was only partially made up by the sales growth of Ronapreve (high-risk patients) in Japan. As expected, the impact of biosimilars on the sales of the cancer medicines MabThera/Rituxan, Herceptin and Avastin continued to slow down (combined CHF 1.9 billion of sales reduction). Sales in the United States decreased slightly (-1%). The sales growth of the newer medicines Ocrevus, Vabysmo, Hemlibra and Tecentriq partially compensated for the sales decline of Actemra/RoActemra (COVID-19) and medicines whose patents have expired. In Europe, sales were also slightly down (-2%), mainly due to lower sales of the COVID-19 medicine Ronapreve. Excluding this base effect, sales in Europe increased by 6%, as the newer medicines more than offset the impact of biosimilars. Sales in Japan increased by a substantial 26%. The key factors were supplies of Ronapreve to the government, followed by sales growth of Evrysdi, Polivy, Hemlibra and Enspryng. This more than offset the impact of biosimilars and government price cuts. Sales in the International region grew by 1%. In China, sales decreased by 7% due to biosimilars, lower sales of Rocephin and local COVID-19 measures. Excluding China, sales in the region increased by 6%, mainly as a result of a higher demand for Perjeta, Hemlibra, Ocrevus and Kadcyla. The Diagnostics Division increased its sales by 3% to CHF 17.7 billion. The division’s base business – up 7% – achieved good results over the year and across all regions. Growth was mainly driven by immunodiagnostic products. Roche’s broad portfolio of COVID-19 tests generated sales totalling CHF 4.1 billion in 2022 (2021: CHF 4.7 billion). Sales in the Asia-Pacific and North America regions increased by 23% and 13%, respectively. The 16% drop in sales in the EMEA region is primarily due to the reduced demand for COVID-19 testing. Pharmaceuticals Division: pipelineIn 2022, Roche brought two important new medicines to patients: Vabysmo (serious eye diseases) and Lunsumio (blood cancer). Currently, Roche has a total number of 87 new compounds and 65 additional indications in clinical development or registration. Oncology remained the primary area for research and development, with the cancer immunotherapy portfolio a key driver. Ophthalmology, neuroscience and immunology represent other significant areas of late-stage investments. Key regulatory approvals, filings and read-outs in the fourth quarter of 2022 (incl. January 2023) Oncology and haematology Roche reached a number of regulatory milestones and presented new data from its leading haematology portfolio, which spans numerous blood diseases, including haemophilia A, paroxysmal nocturnal haemoglobinuria (PNH) and various types of blood cancers. Data from the HAVEN 7 study reinforced the efficacy and safety of Hemlibra in infants with severe haemophilia A without factor VIII inhibitors. These initial results support the benefit of starting treatment with Hemlibra at birth, as early preventive treatment in infants.Based on the results of the HAVEN 6 study, the CHMP recommended the expansion of the EU label for Hemlibra to include people with moderate haemophilia A. If approved, Hemlibra will offer an effective and convenient prophylactic treatment option for these people.New and updated data supported the use of Polivy in diffuse large B-cell lymphoma (DLBCL), an aggressive form of blood cancer, including its potential as a treatment option for previously untreated patients. In January 2023, China simultaneously approved two indications: Polivy for the treatment of previously untreated DLBCL, and for relapsed or refractory DLBCL.Positive new data from a phase III study in China demonstrated that crovalimab is effective and well-tolerated in people with PNH. PNH is an ultra-rare and life-threatening blood condition, where red blood cells are targeted and destroyed by the complement system, a part of the immune system. Based on these data, China granted priority review for approval of crovalimab.The FDA approved Lunsumio to treat people with relapsed or refractory follicular lymphoma (FL), a blood cancer that grows slowly, but is currently incurable. As a first-in-class T-cell-engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio with its high response rates and fixed duration could change the way advanced FL is treated.The FDA granted priority review for approval of glofitamab, a potential first-in-class bispecific antibody that may improve the lives of people with diffuse large B-cell lymphoma (DLBCL).Lunsumio and glofitamab are both part of Roche’s leading programme for bispecific CD20xCD3 antibodies. Recently presented data further support the potential of these two compounds as effective, off-the-shelf, fixed-duration treatment options for people with blood cancer. In December, the FDA approved Tecentriq as the first-ever therapy for certain advanced sarcoma (alveolar soft part sarcoma; ASPS). ASPS is a rare, insidious soft tissue sarcoma most common in younger people that is often advanced at diagnosis, can spread slowly but inexorably over decades, and often returns following surgery. For those diagnosed with advanced ASPS, only an estimated 20% will live for five years. The FDA also accepted the Biologics License Application for the subcutaneous formulation of Tecentriq. If approved, this new formulation would be administered under the skin within minutes, compared with up to an hour for an infusion. Today, more than 70% of people with early-stage liver cancer (hepatocellular carcinoma, HCC) may have their cancer return after surgery, which is associated with a poorer prognosis and shorter survival. In January, Roche reported positive results from the IMbrave050 study. It is the first phase III study to show that a cancer immunotherapy combination, Tecentriq plus Avastin, reduced the risk of a relapse in people with this type of liver cancer. Ophthalmology Vabysmo is the first bispecific antibody for the eye. It simultaneously targets and inhibits two signalling pathways that drive neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME) – two of the leading causes of vision loss. Launched at the beginning of 2022, the eye medicine showed a strong uptake. In October, new encouraging data from two global phase III studies demonstrated that Vabysmo could also provide a new treatment option for people living with retinal vein occlusion (RVO). RVO is a serious retinal vascular condition that can lead to irreversible vision impairment or vision loss. The results add to the extensive evidence supporting Vabysmo’s efficacy in treating multiple types of retinal conditions. NeuroscienceNeurological conditions are very complex to understand and treat, but over the past few years Roche has made significant progress for patients with multiple sclerosis (MS), spinal muscular atrophy (SMA) and neuromyelitis optica spectrum disorder (NMOSD). The company is investigating more than a dozen pioneering medicines for neurological disorders. In October, Roche presented new data for Ocrevus in MS. The data showed that early treatment with Ocrevus leads to reduced disease progression and healthcare costs, and new nine-year safety data reinforced the favourable benefit-risk profile of Ocrevus. In addition, results from more than 2,000 pregnant women with MS treated with Ocrevus do not suggest an increased risk of adverse pregnancy and infant outcomes. In November, Roche announced results from the GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimer’s disease. The studies did not meet their primary endpoint of slowing clinical decline. Roche remains committed to Alzheimer’s disease, one of the most complex neurological disorders and a major public health challenge. The company is continuing to develop and deliver tests to enable early and accurate diagnosis and has a pipeline of investigational medicines for different targets, types and stages of the disease. COVID-19In December, the FDA approved Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults. Actemra/RoActemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalised patients and their healthcare providers who continue to be on the frontlines treating COVID-19. Since the beginning of the pandemic, more than one million people hospitalised with COVID-19 have been treated with Actemra/RoActemra worldwide. Pharmaceuticals: key development milestones in the fourth quarter of 2022 (incl. January 2023*) Compound Indication Milestone Regulatory Lunsumio Relapsed or refractory follicular lymphoma (FL) USA: approval (based on phase II GO29781 study) Actemra/RoActemra COVID-19 in hospitalised adults USA: approval (based on RECOVERY and EMPACTA studies) Tecentriq Unresectable or metastatic alveolar soft part sarcoma (ASPS) USA: approval (based on phase II study by US National Cancer Institute) Tecentriq* Subcutaneous formulation for the treatment of various cancers USA: acceptance of Biologics License Application (based on phase III IMscin001 study) Polivy combination* Previously untreated diffuse large B-cell lymphoma (DLBCL) China: approval (based on phase III POLARIX study) Polivy combination* Relapsed or refractory (R/R) DLBCL China: approval (based on phase III POLAROSE study) Glofitamab* Diffuse large B-cell lymphoma (DLBCL) USA: priority review (based on phase II NP30179 study) Crovalimab Paroxysmal nocturnal haemoglobinuria (PNH) China: priority review (based on phase III COMMODORE 3 study) Hemlibra Moderate haemophilia A without inhibitors (prophylactic treatment option) EU: recommendation of approval (based on HAVEN 6 study) Xofluza Treatment and prevention of influenza in children aged one year and above EU: approval (based on phase III miniSTONE-2 and BLOCKSTONE studies) Phase III, pivotal and other key readouts Tecentriq plus Avastin* Early-stage liver cancer (hepatocellular carcinoma; HCC) Phase III IMbrave050 study Ocrevus Early-stage relapsing-remitting multiple sclerosis (RRMS) Phase IIIb ENSEMBLE study (2-year interim data) Ocrevus Multiple sclerosis in pregnant women Roche safety data Ocrevus Multiple sclerosis long-term safety (RRMS and PPMS) OPERA and ORATORIO OLE studies (9-year data) Vabysmo Retinal vein occlusion (RVO) Phase III BALATON and COMINO studies Hemlibra Infants with severe haemophilia A without factor VIII inhibitors Phase III HAVEN 7 study(interim data) Hemlibra Haemophilia A EUHASS database(real-world safety data) Hemlibra Women with haemophilia A ATHN 7 study Polivy combination Diffuse large B-cell lymphoma (DLBCL) Phase III POLARIX study (new and updated data) Gantenerumab Early Alzheimer’s disease Phase III GRADUATE I and II studies (primary endpoints not met) Pharmaceuticals Division: sales Sales CHF millions As % of sales % change January–December 2022 2022 2021 2022 2021 At CER In CHF Pharmaceuticals Division 45,551 45,041 100.0 100.0 2 1 United States 23,322 22,505 51.2 50.0 -1 4 Europe 8,143 8,876 17.8 19.7 -2 -8 Japan 4,949 4,506 10.9 10.0 26 10 International* 9,137 9,154 20.1 20.3 1 0 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top-selling pharmaceuticals Total United States Europe Japan International* CHFm % CHFm % CHFm % CHFm % CHFm % Ocrevus 6,036 17 4,487 14 1,075 25 - - 474 35 Perjeta 4,087 5 1,533 4 871 -16 234 0 1,449 27 Hemlibra 3,823 27 2,316 22 741 30 377 18 389 65 Tecentriq 3,717 14 1,975 12 794 20 443 -2 505 30 Actemra/RoActemra 2,701 -22 1,196 -35 802 -6 342 2 361 -28 Xolair 2,208 9 2,208 9 - - - - - - Herceptin 2'142 -19 476 -28 422 -17 51 -28 1,193 -15 Avastin 2,122 -28 634 -34 193 -52 490 -17 805 -20 Kadcyla 2,080 7 820 -3 671 5 131 16 458 34 MabThera/Rituxan 2,075 -20 1,316 -19 204 -19 32 -14 523 -24 * Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Pharmaceuticals sales: selected top-selling and new medicines Ocrevus (first approved in 2017; CHF 6.0 billion, +17%). Relapsing and primary progressive forms of multiple sclerosis; two-hour-only infusion. The demand for Ocrevus in both indications remained strong in the United States. In Europe and in the International region, the medicine continued to show a high uptake. Perjeta (first approved in 2012; CHF 4.1 billion, +5%). HER2-positive breast cancer. Sales increased mostly due to the continuing high demand in the International region, mainly in China. Hemlibra (first approved in 2017; CHF 3.8 billion, +27%). Haemophilia A with and without factor VIII inhibitors; only prophylactic treatment that can be administered subcutaneously once weekly, every two or every four weeks. Sales continued to show an impressive uptake, especially in the United States and Europe. Sales in the International region grew across all major markets. Tecentriq (first approved in 2016; CHF 3.7 billion, +14%). Cancer immunotherapy (either alone or in combinations) for various types of cancer, e.g. lung, bladder, breast and liver cancer. Sales increased mostly due to the higher demand in the United States and Europe. Sales in Japan decreased, primarily due to governmental price cuts. Actemra/RoActemra2 (CHF 2.7 billion, -22%). Rheumatoid arthritis, forms of juvenile idiopathic arthritis, giant cell arteritis, CAR T-cell-induced severe or life-threatening cytokine release syndrome and COVID-19. Sales decreased, mainly in the United States and International region, driven by lower demand for patients with severe COVID-19 pneumonia. Xolair2 (CHF 2.2 billion, +9%, United States only). Chronic spontaneous urticaria and allergic asthma. Sales grew in the chronic spontaneous urticaria indication. Xolair remains the leading medicine in the larger allergic asthma indication. Herceptin2 (CHF 2.1 billion, -19%). HER2-positive breast cancer and HER2-positive metastatic gastric cancer. Sales decreased as a result of the biosimilar uptake in various countries. Avastin2 (CHF 2.1 billion, -28%). Advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, relapsed glioblastoma (a type of brain tumour) and liver cancer in combination with Tecentriq. Sales decreased because of the biosimilar competition in various countries. Kadcyla (first approved in 2013; CHF 2.1 billion, +7%). HER2-positive breast cancer. Sales growth was driven by the use of Kadcyla in the early breast cancer setting. Sales increased due to patients switching to this new therapy. MabThera/Rituxan2 (CHF 2.1 billion, -20%). Forms of blood cancer, rheumatoid arthritis and certain types of vasculitis. Sales decreased due to biosimilar erosion across all regions. Ronapreve (first approved in 2021; CHF 1.7 billion, +17%). Antibody combination for the prevention and treatment of recently diagnosed high-risk patients with mild to moderate COVID-19. Sales increased due to supplies of Ronapreve to the Japanese government. Alecensa (first approved in 2015; CHF 1.5 billion, +15%). ALK-positive non-small-cell lung cancer. The global uptake continued, with the International region and the United States being the main drivers. Evrysdi (first approved in 2020; CHF 1.1 billion, +87%). Spinal muscular atrophy (SMA) in adults, children and babies. It is the first and only medicine for SMA that can be administered at home. Evrysdi continued to show a strong uptake across all regions, driven by Europe and the International region. Lucentis2 (CHF 1.0 billion, -28%, United States only). Eye conditions, including neovascular or ‘wet’ age-related macular degeneration. Sales decreased due to competitive pressure. The first biosimilar version of Lucentis (with a restricted label) came to market in the United States at the beginning of the third quarter of 2022. Phesgo (first approved in 2020; CHF 740 million, +121%). Early and metastatic HER2-positive breast cancer (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection). Offers faster administration in just minutes, compared to hours with standard intravenous administration. Phesgo continued to show a considerable uptake, predominantly in Europe and the United States. Gazyva/Gazyvaro (first approved in 2013; CHF 730 million, +9%). Chronic lymphocytic leukaemia, rituximab-refractory follicular lymphoma and previously untreated advanced follicular lymphoma. Approved as a shorter infusion time of 90 minutes, compared to the standard infusion of 3−4 hours. Esbriet (first approved in 2014; CHF 718 million, -31%). Idiopathic pulmonary fibrosis (IPF). The first generic versions were launched in May 2022. Sales of Esbriet were lower as a result of generic competition in the United States. Vabysmo (first approved in 2022; CHF 591 million3). Neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME), two leading causes of vision loss. Sales of this new eye medicine showed an excellent uptake. Polivy (first approved in 2019; CHF 437 million, +85%). Previously untreated and relapsed or refractory diffuse large B-cell lymphoma; part of combination therapy; a fixed-duration treatment option for people with this aggressive form of blood cancer. Enspryng (first approved in 2020; CHF 192 million, +93%). Rare autoimmune disease of the central nervous system (neuromyelitis optica spectrum disorders; NMOSD); first subcutaneous NMOSD treatment that can be self- or carer-administered at home. Enspryng continued to show an impressive uptake across all regions. Rozlytrek (first approved in 2019; CHF 75 million, +51%). Specific form of non-small cell lung cancer (NSCLC); solid tumours expressing a specific gene fusion; ROS1-positive, advanced NSCLC. Xofluza (first approved in 2018; CHF 67 million, >500%). Acute, uncomplicated influenza, for people (including children) with high risk of developing flu-related complications; prevention of influenza following contact with an infected person. Lunsumio (first approved in 2022; CHF 3 million3). Adult patients with relapsed or refractory follicular lymphoma. Market launch in the first European countries is promising. Susvimo (first approved in 2021; CHF 2 million, +75%). Eye implant with continuous medicine delivery for neovascular or ‘wet’ age-related macular degeneration (nAMD) treatment. Diagnostics Division: key milestones in the fourth quarter of 2022Patients admitted for acute heart failure are at high risk of readmission and death. In November, Roche shared the positive outcomes of the STRONG-HF study – which included the utilisation of our Elecsys NT-proBNP biomarker – in patients hospitalised with acute heart failure. It was the first time a cardiac-related diagnostic study was stopped early because of superior efficacy in the active arm of the study. Implementing the study’s strategy in routine clinical practice has the potential to create a paradigm shift in the management of heart failure patients. It emphasised how diagnostics solutions, embedded in a therapeutic strategy, are an integral part of improving patient care. Globally, up to 75% of people living with Alzheimer’s disease have not been diagnosed, and those who have, often report a long and complicated process to receive a diagnosis. In December, the Elecsys AD CSF assays received FDA clearance. They will be available on the cobas fully automated analysers, offering patients broad access to high-quality testing in a timely manner. In 2022, as with the COVID-19 pandemic, Roche demonstrated its ability to respond quickly to new public health threats. In spring, Roche was one of the first companies to develop a suite of tests to detect the mpox virus. In November, the FDA granted Emergency Use Authorization (EUA) for the cobas MPXV test for use on Roche’s fully automated, high-throughput platforms. This real-time PCR test can help individuals to get the right results quickly. Roche’s broad COVID-19 portfolio has also been further strengthened. The cobas SARS-CoV-2 Qualitative test is one of the first FDA-approved COVID-19 PCR tests that is to be performed on fully automated, high-throughput platforms. Testing early for COVID-19 can help determine the proper course of treatment. In this context, Roche announced its collaboration with Pfizer to drive awareness of the importance of timely COVID-19 testing and available treatment options. Diagnostics Division: sales Sales CHF millions As % of sales % change January–December 2022 2022 2021 2022 2021 At CER In CHF Diagnostics Division 17,730 17,760 100.0 100.0 3 0 Customer areas4 Core Lab 7,775 7,560 43.9 42.6 6 3 Point of Care 3,589 3,134 20.2 17.6 17 15 Molecular Lab 3,450 4,174 19.5 23.5 -15 -17 Diabetes Care 1,598 1,690 9.0 9.5 -2 -5 Pathology Lab 1,318 1,202 7.4 6.8 11 10 Regions Europe, Middle East, Africa 5,888 7,537 33.2 42.4 -16 -22 North America 5,141 4,369 29.0 24.6 13 18 Asia–Pacific 5,639 4,756 31.8 26.8 23 19 Latin America 1,062 1,098 6.0 6.2 -1 -3 Core Lab. Focuses on central labs; provides diagnostics solutions in the areas of immunoassays, clinical chemistry and custom biotech. Sales increased by 6%. Immunoassays, such as cardiac and oncology tests, and clinical chemistry products were the main growth drivers. Sales grew across all regions, most strongly in the Asia-Pacific, EMEA and Latin America regions. Point of Care. Focuses on diagnostics solutions in emergency rooms, medical practices or directly with patients; includes SARS-CoV-2 rapid tests, blood gas and electrolyte tests. Sales grew by 17%. The SARS-CoV-2 Rapid Antigen test continued to be the main growth driver. Demand for the cobas SARS-CoV-2 & Influenza A/B assays also increased. The largest contribution came from the Asia-Pacific and North America regions. Molecular Lab. Focuses on molecular labs; provides diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics. Sales decreased by 15% due to lower COVID-19-related sales in the North America and EMEA regions. This was partly offset by growth in the base business across the portfolio. Diabetes Care. Focuses on integrated personalised diabetes management for people with diabetes and healthcare professionals. Sales decreased by 2% due to the base effect of the resolution of a rebate dispute in 2021. Excluding this effect, sales remained stable. The continued contraction of the blood glucose monitoring market, in particular in the United States and Europe, was offset by a higher demand in emerging markets. Pathology Lab. Focuses on pathology labs; provides diagnostics solutions for tissue biopsies and companion diagnostics. These targeted diagnostics support the specific therapy decisions for each patient. Sales increased by 11% due to growth in the advanced staining and the companion diagnostics businesses. Sales grew across all regions.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2021) and all total figures quoted are reported in CHF.[2] Established products (launched before 2012), including Actemra/RoActemra, Avastin, Herceptin, MabThera/Rituxan, Xolair and Lucentis.[3] No growth figures available (product recently approved or growth rate not meaningful).[4] Sales in the Point of Care customer area include sales from the Liat business (POC molecular), and sales in the Core Lab customer area include sales from the Life Science Alliances business. These were both previously shown as part of the Molecular Lab customer area. The comparative information for 2021 has been restated accordingly.POC molecular sales: Q1/21 = CHF 90m, Q2/21 = CHF 92m, Q3/21 = CHF 175m, Q4/21 = CHF 194m.Life Science Alliances sales: Q1/21 = CHF 21m, Q2/21 = CHF 23m, Q3/21 = CHF 23m, Q4/21 = CHF 20m. Cautionary statement regarding forward-looking statementsThis document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Nathalie AltermattPhone: +41 79 771 05 25 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Dr. Barbara von SchnurbeinPhone: +41 79 699 97 44 Sileia Urech Phone: +41 79 935 81 48 Attachments 02022023_MR_FY_Roche2022_en Communications appendix tables_FY 2022_Sales&Results

The positive CHMP opinion is based on the results of the HAVEN 6 study, which demonstrated effective bleed control and a favourable safety profile of Hemlibra in people with moderate haemophilia A without inhibitors1Given that many people with moderate haemophilia A may not receive prophylaxis, they may endure a worsened clinical burden with only 15% living a bleed-free life2If approved, Hemlibra, already approved for severe haemophilia A in the EU, will offer an effective and convenient prophylactic treatment option with a favourable safety profile for people with moderate haemophilia A Basel, 16 December 2022 - Roche (SIX: RO, ROG; OTCQZ: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation. If approved, Hemlibra would also be indicated for the routine prophylaxis of bleeding episodes in people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII ≥1% and ≤ 5%) with a severe bleeding phenotype. It is estimated that people with moderate haemophilia A make up 14% of the haemophilia A population.3 “We know that people with moderate haemophilia A can still have bleeds that cause irreversible joint damage and impact quality of life,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We’re very pleased that the CHMP’s recommendation brings us closer to potentially transforming the day-to-day lives of people in the EU living with moderate haemophilia A.” While the treatment and management of severe haemophilia A are well-established, there is less information and guidance on prophylaxis for moderate haemophilia A.4 Additionally, the severity of haemophilia A, traditionally measured by factor VIII levels, is not always reflective of bleeding behaviour. Some people with non-severe haemophilia may experience symptoms similar to those with severe haemophilia and would benefit from prophylaxis.5 All severities of haemophilia A may significantly reduce the quality of life for people affected, as well as their family and caregivers. 6 Given that many people with moderate haemophilia A may not receive prophylactic treatments, they may endure a worsened clinical burden, with 85% having bleeds within their lifetime. This can lead to long-term joint problems, requiring interventions and impacting quality of life.2,4,5 The CHMP recommendation is based on the results from the phase III HAVEN 6 study, as well as on real world data. The results from the study showed that Hemlibra demonstrated effective bleed control and a favourable safety profile in people with non-severe haemophilia A without factor VIII inhibitors, where prophylaxis was clinically indicated.1 A final decision regarding the approval of Hemlibra is expected from the European Commission in the near future. If approved, this update will provide an effective and convenient prophylactic treatment option with a favourable safety profile, for people in the EU with moderate haemophilia A with a severe bleeding phenotype. Hemlibra is approved as a treatment for people with haemophilia A with factor VIII inhibitors in more than 110 countries worldwide and for people without factor VIII inhibitors in more than 100 countries worldwide. It has been studied in one of the largest clinical trial programmes in people with haemophilia A with and without factor VIII inhibitors, including eight phase III studies. About HAVEN 6 HAVEN 6 is a phase III clinical study designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of Hemlibra in people with non-severe haemophilia A without factor VIII inhibitors. Data from the primary analysis of HAVEN 6 was presented at the 30th International Society on Thrombosis and Haemostasis (ISTH) Annual Congress, on 11 July 2022.1 The analysis included data from 72 participants, including three women, 51 (70.8%) of whom had moderate haemophilia A without factor VIII inhibitors. The data indicate that Hemlibra has effective bleed control and a favourable safety profile in people with non-severe haemophilia A without factor VIII inhibitors, with no new safety signals identified. Hemlibra achieved clinically meaningful bleed control, with 66.7% of participants experiencing no bleeds that required treatment, 81.9% experiencing no spontaneous bleeds that required treatment, and 88.9% experiencing no joint bleeds that required treatment.1 About Hemlibra® (emicizumab) Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins involved in the natural coagulation cascade, and restore the blood clotting process for people with haemophilia A. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once-weekly, every two weeks, or every four weeks (after an initial once-weekly dose for the first four weeks). Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech. It is marketed in the United States by Genentech as Hemlibra (emicizumab-kxwh), with kxwh as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. Food and Drug Administration. About haemophilia A Haemophilia A is an inherited, serious disorder in which a person’s blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Haemophilia A affects around 900,000 people worldwide,7,8 approximately 14% of whom have a moderate form of the disorder.3 However, the severity of haemophilia A is not always reflective of bleeding behaviour, as some people with non-severe haemophilia may experience symptoms similar to those with severe haemophilia and warrant prophylaxis.5 All severities of haemophilia A can significantly reduce the quality of life for people affected, as well as their family and caregivers. People with haemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their symptoms, people with haemophilia A can bleed frequently, especially into their joints or muscles.3 These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility and long-term joint damage.9 A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies. Inhibitors are antibodies developed by the body’s immune system that bind to and block the efficacy of replacement factor VIII, making it difficult, if not impossible, to obtain a level of factor VIII sufficient to control bleeding.7 About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab) and Lunsumio® (mosunetuzumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies glofitamab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law.References[1] Hermans C, et al. Emicizumab Prophylaxis for the Treatment of People with Moderate or Mild Hemophilia A without Factor VIII Inhibitors: Results from the Primary Analysis of the HAVEN 6 Study. Presented at: International Society on Thrombosis and Haemostasis (ISTH) Congress; 2022 July 11. Abstract OC 30.5.[2] Nissen F, et al. An Insight into clinical outcomes in mild, moderate, and severe hemophilia A (HA): A preliminary analysis of the CHESS II study. Presented at: International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress; 2020 July 12-14. Abstract OC 09.3.[3] World Federation of Hemophilia. Report on the annual global survey 2020. [Internet; cited 2022 December] Available from: http://www1.wfh.org/publications/files/pdf-2045.pdf.[4] Walsh C, et al. Identified unmet needs and proposed solutions in mild-to-moderate haemophilia: A summary of opinions from a roundtable of haemophilia experts. Haemophilia. 2021;27(S1):25-32.[5] Collins PW, et al. Clinical phenotype of severe and moderate haemophilia: Who should receive prophylaxis and what is the target trough level? Haemophilia, 2021;27: 192-198.[6] Flood E, et al. Illustrating the impact of mild/moderate and severe haemophilia on health-related quality of life: hypothesised conceptual models. European Journal of Haematology 2014; 93: Suppl. 75, 9–18.[7] Srivastava A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020: 26 (Suppl 6): 1‐ 158.[8] Iorio A, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males. Ann Intern Med 2019 Oct 15;171(8):540-546.[9] Franchini M, et al. Haemophilia A in the third millennium. Blood Rev. 2013; 179-84.Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 61 687 41 47 Karsten KleinePhone: +41 61 682 28 31 Nina MählitzPhone: +41 79 327 54 74 Nathalie Meetz Phone: +41 79 771 05 25 Dr. Barbara von SchnurbeinPhone: +41 61 687 89 67 Sileia Urech Phone: +41 79 935 81 48 Roche Investor Relations Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com Dr. Sabine BorngräberPhone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment 16122022_MR_CHMP opinion Hemlibra in moderate hemophilia A_en