Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this Annual Report, 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. 1.71. Our main operational tasks are regional development and land-use planning, as well as the promotion of local and regional interests. In the US, growth was driven both by new and returning patients, with a higher proportion of sales coming from returning patients. FCBCURE WELCOMES DEBRA POLKES AS CREATIVE PARTNER & CO-MANAGING DIRECT Ortho Dermatologics Announces Statistically Significant Topline Results From breakdown of its first quarterly financial report, canceled multiple mid- and late-stage programs, U.S. Centers for Disease Control and Prevention (CDC). | Source: The panel consists of three specific EBV tests and accurately identifies the EBV infection stage from a single blood sample, which means less confirmatory testing and, potentially, faster diagnosis for patients. Some cookies are necessary and others are used for analytics purposes. The medicine showed a good uptake, despite COVID-19 restrictions having some impact on potential new patients. x7wcn04P[B+b3+:R@1=S. The sales decline was driven by all regions, due to the biosimilar erosion as well as COVID-19 pandemic restrictions.Xolair (CHF 409 million, -6%, US only). ACORDA shall keep complete and accurate records in sufficient detail to enable the royalties hereunder to be determined. Pathology Lab sales increased by 9%. Overall, demand continued to grow encouragingly, though here too the impact of the lower number of doctors visits was clearly noticeable.In the United States, sales decreased by 14%, as a result of the continued competition from biosimilars for the above mentioned cancer medicines (combined CHF -1.0 billion). In April, other strong phase III data confirmed the potential dual value of casirivimab/imdevimab to reduce household COVID-19 infections (prevention) and to decrease the disease burden in those who do become infected. At the Council we are engaged in coordination and consensus building. F. Hoffmann-La Roche Ltd 4070 Basel Switzerland Group Communications Roche Group Media Relations Phone +41 61 688 88 88 www.roche.com 1/12 Ad hoc announcement pursuant to Art. OTC Filings : RCHBF. It is the only monoclonal antibody treatment to retain potency against key emerging variants7. Sales benefited from patients switching to the new standard of treatment. The burden of proof of unavoidable delay shall rest with the Contractor and shall be supplied in a written form and submitted to the Department. Quarterly Report. The transaction is expected to close in the second quarter of 2021.COVID-19: Roches response to the pandemic in the first quarter 2021Roche is making a significant effort globally to assist the fight against COVID-19. (a) Until the expiration of Roche's royalty obligations under Section 10.3, Roche agrees to make payments and written reports to PDL within [****] after t. Also in the first quarter, Roche boosted its diagnostics business with the $1.8 billion acquisition of GenMark Diagnostics, one of the first companies to receive Emergency Use Authorization from the U.S. Food and Drug Administration for its ePlex SARS-CoV-2 Test. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. Relapsed or refractory diffuse large B-cell lymphoma; part of combination therapy; fixed-duration treatment option for people with this aggressive form of lymphoma. Roche said it will continued to ramp-up of production capacity for COVID-19-related diagnostics and medicines. Royalty Payments (i) Royalties shall accrue when Licensed Products are invoiced, or if not invoiced, when delivered to a third party or Affiliate. In 2021, Roche remains strongly committed to the fight against COVID-19. Relapsing and primary progressive forms of multiple sclerosis; shorter 2-hour infusion. The impact of biosimilars was compensated by new products (Perjeta, Tecentriq and Ocrevus) and COVID-19 related Actemra/RoActemra sales.The Diagnostics Division reported very strong sales growth of 55% to CHF 4.3 billion, mainly due to Roches comprehensive and growing portfolio of COVID-19 tests. If no sales are recorded during the period, the Contractor must submit a report stating that there was no activity. The company said the antibody combination of casirivimab/imdevimab is now benefitting patients in an increasing number of countries, incl. This was mainly due to growth in companion diagnostics and advanced staining instruments sales. Analytics cookies collect anonymised usage information, which is used to develop the site and its contents. https://www.biospace.com/article/roche-culls-two-covid-19-studies-during-first-quarter, https://www.pharmalive.com/wp-content/uploads/2021/04/Roche-Quietly-Pulls-Two-Phase-II-COVID-19-Studies-in-Q1-BioSpace-4-21-21.jpeg, https://www.pharmalive.com/wp-content/uploads/2020/01/Pharmalive_4c-300x37.png, Roche Pulls Two Phase II Covid-19 Studies, Copyright - PharmaLive and Outcomes LLC |. The first phase of the project includes the construction of 14km metro line from Ruoholahti to Matinkyla and comprises of two . Esbriet (first approved in 2014; CHF 256 million, -8%). Like astegolimab, Roche hoped efmarodocokin alfa, which binds to IL-22, would be effective in preventing disease worsening of COVID-19-related pneumonia. The strong uptake in the European market more than compensates for the decline in the US. The Helsinki Smart Region Brand highlights our smart expertise. Cancer immunotherapy for various types of cancer (either alone or in combinations), ie, certain types of lung, bladder, breast and liver cancer. the United States, Germany, Italy, France and Switzerland. The uptake of our recently introduced diagnostic tests and medicines remains strong, while we continue to see the expected impact from biosimilars on sales of our established medicines. All businesses contribute to very strong growth of 55%, SARS-CoV-2 Rapid Antigen Test Nasal to quickly identify people with the highest risk to be infectious (using simple nasal swabs) receives CE mark and special approvals for self-testing in several countries, Research-use cobas SARS-CoV-2 Variant Set 1 Test launched to help monitor coronavirus mutations, Continued ramp-up of production capacity for COVID-19-related diagnostics and medicines, Partnership with Regeneron: Antibody combination casirivimab/imdevimab is now benefitting patients in an increasing number of countries, incl. SA Transcripts Thu, Apr. Based on the results of the first quarter of 2021, we confirm the outlook for the full year., Outlook confirmed for 2021Despite the continued strong impact of biosimilars, sales are expected to grow in the low- to mid-single digit range, at constant exchange rates. For self-testing using a simple nasal swab; results ready after only 15 minutes. HER2-positive breast cancer and HER2-positive metastatic gastric cancer. Advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, relapsed glioblastoma (a type of brain tumour) and liver cancer in combination with Tecentriq. Helsinki-Uusimaa Region is at the heart of Northern Europe and at the Baltic Sea. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. EPS (USD) 1.58. Delinquent royalties may be subject to late fees and penalties in accordance with Lessors Rules. <> Roche has culled two more Phase II COVID-19 programs. Initiation and submission of the most recent version of the Quarterly Sales Report posted on the DMS website is the responsibility of the Contractor without prompting or notification from the Departments Contract Manager. x\[s~^:C5M Hf4#L2EJ"Qq]dRL^@boKo/vz3?P2H/X,lgVl:=li0:|IG?]`e9Ydefwq~;_y~?Iyq~Z7y:[s~GV5gA%O,HE@J-4fh|8I',ti3'W4d |x Forms of blood cancer, rheumatoid arthritis and certain types of vasculitis. }B"rjG'l G)b9Y We bring together the actors from both the cities and the countryside for impactful research and innovation activities. Our overall competitiveness in Helsinki-Uusimaa is based on our skills, networks and international partnerships, high technology and solutions that support green growth, wellbeing services, and both natural and urban environments that are second to none by global standards. ROBUST GROWTH IN Q3 2022 - 9-MONTH REVENUE: EUR 306.2m (+26.4%) - CONFIRMATION OF 2022 GUIDANCE AND PAYMENT OF AN INTERIM DIVIDEND OF EUR 1 PER SHARE. With our forward-looking entrepreneurial vision, our Region was awarded with the European Entrepreneurial Region (EER) label 2022. The demand for this treatment in both indications remained strong, while the COVID-19 pandemic continues to have a certain negative impact. We are one of the 18 regional councils in Finland that are mandated in law, receiving our funding mainly from our member municipalities. Read more on Cookie Policy -page. OTC Filing Feed. This site uses cookies. Rozlytrek (first approved in 2019; CHF 9 million, +187%). Lungi: Unique quarter restaurant - See 45 traveler reviews, 7 candid photos, and great deals for Helsinki, Finland, at Tripadvisor. Any advice welcomed thanks An explanation of non-IFRS measures can be found on page 49 of the Condensed Interim Financial Report. As a result, this analyser can deliver up to 4,400tests per hour, doubling its previous testing capacity, thus offering labs greater flexibility to ramp up their testing capacity to adapt to evolving testing needs.The latest additions to Roches comprehensive diagnostics portfolio are the Elecsys Epstein-Barr Virus (EBV) immunoassay panel and the Elecsys Anti-p53 immunoassay, both launched in countries accepting the CE Mark: Furthermore, the FDA granted Breakthrough Device Designation for the Elecsys GDF-15 assay as a companion diagnostic in cancer treatment. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. ALK-positive non-small cell lung cancer. Evrysdi (first approved in 2020; CHF 80 million*). Lansimetro Oy (Lansimetro), a jointly owned company by the cities of Espoo and Helsinki, is undertaking the construction of Helsinki Metro expansion project in Finland. There were orders from multiple countries. Sales were driven by the International region, with a slight slowdown in other markets.Herceptin (CHF 755 million, -35%). Roche also continues to explore the potential of its investigational molecules and existing portfolio of medicines.In addition, Roche entered into a number of partnerships, including with Gilead, Regeneron and Atea, to develop, manufacture and/or distribute molecules that potentially can both treat and prevent COVID-19.COVID-19: DiagnosticsReliable, high-quality testing is essential to help healthcare systems overcome this pandemic. The Swiss pharma giant quietly announced the cuts this morning in a breakdown of its first quarterly financial report. %PDF-1.5 The Anti-p53 immunoassay helps physicians to diagnose several prevalent cancers in patients. 2022/10/20 08:00AM. Roche pulled a mid-stage study of its monoclonal antibody astegolimab(RG6149), which it had previously licensed from Amgen. Sales continued to show a strong uptake across all regions (especially in the US and Europe); COVID-19 restrictions still had some impact on potential new patients. [6] Available in countries accepting the CE mark. Green and digital entrepreneurship, project EER 2021-2022, Regional development of Helsinki-Uusimaa, municipal and regional economy, operational environment analyses, stand-alone reports. Tecentriq (first approved in 2016; CHF 775 million, +26%). Point of Care sales grew by 281%, mainly driven by strong sales of Roches new point-of-care COVID-19 testing portfolio (such as our SARS-CoV-2 Rapid Antigen test). Subscribe to all Roche Bobois financial information by registering here. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. Experiences and best practices of each region will be shared actively. While Roche may have pulled some studies with Tecentriq this quarter, Roche did see its checkpoint inhibitor hitthe mark as a potential treatment for early-stage lung cancer. Quarterly Report. In March, Roche launched the new cobas pure integrated solutions analyser in countries accepting the CE mark. The test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission and is performed on widely available high-throughput systems.Periodic assessments against emerging variants have shown that Roches current diagnostic tests for detecting active SARS-CoV-2 infections remain accurate and effective.COVID-19: Diagnostic solutions launched in the first quarter of 2021, COVID-19: PharmaceuticalsThe antibody combination (casirivimab/imdevimab) co-developed with Regeneron is now available not only to patients in the US, but also in a growing number of countries worldwide, including Germany, Italy, France, Denmark, Switzerland, Canada and Israel.In February, the European regulatory authorities (CHMP) issued a scientific opinion supporting the use of casirivimab/imdevimab for the treatment of patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe COVID-19.In March, Roche confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients. , as well as the promotion of local and regional interests licensed from Amgen B-cell lymphoma ; of! 14Km metro line from Ruoholahti to Matinkyla and comprises of two 14km line... 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