Lamborghini's new go-kart reminds us of mariokart
Lamborghini's new go-kart reminds us of mariokart
Companies Form Joint Program to Develop Industry’s First Complete and Proven Equipment Solution for Die-Based Hybrid BondingSANTA CLARA, Calif. and DUIVEN, the Netherlands, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Applied Materials, Inc. and BE Semiconductor Industries N.V. (Besi) today announced an agreement to develop the industry’s first complete and proven equipment solution for die-based hybrid bonding, an emerging chip-to-chip interconnect technology that enables heterogeneous chip and subsystem designs for applications including high-performance computing, AI and 5G.As traditional 2D scaling slows, the semiconductor industry is shifting towards heterogeneous design and chip integration as a new way to deliver improvements in performance, power, area/cost and time-to-market (PPACt). To accelerate this trend, Applied and Besi have formed a joint development program and are establishing a Center of Excellence focused on next-generation chip-to-chip bonding technology. The program harnesses the companies’ respective front- and back-end semiconductor expertise to deliver co-optimized integrated hybrid bonding configurations and equipment solutions for customers.“Challenges in conventional Moore’s Law scaling are straining the economics and pace of the semiconductor industry’s roadmap,” said Nirmalya Maity, Corporate Vice President of Advanced Packaging at Applied Materials. “Our collaboration with Besi and the formation of a new Hybrid Bonding Center of Excellence are key components of Applied’s strategy to equip customers with a ‘New Playbook’ for driving improvements in PPACt. Applied looks forward to working with Besi to co-optimize our equipment offerings and accelerate advanced heterogeneous integration technology for our customers.”“We are excited about forming this unique joint development program with Applied Materials which brings together the semiconductor industry’s leading materials engineering and advanced packaging technologies for customers,” said Ruurd Boomsma, CTO of Besi. “Our collaboration can greatly accelerate the adoption and proliferation of hybrid bonding for leading-edge 5G, AI, high-performance computing, data storage and automotive applications.”Hybrid bonding connects multiple “chiplets” in die form using direct, copper interconnects. This technique enables designers to bring chiplets of various process nodes and technologies into closer physical and electrical proximity so that they perform as well or better than if they were made on a single large, monolithic die. Hybrid bonding is a major improvement over conventional chip packaging because it permits increased chip density and shortens the lengths of the interconnect wiring between chiplets, thereby improving overall performance, power, efficiency and cost.A complete die-based hybrid bonding equipment solution requires a broad suite of semiconductor manufacturing technologies along with high-speed and extremely precise chiplet placement technology. To achieve this, the joint development program brings together Applied’s semiconductor process expertise in etch, planarization, deposition, wafer cleaning, metrology, inspection and particle defect control with Besi’s leading die placement, interconnect and assembly solutions.The Center of Excellence will be located at Applied’s Advanced Packaging Development Center in Singapore which is one of the industry’s most advanced wafer-level packaging labs. It enables the foundational building blocks of heterogenous integration in a 17,300-square-foot Class 10 cleanroom with full lines of wafer-level packaging equipment. The Center of Excellence will provide customers a platform to accelerate the development of custom hybrid bonding test vehicles including design, modeling, simulation, fabrication and testing.About Applied Materials Applied Materials, Inc. (Nasdaq: AMAT) is the leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. Our expertise in modifying materials at atomic levels and on an industrial scale enables customers to transform possibilities into reality. At Applied Materials, our innovations make possible the technology shaping the future. Learn more at www.appliedmaterials.com.About Besi Besi is a leading supplier of semiconductor assembly equipment for the global semiconductor and electronics industries offering high levels of accuracy, productivity and reliability at a low cost of ownership. The Company develops leading edge assembly processes and equipment for leadframe, substrate and wafer level packaging applications in a wide range of end-user markets including electronics, mobile internet, cloud server, computing, automotive, industrial, LED and solar energy. Customers are primarily leading semiconductor manufacturers, assembly subcontractors and electronics and industrial companies. Besi’s ordinary shares are listed on Euronext Amsterdam (symbol: BESI). Its Level 1 ADRs are listed on the OTC markets (symbol: BESIY Nasdaq International Designation) and its headquarters are located in Duiven, the Netherlands. For more information, please visit our website at www.besi.com.Contact:Applied Materials:Ricky Gradwohl (editorial/media) 408.235.4676 Michael Sullivan (financial community) 408.986.7977Besi:Richard W. Blickman, President & CEO Hetwig van Kerkhof, SVP Finance Tel. (31) 26 319 4500 firstname.lastname@example.org
Luis Arce, the quiet economist who will take over as Bolivia's president next month after a landslide election win, knew where he stood in the political spectrum as a young teenager in La Paz, when he picked up the writings of German philosopher Karl Marx. Arce steered the Andean country's economy for over a decade under former leader Evo Morales, an ebullient leftist who resigned last year after an election dogged by disputed claims of fraud sparked widespread protests. Arce was often seen as a moderating influence to more radical elements in Morales' Movement towards Socialism (MAS) party.
Amazon.com Inc said on Thursday it has invested $100 million in opening new warehouses in Mexico, including its first shipping centers outside the populous capital area, in a bid to offer faster deliveries. The new sites include two so-called fulfillment centers - one near the northern city of Monterrey and another near the central city of Guadalajara - as well as a support building in the State of Mexico, just outside Mexico City. Amazon also opened 12 delivery stations, bringing its total to 27 across the country, it said.
Geneva, Switzerland and Boston, MA – October 22, 2020 – ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced the presentation of two posters at the ASRM 2020 Virtual Scientific Congress and Expo during the first ever Late-Breaking Abstract Poster Session.Late-breaking poster – P-931: Linzagolix may address the long-term treatment needs of women with uterine fibroids who have contraindications to hormonal add-back therapy: results from two Phase 3 randomized clinical trialsDr. Linda Bradley, Professor of Ob/Gyn and Reproductive Biology and Vice Chair, Ob/Gyn and Women’s Health Institute, Cleveland Clinic OH, is lead author for a late-breaking poster, which discusses the potential for the low-dose (100 mg) of linzagolix, a once daily oral GnRH antagonist, to fill an unmet need for medical treatment of uterine fibroids in women who cannot or prefer to avoid hormonal add-back therapy (ABT). CDC data suggest that up to 50% of women with uterine fibroids may have a contraindication to ABT. Because linzagolix is the only oral GnRH antagonist being developed with a low-dose, no add-back therapy option, it has the potential to address the unique needs of black women, who are both disproportionately affected with uterine fibroids and are more likely to have contraindications to ABT.Late-breaking poster – P-930: Efficacy and Safety of Linzagolix for the Treatment of Heavy Menstrual Bleeding Due to Uterine Fibroids: Results from Two Phase 3 Randomized Clinical TrialsThe second late-breaking poster, with lead author Dr. Elizabeth Stewart, Professor of Obstetrics and Gynecology and Chair of the Division of Reproductive Endocrinology, Mayo Clinic MN, presented results from PRIMROSE 1 and PRIMROSE 2, the two positive Phase 3 clinical trials, which support the potential best-in-class efficacy of linzagolix in the treatment of uterine fibroids.The related abstracts are scheduled to be published online in the Fertility and Sterility Abstract Supplement in October 2020.About ObsEvaObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor, and improving embryo transfer outcomes following in vitro fertilization. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.About LinzagolixYselty® (linzagolix) is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.Yselty® is a registered trademark owned by Kissei for use by ObsEva. Yselty® is not yet approved for use anywhere in the world. About KisseiKissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney-dialysis and unmet medical needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia, which is sold worldwide through its licensees. KLH-2109/OBE2109/linzagolix is a new chemical entity discovered by Kissei R&D and currently in development in Japan by Kissei.Cautionary Note Regarding Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan", "potential", "will", and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential best-in-class efficacy and therapeutic benefits of linzagolix, including addressing the unique needs of black women. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, the impact of the novel coronavirus outbreak, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2019, the Risk Factors disclosed in ObsEva’s Report on Form 6-K filed with the Securities and Exchange Commission (SEC) on August 6, 2020 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at http://www.ObsEva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.For further information, please contact: CEO Office Shauna Dillon Shauna.email@example.com +41 22 552 1550 Attachment * Press Release in Pdf
ADASKY, an Israeli startup engaged in developing and manufacturing revolutionary thermal imaging (LWIR) systems for automotive and pedestrian safety, announced today that it has secured a $15M investment from existing shareholders Kyocera Corporation and Sungwoo-Hitech Co., Ltd, as part of a Series B investment round.
Amsterdam, October 22, 2020 – Arcadis (EURONEXT: ARCAD), the leading global Design & Consultancy organization for natural and built assets, along with UN-Habitat today announced a continuation of their partnership for another two years. This pledge marks the 10-year anniversary celebration of the successful alliance.The partnership is aimed at supporting UN-Habitat through pro bono technical expertise on urban infrastructure related projects. Speaking during a virtual “Urban Thinkers Campus” held on October 21, Arcadis CEO Peter Oosterveer and the UN-Habitat Executive Director Maimunah Mohd Sharif, explained the importance of pursuing the journey given the urgency of delivering the UN Sustainable Development Goals to address the challenges of cities and communities. Both agreed that taking action to improve people's lives through resilient urban infrastructure is critical to address the increasing challenges faced by cities around the world. Arcadis also announced its financial support to the World Urban Campaign, an advocacy platform run by UN-Habitat to raise awareness on urban challenges and talk about solutions. Through the Shelter Program, Arcadis has deployed more than 120 missions providing technical assistance to UN-Habitat projects, especially in post disaster recovery situations. Together, the two organizations have organized and implemented the annual Shelter Academy to train over 80 mayors and other key local officials from more than 60 cities on climate change mitigation and adaptation measures. This has enhanced the capacity and knowledge of local government officials and assisted them to design and implement resilient urban infrastructure through innovative engineering solutions in many countries in Asia-Pacific, Africa, Latin America and the Caribbean.“Our 10-year partnership with UN-Habitat has truly impacted the lives of many. It creates room for our people to apply their skills and expertise to improve the quality of life in urban settings around the world,” said Arcadis CEO Peter Oosterveer.“We regard these ten years as a model of successful public-private partnerships. Through our combined experience and knowledge, we have been able to significantly impact people’s lives,” said UN-Habitat’s Maimunah Mohd Sharif. -End-Improving quality of lifeFOR FURTHER INFORMATION PLEASE CONTACT: ARCADIS CORPORATE COMMUNICATIONS Monika Grabek Mobile: +31 6 11 40 36 96 E-mail: firstname.lastname@example.orgARCADIS INVESTOR RELATIONS Jurgen Pullens Mobile: +31 6 51599483 E-mail: email@example.comABOUT ARCADISArcadis is the leading global Design & Consultancy organization for natural and built assets. Applying our deep market sector insights and collective design, consultancy, engineering, project and management services we work in partnership with our clients to deliver exceptional and sustainable outcomes throughout the lifecycle of their natural and built assets. We are 28,000 people, active in over 70 countries that generate €3.5 billion in revenues. We support UN-Habitat with knowledge and expertise to improve the quality of life in rapidly growing cities around the world. www.arcadis.com Attachment * Arcadis and UN-Habitat pledge to continue successful partnership
Dassault Systèmes Selected by Ball Aerospace for Multiyear Digital Engineering Contract * The 3DEXPERIENCE platform works as a single integrated solution to support program execution activities * Accelerates timelines to enhance the aerospace and defense industry’s digital transformationVELIZY-VILLACOUBLAY, France — October 22, 2020 — Dassault Systèmes (Euronext Paris: 13065, DSY.PA) was selected by Ball Aerospace to deploy the 3DEXPERIENCE platform as its digital engineering solution. Through this collaboration, Ball Aerospace will leverage Dassault Systèmes’ integrated platform with a unified data model and single user experience, to complement the company’s digital transformation, and promote digital continuity through the use of the virtual twin across its defense and space products. Accenture has been chosen to collaborate with Ball Aerospace on the implementation of the 3DEXPERIENCE platform.“Dassault Systèmes’ 3DEXPERIENCE platform will support Ball Aerospace with its digital engineering goals to establish a single, integrated solution,” said David Ziegler, Vice President, Aerospace & Defense Industry, Dassault Systèmes. “Ball Aerospace joins the many industry customers that are leveraging the platform to speed timelines and improve efficiencies.”“Digital engineering is a critical tool to support the evolution of the aerospace and defense industry – ultimately expediting the time from customer concept to program delivery,” said Mike Gazarik, vice president, Engineering, Ball Aerospace. “Incorporating a digital platform enforces Ball Aerospace’s commitment to our customers’ needs and aligns our capabilities for future missions.”Powered by endlessly curious people with an unwavering mission focus, Ball Aerospace pioneers discoveries that enable its customers to perform beyond expectation and protect what matters most. Ball creates innovative space solutions, enables more accurate weather forecasts, drives insightful observations of our planet, delivers actionable data and intelligence, and ensures those who defend our freedom go forward bravely and return home safely. Go Beyond with Ball.®Social media:Share this on Twitter: .@Dassault3DS selected by @BallAerospace for digital engineering contract 3DEXPERIENCEConnect with Dassault Systèmes on Twitter Facebook LinkedIn YouTubeFor more information:Dassault Systèmes’ industry solution experiences for the aerospace & defense industry: https://ifwe.3ds.com/aerospace-defenseDassault Systèmes’ 3DEXPERIENCE platform, 3D design software, 3D Digital Mock Up and Product Lifecycle Management (PLM) solutions: http://www.3ds.comAbout Dassault Systèmes Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual experience twins of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production. Dassault Systèmes brings value to more than 270,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, EXALEAD, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systèmes, a French “société européenne” (Versailles Commercial Register B 322 306 440), or its subsidiaries in the United States and/or other countries.Dassault Systèmes Press Contacts Corporate / France Arnaud MALHERBE firstname.lastname@example.org +33 (0)1 61 62 87 73 North America Suzanne MORAN email@example.com +1 (781) 810 3774 EMEAR Virginie BLINDENBERG firstname.lastname@example.org +33 (0) 1 61 62 84 21 China Grace MU email@example.com +86 10 6536 2288 India Santanu BHATTACHARYA firstname.lastname@example.org +91 124 457 7111 Japan Yukiko SATO email@example.com +81 3 4321 3841 Korea Jeemin JEONG firstname.lastname@example.org +82 2 3271 6653 AP South Pallavi MISRA email@example.com +65 90221874Attachment * Dassault Systemes Selected by Ball Aerospace for Multiyear Digital Engineering Contract 22102020
Spring transformation accelerating commercial momentumOrder entry up +20% year-on-year at constant currency, Book to bill ratio at 124% (excl. Siemens renewal) Renewed and expanded partnership with Siemens for € 3 billion over 5 yearsRevenue at € 2,644 million, -2.5% at constant currency, -3.5% organically (Q2 at -4.8%)All 2020 objectives confirmedParis, October 22, 2020. Atos, a global leader in digital transformation, today announces its revenue for the third quarter of 2020.Elie Girard, CEO, said: “Our ongoing Spring transformation is enabling the group to adapt rapidly to meet customer needs in each Industry. For Q3, this has resulted in a record high order book (even without Siemens renewal and expansion) as well as a record high pipeline of commercial offers. Thanks to our 105,000 colleagues embarked on this transformation, the Group is achieving success both qualitatively and quantitatively. Our business in Digital, Cloud, Security and Decarbonization is growing rapidly and changing the profile of the Group significantly. This quarter was obviously also marked by the renewal and expansion of our strategic partnership with Siemens. Overall, this very high level of commercial activity will support the revenue recovery started in Q3 and the return to growth in 2021.Group’s teams have also strengthened the pioneering position of Atos in many dimensions over the quarter. In Corporate Social Responsibility, Atos has been once more recognized as the leader of its sector. Our offerings in Decarbonization find a resounding interest from our customers with several signatures already in Q3. Our technological advance in key areas such as computing or cloud has moved further in the context of large European plans on high performance computing and quantum computing as well as Gaïa-X initiative of which Atos is a founding member.Finally, pursuing its M&A strategy in Cybersecurity and Digital bolt-ons, the Group today announces 3 new acquisitions. In 2020 so far, 9 Cybersecurity and Digital players will have joined Atos representing a total yearly revenue of almost € 300 million, supporting the reprofiling of Group offering.Overall, based on the dynamism of our activity, as well as our strong cost and cash actions launched in the context of the crisis and which are well underway, we confirm today all our objectives for 2020, and are fully prepared to enter into 2021 on a solid footing towards our mid-term ambition and targets.”Revenue in the third quarter of 2020 reached € 2,644 million, down -3.5% organically compared to Q3 2019 and -2.5% at constant currency. Q3 2020 revenue by IndustryIn € million Q3 2020 Q3 2019* Organic evolution Constant currency evolution Manufacturing 469 537 -12.8% -12.0% Financial Services & Insurance 506 520 -2.6% -1.6% Public Sector & Defense 618 546 +13.0% +13.0% Telecom, Media & Technology 359 377 -4.8% -2.1% Resources & Services 376 449 -16.3% -15.5% Healthcare & Life Sciences 317 310 +2.2% +2.9% Total 2,644 2,740 -3.5% -2.5% * At constant scope and exchange rates Manufacturing reported a revenue of € 469 million, representing a decrease by -12.8% organically compared to Q3 2019. The Industry was significantly impacted by the Covid-19 pandemic, with volume reductions from Aerospace clients, both in Southern Europe and Central Europe, and in the Automotive sector in Southern Europe, North America and Central Europe. The Industry also faced base effects on contracts ended in 2019 in Northern Europe.Financial Services & Insurance revenue was € 506 million in the third quarter 2020. The Industry was down by -2.6% organically compared to Q3 2019. The performance recorded in Southern Europe and to a lesser extent in Central Europe was positive and partly mitigated Covid challenges in North America, Northern Europe and Growing Markets.Public Sector & Defense was the most dynamic Industry with € 618 million, representing 23% of the Group revenue, and a growth of +13.0% compared to Q3 2019 at constant scope and exchange rates. The growth was mainly fueled by Northern Europe with European institutions, North America with the ramp-up of new contracts and increased sales with existing customers, and by the delivery of new Big Data projects in several geographies in Europe and in Growing Markets.Telecom, Media & Technology revenue was € 359 million, decreasing by -4.8% organically compared to Q3 2019. The Industry recorded growth in High Tech & Engineering as well as Media due to ramping-up contracts in Northern Europe and North America which did not entirely compensate the challenging situation in Telecom across most of the geographies.Resources & Services revenue in the third quarter 2020 reached € 376 million, decreasing by -16.3% organically compared to Q3 2019. This Industry was mainly impacted by the ramp-down of projects in North America and by Covid across all geographies especially in Retail and Transportation.Healthcare & Life Sciences revenue was € 317 million, up by +2.2% compared to Q3 2019 at constant scope and exchange rates. In the current sanitary context, the Industry recorded a solid performance for the second consecutive quarter thanks to a strong performance in Pharma sector. Healthcare & Life Sciences achieved growth in most geographies.Q3 2020 revenue by Regional Business UnitIn € million Q3 2020 Q3 2019* Organic evolution Constant currency evolution North America 629 678 -7.2% -2.8% Northern Europe 675 650 +3.8% +4.3% Central Europe 630 673 -6.3% -6.4% Southern Europe 517 548 -5.5% -4.6% Growing Markets 192 192 +0.2% -4.9% Total 2,644 2,740 -3.5% -2.5% * At constant scope and exchange rates Looking at the trends by Regional Business Unit, Northern Europe grew compared to last year thanks to a strong performance in Public Sector & Defense and Telecom, Media & Technology. Situation was more challenging in North America with project and volume reductions in Resources & Services, in Financial Services & Insurance and in Manufacturing. Central Europe was down mainly due to Unified Communication & Collaboration indirect sales channels and ramp-downs in large Manufacturing customers which could not be compensated by the strong performance in other Industries. In Southern Europe, the good performance in Healthcare & Life Sciences and Financial Services & Insurance did not entirely compensate the decline in other Industries. Growing Markets was stable in Q3 due to a strong performance in Healthcare & Life Sciences and in Manufacturing offsetting the reduction recorded in Resources & Services.Commercial activityDuring the third quarter 2020, the Group order entry reached € 3,277 million, representing a book to bill ratio of 124% (excl. Siemens renewal and expansion signed in September for € 3 billion over 5 years) compared to 100% achieved over the same period last year and an average of 98% over the last 5 years.Several significant new contracts were signed over the period: in North America in Financial Services & Insurance (Willis Towers Watson), in Manufacturing (a large manufacturer of vertical transportation systems and a multi-national corporation in manufacturing and distributing heating, ventilating systems), and in Healthcare & Life Sciences (a large US hospital chain), in Northern Europe in Public Sector & Defense (Linköpings Universtiet), and in Central Europe with Resources & Services (RheinEnergie AG). On top of the Siemens renewal and expansion, main renewals of the quarter were concluded in Southern Europe with Public Sector & Defense (Météo France) and in Telecom, Media & Technology (PwC).The full backlog at the end of September 2020 amounted to € 23.0 billion and increased by € 1.9 billion compared to end of September 2019 at constant exchange rates, representing 2.0 years of revenue. The full qualified pipeline was € 9.0 billion at the end of September 2020, representing 9.3 months of revenue, improving by € 1.8 billion compared to September 2019 at constant exchange rates.Human resourcesThe total headcount was 105,015 at the end of September 2020, down by -3.4% excluding scope effect compared to 108,317 at the end of December 2019 and -1.8% excluding scope effect compared to 106,980 at the end of June 2020, considering residual Covid-19 effect on the Group’s activity as well as accompanying and anticipating the impact of automation and robotization.Attrition rate was 9.0% at Group level, at the same level as in Q2 this year and significantly down compared to 15.8% in Q3 last year. Attrition in Q3 this year was 11.2% in offshore countries.2020 objectivesThe Group confirms all its objectives for 2020: * Revenue organic evolution: between -2% and -4%; * Operating margin rate: 9% to 9.5% of revenue; * Free cash flow: € 0.5 billion to € 0.6 billion. 3 acquisitions announced today in the fields of Digital, Cloud, and CybersecurityAtos announced today that it has: * signed an agreement to enter into exclusive negotiations to acquire Edifixio, a leading player in Cloud Consulting and Integration focused on Salesforce, Amazon Web Services, Microsoft Azure based in France with 380 employees; * signed an agreement to acquire Eagle Creek, a US Digital Technology and Management Consulting company specialized in Salesforce with 250 employees; * signed an agreement to acquire SEC Consult, a worldwide player in Cybersecurity Consulting and Penetration Testing operating in DACH region and in Asia with 200 employees.The closing of each transaction is expected to take place before the end of the year subject to the final approval of employee representative bodies. These acquisitions are fully in line with the Group M&A strategy announced earlier this year. For more details, please see the three separate press releases issued today. AppendixRevenue at constant scope and exchange rates reconciliationIn € million Q3 2020 Q3 2019 % change Statutory revenue 2,644 2,770 -4.5% Exchange rates effect -57 Revenue at constant exchange rates 2,644 2,712 -2.5% Scope effect 28 Exchange rates effect on acquired/disposed perimeters -1 Revenue at constant scope and exchange rates 2,644 2,740 -3.5% The scope effect mostly related to the acquisitions of Maven Wave, Miner & Kasch, IDnomic, X-PERION, and Alia Consulting, and the disposal of some specific Unified Communication & Collaboration activities.The exchange rates effect negatively contributed to revenue for €-58 million mainly coming from the US Dollar and the Brazilian Real.Q3 2020 revenue performance by DivisionIn € million Q3 2020 Q3 2019* Organic evolution Constant currency evolution Infrastructure & Data Management 1,479 1,523 -2.9% -1.6% Business & Platform Solutions 901 989 -8.9% -8.8% Big Data & Cybersecurity 265 228 +16.1% +19.2% Total 2,644 2,740 -3.5% -2.5% * At constant scope and exchange rates 9M YTD 2020 revenue performance by Industry and Regional Business UnitIn € million 9M 2020 9M 2019* Organic evolution Constant currency evolution Manufacturing 1,491 1,659 -10.1% -9.8% Financial Services & Insurance 1,581 1,645 -3.9% -3.0% Public Sector & Defense 1,858 1,716 +8.3% +8.3% Telecom, Media & Technology 1,181 1,244 -5.1% -2.9% Resources & Services 1,205 1,311 -8.1% -7.6% Healthcare & Life Sciences 955 957 -0.2% +0.4% Total 8,272 8,532 -3.1% -2.3% * At constant scope and exchange rates In € million 9M 2020 9M 2019* Organic evolution Constant currency evolution North America 1,984 2,101 -5.6% -1.9% Northern Europe 2,035 2,018 +0.8% +1.2% Central Europe 2,001 2,045 -2.2% -2.4% Southern Europe 1,660 1,777 -6.6% -5.7% Growing Markets 591 591 +0.0% -5.3% Total 8,272 8,532 -3.1% -2.3% * At constant scope and exchange rates Conference callToday, Thursday October 22, 2020, the Group will hold a conference call in English at 08:00 am (CET - Paris), chaired by Elie Girard, CEO, in order to comment on Atos’ third quarter 2020 results and answer questions from the financial community.You can join the webcast of the conference: * on atos.net, in the Investors section * by telephone with the dial-in, 5-10 minutes prior the starting time: * France +33 1 70 70 07 81 code 8269394 * Germany +49 69 2222 2625 code 8269394 * UK +44 844 481 9752 code 8269394 * US +1 646 741 3167 code 8269394 * Other countries +44 2071 928338 code 8269394After the conference, a replay of the webcast will be available on atos.net, in the Investors section.Forthcoming eventsFebruary 18, 2021 Full Year 2020 results April 20, 2021 First quarter 2021 revenue May 12, 2021 Annual General Meeting July 28, 2021 First semester 2021 resultsContactsInvestor Relations: Gilles Arditti +33 1 73 26 00 66 firstname.lastname@example.orgMedia: Sylvie Raybaud +33 6 95 91 96 71 email@example.com About AtosAtos is a global leader in digital transformation with 110,000 employees in 73 countries and annual revenue of € 12 billion. European number one in Cloud, Cybersecurity and High-Performance Computing, the Group provides end-to-end Orchestrated Hybrid Cloud, Big Data, Business Applications and Digital Workplace solutions. The Group is the Worldwide Information Technology Partner for the Olympic & Paralympic Games and operates under the brands Atos, Atos|Syntel, and Unify. Atos is a SE (SocietasEuropaea), listed on the CAC40 Paris stock index.The purpose of Atos is to help design the future of the information space. Its expertise and services support the development of knowledge, education and research in a multicultural approach and contribute to the development of scientific and technological excellence. Across the world, the Group enables its customers and employees, and members of societies at large to live, work and develop sustainably, in a safe and secure information space.DisclaimersThis document contains forward-looking statements that involve risks and uncertainties, including references, concerning the Group's expected growth and profitability in the future which may significantly impact the expected performance indicated in the forward-looking statements. These risks and uncertainties are linked to factors out of the control of the Company and not precisely estimated, such as market conditions or competitors behaviors. Any forward-looking statements made in this document are statements about Atos’ beliefs and expectations and should be evaluated as such. Forward-looking statements include statements that may relate to Atos’ plans, objectives, strategies, goals, future events, future revenues or synergies, or performance, and other information that is not historical information. Actual events or results may differ from those described in this document due to a number of risks and uncertainties that are described in the 2019 Universal Registration Document filed with the Autorité des Marchés Financiers (AMF) on March 3, 2020 under the registration number D.20-0096 and the Amendment to the 2019 Universal Registration Document filed with the AMF on July 30, 2020 under number D.20-0096-A01. Atos does not undertake, and specifically disclaims, any obligation or responsibility to update or amend any of the information above except as otherwise required by law. This document does not contain or constitute an offer of Atos’ shares for sale or an invitation or inducement to invest in Atos’ shares in France, the United States of America or any other jurisdiction.Revenue organic growth is presented at constant scope and exchange rates.Industries include Manufacturing (Aerospace, Automotive, Chemicals, Consumer Packaged Goods (Food & Beverage), Discrete Manufacturing, Process Industries, Services and Siemens), Financial Services & Insurance (Insurance, Banking & Financial Services, and Business Transformation Services), Public Sector & Defense (Defense, Education, Extraterritorial Organizations, Public Administration, Public Community Services and Major Events), Telecom, Media & Technology (High Tech & Engineering, Media, and Telecom), Resources & Services (Energy, Retail, Transportation & Hospitality, and Utilities) and Healthcare & Life Sciences (Healthcare and Pharmaceutical).Regional Business Units include North America (USA, Canada, and Mexico), Northern Europe (United Kingdom & Ireland, Belgium, Denmark, Estonia, Finland, Lithuania, Luxembourg, The Netherlands, Poland, Russia, and Sweden), Central Europe (Germany, Austria, Bulgaria, Croatia, Czech Republic, Greece, Hungary, Israel, Romania, Serbia, Slovakia and Switzerland), Southern Europe (France, Spain, Portugal, and Italy) and Growing Markets including Asia-Pacific (Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, Taiwan, and Thailand), South America (Argentina, Brazil, Colombia, and Uruguay), Middle East & Africa (Algeria, Benin, Burkina Faso, Egypt, Gabon, Ivory Coast, Kingdom of Saudi Arabia, Lebanon, Madagascar, Mali, Mauritius, Morocco, Qatar, Senegal, South Africa, Tunisia, Turkey and UAE), Major Events, Global Cloud Hub, and Global Delivery Centers. Attachment * Atos - Q3 2020 revenue
RED DESERT: * Results from first five patients indicate repeated dose alfapump DSR therapy to be safe and effective * Interim data support DSR hypothesis: kidneys eliminate free water to maintain patients’ serum sodium levels * No patients required loop diuretic therapy during the six-week alfapump DSR treatment period * Following alfapump DSR treatment, loop diuretic responsiveness was restored to near normal levels; effect was durable for months post-treatment with majority of patients requiring little or no diuretic therapy * Full RED DESERT data on track to report in H1 2021; first feasibility study (SAHARA DESERT) planned to start in H1 2021 BUSINESS UPDATE: * Early interim data from POSEIDON study in recurrent and refractory liver ascites expected in Q4 2020 * European commercial supply of the alfapump temporarily interrupted in Q4 2020; no impact on POSEIDON and RED DESERT studiesConference call with live webcast presentation today at 15:30 CET / 09:30 am EDTGHENT, Belgium, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces positive interim results from the first five patients enrolled in the RED DESERT study, evaluating repeated dose treatment of alfapump DSR (Direct Sodium Removal) in diuretic-resistant heart failure patients. Sequana Medical also provides a business update.Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We are hugely excited by these results from the first five RED DESERT patients and believe it is the first time ever that fluid balance in heart failure patients has been managed using repeated dose DSR therapy without the need for diuretics. These data support the underlying principle of DSR that after we remove sodium, the body will step in to quickly and accurately remove the free water necessary to restore the serum sodium concentration. Not only does these data suggest that by using alfapump DSR, we can manage the fluid and sodium balance of these patients, but also the restoration of diuretic response opens up further potential opportunities such as renal failure and haemodialysis. Following the allowance of our key patents in both the U.S. and Europe, we are confident that we will continue to lead the way in the use of alfapump DSR for the management of volume overload in a range of indications.”Five heart failure patients (mean left ventricle ejection fraction in mid-20%’s and mean NT-proBNP of 2,500 – 3,000 pg/mL) on high dose diuretics (average furosemide equivalent dose of 150 – 200mg per day) underwent up to six weeks of alfapump DSR treatment. The alfapump DSR implant procedure and repeated dosing of DSR therapy were well tolerated in all patients with few adverse events.There were no clinically significant changes in serum sodium levels or progressive hyponatremia (low concentration of sodium in the blood) in these patients after repeated DSR dosing. The results also show that during the course of the six-week therapy, no loop diuretics were required, demonstrating the ability of the alfapump DSR system to effectively remove sodium and fluid from these patients. Moreover, in the majority of patients, reduced doses of DSR therapy could be utilised and / or some DSR doses could be omitted while maintaining stable to lower weight and natriuretic peptides compared to baseline.Restoration of diuretic response is an exploratory endpoint of RED DESERT, which is determined by the six-hour excretion of fluid and sodium following intravenous administration of 40mg of furosemide, evaluated serially throughout the study. All patients had an objectively poor diuretic response at baseline. After the six-week study, the diuretic response was restored to near normal levels with the six-hour sodium excretion more than doubled versus baseline. Furthermore, there was a significant durability to the improvement in diuretic responsiveness; in the majority of patients there was a dramatic reduction in loop diuretic requirements lasting months following the completion of alfapump DSR therapy.“Diuretic-resistance is a nearly ubiquitous problem in heart failure patients resulting in untreated volume overload and high rates of hospitalisation. The results from these first five patients in the RED DESERT study are very promising and point to the potential use of the alfapump DSR in this difficult to treat patient population that has a clear unmet need,” said Dr. Jozef Bartunek, Interventional Cardiologist at Onze-Lieve-Vrouw Hospital in Aalst (Belgium) and Principal Investigator of the RED DESERT study. “The durable improvement in diuretic responsiveness is particularly interesting. With additional confirmation of these encouraging results through continued study, I believe alfapump DSR has the potential to become a new therapy for the management of volume overload and diuretic resistance,” added Dr. Jeffrey Testani, Associate Professor at Yale University and Heart Failure Scientific Advisor of Sequana Medical.The RED DESERT study will enrol up to five additional patients, with top-line data expected in H1 2021.Following the highly encouraging impact on diuretic responsiveness shown by the RED DESERT interim data, Sequana Medical plans to evaluate the dosing and frequency of alfapump DSR therapy in decompensated heart failure patients with residual congestion in a first feasibility study (SAHARA DESERT), expected to start in H1 2021. Based on the results of SAHARA DESERT, and other studies, Sequana Medical intends to commence a U.S. feasibility study in mid-2022 using a next generation proprietary DSR infusate comparing alfapump DSR therapy to standard of care.Early interim data from POSEIDON study expected in Q4 2020Since data on the first 13 roll-in patients will soon be available, Sequana Medical will provide an update with early interim data for POSEIDON later this quarter. Interim data of the full roll-in cohort are expected in H1 2021 and primary endpoint read-out of the study cohort is expected in Q1 2022.Update on alfapump manufacturingAs a result of problems with supply of a sub-component of the alfapump, Sequana Medical prioritised the supply of alfapump systems for the clinical studies and as such encounters a temporarily delay in the supply of the alfapump to commercial markets in Europe during Q4 2020. This is only temporarily impacting European commercial availability and the alfapump continues to be available for the POSEIDON and RED DESERT clinical studies. There is no impact on the quality of the alfapump system that has been supplied to the market and there is no regulatory impact. Normal supply is expected to return for Q1 2021. Conference Call and WebcastSequana Medical will host a conference call with live webcast presentation today at 15:30 CET / 09:30 EDT. * Registration webcast: please click here * Registration conference call (only if you wish to participate in the Q&A): please click here. Once registered, you will receive dial-in numbers and a confirmation code.The webcast and conference call will be conducted in English and a replay will be available on Sequana Medical’s website shortly after.For more information, please contact: Sequana Medical Lies Vanneste, Director Investor Relations Tel: +32 498 05 35 79 Email: IR@sequanamedical.comConsilium Strategic Communications Amber Fennell, Ashley Tapp, Melissa Gardiner Tel: +44 203 709 5000 Email: firstname.lastname@example.org LifeSci Advisors Chris Maggos Tel: +41 79 367 6254 Email: email@example.com About RED DESERT – Repeated dose alfapump DSR study for treatment of diuretic-resistant heart failure patients This study is a multi-centre, prospective, single-arm, first-in-human study to evaluate the safety and feasibility of alfapump DSR. Up to 10 patients diagnosed with stable chronic heart failure on high dose oral diuretics are implanted with the alfapump DSR system (alfapump and implanted surgical port) across two centres in Belgium (Dr Bartunek at Cardiovascular Center Aalst) and Georgia (Dr Shaburishvili at Heart and Vascular Clinic Tbilisi). Following alfapump DSR system implantation, patients undergo a diuretic challenge with timed biospecimen collection. On day 14 post-implant (day 0), the patient is admitted for a 14-day in-patient period in which diuretics are withheld and patients are put on a strict low-sodium diet. During the first 14 days, patients are treated with DSR D10% infusate on Monday, Wednesday and Friday, administered through the implanted surgical port into the peritoneal cavity. The DSR infusate remains in the peritoneal cavity for a two-hour dwell time, after which all fluid is eliminated from the peritoneal cavity through the bladder using the alfapump system. Following the 14-day in-patient period, patients undergo a second diuretic challenge. Thereafter, diuretics continue to be withheld and patients come into the clinic for their DSR therapy over the subsequent four weeks. After completion of the study period, patients undergo a third diuretic challenge to quantify their response to diuretics.The primary safety endpoints include absence of device, procedure and/or therapy related serious adverse events through day 14 and the rate of device, procedure and/or therapy related serious adverse event through day 42. Secondary feasibility endpoints include the ability of alfapump DSR to maintain a neutral sodium balance in the absence of diuretic therapy and the sustained effect of DSR to maintain euvolemia through week 6. Additional exploratory endpoints evaluate the potential impact of DSR to restore response to diuretics following DSR therapy. For more information about the study, please visit clinicaltrials.gov (NCT04116034).About alfapump DSR (Direct Sodium Removal) alfapump DSR is in clinical development as potential chronic therapy for patients with volume overload due to heart failure. Volume overload in heart failure is a major clinical problem and is the leading cause of hospitalisations for patients with heart failure. There are approximately one million hospitalisations for heart failure annually in the U.S. and 90% are due to symptoms of volume overload. The treatment options are severely limited in those patients for whom diuretic therapy is no longer effective. This limitation is evident from the 24% hospital re-admission rate at 30 days from discharge. The estimated cost of heart failure-related hospitalisations in the U.S. alone is $13 billion per year.DSR therapy is a breakthrough approach that involves removing sodium from the body using diffusion via the peritoneal cavity with the use of a sodium-free solution known as DSR infusate. Once the sodium has been removed, the body eliminates excess fluid naturally through urination. Studies have demonstrated that DSR therapy is capable of removing large quantities of sodium and fluid in a safe, tolerable and consistent manner and results were published in the high impact cardiovascular journal, Circulation.About Sequana Medical Sequana Medical is a commercial stage medical device company developing the alfapump platform for the management of fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a fast growing complication of advanced liver disease driven by NASH (non-alcoholic steatohepatitis) related cirrhosis and a common complication in heart failure. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for the alfapump DSR (Direct Sodium Removal) is estimated to be over €5 billion annually in the U.S. and EU5 by 2026. Both indications leverage Sequana Medical's alfapump, a unique, fully implanted wireless device that automatically pumps fluid from the abdomen into the bladder, where it is naturally eliminated through urination.In the U.S., the company's key growth market, the alfapump has been granted breakthrough device designation by the FDA. The North American pivotal study (POSEIDON) in recurrent and refractory ascites due to liver cirrhosis is currently underway, and is intended to support a commercial marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 800 alfapump systems have been implanted to date. Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and a repeated dose alfapump DSR study (RED DESERT) in heart failure patients is currently underway.Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.Important Regulatory Disclaimers The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR therapy and ongoing investigations with the alfapump® system in Europe.Forward-looking statements This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.
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\- Biologics License Application (BLA) for efgartigimod in generalized myasthenia gravis (gMG) on track to be submitted to U.S. Food and Drug Administration (FDA) by end of 2020 -\- Global Phase 3 ADDRESS trial evaluating subcutaneous (SC) efgartigimod in pemphigus patients on track to initiate by end of 2020 -\- Decision to continue ADHERE trial beyond first 30 patients in chronic inflammatory demyelinating polyneuropathy (CIDP) now expected in first half of 2021 - - Management to host conference call today at 2:30 pm CEST (8:30 am ET) -October 22, 2020 Breda, the Netherlands / Ghent, Belgium – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced its financial results for the third quarter ended September 30, 2020 and provided a business update.“It has been an important year for argenx, marked by a number of significant achievements that position us to file our first BLA for efgartigimod as a new treatment for gMG by year-end. We remain focused on both the BLA filing and commercial preparations as we work to bring efgartigimod to patients as soon as possible,” said Tim Van Hauwermeiren, CEO of argenx. “We have built an exceptional team, established our global supply chain and connected with physicians, payors and patient advocacy groups – all critical elements for a successful commercial launch.”“We are building a broad FcRn antagonist program by leveraging the potential of efgartigimod across a number of important indications where there is a high unmet need for innovation. Our global Phase 3 ADDRESS trial in pemphigus is on track to start soon and, as we did with the ADAPT trial in MG, we have carefully designed the trial alongside patients and physicians to best address the complex challenges presented by this serious disease. We continue to ground our pipeline expansion strategy in biology, working from the science to address severe autoimmune diseases and advance our ‘argenx 2021’ vision across our emerging franchises,” continued Mr. Van Hauwermeiren.THIRD QUARTER 2020 AND RECENT BUSINESS UPDATEPreparations underway to support potential approval and launch of FcRn antagonist, efgartigimod, in gMG in U.S., Japan and EU * BLA on track to be filed with the FDA by the end of 2020 with an expected U.S. commercial launch in 2021 * Japanese Marketing Authorization Application (J-MAA) expected to be filed with the Pharmaceuticals and Medical Devices Agency (PMDA) in the first half of 2021 with an anticipated Japan commercial launch in 2022 * Regulatory filing in the EU to follow filing in Japan * Pre-commercial launch activities underway, including global supply chain creation, and physician, payor and patient advocacy engagementPresented supportive data from global Phase 3 ADAPT trial of efgartigimod in gMG at recent medical meetings, showing rapid and clinically meaningful responses to efgartigimod and a safety profile comparable to placebo * Results from Phase 3 ADAPT trial presented at Myasthenia Gravis Foundation of America (MGFA) 2020 Virtual Scientific Session and American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) 2020 Virtual Annual Meeting were consistent with previously announced positive topline results * New data analyses presented on significant magnitude and repeatability of response, clinical benefit in antibody-negative patients and validation of proposed mechanism of action, with notable reductions in total IgG and pathogenic autoantibody levelsBroad efgartigimod development plan progressing with Phase 2 trial of fifth indication expected to start in mid-2021 * Within neuromuscular franchise, efgartigimod is being developed for gMG and CIDP * FDA discussions to occur by end of 2020 to inform bridging strategy for SC efgartigimod for the treatment of gMG * Path forward to be communicated after alignment with FDA * Phase 2 ADHERE trial of SC efgartigimod for the treatment of CIDP is ongoing * Decision to expand trial after analysis of first 30 patients now expected in first half of 2021 due to enrollment delays caused by COVID-19 * Within hematology franchise, efgartigimod is being developed for primary immune thrombocytopenia (ITP) * Communication with FDA planned to discuss development of SC efgartigimod * Updated plan for registration program to include two trials to run concurrently * ADVANCE trial ongoing in up to 156 patients treated with IV efgartigimod * ADVANCE-SC trial expected to start by end of 2020 in up to 156 patients treated with SC efgartigimod * argenx is advancing development of efgartigimod for pemphigus (vulgaris and foliaceus) * Global Phase 3 ADDRESS trial evaluating SC efgartigimod in up to 150 pemphigus patients to initiate by end of 2020 * Trial to evaluate efficacy and safety, including potential to drive fast onset of disease control and complete remission and the ability to taper corticosteroids * Preparations underway to initiate Phase 2 trial in fifth rare disease indication by mid-2021 * Indication details, including on biology rationale, Phase 2 trial design and commercial opportunity, to be shared during investor event in first half of 2021Development of cusatuzumab ongoing as potential treatment for acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (MDS) as part of global collaboration and licensing agreement with Cilag GmbH International, an affiliate of Janssen * Ongoing trials under collaboration include: * Phase 2 CULMINATE trial of cusatuzumab in combination with azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy * Phase 1b ELEVATE trial of cusatuzumab in combination with venetoclax +/- azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy * Phase 1 trial in Japan of cusatuzumab in combination with azacitidine evaluating newly diagnosed, elderly AML patients who are ineligible for intensive chemotherapy * Topline data from CULMINATE trial are anticipated to be reported in early 2021 Initiated Phase 1 healthy volunteer study of IV and SC ARGX-117 targeting complement C2 * Data from Phase 1 healthy volunteer study expected in mid-2021 * Following analysis of Phase 1 data, argenx plans to launch Phase 2 proof-of-concept trials in severe autoimmune diseases, including multifocal motor neuropathy (MMN) * Single-center Phase 1 trial remains open for enrollment to evaluate ARGX-117 as a potential treatment for acute respiratory distress syndrome (ARDS), a frequent and serious complication associated with COVID-19 Continued investment in Immunology Innovation Program to build pipeline of first-in-class antibodies against immunologic targets * New partnerships announced with Chugai and the Clayton Foundation to expand argenx’s access to innovative antibody engineering technologies and to enhance its capabilities to build future antibody candidates with sweeping and half-life extending characteristics * Collaboration with Halozyme for ENHANZE® drug delivery technology expanded to include three additional exclusive targets upon nomination bringing the total to six potential targets Q3 2020 FINANCIAL RESULTS Nine Months Ended September 30, (in thousands of € except for shares and EPS) 2020 2019 Variance Revenue €30,062 €52,264 €(22,202) Other operating income 12,524 8,914 3,610 Total operating income 42,586 61,178 (18,592) Research and development expenses (246,284) (122,800) (123,484) Selling, general and administrative expenses (100,380) (41,734) (58,646) Total operating expenses (346,664) (164,534) (182,130) Change in fair value on non-current financial assets 1,076 — 1,076 Operating loss €(303,002) €(103,356) €(199,646) Financial income/(expenses) (1,683) 10,789 (12,472) Exchange gain/(losses) (55,896) 26,943 (82,838) Loss before taxes €(360,581) €(65,624) €(294,956) Income taxes €(2,715) €(4,433) €1,718 Loss for the period and total comprehensive loss €(363,296) €(70,057) €(293,238) Weighted average number of shares outstanding 44,717,568 37,882,282 Basic and diluted profit/(loss) per share (in €) (8.12) (1.85) Net increase in cash, cash equivalents and current financial assets compared to year-end 2019 468,223 358,679 Cash, cash equivalents and current financial assets at the end of the period 1,804,043 923,248 DETAILS OF THE FINANCIAL RESULTS Cash, cash equivalents and current financial assets totaled €1,804.0 million on September 30, 2020, compared to €1,335.8 million on December 31, 2019. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering, including a U.S. offering and a European private placement, which resulted in the receipt of €730.7 million in net proceeds in June 2020, and net cash flows used in operating activities.Total operating income decreased by €18.6 million for the nine months ended September 30, 2020 to €42.6 million, compared to €61.2 million for the nine months ended September 30, 2019. The decrease was due to the milestone payments following the first-in-human clinical trial with ABBV-115 under the AbbVie collaboration which was achieved in the nine months ended September 30, 2019. This was partly offset by higher revenue recognition of the transaction price related to the Janssen collaboration and the increase in other income driven by higher payroll tax rebates for employing certain research and development personnel.Research and development expenses increased by €123.5 million for the nine months ended September 30, 2020 to €246.3 million, compared to €122.8 million for the nine months ended September 30, 2019. The increase in the first nine months of 2020 resulted primarily from higher external research and development expenses, primarily related to the efgartigimod program in various indications, the cusatuzumab program and other clinical and preclinical programs. Furthermore, the personnel expenses increased due to a planned increase in headcount.Selling, general and administrative expenses totaled €100.4 million for the nine months ended September 30, 2020, compared to €41.7 million for the nine months ended September 30, 2019. The increase resulted primarily from higher personnel expenses and consulting fees related to the preparation of a possible future commercialization of argenx’s lead product candidate efgartigimod.For the nine months ended September 30, 2020, financial expenses, which primarily relate to interest received and changes in fair value of current financial assets, amounted to €1.7 million, compared to a financial income of €10.8 million for the nine months ended September 30, 2019. Financial expenses corresponded mainly to a decrease in net asset value of current financial assets following the impact of the COVID-19 outbreak on the financial markets.Exchange losses totaled €55.9 million for the nine months ended September 30, 2020, compared to an exchange gain of €26.9 million for the nine months ended September 30, 2019. The change is mainly attributable to unrealized exchange rate losses on the cash, cash equivalents and current financial asset position in U.S. dollars.EXPECTED 2021 FINANCIAL CALENDAR: * March 4, 2021: FY 2020 financial results and business update * May 13, 2021: Q1 2021 financial results and business update * July 29, 2021: HY 2021 financial results and business update * October 28, 2021: Q3 2021 financial results and business updateCONFERENCE CALL DETAILS The third quarter 2020 results and business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website.Dial-in numbers: Please dial in 15 minutes prior to the live call. Belgium 0800 389 13 France 0805 102 319 Netherlands 0800 949 4506 United Kingdom 0800 279 9489 United States 1 866 270 1533 International 1 412 317 0797About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/.For further information, please contact: Beth DelGiacco, Vice President, Corporate Communications & Investor Relations +1 518 424 4980 firstname.lastname@example.orgJoke Comijn, Director Corporate Communications & Investor Relations (EU) +32 (0)477 77 29 44 +32 (0)9 310 34 19 email@example.comForward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its 2020 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
MELBOURNE, Australia and ISTANBUL, Turkey, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) and Eczacıbaşı-Monrol Nuclear Products Co. (‘Eczacıbaşı Monrol’) are pleased to announce that the first patients have been dosed in Telix’s Phase III ZIRCON clinical trial of Telix’s renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Turkey. The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth. Under a contract manufacturing agreement, Eczacıbaşı Monrol will supply 89Zr-labelled TLX250-CDx for the Turkish clinical sites.The ZIRCON trial includes four participating clinical study sites in Turkey, comprising Istanbul Training and Research Hospital, Istanbul University-Cerrahpasa, Ankara Hacettepe University and Ankara University.1Telix Chief Medical Officer, Dr Colin Hayward stated, “We are pleased to have commenced the Phase III ZIRCON clinical trial in Turkey and wish to acknowledge the team at Eczacıbaşı Monrol, as well as the principal investigators and study teams at each of the four institutions participating in the study, who have made this important milestone possible.”Aydın Küçük, General Manager of Eczacıbaşı Monrol added, “As one of our missions is to contribute to the human health, we are very honoured to be part of this significant achievement of the ZIRCON clinical trial initiation in Turkey with the first patients’ doses manufactured at our Istanbul facility, and we are thankful to the Telix team for this great collaboration.”About the ZIRCON Study ZIRCON (“Zirconium Imaging in Renal Cancer Oncology”) is an international multi-centre Phase III study at 33 sites in Europe, Australia, Turkey, Canada and the United States (subject to regulatory approval in the various jurisdictions). ZIRCON is a prospective imaging trial in approximately 250 renal cancer patients undergoing kidney surgery, to determine the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic “ground truth” determined from surgical resection specimens.About TLX250 / TLX250-CDx TLX250 (Girentuximab) is being developed by Telix Pharmaceuticals Limited both as a diagnostic PET imaging agent, 89Zr-Girentuximab (Phase III) and a therapeutic radiopharmaceutical, 177Lu-Girentuximab (Phase II). TLX250 is an antibody-based platform that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancer. High CAIX tumour expression is generally correlated with poor prognosis. Telix has prioritised the development of TLX250 for metastatic renal cell carcinoma (RCC), particularly the clear cell variant (ccRCC), which typically over-expresses CAIX.About Telix Pharmaceuticals Limited Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, renal and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.About Eczacıbaşı MonrolEczacıbaşı Monrol Nuclear Products Co. is a leading developer, manufacturer and distributor of radiopharmaceutical products in the Balkans, Middle East, North Africa, Central and Eastern Europe. Eczacıbaşı Monrol exports to more than 40 countries worldwide and also has manufacturing sites and operational projects in different regions. The company produces radiopharmaceuticals used for diagnosis and treatment in its seven world-class production facilities with a total of 12 cyclotrons and two SPECT production lines, one SPECT EU release site employing modern and environmentally friendly technologies. Eczacıbaşı Monrol’s facilities are GMP certified, and the Gebze-Turkey, Romania, Bulgaria facilities also have EU GMP certificates. The company also has been operating cyclotrons in Kuwait, Iraq, Libya, Pakistan and has long term operational agreements with two centres in Turkey and one centre in Dubai. Eczacıbaşı Monrol is headquartered in Kavacık (a district of Istanbul, Turkey) and services regional nuclear medicine needs through 300 employees and more than 20 distributors, delivering high quality and customer-oriented service to nuclear medicine centres. For more information visit www.monrol.comTelix Pharmaceuticals ContactEczacıbaşı Monrol Contact Dr. Colin HaywardMr. Aydın Küçük Chief Medical OfficerGeneral Manager Telix PharmaceuticalsEczacıbaşı-Monrol Nuclear Products Co. E: firstname.lastname@example.orgE: email@example.com W: www.telixpharma.comW : www.monrol.com.tr Mrs. Banu Evliyazade Kaptan Business Development and Projects Director Eczacıbaşı-Monrol Nuclear Products Co. E: firstname.lastname@example.org W : www.monrol.com.tr ______________________ 1 ClinicalTrials.gov Identifier: NCT03849118
Pratteln, Switzerland, October 22, 2020 – Santhera Pharmaceuticals (SIX: SANN) announces that it has issued 1,011,363 reserve shares. The number of shares recorded in the commercial register is now 16,270,000 shares.On October 21, 2020, 1,011,363 shares were issued out of the existing authorized capital as treasury shares. Santhera expects to use these shares for its financing arrangements and/or for general financing purposes. The new shares will be listed as per October 22, 2020.About Santhera Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. Santhera has an exclusive license for all indications worldwide to vamorolone, a first-in-class dissociative steroid with novel mode of action, currently investigated in a pivotal study in patients with DMD as an alternative to standard corticosteroids. The clinical stage pipeline also includes lonodelestat (POL6014) to treat cystic fibrosis (CF) and other neutrophilic pulmonary diseases as well as an exploratory gene therapy approach targeting congenital muscular dystrophies. Santhera out-licensed ex-North American rights to its first approved product, Raxone® (idebenone), for the treatment of Leber's hereditary optic neuropathy (LHON) to Chiesi Group. For further information, please visit www.santhera.com.Raxone® is a trademark of Santhera Pharmaceuticals.For further information please contact: email@example.com or Eva Kalias, Head External Communications Phone: +41 79 875 27 80 firstname.lastname@example.org Disclaimer / Forward-looking statements This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements. Attachment * 2020 10 22_CapIncrease_e_final
Roche Obtains Exclusive Right to Develop and Distribute AT-527 Outside the United StatesBOSTON, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announces that the company has entered into an agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) for the exclusive rights to research, develop and distribute AT-527 as an oral antiviral treatment for COVID-19 in territories outside of the United States. Under the terms of the agreement, Atea will receive an upfront payment of $350 million in cash from Roche with the potential for future milestone payments and royalties. “Roche shares our passion for delivering innovative new medicines to address great unmet medical needs. The COVID-19 pandemic has highlighted the urgent need for a novel, oral antiviral to treat this highly infectious and often deadly virus,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. “This collaboration with Roche enhances Atea’s efforts and underscores the potential for AT-527 to effectively address the COVID-19 crisis on a global scale. AT-527 is expected to be ideally suited to combat COVID-19 as it inhibits viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses. Importantly, the manufacturing process for our small molecule direct-acting antiviral allows us to produce AT-527 quickly and at scale.”"The ongoing complexities of COVID-19 require multiple lines of defence. By joining forces with Atea, we hope to offer an additional treatment option for hospitalised and non-hospitalised COVID-19 patients, and provide important relief for hospital infrastructures during a global pandemic," said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. "In jointly developing and manufacturing AT-527 at scale, we seek to make this treatment option available to as many people around the world as we possibly can."About AT-527AT-527 is an orally administered, direct-acting antiviral agent derived from Atea’s purine nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. AT-527 is designed to inhibit viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses, such as positive single-stranded human flaviviruses and human coronaviruses. AT-527 is currently in a global Phase 2 clinical study for hospitalized patients with moderate COVID-19 and has plans to initiate a global, registrational Phase 3 clinical trial in outpatients in the first half of 2021. Additionally, Atea is planning to study in a Phase 3 clinical trial the use of AT-527 in the post-exposure prophylaxis setting.AdvisorsEvercore served as exclusive financial advisor to Atea in connection with this transaction.About Atea PharmaceuticalsAtea Pharmaceuticals is a clinical stage biopharmaceutical company engaged in discovering and developing therapies to address the unmet medical needs of patients with severe viral diseases. Our lead programs are focused on the development of orally- administered direct acting antivirals for the treatment of patients with COVID-19 in the hospital and community settings, the treatment of patients with chronic hepatitis C infection, the treatment of patients with dengue, and the treatment of high-risk patients with severe respiratory syncytial virus infection. Our medicinal chemistry, virology, and pharmacology expertise, bolstered by our collective experience in drug development, enables us to pioneer new advancements in antiviral science. Leveraging the power of our purine nucleotide prodrug platform, our goal is to rapidly advance novel drug candidates with optimal therapeutic profiles for RNA virus targets. Founded by its Chairman and Chief Executive Officer, Jean-Pierre Sommadossi, PhD, Atea began operations in 2014 and is headquartered in Boston, MA. For more information about Atea and our pipeline of product candidates please visit our company website at www.ateapharma.com.ContactsInvestors: Will O’Connor Stern Investor Relations 212-362-1200 email@example.comMedia: Carol Guaccero 301-606-4722 firstname.lastname@example.org
Press release Atos to acquire leading Cyber Security consulting company SEC ConsultParis, France, Vienna, Austria - October 22, 2020 - Atos, a global leader in digital transformation, today announces it has reached an agreement to acquire SEC Consult Group, a leading international Cybersecurity consulting provider. This acquisition will confirm Atos’ leading position in cybersecurity services in the DACH (Germany, Austria, Switzerland) region with more than 600 experts and will also strengthen its number 1 position in Europe. For SEC Consult this opens the opportunity to expand into additional markets and to gain a new customer base on a global scale.SEC Consult is a leader in providing cybersecurity consulting, penetration testing, red teaming and technical assessment services in DACH, APAC regions (Singapore, Thailand, Malaysia) and North America, serving large customers with a special focus on companies in the Finance, Utilities, Technology and Public Sectors with its team of over 200 highly skilled specialists.Atos will benefit from SEC Consult’s Cybersecurity expertise, especially its pen testing, red teaming and incident response capabilities, offering significant synergy with Atos’ activities and customers – while SEC Consult will benefit from Atos’ extensive expertise and leading rankings in Managed Security Services.“With this strategic move, Atos confirms its position as a leader in the European Cybersecurity market and initiates its Cybersecurity consulting presence in APAC to complement its existing Managed Security Services Provider and Cybersecurity products offering. SEC Consult’s experience, highly skilled people and reputation in the market will strengthen the Atos team in Central Europe and serve as a spring-board for building our business in APAC as a region with very high growth” said Pierre Barnabé, Senior Executive Vice-President, Head of Big Data & Cybersecurity at Atos. “In the context of our latest acquisitions, the acquisition of SEC Consult demonstrates our ambition to become the key Cybersecurity provider for global organizations on their digital journey.” “After running SEC Security Consulting Business completely independently for nearly 20 years, SEC Consult has reached a level of globalization and professionalism where we acknowledge the huge benefits to join forces with Atos to strengthen our mission of helping our customers to become more secure and able to deal with the immensely growing threats arising from cyber.” said Wolfgang Baumgartner, CEO of SEC Consult. “We are convinced to make the right decision and are sure that both our teammates as well as our customers will benefit from this decision with a clear vision and strategy for the future. Together with Atos, SEC Consult can speed up its mission - to protect the information security assets of our clients. Additionally, it is a great development opportunity for our Cybersecurity experts to work on even more exciting projects.”The closing of the transaction is expected to take place before the end of the year and is subject to anti-trust filings.About Atos Atos is a global leader in digital transformation with 110,000 employees in 73 countries and annual revenue of € 12 billion. European number one in Cloud, Cybersecurity and High-Performance Computing, the Group provides end-to-end Orchestrated Hybrid Cloud, Big Data, Business Applications and Digital Workplace solutions. The Group is the Worldwide Information Technology Partner for the Olympic & Paralympic Games and operates under the brands Atos, Atos|Syntel, and Unify. Atos is a SE (Societas Europaea), listed on the CAC40 Paris stock index.The purpose of Atos is to help design the future of the information space. Its expertise and services support the development of knowledge, education and research in a multicultural approach and contribute to the development of scientific and technological excellence. Across the world, the Group enables its customers and employees, and members of societies at large to live, work and develop sustainably, in a safe and secure information space.Contacts:Investor Relations: Gilles Arditti – +33 (0)1 73 26 00 66 – email@example.comPress Relations: Laura Fau | firstname.lastname@example.org | +33 6 73 64 04 18 | @laurajanefauAbout SEC ConsultSEC Consult is one of the leading consultancies in the field of cyber and application security with more than 200 employees. It’s our mission to protect our customers from cyber security threats and help the IT-Industry to develop secure products. SEC Consult is the first address for high quality security testing, incident handling and response as well as for implementation of information security management to organizations.Contacts:Press Relations: corporate identity prihoda gmbh+43 664 3380948 – email@example.com+43 664 1183296 – firstname.lastname@example.org Attachment * PR - Atos to acquire leading Cyber Security consulting company SEC Consult
* Roche and Atea partner to jointly develop AT-527, an orally administered direct-acting antiviral (DAA) currently in Phase 2 clinical trials * AT-527 has the potential to be the first novel oral antiviral to treat COVID-19 patients outside the hospital setting as well as in the hospital and may also be used in post-exposure prophylactic settings * Oral, small-molecule DAAs for COVID-19 patients allow for large-scale manufacturing and facilitate broad patient access * If approved, Atea will distribute AT-527 in the United States and Roche will be responsible for global manufacturing and distribution outside the United States Basel, 22 October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Atea Pharmaceuticals, Inc. announced today that they are joining forces in the fight against COVID-19 to develop, manufacture and distribute AT-527, Atea’s investigational oral direct-acting antiviral, to people around the globe. AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication, and is currently being studied in a Phase 2 clinical trial for hospitalised patients with moderate COVID-19. A Phase 3 clinical trial, expected to start in Q1 2021, will explore the potential use in patients outside of the hospital setting. In addition, AT-527 may be developed for post-exposure prophylactic settings. AT-527, while being a potential oral treatment option for hospitalised patients, also holds the potential to be the first oral treatment option for COVID-19 patients that are not hospitalised. Additionally, the manufacturing process of small-molecule DAAs allows the ability to produce large quantities of a much needed treatment. If successful, AT-527 could help treat patients early, reduce the progression of the infection, and contribute to decreasing the overall burden on health systems. The collaboration aims to accelerate the clinical development and manufacturing of AT-527, to investigate its safety and efficacy, and to provide this potential treatment option to patients around the world as quickly as possible. If AT-527 proves safe and effective in clinical trials and regulatory approvals are granted, Atea will be responsible for distributing this treatment option in the U.S, with the option to request Genentech’s support, and Roche will be responsible for distribution outside the United States. "The ongoing complexities of COVID-19 require multiple lines of defence. By joining forces with Atea, we hope to offer an additional treatment option for hospitalised and non-hospitalised COVID-19 patients, and to ease the burden on hospitals during a global pandemic." said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. "In jointly developing and manufacturing AT-527 at scale, we seek to make this treatment option available to as many people around the world as we possibly can." “Roche shares our passion for delivering innovative new medicines to address great unmet medical needs. The COVID-19 pandemic has highlighted the urgent need for a novel, oral antiviral to treat this highly infectious and often deadly virus,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. “AT-527 is expected to be ideally suited to combat COVID-19 as it inhibits viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses. Importantly, the manufacturing process for our small molecule direct-acting antiviral allows us to produce AT-527 quickly and at scale.” About AT-527 AT-527 is an investigational, oral, purine nucleotide prodrug, which has demonstrated in vitro and in vivo antiviral activity against several enveloped single-stranded RNA viruses, including human flaviviruses and coronaviruses. This highly selective purine nucleotide prodrug was designed to uniquely inhibit viral RNA dependent RNA polymerase, an enzyme that is essential for the replication of RNA viruses. Antiviral activity and safety of AT-527 has been demonstrated in Phase 2 clinical studies of hepatitis C patients, and in preclinical in-vitro assays with SARS-CoV2 virus. AT-527 is not yet licensed or approved for any indication in the United States or any other country. About Roche’s response to the COVID-19 pandemic As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19. We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease. We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future. Our diagnostics solutions: Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes: * a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark) * a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark) * an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19 (FDA EUA and CE Mark) * Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic * a SARS-CoV-2 rapid antibody test to help determine at the point of care whether a person has been exposed to the virus (CE Mark) * a rapid antigen test to support in the detection of SARS-CoV-2 at the point of care within 15 minutes (CE Mark) * a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark) * a second SARS-CoV-2 antibody test, aimed at measuring the spike protein to support vaccination development and complement our existing portfolio * a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark) Our research into therapies: Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules. In August, we announced a partnership with Regeneron to develop, manufacture, and increase global supply of their investigational antibody combination for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted. At the beginning of the pandemic, on 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. On 29 July we announced that COVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced mortality. Separately, we have studied Actemra©/RoActemra© in the EMPACTA study in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. On 18 September we announced that the phase III EMPACTA study showed Actemra/RoActemra plus standard of care reduced the likelihood of progression to mechanical ventilation or death in hospitalised patients with COVID-19 associated pneumonia compared to placebo plus standard of care. However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo. Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations. In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. 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. Moreover, for the eleventh 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 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. 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. Roche Group Media Relations Phone: +41 61 688 8888 / e-mail: email@example.com Dr. Nicolas Dunant Phone: +41 61 687 05 17 Patrick Barth Phone: +41 61 688 44 86 Dr. Daniel Grotzky Phone: +41 61 688 31 10 Karsten Kleine Phone: +41 61 682 28 31 Nina Mählitz Phone: +41 79 327 54 74 Nathalie Meetz Phone: +41 61 687 43 05 Dr. Barbara von Schnurbein Phone: +41 61 687 89 67 Roche Investor Relations Dr. Karl Mahler Phone: +41 61 68-78503 e-mail: firstname.lastname@example.org Jon Kaspar Bayard Phone: +41 61 68-83894 e-mail: email@example.com Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: firstname.lastname@example.org Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: email@example.com Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: firstname.lastname@example.orgDr. Gerard Tobin Phone: +41 61 68-72942 e-mail: email@example.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: firstname.lastname@example.orgDr. Lisa Tuomi Phone: +1 650 467 8737 e-mail: email@example.com Attachment * 22102020_MR_collaboration with Atea Pharmaceuticals_en
Press release Stockholm, 22 October 2020The operating profit for the third quarter 2020 amounted to SEK 5.9bn with a return on equity of 11.7 per cent and a Common Equity Tier 1 capital ratio of 19.4 per cent. The Board of Directors confirms its previous decision to not propose a dividend during 2020. "Despite the challenging economic environment, SEB delivered a robust financial performance. Higher net interest income, lower expenses and lower credit losses were offset by valuation effects that came down from the elevated level in the second quarter. We continue to see limited effects from the pandemic on the asset quality and the guidance on net expected credit losses of around SEK 6bn for 2020 remains. We have a strong capital and liquidity position and the capital buffer above the common equity tier 1 regulatory requirement amounted to 580 basis points. Despite some light at the end of the tunnel, uncertainty still remains. It continues to be our highest priority to support our customers,”, says Johan Torgeby, President and CEO. Q3 Q2 Q3 Jan–Sep Full year SEK m 2020 2020 % 2019 % 2020 2019 % 2019 Total operating income 12 563 13 999 -10 11 942 5 36 651 36 045 2 50 134 Total operating expenses -5 547 -5 712 -3 -5 589 -1 -16 905 -16 918 0 -22 945 Net expected credit losses -1 098 -2 691 -59 \- 489 124 -5 282 -1 297 -2 294 Operating profit before items affecting comparability 5 916 5 598 6 5 864 1 14 463 17 831 -19 24 894 Items affecting comparability1) -1 000 -100 -1 000 Operating profit 5 916 4 598 29 5 864 1 13 463 17 831 -24 24 894 NET PROFIT 4 766 3 501 36 4 772 0 10 623 14 346 -26 20 177 Return on equity, % 11.7 8.7 13.2 8.8 13.1 13.7 Return on equity excluding items affecting comparability, % 11.6 11.2 13.2 9.7 13.2 13.8 Basic earnings per share, SEK 2.21 1.62 2.21 4.91 6.64 9.33 1) Administrative fine issued by the Swedish FSA. See note 6. You can download the Quarterly Report, Results Presentation and Fact Book from https://sebgroup.com/investor-relations/reports-and-presentations/financial-reports.For further information, please contact Masih Yazdi, CFO, +46 771 621 000 Pawel Wyszynski, Head of Investor Relations, +46 70 462 21 11 Frank Hojem, Head of Corporate Communication, +46 70 763 99 47This is information that Skandinaviska Enskilda Banken AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at around 7.00 am CET, on 22 October 2020. SEB is a leading Nordic financial services group with a strong belief that entrepreneurial minds and innovative companies are key in creating a better world. SEB takes a long-term perspective and supports its customers in good times and bad. In Sweden and the Baltic countries, SEB offers financial advice and a wide range of financial services. In Denmark, Finland, Norway, Germany and the United Kingdom, the bank's operations have a strong focus on corporate and investment banking based on a full-service offering to corporate and institutional clients. The international nature of SEB's business is reflected in its presence in some 20 countries worldwide. At 30 September 2020, the Group's total assets amounted to SEK 3,201bn while its assets under management totalled SEK 2,054bn. The Group has around 15,000 employees. Read more about SEB at sebgroup.com Attachment * Quarterly report Q3 2020
In relation to the milder than estimated effects of the coronavirus crisis, LHV Group’s financial results exceed what was forecast previously, which is why AS LHV Group is publishing an updated financial plan for the current year. Compared to the plan that has been in force since April, both forecast revenues and business volumes have increased; at the same time, impairment losses have decreased – therefore, the profit forecast and efficiency indicators have been raised. Pursuant to the updated financial plan, this year, the consolidated revenues of LHV Group will increase by 29%, expenses by 11%, and the impairment losses on loans by 3.7 times. In comparison to the previous year, consolidated net profit will grow by EUR 5.5 million, i.e., 20%. The quality of the loan portfolio is significantly better, compared to the spring-plan. The financial plan that was in effect so far foresaw significantly higher discounts and thereby, a decrease in revenue in the year-on-year comparison.Key indicators Updated FP 2020 2019 results Change YoY Previous FP 2020 Change compared to previous plan Financial results, EURt Total revenue 95,395 73,818 21,577 87,316 8,079 Total expenses 43,749 39,266 4,483 44,773 -1,024 Impairment losses on loans 11,950 3,209 8,740 19,357 -7,408 Earnings before taxes 39,697 31,342 8,354 23,185 16,512 Net profit 32,611 27,092 5,519 19,231 13,380 Business volumes, EURm Loans 2,227 1,687 540 1,806 421 Deposits 3,301 2,701 600 2,985 316 Assets under management 1,531 1,374 157 1,454 78 Key ratios Cost / Income ratio 45.9% 53.2% -7.3% 51.3% -5.4% ROE (pre tax) 16.6% 16.2% 0.4% 10.2% 6.4% Capital adequacy 17.3% 18.0% -0.6% 17.6% -0.2% The updated financial plan also considers the effect of the purchase of the Danske Bank corporate and municipal loan portfolio, and therefore, regarding LHV business volumes, estimates the loan portfolio to grow by 32% this year, and deposits to grow by 22%. Pursuant to the updated plan, the volume of managed funds will increase by 11% this year.Compared to the financial plan disclosed at the peak of coronavirus crisis, the Group will earn 70% more in net profit this year, reaching EUR 32.6 million. Of this, EUR 21.8 million has been earned in the first 9 months. At the same time, the financial plan has not estimated the potential of a success fee by asset management.In the updated plan, the company’s cost/income ratio and the return on equity have improved as the growth of business volumes increase revenues; at the same time, expenses have slightly gone down compared to the previous plan. LHV’s capitalisation and liquidity are still at a strong level.Comment by Madis Toomsalu, CEO of LHV Group: "LHV can only be as successful as our clients. In terms of economic sectors, the situation is different, but the economy as a whole has fared better than what was initially forecast. We have continued with decisions that support our clients and with our local and open credit policy. Through this, our loan portfolio has continued to grow during the crisis as well, and loan discounts have remained significantly lower than what was forecast. The updated forecast takes into account the interest revenues added by the purchase of the Danske portfolio from the beginning of October. The forecast has estimated the capitalisation of LHV Pank and LHV Kindlustus during the current year. In the case of LHV Varahaldus, operating revenues have been taken into account; a potential success fee would be added outside of the forecast, since estimating the inputs that are the basis for the success fee has a high error rate. Besides business in Estonia, we are increasingly focusing on growing the business related to clients in the United Kingdom; from the estimated profit of the Group in 2020 in the amount of EUR 32.6 million, this constitutes EUR 4.8 million in total."LHV Group is the largest domestic financial group and capital provider in Estonia. LHV Group's key subsidiaries are LHV Pank and LHV Varahaldus. LHV employs over 490 people. LHV’s banking services are used by more than 235,000 clients, and pension funds managed by LHV have more than 183,000 active clients. LHV’s UK branch offers banking infrastructure to 130 international financial services companies, via which LHV’s payment services reach clients around the world. Priit Rum LHV Communication Manager Phone: +372 502 0786 Email: firstname.lastname@example.org Attachment * LHV Group updated Financial Plan 2020-Q4 EN
A group of niche Chinese gas firms is set to make waves in the global market with plans to invest tens of billions of dollars and double imports in the next decade as Beijing opens up its vast energy pipeline network to more competition. The companies, mostly city gas distributors backed by local authorities, are ramping up purchases of liquefied natural gas (LNG) as newly formed national pipeline operator PipeChina begins leasing third parties access to its distribution lines, terminals and storage facilities from this month. The acceleration in demand in what is already the world's fastest-growing market for the super-chilled fuel is a boon for producers such Royal Dutch Shell <RDSa.L>, Total <TOTF.SA> and traders like Glencore <GLEN.L> faced with oversupply and depressed prices.
Indian businesses are stocking up more ahead of this year's big festival season than at any time in the last five years, expecting people whose earnings were relatively unaffected by the pandemic to spend the money they saved during months of lockdowns. India's biggest shopping season is at the time of the festivals of Durga Puja and Diwali, which fall 20 days apart in October-November each year. Businesses and shopkeepers expect more purchases than usual this year, beginning with Durga Puja on Thursday, because the months of lockdowns have resulted in pent-up demand.