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Hong Kong residents are buying more houses and apartments to lease out for income in Britain, property agents say, a trend that coincides with what many expect to be a wave of emigration after China passed a national security law last year. Hong Kongers became the fifth largest foreign investors in central London as of last August and have been driving up prices in some popular districts outside the UK capital. But the new wave of buying also includes some Hong Kong residents who are pooling money to invest, a trend property agents expect to continue as more middle-class Hong Kong residents consider leaving for Britain and look to establish a source of revenue in advance.
A secretive Israeli nuclear facility at the center of the nation's undeclared atomic weapons program is undergoing what appears to be its biggest construction project in decades, satellite photos analyzed by The Associated Press show. A dig about the size of a soccer field and likely several stories deep now sits just meters (yards) from the aging reactor at the Shimon Peres Negev Nuclear Research Center near the city of Dimona. The facility is already home to decades-old underground laboratories that reprocess the reactor's spent rods to obtain weapons-grade plutonium for Israel's nuclear bomb program.
An illegal gold mine in Indonesia's Sulawesi island collapsed on nearly two dozen people working inside, killing three and leaving another five missing, officials said Thursday. Survivors estimated about 23 people were trapped in the rubble when the mine in Central Sulawesi province's Parigi Moutong district collapsed late Wednesday due to unstable soil, said Andrias Hendrik Johannes, who heads the local search and rescue agency. Police, emergency personnel, soldiers and volunteers were all taking part in the efforts to find those still missing, though efforts were being hampered by the remote location of the mine and the unstable soil that risked further slides, he said.
NVDA earnings call for the period ending January 31, 2021.
AGR earnings call for the period ending December 31, 2020.
UK economy at the crossroads before lockdown endsOur analysis of Covid effects on businesses examines work, growth and stock markets The number of trips taken on UK roads and public transport increased slightly in the past month. Photograph: Dan Kitwood/Getty Images
Heavy snow blankets parts of Greece as cold front hits countryTemperature drops to as low as -19C, with strong winds disrupting shipping in the Aegean Sea The ancient Acropolis hill in Athens covered with snow. Photograph: Antonis Nikolopoulos/AP
Set children free: are playgrounds a form of incarceration?Play has been the invisible casualty of the pandemic. Is it time to let children reclaim the streets? Our writer looks forward to a post-Covid world of parklets, play streets and repurposed parking spaces Street art … children and parents outside Chisenhale school in east London. Photograph: Chris Burman
The Great British Art Tour: Britten, Pears and a missing armWith public art collections closed we are bringing the art to you, exploring highlights from across the country in partnership with Art UK. Today’s pick: Aldeburgh’s Double Concerto Discretion … Double Concerto (detail), 1969, by Maxwell Ashby Armfield, The Red House, Aldeburgh. Photograph: Britten Pears Arts/The artist's estate: Bridgeman Images
Black-browed babbler found in Borneo 180 years after last sightingExclusive: Stuffed specimen was only proof of bird’s existence until discovery in rainforest last year The black-browed babbler found in Indonesia’s South Kalimantan province last October. Photograph: BirdLife
Sunak’s budget must focus on business investment, not just government spendingWithout fit and competitive firms, there will be no lasting recovery from the Covid crisisCoronavirus – latest updatesSee all our coronavirus coverage Rishi Sunak (right) with the chair of John Lewis, Sharon White, during a visit to the flagship store in Oxford Street, London. Photograph: Simon Walker/AFP/Getty Images
UK businesses plead for further support in run-up to budgetBritain suffering worst economic damage since Covid crisis began, analysis showsCoronavirus – latest updatesSee all our coronavirus coverage Rishi Sunak has warned that the biggest increase in the budget deficit in peacetime will require ‘hard choices’ on tax and spending to be taken. Photograph: Chris J Ratcliffe/Getty Images
Claudette Colvin: the woman who refused to give up her bus seat – nine months before Rosa ParksIt was a spring afternoon in 1955 when a teenager’s spontaneous act of defiance changed US history. Why did it take 40 years for her to get any credit? Claudette Colvin: ‘It felt as if Harriet Tubman’s hand was pushing me down on the one shoulder.’ Photograph: Tamika Moore/The Guardian
One of UK's largest care home firms introduces 'no jab, no job' policyCare UK says new staff must have received Covid vaccination before they start work Coronavirus – latest updatesSee all our coronavirus coverage A nurse administers Covid-19 vaccine to care home worker Pillay Jagambrun at Croydon University Hospital. Care UK which runs 120 homes says all new staff must be vaccinated. Photograph: Getty Images
California vaccine sites see misuse of codes meant to prioritize Black and Latino residentsIntended as a tool to address distribution inequities, the codes were passed around by text and email, sometimes with misinformation Irene Villa receives a Covid vaccine from Jamie Rant at the Moscone Center in San Francisco. Photograph: Anda Chu/AP
Kinepolis limits cash burn in 2020 and maintains a solid financial basis throughout the Covid-19 crisis Regulatory release 25 February 2021, 7 a.m. After a promising start of the year 2020 for Kinepolis, with a 12.0% increase in visitor numbers up to 12 March, the cinema industry was badly hit by the Covid-19 pandemic, with long periods of cinema closures and restrictive measures as well as repeated postponements of blockbuster movie releases. As such, Kinepolis welcomed 12.1 million visitors in 2020, compared to initial expectations of more than 45 million visitors. Thanks to strong cost control and various measures that were taken, the EBITDA loss, adjusted for leases (EBITDAL), has been limited to € -14.0 million. Kinepolis entered the crisis with a conservative debt ratio and a significant liquidity reserve, reinforced by the additional loan of € 80.0 million concluded at the beginning of 2021. Strong cost management, supported by the Group's significant real estate position, ensures that Kinepolis can confidently navigate through the crisis and can continue to cope with the negative effects of the Covid-19 pandemic for a considerable period of time. The Group had € 171.0 million of financial headroom at the start of 2021. In recent months, management has focused on further consolidating its business strategy, resulting in a plan - called ‘Entrepreneurship 2022’ - which, based on further optimisation measures and innovation, should provide maximum support for the restart and performance of the Group from 2022 on. The construction of various new-build projects was also continued in the past year, and these new cinemas will also help support the restart. Important achievements in 2020 Mainly thanks to strong cost management, the cash burn as a result of the Covid crisis was limited to € 32.1 million in 2020 (excluding working capital impact).An additional bullet loan of € 80.0 million, with a term of 3 years, combined with an extension of the covenant holiday until 30 June 2022.Development of the ‘Entrepreneurship 2022’ plans, in further execution of the Kinepolis business strategy.Continuation and completion of various new construction projects: Kinepolis Haarlem (NL), Leidschendam (NL), Metz Waves (FR) and Edmonton Tamarack (CA)Various new initiatives in the context of Covid-19, including ‘Kinepolis on Tour’, a home delivery service and a ‘private cinema’ concept. Key figures for 2020 as compared to 2019 Kinepolis welcomed 12.1 million visitors in 2020 due to the repeated closures of the cinemas from mid-March, the safety measures that were imposed and the postponement of blockbusters.The total revenue per visitor also increased during 2020.Thanks to the cost measures taken, the EBITDAL, i.e. EBITDA adjusted for leases, was only € -14.0 million.The net result amounted to € -69.1 million, mainly due to the high depreciations related to the significant real estate position of the Group.Free cash flow amounted to € -56.5 million for the full year. Without taking the working capital loss into account, the free cash flow was limited to just € -3.6 million per month in the second half of the year.The net financial debt, excluding lease liabilities, compared to 31 December 2019, increased from € 417.0 million to € 513.3 million, mainly due to the negative free cash flow combined with investments in the construction of new complexes.In view of the result and the current circumstances, a proposal will be made to the General Meeting not to distribute a dividend for the 2020 financial year. Eddy Duquenne, CEO of Kinepolis Group, about the results for 2020: “Financially, Kinepolis is still in a very strong position. Our net financial debt has only increased by € 96.3 million. This includes nearly € 40 million in investments in expansion. This debt also includes a working capital loss of € 24.3 million due to the discontinuation of our activities, which we will recover when we restart our cinemas. This means that our actual cash burn in 2020 was only € 32.1 million, something we can be proud of in the circumstances. With a liquidity reserve of € 171.0 million at the start of this year, Kinepolis can stand firm for quite some time and we can say with certainty that our company will survive this crisis. Everyone is waiting for the reopening of the cinemas. Both the US studios, who continue to postpone their blockbusters because of the importance of cinemas in the life cycle of a film, and our customers, who need to be able to relax away from home. And our employees, who have been unemployed for a long time, are also eager to get back into action. We are convinced that we can reopen safely and thereby contribute to everyone's well-being. In the meantime, we are continuing to prepare for the future with our ‘Entrepreneurship 2022’ plans." Full report annual results 2020 attached. Attachment EN_Kinepolis FY results 2020
After a recent investigation threw email tracking into the spotlight, Qais Hussain talks about his decision to use the tools - even when met with anger or disappointment from colleagues and teachers
PRESS RELEASE: REGULATED INFORMATION25 February 2021, 07:00 CET BIOCARTIS ANNOUNCES 2020 RESULTS AND 2021 OUTLOOK Mechelen, Belgium, 25 February 2021 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces its operational highlights and financial results for 2020, prepared in accordance with IFRS as adopted by the European Union as well as selected post period events and its outlook for 2021. Commenting on the 2020 results and 2021 guidance, Herman Verrelst, Chief Executive Officer of Biocartis, said: “2020 was an extraordinary year, to say the least. The pandemic deprioritized and disrupted cancer care globally. Patient access to hospitals was significantly restricted throughout almost the entire year and customer prospection was severely hampered. Nevertheless, we showed resilience and delivered on our pre-pandemic outlook. Oncology volumes continued to grow, mostly in the US, but also in Europe, and the versatility of Idylla™ allowed the rapid rollout of a pandemic response test menu that alleviated the pressure on oncology testing volumes. Furthermore, we continued to expand our global Idylla™ ecosystem, attracted new partners and made significant operational progress on our path towards continued growth. We look ahead with confidence and start 2021 with a better than expected cash position that we plan to put at work to accelerate test menu expansion and diversification in a year that will again be marked by continued impact of the pandemic. We are determined to serve and build on the undebated need for rapid response testing in an overburdened healthcare system, convinced that we are very well equipped to deliver on our customers’ needs in oncology as well as in infectious diseases.” KEY MESSAGES 2020 RESULTS Total operating income: Total operating income increased year-over-year by 47% to EUR 55.6m;Product sales revenues amounted to EUR 31.9m (year-over-year increase of 32%). Commercial cartridge volume: Growth of the commercial cartridge volume by 31% to 230k cartridges;Moderate year-over-year growth in oncology complemented by strong demand for the Idylla™ SARS-CoV-2 Test1. Installed base: Biocartis placed 335 new Idylla™ instruments in 2020;Biocartis’ installed base as per 31 December 2020 increased to 1,581 Idylla™ instruments2. Expansion partnerships: Strengthening of the oncology business through the expansion of the partnerships with AstraZeneca (LON: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) and new partnerships with GeneproDx3 in the thyroid cancer domain;Partner funded expansion of the Idylla™ infectious diseases test menu, together with Immunexpress, LifeArc and Endpoint Health4. Idylla™ test menu: Oncology test menu progress with the EUR 1.2m grant from VLAIO5 for the development of the highly innovative Idylla™ GeneFusion Assay (RUO6);Infectious diseases strategy sparked by the launch of the first pandemic Idylla™ test menu, consisting of the market release of the SeptiCyte® RAPID test on Idylla™ (CE-IVD)7, followed by the CE-IVD launch of the Idylla™ SARS-CoV-2 Test1;US FDA 510(k) submission, led by Immunexpress, of the SeptiCyte® RAPID test on Idylla™ completed in December 2020. China commercialization: Compliance testing of the Idylla™ Instrument and Console with the China NMPA8 successfully completed in January 2021. Cash position: EUR 16m reduction of cash used in operating and investing activities to EUR 43.3m in 2020 compared to EUR 59.7m in 2019;Cash and cash equivalents amounted to EUR 124m as at 31 December 2020. COVID-19 IMPACT AND 2021 OUTLOOKThe year 2021 will again be marked by continued impact of the pandemic. The visibility on normalization of timing of global cancer care is limited. It is equally difficult to reliably predict how the further need for SARS-CoV-2 testing will develop as vaccination progresses throughout the year at varying paces across different countries. Having a broad Idylla™ menu of tests in oncology and an attractive Idylla™ pandemic response menu, Biocartis nevertheless believes it can accelerate its growth and achieve the following objectives: Commercial cartridge volume: Targeting a year-over-year growth of 40%-60% or commercial cartridge volumes in the range of 320k-370k. The high-end of the range will only be delivered in case of consistent strong demand for the Idylla™ SARS-CoV-2 Test at attractive average selling prices throughout 2021;Installed base: Targeting 300-350 new Idylla™ instrument placements;Cash position: Targeting at least EUR 50m cash position at year-end, including potential investments in upgrading and expanding the infectious diseases menu. Biocartis will host a conference call with live webcast presentation today at 14:30 CET / 13:30 BST (UK) / 08:30 EDT (US) to discuss the 2020 results. Click here to access the live webcast. To participate in the questions and answers session, please dial 5-10 minutes prior to the start time the number +44 8444819752 (standard international), followed by the confirmation code 5349189. The conference call and webcast will be conducted in English. A replay of the webcast will be available on the Biocartis investors’ website shortly after. COMMERCIAL HIGHLIGHTS Global – Despite the global pandemic, the number of commercial cartridges sold in 2020 grew by 31% to 230k, from 175k in 2019. After a strong first quarter of 2020, commercial cartridge volumes in oncology were significantly impacted by the disruption and de-prioritization of global cancer care. Restricted access to hospitals also hampered new customer prospection and slowed down new Idylla™ instrument placements in the first half of the year. Testing volumes in oncology started to recover towards the end of Q2, but the global surge of COVID-19 cases in Q4 ultimately tempered the year-over-year growth in oncology. To bridge the shortfall in oncology and to respond to its customers’ need for COVID-19 testing, Biocartis developed the Idylla™ SARS-CoV-2 Test1. Strong demand for this test in Q4, especially in the US, enabled the Company to meet its pre-pandemic guidance with 31% growth in commercial cartridge volumes and the placement of 335 new Idylla™ instruments. As per year-end, the total Idylla™ installed base amounted to 1,581 Idylla™ instruments2. Europe – Sales in Europe proved to be very resilient throughout 2020. After the slow-down in Q2 2020, both cartridge volumes and instrument sales were rapidly tracking pre-pandemic expectations. When growth slowed down again in Q4 as a direct result of renewed lock-down measures across large parts of Europe, lagging sales in oncology were supplemented by demand for the Idylla™ SARS-CoV-2 Test, CE-IVD marked since 10 November 2020. Together with SeptiCyte® RAPID7 on Idylla™, released as CE-IVD in European markets on 6 October 2020, the Idylla™ SARS-CoV-2 Test is ideally positioned to alleviate the pressure on intensive care units (ICUs) and is expected to drive further growth in 2021.US – After strong growth in Q1 2020, demonstrating the continued success of the direct US sales strategy, sales in the US slowed down due to the global pandemic. Cartridge volumes in oncology nevertheless grew by 20% year-over-year. Thanks to additional strong demand for the Idylla™ SARS-CoV-2 Test, US commercial cartridge volumes tripled compared to 2019. New Idylla™ instrument placements in the US also increased year-over-year and accounted for one third of total placements.Distributor markets9 – In 2020, several countries that are served through distributors were hit specifically hard by the pandemic, often compounded by a significant weakening of local currency versus the Euro. As a result, declining volumes in amongst others Latin-America, India, Pakistan and Turkey outweighed continued growth in other parts of the world. New market authorizations were obtained for the Idylla™ MSI Test in Colombia, Canada, Malaysia and Singapore, and for the Idylla™ EGFR Mutation Test in Argentina during H1 2020. End of October 2020, medical device registration certificates were issued for the Idylla™ platform and the Idylla™ EGFR Mutation Test by the Taiwan FDA. Post the reporting period, in February 2021, the Idylla™ platform, the Idylla™ BRAF Mutation Test (CE-IVD) and the Idylla™ EGFR Mutation Test (CE-IVD) completed registration in Russia, as such expanding the distribution network for Biocartis’ IVD medical devices.China commercialization – In 2020, Wondfo-Cartis, the joint venture with Guangzhou Wondfo Biotech Co., Ltd. (‘Wondfo’, SHE: 300482), a fast growing diagnostics leader in China, took further steps towards establishing local manufacturing capabilities. Concerning the registration of products, a CDx partnership was announced on 5 March 2020 with Bristol Myers Squibb Company (BMS), aimed at pursuing the registration in China of the Idylla™ MSI Test as a CDx test in metastatic colorectal cancer (mCRC). First product registrations in China are to be expected earliest by 2022. Compliance testing of the Idylla™ Instrument and Console with the China NMPA8 was successfully completed in January 2021.Japan commercialization – Continued progress in the in vitro diagnostic (‘IVD’) registration preparations for the Idylla™ assays, paving the way to commercialization with Nichirei Biosciences in Japan. First Idylla™ assays registrations in Japan are expected in the course of 2022. TEST MENU AND PARTNERSHIP HIGHLIGHTS ·Oncology: In 2020, Biocartis further strengthened its footprint in oncology activities through progress in its test menu and the launch of several new and expanded partnerships: o Partnership AstraZeneca – On 22 January 2020, Biocartis announced a master collaboration agreement with lung cancer targeted therapy leader AstraZeneca aimed at rapid and easy testing and expanded its partnership to, amongst others, the area of liquid biopsy testing using the Idylla™ ctEGFR Mutation Assay. o Partnership Bristol-Myers Squibb in China – On 5 March 2020, Biocartis announced the expansion of its partnership with Bristol-Myers Squibb Company, to now also pursue, after the US, the registration of the Idylla™ MSI test as a CDx test in mCRC11 in China. o Idylla™ GeneFusion Assay – Biocartis made progress in its oncology test menu, more specifically in the lung cancer domain with the development of the Idylla™ GeneFusion Assay, for which a EUR 1.2m grant from VLAIO was announced on 30 September 2020. o Partnership Exact Sciences – On 29 October 2020, Biocartis and Genomic Health, Inc. (a subsidiary of Exact Sciences Corporation) announced to have agreed to terminate their collaboration12. As part of a termination settlement, Genomic Health, Inc. agreed to pay USD 12m to Biocartis and licensed certain rights and transferred certain assets to Biocartis. o Partnership GeneproDx – On 3 November 2020, Biocartis announced to have signed a license, development and commercialization agreement with GeneproDx, a molecular diagnostics company based in Santiago, Chile, for the development of GeneproDx’s novel genomic test ThyroidPrint® on the Idylla™ platform. Under the terms of the agreement, GeneproDx will take the lead in the development of the Idylla™ ThyroidPrint® test, whereas Biocartis will be responsible for the distribution of the ThyroidPrint® on Idylla™ through its growing commercial infrastructure of Idylla™ instruments across the globe13. o Partnership Amgen – Motivated by a strong demand from partners and customers, Biocartis gave priority to the development of the Idylla™ SARS-CoV-2 Test and re-allocated resources accordingly. Consequently, Biocartis delayed the US FDA submission of the PMA (Pre-Market Approval) application for the Idylla™ RAS tests. More info under ‘Outlook’ below. ·Infectious diseases: Against the backdrop of the pandemic, in 2020 Biocartis paved the way to the gradual build-out of its infectious disease test menu on Idylla™: o Partnership Immunexpress – In March 2020, the agreement with Immunexpress7 was expanded with a co-commercialization agreement for the SeptiCyte® RAPID test for use on the Idylla™ platform. End of December 2020, the 510(k) submission with the US FDA of the SeptiCyte® RAPID on Idylla™, led by Immunexpress, was completed. o Idylla™ SARS-CoV-2 Test – In August 2020, Biocartis submitted a notification of intent to distribute and request for ‘Emergency Use Authorization’ (EUA) from the US FDA for the Idylla™ SARS-CoV-2 Test1. o Partnership LifeArc – In September 2020, Biocartis announced that the agreement with LifeArc14 was expanded to now also include the development of highly innovative prototype assays in the field of infectious and immune related diseases on the Idylla™ platform. o COVID-19 Testing Industry Consortium – In October 2020, Biocartis announced to have joined the COVID-19 Testing Industry Consortium, led by Bristol-Myers Squibb Company which is aimed at improving, innovating and accelerating all aspects of COVID-19 testing15. A first Whitepaper on 'COVID-19 Back-to-Work' was published by the COVID-19 Testing Industry Consortium in January 2021. o SeptiCyte® RAPID on Idylla™ – Also in October 2020, Biocartis announced the market release of the SeptiCyte® RAPID test on Idylla™ (CE-IVD)7. o Idylla™ SARS-CoV-2 Test – In November 2020, Biocartis announced the CE-IVD launch of its Idylla™ SARS-CoV-2 Test1. o Partnership Endpoint Health – Also in November 2020, Biocartis announced the signing of a new partnership with Endpoint Health aimed at the development and commercialization of a novel CDx test on Idylla™ for critical illnesses. ·Idylla™ performance data: During 2020, 29 new Idylla™ papers were published, bringing the total number of Idylla™ papers end of 2020 to 84. Next to the Idylla™ papers, also several dozens of abstracts and posters were published in 2020 at large scientific conferences, including ASCO, AMP, ESMO and ECP16. Some highlights: o In June 2020, Biocartis announced the publication of a new US multicenter study17 published in the ‘American Journal of Clinical Pathology’ which showed that, compared to current standard-of-care testing methods, the Idylla™ platform can substantially improve turnaround time of the results of mutation testing, independent of the size of the laboratory. The study was one of the largest studies performed involving Idylla™, with 20 laboratories of different types and sizes included throughout the US and Puerto Rico, and data from almost 800 colorectal cancer samples. o In August 2020, during the virtual annual ASCO, five Idylla™ abstracts and posters were published by key oncology opinion leaders, including first Idylla™ data from China where amongst others the Idylla™ EGFR Mutation Assay (RUO) showed excellent concordance with other methods. o In September 2020, the FACILITATE study, launched as part of the agreement between Biocartis and AstraZeneca, was selected for presentation at the renowned European Society for Medical Oncology (‘ESMO’) Virtual Congress. The study concluded that Idylla™ reduced turnaround time by more than a week versus reference methods, allowing earlier patient management decisions; o In November 2020, at the annual meeting of the ‘Association for Molecular Pathology’ (AMP), ten Idylla™ studies were published which highlighted the strengths of the Idylla™ platform and assays19 in terms of performance, ease of use and turnaround time, as well as Idylla™’s capacity to overcome the obstacles of working with small amounts of sample20. o Also in November 2020, a global multi-center real world study21 with the Idylla™ MSI Assay was published and demonstrated excellent performance of the Idylla™ MSI Assay (RUO)6 with a very low failure rate. The study was the largest so far published for Biocartis. ORGANIZATIONAL AND OPERATIONAL HIGHLIGHTS Management team – Following the departure of former CFO Ewoud Welten as announced on 27 January 2020, Biocartis announced on 23 April 2020 the appointment of Jean-Marc Roelandt, a senior executive with an established track record of more than 25 years as CFO in globally active publicly listed companies, as the new CFO of the Company.Cartridge manufacturing – In 2020, further progress was made in the transfer of Idylla™ assays to the second cartridge manufacturing line (‘ML2’). After the transfer of the Idylla™ KRAS Mutation Test (CE-IVD) during H1 2020, the Idylla™ NRAS-BRAF Mutation Test (CE-IVD) and the Idylla™ MSI Test (CE-IVD) were successfully transferred to ML2. The transfer of the Idylla™ EGFR Mutation Test (CE-IVD) is near completion. Transferring the production of key Idylla™ assays to this line is driving cost optimizations within the Company’s cartridge manufacturing activities.Ordinary and Extraordinary General Shareholders’ Meeting – During the ordinary shareholders’ meeting held on 8 May 2020, the shareholders of the Company approved all agenda items, including the re-appointment of Ann-Christine Sundell, Luc Gijsens BV, represented by Luc Gijsens, and Roald Borré, as independent directors of the Company. Christine Kuslich, PhD was appointed as new independent director of the Company. During the extraordinary general shareholders’ meeting held on 25 September 2020, the shareholders of the Company approved all agenda items, including the renewal of the authorization to the Board of Directors to increase the share capital of the Company by up to 20% of the then current amount of the share capital, during a period of one year. Convertible bonds – On 7 December 2020, Biocartis announced its agreement with a holder of part of its outstanding EUR 150m 4% Senior Unsecured Convertible Bonds due 2024 (the ‘Bonds’) regarding the exercise of conversion rights in relation to EUR 15m aggregate principal amount of Bonds22. Biocartis agreed to this incentivized conversion of the Bonds, as it allowed to reduce its debt at attractive market conditions while strengthening the Company’s shareholders’ equity at a premium to the then current share price. FINANCIAL HIGHLIGHTS Product sales revenues – Total product sales increased year-over-year by 32% to EUR 31.9m in 2020 from EUR 24.2m in 2019. Income from cartridge sales of EUR 24.8m grew 38% year-over-year for total cartridge volume of 243k cartridges, of which 230k were commercial cartridges and 13k R&D cartridges. In addition to 31% growth of commercial cartridge volumes, good progress was made on the average selling price (‘ASP’) of commercial cartridges, which increased by 7% in 2020.Idylla™ platform sales increased by 14% for a similar level of new Idylla™ instrument placements as in 2019 (335 in 2020, compared to 337 in 2019). Total operating income – Total operating income amounted to EUR 55.6m in 2020, representing a year-over-year growth of 47% and included a settlement payment of EUR 10.3m (USD 12m) received in connection with the termination of the collaboration with Genomic Health, Inc. for the development of the Oncotype DX Breast Recurrence Score® test on Idylla™.Cost of goods sold – Cost of goods sold increased to EUR 26.3m, 23% higher than in 2019 on the back of 31% higher commercial cartridge volumes and leading to an improved gross margin on products of 18% (2019: 12%).OPEX – Total operating expenses (excluding cost of sales) amounted to EUR 76.1m, an increase of 6% compared to EUR 72m in 2019. Cautious cost management triggered by the pandemic and prioritizing the development of the Idylla™ SARS-CoV-2 Test, led to the delay and carry-over of certain projects to 2021.Operational cash flow – Revenue growth, gross margin improvement and lower than planned operating expenses reduced the total cash flow used in operating and investing activities from EUR 59.7m in 2019 to EUR 43.3m in 2020.Convertible bond – Biocartis’ debt was reduced by EUR 13.6m following the incentivized conversion of 10% of total outstanding Bonds. Biocartis paid a cash incentive of EUR 4.3m to the relevant bondholder as part of the transaction.Cash position - Biocartis’ cash position as per 31 December 2020 amounted to EUR 123.7m compared to EUR 178.7m as per 31 December 2019.Additional details – See key figures 2020 below for more details on the 2020 financials. POST-PERIOD EVENTS ·Achievement 2020 key business objectives – On 11 January 2021, Biocartis announced to have achieved its most recent key business objectives for 2020. OUTLOOK Commercial cartridge volume, Idylla™ installed base and cash position outlook: see above.Idylla™ test menu outlook:1. ONCOLOGY MENU: Colorectal cancer menu: US FDA submissions: Subject to further feedback from US FDA interaction, the US FDA 510(k) submission of the Idylla™ MSI Test is expected in Q2 2021;Motivated by a strong demand from partners and customers, Biocartis gave priority to the development of the Idylla™ SARS-CoV-2 Test and re-allocated resources accordingly. Consequently, Biocartis delayed the US FDA submission of the PMA (Pre-Market Approval) application for the Idylla™ RAS tests, which is now expected in Q4 2021. Lung cancer menu: RUO launch of the Idylla™ GeneFusion Assay is expected in Q1 2021;RUO launch of the Idylla™ EGFR-BRAF+ Assay is expected in the course of 2022. Breast cancer: RUO launch of the Idylla™ ABC (Advanced Breast Cancer) Assay in collaboration with LifeArc is expected in H2 2022. 2. INFECTIOUS DISEASE PARTNER MENU: Emergency Use Authorization ('EUA’) with the US FDA of the Idylla™ SARS-CoV-2 Test is pending;The Idylla™ SARS-CoV-2 Panel is in development and is expected in H1 2021 (CE-IVD);510(k) clearance with the US FDA of the SeptiCyte® RAPID on Idylla™ (Immunexpress) is pending. Key figures 2020 The tables below show an overview of the key figures and a breakdown of operating income for 2020. A consolidated income statement, balance sheet, cash flow statement and statement of changes in shareholder equity of Biocartis Group NV is presented in the paragraph ‘Financial information’ at the end of this press release. Key figures (EUR 1,000)20202019% ChangeTotal operating income55,55937,73247% Cost of sales-26,284-21,32823% Research and development expenses-45,783-39,84415% Sales and marketing expenses-15,736-18,011-13% General and administrative expenses-14,618-14,1513%Operating expenses-102,421-93,33410%Operational result-46,862-55,602-16%Net financial result-15,768-7,93499%Share in the result of associated companies-532-631-16%Income tax22899130%Net result-62,934-64,068-2%Cash flow from operating activities-39,267-54,254-28%Cash flow from investing activities-4,007-5,496-27%Cash flow from financing activities-11,523175,023-107%Net cash flow-54,797115,273-148%Cash and cash equivalents1123,668178,725-31%Financial debt150,558166,578-10% 1 Including EUR 1.2m of restricted cash (as a guarantee for KBC Lease financing) Operating income (EUR 1,000)20202019% ChangeCollaboration revenue9,98912,451-20% Idylla™ system sales7,0856,22014% Idylla™ cartridge sales24,80818,00438%Product sales revenue31,89324,22432%Service revenue1,24676962%Total revenue43,12837,44415%Grants and other income12,4312884216%Total operating income55,55937,73247% Product sales revenue (EUR 1,000)20202019% Change Commercial revenue30,70922,86234% Research & Development revenue1,1841,362-13%Total product sales revenue31,89324,22432% Income statement Total operating income increased by EUR 17.8m or 47% to EUR 55.6m in 2020. Collaboration revenue amounted to EUR 10m, a decrease of 20% from 2019. R&D service revenue decreased by EUR 0.9m, license fees by EUR 0.7m and milestone revenue by EUR 0.9m. The collaboration with Genomic Health, Inc., a subsidiary of Exact Sciences Corporation, for the development of the Oncotype DX Breast Recurrence Score® test on Idylla™ was initially delayed and ultimately terminated because of the pandemic and a decision by Exact Sciences Corporation to shift priorities to other initiatives. Genomic Health, Inc. paid a settlement fee of EUR 10.3m, which is recorded as other income. Revenue from product sales increased by 32% from EUR 24.2m in 2019 to EUR 31.9m in 2020, and included Idylla™ cartridge sales of EUR 24.8m (EUR 18.0m in 2019) and Idylla™ system revenues of EUR 7.1m (EUR 6.2m in 2019). Idylla™ cartridge sales included revenue from the sale of 230k commercial cartridges and of 13k R&D cartridges. Services revenue amounted to EUR 1.2m in 2020 versus EUR 0.8m in 2019. Grant income increased to EUR 1.2m and related to the recognition of subsidies awarded in relation to the establishment of a second cartridge manufacturing line, and to the development of the Idylla™ SARS-CoV-2 Test and the Idylla™ GeneFusion Assay (RUO). In addition to the aforementioned settlement fee paid by Genomic Health, Inc., other income included the proceeds of a USD 1.0m loan received under the US Paycheck Protection Program (‘PPP’), established as part of the Coronavirus Aid, Relief and Economic Security Act (‘CARES Act’). On 29 October 2020 Biocartis submitted a loan forgiveness application for the full amount of the loan plus applicable interest to its lender. The lender approved the forgiveness application and recommended full forgiveness to the Small Business Administration (“SBA”). While no response has yet been received from the SBA, the Company believes its use of the loan proceeds met the conditions for forgiveness of the loan. Total operating expenses amounted to EUR 102.4m in 2020, compared to EUR 93.3m in 2019. The increase was primarily driven by the cost of goods sold that increased by EUR 5m or 23% to EUR 26.3m. The increased cost of goods sold reflected the increase in commercial cartridge volume of 31%, partly offset by a reduction in the cartridge manufacturing cost, leading to an improvement of the gross margin on products to 18% (2019: 12%). Total operating expenses, excluding the cost of goods sold, amounted to EUR 76.1m in 2020, compared to EUR 72.0m in 2019. The increase of EUR 4.1m resulted from increased R&D expenses, offset by lower spending in sales and marketing. The increase in R&D expenses was largely driven by the development of the Idylla™ SARS-CoV-2 Test. Sales and marketing expenses decreased by EUR 2.3m, in part because the pandemic significantly hampered normal commercial activities for a good part of the year. Travel was restricted and numerous conferences and events were cancelled due to global lockdown measures. The operating loss for 2020 amounted to EUR 46.9m, an improvement of EUR 8.7m or 16% compared to 2019. Net financial expenses amounted to EUR 15.8m in 2020 compared to EUR 7.9m, and included expenses associated with the Company’s convertible bond, and commitment fees for the multiple purpose credit. In 2020, the interest expense on the convertible bond increased to EUR 6.0m compared to EUR 3.0m in 2019. The bond was issued in May 2019 and last year therefore only included one coupon. Similarly, the debt appreciation expense amounted to EUR 2.7m, compared to EUR 2.2m in 2019. The financial expenses also included a cash payment of EUR 4.3m in connection with the incentivized exercise of conversion rights in relation to EUR 15 million aggregate principal amount of Bonds (see details in the section balance sheet). Balance sheet In 2020, total assets reduced from EUR 268.3m in 2019 to EUR 210.5m. Non-current assets amounted to EUR 50.5m compared to EUR 53.7m, mostly because of the depreciation of intangible assets and property, plant and equipment (EUR 9.7m) and an impairment charge of EUR 1.6m, offset by investments of EUR 3.0m in new equipment. Financial assets amounted to EUR 2.9m (2019: EUR 2,4m) and included the investment in the China joint venture Wondfo-Cartis. In 2020, the Company invested an additional EUR 1.0m in the joint venture and recorded its share of EUR 0.5m in Wondfo-Cartis’ net loss for the year. End 2020, current assets amounted to EUR 160.0m, or EUR 54.4m less than in 2019. Cash and cash equivalents of EUR 123.7m reduced by EUR 55.1m. Accounts receivable increased by EUR 2.8m as a direct result of higher levels of cartridge sales towards the end of the year. Inventory increased by EUR 1.6m, mostly finished cartridges in order to meet increased demand. Other receivables decreased by EUR 4.7m from EUR 8.6m in 2019, to EUR 4.0m in 2020, following the collection of a tax credit on research and development. Other current assets increased by EUR 0.7m. End 2020, total financial debt amounted to EUR 150.6m compared to EUR 166.6m end of 2019. The reduction resulted from the incentivized conversion (EUR 13.6m) of part of the convertible bond and the net reduction of EUR 5.1m of lease obligations, offset by the appreciation of EUR 2.7m of the convertible bond. The incentivized conversion resulted from an agreement with a holder of part of the Company’s EUR 150m 4% senior unsecured convertible Bonds regarding the exercise of conversion rights in relation to EUR 15 million aggregate principal amount of Bonds. The Company agreed to the incentivized conversion of the Bonds, as it allowed the Company to reduce the reported debt at attractive market conditions and to strengthen the shareholders’ equity at a premium to the share price. The amount of the debt reduction in exchange for the new ordinary shares amounts to EUR 9.3m or EUR 8 per share, 70% higher than the closing price on 4 December 2020. The total debt reduction amounts to EUR 13.6m and was recorded as a credit to the share premium in the equity attributable to the owners of the Company. Current liabilities end of 2020 amounted to EUR 29.4m, compared to EUR 23.2m end of 2019. Trade accounts payable increased by EUR 4.8m to EUR 13.9m. Other current liabilities included payroll related provisions and amounted to EUR 7.6m, representing an increase of EUR 1.5m compared to end 2019. Cash flow statement The cash flow from operating activities in 2020 amounted to EUR -39.3m, a decrease of EUR 15m from EUR -54.3m in 2019. The improvement resulted from reduced operating losses and a net reduction in working capital, partly offset by increased financial expenses. The cash flow from investing activities in 2020 amounted to EUR –4.0m, EUR 1.5m less than in 2019, and included the capital contribution made to the China joint venture, capitalized Idylla™ systems as well as investments in laboratory and manufacturing equipment.Financing activities used EUR 11.5m cash for the incentivized conversion of part of the convertible bond (EUR 4.3m), interest on the convertible bond (EUR 6.0m) and the scheduled repayment of lease and other obligations. The total cash flow for 2020 amounted to EUR -54.8m compared to EUR 115.3m in 2019, which included EUR 198.8m net proceeds from the issuance of new ordinary shares (EUR 53.4m) and the convertible bond (EUR 145.5m). Financial calendar 2021 1 April 2021 Publication 2020 annual report22 April 2021 Q1 2021 Business Update14 May 2021 AGM Biocartis Group NV2 September 2021 H1 2021 results10 November 2021 Q3 2021 Business Update Financial information The consolidated financial statements have been prepared in accordance with IFRS, as adopted by the EU. The financial information included in this press release is an extract from the full IFRS consolidated financial statements, which will be published on 1 April 2021. The statutory auditor, Deloitte Bedrijfsrevisoren /Réviseurs d’Entreprises, represented by Nico Houthaeve, has confirmed that its audit procedures, which have been substantially completed, have not revealed any material adjustment that should be made in the accounting information included in this press release. Consolidated Income Statement Years ended 31 DecemberIn EUR 0002020 2019 Revenue Collaboration revenue9,989 12,451Product sales revenue31,893 24,224Service revenue1,246 769 43,128 37,444Other operating income Grants and other income12,431 288 Total operating income55,559 37,732 Operating expenses Cost of sales-26,284 -21,328Research and development expenses-45,783 -39,844Sales and marketing expenses-15,736 -18,011General and administrative expenses-14,618 -14,151 -102,421 -93,334 Operating loss for the year-46,862 -55,602 Financial expense-14,569 -8,008Other financial results-1,199 74Financial result, net-15,768 -7,934 Share in the results of associates-532 -631 Loss for the year before taxes -63,162 -64,167Income taxes228 99Loss for the year after taxes -62,934 -64,068 Attributable to owners of the Company-62,934 -64,068Attributable to non-controlling interest Earnings per share Basic and diluted loss per share-1.11 -1.14 Consolidated Balance Sheet As of 31 December In EUR 0002020 2019 Assets Non-current assets Intangible assets5,645 6,294 Property plant and equipment40,098 43,421 Investment joint ventures2,893 2,358 Other non-current receivables426 13 Deferred tax assets1,472 1,609 50,534 53,695 Current assets Inventories15,712 14,161 Trade receivables13,488 10,695 Other receivables3,960 8,640 Other current assets3,155 2,407 Cash and cash equivalents*123,668 178,725 159,983 214,628 Total assets210,517 268,323 Equity and liabilities Capital and reserves Share capital-220,657 -220,668 Share premium711,874 698,027 Share based payment reserve6,102 4,670 Accumulated deficit-455,343 -392,259 Other comprehensive income-5,152 -5,291 Total equity attributable to owners of the Company36,824 84,479 Non-current liabilities Provisions0 49 Borrowings and lease liabilities18,625 24,000 Convertible debt125,260 136,158 Deferred income363 461 144,248 160,668 Current liabilities Borrowings and lease liabilities6,673 6,420 Trade payables13,907 9,070 Deferred income1,278 1,595 Other current liabilities7,587 6,091 29,445 23,176 Total equity and liabilities210,517 268,323 * Cash and cash equivalents for 31 December 2020 include EUR 1.2 million restricted cash related to KBC Lease financing Consolidated cash flow statement Years ended 31 DecemberIn EUR 0002020 2019Operating activities Loss for the year-62,934 -64,068 Adjustments for Depreciation and amortization9,748 9,719Impairment losses1,698 476Income taxes in profit and loss-228 -99Financial result, net15,768 7,934Unrealized exchange gains/ losses-1,030 0Net movement in defined benefit obligation-323 -150Share of net profit of associate and a joint venture532 631Share based payment expense1,432 1,225Other-80 37 Changes in working capital Net movement in inventories-4,042 -3,858Net movement in trade and other receivables and other current assets1,449 -1,182Net movement in trade payables & other current liabilities6,333 1,507Net movement in deferred income-415 -960 -32,092 -48,788 Interests paid-7,172 -5,288Taxes paid-3 -178Cash flow used in operating activities-39,267 -54,254 Investing activities Interests received13 8Acquisition of property, plant & equipment-3,005 -2,121Acquisition of intangible assets-15 -394Acquisition of investment in a joint venture-1,000 -2,989Cash flow used in investing activities-4,007 -5,496 Financing activities Proceeds from the issue of a convertible bond0 145,438Convertible bond – incentivized conversion-4,306 0Net proceeds from the issue of common shares, net of transaction costs0 53,360Repayment of borrowings-7,167 -23,738Bank charges-50 -37Cash flow from financing activities-11,523 175,023 Net increase / (decrease) in cash and cash equivalents-54,797 115,273 Cash and cash equivalents at the beginning of the year178,725 63,539Effects of exchange rate changes on the balance of cash held in foreign currencies-260 -87Cash and cash equivalents at the end of the year*123,668 178,725 * Including EUR 1.2m restricted cash related to KBC Lease financing Consolidated Statement of Changes in Shareholder Equity Attributable to owners of the Group In EUR 000 Share capital Share premium Share based payment reserve Other comprehensive income Accumulated deficit Total equity attributable to the owners of the Group Total equity Balance as at 1 January 2019 -220,718 632,769 3,445 -67 -328,078 87,351 87,351Loss for the period -64,068 -64,068 -64,068Re-measurement gains and losses on defined benefit plan -171 -171 -171Consolidation translation difference -113 -113 -113Other comprehensive income -5,052 -5,052 -5,052Total comprehensive loss -5,223 -64,181 -69,404 -69,404Share-based payment expense 1,225 1,225 1,225Share issue – private placement on 28 January 2019 50 55,450 55,500 55,500Costs related to private placement on 28 January 2019 -2,311 -2,311 -2,311Share issue - exercise of stock options on 4 April 2019 0 171 171 171Issuance of convertible bond on 9 May 2019 11,948 11,948 11,948Other 0 0Balance as at 31 December 2019 -220,668 698,027 4,670 -5,291 -392,259 84,480 84,480 Balance as at 1 January 2020 -220,668 698,027 4,670 -5,291 -392,259 84,480 84,480Loss for the period -62,934 -62,934 -62,934Re-measurement gains and losses on defined benefit plan 139 139 139Consolidation translation difference -150 -150 -150Total comprehensive income 139 -63,084 -62,945 -62,945Share-based payment expense 1,432 1,432 1,432Convertible bond - incentivized conversion 11 13,847 13,857 13,857Other 0 0Balance as at 31 December 2020 -220,657 711,875 6,102 -5,152 -455,343 36,824 36,824 --- END --- More information: Renate Degrave Head of Corporate Communications & Investor Relations Biocartis e-mail email@example.com tel +32 15 631 729 mobile +32 471 53 60 64 About Biocartis Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a continuously expanding test menu addressing key unmet clinical needs, with a focus in oncology, which represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer, as well as for SARS-CoV-2 and sepsis. More information: www.biocartis.com. Follow us on Twitter: @Biocartis_. Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended. Forward-looking statementsCertain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. 1 In the US, distribution of the Idylla™ SARS-CoV-2 Test was initiated in Q3 2020 per US FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), May 2020, Section IV.C. Commercial Manufacturer Development and Distribution of Diagnostic Tests Prior to EUA Submission 2 Including 64 Idylla™ instruments returned by Exact Sciences in accordance with the termination agreement announced on 29 October 2020 3 A molecular diagnostics company based in Santiago, Chile 4 A Palo Alto, CA (USA) based company developing personalized care solutions and targeted therapies for critically ill patients. Under the terms of the agreement, Endpoint Health will lead the development and registration of the Idylla™ Endpoint CDx test in interventional trials across a range of interventions including targeted immunotherapy and coagulation therapy indications. The parties intend to collaborate on the commercialization of the Idylla™ Endpoint CDx test, building on the growing worldwide commercial infrastructure of Idylla™ instruments 5 The Flanders Organization for Innovation & Entrepreneurship. The grant is intended to support the development of the GeneFusion Assay on the Idylla™ platform, and to support related research studies on different sample and tumor tissue types, including on lung cancer tissue. The Idylla™ GeneFusion Assay will include a highly multiplexed panel of established and emerging biomarkers, and will be the first FFPE (Formalin fixed, paraffin embedded ) RNA based assay (= RNA or Ribonucleic Acid is one of the three major biological macromolecules that are essential for all known forms of life along with DNA and proteins) on the Idylla™ platform. The Idylla™ GeneFusion Assay is expected to bring results in approx. 3 hours, with less than 2 minutes hands-on time 6 RUO = Research Use Only, not for use in diagnostic procedures 7 Developed in collaboration with Immunexpress, a Seattle-based (WA, US) molecular diagnostic company 8 China NMPA requires local type testing for the market approval of Class II and Class III medical device/IVD products. China local type testing is a mandatory step for registration and must be completed before the initiation of local clinical studies if needed. Testing was conducted by a testing lab authorized by the NMPA 9 Defined as the world excluding European direct markets, US, China and Japan 10 A companion diagnostic (CDx) test is a test used as a companion to a therapeutic drug, that helps predict if a patient is likely to respond to a treatment or not 11 Metastatic colorectal cancer 12 The collaboration was focused on the development of the Oncotype DX Breast Recurrence Score® Test and the Oncotype DX Genomic Prostate Score® (GPS™) Test on the Idylla™ platform. As a result of COVID-19, the project had been suspended earlier during 2020, with the project plan and timing under evaluation. The decision to terminate the agreement was driven by the uncertain timing of a product market release because of the pandemic and a decision by Exact Sciences to shift priorities to other initiatives 13 ThyroidPrint® is a qRT-PCR (Quantitative Reverse Transcription PCR) based mRNA-expression classifier test (based on RTqPCR analysis, combined with an advanced machine learning algorithm ) that helps to determine whether a thyroid nodule with an indeterminate cytology result is benign or malignant (this means that the probability of the nodule being malignant drops from 25% to less than 5%, allowing follow-up to be recommended as an alternative to surgery. Info and source: https://thyroidprint.com/en/home-us/, last consulted on 13 January 2021). A benign test result (NPV or Negative Predictive Value > 95%) allows physicians to recommend watchful waiting as an alternative to diagnostic surgery. This reduces exposing patients to surgical risks and permanent thyroid hormone supplementation. Moreover, it significantly reduces health costs associated with unnecessary surgery. PCR or Polymerase chain reaction is an efficient and cost-effective way to copy (amplify) small segments of DNA or RNA. As such, millions of copies of a section of DNA are made in just a few hours, allowing further analysis for clinicians to diagnose and monitor diseases using a minimal amount of sample, such as blood or tissue. Source: www.genome.gov, last consulted on 13 January 2021 14 LifeArc, formerly known as the Medical Research Council Technology (MRC Technology, MRCT) is a London (UK) based life science medical research charity 15 Including research, regulatory oversight, clinical implications, reliability and access 16 ASCO = American Society of Clinical Oncology, AMP = Association for Molecular Pathology, ESMO = European Society for Medical Oncology, ECP = European Congress of Pathology 17 Led by researchers from Dartmouth’s and Dartmouth-Hitchcock’s Norris Cotton Cancer Center (Lebanon, New Hampshire, US). Tsongalis et al., “Comparison of Tissue Molecular Biomarker Testing Turnaround Times and Concordance Between Standard of Care and the Biocartis Idylla Platform in Patients With Colorectal Cancer”, Am J Clin Pathol. 2020 Jun 11;aqaa044. doi: 10.1093/ajcp/aqaa044. Online ahead of print 18 Hummel M. et al, “FACILITATE: a real-world multicenter prospective study investigating the utility of a rapid, fully automated RT-PCR assay vs reference methods (RM) for detecting epidermal growth factor receptor mutations (EGFRm) in NSCLC”, ESMO Virtual Congress 2020 (19-21 September 2020), first published online on 14 September 2020. A large, prospective, study across 16 European sites in Belgium, France, Germany and Italy. The study aimed to prospectively test 100 paraffin-embedded biopsy or cytology tissue samples with ≥10% neoplastic cells per site, from patients with advanced NSCLC (non-small cell lung cancer) 19 All studies were performed with Idylla™ RUO assays, research use only, not for use in diagnostic procedures. Three studies also discussed new Biocartis assays in the area of infectious disease: the Idylla™ SARS-CoV-2 Assay and the SeptiCyte® RAPID on Idylla™ 20 This represents a major challenge for many current molecular testing methods in a variety of different cancer types 21 A. Velasco et al., Multi-center real-world comparison of the fully automated Idylla™ microsatellite instability assay with routine molecular methods and immunohistochemistry on formalin-fixed paraffin-embedded tissue of colorectal cancer, Virchows Archiv, https://doi.org/10.1007/s00428-020-02962-x, November 2020 22 As a result, an aggregate principal amount of EUR 15m of the Bonds was converted, and 1,163,575 new Ordinary Shares were issued by the Company
February 25, 2021 Breda, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that it will host a conference call and audio webcast on March 4, 2021 at 2:30 p.m. CET (8:30 a.m. ET) to discuss its full year 2020 financial results and provide a fourth quarter business update. 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 for one year following the call. Dial-in numbers:Please dial in 15 minutes prior to the live call. Belgium 0800 389 13France 0805 102 319Netherlands 0800 949 4506United Kingdom 0800 279 9489United States 1 844 808 7140International 1 412 902 0128 About 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/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Media:Kelsey KirkKKirk@argenx.com Investors:Beth DelGiaccobdelgiacco@argenx.com Joke Comijn (EU)firstname.lastname@example.org
Excellent progress on clinical programs Unprecedented partnering deal signed with Pfizer for Lyme disease vaccine candidate VLA15, including $130 million upfront payment as part of over $300 million for upfront and milestone payments Positive initial Phase 2 resultsAcceleration of pediatric development announced Acceleration of chikungunya vaccine candidate VLA1553 into Phase 3 Only Phase 3 chikungunya vaccine program to date worldwidePotentially eligible for Priority Review Voucher (PRV)1 - for first company to receive Biologics License Application (BLA) approval Commercial business adversely affected by pandemic impact on travel industry New US military / Department of Defense (DoD) contract for IXIARO® worth up to $166 million over three years Valneva contributing to the global effort against the COVID-19 pandemic Only whole-virus inactivated vaccine candidate in clinical development in Europe Commercial manufacturing commenced Major Partnership with U.K. government, worth up to €1.4 billion including investment in manufacturing plant and clinical trials in the UK Advanced discussions with European Commission FY 2020 cash and cash equivalents of €204.4 million underlining strong balance sheetEGM passes resolutions to allow preparation for possible Nasdaq listing and US IPO Thomas Lingelbach, Chief Executive Officer, commented, “2020 was a transformational year for Valneva, marked by major partnerships with Pfizer and the UK government as well as substantial progress across all of our clinical programs. Our company has responded very well to the challenges presented to us by the COVID pandemic. With over €200 million of cash, Valneva is in a strong position to continue to focus on execution of our key programs which could result in even greater transformation in 2021 and beyond.” FY 2020 financial highlights (unaudited) FY 2020 cash and cash equivalents of €204.4 million, exceeding guidance of between €180 million and €200 million1 FY 2020 cash and cash equivalents include $130 million from the Lyme disease collaboration with Pfizer2 and €96.7 million from the UK COVID-19 vaccine partnership3$60 million drawn down from the $85 million debt financing arrangement with leading US healthcare funds Deerfield Management Company and OrbiMed Total revenue of €110.3 million in 2020 compared to €126.2 million in 2019; Product sales of €65.9 million in 2020 (€129.5 million in 2019) adversely affected by the COVID-19 pandemic impact on the travel industry.FY 2020 total revenue includes €31.6 million resulting from the Lyme vaccine partnership with Pfizer and €12.8 million of Technology and Service revenues. EBITDA5 loss of €45.2 million in 2020 reflecting increased R&D investment and lower sales (compared to EBITDA profit of €7.8 million in 2019) FY 2020 EBITDA reflects planned increase in R&D investment of €84.5 million in 2020 compared to €38.0 million in 2019 Lyme disease, chikungunya and COVID-19 vaccine programs all advanced in 2020€19.0 million of COVID-19 R&D investment is included in the 2020 resultsGross margin adversely affected by inventory provisions and idle capacity costs in manufacturing plants caused by the impact of the ongoing COVID-19 pandemic 4.2% negative impact due to reporting changes G&A costs include additional share option costs given share price appreciation during 2020 as well as one-off costs related to corporate project expenses FY 2021 financial guidanceThe Company is not providing guidance related to its VLA2001 revenues and program at this time. This guidance will be material to the Company, therefore needs to be based on robust information. As far as the non – VLA2001 related business is concerned, the Company expects for 2021: Total revenues, excluding VLA2001, of €100 million to €115 millionR&D expenses, excluding VLA2001, of €65 million to €75 million David Lawrence, Valneva’s Acting Chief Financial Officer, commented, “Valneva’s response to the COVID-19 pandemic has been outstanding. We have more than overcome the adverse impact in product sales with the partnerships on Lyme and our own COVID-19 vaccine program including the major partnership with the U.K. The 2020 financial results reflect the downturn in the travel industry and the great progress made across our R&D pipeline. 2021 is likely to see major development in our revenues and the prospect of a US IPO underlines our strategy to continue to build significant shareholder value.” Financial Information6(2020 unaudited results, consolidated per IFRS) € in million12 months ending December 31 20202019Product sales65.9129.5Total revenues 110.3126.2Net profit/(loss) (64.4) (1.7)EBITDA (45.2) 7.8Cash 204.4 64.4 Saint Herblain (France), February 25, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company focused on prevention against diseases with major unmet needs, reported today its full year unaudited consolidated financial results for the year ending December 31, 2020 and summarized its key achievements in 2020. A brief unaudited report, including the profit and loss statement and the balance sheet, is available on the Company’s website, www.valneva.com. Valneva will provide a live webcast of its full-year 2020 unaudited results conference call beginning at 3 p.m. CET today. This webcast will also be available on the Company’s website. Please refer to this link: https://edge.media-server.com/mmc/p/yz28diuy Commercial Vaccines JAPANESE ENCEPHALITIS VACCINE (IXIARO®/JESPECT®) IXIARO® is the only Japanese encephalitis vaccine licensed and available in the United States, Canada and Europe. Sales of IXIARO® were €48.5 million in 2020 compared to €94.1 million in 2019. Sales in 2020 were significantly impacted by the COVID-related decline in travel. In September 2020, the US Defense Logistics Agency (DLA), awarded Valneva a new contract for the supply of IXIARO®7. The terms of the agreement contemplate an initial base year followed by two option years, each with a range of minimum and maximum potential dose orders. The current base year has a minimum value of approximately $54 million for 370,000 doses, and the option years have minimum values of $46 million for 320,000 doses and $36 million for 250,000 doses, respectively, if DLA exercises those options. CHOLERA / ETEC8-DIARRHEA VACCINE (DUKORAL®) DUKORAL® is an oral vaccine for the prevention of diarrhea caused by Vibrio cholerae and/or heat-labile toxin producing ETEC, the leading cause of travelers’ diarrhea. DUKORAL® is authorized for use in the European Union and Australia to protect against cholera and in Canada, Switzerland, New Zealand and Thailand to protect against cholera and ETEC8. Valneva acquired DUKORAL® in 2015 and recorded sales of €13.3 million in 2020 compared to €31.5 million in 2019. DUKORAL® sales in 2020 have been significantly impacted by the COVID-related decline in travel. OVERALL SALES OUTLOOKTaking into account the ongoing COVID-19 situation, Valneva’s sales could return to 2019 levels in 2023-2024 with the expected sales recovery of its two commercial products and the marketing and distribution partnership with Bavarian Nordic announced in June 20209. The successful development of a SARS-CoV-2 vaccine could accelerate that timeline. Clinical Stage Vaccine Candidates LYME DISEASE VACCINE CANDIDATE – VLA15 Collaboration agreement with Pfizer; Positive initial results reported for the two Phase 2 studies; Acceleration of pediatric development Valneva has developed VLA15, a vaccine candidate against Borrelia, the bacterium that causes Lyme disease. VLA15 is a multivalent recombinant protein vaccine that targets six serotypes of Borrelia representing the most common strains found in the United States and Europe. VLA15 is the only vaccine undergoing clinical trials against Lyme disease. Valneva announced a collaboration with Pfizer for late phase development and, if approved, commercialization of VLA1510. Valneva has reported positive initial results for two Phase 2 clinical trials of VLA15 in over 800 healthy adults. As part of this collaboration, Valneva announced in December 202011, that it had accelerated the pediatric development of VLA15 with an additional Phase 2 clinical trial anticipated to commence in March 2021. The dosing of the first subject in this trial will trigger a milestone payment from Pfizer of $10 million. Initial pediatric data are expected by mid-2022. Together with Pfizer, Valneva expects that its Phase 3 clinical trial will start in the third quarter of 2022 to ensure administration of VLA15 in time for the pivotal, placebo-controlled field efficacy trial that the parties are planning for the 2023 tick season. Clinical readout, based on one tick season, is projected for end 2023. If the results from these clinical trials are positive and, subject to regulatory approval, first licensure is anticipated for the first half of 2025. VLA15 has received Fast Track designation from the U.S. Food and Drug Administration (FDA)12. CHIKUNGUNYA VACCINE CANDIDATE – VLA1553Phase 3 initiated; EMA PRIME designation granted VLA1553 is a vaccine candidate against the chikungunya virus, a mosquito-borne virus that has spread to more than 100 countries with the potential to rapidly expand further. There are currently no preventive vaccines or effective treatments for the chikungunya virus available and, to Valneva’s knowledge, VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials worldwide. VLA1553 is a live-attenuated, single dose vaccine candidate for protection against chikungunya disease. VLA1553 has been designed by deleting a part of the chikungunya virus genome. As a live-attenuated vaccine, VLA1553 is particularly well suited to target long-lasting protection which differentiates it when compared to other chikungunya assets that are being evaluated in clinical trials.The pivotal Phase 3 trial, VLA1553-301, was initiated in September 2020. The primary objective of the trial is to evaluate the immunogenicity and safety of VLA1553 at 28 days following a single immunization in approximately 4,000 participants aged 18 years or above. Valneva has also initiated a clinical lot-to-lot consistency Phase 3 trial in February 202113 to show manufacturing consistency of the vaccine. These two Phase 3 trials will run in parallel. Valneva has received confirmation that it may seek licensure through the FDA’s accelerated approval pathway. Via this pathway, the Company plans to seek licensure of the vaccine based on a surrogate of protection, subject to agreement with the FDA that this surrogate endpoint is reasonably likely to predict protection from chikungunya infection. Current clinical activities are affected by the ongoing pandemic but, with more than 80% of the study enrolled to date, Valneva now projects primary endpoint read-out around mid-2021. VLA1553 received Fast Track designation from the FDA and PRIME designation from the European Medicines Agency. The sponsor of the first chikungunya vaccine BLA to be approved in the United States will be eligible to receive a Priority Review Voucher. To make VLA1553 also accessible to Low and Middle Income Countries, Valneva and the Butantan Institute in Brazil signed a collaboration agreement in January 2021 for the development, manufacturing and marketing of VLA155314. The collaboration falls within the framework of the $23.4 million funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 201915. SARS-CoV-2 VACCINE CANDIDATE – VLA2001 Major COVID-19 Vaccine Partnership with U.K. Government VLA2001 is a vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. The Phase 1/2 clinical trial is fully enrolled and is expected to report initial results in April 2021. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. Valneva has commenced production in parallel to the ongoing clinical trial in order to optimize the timeline for potential deliveries of the vaccine. Assuming positive results from the ongoing Phase 1/2 trial and subject to regulatory approval Valneva plans to progress expeditiously into Phase 3 clinical development. Valneva is currently discussing Phase 3 design with the UK Medicines and Healthcare Products Agency (MHRA). Although vaccines against SARS-CoV-2 have already been approved, given the potential advantages often associated with inactivated whole virus vaccines, Valneva believes its vaccine can be incorporated into the current and future portfolio of SARS-CoV-2 vaccines to address the global need for billions of doses of vaccines to prevent further spread of the virus. In September 2020, Valneva announced a collaboration with the UK Government, which has the option to purchase up to 190 million doses through 202516. Following an initial order for 60 million doses to be delivered in 2021, the UK Government exercised an option in February 2021 to order 40 million doses for supply in 202217. This brings the total volume of the Valneva vaccine ordered by UK Government to 100 million doses and the UK Government retains options over a further 90 million doses for supply between 2023 and 2025. The total value of the 190 million doses, if all options are exercised, is up to €1.4 billion. Valneva also announced in January 2021, it is in advanced discussions with the European Commission to supply up to 60 million doses of its COVID-19 vaccine18. Full Year 2020 Financial Review (Unaudited, consolidated under IFRS) RevenuesValneva’s total revenues in 2020 were €110.3 million compared to €126.2 million in 2019. Product sales declined by 49.1% to €65.9 million in 2020 compared to €129.5 million in 2019. On a CER basis19 2020 product sales declined by 48.2% compared to 2019 with both commercial vaccines impacted by COVID-19 related consequences on the travel market. The sales decline was caused by a 48.5% (47.2% at CER) decrease in IXIARO®/JESPECT® sales and a 57.7% (57.9% at CER) decrease in DUKORAL® sales while sales of Third Party products grew by 6.7% (8.5% at CER) compared to 2019. Other Revenues, including revenues from collaborations, licensing and services, amounted to €44.4 million in 2020 and included revenues related to the Lyme R&D collaboration agreement with Pfizer amounting to €31.6 million. In 2019, negative Other Revenues amounted to €3.3 million, including the effect of the termination of the SAA with GSK. Excluding the termination effect, other revenues would have amounted to €7.4 million in 2019. Operating result and EBITDA Costs of goods and services sold (COGS) were €54.3 million in 2020. Gross margin on product sales was 36.6% compared to 63.1% in 2019, with the decline mainly related to provisions taken for excess stock driven by reduced demand (due to the COVID-19 pandemic) and idle capacity costs in both of Valneva’s manufacturing sites. COGS of €24.8 million were related to IXIARO®/JESPECT® sales, yielding a product gross margin of 48.9%. COGS of €14.3 million were related to DUKORAL® sales, yielding a negative product gross margin of 7.3%. Of the remaining COGS in 2020, €2.8 million were related to the Third Party Product distribution business and €12.5 million were related to cost of services. In 2019, overall COGS were €52.8 million, of which €47.8 million related to cost of goods and €5.0 million related to cost of services. Research and development investments in 2020 continued to increase as planned, more than doubling to €84.5 million compared to €38.0 million in 2019. This was driven by investments into Valneva’s clinical stage vaccine candidates, notably Lyme and chikungunya, and was also impacted by spending related to the Company’s SARS-CoV-2 vaccine candidate. Marketing and distribution expenses in 2020 amounted to €18.3 million compared to €24.1 million in 2019. The decrease was the result of lower marketing and distribution spend across all Valneva’s direct markets due to reduced sales activity further to the COVID-19 pandemic. In 2020, general and administrative expenses increased to €27.5 million from €18.4 million in 2019, mainly driven by increased costs to support corporate transactions and projects as well as costs related to Valneva’s employee share option program. Other income, net of other expenses in 2020 increased to €19.1 million from €6.3 million in 2019. This increase was mainly driven by increased R&D tax credit directly resulting from increased R&D spending along with income from the CEPI funding for Valneva’s chikungunya R&D program. Valneva recorded an operating loss of €55.1 million in 2020 compared to an operating loss of €0.8 million in 2019. EBITDA loss in 2020 was €45.2 million compared to an EBITDA profit of €7.8 million in 2019. Net result In 2020, Valneva generated a net loss amounting to €64.4 million compared to a net loss of €1.7 million in 2019. Finance costs and currency effects in 2020 resulted in a net finance expense of €10.0 million, compared to a net finance expense of €1.6 million in 2019. The increase of expenses was mainly the result of increased interest charges related to the financing arrangement with US healthcare funds Deerfield and OrbiMed entered into in 2020 as well as interest charges of €3.2 million related to the re-payment obligation to Pfizer for Valneva’s contribution to the Lyme VLA15 Phase 3 costs. Cash flow and liquidity Net cash generated by operating activities in 2020 amounted to €137.7 million compared to €5.5 million in 2019 mainly driven by the $130 million upfront payment received from Pfizer related to the Lyme R&D collaboration agreement as well as funds received related to the COVID supply agreement concluded with the UK Government in September 2020. Cash outflows from investing activities in 2020 amounted to €19.3 million compared to €10.7 million in 2019 mainly as a result of purchases of equipment. Cash inflows from financing activities amounted to €21.7 million in 2020 and consisted mainly of €48.8 million net proceeds from the financing arrangement with US healthcare funds Deerfield and OrbiMed, offset by €20 million repayments of borrowings to the European Investment Bank (EIB). Cash outflows from financing activities amounted to €7.7 million in 2019, which included the repayment of the Biopharma (Pharmakon) loan of €11.3 million in early 2019.Liquid funds on December 31, 2020 strongly increased and stood at €204.4 million compared to €64.4 million on December 31, 2019. The main changes resulted from the $130.0 million upfront payment related to the Lyme collaboration agreement with Pfizer, proceeds from the new debt line net of loan repayment to the EIB in March 2020 and payments made by the UK Government within the framework of the UK COVID-19 partnership. About Valneva SEValneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. The Company has several vaccines in development including unique vaccines against Lyme disease, COVID-19 and chikungunya. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 580 employees. Valneva Investor and Media ContactsLaetitia Bachelot-FontaineDirector of Investor Relations & Corporate CommunicationsM +33 (0)6 4516 email@example.com Teresa PinzolitsCorporate Communications SpecialistT +43 (0)1 20620 firstname.lastname@example.org Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future performance. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 https://priorityreviewvoucher.org/ 2 Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA15 Valneva Announces Major COVID-19 Vaccine Partnership with U.K. Government4 Valneva Announces New $85 Million Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed 52020 EBITDA was calculated by excluding €9.9 million of depreciation, amortization and impairment (€8.6 million in 2019) from the €55.1 million operating loss (€0.8 million in 2019) as recorded in the consolidated financial statements under IFRS.6 Financial statements are not audited. The audit procedures by the Statutory Auditors are underway. The Company plans to publish its audited annual financial report on March 24, 2021.7 Valneva Announces New IXIARO® Supply Contract with the US Government worth up to $166 million8 Indications differ by country -Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium9 Valneva and Bavarian Nordic Announce Marketing and Distribution Partnershi10 Valneva and Pfizer Announce Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine, VLA111 Valneva Announces Acceleration of Pediatric Development for Lyme Disease Vaccine Candidat12 Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA1513 Valneva Initiates Phase 3 Clinical Lot Consistency Study for its Single-Shot Chikungunya Vaccine Candidate14 Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries15 CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccin16 Valneva Confirms Participation in UK Government COVID-19 Vaccine Response Program17 Valneva Announces UK Government Exercise of Option for 40 Million Doses of its Inactivated, Adjuvanted COVID-19 Vaccine18 Valneva in Advanced Discussions with European Commission to Supply up to 60 Million Doses of Inactivated, Adjuvanted COVID-19 Vaccine Candidate19 CER: Constant Exchange Rate; Full Year 2019 actuals restated to Full Year 2020 average exchange rates Attachment 2021_02_25_VLA_FY_2020_Results_PR_EN_Final