CureVac N.V. (CVAC) Earnings Call Transcript & Summary

June 22, 2022

NASDAQ US Health Care Biotechnology shareholder_meeting 68 min

Earnings Call Speaker Segments

Jean Stéphenne

executive
#1

Ladies and gentlemen, welcome to the Annual General Meeting of the Shareholders of CureVac N.V. My name is Jean Stéphenne, Chairman of the Supervisory Board of CureVac N.V. In accordance with our Article of Association, I will share today's meeting. Our General Counsel, Marco Rau will act as secretary of this meeting. First, allow me to introduce the Managing Director, Supervisory Director, Officer and other representatives of the company present here today: Franz-Werner Haas, our CEO; Pierre Kemula, our CFO; Malte Greune, our Chief Operating Officer and Managing Director nominee; Igor Splawski, our Chief Scientific Officer; Antony Blanc, our Chief Business Officer and Chief Commercial Officer; Craig Tooman, one of our Supervisory Director; and Marco Rau, our General Counsel. I would like also to welcome the other board members who are our colleagues in the Board, Viola Bronsema, Chris Tanner and Mathias Hothum. Also present are our Dutch Legal Counsel, Paul van der Bijl and Sanne Mesu; [ Peter Mau ] our auditor; Mr. [ Rene Frenz ] working with Ernst & Young accountant is present. Before proceeding, I will now give the floor to our General Counsel, Marco Rau, who will discuss certain legal formalities relating to the meeting. Marco?

Marco Rau

executive
#2

Thank you, Jean. For the record, I note that today's meeting has been convened with due observance of all applicable provisions of U.S. and Dutch law and the company's Articles of Association. At this meeting, 141,532,328 shares and the company's capital are represented, which is approximately 75.66% of the company's issued share capital. This meeting will be conducted in the English language. We are live streaming this Annual General Meeting. However, please note that shareholders and others following the live stream will not be able to vote or ask questions. As an aid in the preparation of the minutes of this meeting, the proceedings will also be recorded. I now give the floor back to the Chairman.

Jean Stéphenne

executive
#3

Thank you, Marco. I will now give the floor to Franz-Werner Haas, our CEO, who will discuss certain highlights of our company during the financial year 2021 and first half of 2022. Thank you, Franz.

Franz-Werner Haas

executive
#4

Thank you, Jean. Ladies and gentlemen, a warm welcome to this Annual Shareholder Meeting of CureVac N.V. from us as CureVac. I would like to start my presentation with a brief overview of CureVac. We are a pure RNA company founded in 2000 in Tübingen to develop a new class of transformative medicines based on RNA to open new avenues to enable the body to make its own drugs and improve people's life. Headquartered in Tübingen, Germany, CureVac currently employs more than 900 people globally. Our ordinary shares have been listed on the NASDAQ Stock Exchange since August 2020, and we have been part of the NASDAQ Biotech Index since December 2021. We are continuously expanding our position as central RNA player based on our strong core competencies in product development, a broad technology platform and robust manufacturing. Our proprietary technology platform is based on our fundamental expertise in RNA optimization to improve RNA-induced immunoactivation and protein expression. It forms the basis for our development of innovative RNA vaccines, therapies for diseases with high unmet medical need, fueling our deep clinical development pipeline. In our pipeline, we focus on 3 therapeutic areas: prophylactic vaccines, immuno-oncology and molecular therapies. Strong in-house manufacturing capacities form an important part of our strategy and allow us to match our flexible and versatile technology platform with equally flexible and versatile manufacturing setups. Today, we have got 3 GMP manufacturing units at our German headquarters to provide clinical trial as well as first potential commercial material. In addition, we built an industrial-scale fourth GMP suite also at our headquarters in Tübingen, Germany. We are also developing the RNA printer, our end-to-end solution for automated integrated manufacturing of GMP-grade RNA vaccines and therapeutics. We recently established, for this aim, a fully-owned CureVac subsidiary to accelerate the development of the RNA printer. We have also entered into several strategic collaborations that further support the development of our pipeline and strengthen our business evolution. On the next slide, I would like to discuss one of the CureVac's most valuable assets, our extensive intellectual property portfolio. Over the past 2 years, the development of a safe and effective COVID-19 vaccines in record time based on RNA was accomplished based on a technology that had to be developed over decades of intensive scientific research. As the pioneers in harnessing the medical potential of RNA, CureVac has played and continues to play a critical role in developing many of the innovations that have enabled today's mRNA COVID-19 vaccines. Accordingly, we hold one of the largest and most diverse patent portfolios in this field. Our patent portfolio comprises 120 patent families with more than 1,550 individual patent family members, divided into large clusters that define our core competencies in RNA technology, product development and manufacturing. Our technology cluster encompasses fundamental RNA optimization expertise as well as targeted strategies to improve mRNA immunostimulation and protein expression. Looking at an extract from an independent analysis of the patent landscape related to COVID-19 vaccines, you can see the global patent portfolios of a number of industry players listed according to size and technological strength. While the orange bars represent portfolio size, the blue bars represent the patent asset index, a measure for the technological strength of the portfolio based on the frequency with which a patent is cited in other patent applications and filings. The CureVac patent portfolio shows, by far, the strongest technology relevance in comparison to other RNA players. The CureVac patent asset index is, in fact, almost twice as high as a patent asset index of the next mRNA vaccine company, reflecting the strength of our innovation and our central position in the field of RNA. Based on our ability to develop and manufacture pandemic vaccines together with GSK, we were recently awarded a pandemic preparedness tender by the German government to strengthen the national resilience for the current COVID-19 pandemic as well as future infectious disease outbreaks, which might come. The contracts that the German government concluded with 5 different companies or consortia differentiate between the contribution as a sole manufacturer and as a so-called originator for the delivery and supply of an additional 80 million dosages of a pandemic vaccine than needed. Out of the 5 consortia, the CureVac GSK consortium is one only of 2 originators, delivering 80 million dosages as well if needed. In this role, we plan to provide manufacturing capacity at our German-based industrial-scale manufacturing facility GMP IV, currently in an advanced stage of construction. For the vaccine part of the contract, regulatory validation of the second-generation mRNA backbone, if granted, will provide the basis for rapid progression of pandemic vaccines developed by us and GSK. We plan to prepare both deliverables within the now ongoing 2-year setup period of the contract. Under the contract, the German government will pay CureVac and GSK an annual standby fee to maintain manufacturing capacity at a constant readiness. Upon delivery of the 80 million dosages, payment per dose would be added. We, of course, appreciate the strong commitment of the German government acknowledging our ability to protect public health now and in the future based on our new technology, in our case, the mRNA technology. On the next slide, let me briefly remind you of CureVac's pipeline to show how we are translating our strong mRNA technology expertise into a diverse portfolio of product candidates across the 3 therapeutic areas: prophylactic vaccines, oncology and molecular therapies. In prophylactic vaccines, together with GSK, we have advanced development of CV2CoV, an unmodified mRNA vaccine candidate and the first of our second-generation COVID-19 vaccine candidates to reach a Phase I clinical trial. Also, within the GSK collaboration, we have successfully manufactured and advanced our first and highly differentiated multivalent, unmodified mRNA influenza vaccine, candidate to Phase I clinical trial. According to our broad development strategy, clinical programs with chemically modified mRNA for COVID-19 as well as for influenza are expected later in this year. A comparison of both technologies will allow us to make a data-driven decision for the best suited technology platform for prophylactic vaccines and best suited candidate for the advancement to later-stage clinical testing. Our technology improvements are expected to have a clear readout into our immuno-oncology pipeline, where we can -- where we then plan and build a meaningful portfolio of cancer vaccine candidates. Our recently announced partnership with myNEO and our acquisition of Frame Therapeutics strongly expand our capabilities for the identification and validation of promising tumor neoantigens, driving the development of differentiated cancer vaccine candidates. The third therapeutic area, molecular therapy, we are developing optimized mRNA therapeutics, together with several renowned collaboration partners for the development of antibodies included on RNA and therapeutic proteins intended to treat disease characterized by missing or inactivated proteins. On the next slide, I would like to focus on our progress in prophylactic vaccines and walk you through the Phase I clinical trials that we are conducting in collaboration with GSK for our jointly developed COVID-19 and influenza candidates. For CV2CoV, the unmodified construct, a Phase I dose escalation study was initiated in the U.S. earlier this year in March. CV2CoV encodes for the original SARS-CoV-2 strain to allow us to directly compare immune responses to our first-generation candidates. The recent preclinical study in mice has shown that the second-generation mRNA backbone used in CV2CoV can be flexibly used in a multivalent format and elicits good immune responses against different encoded variants. I will update you on these findings later in this presentation. The Phase I clinical trial is expected to recruit up to 210 subjects and 6 dose groups remaining from 2 to 20 micrograms per dose. It targets 0 positive participants to test administration of 2 doses of CV2CoV as a booster vaccination. For the influenza candidate, an equivalent Phase I dose escalation study was initiated in February this year, and the candidate is a differentiated multivalent vaccine featuring multiple mRNA constructs. It was designed to elicit an immune response against recent antigens of 4 different flu strains that cause seasonal outbreaks. The trial is conducted in Panama and is fully recruited with 240 participants in 5 dose groups ranging from 3 to 28 micrograms per dose. And in accordance with the conventional flu vaccines, it applies a 1-dose booster vaccination. A preliminary set of reactogenicity data across all dose groups confirmed good tolerability with no serious adverse events or other dose-limiting effects up to the highest dose of 28 micrograms. As already highlighted, clinical trials for the respective chemically modified candidates for both programs, flu and COVID, are expected to start later this year. Let me now show you the details of the tolerability profile of our influenza candidate on the next slide. Shown here is the percentage occurrence of the solicitated systematic as well as local -- systemic as local symptoms for all tested dose groups in our Phase I influenza trial. The data are stratified according to predefined age groups, including a younger population between the ages of 18 and 55 and older age group at or above the age of 65. From left to right, the data show adverse events in a scanning older -- scanning order of severity starting from the grade 0 for no side effects to grade 3 to severe side effects. CVSQIV was generally well tolerated among systemic symptoms. There were only a few grade 3 fever events. Notably, there were no grade 3 events in the highest 28-microgram dose group. Overall, all adverse events were transient and rapidly resolved within the next 24 to 48 hours. These first preliminary safety data strengthen our confidence in the increased clinical value of our second-generation backbone. Based on the targeted optimizations, we implemented going from the first to second generation mRNA backbone. On the next slide, I would like to briefly touch on our most recent preclinical COVID-19 study conducted in collaboration with the Friedrich-Loeffler-Institut in Germany. The study assessed CV2CoV, CV2CoV adoptions for Beta or the Delta variant as well as first bivalent candidate combining beta and delta-specific mRNAs in one vaccine candidate. In the study, mice were fully vaccinated with each candidate, including the bivalent candidate, which was composed of only half a dose for each of the 2 combined mRNAs. The graph on the left-hand side illustrates the impact of Beta or Delta variant on neutralizing antibody titers in vaccinated animals. A match between the variant specific vaccination and a tested variant showed best antibody titers that is CV2CoV Beta performed best against beta variant and CV2CoV Delta performed best against the Delta variant. Importantly, to recognize that although the combined CV2CoV Beta/Delta candidate contains only half of the dose per variant mRNA, it elicitates neutralizing antibody titers against both variants that are fully comparable to the full dose of the individual candidates against their matched variant. The middle graph shows that high neutralizing antibody titers are accompanied by robust T cell responses, which is very important. In a separate set of experiments illustrated in the right-hand side of the slide, serum from vaccinated rats were tested against Delta or Omicron variant. Animals were vaccinated either with several controlled vaccine candidates, including a bivalent candidate combining CV2CoV with CV2CoV Delta, and the already discussed CV2CoV Beta/Delta candidate. Utilizing antibodies, titers were generally 3x to 9x lower against Omicron variant and against the Delta variant for all candidates, except for the bivalent CV2CoV Beta/Delta candidate, including Beta mRNA resulted in a twofold increase of neutralizing antibody titers against Omicron compared to Delta only. Taken the preclinical study confirms the capacity of our second-generation mRNA backbone to encode 4 and to flexibly elicit strong immune responses against COVID-19 variants in the monovalent as well as in a bivalent setup. The Delta -- the data -- sorry, the data further suggests that combining mRNAs for different variants has the potential to increase the overall breadth of the immune response as shown in the study for the Omicron variants. I'm now moving on to our oncology area. The next growth driver that we are rapidly advancing beyond our progress we are doing in prophylactic vaccines. While expanding our oncology footprint is based on mastering similar medical challenges as an infectious diseases, cancer is a complex and individual disease and antigens vary greatly between the different patients. To address these challenges, we have started to execute on our oncology strategy based on 3 strategic pillars. First, apply our learnings, particularly from the second-generation mRNA backbone to validate and optimize our technology for different classes of antigens and a focus on strongly T cell-mediated immune responses. Second, build a meaningful pipeline of new cancer vaccine candidates based on assessing novel antigen classes, leveraging the agility and the speed of the mRNA printer, our modular solution for integrated and automated manufacturing of GMP-grade mRNA vaccines and therapeutics. And finally, add highly complementary technology platforms to expand our expertise for efficient antigen discovery as well as new avenues for immunostimulation and vaccine design, including formulation. We have recently demonstrated our execution on these strategic pillars with the acquisition of Frame Cancer Therapeutics, a Dutch private company focused on the advanced genomics and bioinformatics to identify novel neoantigens across different cancer types. Furthermore, we have initiated a strategic partnerships with myNEO, a Belgium biotech company, focused on the development of cancer immunotherapies. Highly synergistic technologies of both companies target the identification and validation of new classes of tumor antigens based on advanced data analysis platforms. Within the acquisition of Frame Cancer Therapeutics, we bring a strong complementary bioinformatics platform in-house that expands and supplements our existing bioinformatics expertise. The Frame Cancer Therapeutics platform combines detailed genetic and gene expression data of tumors to identify so-called frame shifts. Frame shifts result in novel tumor proteins that are absent in healthy tissue. Since these proteins can be recognized by the immune system as foreign, they have the potential to trigger a defense immune response, and they thereby serve as templates for mRNA-based cancer vaccines. MyNEO also utilizes a broad range of data on genomic alterations seen in tumors to identify novel classes of tumor antigens. On top of their strong antigen discovery capabilities, myNEO applies artificial intelligence methods to predict the immunogenicity of identified antigens. By incorporating new ranking methodologies for identification of antigens, their technology enables the selection of antigens with the highest probability of success for potential clinical testing. Both synergistic platforms strongly complement our expertise in mRNA technology and manufacturing. We are convinced that the continuous screening, identification and validation of novel and potentially promising tumor antigens provides a powerful antigen discovery engine to support the building of a meaningful pipeline of cancer vaccine candidates. Flexible and rapid access to mRNA encoding new antigens will be enabled by the RNA printer, which continues to perform an integrated part of our strategy as we look to further accelerate our oncology focus. Let me now update you on the latest advances in the mRNA printer. The already -- as already mentioned, the system is expected to play an important role on the planned expansion of our oncology pipeline. However, the scope of the RNA printer goes much further. In March this year, we established a fully owned CureVac subsidiary to accelerate the development of the printer under the leadership of Markus Bergmann, the Managing Director of the unit. The dedicated operational infrastructure will unlock the broad scope of the system as a product-enabling platform, not only for academic and commercial partners, but also for CureVac itself. Designed for flexible smaller scale quantities, the RNA printer is expected to facilitate broad access to mRNA for the rapid translation of science, to products and to open new avenues for the point of and pandemic preparedness as well as personalized mRNA-based cancer vaccines. It's all about speed. The system is currently in regulatory review and a decision by the regulatory authorities is expected still this year. Let me now quickly summarize the key takeaways from today's presentation. In 2021 and in the first half of 2022, we have made significant process in each of our core competencies, including technology, product pipeline and manufacturing, propelling us forward in our corporate development. Our 3 core competencies are built on one of the largest and most diverse IP portfolios, which enables our future ability to innovate and secures our competitive situation and position as a central RNA player. A total of 4 clinical trials will have begun in prophylactic vaccines in the year, in COVID-19 and influenza, 2 of which have already been initiated and will provide wealth of clinical data to advance and validate our second-generation mRNA backbone, covering unmodified, modified mono- and multivalent mRNA approaches. The recent award of a pandemic preparedness tender by the German government signals strong confidence in the potential of mRNA and CureVac's ability to contribute our proprietary technology and manufacturing expertise to protect and cover human health. We are transferring our experience from our technology advances to our next growth driver, which is oncology, where we are preparing to build a meaningful pipeline based on the strategic -- on strategies for novel antigens and complementary platform technologies. The recent acquisition of Frame Cancer Therapeutics and the strategic partnership with myNEO will strongly accelerate our oncology focus. And lastly, our cash balance positions us well to execute on our programs and priorities in 2022 and beyond. And now I'll give the floor back to you, Jean, as the Chairman. Thank you.

Jean Stéphenne

executive
#5

Thank you, Franz. I will now allow questions from the audience. Are there any questions in the room? If not, we -- Franz, we will proceed to the questions sent by the shareholders in advance of this meeting. Can you read this question and answer. Thank you.

Franz-Werner Haas

executive
#6

Thank you, Jean. The first question is around CureVac is -- or does CureVac N.V. have its own operational business. And the answer is no, it has not. It is the entity as a holding for the purpose of the stock listing at NASDAQ. The second question with this regard is what were the main reasons for cancellation of the Dutch N.V. And the reason for this cancellation was only to have a better access to the U.S. market which is then via the Netherlands to be regarded as a standard facility to enable that. Questions with regard to research and development. In which other areas of research outside COVID-19 vaccines, cancer medicine and individualized medicine is CureVac active? And the answer is, as you could see from our pipeline, CureVac focuses on 3 therapeutic areas where we believe RNA truly can make a difference, which is prophylactic vaccines, oncology and molecular therapies. In prophylactic vaccines and beyond COVID-19, we work on a broad range of infectious diseases. This is based on our GSK infectious disease collaboration and franchise, which covers 5 indications, of which flu has already been initiated next to other indications. Second question, what are the market expectations behind the development in Phase II and III? The answer is our current focus is on the regulatory validation of our second-generation mRNA backbone. Once we can advance a selected COVID-19 vaccine candidate to the Phase II to III, we would proceed to a potential regulatory approval and subsequent commercial product launch. Generally, COVID-19 vaccines still need innovation and improvements to address, for example, questions about the duration of the protection and the storage stability. Next question, did the development of the 3 well-known companies, BioNTech, Moderna and CureVac take place completely independently or of each other and do the stakeholders know each other? The answer is, if there is an origin of the 3 companies, you could say that CureVac is indeed the origin founded in 2000 and 8 years before BioNTech was founded and 10 years before Moderna was founded. CureVac thereby helped to pave the way certainly with the innovation patents and papers for this technology to play a key role in fighting the COVID-19 pandemic. And yes, the 3 companies and the players, we know each other, and we already founded in 2013 the first mRNA conference, which is an annual conference. And of course, we know and deeply respect each other and we value the competition that accelerates innovation. Now questions around the founder of CureVac, which is Ingmar Hoerr. And the question is -- the first question is what is his function today? Ingmar today has no function at CureVac. And since his illness-related retirement from CureVac as a CEO in March 2020, nor does he perform any other function within CureVac. Next question is regarding any potential sale of Ingmar Hoerr, which has taken place, whether this is in connection with the first-generation vaccine and the data which came out mid last year, and we only can say that we have no knowledge about this one. Since the time of his departure in March 2020, Mr. Hoerr had no access to confidential information from the company, and please note that the stock trading, based on confidential company information is certainly punishable by law. And the next question, what Mr. Hoerr is doing today? We have no knowledge and I cannot comment on this one, especially as it is a personal matter. These were the questions for me.

Jean Stéphenne

executive
#7

Thank you, Franz. We will now proceed to the next item on the agenda. So the second item on the agenda is the discussion of the company Dutch statutory annual report over the financial year 2021. Our annual report has been published on our website for public inspection. I will now give the floor to Pierre Kemula, our Chief Financial Officer, who will discuss the financial information included in the statutory annual report over the financial year 2021. The floor is yours, Pierre.

Pierre Kemula

executive
#8

Thank you, Jean. Good morning, and good afternoon to everyone in Amsterdam and those following on the live stream. Looking at the profit and loss statement for the CureVac Group. Our revenues for the 12 months of 2021 increased by EUR 54.1 million to EUR 103 million compared to the same period in 2020. The increase was mainly driven by GSK collaborations and the termination of the Boehringer Ingelheim collaboration. Operating loss for 2021 increased by EUR 302.5 million to a total of EUR 412.3 million compared to the same period in 2020. This was mainly driven by R&D activities and the preparation and supply of CVnCoV, our first-generation COVID-19 vaccine candidate, which we withdrew from the regulatory approval process in October of last year. Cost of sales increased from EUR 14.2 million for the full year 2020 to EUR 238.2 million, primarily due to the recognition of expenses related to CMO setup activities and, to a lesser extent, write-offs related to inventory. The overall increase in expenses was partially compensated by income related to release of governmental contract liabilities, related to upfront payment from the European Commission and the grant of the General Federal Ministry of Education and Research amounting to a total of EUR 574.5 million. Financial results increased by EUR 18.9 million to minus EUR 0.2 million over the 12 months of 2021. Net financial loss was based on negative interest rates on cash, and we hold liquid funds to support the development and manufacturing activities of CVnCoV and CV2CoV, our next-generation COVID-19 vaccine candidate, developed in collaboration with GSK. It was almost fully offset by the foreign exchange gain. On the next slide, I'd like to take a little more detailed look at the full year 2021 revenues that amounted to EUR 103 million, as already highlighted. The increase was primarily driven by revenues from our GSK collaborations, providing a total of EUR 74.3 million. The broad infectious disease collaboration contributed EUR 47.1 million, of which EUR 27.3 million were recognized as upfront in milestone payments. The COVID-19 collaboration contributed EUR 27.2 million, of which EUR 24.4 million were recognized as upfront in milestone payments. Following the termination of the Boehringer Ingelheim agreement, which we've been signed in 2014, the remaining contract liabilities related to the upfront payment was fully recognized and provided a revenue contribution of EUR 14 million. And in addition, there was an option fee payment of EUR 12 million, which was fully recognized. Basically, so for the full year 2021, this led to a total of EUR 26 million being recognized as revenue coming from the Boehringer Ingelheim collaboration compared to EUR 1.9 million for the full year 2020. Now moving on to more detail on the cost of sales. In 2021, cost of sales amounted to EUR 238.2 million, the increase of -- sorry, EUR [ 224 ] million compared to the full year 2020 was, of course, driven by EUR 145.5 million related to the recognition of expenses for third-party services. The total includes CMO setup activity expenses as we created our network for the first-generation vaccine candidate, CVnCoV of EUR 129 million. To a lesser extent, cost of sales was impacted by EUR 46.3 million of material costs, which included write-offs of EUR 33.8 million related to the inventory in the period preceding the withdrawal of CVnCoV from regulatory approval. Personnel costs added EUR 22.2 million, while amortization and depreciation, driven by write-off of CMO manufacturing equipment, added EUR 21.3 million to the cost of sales. On the next slide, let us have a closer look at the R&D expenses. In 2021, R&D expenses were mainly driven by EUR 531.8 million of third-party services, composed of cost of EUR 315 million incurred to CROs for conducting the clinical trials or clinical studies of CVnCoV. EUR 162.4 million were also incurred in R&D for CMO services in recognition of select settlement costs following the withdrawal of CVnCoV from regulatory review. A further EUR 233 million -- sorry, EUR 232.3 million of material expenses included write-off of CVnCoV related inventory, following CVnCoV withdrawal from regulatory review. Including further expenses, this led to a total of EUR 815.9 million of R&D expenses for the full year of 2021. Now looking at the balance sheet of CureVac Group on the next slide. Assets showed a net decrease year-on-year of EUR 353.1 million from EUR 1.51 billion at the end of 2020 to EUR 1.16 billion at the end of 2021. Noncurrent assets increased mainly driven by the ongoing buildup of our industrial scale manufacturing plant, GMP IV, that Franz talked about as well as an increased CapEx for our CMO network. In current assets, our increase of inventory of raw material as well as increase in the trade receivables mainly related to GSK was contrasted by a decrease in cash. The decrease in cash and cash equivalents was mainly related to CVnCoV, but was partially compensated by the sale of shares in February 2021. A milestone payment by GSK and payment from the grant of the German Federal Ministry of Education and Research. The decrease in equity and liability was driven by noncurrent liabilities, financial liability decreasing following the repayment of the financing received by the EIB or European Investment Bank entered into July 2020. Additionally, contract liabilities strongly decreased with the release of several payments, including upfront payment from the European Commission for the CVnCoV advanced purchase agreement, the grant by the German Federal Ministry of Education and Research, the upfront in milestone payment from Boehringer Ingelheim collaboration that we just discussed and the partial release of GSK upfront in milestone payments. In equity, the increase of capital reserves was due to the issuance of new shares for EUR 403.4 million was compensated by negative P&L results of EUR 411.7 million. Current trade liabilities and other trade liabilities increased as a consequence of increased accounts payable volumes and CMO-related commitment accruals. Let me now turn over to the financial statement of CureVac N.V., so the Dutch topco company, our holding company located here in the Netherlands. CureVac N.V. only acquired operational activities at the time of CureVac's IPO, which took place in August 2020. So therefore, please note that the given numbers reflect the comparison from August to December 2020 versus the full year of 2021. In 2021, CureVac N.V. posted a net operating gain of EUR 3.6 million. That gain was mainly driven by cross charges of personnel expenses, legal services and insurance to the operational CureVac companies. Personal expenses cover the member of the CureVac N.V. Management Board and were incurred since October 2021. CureVac N.V. posted a financial gain of EUR 2.3 million, driven mainly by the gain of currency interest related to CureVac AG loan. Lastly, the N.V. is the parent company of the CureVac Group. It consolidated the share of loss of the subsidiaries after tax that amounts to EUR 418.9 million, mainly driven by efforts to the development of CVnCoV and including all CVnCoV-related wind-down activities resulting in CureVac N.V. loss of close to EUR 412 million for the full year 2021. On the balance sheet side of CureVac N.V., noncurrent assets, the investments -- so these are the investments in the subsidiaries were decreased by the operational losses of respective subsidiaries, right, and the settlement of share-based payments on behalf of the AG. This was partially compensated by capital contribution into the CureVac AG. Current assets were driven by intercompany receivables, a VAT reclaim to the tax. So the receivables of reclaim for the tax authorities and cash in the N.V. The equity and liability side of the balance sheet is mainly driven by capital increases due to the follow-on financing in the first quarter of last year, compensated, of course, by additional accumulated loss that we discussed before. In addition, the liability increased due to higher intercompany payables. With this financial overview, I wish to thank all of you and hand back to the Chairman. Jean?

Jean Stéphenne

executive
#9

Thank you, Pierre. I will now allow questions from the audience. Are there any questions? If there are no questions from the audience, Pierre, can you proceed to the questions sent by the shareholders in advance of this meeting.

Pierre Kemula

executive
#10

Sure. Thank you, Jean. So we received a handful of questions regarding shares and other topics. I'll go through the questions. The first question is, please explain the equity stake of shareholders regarding national companies so CureVac AG and CureVac N.V. So it's important to understand that all the shares which are available are issued by CureVac N.V., right? So for a bit of history, basically, the former CureVac GmbH converted into a stock corporation of CureVac AG in 2015. And of course, as the IPO in 2020 took place, all shareholders of the AG basically transferred their shares into the N.V., which became the sole parent company of CureVac AG. The second question is, in what form are the shares of the AG traded on the stock market. So there's no shares traded from the AG, right? It's just the N.V. and these are common shares, basically. They are not ADRs. Question 3 is what were the main reasons for IPO in the U.S.? I mean we recognize that probably the deepest investor market on biotech front is in the U.S. So having access to a market which everybody has access to, but also the pool of capital for us made a lot of sense. Question number four. On which other exchanges apart from NASDAQ does CureVac have a listing? We do not have a listing beyond NASDAQ. Question five. Is a listing on the German Stock Exchange intended soon? So while double listings are feasible, right? At this stage, there is no such plan. So we're moving to another set of subgroup of questions. So raising capital for start-ups and companies in the field of biotechnology. So the question basically, the first question here is, what are the reasons for a company like CureVac to do an IPO in the U.S. and not to raise capital on German stock? And what would have been -- what would have to change in the German capital market so that start-up companies in the field of biotechnology would actually list in Germany? It's a pretty broad question. I think we answered partly to that question in the previous question. But fundamentally, as Franz explained earlier on, the construct of having a topco in Holland to especially list in the U.S. is to have access to more open corporate law, right, where there is easier access to capital here than as the law is in Germany today. So second question is what essential criteria would a German stock exchange need to meet for CureVac to do an IPO in Germany? I think this is basically the same type of answer that I just gave. We have a question here that the Federal Government provided EUR 10 billion for a future fund at the KfW. What state did CureVac benefit from? So here, we had great support from the German Ministry of Education and Research for which we had a grant of close to EUR 200 million over to help us during the COVID efforts. We have questions on shareholder structure as well. So the first question is, are the individual shareholders known to the AG and in the case of registered shares. So the AG has only one shareholder, which is the N.V. as we saw, right? And within the N.V., what is the main shareholder structure and holdings? So we have a dievini holding, which basically owns about between 45% and 46% of the company that is followed basically by the KfW's, the German government for close to 16% ownership. And we have GSK, of course, which invested in the company before the IPO in as close to 8% of the company. So I guess the question that is next to this one is what is the free float? We believe we have a free float of around 30% of the total amount of shares, which is 188 million shares. And there's a question on the national, I would say, breakdown structure of shareholders? So we try to follow that. Of course, we have a majority here, I mean in Europe, yes, but in Germany with the main shareholders, right? And when it comes to the float, we have shareholders basically from the whole world, where we have shareholders from Europe, we have shareholders from the U.S. and beyond. In terms of Investor Relations now, to what extent do the common shares of CureVac AG, which can be traded on NASDAQ differ from shares on the -- to German law. I think a share is a share and here there's no difference. It's more the ability of companies to raise capital. We change between different exchanges and different local jurisdictions. Second question, to what extent does the AG ensure that the shareholders receive conventional information on its own page, right? So this is a very key question. I think as a listed company, we, of course, have to disclose all material information. We have an up-to-date website. We have filings with the SEC. Every time we have something, it's actually [ foundable ] as well at the SEC portal. And we also have active social media as well. So I think we can also sign up for one of these e-mails so that if you want to have information without doing anything is to sign up to our e-mail list. And there's a last question, I believe, on financial numbers, is how high is the capital investment in the company since it was founded? So here, we are referring to the amount of capital that was laid -- no, before and after the IPO, and that amount is approximately EUR 1.7 billion and is reflected in our capital reserve. Thank you very much.

Jean Stéphenne

executive
#11

Thank you, Pierre, to address these important questions. I would like now to ask Marco to address the latest question and remainder question that have been sent, Marco?

Marco Rau

executive
#12

Yes. Thank you, Jean. Yes. So some further questions we received on the AGM organization and process. Question number one, why does CureVac not allow questions during the AGM? And [ was it due ] to the COVID-19 restrictions? Well, CureVac, as you see, does allow questions during the AGM from on-site participants and all investors were able to submit questions in the run-up to the AGM. And we are, as you see, happy to respond to these. Question number two, how does the AG ensure that the shareholders receive the invitation to the Annual General Meeting in good time and in what form? So first thing, as Pierre already mentioned, so the traded shares are of those of CureVac N.V., our Dutch topco and we work with a professional external service provider in the U.S. which has specialized in logistics of AGMs to send these and communicate the materials to our shareholders. Invitations are sent out via postal mail in the U.S. as well as electronically via the dedicated international banking system to all our shareholders. And of course, we also post all AGM materials on our website, which anyone can access. And we also post this, of course, in the Dutch Gazette. Moving then to the third question. How does the AG intends to hold the Annual General Meeting in the future after the expiry of the COVID-19 loss? Well, driven by necessity and following the COVID-19 pandemic, the world has become a lot more digital as we see also today. We don't think that this development will actually should be reversed. And as with the new and flexible hybrid working formats you see today, we believe that the hybrid AGM format will be also the concept of the future. So allowing, of course, shareholders to attend here in person and being also online. And then further set of questions. Number four, please take a position on place in the country of the AGM of CureVac N.V.? Well, under Dutch law, the AGM of CureVac N.V. has to be conducted in the Netherlands as we are simply a Dutch N.V. And this is the end on this one. The language of the AGM? Well, our language of the AGM is English to ensure the best communication with our international shareholder base, which we are, of course, very proud of. The type of event, physical or virtual? As already said, while currently sort of as a hybrid event and due to the precautions in view of the ongoing COVID-19 pandemic, our future AGMs will probably also stay hybrid. This is it.

Jean Stéphenne

executive
#13

Okay. Thank you, Marco. We will now proceed to the next agenda item. Agenda item #3. The next agenda item is just the adoption of the company Dutch statutory annual account over the financial year 2021. These accounts reflect the financial information that our CFO just highlighted in his presentation about the previous agenda item. Are there any questions here from the audience? If no, we can proceed to the voting of this agenda item, and I will determine the voting procedure for this meeting. All shareholders who have registered timely and are attending this meeting in person have received the electronic voting device and personal logging details and should now be logging in the online voting platform. Please raise your hand if it's not the case and you need assistance. When the voting for a specific voting item is open, you can submit your vote via the electronic voting device. Please vote for if you would like to vote in favor of the resolution. Please vote against if you prefer to vote against the resolution, and you can select abstain if you want to abstain from voting. After each vote, I will announce the voting result and determine whether the resolution has passed. Only the vote for and against will be counted towards the voting result. Abstention will not be counted to votes cast in accordance with the rule provided in the Article of Association of CureVac N.V. If there are no future questions, I will put this agenda item for voting. I open the voting. [Voting]

Jean Stéphenne

executive
#14

I can close the voting. Thank you. The vote has passed with the requisite majority of this votes cast. We will now proceed to the next item on the agenda. The next item on the agenda is the explanation of the company's dividend and reservation policy as set out in the explanatory notes to the agenda for today meeting. Are there any question on this agenda? If there are no future questions, we will proceed to the next item of the agenda. The following item on the agenda is the release of one company Managing Director from liability from the exercise -- for the exercise of their duties during the financial year 2021. Are there any question on this topic? As there are no questions, I will put this agenda item for voting. [Voting]

Jean Stéphenne

executive
#15

We close the voting. Thank you. The vote has passed with the requisite majority of the votes cast. We will now proceed to the next item on the agenda. The following item on the agenda is the release of the company's Supervisory Board from liability from the exercise of the duties during the financial year 2021. Are there any question on this topic? If not, I will put this agenda item for voting. I open the voting. [Voting]

Jean Stéphenne

executive
#16

I close the voting. Thank you. The vote has passed with the requisite majority of the votes cast. We will now proceed to the next item on the agenda. The next item on the agenda is the reappointment of Franz-Werner Haas as a Managing Director and Chair of the Management Board. The current term of office of Dr. Haas will end today after this meeting. Therefore, the company's Supervisory Board has made a binding nomination to reappoint Dr. Haas as Managing Director of the company and Chair of the Management Board for a period ending at the end of Annual General Meeting of shareholders of the company to be held in year 2023. If appointed at today meeting, Dr. Haas will continue to serve as company Chief Executive Officer. Future information of Dr. Haas is included in the explanatory note to the convocation notice for this meeting. Dr. Haas is present today meeting. I will now allow questions from the audience. As there is no question on this topic, I will put this agenda item for voting. I open the voting. [Voting]

Jean Stéphenne

executive
#17

I close the voting. Thank you. The vote has passed with the requisite majority of the votes cast. And congratulations and thank you, Franz. We will now proceed to the next item on the agenda. The next item on the agenda is the appointment of Malte Greune as Managing Director. The company's Supervisory Board has made a binding nomination to appoint Dr. Greune as a Managing Director of the company for a period ending at the end of Annual General Meeting of shareholders of the company to be held in the year 2024. Dr. Greune will serve as the company Chief Operating Officer. Future information on Dr. Greune is included in the explanatory note to the convocation notice for this meeting. Dr. Greune is present at today meeting. Malte, can you introduce yourself briefly? Thank you.

Malte Greune

executive
#18

Thank you, Jean. My name is Malte Greune. I currently serve the function as Operations Head, covering the functions, technical development, clinical and commercial manufacturing, quality engineering and supply chain. I have 25 years of experience in the industry. And up to today, I have led 36 sites in 15 different countries. I have managed organizations as GM, Division Head, VP, Senior Vice President and Board Member; and organizations up to the size of 4,400 employees and the [ laboratoy ] companies I've served were Schering-Plough, Merck U.S. and Sanofi. I've been responsible for drug substance as well as drug product as well as investment programs and supported in the last 10 years within the area of my responsibility at Sanofi, the launch of 10 new products. Major therapeutic areas covered were vaccines, diabetes oncology, success in operations all about people. And today, I feel honored to be part of the mRNA company and look forward to continue to support this successful journey of CureVac.

Jean Stéphenne

executive
#19

So thank you, Malte and congratulations. I will now allow questions from the audience. Are there any questions on this topic? As there are no future questions, I will put this agenda item for voting. The voting is open. [Voting]

Jean Stéphenne

executive
#20

I close the voting. Thank you. The vote has passed with the requisite majority of the vote cast. Congratulation Malte, and thank you and good luck for your future role in CureVac. We will now proceed to the next item on the agenda. The next item on the agenda is the appointment of Klaus Schollmeier, a Supervisory Director. Dievini as defined in our Article of Association, which is our majority shareholder has made a binding nomination to appoint Dr. Schollmeier, a Supervisory Director of the company, for a period of 3 years ending at the Annual General Meeting of shareholders of the company to be held in the year 2025. Future information on Dr. Schollmeier is included in the explanatory note to the convocation notice for this meeting. If appointed today meeting, Dr. Schollmeier will receive compensation for his service as Supervisory Director, consistent with the compensation package approved by the company's General Meeting held on 24th of June 2021. Unfortunately, Dr. Schollmeier could not be present at today's meeting due to other personal commitment. I will now allow questions from the audience. If there are no questions on this topic, this item is open for the vote. [Voting]

Jean Stéphenne

executive
#21

I close the voting. Thank you. The vote has passed with the requisite majority of the vote cast. We'll now proceed to the next item on the agenda. Agenda item 10. The next item on the agenda is the reappointment of Craig Tooman as Supervisory Director. Craig Tooman is present in this room. The company's Supervisory Board has made a binding nomination to reappoint Mr. Tooman as a Supervisory Director of the company for a period of 3 years ending of the Annual General Meeting of shareholders of the company to be held in the year 2025. Future information on Mr. Tooman is included in the explanatory note to the convocation notice for this meeting. If appointed today meeting, Mr. Tooman will receive compensation for his service, Supervisory Director consistent with the compensation package approved by the company's General Meeting held on 24th of June 2021. Mr. Tooman, who is present today, will thus continue to help the company to succeed. I will now allow questions from the audience. Are there any questions for this topic? If there are no future questions, I will put this agenda item for voting. I open the voting. [Voting]

Jean Stéphenne

executive
#22

I hereby close the voting. Thank you. The vote has passed with the requisite majority of the vote cast. We will now proceed to the next item on the agenda, item 11. The next item on the agenda is the appointment of Debra Barker as Supervisory Director. The company's Supervisory Board has made a binding nomination to appoint Dr. Barker as a Supervisory Director of the company for a period of 3 years ending of the Annual General Meeting of shareholders of the company to be held in the year 2025. Future information on Dr. Barker is included in the explanatory note to the convocation notice for this meeting. If appointed today meeting, Dr. Barker will receive compensation for her service as Supervisory Director, consistent with the compensation package approved by the company's general meeting held on 24th of June 2021. Unfortunately, Dr. Barker could also not be present at today meeting due to other commitment. I will now allow questions from the audience. If there are no questions on this topic, I will put this agenda item for voting. I open the voting. [Voting]

Jean Stéphenne

executive
#23

I close the voting. Thank you. The vote has passed with the requisite majority of the votes cast. We'll now proceed to the next item on the agenda, item #12. The following item on the agenda is the appointment of KPMG Accountant N.V. as the company independent auditor for 2023 for purpose of Dutch law. I will now allow question from the audience. As there are no question on this topic, we can proceed to the vote. I open the voting. [Voting]

Jean Stéphenne

executive
#24

I close the voting. Thank you. The vote has passed with the requisite majority of the votes cast. We will now proceed to the last item on the agenda. If anyone present has any question, he or she would like to raise, you have the opportunity now to do so. There are no future question. I can now close the meeting. Thank you for your attendance and participation in this meeting. Thank you.

Read the full transcript via the API

You're viewing the first half of this call. Get the complete CureVac N.V. transcript — plus 255,000+ transcripts from 12,000+ companies, speaker segments, AI summaries and full-text search — through the EarningsCalls.dev API.

Get the API View API docs →

This call discussed

For developers and AI pipelines

Programmatic access to CureVac N.V. earnings transcripts and 255,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.