Q4 2020 CureVac NV Earnings Call
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Greetings and welcome to the curve a fourth-quarter and full-year 2020 Financial results and business updates conference call at this time. All participants are in a listen-only off a question and answer session will follow the formal presentation anyone's require operator assistance during the conference, please press zero on your telephone keypad off as a reminder. This conference is being recorded. It is now my pleasure to introduce head of investor relations. Thank you. You may begin.
Thank you. Good morning. Good afternoon and Welcome to our conference call. My name is Sarah and I'm the vice president of investor relations at cubic. Please let me introduce to the speakers off on the call with me a function of the Chief Executive Officer of cubic Jackie Mula our Chief Financial Officer and has not formed our interim Chief development officer. Took the key of a chief technology officer will be available for the Q&A session after the presentation.
Please note that this call is being webcast life and will be archived on the events and presentations section under investor relations on our website before we begin a few forward-looking statements the discussion responses to your questions on this call reflect Management's view as of today Thursday, April 15th, 2021. We will be making statements and providing responses to responses to your questions with the state. Oh intentions leaves expectations or predictions of the Future these constitute forward-looking statements for the purpose of the Safe Harbor Provisions, these statements involve risks and uncertainties that could cause actual results to differ materially from those projectors.
Do you like disclaims any intention or obligation to revise any forward-looking statements? For more information, please refer to our filings with the Securities and Exchange Commission. I will now turn the front the call back. Thank you, Sarah ladies and gentlemen warm. Welcome to the call from all of us here at kirok 2020 was the year of fundamental corporate for confirmation, which has propelled us forward in our cruise from a research orientated biotech company into an integrated commercial biopharma company.
We Believe
The progress we made in developing the company but also in advancing our COVID-19 vaccine program based on our differentiated mRNA technology has created a solid foundation for continued age within 20 21. Let me Begin by giving you an overview of selected key highlights and twenty twenty and of the success we were able to achieve since the beginning of this year and the clinical development our leads COVID-19 vaccine candidates CV and cough. We have successfully completed enrollment for our to central clinicaltrials face to a trial with over 670 participants and our people face to be clinical trial with over 40,000 subjects recruited.
For our face to a trial the occurrence of a high number of COVID-19 cases prompted us to submit a protocol amendment to introduce secondary endpoint for vaccine efficacy. I believe additional data in the total population by particularly in a group. It's above 60 will be highly complementary to the data of the face to be 3,000 the interim analysis, which is expected in the second quarter of this year.
We are further expanding the COVID-19 vaccine program and are expecting to initiate three clinicaltrials soon. The trial will evaluate OneDrive offer you a team, you know responses in different age groups. The flu co-administration trial is the second and a third trial looking at a selected, body and comorbidities or rigor will tell more about these trials later in this presentation in oncology. We announced the expansion of the ongoing Phase 1 trial of our lead assets CV 8102 in advanced melanoma following the promising results announced in the third quarter of 2020 the extension of the phase one trial aims to confirm the safety and preliminary if I could see of 5802 at the selected dose of six hundred micrograms.
Our strategic Partnerships with buyer risque and the UK government the letter being under Advanced negotiations progressing well and continue to accelerate the development of our first and second generation COVID-19 vaccines, both of which will be Advanced to also address new virus variants.
To rapidly to readily Supply CV and cough. Our integrated European manufacturing network is rapidly expanding with experienced cdmo partners and the additional support of our strategic Partners buyer and GSK. We reaffirm our anticipated manufacturing capacity for 20 21 of up to three hundred million dollars is produced and have raised our manufacturing guidance for 20 22 to 1 billion doses of golf on the financial side. We close 2020 with a favorable cash mission of 1.32 billion euros since then we were able to raise an additional five hundred Seventeen million dollars if you use shares in a successful follow along to our IPO in August last year. We'll later walk you through the financial details.
I'm not.
On slides five of the presentation to briefly highlight the fundamental corporate transformation that has taken the company to a new level in 2020 and is continuing in 20 21 months since initiation of our COVID-19 vaccine program at the beginning of 2020. Our business has evolved as a clinical development of the lead vaccine candidates wage accelerated. We are going to we we are growing the talent base in every area of the company and are rapidly building up commercial infrastructure and expertise under the leadership of Anthony blow who joined us as Chief business and Commercial officer in December 2020.
In twenty-twenty we secured commercial commitment from the European commission for 225 million doses of golf with the option of an additional eighty million dosages to be delivered. We are executing on our financial strategy and in 2020, we're able to secure significant funds through private life through a private financing round directly followed by our NASDAQ listing as well as a crown from the German government in addition. We received a 450 million years upfront payment from the European commission as part of the order for the 225 million vaccine dosages since then we were able to add another $570 million u s. Thursday through a successful IPO follow-on financing
We believe that this progress has put us into an optimal position to further grow the business and accelerate our corporate transformation and development from a biotech into a commercial biopharma company.
Bookflight 6 you can see how the corporate transformation is based on a solid foundation of our 20 years of scientific expertise and differentiated mRNA Technologies. Both of which continue to be the court drivers of our success as a biopharma company, the rapid build-up of our commercial organization is expected to enter the next month stage with a plant Lawns. Of course as our first commercial product and the anticipated generation of revenues both of which are contingent on regulatory approval to expedite our commercial development. We have already started to prepare commercial territories inside and outside the European Union while also planning to Leverage The International reach of our partners by our country is K moving into twenty Twenty-One. We continue to to transform as a business and move to towards executing on our equipment dead.
To deliver a safe and effective COVID-19 vaccine to achieve this goal. We Leverage The solid foundation. We have laid in 2022 first month seed in the clinic in the second quarter of this year. We expect to deliver clinical result from our people face to be three trial into analysis that we expect will enable us to finalize the ruling submission to email to allow for a potential conditional approval and shortly thereafter second to create manufacturing capacity.
Internally, we are driving.
What's the optimization of origin P3 manufacturer and sweet here in tubing and and the progressive built up of our large-scale GMP for manufacturing site also him doing external We are continuing to build our Broad and integrated European manufacturing network with experienced partners and with additional support from our strategic Partners buyer and GSK. We are already producing CV and cuff dosages at risk as we speak to readily Supply at the time of a potential Market authorization.
Service to deliver the vaccine. We are adding operational muscle and execution power with the partner buyer to accelerate the development Market Readiness and Market access Samsung TV nu8000 on the basis of advanced second-generation COVID-19 vaccine.
Let me now hand over to our interim Chief development officer to guide you through our clinical program and program updates.
Thank you friend.
I'm sorry 8 please let me remind you of a broad and diverse pipeline which bills on a differentiated MRA technology platform in 20-25 much as a key technology in the fight against the COVID-19 from dentist. However, we believe that the technology is only in its infancy and has great potential in a broad range of medical education and well-connected represent account to explore his full potential of em on a focus our preclinical and clinical scientist receives that area in which we think we can make a difference or connecting screen protectors. You have therapy and oncology and brought into our peaceful Life by
Kinetic that pipeline is left out of COVID-19 Mexican beach candidate tea and coffee which we are advancing together with our partner.
A large part of a person in collaborations GSK initial partnership be entered into in July 10:25 a.m. On 16th and monoclonal antibodies protectors diseases and it was recently expanded to also include COVID-19 aquavit 1980s pay already jointly developing second-generation vaccines based on new amount of Excellence. Second-generation vaccines will also accept virus variance and new vaccines for month of March 16th to provide Advanced solutions by encore demek.
You know, our candidate is Cindy 8102. I mean, you know more later activating PLS 703 guy for which we presented updated phase one data boost of cancer conference in November 2017 in February twenty one who initiated the expansion of a phase one trials at a selected those of took my program in patients with Advanced. Melanoma.
In addition to collaborating with Chris Biotherapeutics and Jenna. We have also collaboration to the scale and Harvard University and a focus on lung diseases and ocular disease. Y'all also developing of the Fireside formulation technology.
I'm almost like mine show you a detailed overview of COVID-19 program including the studies that account be under way as well as the status here planning to purchase.
Special stuff too Slim Shady COVID-19 protection. We expect to initiate three new clinicaltrials between 12 for high-risk populations to suggest, Please administer of TBS cost and the license plate prevalent influence of excellence and a Facebook page for deep characterization of immune response in the age group of 18 to 45 in comparison to the age group of about 65.
All the H related data is expected to be generated by a protocol amendments of the ongoing safe to a drive-in pillow and Panama enroll adolescent birth.
Data, and the management was fired on March of 2017 Road and initial cohort approximately fourteen adolescence participants in. I just expect us to stop the equipment to walk and state functions on a successful secular view. It is Lance to fill the environment in this age group and there's extensive selection American countries develop Europe.
Let me go into a little more detail about individual trial.
Okay, sweetie trial including have two systems to the select. The Chrome abilities is expected to begin very shortly as comorbidities represent a high risk factor for cvd across COVID-19 infection. We aim to evaluate the safety we opportunity and human Ingenuity of VPN Carfax information and he's vulnerable populations selected from each other in the file includes obesity chronic cardiovascular disease chronic kidney disease chronic obstructive pulmonary disease or c o p p h i v type two diabetes mellitus and possibly an oil change stations to try it is planned as a multi-center trials to be conducted in Belgium and is expected to hold approximately 1,200 participant.
Ongoing Lobster COVID-19 vaccination program Administration, excuse me to vaccination maybe a status to simplify the process to provide me the most effective protection or the population.
Because I was walking up there. We will therefore initiated for administration study of compatibility with a live instructor available plans focusing on statistics. All the age of 60 will evaluate the safety. We are switching the 15 and similar to the city of the following month and and approximately 1,000 participants.
Not intend to collect all the data in another case to trial just try the focus on driving in the court of law of the age of sixty-five compared to a quart of younger level H between 18 $45 why we already collect data and his age group home. I'm going they said 25 replied is intended to provide a much deeper analysis on Broad and partially exporter Range Community. This is America.
Normal amount of my spoken labels in Excel file is expected to start in the second quarter of 21. It's really conducted in France and include approx 1018 participant.
Let me know for him to a public accounting and significant influence of context and the cost of almost every COVID-19 clinical trial new virus variance ask me 70 reading since the end up 10% COVID-19 screen and select and you can see an overview of the estimated prevalence of them the most prominent very important to focus on the general geographies how we conduct our water safe to be three trials variants of that cost to attract some evidence of an increase in transmissibility more severe course of the disease and for some variants a reduction of neutralizing antibodies generated either after previous infection or vaccinations.
Yes, I believe that's a potential to evade an existing Unity needs to an impairment of the tickets. Although the two impacts needs to be better off looking at remaining balance commonly referred to as opposed to Texas mainly UK strength, which is considered to be approximately fifty percent more transmissible. But to remain susceptibility neutralizing antibodies induced by that inspections the South African strength, which is also consider to be approximately fifty percent more consumers report and the chest insurance is less susceptible to neutralizing antibodies from previous vaccinations or infection in numerous studies.
Which also seems to be less susceptible?
more caressing antibody
pipe shop on the slide illustrates the threat and the estimated and rapidly increasing violence threats and South America and Europe or your reference to specific countries really dead box office if you treat while a month internet
Clinical trials for safety and efficacy staff in the middle of December 2020 you believe that it's likely that there will be a contribution of variants of control, you know Deja which is present. He's difficult to estimate.
On the next slide. I will go into detail of how we plan to address this additional complexity.
Looks like it. I would like to walk you through the reason for the call for our trial.
Orr safety and efficacy phase II III trial is expected from an upcoming interim analysis.
I said earlier to tell them in civilian screen potential to be less susceptible to anybody new presentation by vaccination am rich and explain some frequency against might be lower.
You would takes the contribution of his strengths are COVID-19 into account when interpreting the results of our trials.
On March 27th Amendment to be 312 following discussions European medicines agency to include an additional secondary endpoint dispatch political. The secondary endpoint will allow us to provide a mistake of totally based on pages from the original strain as well as you page frame in addition to the Oval Office speaker.
Those confirmation to 8:12 or 5 in the maintenance included secondary endpoints for 3:50 on March 31st, 2192. And, she also course of the price you were able to record relevant number of COVID-19 section in Channel 286 number to provide a frequency data, which we believe would be highly complementary the face to be 3 if you receive data gift two days, I will be reporting a confirmation however considered data and approximately two hundred Seventeen participants above the age of sixty-five eleven you on the phone.
Louis Department in this presentation, I would like to highlight weekend is a study on the protective effects of the end up against the South Africa stream. You have finished the fire protection provided by vaccination in mice exposed to ease of the original Taco Tuesday, or the number one commonly referred to as the South Africa variance why we were able to confirm the phone now just need to swap production of neutralizing antibodies and media and contacts animated life exposed to the South Africa stream partnership original strain vaccination fully protected month signs of the disease as well as fast and easy.
Consider an important study is the first challenge infection starting in the curriculum is a mouse model.
About evidence for protection against the variance of contract with compliments earlier preclinically study required for CDN cost with verion specific data to provide further Evidence.
Gil Rican I'm now on slide 13 to update you on the progress. We are making an hour Broad and integrated European manufacturing Network to accelerate the availability of large volumes of CBN cough at the time of marketing authorization contingent certainly on the regulatory approval.
Please let me remind you that at its core the network is based on the optimize production process. We established in 2024 CVO cost in our in-house gp3 manufacturing facility here in tubing in which serves as a blueprint for the tech transfer to our manufacturing partner sites.
The network is expanding with highly experienced cdmo partners and the additional support of our strategic Partners buyer and risque. We are steadily expanding the European Network in 2021. Our manufacturing capacity will increase accordingly. We reaffirm our 20 21 capacity guidance for three hundred million dosages of six of produced and we are able to raise our guidance for manufacturing capacity for 2022 from six hundred million doses to 1 billion doses of CVN costs while progressing along the regulatory pathway for we are already producing commercial vaccine dosages at risk as we speak to be able to start distribution of CVO of once Market authorization is granted.
Why we extending our large-scale manufacturing capacity. We are also advancing our system for downscaled manufacturing and let me update you on the latest development status of our mobile and fully automated production system for dmpk mRNA vaccines and Therapeutics which are developing in which we are developing and collaboration with Tesla the RNA printer. We have advanced the RNA printer to the next systems generation preceding from the first generation in which we introduced the highly Innovative core for mRNA synthesis, the RNA printer 2.0 completes the manufacturing workflow around this core to cover the entire mRNA drug substance production work flow.
The combination of decentralized manufacturing and of approximately 1 to 3 grams of vaccine per week to be produced and cloud-based connectivity for Rapid exchange of data and protocol positions positions are in a printer as an idiot system for future pandemic preparedness and containment directly at the outbreak side off manufacturing needs with independent demek would depend Less on large Consolidated manufacturing facilities and would be supported by Rapids point of need access to Gene P Kratom on a vaccines at site.
Currently establishing a full second generation system and clean room conditions at korvac your tubing and to further verify the GMP manufacturing process and expect to ship the first systems. Talk to customer sites early 2022
I'm now on slide 15 to review the $0.02 invested COVID-19 Partnerships. We entered into of the past month with buyer and GSK within which cubic occupation of central position.
In addition we are on the final discussions with the UK government and its vaccine taskforce for an R&D collaboration agreement these two Partnerships and the expected partnership with the vaccine taskforce. Not only enable us to support the fight against the pandemic and virus variance, but also expand our pipeline beyond the pandemic with second generation COVID-19 vaccines.
Aspire we have a farmer partner who's operational expertise and execution power accelerate the development of and delivery of our first generation vaccine CVM cough as well. I addressing variants of conserve.
Opposite this our co-development partnership with GSK lays a strong Foundation to create value also beyond the pandemic together with this world leading expert we will jointly Advance second-generation mRNA vaccines for COVID-19. New vaccines will address new virus variance and feature new formats such as month or so-called combination vaccines. The letter is particularly of interest in light of our initial collaboration with GSK in 2020 in the field of nonprofit infectious disease.
As I mentioned briefly before we are currently in a final negotiation stage of an R&D collaboration agreement with UK government and its vaccine taskforce off once finalized the R&D collaboration with the task force is expected to grant us access to the best quality scientific input for COVID-19 variants epidemiology and genetics Thursday. We expect this will allow assert as fast truck selection of the most relevant mutations for both our first and second generation vaccines in raccoon cubic which Tech transfer its manufacturing process for the manufacturing of fifty million vaccine dosages in the UK, which the UK government is expected to order.
With this I would like to hand over to you for the financial update. Thank you France and good morning and good afternoon to everyone on the call. We are continuing to execute our financial strategy who were able to consider re change the financial profile of the company in 2020 as it is stated on slide sixteen the development of our cash position throughout 2020 was mainly driven by the following Thursday. We raised 874 million euros inequity, mainly driven by the private placement around that took place in July 2020 raising approximately 560 million euros home, and I'm not that a PO in August 2020 with net proceeds of approximately 193 million euros and the current pricing private placement of mr. Hub four hundred million years.
We raise another.
In seventy nine million euros from collaboration and upfront payments of which a hundred and twenty million euro upfront payment came from the Cheesecake partnership signed in July twenty and a phone number and upfront payment was made by the European commission within our Advance purchase agreement.
The cash position was further strengthened by Grant at the federal but the German Federal Ministry of Education and Research for a total of up to 262 million euros the ground support the development and manufacturing of the encode under a time period of two years.
And just over a hundred million euros with claimed in 2020. All of this is partially offset by a third-party related costs. We close the full year twenty-twenty with a favorable cash position of 1032 billion euros as of December 31st 2020.
Sounds like Seventeen. I would like to briefly highlight our first follow in financing after a NASDAQ listing which was closed in early, February of 2021.
The follow one we issues five. We should five million common shares to raise approximately $450 million dollars, the underwriters fully exercise their options to purchase the additional 750,000 common shares which resulted in a total gross proceeds of approximately 517.5 million US Dollars this clearly further strengthens our favorable cash position as we were moving into twenty twenty-one.
Looking at condensed profit-and-loss statement and slide eighteen a rather news for the fourth quarter of twenty twenty degrees 5.8 billion to 6 million euros compared to the same period in 2019. This is Chris with may need you to lower sales following the termination of the any agreement in June twenty twenty degrees was partially compensated by the recognition of 4.1 million euros from the Deferred 100 million-euro upfront payment from the disk a partnership for the first 12 months of 2020 revenues increased Thirty one point five million euros to 48.9 million euros compared to the same period of 2019.
Just decrease just increased or he was mainly driven by the one of the event of the time any termination of the LED partnership as a result. We recognize the full different Revenue amount of 33.1 million months is not
operating loss was 46.6 million euros for the fourth quarter of 2020 representing a 32.8% increase compared to the fourth quarter of 2019 increased operating loss was mainly driven by the R&D cost for the city and course development program. This was in turn partly offset by other operating income driven by higher cost reimbursements received from both safety package and the German government.
But a 12-month of twenty-twenty, we posted an operating loss of 109.8 million euros increasing by 10.4% compared to the same period in 2019. This was mainly driven a higher R&D cost in relation to the hi CV includes expenses in parts, and of course partially offset by the recognition of 33.1 million euros in contract liabilities upon the termination of the the lady collaboration.
Additionally during both these terrorists and twenty-five compared to 2019 The increased operation operating loss was partially offset by a decrease in cost of sales do to lower set of activities and lower commercial manufacturing for a collaboration parliament in 2020. We posted a final Financial loss of twenty million euros mainly driven by interest for convertible loans, which were fully repaid in August 2020 as well as a negative interest rate on cash and the net negative FX impact mainly in the fourth quarter of this year.
And the 12-month of twenty-twenty recorded a lost before tax of 129.8 million euros compared to a loss before tax of 100.1 million euros for the same period in 2019 off with this I would like to hand back the funds for today's key takeaway messages. Thank you. Let me quickly summarize before we move into the question and answer session 2012 was a year of a fundamental corporate transformation, which has taken us to the next level in our development from a research orientated biotech to commercial biopharma company based off a unique platform technology and Broad clinical cool with 19 vaccine program. Our lead vaccine candidate CVM coffee is in the final stage of its clinical development. We are expecting important data readouts from our late-stage clean clinicaltrials in the coming weeks, and we believe that they will allow us to see
Latoria approval in the second quarter of this year
We have positioned cure back to create sustainable value during the during and Beyond the pandemic with this with strong and experienced Partners based on our COVID-19 piles of first and second generation COVID-19 vaccines including the variance. Our European manufacturing network is successfully ramping up with experienced Partners the cock we are creating with these Partners enabled us to raise our 20 20 manufacturing guidance from 600 million to 1 billion dosages of CVN. Come home. We close 2020 with a very favorable cash position of 1.32 billion euros, and since then were able to raise another $517 US dollars in a highly successful follow on to our 2020 IPO.
This will continue to fuel our ongoing transformation and the clinical expansion around and Beyond CV and cost including oncology with this package include our presentation and would like to open the webcast to your questions. Thank you.
Thank you. We will now be conducting a question-and-answer session. It would like to ask a question. Please. Press star and one on your telephone keypad a confirmation tone it your line is in the question queue. You may press star to if you would like to remove your question from the Q4 participants using speaker equipment and maybe necessary to pick up your handset before pressing the star key. One moment, please while we call for your questions.
Thank you. Our first questions come from the line of Japanese with Bank of America. Please proceed with your questions.
Hey guys, it's time for questions. So first off. I just want to get a sense of how you are framing. The the two studies you have reading out sometime within a couple of weeks. I'm being the the face to improve study on the phase to be three study, you know, which one should we expect to read out first and if it is the face to a steady now the vaccine efficacy that's included. Should we think of that as as telegraphing for the data for the face to be free or are there some nuances you'd want to point out there? And I have a follow-up question as well.
Okay. Thank you very much. Jeff, Ricky. Do you want to take this please?
Yes, so, of course, it is difficult to say precisely the exact date options out. Our expectation is Dead episode needs all of the old, the second quarter for both trials that answer your question.
Yeah, and then on top of that is I guess do you think that the is there any other thing you want is between the two studies that you think are worth pointing out like let's say we get the data from one before or other. Yes. We've reviewed as a one-to-one read through and efficacy data or or there's something you'd want going on differences there.
Yeah, did I answer your question or I'm not sure I understood your second question. Could you maybe repeat wage? Yeah sure. So I guess I'm just trying to understand what the differences are between the phase to a new study and the phase to be three study. But if we should think about the ethics see results from both studies to be should we compare those as an apples-to-apples comparison or their differences between the two studies? You think that'll work? No dead. Yeah. Yeah. So of course, he says to VP is 3880 design schedule to bring the secrecy me out. So I would say the data from 2 through 8 that will be complimentary after the birth.
Phase nothing anymore provide complimentary data and particular or the age group about sixty opposite the main page read out in consultation increased and Perhaps Perhaps the after this we started the face to a study in order to do you have sooner than later also elderly people Beyond sixty years included in the clinicaltrials. So the trial was first of all set up as a safety trial month to cover a more subject than we started in the phase one and a confirmatory trial on the dosage therefore we started with 6 and 12 microgram and then with 12 microgram. We took quite a lot of elderly there as well. So people Beyond sixty years and then we saw well what what we collected there including the the number of subject that we ma'am.
They're the input in order.
To have these data also as confirmatory for efficiency Drive, which is a face to be three.
Got it. Got it. That's very helpful. And and one more last fall off if you don't mind. So it's very clear that you guys are keeping a pretty comprehensive approach to connect me COVID-19. I think slide 9 was wage outline all these different studies you have going on but but how about outside of COVID-19 for the other vaccine infectious disease programs are those you know less priority now or may help us understand what the status of those are those are progressing.
Yeah, absolutely. Thanks for the question. So we have signed mid last year twenty-twenty with GSK abroad collaboration, which is the kind of platform collaboration where we have the entire infectious disease included. So unfortunately, we cannot talk about the activities on the on the different pathogens. We're working here but these took considerable huge indications which certainly are falling outside the pandemic which what we saw on the basis of our our phase one COVID-19 trial and and to a month so far is was very convincing also for GSK to say well, this is really nice what we see on the other activities. We had to say, well can we not based on the 2nd generation something more on multivalent kind of development in including certainly combo products with other pathogens again wage.
We'll talk about this but these are quite quite very interesting indications outside the pandemic.
Okay. Thank you.
Thank you. I will next questions come to the line with Jeffrey. Please proceed with your question. Hi, this is Sarah on for you. I'm just a couple of for me really appreciate the details update. It's a it's a little puzzling that we haven't seen the efficacy data yet for the COVID-19 vaccine, but there are still a continued Amendment issue trials being added. How should we interpret this and why not report the face to a data you have in hand while enrolling the new group and then I have a follow-up as well.
Arika, you want to take this?
Yeah, so as you may have noticed in recent press release. Yeah, we have filed an amendment to add an endpoint off a trial and that is the reason why we just not yet initiate to read out. So we have to offer lunch COVID-19 cases in Peru and Panama and in order to utilize the case of data, we have decided to add specific p.m. And come out until the point in time when we will have mentioned to me that analyzer trial. That was the reason behind that answer your question.
Yes, thank you. And then
Just one further space to be three. Are there any changes to the statistical plan? And what should we expect for the efficacy for the UK variant versus the program stream?
So I think I cannot go into the level of details of the plan today. But Thursday we have mentioned. So we we just not change the primary endpoint of the flyer with regard that we were adding spent specific time to take a seat there. But the edit the efficacy against UK and who has trained as a secondary endpoint that will allow us to look and the efficacy particular stream but as a secondary endpoint
Okay. Thank you.
Thank you. I will next question is something the line Tzu Chang shoe with Baron. Please proceed with your questions.
Hi, thank you for taking my questions congrats on the progress the first question probably appear off the financial. Maybe you can you provide a bit color on the front page you 450 million. How how how much does does the does it cover and also on that that that the second one for Thursday is for the one I calculated 1.8 billion euros currently in the bank. How would you plan to use that cash for for further development of the company?
Yeah, thanks for the question and happy to jump in. So the way that we discussed with you have been commissioned was that when you of course put you know, a lot of resources up front on Thursday, but also production it was very important. Some of the risk would be shared right out front. So basically the for the following fifteen years is a share of the price of of of the edge of a scene and the way it works is that you know, as we file there will be another Milestone and then as we deliver those those needs will be recognizing the revenues. So that's that's the way the steelworks off on your other question. So you are mentioning 1.8 billion euros in cash. So I don't believe we we actually stated that number there's a bit of dollars is a bit of euros and there's also a little bit of spend in the first quarter. So we spoke but you know, of course the the the immediate use of of this cash is to push, you know, all these clinical efforts that we have and you heard about neutrons coming in dead.
As well and you know beyond that I think you know if you put go to the side for a little while and it's really, you know, we we are as a company of being super Capital efficient, but we really ought to grow. Uh,
The company the structures to be able to really tap into full potential of of messenger RNA. So we will need to have you know, bigger clinical teams. We need to have to go registry teams will have to beef up our you know, uh, I would say disease area teams et cetera et cetera. So I mean this is you know, I think what you know consoles trying to explain is, you know, they're willing to offer is turning point and we need to continue to grow the company. So this is really one of the key, you know, I can use use cases for the cash.
Got it, and it's a question. Maybe if a friends or or by the in terms of 20/22 you up, the the guidance were production, I guess have you have you been in the negotiation with governments for for contracts or 2022?
Yes, definitely. We we we are and and you know, the overall landscape of the availability of vaccines independently from which platform doesn't look good club really saying there is much more vaccines needed than than available and certainly we are talking.
Well primarily with the government but also International organizations as you can imagine with Kovacs, and yes, there is a huge demand and and certainly education on also are adapt to come in and our vaccine adding to the demand and available vaccine. So you're absolutely right. There are very hot discussions. And the the frustrating part certainly is as with all the others is that the vaccines are needed now in order to fight the pandemic and then in parallel and this is also why we are so broad a working on the Valiants as well to say, okay, how can we get a protection also against the variance so therefore even more so it's so important that we are building up these franchise not only with regard to the manufacturer capacity because more variance are there the more capacity you need in order to produce also this and so we are still adding Partners to the network and birth.
On the other side also on the development part it is so important to have this further clinical trials, but also the 2nd gen in order to have perhaps even multivalent vaccines which are covering more than just one strange.
Got it. This is harmful and final question. I mean maybe from Arizona on the phase three reporting dead reporting. I remember you guys earlier that would be the case is based on the way the original variant or the or the new variants would you clarify that? Would that still be either case when you may report the efficacy endpoint?
If you do in the trials, yeah, we've collect all the cases and we will sequence all of them. This is the goal to have off the very information. What kind of strange are we facing and all our trials? This will be an hour face to beat free trial health study pack our and study in Peru and Panama only for the last cases here because originally the study was not planned yet to do this, but other here we tried at least for the last cases. Yep to implement sequencing as well.
Great.
Thanks very much. Thanks for the great work.
Thank you. Thank you.
Thank you. I will next questions come from the line and Seamus Fernandez with Google security. Please proceed with your questions.
Oh great. Thanks very much for the the questions and and all the updates maybe just to to start off. I just wanted to clarify is the reason that you're looking to incorporate the the phase II a events analysis and advocacy analysis. Is that based on a rapid accrual of again? And you do not actually have the data in hand. So you don't actually know what the difference is. You're you're not you're you remain on blinded to that information or have you been on a blind date and if you put in blinded how what is it that that uh is preventing the the release that information. I just think there's a little bit of confusion in that regard. We could just maybe clarify that first.
Absolutely. Thank you very much for the question. If this is not clear, absolutely. So we are we are still blinded and the ratio between in in this recruiting was ninety percent of of vaccine group and 10% Placebo. And as we can see that the attack rate in Peru and Panama is quite high and we see the case is coming in, So this is very predictable predictive for us. And therefore we wanted to stay blinded in order to make much more out of this clinical trial.
Perfect know that that that makes that makes perfect sense. I just wanted to clarify that and then second question as we think about and I'm sure monitoring the the evolution of the strains in the markets where you're conducting your clinical study, you know in terms of where we've met other interim analyses at let's say fifty events for your interim analysis. Will that also be at fifty events? Will it be at a higher number because of the wage variability in the strains? And we need to evaluate different strains. Just wanted to get a better sense of of the compare and contrast that I'm confident. We're all likely to do down the data when the data initially hit.
See I can comment on this article mentioned here. We didn't change our primary endpoint. Yeah for the study is still and protection against an estranged. Yeah, and therefore also our first analysis will be done for the case something about 50. Yeah, but for sure, yeah. Oh those are following father. Yeah with the higher numbers and we will collect explain data to be able to discriminate but I need the interim phase of the cases needed here for the internet data as is not increasing.
Okay, great. And and then
Just in terms of the the the I guess evolution of strains in the countries are evaluating. But you know, it just wanted to get or see the end called just wanted to get a sense of you know, what you have a good sense of the month in the trial. Do you expect it to be predominate c117 and you know, I imagine that you have a decent sense of em in there and any guests at kind of how the percentage is in in the markets where you are expecting your studies are evolving. Yeah. I think we presented this also on this life is very closely and what we do differences. Yeah, so in Europe UK, very dominating it's not the case for Latin club.
So we have different here circulating strains and in different areas and therefore it's so important. If you look on the data how this month, you know, what are the cases how many cases in different? Oh, yes. I am. Sure. You will learn a lot of our parents study Also regarding this point. Yeah, I think you know God, you know, they will be uh about in total, you know, say to make it simple a third of European subjects and two thirds of South American subjects in in the in the heavens study. It is key that in Europe. I think the Epic emojis is pretty good. I think we know more or less, you know, what is out there. I think the situation is more contrasted in South America where you don't always have super up-to-date data and I think the track will approve and you know, what will bring us a lot of information when you know, the the cases will be you know sequenced.
Right, and and I know it seems somewhat obvious but is it possible that the first interim or that I can you just tell us whether or not the number of events has has actually occurred that that we've passed fifty events or you do you actually expect that that threshold to be achieved their future. So we we we didn't three digits. Yeah, I could tell you you are the cases are coming, but we are not very
Okay, I'm just said, you know just in terms of some of the updates that we received and and presentations from competitors in the last week it just love to get your thoughts on a couple of activities on a go-forward basis first is really it seems like there are second Jem a dilution of the vaccine programs in our SV in particular as some computers that are showing meaningful changes in immunogenicity particularly in our life. Just love to know you know, how pure vac is is thinking about that potential opportunity and you know separately and I know it may fall under the GSK program and then separately also sort of the flu opportunity from your perspective and and how you envision the the market for flu, perhaps involving and the page that which it could evolve wage.
It's with the entry of mRNA vaccines. You know, how
Thomas do you think that is thanks to you thank you for the question. If we are not surprised. Yeah that other competitors go from a second generation like six different areas. Is this the sizing here with the success of this copied vaccine? It's it's obvious and and and everybody is accelerating. Although other programs. They are showing off at this huge potential and you can imagine that the same as although the keys for us. Yeah, nobody stopped the other optimization of messenger RNA draft 2018 coffee to trial and also we have different programs in our pipeline. We enter the collaboration with GSK for different indication outside of college and all of this. Yeah also benefit from the experiences and colleagues, you know, always optimization on messenger when they will be also dead.
Implemented and other programs as well and for sure the safety data, we are collecting now from huge amount of people. This will be also relevant for all other program. Is that fall? Yeah both it's what you could expect and other phone companies. Yeah that you will try to use this potential and and go. I've seen as soon as possible.