2/1/2021

speaker
Rob
Conference Operator

Greetings. Welcome to the Quotient Limited Third Quarter Fiscal Year 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. I'll now turn the conference over to Peter Mueller, Chief Financial Officer. You may begin.

speaker
Peter Mueller
Chief Financial Officer

Thank you, Rob. Good morning everyone and welcome to Quotient's early conference call for our third quarter of fiscal year 2021. Joining me today is Franz Wald, Chief Executive Officer of Quotient. Today's conference call is being broadcast live through an audio webcast and the replay of the conference call will be available later today at www.quotientpd.com. During this call, quotients will be making forward-looking statements, including guidance and projections as to future operating results and expected development and commercialization timelines. Because such statements deal with future events, actual results may defer material from those projected in the forward-looking statements. Additional information concerning factors that could cause actual results to defer materially from those in the forward-looking statements can be found in quotients filed with the U.S. Securities and Exchange Commission as well as in this morning's release. The forward-looking statements, including guidance and projections provided during this call, are valid only as of today's date, and Quotient assumes no obligation to publicly update these forward-looking statements. With that, I would like to turn the call over to Quotient's Chief Executive Officer, Franz Wald.

speaker
Franz Wald
Chief Executive Officer

Thanks, Peter, and good morning, everyone. Since our last earnings call in early November, The second wave of the global pandemic has adversely impacted business activities in Europe. Government travel restrictions and lockdowns imposed in response to the second wave seriously affected our operations in Europe and the UK. I'm happy to report that notwithstanding this environment, our reagent manufacturing operations in Edinburgh continue to function well as we continue to supply reagents to our customers.

speaker
Rob
Conference Operator

Ladies and gentlemen, please stand by. We're experiencing technical difficulties. We'll resume in one moment. Thank you for standing by, ladies and gentlemen. You may continue, gentlemen.

speaker
Franz Wald
Chief Executive Officer

Yeah, I don't know exactly when the cutoff was, but I will start from the beginning with my prepared remarks here. So thanks, Peter, and good morning to everyone. Since our last earnings call early November, the second wave of the global pandemic has adversely impacted business activities in Europe. Government travel restrictions and lockdowns imposed in response to the second wave seriously affected our operations in Europe and the UK. I'm happy to report that notwithstanding this employment, our reagent manufacturing operations in Edinburgh continue to function well as we continue to supply reagents to our customers. As you will hear in a moment, that success in our reagent business was reflected in its operating results. Unfortunately, COVID's impact on our Mosaic business was more significant. We continued to make good progress on Mosaic, but it was not as rapid as I would have liked. The field trials we have been conducting were especially impacted. Travel restrictions made it difficult or impossible for our teams to spend their time on site, and lockdowns meant field trials kept stopping and starting. And travel restrictions and lockdowns limited our ability to hold the collaborative get-togethers that are important to our R&D and product development. Finally, COVID-related travel restrictions and lockdowns have affected the regulatory approval process for our products. For example, in many parts of Europe, at the moment, regulatory bodies are not performing site inspections of manufacturing facilities. So if you need a site inspection for an approval, your approval cannot proceed right now. COVID also appears to have delayed the timing of tenders by potential customers for our immunohematology products. I am proud of the entire quotient team who continue to focus on execution through this difficult period. I would like now to report on the progress we have made since our last earnings release. I will focus on several areas. Our new Mosaic COVID-19 semi-quantitative antibody test, the status of our expanded IH microarray European launch, and finally an update on our commercial performance and current cash position. Our R&D organization successfully completed the development of our Mosaic semi-quantitative COVID-19 antibody microarray. The test was CE marked on 29th of January, and we intend to submit an application for FDA emergency use authorization in February. The semi-quantitative test is primarily an update of the software running the relative quantity of COVID-19 antibodies present in a blood sample. The cautious enhancement was based on a software upgrade that the EMART process did not require site inspections and we were able to get it quickly. For reasons that are not entirely clear, COVID-19 antibody tests are not being widely used, and therefore we do not see a significant revenue stream resulting from these semi-quantitative tests. But I believe that this product enhancement nonetheless is important for us as a proof of concept for our capability, and this capability will be significant as we roll out products a few years from now for central app applications. So let me now move to our mosaic transmission diagnostic development pipeline. On November 30th, we announced preliminary field trials of mosaic expanded immunohematology microarray. After further analysis, we determined that a limited number of tests on the expanded microarray did not perform to the level we expected based on our internal testing. While a CE mark submission would still be possible with those results, we decided to postpone the CE mark application until the second quarter of 2021 and to use the time between now and then to further improve the performance of the test on the IH microarray, allowing us to submit an application on what we expect will be a better and more competitive product. Frankly, this decision was not difficult because the CE mark application requires a site inspection by a modified body, which is in Germany, and right now the body is not conducting site inspection. So rather than submit an application that just sits there, we are going to make the best of a difficult situation by further enhancing the product and then submitting our CE mark application in the hope that by then COVID restrictions will be lifted and site inspections will be possible. We don't think this materially affects the timing of future revenues from the IH microarray because we see on the market pretty much all tenders by potential customers have been postponed until later this year due to the pandemic. With this, we anticipate having our first commercial menu for the donor transfusion market ready in the fourth quarter of 2021. Other Mosaic programs are impacted by the pandemic as well, but we are nevertheless making progress on our various menus, and I will provide a full update on our anticipated submission timelines at the end of this call. Now let's look at our commercial performance. Despite adversity, our Alba by Quotient business continues to deliver an excellent performance with a 9.8% organic growth over the previous year. This performance is driven by both OEM and direct sales. Sales of COVID-19 antibody tests were 0.4 million in the third quarter. With this, we exceeded 1 million sales on a year-to-date basis. We observed that there is a low market demand for antibody testing, and it seems that the rollout of vaccines has not changed this. However, as I mentioned previously, the development of the COVID-19 antibody test and the enhancement to deliver quantification is a demonstration of the flexibility of the Mosaic platform and its applicability for future central application. In addition, we could demonstrate that customers are willing to sign contracts for this new technology, and we could test our sales and service organization prior to the launch of the transfusion menus. Finally, our preemptive equity offering in December 2020 was the right decision in order to make sure the company is equipped with the appropriate financial means to safely navigate through the global pandemic. Our strong cash position is sufficient to carry us into commercialization. With that, I will now turn it back to Peter for the financial update.

speaker
Peter Mueller
Chief Financial Officer

Thank you, Frank. Fiscal third quarter product sales were $8.7 million. an increase of 14% from last year's third quarter. Alba by quotient sales for the quarter are reported at $8.4 million, a year-over-year increase of 9.8%. Sales to OEM customers increased by 9.2%, while direct sales increased by 11%. Within direct sales, we see a continuous strong increase in sales to customers in the U.S. Sales of the Mosaic COVID-19 antibody test reached $358,000 for the quarter, compared to $567,000 in the second quarter of the current fiscal year and $111,000 in the first quarter. On a year-to-date basis, total product sales increased by 9.9% to $26.2 million, and 69% of our year-to-date product sales are related to standing orders. Total year-to-date revenues also include the $7.5 million upfront milestone payment received from Ortho Clinical Diagnostics in September 2020. Gross margin on product sales was 43.1% in the third quarter of financial year 2021, compared to 40.6% last year. The improvement versus last year is primarily due to improved product mix and pricing increases and a lower level of materials craft. On a year-to-date basis, gross margin on product sales was 43.2%, while it was 42.9% a year ago. In the third quarter, we recorded an operating loss of $21.7 million compared with $22.4 million last year. On a year-to-date basis, operating loss reached $54.5 million versus $59.2 million in the nine months of fiscal year 2020. Operating expense for the third quarter were $25.5 million, a slight increase of $260,000 over the prior year. Sales and marketing costs were $2.3 million in line with prior year. Research and development expense was $14.5 million, a $300,000 decrease, despite an inventory provision of $2 million in the third quarter of the current financial year. The inventory provision relates to certain raw material and work in progress and following changes in the manufacturing process. General and administrative expense were $8.7 million, compared to $9.3 million in the prior year, a decrease of $600,000 driven by lower legal costs and certain termination and transition benefit costs incurred in the prior year, offset by an increase in our D&O insurance costs. G&A costs include stock compensation expense of $1.2 million in both the current quarter and the third quarter of FY20. In the third quarter, depreciation and amortization were $2.4 million versus $2.9 million in the prior year. The decrease in depreciation is due to assets at our EZAN site that are now fully depreciated. Total other than net expense was $6.6 million compared with $5.1 million in the third quarter of last year. Net other expense consisted of interest expense of $6.8 million and the $0.2 million foreign exchange gain compared to interest expense of $7 million and the $1.9 million foreign exchange gain in the third quarter of fiscal 2020. our net loss for the quarter was $29.8 million, or 29 cents per ordinary share, compared with $27.5 million, or 37 cents per ordinary share in the prior year's third quarter. On a year-to-date basis, net loss reached $70.2 million, or 79 cents per share, versus $78 million, or $1.14 per share, one year ago. Net cash used in operating activities totaled $56.7 million during the first nine months of fiscal 2021, compared with $64.8 million in the nine months of fiscal 2020. The use of cash significantly improved due to the also upfront milestone. Capital expenditure in the third quarter of fiscal 2021 was $1.5 million compared with $1.3 million in the prior year. For the first nine months, Total capex was $3.6 million compared to $3.9 million in the prior year. The majority of our capex in the current fiscal quarter relate to the acquisition of Mosaic instruments and the upgrade of the manufacturing execution system in our Mosaic manufacturing facility in ESA. Moving on to the balance sheet, with available cash and short-term investment at December 31, 2020 of $134.5 million, compared to $120.8 million at the end of March 2020. An additional $9 million of cash is held in a restricted reserve account under the terms of our borrowing facility of $145 million and our ESA facility lease. On December 31st, accounts receivable totaled $4.5 million and inventory totaled $23.7 million. Accounts receivable decreased compared to the end of the last fiscal year while inventories decreased by 3.2 million. The changes in accounts receivable is related to timing of customer payments, while the increase in inventory is related to Mosaic. The company has an outstanding debt of $145 million with the first reimbursement due in April 2021. As previously announced, we are exploring options to restructure the debt or defer reimbursement until substantial cash is generated from the sale of Mosaic. Moving on to guidance. For fiscal 2021, we increased our full-year revenue from product sales of our Alba by Quotient reagents and expect sales in range of 33.5 to 34 million. No further milestone-related other revenues are expected. For the fourth quarter of fiscal 2021, we expect sales of Alba by Quotient reagents between 8.3 and $8.8 million. We forecast for capital expenditures to be in the range of $6 to $8 million in the fiscal year and the cash used in operations of approximately $5 to $6 million per month. With that, let me now turn the call back to Franco. Thank you, Peter.

speaker
Franz Wald
Chief Executive Officer

Looking forward now, I would first like to share upcoming plans for the next few quarters. Our ALBA by Quotient business will have started the process to extend the certificates to 2024, which includes renewal under IVDD, as well as generation of the additional data for the first batch of products that must be IVDR certified by May 2022. We expect to submit to the notified body in June 2021, so we will be ready on time to transition from IVDD to IVDR. On the Mosaic platform, our plans are the following. As far as our COVID-19 antibody test is concerned, we will submit the semi-quantitative test for FDA emergency use authorization in February. After that, we have no further development plans related to COVID-19. The next step for our transfusion diagnostic pipeline will be the following. In Europe, we will focus on finalizing the development of our first commercial menu for the donor transfusion market. As mentioned at the beginning of this call, we see an opportunity to use the time caused by the disruption of the global pandemic, in particular with the increased burden since the month of December, to further improve certain tests of our expanded IH microarray and we will run additional field trials in Europe. We will report on the results that meet for CE mark and anticipate receiving CE mark in Q4 this calendar year. At this point, we will be ready to enter the donor-consumption market and participate in potential European tenders from Q4 onwards. On expanded SDS, we will finalize the development of the expanded microarray and plan to enter field trials in the fourth quarter of the current calendar year. We also changed our approach to field trials and will run a combined field trial with sites in Europe and the U.S. in parallel. This will reduce costs and advance timelines for the U.S. FDA submission. Submission for the e-mark is anticipated in the second quarter of calendar year 2022. Regarding the ortho patient immunohematology microarray, we announced in November that we have already started the development, which is an incremental development over the existing donor immunohematology products. We have hired additional resources to progress towards a planned regulatory filing in the first half of calendar year 2022. And now to the U.S. Our next steps are resubmission of the initial FDA's 510K. We announced on December 10 that the FDA requested additional information concerning the individual performance characteristics of the assay on the microarray. We will collect this data and expect to resubmit in the second quarter of the current calendar year. We are confident to obtain FDA approval once we gather this additional information. With the COVID-19 antibody test, we demonstrated our ability to get a mosaic product through an FDA approval process. As a reminder, we do not intend to sell the initial STS microarray independently, but only together with the expanded IH microarray. The 510K approval is therefore not on the critical path for commercial launch in the U.S. Field trials for the expanded IEH are planned to commence in Q1 of calendar year 2021 at three separate sites across the U.S., and customers confirmed their participations. Not everything is under our control, and the assumption here is that the pandemic situation in the U.S. by then will allow us to access donor labs and perform field trials. As previously announced, we hired and trained staff on the ground in the U.S., allowing us to run field trials independently from Europe. On the molecular disease screening microarray, our development work continues and we expect to provide a more detailed plan, detailed update during our full year earnings call. We all know that we are living through unprecedented times and quotients like any other company faces some adversity caused by the global pandemic. However, we have a clear path forward and are confident as ever to have our first commercial proposal available soon. Our high cash position provides us with sufficient liquidity to get us into the commercial launch. In addition, we have identified options to generate additional non-dilutive funding in case this should be required in the future. Although some of the anticipated Mosaic launch dates changed, we believe that the underlying value of our business is unchanged. Even external experts confirm that our technology is innovative and promising as we won the 2021 Big Innovation Award. So we are ready to launch an attractive product offering to the donor transfusion market this year and generate substantial value for our shareholders over time. With this, I would like to hand over to Rob to open the Q&A session.

speaker
Rob
Conference Operator

Thank you. We'll now be conducting the question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad, and the confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you, and our first question is from the line of Josh Jennings with Cowan. Please proceed with your question.

speaker
Josh Jennings
Analyst, Cowen

Hi, good morning, Franz and Peter. Thanks for taking the questions. It sounds like there's a lot of challenges from the pandemic you guys are facing and navigating through. I wanted to ask initially on the optimization process that you detailed while you're waiting to submit the CE mark. Can you help us understand which tests are going to be optimized and what steps need to be taken to optimize those tests?

speaker
Franz Wald
Chief Executive Officer

Yeah, basically we made the press release and you saw in the press release that there were three antigen types where the concordance was below 99% GPA, Duffy and Kit. And further data analysis has shown that these values are not improving, but in the internal testing we have seen the technology to perform better. So we decided then to stop processing the document as it would not be possible right now anyhow to receive the CE mark because the notified body cannot come for an on-site inspection which would be required as a precondition to process the CE mark. And also, the Field Force told us there are no tenders right now. The anticipation is that in November, if everything calms down, will be the first tender. So we decided to use the time, work on the microwave to make it more stable. We think there are a couple of small improvement processes we can implement as we have the extra time. And then we are confident that the tests, if the field trial can be conducted like a normal field trial, will show an even stronger product. The conditions under which we conducted the previous field trial were suboptimal yeah you basically do a contract with a customer you do the training you go you install everything on site and then you're ready to go and then the customer tells us well they have a policy because of copy they can't do the testing Then you have to go and collect everything. You move to a different site. You redo the entire work. You start and then halfway through they stop it. So it was always stop, go, stop, go, stop, go on various sites. That's just not ideal to get the required results. We could have submitted anyhow. But we decided to do some fixing and do an extra field trial because we are confident that technology can do even more and that we get these test values over 99%.

speaker
Josh Jennings
Analyst, Cowen

Great. Thanks for that. And what are the steps that need to be performed in this optimization process? Is it mostly software enhancements or are there reagent enhancements? Anything on the disposable microarray? What exactly has to happen for those concordance levels to improve to 99%?

speaker
Franz Wald
Chief Executive Officer

Yeah, so we are not disclosing any technical steps necessary for that, but we have run already a test run actually on Saturday, and the test levels were there where we wanted to have them. We are pretty confident, and we have to have now, of course, customers willing to do the testing. And as soon as we can do that, we will proceed, process it, and come with a strong product to the market.

speaker
Josh Jennings
Analyst, Cowen

Great. And just thinking about the FDA pathway, I know with 510K, the timing doesn't impact anything on the commercialization front. But can you just help us understand the questions that the FDA – got back to quotient. Is the focus on the specificity of the CMV test, or are there issues with the system that the FDA is working on?

speaker
Franz Wald
Chief Executive Officer

more data and what we have to get externally is reproducibility testing which basically means you should get the same results over multiple machines using multiple operators twice a day with multiple different lots of the assay during 20 non-consecutive days. So basically, it's a fully automated process. So if I push to start bottom, then they want to know if you would have pressed it, would it have been the same result? So we need a customer willing to do that, and we have a customer who gave us the commitment, and the plan is, I think, if I recall, recollected correctly in about March, that we can do this testing, and then we proceed with the submissions. But it's anyway not on the critical path because we still have to wait for the expanded IH to have a commercial combination which is attractive for product launch.

speaker
Josh Jennings
Analyst, Cowen

Great. And how involved is Stratech in the optimization process for the extended IH menu microarray? Are they involved as a partner working hand-in-hand with Quotient's team, or is this all Quotient's internal team that is –

speaker
Franz Wald
Chief Executive Officer

It's hand-in-hand, and we are really getting fantastic support from Stratec. We have a team on our side dedicated on software improvements and instrument improvements, and they work in collaboration with Stratec to incorporate that. But it's continuous improvement. Every time we see something that could be improved, of course, we are building it in. So very good collaboration and working hand-in-hand.

speaker
Josh Jennings
Analyst, Cowen

Great. And just one last one, just to follow up on STRATEC. You guys had ordered, I think, 20, I don't think you quantified the number of systems you ordered from STRATEC last year. Have those systems been received? I know you mentioned in your prepared remarks that antibody testing demand has waned over the course of 2020. But any update on the installed base of MOSAICS for COVID testing? in the U.S. and internationally?

speaker
Franz Wald
Chief Executive Officer

We have the instruments in place in case there are COVID antibody testing pickup. They're in place and ready to go if that happens. We have instruments for the upcoming field trials and we have ordered enough instruments for a successful launch in Europe in a few months from now. And they're coming in as we speak. Every week we receive more. So we will be ready and we will be ready on time for the market launch. We also have heat on internally. Our business planning and the total value for us internally is exactly the same. There's a delay in launch, but it's the same cumulative value as before the pandemic. Great.

speaker
Josh Jennings
Analyst, Cowen

Thanks for taking all my questions, Franz. Thank you very much.

speaker
Rob
Conference Operator

Our next question is from the line of Shinji Nam with BTIG. Please just use your question.

speaker
Shinji Nam
Analyst, BTIG

Hi, thanks for taking the questions. Maybe a COVID test question just to get it out of the way. Just totally understand that, you know, obviously that's not the priority and you don't anticipate significant revenue generation there. But just would love to get your thoughts on given the vaccines are being rolled out and, you know, it would make sense that in certain cases or in many cases you might want to measure the antibodies, right, to see if the vaccines are being effective. And so just kind of curious, is this a function of quotient kind of prioritizing on your core business, or do you think that there's just not going to be the demand for antibody follow-up testing, you know, after vaccination?

speaker
Franz Wald
Chief Executive Officer

So when the whole crisis started, we anticipated or we were expecting once vaccines become available, there won't be enough vaccines for everyone immediately. And therefore, for a stratification process, which parts of the population should get the vaccine first in terms of priority versus others, they would use antibody tests to see who has already antibody and is temporarily protected and maybe use the available vaccine for those who have no antibodies. But in reality, all the governments right now have a very different approach. They go according to age and people with underlying conditions. So it's like here in Switzerland, 75 and older, and then they go down the categories. They are not using antibody tests to separate those which are currently immune and vaccine the others first. But nobody saw that coming. And it's very difficult to speculate beforehand because we have never seen a crisis like this. But it's more or less the government who are deciding or the health care authorities in the countries who are deciding on the strategy to deploy vaccinations.

speaker
Shinji Nam
Analyst, BTIG

Gotcha. That's very helpful. And then just kind of curious, going back to the U.S. FDA resubmission, just hearing from others that the FDA is not reviewing anything that's not COVID-related at the moment. So just kind of curious in terms of your timing or your target timing of second quarter resubmission, do you think that's – have you gotten any – you know, additional indications from the FDA in terms of when they, if that's a feasible timeline, or is it just kind of your estimate in terms of when they might be available?

speaker
Franz Wald
Chief Executive Officer

Yeah, what we have to do is to get this extra data. And we need a customer who is doing this reproducibility study with us. And we have a customer and we have a commitment, but it can't just not be done right now. So we're waiting for this, and then we submit it. And we anticipate for a 510K, because this one is a 510K, about six months approval time. But as I said before, it's not on the critical path, because the IH expander is a VLA, and a VLA takes longer, 18 months, and we need that microarray in addition to the initial SDS for a valuable product for the customer sent to launch.

speaker
Shinji Nam
Analyst, BTIG

Gotcha. That makes sense. And then just lastly for me, sorry if I missed it, but in terms of other programs, other R&D developments underway, kind of curious, you know, for your molecular testing capabilities and others, are those also kind of delayed as well currently given the pandemic?

speaker
Franz Wald
Chief Executive Officer

I think we made the – We made progress across the borders, but not as fast as we would like to have seen it. It's difficult to get people together. Our scientists and development people are from Switzerland, France, the UK, different parts from Scotland to Ireland to Wales, and everybody has different jurisdictions and different guidance, so it was not possible to get them together and work together the way they could have under normal circumstances. So at any given point in time, about 50% of the workforce was on location. So especially the second wave with significant and strict lockdowns has impacted us significantly. And 50% of the workforce in ASAS are coming from France, and they have to cross border every day, forward and backward. And everybody needs a special certificate in order to be able to do that. And over the last, since the pandemic, we had 162 cases where individuals had to go for imposed self-isolation for 10 days. So it's continuous interruptions, continuous interruptions, and everybody tries to do everything as good as possible, but you can't do everything by phone. So we made progress, but not as fast as we wanted. But the underlying value of this business proposition has not changed, and the technology is really unique. It's also externally recognized with the big innovation award that this is a unique and a creative solution. And we think our business plan value is the same, but it's just a little bit late. I think last time during the earning call, I mentioned that we are intending to have the commercial launch in Europe in Q2. Now it's Q4. And the underlying hypothesis for that is that the restrictions will be lifted and that we go back to a more normal towards mid of this year. That's what we factored in. So if you listen to the different recommendations from the government or policies from the government right now, everything is in complete lockdown. There should be some relaxation by end of February. And most authorities have given a signal that they expect that a big portion of the population will be vaccinated by mid-year. So that's why we assume that in the next couple of months, we will go back maybe not to normal, but to a much better situation than today. And based on that, we have adjusted the timeline from Q2 to Q4.

speaker
Shinji Nam
Analyst, BTIG

Gotcha. That makes a lot of sense. Thank you so much.

speaker
Franz Wald
Chief Executive Officer

Thank you for your questions.

speaker
Rob
Conference Operator

Our next question is from the line of Brandon Couillard with Jefferies. Please proceed with your questions.

speaker
Brandon Couillard
Analyst, Jefferies

Hey, good morning, Franz. Good morning. Just to start off, you've referenced a number of times in the ability of regulators to be on site physically for site inspections. Just curious, which of your sites still require an inspection? I was kind of under the impression that was already behind us at this point, and do you have any visibility on a timeline for that type of process?

speaker
Franz Wald
Chief Executive Officer

Yeah, so we had, it's ASAS. We are talking about ASAS because the expanded immunohematology microarray will be produced in ASAS. We had in ASAS already an inspection. That was in order to get the ISO certification, and we passed this inspection without any observation, so no problem at all. But as we are submitting now this expanded IH microwave, they have to come and conduct an additional on-site inspection as part of this dossier. For the COVID-19 semi-quantitative antibody test, this was not necessary. That was a software improvement over an existing test, and this was not required. In Germany right now, they say they will loosen the restriction in February. We don't know exactly when, mid-February, end-February, but then it also depends on the policy of the notified body, which in this particular case is TÜV-Sied in Munich. I don't know what they are going to have, what kind of policy they are going to have in place. And then it also depends on the situation in Switzerland. You know, how risky is it for them to travel to Switzerland? So all these have to come together. I think we were careful with our assumptions here. As I said before, we assume towards mid-year everything will be back to a new normal and that we can process everything and that we can launch in Q4. So Q4 should be a careful estimate.

speaker
Brandon Couillard
Analyst, Jefferies

Okay. And then I'm also curious how you communicate To some extent, you know, even those who have had tenders that are coming up may have been sort of holding them back a bit to be able to evaluate Mosaic and now sort of talk about the end of the year. You know, how do you sort of communicate this timeline to customers?

speaker
Franz Wald
Chief Executive Officer

So our sales force is in continuous dialogue with the customers. And I think also the customers, when the whole pandemic started, they had no clue how long this will last. And you remember maybe at the very beginning we thought, yeah, maybe three months, but now we are already a full year into this. And then customers told us in the beginning they will postpone their tenders for a couple of months, but right now there is no tender in sight. I think the What we think is going to happen is that the first ones will come up in November this year. There is a certain backlog. So we expect in the first 24 months after our product launch in Q4 that we will have participants to participate in about 25 tenders. The tenders have been postponed. Customers couldn't tell us. Well, they don't tell anything. It will be public as soon as the tender is activated. But based on their signals we get and intelligence we have, it's about November. And because of the backlog, it might be then more intensive from Q4 onwards.

speaker
Rob
Conference Operator

Thank you. Thank you. At this time, we've reached the end of the question and answer session. I will now turn the call over to Frans Waltz for closing remarks.

speaker
Franz Wald
Chief Executive Officer

Frans, please go ahead. Okay, thank you. Yeah, thank you, Waltz. Thank you, Waltz. So thank you, everybody, for joining us in this call today, and we look forward to updating you on the progress we expect to have made by the time of our full year fiscal 2021 conference call. So thank you very much. Stay safe, everybody. Bye-bye.

speaker
Rob
Conference Operator

Thank you to everyone, and this concludes today's conference. You may disconnect your lines at this time. We thank you for your participation.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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