Earnings Call: Q2 2021

Aug 18, 2021

Quarterly report

Hello, and welcome to the BayerPorto Interim Report for the 6 Month Period Ended June 30, 2021. Throughout the call, all participants will be in a listen only mode and afterwards there will be a question and answer session. Speakers, please go ahead. Thank you very much. A pleasure again to present the half year results from BioPortal. The walk through today is going to be highlights, 2nd first half financials And regulatory update and the expected milestones for 2021. If we look at the highlights for the 1st 6 months of our quarter, we had an increase in Sales in Danish kroner of 11%. If we look at U. S. Dollars, it was 20%. We have seen an increase Of the revenue in U. S. Dollars, primarily on Research use only sales in U. S. It's really picking up with the right sites that we are seeing The interest of research use investigations in U. S. In the Rest of the World, we have seen a Decline in revenue, primarily due to one order from one of the big distributors, which we do believe we are going to It's only a shift to the second half. Other on the highlights is that the enrollment on the NGAL trial is Going according to plan, we have decided here that we are going to make an interim analysis of the results Because one of the key concerns we have, because we want to be sure that we are delivering the right material to FDA, is Do we have the right statistical power, etcetera? So we are doing an interim report, and we are going to make an announcement about that End of August. And there, we'll also tell you an update about when we do submit to the FDA. If we look at also another highlight is the data collection to GRAD COVID-nineteen tested will continue here In Q3 of 2021. The key thing is that we do see an Improvement in our sensitivity, and that was one of the key questions we had last quarter. We are, right now, in fully Mode of testing the delta variance, we have seen that we successfully can look at the bridges and also the South African one. And we have to, here in the month of August, look at the Delta version. So it is progressing. But Again, be aware that we are looking for a sensitivity of 80% before we are Going to release it as a product. And I do think that if we are doing it probably now, we will see new mutations in the pandemic that we will need the That we will need the NGL COVID test. On top of that, We are in dialogue with FDA about making an emergency use application for the NGAL test In connection with COVID-nineteen patients, and I'll come further into that. We are also, as all of you are Fully aware of in a search of a new CFO and CFO, and that is progressing according to plan. I have had several interviews both on the CFO and the CEO side, and I can see that the interest It's high, and we are looking at extremely competent people being interesting in the position. The key thing for the investors is guidance for 2021 is maintained, and we are going to come back to that. The key findings here is that we if we are looking at the revenue, the key thing is that, as I Told you, Rest of the world on NGL is down primarily due to one big order, which is postponed to second half. But we are looking at a 68% increase in Danish kroner on research use sales in U. S. So we are really doing and the organization in U. S. Are doing extremely well. If you look in U. S. Dollars, it's Approximately 80% year over year increase in U. S. NGL sales. We also have seen an antibody way over last year's expectations, and it's Going to continue. We are here probably seeing a backlog of people needing antibodies. We Primarily see it because a lot of the research institutions have opened their doors again. And that's why we are seeing this increase. And we do believe that we are going to see that for the rest of the or the remainder of the year. The next slides, we are going to jump over just in to secure time. If we're looking at EBIT, we are slightly better than Q2 in 2020 And mainly due to the fact that we still, on travel and other expenses, are reduced To limited traveling, we are spending a lot more in our R and D sections or our clinical trials. So I do think that we really are progressing here. The key thing for investors is that we, by the end of June, is Having ZAR 75,000,000 still in cash position, that's key. That is keeping us that we have Sufficient financing until the end of Q2 of 2022, so as strong financial situations. And as always, we will be looking at different funding during the period Until Q222. We are also, as mentioned before, Looking at in connections with a submission to FDA if we should consider a dual listing in the states. So That's things that we are working with as well. I think it's key for An organization to have a strong leadership behind you. And we were so lucky in connections with the Annual General Meeting to get Don Hardison, which have a supreme experience in diagnostic Joining the Board as well as John McDonough, which also happened the same. He, in fact, have just brought a company True. Almost the same phases that we have to go through here for the next period of time. And as well as getting experienced Investor contact into. So Jain Lech Christensen is representing the investors. And I do think That he is putting a great perspective into the Board collaboration. So I think the new board is working fantastic well. If we look at The key thing here is, of course, getting the pediatric approved and submitted to FDA. And I do think that We are showing really diligence by making the interim analysis, which we haven't done before. And I can Thank the strong regulatory and clinical team in U. S. Saying that we have to sit down And take a break to make this analysis. And as soon as we have these informations end of August, we are going to inform About the outcome and how things are looking to the investors. And remember, again, NGL, for you who have forgot about it, NGL is the real potential here with an addressable Market potential of between USD 3,000,000,000 and USD 5,000,000,000 yearly. So it is significant what the team are working at. The NGAL test is also being evaluated for a EUA. It's not a kidney marker. It's Indirectly, a marker measuring if you need RT or renal replacement therapy. And we are doing this because Colombia have made a substudy using our NGAL dipstick. And looking at that, it Showed a 97% negative predictive value. And that means that we can detect if People are needing RRT. And we do believe when you start to see an increase in hospitalization again, That is really key for the hospitals to direct the people in the right direction to make an optimal Treatment. And we are going to see that. I know, for example, in Miami, that a lot of hospitals is already now overburdened. We have submitted to FDA the protocol and asked them if they believe it's feasible, what it is we want to do. And hopefully, within the next week, we will get a feedback from the FDA. In case they are positive on the EUA, It will take approximately 3 months before we are doing the submission. And then Hopefully, we are ready to go right away. If we look at the COVID, I explained a little about the sensitivity that we need To go up to 80%. We are in progress now. We have enrolled more than 25 This month, and we'll continue enrolling to optimize the settings. And the key thing for that, if you're an investor, is not to get it out now with the limited number of diseases. It is to be ready when we are seeing a new mutation, a new form. If you believe what WHO is saying, you're going to see that beginning of next year. The last thing I'm going to talk about is something we haven't really talked about is Sepsis, it's a trial that we are running together with the Danish Greece Hospital. We currently have enrolled 195 patients, where it's a combination between a diagnostic test with thrombomodulin, Which are used then in combinations with a treatment afterwards. As soon as they are hitting the number 200, And it was 195 here last week. We are doing an interim report. I do believe if that's giving positive income Our outcome, then we are going to see some new decisions we have to take on What we are going to do, are we going to start an approval process as a diagnostic tool or a companion diagnostic? For you who don't know, the difference is that diagnostic is like NGAL, it's difficult but Easier, if you're looking at companion diagnostic, where you give results and then Trigger treatment. It is a little longer decision making. We have to get a clearance. So a lot of things that we have to look forward here in the months of August September. So The strongest news flows expected in Q2 is the interim analysis of the NGAL test, the EUA application, of course, the update on COVID and the interim data on the sepsis test. Again, guidance for the year It's that we are going to hit the performance that we have promised before. It's a DKK 30,000,000 in revenue and a DKK 73,000,000 loss in EBIT. So we are going to maintain that. So things are running very good in the First half, and I do think that the activities that we have and the Focus we had on getting also new key resources in is going to bring A prosperous 2021 and a good start to 2022. That was all for me. Thank you. And there seems to be no questions. So I'll hand it back to the speaker for closing remarks. Thank you very much. And I Hope that all the things that we have promised you, we are going to deliver here in Q3 is going to be prosperous and That we will have a good presentation at the Q3 meeting in November. Thank you very much.