Bioporto A/S
CSE:BIOPOR
If you don’t study any companies, you have the same success buying stocks as you do in a poker game if you bet without looking at your cards.
Utilize notes to systematically review your investment decisions. By reflecting on past outcomes, you can discern effective strategies and identify those that underperformed. This continuous feedback loop enables you to adapt and refine your approach, optimizing for future success.
Each note serves as a learning point, offering insights into your decision-making processes. Over time, you'll accumulate a personalized database of knowledge, enhancing your ability to make informed decisions quickly and effectively.
With a comprehensive record of your investment history at your fingertips, you can compare current opportunities against past experiences. This not only bolsters your confidence but also ensures that each decision is grounded in a well-documented rationale.
Do you really want to delete this note?
This action cannot be undone.
| 52 Week Range |
1.222
2.965
|
| Price Target |
|
We'll email you a reminder when the closing price reaches DKK.
Choose the stock you wish to monitor with a price alert.
This alert will be permanently deleted.
Bioporto A/S
You don't have any saved screeners yet
Hello, and welcome to the BioPorto interim report for the 6-month period ended June 30, 2021. [Operator Instructions]Speakers, please go ahead.
Thank you very much. A pleasure again to present the half year results from BioPorto. The walkthrough today is going to be a highlight second -- first half financials and regulatory update and the expected milestones for 2021.If we look at the highlights for the first 6 months of BioPorto, we had a 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 1 order from one of the big distributors, which we do believe we are going to -- it's only a shift to the second half.On -- other only 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, et cetera. So we are doing an interim report, and we are going to make an announcement about that end of August. And there, we will also tell you on an update about when we do submit to the FDA.If we look at also another highlight is the data collection to gRAD COVID-19 test will continue here in third quarter 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 variants. We have seen that we successfully can look at the British 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 NGAL 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-19 patients, and I'll come further into that.We are also, as all of you are fully aware of, in the search of a new CFO (sic) [ CEO ] 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 is 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're looking at the revenue, the key thing is that, as I told you, rest of the world on NGAL is down, primarily due to 1 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 the U.S. are doing extremely well. If you look in U.S. dollars, it's approximately 80% year-over-year increase in U.S. NGAL sales.We also have seen in 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 slide, 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're still on travel and other expenses are reduced to limited traveling. We are spending a lot more in our R&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 DKK 75 million still in cash position. That's key. That is keeping us that we have sufficient financing until the end of Q2 of 2022. So a strong financial situations. And as always, we will be looking at different funding during the period until Q2 '22.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 have the same. He, in fact, have just brought a company through 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 in too, so Jan Leth 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, NGAL, for you who have forgot about it, NGAL is the real potential here with a addressable market potential of between USD 3 billion and USD 5 billion 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 maker, it's indirectly a marker measuring if you need RRT, or renal replacement therapy. And we are doing this because Columbia 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'll 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 will continue enrolling to optimize the settings. And the key thing for that, if your 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 are 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 Rigshospitalet. We currently have enrolled 195 patients, where it's a combination between a diagnostic test with thrombo modeling, 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 or 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 a result and then that trigger a 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 and September. So the strong new 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 is that we are going to hit the performance that we have promised before. It's a DKK 30 million in revenue and a DKK 73 million loss in EBIT, so we are going to maintain that. So things are running 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.
[Operator Instructions] 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. It is going to be prosperous and that we will have a good presentation at the Q3 meeting in November. Thank you very much.