Earnings Call: Q1 2021

May 12, 2021

Hello, and welcome to the BioPorto Investor Meeting. 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. It's a pleasure being allowed to present the Q1 number for BioPortal. And my name is Peter Erickson, I'm CEO of BioPortal. I'm going to start with the highlights for the quarter. And one good thing you can say about the present time is that you can start to see light of The end of the tunnel with the pandemic, we see more and more sites focusing on other things than COVID-nineteen, we start to see enrollments going faster. We came out with an announcement in March That we believe that we are going to submit our pediatric kidney marker and gal this summer as well as we do believe that we are done with the testing on our Saliva test for COVID-nineteen patients will be done with the testing in Q2. The great thing why we do See that it's getting back more to normal is that we look at the it's a small revenue, but we are seeing a growth of 33% on revenue. We are seeing a flat, but very stable NGL sales on the research use only size. We also have to recall that Q1 last year was fantastic, but we are seeing it flat this year. We are seeing a Sharp increase in the numbers on antibody. And that means that Universities and research labs are starting to do research other than COVID-nineteen. So that's fantastic news For the cooperation, we see progress all over on the clinical side. We have enrolled more sites or included more sites and we'll continue doing that until the end of the trial this summer. We have seen an uptake in the number of enrolled patients, and That's giving us the confidence that we will be able to, in August, September, to submit to FDA. And it's going to be submitted as a de novo, as you probably have heard before. And that means that you have a Minimum of 150 day, that's the minimum FDA requirement. And then there will probably be Halls where they have questions. But currently, we are looking into Q2 of 2022 for a cleared product. The highlight is that we do really see that There is an interest for what we are doing. There's a bigger and bigger interest, especially also in the U. S. Market on the research use only product That you see a more constant demand on NGAL. And I do think that's Extremely encouraging. I think that my U. S. Team is doing a wonderful job, both on Providing the current customers with the product but also in the training, I know that the people in U. S. Is having a lot of grand rounds educating the hospitals in how to use NGAL because we are all fully aware of we are going to change the whole paradigm on how You're looking at kidney disease. And I think it's key that we, prior to a clearance, have a educate hospital sector, and I think that the people over there is doing a fantastic job. We on the clinical side, the medical officer and the regulatory teams are doing the utmost to get All the samples collected in due time. We are in full process of Writing the submission, so as soon as we're done with the clinical numbers, it should take 4 to 6 weeks before we are submitting to the FDA. I'm not going through the whole presentation. It will be found on our Home page, if we are looking at COVID-nineteen, we have had a lot of questions on COVID-nineteen. And the key thing about COVID-nineteen is that we currently are testing to secure that we will have a sensitivity, which is over 80%. That have been the whole leadership's demand. If we are looking at the antigen test, which is currently out there, We are looking at, unfortunately, a sensitivity Around the 60% to 70% and especially false positive, it's close to 50%. And we want to avoid that if we want to be a professional partner in the game. 1st quarter is the beginning, I think the Q1 is the beginning of something extremely important for Bioporto. We have the right progress. We are Seeing good results from the analyzicals that we are doing in connections with the submission to FDA. So the only question mark we currently have in connection with the submission is the clinical data, and we don't have them Before end this summer. So and therefore, we also, organization wise, is preparing for the big launch in U. S. And as you probably have read is That I'm going to leave the company by the end of January in 2022. And The reason for that is not at this coordination with the board. It's I think it's the right timing after 8 years. We need a new energy, a new way forward when we have the product in U. S. And we also need to find the right person to run the company for the next many years to come. And the profile that we are going to look for is going to be that we are getting a U. S.-based and Person to run the company. And hopefully, we will find that person End of Q3, we have started the process late last night after the Board meeting. And I do think that it will be very beneficial to the company. This is a very short presentation. It means that everything is going according to plan. So there is no real surprises to the Q1. So from now on, I would like to take questions. Thank you. To withdraw your question, you may do so by pressing 2 to cancel. And we have no question at this time. Please go ahead, speaker. Okay. Then I would like to thank all of you for listening in. If there is any additional questions, all of you know how to contact me on my mail, pme@ bioporto.com. And you're always welcome if you need additional explanations or any further information. Thank you very much. Have a wonderful day.