Bioporto A/S

CSE:BIOPOR

Earnings Call Transcript 2021-Q3

[Operator]

Welcome to the BioPorto Interim Report for the 9-month period ended September 30, 2021. [Operator Instructions]. Speakers, please begin your meeting.

[Peter Morch Eriksen, Chief Executive Officer]

Thank you very much. My name is Peter Eriksen, CEO of BioPorto. I'm looking forward to introducing the interim report for Q3. It has been a great quarter. We have seen -- the highlights for the quarter is that the revenue growth have been 13% in U.S. in research use-only test kits, and we have seen great orders in antibodies in ELISA kit. It's also the quarter where we have had the pleasure to introduce that we have hired a new CEO, Tony Pare and Neil Goldman, who is appointed CFO. They will start the 20th of November in their role, and we are really looking forward to having to capacities like the 2 guys in bringing BioPorto the next step. The enrollment of the U.S. clinical trial is, unfortunately, slower than expected, and we sent out a message to the stock exchange that we expect to be finalized with the enrollment of the pediatric trial first half of 2022. The great thing about it is that we during the quarter also had a analysis of the interim data of the pediatrics. And the data is looking as up to -- living up to our expectations. So that's really good news. So we really hope that data that we're seeing in the rest of the patient population is similar that will be promising for BioPorto. We are also currently investigating to use the NGAL test for EUA in connection with COVID testing. Interim data for the gRAD based sepsis and COVID is expected in Q4, and I'll go deeper into that later on. Our guidance have been adjusted. We are looking at an EBIT guidance going down from DKK 73 million to DKK 33 million in loss. So a positive adjustment. We are adjusting also the revenue to DKK 24 million. The adjustments on the EBIT side is giving us a great liquidity situation or cash situation, we do believe that we -- with the current cash position is having sufficient funding until the end of Q3 2022. If we are looking at the growth in the quarter, we see a great growth in U.S. on research use-only selling. Unfortunately, we are also seeing a slowdown in rest of the world of sales of NGAL, it's primarily due to a rose order which are delayed until first quarter of 2022. We see strong sales in ELISA kits and the antibody is almost at the same level as Q3 in 2022. So a fine revenue target, except our rest of the world numbers, sales in NGAL. If you're looking at the revenue growth of 90% in the first 3 quarters, 11% in DKK, it is showing that we are doing a fantastic job pushing the market even in this pandemic where the things that we are providing are not yet COVID related. So we are very satisfied with the revenue numbers. If we look at the EBIT numbers, as you can see, that we have a cash position of approximately DKK 59.6 million end of September. We are expecting to have around DKK 46 million end of the year. So it is looking promising for the first 9 months of next year. We are, of course, exploring funding opportunities and when we are getting closer to a decision, we are, of course, going to inform the market about that. The key thing in the quarter is also, as you know, that I have announced that I'm stepping in the company in May and expected to stop here as CEO, the 20th of November, and Tony Pare is really asset getting into the company. He have a long track record of commercial experience and introducing new products to the market. And we are convinced that his skill set is going to be extremely valuable for the company in connection with the clearance of our NGAL product. Neil Goldman is our new CFO, a strong market experience, have a lot of NASDAQ experience, have a CPA background. So also a real asset coming into the company. As you probably have seen the announcement, the former Chairman, Thomas Magnussen have left the Board of Directors. The new Chairman is Christopher Lindop. The new Vice Chair is John McDonald. And as you can see in the presentation, I have been elected in as an ordinary member of the Board from November 15. Regulatory update. If we are looking at it, the interim report was extremely good to see that patients we have enrolled so far are looking as expected to deliver to FDA and the conversations we have had with FDA. So that's promising. But unfortunately, we are still impacted by the COVID situation. Sometimes, some states are closing the hospitals because of the pandemic and others, we are running up. That's also why we are including more sites than we have had, just to be sure that we are hitting the deadline that we have promised the market that we have done with the enrollment first half of next year. The U.S. regulatory strategy is, as you all probably know that we do the submission, get, hopefully, the clearance. It is a de novo. And so FDA have a minimum of 150 days, and then we know that they have questions. So when we are done with that, we are going to use that clearance as the predicate for the adults. That means that when we are testing the adult samples that the things we have to measure up against is the pediatric and that's our own product. So hopefully, that's going to help on a more secure, lesser risk clinical trial for the period. And then at the same time, we'll look at expanding areas. The test of the NGAL test for EUA related to COVID. I do think that 1 of the key thing is here that Colombia has made a test on using NGAL in connection with very sick patients. They're getting a lot of very solid results in connections with very sick COVID patients, so they can define if you have to go on RRT, or renal replacement therapy, directly when they are admitted into the ICU, and that will hopefully help a lot of patients from losing their kidneys and thereby dying. So we do believe that we have something significant. The key thing here is that it has been tested using our NGAL DS stake on the GI platform. The things that we currently are doing is that we are testing all the samples from Colombia with the automated assay and comparing these data. And when we have these data, we are going to submit an EUA to FDA. The next in line is that we have talked about another gRAD product, where we are using thrombomodulin to check for sepsis. Also in this trial, there is a pharmaceutical drugs administered if the thrombomodulin level is at a certain level. And we hopefully are getting the interim data here in December. It is the Danish [indiscernible], who is making that test. So we are really looking forward to seeing some of the outcome. It is also a big market, and it's also the first product that we are having that we -- making combinations between a diagnostic test and a treatment algorithm. If we look at the last 1 we have in work, we have got data from France and [indiscernible] about the COVID-19 test, home test, and it seems like we are getting up to the sensitivity level that we have acquired. We are doing some few additional tests just to be sure, and then we'll take a decision where to launch this is really depending on the regulatory pathway, where we can do it fast. If we can do a self-declaration and CE Mark, that is probably then going to be the first product. The 2021 milestones is, of course, the continuous focus on enrollment to the pediatric trial. It's also data to support the adult trial. But here is a key thing. It's really important that we're getting the feedback in connections with the pediatric to decide the final data that we need for the adult trial. Then it is to conclude the interim data for the gRAD based sepsis test, evaluate data on gRAD and COVID-19 and then continue growing revenue sales on NGAL and antibodies. The key thing is we have to continue pushing on research use-only test because that will be the foundation of the adoption of NGAL when we launch it in U.S. The last thing is that we're reducing cost and thereby having a lower EBIT loss of DKK 63 million, and we expect the revenue to be DKK 24 million. That was BioPorto's third quarter interim report presentation. If you have any questions, please feel free.

[Operator]

There are no audio questions at this point.

[Peter Morch Eriksen, Chief Executive Officer]

Thank you.