Good morning, and welcome to the BioPorto first quarter 2023 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Tony Pare, Chief Executive Officer. Please go ahead. Thank you, operator. Thank you to everyone joining us today for our Q1 2023 financial results and business update call. I apologize in advance that if you're not able to see the slides through the webcast. We will have these slides available later. With me today is Neil Goldman, BioPorto's Executive Vice President and Chief Financial Officer. Before we begin, let me remind you that the company's remarks made during this conference call today, May 10, 2023, may include predictions, estimates, and other information that may be considered forward-looking. For your information, I refer you to our public filings. Let's proceed. 2023 has started off strong for BioPorto. We are encouraged by our 24% year-over-year revenue growth with DKK 8 million in sales. We are on track towards our full year 2023 revenue outlook of approximately DKK 30 million-DKK 33 million. Adjusted EBITDA for the first quarter is similarly in line with our full year 2023 outlook. That said, I would like to remind you that the revenue outlook assumes minimal growth in U.S. NGAL Test revenues during the FDA review process. Similarly, since approval timing is unknown, the outlook does not include any post-approval U.S. revenue as well. We aren't sitting and waiting for FDA approval to drive NGAL Test adoption, however. We have invested and will continue to invest in commercializing NGAL Test in countries where we already have regulatory approval to sell, such as in the E.U. and elsewhere that accepts CE mark product. We are also focusing on promoting our high-margin antibody business. Together, these can offset the company's capital requirements. In addition to expanding revenues at favorable margins, we have adopted measures to maintain a strong cash position, which is DKK 57.7 million. I will spend a few minutes reviewing the clinical value of The NGAL Test and introduce the business and investment thesis to new listeners. Our primary reason for being is to commercialize The NGAL Test. The NGAL Test provides an early detection and prevention of acute kidney injury or AKI. AKI occurs when there is a lack of blood flow or poor perfusion of the kidney, even temporarily, where the kidney is directly damaged by nephrotoxic drugs or contrast agents. The injury occurs, you lose the function of the kidney, which is to filter blood and to remove waste and excess fluid and produce urine. Initially, there are typically no symptoms associated with AKI, if you can detect its onset early enough, you can save the kidney. If detected too late, it does not resolve on its own, the kidney could start to fail, resulting in death or chronic kidney disease and a lifetime of dialysis. The problem is with today's diagnostics, detection can only really occur in the latter stages. As such, clinicians operate in the dark for the first couple of days in the ICU, and based on their training and experience, will either choose to wait to make any kind of therapy changes or perform prophylactic early intervention measures such as dialysis, which takes time, resources, including people and dialysis instruments and money. If AKI is detected too late and it does not resolve on its own, the kidney can progress through the stages of AKI, acute kidney disease, and chronic kidney disease, likely leading to a lifetime of dialysis or even death. AKI is highly prevalent, expensive, and hard to detect. It affects one in four children and one in five adults that are hospitalized, it represents up to $24 billion burden on the U.S. healthcare system alone. There are no early biomarkers for AKI marketed today, the standard practice of using serum creatinine measurements is highly deficient in terms of sensitivity, specificity, and time delay relative to the actual onset and progression of AKI. Relying solely on serum creatinine and urine output, AKI can be missed, or by the time it is detected, it is too late to meaningfully intervene. By contrast, when AKI is detected and treated early, further AKI progression can be halted, allowing the kidney to recover, resulting in minimal or no dialysis and shorter stays in the ICU. BioPorto is already shifting the paradigm of AKI detection through our proprietary NGAL Test, which detects the biomarker NGAL in urine within only two to three hours after initial kidney injury. NGAL Tests are already marketed in Europe, Korea, and other countries. Unlike serum creatinine, NGAL Test can detect AKI in the absence of any other detectable marker or observable symptom. NGAL stands for neutrophil gelatinase-associated lipocalin. NGAL is a urinary biomarker that identifies AKI-induced structural damage to the kidney. If in your kidney you have approximately one million nephron, whose job is to remove waste products from the blood, and produce urine. It is essentially a filter in the bloodstream. If you have the slide in front of you can see on the left side of the screen, you will normally see a normally functioning nephron sample, which has a normal level of NGAL protein expression that will show up in urine as well as blood samples. The undamaged nephrons will effectively move fluid from one end to the other, allowing for efficient removal and reabsorption of salts, water, proteins, and minerals. The output is urine. Urine output and common functional kidney measurements, including serum creatinine, urea nitrogen, albumin, sodium, potassium, as well as others, all remain within normal ranges. The undamaged nephrons will not produce NGAL at high levels. If you look on the right side of the slide, when the nephrons are damaged due to surgery, sepsis, or other causes, they will not effectively move fluid from one end of the nephron to the other. As such, these damaged nephrons will not be able to effectively perform their filtration function. The loss of function is identified by a reduced urine output, increased serum creatinine. The problem, though, is that this reduced function is very slow to respond. Additionally, the other common functional kidney measurements are very unreliable. Lastly, the lack of urine output can be misinterpreted as somebody not getting enough fluids. NGAL, however, is rapidly increased in the damaged nephron and detectable soon after kidney damage. The rapid detectability of NGAL allows clinicians to assess a patient's fluids and nephrotoxic drug dosage in order to protect the kidneys from further irreversible damage. The first reaction to high NGAL levels when combined with other clinical evaluation would be to stop or minimize the use of nephrotoxic agents such as strong antibiotics or contrast agents. In patients with established AKI who are unresponsive to fluid administration, fluid restriction is the treatment of choice. When fluid therapy is indicated or required for AKI patients, isotonic crystalloids should be the preferred agent. As a last measure, dialysis would be considered. Our test is run on urine samples on very common chemistry analyzers such as the Abbott Alinity or the Roche cobas, whose picture is seen on the slide. Every hospital has a core lab, and every core lab has at least one of these standard instruments. As such, the hospital does not require any capital investment in equipment to implement an NGAL program. Also, our assay is a reagent-only product enabling the attainment of very high gross margins. It also makes our regulatory pathway typically shorter. As or more important than BioPorto's NGAL test superior sensitivity is its ability to detect AKI significantly sooner than current approaches. When used as part of clinical assessment, clinicians have a clearer, more complete picture of the patient's disease state. Patients benefit from a higher likelihood and rate of kidney recovery, shorter hospital stays, and fewer days on dialysis. While dialysis is an important and effective short-term life-saving tool, it is also very invasive and generally not recommended if avoidable due to its well-recognized impact of shortening the overall life of kidney function. As discussed on our year-end 2022 call, over the last several months, we have been actively investing in sales and marketing of the NGAL test in Europe, where it is already commercially available under CE mark. However, our gaze is squarely set on the FDA's ongoing review of our De Novo application for marketing authorization of NGAL test for patients from three months up to 22 years old on a Roche Diagnostics clinical chemistry instrument. The submission was well-supported by a strong body of data from our GUIDANCE clinical trial demonstrating highly specific near real-time detection of AKI to empower clinicians to, for the first meaningful time, treat the devastating consequences of AKI. The unmet need for superior AKI detection and treatment in children is well-established and certainly a contributing factor to receiving Breakthrough designation from the FDA. It is also why we received why we have selected this pediatrics classification as our entrée into the U.S. market and where we expect greater leverage to meaningfully drive adoption. As an update on our FDA status, after a three-part clinical study, we submitted our De Novo application for approval on November 10th of last year. We have been in communication with the FDA, answering questions which started almost immediately after submission. In January, we received an official request for additional information or clarification on 14 specific points. This is very normal, and most De Novo submissions will receive one or more of these requests. Although we have completed answers to most of their questions, their process dictates that all answers are supplied at once. Some of these observations require additional laboratory testing, which we are performing with what appear to be positive results to date. We do not anticipate needing to expand the study with additional patients. We remain on track to respond to the recent request for additional information from the FDA by the end of this quarter, which is in advance of the July 23rd, 2023 deadline. The team has made meaningful progress in preparing the materials, which will be submitted together when complete. Last year, we established three pillars of our strategy to operate from. While the tactics underneath this strategy will change year to year, the overall pillars remain the same. The first pillar is to drive NGAL Test market adoption and have a pipeline of high medical value products. First and foremost is to get our pediatric submission approved by the FDA. In the meantime, we can perform the work necessary to expand our indications for use to other instruments and for other clinical indications beyond pediatrics in the ICU. We can also drive sales of NGAL in Europe, where we are already approved but relatively untouched in terms of sales efforts. Our second pillar is to strengthen the company to scale and execute. In 2023, this means closely managing our cash during the uncertainty in capital markets. As indicated in a recent news release, we will execute a financing round this year. The last round we had was in March, April of 2022. We need to ensure we exit 2023 with a good cash position. It includes driving sales on our high-margin antibody business to help offset expenses. It also means suspending certain activities such as new biomarker development until we have certainty in our NGAL test regulatory approval in the U.S. The third and very important pillar is to attract, develop, and retain the best and brightest employees aligned with our values. As we build a team, we need to recruit the very best to help drive success. As part of good expense management in using our cash judiciously, we have trimmed our overall staffing. We are not unique in this endeavor, as many companies have taken similar steps recently to manage their capital reserves. Of course, we also need to continue motivating and rewarding our existing employees to ensure long-term positive retention. I'd like to wrap up this part, this segment of the call by sharing one of the several presentations that discussed NGAL at a recent AKI & CRRT conference in San Diego. AKI & CRRT is a preeminent global conference for critical care nephrology. The presenter in the photo is Dr. Natalja Stanski, a critical care clinician at Cincinnati Children's Hospital Medical Center. Her presentation described how she routinely uses BioPorto's The NGAL Test at the hospital while treating patients. What is interesting is the fact that she has always used The NGAL Test as part of her diagnosis. This is just one indication that the next generation of clinicians are being educated by their leading colleagues in the value of The NGAL Test in their diagnosis decisions and incorporating into standard care. Before I turn things over to Neil, I'd like to provide further word on future capital requirements. Improving revenue from The NGAL Test sales to European and other markets, combined with our growing antibody revenues, are important actions to mitigate capital risk given the current turbulent financial markets. We also don't control the approval timeline with the FDA. We continue to maintain a conservative cash spend strategy and have implemented cost control measures to extend our cash runway. These, combined with Unknown factors, drive us to conclude that the likelihood to raise additional capital in advance of the FDA approval is high. As such, we have been and are continuing to explore these avenues to provide the company with the flexibility when we reengage in the capital markets. With that, I'll turn the call over to our Chief Financial Officer, Neil Goldman. Thanks, Tony, hello, everyone. I'm happy to walk through our strong first quarter 2023 financial performance. Starting off with revenues, which are illustrated for those of you with the slides on the chart on the right side of the page. In the first quarter of 2023, revenue totaled DKK 8 million, or $1.2 million, representing a growth of 24% over the prior year period. Total revenues continue to be driven by our two largest product categories, NGAL tests and antibodies. To illustrate this, the slides have a chart on the left which shows annual revenue by product group. Each bar also shows the contribution by quarter, the labels at the top of the bars are the annual, or in the case of this year, the first quarter, amounts in millions of DKK. While we only have the first quarter to look at for 2023, you can see the year-over-year sales growth of both NGAL tests and antibodies. NGAL test revenue in the first quarter of 2023 totaled DKK 4.8 million, an increase of DKK 1.1 million or 29% over the prior year period. Antibody revenue in the first quarter of 2023 totaled DKK 2.8 million, an increase of DKK 0.9 million or 50% over the prior year period. This growth was somewhat offset by a DKK 0.5 million reduction in revenue from ELISA kits and other items compared to the prior year period. As we have mentioned on prior calls, NGAL test sales may have timing variability among U.S. customers because the test is presently a research use only product in that region. In addition, antibody sales can, on occasion, be impacted by bulk customer orders. Our next slide provides historical trend information on sales of NGAL Test over rolling last 12-month periods. NGAL Test sales have continued on their positive growth trend, including being up 15% over the last 12 months compared to the previous last 12 months. These revenues realized gross profit of DKK 5.3 million during the first quarter of 2023, corresponding to 66% margins. Gross profit increased by DKK 1.4 million over the prior year period. The increase in gross profit reflects the combined benefit of higher sales volume and a 530 basis point improvement in gross profit percentage over the prior year period. Adjusted EBITDA loss totaled DKK 15.2 million, or $2.2 million, which is consistent with the company's 2023 outlook. Therefore, we are maintaining our 2023 guidance with revenues of approximately DKK 30 million-DKK 33 million and adjusted EBITDA loss of approximately DKK 60 million-DKK 65 million. EBIT loss for the period was DKK 17 million, or $2.4 million, representing an improvement of 7% over the prior year period. These are also illustrated on the slides, which in particular show historical quarterly adjusted EBITDA and cash balances. As part of the expense and cash control measures that Tony described earlier, after the end of the quarter of the first quarter of 2023, we implemented a reduction in force that affected 28% of our global employees to better align the company's resources with its strategic priorities to grow revenues in European and other markets that accept CE mark, prepare responses to the FDA's request for additional information and expand the total addressable market for NGAL tests. The company expects to record a restructuring charge related to the reduction in force of approximately DKK 2.5 million during the second quarter of 2023. Moving to the balance sheet, we had cash and cash equivalents of DKK 57.7 million, or $8.4 million as of March 31, 2023. The use of cash from operations during the first quarter of 2023 reflects the planned payment of clinical trial costs that were invoiced by our contract research organization and trial sites in December 2022 and annual incremental expenses. Our team has continued their effective management of working capital, which as of March 31, 2023 totaled DKK 55.3 million. As I said, we are reiterating the 2023 outlook, for which we remain well on track. We continue to operate with fiscal discipline, given broad-based capital market uncertainty. As benefited the company over the past many months, Tony, the team, and I will continue to take responsible measures with careful and conservative expenditures that focus on our program's critical paths. Finally, BioPorto's outlook is subject to risk factors, including those described in the 2022 annual report, as supplemented in the interim report for the first quarter. With that, I will turn the call back to Tony for closing remarks. Thank you, Neil. I'd like to wrap up by sharing some pictures of the BioPorto team watching tests in progress at Boston Children's Hospital. Boston Children's is consistently ranked as the number one or number two pediatric hospital in the world. As such, Boston Children's had the resources and capabilities to qualify our NGAL test, which in advance of FDA approval, is only sold in the U.S. on a research use only basis. They were able to do this by validating as a laboratory-developed test. They qualified the NGAL test in-house, Boston Children's is permitted to utilize them clinically for diagnosing children without FDA approval. The pictures show the instrument that runs our test and a picture of our director of operations, who is happily pointing to the BioPorto boxes on the shelf in the hospital's inventory of reagents. It was indeed heartwarming to walk through the hospital and see the children and parents that are going through some very difficult times, but know that our tests are helping clinicians support their quick recovery. I would like to thank all of our customers, employees, and shareholders for all the support required to get this life-saving test to the market and into eventual routine use. I am confident in the continued momentum built into and through this first quarter of 2023 and eagerly anticipate a very positive 2023. With that, I would like to turn it back to the operator for questions. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question is from Yi Chen with H.C. Wainwright. Please go ahead. Thank you for taking my questions. My first question is, once you submit the additional information requested by the FDA, typically, how long would the FDA need to complete the review process? Yeah. You know, because we are Breakthrough status, we anticipate that they'll look at our responses very quickly after submitting. However, that being said, Yi, it could be that they come back with additional set of questions, which is not unusual. Again, we don't know how quickly they'll come back with questions or if they'll just move through their, you know, their standard approval analysis. Got it. Also, can you let us know the number of U.S. hospitals that are currently using The NGAL Test for research purpose? Yeah. We have over 30 hospitals today that are utilizing the test as an RUO, yeah. How many U.S. hospitals are out there focused on pediatric patients that could use the NGAL test once it's commercialized? You know, you have over 5,000 hospitals in the U.S. with ICUs. In terms of pediatric hospitals, I believe the number is close to 300 hospitals that are dedicated to pediatrics. Remember that our test will be indicated for ages three months up to 22 years old. You have a cadre of folks that are in that 20, that 18 to 22-year-old that could be admitted to an adult ICU as well. All of those hospitals are targets. Got it. How do you plan to effectively market The NGAL Test to all those hospitals? How many sales reps do you think you would need to do that? Yeah, I mean, we'll start out small and grow big, right? I think success breeds success. Right now, we are waiting for FDA approval before we start to really expand our sales force. You know, once we're in expansion mode, we'll probably start, you know, with six sales folks and then continue to build on that as we get more and more success. Okay. Finally. And we- What- Yeah. I'm sorry. This is Neil. I just wanted to. Mm-hmm P unctuate one thing Tony said. The approach we're taking from a sales force standpoint in the U.S. is purely a function of being prudent from a capital management standpoint. Yeah, exactly right. Got it. Thank you, Neil. Lastly. Sure. Is there any hurdles in terms of reimbursement or in terms of the cost needs to be absorbed by the hospitals or the patients? You know, reimbursement can come in a couple of different ways. We have started a process that we've suspended to basically establish a separate reimbursement code. However, that being said, there are different DRGs. You know, basically DRGs is the reimbursement vehicle for hospitalized patients, where you get reimbursed a fixed amount depending on the disease state. If somebody goes in and has cardiac, you know, for cardiac surgery and is recovering from that cardiac surgery, there's actually a different DRG for folks that have your typical recovery and then folks that actually have kidney issues, right? So if you can diagnose kidney issues while they're in there, you get a higher level of reimbursement on the order of, like, $1,000. Got it. Thank you. Yep. This concludes our question and answer session. I would like to turn the conference back over to Tony Pare for any closing remarks. Thank you, operator. I just, again, wanna thank all our customers, employees, and shareholders for all the support that they continue to provide us to get this, very, very valuable test onto the market. Thank you. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.