Greetings, welcome to BioPorto Fourth Quarter and Full Year 2022 Earnings Conference Call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Tony Pare. Thank you. You may begin. Thank you, Rob, and thank you to everyone joining us today for our Q4 and full year 2022 financial results and business update call. Joining 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, March 30th, 2023, may include predictions, estimates, and other information that may be considered forward-looking. For your information, I refer to our public filings. Let's proceed. 2022 has been a remarkable year of progress and achieved milestones for BioPorto. The most significant is the submission of our de novo application to the U.S. Food and Drug Administration, or FDA, for commercial approval to begin marketing an NGAL Test. This test will aid in identifying the risk of moderate to severe acute kidney injury, or AKI, in patients from three months up to 22 years old on a Roche Diagnostics clinical chemistry instrument. This age group is considered pediatric for regulatory purposes. Since submitting our application in November of 2022, we have been in a normal course of dialogue and providing additional data to the FDA to support their review of the application. to illustrate FDA's active review, BioPorto received an Additional Information or AI letter from the FDA in January. We are well underway to deliver our response in advance of the July 23rd, 2023 deadline. Our work to respond to the AI letter includes producing additional analytical data in the laboratory and performing additional statistical analysis to inform our proposed labeling. If approved, NGAL Test would be the first authorized pediatric AKI biomarker test commercially available in the U.S. Our entire team is committed to achieving that objective. Secondly, we achieved solid revenue results of DKK 29 million, which represents a 19% increase over 2021, while ending the year with DKK 81.8 million in cash. Just a short reminder of why we are in the business of addressing kidney injury. Acute kidney injury is defined as a rapid loss of kidney function. Since it is often painless and without any symptoms in its initial stages, it can be very difficult to diagnose. Acute kidney injury can occur as a result of an ischemic event or through the administration of strong nephrotoxic agents. Events that may cause AKI are sepsis, cardiac surgery, or any major surgery, and kidney transplants. When the injury occurs, you lose the function of the kidney, which is to filter blood and remove excess waste, excess fluid and waste, and produce urine. If detected too late and it does not resolve on its own, the kidney can progress through the stages of AKI, then on to acute kidney disease, and then on to chronic kidney disease, likely leading to a lifetime of dialysis or even death. AKI is prevalent in adults, but even more prevalent in children, and it is expensive, costing up to $24 billion in the U.S. healthcare system alone. There are no early biomarkers of AKI that are on the market today, and with the standard of care of measuring serum creatinine, AKI can often be missed. If you can catch it, therapies can be quickly applied that result in minimal or no dialysis and shorter stays in the ICU. Fortunately, our assay, which measures a protein in the urine stream called NGAL, can detect AKI when no other symptoms exist. The test is run on standard clinical chemistry instruments that are in use in all hospital core labs, there is no investment that customers need to make in terms of capital equipment to run the assay. By utilizing NGAL Test combined with other forms of clinical assessment, patients can experience a higher rate of kidney recovery, shorter hospital stays, and more dialysis-free days. Dialysis is a life-saving tool, it is not recommended if you don't need it since it has an overall effect on the life of your kidneys. The basis for our FDA submission was a strong body of clinical trial evidence demonstrating the power of NGAL Test to detect AKI in at-risk pediatric patients. Data from our guidance clinical trial clearly demonstrates that NGAL Test provide highly specific, near real-time detection of AKI that can be integrated with clinical acumen to attend to those patients truly at risk for the devastating consequences of AKI. There is a significant unmet need to address this issue in children, which is why we were able to get the FDA Breakthrough status. It is also the reason why we have established pediatrics as our beachhead, as it has the potential to drive adoption more rapidly. As we eagerly anticipate the results of the FDA review and work with them to make sure they have all the data they are requesting, we are actively working on additional initiatives to expand the market for NGAL Test. in the U.S., beyond its initial pediatric single Roche instrument introduction. The first element of this strategy is instrument expansion. The current initial FDA submission under review is limited in scope to the Roche cobas c 501 clinical chemistry analyzer. This was purposeful. We selected one instrument to take advantage of the FDA's instrument family policy for in vitro diagnostic devices, which allows for simpler future filings for similar additional instruments after the approval of the first one. There are several additional Roche diagnostic instruments already in place and suitable for use with NGAL Test. a first priority for us upon prospective approval will be to expand approval to the full fleet of Roche instruments on which NGAL Test can be run, expanding our market reach. While Roche is the market leader with approximately 1/3 of all hospital instrument placements, additional instruments from top companies, including Siemens and Abbott, are equally capable of supporting the NGAL Test. Therefore, we will pursue with similar vigor, approval NGAL Test for use on this additional 2/3 of the U.S. market. The following logical step, for which we are already preparing, is advancement towards adult indication. First with one to be determined, then several more. This will undoubtedly require additional clinical testing. However, the market for adult being approximately $1.2 billion, or 9x the size of the pediatric market. The effort and investment, even at this pre-approval point, is well justified. Ultimately, we estimate the global addressable market for NGAL Test is approximately $3 billion. All the while, as we continue to advance our U.S. commercial authorization, we continue to grow and expand our European market footprint under our CE mark. This is best evidenced by the addition of key executives to lead our international commercial efforts, including the appointment of Mr. Nis Kruse as EVP of Strategic Partnerships and the GM of EMEA and APAC, and Dr. Tabari Baker as VP of Global Medical Affairs. Combined with the company's global marketing organization, BioPorto's executive team will focus on assisting our sales channels to drive market adoption in select European markets. This will include extensive market education on AKI and the value of testing for NGAL while strengthening our distribution network. I'd like to wrap up this segment of the call by sharing a portrait of, or a picture of the Dr. Yaacov Shechter of Tel Aviv University and the acting director of Cardiology Intensive Care Department at Tel Aviv Sourasky Medical Center, who presented on the value of the NGAL biomarker and its predictive value in treating myocardial infarction patients. This paper, which was published in the Journal of Clinical Medicine, concluded that among patients undergoing primary coronary intervention, NGAL levels are associated with adverse renal and clinical outcomes, independent of other traditional inflammatory markers. Before I turn things over to Neil, I'd like to provide a word on future capital requirements. Improving revenue from European markets combined with growing our current antibody revenues are important actions to mitigate capital risk, given the current turbulent financial markets. We also don't control the approval of the approval timeline with the FDA. We continue to maintain a conservative cash spend strategy and will consider other cost control measures to extend our cash runway. These combined unknown factors drive us to conclude that the likelihood of the need to raise additional capital at some point in advance of FDA approval is high. As such, we are exploring those avenues to provide the company with flexibility when we re-engage in the capital markets. Appropriately turning to financials, I will turn the call over to our CFO, Neil Goldman. Thanks, Tony. Hello, everyone. I'm happy to walk through the 2022 financial results. As we pre-announced earlier this month, 2022 ended favorably in several respects. Starting off with revenues, 2022 total revenue was DKK 29.0 million or $4.1 million, representing a growth of 19% over the prior year period. Total revenue exceeded both the company's original outlook of DKK 24 million-DKK 26 million and its updated range of DKK 24 million-DKK 27 million, reflecting favorable performance with both our two largest product NGAL Tests and antibodies. To illustrate this, please refer to the chart on the left, which shows the annual revenue by product group. Each bar also shows the contribution by quarter. The labels at the top of the bars are the annual amounts in millions of Krone. NGAL Test revenue in 2022 totaled DKK 14.9 million, an increase of DKK 2.5 million or 20% over the prior year period. Antibody revenue in 2022 totaled DKK 12.0 million, an increase of DKK 2.7 million or 29.5% over the prior year period. This growth was somewhat offset by a reduction in revenue from ELISA kits and other items of DKK 0.5 million compared to the prior year period. The right side chart shows revenue by quarter for 2022 and 2021. Revenue in the fourth quarter of 2022 was DKK 8.7 million or $1.2 million, which was 28% higher than the fourth quarter of 2021. As we have discussed on prior earnings calls NGAL Tests, sales may have timing variability among U.S. customers because the test is presently a Research Use Only product there. This next slide provides further historical trend information on sales NGAL Tests, which as I said, are up 20% on a year-to-date basis over the prior year period. The chart shows the rolling last 12 months sales NGAL Tests. gross profit for 2022 totaled DKK 19 million, corresponding to 65.7% margins. These results also represented a DKK 4.0 million increase in gross profit over the prior year period. The increase in gross profit resulted from the combined benefit of higher sales volume and a 370 basis point improvement in gross profit percentage over the prior year period. Both the EBIT and Adjusted EBITDA operating loss results were also favorable compared to the company's original outlook and its most recent guidance. EBIT loss for the period was DKK 81.5 million or $11.5 million, a 25% increase over the prior year period. Adjusted EBITDA loss for the fourth quarter of 2022 was DKK 17.9 million or $2.4 million, a 6% increase over the prior year period. These are illustrated on the chart, which in particular shows historical quarterly Adjusted EBITDA and cash balances. I'd like to highlight one particular component of the EBIT loss because it illustrates the judicious mitigating actions we have taken and will continue to take to protect or strengthen BioPorto's financial position. BioPorto recently executed a letter of intent to sublease our office space in Needham, Massachusetts in the U.S. We expect that this will reduce our cash infrastructure costs by approximately DKK 2.8 million over the next three years. As a function of the lease accounting rules, the fourth quarter EBIT loss includes a non-cash lease impairment charge of DKK 2.6 million. For the year ended December 31, 2022, Adjusted EBITDA was a loss of DKK 67.3 million or $9.5 million. This represents a DKK 5.3 million or 8.5% increase compared to the DKK 62 million Adjusted EBITDA loss in the prior year period. Moving to the balance sheet, we had cash and cash equivalents of DKK 81.8 million or $11.7 million as of December 31, 2022. I'm pleased to report that we've reduced our total 2022 cash used in operations by 11.2 million DKK or 16% over the prior year period. This improvement was principally related to our favorable management of working capital, in particular accounts receivable, together with the timing benefit of accounts payable and other items. Net working capital as of December 31, 2022 totaled 70.5 million DKK. I will review the 2023 outlook that was announced yesterday, specifically revenue of approximately DKK 30 million-DKK 33 million and an Adjusted EBITDA loss of approximately 60-65 million DKK. The 2023 outlook is supported by key assumptions in six areas. First, it assumes minimal growth in NGAL Test revenues during the FDA review process. Since approval timing is unknown, no post-approval U.S. revenue is included in the 2023 outlook. Second, costs related to clinical studies are assumed to be lower than in 2022, while the current FDA approval is pending. Third, as Tony described, while FDA approval is pending, we are focused on NGAL Tests where they are already approved with a CE mark product in Europe, and we're similarly seeking to expand antibody sales. We expect sales and marketing costs to increase compared to 2022, associated with business development and global product marketing, including travel and related expenses, reimbursement studies, and expanded distributor material and content support. Fourth, R&D costs, excluding those related to clinical trial activities, are assumed to increase compared to 2022, including due to the full year impact of hiring over the last year, investments in studies to prepare regulatory filings to increase the addressable U.S. market through expanded clinical chemistry analyzer claims and investments in manufacturing and quality systems. Fifth, administrative costs are expected to be comparable to 2022. Finally, as Tony and I have already highlighted, we'll take judicious mitigating actions throughout the year to protect or strengthen BioPorto's financial position, including reducing operating expenses in targeted areas. Like other prudent companies, we have taken and will continue to take proactive measures to run lean, conserve capital, and plan expenditures carefully and critically. Finally, BioPorto's outlook is subject to risk factors, including those described in the 2022 annual report. With that, I'll turn the call back to Tony for closing remarks. Thank you, Neil. I'd like to wrap up the call by talking about announcements we made yesterday regarding the board of directors. First, I am very excited that the board plans to nominate Dr. Norma Padrón to join the board at the annual general meeting next month. Dr. Padrón was most recently the President and CEO of one of the largest healthcare systems in the U.S. Her impressive background is in the announcement, but I will also share that I've known and had the opportunity to work closely with her in the past, and I am confident that as someone that has led the operations of a large healthcare provider, she will bring the unique provider and payer perspective on how to drive adoption of our valuable assay. I want to recognize Christopher Lindop, who has served on the board of directors for several years, most recently as its chairman. Chris has decided for personal reasons not to stand for re-election. On behalf of the entire company, I want to thank him for his leadership and wish him well. I would like to thank all of our clinical collaboration partners, our customers, employees, and shareholders for all the support required to get this life-saving test to the market in eventual routine use. With that, I would like to turn it back to Rob for questions. Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from Yi Chen with H.C. Wainwright. Please proceed with your question. Hey, this is Chase on behalf of Yi Chen. My first question is on the FDA authorization timeline. I know you said it's unknown, but have you received any feedback from the organization and any other feedback as it relates to the review process, you know, additional data or any other questions that the FDA might have asked you? And the other one, and please bear with me, my I was having connectivity issues earlier on, but could you provide more color or could you reiterate your plans with, you know, potential plans with Roche and similar companies in the future? Thank you. Sure. Yes, we've had both informal and formal interactions with the FDA. Just to be clear, when you know, you make a submission like this, it's pretty much a interactive process with the FDA as they work to understand the data that you submitted, or ask for additional information. They did provide us with an Additional Information letter, which is a formal letter where they list out their observations of the application and ask you to come back with, you know, with data or explanations on cases. That's what we're working through with the FDA right now. The deadline to get all the responses back to them is July 23rd, and we're definitely confident that we can meet that date without any issues. In terms of, I'm sorry, the second question, Chase, was? Oh, your potential plans with companies like Roche. I know you were speaking about it. Oh, yes. At some point. Sorry. Sorry. Yes. Yeah. We do have our strategic partnership with Roche, where Roche acts as a distributor for our NGAL product today in, you know, outside the U.S., we don't necessarily have a product for sale in the U.S. It is a relationship as the term of the partnership is called a close partner channel, which allows our test to be run on specific channels with, you know, on the instruments, it, you know, in a way that full traceability is maintained. We continue to have that relationship. We continue to meet with them on a very regular basis, and we're working with them in terms of future rollout of the test in the U.S. Great. Thank you so much. Yeah. Then as it relates to other manufacturers, as Tony described in his prepared remarks, this is Neil speaking. Hello, by the way. Part of the process, after the FDA approval would be to undertake the steps to expand approval to additional instrumentation, not just within the Roche family, but to other instrument providers, including those you mentioned. Great. Thank you. We have reached the end of the question and answer session. I would now like to turn it back over to Tony Pare for final closing comments. Thank you, Rob. Thank you to all the participants for listening to our year-end conference call, and thank you for your ongoing support of the company as we work to get this valuable test on the market. This concludes today's conference. You may disconnect your lines at this time. We thank you for your participation.