Greetings, welcome to the BioPorto Fiscal Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operational assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tony Pare, Chief Executive Officer. Thank you, Mr. Pare. Mr. Pare, you may begin.
Thank you, Mauricio. To all who joined our Q2 2023 Business Update and Financial Results Call. Joining me today is Neil Goldman, BioPorto's Executive Vice President and CFO. During this call, we would like to refresh your knowledge about the company and our NGAL test while delivering a comprehensive update on our recent quarterly events. We welcome questions and clarification requests at the end of this call. Before we begin, let me remind you that the company's remarks made during this call today, August 1st, 2023, may include predictions, estimates, and other information that might be considered forward-looking. For more information, I refer to you to our public filings. Now, let's get started. In Q2 2023, we continued executing to the objectives consistently communicated in our updates.
Our year-to-date revenue performance of DKK 15.8 million reflects growth of 5% compared to the same period from last year. This development is the result of an increase in revenue from NGAL test, which I find to be a solid signal of our efforts to increase sales of the test globally. It is, however, offset to some degree by a decline in antibody sales. During the second quarter, we also completed and submitted our response to the FDA's Additional Information letter received earlier this year. This response is connected with BioPorto's de novo application to the FDA for marketing authorization of an NGAL test. The test aids in identifying pediatric patients at risk of moderate to severe acute kidney injury, or AKI, which had received Breakthrough Designation status from the FDA for expedited review.
Additional information letters are a standard part of the regulatory review procedure. BioPorto executed the requested additional analytical studies and the statistical analysis and submitted it to the FDA at the end of Q2, following the schedule we had previously shared. Active dialogue with the FDA has resumed, and we know they are actively reviewing our application. We also successfully closed a preemptive rights issue last month that bolstered our cash position by DKK 41.4 million. We were very appreciative and glad to see that the offering was supported by existing and new shareholders, including our largest shareholders, as well as the entire board of directors and member, members of management. The offering elevated our total cash at the end of June 2023 to DKK 85.4 million.
While we eagerly await the FDA's decision, we are maintaining our revenue and EBITDA guidance for 2023. Our focus remains on extending the sales of our NGAL test in European markets and other regions recognized in the CE mark. I would like to remind those on the call why our NGAL test is important to saving kidneys and patients' lives. The kidney's primary and essential function is to filter blood, remove waste and excess fluid, producing urine. Acute kidney injury, or AKI, occurs when there is an interruption of healthy perfusion of the kidney, even temporarily. AKI also occurs during the administration of nephrotoxic drugs, like antibiotics or contrast agents. AKI is particularly challenging to identify and timely treat because of its lack of specific symptoms. General symptoms, including reduced urinary output, swelling, or fatigue, are not specific to AKI and therefore can be misinterpreted.
This makes AKI difficult to detect and diagnose. Complicating matters further, AKI is a time-sensitive condition. The longer it goes undetected and untreated, the greater the damage to the kidneys and the higher the risk of severe outcomes. Potential late-stage outcomes include chronic kidney disease, necessitating dialysis, kidney failure requiring transplant, and even death. Fortunately, early detection of AKI can help guide effective therapeutic interventions. AKI is alarmingly common, affecting one in four children and one in five adults who are hospitalized. It often accompanies other recognized events, injuries, or procedures, including cardiac surgery, mechanical ventilation, transplants, and the many circumstances when nephrotoxic agents or drugs are used as its treatment. AKI is also a significant economic burden and is detected in a shocking 12% of critically ill patients, with 21% of these unfortunately succumbing to it.
It is clear that AKI is far more a far more significant problem than most realize, from detection to treatment and ultimately prevention. The crucial question now is: Why is progressive AKI so prevalent, leading to disastrous consequences? How can we detect and prevent its progression earlier? The absence of a readily available, early biomarkers like NGAL, serum creatinine, and urine output are currently the standard method for detecting AKI. However, the time frame to intervene effectively and prevent AKI progression is both early and limited. Serum creatinine and urine output unfortunately fail in terms of sensitivity, specificity, and timeliness of detection relative to AKI onset and progression. In fact, published studies have shown that when only these criteria are used, between 28% and 43% of AKI cases are missed entirely, and two-thirds of AKI cases are misclassified.
With statistics like that, it should be no surprise that 70% of clinicians believe they are missing AKI. That's why NGAL can make such a big difference in both patient outcomes and healthcare costs. Early detection can lead to sparing, kidney sparing intervention, reducing or halting the risk of further damage. The benefits are significant: minimized or no dialysis and patient survival, accompanied by shorter ICU stays. The shorter the ICU stay certainly benefits the patient, but also benefits the hospital through lower treatment costs. BioPorto's NGAL test is already marketed in Europe under the CE mark, in Korea, and in additional countries. Some additional practical and commercial benefits of the test include that it can be run on a standard equipment, eliminating the need for additional capital expenditure. It is also brand agnostic, compatible with Abbott, Roche, and all other premier clinical instruments.
The test is a reagent-only product, boasting high gross margins, even at the current production level, with the potential for further economics as we grow and expand. Moreover, it generally entails a simpler and shorter regulatory process. Over 30 institutions in the U.S. are already using the NGAL test clinically after validating as a laboratory-developed test. After a positive three-part clinical study, we submitted our de novo application to the FDA for commercial approval to market the test for pediatric use in the ICU. In the U.S., the term pediatric means patients between the greater or equal to a, three months and under 22 years of age.
The FDA previously granted the NGAL test Breakthrough Designation status, which is the FDA's, which the FDA reserves for diagnostics that have, that provide for a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. As mentioned earlier, during the last fiscal quarter, we responded to an Additional Information letter received in January as part of this ongoing FDA review. We have confidently provided comprehensive responses to all points of the inquiry, which required some additional lab work, but no further clinical or patient testing. We continue to actively communicate with the FDA and feel well prepared to address any further inquiries or questions that may arise.
With cautious optimism about the prospective U.S. approval of the NGAL test for use in pediatric populations in the ICU, we are actively planning for situational instrument, instrumental and adult population expansion, including use beyond the ICU and into the ED. Simultaneously, we plan to expand the initially designated Roche instrument to include use not only in additional Roche instruments, for which the test is already compatible, but all other manufacturer instruments as well. Ultimately, we build momentum along this commercial strategy. We aim to pursue a full adult indication for one or several specific disease-associated NGAL test uses, which will require additional clinical testing. However, we anticipate this will be strongly supported by all the preceding clinical and real-world use of the NGAL test. We have an additive effect of indication, instrumentation, and population expansion in the U.S., as I described.
The sum of all these markets could increase the potential market almost tenfold, from $134 million for the pediatric ICU population to approximately $1.2 billion in the U.S. This is possible with the inclusion of a level instrument field application beyond the ICU, and more importantly, the addition of one or more adult testing indications. Ultimately, we estimate the global addressable market for the NGAL test is approximately $3 billion. While we continue our dialogue with the FDA in eager anticipation of a potential U.S. launch, we are working to expand the already available ex-U.S., U.S. opportunity through a multipronged approach that engages all key stakeholders in these open markets.
Those stakeholders include our distributors and sales partners, who we are increasingly engaged in rationalizing whether they have the correct capabilities and willing to make the appropriate investment. With those distributors, we will thoroughly train and proactively support. They also include our customers, who we market to directly and engage directly to co- in coordination with the distributors and our key opinion leaders and clinical champions, whom we work with proactively to leverage their experience and appreciation for the NGAL test and all the benefits it offers. The market in Europe is large, but traditionally requires extensive effort to get established, which is the reason that we have focused on select countries and distributors to get started.
In summary, I would like to revisit the three pillars of our operational strategy that we established at the beginning of the year and presented during our last update at the end of Q1. While the underlying tactics may change year by year, the pillars themselves are expected to remain constant. As we move forward into the second half of the year, the tactics have also not changed. We are focused on getting the FDA approval, expanding our total addressable market in the U.S., pushing forward in Europe, managing our cash position through financing, promoting high-margin product sales, and managing our expenses, all while making sure that we have motivated, talented employees to execute. Now, I will turn the call over to our CFO, Neil Goldman, to summarize our recent financial performance.
Thank you, Tony, and hello, everyone. I'm pleased to walk you through our financial performance. Starting with revenues, year-to-date total revenues were DKK 15.8 million , or 5% ahead of the prior year period. The chart on the right of the page breaks down revenue by quarter. In the second quarter of 2023, revenue totaled DKK 7.7 million , or approximately $1.1 million, a 9% decrease over the prior year period. The second quarter of 2022 benefited from a large tender-driven bulk shipment of antibodies. Referencing the chart on the left, we can see annual revenue by product group. Each bar also shows the quarterly contribution, and the labels on the top of the bars are the annual amounts in millions of kroner.
NGAL test revenue in the second quarter of 2023 totaled DKK 4.6 million, an increase of DKK 1.2 million, or 37% over the prior year period. Year- to- date, in 2023, NGAL test revenue is up DKK 2.3 million, or 33% over the prior year period. Antibody revenue in the second quarter of 2023 totaled DKK 2.9 million, a decrease of DKK 2.1 million or 43% over the prior year period, again, representing the bulk shipment of antibodies during the second quarter of 2022. Year- to- date, in 2023, revenue from antibodies is down DKK 1.2 million, or 18% over the prior year period.
As we've mentioned in prior calls, NGAL test sales can show timing variability among U.S. customers, as the test is currently only approved for research use in that region. Additionally, antibody sales can be influenced by the timing of tender-driven bulk customer orders. This slide provides additional historic trend information on sales of NGAL tests over rolling last 12-month periods. NGAL test sales have continued their positive growth trend, with an increase of 27% over the last 12 months compared to the previous year. Second quarter revenues delivered gross profit of DKK 5 million during the second quarter of 2023, as I said, corresponding to 64% margins.
However, gross profit during the second quarter of 2023 decreased by DKK 1.1 million over the prior year period, reflecting the combined effect of lower sales volume and a 700 basis point decrease in gross profit percentage over the previous year. Adjusted EBITDA loss for the second quarter of 2023 totaled DKK 16.3 million, or $2.4 million, a 5% improvement over the prior year period. That brings year-to-date adjusted EBITDA loss to DKK 31.5 million, a 3% improvement over the prior year period. These are illustrated on the chart, which shows historical quarterly adjusted EBITDA and cash balances. The EBIT loss for the second quarter of 2023 was DKK 20.9 million, a 4% additional loss over the prior year period. EBIT loss includes a restructuring charge that I will address now.
As previously announced, during the second quarter, we implemented a restructuring, including a workforce reduction that affected 28% of our global employees. The restructuring better aligned the company's resources with its strategic priorities of gaining NGAL test regulatory approval in the U.S., growing revenues in European and other markets that accept CE mark, and expanding the total addressable market for NGAL tests. The company recorded a restructuring charge of approximately DKK 3 million during the second quarter of 2023. Naturally, this has reduced our staff and related costs, costs in advance of the ultimate approval timing for the FDA or from the FDA. Moving to the balance sheet, cash and cash equivalents as of June 30, 2023, totaled DKK 85.4 million, or $12.5 million.
This balance includes the DKK 41.4 million net proceeds of the preemptive rights offering that we completed near the end of the second quarter. Our team has continued their effective management of working capital, which, as of June 30, 2023, totaled DKK 80.9 million . As Tony mentioned at the start of the call, we are maintaining our 2023 outlook, with projected revenues for the year of approximately DKK 30 million-33 million and an adjusted EBITDA loss of approximately DKK 60 million-65 million . We have operated with fiscal discipline and will continue to take responsible measures with careful and conservative expenditures that focus on our program's critical paths. Finally, please note that BioPorto's outlook is subject to risk factors, including those described in the 2022 annual report, as supplemented in the 2023 interim reports.
With that, I will turn the call back to Tony for his closing remarks.
Thank you, Neil. In closing, I'd like to express my gratitude to all of our employees, customers, and shareholders, both long-standing and new, from our recent financing, for their continued commitment, support, and effort. This dedication is crucial to our profound mission to address the significant unmet need and devastating impact of AKI. Whether we are advancing our FDA submission or closing a financing, it all comes back to our shared vision, persistence, and dedication. I remain confident in our team and optimistic about our execution on all fronts. With that, I'd like to turn things back to our operator, Mauricio, for questions.
Thank you. We now 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 that your line is in the question queue. You might press star two if you would like to remove your question from the queue. For participants using speaker equipment, it might be necessary to pick up your handset before pressing the star key. Our first question is from Mr. Yi Chen, for H.C. Wainwright. Please, sir, go ahead.
Hey, everyone. This is Chait on behalf of Yi Chen. Just a couple of quick questions. I know you briefly indicated during your prepared remarks, but could you elaborate on your market expansion plans in Europe? On one of your slides, you indicated that you're suspending any future biomarker studies. Is that just a cost-cutting step? Thank you, I'll hop back in the queue.
Yes. In terms of Europe, we are focusing on a few select countries, initially, in terms of finding correct distributors. I, I, shouldn't say correct, but distributors that are willing to invest in the staff, as well as the training to, you know, properly position our product in, in those specific countries. We've identified three countries that we're focused on. We also have a country, in terms of Korea, outside of Europe, obviously, where we've had solid business in the past but are putting extra effort to make sure that that team, that sales team, has the training they require to basically expand, you know, their market share within that particular country. It's actually getting very good results.
If you look at the growth of our NGAL business, Korea is one of the areas that, that is starting to expand, very satisfactorily for us. In terms of additional biomarker development, you're exactly right, Chait. This, this was a cost-cutting exercise to put these things on hold, while we wait for FDA approval. It is really, you know, incumbent on us to manage our, our cash very, you know, tightly, at this point in time, while we're waiting for the approval.
Yeah, that's right. To build on that, this is Neil, thanks for the questions, is the teams that would otherwise be doing the work on antibody development, you know, they're focused on the market expansion, the TAM for additional instrumentation and additional indications and eventually the adult market, as well as supporting the ongoing dialogue that we're having with the FDA. Very, very focused is, is how I'd summarize it.
Excellent. Thank you.
There is no further questions at this time. I should like to turn the floor over to Mr. Pare for closing comments. Please, sir, go ahead.
Thank you, Mauricio, and thank you all for listening today. Again, thank you for your continued support.
This concludes today's teleconference. You might disconnect your line at this time. Thank you for your participation. Have a great day.