Good morning and welcome to the Nuwellis First Quarter 2023 Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note that this event is being recorded. I would like now to turn the conference over to Ms. Vivian Cervantes, Investor Relations at Gilmartin Group. Please go ahead.

Thank you, operator. Thank you, everyone, for joining us for today's conference call to discuss Nuwellis' corporate development and financial results for the first quarter ended March 31st, 2023. In addition to myself, with us today are Nestor Jaramillo, Nuwellis' President and CEO; and Lynn Blake, CFO. We also have Dr. John Jefferies, Nuwellis' Chief Medical Officer, and John Kowalczyk, the Company's Senior Vice President of Sales & Marketing. At 8'o Clock Eastern today, Nuwellis released financial results for the quarter ended March 31st, 2023. If you have not received Nuwellis' earnings press release, please visit the Investors page on the company's website. During this call, the company will be making forward-looking statements. All forward-looking statements made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Any statements that relate to expectations or predictions of future events and market trends as well as our estimated results or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. Please refer to the cautionary statements and discussion of risks in the company's filings with the SEC including the latest 10-K and subsequent reports. With that, I would now like to turn the call over to Nestor.

Thank you, Vivian, and good morning, everyone. Welcome to Nuwellis first quarter 2023 earnings conference call. On today's call, I will provide an overview of our first quarter performance and give an update on our strategic initiatives. Our Chief Financial Officer, Lynn Blake, will then provide detailed commentary on the financial results. Before I open the call up for questions, followed by my closing remarks. Dr. John Jefferies, our Chief Medical Officer, and John Kowalczyk, our Senior Vice President of Sales and Marketing, are also on today's call and will be available during the question-and-answer section. Turning to our first quarter results. In the first quarter of 2023, Nuwellis generated $1.8 million in revenue, a decrease of 5% over the first quarter of 2022. By segment, first quarter 2023 revenue in heart failure increased 21% over the same period last year, while pediatric and critical care revenue declined 28% and 4% respectively. In heart failure, which in the last six months has had a bolus of support from multiple peer reviewed publications. The 21% revenue growth in Q1 follows similar strong year-over-year heart failure revenue growth of 47% in Q4 of 2022. We attribute the growth in heart failure to the steady flow of positive peer review publications and clinical evidence, bolstering the activities of the sales and marketing organization which is now fully staffed in all territories. We remain committed to driving market penetration in our ultrafiltration treatment earlier in the hospital admissions cycle and across multiple hospital specialty units. Key to the execution is driving awareness among clinicians and providers to understand that ultrafiltration is the next logical step in the care pathway. In other words, patients from whom oral or intravenous diuretics are not effective should immediately move to ultrafiltration therapy, which is a mechanical fluid removal…

Thank you, Nestor, and good morning, everyone. Revenue for the first quarter of 2023 was $1.8 million, a 5% decline year-over-year. By segment first quarter 2023 revenue in heart failure increased approximately 21% over the same period last year, while pediatrics and critical care declined approximately 28% and 4% respectively. In pediatrics, as Nestor mentioned, the decline was driven primarily by lower patient census, with lower than expected neonate hospital admissions. Gross margin was 58.4% of sales for the fourth quarter, an increase of 120 basis points compared to gross margin of 57.2% in the prior year quarter, driven by an increase in circuit ASPs and to a lesser extent, favorable product and geographic sales mix. Selling, general and administrative expenses were $5.5 million in the first quarter of 2023 compared to the first quarter last year, SG&A expenses increased by approximately $1.1 million or 24%. This increase reflects both increased staffing expenses and seasonally higher year-end related public company expenses, which were increased this year due to additional year-end audit and legal work associated with our October 2022 financing and related stockholder meetings. Additionally, we incurred incremental professional fees associated with consulting related to our strategic initiatives in the quarter. First quarter research and development expense was $1.4 million, an increase of approximately $300,000 or 29% compared to the first quarter last year. On a sequential quarter basis, R&D costs increased $227,000 or 19%. These increases were driven by increased product development expense associated with the ongoing development of our pediatric dedicated device. Total operating expenses were $6.9 million in the quarter, an increase of approximately $1.4 million as compared to $5.5 million last year. Given the factors discussed. The net loss in the first quarter was $6.5 million or a loss of $5.76 per basic and diluted common share compared to a net loss of $4.5 million or $42.45 per basic and diluted common share for the same period in 2022. That loss is adjusted for our December 2022 reverse stock split. The current quarter's net loss includes a non-recurring non-cash expense of approximately $750,000 associated with the revaluation of the warrants issued in conjunction with our October financing. Debt expense was recorded in other expense on the income statement. From a liquidity perspective, we ended the first quarter with $12.1 million in cash, cash equivalents and marketable securities and no debt on the balance sheet. We had approximately 1.2 million common shares outstanding at the end of the quarter. This concludes our prepared remarks. Operator, we'd like to open the call to questions now, please.

Thank you. We'll now begin the question-and-answer session. [Operator Instructions] The first question comes with Jeffrey Cohen with Ladenburg Thalmann. Please go ahead.

So a few questions from my end. I guess, firstly, could you talk about pediatrics that came in light and talk about. It sounded like the census was lower for candidates for your therapy. Talk about that. And also could you give us a frame of reference as far as percent of revenue for the quarter that pediatrics was?

Okay. Good morning, Jeff. Thank you for your question. The pediatrics shortfall was mainly in our large legacy accounts. In these accounts, we have experienced much lower census than we expected and meaning those patients that qualify for our therapy neonates being admitted and also needing critical care. As you remember, most of these patients that are treated with the Aquadex ultrafiltration system are off label. Our indication is on 20 kilograms and above. We're still increasing our focus on pediatrics, on other indications such as cardiac surgery, heart failure to compensate for the lower census that we are seeing right now. And Lynn, do you want to provide the answer on the percentage of the revenue that was attributed?

Sure. Hi, Jeff. The Q1 revenue was 23% pediatrics. 23% of total in the quarter.

Perfect. Okay. Got it. And jumping over to -- while we're on pediatrics, you answered you're anticipating an ID approval in the first quarter of '24. Is that correct?

That's correct, Jeff.

Okay. And then could you talk about the reverse heart failure trial a little bit? 11 centers, what percent enrollment are you at? I think I heard a number. But what's the total enrollment number that you're trying to get to and what percent you there and when might that conclude?

Right. Jeff, the total number that we anticipate to have is somewhere around 372 patients. However, we are redoing our statistical analysis that perhaps that may change in favor of a lower number, a sample size, but we're not completely done with all the statistical analysis that need to be done. We are about if I use the 370, we are about a little bit over 10%, 15% of total enrollment. But we anticipate to finish enrolling patients in 2024. That's our target that we have discussed with all our principal investigators, and we believe that is achievable.

Got it. Okay. Then I'm going to jump over to heart failure. Now that you're fully staffed on your territories. What would you anticipate to be the impact on the top line for the balance of this year?

We will continue to see double-digit growth in heart failure and we will continue to execute on all the clinical data that we have obtained to drive awareness among clinicians.

Okay. Got it. And you talked about some other areas such as liver and LVAD. Could you talk about in what segment of the hospital and what typical populations that you're seeing some utilization there on?

Yes, good question, Jeff. Recently on my visit, we visited an account that has been a good account for us. I've used it for a number of years. And they mentioned to us that they have quite a few LVAD patients that have been treated with Aquadex immediately after transplant and on later follow-ups. On the liver, we have a very important center in New York City who has been using it for liver. They have submitted a publication that we are waiting for that publication to be published in a journal. But that delivery is usually in the liver department, a unity -- unit of the hospital.

Got it. Okay. I think that does it for us. Thanks for taking the questions.

Thank you, Jeff.

Thank you. The next question comes with Anthony Vendetti with Maxim Group. Please go ahead.

Thanks. Maybe just a follow-up on the reverse HF trial. Did you say all the sites are activated at this point?

No, Jeff. Excuse me, Anthony, we have a target of 20 sites to be participating. We have now 11 activated, and the rest of them are in the process of getting activated, getting approvals for the IRBs contracts et cetera.

Okay. Thanks for clarifying that. And then just in terms of because you have more salespeople, can you talk about the messaging for the Aquadex. I mean, clearly, as you stated, it's a huge market opportunity. Do you feel that the message is on point? How do you. I guess, what's the goal in terms of trying to convince other sites that this is something that you should the Aquadex is something you should have multiple depending on the size of the hospital, but multiple units in the hospital to treat fluid overload.

Yes, Anthony, that's a very good question. I'm going to let John Kowalczyk, our Senior VP of Sales and Marketing answer that question. But before I turn it over to him, fluid overload is everywhere in the hospital. It is in the ICU. It is in the burn units. It is in heart failure and the step down in the emergency room. So our target is to create awareness among physicians. And soon you will hear more marketing strategy that we are implementing to go after the patient's awareness. But let me turn it over to John for him to tell you about the message is that we are conveying to our sales organization for them to deliver to our customers. John?

Yeah. Thank you, Nestor. Good morning, Anthony. So the message is really this. As Nestor indicated, fluid overload is everywhere and it's supported by the data. As a matter of fact, 40% of the patients that are admitted to the hospital will be experiencing some degree of diuretic resistance or suboptimal results. And so our messaging, based on the published data, is to identify those patients earlier in the process by identifying those patients earlier and using the clinical data like Kazory and other published documents to include Dr. Haas' Abington tenure real world experience. We're educating physicians to say use a mechanical fluid removal system Aquadex earlie and by doing so, the message then is supported by the clinical data that says we potentially can alleviate or minimize downstream sequela that occur with multiple medications being given over time that contribute to potentially AKI, which then leads ultimately to more aggressive forms of clearance like CRT and or dialysis. Through that process, that then extends the length of stay for the patient, which then incurs not only a less advantageous result for the patient, but also drives up the cost of what the hospital needs to incur. So those are our messages. And it's based on the published data. And the physicians are now responding to this pretty well.

Okay, great. So this is a data presented to them. And when you're dealing with the actual sale process, is it one of the key executives at the hospital? Is it the physicians? Is it a combination? How does that work? And then lastly, on the conference side, getting the KOLs, are there specific upcoming conferences that you'll attend to get the message out there broadly?

Good question, Anthony. Let me turn it over to Dr. John Jeffries, who joined the company as a Chief Medical Officer, and he is a practicing clinician and has used our therapy. And I believe that he would be the best person to answer your question as to how is the process in the hospital to determine the use? John?

Sure. Thank you. Thanks for the question. I think every hospital is unique, but most of the time to get the messaging, it really needs to be sort of a dyad approach. I mean you need to speak with the clinicians and part of the clinician discussion is about having data, right? How can you support the use of your science. Obviously you've been hearing about reverse HF. That's exactly what that is intended to do is provide contemporary data. The other piece, though, obviously is on the administrative side. Just because a physician wants a technology doesn't mean that it just happens. It has to go through budget and approval and lots of other different committees before those things happen. So what I've been trying to do whenever we approach accounts or I think this collectively is true is that we're trying to keep that in mind and that we want to message the value proposition to the hospital, the administration, but obviously to the physicians and the clinicians provide the data that support the use of the technology, which at this point are very substantial. So I think this is just a matter of continuing to build momentum, which will happen with the data. But you heard from Nestor about the different sort of phenotypes that we can use the technology for very successfully. I think that's going to expand the number of touch points we can have in any one hospital. So not just a cardiologist. Now, you could talk to a hepatologist, to a liver transplant surgeon, a cardiothoracic surgeon, an intensivist, a pediatrician, a pediatric nephrologist. So all these different sorts of opportunities are only going to continue to grow.

Thank you, John.

Thank you.

Thank you. This concludes our question-and-answer session. I would like to turn the conference back over to Mr. Nestor Jaramillo for any closing remarks. Please go ahead.

Yes. As we conclude this call, I hope that we were able to convey to you the optimism that we have and also our execution on our growth strategy from heart failure, other indications such as liver, LVAD, pediatric. Our pediatric dedicated device as well as our unique therapy device that we're building and also the heart failure clinical trial. With that, I would like to thank all our stakeholders, our employees, our shareholders, our physicians and clinicians as well as all the medical health care staff. Thank you very much for your support. Without your help, we would not be able to help transforming the lives of patients suffering from fluid overload. So with that, thank you very much for your participation.

This conference is now concluded. Thank you for attending today's presentation. You may now disconnect. Have a good day.