Good morning, everyone, and welcome to the Nuwellis Fourth Quarter and Full Year 2023 Earnings Conference Call. [Operator Instructions] Please also note, today's event is being recorded. At this time, I'd like to turn the floor over to Vivian Cervantes, Investor Relations. Ma'am, please go ahead..

Thank you, operator. Good morning, everybody. Thank you for joining us on today's conference call to discuss Nuwellis' corporate developments and financial results for the fourth quarter and full year ended December 31, 2023. In addition to myself, with us today are Nestor Jaramillo, Nuwellis' President and CEO; Rob Scott, our CFO; and Dr.

John Jefferies, our Chief Medical Officer. Mr. Jaramillo is reporting from Boston. He's attending the 2024 THT conference. At 8 a.m. Eastern today, Nuwellis released financial results for the quarter and year ended December 31, 2023.

If you have not received Nuwellis' earnings press release, please visit the Investor Relations page on the company's website. During this conference 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 risk in the company's filings with the SEC including the latest 10-K. With that, I would now like to turn the call over to Nester..

New Technological and Clinical Developments, where 4 of our key opinion leaders presented 3 separate significant clinical evidence findings on the safety and efficacy of the Aquadex therapy. Dr. Jefferies will provide more detail later on this call on this symposium.

Yesterday, we had on podium presentation showing a statistical significance in several endpoints at 30 days, including fewer patients rehospitalized fewer days in the hospital due to heart failure readmissions, lower rehospitalization rates due to cardiovascular events fewer rehospitalization days due to cardiovascular events and fewer patients rehospitalization for cardiovascular events.

More detail on this data will be presented tomorrow in a late-breaking clinical trial presentation. This conference has served as a platform for the clinical reestablishment of the superiority of ultrafiltration using Nuwellis Aquadex technology as compared to the traditional diuretics.

I'm happy to open our call today with an emphasis on how excited we are about the future of Nuwellis despite the difficult environment for micro-cap companies like Nuwellis. With our steadfast focus on executing on our strategic growth initiatives, positive momentum in our business continues to build.

2024 is poised to be another important year for us with key value milestones targeted. This includes continued commercial introduction of our strategic collaborator, SeaStar Medical with their selective ciophereutic device branded coalmine. For pediatric -- for treatment of pediatric acute kidney injury, where we have an exclusive U.S.

license and distribution rights. And also the steady progress on our product pipeline with our new pediatric dedicated CRRT device, branded Vivien. We also look forward to completing our DaVita pilot program in 2024, paving the way for expanded clinical and market access for our Aquadex system.

And finally, we expect to complete the IDE submission for Vivian. I will dive deeper into each one of these initiatives momentarily and provide an overview of our fourth quarter and full year results. Dr.

John Jefferies, our Chief Medical Officer, will also discuss recent positive peer-reviewed publications on our Aquadex system, including expanded applications for our therapy to the end-stage liver disease, in addition to providing an update on the clinical evidence presented here at PHD conference.

Our Chief Financial Officer, Rob Scott will provide detailed financial results before opening up the call for questions, followed by my closing remarks. I'm pleased to report that we ended 2023 on a high note, recording our highest total quarter revenue in the company history.

In the fourth quarter of 2023 Nuwellis has generated $2.6 million in revenue, a 9% increase versus the fourth quarter of 2022, led by an increase in disposable utilization and record quarterly international sales. For the full year 2023, Newells generated revenue of $8.9 million, a 4% increase versus full year 2022.

While our overall growth might seem modest at 4%, we had a very strong second half of the year, resulting in a 27% revenue growth compared to the first half of the year. Our capital equipment sales faced industry-wide headwinds in the first half of the year.

However, we saw a remarkable turnaround in the second half with domestic console sales skyrocketing 207% compared to the first half. This signifies strong potential for future utilization growth.

Hospitals navigated budget limitations by utilizing our rental programs resulting in a 23% year-over-year revenue growth, highlighting the flexibility and affordability that we offer.

Despite the nursing staff shortages, the number of patients treated with Aquadex therapy increased by 9% from the first half of 2023 to the second half of 2023, demonstrating the value of our therapy provides. Now back to the fourth quarter results.

In the fourth quarter, our pediatric customer category once again led the way with 35% growth over the prior year driven by a 28% increase in utilization and a 49% increase in console sales, and we opened 4 new pediatric accounts. Heart failure and critical care sales declined 27% and 7%, respectively.

For the full year 2023, there was a 7% increase in disposable utilization. The pediatric customer category led with an 11% increase in utilization followed by critical care with a 9% increase in utilization. Heart failure was relatively flat, posting a 1% decline in utilization.

Total sales decreased -- total console sales, excuse me, decreased by 21% and for the year because of the industry headwinds we faced in the first half of the year.

Overall, we continue to drive utilization gains and opening new accounts which reflects continued increase in the number of patients being treated with the Aquadex therapy on an expanding console footprint. Now turning to our recent commercial developments and expected new product introductions.

In early January of this year, we were pleased to announce that received FDA clearance for an additional dual lumen extended length peripheral catheter also called dELC.

The addition of a new 12-centimeter catheter provides clinicians who treat patients with fluid overload with an additional venous access option to use our Aquadex ultrafiltration system.

This new 12-centimeter dELC has the same features as the longer 16-centimeter option but eliminates the need for trimming when a shorter catheter is needed, ultimately, leading to increased patient comfort. The introduction of these new asset catheters should be well received with clinicians firming to us the need for this product.

On February 22, we were pleased to announce that our strategic collaborator, SeaStar Medical, received the Humanitarian Device Exemption or HDE from the FDA for its selective cyokine cytoperetic device also called SCD, branded Quelimmune for use in pediatric acute kidney injury patients. We have exclusive U.S.

license and distribution rights for column, and we have begun commercial launch activities at targeted medical centers with further commercial expansion expected later in the first half of this year. The unique technology be high in Quelimmune has demonstrated a 50% reduction in mortality rate in children with potentially deadly hyperinflammation.

The addition of this product to our growing pediatric customer category will help save lives of many pediatric patients and further bolster our top line growth.

We also remain encouraged by our own internal product development program as we continue to advance development of our pediatric continuous kidney replacement therapy device branded as Vivian.

We, along with many pediatric nephrologists, believe this product will have extremely positive impact on survival and significantly improve the lives of neonates and small children with kidney malfunction kidney issues or those born without kidneys.

This device is complementary to SeaStar's medical Quelimmune, and we believe these 2 products will add tremendous value to our growing portfolio of products with pediatric patients with fluid overload and renal disease. Our collaboration with DaVita is progressing well.

with both teams actively engaged in key areas like pilot selection, patient criteria development, target metric definition and establishing patient care pathways and order sets for medical staff to start treating patients.

We recognize the novelty of these initiatives for DaVita for hospitals and for all of us at Nuwellis, and we are taking a meticulous approach to ensure a successful pilot launch. We will enable us -- this initiative will enable us to begin treating patients in the inpatient setting with DaVita's personnel and resources.

We look forward to sharing further updates on this program advances in the near future. I would now like to turn the call over to our Chief Medical Officer, Dr. John Jefferies, to discuss recent peer-reviewed publications on our Aquadex system and provide an update on last night's Symposium.

John?.

Thank you, Nestor, and good morning, everyone. We are pleased to continue to expand our clinical evidence, including a symposium yesterday at THT on the clinical merits of Aquadex for a growing number of patients. THT is a conference attended by heart failure specialists who are looking for innovative med tech solutions.

The presentations at the symposium last night highlighted 3 important topics including the role of ultrafiltration in the treatment of acute decompensated heart failure, a clinical comparison of ultrafiltration and diuretics using the data from a 224 patient trial called AVOID-HF and the ultrafiltration best practice from a high-volume center.

These 3 presentations further reinforced the efficacy of ultrafiltration reestablishing Aquadex as the preferred method of treating congestion in patients with fluid overload resistant to diuretics.

Of the recent clinical publications that featured the benefits of our Aquadex therapy, let me highlight the new case series featured in clinical transplantation, which demonstrated the potential of Aquadex to safely and effectively remove fluid volume for end-stage liver disease patients who do not respond to diuretics.

Of note, the findings present a new clinical application for Aquadex already within its current FDA labeling and adds a new patient population for treatment.

The publication is a single-center retrospective case series that assessed the utilization of aquapheresis therapy with Aquadex in the intensive care unit setting at Mount Sinai Hospital between January 2020 and July 2023. 14 severely ill patients with end-stage liver disease were treated with the Aquadex system during this period.

For clinicians treating patients with end-stage liver disease, it can be an enormous challenge to remove fluid when patients don't respond or can't tolerate diuretic therapy safely and effectively. This study demonstrates a new application for the Aquadex system for a large and growing patient population with end-stage liver disease.

Unlike continuous renal replacement therapies, Aquadex allows for slow, controlled and predictable fluid removal that can be to reduce the risk of kidney injury and help alleviate the hepatorenal syndrome.

Additionally, treatment with Aquadex may help patients participate in physical therapy and help better prepare them for subsequent surgery and liver transplantation. Let me turn it back over to Nestor. Thank you..

Thank you, Dr. Jefferies. I'd like to now return the call to discuss our Q4 financial results, and I'm going to turn it over to our CFO, Rob Scott..

Thank you, Nestor, and good morning, everyone. Turning to the Q4 financial results. Revenue for the fourth quarter was $2.6 million, representing 9% year-over-year growth and a 6% sequential increase from the third quarter of 2023. This follows a similarly strong third quarter, which saw a 16% growth over Q2 2023.

Our pediatric customer category had the strongest growth in Q4 with a 35% increase year-over-year. Heart Failure and Critical Care decreased 27% and 7%, respectively. Gross margin was 54.4% for the fourth quarter compared to gross margin of 56.9% in the prior year quarter.

The margin decline is primarily driven by product and geographical sales mix and lower fixed overhead manufacturing absorption, leading to more efficient inventory levels. Selling, general and administrative expenses were $3.6 million in the fourth quarter, a decrease of 23% as compared to $4.7 million in the fourth quarter of 2022.

The decrease in SG&A was primarily due to reduced head count and related compensation expense. Fourth quarter research and development expense was $1.4 million compared to $1.2 million in the prior year period. reflecting a modest increase in R&D spend related to the development of our new pediatric dedicated CRRT device as we approach IDE submission.

In the current year period, the company recorded a nonrecurring expense reduction of approximately $800,000, reducing incentive compensation impacting both SG&A and R&D. Additionally, the company recorded a $550,000 SG&A expense in the current year period for contractual spend related to the SeaStar license and distribution agreement.

Total operating expenses were $5 million in the quarter, a decrease of approximately $884,000 as compared to the fourth quarter of 2022. The period-over-period decrease was due to cost-saving measures implemented early in the second half of the year and carried through year-end 2023 as we continue to drive operating efficiencies.

Operating loss in the fourth quarter was $3.6 million compared to an operating loss of $4.5 million in the prior year period, resulting in a $941,000 period-over-period reduction.

Net loss attributable to common shareholders in the fourth quarter was $7.9 million or a loss of $2.24 per share compared to a net loss attributable to common shareholders of $1.9 million or $5 per share for the same period in 2022.

The current period net loss attributable to common shareholders includes $2 million of other expense and $2.4 million of a deemed dividend and PIK dividend related to the company's October 2023 financing.

The prior year period net loss attributable to common shareholders includes $2.6 million of other income related to the company's October 2022 financing. We ended the fourth quarter with $3.8 million of cash and cash equivalents and with no debt on the balance sheet.

Understanding the near-term need to raise capital, we have recently undertaken steps to reduce our monthly cash burn rate by approximately 40%, balanced against our strategic growth initiatives which will provide more flexibility in anticipation of tougher capital market conditions for micro-cap companies like Nuwellis.

This concludes our prepared remarks. Operator, we would now like to open the call to questions..

[Operator Instructions] Our first question today comes from Jeffrey Cohen from Ladenburg Thalmann..

Just a couple of questions from our end.

So could you talk about the SeaStar Quelimmune device as far as any patient experience thus far? Or what you're saying is your second half launch?.

The most of, if not all of the clinical experience with Quelimmune has been in the clinical study that they have done, that they have performed. We have not done any patients under the collaboration agreement yet. We -- now that we have the HD, the next step is for census in HDE approval. Each site needs to get their own IRB approval.

So we are in that process right now and then the utilization can start..

Okay. Got it.

And nextly, is the [indiscernible], the 12-centimeter one? Is that also being manufactured in your facility?.

That is correct, yes. It has been manufactured in our facility and we plan to start selling it in the next 2 weeks..

Got it. And then could you compare and contrast with us.

What's working in peds that's so beneficial on the top line growth and what's not working, in particular, in heart failure that's driving the decline?.

Okay. Regarding the pediatric, the babies, this pediatric [indiscernible] started back in 2019 with a very landmark publication, which shows that when you have kids under 10 kilograms born with renal disease or absence of kidneys, having a continuous renal replacement therapy to act as the kidneys of the children is beneficial.

However, there has not been a pediatric dedicated device. Most of this children's are treated with adult CRRT because of the Aquadex have such a slower rate raw rates as well as a very small extracorporeal volume of fluid. It became very safe, gentle and effective to treating these children under 10 kilograms.

The fact of the matter is that it was not such a therapy, the results of this study show that patients under 10 kilograms treated with the Aquadex survived the therapy at a rate of 66%. So that's what drove our business. That started in 2019.

And I'm just going to make apprentices here because that's exactly what is -- what we are seeing right now with the end-stage liver disease. So coming back to the pediatric, I mentioned the reason for this success on the pediatric because there is no other therapy. On heart failure, the decline is something that is explainable.

We believe that now with the clinical data that we have, there would be more appetite for using the Aquadex in heart failure patients. We're still working on our evidence, that reimbursement. So once we get those in place, we'll see -- we expect to have an increase in sales..

And I can provide a little bit more color on just the heart failure decline specifically for the quarter. again, from dollars perspective, it was about $160,000 decline. Again, the percentages kind of get kind of wild, but the $160,000 was the total dollar amount. About $90,000 of that was driven by capital sales, so about a $90,000 reduction.

So we had 3 less capital sales period-over-period. So again, a majority of that is driven by capital, which can be certainly bumpy from time to time. Utilization kind of made up the balance there. We had a couple of accounts that were just a little bit soft in Q3, just a handful of them.

If there was both accounts sort of came in where we typically expect this quarter could have been even a better quarter for us as far as revenue goes..

That's helpful. And then lastly, first, could you talk about what's the current commercial footprint as far as FDA is out there and maybe give us a breakdown of the commercial organization focus in what particular areas..

We have about 23 people in the field right now. 9 of them are account managers, the other 14 are clinical specialists that provide clinical and technical support in the hospitals. And all the utilization growth that Rob just mentioned, has been purely organic..

[Operator Instructions] Our next question comes from Anthony Vendetti from Maxim Group..

So just on the SeaStar device, the SCD device. So because they have HDE, you can now go forward, but each hospital has to get their IRB. How long does that take? And are you targeting the hospitals where you already have relationships with your Aquadex system. And then what's the plan to rollout beyond that.

Is that a multi-quarter plan? Or do you feel that as you start to commercialize it into your current base you could simultaneously start marketing this device with your device to other hospitals?.

Good questions, Anthony. Let me see if I can answer the three question part there. The first one part was you talked about the period that it takes to get the IRBs, and it depends on the hospitals. Some hospitals will have IRBs that need on a monthly basis, on a weekly basis. So we expect those to be a lot quicker.

Other ones use general IRBs so that may take a little longer. So that's on the IRB time of the IRBs. But the reason that they require IRB is because this is a humanitarian device exemption by the FDA is not the regular 510(k) approval.

In terms of the overlap, which was the second part of your question, the reason why we believe that this collaboration is so strategically fit between the 2 companies is because of that.

the majority of the centers that participated in the clinical studies of Quelimmune are the same customers that are using our product and are reporting on our products. So they are the top pediatric accounts in the United States. So there was a significant overlap on that.

So the first 5 and this starts to answer your third part of your question of the first 5 accounts that we're targeting, 3 of them are top users of the Aquadex device. And then after that, we're going to roll out the following quarter. We're going to continue adding another 10 and so on until we have a full launch..

Okay. Great. And then obviously, since there is a lot of overlap, it seems like there's obvious cross-selling opportunities. does that go both ways? In other words, you SeaStar in some hospitals that you're not? And does that make it easier? Do you believe sell the Aquadex system as well..

Absolutely. By being there with Qualimmune it's an opportunity to talk about Aquadex, our current device and also started paving the way for our pediatric dedicated device..

That's right. And then on the cost-cutting, I heard a 40% cut in monthly costs.

Can you outline where that is coming from? And then when did the cuts start happening, what month?.

Yes, it started in March, March 1. And there are general expenses. We're becoming more efficient in our headquarters in terms of the people that we need for our strategic growth initiatives. It also includes travel and travel and expenses and also includes salary cuts for the executive team and also the board fees..

I see. And it doesn't -- it sounds like obviously critical to your success is the clinical specialists and the sales. So that's an area that has -- is pretty much I wouldn't say off limits, but hasn't borne the brunt of the cost cutting at this point.

Is that correct?.

Correct. Correct. We're not touching the sales organization as they are key for continuing our growth in 2024..

Okay. And then lastly, some companies at this stage also employ independent distributors.

Is there an opportunity to do that to help further spur sales going forward?.

Absolutely. Yes. We -- that's a very good point, Anthony. And we have 2 of them in key markets for us. One is in New York City and the other one is in Northern California. So we continue to look at opportunities to add more on this type of independent distributors..

Ladies and gentlemen, with that, we'll be concluding today's question-and-answer session. I'd like to turn the floor back over to Mr. Nestor Jaramillo, CEO, for closing remarks..

Yes. Thank you, everyone, for participating. As I mentioned before, we're very excited about the 2024. We continue to execute on our strategies redesigning our commercial strategy by adding DaVita and adding the collaboration with SeaStar.

We'll also continue our product development with our pediatric dedicated device and we continue to -- committed to clinical research with our reverse heart failure trial.

I want to thank all our stakeholders, including our employees, stockholders, medical staff, visions and health care workers without your help, we will not be able to achieve the transformation in the lives of patients suffering from fluid overload. Thank you..

Ladies and gentlemen, with that, we'll conclude today's conference call and presentation, we thank you for joining. You may now disconnect your lines..