Good day and thank you for standing by. Welcome to the Nuwellis, Inc. Third quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator instructions] I would now like to hand the conference over to your speaker today, Matt Beckel.

You may begin..

Thank you, operator. Thank you for joining today's conference call to discuss Nuwellis' corporate developments and financial results for the third quarter ended September 30, 2021. In addition to myself with us today, are Nestor Jaramillo, the company's CEO and George Montague, the company's CFO.

At 8:00 AM Eastern today, Nuwellis released financial results for the quarter ended September 30, 2021. If you have received Nuwellis' earnings release, please visit the Investors page on the company's website. During this conference call, the company will be making forward-looking statements.

Except for historical information mentioned during this conference call, statements made by the management of Nuwellis are forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

Forward-looking statements involve known and unknown risks and uncertainties that are based on management's beliefs, assumptions, expectations, and information currently available to management.

Those risks include, but are not limited to risks associated with the possibility that the company may not grow revenue in future quarters, that the company may not be able to commercialize its products successfully, the possibility that it may be unable to raise the funds necessary for the company's anticipated operations and the other risk factors described under the cash and risk factors and elsewhere in the company's filings with the Securities and Exchange Commission.

The company believes that these forward-looking statements are reasonable as and when made, however, you should not place under reliance on forward-looking statements because they speak only as of the date when made.

By providing this information, the company undertakes no obligation to update or revise any projections or forward-looking statements, whether because of new information, new developments or other circumstances that might subsequently arise.

You should review the caution, the cautionary statements and discussions of risk factors included in company's press release issued today, the company's latest 10-K, subsequent reports, as well as its other findings with the Securities and Exchange Commission under the title Risk Factors or Cautionary Statements related to forward-looking statements.

For additional discussion of risk factors that could cause actual result to differ materially for management's current expectations, those discussions regarding risk factors, as well as discussion of forward-looking statements in such sections are incorporated by reference in this call and are readily available to the company's website.

With that, I would like to turn the call over to Nestor Jaramillo, Nuwellis' CEO..

Thank you, Matt and good morning, everyone. Welcome to Nuwellis third quarter 2021 earnings call.

Following an extremely strong second quarter where we reported record revenue on a strong momentum across all three business segments, third quarter financial results proved challenging, primarily due to the surge of COVID-19 Delta variant hospitalizations impacting elective procedures.

In the third quarter of 2021, we generated $1.9 million in total revenue representing a decline of 3% compared to prior year period. Third quarter sales were negatively impacted on three fronts associated with the Delta variant.

First, COVID prompted some hospitals to limit public access either to decrease the risk of COVID transmission or focused efforts on treating critically ill patients. This restricted our ability to meet with some customers.

Second, due to reduce medical staff, some hospitals had to ration care and prioritize treatment of COVID patients prompting the cancellation of elective procedures, including cardiac surgeries, which had a negative impact in our critical care segment.

Moreover, some of the largest accounts are based in regions of the country most affected by the Delta variants. So we have felt the impact more than others. Although other medical device companies have also reported the outburst impact of COVID on the third quarter performance.

And thirdly, treatment protocols to treat critically ill COVID patients have evolved over the last year. Specifically, fewer COVID patients are now being treated with fluid resuscitation as other treatment options, such as Remdesivir rapidly improved patient symptoms.

Despite the setback experienced in the third quarter, on a year to date basis, we generated $6.3 million in total revenue, representing growth of 16% compared to the prior year period and 52%, relatively to 2019.

We believe our growth relative to 2019 pre-pandemic levels is a better representation of the soundness of our strategy as we have expanded and diversified meaningfully in pediatric and critical care markets.

Similar to previous cycles where COVID cases dropped following spikes in geographic hotspots, we believe we are -- we will be able to execute our operating plan and accelerate revenue growth in our key markets when the healthcare environment begins to normalize similar to what we achieved in the second quarter.

Another matter affecting our business is that over time revenue has become more concentrated as utilization rates at our largest accounts have grown faster than those across our broader customer base.

We believe this illustrates the potential for the Aquadex therapy, especially because these top accounts include most of the prestigious hospitals in the country.

We have begun working to capitalize on this opportunity by increasing utilization at other accounts, and ensuring that all active accounts continue to use and benefit from our therapy ultimately, leading to a larger customer base.

Now to demonstrate the strength of our business fundamentals, I would provide further details on each business segment, starting with the critical care. Critical care was once again our strongest and most durable business segment in the third quarter with revenue more than doubling compared to the period last year.

While revenue declined modestly on a sequential basis, we continue to see strong from key accounts that rely heavily on the Aquadex system to treat non-COVID critically ill patients.

Moving to our pediatric business, on a sequential basis, revenue declined materially compared to the second quarter of 2021 due to forward patient volumes in certain accounts, our belief that this is transitory is supported by the fact that we opened three new pediatric accounts during the third quarter, the most we have opened during any quarter in 2021.

Moreover, we are encouraged that the pediatric accounts more affected during the third quarter has already bought consumables in the fourth quarter, suggesting perhaps an increase in patient census.

We also continue to make progress on other pediatric initiatives, most notably the development of a pediatric dedicated device for infants and neonates under 20 kilograms.

You will recall that our product development partner Koronis Biomedical Technologies Corporation was recently awarded a $1.7 million grant during the third quarter, from the National Institute of Health to support this important development program. Turning now to our heart failure business.

You may also recall that sales of the heart failure market declined sequentially from the fourth quarter of 2020 to the first quarter of this year, due to COVID impact on heart failure patients behavior, overall procedure volumes and our limited access to hospitals.

That trend reversed in the second quarter, due to more normalized patient behavior and increased access to hospitals as COVID infection rates decline. During the second quarter, users of the Aquadex system released additional clinical evidence demonstrating the therapeutic benefit of Aquadex therapy.

However, Q3 the Delta variant call spike in COVID cases, prompting a sequential sales decline compared to Q2 of 2021. It should be noted that on the year to year basis, this quarter's heart failure sales remained higher than those in the third quarter of 2020.

This concludes my business segment's update and looking forward although we were disappointed with the third quarter sales performance, we remain optimistic regarding the long term potential of the Aquadex therapy. We believe that sales in 2022 will be impacted positively by the following three future growth catalysts.

First, the category three CPT code for the use of therapeutic ultrafiltration, which will become effective on January 1, 2022. This CPT code allows for reimbursement of ultrafiltration in an outpatient setting and payment for physicians.

The category three does not impact the current payment to the hospitals for ultra-filtration when performed in an inpatient setting.

The second catalyst, our national purchase agreement with Premier Incorporated, one of the nation's largest group purchasing organization, which should improve access to affiliated hospitals, specifically New Wellness and Premier partnered to create a new aquapheresis category, which allows premier members to purchase the Aquadex smart flow consoles at a pre-negotiated price.

Aquadex is the first and only therapy currently available in the newly established aquapheresis product category. And we are actively working with premier affiliates to show how their own data demonstrates the improved therapeutic benefits and economic value provided by our therapy.

Lastly, relating to our strategy of making ultrafiltration a viable therapy for outpatient care, during September, we received the CE Mark certification for our 24-hour blood circuit set. This new device will help Nuwellis expand access to ultrafiltration among patients who need less than 24 hours of Aquadex therapy.

For the past two years, we have watched hospitals around the world experience tremendous capacity pressures, which has further emphasized the important role that the ambulatory setting can play a significant role in heart failure patient care, reducing healthcare cost and improving patient's quality of life.

We remain very excited about this opportunity as the ambulatory care setting is one of the fastest growing segments in the healthcare industry and we believe this unique offering positions us very well for the future.

When you put it all together, the reassurance of COVID during the third quarter negatively affected sales performance, but it did not prevent us from executing on our growth strategy and serving our customers. I applaud our employees for their continued resilience in doing so through the pandemic.

We expect once the healthcare environment begins to normalize, our strategy will yield a resumption of positive revenue growth as demonstrated from late 2019 through second quarter of 2021.

Moving forward, we will continue to execute on our growth strategies by building additional supporting clinical evidence, establishing a firm foundation for appropriate reimbursement, expand commercial relationships and launch differentiated products to ultimately drive sustainable growth.

Now, I would like to turn the call over to George to discuss the financial statement..

Thank you, Nestor and good morning, everyone. Turning our financial results, revenue for the third quarter was $1.9 million down 2.7% from the third quarter of last year and 26.1% below the second quarter of 2021. Compared to prior year, positive growth in critical care and heart failure were offset by lower pediatric and international sales.

The higher sales, the critical care in heart failure came from increased utilization of consumable blood products, partially offset by lower console sales. Compared to prior quarter sales to all segments declined sequentially for the reasons previously discussed by Nestor.

Gross margin was 60.4% for the third quarter, a full 14 percentage point higher than the prior year due to favorable geographic and product mix, meaning relatively more US sales and circuit sales.

Gross margin also improved resilient compared to the prior quarter, increasing 20 basis points despite the sequential sales decline due to the timing of production period costs and favorable geographic mix. Selling, general and administrative expenses were $4.6 million for the third quarter.

The 9% increase compared to the third quarter of 2020 came from higher sales training and administrative expenses. However, SG&A costs decreased 8% from the prior quarter due to the non-recurring leadership transition costs that I mentioned during our last earning call along with increased cost amid the uncertain market environment.

Third quarter research and development expenses were $1.7 million a 98% increase compared to prior year. This is driven primarily in new products, by investments in new products, especially our new pediatric system and our new catheter, along with increased clinical, regulatory and reimbursement activity.

The net loss for the quarter was $5.3 million or $0.75 per share compared to a loss in a third quarter of 2020, a $4.3 million or $2.08 per share, based on adjusted share count.

Regarding our liquidity position, we bolstered that position on September 17th by raising approximately $10 million in gross proceeds through the issuance of four million shares in an all common stock offering made pursuant to a shelf registration statement that we had filed during the second quarter.

This was partially offset by financing costs and the $4.5 million of cash used during the quarter to fund operations. As a result, we ended September with $28.4 million of cash and marketable securities up from $24.0 million reported in June.

Looking forward to our projection for the remainder of 2021, we are cautiously optimistic as we continue to closely monitor the situation caused by the COVID pandemic and availability of healthcare workers. We remain focused on winning new business and increasing utilization among our existing customers.

However, we have also scaled back spending in areas not critical to our growth or key strategic initiatives, thereby decreasing the cash burn until revenue visibility improves. Given this macro uncertainty, we are not providing specific fourth quarter guidance at this time. I will now turn the call back to Nestor for some final remarks..

Before concluding our formal remarks, I would like to provide some context around the equity financing we completed during the quarter.

Early Q3 as we saw the Delta variant start to impact businesses in certain accounts and saw signs of uncertainty in the financial markets, we consider it prudent to pursue an all common stock financing to further strengthen our financial position. The offering was well received.

The underwriters fully and immediately exercised their over-allotment option. As a result, we ended the quarter with over $28 million of cash in our balance sheet, roughly double where we started the year and in a strong position to continue executing our growth strategy.

I want to reiterate that Nuwellis has enhanced its financial position and entering an exciting new phase in making the Aquadex therapy, a standard of care with significant opportunities in critical care, pediatrics and heart failure.

We believe that now we have sufficient cash in the balance sheet to provide a meaningful runway to fund operations to the first quarter of 2023 while we execute our growth strategy. Operator, you can open the call to questions..

[Operator instructions] Our first question comes from the line of Jeffrey Cohen from Ladenburg Thalmann. Your line is open..

So firstly, could you talk about your new 24-hour circuit and talk about the labor requirements from the staffing side and how that's affecting the business?.

Yes. Good question. Jeff. The 24-hour circuit is a special circuit that has some features that allows for the device to be used less than 24 hours, during that time 24 hours there is less need for some sensors that the regular filter and the regular circuit have.

So therefore we can price it at a more -- a much more beneficial price for accounts that wants to use ultrafiltration in patients for less than 24 hours..

Got it. Okay. Can you talk about the new catheter and we did see the news of the Corona biomedical receiving the grant from the government.

Can you talk about what stage they're at? I'm assuming that's a Class two and when might that be filed and available?.

Okay, let me, clarify that. We have a product development partner, Koronis Biomedical Technologies Corporation here in Minneapolis, and they are very good at submitting grants and getting grants accepted. So we partner with them because of the technology, expertise and their expertise in getting grants to develop a pediatric dedicated device.

For that we receive the $1.7 million to develop this product. The catheter that we mentioned in our comments is a different length of catheters to access the peripheral venous system. As you may know that a lot of these patients have different anatomy and we need to provide our customers with different options to treat or to access the Venus system.

Did that clarify your question Jeff?.

Yeah.

So would that product be filed for in the near term? When do you expect that the new catheter would be available?.

Yes. Good question. We plan to introduce the catheter, the new catheter in January of next year and the pediatric dedicated device we have not provided a definitive date as to when we're going to release it, but it will be a normal MedTech product development and it will require regulatory approval.

We don't know yet if it's going to be a 510 K or an IDE..

And the only thing I'd add Jeff is we submitted the application -- regulatory application for the catheter. So that's in a regulatory review right..

Okay. Got it. And could you talk about the pediatric centers? Congratulations, you opened three, I'm assuming you're in totality, you're in the 20 to 30 range.

Could you talk about that a bit and talk about future ads and utilization at current pediatric centers?.

Yeah. Let me start with the second part of your question. We've seen in some of the accounts that had a decline in utilization in Q3 starting to reorder consumables. So that is a very good sign that they continue to believe in the therapy and they are having a increase in patient census.

On the first part of your question, the pediatric -- the three accounts that we opened in this quarter were accounts that we've been working with them on the last six months to get their approvals, get the purchase orders and we have other accounts in our pipeline that would allow us to open in the future quarters..

Got it. And then lastly for us congratulations on receiving the International Trade Award by the governor there.

Can you talk about the OUS business as far as current placements now and activities, and forward-looking over the next, say year or two, how that may develop a change?.

Yes. Be, be glad to do that. Our international business continue to be relatively small compared to the US revenue. You know that we are primarily operating with distributors outside of the United States and they have been impacted equally if not more than we have here in the United States, due to the COVID pandemic.

So we expect them as their environment outside of the United States to normalize, we will expect sales to increase significantly..

The one thing I'd add is the 24-hour device actually aligns well with the way the therapy is administered in some European markets, albeit in an inpatient setting.

So that will enable able us to sell to those accounts where we might have not have been the most cost effective solution before while also giving us real world experience with that product as you prepare for the larger longer and longer term outpatient opportunity..

Perfect. Thanks for taking our questions..

Your next question comes from the line of Brooks O'Neil from Lake Street Capital Markets. Your line is open..

Good morning, guys. I have a few questions. So first I was pleasantly surprised by the strong gross margin.

Do you guys think that's sustainable going forward?.

It's a great question, Brooke, as we've shared before, there's given our relatively low volumes, there is a S sizeable fixed overhead components. So, as we grow maintaining 60-plus risk margin should be something that you can count on in a sense, more unstable environment it's -- we stayed, we increased but just by 20 basis points.

So it gets a little bit trickier, but I think for our, I can tell you for our modeling purposes, we're right around 60 plus or minus percentage point or two.

But you won't see the -- I don't anticipate seeing the big dips like you saw in Q3 of last year, right? Because we want to maintain the stable contribution from the sales growth and working with, the job teams doing a great job providing that consistency that we need..

Great. George, you mentioned healthcare worker shortages, and I've heard about some from some other companies we cover.

Would you say your impression is the hospital environment has contracted for you guys because of overall shortages, or are they specifically related to impacts from COVID or how would you parse that out?.

It's a great question, Brooks. The primary headwinds that are field-based personnel keep relating to us, relate more to COVID and its impact on procedural volumes and customer access.

So although the staffing shortages reported by other companies would also affect us, the flip is the two advantages of therapy is that it can actually help decrease readmissions and require less intense and nursing coverage than some alternative therapies.

So I'd like to think that that could actually help us if we play it we'll, but for us, we talk more about the COVID impact, but we were not immune, if the hospital doesn't have the nursing personnel necessary to administer the therapy..

And I would add to that Brooks that you may recall that early in the pandemic last year when there was a shortage of CRT device, dialysis machines and patients were treating -- were treated with fluid resuscitation, that fluid needed to be removed.

And our device play a really good role because it requires less nursing per patients, but in this case now the second time around with this Delta variant, that's not the case. Patients are not being treated with fluid resuscitation as much as they did in the beginning of the pandemic..

Makes sense. Could we talk just a little bit about this outpatient opportunity? My personal view is it's a huge opportunity for you guys, and I just want to be sure I'm clear about the reimbursement, whether you think it's going to be sufficient to drive adoption in outpatient settings, particularly the physician reimbursement.

I know it's a category three code. I know it's kind of a temporary code and an experimental code, but what's your assessment of the sufficiency of reimbursement to drive a change of behavior in outpatient settings, beginning in January,.

Right? This is a very good topic and one that we are very excited about it and the reason for that, that in the past three weeks, myself, as well as our VP of Marketing have traveled across the nation, talking to customers that used to or are still doing outpatient treatment using the Aquadex and those that discontinue the use was specifically because of the reimbursement.

And they mentioned not only CMS, but also private payers were not recognizing ultrafiltration as a valid therapy for them to reimburse. Now that this reimbursement code exists and it would be effective in January, we believe that this is going to have a positive impact on our revenues..

Great. I'm excited. Thank you very much..

Your last question comes from the line of Anthony Vendetti from Maxim Group. Your line is open..

Thank you. Yeah, most of my questions have been answered Nestor, but I just wanted to focus on the pediatric side. I know you said utilization was down and I'm just trying to understand, is it because of Delta? I know you said in your prepared remarks, Delta did impact the opening or the availability of accounts.

I'm just trying to understand, is it because the pediatric hospitals had an increase in COVID patients that they weren't utilizing the Aquadex therapy system, or was it something else?.

Okay. Let me see if I can separate that question into two. One is opening new accounts and as you heard me, we have done a good job in opening accounts. We opened three, the most that we have ever opened this year and to open an account, we need to start working with them, six to nine months before getting them ready, getting them trained.

And so we -- this three centers that we opened, we've been working with them for the last six to nine months. Now we have a very extensive and robust pipeline that we are discussing with centers right now that will be opening the near future. Remember, they need to be trained, they need to get all their purchasing the contracts, etcetera.

So we feel really good about our pipeline on that. So we will continue to see new centers starting to use the therapy. Regarding the decline in units or declining sales, we believe that has to do with two things happen there. One is a patient census.

I traveled to three of the -- three of our largest accounts and two of them I walked through the NICU and the PICU, and they were empty. They were empty beds. So, for some reason there wasn't enough patients coming through the hospital. The second part is that a few of our largest users were also participating on a raft study, is the name of the study.

And that study had the purpose to treat fetus while they were still in the womb with some sort of a treatment. Once the baby was born, then that fluid need to be removed. So there was a pause in that study. So therefore we saw a decline in the few of those accounts that we have that we participating in the study.

So those were the two reasons, a decline in patient senses, as well as a pause in this clinical trial..

So this clinical trial, just to elaborate a little further on that. So, so fluid removal in infants, there was a pause in that trial in that clinical trial. So any, what was the medical reason to do that? I would assume excess fluid should always be removed..

Yeah, no, this is George, let me try a little bit more complete answer. So the rap trial, which is publicly available the principal investigator based at Johns Hopkins, this is a trial for fetuses that otherwise wouldn't survive because they were not properly functioning kidneys.

And so through this experimental procedure, they would inject amniotic fluid into the into the womb.

And then when -- but then when the baby -- if the baby was born alive, it would need to go on therapy and what we've learned that our therapy was used with the number of these babies until they could have well, unfortunately until they either died or could have a kidney transplant.

So then unfortunately, actually the principal investigator passed away and that's what led to this trial suspension of the trial. And we do know that some of our accounts, which are sent again, some of the leading academic pediatric hospitals that do this extensive of work were involved in that and that's what, this is off label.

We're not all at all with this. We learned through them that our product have been used to keep these data visualized as part of this trial. So, if you Google, if you Google the rap, you'll, learn more all about it centers..

Important point is that we were not boiling in that trial, right. Our device was not part of the protocol and not every one of our accounts was part of the -- was an implanting site. Yeah.

But as you know, with this relatively small business, we have account level visibility and we were able to go in and say, okay, when we saw the decreases in circuit sales, which we translated into decrease utilization yeah. And we went in to find out why do you learn that that was a contributing factor. Yeah..

And Anthony, the top academic pediatric centers was part of these studies and they were using our device because they knew that was the safest, most effective way to treat these patients when they were born..

The thinking that it illustrates the importance of the pediatric device and the critical unmet need that that device will serve..

Okay. That's helpful. And then just maybe talk a little bit more about the change in protocol. I'm not clear as to why that change occurred to minimize the use of fluid resuscitation and critically ill COVID patients.

Can you just talk about that change in protocol?.

You're talking about this study. Oh, the COVID, to treating the COVID patients. Yeah, COVID patients. The early pandemic, the physicians were treating patients with fluid re resuscitation. Fluid resuscitation is just an infusion of fluid to stabilize the hemodynamics of these critically ill patients coming in with COVID. Okay.

During this year that treatment has evolved. The medical community have learned how to treat these patients. And there are other options such as remdesivir, prone respirators. These are therapies that can alleviate the symptoms very quickly without the need of fluid re resuscitation.

So that's the reason why we've seen less use of the Aquadex in this critically ill patients COVID-19 patients..

Right. Right. Okay. So if they're not using fluid, then obviously you don't need to use the Aquadex to remove the excess fluid. So that's the implication you saw in this particular quarter,.

Correct? Correct. Okay. But after that fluid resuscitation still a very valid option treatment for non-COVID 19 critically ill patients, that's the importance. The synergy that we have obtained from using it in COVID 19 patients now treating non-COVID 19 patients continue to very strong amount of critical care customers..

Okay. So, for non-COVID patients the fluid resuscitation is still a primary treatment protocol for critically I'll patients. And that continues to benefit your critical care channel in terms of revenue and utilization opportunities.

Correct?.

Correct. That is correct. One, example is also for post-cardiac surgery patients. These patients are infused with fluid during this surgery. So that fluid needs to be removed and they do that in the ICU and they use our device to mechanically remove that excess fluid..

Right. Okay.

And then, and I know you don't provide an exact breakdown of revenue by channel, but in terms of critical care, the critical care channel and the pediatric channel, in terms of percent of revenues for the quarter, do you have an approximation for that?.

Yeah. Critical care continues to be our strongest followed by -- this quarter, followed by heart failure and then pediatric. Previous quarters pediatric has had a stronger performance..

Last two quarters pediatric was number two, but this quarter, because of the fact that we just discussed pediatric is a close third, but critical care continues to be the largest the sector..

Okay. And then I just want to make sure, I heard your comments, your prepared comments correctly, while we're obviously in the fourth quarter here.

You said that pediatric, especially after the addition of these three new pediatric accounts, you have seen now an increasing utilization in the pediatric channel, is that correct?.

That is correct. Especially on those -- in those accounts where had a decline in Q3, we've seen them reorder consumables this quarter..

Okay. and then the last question on the pediatric channel, I thought, I'm a little bit surprised at when you said that some of your top pediatric accounts, some of the top pediatric hospitals had lower ICU and PICU patients, you just didn't see as many in there.

I'm just, I'm shocked at that because of everything that I've read you because of the Delta variant, I've heard some pediatric hospitals are actually full, but maybe full with COVID patients, but they're not in the PICU or the ICU.

Is that correct?.

That's correct. That is correct. And they may not be treated with fluid resuscitation or any source of fluid therapy. And it's something that even the hospitals and the pediatric nephrologist can explain either. They just have had a low volumes coming through the ICU and the NICU and the POCU..

Okay. Very helpful. All right, thanks. I'll turn it back into the queue..

There are no question at this time. I will now like to turn the call over to Mr. Nestor Jaramillo for any closing remarks..

Well, I want to thank you all for joining our third quarter conference call, and I wish you all a good day. Thank you..

This concludes today's conference call. You may now disconnect. Thank you for participating..