Good day and welcome to the Nuwellis Third Quarter 2022 Earnings Conference Call. [Operator Instructions] Please be advised today's conference is being recorded. I would now like to turn the conference over to Vivian Cervantes, Investor Relations. Please go ahead..

Thank you, operator. Thank you everyone for joining us in today's conference call to discuss Nuwellis' corporate developments and financial results for the third quarter ended September 30, 2022. In addition to myself, with us today are Nestor Jaramillo, Nuwellis' President and CEO; and Lynn Blake, CFO.

At 8:00 Eastern this morning, Nuwellis released financial results for the quarter ended September 30, 2022. If you have not received Nuwellis' earnings release, please visit the Investors page on the company's website. During this conference call, the company will make 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 be unable to 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 caption of Risk Factors and elsewhere in the company's filings with the SEC.

The company believes that these forward-looking statements are reasonable as of today's date. However, you should not place undue 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 cautionary statements and discussions of risk factors included in the company's press release issued today, the company's latest 10-K, the subsequent reports as well as its other filings with the SEC under the titles Risk Factors or Cautionary Statements related to forward-looking statements for additional discussion of risk factors that could cause actual results to differ materially from management's current expectations.

Those discussions regarding risk factors as well as the discussion of forward-looking statements in such sections are incorporated by reference in this call and are readily available on the company's website. With that said, I would like to turn the call over to Nestor..

Thank you, Vivan and good morning, everyone. Welcome to Nuwellis third quarter 2022 earnings call. First, I'd like to start this call by welcoming our new Chief Financial Officer, Lynn Blake, who started in this position on October 19th.

I'm confident that Lynn will be an asset to the Nuwellis team and create significant value for all the stakeholders of the company. And on behalf of the Nuwellis team, I would also like to thank George Montague for his significant contributions to Nuwellis. George will be missed.

On today's call, I would like to provide an overview of our third quarter performance and give an update on our strategic initiatives. Lynn will then provide detailed financial results followed by my closing remarks before opening the call up for questions.

During the third quarter, we achieved double-digit year-over-year revenue growth and gained significant momentum on our key strategic initiatives.

Our goal of making the Aquadex system the standard of care for restoring fluid balance remains with clear focused on executing our strategic initiative, which include to build out our clinical education team and continue rollout of our focused sales strategy.

Penetration of our ambulatory clinical treating heart failure patients, continued development of clinical data supporting the Aquadex systems, clinical and economic value, and a steady progress on our new product pipeline such as our product, our pediatric continuous renal replacement therapy device.

In my following remarks, I will provide an update on each of these initiatives. Before doing so, I would like to thank the entire new well team you make possible everything that we do, and without your hard work and dedication to our mission, we will not be at this exciting point of growth. Turning, turning now to our quarterly results.

Revenue for the third quarter of 2022 was $2.1 million, representing 11% year over year growth and a decline of 7% as compared to the second quarter of 2022. Compared to the third quarter of 2019, we saw significant growth of 65%.

In late 2019, we implemented our expansion strategy to diversify our therapy base beyond heart failure and are pleased to see this strategy continues to gain traction. The third quarter year-over-year revenue increase was driven in large part by our pediatric customer segment.

Since we decided to increase our focus on this patient population, we have seen our efforts pay off and we look forward to helping more children suffering from fluid overload in years to come. On a sequential basis, the results reflect typical seasonal trends in our business and follows a relatively strong second quarter.

Our third quarter revenue mix was 42% from critical care, 37% from pediatric, and 21 from heart failure. Increasing contribution from our pediatric business again demonstrates that our investment in this patient population is paying off and provides further support.

For the expansion strategy we implemented beginning in late 2019 compared to the third quarter of 2021, our pediatric customer segment grew 106%. Our critical care segment declined by 9% and our heart failure customer segment remained the same.

We are encouraged by the steady adoption and increased use of our aqua ultrafiltration therapy, as well as continued positive reception of our smart flow console, which is our latest generation aquatic system that incorporates smart diagnostics to guide therapy. In the third quarter, we added three new accounts and reactivated five accounts.

We sold eight consoles to the three new accounts in the quarter for a total of 17 consoles sold versus 14 in the period in the period in the prior year period.

This tell us that our customers have incorporated ultrafiltration into multiple specialty units within the hospital, positioning, positioning us well for increasing this possible utilization in our install base Throughout the third quarter, we have decreased our total operating expenses by 15%.

This decrease in spent and put in allocation of capital has allowed us to effectively manage our expenses while focusing our efforts and investments on our strategic initiatives, including the hiring of field personnel, progress on clinical research and the development of a new pediatric device.

Next, I would like to provide a business update on our four key strategic initiatives outlined earlier. Our first initiative is the implementation of our new and focused sales strategy. As we have previously mentioned, this is both a strategic and operational in nature.

The goal of this strategy is to drive utilization gains and target high volume accounts in geographic locations where we are confident in our ability to create significant growth of note utilization rate in our top 10 accounts continue to show year over year improvements.

We also continue to make progress on our field organization expansion, which includes the hiring of key clinical education specialists or CES.

The CES plays an important role supporting our account manager within the inpatient and outpatient facilities, our CES, all of whom our trained nurses directly partner with the patient's care team on the optimal use of our ultrafiltration system. In so doing, they facilitate not only successful patient outcome but also increasing use of our therapy.

We are encouraged that the staffing shortages that we were, that were widespread throughout March of last year are beginning to ease and we have been successful with our hiring activities. We remain on track to complete our targeted number of clinical education specialist hires by the end of this year.

Longer term, we plan to continue to invest in our clinical education team and maintain a ratio of two clinical specialists supporting one account sales manager. Our internal metrics show that this two to one ratio equates to greater utilization within the accounts, increase efficiency and stronger, more sustainable growth.

The second strategic initiative is to target outpatient clinics treating heart failure patients following the assignment from CMS of our new and dedicated category three CCPT code for therapeutic ultrafiltration from the American Medical Association.

In January of this year, we have been in active conversations to reactivate outpatient clinics who had been using our aquatics therapy but discontinued due to lack of reimbursement. As previously noted, our category three CPT code provides reimbursement for ultrafiltration administered in outpatient setting.

Our conversations to reactivate this outpatients facilities have been constructive and well received because of the potential to reduce inpatient admissions on reimbursed readmissions and hospitalizations due to fluid overload and as these outpatient clinics welcome patients, they there is an opportunity to generate real world patient data that can leverage in support of increasing reimbursement and to obtain broader category one CCPT code likely to happen in the next two to three years.

We have also made progress building awareness in outpatient centers that have historically performed similar therapies laying the foundation to develop and penetrate this market. Our third strategic initiative is to grow new wellness body of clinical evidence.

On June 29th, we announce enrolment of the first patient in the pivotal reverse heart HF trial representing a key milestone for the company. At a reminder, the primary effectiveness endpoint of reverse HF will evaluate mortality and heart failure events within 30 and 90 days as comparison between aqua therapy and intravenous loop diuretics.

As an update to this trial on September 27, we were pleased to announce the activation of three additional sites, Jefferson Abington Hospital in Pennsylvania, the University of California, San Francisco, and Baker Morton Plant Hospital in Florida.

In addition to these sites, we anticipate at least 12 additional clinical institutions to participate in this study. We are grateful to the many doctors who are making this study possible and for their contribution in gathering additional evidence supporting the benefits of ultrafiltration therapy in heart failure patients.

As a company, we are committed to the ultimate goal of making aquatics therapy the standard of care for fluid management in fluid overloaded patients that are unresponsive to diuretics.

We believe a successful trial will provide additional evidence including evidence of healthcare economic benefits needed to have ultrafiltration included within medical society practice guidelines, which will lead to many more patients benefiting from the aquatics therapy in the future as it would be the standard of care.

Additionally, on the clinical front, on August 31st, we announced the publication of new peer review clinical data demonstrating hundred percent survival at 30 days following the use of ultrafiltration in high risk postoperative coronary artery bypass grafting or cabbage patients. This results are very exciting for new and our physician customers.

This data shows ultrafiltration for these patients provides a safe and effective method for managing fluid balance and reducing mortality rates. To provide context on the prevalence of this indication, there are around 520,000 cabbage procedures performed per year worldwide, of which approximately 120,000 are performed in the us.

Of this, an estimated seven to 10% are for high risk patients representing a large marketing opportunity for new wells. This study was the first of its kind and highlights the benefits of Aquadex therapy for this high risk cabbage patient population.

Lastly, on the clinical front, the new results of the AVOID-HF clinical study demonstrating a statistical superior clinical benefit of the aqua therapy in reducing heart failure events and mortality were presented at the 2022 Heart Failure Society of America's Annual Scientific Meeting in September.

As we expected, the results of this new analysis demonstrated in a statistically superior benefit from using ultrafiltration over diuretics for fluid overload heart failure patients, ultimately creating the potential to provide significant cost savings to hospitals and improving the quality of life for patients.

The manuscript for the study is being submitted for publication in a peer review journal. One of Nuwellis' longstanding goals is to have a strong clinical data to demonstrate our effectiveness in treating patients suffering from fluid overload. We made major strides on this strategy in the third quarter.

We believe that the clinical data that we have developed and will continue to develop will put the Aquadex therapy at the forefront of this field and ultimately make it the standard of care. Finally, our fourth strategic initiative is on the product development front.

We continue to make progress in the quarter on our pediatric continuous renal replacement therapy device.

We have experienced significant traction in our pediatric customer segment and in order to best serve that patient population, we remain committed to rolling out this device to help as many children as possible and are anticipating an IDE submission by early 2024.

We are highly committed to investing in our pipeline technologies, including protecting our intellectual property. During the quarter, we strengthen our intellectual property portfolio with a new US patent for a novel innovation that improved fluid balance and safety in pediatric dialysis and hemofiltration.

In conclusion, our goal remains the same to make the Aquadex therapy, the standard of care for restoring fluid balance.

We believe that the work we are doing now in terms of clinical data generation, investments in new product development, implementing a new and focused sales strategy and targeting outpatient facilities is setting the stage for strong and sustainable growth for years to come.

Now, I would like to turn the call over to our new Chief Financial Officer, Lynn Blake, to discuss the Q3 financial results..

Thank you, Nestor, and good morning, everyone. I'm happy to be speaking with you today on my first earnings call as Nuwellis' Chief Financial Officer. Since joining the company last month, I've been working closely with the team to better understand the business end market and I can confidently say I see tremendous growth potential for this company.

I'm looking forward to updating you on our progress for many quarters to come. Now turning to the Q3 financial results, revenue for the third quarter was $2.1 million representing 11% year over year growth and a 7% sequential decrease from the second quarter.

We were pleased with the strength in our pediatric segment, which grew 106% over the prior year, validating that our commitment and investment in this patient population is paying off. This growth was partially offset by a 9% year over year decrease in our critical care customer segment.

Our heart failure segment was roughly flat compared to the third quarter of 2021. Gross margin was 61% for the third quarter, an increase of 53 basis points compared to gross margin of 60.4% in the prior year quarter. Our reported gross margin includes margin from our capital console products and disposable circuit products.

Continued increase in utilization by our existing and growing installed base of customers will represent a tailwind to gross margin over future periods given the higher margin rate on our disposables. Selling, general and administrative expenses were $4.3 million in the third quarter.

Relative to the third quarter of 2021, SG&A expenses decreased by approximately $400,000 or 8% year-over-year and were roughly flat sequentially.

The year-over-year decrease reflects both our previously communicated commitment to conserve capital given the challenging macroeconomic environment, as well as the fact that we had a number of open positions in the third quarter this year.

Third quarter research and development expense was $928,000, a decrease of approximately $800,000 compared to the third quarter of 2021 and a decrease of approximately $200,000 sequentially.

The year over year decrease is largely attributable to a non-recurring license fee expense of approximately $430,000 in the third quarter of 2021, as well as some timing of expenses between quarters.

While we have been exercising increased cost vigilance, we also maintain committed to allocating a sufficient level investment to the four key strategic growth initiatives that Nestor outlined earlier, and specifically as it relates to R&D, the progress on development of our pediatric device continues as planned.

Total operating expenses were $5.2 million in the quarter, a decrease of about $1.2 million as compared to the prior year period and a decrease of approximately $200,000 compared to the second quarter of 2022. Total operating expenses year to date have decreased 15% compared to the prior year.

We will continue to prudently watch our spending levels for the foreseeable future, while at the same time still prioritizing investment in our strategic initiatives. The net loss in the third quarter was $3.9 million or $0.37 per share compared to a net loss of $5.3 million or $0.75 per share. In the third quarter last year.

We ended the third quarter with $12.1 million in cash and cash equivalents and no debt. On October 18, we closed an underwritten public offering that raised gross proceeds of approximately $11 million.

After deducting underwriting discounts and commissions and offering expenses from the proceeds, a pro forma cash balance at the end of the quarter would've been approximately $22 million.

This new capital strengthened the balance sheet as we earmark use of funds to increase our field team, drive penetration of the outpatient market, expand our growing body of clinical data and advance our product pipeline.

Again, as Nestor discussed earlier, progress on these strategic initiatives will not only drive strong future revenue growth, but will enable Nuwellis to become the standard of care for treating patients with fluid overload across a continuum of vindications. I'll now turn the call back to Nestor for some closing remarks..

Thank you, Lynn. As discussed earlier, we are encouraged by key milestones achieved in the quarter and remain focused on executing on our strategic initiatives. We're committed to growing our commercial operations, including the expansion of clinical education specialist additions to our product portfolio and building our body of clinical evidence.

Further progress on this collective objectives will not only help Nuwellis win new business, increase penetration in existing accounts and fuel a steady growth, but also enable us to achieve our vision of making the Aquadex treatment the standard of care for fluid overload.

I would like to conclude by thanking all stakeholders, employees of Nuwellis and healthcare workers in the field. Without your support, we would not be able to achieve the key advances in the treatment of patients suffering from fluid overload. I would now like to open the call for questions..

We will now begin the question-and-answer session. [Operator instructions] And our first question will come from Jeffery Cohen with Ladenburg Thalmann. Please go ahead..

So I guess firstly, can we talk about the placements and the consoles? It looks like you've done quite well recently on new accounts and consoles place, but we're just trying to get a better understanding of the growth and what's driving it and where is it coming from? Is it coming from the new placements and their utilization, or are you getting any traction from accounts which are being reactivated as well? Mm-Hmm..

Good question, Jeff. The growth in the console is coming from two areas. One is opening new accounts and the second one is in our existing accounts. The customers are starting to expand the utilization of Aquadex in other specialty units requiring additional consoles. Many of them are also upgrading to the smart flow from their flex flows.

So those are the two, three areas where the increase sales or console is coming..

Okay, got it.

And then could you talk a little bit about FTEs [ph] and new hires and how that relates generally speaking to OpEx levels? Does it feel like this is a good level where you're at now from Q3 to carry forward into the short term or medium term, or would you expect more ads there on the on the FTEs?.

Yes, as Lynn mentioned, in the third quarter, we have some openings in the field but we feel that now we have all territories fully staffed with the exception of one, which we are right now in the process of recruiting an account manager. But in terms of CES', we have every territory fully staffed with our clinical specialist..

Okay, got it. And could you talk about the trial a little bit, this HF trial, it looks like you've got four or five centers open now, enrolling, I know that the expectation is 372.

Could you give us an update on how many IRBs are out there and enrolment data if you could?.

Yes we have approximately five sites right now enrolling patients. We have started the process and also calibrating the protocol.

As you know, this is a new study for us and we are calibrating the inclusion and exclusion criteria to make some slightly modifications to make sure that we enrol in the right amount of patients and the right type of patients. So it's going well. Jeff, it's going well. We're very pleased with the progress that we have made..

Okay, got it.

And then one more for us on the clinical side, as far as heart failure and cabbage, are you seeing utilization prior to procedures or is the vast majority postprocedure?.

The vast majority is post procedures.

We have accounts that are starting to use the Aquadex in transplant patients and in that patient population, they are using it pre-transplant and post-transplant, and the pre-transplant is used to tune the patient as physicians call it, but after the transplant is primarily to remove the additional fluid that is infused in the patients during the transplantation..

Okay, got it. That's helpful. Thanks for taking our questions and congrats Lynn on joining..

Our next question will come from Thomas McDevin, Apologies, Thomas is just disconnected. Our next question will come from Brooks O'Neil with Lake Street Capital Markets. Please go ahead..

Hi, this is Charlie Montang for Brooks O'Neill. Just a couple quick questions for me.

This is kind of a two part question, but given the significant risks to hospitals and others from hospital readmissions as well as clinical risks to patients from heart failure and other conditions, kind of, why do you think it's taking so long to gain acceptance of your ultra-filtration products now?.

Well the main reason has been the lack of direct clinical evidence to support the reduction in readmissions and hospitalization.

In the past, most of the clinical studies that we have -- that we have so far on the therapy have signaled benefits and improvements using the Aquadex, but with the avoid heart failure, the new data proves that indeed there is a significant benefits, statistical superior benefit, as you say of using the Aquadex and removing fluid overload especially in heart failure patients that are unresponsive to direct.

So I believe that now that we have the clinical evidence, we will see an increase in cells..

Could I just add Charlie, Nestor in addition to the clinical evidence that we can now demonstrate, maybe touch on the healthcare economic benefits that we're beginning to lay out for the decision makers, administrators in the hospitals?.

That is a good point. We have been showing performance to hospitals about the risk, the financial risk that they have with the unreimbursed readmissions, and it's getting a lot of positive response from the administration of hospitals..

Okay, great. Thank you for that explanation. That actually answers both of my questions. So that's it for me. Thank you guys..

[Operator instructions] As there are no more questions, this concludes our question-and-answer session. I would like to turn the conference back over to CEO, Nestor Jaramillo for any closing remarks..

Thank you very much everyone for joining our third quarter 2022 earnings call, and I wish you a happy day..

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect..