Earnings Labs

Nuwellis, Inc. (NUWE)

Q1 2020 Earnings Call· Tue, May 12, 2020

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Transcript

Operator

Operator

Good morning and welcome to the CHF Solutions earnings conference call for the first quarter ended March 31, 2020. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today’s presentation there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press pound or hash key on your telephone keypad. Participants of this call are advised that the audio for this conference call is being broadcast live over the internet and is also being recorded for playback purposes. A replay of the call will be available approximately one hour after the end of the call. I would now like to turn the conference over to Claudia Drayton, the company’s Chief Financial Officer. Please go ahead, madam.

Claudia Drayton

Management

Thank you Crystal. Thank you for joining today’s conference call to discuss CHF Solutions’ corporate development and financial results for the first quarter ended March 31, 2020. With us today are John Erb, the company’s CEO and Chairman of the Board, myself, Claudia Drayton, the company’s CFO, and Nestor Jaramillo, the company’s Chief Commercial Officer. At 8:00 am Eastern time today, CHF Solutions released financial results for the quarter ended March 31, 2020. If you have not received CHF Solutions’ earnings release, please visit the Investor page of www.chf-solutions.com. During the course of this conference call, the company will be making forward-looking statements. Except for historical information mentioned during the conference call, statements made by management of CHF Solutions 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 be unable to execute in its commercialization strategy, the possibility that it may be unable to raise the funds necessary for the company’s anticipated operations, that the company may not be able to commercialize its products successfully, and other risk factors described under the caption Risk Factors and elsewhere in the company’s filings with the Securities and Exchange Commission. By providing this information, the company undertakes no obligation to update or revise any projections or forward-looking statements whether as a result of new information, new developments or otherwise. You should review the cautionary statements and discussion of risk factors included in the company’s press release issued today, the company’s latest 10-K, subsequent reports, as well as other filings 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 results to differ materially from management’s current expectations. Those discussions regarding risk factors as well as discussions of forward-looking statements in such sections are incorporated by reference in this call and are readily available on the company’s website at www.chf-solutions.com. With that said, I would now like to turn the call over to John Erb, CHF Solutions’ Chief Executive Officer and Chairman of the Board. John, you might be on mute. John, can you unmute your line? Operator, can you look into John Erb’s line?

Nestor Jaramillo

Management

Claudia, I don’t know if anybody is hearing you. I can hear you.

Operator

Operator

You may begin.

John Erb

Management

Great, thank you. Sorry for that disruption. Thank you Claudia and good morning everyone. Welcome to the first quarter 2020 earnings call and corporate update. This year has been a challenge for the world, for the United States, and certainly for CHF Solutions. We are very pleased that we are less impacted than many small medical device companies, but the rest of the year is full of uncertainty and optimism. Although the world has dramatically changed for the time being, we know our business model has not changed in the long run and really we remain optimistic about the durability of our business. We are confident that our priorities are clear and focused. In the nearest term, CHF Solutions will be focused on the health and safety of our employees. Our production staff continues to work onsite at our manufacturing facility and the rest of our team is maintaining business operations by working remotely. While this may translate into less than optimal use of resources, human capital will remain critical to weathering the storm and ensuring shareholder value in the medium to longer term. Also, we will continue to do all we can to support our customers as they strive to manage and control the impact of the COVID-19 pandemic. With a considerable level of uncertainty for the future, we are closely managing our cash, implementing expense controls, and pursuing avenues to fund operations. We have been able to help many hospitals, physicians and nurses battle the COVID-19 pandemic by providing consoles and remote training on the Aquadex system. In the past six weeks, we have provided over 20 Aquadex consoles as loaners to several hospitals in the COVID-19 hotspots. We have established training protocols using remote video web tools and webinars. We have worked closely via telephone, text, emails…

Claudia Drayton

Management

Thanks John. Good morning everyone. Turning to our financial results, revenue for the first quarter was $1,630,000, an increase of 34% from Q1 2019 and up 19% sequentially from Q4 of 2019. Revenue performance for the quarter was driven by strong performance in our critical care segment where the demand of our products was favorably impacted by hospitals treating COVID-19 patients. Regarding our cost of sales and operating costs, I will briefly comment about major driers. First regarding our cost of sales, our gross margins were about 51.2% for the quarter, which represented an increase of 150 basis points from last year’s Q1 margins and 40 basis points from Q4 2019 margins. Margins were favorably impacted by a high mix of disposable sales. Next regarding our SG&A expenses, Q1 2020 expenses were $4.5 million, an increase of 12.9% over Q1 2019. The increase results from having fully staffed territories, including clinical specialists we hired during 2019 to assist in opening and training new accounts. Our R&D expenses were $864,000 in Q1 2020, a 34% decrease compared to Q1 of last year and a 9% decrease from Q4 of 2019. Last year, we had reported an increase in product development spending to support our pediatric submission and improvements for the next generation Aquadex SmartFlow console, which received FDA clearance and CE Mark during the first quarter. The net loss for the quarter was $4.6 million or $0.37 per share compared to a net loss in the first quarter of 2019 of $4.7 million or $11.47 per share. Regarding our liquidity position, we used $5.5 million in cash in the quarter to finance our operations, an increase of $600,000 from Q1 2019 mainly as a result of higher inventory purchases and decreases in our outstanding payables. During the quarter, we announced the…

John Erb

Management

Thank you Claudia. I want to reiterate that we are very pleased that we produce a product that is providing a meaningful therapy for treating the COVID-19 patients. We know we are very fortunate to be less impacted than many small medical device companies, but the rest of the year is full of uncertainty. We are very optimistic about the value we can bring to our customers and our investors. We anticipate that when healthcare returns to some level of the new normal, we will see accelerating sales growth by continuing to position ourselves as the primary provider of ultra filtration therapy for cardiologists, hospitalists, intensivists, cardiac surgeons, pediatricians, and nephrologists who treat fluid overload. Our goal is to grow our global business, our global market leadership in fluid management with solutions that change patients’ lives. As I have described in the past, we are expanding beyond our initial business of serving the needs of chronic heart failure patients to meeting acute needs in critical care, such as cardiovascular surgery and the lifesaving needs in pediatric kidney care. The use of Aquadex by intensivists and nephrologists in treating their COVID-19 patients has demonstrated the opportunity to prevent acute kidney injury and mitigate the need for dialysis. After receiving FDA market clearance for the pediatric indication in late February, we began to initiate our training program with a couple of children’s hospitals. In early March, we had 20 children’s hospitals in a queue to receive training. The training program requires not only our clinical education specialist but physician support from one of the three busy pediatric physicians that have extensive experience in using the Aquadex system in pediatrics. Training was completed in two additional children’s hospitals before all hospital access was stopped due to the fear of COVID-19 contamination. We anticipate…

Operator

Operator

[Operator instructions] Your first question comes from the line of Jeffery Cohen from Ladenburg Thalmann.

Jeffrey Cohen

Analyst

Hi John and Claudia and Nestor. How are you?

John Erb

Management

We’re well, thank you.

Jeffrey Cohen

Analyst

I guess I wanted to ask some questions specific to two areas, obviously. Firstly on the pediatric side, you spoke about having about 20 facilities in the training queue, which a couple were accomplished and the rest were held off on for the time being. As I recall, you had about 12 or 14 centers that were using the system in a pediatric setting, so would they have overlap with the 20 you referenced or would that have been an additional 20, and from your standpoint that would have gotten the total up into the mid-30s?

John Erb

Management

Yes Jeff, just to provide a little correction there, we actually would have six children’s hospitals that were using Aquadex on a regular basis. We had several phases as we were bringing children’s hospitals online once we received FDA market clearance to actually be able to do the necessary training. There’s probably another six or eight that actually had bought equipment and waiting for training, the training was really governed by our ability to get in and the ability of the three primary pediatric physicians that have been doing now for some period of time working with these children, so their availability to do the training is also part of the governor. There’s probably now eight children’s hospitals that are using the product and another 20 that are in queue to be trained. Does that help?

Jeffrey Cohen

Analyst

Yes, so one would anticipate hopefully those get accomplished in 2020.

John Erb

Management

Correct, and we are actually working on a process where we can do training via video conference. Actually, a couple of the physicians have been willing to set up training at their facility. It’s been pushed out a little bit to get a little bit further past the height or the peak of the pandemic, but definitely there will be ongoing training in 2020.

Jeffrey Cohen

Analyst

Okay. Then on to the traditional business being used in the COVID setting, can you give some indication of how many placements were made, at least year to date approximately? I think you talked about 20 placements. What’s the size of the fleet now, and amongst the fleet out there, how many facilities or placements do you think are specifically being used in COVID settings in ICUs?

John Erb

Management

Yes, I would estimate that we have approximately 10 hospital sites today that are using Aquadex to fight the battle with the COVID-19 virus. We probably have 25 consoles, 20 that we’ve put out there as loaners, some being rentals. There has actually been five or six that have been purchased that are being dedicated specifically for the COVID-19. The VA in Tampa, as you probably remember historically, we have a clinical trial that’s been going on there, but they are actually going to be purchasing machines to--or consoles, I should say, to specifically treat COVID patients, so it’s still expanding out there but at this point in time, I’d say we have approximately 25 consoles that are dedicated to COVID-19.

Jeffrey Cohen

Analyst

Okay, then can you discuss a little bit further about the manufacturing and assembly? I see the inventory is up about $400K, which is about 20% for the quarter. Can you give us a sense of where we stand on actual circuits, circuit production and throughput, and how you’re seeing margins as well as Aquadex machines and what the situation is there with parts in inventory and assembly?

John Erb

Management

Yes, as I’ve mentioned, we have doubled our production capability of producing consoles, and a lot of the raw material purchases were for components required for console production, so have increased our purchases of components considerably just to meet the anticipated demand for the consoles. Production of circuits have continues to be pretty steady. We right now have approximately three months of inventory on circuits, a forecasted three months, so we’re pretty much steady as it goes on circuit production. That will be increasing as the demand obviously increases once those consoles get put in place.

Jeffrey Cohen

Analyst

Okay, and can you give us any sense of during the past six weeks in the second quarter, any general trends you’re seeing as far as the traditional heart failure, cardiologist setting?

John Erb

Management

Well, it’s been slow because of they are considered procedures that are not emergent. There have been some, obviously, but until those ICU beds become available with the slowdown of COVID-19 of taking up everything, it will remain minimal for a period of time.

Jeffrey Cohen

Analyst

Okay, got it. That does it for me. Thanks for taking the questions.

John Erb

Management

You’re very welcome. Thanks Jeff.

Operator

Operator

Again ladies and gentlemen, if you have a question at this time, please press star then the number one on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. At this time, I would like to turn the conference back to John Erb, the company’s Chief Executive Officer and Chairman of the Board.

John Erb

Management

Thank you Operator. I want to thank you all for joining our first quarter 2020 conference call, and I wish you all a great day. Thanks.

Operator

Operator

Ladies and gentlemen, this concludes today’s conference. Thank you for your participation and have a wonderful day. You may all disconnect.