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Nuwellis, Inc. (NUWE)

Q4 2017 Earnings Call· Tue, Mar 20, 2018

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Transcript

Operator

Operator

Good morning and welcome to the CHF Solutions Earnings Conference Call for the Fourth Quarter Ended December 31st, 2017. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A replay of this call will be available approximately one hour after the end of the call. I would now like to turn the call over to Scott Gordon, President of CORE IR, the Company’s Investor Relations firm. Please go ahead, sir.

Scott Gordon

Analyst

Thank you, Tekia. And thank you for joining today’s conference call to discuss CHF Solutions corporate developments and financial results for the fourth quarter ended December 31st, 2017. With us today are John Erb, the Company’s CEO and Chairman of the Board; Claudia Drayton, the Company’s CFO; and Jim Breidenstein, the Company’s Chief Commercial Officer. At 8 am Eastern Time today, CHF Solutions released financial results for the quarter ended December 31, 2017. If you have not received CHF Solutions’ earnings release, please visit the investors page at 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 the 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 not be able to raise the funds necessary for the development and commercialization of its products, that the Company may not be able to commercialize its products successfully, that the Company may not be able to successfully integrate acquired businesses, that the Company may not realize anticipated synergies and benefits from acquired businesses and the 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 its other filings with the Securities and Exchange Commission 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 and those discussions regarding risk factors as well as a discussion of forward-looking statements in the 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?

John Erb

Analyst

Thank you, Scott, and good morning, everyone. Welcome to our fourth quarter 2017 earnings call and corporate update. CHF Solutions’ mission is to improve the quality of life for people suffering from fluid overload primarily associated with heart failure and related conditions. We provide healthcare professionals with a sophisticated, yet easy to use mechanical pump and filtration system to remove excess fluid. We believe that our technology will provide a competitive advantage in the fluid management market by providing an effective solution for decongestion and reducing the cost of care relative to other treatment alternatives. I would like to remind you that the Aquadex FlexFlow system consists of three primary components, the console pump, which has a $31,000 list price; a one-time use disposable blood circuit set with a list price of $980; and a small dual-lumen peripheral catheter that simultaneously withdraws blood and returns filtered blood to the patient’s arm. Aquadex is a unique proprietary product that is used for the temporary ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy. Ultrafiltration is a process that removes water and process that removes water and salt from a patient in a manner similar to how the kidney functions. Fluid overload is a condition that is prevalent in heart failure patients, which can lead to decompensation resulting in lengthy and costly hospitalizations. There are over 1 million patients hospitalized per year in the U.S. for acute heart failure and approximately 90% of these patients present with symptoms of fluid overload. Aquadex has been shown in randomized controlled clinical trials to remove more fluid than diuretics and to reduce repeat hospitalizations. Before reviewing our fourth quarter achievements, I would like to provide a short review of 2017. 2017 was a year of strong growth for CHF Solutions as we…

Claudia Drayton

Analyst

Thanks, John. Good morning, everyone. Turning to the P&L. Revenue for the fourth quarter was $831,000, a growth of 11.4% over the fourth quarter of 2016. For the year 2017, revenue totaled $3.6 million and grew by 12.4% versus the prior year on a pro forma basis. Our cost of goods sold reflected prices paid for the finished goods we purchased from Baxter under the manufacturing and services agreement we signed at the time of acquisition. Under this pricing structure, our standard margins are around the mid-60s. As previously announced, in the fourth quarter of 2017, we completed the manufacturing transfer to in-house operations with the completion of our first production build. Included in our cost of sales are the start-up manufacturing costs related to this manufacturing transition. We expect that the margin benefits from bringing manufacturing in-house will begin to materialize later in 2018 as we consume the Baxter manufacturing units and our own internal production volumes and efficiencies increase. In terms of other operating expenses for the fourth quarter, they totaled $7.1 million versus $3.3 million in the fourth quarter of 2016. In the fourth quarter of 2017, we recorded a non-cash write-off of our intangible assets and goodwill totaling $4 million. This non-cash write-off was the outcome of the annual impairment review we performed every year during the fourth year. As part of this evaluation, we compare the fair value of our net assets to their book value. The fair value was based primarily on risk-adjusted discounted cash flow projections and the market valuation of the Company’s common shares versus the recorded book value of the Company’s assets and liabilities. This non-cash write-off reflects the amount by which the book value of our net assets exceeded the calculated fair values. Excluding this non-cash write-off, other operating expenses…

John Erb

Analyst

Thank you, Claudia. Before opening the call for questions, let me reiterate that we continue to be very optimistic about our future. The key milestones achieved and all the behind the scenes work executed during the year are a direct result of the tireless effort and determination of our highly capable and committed team. The achievements of this past year set us in good stead to continue progressing our strategy in 2018 including the continued expansion of our U.S. sales force, continued growth of our international commercialization as well as the R&D of new product enhancements for Aquadex product franchise. We will continue to provide you milestones to track our progress over the coming quarters. Operator, please open the call to questions.

Operator

Operator

Thank you. [Operator Instructions] Our first question comes from the line of Jeffrey Cohen of Ladenburg Thalmann. Your line is now open.

Unidentified Analyst

Analyst

Hi. This is actually Destiny on for Jeff. How are you guys doing? Good morning.

John Erb

Analyst

Doing well. Thank you. Good to hear from you.

Unidentified Analyst

Analyst

Yes. I just had a couple of quick question. Could you remind us how many accounts you currently have, and of those accounts, how many have more than one system?

John Erb

Analyst

Let me direct that to Jim Breidenstein, our Chief Commercial Officer.

Jim Breidenstein

Analyst

Certainly, John, thanks. Good morning, Destiny. Currently, as we conclude Q4, we have 120 active accounts. Active is defined as ordering our disposable products. We have approximately 170 accounts out there that exist in the marketplace as we end Q4 that have ordered technical services as well as disposable product. On average, Destiny, from acquiring the business from Baxter, we feel on average that our accounts have 1.5 to 1.8 accounts -- or I am sorry, consoles per account. We feel that there’s approximately upwards of 500 consoles across the country at nearly 300 facilities.

Unidentified Analyst

Analyst

And just one follow-on, gentlemen. The educational materials that you are now using for marketing, are they aimed more for accounts -- existing accounts or are you also using them to acquire new accounts?

Jim Breidenstein

Analyst

Yes. That’s a great question. Thanks for asking it. It’s both. And the reason it’s both is that our current customers and our current operators need some guidance as to best optimize the therapy because it’s a tough to treat patient population. So, what we are doing is relying a tremendous amount on our service and support teams, our sales reps as well as our clinical specialists to educate and quite frankly re-educate our current customer base. And as we continue to add accounts, every single quarter adding over 50 accounts, last year, we know that the best way and the most proper way to launch these accounts is through thorough education. So, short answer Destiny is that these tools and aids will be used at both current customers and our ever-growing and expanding customer base.

Unidentified Analyst

Analyst

Okay, got it. And I just want to clarify, the clinical specialists are typically the individuals facilitating these education materials or is there someone else that’s doing that as well in your sales force?

Jim Breidenstein

Analyst

Yes. Again, the answer to that is well, it’s both. We have three clinical specialists that are highly trained in clinical nursing and many of them have been bedside experienced for many years. And they also will be leading the charge to further educate and use these materials. However, we also have 10 highly, highly trained sales personnel that are also very capable and confident speaking the clinical language, if you will, to further educate the RNs as well as the physicians on the appropriate use of the device. So, both, the reps and the clinicals will be utilizing the technology and doing the trainings.

Unidentified Analyst

Analyst

I just want to take it for a moment and ask about the timeline for the clinical trial or study that’s being carried out for Houston [Ph] Children? Do you have any clarity on that at the moment?

Jim Breidenstein

Analyst

I don’t personally, when you say Houston Children, but John, can you reflect to that or may be Destiny means Stanford?

John Erb

Analyst

Yes. I think, she is talking about Stanford trial.

Unidentified Analyst

Analyst

Yes. That’s right.

John Erb

Analyst

So, they are beginning to enroll. And as far as how long enrollment will take, I don’t think they’ve actually communicated that to us. I think, it was -- early on they talked about 12 months to enroll. But Jim, I don’t know if you have any more recent update?

Jim Breidenstein

Analyst

No. I think that’s appropriate, John. They are preparing to launch the trial and we should be hearing from them soon. But, as of today, Destiny, that’s the latest and greatest information that we have.

Unidentified Analyst

Analyst

Okay, got it. And last question, I’m just curious if you could offer a little more color on the product advancements that you have?

John Erb

Analyst

Well, we -- actually, the product we inherit from Baxter had not had a lot of engineering support for some period of time. And we have found opportunities here for initially some minor improvements in the console and how the console functions. One of the nice things is that the console has been very robust and the initial design that was that was put together is still working exceptionally well. But, just in some of the algorithms how it handles the blood flow, those are improvements. We are also right now working on a new designed catheter. Again, the catheter that currently has been marketed is an older design. And there’s a lot of new materials available in catheter design that we are implementing in the new catheter. We anticipate having your catheter on the market before the end of the year.

Operator

Operator

Thank you. [Operator Instructions] And I’m showing no further questions in queue at this time. I would like to turn the conference back over to John Erb for closing remarks.

John Erb

Analyst

Thank you, operator. I would just like to thank everybody for joining our fourth quarter conference call, and I wish you all have a really good day. Thank you.

Operator

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This concludes today’s program. You may now disconnect. Everyone have a great day.