Earnings Labs

Nuwellis, Inc. (NUWE)

Q2 2018 Earnings Call· Tue, Aug 7, 2018

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Transcript

Operator

Operator

Good morning and welcome to the CHF Solutions’ Earnings Conference Call for the Second Quarter ended June 30, 2018. All participants will be in listen-only mode. [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 the call will be available approximately 1 hour after the end of the call. I would now like to turn the conference over to Scott Gordon, President of CORE IR the company’s Investor Relations firm. Please go ahead, sir.

Scott Gordon

Analyst

Thank you, Armani and thank you for joining today’s conference call to discuss CHF Solutions’ corporate developments and financial results for the second quarter ended June 30, 2018. With us today are John Erb, the company’s CEO and Chairman of the Board; Claudia Drayton, the company’s CFO. At 8:00 a.m. Eastern Time today, CHF Solutions released financial results for the quarter ended June 30, 2018. 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 maybe unable to grow revenue in future quarters; that the company may be unable to execute in its commercialization strategy; the possibility that it maybe unable to raise the funds necessary for the 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 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 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 second quarter 2018 earnings call and corporate update. CHF Solutions’ vision is to be the global market leader in fluid management with solutions to improve patient quality of life. We provide healthcare professionals with a sophisticated yet easy to use mechanical pump and filtration system to address fluid overload primarily associated with heart failure and related conditions when diuretics have failed. Our technology, the Aquadex FlexFlow system provides a competitive advantage in fluid management offers an effective and clinically proven solution for decongestion and may assist in reducing hospital readmissions and length of stay upon readmission providing our customers an economic solution to reduce the cost of care in this clinically challenging patient population. We are very pleased with having now achieved five consecutive quarters of double digit year-over-year revenue growth. In Q2 of 2018, we achieved significant revenue growth with a 27% increase over the second quarter of 2017 and a 6% increase over the first quarter of 2018. We believe our revenue growth is a result of successful execution of our commercialization strategy which includes adding marketing strength to the organization, adding appropriately scalable sales territories, adding dedicated clinical specialists to the field based team and continuing our focus on increasing the utilization of the Aquadex FlexFlow system – within our currency – within our current accounts as well as expand into brand new accounts across the U.S. We started the second quarter with 10 U.S. sales territories and expanded our commercial team during the quarter by hiring three season sales representatives and increasing our territories to 13. Those territories were selected by identifying the largest heart failure admission statistics for hospitals specific to each territory. Over the last 12 months, we have not only added to our…

Claudia Drayton

Analyst

Thanks, John. Good morning, everyone. Turning to the P&L, revenue for the second quarter was $1.1 million, a growth of 27% over the second quarter of 2017 and 6% growth sequentially from Q1 2018. Total cost and expenses for the quarter were $5.3 million versus $3.4 million in the second quarter of last year. The major increases were driven by our cost of goods and my investments in selling and marketing expenses. Our cost of goods sold reflected prices paid for the finished goods that we purchased from Baxter under the manufacturing and services agreement we signed at the time of acquisition. The pricing includes a markup of 60% over the cost of Baxter incurred to manufacture the product. Additionally, cost of sales includes startup manufacturing costs associated with the transition of the manufacturing activities to our facilities in Eden Prairie, Minnesota. As we have previously announced at the end of 2017, we completed the manufacturing transfer to in-house operations with the completion of our first production mills. We expect to start selling our own manufactured inventory late in 2018 or early 2019. At that time, we expect to begin to see the margin benefits from eliminating the Baxter manufacturing markups. In later quarters, as our internal production volumes and efficiencies increase, we expect to see additional margin improvement. In terms of increases in selling and marketing expenses, the increases were driven mainly by the investments we have made in our sales and marketing organization over the last 12 months, including adding sales territories, clinical support and sales and marketing leadership. We are also making modest investments in R&D mainly to improve the functionality of our products. We have no significant non-operating income or expense items in the second quarter of 2018 or 2017. The net loss for the quarter…

John Erb

Analyst

Thanks Claudia. Before opening the call for questions, let me reiterate that we continue to be optimistic about our future. Looking ahead, we continue to fine tune growth strategies to optimize significant opportunities, to improve clinical outcomes and healthcare cost reduction by giving healthcare providers a viable and clinically proven alternative to diuretics. We continued to develop and refine our focus to demonstrate a strong business model by driving revenue which is the key metric our employees, shareholders and potential investors were used to measure our performance. Our organizational enhancements of this past quarter stand us in good stead to continue progressing our strategy in 2018, including the continued expansion of our U.S. sales force, continued growth in our international commercialization as well as the R&D of new product enhancements for our Aquadex product portfolio. CHF Solutions is devoting its energy to building new solutions to assist in the treatment of fluid management. We are dedicated to bringing proven solutions to improve the quality of life for these patients and the clinicians who have the passion to treat them. Operator, please open the call for questions.

Operator

Operator

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

Destiny Buch

Analyst

Good morning John and Claudia. This is actually Destiny on for Jeff, how are you?

Claudia Drayton

Analyst

Good Destiny.

Destiny Buch

Analyst

Good. I just have a couple of quick questions and let me start with some of the marketing question, I believe last you spoke on the Q1 call, you had introduced some new marketing materials, I mean educational materials, I am just curious are you utilizing those internationally as well or is that more just for domestic sales force and account?

John Erb

Analyst

It’s primarily for the domestic sales force. There certainly are parts of that that are applicable internationally which we are sharing with our international distributors. But a lot of the emphasis right now is on the ISPOR data showing that the health economic savings is considerable. A lot of the data we are now going hospital account by hospital account and demonstrating to them their specific statistics on their readmission rates and their costs and how much that can be reduced by using ultrafiltration has been pretty effective to this point.

Destiny Buch

Analyst

Okay, got it. And thinking of international activity, I am just curious if you are getting any feedback from distributors on reception, utilization and average sales cycle for them, are you getting any feedback from them at all?

John Erb

Analyst

We are getting feedback. It’s a little early. As you know, we bring them online, they build their inventory. They get out to the accounts that have previously used Aquadex and getting them restarted. There is a process, where we bring their consoles back in for servicing, recalibration and they get a back out to them. So there is a bit of a startup that they are going through now. So a little early to really see trends, but we certainly have distributors that are getting positive input from it being – for it being available again to those international hospital accounts.

Destiny Buch

Analyst

Okay, got it. And I am also curious to know if you had noticed any changes in pricing trends in this quarter and do you think you also might recognize some going forward as we are moving to international markets and also expanding domestically?

John Erb

Analyst

First, addressing the U.S. market, we have been able to hold our average selling price very near list price and that’s been very consistent. We have not had a need to discount the capital equipment nor discount the circuits that are being purchased. Again, internationally a little early to really give you a good idea around trends there, but I would expect the same situation internationally as we have in the U.S.

Destiny Buch

Analyst

Okay. I think that does it for me. Thank you so much for taking the questions.

John Erb

Analyst

You’re very welcome, Destiny.

Operator

Operator

Thank you. This concludes today’s Q&A session. I would now like to turn the call back over to John Erb for closing remarks.

John Erb

Analyst

Well, I want to thank you all for joining our second quarter 2018 conference call and wish you all a really good day. Thank you.