Nyxoah S.A. (NASDAQ:NYXH) Q1 2023 Earnings Call Transcript

Nyxoah S.A. (NASDAQ:NYXH) Q1 2023 Earnings Call Transcript May 16, 2023

Nyxoah S.A. beats earnings expectations. Reported EPS is $-0.29, expectations were $-0.34.

Operator: Thank you for standing by, and welcome to Nyxoah’s First Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, today’s call is being recorded. I would now like to turn the conference over to your host, Ms. Mikaela Kirkwood, Corporate Communications and Investor Relations Manager. Please go ahead.

Mikaela Kirkwood: Good afternoon and good evening, everyone, and welcome to our earnings call for the first quarter of 2023. I am Mikaela Kirkwood, Corporate Communication and Investor Relations Manager at Nyxoah. Participating from the company today will be Olivier Taelman, Chief Executive Officer; and Loic Moreau, Chief Financial Officer. During the call, we will discuss our operating activities and review our first quarter financial results released after U.S. market closed today. After which, we will host a question-and-answer session. The press release can be found on the Investor Relations section of our website. This call is being recorded and will be archived in the Events section of the Investor Relations tab of our website.

Before we begin, I would like to remind you that any statements that relate to expectations or predictions of future events, market trends, results or performance are forward-looking statements. All forward-looking statements are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. All forward-looking statements are based upon current available information, and the company assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. For a list and description of these risks and uncertainties associated with our business, please refer to the Risk Factors section of our Form 20-F filed with the Securities and Exchange Commission on May 16, 2023.

With that, I will now turn the call over to Olivier.

Olivier Taelman: Thank you, Mikaela. Good afternoon and good evening, everyone, and thank you for joining us for our first quarter 2023 earnings call. 2023 will be an important year for Nyxoah with DREAM patient follow-up and further PMA module submissions. We completed all 115 implants in our U.S. pivotal study DREAM in the fourth quarter, and the clock is ticking to 12-month data in the first quarter of 2024. We are highly confident in DREAM outcome based not only on our prior clinical and commercial experience but also on the data released on the first 34 patients in the DREAM study. These 34 patients demonstrated a 65% AHI response rate, a 76% ODI response rate and safety in line with expectations. As a reminder, for the trial to be successful of the 115 patients at least 63% need to be AHI and ODI responders at the 12-month follow-up.

These abstract data will be presented at SLEEP 2023 on June 6 in a late-breaking poster session. The model of PMA submission was kicked off with the first module having been submitted during the first quarter. We anticipate filing three out of the four modules in 2023. The final fourth module, which will include 12-month safety and efficacy data will be submitted shortly after the follow-up period is complete. Our increasing conviction in DREAM outcomes and the market opportunity for Genio has driven our decision to accelerate preparation to enter the U.S. market. To that end, I’m very pleased to announce that Christoph Eigenmann has joined Nyxoah as Chief Commercial Officer. Christoph brings a wealth of medical device experience to Nyxoah having spent over 20 years at Johnson & Johnson leading orthopedic and neuro businesses in the U.S. and other global geographies.

Christoph and his family are based in the U.S., and his priority will be preparing the U.S. commercialization strategy and driving international sales growth and further market access. The U.S. ACCCESS pivotal study, focused on complete concentric collapse patients is well underway with implant expect to be completed in 2024. As a reminder, CCC patients represent approximately 30% of AG&S eligible-to-treat OSA patients who are contraindicated to our commercially available hypoglossal nerve stimulation therapy in the U.S. and do not have suitable treatment options other than major palate surgery. The ACCCESS primary endpoints are similar to the DREAM study primary end points as Genio has demonstrated similar results in both CCC and non-CCC patients.

Commercially, we reported European sales of Є441,000 during the quarter, which was below expectations. However, after an in-depth review, we see the quarter was impacted by several transitory factors. First, our highest volume accounts saw a seasonal reduction in OR capacity. Second, several newly activated accounts were slower to implant due to the administrative burden necessary to clear procedure funding. Lastly, doctor availability was limited during the quarter. And therefore, several new accounts had to postpone procedures. The German team managed to resolve these challenges, resulting in sales thus far in the second quarter exceeding first quarter revenue. Finally, we reported our first implant in Austria during the quarter. We continue to achieve becoming an innovation leader in the obstructive sleep apnea space.

Clinicians have embraced Genio technology, driven by a single incision, leadless system offering bilateral stimulation, powered by an external battery and full-body MRI compatibility. For patients, Genio’s ability to upgrade to the latest technology without the need for another surgical intervention is strongly resonating. This is demonstrated with our recent approval of the Genio 2.1, which improves patients’ comfort and compliance without the need for a surgical procedure to replace the implantable component. Finally, we anticipate the ansa cervicalis feasibility study to begin this year, which will explore the stimulation of the ansa cervicalis nerve in patients who are hypoglossal nerve stimulation non-responders. We are making strong progress towards our key objectives for 2023, which are to focus on patient follow-up in the DREAM study, resulting in reaching the primary end points.

We begin preparations to enter the U.S. market with regulatory, manufacturing and market access readiness and drive further revenue growth in Germany while opening new European markets. With that, I’m pleased to turn the call over to our CFO, Loic Moreau, who will provide a financial update.

Loic Moreau: Thank you, Olivier. Good day to everyone and thank you for joining us today. Revenue for the first quarter ended March 31, 2023, was Є441,000. The average selling price in the quarter was Є20,000, consistent with prior quarters. Total operating loss for the first quarter was Є11.4 million versus Є7.3 million in the first quarter of ’22, driven by an acceleration of clinical activities, notably the start of the ACCCESS study as well as commercial investments in Europe. Last quarter, we raised Є15.9 million through private investments in our ATM with historical shareholders, including ResMed, Cochlear and Robert Taub, Nyxoah’s Chairman and Founder. As of March 31, 2023, cash and financial assets totaled Є96.1 million compared to Є94.9 million in December 31, 2022.

During the first quarter, our monthly cash burn was Є4.9 million. And based on our current cash position, we have runway until late 2024. With that, I will turn the call back over to Olivier.

Olivier Taelman: Thank you, Loic. I would like to reiterate our key objectives for 2023, which are focusing on patient follow-up in the U.S. DREAM study, resulting in reaching the primary end points, beginning preparations to enter the U.S. market, and driving further revenue growth in Germany while entering additional European markets. This concludes the formal part of our presentation. Operator, I will turn the call over to you and begin our Q&A session.

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Q&A Session

Operator: [Operator Instructions] Our first question comes from the line of Jon Block of Stifel. Your line is open.

Operator: Thank you. One moment please. Our next question comes from the line of Adam Maeder of Piper Sandler. Your line is open.

Operator: Thank you. One moment please. Our next question comes from the line of Michael Polark of Wolfe Research. Your line is open.

Operator: Thank you. One moment please. Our next question comes from the line of Suraj Kalia of Oppenheimer. Your line is open.

Operator: Thank you. One moment please. Our next question comes from the line of Ross Osborn of Cantor. Your line is open. [Operator Instructions] I’m showing no further questions at this time. I’d like to turn the call back over to Olivier Taelman for any closing remarks.

Olivier Taelman: So thank you. And for the closing remarks, I would like to repeat again that our key objectives for 2023 are focusing on patient follow-up in U.S. DREAM study, resulting in reaching primary endpoints. And of course, we will continue with the preparation for the U.S. market and driving further revenue growth in Germany and also continue opening new sites in Europe. So thank you all for joining. Thank you for the questions. I’m happy to connect more if there should be more questions. Good evening or good afternoon.

Operator: Thank you. Ladies and gentlemen, this does conclude today’s conference. Thank you all for participating. You may now disconnect. Have a great day.