Q4 2023 Nyxoah SA Earnings Call - Q&A
Unknown Executive: Good day, and thank you for standing by. Welcome to Nyxoah's fourth quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode.
Good day, and thank you for standing by and welcome to next all fourth quarter 2023 earnings Conference call.
At this time all participants are in a listen only mode. After the presentation. There will be a question and answer session to participate simply press star one one on your telephone you will hear in message advising your hand is raised to.
Unknown Executive: After the presentation, there will be a question and answer session. To participate, simply press star 11 on your telephone. You will hear a message advising that your hand is raised. To withdraw the question, simply press star one one again.
To withdraw your question simply press Star One again. Please note that today's conference is being recorded I would now like to pass the call over to the Investor Relations and communications manager Mccalla Kirkwood.
Mikaela Kirkwood: Please note that today's conference is being recorded. I would now like to pass the call over to the investor relations and communications manager, Mikaela Kirkwood. Thank you, Carmen. Good evening, and good afternoon.
Thank you Carmen good evening, and good afternoon, everyone and welcome to our earnings call for the fourth quarter and financial year of 2023.
Mikaela Kirkwood: Welcome to our earnings call for the fourth quarter and financial year of 2023. I am Mikaela Kirkwood, Investor Relations and Communications 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 fourth quarter financial results released after the U.S. market closed today, after which we will host a question and answer session. The press release can be found in 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.
I am the killer Kirkwood Investor Relations and communications manager at next seller.
Participating from the company today will be Olivier Chairman, Chief Executive Officer, and a weak morale Chief financial Officer.
During the call we will discuss our operating activities and review our fourth quarter financial results released after the 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 your expectations or predictions of future events market trends results or performance.
Forward looking statements.
Mikaela Kirkwood: All four 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 them.
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 of the description of these risks and uncertainties associated with our business. Please refer to the risk factors sections of our form 20-F filed with the Securities and Exchange Commission on March 22.
Olivier Taelman: For a list and description of these risks and uncertainties associated with our business, please refer to the risk factor sections of our Form 20-F filed with the Securities and Exchange Commission on March 22nd, 2023. With that, I will now turn the call over to Olivier. Thank you, Mikaela. Good afternoon and good evening, everyone.
2023 with that I will now turn the call over to Olivier.
Thank you Micaela.
Afternoon, and good evening, everyone and thank you for joining us for the fourth quarter and financial year 2023 earnings call.
Olivier Taelman: And thank you for joining us for our fourth quarter and financial year 2023 earnings call. I would like to open with our 2023 accomplishments that have strengthened our confidence for a transformational 2024. Clinically, we completed enrollment in our dream U.S. Pivotal Study in March and initiated enrollment in our Access Complete Concentric CoLab U.S. Pivotal Study. From a regulatory perspective, we filed the first three modules in the model of a PM
I would like to open with over 2023 accomplishments.
<unk> come to them for the canceled national 2024.
Clinically we completed enrollment.
<unk> U S pivotal study in March and initiated enrollment.
Complete concentric collapse U S pivotal study.
From a regulatory perspective.
The first three module and the model of a PMA submission.
Olivier Taelman: The fourth and final module will contain the DREAM safety and efficacy data. Commercially, we reported 2023 sales of 4.3 million, an increase of 43% from 2022, benefiting from our direct-to-consumer initiatives launched early in the year. We also initiated a partnership with ResMed Germany to further increase overall OSA therapy penetration, ensuring that patients have access to the right treatment. Finally, we continued building our U.S. leadership team, strengthening our U.S. presence.
Before and final module will contain between safety and efficacy data.
Commercially we reported 2023 sales $4 3 million.
Increase of 43% from 2022 benefiting from our direct to consumer initiatives launched early in the year.
We also initiated a partnership with the vast majority to further increase overall OSA therapy penetration, ensuring that patients have access to the right treatment.
Finally, we continued building of our U S leadership team strengthening of U S patents.
Looking ahead 2024 is set to be the most exciting year in Companys history by early April we expect to report safety and efficacy results from the Dream study.
Olivier Taelman: Looking ahead, 2024 is set to be the most exciting year in the company's history. By early April, we expect to report safety and efficacy results from Dreamstone. Confidence in Dream Outcomes is supported not only by roughly 500 commercial and clinical geneal implants globally, but also by dream efficacy and safety data released in a late-breaking poster session at SLEAP 2023 in June. In this poster, we reported the efficacy data on the first 34 dream patients reaching 12-month follow-up, which demonstrated a 65% HIV-respondent rate. 76 ODI response rate and safety data on all 115 patients involved in the study were in line with expectations.
Our confidence in the outcomes is supported not only by roughly 500 homes commercial and clinical generic implants globally, but also by dream of efficacy and safety data released in a late breaking poster session at sleep 2023 in June.
In this poster we reported the efficacy data on the first 34 Green basin.
Reaching 12 month follow up.
Which demonstrated a 65% HIV spot rate of 76, <unk> and <unk>.
Safety data on all one homeless 15 patients enrolled in the study that was in line with expectations.
Olivier Taelman: As a reminder, for the trial to be successful, of the 115 patients, at least 62.6% need to be AHI and ODI responders at 12-month follow-up. We anticipate submitting the fourth and final module in our modular PMA filing, which will include DREAM 12-month safety and efficacy data, during the second quarter of this year. We are preparing for a launch by the end of 2024, and it's based on a modular PMA review cycle. We anticipate FDA approval in late 2014 for Early25, as we do not control FDA talent.
As a reminder.
For the trial to be successful.
<unk> hundred 15 basin at least 62, six books them need to be HIV and <unk> at the 12 month follow up.
We anticipate submitting the fourth and final module and module of the PMA filing which will include dream 12, months' safety and efficacy data during the second quarter. This year.
We are preparing for the launch by the end of 2012 before is based upon model be amazed if your cycle times.
We anticipate FDA approval in late 2004.
Early 'twenty five as we do not control FDA guidelines.
Olivier Taelman: To ensure we are fully prepared at launch, we are accelerating investments in our U.S. commercial team. We anticipate having the commercial U.S. leadership onboarded by mid-year and bringing on our sales force, patient management teams, and reimbursement specialists during the second half of 2024. The current hypoglossal nerve stimulation market in the U.S. is very constant.
To ensure we are fully prepared for that launch we are accelerating investments in our U S. Commercial team, we anticipate having the commercial U S leadership on board by mid year.
And the new normal sales folks based on management teams and reimbursement specialists during the second half of 2024.
The government will also mark stimulation market in the U S.
Very concentrated allowing for a focused strategy on high volume sites.
Olivier Taelman: Allowing for a focused launch strategy on high-volume sites, complemented by robust prior authorization and patient care team. A streamlined patient referral pathway from sleep specialists to these sites will accelerate market growth. A key differentiator of bilateral stimulation to unilateral stimulation is the ability to treat complete concentric collapse or triple C patients.
Complemented by August prior authorization and patient care teams.
Our streamlined patient referral pathway from sleep specialists to these sites will accelerate market growth.
A key differentiator of bilateral stimulation to unilateral accumulation is the ability to treat complete concentric collapse or triple C patients.
Olivier Taelman: The US Access Pivotal Study continues to unfold. As a reminder, CCC patients represent approximately 30% of hypoglossal nerve stimulation eligible to treat OSA patients who are contraindicated to commercially available AGNS therapy in the US and do not have suitable treatment options other than major pallet surgery. In the Better Sleep study, we demonstrated bilateral stimulation can treat CCC patients, which led to a complete concentric collapse label expansion in neurons.
The U S excess pivotal study continues to enroll as a reminder.
<unk> basis.
Approximately 30% while people, who also neuro stimulation eligible to treat OSA patients who are contra indicated to commercially available <unk> that would be in the U S.
And do not have suitable treatment options other than the major bulk strategy.
In the better sleep study, we demonstrated bilateral stimulation can treat triple C basin, which led to a complete concentric collapse a label expansion in Europe.
Olivier Taelman: Recently, Genio's success in treating CCC patients commercially was demonstrated in a real world case series that showed an average apnea hypopnea index decrease of 73%. The additional primary endpoints are similar to DREAM, with the objective to expand our U.S. labeling to include complete concentric collapse indication and eliminate the need to perform a drug-induced sleep endoscopy to determine whether a patient has Commercially, the fourth quarter was very strong, with sales of 1.8 million euros, showing 87% sequential and 42% year-over-year growth.
The recently <unk> success in treating CCC basin commercially was demonstrated in a real world case series that showed an average up near Hypopnea index decrease of 73%.
The excess primary endpoints of similar to dream with the objective to expand our U S. Labeling to include complete concentric collapse indication and eliminate the need to perform a drug induced sleep endoscopy to determine whether the patient testing CCC or not.
Commercially the fourth quarter was very strong with sales of $1 8 million euro showing 87% sequentially and 42% year over year growth.
This is a result of both strong underlying demand for <unk> and the recent commercial investments, including direct to consumer online campaigns and are based on top line.
Olivier Taelman: This is the result of both strong underlying demand for Genio and recent commercial investments, including direct-to-consumer online campaigns and a patient hotline. Continued investing in understanding the patient's journey resulted in the launch of a patient helpline and the kicking off of a ResMed Germany collaboration to ensure every patient gets the most appropriate OSA treatment. This is not only resulting in educating the force by calling the helpline, but it can be considered a key pillar in our fourth quarter success, together with the strong work of our sales and commercial team in Germany. In 2024, the recent ResMed Germany collaboration will further expand the OSA continuum of care, guiding patients to the appropriate therapy. For CPAP-quitting patients suffering from moderate to severe OSA, Genu is the solution, and for untreated patients, CPAP remains the golden standard. We continue to position ourselves as an innovation leader in the obstructive sleep apnea space, with Always Putting Patients First and Listening to Observe. As a result, Genio is a different approach to hypoglossal nerve stimulation.
Continued investing and understanding the patient journey that resulted in the launch of a patient to outline and kicking off road map, Germany collaborations to ensure every basin you've got the most appropriate OSA treatment.
This is not only resulting in advocating for.
Historically by calling the outline.
But can be considered a key pillar.
Fourth quarter success together with the strong work of our sales and commercial team in Germany is doing.
In 2024th the recent rest map, Germany collaborations we will further expand the OSA continuum of care guiding patients to the appropriate therapy.
For keep up liquidity basin.
For moderate to severe OSA Gino as a solution and for untreated patients see pulp remains the golden standup.
We continue to position ourselves as an innovation leader in the obstructive sleep apnea space with.
With always putting patients first and listening to acceptance as a result.
<unk> is a disciplined approach to HIPAA local knowledge stimulation.
Olivier Taelman: That's what they did with its LEAD and CAF solution. JINU offers patients a leadless, full-body MRI-compatible, non-implanted battery solution, powered and controlled by a wearable. Thanks to the fully upgradable wearable component, Genio patients can always have access to the most advanced technology without needing another service. The recently launched Genio 2.1 enables greater stimulation adjustability and gives patients the autonomy to adjust stimulation amplitude within predefined boundaries. This will definitely help patients that are very sensitive to neurostimulation overall.
<unk> with its lead and gas solutions.
G New office space in the leafless full body MRI compatible moment plugged with battery solution bulk and controlled bio available.
Thanks to the fully Upgradable variable component GTO patients can always have access to the most advanced technology without needing a mobile strategy.
The recently launched the <unk> $2, one enabled greater stimulation adjustability and gifts basins, the autonomy to adjust stimulation amplitude within <unk> boundaries.
This will definitely help.
There are very sensitive to neuro stimulation.
While the <unk> $3, one implantable stimulator is under regulatory review and will further support our implant for life concept.
Olivier Taelman: While the Genio 3.1 implantable stimulator is under regulatory review and will further be supported or implanted for life, future generations of the GENIOS system will have a more ergonomic wearable component, have sensors that will adjust stimulation based on sleeping position, and provide patients with real-time feedback through data collection that will improve the patient experience. We are making strong progress towards our key objectives for 2024, which are to complete patient follow-up in the DREAM US pivotal study and report efficacy and safety data by early April; file the fourth and final module on the model of PMA submission. Complete Patient Enrollment and Access US Pivotal Study.
The generation of Virginia system will have a more aggro moment accretable component.
Have some folks that will adjust stimulation based on sleeping position and provide patients with real time feedback to data collection that will improve the patient experience.
We are making strong progress.
Our key objectives for 2024.
Which ought to complete patient follow up into the leading U S. Pivotal study and the bulk of efficacy and safety data by early April.
Filed before the final module on the mobile PMA submission.
Complete patient enrollment in excess U S pivotal study.
Loic Moreau: Continue 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 Chief Finance Officer, Loic Moreau, who will provide a financial update. Thank you, Olivier. Good day to everyone and thank you for joining us today.
Continued 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 Chief Financial Officer, Luke model, we will provide a financial update.
Thank you Olivier.
Good day to everyone and thank you for joining us today.
Revenue for the fourth quarter ended December 31, 2023 was $1 8 million.
Loic Moreau: 42% increase over the fourth quarter of 2022 and an 87% increase over the third quarter of 2020. However, I would like to point out that the fourth quarters benefit the most from seasonality, and while we expect a strong year-over-year growth in the first quarter, we anticipate sales to be down sequentially. Total operating loss for the fourth quarter was $10.8 million versus $9.1 million for the fourth quarter of 2022, driven by an acceleration in clinical activities, as well as commercial investments in Europe and the U.S. As of December 31, 2023, cash and financial assets totaled 58 million euros, compared to 95 million euros on December 31, 2023.
42% increase over the fourth quarter of 2022.
And then.
7% increase over the third quarter of 2023.
I would like to point out that the fourth quarters, but if you do most from seasonality and while we expect strong year over year growth in the first quarter, we anticipate sales to be down sequentially.
Total operating loss for the fourth quarter was $10 8 million versus $9 1 million for the fourth quarter of 2022, driven by an acceleration in clinical activities as well as commercial investments in Europe as well as U S.
As of December 31, 2023, cash and financial assets totaled 58 million euros compared to 95 million euros on December 31 2022.
Olivier Taelman: During the fourth quarter, our monthly cash burn was $4.9 million, a slight increase from 3Q driven by US commercialization preparation activities. Based on our current cash position, we have runway into late 2024. With that, I will turn the call back over to Olivier. Thank you, Loic. As I hope you all agree, we are entering the most exciting time in Nyxoah's history.
During the fourth quarter, our monthly cash burn was $4 9 million.
Slight increase from <unk>, driven by U S commercialization preparation activities.
Based on our current cash position, we have runway into late 2024.
With that I will turn the call back over to <unk>.
Thank you Louie as I Hope you all agree we are entering the most exciting time in <unk> history.
Unknown Executive: We are a few weeks away from the dream clinical data reload, which, if positive, should result in obtaining FDA approval in late 2024 or early 2025, depending upon FDA timings. I look really forward to accelerating investments in the U.S. commercial organization, so we will be ready for the late 2024 launch and continued sales growth in Europe. This concludes the formal part of our presentation. Operator, I will turn the call over to you to begin our Q&A session. Thank you so much.
We have a few weeks away from dream clinical data.
Which if positive should result in obtaining FDA approval in late 2012 before or early 'twenty five depending upon FDA timeline.
I look really forward to accelerating investments in the U S. Commercial organization. So we will be ready for a late 2004 launch and continued sales growth in Europe.
This concludes the formal part of our presentation.
Operator, I will turn the call over to you to begin the Q&A session.
Thank you so much and as a reminder to ask a question simply press star one one to get into Q1 moment for our first question that is from Jon block with Stifel. Please proceed.
Unknown Executive: And as a reminder, to ask a question, simply press star 11 to get in the queue. One moment for our first question. That is from John Block with Stifel. Please proceed. Great, thanks guys, and good afternoon. I'll start with, you know, the 4223 top line was certainly solid, I think ahead of most prior estimates and certainly ahead of ours. Olivier, maybe if you could just talk about, you know, what was that strength attributable to? Was it the DTC?
Great. Thanks, guys and good afternoon, I'll start you know the <unk> hundred 23 top line was.
I was certainly solid I think had a most prior estimates and certainly ahead of ours Olivia maybe if you could just talk about what was that strength attributable to was it a DTC was it the resume partnership I think there was a competitor that had some lead issues in Germany, Italy, and Germany pardon me.
Olivier Taelman: Was it the ResMed partnership? I think there was a competitor that had some lead issues in Germany, in Germany, pardon me, so maybe if you could just talk about, you know, the main drivers or even rank order them, if you can, that'd be helpful as we think about our models. So thank you, John. Thank you for the question. And I can only agree. I think we can say that the fourth quarter was a very strong quarter in Germany.
Maybe if you could just talk about you know.
The main drivers are even rank order them. If you can that'd be helpful. As we think about our model.
No.
So thank you Joe and thank you for the question.
I cannot really agree I think we can say that the fourth quarter was a very strong quarter in Germany. We estimate also that we are nearly to 50% of the German market share in the fourth quarter motor drivers I think first of all it's a confirmation that there is a high acceptance from each organization that is one thing second.
Olivier Taelman: We estimate also that we are nearly to 50% of the German market share in the fourth quarter. Now the drivers, I think first of all, it's a confirmation that there is high acceptance from all German physicians. That is one thing. Second, we have 48 centers that are now fully trained and also implanting patients. We are offering doctors and patients a choice in the hyperlipidosal nerve stimulation implant and stepping away from an invasive pacemaker solution into a single incision procedure.
We have 48 samples that are low fully trained.
On the wholesale in bumping, we are offering doctors for patients.
In April also most stimulation implant and stepping away from an invasive space <unk> solution into a seamless ecosystem. It is definitely helping further as the product differentiation putting patients at December and of course, there is a sleep physician focus to DTC I think dose those components are really driving.
Olivier Taelman: This is definitely helping. Further, there is the product differentiation, putting patients at the center. And, of course, there is the sleep physician focus through DTC. I think those components are really driving what you focus on.
For Q forceful diesels.
Unknown Executive: Perfect. Great. That was very helpful.
Perfect Great that was very helpful and maybe just a pivot for the second question you touched on some of the next steps for U S approval, and then commercialization, maybe just to probe a little bit more.
Olivier Taelman: And maybe just to pivot for the second question, you touched on some of the next steps for U.S. approval and then commercialization. Maybe just to probe a little bit more, can you comment on the status of, call it, the first three modules, right, that have already been submitted? And then, is there anything new or incremental when we start thinking about the reimbursement path and which road you're going to go down? Thanks for your time, guys. Yes, no, no. So, as you correctly mentioned, in total, there are four modules.
Can you comment on the status of call. It. The first three modules that have already been submitted and then is there anything new or incremental when we start thinking about the reimbursement path in which youre going to go down. Thanks for your time guys.
Yes.
As you mentioned correctly in total there are four modules, we have submitted to FERC modules already in the fourth and final module will contain the telephone dream safety and efficacy data and will be filed shortly in the second quarter.
Olivier Taelman: We have already submitted the first three modules. The fourth and final module will contain the 12-month dream safety and efficacy data and will be filed shortly in the second quarter. So the first three are done; the fourth will go hand-in-hand with the dream safety data. Now, when we are coming to our further market access strategy, because I think that was also part of the question, currently, we have a team in place that is working to secure reimbursement from both CMS and the commercial payer. That team will also work with customers through the prior authorization process when we launch in the U.S. We are currently also in close conversation with the AIO, who will make a recommendation on CPT codes to AMA. There are a few different strategies one would be using. Another one would be using an existing neuromotivation code that covers technology very well.
The first three of them before they will go hand in answer to the beam safety data.
No.
Coming to further market access strategy, because I think that was also part of the question.
Currently we have a team in place that is working to secure reimbursement from both CMS and commercial payers.
<unk> will also work with customers through the prior authorization process when we launch in the U S.
We are currently also in close conversations at the AAR, who will make a recommendation on CPT codes to Ami.
There are a few different strategies, one would be using.
Okay.
And the other one would be using the existing Neuromodulation code that covers of technologies that you well, but I think most important is that the reimbursement in both scenarios, we will be in line with Ags.
Olivier Taelman: But I think most important is that the reimbursement in both scenarios will be in line with current AG&S payment rates. So I hope that this has provided you with an opportunity. Great color, too.
<unk> payment rates.
So I hope that this providing you answer John.
Great color I'll jump back in the queue. Thanks, guys.
Unknown Executive: I'll jump back in the queue. Thanks, guys. Thank you. One moment for our next question, please. And it's from the line of Ed White with H.C. Wainwright.
Thank you one moment for our next question. Please.
And he is from the line of Ed White with H C. Wainwright. Please proceed.
Unknown Executive: Please proceed. Hello, thanks for taking my question. Thank you. Thank you. Perhaps if you could just quantify, if you can, the impact of seasonality in the first quarter of this year that you're expecting.
Hello, Thanks for taking my questions.
Perhaps if you could just quantify if you can the impact of seasonality in the first quarter of this year that youre expecting.
Loic Moreau: Thank you, Ed, for this question. And I think the best person to answer this is our CFO, so we'll hand it over to him. Thank you. Thank you, Olivier, and thanks for the question, Ed. So, as you are aware, the fourth quarter seasonality is driven by the phasing of hospital budgets and spending in Germany. We, and as you know, we do not provide revenue guidance, but last year, if you observe the German HG&S market decline, approximately 25% from the fourth quarter 22 to the first quarter 26, and we would anticipate a similar seasonality in the first quarter 2020. Given we still have high customer concentration, the impact of seasonality on our first quarter could be more pronounced.
Thank you for this question and I think the bed.
This person to answer this is <unk> CFO suitable amdocs.
Thank you Charlie and thanks for the question Ed.
So as you are aware of the fourth quarter seasonality is driven by the phasing of hospital budgets and spending in Germany.
And as you know, we do not provide revenue guidance, but last year as you observed the German <unk> market declined approximately 25 person from the fourth quarter 'twenty two to the first quarter of 'twenty three.
And we would anticipate assuming that seasonality in the in the first quarter 2024.
We still have high customer concentration the impact of seasonality on our first quarter could be more pronounced.
Loic Moreau: That's what we anticipate. Okay, thank you. And also, just to clarify, are essentially all of your sales right now coming from Germany? Is there a number you can use to quantify that?
What we anticipate.
Okay. Thank you.
And also just to clarify.
Or essentially all of your sales right now coming from Germany is there a number you can use to quantify that.
90% of our sales in Europe.
Loic Moreau: and 90% of our sales in Europe are currently in Germany. Okay, great. Thank you. And my last question is, just on the, how should we be thinking about ResMed's impact on sales so far? What are you seeing?
Occurance in in Germany.
Okay, great. Thank you.
And my last question is.
Just on the Rev. Matt how should we be thinking about the <unk> impact.
And sales so far what are you seeing is there any way to determine if that's having an impact already.
Olivier Taelman: Is there any way to determine if it's having an impact already or if it should be a later 2024 event? And also, is there the possibility of a ResMed agreement in the U.S. as well? Thank you again for this question. Olivier, again, I will answer these two questions. So first of all, in ResMed Germany's collaboration, we announced the collaboration at the end of September 2023. We do not expect to see an impact for the first six months, so we are anticipating beginning to realize benefits in the second quarter of this year. So that is, I think, the answer to the first part.
Or if it should be a later in 2024.
Event.
And also is the possibility of a RESNET agreement in the U S as well.
Well. Thank you again for this question Olivia again I will answer these two questions. So first of all in geographic majority of any collaboration we announced the collaboration <unk> September 2023.
We do not expect to see an impact for the first six months are we anticipating beginning to realize benefits in the second quarter of this year.
I think the answer on the first part modus second do you anticipate also partnering with restaurants in the U S.
Olivier Taelman: Now, the second question: do you anticipate also partnering with ResMed in the U.S.? Our strategy is to go direct in the U.S. If there are opportunities to augment the direct approach with partnerships, like with ResMed, touching on their relationship and tapping into their relationships with sleep physicians, we will definitely explore those in going forward. Great, thank you for taking my question. Thank you. One moment for our next question, please, and it is from the line of Ross Osborn with Cantor Fitzgerald. Please proceed. Hey guys, congrats on the progress. Thanks for taking our questions. So starting off just in the U.S. market, would you walk us through how you're thinking about initially commercializing JNEO in terms of targeting existing Inspire users versus growing the market, or in other words, getting first-time HTNS users to adopt JNEO?
Our strategy is to go direct in the U S is there are opportunities to augment but its approach with partnerships likelihood asthma touching on that relationship definitely modal desk relationships with key physicians, we will definitely explore dose and going forward.
Great. Thank you for taking my question.
One moment for our next question please.
And he is from the line of Ross <unk> with Cantor Fitzgerald. Please proceed.
Hey, guys. Congrats on progress thanks for taking our questions.
So starting off just on the U S market or would you walk us through how youre thinking about initially commercializing <unk> in terms of targeting existing inspire user versus growing the market or in other words getting first time HCN as users to adopt <unk>.
Olivier Taelman: Thank you, Ross, for the question. I mean, we are thinking about and preparing a lot of different strategies at this point, but I can really be precise in the answer. So the US market today is very concentrated.
Thank you Ross for the question.
I mean, we are thinking and we are preparing a lot of difficult probably on this point, but I can I can't really be precise in the answer so the U S market today is very concentrated with.
Olivier Taelman: We plan a targeted launch focused on top accounts, which constitute over 85% of current AG&S sales in the US. We will have a dedicated sales force sized appropriately for the project at launch. There will be targeted DTC focus on product differentiation and patient referral pathway. I think this will be a main differentiator from what is happening today. It will really be a targeted DTC focus. We will be engaging with sleep specialists, enabling a steady stream of patient referral. Scalable Patient Follow-Up Strategy, and Sales, Marketing, and Prior Authorization Teams Ahead of Launch, and more details I'm really happy to share later this year. Okay, great. And then maybe one more qualifying question on the ResMed partnership. Would you just remind us why they are incentivized to market Genio?
Planet positive launch focus on top accounts.
Which constitute over 85% of Ags sales in the U S.
We will have a dedicated sales folks sized appropriately for the target of launch.
There will be probably the DTC focus on product differentiation and patient referral pathway. I think this will be a main differentiator to what is happening today. It will be really a positive DTC focus.
We'll be engaging with sleep specialist, enabling a steady stream of patient flow.
Scalable patient follow up strategy and sales marketing and prior authorization fees ahead of launch.
And more details I'm really happy to share later this year.
Okay, Great and then maybe one more qualifying question on the <unk> partnership or would you just remind us why they are incentivized to market <unk>.
Olivier Taelman: Yeah, so, first of all, I would like to maybe talk about partnership. Because through this partnership, we really aim both ResMed and Nyxoah at our patient-centric approach, developing a complete OSA ecosystem where patients can be guided to whichever OSA treatment best suits their needs. We will collaborate on DTC initiatives, sales, and marketing efforts to target both sleep physicians and ENT surgeons. I think the goal of this partnership is to expand OSA therapy penetration and increase our market share. Now, what are the benefits?
Yes. So in fact first of all I would like to maybe.
Homeownership because through this partnership we really aim both restaurants and make sure they know.
Patient centric approach developing the complete OSA ecosystem with patients can be guided through whichever OSA treatment that suits their needs.
We will collaborate on DTC initiatives sales and marketing efforts to target both sleep physicians and surgeons and I think the goal of this partnership to expand to a safe therapy penetration and increase of market share what.
What are the benefits I think for <unk>, it's pretty it's pretty obvious that having access to patients who are quitting sleep app that can be offered xenial. This will drive share gains and strengthen our relationship with sleep specialist.
Olivier Taelman: I think for Nyxoah, it's pretty obvious that having access to patients who are quitting CPAP that can be offered Genio will drive share gains and strengthen our relationship with sleep specialists. For ResMed, benefits from having access to more OSA patients through the ENT surgeon that we have at Nyxoah, also our helpline, and increasing sleep specialist capacity by sending CPAP struggling patients who are time-consuming to Genio. I think something also not to neglect is the health care system benefit. As untreated OSA patients are at high cost, ensuring these patients are optimally treated, either with CPAP or with Genio, will definitely have a positive impact on reducing health care spending.
For last month benefits from having access to more OSA patients through the ERP. So that we are having a big sur.
Also our helpline, and increasing sleep specialists capacity by some seahawks struggling patients will start consuming to Gino.
I think something also not to neglect is the healthcare system benefits as untreated OSA patients will have high costs and ensuring these patients are optimal treated either with seaport global regional we will definitely have a positive impact on reducing health care spending.
Unknown Executive: And overall, this partnership will also increase OSA therapy penetration and will benefit. Great, thanks for taking our questions. Thank you. One moment for our next question, please, and it is from the line of David Rescott with Baird. Please proceed.
And overall this partnership will also increase OSA therapy penetration and will benefit patients.
Yeah.
Great. Thanks for taking my questions.
Thank you one moment for our next question. Please.
And he is from the line of David <unk> with <unk>.
Please proceed.
Okay, great. Thanks for taking the questions.
Unknown Executive: Thanks for taking the questions. I know you touched a little bit on the reimbursement landscape in the U.S. Again, I know you mentioned that in September of last year at AO, there was some discussions around new codes. Can you remind us what specifically are the next steps as you look out over the next several quarters or so around what we'll find out and when we're going to kind of find that update out around what a U.S. reimbursement code would look like? Yes, no, definitely.
I know you touched a little bit on the reimbursement.
<unk> in the U S again.
You mentioned that September of last year that there was some discussions around around new codes can you remind us what specifically are the next steps.
As you look out over the next several quarters or so around what we'll find out and when we're going to kind of find that update out around what our U S reimbursement coverage look like.
Yes, no definitely so.
Olivier Taelman: So the next step will be very precise: the AO will make a recommendation on CPT codes to AMA. So from our side, we are working immediately to secure reimbursement from both CMS. Once we have FDA approval, so that we can immediately start commercializing, and in parallel, of course, preparing commercial payers also, and educating and training them on. We have already engaged in an informal discussion with the payers and expect to re-enable those policies. At launch, very precise, we anticipate being reimbursed for prior authorization and would expect to be included in coverage policies with commercial pairs within 12 months.
The next step will be very precise that the <unk> will make a recommendation on the CPT code to Amy.
So from all sides, we are working immediately to secure reimbursement from both CMS. Once we have FDA approval for <unk>.
Immediately start commercializing and in parallel of course, preparing also commercial payers and educate and train them.
And while that's been wholesale convince them to soft.
In boxing of technology.
No.
Part of that as you know has done a terrific job educating the commercial payers are both the benefits of Atms, resulting in all having agm's property.
Coverage policies, we are already engaged in the informal discussion with the pace and expect.
With NBA those policies at launch very precise we anticipate being reimbursed through prior authorization and would expect to be included in copel coverage policies with.
Commercial base within 12 months afterwards.
Okay.
Olivier Taelman: Okay, and then you mentioned some investment in Salesforce ahead of the U.S. launch. I heard you also mentioned some investments in manufacturing. I'm curious what specifically is going on from the manufacturing side. And historically, I think you talked about this 4 million dollars of quarterly cash burn.
You mentioned.
Some.
In the.
Sales force ahead of the U S launch.
I heard you also mentioned some of the investments in manufacturing I'm curious, what specifically is going on from the manufacturing side and historically I think you've talked about this.
$4 million and $1.
Quarterly cash burn.
Olivier Taelman: Is that kind of the right way to think about that into 2024? Or should there be some type of acceleration, assuming that you continue to invest in some of the Salesforce platform and manufacturing capabilities ahead of the U.S. launch? Thank you. The first part is on the manufacturing side. We really invested heavily, so we have now a fully approved site in Belgium manufacturing our products.
Is that kind of the right way to think about that into 2024 or should there be some type of acceleration assuming.
You continue to invest in some of the sales force and manufacturing.
<unk> ability to add about U S launch thank you.
Yes.
First part is on the manufacturing side.
We really invested heavily so we have a complete approved site in Belgium manufacturing of products and next to this we are working with a service provider in the U S that will also manufacturing over also manufacture of products. So with both sides. We do believe that we totally completely have derisked the manpack.
Olivier Taelman: And on top of that, we are working with a service provider in the US that will also manufacture our products. So on both sides, we do believe that we totally, I completely have de-risked the manufacturing volume capacity that we will be able to start building inventory before launch so that at all times when we launch, we will have significant inventory in our possession so that there will never be a product shortage in the first 12 months of launch. That is one thing.
<unk> volume capacity that we will be able to score one building inventory before launch so that at all time or the new launch we will have significant inventory in our possession, that's available that would be a product shortage in the first 12 months of launch it is lumpy when it comes to the cost related to this and the <unk>.
Loic Moreau: When it comes to the cost relating to this and the overall spend, Loic, I'm sure that you would like to comment on this a little bit further. So, you have seen that we burned 4.9 million in the last quarter of 2023. When we look forward, we expect the burn rate to remain steady for the first half of the year while we start doing our pre-commercial investment. And then when we start this summer, we expect this burn rate to accelerate as we see more and more investments in the US Commercialization Act. Okay, great. Thank you. Thank you. One moment for our next question, please. And it's from the line of Adam Maeder with Piper Sandler.
<unk> expense will be I'm sure that you would like to comment on this little bit slower.
So you have seen that we burned $4 9 million in the last quarter of 2023, when we look forward, we expect the burn rate to remain steady for the first half of the year.
While we are start doing our pre commercial investments and then when we starting December we expect this burn rate to accelerate as we see more and more investments.
In U S commercialization activities.
Okay.
Okay, great. Thank you.
Thank you one moment for our next question. Please.
And he is from the line of Adam either with Piper Sandler. Please proceed.
Unknown Executive: Please proceed. Hi, good afternoon, congratulations on the nice finish to the year and the recent progress, and thanks for taking the question. I wanted to start with the dream study.
Hi, good afternoon, and congrats on the nice finish to the year and the recent progress and thank you for taking the questions.
I wanted to start on the Dream study and.
Olivier Taelman: And just the disclosure strategy around full dream results. I heard the data should be communicated by early April. Olivier, are you able to talk a little bit more about exactly what's gonna be shared at that point in time? Is it simply just top line information?
And just the disclosure strategy around dream results.
I heard the data should be communicated by early April.
Olivier are you able to talk a little bit more about exactly what's going to be shared at that point in time is it simply just topline information when we get additional details.
Olivier Taelman: Will we get additional details? I'm assuming it's going to be messaged in the form of a press release, but maybe just talk about a disclosure strategy and then I'd follow up. So, as I mentioned, and I knew we would communicate the data at the latest, beginning of April, in a press release, followed also by a call.
Im assuming thats going to be messaged in the form of a press release, but maybe just talk about disclosure strategy and then I had a follow up thank you.
So thank you Adam for the question so as I mentioned, a new we will communicate later.
Beginning of April the data that will be in the press release, followed also by our call. We will be focused on topline results HIV reduction responder rate ODI reduction and then we are planning and moving forward to reveal all the data in detail during the ISS conference in September where we will level pie.
Olivier Taelman: We will be focused on top-line results, HI reduction, response rate, and ODI reduction, and then we are planning and moving forward to reveal all the data in detail during the ISSS conference in September, where we will have our PI talking about the data and the details. So, what you can expect is top-line data being released in a press release, followed by a call, where there can be more questions, and we will be focusing on, in fact, response rate, HI reduction, and ODI reduction. We will also talk high-level about the safety data that we have, and then, of course, in parallel, we are preparing everything for a publication in a Tier 1 journal. That's perfect.
Talking.
Due to the data and the detail. So what you can expect this topline data being released in the press release, followed also by a cold weather that can be more questions and we will be focusing on in fact.
This form of HIV deduction ODI reduction will also talk high level on the safety data that we are having and then of course in parallel we are preparing everything for publication in a peer one channel.
That's perfect. Thank you for that color Olivier.
Olivier Taelman: Thank you for the color, Olivier. And then for the follow up, I wanted to ask about the access study. You know, I think it was mentioned in the prepared remarks, but I was hoping just to get a little bit more granular in terms of, you know, enrollment progress in that study. How should we think about potential timelines for enrollment completion and ultimately potential FDA commercial approval for CCC patients? Thank you for asking the question. As we continue to make progress with the study, we will not disclose the number of patients implanted already, but that being said, we still continue to plan to close all implants by the end of 2024. Then there is a 12-month patient follow-up, so that brings us to the end of 2025, and then the aim is to submit the CCC data as a PMA supplement that should take a maximum of 6-9 months.
And then for the follow up I wanted to ask about the access study.
I think it was mentioned.
Paired remarks.
But was hoping just to get a little bit more granular in terms of.
Enrollment progress on that study.
How should we think about potential timelines for enrollment completion, and ultimately potential FDA commercial approval for our Triple C patients. Thank you for taking the questions.
So we continue to make progress with the study.
We will not disclose the number of patients implanted already but that being said, we still continue to plan to close all implants by the end of 'twenty four.
And then there is a 12 month patient follow up so that brings us to the almost 75 and then the aim is to submit the CCC data as a PMA supplement that should take maximum six to nine months review period. So we plan to have the label expansion, assuming all paid off positive mid 2026.
Olivier Taelman: So we plan to have the label expansion, assuming all data are positive, mid-2025. Very helpful. Thank you. Thank you. One moment for our next question. And it's from the line of Laura Roba with Gross Peter Kahn.
Very helpful. Thank you.
Thank you one moment for our next question. Please.
And he is from the line of Laura rolled up with the growth Petercam. Please proceed.
Unknown Executive: Please proceed. Hi, thank you for taking my question. We see that gross margin was lower in Q4.
Hi, and thank you for taking my question.
Gross margin was lower in Q4 could you elaborate a bit on it doesn't what do we expect for 2024.
Loic Moreau: Could you elaborate a bit on that and on what we could expect for 2024? Definitely, and this is definitely a question for the CFO. Thank you. Thank you, Laura. Yes, indeed, we were at 60% in Q4 versus 62% for the rest of the year. But actually, this is explained by our scale. And specifically, the fact that we have a newly opened manufacturing site in Belgium that is not yet at full capacity. So we see some modest variability quarter over quarter. That said, we anticipate the gross margin to increase over the coming quarters as we scale up volumes.
Definitely this is definitely a question for our CFO.
Thank you thank you Noah.
Yes indeed.
We were at 60% in Q4 versus <unk> 62 for the rest of the year.
Actually this is explained by our scale and specifically the fact that we have a newly opened.
Manufacturing site in Belgium.
That is not yet.
At full capacity, so we see some modest variability quarter over quarter.
That said, we anticipate gross margin to increase over the coming quarters.
We scale up volumes.
Loic Moreau: Over time, we expect our growth margin to eventually approximate the level of other neural stimulation companies and to be above 80%. Okay, that's very clear. Thank you. Thank you so much.
Over time, we expect our gross margin to inventory approximate the level of or the stimulation companies and to be above 80%.
Okay, that's very clear thank you.
Thank you so much and one moment for our next question. Please.
Unknown Executive: And one moment for our next question, please. All right. And our last question will be from Suraj Kalia with Oppenheimer. Please go ahead. Olivier, Loic, can you hear me all right? Yes, we can. Hello.
Alright, and our last question will be from Suraj Kalia with Oppenheimer. Please go ahead.
Olivia Leigh can you hear me all right yes.
Hello pardon pardon.
Suraj Kalia: Pardon the background noise and congrats on the progress. So, Olivier, a few questions from my side. As we look forward to the stream, what would you say?
Pardon the background noise.
So looking at.
Two questions from my side.
Look forward to rule.
So let me.
You say.
Olivier Taelman: In your position, say... The results are, you know, how can you characterize the delta between bilateral versus unilateral? What would make you say these results are better than unilateral? What would make you say these are somewhat less than unilateral? So, if I understand the question correctly, Suraj, because there is a little bit of a background. So, you're asking about the results, the comparison between bilateral results and unilateral results that we are seeing. Is this correct?
In your position.
The results are.
How do you characterize that still sounds like bilateral versus unilateral what would make you say if these results are better.
Again the lateral.
This is these are.
Somewhat less in the lateral.
So if I understand the questions go ahead to us because there is a little bit bejeweled, who are seeing the results.
Paraison between bilateral his opened unilateral result that we will see this correct.
Yes, I guess, what I'm trying to understand Olivia.
Olivier Taelman: Yeah, I guess what I'm trying to understand, Olivier, is that you can rest assured that the numbers are going to be sliced and diced in different ways to make different arguments, right? I guess what I'm trying to understand is, hypothetically, if you had a 60% responder rate in the complete cohort of INSPIRE and a certain responder rate. We can slice and dice different metrics. What would make you say, you know what? This is the totality of these results showing that bilateral is better than unilateral? What would make you somewhat cautious and say, you know what, we missed some, some, somewhere versus Yoon Blad? Yes, so first of all, I have to point out that the study was not designed to show superiority, and it was even not a head-to-head trial. But on the other hand, you are... Yeah, yeah, I get it. So we are...
You can rest assured.
Give us a number or is that going to be.
Sliced and diced and different ways to different make different arguments right I guess, what I'm trying to understand is hypothetically if you have 50% responder rate.
Cohort.
Inspire has a certain responder rate.
Yes, we can slice and dice different metrics, what make you say you know what this is.
Yes.
The totality of these results show bilateral is better than unilateral what would make you.
Got cautious that say you know what.
B B missed some some.
Some better versus unilateral.
Yes, so I first of all I have to point out that the study was not designed to show superiority.
Even though the head to head trial, but on Johan.
Got it.
Ed.
So the patient Phenotyping, we look at the inclusion criteria that we look at the BMI type CAGR. So the studies are really similar or compatible.
What would we expect so.