Q1 2022 Neuropace Inc Earnings Call
Good afternoon, and welcome to narrow basis first quarter earnings conference call. At this time, all participants are in listen only mode.
We'll be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes.
I'd like to turn the call over to Matt back so.
From the Gilmartin group for a few introductory comments.
Thank you operator, good afternoon, and thank you for participating in today's call joining me from neuro pace or Mike that at CEO , and Rebecca Cohen CFO earlier today neuro pace released financial.
For the first quarter ended March 31 2022.
You have the press release is available on the company's website before we begin I'd like to remind you that management will make statements. During this call that include forward looking statements within the meaning of federal Securities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1995 any statements made during this call that relate to expectations or predictions of future events results or performance.
Forward looking statements.
All forward looking statements, including those around neuro patients clinical trials and those relating to our operating trends and future financial performance FDA approvals the impact of COVID-19 on our business and prospects for recovery.
Expense management expectations for hiring growth in our organization market opportunity revenue outlook commercial expansion product performance and product pipeline development 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 implied by these forward looking statements. Accordingly, you should.
Not place undue reliance on these statements for more detailed description of the risks and uncertainties associated with our business. Please refer to the risk factors section of our public filings with the Securities Exchange Commission or SEC, including our annual report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 10 2022.
And our quarterly report on Form 10-Q to be filed with the SEC on May 12, 2022, as well as any reports that we may file with the SEC in the future. This conference call contains time sensitive information, which we believe is accurate only as of the live broadcast on May 20 May 12 2022.
Aerospace disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward looking statements, whether because of new information future events or otherwise and with that I will turn the call over to Mike.
Thanks, Matt Good afternoon, everyone and thank you for joining us for today's call I will provide opening comments on our business update followed by Rebecca who will provide additional detail regarding our quarterly results and full year 2022 financial outlook before opening the call to Q&A.
Moving onto our quarterly results.
We started the year strong generating $11 4 million of total revenue for the first quarter of 2022.
Initial implant revenue in the first quarter of 2022 was $8 $8 million and came in above the top end of the first quarter guidance range. We.
We experienced significant business disruption from January through early February primarily as a result of the omicron variant, resulting in one of our most COVID-19 impacted periods to date.
We rebounded nicely in the second half of the quarter specifically in the second half of February we saw a marked improvement in procedure volumes from January levels are.
Our business improved further in March when we saw a meaningful uptick in implant procedure volumes, which we believe to be a combination of rescheduled procedures from earlier in the quarter and new procedures.
Given the COVID-19 related challenges faced in the early part of the quarter. We are pleased with our results.
Although we experienced a nice recovery fueled in part by rescheduled implant procedures in March we believe that severe COVID-19 related disruptions in January and February caused a significant reduction in the number of patients coming through epilepsy monitoring unit or <unk> during that time.
The patients coming through the EMU diagnostic process feed the pipeline for our rns system implants.
We believe that the EMU volumes largely returned to 2021 levels in March as the impact from omicron subsided, but that the reduced number of patients coming through the <unk> used in the first half of Q1, we will limit the number of patients implanted with the RMS system in the second quarter.
Given what we saw in the first quarter of 2022, we believe that we remain on track for our 2022 revenue guidance of $45 to $48 million.
As well as meeting our 2022 target of approximately 10% growth in centers implanting, our Rms system.
Without additional Covid disruptions, we also expect that the number of patients coming through the IMU diagnostic process will return to pre pandemic levels and continue to grow.
We believe that there is a growing backlog of patients are happy and us both as a result of the most recent disruptions in the first half of the quarter as well as the longer term impacts of the COVID-19 pandemic.
It typically takes approximately six months from initial IMU admission until the implanted in Rms system.
Given this we believe that our 2000 and our growth in 2022 will be driven by commercial execution, resulting in an increasing number of centers implanting, our RMS system and increased utilization within those centers.
We expect that longer term growth will be assisted by an increasing number of patients coming through the diagnostic process.
In anticipation of an improving environment with increasing IMU patient volumes. We previously previously announced a number of commercial initiatives. Specifically, we are on track with our accelerated field hiring plan with many of the new hires already in place.
The larger field team will allow us to increase focus on epilepsy specialists, who practice outside of level. Four centers. This provides additional market opportunity for our business.
We plan to educate these epilepsy specialists about the RMS system, helping them collaborate with cec's to have our rns system implanted.
Through these relationships, we can make rns therapy available to a larger number of patients with ongoing device programming and patient management provided by epilepsy specialists practicing outside the level for Ccs we.
We believe that the ability to have device monitoring and oversight on locally we will have a significant benefit to patients.
No we are resuming in person physician education events, starting this summer for the first time since the start of the pandemic and our field team access to customers has improved significantly.
Believe this trend is a leading indicator of improved clinician engagement and future adoption.
We are also driving demand generation by identifying and educating drug resistant epilepsy patients earlier in their treatment journey as they consider treatments beyond medication.
We are expanding our marketing programs, including an increase in digital and social advertising lead generation efforts and patient ambassador connections.
As we connect with more rns candidates earlier in their care journey, our patient education team will provide information about narrow basis, RMS system and guide appropriate patients through the process.
Moving onto recent clinical updates in future future indication expansion opportunities, we remain on track to start enrolling patients around the middle of the year and our Nautilus pivotal trial to support a PMA supplement to expand our indication to include primary generalized epilepsy.
While we are still early in our pursuit of generalized epilepsy indication expansion.
We are excited about what this would mean for our business and for patients. In addition to expanding the rns indication to cover a larger number of patients. There are important differences from our current focal epilepsy patient population that make this an excellent opportunity for rns therapy.
Surgical resection, and ablation are not appropriate for treatment of generalized epilepsy and there are no other approved neuromodulation therapies for this patient population.
We believe that the diagnostic process for generalized epilepsy will be faster and simpler than for focal epilepsy with less need for IMU evaluation and no need for invasive monitoring.
Upon FDA approval, we expect a relatively fast commercial rollout because we anticipate selling to the same physicians who are already treating focal epilepsy patients using the same neuro based device.
We are excited to begin enrollment in the Nautilus study and.
And look forward to an indication expansion into this underserved patient population.
Next I would like to provide an update on replacement implant revenue.
As stated last quarter, we received approval from the FDA to update our labeling to claim an estimated average battery life of nearly 11 years under typical use conditions.
This updated label represents more than a two year increase from our previously approved labeling.
And we have been actively marketing this benefit to customers.
Early customer feedback has been very positive.
As a longer battery life removes an important barrier for initial implant adoption and it gives us a distinct competitive advantages advantage over other neuromodulation devices for epilepsy, which have much shorter expected battery life.
Revenue from replacement implants was $2 $6 million in the first quarter of 2022, which came in slightly above the top end of our Q1 guidance range.
Due to the timing of when the first generation of implants are replaced there can be variations quarter to quarter.
That said replacement revenue trends remain in line with our expectations and historical replacement rates.
To provide continued transparency as of March 31, 2022, there were 207 patients being actively treated with first generation devices.
Placement revenue trends remain unchanged and we continue to expect quarterly replacement revenue to sequentially decline throughout the year with a full year 2022 replacement revenue of approximately $6 million.
In summary, we started the year strong despite meaningful COVID-19 headwinds in the first half of the quarter and continue to make significant progress on key strategic initiatives and the clinical side. We remain on track to begin enrolling patients in the Nautilus study around mid year, which will be an important step to expand the market opportunity for our Rms system.
On the commercial side, we increased the number of centers implanting, our rns system in the first quarter and are on track with our field team expansion and patient demand generation initiatives.
All of these position us well as we anticipate <unk> patient volumes, increasing leading to more patients being deemed candidates for our Rms system.
With that I will turn the call over to Rebecca Neuro pesos Chief Financial Officer.
Thanks, Mike.
Newer paces revenue for the first quarter of 2022 was 11 4 million.
Hedged your $11 2 million for the first quarter of 2021.
Growth in the quarter was primarily driven by an increase in unit sales.
<unk> comprehensive epilepsy centers.
Asia and grant proceeds yet.
In the first quarter revenue from the initial implants with $8 8 million.
Compared to $8 1 million for the first quarter of 2021.
Growth in the quarter was driven primarily by an increase in the number of initial implant procedure.
<unk> headwinds from the Karnes area.
First half of a quarter.
Revenue from replacement implants, with $2 6 million compared to $3 1 million.
In the first quarter of 2021.
We continue to expect replacement and grant revenue generally to decrease for the next several years due to the transition to the model if I divide.
It has a longer lasting battery.
Gross margin for the first quarter of 2022 was 73% compared to 76% in the first quarter of 2021.
The decline in gross margin relative to the prior year period was primarily due to an increase in indirect labor cost.
Okay.
Stock based compensation and reduced production volume as a result of the increased volatility, resulting from the COVID-19 pandemic.
Total operating expenses in the first quarter of 2022 by $18 million.
Compared with $12 4 million.
In the same period of the prior year.
R&D expense in the first quarter of 2020, Q was $5 6 million compared with $1 million.
Same period of 2021.
The increase in R&D expense was primarily driven by an increase in personnel product development and clinical study expenses.
SG&A expense in the first quarter of 2022 was $12 4 million compared with $8 3 million.
Prior year period.
The increase in SG&A was primarily driven by increased cost associated with operating as a public company.
Personnel related expenses and increased sales and marketing cost to support commercial expansion initiative.
Loss from operations was $9 8 million in the first quarter of 2022 compared to $3 9 million in the prior year period.
We have recorded $1 8 million and interest expense in the first quarter, that's flat compared to the prior year period.
Net loss was $11 5 million for the first quarter of 2022 compared to $8 8 million in the first quarter of 2021.
Our cash and short term investments balance as of March 31, 2022 was $103 2 million.
Well, our long term borrowings totaled $50 1 million.
Now turning to our outlook for 2022.
We continue to expect annual revenue between 45 and $48 million.
This assumes initial plant revenue.
Between 39 and $42 million.
Because the operating environment has improved over the last 60 days, we expect initial implant revenue to normalize in the second half of 2022 as the pipeline of new patients continues to build and they transition to the fixed line diagnostic evaluation process.
We continue to expect 2022 replacement revenue.
To be approximately $6 million.
Moving down the income statement we.
We continue to expect gross margin to be in the mid 70% range.
And operating expenses between 74 and $76 million.
Of which approximately $8 million to $9 million.
With noncash stock based compensation expense.
This concludes our prepared remarks.
I would like to turn the call back over to the operator, who will open the call for questions.
As a reminder, if you'd like to ask a question. Please press Star then one.
Your question has been answered and you'd like to remove yourself from the queue press the pound key.
Our first question comes from Robbie Marcus with Jpmorgan. Your line is open.
Hi, This is actually <unk> on for Robbie Thanks for taking the question and congratulations on a good quarter.
Just start would you be able to give us some more color on revenue cadence for the year. The first quarter came in a little higher than expectations due to a better recovery in February. So how do you view current guidance in light of this also does the range contemplate any further COVID-19 variability.
And then I have a follow up question.
Very good thanks for the thanks for the question so.
Let me start off with just say just a general comment then the observation that you made were very.
Pleased with the way that we started the year with able to being able to recover from the challenges at the beginning of the quarter due to the omicron variant.
As we think about the guidance for the year, we agree reiterated the $45 million to $48 million guidance.
We provided in the Q1 and the earnings call a few months ago.
They're really really the rationale for that is that we're continuing to execute on the core commercial strategies and quick increase in the number of centers that are implanting.
Creasing utilization.
We anticipate that through the year, we will continue to drive increases in both utilization and number of centers and planning, resulting in implant revenue from initial system implants, continuing to increase through the year.
Counterbalancing that we expect that the replacement implant revenue has anticipated will continue to decrease.
Through the year, resulting in that resulting in that total amount.
We did have the near term short term dynamics that were happening in Q1.
The delays in procedures that happened in the early part of the quarter and we were very pleased at the speed at which we were able to recover those delayed cases in the second half of Q1.
And anticipate that there's going to be some impact of the number of patients coming through the epilepsy monitoring units in Q1, I'm, having an impact on Q2.
The recovery happening happening there faster than we anticipated when we when we provided an update a few months ago.
But the trends that we're seeing overall in the epilepsy monitoring units are positive we are seeing that those volumes of patients coming back coming through the <unk>.
Increased over the last couple of months compared to the decreased levels that we saw at the beginning of Q at the beginning of Q1.
And overall the backlog of patients that we're hearing from our customers at the epilepsy monitoring unit.
<unk> continued to grow and we're anticipating that those numbers of patients coming through will continue to increase through the course of the year, providing providing a great.
Opportunity for us to be able to grow the business and.
In addition through our in addition to the efforts that we're doing on the commercial side.
So just in general we're seeing that second half of the year is going to be continuing to grow and initial implant revenue, allowing us to get to the guidance that we provided for the year overall.
Okay, Great and would you be able to comment on how much of a headwind staffing is in the EMU relative to lower patient volumes due to COVID-19 at least in the first quarter and what youre seeing with staffing moving forward.
Are you seeing kind of like higher utilization levels offsetting this with more doctors implanting a greater share of patients alongside the new center additions I just wanted to get your thoughts on that dynamic. Thanks.
<unk>.
The dynamic that happened in the first quarter with omicron was different than what we saw in the previous waves of the pandemic, where previously the delta variance under the other variance where more causing couple FC centers, causing hospital administration to say that they werent going to be doing elective procedure.
Because of concerns about the hospitals going up ICU capacity.
What we saw from the Omicron variant was.
Much larger number of people being infected that included staff at the hospitals, which limited the ability of the centers to treat patients to schedule procedures to bring them through the diagnostic process.
That.
Exacerbated staffing challenges so we've talked previously about.
Hospital staffing in particular, the nurse staffing and the technician staffing.
Omar crime and the number of people that were impacted made that even worse than the first half of the quarter.
Know that the hospitals are continuing to try to build up their capacity in terms of patient in terms of the staffing.
That continues to be a factor and when we look at the number of patients coming through the epilepsy monitoring unit.
Now many of the last couple of months.
That is primarily benefactor of staffing and then just increasing patient confidence of coming into the coming into the hospitals and we expect that as a longer term trend where the hospitals are trying to read to increase those staffing levels.
And we know that they are working to do that but that's definitely been a key reason why in 2021 and the start of 2022, we haven't gotten epilepsy monitoring unit volumes you got back to the levels that they were pre pandemic.
Okay, great. Thank you so much.
Our next question comes from Larry Eagleson with Wells Fargo. Your line is open.
Hey, good afternoon, guys. Thanks for taking the question and congrats on a nice quarter here.
Mike just maybe to put a finer point on the.
One of the prior questions.
Are you signaling because of the.
The pipeline here within the <unk> that Q2 is going to be for initial implants is going to be flat or down sequentially. I think it was pretty clear that you expect.
Replacement to kind of continue to decline through this year, but on initial implants I wasn't sure. What you were signaling for Q2.
We didn't provide specific Q2 guidance, we reiterated our full year guidance and coming off of Q1. When we came in ahead of the guidance that we provided for Q1.
Reason part of part of the reason for coming in ahead of the guidance. We provided in Q1 was the patients that we knew were delayed at the beginning of the quarter. The recovery of those patients are there.
<unk> and completion of the implant of those patients happened faster than what we had anticipated that they would so we were very pleased with the recovery and overall the growth that we were able to demonstrate in the first quarter.
The result of that is that those patients did get delayed patient to get implanted in Q1.
And we're feeling the impact of the patients coming through the fewer patients that came through the view that the first part of the quarter. So so not providing specific numbers for Q2, but just thinking about that.
The dynamics that are happening in the near term we are having some effect of the of the <unk> process in the first quarter impacting this.
Start, especially specifically the start to the second quarter, and then seeing that normalize here through the last couple of months, which continues to give confidence in the ability to grow the business in the second half of the year.
Okay, and just switching gears on the market expansion studies, so nautilus and.
The adolescent study.
Can you remind us again pleased of how long you think those will take to.
To enroll so we just kind of.
I think through kind of approval timelines.
We haven't provided specific enrollment time guidance, so that I'll remind you of the key factors that are involved with that so the Nautilus study, which is our top priority for expanded indication we're expecting to start enrollment in that study around the middle of this year, we know that we need.
To enroll about 100 patients to be able to implant over 80 patients in that trial.
No that it's a one year follow up study for the indication and then a PMA submission of our PMA supplement submission that happens on the other side of that so the time to enroll those 100 patients in the trial. We haven't provided that information, yes, we will give more clarity on that as we are able to get enrolling and understand how many sites are able.
To get up and running.
To be able to complete that so the startup enrollment again around the middle of this year about 100 patients that we need to enroll in that it had been a one year follow up for the primary endpoint.
They are responding study of the adolescent study is very similar to that so.
Little bit smaller in number of patients. So it kind of 75 patients that need to be implanted at a minimum for that study, but similar kind of magnitude one year follow up for the primary endpoint of that study as well. So I would say overall kind of similar similar sized study somewhere similar amount of follow up and then PMA supplement submission for both.
With us.
Are there any precedence Mike did you can point us to and how long it would take to enroll 100 patients that implant 80.
So I don't have any specific precedence for the amount of time that it's going to take to enroll I will specific I will reiterate that our focus is primarily on the Nautilus study. So is it as an organization, that's where we're putting the majority of our effort it represent.
The largest market opportunity in terms of the number of patients and a new opportunity to expand into an area. The work that we're quite excited about so internally, we're focused primarily on the model of study and moving into generalized epilepsy.
Again, we'll provide more clarity more clarity as we get into the enrollment in the study and understand the number of centers, but I don't have that specific comparison to be able to point you to.
Alright, thanks, so much.
Our next question comes from Michael <unk> with Wolfe Research Your line is open.
Hey, good evening. Good afternoon. Thank you for taking the questions first one gross margin.
It sounded like.
Some noncash comp lower overhead absorption in the quarter, but I also heard COVID-19.
Volatility and it wasn't clear if that was just hey look volumes have been disrupted.
Yes.
In the trailing six months to 12 months and so you have been.
Turning down production and so there is.
Deleverage or.
That was a comment on supply chain and sourcing and componentry and input costs going out so any any additional color on the.
Cost of goods here in what influenced gross margin in the quarter would be helpful.
Sure I'll take that thanks, Mike.
So our gross margin in the first quarter was 73% thats consistent with our gross margin in the fourth quarter.
And currently that's our baseline.
There is nothing.
Really unusual in the first quagga, we did have some increase in cost related to SBC.
And we had some lower absorption volatility in demand led to volatility in production and then lower production overall.
But we're not seeing supply chain disruption.
Yeah.
We have.
Purchased some components and materials earlier than we might otherwise to mitigate any potential risks that could develop in the future, but we're not seeing supply chain disruption so really.
It's just the.
Factors that we mentioned.
Okay.
Nothing really unusual that stands out for the quarter.
And then a follow up just on the commercial investments it sounds like it's on track, but I'd be curious to get an update on your progress.
In terms of hiring informing some new territories, bringing new centers online I mean, it's a difficult environment <unk>, especially difficult for providers how has that.
Played out so far this year and.
Any any stranger successes in.
Ramping the commercial org to call out. Thank you so much for taking the questions.
Thanks, Mike.
Quite pleased with the progress that we've been able to make here over the first part of the year and the commercial initiatives. So just as a reminder, there's two primary areas, where we're making an investment in the organization of the commercial part of the organization. One of those is an acceleration of the expansion of our field team, we're targeting to get to around 56.
<unk> in the field organization by the end of the year.
The net net increase of on the order of 2014 people compared to where we were back at the time of the IPO with most of those hires scheduled to be happening here in the first half of 2022 and pleased to say that we're more well on track for that so the progress that we've been making at expanding the field team is going per plan.
With the with some really great people that we've been able to identify and start them through the training process. The other.
A key area of initiative is around patient education, and patient awareness and so with that we have increased the amount of work that we're doing to get information about the RMS system. The benefits of the rns system out to a broader number of patients.
That are working their way through the diagnostic process to help influence and help to assist them as they are moving through that process.
So we've made some good good initiatives there brought some people into the organization that have expertise in that area.
And are doing doing what we would expect to do what we had expected to do as we ramp up in that area. The other comment that I would make is part of the reason that we've expanded or accelerated the hiring of the field team.
Is that it allows us to continue to grow the number of centers that are implanting the device.
We have in the past when can I expect that we continue to do that here in 2022. It also enables us to go out to a larger number of epilepsy specialists that are practicing outside of the level four centers and thats been a trend in recent years, but theres more epilepsy specialists that are setting up practices outside of these level for Ccs.
And the larger field organization will allow us to call on those so they are treating a large number of drug resistant epilepsy patients working with them to create a referral dynamic into a comprehensive epilepsy centers for the implantation of our device.
RMS system, and then having those patients go back to the epilepsy specialists in the community for their ongoing care and so that accelerated hiring is a key part of that strategy of expanding the number of epilepsy specialists and we're calling on.
Our next question comes from Danielle and philosophy.
SDB Securities Your line is open.
Hey, good afternoon, everyone. Thanks, so much for taking the question and congrats on a great start to the year.
To address this Mike, but just a.
A quick question for you on the guidance.
And why you did put up a pretty decent topline.
In the quarter from relative to us both on the initial implants and and.
Well I guess just on initial implants, and so just curious about why not take the guidance up is that just conservatism or do you anticipate something transpiring a little bit differently.
For the rest of the year than maybe you had thought back in March or whatever when you provided the guidance.
Thanks Danielle.
The guidance for the year.
As we've talked about reiterating the guidance for the year, we are coming off of the first quarter that we felt we felt very good about.
Part of that is that we recovered the patients that were delayed out of the first part of the quarter.
Rather quickly faster than we anticipated that we would so we had anticipated that we would recover those patients in the guidance that we provided the timing of it happened a little bit faster than what we had anticipated which contributed to the beat in Q1.
So with that just wanting to keep the guidance where it is knowing that the remainder of the year is really being driven by new patients that are coming through the process and our ability to turn those into rns system implants, and so there is some timing effect and then really filling overall like the trend that we expect it to be honest, where we continue.
The operating team.
Okay. That's totally fair and then just as we think about going beyond the level four centers and I know it's very early.
But I guess as we think about the investment there and building out the sales force et cetera et cetera.
Should we think about that really starting to contribute to top line growth and getting patients through the system and I guess is there an opportunity as well sorry. This is like a two part question. The first part and then the second part is there an opportunity to shorten the timeline from a patient sort of getting to.
<unk>.
I guess for a patient getting through the process to getting an implant or is six months like what is always going to be reached.
But yes, that's just.
Thanks, so much.
Thanks Danielle.
So the <unk>.
Investment that we're making in the commercial organization, both the accelerating the hiring of the field organization as well as the patient education and awareness initiatives that we've undertaken those are investments that will pay off over a period of time. If you think about the sales force hiring when we hire somebody into the field.
Station that that allows us to have more call points that we can go out to these referring physicians that provide additional opportunity for us.
And then those patients that come out of that go through the epilepsy monitoring unit in the process for the work up in the.
Increasing the numbers that come out of that so overall, if you think about 2022 the guidance that we provided for 2022 is really based on the execution of the strategy within the CEC. So it's about getting more of those centers to be prescribing.
More utilization from those centers the initiatives that we're doing to expand the field organization to move outside of the level four cec's two additional comfort to additional epilepsy specialists.
Those are really opportunities that will benefit the organization beyond 2022.
In terms of your heavier question about six months on average that it takes to get through the epilepsy monitoring unit from initial <unk> admission to implantation of the rns device.
Our working to influence that where we can process more.
More connection earlier to patients that are working their way through that process.
We can do that we can help facilitate for those patients.
Moving through the steps that they need to go through.
There is some potential that we could with those initiatives specifically for those patients that we can contact earlier on being able to help them navigate through the system more quickly.
That much of the process at the IMU is driven by the procedures at the hospital and also the capacity.
The institution has so so there is I would say some opportunity around that and we are definitely pushing on those areas, where we can push on those areas, but I don't anticipate that there is a dramatic movement in the amount of time it takes patience to get through the NDA process.
Okay. Thank you.
And our last question comes from drew <unk> with Morgan Stanley . Your line is open.
Hi, Mike and Rebecca Thanks for taking the questions.
Just maybe to start I can appreciate that the first quarter. There is still some challenges with the new capacity.
And staffing shortages, there just as youre going through the year into the back half I just wanted to be clear.
Just wanted to make sure that I'm clear here are you, saying that you have you visits normalized 2021 levels or are they normalizing to pre pandemic levels and just as Youre looking even further ahead into 2023.
You were to stay at 2021, <unk> levels would you be able to accelerate growth next year in new patient implants, just given some of the initiatives that you have in place with the sales force.
And some of the other training initiatives.
Great. Thanks for the question drew.
Alright I appreciate the complexity of this is there's trends on top of trends until it can be it has the potential to be confusing. So.
In Q1 in the first half of Q1, we saw that the number of patients coming through the epilepsy monitoring unit in particular, the EMU visits that are part of that process.
<unk> decreased relative to 2021, so relative to pandemic level, if you will.
Starting in March we saw those <unk> numbers recover back or move back too.
Or at least or at least close to the numbers that we saw in 2021. So we are now operating and getting getting around to the levels that I would call <unk>.
Make normal 2021 kind of levels.
With anticipation that over time, given improving environment around COVID-19, which is an uncertainty but over time.
We anticipate those numbers could get back to the pre pandemic levels. That's a that's a future statement not a not where the where the game use are today. We don't we do know from talking to our customers that they're telling us that there is a backlog of patients that they have looking to get into the <unk>.
And so there is potential there there's.
There is demand if you will from the patient side to be able to increase those numbers, but there is a number a number of factors that have to go into getting back to pre pandemic levels and then growing from there as well.
We think about 2023 and again for 2022.
Our growth in 2022 isn't anticipating that a return to pre pandemic levels of EMU visits would impact our numbers in 2022, given the time it takes for those patients to get through the process. So that returned to pre pandemic levels as more of a longer term.
Both accelerator for the for the organization.
Part of the reason that we've made the investments that we've made in the commercial part of the organization is to have influence to accelerate growth in areas that we can control. So looking at calling on more epilepsy specialists outside of the level of core centers tapping into that that group of drug resistant epilepsy patients that they're treating to be able.
To facilitate their work up through the process.
More awareness at the patient level earlier in the process all of those are initiatives that we believe benefit our organization and the growth of our organization independent of the number of patients coming through the ease of use.
And the growth of the US provides an additional opportunity with us. So they are there reasons. The reason, we're making those investments to be able to control those aspects of growth that we have the ability to influence or we have to get the ability to endpoint.
Got it I appreciate the answer.
Maybe just.
Rebecca.
Got that.
You purchase more components to make sure. There is a steady state of supply criticized youre kind of looking at the inflationary environment. Just how are you thinking about pricing for.
For your devices, whether in the new patient implants side.
Or replacement side.
Especially considering I think the DRG code is going up by 3% for 2023, just any any comment would be great. Thank you.
Sure.
As we've discussed.
Previously we are.
In the process of implementing a price increase.
In the low single digits. This year that price increase will take place over the course of the year. We don't expect it will have taken Pat the Seattle have more of an impact in 2023 by Tam.
We are doing that on the pricing side and then.
We are cognizant of price.
Pressure is in the marketplace.
And where we are with price increases factoring that into our planning.
<unk>.
So I hope that addresses your question.
It does thank you.
Thank you there are no further questions I'd like to turn the call back over to Mike Davis for any closing remarks.
Alright. Thank you everybody I appreciate your time today and look forward to following up with you in the coming months.
Okay.
This concludes the program and you may now disconnect everyone have a great day.
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Good afternoon, and welcome to Neuro cases first quarter earnings conference call. At this time, all participants are in listen only mode.
We will be facilitating a question and answer session towards the end of today's call.
A reminder, this call is being recorded for replay purposes.
I'd like to turn the call over to Matt back so.
From the Gilmartin group for a few introductory comments. Thank you operator, good afternoon, and thank you for participating in today's call joining me from neuro pace for Mike Babich, CEO and Rebecca CFO earlier today <unk> released financial results for the first quarter ended March 31, 2022, a copy of the press release is available on the company's website before we begin I'd like to.
Remind you that management will make statements. During this call that include forward looking statements within the meaning of federal Securities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1995 any statements made during this call that relate to expectations or predictions of future events results or performance are forward looking statements.
All forward looking statements, including those around neuro patients clinical trials and those relating to our operating trends and future financial performance FDA approvals the impact of COVID-19 on our business and prospects for recovery.
Expense management expectations for hiring growth in our organization market opportunity revenue outlook commercial expansion product performance and product pipeline development 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 implied by these forward looking statements Accordingly, you should not.
Place undue reliance on these statements for more detailed description of the risks and uncertainties associated with our business. Please refer to the risk factors section of our public filings with the Securities Exchange Commission or SEC, including our annual report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 10 2022.
And our quarterly report on Form 10-Q to be filed with the SEC on May 12, 2022, as well as any reports that we may file with the SEC in the future. This conference call contains time sensitive information, which we believe is accurate only as of the live broadcast on May 20 May 12, 2022, aerospace disclaims any intention or off.
Obligation, except as required by law to update or revise any financial projections or forward looking statements, whether because of new information future events or otherwise and with that I will turn the call over to Mike.
Thanks, Matt Good afternoon, everyone and thank you for joining us for today's call I will provide opening comments on our business update followed by Rebecca who will provide additional detail regarding our quarterly results and full year 2022 financial outlook before opening the call to Q&A.
Moving onto our quarterly results.
We started the year strong generating $11 4 million of total revenue for the first quarter of 2022.
Initial implant revenue in the first quarter of 2022 was $8 $8 million and came in above the top end of the first quarter guidance range.
We experienced significant business disruption from January through early February primarily as a result of the omicron variant.
<unk> in one of our most COVID-19 impacted periods to date.
We rebounded nicely in the second half of the quarter specifically in the second half of February we saw a marked improvement in procedure volumes from January levels are.
Our business improved further in March when we saw a meaningful uptick in implant procedure volumes, which we believe to be a combination of rescheduled procedures from earlier in the quarter and new procedures.
Given the COVID-19 related challenges faced in the early part of the quarter. We are pleased with our results.
Although we experienced a nice recovery fueled in part by rescheduled implant procedures in March we believe that severe COVID-19 related disruptions in January and February caused a significant reduction in the number of patients coming through epilepsy monitoring unit or EMU <unk> during that time.
The patients coming through the EMU diagnostic process feed the pipeline for our rns system plants.
We believe that the EMU volumes largely returned to 2021 levels in March as the impact from electron subsided, but that the reduced number of patients coming through the <unk> in the first half of Q1, we will limit the number of patients implanted with the RMS system in the second quarter.
Given what we saw in the first quarter of 2022, we believe that we remain on track for our 2022 revenue guidance of $45 to $48 million as well as meeting our 2022 target of approximately 10% growth in sensors implanting our Rms system.
Without additional Covid disruptions, we also expect that the number of patients coming through the IMU diagnostic process will return to pre pandemic levels and continue to grow.
We believe that there is a growing backlog of patients abbvie and use both as a result of the most recent disruptions in the first half of the quarter as well as the longer term impacts of the COVID-19 pandemic.
Typically it takes approximately six months from initial EMU admission until the implants are in our in our system.
Given this we believe that our 2008 our growth in 2022 will be driven by commercial execution, resulting in an increasing number of centers implanting, our RMS system and increased utilization within those centers.
We expect that longer term growth will be assisted by an increasing number of patients coming through the diagnostic process.
In anticipation of an improving environment with increasing IMU patient volumes. We previously previously announced a number of commercial initiatives. Specifically, we are on track with our accelerated field hiring plan with many of the new hires already in place.
A larger field team will allow us to increase focus on epilepsy specialists, who practice outside of level. Four centers. This provides additional market opportunity for our business.
We plan to educate these epilepsy specialists about the RMS system, helping them collaborate with <unk> to have our rns system implanted.
Through these relationships, we can make rns therapy available to a larger number of patients with ongoing device programming and patient management provided by epilepsy specialists practicing outside the level for Ccs we.
We believe that the ability to have device monitoring and oversight on locally you will have a significant benefit to patients.
No we are resuming in person physician education events, starting this summer for the first time since the start of the pandemic and our field team access to customers has improved significantly.
Believe this trend is a leading indicator of improved clinician engagement and future adoption.
We are also driving demand generation by identifying and educating drug resistant epilepsy patients earlier in their treatment journey as they consider treatments beyond medication.
We are expanding our marketing programs, including an increase in digital and social advertising lead generation efforts and patient ambassador connections.
As we connect with more rns candidates earlier in their care journey, our patient education team will provide information about narrow basis rns system and guide appropriate patients through the process.
Moving onto recent clinical updates in future future indication expansion opportunities, we remain on track to start enrolling patients around the middle of the year and our Nautilus pivotal trial to support a PMA supplement to expand our indication to include primary generalized epilepsy.
While we are still early in our pursuit of generalized epilepsy indication expansion.
We are excited about what this would mean for our business and for patients. In addition to expanding the rns indication to cover a larger number of patients. There are important differences from our current focal epilepsy patient population that makes this an excellent opportunity for our rns therapy.
Surgical resection, and ablation are not appropriate for treatment of generalized epilepsy and there are no other approved neuromodulation therapies for this patient population.
We believe that the diagnostic process for generalized epilepsy will be faster and simpler than for focal epilepsy with less need for EMU evaluation and no need for invasive monitoring.
Upon FDA approval, we expect a relatively fast commercial rollout because we anticipate selling to the same physicians who are already treating focal epilepsy patients using the same neuro based device.
We are excited to begin enrollment in the Nautilus study and.
And look forward to an indication expansion into this underserved patient population.
Next I would like to provide an update on replacement implant revenue.
As stated last quarter, we received approval from the FDA to update our labeling to claim an estimated average battery life of nearly 11 years under typical use conditions.
This updated label represents more than a two year increase from our previously approved labeling.
And we have been actively marketing this benefit to customers.
Early customer feedback has been very positive.
As a longer battery life removes an important barrier for initial implant adoption and it gives us a distinct competitive advantages advantage over other neuromodulation devices for epilepsy, which have much shorter expected battery life.
Revenue from replacement implants was $2 $6 million in the first quarter of 2022, which came in slightly above the top end of our Q1 guidance range.
Due to the timing of when the first generation of implants are replaced there can be variations quarter to quarter that said replacement revenue trends remain in line with our expectations and historical replacement rates.
To provide continued transparency as of March 31, 2022, there were 207 patients being actively treated with first generation devices.
Replacement revenue trends remain unchanged and we continue to expect quarterly replacement revenue to sequentially decline throughout the year with a full year 2022 replacement revenue of approximately $6 million.
In summary, we started the year strong despite meaningful COVID-19 headwinds in the first half of the quarter and continue to make significant progress on key strategic initiatives and the clinical side. We remain on track to begin enrolling patients in the model of study around mid year, which will be an important step to expand the market opportunity for our Rms system.
On the commercial side, we increased the number of centers implanting, our rns system in the first quarter and are on track with our field team expansion and patient demand generation initiatives.
All of these position us well as we anticipate IMU patient volumes, increasing leading to more patients being deemed candidates for our Rms system.
With that I will turn the call over to Rebecca Neuro pesos Chief Financial Officer.
Thanks, Mike.
Newark paces, rather for the first quarter of 2022 was $11 5 million.
Compared to $11 2 million for the first quarter of 2021.
Credit in the quarter was primarily driven by an increase in unit sales of our rns extends the comprehensive epilepsy centers.
Michelle implant procedure.
In the first quarter revenue from the initial implants with $8 8 million.
Compared to $8 1 million.
The first quarter of 2021.
Credit in the quarter was driven primarily by an increase in the number of initial implant procedure.
Spike headwinds from the other kind of areas in the first half of the Quaker.
Revenue from replacement implants, with $2 6 million compared to $3 1 million in the first quarter of 2021.
We continue to expect replacement and Quant revenue generally to decrease for the next several years due to the transition to the current model of eye Dubai.
It has a longer lasting battery.
Gross margin for the first quarter of 2022 was 73% compared to 76 for Japan in the first quarter of 2021.
The decline in gross margin relative to the prior year period was primarily due to an increase in indirect labor cost.
<unk>.
Stock based compensation and reduced production volume as a result of the increased volatility, resulting from the COVID-19 pandemic.
Total operating expenses in the first quarter of 2022 by $18 million.
Tagged with $12 4 million.
In the same period of the prior year.
R&D expense in the first quarter of 2022 was $5 6 million compared with $4 $1 million.
Same period of 2021.
The increase in R&D expense was primarily driven by an increase in personnel product development and clinical study expenses.
SG&A expense in the first quarter of 2022 was $12 $4 million compared with $8 3 million.
Prior year period.
The increase in SG&A was primarily driven by increased costs associated with operating as a public company.
Personnel related expenses and increased sales and marketing cost to support commercial expansion initiatives.
Loss from operations was $9 8 million in the first quarter of 2022 compared to $3 $9 million in the prior year period.
We recorded $1 8 million and interest expense in the first quarter was flat compared to the prior year period.
Net loss was $11 5 million.
First quarter of 2022 compared to $8 8 million in the first quarter of 2021.
Our cash and short term investments balance as of March 31, 2022 was $103 2 million.
While our long term borrowings totaled $50 1 million.
Now turning to our outlook for 2022.
We continue to expect annual revenue between 45 and $48 million.
This assumes initial plant revenue.
<unk> 39 and $42 million.
Because of the operating environment has improved over the last 60 days.
We expect initial implant revenue to normalize in the second half of 2022 as the pipeline of new patients continues to build and they transition to the fixed line diagnostic evaluation process.
We continue to expect 2022 replacement revenue to be approximately $6 million.
Moving down the income statement.
We continue to expect gross margin to be in the mid 70% range and.
And operating expenses between 74 and $76 million.
Of which approximately $8 million to $9 million.
With noncash stock based compensation expense.
This concludes our prepared remarks.
I would like to turn the call back over to the operator, who will open the call for questions.
As a reminder.
Wonder if you'd like to ask a question. Please press Star then one if your question has been answered and you'd like to remove yourself from the queue press the pound key.
Our first question comes from Robbie Marcus with Jpmorgan. Your line is open.
Hi, this is actually Rohan.
Robbie Thanks for taking the question and congratulations on a good quarter.
Just start would you be able to give us some more color on revenue cadence for the year. The first quarter came in a little higher than expectations due to a better recovery in February so how do you view your current guidance in light of this also does the range contemplate any further COVID-19 variability.
And then I have a follow up question.
Very good Robyn thanks for the thanks for the question so.
Let me, let's start off with just a just a general comment then the observation that you made were very.
Pleased with the way that we started the year with able to being able to recover from the challenges at the beginning of the quarter due to the omicron variant.
As we think about the guidance for the year, we agree reiterated the $45 million to $48 million guidance.
We provided in the Q1 and that can be earnings call a few months ago.
They're really really the rationale for that is that we're continuing to execute on the core commercial strategies and quick increase in the number of centers that are implanting increasing utilization.
We anticipate that through the year, we'll continue to drive increases in both utilization and number of centers and planning, resulting in implant revenue from initial system implants, continuing to increase through the year and then counter balancing that we expect that the replacement implant revenue has anticipated we will continue to decrease.
Through the year, resulting in that resulting in that total amount we.
We did have the near term short term dynamics that were happening in Q1.
The delays in procedures that happened in the early part of the quarter we were.
Very pleased at the speed at which we were able to recover those delayed cases in the second half of Q1.
And anticipate that there's going to be some impact of the number of patients coming through the epilepsy monitoring units in Q1, I'm, having an impact on Q2.
The recovery happening happening there faster than we anticipated when we when we provided an update a few months ago.
But the trends that we're seeing overall in the epilepsy monitoring units are positive we are seeing that those volumes of patients coming back coming through the <unk>.
Increased over the last couple of months compared to the decreased levels that we saw at the beginning of Q at the beginning of Q1.
And overall the backlog of patients that we're hearing from our customers at the epilepsy monitoring unit.
<unk> continued to grow and we're anticipating that those numbers of patients coming through will continue to increase through the course of the year, providing providing a pay.
Opportunity for us to be able to grow the business and.
In addition through our in addition to the efforts that we're doing on the commercial side.
So just in general we're seeing that second half of the year is going to be continuing to grow and initial implant revenue, allowing us to get to the guidance that we provided for the year overall.
Okay, Great and would you be able to comment on how much of a headwind staffing is in the EMU relative to lower patient volumes due to COVID-19 at least in the first quarter and what youre seeing with staffing moving forward.
Are you seeing kind of like higher utilization levels offsetting this with more doctors implanting a greater share of patients alongside the new center additions I just wanted to get your thoughts on that dynamic. Thanks.
The dynamic that happened in the first quarter with one micron was different than what we saw in the previous waves of the pandemic, where previously the delta variance. Some of the other variants were more causing couple FC centers, causing hospital administration to say that they werent going to be.
Electric procedures because of concerns about the hospitals going up ICU capacity really what we saw from the omicron variant was a much larger number of people being infected that included staff at the hospitals, which limited the ability of the centers to treat patients to schedule procedures to bring them through the diagnostic.
Process.
That.
<unk> staffing challenges so we've talked previously about.
Hospital staffing in particular, the nurse staffing and the technician staffing on the <unk> and the number of people that were impacted made that even worse than the first half of the quarter.
Know that the hospitals are continuing to try to build up their capacity in terms of patient in terms of the staffing on that continues to be a factor and when we look at the number of patients coming through the epilepsy monitoring unit.
Now maybe in the last couple of months.
That is primarily benefactor of staffing and then just increasing patient confidence of coming into the coming into the hospitals and we expect that as a longer term trend where the hospitals are trying to reach to increase those staffing levels.
And we know that they are working to do that but that's definitely been a key reason why in 2021 and the start of 2022, we haven't gotten epilepsy monitoring unit volumes you got back to the levels that they were pre pandemic.
Okay, great. Thank you so much.
Our next question comes from Larry <unk> with Wells Fargo. Your line is open.
Hey, good afternoon, guys. Thanks for taking the question and congrats on a nice quarter here, Mike just maybe to put a finer point on that.
One of the prior questions.
Are you signaling time because of.
The pipeline here within the <unk> that Q2 is going to be for initial implants is going to be flat or down sequentially. I think it was pretty clear that you expect.
Placements to kind of continue to decline through this year, but on initial implants I wasn't sure what you were particularly for Q2.
Okay.
We didn't provide specific Q2 guidance, we reiterated the full year guidance and coming off of Q1. When we came in ahead of the guidance that we provided for Q1.
Reason part of part of the reason for coming in ahead of the guidance. We provided in Q1 was the patients that we knew were delayed at the beginning of the quarter. The recovery of those patients are there.
<unk> and completion of the implant of those patients happened faster than what we had anticipated that they would so we were very pleased with the recovery and overall the growth that we were able to demonstrate in the first quarter.
The result of that is that those patients did get delayed patient to get implanted in Q1.
And we're feeling the impact of the patients coming through the fewer patients that came through the view that the first part of the quarter. So so not providing specific numbers for Q2, but just thinking about that.
The dynamics that are happening in the near term we are having some effect of the of the <unk> process in the first quarter impacting this.
Start, especially specifically the start to the second quarter, and then seeing that normalize here through the last couple of months, which continues to give confidence in the ability to grow the business in the second half of the year.
Okay, and just switching gears on the market expansion studies, so nautilus and the adolescent study.
Can you remind us again pleased of how long you think those will take two.
To enroll so we just can kind of.
I think through kind of approval timelines.
We haven't provided specific enrollment time guidance, so that I'll remind you of the key factors that are involved with that so the Nautilus study, which is our top priority for expanded indication we're expecting to start enrollment in that study around the middle of this year, we know that we need.
To enroll about 100 patients to be able to implant over 80 patients in that trial.
No that it's a one year follow up study for the indication and then a PMA submission of our PMA supplement submission that happens on the other side of that so the time to enroll those 100 patients in the trial. We haven't provided that information, yes, we will give more clarity on that as we are able to get enrolling and understand how many sites are able.
To get up and running.
To be able to complete that so the startup enrollment again around the middle of this year about 100 patients that we need to enroll in the one year follow up for the primary endpoint.
They respond to study the adolescent study is very similar to that so.
A little bit smaller in number of patients. So it kind of 75 patients that need to be implanted at a minimum for that study, but similar kind of magnitude one year follow up for the primary endpoint of that study as well. So I would say overall kind of similar similar sized study somewhere similar amount of follow up and then PMA supplement submission for ball.
With us.
Are there any precedence Mike did you can point us to and how long it would take to enroll 100 patients that implant 80.
So I don't have any specific precedence for the amount of time that it's going to take to enroll I will specific I will reiterate that our focus is primarily on the Nautilus study. So is it as an organization, that's where we're putting the majority of our effort. It represents.
The largest market opportunity in terms of the number of patients and new opportunities to expand into an area that we're quite excited about so internally. We're focused primarily on the model of study and moving into generalized epilepsy.
Again, we'll provide more clarity more clarity as we get into the enrollment in the study and understand the number of centers, but I don't have that specific comparison to be able to point you to.
Alright, thanks, so much.
Our next question comes from Michael <unk> with Wolfe Research Your line is open.
Hey, good evening. Good afternoon. Thank you for taking the questions first one gross margin.
It sounded like.
Some noncash comp lower overhead absorption in the quarter, but I also heard COVID-19.
Volatility and it wasn't clear if that was just hey look volumes have been disrupted.
Yes.
In the trailing six months to 12 months and so you have been.
Turning down production and so there is.
Deleverage or if that was a comment on supply chain and sourcing and componentry and input costs going up so any any additional color on the.
Cost of goods here in what influenced gross margin in the quarter would be helpful.
Sure I'll take that thanks, Mike.
So our gross margin in the first quarter was 73% that's consistent with our gross margin.
Fourth quicker.
And currently that's our baseline.
There's nothing.
Really unusual in the first quagga, we did have some increase in cost related to FCC.
And we had some lower absorption volatility in demand led to volatility in production and then lower production overall.
But we're not seeing supply chain disruption.
Yeah.
We have.
Purchased some components and materials earlier than we might otherwise to mitigate any potential risks that could develop in the future, but we're not seeing supply chain disruption so really.
It's just the.
Factors that we mentioned.
Okay.
Nothing really unusual that stands out for the quarter.
And then a follow up just on the commercial investments it sounds like it's on track, but I'd be curious to get an update on your progress.
In terms of hiring informing some new territories, bringing new centers online I mean, it's a difficult environment <unk>, especially difficult for providers how has that.
Played out so far this year.
Any any strangers successes and then.
Ramping the commercial org to call out. Thank you so much for taking the questions.
Thanks, Mike.
Quite pleased with the progress that we've been able to make here over the first part of the year and the commercial initiatives. So just as a reminder, there's two primary areas, where we're making investments in the organization of the commercial part of the organization. One of those has been an acceleration of the expansion of our field team.
Getting to get to around 56 people in the field organization by the end of the year.
Net net increase of on the order of 2014 people compared to where we were back at the time of the IPO with most of those hires scheduled to be happening here in the first half of 2022 and pleased to say that we're more well on track for that so the progress that we've been making at expanding the field team is going per plan.
With the with some really great people that we've been able to identify and start them through the training process.
A key area of initiative is around patient education, and patient awareness and so with that we have increased the amount of work that we're doing to get information about the rns system. The benefits of the rns system out to a broader number of patients that are working their way through the diagnostic process to help.
Influence them and helped to assist them as they are moving through that process.
So we've made some good initiatives there brought some people into the organization that have expertise in that area.
And are doing doing what we would expect to do what we had expected to do.
As we ramp up in that area. The other comment that I would make is part of the reason that we've expanded or accelerated the hiring of the field team.
Is that it allows us to continue to grow the number of centers that are implanting the device.
We have in the past you can expect that we continue to do that here in 2022 and also enables us to go out to a larger number of epilepsy specialists that are practicing outside of the level four centers and thats been a trend in recent years, but theres more epilepsy specialists that are setting up practices outside of these level for Ccs.
And the larger field organization will allow us to call on those so they are treating a large number of drug resistant epilepsy patients working with them to create a referral dynamic into a comprehensive epilepsy centers for the implementation of our device.
RMS system, and then having those patients go back onto the epilepsy specialists in the community for their ongoing care and so that accelerated hiring is a key part of that strategy of expanding the number of epilepsy specialists and we're calling on.
Our next question comes from Danielle and philosophy with SBB Securities. Your line is open.
Hey, good afternoon, everyone. Thanks, so much for taking the question and congrats on a great start to the year I guess.
Kind of already addressed this but just a quick question.
<unk> for you on the guidance and why.
You did put up a pretty decent top line.
In the quarter relative to us both on initial implants and and.
I guess just on initial implants, and so just curious about why not take the guidance up is that just conservatism or do you anticipate something transpiring a little bit differently.
And for the rest of the year than maybe you had thought back in.
March or whenever when you provided the guidance.
Thanks Danielle.
The guidance for the year.
As we've talked about reiterating the guidance for the year, we are coming off of the first quarter that we felt very good about.
And again part of that is that we recovered the patients that were delayed out of the first part of the quarter.
Rather quickly faster than we anticipated that we would so we had anticipated that we would recover those patients in the guidance that we provided the timing of it happened a little bit faster than what we had anticipated which contributed to the beat in Q1.
So with that just wanting to keep the guidance where it is knowing that the remainder of the year is really being driven by new patients that are coming through the process and our ability to turn those into rns system implants, and so there is some timing effect and then really filling overall like the trend that we expect it to be honest, where we continue.
Two the operating team.
Okay. That's totally fair and then just as we think about going beyond the level sort centers and I know it's very early.
But I guess as we think about the investment there and building out the sales force et cetera et cetera.
Should we think about that really starting to contribute to top line growth and getting patients through the system and I guess is there an opportunity as well sorry. This is like a two part question. The first part and then the second part is there an opportunity to shorten the timeline from the patient sort of getting to.
I guess for a patient getting through the process to getting an implant or is six months like what is always going to be and we just have to.
But yes, that's just is what it is thanks so much.
Thanks Danielle.
So the.
Investment that we're making in the commercial organization, both accelerating the hiring of the field organization as well as the patient education awareness initiatives that we've undertaken.
Those are investments that will pay off over a period of time. If you think about the sales force hiring we hire somebody into the field organization that allows us to have more call points that we can go out to these referring physicians that provide additional opportunity for us.
And then those patients that come out of that go through the epilepsy monitoring unit in the process for the work up in that.
Increasing the numbers that come out of that so overall, if you think about 2022 the guidance that we provided for 2022 is really based on the execution of the strategy within the CEC. So it's about getting more of those centers to be prescribing.
More utilization from those centers the initiatives that we're doing to expand the field organization to move outside of the level for CEC to two additional comfort to additional epilepsy specialists.
Those are really opportunities that will benefit the organization beyond 2022.
In terms of your heavier question about six months on average that it takes to get through the epilepsy monitoring unit from initial <unk> admission to implantation of the rns device.
Our working to influence that where we can process more.
More connection earlier to patients that are working their way through that process.
We can do that we can help facilitate for those patients.
Moving through the steps that they need to go through.
There is some potential that we could with those initiatives specifically for those patients that we can contact earlier on being able to help them navigate through the system more quickly.
Much of the process at the IMU is driven by the procedures at the hospital and also the capacity.
The institution has so so there is I would say some opportunity around that and we are definitely pushing on those areas, where we can push on those areas, but I don't anticipate that there is a dramatic movement in the amount of time it takes patience to get through the FDA process.
Okay. Thank you.
And our last question comes from drew <unk> with Morgan Stanley . Your line is open.
Hi, Mike and Rebecca Thanks for taking the questions.
Just maybe to start I can appreciate that the first quarter. There is still some challenges with the new capacity.
And staffing shortages, there just as youre going through the year into the back half I just wanted to be clear.
Just wanted to make sure that I'm clear here are you, saying that you have you visits normalized 2021 levels or are they normalizing to pre pandemic levels and just as Youre looking even further ahead into 2023. If you were to stay at 2021, new levels would you be able to accelerate growth next year.
In new patient implants, just given some of the initiatives that you have in place with the sales force.
Some of the other training initiatives.
Great. Thanks for the question drew.
Alright I appreciate the complexity of this is there's trends on top of trends until it can be it has the potential to be confusing so and Q1 in the first half of Q1, we saw that the number of patients coming through the epilepsy monitoring unit in particular, the <unk> visits that are part of that process.
Was decreased relative to 2021, so relative to pandemic level, if you will.
<unk> in March we saw those <unk> numbers recover back or move back to.
Or at least or at least close to the numbers that we saw in 2021. So we are now operating and getting getting around to the levels that I would call pandemic normal 2021 kind of levels.
With anticipation that over time, given improving environment around COVID-19, which is an uncertainty but overtime.
We anticipate those numbers could get back to the pre pandemic levels. That's a that's a future statement not a not where the where the game use are today. We don't we do know from talking to our customers that they're telling us that there is a backlog of patients that they have looking to get into the <unk>.
And so there is potential there.
Demand if you will from the patient side to be able to increase those numbers, but there is a number a number of factors that have to go into getting back to pre pandemic levels and then growing from there.
As we think about 2023 and again for 2022.
Our growth in 2022 isn't anticipating that a return to pre pandemic levels of EMU visits would impact our numbers in 2022, given the time it takes for those patients to get through the process. So that returned to pre pandemic levels.
<unk> have a longer term growth accelerator for the for the organization.
Part of the reason that we've made the investments that we've made in the commercial part of the organization is to have influence to accelerate growth in areas that we can control. So looking at calling on more epilepsy specialists outside of the level of poor centers tapping into that that group of drug resistant epilepsy patients that they're treating to be.
To facilitate their work up through the process.
Getting more awareness at the patient level earlier in the process all of those are initiatives that.
We believe benefit our organization and in the growth of our organization independent of the number of patients coming through the ease of use.
And the growth of the abuse provides an additional opportunity with us. So they are there reasons. The reason, we're making those investments as to be able to control those aspects of growth that we have the ability to influence or we have to have the ability to that point.
Got it I appreciate the answer.
Maybe just.
Rebecca.
I get that.
You purchase more components to make sure there is a steady state of supply just as youre kind of looking at the inflationary environment. Just how are you thinking about pricing for.
For your devices, whether on the new patient implants side.
Or replacement side.
Especially considering I think the DRG code is going up by 3% for 2023, just any any comment would be great. Thank you.
Sure.
As we've discussed previously.
Previously we are.
In the process of implementing a price increase.
The low single digits. This year that price increase will take place over the course of the year. We don't expect it will have a big in past this year I will have more of an impact in 2023.
We are doing that on the pricing side and then.
Of course, we are cognizant of price.
Pressure is in the marketplace.
And where we are with price increases factoring that into our planning.
Sure.
Yeah.
Yes.
So I hope that addresses.
That addresses your question.
It does thank you.
Thank you there are no further questions I'd like to turn the call back over to Mike Davis for any closing remarks.
Alright. Thank you everybody I appreciate your time today and look forward to following up with you in the coming months.
This concludes the program and you may now disconnect everyone have a great day.