Nevro - Q1 2022

Transcript

Speaker 0

Good afternoon. My name is Chris, and I'll be your conference operator today. At this time, I'd like to welcome everyone to Nevro's First Quarter 2022 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session.

Thank you. I would now like to turn the call over to Julie Dewey for introductory remarks. Please go ahead.

Speaker 1

Good afternoon, and welcome to Nevro's Q1 2022 earnings conference call. We appreciate you joining us. I'm Julie Dewey, Nevro's Chief Corporate Communications and IR Officer. With me today are Keith Grossman, Chairman CEO and President and Rod MacLeod, Chief Financial Officer. The format of our call today will be a discussion of Q1 business results from Keith, followed by detailed financials and guidance from Rod, and then we'll open up the call for questions.

Please note, there are also slides available related to our Q1 performance on the Nevro Investor Relations website on the Events and Presentations page. Earlier today, Nevro released its financial results for the Q1 ended March 31, 2022. A copy of our earnings release is available on our Investor Relations section of our website atnevrodot com. This call is being broadcast live over the Internet to all interested parties on May 4, 2022, and an archived copy of this webcast will be available on our Investor Relations website. Before we begin, I'd like to remind everyone that comments made on today's call may include forward looking statements within the meaning of federal securities laws.

Our results could differ materially from those expressed or implied as a result of certain risks and uncertainties. Please refer to our SEC filings, including our Form 10 Q4. The forward looking statements in this call speak only as of today, and we undertake no obligation to update or revise any of these statements. In addition, we will refer to adjusted EBITDA, which is a non GAAP measure that is used to help investors understand Nevro's ongoing business performance. Non GAAP adjusted EBITDA excludes certain litigation expenses, interest, taxes and non cash items such as stock based compensation and depreciation and amortization.

Please refer to GAAP to non GAAP reconciliation tables within our earnings release. And now, I'll turn the call over to Keith.

Speaker 2

All right. Thanks, Julie, and good afternoon, everyone. Thank you for joining us. I'll focus my comments today on our Q1 results, the current state of our business and COVID recovery and on the progress of our PDN launch. Following my comments, Rod will cover the specifics of our Q1 results and our guidance.

Overall, Q1 was a quarter of solid execution and progress, evidenced by revenue and adjusted EBITDA results that were above the high end of the guidance range we communicated on our last earnings call. Although both U. S. And international revenue were impacted by COVID related issues, primarily in the first half of the quarter, we were really encouraged by the level of recovery in procedures, which steadily improved throughout the quarter, a trend by the way that has continued through the month of April. We believe this is a positive indication that our market has started on the path of a more durable recovery and that one that we assume will continue in the months ahead.

Our excitement continues to grow for the PDN opportunity, which I'll discuss in a little bit more detail in a moment, as well as our recent FDA approval for a specific indication to treat NSRBP or nonsurgical patients. All of this progress further differentiates our high frequency, paresthesia free SCS technology, and we're confident that we've laid a strong foundation for attractive future growth, and we're well positioned for a strong second half of this year and beyond as the impact and uncertainties of COVID on our market continue to subside. Now let's take a look at actual procedure activity. Despite the significant omicron impact in January and into early February, Q1 total U. S.

Permanent implant procedures increased 2% compared to prior year and 14% compared to Q1 of 2019, while trial procedures increased 10% compared to prior year and 13% compared to Q1 of 2019. I'm encouraged by the recovery in trial and permanent implant volumes we saw in the second half of the quarter, and as I said, that has continued in the Q2 to date. Our data confirms to us that patients' willingness to engage in the therapy is still improving. And importantly, the underlying fundamentals of the addressable market and the opportunity for attractive growth rates remain intact. Based on this and the trend in procedures, particularly trials, we believe the FCS market has taken the first encouraging steps toward recovery and is positioned to return to solid revenue growth in the second half of the year as the funnel of trial procedures refills in the 1st and the second quarters.

And this is reflected in our guidance that we reiterated today. We're now 9 months into our PDN commercial launch and are very pleased with our progress and success on all fronts, including educating referring physicians, creating awareness with patients and increasing access to our therapy. During the quarter, PDM trials grew 47% sequentially compared to Q4, despite not only the Omicron impact early in the quarter, but the typical downward seasonality that is generally seen in the FCS business from Q4 to Q1. PDM trials represented approximately 11% of our total U. S.

Trial volume, up from 7% of our total U. S. Trial volume in Q4 and improved throughout the course of the quarter. As it relates to permanent implant procedures, PDN represented 7% of total procedures worldwide, which resulted in approximately $6,000,000 in revenue contribution. Based on the demonstrated success we've seen today from our PDN referral sales team, we've moved forward with our plan to expand our PDN referral territories and the hiring of additional sales reps is well underway.

We plan to have these new PDN referral reps trained and in their territories by the end of Q2. That will bring the total number of PDN reps to between 4550. Our existing SCS sales team calling on our pain specialists is seeing tremendous interest among these physicians to reach out to referring physicians in their local communities to drive awareness for 10 kilohertz HFX therapy for PDN. And as we mentioned on our last call, the number of paying physicians that say they're proactively seeking PDN referrals has nearly doubled from before our PDN approval and that continues to grow. Our new co marketing platform, which launched in January, enables interested implanting physicians to implement their own local marketing programs to their referring physicians.

When paying physicians initiate local outreach marketing, we've seen that PDN can rapidly become a very meaningful percentage of their monthly patient volume. For example, as we look at our top PDN implanting physicians, we've seen that for some PDN can quickly grow to 25% to 45% of their monthly trial volume. Further up the patient demand funnel, our direct to consumer campaign continues to be a strong source of qualified PDN patient leads. More recently, we're now starting to see a higher percentage of PDN patient trial procedures coming from our DTC efforts as our HFX coaches and our sales team members continue to nurture these leads. This process, by the way, typically takes months to quarters in our core market DTC efforts as well.

Roughly 1300 of these qualified leads have now been handed over to our field team and in the month of March, 16% of our total U. S. PDN trial procedures came from these DTC patient leads. We're looking forward to participating in the Annual American Diabetes Association or ADA Scientific Sessions in New Orleans next month. We'll be sponsoring a product leader presentation in the main exhibit call on Sunday, June 5.

And I'm also pleased to announce that our late breaking scientific abstract detailing the 24 month data from the original 10 ks arm of our SENSA PDN trial was accepted for presentation. And this will be the first time 24 month data will be presented for the 10 kilohertz arm. We expect the complete 24 month data to be available in Q4 and our plan is to submit that data set for presentation at NANS in January and then publish as soon as we can thereafter. In terms of payer coverage, we're continuing our outreach to the payer universe to expand market access and drive adoption. In the Q1, we made significant progress with the positive decision by UnitedHealthcare to expand their SDS coverage to include PDN patients as well as the Medicare coverage update by Noridian.

This now means that 5 of the 7 Regional Medicare Area Contractors or MACs now provide access for PDN patients. Both of these updates became effective in the Q1, increasing formal policy coverage to approximately 43% of the addressable U. S. PDN population, and that's up from, as a reminder, 25% at the end of 2021. In addition, UnitedHealthcare also recently updated its policy by adding explicit language requiring FDA approval for SCS devices that are used for specific indications, including PDN.

We believe this was United's intent all along, but now their policy very clearly states this and that update to the policy will become effective on June 1 this year. Overall, however, this will be a process that takes time as we indicated to you at the beginning. Some payers will make updates based on the 12 month data just as UnitedHealthcare and Noridian did, while other payers will wait for longer term follow-up data or even increased patient and provider demand. For example, Aetna and Cigna recently reviewed all of their coverage policies and didn't include expanded coverage to include PDN in this particular review. As we publish more and longer term data and more patients are presented for treatment, we'll continue to work with these and other payers to make the right data back decisions.

This is a pretty typical part of the process, and I'm sure most of you have seen this process play out with other new products and indications, remember that almost the entirety of the payer universe covers SCS therapy for lower back and leg pain indications and we believe this will ultimately be the case for PDN as well. Also remember that coverage policy decisions are important, but they're just part of our efforts. We continue to seek individual patient coverage on a case by case basis through prior authorization procedures and the appeal of payer denials, including with payers who don't have a specific PDN coverage policy. For example, our HFX Access team has been In fact, for those PDN cases that have come through our own HFX Access Group, we've seen an approval rate of nearly 70%, which is approaching approval rates that we see in our core back and leg patients as well. Our reimbursement team is continuing to work closely with commercial payers and the remaining regional Medicare contractors to expand PDN coverage for our therapy, and we believe our strong and growing body of published peer reviewed and clinical and real world data will be the basis for further coverage decisions by other major health plans this year and beyond.

Included in our 2022 sales guidance is now a $27,000,000 to $32,000,000 contribution from PDN. And we're really encouraged by the continued growth of PDN volumes in the Q1. And as I've mentioned, that continues into the Q2. In summary, we just we couldn't really be more excited about the progress we've made so far in PDN and how impactful we think this is going to be for providers and their patients. We're really encouraged by the high levels of interest among referring physicians and patients, early trial volumes and most importantly, the consistent and validating clinical outcomes in those patients who have already received their permanent implant.

And we're looking forward to continuing to develop this exciting growth platform in the months and the quarters ahead. Moving now to NSRBP or nonsurgical back. After receiving FDA approval of this indication in January, we began commercial activities to expand access to HFX therapy for this patient population. We saw sequential monthly growth in NSR VP trials during Q1 with these trials coming from both current and new users. This is a large and underpenetrated market with approximately 500,000 patients annually in the U.

S. Who are not candidates for surgery and who have limited treatment options available when less invasive therapy and medical management are not successful. While NSRBP has historically made up around 30% of our patients, only about 5% of this large patient population are currently receiving SCS therapy. To further understand the unique needs of NSRBP patients, we conducted quantitative research in February of this year with 200 of these patients. Similar to PDN, this research validated our assumption that patient deposition education and support will be key drivers of the successful commercial execution strategy.

Speaker 1

There are

Speaker 2

a few important takeaways from our research, including these facts. Nearly 60% of these patients have been seen by patient specialist by pain specialists rather already. So these are patients who are already accessible to our current customers. 41% of this cohort said they are not satisfied with their current treatment and 90% of these patients say they are constantly searching for ways to treat their chronic pain. Only 48% of these patients have heard about SCS and 2 thirds of these patients believe that SCS as a treatment option would solve a problem or fulfill a need.

And finally, 81% said they would do an SCS trial if it was recommended by their physician. Given that we're the only SCS company with published long term outcomes data and a specific FDA approved label for NSRBP, we think we're well positioned to serve these patients. So our strategy, not surprisingly, is focused on the identification and education of patients at these existing pain practices who have not had prior back surgery and who are not a candidate for surgery. In addition to focusing the pain physicians' attention on these patients, we'll work towards broadening commercial payer coverage for non surgical back patients by leveraging both our peer reviewed published RCT data and our FDA approval. Medicare through both national and local coverage policies currently has broad coverage for NSRBP and we've not experienced nor do we anticipate any coverage challenges as long as SCS is used consistent with these policies.

On the commercial side, we estimate about 78% of covered lives are not explicitly covered for NSRBP. Another 21% of covered lives have a coverage policy written such that patients we believe are covered on a case by case basis and only 1% of this patient population are in a policy that where they are explicitly covered by the wording of that policy. Even if a patient is not covered, our patient access team is prepared to support case by case approvals through the prior auth process just as we've done with these patients for years, though certainly now our case is much, much stronger. Over time, we expect NSRBP will be an important contributor to overall SCS market growth for the treatment of back and leg pain as we and eventually our competitors continue to educate pain physicians and make progress on payer access initiatives. So in closing, we made encouraging progress in our core SCS and PDM businesses in the Q1 and are seeing the first leg of what we believe will be continued recovery in our markets.

We continue to believe we're well positioned for mid to longer term attractive growth, and I'm very optimistic as we think about the rest of this year. We participate in 3 large underpenetrated SCS patient populations that should continue to provide growth for years to come, and we remain very bullish on our ability to continue to capture share of this market over time with better technology, better outcomes and solid execution. Over these last two challenging years, we've worked hard to dramatically improve our company's position. We've introduced new products such as Omnia, HFX Connect, which included upgrades to Omnia to provide versatility to remotely optimize patient care, especially when paired with our HFX cloud database, our large team of HFX coaches and our HFX access team. And

Speaker 3

finally, the

Speaker 2

FDA approval for 2 new and very large populations of patients in PDN and NSRBP. And And of course, we published lots of new data in support of those approvals. We strengthened our technology development roadmap and have very exciting things coming over the next 5 years with the next product platform coming toward the end of this year. Organizationally, we kicked off and have now nearly completed our in house manufacturing capacity in Costa Rica, and we created a new commercial arm focused on the diabetes market, including a dedicated referral sales organization. So while it was a tough 2 years for the SCS markets, we've been very busy as a company preparing for this recovery phase.

And as the market returns to normal levels of activity, we're set up well to drive growth this year and beyond. And with that, I'll pass the call over to Rod to provide further details on our Q1 results and on our guidance.

Speaker 4

Great. Thanks, Keith, and good afternoon. I'll begin with our worldwide revenue for the Q1 of 2022, which was 87,800,000 a 1% decrease as reported and flat on a constant currency basis compared to $88,600,000 in the prior year period and a 7% increase both as reported and on a constant currency basis compared to $82,100,000 in the Q1 of 2019. PDN represented 7% of worldwide permanent implant procedures, which resulted in approximately $6,000,000 in revenue in the Q1 of 2022. As a reminder, this quarter included 1 more selling day in Q1 of 2021 Q1 of 2019.

In addition, I'd like to point out that we do not have any revenue, employee or supply chain exposure in Ukraine or Russia. U. S. Revenue in the Q1 of 2022 was 70 $3,200,000 a decrease of 2% compared to $74,700,000 in the prior year period and an increase of 11% compared to $65,800,000 in the Q1 of 2019. Our unit average selling price declined approximately 200 basis points in the quarter versus prior year, primarily driven by site of service mix in the U.

S. With a greater number of shipments to ambulatory surgery centers due to omicron impact in the hospitals at the beginning of Q1. International revenue was $14,600,000 an increase of 5% as reported or 12% constant currency compared to $13,900,000 in the prior year period and a decrease of 10% as reported or 11% constant currency compared to $16,300,000 in the Q1 of 2019. Similar to the headwinds seen in the U. S, international revenue continued to be impacted by COVID related issues as well, including both patient behavior and healthcare facility restrictions, though these factors improved over the course of the quarter.

Now moving on to some detail below the sales line. Gross profit for the Q1 of 2022 was $59,100,000 a decrease of 5% compared to $62,300,000 in the prior year period. Gross margin decreased to 67.3 percent in the Q1 of 2022 compared to 70.3% in the prior year period. This gross margin decrease was primarily due to the impact of Costa Rica manufacturing investments we are making ahead of FDA approval of our facility. We're excited about Costa Rica coming online in the second half of this year and helping drive margin expansion going forward.

Operating expenses for the Q1 of 2022 were $91,900,000 an 8% increase compared to $84,800,000 in the prior year period and a 4% decrease compared to $95,500,000 in the Q1 of 2019. Looking at operating expenses year over year, the increase was primarily related to personnel related costs, including stock based compensation and PDN marketing and selling related activities, partially offset by lower litigation fees. Excluding all litigation related and PDN expenses, operating expenses would be less than the Q1 of 2019 by $9,500,000 or 10%. Litigation related legal expenses were $3,700,000 for the Q1 of 2022 compared to $5,900,000 in the prior year period and $2,300,000 in the Q1 of 2019. We will continue to defend ourselves in our ongoing disputes relating to spinal cord stimulation technologies and continue to protect our innovations in parasthesia free SCS therapy.

Net loss from operations for the Q1 of 2022 was $32,800,000 compared to a loss of $22,500,000 in the prior year period and a loss of $42,300,000 in the Q1 of 2019. Non GAAP adjusted EBITDA for the first quarter of 2022 was a loss of $14,000,000 compared to a loss of $6,600,000 in the prior year period and a loss of $28,700,000 in the Q1 of 2019. We believe that once we begin to recover post COVID and with ongoing PDN investments that roughly $110,000,000 in quarterly sales is our breakeven point on an adjusted EBITDA basis. Just a reminder that non GAAP adjusted EBITDA excludes interest, taxes and non cash items such as stock based compensation and depreciation and amortization as well as litigation related expenses and certain litigation charges. Cash, cash equivalents and short term investments totaled $323,600,000 as of March 31, 2022.

This represents a decrease during the Q1 of 2022 of $38,400,000 As a reminder, the Q1 of each year is always a high cash outflow quarter, primarily due to annual incentive compensation payouts. Excluding these items, uses of cash were in line with normal business operations as well as our internal projections. We continue to manage our working capital with days sales outstanding and days in inventory down 2 days 9 days respectively from prior year. We're comfortable with our balance sheet to fund operations and still project positive cash flows in the second half of the year assuming the business and COVID recovery continue as I will discuss in our guidance. I also want to point out that we adopted the accounting standard ASU 20,2006 on January 1 of the year, which simplifies the accounting for our existing convertible notes due in 2025.

For us, the primary impact of the adoption of this new accounting standard is an increase of $34,300,000 to long term debt to reflect the full principal amount of our 2025 notes, net of debt issuance costs. Additionally, we will see lower interest expense of approximately $2,300,000 per quarter as we no longer will be amortizing the previously recorded debt discount to interest expense. So just to be clear, the increase in long term debt on the balance sheet in Q1 is due to the adoption of this new accounting standard and not due to the incurrence of any new additional debt. Now let's turn to guidance. It's important to note that we will be using non GAAP financial measures to describe our outlook for the business.

Please see the financial tables in our press release issued today for GAAP to non GAAP reconciliations. Keep in mind that the guidance we are providing today is highly sensitive to the company's assumptions regarding the pace and sustainability of COVID recovery and its related impacts on patient willingness to seek elective care, healthcare facility restrictions and healthcare facility staffing limitations, all of which are difficult to predict. If these assumptions differ from the actual case of COVID recovery and its impact on the company's market, then the company may need to change or withdraw this guidance in the future. As stated in today's press release, we expect Q2 2020 2 worldwide revenue of approximately $103,000,000 to $106,000,000 If foreign currency exchange rates hold at current levels, we expect revenue in the Q2 will be adversely impacted by less than 1%. This guidance assumes that the COVID related impact will continue to steadily decline in the quarter.

We believe PDN revenue in Q2 will actually still be slightly ahead of Q1 given the underlying momentum in this indication. We also expect 2nd quarter 2022 non GAAP adjusted EBITDA to be a loss of approximately $7,000,000 to $9,000,000 We continue to expect worldwide revenue for full year 2022 of approximately $415,000,000 to 430,000,000 which implies an 8% to 12% increase on a constant currency basis over the prior year. If foreign currency exchange rates hold at the current levels, we expect revenue in the full year will be adversely impacted by less than 1%. This range now assumes $27,000,000 to $32,000,000 in PDN revenue in 2022, an increase from our previous guidance of $25,000,000 to $30,000,000 This guidance assumes the remainder of 2022 will see a steady recovery, which includes no significant business impact from new COVID variants or waves and near term improvement in healthcare facility restrictions and steady improvement in healthcare facility staffing limitations throughout the year. Our guidance also assumes most of this annual year over year growth is driven by continued recovery in the second half of twenty twenty two, which implies year over year growth in the second half of the year of 15% to 22%.

We are maintaining our guidance for full year 2022 non GAAP adjusted EBITDA loss of $8,000,000 to $18,000,000 which compares to a non GAAP adjusted EBITDA loss of $17,200,000 in 2021. To assist you in modeling for the rest of 2022, we continue to expect the 2 quarters in the back half of the year to have roughly equivalent revenue growth rates over Q3 and Q4 of 2021 as we assume we will benefit from improving COVID environment, the recovery of the SCS market and accelerating progress in our PDN launch. Our full year guidance also implies core back in leg growth excluding PDN in the second half of the year of approximately 9% to 15%. Regarding inflation, to date, we are seeing some expected impact in areas such as freight and cost of goods cost of goods sold or cost of goods. Our supply chain and cost of sales has shown some modest increases that were anticipated and are expected to be more than offset by Costa Rica manufacturing cost reductions.

We are also seeing some inflationary pressure on certain operating expenses such as compensation, which is already contemplated in our guidance. We continue to manage our costs amidst these pressures and expect that we will be able to drive leverage over the next several years in our income statement. In closing, we made good progress in the Q1 and remain on track to drive growth and scale profitably in our core business in the years ahead. We are in a great position strategically with best in class SCS technologies, remaining share gain opportunities, future growth opportunities in PDN and NSRVP, superior clinical data and a strong commercial organization. Overall, we're pleased with our start to 2022 and look forward to aggressively attacking the significant opportunities to drive the performance of the business the rest of the year.

That concludes our prepared remarks, and I'll turn the call back over to Julie to moderate the Q and A session.

Speaker 1

Thanks, Rod. In order to get through the question queue efficiently and take as many questions as we can, we ask that you please limit yourself to one question and a real quick follow-up if necessary. You can then rejoin the queue and if time allows, we'll take additional questions. Operator, we're ready for Q and A instructions.

Speaker 5

Thank you.

Speaker 0

First question today is from Cecilia Furlong with Morgan Stanley. Your line is open.

Speaker 3

Hey, thanks for taking the question. This is Calvin on for Cecilia. Just two quick ones for me. The first one is you reiterated the full year revenue guidance and raised the PDN guidance by 2,000,000 dollars and with 1Q coming in slightly ahead of expectations. So is the read through that you're trimming the core SCS outlook for the balance of the year?

Is that just sort of stemming from the prudence for the balance of the year? Just hoping you could unpack that a little bit.

Speaker 2

Yes, I'll take that at a high level at least. Look, I think we're it's been a tough and somewhat unpredictable couple of years for the SCS markets relative to the COVID environment and we're only 1 quarter into the year. So I think you can safely assume that there's a bit of conservatism here. We really don't want to get out ahead of our recovery assumptions until we see a little bit more. And it really is nothing more than

Speaker 6

that. Got

Speaker 3

it. Okay. Makes sense. And just quickly on the U. S.

Trial procedure mix between core and PDN, it sounds like 1Q was 11% PDN. So where does this trend throughout the year? And what do you think is the biggest driver that could support a more meaningful step up in just volumes for PDN trials, for instance, from outreach initiatives and others? Thank you.

Speaker 2

Well, I'll certainly answer the second part of that question. I think the things we're doing now are the things that we believe will continue to drive. If your question is about PDN trials specifically,

Speaker 4

if you

Speaker 2

look at the sequential growth that we had from Q4 to Q1, it was pretty dramatic. And this despite the fact that we normally see seasonality that goes down from Q4 to Q1 and included in that was a really tough January and an early February that wasn't a lot better. So I think the things we're doing now are driving a ton of growth in PDN trials and I think that will continue. I think we're starting to feel a little bit of momentum In PDN, it's early. So I want to be a little bit careful using that word.

But nonetheless, it does feel like that more referring doctors are becoming aware of this. More referrers that have sent a patient are beginning to send more patients and more implanting doctors are rolling out initiatives in their local markets to generate those referrals as well. Our direct to consumer activities are beginning to show some productivity and those take longer. So we're just now beginning to see those beginning to come through in the trial volumes as well. So I think we feel really good about PDN trial volumes and where this is going and feel like there's lots of upside there.

Thanks so much.

Speaker 0

The next question is from Adam Maeder with Piper Sandler. Your line is open.

Speaker 7

Hi, Rod. Hi, Keith. Thank you for taking the questions. This is Simran on for Adam. So I just wanted to start off with PDN.

Obviously, you guys saw quite a bit of momentum there in Q1 and that despite being a new entrant to the marketplace. So in general, how do you think about your competitive positioning in the PDM segment and future share dynamics here and the potential for additional competition from legacy SCS players?

Speaker 2

Look, we talked a little bit about this last quarter after one of our competitors came through with a surprisingly early approval for this indication. We feel really good about it. Look, I think having additional competitors, there is some upside. We've seen this and you've all seen this in other medical device markets over the years that markets tend to grow faster when there are multiple participants. And this is a very large, very unpenetrated, much less underpenetrated market.

So I think we can use some help with educating patients and referring doctors. On the other hand, we look at our competitive position and we look at the data that's available with high frequency for these patients. And it's rare that I think you get a competitive position that's just differentiated. Basically twice the number of responders, twice the average pain relief, 2 thirds of patients getting neurological relief or relief of their neurological symptoms where there are none reported in competitive data. So I think we feel very comfortable that we can differentiate ourselves with the referring doctors, with the patients, with implanting doctors and frankly even with payers.

So far, so good. I mean, we're early on in this competitive landscape, but I know our commercial team feels very good about how we're positioned. And so far, we really like the activity that's done nothing but increase in that short period of time since we've had a competitor.

Speaker 7

Got it. And then can you talk about PDM guidance specifically? So it was raised by about $2,000,000 at the midpoint. What is assumed from a reimbursement coverage standpoint? Do you anticipate that more large payers or MAX will issue positive policies embedded in that range?

Speaker 4

Hey, this is Rod. We've stated this before that as we think about how the year plays out, we don't have anything specifically planned out in terms of when certain payers will come online from a coverage perspective. It's too difficult to plan out at what time of the year they might come on and in what order. So we've had really great success so far in being able to push through reimbursement with a lot of our patients. And we'll continue to work with the payers as they're reviewing their policies throughout the remainder of this year and into next.

Speaker 2

I don't view our guidance as being contingent in this regard on increases in access or coverage policies.

Speaker 7

Got it. Okay. And then if I could squeeze one quick one in there.

Speaker 0

The next question is from Larry Biegelsen with Wells Fargo. Your line is open.

Speaker 5

Hi, this is Nathan on for Larry. Thanks for taking the question. I just wanted to go back to the guidance. In terms of the 15% to 22% in the second half, how confident are you in this ramp and what is assumed in the ramp? And then is that a good starting off point for how we should think about growth in 2023?

Speaker 2

Well, listen, we're not guiding for 2023 at this point. That's a bit distant for us to probably comment on. But Rod, maybe you want to talk about second half of the year guidance.

Speaker 4

Yes. So I think a couple of things to keep in mind, Nathan. 1, we are assuming that the markets continue to recover, that COVID continues to subside and that patient willingness, staffing, all of those sorts of issues that have plagued us and been issues with COVID over the last few years become less and less of an issue and that patient willingness to return to therapy continues to increase. Also remember that our comparables from last year are a little for Q3 and Q4 are a little bit on the softer side. And so as of where we stand right now, we're seeing trialing activity that is in line with how we were thinking the year would play out.

We still got a lot of work to do. We have the summer months ahead of us. But right now, I'd say that we feel confident in our ability to be able to deliver a strong second half.

Speaker 5

Great. That's very helpful. And for my follow-up, just around the core SCS market, it's continued to be weak. Is there any update you could provide for us like what is driving this? Are patients still on the sidelines?

Do you see them coming back? Thanks.

Speaker 2

Yes, we do see them coming back. I mean, remember that the lead indicator here is trials, and we talked a little bit about trial growth as you compare it to prior year, but importantly to 2019, which is sort of the last unaffected year. So we do see patients coming back. I'll tell you anecdotally, we see this in a big way. We just had a U.

S. National sales meeting over the weekend and got a lot of input anecdotally on what's happening in our practices around at least the U. S. Market. But our trial volumes suggest that patients are coming up.

The funnel is being refilled, and we think that bodes well.

Speaker 5

Great. Thank you.

Speaker 0

The next question is from Robbie Marcus with JPMorgan. Your line is open.

Speaker 3

Great. Thanks for taking the question. Maybe you could walk me through, you mentioned in the call and you reiterated this in the guidance about a pretty big step up in 3rd and fourth quarter, both on a year over year basis and on a dollar basis. And so maybe just walk us through what gives you the confidence today to be able to make that call, what you're seeing, what you're hearing from doctors? And you mentioned filling the pipeline.

Just any more details around that you could add. Thanks.

Speaker 4

Yes. Hey, Ravi, this is Rod. So I'd say a couple of things and then Keith can add some at the end here. One, we are seeing good traction in PDN, and we do anticipate that as we go throughout the year, PDN will continue to grow and become a more and more meaningful part of our business. And so obviously, that creates a strong year over year comparable when we just started out with it in July of last year.

Secondly, as I just kind of mentioned, we're seeing the recovery in line with how we were thinking it might play out. Now there's still as I mentioned, there's a lot of work ahead of us, a lot of recovery ahead of us, but we are seeing the trialing and the perm activity with how we thought that the year would play out. And if we can see that continue to improve as we go throughout the year with patient willingness continuing to improve, staffing shortages continuing to be mitigated or minimized. We feel good about our opportunity to deliver the numbers that we've guided to in the second half of the year.

Speaker 6

And I don't know, Steve, if you want to

Speaker 2

Listen, I don't think it's that mysterious. I mean, we triangulate from a few different areas of data points. One is our trial activity, where we think it is right now, where we project it going over the coming 3 to 4 months because those will inform those months of activity will all inform the second half of the year. We look heavily at our market research and what we're being told by our doctors, by our referring doctors, by patients. And we look at where we think the market is kind of going from a top down basis post recovery.

And we've got some internal models that allow us to kind of think about the level of pent up demand activity and that kind of thing. And I think for us, as we look at our guidance for the second half of the year, we look at our trial volumes, where they are right now, where we believe they're going in the next few months. We take out where we think we're headed on PDN and that contribution. And we feel like it's a very reasonable set of guidance expectations for our core market growth in the second half of the year.

Speaker 3

Great. Appreciate that. And then maybe one on expenses. You continue to build the sales force in PDN here and you're spending to grow the top line. How do you think about what future spending looks like if revenues stay where they are?

And how are you thinking, at least, as you sit here today and hopefully with the recovery in the back part of the year about where potential breakeven on net income might be? Thanks.

Speaker 4

Yes. Well, from an adjusted EBITDA perspective, we anticipate that we hit that breakeven around $110,000,000 in quarterly sales. And as we look at the year, particularly second half, we're anticipating that we're going to be into that positive adjusted EBITDA territory in the second half. So we're continuing to manage our expenses. We're going to have a bias towards investing in future growth, whether that's the PDN opportunity, NSRBP, building our product pipeline, but we're also doing that with a really strong eye towards driving leverage organizationally and watching our spend.

So we're really kind of targeting that $110,000,000 figure as we move forward from an adjusted EBITDA perspective.

Speaker 3

Got it. Thanks a lot.

Speaker 0

The next question is from Danielle Antalffy with SVB Securities. Your line is open.

Speaker 7

Hey, good afternoon guys. Thanks so much for taking the question. Keith, I wanted to ask if I could get a little bit more color on exactly what ADA could look like for you guys this year. And I would love to hear a little bit about what part of the message is resonating with referring resonating with referring endocrinologists and sort of exactly how you're going about building that network and and where you think you are in the adoption curve? Sorry, that was a lot of questions.

So I'll just leave it at that. I won't ask a follow-up.

Speaker 2

Well, I think we're pretty happy with our the traction we've gotten with referring doctors. And we said this almost from the 1st month of commercialization on that the story has resonated with referring doctors just as we thought it would. There really aren't any huge sticking points. I think there are occasionally some. There are some doctors who don't have any familiarity with SCS therapy and maybe have a misunderstanding about what SCS therapy is, don't understand whether or if they'll get their patients back following the referral.

So they need to understand that this doesn't affect their management of the patient. They need to get to know population of pain physicians in their area and to whom they're referring these patients. But these are all sort of the things that you would expect, all the obstacles you would anticipate we would get over with a new referring doctor for a new therapy. I don't think there's been any element of that that's been problematic, that's been more sticky than we would have thought. I will say the response to the data from our trials and all of our publications has been overwhelmingly positive from referring doctors because they've been dealing with these patients for a long time and haven't had much to do with them or to do for them.

So I think once they realize what the therapy is, how good the results are, particularly those that have referred a patient and have gotten a really good outcome, And we always close that loop with a referring doctor to make sure they know that. It's been a path that with each one of these referring doctors has gotten better over time, not tougher. Remember that the referring universe doesn't include just endocrinologists. There are other important doctor groups that are very receptive to that are managing these patients that are very receptive to referring them. In terms of ADA, I think what we want to talk about is generally what you would expect, who these patients are, how to identify them, how we triage these patients in terms of inclusion into their clinical trial, what that means about how they think about their patients, the clinical data, etcetera.

We're going to have a product theater there and we're going to be, as I said, releasing our 24 month follow-up for the test arm from our SENSA PDM trial. So I think so far the reception from the referral audience, not just endocrinologists, has been really positive with the kind of the normal hurdles that you would expect to have to get over in this situation with the new indication.

Speaker 7

Thank you.

Speaker 0

The next question is from Joanne Wuensch with Citi. Your line is open.

Speaker 7

Good evening and thank you for taking the question. 2, I'll just say upfront, could you give us a highlight of what's going on in the international market? And that refers to sales and for my second question, how you're dealing with some of the expense headwinds that are outside U. S? Thank you.

Speaker 6

Yes. I'll on the expense headwinds,

Speaker 2

I assume maybe you mean some of the currency issues, though I'm not sure. I'll let Rod handle that. In terms of the condition of the international markets, they're really they're very different. We've seen really some really good results starting to come out of Australia. I would say we're starting to see some nice recovery in volumes coming out of the German market.

The UK market has been probably at least recently probably our most challenging international market. And I think it's a general state of elective procedures and healthcare market recovery in the UK that is a little bit tough to get back to normal level. So I think we've seen a little bit of a struggle in the UK market. But by and large, I think the international markets did reasonably well this quarter. We're comfortable that recovery is going to impact them just as it's impacting the U.

S. And I think maybe the one watch out for us now is we're keeping an eye on the ability of the UK market to recover elective procedure volumes. Rod, you want to take the other part of that?

Speaker 4

Yes. To answer, if you're talking about current semmer, we're obviously keeping an eye on that like everybody else out there. We don't have a huge amount of exposure at this point. As we mentioned, it's less than 1%. But as we go along here, we'll definitely keep an eye on that and stay close to it if it continues to

Speaker 7

change. Perfect. Thank you so much.

Speaker 0

The next question is from Suraj Kalia with Oppenheimer. Your line is open.

Speaker 6

Good afternoon, everyone. Keith, I'll throw in both my questions together. So for FY 'twenty two, the implied outlook for PDN, what percent are from your existing 50 PDN reps you referenced, are these new hires predominantly from the SCS or Neuromod space or are you all more focusing on endocrinology relationships? Thank you for taking my questions.

Speaker 2

On the percent of the PDN volumes and where they're coming from, I don't have that actual number off the top of my head. I would say the PDN volumes probably come not surprisingly disproportionately from our existing customers, But there's a very meaningful section. It's not this isn't 10% that's coming from practices where we've done little volume over the next over the last couple of years or maybe none. So the PDN indication has enabled us to get into sites where we've had either reduced activity volumes or none over the last couple of years. I'm sorry, Suraj, I just don't know what the that percentage is off the top of my head.

On the new hires for the PDN referral group, that typically is not that group is not populated by people with prior SCS experience. They oftentimes have very relevant experience in diabetes and in endocrinology, although not necessarily, they almost certainly have experience in calling on the generalist population. But these are not usually these are not usually that have deep experience in medtech or necessarily even experience in SCS. That's training they get from us.

Speaker 6

Thank you.

Speaker 0

The next question is from Rich Newitter with Truist Securities. Your line is open.

Speaker 8

Hey, this is David Rescott on for Rich. Thanks for taking the questions. First for me, I guess, I think if I heard you correctly, you mentioned a new product platform for the end of the year. Could you just touch on maybe what we should expect from this product and really how you're thinking about the launch of this with regards to the share positioning, especially with some new waveforms?

Speaker 2

I didn't hear the last little part of that, but I gather your question is about the new product platform coming

Speaker 0

at the end of

Speaker 2

the year. We haven't said a whole lot about that. As you know, we typically that's one of the few areas where we're just not we're not that transparent until we get much closer for competitive reasons. But this is a platform that I think will kind of better connect all of our various strengths and capabilities with high frequency therapy to better improve outcomes, the quick reprogramming and responsiveness to the patient for optimizing those outcomes and the ability of the patient to play a larger role in connecting changes in programming to improving their own outcomes. So I know that sounds all very vague.

It was supposed to, but we think it's really a significant new platform for us and will allow us to do things over time with our therapy and with the ecosystem around our therapy that we just can't do right now. In terms of the launch, we'll start out as we always do with some form of limited market release and move from there after an appropriate period of

Speaker 6

time to a full market release.

Speaker 2

And I think your expectation should be toward the end of the year Q4 kind of timeframe.

Speaker 8

Okay. That's helpful. And I guess on PN, you mentioned some commentary kind of around the contribution there. But give us a sense, I guess, or provide some color around what maybe a typical PDN account looks like. I mean, they typically kind of meant for heavy users, high volume academic centers.

And I'm sure that's likely still obviously a pretty large new greenfield opportunity. But I guess, do you have a sense at this point whether or not you're even seeing competition in the space there for patients? Or is it still pretty new and large at this point?

Speaker 2

Okay. Again, for whatever reason, I don't know if it's a connection or my bad hearing, but I'm in a little trouble with some of the details of that question. But I will tell you that the nature of the implanting doctors that are driving the early PDN volumes thus far is difficult to characterize as one particular sub segment. I think they're all over the map. They are implanting interventional pain management doctors.

They are implanting neurosurgeons. They're in both academic and private practice. They're implanting in both hospitals and ASCs and they're spread rather evenly around the country. So I think what we're seeing is a pretty broad adoption. There really there isn't a subset of at least in our anecdotally or in our research, there isn't a subset of implanting SCS doctors who don't want to participate in PDN.

They have acted with different levels of aggressiveness in getting out there and trying to drive referrals themselves. There are obviously some that are in wait and see mode, some that are really aggressively out there marketing their practice to this referral base into this patient population and a big bunch in the middle. But I don't think there's a lot to take away from the early adopters in PDM. They're really spread, I think, pretty randomly across the various segments of our users.

Speaker 8

Okay, that's helpful. Thanks for taking the questions.

Speaker 0

The next question is from Margaret Kaczor with William Blair. Your line is open.

Speaker 7

Hey, guys. This is Maggie Bouie on for Margaret today.

Speaker 1

I just want to

Speaker 7

ask one on NSRBP. While I can appreciate it's still in the early days, you guys obviously now have FDA approval and the clinical data to back it up and are working on market development. So how are you thinking about NSRBP contributions to growth within your 2022 guidance, if at all? And then what the ramp up looks like for growth in 2023 and beyond within that market? Thank you.

Speaker 2

Well, we've opted not to break that out as a segment of our guidance. It's a little bit the difference between the NSRVP patient population and the failed back and leg patient is a little grayer than the distinction with PDN patients. It's not always as easy for us to capture the difference between those two patients. And so we've been a little bit reticent to call it out the way we have PDN, which is much more we have much more visibility to the differences in those patients as they present themselves. We've always thought that it would be kind of a slow and gradual process that the publication of the data, the receipt of the FDA approval would give us a much stronger case to adjudicate these patients as they come into the prior auth process with existing payers.

Remember, about 30% of our patients are already in this category. We just get we have always gotten more frequent denials of care for these patients because we didn't have the data and we didn't have an FDA claim. So I think a lot of this will just be a higher and higher success rate with payers both in their coverage policies and on a patient by patient basis, and that will build over time. I think this has always been an area where we assume that our competitors will follow with data and maybe even with indications and will help us develop this patient population. But to the core of your question, we just haven't broken it out.

We do think that it provides a little bit of tailwind to market growth rate. So if I think about the next 3 years and I take out PDN and I just look at the core lower back and leg pain market, to me this segment of population this population of patients represents a tailwind to overall growth rates for the market. Once again, we haven't broken out with that does that mean? Is it 1, 2 or 5 percentage points to market CAGRs? We don't know yet, first of all, and we certainly haven't guessed.

But I do think it's positive uplift to a market that will be reverting to growth.

Speaker 7

Makes sense. Thanks so much.

Speaker 0

We have no further questions at this time. I'd like to turn the conference back to Mr. Grossman for any closing remarks.

Speaker 2

Okay. Thanks everyone for joining us today. It's a really positive quarter and a good step in the right direction for us and we'll look forward to updating you after Q2 and each quarter the rest of the year with hopefully the trajectory that we think is coming. Thanks again.

Speaker 0

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.