NuVasive, Inc.
Q2 2021 Earnings Call Transcript

Published: 28 Jul 2021

[Operator:]

Good day, ladies and gentlemen, and welcome to the NuVasive Second Quarter 2021 Earnings Conference Call. I would now like to introduce your host for today's call, Ms. Juliet Cunningham, Vice President of NuVasive Investor Relations. Please go ahead, Ms. Cunningham.

[Juliet Cunningham:]

Thank you. Good afternoon, everyone, and welcome to our second quarter 2021 financial results conference call. Joining me today are Chris Barry, Chief Executive Officer; and Matt Harbaugh, Chief Financial Officer. Chris will provide an overview of NuVasive's recent business results and trends and Matt will review our detailed financial results, as well as the company's 2021 financial guidance. Then we'll host a question-and-answer session. If you have not had a chance to review our earnings release, which was released after market closed today, it can be found on the Investor Relations section of our Web site at nuvasive.com. The release has also been filed with the SEC on Form 8-K. In addition, we posted to our Web site supplementary slides to summarize our results. If you'd like to be on the distribution list for our IR materials in the future, please drop me a note and I'll be happy to add you to our list.

[Chris Barry:]

Thank you, Juliet, and good afternoon, everyone. Earlier today, we reported second quarter 2021 financial results. On this call, I will provide updates on our progress delivering multiple vectors of growth in key procedural segments and international markets, and our upcoming commercial launch of the Pulse platform. We are evolving from an implant focused company to the largest spine technology company in the world. As discussed, we continue to focus on multiple vectors of growth, making deliberate investments in select procedural segments where we've historically had underrepresented market share and commercial operations to further globalize our business. This was reflected in our quarterly performance, which was in line with 2019 results. And I'm encouraged by the progress and momentum we are building for the back half of the year.

[Matt Harbaugh:]

Thanks, Chris, and good afternoon, everyone. I'll begin by reviewing our second quarter 2021 results and then discuss our 2021 financial guidance. Net sales for the second quarter of 2021 were $294.8 million, up 44.8% compared to the prior year period on a reported basis and 43.3% on a constant currency basis. We saw surgical volumes improved sequentially with some modest variability in May and June. We believe this volume improvement was primarily related to continued positive recovery in the spine market, as well as the broader global economy beginning to reopen. Signs of recovery in the second quarter continue to support our outlook that we can deliver 2021 net sales growth that exceeds our pre-pandemic 2019 results. US Spinal Hardware net sales were $160.1 million in the second quarter, up 40.7% year-over-year and a return to 2019 levels. These results were primarily driven by continued demand for products within our Advanced Materials Science portfolio within each procedural segment. In particular, ALIF was the primary growth driver within thoracolumbar procedures as we continue to see strong adoption of Modulus ALIF. Additionally, we saw increased momentum in cervical as our C360 portfolio continue to gain traction and the market responded very positively to the Simplify cervical disc, which contributed nearly $2 million of net sales during the quarter. Simplify was off to a great start in our first full quarter since acquisition, and we're working through manufacturing, integration and ramping up surgeon training to maximize its momentum for years to come. The strength from our innovation in these procedures was partially offset by slower recovery in XLIF as expected. Surgeon training, which is typically a good leading indicator of procedural growth continues to pick up as travel returns. We were pleased to see training demand in Q2 exceed Q2 2019 levels.

[Operator:]

Our first question is from Matthew O'Brien with Piper Sandler.

[Matthew O'Brien:]

A lot of places I could go here, but I think for the story specifically, that's the most interesting that I heard today was just this double digit increase in the number of docs that you trained during Q2. Can you talk a little bit about those clinicians? Are they existing clinicians, are they new, are you getting some people back from competitors that you've lost? And then Simplify specifically helping you or the C360 specifically helping you accelerate some of the growth in the new docs that you saw here in Q2?

[Chris Barry:]

It's a bit of all of the things that you just mentioned. We're bringing in -- clearly, we had a bit of a pent-up demand that's opened up and we saw double-digit growth comparative sequentially quarter-to-quarter and the number of surgeons trained. So all things considered, we're ramping up our ability to train on Simplify, I think that's garnering interest in the portfolio. We continue now to reestablish the focus we had with X360 prepandemic. So all in all, just probably both pent-up demand and just the normal training that we've traditionally done. So it's a little bit of everything. I think the broader portfolio is attracting a new subset of surgeons to our campus that likely hasn't been there in the past, specifically in the fact that we didn't have certain aspects and we talk about multiple vectors of growth, we think that will continue. Obviously, we talked a little bit about the experience center on the East Coast. We think that also expands our reach. So that's still in our future. But all in all, positive signs, positive indicators that the market is returning with the number of people we're seeing come through in training.

[Operator:]

Our next question is from Robbie Marcus with JPMorgan.

[Unidentified Analyst:]

This is actually Allen on for Robbie. Just the first quick question. You gave a little bit of directional guidance on third quarter. I just wanted to ask you about kind of specifically the trends that you were seeing so far in July. And also just to throw it out there. I think right now, the Street is kind of at like $313 million number on the top, $0.65 from the bottom. Is that like an appropriate range for us to be in, just in light of the guidance update you provided today?

[Chris Barry:]

So let me just kind of back up. I think if you look at Q2, we sort of mentioned this in some of the prepared remarks, but we saw continued sequential improvement, April through June. And interesting enough, in June, we really saw a return to what the pre-COVID seasonality look like. So for all intents and purposes, we're seeing trends that the full year sort of playing out the way we thought it was with the exception of June was better than we expected. Now coming into July, as you know, with seasonality, specifically in this business, you have holiday, you have certain vacations that happen. I think that's actually even more pronounced coming out of the pandemic. But we're seeing that return to normal seasonality. So for the full year, we're right on track. We're super excited as we talked about with really some of the key investments coming to fruition with cervical with our focus on ALIF, the eve of launching Pulse. And as we continue to see our international business really just produced really strong results. So Matt, I don't know if you have anything to add on that?

[Matt Harbaugh:]

Chris, the only other thing I'd add is that from a net sales perspective, I would say we're looking at the third quarter to be likely in kind of the low 300s. But really, nothing has changed. It's just kind of inter quarter change that we're seeing here. We've been saying since February that we're going to be plus or minus against $1.2 billion. And obviously, in the guidance we provided today we still feel very confident that that's a good range for us to deliver on, on a full year basis.

[Operator:]

Our next question is from Joanne Wuensch with Citi.

[Joanne Wuensch:]

I want to spend a little bit of time on Pulse. With the CE Mark approval in June, it sounds like you're looking near term for the 510(k) or okay, okay, in the US, but also how you're thinking about rolling out into those six countries and then into a more fulsome launch?

[Chris Barry:]

Listen, number one, we're very excited about the Pulse system and we did receive CE Mark earlier and we've been in doing, as we talked about clinical valuations in six European countries. We are, to your point, we're literally waiting day by day on the FDA 510(k) approval. That will then kick off evaluations that we'll schedule for the US market. As we roll it out, it's really going to be relegated on Phase 1, I would say, with Western Europe and US. We feel like we've got good demand. We've got good line of sight to delivering what we say we're going to deliver. And I've said all along with Pulse that we're being disciplined on how we roll it out. We're making sure that we obviously have been building a pipeline to sell the product. We've been building flexibility and a portfolio of options to offer our customers. We want to make sure we in-service appropriately and install the system to actually do what we've talked about, which is participate in a 100% of spine cases. So we're being very disciplined but we feel very confident in how we roll the product out and what it represents for us going forward. From there, we'll start to move into other regional geographies over the 2022 and beyond. But as we look forward over the course of this year, really into Q4, rolling through Q3 as clinical evaluations and looking to fully start to commercialize in the Q4 time frame.

[Operator:]

Our next question is from Josh Jennings with Cowen.

[Joshua Jennings:]

I wanted to follow up on the Pulse question. Some of our checks with surgeons that have attended the training sessions have implied that they've gotten some -- been introduced to Pulse, the latest generation of Pulse. And there's a little bit of buzz created, especially around the evasive surgeons. I was wondering how much are you able to train surgeons on Pulse here preapproval and maybe just give an update on the US demand funnel that's being created here?

[Chris Barry:]

And we have gotten -- I think we talked about this in subsequent calls. The latest iteration, one of the things that we're excited about we believe really hit the mark. And it's been echoed through the voices of our customers that have come in. We are limited. We can't fully train on the technology in the US until we get 510(k) approval, but we've had people in the lab setting, test driving and seeing how the product performs. More recently we have been in the clinical setting in the European market and it's further validated exactly what we've seen in the lab setting in the US. So we're excited. We're waiting on FDA approval. We're ready to go with our training in the US to start that process quickly. We've got our testing sites established. And as soon as we get that 510(k), we'll be moving into clinical evaluation in the US. There was a cadaveric study that recently came out that I think really showcases the power of the system. It basically measured efficiency, accuracy and safety. And one of the things I've talked a lot about is the value of Pulse. And I said in my prepared remarks, it's not just a navigation system but an integrated system that provides a host of application. And it's shown in the fact that first traditional fluoroscopy, which I would remind you, 75% of cases are still done with traditional fluoroscopy. It showed significant faster screw placement. It showed significantly better accuracy and it also showed with the integration of LessRay in the technology and in the platform, a significant reduction of fluoroscopy to the staff and to the surgeon. So I think the first two really represent how this would line up against the traditional way to do surgery. I think that last one is critical when you look at the incumbents, that 25% of the market that's occupied by competitors. We believe the system and what's integrated and the application within Pulse truly differentiate us. So we're excited, we're moving quickly, we're doing it the right way and clearly waiting on the FDA. But we feel very, very confident that we're within days of getting that 510(k) approval.

[Matt Harbaugh:]

Josh, the only other thing I'd add to that because you had asked about demand. We feel good about that $5 million. We feel good about the demand. But I'll just echo what we've been saying now for a number of months, which is the lion's share of the net sales that we're anticipating in the $5 million number that we put out there is going to come from the US market. But there are a few of them in Europe.

[Operator:]

Our next question is from Matt Miksic with Credit Suisse.

[Matt Miksic:]

I'll just ask maybe one question about the environment and sort of what you're seeing across different regions. We've heard a lot of different types of comments from the folks that have reported business metrics so far and things like deferrable, more deferrable, maybe more affected by variability across the country, but your US numbers look really strong and sequentially improved as you're describing. And just wondering what, if anything, that you are seeing in terms of variability across the US, pockets of strength, there is weakness, any effect of delta? And any color you'd provide overseas would be super helpful.

[Chris Barry:]

I'll get to the delta last, the delta question. I think that's something that's kind of playing out as we speak. But generally speaking, we saw -- and one of the things we were encouraged by was more uniformity in the market in the US specifically during the quarter and that’s the uniformity, I'll say that with the context that we saw sequential improvement, April to May, to June. So sequential improvement and more uniform volumes coming out of the US. So I'd say that gave us good confidence that we're sort of past the pocketed areas. Now I'll hold my breath on, will that hold through the quarter based on what we're talking about with Delta variant. But in the international markets, it's still a little bit choppy in the European market. The UK is still a little bit sluggish. So we're still watching certain countries. Asia Pac has been a real strength for us, specifically in Japan with a little bit slower laggard in some of the Asia Pac countries and in Australia and New Zealand. So I would just say, in general, more uniformity in the US, still a little choppiness international with some real standouts like Japan and some key European countries, we're still moving forward. Now the Delta variant, I think, creates a bit of a concern, I think, for everybody. I do believe that the market is more equipped to manage. I think the big question is, will patient sentiment play into any deferrals or procedures and maybe that's what your original part of your question was, do we see any -- is Spine more exposed to deferrals than maybe hips or knees. I don't really have a great answer for you there. We clearly saw a pretty quick shutdown during the COVID situation. We saw a pretty quick return. But certain pockets were a little bit sluggish. So I think time will tell. We're hopeful that we move past the Delta variant and we move back into a more normal business as we go through the next several weeks and months.

[Operator:]

Our next question is from Rich Newitter with SVB Leerink.

[Rich Newitter:]

Maybe I'll just squeeze two quick ones in. The first is you mentioned the training demand or the demand for training on X360, very encouraging data point there exceeding 2Q 2019 levels, and that a very high watermark for you where growth is accelerating in the business. I'm curious what the time frame is between training and actually getting to adoption, what is the time gap for the lead time there? And then the second question, just could you walk through the puts and the takes between recovery that's anticipated in the back half, normal seasonality, which you called out and an abnormal vacationing that you also called out at the same time and backlog work out? I'm just trying to figure out what's contemplated into your back half guide there amongst those pushes and pulls?

[Chris Barry:]

I'll take the first, and I may have Matt help me a little bit on the second one. On the training, we usually look at one or two quarter turnaround on when we see training really result in adoption and we track everything pretty closely. But we're in the process of ramping up our campuses, is likely again on Fridays and Saturdays, which is a great thing to see. And so under historical rates, we look over the next couple of quarters for that to really start to then result in adoption of the key technologies. I would just say it isn't just X360 we're training on anymore, it’s also C360, it’s Simplify. So we've got a multitude, and I've talked a lot about multiple vectors of growth, and now fully playing in the broader spine market inclusive of the $2.6 billion global cervical segment. And then obviously, as we move into the next several weeks and months training on our Pulse system, we think gives us a unique opportunity to take advantage of the opportunity we see now within the broader portfolio. As far as what the puts and takes are, I'll let Mat take that one.

[Matt Harbaugh:]

I would say, look, June, as Chris mentioned earlier on a previous question, we saw lot more uniformity. And so we kind of feel like we saw some volume in June that we had kind of forecasted back in the late April, early May time frame when we did our last call. We kind of were thinking it was going to happen more in the third quarter but we started seeing it kind of manifesting itself in June because of the uniformity. And so that's why I said earlier, we're thinking that the third quarter will be in the low 300s. That's great because if you think about it, if you're comparing to 291 from 2019, that kind of gets you in kind of the mid single digits range that pre-COVID we saw. And then as you're getting into the fourth quarter, what you're getting is continued underlying strength in the business. And then you add in Simplify, you add in Pulse, you're getting more out of C360. And generally, the fourth quarter, when you don't have a pandemic going on, is typically our strongest quarter as well. So that's why we really feel confident and have since February around this $1.2 billion range. And obviously, the guidance range of $1.19 billion to $1.21 billion puts us squarely with what we've been saying all along.

[Operator:]

Our next question is from David Saxon with Needham.

[David Saxon:]

I guess just wondering if we can get some more color on each of the businesses. I mean it sounds like international, despite the choppiness, should grow double digits year-on-year at least. But just wondering if you could give some color on the domestic business and specifically for surgical support, I mean that's tracked below 2019 levels. So in the back half relative to 2019, do you think that can grow? And if so, maybe what can drive that?

[Chris Barry:]

I'll start with sort of the domestic international split on the hardware side, then I'll move to surgical support, but we sort of covered some of this. But we feel there's more uniformity and more predictability in the US market. And that, coupled with the fact that the key launches and the key areas of focus that we've developed over the last couple of years are really coming to market, the cervical portfolio, our Pulse system, our focus on continuing training and defending our leadership position in the anterior lateral space, our growth of ALIF, all brings us into a stable market environment in the US. International, we're still very bullish on. We're hitting our stride with still certain markets that are still sluggish and having impact of the pandemic. So we feel very good about the domestic international segment. As far as surgical support, we've been challenged on the NCS side. If you look back at '19, we ran some pretty solid numbers on billing and collections. So we're running against a bit of a tough comp in the back half. That coupled with that business really grows with the rate of market and has been a bit of a laggard to return for us. So it's going to be a bit of a drag for us in the back half. As far as NSO, we've had some product related issues that we had to resolve. The good news is we're resolving those as we speak. That's been a bit of a drag. We expect that to come back. It's a function of timing of when that really comes back for us, all of which are contemplated in our guidance. So there's nothing I'm saying within any overview of these businesses that materially detract from anything we've said. They're all contemplated in what we said and we feel very confident in our ability to overcome any of the drags that we may see and take full advantage of the opportunities I spoke of.

[Operator:]

Our next question is from Kaila Krum with Truist Securities.

[Kaila Krum:]

So just on Simplify, you said I think you generated about $2 million and in Q2, you're expecting only $5 million for the full year because of manufacturing issues. So I mean do you think that these manufacturing issues will be over by the end of this year? And if that's the case, I mean, how big of a product could this be next year? I mean is something $25 million to $30 million totally off the table? Just would love to get your thoughts on it longer term?

[Chris Barry:]

Just let me -- always find it interesting to answer some of these questions. But I just want to make sure that we level set. We just purchased this technology this year, but the first case of this was done in December of 2020. So I just want to make sure that we're clear. We don't have manufacturing issues. It's just ramping up and transitioning the manufacturing capability that the company had versus integrated and what we're going to do with it. So it's all about transitioning the manufacturing to West Carrollton, which is a PMA product, which has some complexities to it. We're, as we speak, working diligently. I'm very hopeful to be able to give a different answer to the $5 million question this year and be more clear on what the numbers will look like next year. I can tell you, we're selling as much as we can make right now. And our supply or our demand, I should say, well outstrips our current supply. And as I sit here today, we haven't transitioned to West Carrollton, but we're in the process of making that happen. There are some hurdles and some milestones we have to achieve in order to make that happen. But we're very confident in the $5 million. I'm hopeful if we can move past those milestones in Q3, we open up upside for us potentially in the Q4 time frame. That leads us into next year. I haven't commented. I know there's been a lot of speculation. But I don't think your numbers are too far off what's possible. We've got to execute. We've got to get our training education in order, which we're doing as we speak. We get our manufacturing in order, which is the long pull on the tenant. But having said all that and assuming we're going to do all that, I think we're within reason to think this could be a really big product for us in the next couple of years.

[Matt Harbaugh:]

Kaila, the only thing I'd add to your question, just to put a finer point on it. I think Chris covered it. But to be crystal clear, the $2 million is really a signal of just how strong the demand is in the marketplace for this product. And so once we work our way through these supply issues, we know we've got good demand out there. And that's why we're so excited about the acquisition and where we can go with it.

[Operator:]

Our next question is from Kyle Rose with Canaccord Genuity.

[Kyle Rose:]

I wanted to see if you could touch just a little bit more on the strength you see in cervical and maybe kind of help us understand what the customer base looks like there. And I guess what I'm really trying to understand is, can you convert entirely new customers with C360, such that you can then cross-sell some of the more complex higher ASP-type products? Or is C360 really more about just capturing that incremental dollar from the existing NUVA customers?

[Chris Barry:]

The simple answer is yes, we believe we can reach a whole new customer subset with C360 that hasn't necessarily been interested in our business in the past. If you think about it, we've been more of a thoracolumbar space leader. And many surgeons that we speak to or that are doing these cervical cases are highly specialized in cervical and treating service spine. So we believe and we're seeing it come through in some of the training and education engagements that we've had of people that aren't familiar with NuVasive become now interested in where we're going, and that's a testament not only to the Simplify acquisition but just the investment we made to really overhaul our entire cervical portfolio. I can't stress them off. The ACP plate, the anterior cervical plate that we launched and the benefit that actually creates by being the thinnest plate in the market, extending our posterior fixation system now to Reline-C and just the investment that represents to what I consider to be a space that has not had a ton of innovation in the past couple of years, maybe the past several, it's truly creating a new interest for us. And this is exactly what we were hoping for by investing in the space. And as a reminder, cervical is a $2.6 billion global market opportunity. If you look at the entire anterior space is $900 million and the posterior space is $1.6 billion. Winning for us in cervical represents a tremendous growth opportunity for us over the next several years. So we're excited and we're excited to meet these new folks that are coming in, interested in, in our cervical portfolio.

[Operator:]

Our next question is from Anthony Petrone with Jefferies.

[Anthony Petrone:]

Just going to stay on cervical for a moment. And trying to just tie the knot between the $2.6 billion opportunity you call out globally to cervical. Just wondering the current C360 portfolio, is everything in that portfolio at this point to tackle that global opportunity? And then the follow-up there would be on the Simplify Level 2 FDA clearance. And how much specifically is that motion management piece of it in the US, what percent of motion management constitutes the $2.6 billion?

[Chris Barry:]

On the $2.6 billion segment, I would say our portfolio is fully equipped now to go completely after that market. We have the full instrumentation set. We have the implantables. We have the posterior fixation. And now we have the total disc replacement with the Simplify disc that we believe fully equips us to take full advantage of that market opportunity. On your second piece of that, I'm sorry, I'm just trying to remember what you said on the two level indication. Listen, it represents maybe a lower percentage of what's being done. But a lot of the surgeons we're interacting with don't want to use two different discs for a single level or a two level. So we think it plays heavily. There's only two other companies out there that have a two level indication. So we're walking through that now. We're trying to understand what is the percentage that do a two level cTDR versus a single level. But what we're finding is it's meaningful for us to have that indication with the eyes of our customers. So we think it's important. We think it puts us in a very unique position. And again, going back to the value of Simplify, really striking -- that technology is striking the bounder in mobility and stability with that two level indication, not only gives us the two level indication benefit versus all other disc, it also gives us benefit over the existing competitors that actually have the two level indications. We're excited. We're obviously talking about getting our supply up to meet that demand, but we feel the demand is there.

[Operator:]

Our next question is from Matthew Blackman with Stifel.

[Mathew Blackman:]

I was hoping you could talk to the procedure mix you saw in the quarter. Just curious if it was skewed in any direction either to higher revenue generating procedures or perhaps some more straightforward cases? And as we think about the second half of the year, do you think there's opportunity for any mix tailwinds as you claw back more of these deferred procedures, some of which, as we've talked to clinicians, maybe disproportionately more complex and therefore, higher revenue per procedure opportunities?

[Chris Barry:]

don't know that we necessarily, I mean -- let me go back. During the pandemic, I think we saw some lag with some of the more complex decides based upon -- procedures based upon the fact that there was health care scarcity, if you will. There were limited ICUs or limited hospital beds. And so there may have been a deferral of more complex cases that had a more acuity associated with them. That mix shift, I think, sort of evaporated for us earlier in the year, and we saw although lower volumes, more consistency and more historical mix. That hasn't necessarily changed. So I don't necessarily look for more complex cases to come back into the SKU. There are seasonality, there is seasonality to our mix. Kids that are on break specifically in the P segment that are doing high-level deformity or early scoliosis cases happen in certain parts of the year, over the Christmas holiday or the end of the summer or beginning of the summer. Things like that are normal seasonality, and that's kind of what we're seeing. So I we'll keep a close eye on it, but I don't expect any massive mix shift or either detriment or benefit to an anomaly in the mix over the course of the year.

[Operator:]

Our next question is from Drew Ranieri with Morgan Stanley.

[Drew Ranieri:]

Chris, earlier in the year, you talked about two emerging growth opportunities for the company. One was just approaching hospital administrators kind of as the company expands the portfolio and the second on the ASC. But just on the hospital administration side, kind of as you're entering the back half of the year with Pulse, kind of what's your confidence level on being able to approach hospital administrators increasingly so? And then with the ASC setting, anything new to offer up there? I think that you're bringing in some new leadership maybe earlier in the year, but any update would be appreciated.

[Chris Barry:]

One of the things that we've talked a lot about is establishing these multiple vectors of growth to become more outside of just the surgeon but become more to the hospital. We've invested in new capabilities throughout the organization to complement our increasing portfolio. So we were selling to degenerative surgeons doing lateral cases. Now we can sell the entire X360 portfolio. We're leading now and driving our ALIF portfolio. We've got a full gamut of cervical opportunities or portfolio options. We've got a navigation system embedded in a Pulse platform that also provides things like LessRay, rod bending, intraoperative connectivity, all the things I spoke about earlier in the prepared remarks and on the horizon, a robotic opportunity. So we think that elevates our opportunity and our value proposition to hospital administration. I think we have to bring these technologies to market first. So I think our first step is happening as we speak. But we have in the process of building the portfolio, invested in capital sales leaders, we've invested in an ASC leader. We've continued to bolster our corporate accounts, our national accounts capability to start to become proficient in selling at the C-suite and really, really transitioning the value proposition invasive from just a great portfolio to help a surgeon and a patient to truly a value driver for the hospital system. So we're on our way to taking advantage of that opportunity, but I would say we've got to got to walk before we can run. And step one is launching these technologies and showing success over the next couple of quarters.

[Operator:]

Our next question is from Craig Bijou with Bank of America.

[Craig Bijou:]

Just have a couple of quick ones on Pulse. So most of the $5 million that you guys expect this year is going to come in Q4, as you said. So is that a good way to think about the quarterly revenue run rate from Pulse going into '22 and then maybe assume some sequential growth there. And then secondly, on Pulse, just wanted to get any update on the robotics platform on timing there?

[Matt Harbaugh:]

I'll start with your first question. I'll turn it over to Chris to talk through robotics timing. No, the $5 million really is kind of a base, I would say. Obviously, we're in launch phase. So that would not be a good number to use as a run rate into 2022. Obviously, we are just in the initial phase of launching in Europe and we're waiting to get approval here in the United States before the end of the summer. So it's a bit premature for us to kind of throw numbers out there as it relates to 2022, but do not use the $5 million and use that as a run rate into next year that would be very conservative from our perspective.

[Chris Barry:]

And I'll take a shot at the second one. On the robotics side, really no change in what we previously communicated. The time line, the targeting is still in the 2022 time frame for our first in human. We're building out -- continue to build out capabilities on the R&D side, continue high roboticists and continue to evaluate our time line. And we've established milestones and we're looking towards moving into the phase where we're looking at regulatory approvals. But we're right now continuing to build out that platform in the process of launching out the Pulse platform, which, again, will house the robotic technology. We look at robotics as the next application of Pulse. So getting pulse out, getting that system integrated, getting that system installed, getting that system used in 100% of spine cases, we think provides a tremendous launching ground for us to then introduce a robotic application. So no changes what's been previously communicated. We'll continue to update you in subsequent quarters as we make progress.

[Operator:]

Our next question is from Matt Taylor with UBS.

[Matt Taylor:]

I actually wanted to ask one on -- Matt, you had the reversal of the voluntary ship hold. And I was just wondering if you could characterize what impact that could have or maybe what hold that headwind were off market as you bring it back in the second half of the year?

[Matt Harbaugh:]

Matt, very simply, it does create some volatility in the third quarter, but everything was taken into consideration in the $1.2 billion, plus or minus the $1.19 billion to the $1.21 billion that we put out today, our formal guidance, if you will. So the numbers that I've put out here on this call are consistent with how we view that unfolding.

[Chris Barry:]

I'd just say on that, Matt, we've seen product availability challenges with that business, but pleased with the work we've done with the FDA to help make the MAGEC system available. These are very high-risk patients. And so we're excited with the fact that we're now focused back on supporting our surgeons with case demand, however, it'll probably take some time to bring this back to full product capability fully to market. And we're still obviously working from an international perspective with other global regulators to do the same. But all in all, as Matt said, it's contemplated in our financials and we feel like we're on track.

[Operator:]

Mr. Barry, there are no further questions at this time. I would like to turn the call back over to you for closing comments.

[Chris Barry:]

Thanks, Joe, and thanks, everyone, for joining us today. I just want to thank everyone for participating. Guided by long term strategy, I truly believe we'll continue to drive diligent performance across our business and deliver innovation that benefits our surgeons, partners, health care providers and most importantly, patients around the world. I look forward to speaking to you all again next quarter. Thanks.

[Operator:]

This concludes today's conference. You may disconnect your lines at this time. Thank you very much for your participation. Have a great day.