NuVasive Inc

F:NK8

Earnings Call Transcript 2022-Q2

[Operator]

Good day, ladies and gentlemen, and welcome to the NuVasive Second Quarter 2022 Earnings Conference Call.

I would now like to introduce your host for today's call, Ms. Juliet Cunningham, Vice President of Investor Relations at NuVasive. Please go ahead, Ms. Cunningham.

[Juliet Cunningham, Vice President-Investor Relations]

Thank you. Good afternoon, everyone. Joining me today are Chris Barry, Chief Executive Officer; and Matt Harbaugh, Chief Financial Officer. Chris will provide an overview of NuVasive's second quarter 2022 business results and trends as well as innovation highlights. Matt will review our detailed financial results and full year 2022 outlook. And then we'll host a question-and-answer session.

The earnings release, which we issued earlier this afternoon, is posted on the IR section of our website and has been filed on Form 8-K with the SEC. We have also posted supplemental financial information on our IR website. As a reminder, this call is being recorded and an archive will be available on our website later today.

Before we get started, I’d like to remind you that our comments during this call will include forward-looking statements, which are based on current expectations and involve risks and uncertainties, assumptions and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.

The factors that could cause actual results to differ materially are described in NuVasive’s news releases and periodic filings with the SEC. Except as required by law, we assume no obligation to update any forward-looking statements or information, which speak as of their respective date.

In addition, this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures are included in today’s earnings release and in the supplemental information, which are accessible from the IR section of NuVasive’s website.

And now, I’d like to introduce Chris Barry.

[Chris Barry, Chief Executive Officer]

Thank you, Juliet. And good afternoon, everyone. Earlier today, we reported second quarter 2022 financial results. On today’s call, I will review our performance for the quarter, share our progress on delivering multiple vectors of growth and provide an update on our innovation roadmap and how we believe it uniquely positions NuVasive to disrupt the future of spine surgery. After that Matt will provide additional financial details on the quarter and commentary on the remainder of the year.

NuVasive delivered second quarter 2022 net sales of $310.5 million, an increase of 5.3% on a reported basis or 7.8% on a constant currency basis compared to the prior year period. In spite of a challenging backdrop of macroeconomic and market pressures, we saw procedural volumes increase over the prior year period and continued surge in demand for our existing innovation and new product introductions. This is reflected in our performance in both the U.S. and international markets.

Within our international business we delivered another strong quarter of net sales resulting in double digit growth on a constant currency basis led by Europe and Latin America. In Asia Pacific, where COVID-19 challenges were most acute, we saw growth in the region, led by Japan, where we continue to see strong execution by our team.

U.S. Spinal Hardware delivered low-single digit year-over-year growth driven by continued growth in the X360 portfolio led by the XAlift procedure and strong demand for the C360 portfolio led by the simplified cervical disc.

Our U.S. Surgical Support business performed well in the second quarter, supported by Pulse platform net sales. This was offset by decrease in biologics, driven by a shift in case mix and lower attachment rates in the quarter. We're proud of our history as the leader in spine innovation with spine's most comprehensive portfolio of procedurally integrated solutions.

As we continue to integrate our industry leading procedures with Pulse, we're well positioned for continued growth. In addition to new Pulse sites going live in the United States, we achieved numerous key milestones with Pulse in the second quarter, including over 100 Pulse cases in early sites, both in the U.S. and Europe, our first Pulse cases in Italy, as well as our first Pulse case for pediatric scoliosis. Driving clinical utilization and adoption is key to the near and long term success of Pulse. The Pulse software ecosystem integrates multiple technologies into a single platform and can be utilized in 100% of spine surgery cases.

Unlike other enabling technology systems on the market Pulse provides surgeons, a seamless and efficient workflow through integrating 3D navigation, neuromonitoring, radiation reduction, imaging enhancement tools, patient-specific rods and global alignment planning. A recent study published in Scientific Reports found that Pulse outperformed two other common imaging and navigation systems with respect to screw placement accuracy. Notably, Pulse with Cios Spin from Siemens Healthineers, was significantly more accurate than Stealth with OR. We continue to make progress building out the broader Pulse ecosystem and its extensible software architecture allows for the integration of current and future innovation.

The future of spine care will not start and stop with intraoperative surgical procedures. And we remain committed to leveraging the power of Pulse to extend from preoperative to postoperative spine care.

Another key strategic growth driver for our company is cervical, which delivered greater than 20% growth in the U.S. for the third consecutive quarter. Surgeon interest in the C360 portfolio and specifically the simplified cervical disc remains high. The simplified cervical disc achieved multiple milestones in the second quarter, including first cases in Switzerland, Austria, the UK, and most recently, Australia. We're taking share and will continue to do so with the industry's most clinically effective cervical total disc replacement.

To further enhance the C360 portfolio, which currently features the NuVasive ACP system with Advanced Material Science interbodies and the simplified cervical disc, we remain on schedule to introduce Reline Cervical this quarter. Reline Cervical, our next-generation posterior cervical fixation system, is fully compatible with Pulse and integrates with our thoracolumbar Reline portfolio. This creates a single comprehensive posterior fixation system to seamlessly treat pathology from the occiput down to the pelvis.

With yet another new product introduction joining the C360 portfolio, we continue to target and take share in the $2.6 billion cervical sub segment. As the leader in liaison basis spine surgery, and in support of our multiple vectors of growth we remain focused on new product introductions in international markets. In the $900 million anterior sub segment surgeon demand remains high for the X360 portfolio. Within our advanced material science portfolio, we continue to introduce our market leading interbodies in key markets around the globe.

Modulus ALIF commercially launched in Australia in the third quarter of 2021. And we have seen significant growth in that market. Modulus XLIF commercially launched in Japan in the second quarter, and we have performed nearly 500 cases to-date. In addition, we received FDA clearance in Q2 for Modulus XXLIF our next generation expandable interbody for lateral procedures. Our R&D team continues to leverage our proprietary, 3D-printed porous modulus technology to other expandable interbodies and procedures.

And we remain on schedule to launch the invasive tube system later this year. Our new tubular retractor system will be the company's first tube system, and a key addition to our comprehensive portfolio of solutions to support less invasive posterior procedures. Late last year, we welcomed the return of precise titanium products from NuVasive Specialized Orthopedics in key global markets, surgeon demand, and patient interest for precise remains high. And we anticipate continuing to benefit from the products return as we look to the back half of 2022.

In support of international growth and to further our industry leading clinical professional development program, we held a ribbon cutting for our new Singapore Experience Center in June. The new center features a dedicated pulse demonstration site to provide hands-on experience with the platform, educational training rooms with advanced cameras and streaming capabilities for virtual learning and a technology rotunda with the ability for live and virtual demonstrations of our procedural offerings.

Our vision is bold, to change a patient's life every minute and our purpose remains unchanged, to transform surgery, advanced care and change lives. Like many companies around the globe we're not immune to the challenging macro economic and market pressures. However, we are making progress on our commitments to deliver multiple vectors of growth, through extending our leadership position and less invasive surgery. Taking share in sub-segments where we historically had underrepresented market share, delivering on our enabling technology roadmap and driving continued growth in our international business.

The future spine surgery will not be solved with a new interbody or procedure. It will be defined by improving patient selection, selecting the right procedure in the most appropriate surgical setting, creating a patient specific surgical plan, utilizing and enabling technology for inoperative execution and enabling postoperative outcomes management for the patient, the surgeon and provider. As a company, this is our focus. We're building upon our industry, leading procedurally integrated solutions and deep know-how to redesign the future of spine care.

In closing, we're excited about the opportunity before us and believe that NuVasive will make surgery more intelligent. This in turn will fundamentally change the quality of care patients receive by providing smarter and more clinically validated tools to surgeons. Simultaneously, this will unlock value and support our progress against our vision to change the patient's life every minute. I'll now turn the call over to Matt to discuss the company's financial results in more detail.

[Matt Harbaugh, Chief Financial Officer]

Thank you, Chris and good afternoon. Today, I will provide an overview of our second quarter 2022 financial results and drivers, as well as update you on our full-year 2022 outlook. Our detailed financial results have been provided in today's press release. During my remarks, I will be discussing both GAAP and non-GAAP measures and refer you to our press release for GAAP to non-GAAP reconciliations. I'll begin with worldwide net sales.

Our second quarter results reflect strong net sales growth compared to the prior year period, as well as sequentially, that said our bottom line results were pressured by macro environmental issues, including inflationary costs, supply chain delays, volatility of foreign exchange rates and the ongoing impact of COVID. I will provide greater detail on these challenges as we dive deeper into our results. Importantly, procedural volume remains strong and we continue to execute well on our new product introductions.

Second quarter worldwide net sales were $310.5 million, an increase of 5.3% as reported and 7.8% on a constant currency basis compared to the prior year period. This growth was driven by higher procedure volume and continued positive momentum from our new product introductions, including the Pulse platform and our C360 portfolio led by the Simplify Cervical Disc. International sales of $73.6 million in the second quarter, demonstrated continued strength with double digit constant currency growth compared to the prior year period. These results were driven by Europe, Latin America and Asia Pacific, particularly in Japan. NuVasive Specialized Orthopedics or NSO also contributed to international results, driven by strong demand for our precise titanium products, which return to market in late 2021.

Turning now to U.S. net sales by product line, U.S. spinal hardware net sales were $165.1 million in the second quarter of 2022, representing a 3.1% increase over the prior year period. Cervical grew more than 20% for the third consecutive quarter. This performance was led by our C360 portfolio, specifically the Simplify Cervical Disc which continues to experience strong surgeon demand. U.S. surgical support net sales were $71.8 million in the second quarter, an increase of 6.2% driven by Pulse sales.

Moving to operating results. Non-GAAP gross profit in the second quarter was $224.7 million compared to $217.1 million in the prior year period. The year-over-year increase was primarily driven by higher procedure volume. As a percent of net sales, non-GAAP gross margin was 72.4% a decrease of 120 basis points compared to 73.6% in the prior year period. The year-over-year decline was primarily driven by pricing pressure that was once again in the low-single digits, partially offset by a decrease in inventory charges in the quarter. Second quarter 2022 non-GAAP operating expenses were $184.2 million, an increase of 4.6% compared to $176.2 million in the prior year period.

The year-over-year increase was primarily driven by variable expenses on higher net sales, freight costs and our continued investment in R&D to further our core spine and enabling technologies product portfolios. Increased cost due to inflation negatively impacted several expense areas including fuel surcharges on freight shipments, increased travel costs and higher compensation costs. Non-GAAP other income and expense was $8.4 million of expense compared to $1.7 million of expense in the prior year period. The increase was primarily driven by unrealized foreign currency losses in the second quarter of 2022. During the quarter, a number of foreign currencies weakened against the U.S. dollar. Second quarter 2022 non-GAAP operating margin was 13%, a decrease of 90 basis points from the prior year period. The year-over-year decline was primarily driven by lower gross margin, continued R&D investments and higher costs due to inflation. Non-GAAP tax expense in the second quarter of 2022 was $7.2 million compared to $8.1 million in the prior year period. Our second quarter 2022 effective tax rate was 22.5%.

On a GAAP basis we reported a net loss of $900,000 or diluted loss per share of $0.02 in the second quarter of 2022, compared to net income of $1.8 million or diluted earnings per share of $0.03 in the prior year period. Included in our GAAP results for the second quarter were unfavorable impacts of foreign currency exchange fluctuations of approximately $25 million associated with the weakening of the Australian dollar against the U.S. dollar principally related to our 2021 acquisition of Simplify Medical. On a non-GAAP basis we reported second quarter net income of $24.8 million or diluted earnings per share of $0.47 compared to net income of $31.2 million or diluted earnings per share of $0.60 in the prior year period.

The year-over-year decrease in non-GAAP earnings per share was primarily driven by unfavorable currency exchange rate fluctuations. Notably FX accounted for approximately $0.06 of negative EPS impact during the second quarter of 2022. Free cash flow for the second quarter of 2022 was $26 million versus $19.3 million in the prior year period. The increase was primarily due to increased operating cash flow offset by continued investments in our capital expenditures to support our net sales growth and new product launches. As of June 30, 2022 we had cash and cash equivalents of $226 million, or $550 million revolving credit facility remains undrawn.

Now I'd like to provide our current perspective on the state of our business for the second half of 2022. Stepping back for a minute when we shared our full year 2022 financial guidance in late February we issued a range that was wider than what we would've provided historically given the many uncertainties surrounding the macro environment, including inflation, currency fluctuations, supply chain, COVID and geopolitical issues. As a reminder based on our strong first quarter results in May we raise the lower end of our non-GAAP net sales growth range from 6% to 9% to 7.5% to 9.5% on a constant currency basis.

However, we purposefully did not change our non-GAAP operating margin guidance range of 13% to 14.5% due to these macro environmental uncertainties. Unfortunately, the macro environment has remained uncertain and we can reasonably expect these pressures to continue. On the positive sign procedure volumes are healthy and we are executing well on our multiple vectors of growth strategy. We're seeing continued success with our new product introductions, especially with both the Simplify Cervical Disc and Pulse.

In addition, we expect low- to mid-double digit growth in our international markets. Taking into account current macro conditions we have updated our full year 2022 financial guidance accordingly as follows. We reiterated our full year guidance for reported net sales growth of 6% to 8% compared to 2021. We updated our GAAP diluted earnings per share guidance from a range of $1.5 to $1.35 to a range of $0.95 to $1.25 reflecting current foreign currency expectations. And finally, we maintained our prior non-GAAP diluted earnings per share range of $2.15 to $2.45 that we provided on May 4, 2022. We are working diligently to navigate and manage the macro environmental challenges that we face. We remain confident in the underlying health of our business, our continued strong cadence of new product introductions and the many opportunities that lie ahead.

Now I'd like to ask the operator to please open the call for questions.

[Operator]

[Operator Instructions] Our first question comes from Josh Jennings with Cowen. Please proceed with your question.

[Josh Jennings, Cowen]

Hi, good afternoon. Thank you for taking the questions. I wanted to ask on Pulse and primarily my – I'm curious about the note realizing its still early days, but are you seeing increased utilization and pull through of NuVa spinal hardware in your initial Pulse accounts and how is that trending and sorry, this is one question on Pulse with two parts. I mean, any updates on the robotic module development program? Thanks.

[Chris Barry, Chief Executive Officer]

Thanks Josh. Thanks for the question. So yes, we're early days on Pulse. The goal is obviously getting broad utilization. We've got limited number of sites, but encouragingly we are seeing some pull through and we look at those sites compared to the base business of other sites. So simple answer is we are seeing pull through now putting a magnitude on that, at this point is probably a little early. But the fact is, it is a – it seems to be a stickiness that that we've been looking for and hoping for at least the initial placements of the technology.

Robotic as we talk about Pulse, we've always talked about the fact that we wanted to be a really a suite of technology. Obviously it incorporates all the different technologies I mentioned in some of the prepared remarks. Robotics will be a part of that. We continue to make progress on the robotic development. No updates at this point on timelines, but good progress and we look forward to really equipping pulse with the robotic module as well as many other technologies in the near future.

[Josh Jennings, Cowen]

Understood. Thank you.

[Chris Barry, Chief Executive Officer]

Thanks Josh.

[Operator]

Our next question comes from Vik Chopra with Wells Fargo. Please proceed with your question.

[Vik Chopra, Wells Fargo]

Hey, good afternoon and thanks for taking the questions. So I guess one – first question I had was pricing. Can you just talk about how pricing was in the quarter and what's your ability to take price in this inflationary environment? And then I had one follow up. Thanks.

[Matt Harbaugh, Chief Financial Officer]

Yes. Vik, this is Matt. Thanks for the questions. Pricing was kind of in line with what we've seen before. Obviously it is a headwind for us, but it was in the low-single digits, which is very normal. As far as taking price, difficult to do it on products that have already been introduced, but obviously we're thinking about it as we bring new technologies to the marketplace whether we need to be more aggressive on pricing.

[Vik Chopra, Wells Fargo]

Great. And then just one follow up. Just on procedure volume can you just talk about what impact you've seen in Q2 from hospital staffing shortages? Thanks so much.

[Chris Barry, Chief Executive Officer]

Yes. Thanks for question Vik. We still see it. The interesting thing is we're seeing procedures schedule and then we see procedures canceled from time-to-time and that could be staffing related or it could be patient related, somebody tests positive. So there's still – still really choppy and lumpy. We saw good volume, but a lot of that had to do with the fact that we really entered in markets that we didn't really have any business in very, very low share like cervical. So even with some of the downward pressure we saw good volume growth, but we also saw a bit of mixed pressure there as well.

So some of the complex cases were a little pressured, some of the thoracolumbar where we have high share, little pressure there, still flattish but pressured in area like cervical, where we think we're taking a lot of share, we saw those volumes really high. So mixed bag, but overall we felt good about the volume that we saw in the quarter.

[Matt Harbaugh, Chief Financial Officer]

Yes. And I would just add globally we were really pleased with the results in our international businesses as well. We've said all along low- to mid-double-digit growth and they were squarely in that zone. So another good quarter for our international team as well.

[Operator]

Our next question comes from Joanne Wuensch with Citi. Please proceed with your question.

[Joanne Wuensch, Citi]

Hey, thank you so much for taking my questions. Do I miss it, but did you quantify what you think your new FX headwind will be versus year old?

[Chris Barry, Chief Executive Officer]

Yes. We haven't quantified it on a full year basis. But we did include it in our thinking around reiterating our guidance range. So we didn't change anything from what we said on May 4th as it relates to non-GAAP numbers. So we've included that in our thinking. We did say on the call that we had a $0.06 impact to EPS. So you can back calculate that. Hard to give you a hard number right now because it's volatile. The currencies that we saw – the greatest fluctuation from an operational viewpoint were Japan and the Euro. So we spent a lot of time watching those fluctuations and obviously it's pronounced across the industry. But as we have been growing our international business, obviously it creates more fluctuation for us.

[Joanne Wuensch, Citi]

And the impact on revenue in the quarter and in your guidance?

[Chris Barry, Chief Executive Officer]

Yes. We didn't disclose the impact on our revenue but obviously you can look at it on a constant currency basis versus not, and you can pretty much figure out exactly what the calculation is.

[Joanne Wuensch, Citi]

And the guidance aspect of it, I'm sorry to push on this.

[Chris Barry, Chief Executive Officer]

Yes. Just look at the table that we provided in the release and it'll give you all your answers.

[Joanne Wuensch, Citi]

Okay. Then I'll ask a more product specific one. Could you quantify how simplify sales were in the quarter or qualify if you can't quantify it?

[Chris Barry, Chief Executive Officer]

Yes. We were really pleased with the results and Simplify. We had a nice jump from what we did in the first quarter. So we're really pleased with the results. We really don't want to get into just talking about Simplify because it's really about the cervical portfolio and it's about C360, Simplify, new products that are coming out later this year. The way we think about it is if you ask yourself, are we being successful in cervical? This is our third quarter in a row where we grew greater than 20%, so very notable results.

[Operator]

Our next question comes from Shagun Singh with RBC Capital Markets. Please proceed with your question.

[Shagun Singh, RBC Capital Markets]

Thank you so much for taking the question. So just a question on guidance. So on sales, you've raised your ex-FX outlook and maintained reported growth despite higher FX pressure. I'm just trying to understand what's driving this underlying momentum. You did call out some of the products, but I'm just curious what trends you're seeing into Q3. So in July and maybe I don't know, two days of August, and then any contribution from backlog?

And then on EPS, you've maintained your outlook despite the Q2 myth, so can you just talk about maybe the timing of expenses or R&D projects, inflation, supply, FX and what are you factoring in that gets better in the second half? Thank you for doing the questions.

[Chris Barry, Chief Executive Officer]

Thanks Shagun. I'll take the first one and I'll let Matt cover the second part of the question. So we're seeing underlying momentum in some of the key investments we made. I've talked over the last several quarters about this idea that we've sort of shifted from that singular focus and [indiscernible] to really broadening our focus across – across many different sub-segments, and also continuing to see growth as Matt just talked about in our international market. So those are really the two contributing factors, new products, things like Pulse obviously the focus we have in cervical. Our international growth, all those things I think give us a lot of confidence that we can continue to even in challenging macroeconomic situations continue to deliver on the top line.

So with that I'll turn to Marr on the second part.

[Matt Harbaugh, Chief Financial Officer]

Yes. So with regard to your question around maintaining our earnings per share guidance and keeping the operating margin range the same on a non-GAAP basis. Look we said on the last call that there were a lot of swing factors going on and in the prepared remarks you heard us talk about incremental freight charges, travel charges, increased compensation costs. We have taken all that into consideration and it's the reason why we gave this wide range as we did both from an operating margin as well as diluted earnings per share perspective, but we're still comfortable based on everything we know right now that we can navigate these headwinds. We have looked hard at our expenses and we're looking where we can find the right of offset to deliver on this guidance. But we feel good about the fact that we didn't need to change guidance from where our thinking was on May 4th.

[Operator]

Our next question is from David [indiscernible]. Please proceed with your question.

[Unidentified Analyst]

Yes. Hi Chris and Matt. Thanks for taking the questions and congrats on the quarter. I just had one on kind of like the cadence for revenue through the back half. It looks like last year sequentially third quarter was down around 8%. So just wondering, I think you have a larger NSO benefit in the third quarter. And then with Simplify and Pulse continuing to ramp, could we see something better than that, or should we be thinking in line with what you saw in the third quarter of 2021 sequentially?

[Chris Barry, Chief Executive Officer]

Yes, typically our two highest quarters are the second quarter and the fourth quarter. And you didn't see that in last year’s results, we came in at $270.8 million, which I'm sure, you know. Last year we got to remember the third quarter of last year, the Delta variant was putting pressure on procedural volumes in that quarter. So it's not a good apple-to-apple comparison. I would say we still – we see the third quarter being below what we just posted today for the second quarter. And then the fourth quarter will ramp back up.

And to answer your question on NSO, yes, traditionally, historically, the third quarter has been the highest quarter, although in the results we announced today, they had a very strong second quarter as well.

[Unidentified Analyst]

Okay. That's helpful. And then just my second one on simplified, any way to quantify the kind of halo effect it's having. I mean, it seems like its driving strength across the cervical portfolio, but are you also seeing it pull through across the broader spine portfolio? Thanks for taking the questions.

[Chris Barry, Chief Executive Officer]

Yes, thanks David. We are, that's one of the things that gives us a lot of confidence. We've seen greater than 50 plus surgeons that really didn't have anything to do with this, they have not only started picking up the simplified product, but also the broader C360. We also have greater than a 100 of our surgeons that have been introduced that we see other parts of the portfolio kind of coming into.

So the simple answer is yes, we want to continue to see that put some quantification around it over time, but early indicators would say there is a halo effect. It is giving us better exposure. It will be, as we talked about, we think a door opener for the broader NuVasive portfolio. So early days here, but encouraging results thus far.

[Matt Harbaugh, Chief Financial Officer]

Yes, the other thing I would add on that is we also talked in the prepared remarks around the first cases globally. So we're now introducing simplified in Switzerland, and Australia, and UK, and so on in Austria. So it's exciting times because we've got a really strong base set up in the U.S. market and now we're starting to chip away internationally.

[Unidentified Analyst]

Okay. Thanks. And if I could just ask a clarifying question, Matt, I think, you said for the back half low- to mid-double digit growth internationally. Did I hear that right? And is that on a reported basis or constant currency? Thanks.

[Matt Harbaugh, Chief Financial Officer]

Yes, that's on a reported basis. Obviously with currency fluctuating, like it is, we're trying to give you a sense of what the underlying business is doing. And the guidance of low- to mid-double digits we introduced to JPMorgan in January of 2020. So what we were saying in any given quarter, you should expect the international business, kind of in that 11% to 14% constant currency range.

[Unidentified Analyst]

Got it. Thank you.

[Matt Harbaugh, Chief Financial Officer]

You bet.

[Operator]

Our next question is from Allen Gong with JPMorgan. Please proceed with your question.

[Allen Gong, JPMorgan]

Hi, I'll just put them both together. But when we look at your gross margins, we obviously saw some pressure as you highlighted in the prepared remarks from pricing and inflation. So how should we think about the cadence of that either improving or staying a bit more pressured through the balance of 2022? And then in 2023, assuming trends hopefully continue to get better, how should we think about the kind of leverage we can get on that line as you work through some costs that have been capitalized into your balance sheet?

[Matt Harbaugh, Chief Financial Officer]

Yes. So for this year, what I would say is the fourth quarter, because of what I said earlier, which is, is expected to be the strongest net sales quarter for us. You'll get a stronger operating margin number there. So we'll still continue to see the pressure in the third quarter, because as I basically said, the second and fourth quarter are our top quarters for net sales and that does have impact on margin, operating margin.

As far as 2023, look, I'd love to see inflation come down, the travel costs, as we calculated are up very significantly and travel is a big component of what we do at NuVasive. So we like to see that come down because that will reduce our travel cost. Also with freight, freight has been a challenge starting in the second quarter of last year. And we've seen that continue through this quarter. But again, this is why we gave a wide range for the operating margin from the guidance so that we could feel comfortable, but accommodate some of these factors that are hard to predict.

[Operator]

Our next question is from Rich Newitter with Truist Securities, please proceed with your question.

[Rich Newitter, Truist Securities]

Hi, thanks guys. Thanks for taking the question. Wanted to just start off with the guide first on the earnings, I appreciate that you are keeping your guidance range unchanged. It was a large range. You called out $0.06 of currency impact in the second quarter. Is that a reasonable kind of rate to just kind of run through the rest of the year? And if so, I guess, do you feel like you are more or less likely to be towards the midpoint or perhaps towards the midpoint to lower end of the range, or whether enough offsets, especially with the increased rev guide that you still feel comfortable with that midpoint of the range? Thanks.

[Matt Harbaugh, Chief Financial Officer]

Yes. Hard to predict right now, because our biggest quarter is in the fourth quarter as we think about the balance of the year. Predicting currencies is very challenging. We just looked at currencies earlier today to see if there was any change in the numbers. And Japan has gotten a little favorable and Europe has gotten a little unfavourable. And net-net they are falling out to the same place.

With all this volatility, it would not be unwise to include in your model some impact $0.06 maybe a good number to use. But I do anticipate the volatility to continue in the back half of the year. It's unlikely that it will kind of go back to where we were in previous years where the amount of impact was not very material.

[Rich Newitter, Truist Securities]

Okay. Well I guess just to follow-up, on that, I mean, if currency rates were to remain constant and pulled right, is it safe to assume you are thinking about the range with kind of the midpoint and all parts of the range are on the table still?

[Matt Harbaugh, Chief Financial Officer]

Yes, we pretty much took the impact we saw year-to-date at the end of June and said, if that continues, that would be the impact. And you can calculate that based on our first quarter and our second quarter release.

[Rich Newitter, Truist Securities]

Okay, great. And one more if I can just squeeze it in. Any comments on kind of what kind of trends you saw through June and even if you can into July and August? I know its fluid, there are vacations, we're kind of an unchartered territory here in a post pandemic period. So, I'd be curious, just what you're seeing there. Obviously, you raised your guide, so you are able to power through whatever might be seeing, but can you talk to the trends month-to-month? Thanks.

[Matt Harbaugh, Chief Financial Officer]

Yes, I mean, I'll give you an overview of that Rich. It’s just been choppy. I mean, I'll just tell you week-to-week it's choppy. So it's really hard to trend out. Some normal seasonality appear to be in the numbers, which we expect in the back half of the summer, where specifically in some international markets and in the U.S. we just see increased level of travel. So what's contributing to the choppiness is still hard to sort of to distill out.

But clearly I would say on an average, we're seeing pretty good volume. On a week-to-week basis or month-to-month basis it's still a little up and down. So the simple word is choppy. But I would say underlying that choppiness is a trend line that least shows volumes that exceed pre-pandemic levels or right at pre-pandemic levels. So we think that's potentially a good floor. Just want to see a more predicted trend kind of start to form hopefully over the next few months.

[Operator]

Our next question is from Drew Ranieri with Morgan Stanley. Please proceed with your question.

[Drew Ranieri, Morgan Stanley]

Hi, thanks for taking the questions. Maybe just to follow-up on Rich's questions, if you could go a little bit more into what you're seeing in terms of the market in general, Chris, you talked about your confidence in taking share in cervical, but just kind of wondering where you are thinking in terms of the broader spine market and maybe what underlying growth was,

And then just to add a second question in there, can you give us any type of preview of what we should be expecting on the upcoming Investor Day? Thank you.

[Chris Barry, Chief Executive Officer]

Yes, I'll try to glean it out. I mean, really, if you think about our portfolio where we had areas of strength we saw more downward pressure from volume perspective, not negative comparatively, but down just not underlying growth that would have expected areas, some of thoracolumbar procedures, posterior is down fairly sharply. We were flattish in the anterior segment and that's with some good growth in ALF where again, where we're still taking share.

Some of the complex cases were down and then areas that we've made a lot of investment like in cervical, I think even with the downward pressure, we saw some strength just because we were all out share taking so it's hard to kind of get to glean the underlying market growth. We look at the NCS data that we have, and that would show that it was sluggish at best in the quarter. So we feel pretty good about our performance in general.

As far as Investor Day I don't know that we've let anything else on it. We're looking very much forward to talking to everybody and kind of reshaping some of the narrative, filling in some of the blanks for everyone. So we're committed to it in scheduling, but I don't think we have any other updates other than that at this point.

[Matt Harbaugh, Chief Financial Officer]

Yeah. The only other thing I would add on that is we do intend on doing a product fair. What we have found is that when people actually get to see the technology and talk to folks below Chris and I, that know the products in and out, that people more fully appreciate the technologies that we're bringing forward, which obviously is manifesting itself in the strong growth we've posted today. So we will do a product fair and look forward to introducing the products at a deeper level.

[Operator]

Our next question comes from Jason Wittes with Loop Capital. Please proceed with your question.

[Jason Wittes, Loop Capital]

Hi, thanks for taking the questions. Just first off in terms of the guidance just the housekeeping thing. I see GAAP was lower with non-GAAP rate is that a one-time charges? Is that the difference between the two estimates or guidance?

[Matt Harbaugh, Chief Financial Officer]

Yeah. It's just taking into consideration charges that occurred between GAAP and non-GAAP. The numbers you should focus on Jason are really on the non-GAAP, because we're basically reconfirming that, there are going to be fluctuations in GAAP and you can see all that in the reconciliations that came out in the table release.

[Jason Wittes, Loop Capital]

Okay. I thought so. And then the real question I wanted to ask was about Simplify and Pulse in terms of, it sounds like at least on Simplify, at least from some of the commentary you made a lot of the growth is coming from new accounts. I assume those are accounts that had already been using disc and you're displacing some competing discs? And then the same for Pulse. And if you think about the customer or the users at this point, is that primarily your own customer base or is that also extending into new territories?

[Chris Barry, Chief Executive Officer]

On simplify, I would say that, it's primarily cTDR users that are moving from other companies and there are several companies, but I would also say that, it would feel and again, we got to see this trend out that the market has accelerated a bit. And I think that may be some of it is our performance there and our introducing the cTDR the Simplify disc into the market. So there is definitely some new interest in using artificial disc in the cervical space. But I would say the majority of our, our growth is likely from competitive users at this point.

As far as Pulse it's a little tricky to say, that they're clearly, they may have been using some of our hardware, but clearly not using anything navigation or anything enabling tech from us other than potentially our neuro-monitoring systems or maybe in certain situations Lessray. So we think that anybody that's picking up Pulse right now is moving from a likely, a predicate system that they've employed at some point.

So new technology for us in the market, not new technology specifically in the market in some cases, but new technology for us. So that's one that we'll see trend out a little further. But as I said earlier we are seeing some good pull through the account that we have installed Pulse in. We see a material increase in the overall business that we're getting those accounts.

[Operator]

Our next question comes from Matt Miksic with Barclays. Please proceed with your question.

[Matt Miksic, Barclays]

Yeah, thanks so much for taking the question. One follow-up on Simplify. Chris, you were just talking about the nature of growth and share gains. Wanted to get a sense of sort of, part of this has to do with taking surgeons and centers where you have good relationships who may be using in another disc and converting them to Simplify, where you are in that? You said in fact that's one of the drivers, just trying to get a sense of how important that is, and how much runway you have along that pathway of growth for Simplify? And then I had one follow-up.

[Chris Barry, Chief Executive Officer]

Thanks, Matt. Yeah, I said earlier, I quoted the number that I've seen a few days ago that 50 plus may maybe even 50 to 60 plus surgeons that sort of started out using Simplify have now adopted other parts of the cervical portfolio, which tells me that, that it's bringing along the interior cervical plate, and we're launching Reline C late at this quarter. So we've got – I think we've got a lot of dry powder still pent up, and we're just now getting out of the gate really with Simplify.

We're still ramping up our capacity. We're still ramping up the number of sets that we're releasing. We're still entering new geographies as Matt mentioned earlier. So I think we've got a good runway. And I think the artificial disc space in general will continue to grow faster than the relative cervical market, which is fairly large, but fairly flattish in growth. So $2.6 billion market, we think the cervical disc space is probably $250 million to $300 million you know, I think the $250 million number is probably antiquated. So we look at more the $300 million growing, near double digit.

We think now we've got to quantify that coming out of the pandemic. But so all those things considering the fact that we estimate we still have less than 5% share, we think we've got a lot of runway to grow in the cervical to really grow the cervical market.

[Matt Miksic, Barclays]

That's great. I appreciate that. And then the follow up just comment you made around sort of the systemic and supporting technology and patient follow-up quality of outcomes being, the things that are really going to change spine surgery going forward as opposed to sort of a new interbody maybe. I wanted to get a sense of, I think I know the answer to this, but I'm guessing that you have a fair amount of sort of new implants, revised implant systems and technologies in the pipeline. Just love to understand how you're balancing your spend on R&D, which I know is significant to get, particularly Pulse opened out the door and support that. But also to kind of continue to back it up with kind of things that NuVasive has been known for in the past, which is a steady flow of well designed implant systems as well?

[Chris Barry, Chief Executive Officer]

Yeah, that's a great question. And one that we've talked a lot about, when you think about kind of Phase 1, as I've sort of come in, I think NuVasive has always been known for fantastic instrumentation, great implant technology, and there's still work to be done there. By no means, are we finished and we'll continue to refresh the portfolio. As we see innovation opportunities, the R&D team does a phenomenal job there.

But having said that I believe that what happens pre-surgery and what happens post-surgery are part and parcel to the overall success for that patient. And choosing the right patient with the right procedure, a patient presents with pathology and there's just unlimited options that they pursue. So we got to get smarter as an industry and ensure that the pathway is clear and its data driven. And then what happens, post-surgery, what can we measure? There's a lot of things that we can measure. And there's clearly a lot of things that we can't measure, what the impact of the surgery was on the patient longer-term.

A lot of its patient reported outcomes, which is are you still in pain? Are you not in pain? So I think there's more we can do. And there's technology out there that we think we can incorporate. So we believe that our proceduralization strategy is truly sets us up uniquely, specifically, as we add in something like a Pulse system to really start to think more broadly about the whole patient care continuum. And that's where we're looking for. We're looking – we continue to really hone in our focus on measuring what's unmeasurable and providing support in areas that we don't necessarily today. And we think doing those things will increase the overall outcome for the patient. And as we said create value for us and our shareholders.

[Matt Miksic, Barclays]

That’s great. Thank you.

[Operator]

There are no further questions at this time. I would now like to turn the floor back over to Chris Barry for closing comments.

[Chris Barry, Chief Executive Officer]

Thanks, Maria. And thanks everyone for joining us today. I just want to just reiterate the fact that we're excited, happy with the performance in the quarter, continue to focus on this idea of multiple vectors of growth, extending our leadership in less invasive surgery, taking share in those underrepresented segments, delivering on enable technology roadmap and our starting point here is Pulse. And then obviously continue to drive our international growth.

And as I just mentioned with Matt, ultimately extending the parameters innovation to really create a more intelligent spine surgery. So with that, I thank you all for your participation. And we look forward to speaking with you again in the next quarter.

[Operator]

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.