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Good day, ladies and gentlemen, and welcome to the NuVasive Third Quarter 2022 Earnings Conference Call. [Operator Instructions]
I would now like to introduce your host for today's call, Miss. Juliet Cunningham, Vice President of Investor Relations at NuVasive. Please go ahead, Miss. Cunningham.
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 third 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. 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 the supplemental financial information, both of which are accessible on NuVasive’s website.
And now, I’d like to introduce Chris Barry.
Thank you Juliet and good afternoon everyone. Earlier today we reported third quarter 2022 financial results. On today’s call I will review our performance for the quarter, discuss the three fundamentals of our growth strategy and review how the company’s innovation strategy uniquely positions us to deliver on the future spine and specialised orthopedics. After my remarks, Matt will provide additional financial details on the quarter and commentary on the remainder of the year.
NuVasive delivered third quarter 2022 net sales of $295.3 million an increase of 9% on a reported basis. On a constant currency basis the third quarter net sales were $305.8 million an increase of 12/9% compared to the prior year period. Like many other global leading companies, we’re not immune to macroeconomic pressures; however, we continue to grow above market in both our U.S. and international businesses. We had another strong quarter in our international business achieving double-digit growth in every region on a constant currency basis. Led by core spine growth and higher net sales from NuVasive specialised orthopedics.
In the U.S. our spinal hardware business delivered double-digit year-over-year growth driven by continued demand for the X360 portfolio led by marginal sale of adoption and [Indiscernible] procedure volume recovery, strong performance by NuVasive specialised orthopedics and higher cervical net sales led by the C360 portfolio.
This quarter, we delivered more net sales from our cervical portfolio than any quarter in our history. And most importantly, we still have significant runway in this key procedural segment. Our U.S. surgical support business delivered mid-single digit year-over-year growth in the third quarter driven by procedure volume recovery, and NuVasive clinical services, growth and interruptive neuro monitoring disposables, and pulse platform sales. While we cannot control fluctuations in foreign currency rates, we can control how we execute on our growth strategy.
As evidenced by our net sales performance this quarter, we continue to outpace the global spine market. We have seen an increase in procedure volumes, specifically in lower acuity thoracolumbar and cervical procedures. And given our leading portfolios within those respective segments, we are well positioned for continued volume recovery. Conversely, higher acuity cases within the complex procedural segment have not rebounded as quickly.
In early October, I outlined at our 2022 investor day, the three fundamentals of our long term growth strategy, fundamental number one, delivering core growth, which continues the momentum and our core business and opportunities from globalization.
Fundamental number two, introducing intelligent surgery, which extends the pulse platform with integrated solutions supporting the care pathway from preoperative to post-operative care and fundamental number three, aggressively pursuing the attractive market opportunities both in and outside of traditional spine.
Starting with core growth, we have significant procedural runway that our 360 strategies will continue to target through meaningful innovation. To remind you, 360 represents our comprehensive, procedurally integrated solutions that are applied to a surgical approach, giving surgeons the flexibility to choose the right procedure for the right patient. Within the $900 million anterior segment, we remain the market leader and have a strong foundation to build upon. We continue to see high demand for modulus ALIF as well as our core procedural offerings within X360 portfolio, including XLIF XALIF and XFixation.
We have continued to grow our advanced material science portfolio, the company's best-in-class implant portfolio to include our next-generation expandable technology Mod-EX. In early 2023 Mod-EX XLIF will begin clinical evaluations, which we expect will bring continued interest in our market leading X360 portfolio. Within the $1.7 billion posterior segment, we have tremendous runway with our P360 portfolio, providing comprehensive pathology driven solutions from the prone position.
To that end Mod-EX PL began clinical evaluations in the U.S. market this month. In addition, the recent commercial launch of the NuVasive tube system provides surgeons less invasive surgical access for both TLIF and decompression applications and is the company's first tubular access system today.
Turning to the $2.6 billion cervical segment as I mentioned earlier, our C360 portfolio delivered a record quarter in net sales. We have a highly differentiated portfolio and we will continue to take share with the industry's most clinically effective cervical total displacement with the Simplify Cervical Disc, the thinnest interior plate system on the market with NuVasive ACP, and our most recent addition to the C360 portfolio, Reline Cervical, the cervical extension to the industry's most comprehensive fixation system Reline. Central to our core growth strategy is enabling technology and integrating the pulse platform with each procedure. While other enabling technologies in market deliver limited clinical utility, pulse differentiates itself in that it can be used in 100% of spine procedures.
Our customers are experiencing the benefits of the platform. We've achieved new milestones this quarter, including our first pulse case and an ambulatory surgery center, our first pulse case in Australia and increased X360 integration with pulse and multiple global markets. Our customers are not just focused on the neck screws, plates, implants and standalone navigation systems. Surgeons and providers need intelligently designed solutions. And we remain laser focused on furthering our philosophy of comprehensive procedurally integrated solutions with our 360 portfolios and the pulse platform.
That focus is reflected in the recent commercial launch of Reline Cervical. From the onset, Reline Cervical was designed to be integrated with Pulse giving surgeons the ability to support more complex deformity cases with the help of global alignment planning, neuro monitoring, radiation reduction in imaging enhancement, navigation and patient specific Rod bending.
Combining state of the art technology for posterior cervical fusion with pulse, delivers an optimal solution for our surgeons, and most importantly, for our patients. As the foundation of our enabling technology strategy, pulse is key to unlocking our vision for our second fundamental of growth, intelligent surgery. Unlike other orthopedic segments, the spine industry has been challenged to drive clinical standardization due to the variability in outcomes. Outcomes will improve when clinical decisions are fact based and not subjective, and enabling technology support this focused effort.
To achieve better outcomes, we must help surgeons identify whether a patient is an appropriate surgical candidate, what the right procedure is for the patient, will it lead to the patient's desired outcome, and whether the surgeon achieved that intended outcome? To do so, we need to provide data and advanced planning preoperatively. Integrate smart tools that deliver real time information inter operatively and make intelligent devices available that track outcomes postoperatively. Our vision to change a patient's life every minute, and our purpose to transform surgery, advanced care and change lives, guides our next phase of innovation. By delivering on the promise of intelligent surgery will help define the standard-of-patient care from pre-op to post-op. We are investing and will continue to invest in meaningful innovation to drive the future of spine surgery.
Our growth journey will be aligned with aggressively pursuing market opportunities, including those outside of traditional spine, which is our third fundamental for growth. Our team is actively identifying novel technologies that further our spine and specialized orthopedic portfolios and expand into other adjacent markets. An example of this is our recent partnership with SMAIO, a French-based technology company that specializes in the use of clinical data and preoperative planning.
Like many companies with a scaling global presence, we're not immune to current market challenges. However, we're making continued progress to deliver multiple vectors of growth, through extending our 360 strategy across all key segments. Integrating our procedural solutions with enabling technology and pulse and driving continued above market growth in global markets.
I'm confident in the three fundamentals of our growth strategy, the durability of our business, and how we are strategically positioned to deliver on our commitments in the short and the long term. NuVasive will make surgery more intelligent, and as we do will transform the future of surgery, supporting our surgeons, but also helping change the lives of millions of people around the world suffering from back pain.
I'll now turn the call over to Matt to discuss the company's financial results in more detail.
Thank you Chris and good afternoon. I'm going to cover our third 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 and supplemental information. During my remarks, I will be discussing both GAAP and non-GAAP measures. Please see our press release for GAAP to non-GAAP reconciliations.
I'll begin with commentary on worldwide net sales. Our third quarter results reflect strong net sales compared to the prior year period. Third quarter worldwide net sales were $295.3 million, an increase of 9% as reported compared to the prior year period. This includes a $10.5 million negative impact on our net sales due to foreign currency fluctuations.
On a constant currency basis, third quarter net sales were $305.8 million, a 12.9% increase compared to the prior year period. International net sales for the third quarter showed continued strong momentum at $68.8 million, representing growth of 5.3% as reported and 21.3% on a constant currency basis compared to the prior year period.
As a percentage of total net sales, international was approximately 26% on a constant currency basis. Our U.S. business demonstrated double-digit growth during the third quarter of 2022.
Turning now to our U.S. net sales by product line. U.S. Spinal Hardware net sales were $163.5 million, representing a 12.7% increase over the prior year period. Our cervical portfolio achieved a record quarter in net sales led by the C360 portfolio and the Simplify Cervical Disc, which continues to experience strong surgeon demand due to its differentiated features.
In addition, our thoracolumbar portfolio growth was fueled by continued demand for Modulus ALIF as well as procedural growth in XLIF.
U.S. Surgical Support net sales were $63 million, an increase of 4.2% compared to the prior year period. Growth in our Services and Pulse business was partially offset by a decline in Biologics, which was due to fewer stocking orders as well as shifts in procedure volume towards cervical cases, which utilize a lower proportion of biologics.
Moving to operating results. Non-GAAP gross profit for the third quarter was $214.4 million compared to $197 million in the prior year period. The year-over-year increase was largely driven by net sales associated with higher procedure volume. As a percentage of net sales, non-GAAP gross margin was 72.6%, essentially flat compared to 72.7% in the prior year period.
Third quarter 2022 non-GAAP operating expenses were $174.3 million, an increase of 4.7% compared to $166.6 million in the prior year period. The year-over-year increase was primarily driven by variable expenses on net sales higher depreciation costs from investments in surgical instrument sets and inflationary impacts in areas such as travel and freight costs.
Third quarter 2022 non-GAAP operating margin was 13.6%, an increase of 240 basis points compared to 11.2% in the prior year period. The year-over-year increase was primarily driven by higher net sales, lower R&D expenditures as a percentage of net sales and increased commercial efficiencies. Fluctuations in foreign currency exchange rates also had a material negative impact on non-GAAP operating margin during the quarter.
Current quarter non-GAAP operating margin using foreign currency exchange rates from the third quarter of 2021 would have yielded a non-GAAP operating margin of 15% and approximately 140 basis point improvement from our reported results.
Non-GAAP other income and expense for the third quarter was $5.1 million of expense compared to $7.1 million of expense in the prior year period. The decrease was mainly driven by unrealized foreign currency losses due to fluctuations in exchange rates. Non-GAAP tax expense for the third quarter of 2022 was $6.6 million compared to $6.4 million in the prior year period.
Our third quarter 2022 effective tax rate was 18.9% compared to 27.5% in the year ago period, and we continue to expect the full year 2022 non-GAAP effective tax rate in the low 20s percent range.
On a GAAP basis, we reported a net loss of $2 million or diluted loss per share of $0.04 in the third quarter of 2022 compared to a net loss of $21.6 million or diluted loss per share of $0.42 in the prior year period. Included in our GAAP results for the third quarter were unfavorable impacts of foreign currency exchange fluctuations of approximately $20 million, primarily associated with the weakening of the Australian dollar against the U.S. dollar related to our 2021 acquisition of Simplify Medical.
On a non-GAAP basis, we reported third quarter net income of $28.3 million or diluted earnings per share of $0.54 compared to net income of $16.9 million or diluted earnings per share of $0.32 in the prior year period. The year-over-year increase in non-GAAP earnings per share was primarily driven by operating profit growth.
Turning to the balance sheet. We ended the third quarter with cash and cash equivalents of $237.5 million. In addition, we have an undrawn $550 million revolving credit facility, and our total net debt leverage is 3.3. We generated $15.9 million in free cash flow during the quarter compared to $33.2 million in the prior year period. The decrease was primarily due to timing of net sales and collections within the quarter as well as continued investments in surgical instrument sets to support net sales growth and new product launches.
Moving on to full year 2022 guidance. Our updated outlook takes into account our year-to-date performance through the third quarter, along with fourth quarter expectations. We have also considered macroeconomic pressures on net sales and operating profit experienced to date and expect to experience similar levels of impact through the remainder of the year.
Based on our current business outlook, we are updating our full year 2022 guidance as follows: We are updating our full year reported net sales growth range to be between 5.5% to 6.5%. We are narrowing the top end of our net sales growth range on a constant currency basis and now expect growth of 8.7% to 9.7% based on foreign exchange rates as of September 30. We now expect non-GAAP operating margin of 12.3% to 13%, a reduction from the 13% to 14.5% range to which we previously guided.
From a full year perspective, foreign currency exchange rates are negatively impacting our expected non-GAAP operating margin by approximately 120 basis points on a constant currency basis. It is worth noting that this impact has materially worsened from expectations assumed in our prior guidance ranges, and we now expect non-GAAP diluted earnings per share to be between $2 to $2.10 per share. We continue to work diligently to navigate and manage the challenging macro environment we face. We remain confident in our business, our competitive position and product portfolio in our near- and long-term growth opportunities.
Now I'd like to ask the operator to please open up the call for questions.
[Operator Instructions] The first question comes from Matt Miksic with Barclays. Please go ahead.
Hey good evening. Thanks so much for taking the question. So one on sort of the top line, if I could, and one on some of the impacts on EPS on margins. So impressive, I love to -- I think we're all happy to hear the progress on cervical. It's a long battle, and it sounds like you're winning it finally. If you could talk maybe a little bit about the difference between contribution and sort of the implant side, the cervical side versus maybe what you thought or where expectations were for Pulse. And then I have just, as I mentioned, one follow-up on the P&L, if I could.
Matt, can you hear me now?
We can, yes. Thank you.
Listen, I was -- I had a really good answer for your question first time, but is get me off. So I'll try to repeat it. Listen, we're very pleased with our results. Cervical has been a great growth engine for us. So we've had now consecutive quarters of very strong growth led. We talked about with this quarter being the highest net sales growth. We're more than on track for the deal model we put together for Simplify. That continues to be a key growth.
Now I'll just kind of backing up. If you think about our core strategies, and we talked about at Investor Day, we talked about core grow of really X360, C360, P360 complex surgery in Pulse. And all of those things are actually contributing. I would say, really, our X360 franchise with growth in ALIF, cervical, really growing across the board. Our P360 is really just getting started and work to do to invest more in complex, and then the globalization efforts have continued to produce as well as our introduction of Pulse. So we're pleased across the board with the growth profile and feel like it's got the durability and the run what we talked about a few weeks ago.
Appreciate that. And just on margins, if I could, for Matt, as we turn the corner here into 2023 and think about the impact that FX had worsening, FX had on your margins and EPS. Can you help us at all to think about what sort of an underlying margin assumptions might be that we could start thinking about for next year? And then how FX should continue to weigh on that, if that's in fact sort of the expectations you have at this moment.
Yes, Matt. It's a bit early to be talking about 2023, but let me kind of frame this for you from a 2022 perspective. I think what has happened is the currency fluctuations have been much more material at least for us than what we've seen in prior quarters. And in the second quarter, we had a $7 million hit on the top line from currency.
And so as we came out of that earnings call for the second quarter, it was kind of hard to predict where currencies were going to go. They've gotten worse since August. You can calculate it out we saw little over a $10 million impact in the third quarter. And as we're thinking about the fourth quarter and looking at currencies, we think it will actually be up a couple of million worse than that probably based on our current forecast. So it's weighing the top line and the bottom line, unfortunately.
But if you see through the clearing, this was a very strong quarter for us, as Chris mentioned, we did come in above consensus on operating margin and on EPS despite the currency headwind. So we were able to kind of offset it. But as we're coming into the fourth quarter, we're seeing more and more material impact from currency.
Okay. Well I appreciate the color you provided. And congrats again on the topline and hope to catch on you later.
Thanks Matt.
The next question comes from Josh Jennings of Cowen. Please go ahead.
Hi, good evening. Thanks for taking the questions. Wanted to ask, Chris, on this X360 integration with Pulse. It sounds like you guys are making some progress. I want to better understand the steps essential in crossing the finish line there, just getting your customer base with this integration. Is there anything on the software or hardware side that there's more just training?
And then just a quick follow-up on U.S. Cervical Support and other just wanted to just understand if there's seasonality in that business and just thinking about the 2Q performance in U.S. surgical support and other versus the 3Q sequentially. It's just I think we mis-modeled a mid-single-digit obese an aggressive assumption, but I just wanted to better understand seasonality or anything changed sequentially in that business? Thanks a lot.
All right. Thanks, Josh. I'll take the first one, and I'll let Matt handle the second one as far as if there's some sort of seasonality or anomaly there. But with X360 integration with Pulse, a lot of the applications are there today, the software integration, we continue to make really enhance the navigation relationship with both the navigation system and the instrumentation that we use in those cases.
So we're applying that to not just X360, but across the entire portfolio over time. And a lot of the rep we're doing with our software iteration and upgrading our software overtime to continue to enhance the proceduralization, if you will, to be inclusive of not only the instrumentation implants but now the Pulse ecosystem.
So natural part of the investment strategy that we've had around Pulse. And clearly, I think a value add moving forward that pays hopefully, increases the value of the system with our customers as we move forward over time. Does that make sense?
Definitely. Thanks.
Yes, Josh, thanks for the question. Pull stood time for the quarter for us, which is in surgical support. NCS did have rough quarter last year. It had a better quarter this year. So that did put some variability in there. But all in all, not much that's very notable and U.S. surgical support to go through.
All right, thanks Matt. Appreciate it.
Thanks Josh.
Thank you. The next question comes from Vik Chopra from Wells Fargo. Please go ahead.
Hey good afternoon and thanks for taking the questions. Two for me. First, Matt, I guess, I appreciate all the comments you've made on the margin, right. But how are you thinking about the pace of margin expansion, especially as you think about your LRP goals.
And my second question is for Chris. Chris, at your Analyst Day, you spoke about getting more aggressive on M&A. Just wanted to follow up on that and if you're actively looking for M&A and if so, what areas. Thank you.
On your margin question, I feel good about the plan that we rolled out on October 6. We're fully committed to delivering on that plan. We do hope to see progress next year in our bottom line performance in particular. The good thing about the currency situation is, is it's transient, right? So we really try and look at the math without currency to see what the underlying trends are. And when you look at those trends, whether it's cervical, international growth, we're firing on all cylinders.
Yes, Vik, I would just say I did talk a little bit about M&A and our focus. It's kind of a natural progression of our investment strategy. We've even through the pandemic really accelerated a lot of our R&D to produce a lot of the technology that you're seeing translating into growth today and we'll continue that translation over the next couple of quarters into 2023, 2024 and beyond. A lot of that is the core growth strategy.
And Ryan and the R&D team has done a phenomenal job. We've got great product launches coming out this year that continue to complement X360, C360, P360 and extend the whole MOD-EX, with MOD-EX XLIF, MOD-EX TL. We also have the RELICE-C [ph] system coming out. So a lot of great technologies coming out. But we also recognize the power that we're seeing in products like Simplify.
So we'll continue to try to deploy capital to add complement to our core to continue to accelerate this whole intelligent surgery strategy, continuing to build out technology like SMAIO and add those into the portfolio. And also look at things like NSO, it's a material growth driver for us over the strapline. We've talked a little bit about it, we'll talk more about it. I consider that a near adjacency and we'll continue to explore not only building on NSO, but other near adjacencies within the portfolio.
So really, those three areas are the areas that we really want to focus on. But we're excited, like I said, the core is growing, simplifying the acquisitions we've done have been fruitful, and we'll continue to support capital as we see opportunities. Is there a follow-up Mr. Chopra?
No that was it. Thank you.
Thank you. The next question comes from Joanne Wuensch with Citibank. Please go ahead.
Good evening. And thank you so much for taking the question. Can we spend a little bit of time on what's going on in the international market because on a constant currency basis that looked quite strong to me.
Thanks, Joanne. It was -- as reported, I believe it was around 5.3% at constant currency risk -- a little over 21%. So very strong performance. I would just say that the sort of the net average diversification strategy, if you will, that we've deployed really is working well. And as I've talked about before, we sort of shifted gears around 2, 3 years ago, not just to export product but really try to expand our brand and presence in these markets.
A good example is the Experience Center we opened up recently in Singapore. We've done a lot of work in areas like Japan, where we've had market specific launches. We continue -- I believe, the teams in those markets will continue to do a great job of going out and marketing our technologies and really in building out the right commercial teams to execute. So we were hitting on all cylinders really over the last quarter with all markets growing above double digits.
So in other quarters, I would say, we might have had a bit of a whack the hole for like in a better term, where you might have a one or two market situation due to covet or some external factor made up by the others. This particular quarter, we saw pretty consistent growth across all the key markets. So we're pretty happy with the success the teams are driving. And we think that's like we talked about a lot. We think globalization is a very durable growth engine for us with some good runway.
As a follow-up, is there a particular product that's driving this? Or is it just broad-based?
It's fairly broad-based. But think about it like this. There's probably work generationally, but that's the only way that comes to mind. We're just introducing XLIF in some of these markets. We've yet to really drive our cervical portfolio in a meaningful way. So that's where I get the confidence that we not only can grow today, but have the opportunity to continue to introduce new technology to market because we're on a bit of a lag.
So that's -- it's not one specific. I think our interior portfolio is likely growing. Complex surgery is growing. We're likely just getting into some of these markets in areas like cervical. Pulse is being introduced in certain markets as we speak. So I think it's just general momentum we're generating as a company with a good runway of technology to follow-up. Next question.
The next question comes from Richard Newitter of Truist. Please go ahead.
Hi, thanks for taking the question. This is Sam on for Richard. Just one more on international and can qualify it to the U.S. as well. Is there any way you can break down sort of NSO contribution and how that grow versus sort of the core portfolio in 3Q?
Yes. Chris I would answer it. From an international perspective, our core Spine business we said low to mid-double-digit growth very consistently over the last 3, 4 years, and the underlying business was in that zone and then the rest would have been driven by NSO recovery.
The next question comes from Shagun Singh with RBC. Please go ahead.
Thank you so much for taking the question. Just I guess, if you can help us with the guidance a little bit. So you've lowered EPS by 11% at the midpoint or about $0.25. I'm assuming the majority is export. Is there anything else in it like inflation supply just any other factors?
Yes. Shagun, we have been able to absorb through the third quarter the impact that we've seen from freight and oil related to oil costs. So we've done okay there. We put in some measures to contain costs where we could. And so that's been successful through the third quarter. The challenge we find ourselves in and why we adjusted the guidance today is the bottom line impact from currency is significant and difficult to overcome, but yes, and currency has been a challenge for us. But as we said earlier, the business itself is very strong, and we're poised to set ourselves up well for 2023.
The next question comes from David Saxon with Needham & Company. Please go ahead.
Hi, good afternoon and thanks for taking the questions. Maybe a follow-up on a previous question. Just wondering how we should think about your appetite for M&A, that's dilutive or would maybe make it more difficult to achieve your LRP operating margin target? One, you're prioritizing over the other?
And then I'll just ask my second upfront, Matt, any update on how you're thinking about the $450 million coming due in June? I'd imagine you have to refi at a maybe higher rate. So any thoughts on how you're thinking about paying down a portion versus refinancing the full $450 million. Thanks so much.
David, I'll take the first one. Thanks for the question. Listen, I never try to make a hard fast rule on margin dilution in relation to innovation and how that actually fits into the growth of the company. Having said that, we do believe we are committed to the op margin expansion story. So we definitely favor the type of technology that we can synergize and ultimately drive some neutrality or at least create a non-dilutive scenario over the strapline period. Could have some disruption in the short term, but we're committed, as we talked about, to get it up to that 18 to 21 range that we talked about a few weeks ago in 2027. So I'm contemplating that as we talked. Now clearly, something comes about that I think is a game changer. I'll come back and talk about it. But that's how we're thinking about it today in those categories I mentioned in the earlier question.
Yes. We don't always see you a simplify like deal where you're getting a nice return within 1 year of the acquisition. Turning to your question on the convertible notes. We continue to monitor the market. As you might imagine, I spend a lot of time talking with bankers. We’ve said clearly that if need be, we can cover the $450 million through the revolver and cash on hand. But we'll be sensible and we'll be thinking about how to navigate the debt. And as I joke with Chris from time to time, I'm hopeful that we'll be doing a transaction, a business development transaction while we're looking to solve that $450 million.
The next question comes from Jeff Johnson of Baird. Please go ahead.
So maybe just two follow-ups, Matt, on the guidance again. I just want to understand. So the 1 point adjustment to the top end of the constant currency guidance for the year, what changed just between second quarter and third quarter that made you tighten the midpoint of that range a little bit?
And then it sounds like your answer on EPS, the guidance reduction there is all FX. In my model, the FX has flown through maybe $0.10 to $0.15 of the $0.25 takedown. So just trying to compare my math to yours. Was there anything else besides FX in that $0.25 reduction to the midpoint of the EPS guidance or is it all FX? Thanks guys.
Yes, you bet. So as we're getting closer to the end of the year, obviously, it's November 9. We wanted to narrow the ranges and kind of be clear as to the above $10 million impact we're likely to see from currency in the fourth quarter, and we calculated based on the end of October. So it's the precious number we have. There is some room in there just for the uncertainties that we have out there from a macroeconomic perspective. But certainly, currency is a key driver of the EPS adjustment and the operating income for that matter. Thanks for the question.
The next question comes from Matt Taylor with Jefferies. Please go ahead.
Hi, thank you for taking the questions. I just want to ask you about market dynamics, which you touched on in the prepared remarks. I guess my question comes from you're looking at the Q4 range, it's a bit wide. So I was wondering if you could give us any update on what you're seeing in early Q4 over Q3? And what do you think are the main variables that would put you higher and lower in the range.
Yes, I'll take a shot at a little early. I mean we've seen -- we saw sluggish volumes in kind of the July, August better in September, improving that improves into October. As I've said all along for the last couple of years, we want to see something trend out and show some normal seasonality. So we hope that transitions. And if we get into a very normal seasonality, then I think there's potential upside. We're also seeing some clear differentiation in kind of lower duty versus power acuity types of cases.
And what that translates to is really strong volume, but those higher acuity cases generate generally more revenue. If those were to come back into Q4, not only we'll be well positioned in the lower acuity where we're seeing a lot of our growth now and allows us to actually grow as you're seeing double digit in what I'd consider to be a flattish market, but also positions us to take very much -- take an opportunity to really pick back up the upswing in some of the lower acuity -- I'm sorry, the higher acuity cases complex cases.
A lot of dynamics are governing this. These cases aren't going away, but the velocity has clearly slowed down. And some of the reasons that I would just point to are likely or block times are probably being used for lower acuity cases, you can do more of those cases, get more patients through. These complex cases I'm talking about are what daylong cases that take up a lot of time. There could be some patient dynamics influencing. But better, more improved volume over the last couple of months into the first couple of months of Q4, still seeing some differential in the mix, as I talked about, but all things considered, I feel very good about our position in the scenario that we're talking about.
The only other thing I'd remind you, our fourth quarter is typically one of our strongest quarters and it tends to be weighted towards December. So October is kind of the smallest month, then November gets bigger and December gets bigger. So we're counting on good volume throughout.
Thank you guys.
The next question comes from Allen Gong with JPMorgan. Please go ahead.
Hi, team thanks for taking the question. I just had a quick one on the organic side of the top line guidance. You lowered that to the bottom half of the range and apologies if you have asked this already. But it seems like the main shortfall this quarter was really on the biologics side of the equation. So should we think of that as being the main driver of the shortfall once again in fourth quarter? And you related that to essentially growing utilization of cervical and the lower reliance on biologics there. So should we think of this as a more durable challenge that you'll be facing going forward?
Look, I would say biologics pretty much goes with spine growth rates, market growth rates that is, whereas a Pulse and some of the other businesses, Cervical, we're growing significantly above the market. And so yes, we're probably more conservative on biologics in the fourth quarter and what we saw in the third quarter, but not a huge needle driver from a bottom line perspective. I'd say we've talked about earlier, the currency is really a significant part of why we adjusted the net sales guidance. Next question.
The next question comes from Matthew O'Brien of Piper Sandler. Please go ahead.
Al right. Thanks for taking my question. So I want to talk about the U.S. spinal hardware business. You had a good quarter, but you did have the easiest comps of some of the pure-play spine companies out there and a couple of them grew faster than you can have any much harder comps. The cervical business is clearly, I think, leading the charge at age.
So it would imply that the lumbar business is doing fine, but still somewhat exposed you talk about the dynamics there and then X360, P360 and the tube product, which I don't think people realize that's an important launch for you guys as far as stabilizing that lumber business and getting you back to maybe market growth even a little bit better based on what we're seeing from some of your competitors? Thanks.
Yes, Matt, let me clarify. I can't compare the comps of all the other companies out there. But I'll just say, if you look consistently over the last several quarters, including this one, we continue to outboard in our markets and the majority of our peers. And a reminder of what I talked about in the Investor Day is X360 is the interior segment. We're the market leader in XLIF. That's probably a competitive area that we've got to protect ourselves in. But complementing what we've done there is now we generate leadership in ALIF, and we're seeing strong growth.
So if you look at the interior segment in general, we're still outpacing the entire growth of the market and leading in the growth in that market. Cervical in a flat to declining market likely. If the market pressures are down because we are taking share, we're growing that segment clearly on P360 or the posterior side, we're just really getting started. That's a tubular tractor system that's MOD-EX TL. A lot of the technology that we launching over the next 12 months or so, we think will really give us a shot to go in and take further share in TLIF and put the midline surgery.
So we feel -- from our perspective, we are diversified within the key segments in the U.S. spine market today and seeing growth across the board with key launches coming up. So I feel very good about it. Clearly, it's hard to kind of characterize the entirety of the spine market. There's a lot of flares, maybe 8 or 10 make up 70%, 80%. And you can kind of look at the numbers one way or the other. But if you look at what we're posting and the growth in interior, the growth in cervical, the key launches coming to fruition now in the posterior segment. We feel like we're not only well positioned today but well positioned in the next year, two years to continue to take share.
The next question comes from Matthew Blackman with Stifel. Please go ahead.
Hi, good afternoon everybody. Thanks for taking my questions. I 've got a few simplified questions. I'll just rapid fire them upfront here. The first, are you able to fully meet demand now? So do you have full supply? Number two, are you seeing pull-through? You obviously talked to strength in the C360 portfolio broadly wondering if Simplify is an anchor product, pulling that through.
And then the last question. I think at Analyst Day, you mentioned new geographies for Simplify. Can you just remind us on timing and magnitude of the opportunities and whether they could be visible contributors in 2023 or 2024 from these new geographies? Thanks.
Yes, Matt, thanks for the questions. And it's sort of yes on all, but let me just kind of unpack on as far as the meat demand, yes, team has done a great job. Our team in West Coast [ph] does a great job. Our supply chain leaders have done a great job. So we are meeting demand now and demand continues to grow.
From a pull-through perspective, we are seeing pull through. We're seeing introduction to the other aspects of our cervical portfolio as well as connectivity and introduce and simplify and having some bleed over to areas like thoracolumbar. So it's still, like I said, early days, but there is a halo effect there that's taking shape.
As far as new geographies it's all been a function of set of instrumentation and getting those sets out as we've all talked about supply chain on the set side, has been delayed. We're meeting demand, but we've likely not gone as fast as we'd like to in some of the key geographies. Australia is a key market we're going to go into as well as some of the European markets. So it will be a contributor to our growth next year. I would say, not overly material this year, most of the growth is coming in the U.S. But clearly, these markets are clamoring, they're attending the same conferences surgeons are hearing the information on the CPDR market and excited about Simplify. So pretty much yes to all your questions.
And like I said before, we're excited about the cervical portfolio in its entirety, I would also just also reinforce. We're just now launching RELINE-C, which is the third kind of the leg of the stool of the ACP play, the cTDR, the simplified disk now post terra fixation, well positioned to continue to take advantage of the opportunity we see in this market.
Thank you Chris.
This concludes our question-and-answer session. I would like to turn the conference back over to Chris Barry for any closing remarks.
Thank you all, and thanks for participating in the earnings call today. Guided by our strategy to drive continued growth we'll continue to deliver on our core growth. Intelligent surgery and market opportunity fundamentals that create value for our surgeon partners, health care providers, and most importantly, patients around the world. I look forward to speaking with you all again next quarter. Thank you.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.