Orthofix Medical Inc. Q2 FY2022 Earnings Call

Thank you for participating in today's call. Joining me from SeaSpine is CEO, Keith Valentine; and COO and CFO, John Bostjancic. Earlier today, SeaSpine released full financial results for the second quarter ended June 30, 2022. During this conference call, we will make forward-looking statements within the meaning of the securities laws in regard to our business strategy, expectations and plans, our objectives for future operations and our future financial results and conditions. All statements other than statements of historical facts are forward-looking statements. Such statements may include words such as believe, could, would, will, plan, intend and similar expressions. You are cautioned not to place undue reliance on forward-looking statements, which are only predictions and reflect our beliefs based on current information and speak only as of today, August 2, 2022. For a description of risks and uncertainties that could cause material differences between our actual results and those stated or implied by the forward-looking statements, please see our news releases and periodic filings with the Securities and Exchange Commission, which are available on our corporate website. Our discussion today will also include certain financial measures such as adjusted gross margin and adjusted EBITDA loss that are not calculated in accordance with Generally Accepted Accounting Principles or GAAP. Management believes that the presentation of these non-GAAP financial measures provides important supplemental information to management and investors regarding financial and business trends relating to the company's financial results of operations. These non-GAAP financial measures should not be considered replacements for and should be read together with the most directly comparable GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are provided in the tables accompanying the press release we issued today. I will now turn the call over to Keith Valentine.

Thank you, Leigh. Good afternoon, and thank you all for joining us. Our second quarter results surpassed expectations despite some nominal disruptions from hospital staffing challenges throughout the quarter that were widely experienced throughout the industry. We successfully navigated these sporadic headwinds with our surgeon customers and distributor partners to deliver outstanding revenue growth and gross margin expansion. On the innovation front, we've fully launched seven new products and systems so far this year, including three significant spinal implant systems since our first quarter earnings call. An increasingly more complete spinal implants and orthobiologics product offering, combined with our 7D enabling technology platform is helping attract many distributors from our large competitors to partner with SeaSpine, a few of whom we've already fully onboarded. These groups, along with those we are in the process of onboarding, are expected to generate even more momentum as we move further into the second half of the year. Based on all of this, we have confidence in our decision to raise full-year 2022 revenue guidance to a range of USD234 million to USD236 million, representing year-over-year growth of 22% to 23%. In the second quarter, we grew total revenue 19% over the prior year period to $56.3 million. In the US, where we generate approximately 90% of our total revenue, we saw revenue increase 16%, reaching $49.5 million. International revenue grew 39% to $6.8 million. As I noted earlier, we continue to expand our product portfolio to address our surgeon customers' needs and attract larger distributors with the recent full commercial launch of three products and systems. This includes WaveForm C, a 3D-printed cervical interbody and WaveForm TO, a 3D-printed lumbar interbody, both of which utilize our innovative WaveForm 3D technology to deliver a highly porous yet robust interbody solution, with a design intended to optimize subsidence resistance, implant stiffness, and orthobiologics packability, while maintaining radiographic visualization during interoperative and postoperative imaging, and the Meridian Anterior Lumbar Interbody System featuring the Reef A interbody. The full launch of Meridian has been one of the most eagerly anticipated launches in recent memory for SeaSpine, as well as our distributor partners and surgeon customers. Meridian replaces our legacy ALIF system that offered only three stand-alone options without supplemental fixation. Meridian leverages the success of our flagship Shoreline modular anterior cervical system by featuring multiple TruProfile plating options to provide interoperative flexibility from the simplest case to the most complex reconstruction and stabilization. Collectively, these three products and systems address market segments in excess of $900 million in the US alone. Turning to 7D Surgical, we generated $2.2 million of enabling technology revenue in the second quarter of 2022, with the placement of six units all via capital sale, and further increased our pipeline for earn-out opportunities in the US to the highest levels we've seen so far. We're very optimistic that we'll close multiple earn-out opportunities in the third quarter and add to the nearly $2 million of annual revenue commitments from previous earn-out placements. Additionally, in terms of non-contractual revenue pull-through of our spinal implants and orthobiologics products, we're seeing a revenue increase six months out in more than half of those accounts that purchased FLASH Navigation systems via capital sale. The pipeline remains robust, and the combined sales teams are working together to generate cross-selling opportunities across all portfolios. Before handing off the call to John, I would like to conclude with this. Although we did experience and continue to expect minor headwinds from hospital staffing challenges, these issues appear to be caused by the same limited labor resources experienced across many industries. But we had a great second quarter, and I believe we reached a turning point with respect to expanding our gross margins, which is a critical milestone on our pathway to profitability. These strong results are the product of our unwavering commitment to innovation, despite all the challenges that COVID threw at us in our industry over the past two years. We would not have achieved these results without the trust and confidence of our investors, delivering the growth capital needed to enable these positive results and securing a stronger future for SeaSpine. And now, I'll turn the call over to John for more detail on our financials and our financial outlook. Then I will wrap up.

Thanks, Keith, and good afternoon, everyone. As Keith noted earlier, total revenue for the second quarter of 2022 was $56.3 million, a 19% increase over the prior year. In the US, we posted 16% growth to $49.5 million. International revenue increased by 39% to $6.8 million. US spinal implant and enabling technologies revenue in the second quarter increased 17% to $25 million, with the 7D FLASH Navigation platform contributing $1.1 million of revenue. Products launched or enhanced via line extensions within the past five years continue to fuel revenue growth and drive market share gains and accounted for 74% of US spinal implant revenue. It continues to be an encouraging indicator for sustained growth throughout 2022 and beyond. US orthobiologics revenue in the second quarter increased 16% to $24.5 million and continues to be driven by growth in the OsteoStrand Plus fibers-based DBM product line. Sales of products launched within the past five years accounted for 43% of the US orthobiologics revenue. Our US spinal implant surgery volumes increased 22% compared to the second quarter of 2021, while revenue per case increased mid-single digits compared to the prior year. Utilization of our spinal implant systems and orthobiologics products increased to 2.2 per procedure in the second quarter of 2022 compared to 2.1 a year ago. We experienced low single-digit average price declines in both the spinal implants and orthobiologics portfolios consistent with prior years. International revenue in the second quarter of 2022 totaled $6.8 million, a 39% increase compared to the prior year and included $1.1 million of enabling technologies capital sales revenue. Our continued focus on margin improvement yielded GAAP gross margin for the second quarter of 2022 of 66% compared to 63.2% for the second quarter of 2021. Adjusted gross margin also improved to 67.9% for the second quarter of 2022 compared to 64.5% for the second quarter of 2021. The increase in GAAP and adjusted gross margin was primarily due to lower excess and obsolete inventory charges and production efficiencies gained at our Irvine manufacturing facility. Operating expenses for the second quarter of 2022 totaled $51.7 million, a $10.6 million increase compared to the second quarter of 2021, of which $2.2 million of that increase related to operating expenses directly attributable to 7D Surgical. The increase in operating expenses was driven primarily by $7.6 million in higher selling and marketing expenses, the substantial majority of which related to the 7D Surgical sales and marketing organization and increased commissions on higher sales; $800,000 in higher research and development expenses, which was entirely attributable to 7D Surgical; and $2.2 million in higher general and administrative expenses, which was attributable to higher headcount-related expenses and an increase in information technology costs associated with the implementation of a new inventory management system earlier this year. That system is expected to improve our ability to manage our spinal implant inventory and sets more efficiently in the future. Net loss for the second quarter of 2022 was $13.9 million, compared to a net loss of $5.2 million for the second quarter of 2021. Net loss in the second quarter of 2021 included the $6.2 million non-operating benefit from the forgiveness of our Paycheck Protection Program loan. Adjusted EBITDA loss for the second quarter of 2022 was $4.7 million compared to a loss of $3.5 million for the second quarter of 2021. The increase in adjusted EBITDA loss was entirely the result of the dilutive impact of 7D Surgical on the current quarter results. Adjusted EBITDA loss is a non-GAAP financial measure that we believe provides valuable information on our operating results that facilitates comparability of our core operating performance from period-to-period and against other companies in our industry. A reconciliation of GAAP net loss to adjusted EBITDA loss was presented in the financial tables of the press release we issued this afternoon. Cash and cash equivalents at June 30, 2022, totaled $66.1 million and included $25 million of outstanding borrowings under our credit facility. In July, we announced that we extended the credit facility by three years through July 2025 and expanded the total potential borrowing capacity to $40 million. Our free cash flow burn, which includes operating cash flows and purchases of property and equipment was $15.9 million for the second quarter of 2022 and $40.2 million year-to-date through June 30, 2022. This relatively heavy spend is in line with a large amount of inventory and set build capital expenditures we forecasted for the first half of the year to support the recent and upcoming full launches to fulfill the final European spinal implant stocking orders and our aggressive US revenue growth expectations for the full year. Turning to our financial outlook for 2022. As Keith noted earlier, we now expect full-year 2022 revenue to be in the range of USD234 million to USD236 million, which includes USD10.5 million to USD11 million of total anticipated revenue based on current FX rates from the final European spinal implants stocking orders and for US spinal implants growth to exceed 20%. This compares to previous revenue guidance of USD231 million to USD235 million. With the benefit of those European stocking orders, we are anticipating year-over-year revenue growth of 40% to 41% for the third quarter. Therefore, excluding the impact of the absence of any European spinal implants revenue in the fourth quarter, our annual guidance implies mid to high teens year-over-year growth for the fourth quarter for the rest of the business. Moving down the P&L and notwithstanding the temporary impact on the third quarter of the relatively low gross margin European final stocking orders, we still anticipate generating 150 basis points to 200 basis points of adjusted gross margin expansion for the full-year 2022 compared to the 63.5% we reported for 2021 and to reduce our adjusted EBITDA loss by 15% to 20% compared to the $22.9 million we reported in 2021. We expect to generate these operating improvements through a combination of more efficient revenue growth fueled by the continued onboarding of more exclusive and high-quality distributor partners from the robust cadence of transformative product launches from further market penetration of the unique 7D FLASH technology and from higher adjusted gross margins through an increasingly favorable sales mix. Our expectation for free cash flow burn in excess of $60 million for 2022 remains the same as we reinvest that P&L leverage in the more than $40 million of additional inventory and spinal implant sets we committed to purchase to support our product launches and the onboarding of transformative distributor partners and to position ourselves for the sustained 15% to 18% long-term revenue growth rates we committed to earlier this year. To date, we have received and paid nearly $30 million of that significant investment. Contemplated within that 2022 free cash flow burn guidance is the negative impact this year from the extended payment terms we provided to our European distribution partners for those final spinal implant stocking orders and for which we'll see a reciprocal cash flow benefit from in 2023. And finally, despite the supply chain challenges affecting many markets in the industry these days, we remain on track to receive and deploy the more than $10 million of additional planned sets and inventory on time. We remain in constant communication with our suppliers and are not seeing any meaningful disruptions in our supply chain that would change our expectations for the timely receipt and deployment of these assets that will be so critical to our future growth plans.

Thank you, John. We are in a period where our largest competitors saw a loss in market share or experienced a slowdown in revenue growth, whether from ongoing supply chain challenges, higher than typical summer vacations or other transitory and COVID-related factors. However, SeaSpine is gaining momentum. We are raising our revenue outlook for the rest of this year and are on track to deliver the meaningful gross margin and P&L leverage we committed to for 2022. We are winning and taking market share with new and existing surgeons and distributors on the strength of our past successes, as well as our continued commitment to acquiring or commercializing innovative and differentiated technologies and complete procedural solutions. We enjoyed for years being called the best-kept secret in spine by visiting surgeons and new distributors coming to our offices. That time is gone. The secret is out, as we continue to invest aggressively in growth and to relentlessly execute on our strategy to be the most innovative and customer-focused spine company. With that, thank you all for your time and more importantly, your support. We will now open it up to questions.

Our first question comes from Matthew O'Brien of Piper Sandler.

This is Phil on for Matt. Can you hear me all right? Congrats on the quarter. Just from what I see, 7D seemed to come in a bit sluggish. Can you talk about the capital environment right now and the impact it has on your business as a result? And is there any line of sight into how this capital environment will play out in the back half of this year and into '23?

Yes. I think the progress we're seeing on the earn-outs may or may not be indicative of some of the capital constraints that we're seeing with other companies reporting. But we're not seeing any fundamental shift in the outlook for capital sales for the full year or earn-outs. I mean, if anything, we're seeing a greater percentage of earn-outs showing up in the pipeline, but that's kind of what we anticipated as we got our distributor network working with the 7D sales force and really leveraging the spinal implant and orthobiologics portfolio. So obviously, we don't have a huge slice of the market. So it's tough for us to really say we're a barometer. But we're not seeing any fundamental changes, like I said, in the outlook for the year. And if anything, if there are capital constraints in the broader market, it probably plays well for the earn-out opportunities, which produce the longer-term revenue opportunities for us anyway.

And just a quick one here on gross margin. Adjusted gross margin of 67.9% was certainly above our estimates. What's the durability like here? And I appreciate you reiterating the 150 basis points to 200 basis points of leverage. But what's your cadence expectations for the second half?

Yes. So with the large stocking orders for the spinal implants in Europe coming in the third quarter, that's relatively low gross margin. So, we will see a dip in the third quarter gross margin solely because of the impact of that low gross margin final stocking orders. However, we expect it to pick back up in the fourth quarter when we don't have that low gross margin burden from the European spinal implants revenue. So yes, we wanted to reiterate the expectations for the full year to deliver that gross margin expansion even in the face of the lower gross margin of roughly $10 million of relatively low gross margin for that European business. So it will be a dip in the third quarter because of that, but we expect it to pick back up to kind of current rates as we get into the fourth quarter and beyond.

All right. I'll hop back in the queue, but congrats again on the quarter.

Thanks.

Our next question comes from Kyle Rose of Canaccord Genuity. Kyle Rose, your line is open.

Great. You're breaking up a little bit there. So hopefully, you can hear me fine.

Yes.

Just wanted to think about the 7D commentary, just about the placements in the quarter and then the trends towards earn-outs. Just how we should think about that layering into the spinal implants business specifically from an earn-out perspective, whether it's internationally or in the US? How should we think about that from a modeling perspective there?

Yes, the earn-outs are really a US transaction. There's not much opportunity for us to do anything outside the US because we're selling to our stocking distributors. They may do earn-outs themselves. But for us, all the upside opportunity for earn-outs is in the US. And I suspect that it will be heavy on spinal implants, although we are seeing some interest in the orthobiologics as a sort of the catalyst for the earn-out. But most likely, that will be triggering higher revenue on the spinal implant side. The $2 million of annualized commitments we have and the units we've got in the pipeline that we expect to go to an earn-out in the third quarter and fourth quarter is kind of what gives us the confidence to say we expect spinal implants revenue growth in the US to be above 20% for the year because, one, we're taking market share, right? We're seeing growth from bringing on new distribution, existing distributors going deeper with surgeons and bringing on new surgeons, but also just the clarity we're seeing from the earn-out commitments we already have and those we expect to close in the third quarter because those will be the ones that make an impact in the fourth quarter. Anything we close in the fourth quarter probably won't be a significant driver. But it's part of what gives us the confidence to raise our revenue guidance is what we anticipate generating revenue from those earn-outs mostly on the spinal implant side.

Okay, that's helpful. Keith, you mentioned a lot about the commercial channel and bringing on new distributors. Can you help us understand what differentiates these distributors from those you've engaged with in the past? Also, could you outline the potential opportunities for enhancing performance with these distributors?

Yes. What's a little bit different is the size and market share opportunity that we have with bringing aboard some of these new distributors. And so there's been a balancing act, if you will, between when we can bring them aboard, making sure that we have enough inventory. We have the investment in sets. A lot of the new products that we talked about that we're launching were key in making sure they were comfortable transitioning, meaning the products fit nicely into the portfolio for their surgeons and their surgeons' needs. And so it's different in the sense that we're investing ahead. We're making the right investments in inventory to bring them over and to make sure that we can satisfy the demand. And a little bit different than previous because a lot of our transitions before, we expected it to be a slower ramp. And these distributors, we are anticipating a faster ramp in how they're able to go after the market.

Okay, great. I have one last question to ask.

Our next question comes from Ryan Zimmerman from BTIG.

Can you put Kyle back in the queue? It sounds like he had another question.

Our next question comes from Ryan Zimmerman from BTIG. Can you put Kyle back in the queue? It sounds like he had another question.

Sorry to interrupt. He will be fine. So let me ask a few questions, everyone. Keith, I would like to know your thoughts on market sentiment and the trends in July and August. Many companies have commented during this earnings season about strong momentum in March and April, but we heard some comments today indicating a slight slowdown into July. I would love to hear your perspective on the market conditions for July and August. Also, that comment was specifically regarding a large joint reconstruction, just to clarify, so it may differ for spine. I have a follow-up question as well.

Yes, we noticed some inconsistency in the quarter as mentioned earlier. We experienced initial strength, followed by slight shifts in May and June, but we ended strong. It appears there are various factors at play. In our support areas across the United States, there were reports of challenges with operating room staff and some clinicians contracting COVID, leading to temporary absences from surgeries. These issues seem to be specific to our business and market share rather than significant trends. Looking ahead to the third quarter, we expect similar conditions, including vacation schedules and ongoing staffing challenges in certain regions. However, we believe that our coverage across the United States can manage these fluctuations. The sentiment you are hearing aligns with what we are experiencing, although the situation may vary in different areas.

No, that's fair. I appreciate that, Keith. And John, when I think about the investments in sets, this is obviously a significant amount, and you've already purchased a lot. Everything is on time, which is really great to hear given the supply chain environment. When do we see the impact of those spinal implant sets really having a material impact on growth? And as you think about the distributors you're bringing onboard, are you satisfying all their capacity? What I mean by that is, do we expect to see more investments next year to meet the demands and capacity of the new distributors you've brought on this year?

Yes, there are several ways to approach this. The investments we've made in the first half primarily support new product launches such as the two WaveForm footprints and the Explorer Expandable Interbody. We recently announced Meridian, which is one of the most anticipated launches in SeaSpine's history. These products are currently being deployed and should significantly impact revenue in the second half of the year, especially when combined with the onboarding of new distributors. Initially, many of these distributors may not utilize the sets in their territories very effectively for the first month or two as they ramp up. We are careful to ensure that we supply more than enough sets in those territories, so they feel comfortable growing their business quickly without the risk of missing out on surgeries. Typically, there is a 2- to 3-month delay between deploying a set, particularly for a new launch or during the onboarding of a distributor, and when we begin to see those generate revenue with efficient turnovers, which we define as a minimum of 3 surgeries per month. This is because we are bringing on board transformative distributors who have confidence in us and our systems. We need to make sure they have enough sets—more than enough—to launch their businesses and convert as much as possible, especially for those that can immediately switch their operations. For others, the conversion is more gradual, surgeon by surgeon, and we may not need to park as many sets; however, we prefer to provide a surplus to ensure they can convert as much business as quickly as possible. That’s why you’ll notice a bit of a lag. We’ve deployed about $30 million of the $40 million investment this year in the first half, with an additional $10 million planned to support further product launches, including the remainder of the WaveForm footprint. This will contribute to revenue growth in the first half of next year, as many of these sets will be deployed in the latter half of this year and will be utilized more efficiently next year, ultimately driving revenue.

Kyle Rose, your line is open.

Back in. We discussed the commercial team regarding distributor hiring. I also wanted to check on the progress of building the small direct sales force and any insights you could share about the timing would be appreciated.

Yes. So, we kind of mapped out that, that was going to be a focus for us in the second half of the year. And so we are in and around decisions and driving that process right now. Obviously, we're looking at a couple of different ways. One is areas of white space that need the greatest help that we haven't been able to find the appropriate partners. And then the other is also ensuring that we're doing it as cost-effective as possible. So, we'll be giving more updates on future calls on how progress is going on the direct side.

Our next question comes from Richard Newitter of Truist.

Congrats on another great revenue performance.

Thanks.

I would like to discuss gross margin, SG&A, and R&D. First, regarding gross margin, should we consider the second quarter as a baseline for 2023, especially since the mix will improve without Europe next year? Also, concerning sales and marketing as a percentage, it's increasing in line with the revenue from last quarter. When can we expect to see leverage there? Will that start in the second half of the year, or is that more likely to happen in 2023? Lastly, how should we approach raising the R&D margin towards the 12% target you mentioned during Analyst Day? I'd appreciate any insights you can provide.

Yes. So Q2 gross margin, I think, yes, is probably a good indicator of where we can be in 2023 because we won't be having the lower gross margin European spinal implants revenue. We think we're past the biggest risk of excess and obsolete inventory provisions related to new product launches. Excess and Obsolete is a recurring part of the business, right? So that component will never go away. But I think we're past the greatest point of risk as it relates to new product launches, and we continue to see efficiencies slow but steady at the Irvine manufacturing facility and with volumes going up and being able to grow our orthobiologics revenue more than 10%, 15%, 16% this quarter. We're going to continue to get efficiencies out of that facility because of the fixed costs and the higher volumes, but also that team is implementing more efficient means to manufacture. So as we outlined in that March Analyst Day, there's lots of levers to pull to get that margin. And I think Q2 is a pretty good indicator for where things could go in 2023. On the sales and marketing front and R&D, the lack of leverage in sales and marketing, keep in mind, we had a full quarter of 7D sales and marketing Q2 this year, whereas when we had about a month in last year's Q2. So, a lot of that lack of leverage for sales and marketing is just a full quarter impact of 7D in the year-over-year comparison. On the R&D side, yes, we expect it to be ramping up, particularly with 7D and some of the initiatives they're going to be undertaking in the back half of the year. That will be some heavier project spend that will likely bump that rate up closer to what we expected for the full-year guidance where we said 12% as 7D continues to accelerate their development programs to bring those next-generation enhancements to market as fast as possible.

Thank you. Our next question comes from Jeffrey Cohen of Ladenburg.

I wanted to ask about your purchasing cycles. You mentioned it's about a 6- to 9-month process. Given the increased awareness you've referred to and comments like the secret is out, are you noticing that this cycle is decreasing, especially considering that you are a much lower cost option?

Are you talking about the lead time with our suppliers?

No, I'm talking about the purchasing cycles for 7D.

Yes. There are a few things we've emphasized recently, and one of them is that several factors are making it easier for 7D. One significant factor is the pricing on the capital. However, a more critical aspect is our discussions with hospitals and ASCs regarding the metrics for an earn-out. The earn-out is now much more appealing. While there is a pricing component, there's also the fact that we currently hold a small market share in many of the accounts we are engaging with about 7D. Therefore, the shift in market share required to justify the earn-out presents an easier challenge. This is why we have had success in obtaining earn-outs in ASCs, as these settings often face difficulties in joining earn-out programs.

Got it. Okay. And then of the systems sold in place this quarter, were they all into new accounts? Or were those any additional placements in existing accounts?

It's a mix, but more so into existing accounts. However, the pipeline we're looking at is a lot of new accounts in both capital sales and earn-outs.

Okay. And then just like a quick housekeeping question for me. Actually, technically for you, John. I heard you mention different payment terms for your EU distributors. Should we assume a little higher accounts receivable in the near term?

Yes.

Our next question comes from Ross Osborn of Cantor.

So just looking at 2Q, could you parse out how much of growth was from new distribution agreements versus driving further penetration in existing accounts for the portfolio outside of 7D?

I don't have good metrics on the growth sources from new distributors versus existing distributors going deeper. Sorry. The good news is, we've talked about it in the past, the growth is predominantly coming from new distributors. But we're starting to see a shift of existing distributors going deeper and bringing on competitive reps in the distributorship and recruiting more surgeons to work with SeaSpine. So, I don't have exact metrics, but anecdotally, most of the growth is still coming from recently onboarded distributors. But I think that will shift in the near term. But with some of the other larger distributors we've got in the pipeline that we anticipate onboarding that can shift right back to the growth coming mostly from new distribution. So, sorry, that's perhaps not the most helpful answer to be able to quantify it. But the good news is both of those sources of growth are alive and well.

No, no. That's perfectly fine. And then I guess just one more on 7D for me. Do you see any increase in demand or at least new interest from ASCs and midsized hospitals?

Yes. It's both in capital sales and earn-outs. But...

Yes, I think that currently, from an ASC perspective, we are observing a rise in interest regarding various discussions and potential opportunities. This aligns with what we mentioned earlier about the economic prospects being appealing. The possibility of earn-outs is attractive, and if they opt for a capital purchase, it is more appealing than what competitors offer. Additionally, the knowledge that we are in the later stages of our MIS early launch, moving from alpha and beta towards a full launch, creates significant excitement about the simplicity of our system when used in an MIS manner.

Great. Congrats on the quarter.

Thank you.

Thanks.

Our next question comes from Jason Wittes of Loop Capital.

First off, just to clarify, you mentioned the tool set and inventory, a lot of it was going to hit at the end of the year and really kind of accelerate in the first half of 2023. Did I hear that correctly? Or is it a more bigger impact in 2022?

No. The question we got asked was the timing of when the sets we're deploying this year are going to impact revenue. A lot of what we spent in the first half of the year, $30 million of that $40 million investment was to support full commercial launches and also some additional sets we're deploying. But the back half of the year, it will be a bit more balanced between just launching more of our high-running sets, but still a meaningful investment in product launches because we still have WaveForm anterior and lateral to be fully launched, the Mariner Adult Deformity to be fully launched in the back half of the year. But we were just talking about the timing of when those set deployments are expected to generate revenue growth. And I was saying it's typically a couple of month lag because we want to park those sets in a distributor's territory as they're converting business. And we err on the side of putting too many sets in those regions because we want to make sure they've got the confidence they can flip as much business as fast as possible. But with that, we have the expectation those sets won't be as heavily utilized in the beginning as we anticipate later on, as those distributors ramp their revenue up. So, hopefully, that clarifies it.

Yes. That does. Thank you for the clarification. And maybe another clarification. I think you said that 7D was seeing something like 50% pull-through of implant products or just general products, including biologics. Is that...yes.

Certainly. Regarding the non-contractual revenue, we previously discussed the $2 million of committed annual revenue associated with earn-outs. Additionally, we mentioned that in cases where we sell a 7D unit without any earn-out revenue commitment, about half of those sales lead to increased purchases of our spinal implants and orthobiologics by those accounts. It's important to note that even the non-earn-out sales are generating additional revenue opportunities in spinal implants and orthobiologics. This is logical since we are integrating our spinal implants to work seamlessly with 7D technology. Although our system is agnostic, we aim to make our spinal implants the most user-friendly with this technology. Therefore, we anticipate some additional revenue from our implants and orthobiologics linked to those non-contractual capital sales.

You anticipated my full question. Regarding biologics, they are experiencing significant growth, considerably exceeding the market's rate—almost double or even triple that of the market. Are you surprised by these figures? I know there are some notable new products involved. How should we view the sustainability of this growth rate?

Yes. It's a great question, Jason. We have been kind of messaging the past 1.5 years or more with a great deal, I think, of interesting data, some that has been even accepted to JBJS and very important publications. And I think what we're seeing now is kind of that momentum shift of hospitals pushing back on expensive biologics, whether that's BMP or cellular technologies. The reality that cellular technologies more and more is being discussed that what you're paying for is not an increase in performance. And further, that DBMs, especially the research that we continue to publish and continue to push forward shows that high-powered newer DBMs with newer technology have the ability to not only be a great graft alternative, but also to be very cost effective. And I think what we're seeing is kind of the culmination of so much of that data finally getting absorbed in the marketplace, accepting that it's a great alternative for their patients in addition to having a nice cost savings for the hospital.

I'm showing no further questions at this time. I would like to turn the call back over to Keith Valentine, CEO, for any closing remarks.

Again, thank you, everyone, for joining us this afternoon. And we look forward to updating you on results after the next quarter. Have a good afternoon.

Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all for participating. You may now disconnect. Have a great day.