Orthofix Medical Inc. (OFIX) Q4 2021 Earnings Report, Transcript and Summary

Good morning and welcome to today's Orthofix Medical Inc. Fourth Quarter 2021 Earnings Conference Call. My name is Candy and I will be your moderator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for question-and-answer at the end. [Operator Instructions] I would now like to pass the conference call over to our host Alexa Huerta, Senior Director of Investor Relations. Please go ahead.

Thank you, operator, and good morning, everyone. Welcome to the Orthofix fourth quarter 2021 earnings call. Joining me on the call today are our President and Chief Executive Officer, Jon Serbousek; and Chief Financial Officer, Doug Rice. I'll start with the safe harbor statement and then pass it over to Jon. During this call, we will be making forward-looking statements that involve risks and uncertainties. All statements other than those of historical facts are forward-looking statements including any earnings guidance we provide and any statements about our plans, beliefs, strategies, expectations, goals or objectives. Investors are cautioned not to place undue reliance on such forward-looking statements as there is no assurance that the matters contained in such statements will occur. The forward-looking statements we will make on today's call are based on our beliefs and expectations as of today February 25 2022. We do not undertake any obligation to revise or update such forward-looking statements. Some factors that could cause actual results to be materially different from the forward-looking statements made by us on the call include the risk factors disclosed under the heading Risk Factors in our Form 10-K for the year ended December 31, 2021 filed this morning February 25, 2022 as well as additional SEC filings we make in the future. If you need copies of these documents, please contact my office at Orthofix in Lewisville, Texas. In addition, on today's call, we will refer to various non-GAAP financial measures. We believe that in order to properly understand our short-term and long-term financial trends, investors may wish to review these matters as a supplement to the financial measures determined in accordance with U.S. GAAP. Please refer to today's press release announcing our fourth quarter 2021 results for reconciliations of these non-GAAP financial measures to our U.S. GAAP financial results. At this point, I will turn the call over to Jon.

Thank you, Alexa. Welcome everyone and thank you for joining our fourth quarter and full year 2021 results conference call. On today's call, I'll provide an update of our fourth quarter performance and review progress against our strategic initiatives before handing the call over Doug who will provide our financial updates. I'll close with our perspective on the business in 2022 before opening lines for questions. Turning to our fourth quarter performance, we're very pleased with what we were able to accomplish and the momentum we will continue to build despite the prevailing macro landscape. In the quarter, we delivered total revenue of $125 million, an increase of 6% on a reported basis and 7% on a constant currency basis compared to the prior year quarter. This growth we're seeing across both franchises. Starting with a Global Spine business unit. The Spinal Implants team executed another outstanding quarter with strong U.S. motion preservation performance and market share capture overall. In our Global Orthopedics business unit, we executed double-digit growth year-over-year growth predominantly coming from our recovery among our international markets and share capture with FITBONE. On a sequential basis, we drove double-digit growth across all product categories compared to our third quarter of 2021. Now shifting to the performance within each of our product categories, starting with our Bone Growth Therapies or BGT, sales for the quarter were $50 million down 2% versus prior years due to the negative impact of COVID including nursing shortages on complex spine procedures within the fourth quarter, partially offset by continued market share capture with PhysioStim. We are happy to announce that in the fourth quarter, we reached the 1 million patient treated with our BGT portfolio. This major milestone demonstrates our committed leadership position in the bone growth stimulation on that we look to continue to build upon in the future. Thank you to our BGT sales and corporate teams for your leadership and efforts in obtaining this remarkable patient focus achievement. Moving to Spinal Implants, we are excited to report that global revenue was up 12% [indiscernible] fourth quarter in a row of double-digit year-over-year growth. As a reminder, this category is made up of our spine fixation and motion preservation products with the majority of which are used in procedures that are typically considered elective. The primary drivers of growth for increasing U.S. market share capture with 12% growth in the revenue from both new distributors and over 20% increase in total surgeon users and a rebound in international market procedure volumes. Turning to our Biologics portfolio, revenue was down 1% compared to the fourth quarter of 2020 due primarily to the negative impact of COVID on procedures and nursing shortages in the fourth quarter, offset somewhat by sales growth from our fiberFUSE allograft, which continue to gain momentum with our fiberFUSE Strip introduction this past fiscal year. Lastly, moving to our Global Orthopedics business which is primarily focused on limb reconstruction and deformity correction. Sales in the fourth quarter were up 21% over 2020. This increase is primarily a result of recovery of our international markets and share capture driven by the FITBONE intramedullary limb-lengthening system. During the fourth quarter, FITBONE generated over $2 million in sales, mainly in the European markets, bringing the full year revenue contribution from FITBONE to over $7 million. Thank you to our orthopedics team for their leadership and market success with FITBONE as its first full year of commercialization. Before discussing our key initiatives, I want to share how excited we are that Thomas West joined our Board of Directors in December. He brings over 30 years of global experience in the medical device industry to Orthofix. Thomas currently the President and CEO and Director of Intersect ENT, where he's led the transformation that business resulting in a definitive agreement to be acquired by Medtronic. Prior to Intersect ENT, Thomas served as a decision President of the diagnostic solutions at Hologic after spending over 20 years at Johnson & Johnson. Tom's very global experience will be an asset as we continue to scale the Company and we look forward to working with him on our board. Now, I'd like to provide an overview of our progress. We have made in the past year on key initiatives around product innovation, commercial channel, and operational execution. Starting with product innovation differentiation, during 2021, we made solid progress developing and acquiring products and procedural solutions to address unmet needs in the marketplace, and strengthen our product portfolio. We introduced key products in our Spinal Implants portfolio with the launch of CONSTRUX Mini and FORZA 3D-printed titanium interbody. We are happy with the progress we made in the year. We anticipate further growth acceleration of these products as they gain traction in the marketplace. We continue to also provide additional investments in the portfolio in both organic and inorganic technologies. Changing the pipeline of new technology introductions is key to our strategy and will fuel future revenue growth. Again Biologics, our goal is to have a comprehensive offering of products and solutions for surgeons to use in our spine and orthopedic procedures. We significantly expanded our portfolio during the year with introductions of AlloQuent Structural Allograft Q-Pack, fiberFUSE Strip and Opus Mg Set. We also recently extended our exclusive partnership agreement with MTF Biologics for Trinity cellular-based allograft lines through 2032. Orthofix and MTF Biologics have a long history of bringing advanced biologic solutions to markets with over 350,000 patients treated and that number is growing. We anticipate this more robust portfolio will continue to help drive incremental pull-through of our spine and orthopedics hardware offerings. Finally, within Orthopedics, we focused on investments in limb reconstruction and pediatric deformity, which included upgrades to our existing products as well as new products with incremental indications to increase our addressable markets. The strong performance of FITBONE throughout the year following its global introduction in early 2021 is an example of the success we have been able to bring to this highly innovative technology to the market to address unmet needs. Turning to our second initiative commercial channel development. For this initiative, we are focused on our U.S. channels for biologics, spinal implants, orthopedics and working to make these channels as dedicated and predictable as our current BDC channel. In Q4, our U.S. strategic channel partners which we defined as distributor partners that carry multiple orthopedics product carriers like hardware and biologics generated over one third of our spinal implants, biologics and orthopedics U.S. revenue and has grown 5% when compared to the prior year quarter, and 15% compared to the fourth quarter of 2019. We will continue to invest in the development and optimization of these channels to support our growth initiatives moving forward. Moving on to our third and final initiative, operational execution. Throughout 2021, we've managed to several supply chain challenges including the microchip shortage without missing a beat. We're very proud of how our team has managed through all of the macro challenges during the year and believe that we are well positioned to continue to execute all aspects of our global supply chain. I'm very proud of what our organization has been able to accomplish during 2021 which was without a doubt a challenging year. Some momentum we're able to generate was a direct result of a successful execution of our strategy and we look forward to continuing that momentum to 2022 and beyond. With that, I'll turn the call over to Doug to review our financial performance. Doug?

Thanks, John, and good morning everyone. I will provide some additional details into our net sales and earnings results and then discuss some of our other financial measures because many of the financial measures covered in today's call are on a non-GAAP basis. Please refer to today's earnings release for further information regarding our non-GAAP reconciliations and disclosures. Starting with revenue, as John mentioned, total net sales in the quarter were $125 million, up 6% on a reported basis and 7% on a constant currency basis when compared to the fourth quarter of 2020. In the U.S. total net sales of $97 million or 78% of our global total revenue for the fourth quarter, were up 2% over the fourth quarter of 2020, mainly due to U.S. M6-C growth offset by the reduction in complex procedures seen early in the fourth quarter. International total net sales of $28 million were up 23% as reported over the fourth quarter of 2020, reflecting the growth from our FITBONE limb lengthening system as well as international market recovery. Gross margin in the fourth quarter of 2021 was 73% compared to 75% in the prior year period. The decrease was primarily due to changes in our sales mix from the timing of international orders as well as a short term increase in electronic procurement costs due to the global microchip shortage, offset somewhat by decreased non-cash inventory reserve charges versus 2020. For the full year 2021, gross margins were 75% of total net sales. For the full year 2022, we expect gross margin to be similar to 2021 or approximately 76%, which reflects the continued impact of the changes in our sales mix as well as the expected short-term increase in microchip costs in the first half of the year. Sales and marketing expenses in the fourth quarter of 2021 were 46% of net sales, flat to the fourth quarter of 2020. Although, we saw travel expenses and investments in our commercial channels increasing in the fourth quarter of 2021, these expenses were offset by the one-time $2.5 million expense reduction related to a decrease in our Italian medical device tax liability that resulted from a recent law change by the Italian government that provides limited COVID-related relief to certain suppliers of their public hospitals. This non-recurring credit is adjusted out of our non-GAAP earnings. In 2022, we expect sales and marketing expenses to be in the range of 49% to 50% of net sales, due to further investment in our U.S. BGT and Global Orthopedics direct distribution channels early in the year to support expected revenue growth including our launch of [Excel stem] as well as an increase travel and in-person events in anticipation of regional COVID restrictions easing throughout the year. GAAP G&A expenses in the fourth quarter of 2021 were flat on an absolute dollar basis and 15% of net sales on a relative basis, down from 16% in the prior year period. Although, we have increased spending on strategic investments in the fourth quarter of 2021 and certain employee benefits that have been suspended in 2020. The spend increases were offset by the completion of the GAAP charges related to the 2019 CEO transition as well as decrease expenses related to COVID disruption. GAAP R&D expenses for the fourth quarter increased to 11% of net sales, up from 9% in the prior year period. This increase reflects our planned spending to support new product development, clinical studies, as well as costs associated with our EU MDR compliance efforts. We will continue to ramp up our efforts to drive organic innovation and differentiation to invest in clinical trials such as a rotator cuff repair study within BGT and our M6-C two-level indication study and continue to spend to build a robust product pipeline in both spine and orthopedics. These investments will continue to cause our R&D spending growth to outpace revenue growth in the near-term. We expect 2022 GAAP R&D expense to be approximately 12% of net sales, including an impact of about 200 basis points related directly to our EU MDR implementation efforts for which we adjust within our non-GAAP financial metrics. R&D spends will be somewhat frontloaded this year based on the timing of certain product lunches, clinical side enrollments and milestone payments. We expect our spending related to the 2024 EU MDR implementation requirements to taper somewhat after 2022. Adjusted EBITDA on the fourth quarter decreased to $17 million, or 14% of sales compared to $22 million in the fourth quarter of 2020, driven by the investments we've made in R&D related to product development and clinical trials as well as investments in building our commercial channel to accelerate future revenue growth. The cost of sales expenses have also increased with the changes in our sales mix as well as increased procurement costs related to supply chain disruption. Adjusted EBITDA for the full year 2021 was 13% of total net sales, compared to 12% in the prior year. A quick note that based on our orthopedics reporting unit goodwill analysis, we incurred a non-cash GAAP write-off of $12 million in the fourth quarter, which is reflected in the acquisition expense line items in our P&L. The write-off reflects our current and planned investments in our growth including our EU MDR implementations and FITBONE integration spend. Now turning to tax, we have GAAP income tax expense for the quarter of $23 million or negative 240% of loss before income taxes as compared to GAAP income tax expense of $15 million or 270% of income before income taxes in the same period of 2020. In addition to the timing of earnings during the year, this quarter's tax provision was significantly impacted by a $25 million non-cash charge to increase the reserves against our U.S. deferred tax assets. Due to the accounting recognition rules involving historical and forecast to GAAP earnings, which is a non-cash charge in the quarter. We continue to expect to fully realize our NOL carry forward in tax assets overtime as the Company grows and our profitability increases. For our non-GAAP results, we utilize the 27% long-term adjusted effective tax rate on the fourth quarter. However, we will prospectively utilize a 28% long-term adjusted effective tax rate in order to recognize the current and expected general increases in international statutory income tax rates as well as our expected adjusted earnings and the elimination of certain non-cash tax impacts. For the fourth quarter of 2021, we reported GAAP loss of $1.65 per share as compared to GAAP loss of $0.48 per share in the fourth quarter of 2020. After adjusting for certain items and when normalizing for tax using our non-GAAP long-term effective tax rate, adjusted earnings for the fourth quarter of 2021 was $0.27 per share compared to an adjusted EPS of $0.44 per share in the fourth quarter of 2020. The decrease was primarily driven by COVID impacted lower spending in 2020 as well as increased 2021 short-term expenses due to the global microchip shortage, increased R&D spend to drive organic innovation and differentiation and increase them to build out our commercial channel. Regarding cash, we continue to maintain a strong liquidity position with $88 million at the end of the fourth quarter of 2021 compared to $83 million at the end of the third quarter of 2021. We currently have no borrowings outstanding under $300 million senior secured revolving credit facility. We commenced repayment of the $14 million 2020 Medicare Advance in the second quarter of 2021. The balance of the remaining advance as of December 31, 2021 was approximately $5 million. We still expect the repayments to be completed by early Q2 of 2022. Net cash provided by operating activities was an inflow of $12 million in the quarter, down $10 million, compared to an inflow of $22 million in the fourth quarter of last year, primarily due to the recruitment of the 2020 Medicare Advance in 2021. The change in accounts receivable due to an increase in net sales in 2021, over the prior year, and the 2020 cost reduction initiatives such as the 401(k)-match suspension, travel freezes and conferences being held virtually. Capital expenditures were approximately $7 million in the quarter compared to just over $4 million in the prior year period, due primarily to the timing of spend for instruments in the U.S. spine to support our strategy to bring in additional strategic distribution and feature accelerated growth plans. CapEx for the full year 2021 was $20 million. We expect capital expenditures in 2022 to be in the $25 million to $27 million range. This increase over the prior year is due to the investments in instruments sets to support distribution growth for our new product launches, investments in our technology abilities, as well as investments in our facilities and operations. Consistent with our decreased operating cash flow, our free cash flow which we define as cash flow from operations minus capital expenditures was a $5 million inflow during the quarter which was down from $18 million of inflow in the fourth quarter of 2020. As anticipated, our free cash flow decreased significantly in 2021 compared to 2020, due to several items that we mentioned at the beginning of '21, including the partial repayment of the Medicare Advance investments in our sales channels and product innovation to support future sales growth to Spinal Kinetics milestone payment and increased spending on the EU MDR implementation efforts. For 2022, we expect cash flow from operations to increase modestly due to the timing of the 2021 Spinal Kinetics milestone payment and the payback of the Medicare Advance payments, ending early in the second quarter of 2022. Now shifting to guidance. For the full year of 2022, we expect revenue to be in the range of $475 million to $490 million, which represents mid-single-digit growth at constant currency. We are currently anticipating about a 1% headwind to our top-line reported rates due to the strength in the U.S. dollar compared to 2021 FX rates. Similar to the experience of other companies in the medical device industry, in January and in the February of this year, we saw significant increase in elective procedure restrictions as a result of the increase in hospitalizations related to the Omicron variants. From a macro perspective, we continue to expect the COVID overhang during the first half of the year with a revenue acceleration in the back half of the year as key products continue to gain momentum and COVID subsides throughout the year, as well as delayed or deferred procedures are being made up. We expect Q1 to be slightly down to flat to 2021 on a reported basis. We expect Q2 to be flat on a reported basis and Q3 likely to show strong growth versus 2021. In both cases due to the COVID impact during the prior year's quarters. Due to the inability to predict the impact or trend of the global pandemic our guidance does not assume any additional surges and COVID variants at this point in time. For the full year 2022, we expect our adjusted EBITDA to be in a range of $56 million to $61 million were approximately 12% of revenue. And our adjusted EPS is expected to be between $0.58 and $0.73, using a non-GAAP long term tax rate of 28%. These ranges reflect our continued investment in delivering a robust pipeline of differentiated products, expanding our distribution channel to accelerate our growth trajectory. I'll now turn the call back over to Jon.

Thanks Doug. Looking ahead, we view 2022 is an inflection point for our business. In recent years, we have been a low single-digit top-line growth company. As you just heard, our guidance for this year represents mid-single-digit growth, which is largely a result of the investments we've made over the last two years across the organization and in particular those investments into our talent leadership, product portfolio, and commercial channels. As we move into '23 and beyond, we expect to further accelerate our trajectory to become a mid to high single digit growth company while still delivering a positive adjusted EBITDA. To achieve that growth, we are focused on two areas. First, continued product innovation and differentiation. This includes delivering near-term growth through the increased adoption of recently launched products, as well as accelerating our organic and inorganic investments in new products, new indications, and new solutions that build on our core strengths as an organization. Second, the ongoing development of our commercial channels to drive our products into the hands of surgeons and physicians worldwide. Beginning with product innovation and differentiation. In a continuation of last year, the primary drivers of growth in 2020 will be our M6-C cervical disc, FITBONE limb lengthening system and our recently bolstered technology leading interbody portfolio. We also expect additional top-line growth to benefit from the over 20 new products we launched in 2020 and the products we will launch in 2022. As we work to drive accelerated growth in future years, we plan to increase investments during 2022 in the key areas of strength within our product portfolio. All we have a real sweet broad product portfolio today which is required to enable the type of distribution needed to compete in this market with by no means want to be everything to everyone. There are several areas our business where we have clearly differentiated ourselves and we're going to put capital to work in areas that leverage our expertise and current market position to accelerate our growth. These key areas of strength and opportunities are. First, regenerative technologies, a category that includes bone and soft tissue stimulation and biologics; second, spinal technologies, which includes innovative implants and surgical solutions; third, limb reconstruction and pediatric deformity; fourth, enabling technologies; and lastly, alternative surgical site development and single-use sterile pack product technologies. Starting with regenerative technologies, one of the fundamental aspects of our business that differentiates us from others in the spine and orthopedics space is our industry leading regenerate portfolios. We offer a bone growth simulation portfolio, which provides post-operative and adjunctive healing solutions, and a biologic portfolio which provides surgical procedure based healing solutions. We are highly focused on investing in the development of both of these regenerative product portfolios. As previously noted, we recently submitted a PMA application to the FDA for the approval of cell stem bone healing therapy, a low intensity pulsed ultrasound product for the healing of both fresh fracture and non-union fracture. Upon approval, this will expand our bone growth therapies portfolio and complement our current [TEMP] technologies that focus on non-union fractures and spinal treatments. We continue to expect the initial market release during the second half of 2022. We also continue to invest in our ongoing rotator cuff IDE trial, which if successful, will be our initial entry into the soft tissue regeneration market. As a first of its kind therapy to enhance patient care for those undergoing rotator cuff reconstruction, we would have a first mover advantage to tap into the over 650,000 patients who received rotator cuff repair surgery in the U.S. every year. We're making meaningful investments in our biologics regenerative portfolio as recently announced with our launch of our open synthetic products and the extension through 2032 of our exclusive partnership with MTF Biologics for the flagship cellular allograft technologies. As part of this partnership, we will also look forward to launching two additional biologics products mid-year, one of which we believe will be an important differentiated solution in the market. We're striving to provide a full portfolio of biologics solutions to surgeons, so that for any surgery procedure, there is an Orthofix solution that meets the specific needs of the surgeon and the patient. In Spinal Implants, we currently offer an extensive portfolio of products and technologies, including a comprehensive cervical offering and a differentiated artificial cervical disc. Additionally, we've been reevaluating a portfolio to bring an additional innovative and differentiated products and procedures. In the first half of 2021, we initiated five key spine R&D projects. These projects are developing spine product innovations and solutions for anterior collar support and lumbar minimally invasive spinal platform, a posterior cervical system and a deformity correction system in the FITSPINE deformity technology platform. These organic innovation programs have engaged key surgeons throughout the world to create innovations and clinical solutions, which will assist Orthofix to stand out in the market and create long-term top-line growth. We anticipate these developments to be introduced late this year and throughout 2023. Turning to limb reconstruction and pediatric deformity. Another key area of differentiation for our business is our narrow and dedicated focus within orthopedic markets. Many of our peers have exposure to highly competitive or crowded markets such as hip and knee replacements. However, we are squarely focused on a small segment of orthopedics, where we have expertise and a longstanding track record of leadership and innovation in limb reconstruction and deformity correction. Well, we have a number of projects ongoing in this space, I want to highlight two. We plan to expand our TrueLok Ring Fixation System portfolio to become radiolucent. This system was developed at Texas Scottish Rite Hospital for Children in Dallas, Texas, and allows precise alignment of fixation segments without compromise stability and also enhancing imaging characteristics. We will also continue to invest in our cutting-edge German engineered FITBONE technology with the development of new products in response to the input from leading U.S. pediatric orthopedic surgeons an identified need within the U.S. smart pediatric markets. We believe that with the extensions of the FITBONE system in early 2023, we'll be able to drive the same type of adoption and growth in the U.S. that we currently see in the European market. These two new projects along with our JuniOrtho Plating System which is a complete plating system designed to address the specific demand and advanced deformity and trauma reconstructions of the lower extremities will give Orthofix the broadest deformity care system in pediatrics. Turning to enabling technologies, Orthofix focused on the future of digital preoperative planning of limb reconstruction and deformity corrections for clinicians across the world. OrthoNext, our organically developed planning software will soon be connected to most of the major products within the orthopedics business. Our goal is to provide preoperative planning and surgical assistance to surgeons throughout our intuitive preplanning software in both pediatric and adult patients. In January, we also announced a partnership and investment agreement to jointly develop and co-market to innovative nView systems with cervical spine and pediatric limb deformity correction procedural solutions. The nView s1 imaging and surgical guidance system features a unique ability to instantaneously capture 3D images, but very low dose radiation, making the 3D images available throughout the surgery and enabling real-time visualization. This technology complements our preoperative and postoperative software platforms, and we are excited to collaborate with nView to broaden the use of this technology and cervical spine surgeries and pediatric procedures. Finally, under product differentiation innovation, we're looking to continue to develop procedures for our alternative surgical sites of care as more procedures continue to be moved out of the hospitals and into ACs. To our Neo partnership, we're developing single use sterile pack instrument technologies. We'll focus on the continued expansion of our already robust surgical offering with an outpatient setting emphasis. Turning to the optimization of the commercial channel, we will invest further in the expansion of our distribution channel with the addition of targeted direct reps in our U.S. limb reconstruction and deployment business to increase focus on pediatrics and geographies where direct employees make sense. With the anticipated 2022 launch of a [cell stem], we're making investments in our BGT channel to drive growth in long bone from non-union and fresh fracture care. We are also continuing to focus our efforts on driving synergies within our channels to increase the number of strategic channel partners trying multiple Orthofix product lines, which improves our product pull-through and provides for more predictable and reliable sales channels. In summary, we are very excited about the future at Orthofix. We generate tremendous momentum over the last few years, and we're moving into an inflection period and our growth trajectory. We will continue to invest to accelerate growth in future years, and importantly, do so while remaining sustainably profitable. With that I would like to open the line for questions. Operator?

[Operator Instructions] Our first question comes from Mathew Blackman of Stifel. Your line is now open. Please go ahead.

Maybe just to start with the housekeeping questions for Doug on the '22 guidance. The one point top-line currency headwind, is there any way to quantify that drops through impact the EBITDA and/or EPS? And then I have a couple of follow-ups?

It's a good question. So, you're right about 1% on the top line. It's mostly reporting translation risk obviously at revenue level as well as the cost level. We're fairly and actually hedged at most of the GEOs where we have exposure primarily to the Euro dollar rate and some to the Brazilian real. So, I would look at it as a lot less or fairly material at the EBITDA and EPS level in terms of FX impact.

And then, Jon, a couple for you. Just sort of thinking about the longer term expectation for upper single digit growth, what's the bridge to get there from mid single digit growth? Is it another step up in Spinal Implants growth that gets you there? Does it contemplate rotator cuff and bone stem? Essentially just asking whether the acceleration would be balanced across the business or to be disproportionately weighted to any particular segment or new product launch? And then one more follow-up after that.

Matt, thanks for the question. I think there's a general maturation of our strategies going forward. I mean, it's a combination between new product innovation and launch as well as differentiating the marketplace, which attracts these surgeons through organization as well as building the commercial channel and those two go hand in hand. We continue to focus on commercial channel both direct and indirect as well as and we tract better talent when we have better portfolios. So, they tighter back and forth across one another. As far as where it's going to occur, we look at -- we've seeing growth and we've been focused on both the orthopedics limb reconstruction and deformity sectors as well as the spine areas. And so, you saw the performance in Europe with the limb reconstruction deformity, that's a combination of both our TL-HEX our FITBONE and then also our JuniOrtho Plating System have a very comprehensive line partner reports OrthoNext for a planning standpoint. For spine, we saw that we also had good performance in Europe and the other regions, where we'll continue to invest in that area as part of our investment strategy, as well as in the U.S. and we continue to execute those plans, not only in spine fixation, but also in BGT. And then, also a BGT, we look forward to the new product innovation which is not occurred in many, many years with BGT with the [cell stem], and we look forward to lunch now the second half the year.

And then the last question and I'm not asking for more explicit long-term guidance. I appreciate what you gave this morning, but as we think about where EBITDA margins could go beyond 2022. Is there anything structurally that prevents you from getting to upper teens or even 20% of really just trying to frame what the profitability profile could be with a higher single-digit top-line growth trajectory?

We stated consistently that as we build or rebuild the organization that we know where we're spending our dollars, and as we basically get those product portfolios refreshed and sales channels put in place that we believe there'll be EBITDA leverage in the out years, so that is, by plan and designed. And so from that standpoint, we do expect to EBITDA leverage in the out years. And we should be able to operate in any incomparable to any other company of our size and style and that increase our profitability over the near-term in the park and mid-term.

Thank you. Our next question comes from Jeffrey Cohen of Ladenburg. Your line is now open. Please go ahead.

Firstly, is there any update on the M6 two-level study?

Jeff, we continue to add enrollment sites here you see enrollment within those sites we've already established and we are just on plan as far as the M6 two-level study.

Could you talk a little bit about the substance technology and how that falls into the BGT platform, and on commercial standpoint, it's sounds like late this year or is that back half of '22 will be commercial on that, and those channels will be largely the same and they'll kind of bolt-on to your current platform?

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Would you expect the [cell stem] substance technology to as well as BGT to be roughly focused domestically here?

Yes, we contemplated looking outside of U.S. but really this is a U.S. position for our product and has been for BGT for many years and it be will remain focused on the U.S.

And then a couple for Dug, I guess firstly, the 23.3 income tax expense I know you've been carrying there for a number of years and it's 23 last quarter. So that hits to zero looks like your actual 1.77 on the balance, so we should expect that to remain at that very low level going forward. Is that a safe assumption?

Jeff, if I understand the question correctly, you're asking about the volatility or income tax rate?

No, directly the income tax expense that the $23.2 million Q4 income tax expenses. Is it something that caused that to come toggled off because we were a bit unexpected that that will come through now?

So, we're still normalizing to a long-term rate. In the script, I mentioned that we're moving from 27% for an adjusted long-term rate to 28% to reflect changes in the world. International tax rates starting to interrupt in jurisdictions where we do business, but what you're seeing in Q4 was the GAAP charge. It was a non-cash charge of the expense related to evaluation allowance on our U.S. deferred tax assets. Because of our historical GAAP losses over the last couple years, you're seeing pressure on our ability to record the full value around our DTAs and so we were in a position in the U.S. similar to Italy last year to reserve our tax rates. So, that's about $45 million of tax expense additional in the fourth quarter, but I would simply look to the longer term rates for more normalized. We do continue to expect to fully realize all of our net operating losses carry forwards in tax assets as our earnings improve overtime.

Okay. And then related to the acquisition-related amortization and remeasurement of 12.56 for the fourth quarter, what should we expect or what should we model for '22 and going forward on that line?

For the Spinal Kinetic final milestone, I would expect that in 2022 to accrete up a lot closer to the ultimate payment amount of $30 million. It will happen semi-ratably over each quarter. Also notice in our balance sheet, that that final milestone liability payments slip from long-term to current. So, that'll give you an idea of the speed of the accretion.

Okay. So, is the 12.5 part of the 30 or should we expect 30 during 2022?

The current liability is simply an accounting fair value that's discounted to today's dollars, and we go through a lot of simulations with a third-party to value that payment, the ultimate payment. And so, the liability at the end of the fourth quarter was roughly $17 million, that 12 is just a part of the 30.

Okay. And then lastly, any specific commentary and labor issues that you've been seeing or you expect see going forward into '22 both domestically as well as internationally?

Jeff, this is an ongoing issue, it's going to be an ongoing issue for all companies. I was just recently with three institutions, East, Mid and West Coast, very large institutions, and they see labor going out in 12, 18 months plus as far as just the dynamics that are going on in their institution. So, the good news is that, the good news, I think, the positive side of that is that those institutions as well as the surgeons are out there ready and motivated to care for those patients that come to them. And we'll be there right with them as far as ready to do that.

[Operator Instructions] Our next question comes from Jim Sidoti from Sidoti & Company. Your line is now open. Please go ahead.

It's nice to hear somebody asking questions about the non-GAAP adjustments or even me for a change. Can you repeat what your guidance was for gross margin for 2022?

Gross margin for '22, we expect to be at 76% approximately reflects sales mix. We've got some pressure in the first half of the year for the chip shortage that we experienced late last year and so those are the primary items at 76%.

And then I wanted to focus in on the capital spending because I think you said you're going to be roughly $25 million to $27 million for CapEx, which is about $10 million more than you did this year and I assume that's more mostly instruments set. Is that primarily for the spine business? And is that a function of the new products or the new distributors or combination of both?

It's a little bit of both. It's about a $7 million increase over a $20 million CapEx level in 2021. I would characterize it in big buckets of about two-thirds of that spend is related to instruments and the majority of that is to increase distribution. It just takes more cash to support the increased distribution for our products like M6 and [Excel Stem] rolling out. So, those are the primary drivers. We've also got some investments in operations in some of our facilities as well.

And then last one for me. And this is strictly long-term question. But I mean, if you look at the new products you have coming out for stem and you have the M6, you have the increased distribution. Do you think at some point did this becomes a double-digit grower, because I mean, there just seems to be a lot of levers here that you can push? And I know it's not going to happen right away, but it's just feels like growth to be going beyond that mid-single-digit target at some point.

We've basically stated where our trajectory is at right now. And also, the new product activity does not include any M&A. And so we actually have the organic side and so we see as markets grow and as we basically improve our portfolio and improve our channel that we see a good future for Orthofix. I can't really say right now as far as what we're going to be at as far as the ultimate, high singles, doubles and all the rest of that. I don't think that's fair to do that right now, but we are very comfortable where I look at provided.

Okay. And then I just want to be clear one thing, it's spending for seen approvals [indiscernible] like that's starting to taper off a little bit. I mean, does that mean there's a light at the end of the tunnel with regard to getting wellness products registered?

I know your questions related to MDR and maintaining our CE Marks in Europe, your questions about spending levels. We're getting each word you were saying there, but anticipating if I say correctly, yes.

Is there light at end of the tunnel to that process?

Yes. So from a spending perspective, we are on track. We spent about $8 million in '21. We'll spend -- we call out about 200 basis points or about $10 million this year. And then, we expect to start tapering as everything comes together in advance of the spring of 2024 deadline for MDR.

Thank you. There are no additional questions waiting at this time. So, I'll pass the conference over to management team for closing remarks.

Thank you for everyone who joined the call today. I look forward to a very positive year in 2022 and beyond, and we'll be talking to you throughout the year. Have a wonderful day.

This concludes today's conference call. You may now disconnect your lines.