Orthofix Medical Inc.

Good morning, everyone, and welcome to today's All4Fix Medical First Quarter 2022 Earnings Conference Call. My name is Candice, 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. If you would like to ask a question, please press Start, followed by 1 on your telephone keypad. I would now like to pass the conference over to our host, Alexa Werther. Senior Director of Investor Relations, Alexa Ovete.

Thank you, Operator, and good morning, everyone. Welcome to the OrthoFix first quarter 2022 earnings call. Joining me on the call today are our President and Chief Executive Officer, John Cervosic, and Chief Financial Officer, Doug Rice. I'll start with a safe harbor statement and then pass it over to John. 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 matter 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, May 6, 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, and Form 10-Q for the quarter ended March 31, 2022, filed this morning, May 6, 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 Louisville, 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 first quarter 2022 results for reconciliations of these non-GAAP financial measures to our US GAAP financial results. At this point, I will turn the call over to John.

Thank you, Alexa. Welcome, everyone, and thank you for joining our first quarter 2022 results conference call. On today's call, I will provide an update of our first quarter performance and review progress against our strategic initiatives before handing the call over to Doug, who will provide our financial update. I'll close the call with our perspectives on the balance of 2022 before opening the line for questions. Starting with our first quarter performance, total revenue in the quarter was $106 million, growing approximately 1% over 2021 on a reported basis and 2% on a constant currency basis. In January and February, we experienced a significant slowdown in procedure volumes due to hospital COVID restrictions and staffing shortages across most of our geographies in the US and Europe. In March, we saw an increase in procedure volumes highlighted by a strong month-over-month growth coinciding with the declining COVID hospitalizations and lessening of global restrictions. The March into April trends this year look similar to the prior year. Turning to the performance of each of our product categories, starting with bone growth therapies or BGT, sales for the quarter were 42 million, down 2% compared to the first quarter of 2021. The decline was due to the lingering effects of COVID, which impacted procedure volumes on complex cases. Despite the headwinds experienced broadly in BGT, we saw another quarter growth in our physio stem fracture therapy products. which are prescribed after 90-day period of nonunion of a fracture. As a reminder, the physio product portfolio is focused on nonunion fractures within the orthopedic market and will be a key growth driver for us in this year and beyond. I am proud of the team's focus despite the environment. Moving to spinal implants, which includes both spine fixation and motion preservation. Revenue is up 4% on a reported basis and constant currency basis as compared to the first quarter of 2021. We saw growth across the portfolio during this period, which was primarily driven by our international spine fixation sales and growth with the M6C artificial cervical disc in the U.S. Turning to our biologics portfolio, revenue was up 3% compared to 2021. The growth was driven by sales of fiber fuse and our other new offerings as we continue to broaden our biologics portfolio. Lastly, in our global orthopedics business, sales were up 2% on a reported basis and 7% on a constant currency basis over 2021. The increase was due to lessening COVID restrictions in our international markets, orders from international stocking distributors and continued strong contribution from the fit bone limb lengthening system. Before discussing the progress on against our key initiatives, I wanted to mention the recently announced leadership transition in our orthopedic business. Last month, Kim elting our chief legal and development officer became the President of the global orthopedic business she succeeds Paul gonzalez who left the company to pursue other opportunities. Kim has more than 25 years of medical device experience, including her more than five years at OrthoFix. She has significant experience in the medical device product lifecycle, supporting research and development and commercialization functions, and leading business development initiatives that strengthen organic and inorganic growth for our company. Since starting at OrthoFix in 2016, Kim has led many functions including regulatory and quality, corporate communications, and business development, in addition to her legal group. We will transition her current responsibilities over the near term, and the replacement search for the new chief legal officer has already begun. I am confident Kim will bring strong leadership and continue to drive growth in the orthopedic business, which has seen a significant investment over the past couple years. The team has responded very well to her new leadership role, and we believe the momentum we have in the business will continue. I'd like to take a moment to thank Paul for his contributions and wish him best of luck in his next endeavor. Now I'd like to provide an update on our key initiatives. Recall from our last earnings call, I provided our growth expectations over the coming years, targeting mid single digits for 2022 at constant currency and growth accelerating to mid to high single digits in 2023 and beyond with increasing adjusted EBITDA margins. All of this assumes the macro environments will cooperate, of course. In order to achieve that growth, we are focusing on two key initiatives, product innovation with differentiated technologies in our commercial channel. First, our focus on new product innovation and differentiation. This includes delivering near-term growth through our increased adoption of our recently launched products. In addition, We have also accelerated our organic inorganic investments and new products indications and procedural solutions that build on to our core strengths. In the first quarter, we made significant progress in this initiative across all of our product categories since January of 2020 we have launched 26 spine and orthopedic products. Starting with bgt. We recently expanded our portfolio in a meaningful way with the FDA PMA of a cell stem bone healing therapy, a low-intensity pulse ultrasound, or LIPAS, product for the healing of bone, both fresh fracture and non-union fractures. We've been building out and training the commercial team in preparation for the planned initial U.S. market launch, which will be staged during the second and third quarter. This product is the result of our exclusive license of the J portfolio and we will continue to evaluate and leverage our EJ a partnership, as we look to expand our bgt offerings into the future. We are proud of investment, we are making in the external bone growth stimulator market and, frankly, at a significantly higher level than any of our competitors, this will enable us to expand our leadership in this space. With biologics our goal is to continue to build on our leadership position in the marketplace by providing a comprehensive offering of products and solutions for surgeons. To use in both spine and orthopedic procedures during the quarter we launched and saw the first cases completed with our opus BA our synthetic bioactive bone graft solution for spine fusion procedures. Opus BA is an excellent complement to our Opus MG set technology, which we launched in the second half of 2021. We are working with hospitals, health systems, and our channel partners on commercial expansion to provide a comprehensive portfolio in this rapidly growing synthetics category. Earlier this week, we announced the extension of our agreement with MTF Biologics. Together, we have built out a highly competitive allograft portfolio and have worked tirelessly to become leaders in the cellular bone allograft space with our Trinity allografts. I'm happy to announce our continued investment in our partnership through the planned introduction of two new important allograft additions in our biological portfolio, Virtuous and Legacy. As you know, For the effects, together with mtf have been a pioneer and innovator in the cellular based paragraph market which resulted in our market leading position with the Trinity franchise. Today we are excited to announce the beginning of the next evolution of this space with an entirely new category, we are calling lyographs the first issue launched it's called virtual lyograph. which is derived from a breakthrough tissue processing and preservation approach developed by MTF. This innovative approach, called Lyograph preservation, is the process in which inherent growth factors and viable cells are preserved in the graft to provide a shelf-stable option for clinicians. Virtuose has been developed by MTF over the course of several years which preserves the inherent osteoconductive, osteoinductive, and osteogenic properties necessary for bone formation. Virtuose is the first of its kind, shelf-stable, complete autograft substitute. This tissue offers significant logistical advantages to the hospital, providing efficiencies in the operating room by being available for immediate use and supports sustainability. We'll begin an exclusive launch of Virtuose This month, with a broad commercialization later in the year. we're excited to enter into this next phase of revolutionizing biologics through our partnership with mtf biologics. Our second allograft offering legacy is an a separately process pre hydrated global dbm putty that is ready to use out of the syringe. Leveraging decades of experience with demineralized bone processing with MTF biologics, Legacy allows us to expand our DDM portfolio by providing a cost-effective option that has a strong history of positive clinical performance. Rounding out our portfolio with orthopedics. Our focus remains on investments within limb reconstruction and pediatric deformity, building on our strong portfolio of internal and external limb reconstruction and deformity correction solutions. We have long been a leader in the external training and during the quarter we announced the FDA clearance and first cases of the true lock Evo ring fixation system. Because of the only circular fixator in the market with both radio lucent rings and struts allowing for clear radiographic visualization which assists with clinical care. The Trulock EVO system is also the first circular fixator system kit available as a preassembled frame in a ready-to-use, single-use sterile packaging, allowing for ease of application and potential time-saving during surgery, particularly when treating post-traumatic injuries. Initial surgeon feedback has been encouraging, and we plan to prudently expand the launch of this system in the U.S. and international markets. We also released Galaxy Gemini Fixator in limited markets, the next generation of the modular fixation system for fracture treatments of lower and upper limbs. The Galaxy Gemini system combines two different procedure configurations to better address the customer needs, offers a versatile choice of clamps, radiolucent rods, and instruments in one sterile tray, and provides a wide choice of ready-to-use sterile kits and components for different anatomical applications. Importantly, this up-to-date pin-to-bar system can be used as a hybrid system in conjunction with our TruLock family of products, extending its functionality. These new products build on the already innovative and comprehensive limb reconstruction and deformity correction portfolio, and we expect them to contribute to our growth in Orthopeek's business in 2022 and 2023. Turning to our second initiative, the ongoing development of our commercial channel to expand patient and surgeon access to our products worldwide. In Q1, our US strategic channel partners, which we define as distributor partners that carry multiple orthofix product categories, such as hardware and biologics, grew revenue 19% compared to the prior year quarter. Most of our channel investment in the quarter was focused on adding US direct reps in our bone growth therapies business. Along with the channel expansion with direct rep hires, we are preparing for the initial launch of a cell stem with increased commercial readiness activities and training. We will continue to expand dedicated resources as we gain commercial traction. I would also like to highlight our continued investment in clinical data development. As we see this as a critical factor in supporting the clinical efficacy and safety of our current and future devices to support the long-term growth and expansion of product indications. One example is the M6C artificial disc where we are investing in the two-level study to support future indications, conduct IDE post-market surveillance, and collecting real-world evidence that will collectively highlight the safety and efficacy while protecting our innovation investment. We will continue to invest and build upon our clinical database of over 60,000 implanted M6C discs, which has created one of the most robust sets of data in the artificial cervical disc market. These efforts will be utilized to help expand the cervical disc arthroplasty market segment call assisting us in our marketing efforts as new products and companies enter the space and elevate the competitive environment. Overall, I'm very proud of our performance from the quarter, which highlights the team's hard work and the growing demand for our evolving portfolio of products in the marketplace. We've made great strides working towards our growth transformation and have capitalized on strong foundation built in 2021, despite some challenges with COVID early on. These developments provide us with elevated enthusiasm for our business, and we've had a great start to the year, putting ourselves in a great position for success in 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 on a non gap basis, please refer to today's earnings release for further information regarding our non gap reconciliations and disclosures. Starting with revenue, as John mentioned, total net sales in the quarter were $106 million, up 1% on a reported basis and 2% on a constant currency basis when compared to the first quarter of 2021. In the U.S., total net sales of $82 million or 77% of our global total revenue for the first quarter were approximately flat year over year as both periods experienced reductions in complex procedures due to COVID restrictions. International total net sales of $24 million were up 14% in constant currency over the first quarter of 2021 as both of our business units had increased orders from stocking distributors as well as contributions from new products. GAAP gross margin in the first quarter of 2021 was 73% compared to 75% in the prior year period. The decrease was primarily due to changes in our sales mix, as well as a short-term increase in certain component costs driven by global supply chain disruptions. For the full year 2022, we expect gross margin to be approximately 75 to 76%. Given the continuing COVID-19 related disruptions, including staffing shortages and the Russian war on Ukraine, our global supply chain is under pressure and remains a top priority. We do not source any raw materials or components from Russia, Ukraine, or China. However, we have observed and anticipate a highly volatile supply environment, mainly affecting price and availability this year. With that in mind, we have taken the step of purchasing raw materials, including items such as titanium and semiconductor chips to ensure a year's worth of supply. We believe this is an effective use of our strong balance sheet and is a prudent step that will ensure that we meet customer demand and worth the modest impact to our margins as a result. Sales and marketing expenses in the first quarter of 2022 were 51% of net sales, up from 48% of net sales in the first quarter of 2021. As communicated previously, we have prioritized the investment in our direct and indirect commercial channels over the last couple of years, In the first quarter of 2022 we made investments in direct sales reps and both orthopedics and BGT and we've increased our sales training efforts in both areas. Travel and conference spend is up for the quarter as trade shows were brought back in person, including double iOS and our internal global sales meetings. For the full year 2022 we expect sales and marketing expenses to be in the range of 49 to 50% of that sales. This spending reflects further investment in our distribution channels and sales management early in the year to support our expected revenue growth, including our launch of Excel, STEM, and Virtuos, as well as the continued increase in travel and in-person events. As a percentage of revenue, sales and marketing expenses will decrease throughout the year. GAAP G&A expenses in the first quarter of 2022 were 18% of net sales, up from 16% in the prior year period. This increase reflects increased stock-based compensation expense as we return to historical levels of spend as the tenure of our new management team increases. We also saw an increase in employee-related spending, including travel and medical expenses. For those investors and analysts calculating the full year impact of certain non-cash items for the full year 2022, we expect stock-based compensation expense to be approximately $20 million. of which about 75% is recorded in GNA. We also expect full year depreciation and amortization to be around $31 million, of which about 75% is in COGS. GAP R&D expenses for the first quarter increased to 11% of net sales, up from 10% in the prior year period. The 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 through investment in clinical trials such as the rotator cuff repair study within VTT and our M6C two-level indication study and continued spend to build a robust product pipeline in both spine and orthopedics. We expect 2022 gap R&D expense to be approximately 11.5% to 12% of net sales for the full year, including an impact of about 200 basis points related directly to our EU MDR implementation efforts, for which we will adjust within our non-GAAP financial metrics. R&D spend as a percentage of revenue will be the highest on both an absolute and relative basis in the second and third quarters of this year, based on the timing of certain product launches, clinical site enrollment, and milestone achievements. We expect our spending related to the 2024 EU MDR implementation requirements to taper somewhat after this year. Adjusted EBITDA margin in the first quarter decreased to 7% of net sales compared to 13% in the first quarter of 2021, driven by the increased COGS as well as growth investments in our sales channels and product development. We continue to expect our adjusted EBITDA margin for the full year 2022 will approximate 12% of total net sales as we continue to profitably invest in growth. We expect our adjusted EBITDA margin to increase sequentially throughout 2022, which is reflective of the heavier spending in the first half of the year that I mentioned earlier, as well as leverage from the strong sales growth we expect in the back half of this year. The $8 million gap acquisition-related remeasurement expense decrease in the first quarter primarily reflects a $5.5 million non-cash credit related to a change in the fair value of the Spinal Kinetics contingent revenue milestone payment liability. This final revenue-based milestone must be achieved within five years of April 30th, 2018. Based on our first quarter results and the current operating environment, including the introduction of new competitive products Our current forecast achievement of this revenue milestone trigger was extended to Q1 2023. Using the updated forecast and our probability approach, the estimated fair value of this contingent liability at March 31, 2022 was $11.7 million, which was $5.5 million lower than the balance at December 31, 2021. Now turning to tax, we had gap effective tax rate of negative 2% of loss before income taxes as compared to positive 3% in the same period of 2021. The low tax rate in both periods is driven primarily by gap losses without a corresponding tax benefit. For our non-gap results beginning in 2022, we are utilizing a 28% long-term adjusted effective tax rate. which normalizes for acquisition-related expenses, certain changes in law, and operating losses that have no GAAP tax benefit. For the first quarter of 2022, we reported GAAP loss of 22 cents per share as compared to GAAP loss of 30 cents per share in the first quarter of 2021. After adjusting for certain items and when normalizing for tax using our non-GAAP long-term effective tax rate, Adjusted earnings per share for the first quarter of 2022 was a loss of $0.10 per share compared to an adjusted EPS of $0.17 per share in the first quarter of 2021. The decrease was in line with our internal expectations and was primarily driven by short-term expense increases due to supply chain disruption, increased R&D spend to drive organic innovation and differentiation, and increased spend to build out our commercial channels. Regarding cash, we continue to maintain a strong liquidity position with $72 million at the end of the first quarter of 2022 compared to $88 million at the end of the fourth quarter of 2021. The main decrease to cash this year from the end of 2021 is from increased inventory, the timing of bonus payments in the first quarter, and the final contractual payment to the FitBone seller for the fulfillment of its manufacturing and supply obligations. We currently have no borrowings outstanding under our senior secured revolving credit facility. The repayment of the 2020 Medicare advance is now complete. Net cash provided by operating activities was an outflow of $8 million in the quarter, down $10 million compared to an inflow of $2 million in the first quarter of last year, primarily due to the recruitment of the 2020 Medicare advance beginning in the second quarter of 2021 and the increase of inventory due to new product launches over the prior year, the buildup of raw materials to protect our top line and to support new distribution. Capital expenditures were approximately $6 million in the quarter, compared to $5 million in the prior year period due primarily to investments in operations and our facilities as we expand manufacturing capabilities and build out a customer training and experience center for our partners at our headquarters in Louisville, Texas. We still expect capital expenditures to be in the 25 to $27 million range for 2022 the increase over the prior years do primarily. To investments in our technology abilities, as well as investments in our facilities and operations. Consistent with our decrease operating cash flow or free cash flow which we define as cash flow from operations minus capex. was a $13 million outflow during the first quarter, which was down from a $2 million outflow in the first quarter of 2021. For the full year of 2022, we expect free cash flow to decrease somewhat year over year as we build up inventory for new product launches, acquire raw materials in response to macro environment risk, support new distribution, and absorb the estimated impact from FX headwinds. Now shifting to guidance for the full year of 2022, we still expect revenue to be in the range of $475 million to $490 million, which represents mid-single-digit growth at reported rates. The guidance represents a modest raise in our growth rate at constant currency from our previous guidance, reflecting the absorption of about a $4 million headwind due to FX rates. We are currently anticipating around a 2% headwind to our top line at reported rates due to the strength in U.S. dollar compared to the 2021 FX rates. From a macro perspective, we continue to expect a modest COVID overhang to the end of the second quarter with revenue acceleration in the back half of the year as key products like Excel, STEM, and Virtuos gain momentum and delayed or deferred procedures continue to be made up. However, we do assume that workforce challenges and hospitals will continue throughout this year and into 2023. From a timing perspective, we expect Q2 revenue to be similar to the prior year and expect the third and fourth quarters to show strong year-over-year growth. For the full year 2022, we continue to expect our adjusted EBITDA will be in the range of $56 million to $61 million, or approximately 12% of revenue, and our adjusted EPS will be between 58 and 73 cents. These ranges reflect the $4 million FX headwind to our top line due to the strength in US dollar since the year end 2021 earnings call. Supply chain issues, which have expanded since the Russian war on Ukraine, our continued investment in delivering a robust pipeline of differentiated products and continuing to expand our distribution channel to accelerate our growth trajectory. I'll now turn the call back over to John.

Thanks, Doug. Looking ahead, we continue to believe that 2022 will be an inflection point for our business. As we move into 2023 and beyond, we're anticipating acceleration in our top line growth, largely a result of our investments made across our organization over the last two years. We have made important progress this year With key product approvals and introductions and for the balance of 2022 we will continue to invest in our growth, especially in areas of our business, where we have a competitive leadership position as a reminder, these areas are biologics and regenerative technologies. A category that includes both bone and soft tissue stimulation and biologics second. spinal technologies, which includes innovative implants and cervical solutions, and third, orthopedics, where we specialize in limb reconstruction and pediatric deformity. Our investments in these product portfolios are focused on enabling technologies, alternative surgical site development, and single-use, sterile-packed product technologies, as we believe these are important ways to deliver value to our customers. We have several exciting updates on these investments that we believe will have positive near-term impacts on growth, specifically from fit bone, a cell stem, virtuose, and legacy. The fit bone limb lengthening system remains an important growth driver as demonstrated in the first quarter with 50% growth in surgeries over the first quarter of 2021. The development of a new trochanteric nail for the US pediatric market, which uses our cutting-edge German engineering fit bone technology, is still on track for a 2023 launch. As mentioned earlier, we will soon be launching Virtuos Lyograph, and initial cases are anticipated in the second quarter. It is worth restating that Virtuos is the first graft to deliver all of the necessary properties for bone formation in a shelf-stable form. In addition to the upcoming exclusive launch will be highlighting virtuals at the ice ass meeting in early June. Our second new biologic solution legacy is an effective bone graft extender that has clinical value or maintaining a cost effective option for our customers. This solution, in conjunction with our recent biologic addition of fiber to strip and fiber fees putty allows us to compete in an almost $500 million to mineralize bone allograft US market. We anticipate that legacy will be initially available in Q3 of this year. In summary, i'm very happy with our performance during the quarter and the progress we've made towards our initiatives, despite a significant coven impact restrictions early in the quarter. We drove year over year top line growth, supported by contributions from recently launched products validating the strategic investments, we have made over the last two years. We continue to accelerate our product innovation efforts. With achievement of a number of key accomplishments, including the launch of opens BA true lock Evo and galaxy Gemini. Additionally, we put ourselves in a position to introduce a number of game changing products this year, including the initial market release of a cell stem in the second quarter. As well as a near term launch of two key biologic offerings we talked about, which will be hitting the market in the second third course. Taken together with the rest of our growth pipeline, the strength of our existing portfolio, and the progress made enhancing our commercial organizations, I'm excited to see what the rest of 2022 brings as we execute on our growth transformation. With that, I'd like to turn the call over to Q&A.

Thank you. If you would like to ask a question, please press Start followed by 1 on your telephone keypad. If for any reason you'd like to remove your question, please press Start followed by 2. Again, to ask a question, it is Start followed by 1. I would now like to start the questions with Matthew Blackman of Stifle. Your line is now open. Please go ahead.

Good morning, everybody. I hope you're doing well. Thanks for taking the question or questions. Maybe just to start, I wanted to start on the guidance. You raised it by about 100 basis points, the underlying growth. Where is that manifesting? Is it in any particular franchise or geography, or is it more broad-based? And I just have a couple of follow-ups.

Yeah, Matt, it's a good point. With about 23% of our revenue outside of the U.S., we're impacted primarily by the Euro dollar rate. So you're right, even though we held reported guidance flat on a dollar basis, effectively it was about a 1% raise. And we think we're going to get that based on the strength of Our orthopedics growth primarily was a shining star for us last year, year over year, and they had another good quarter in Q1 that benefited by FitBone and other new products. And so we feel like that's an achievable metric for us.

Great. Another bigger picture question, just reflecting on your commentary about complex cases coming back slowly. So you just think about the recovery trajectory of cases and and then how that flows through your portfolio. Is it fair to say that the easier cases come or are coming back first, then complex follows, which then should pull through more of the biologics portfolio, and then maybe on a lag thereafter, you see some uplift in particularly the spine spin business? Is that the right way to think about the cadence of recovery and then how that potentially flows through your top line?

Matt, this is John. Thanks for the question. And that is the way we think about it as far as the complex cases by their nature have multiple hospital night stays. And they also oftentimes have to be backed up by ICU. Not that they go to the ICU, but they have to have capacity. So as hospitals have that capacity, they'll take more of those cases on. What we're seeing in the physician's office, though, people are coming back and looking towards having those cases done. So we see those coming back. Physicians backlog as far as their wait periods are coming up too. Is there anywhere from four to six to eight weeks? And so those patients come back. We saw a 2.3% reduction in complex cases in the first quarter. And so we know they're out there and they'll be coming back. To your point about other products such as biologics, biologics we've stated in the past has been a leading indicator that those complex cases will come back. And so we saw a small lift in our biologics business, and we're seeing more momentum there as well. And then as far as the BGT question, BGT does go with those complex cases, and so they follow along with that. So we look at the open orders for BGT, and they're coming back as well. So from that standpoint, you have it directionally correct, and we're looking forward to those cases coming back into the market.

And just are you seeing in April some improvement in that complex mix, just any color? I'm sure you'd love to give inter-quarter color, but to the extent you can, any color on how that's playing out in April?

Well, we've been sharing our prepared... Yes, we shared and prepared that our trajectory between March and April is consistent from 21 to 22, and that's a mix. We can't necessarily tell in the month what the mix of our cases are until we analyze it several weeks later.

Okay, and then I'm just going to sneak one more in on a self-dim. It came a little bit earlier, I think, than we anticipated, so congrats to that on that. How quickly can it visibly contribute to growth? That's sort of part one of the question. And then sort of part two, a bigger picture one. Is it unreasonable to think that now OrthoFix being the only company with all the approved indications and now multiple modalities that a self-STEM could potentially have a halo effect on the broader BGT portfolio?

Man, I like the way you phrased that question, the answer, and generally say yes, but let me get into a little detail on that as far as. At Cell Stem, we licensed the technology from EGEA in April of 21, and we received our PMA approval and the first week of May of 2022. A truly remarkable effort on the teams within OrthoFix and also working collectively with EGA. We couldn't be more proud of that relationship. And yes, it does put us into the lightest technology with fresh fracture and non-union. As we highlighted our PEMF, PhysioSTEM nonunion has had good success here in the quarters, and we've been building that channel over the last several quarters to put more direct reps in those areas. So from that standpoint, we expect that the combination of the CellSTEM plus PhysioSTEM will be a powerful combination for both fresh fracture and nonunion. And the way our channel is set up, we do expect that there will be more momentum. I was just with a number of them in the last weeks, and the excitement around the overall BGT franchise. We took proactive training in the month of April. We had the first 40 reps in to train them on a cell stem, and some of those reps also carried the broader BGT line. It's a great product for us. We're really excited about where it could take us, and it's the first product we put into the BGT, first new product we put into the BGT product category for 15 years. And so the team's there. It's our broadest and most mature distribution channel. We're looking forward to really seeing the sales stem, as well as our BGT product portfolio excel.

Great, John. Really appreciate it. I'll get back in queue. Thanks.

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

Hi, John and Doug. How are you?

Good morning, Jeff. How are you? Good morning, Jeff.

Fine. So firstly, could you walk through the virtuous and the biologic platform as well as legacy? And could you talk about... this being a 351 or 361 and is has and will mtf be responsible for uh the clinical work and the filings or is that something you're taking on on your end this this a lot thank you jeff the question uh this

Virtuose and Legacy do align with our traditional relationship with MTF, which we've highlighted in the last week. We've extended for another 10 years. MTF, this is a 361. Both of them are 361 tissues. And with that, MTF manages that for us. That's the relationship we have. And as I said in the past, I'm a absolutely believe mtf biologics is the best uh processing and and partner we could have in the business and so we really rely on that their expertise and they brought with us this new uh virtuose which is a the lyograph a whole new process how to pro how to manage and process tissues and we're looking forward to seeing how that well looking forward how that performs in the marketplace

Perfect. And then I'm going to jump back to Selston. Could you talk about currently the number of SKUs that you're planning on introducing? Is it just one? Are you going after other limbs and areas of the body? And then can you also talk about the manufacturing and assembly process? Is it similar or co-joined with the PEMF technology?

Yes. There are... more there's more than one skew there's one major skew the fact that there are some ancillaries that go with it but effectively there's one skew that's the beauty of this technology it is manufactured in uh with the egea in italy and it is what we worked collectively with them and so it runs under our quality system as well and so we have a direct uh connection with them as far as all the operational work that goes forward we are that we are the uh the approval holder of that technology, so we do have responsibility for that. But we've been producing these products over the last six to nine months. There are products sitting on our shelf here in Louisville, Texas, and we're going through the final labeling, as you might imagine, just obtaining a PMA. So we're excited where we're at, and we're aligned with EGA on this to bring this product forward to the market.

Perfect. And then one more quick one for me. Could you talk a little bit about the – the OUS and global business, I mean, outside of the headways on dollar and currency, does it feel like you're picking up some traction there heading back to a $100 million business on an annual basis?

Well, let's talk specifically as far as – thank you for the question. From the orthopedic standpoint, we are – very strong traction there. The team, the commercial team there continues to perform. They performed in 2021 and they're performing in 2022 as well. Regarding the spine group, we've been building a spine group in the international markets and they've continued to excel. And that's what generated a number of our results this quarter. I'll also highlight that we talked about our stocking distributors buying and buying product. That's a good indicator going forward. When our stocking distributors buy product, they're getting ready for markets that are available and open to sell. So we look at our international businesses as working well for us, and we still have work to do there, but we're pleased where we're at.

Perfect. Thanks for taking our questions. Thank you, Jeff.

Thank you. Our final question comes from the line of Jim Sedotti of Sedotti & Co. Your line is now open. Please go ahead.

Hi. Good morning. Thanks for taking the question. You know, I've been on these calls for 20 years, actually, and I've never heard the new product pipe on as full as it is right now. So like everyone else, I'm interested in the AccelStim product. Can you talk a little bit more about that? When would you use that as opposed to using PhysioStim?

Jim, thanks for the question. You faded away at the last question.

When would a physician use the AccelStim as opposed to using the PhysioStim?

Oh, okay. Yeah, thanks. The CellSTEM and its LIPAS technology is approved for both fresh fracture and non-union. Our previous physio stem was approved for just non-union. So we will be using a cell stem in the fresh fracture category, which is really beneficial to our sales channel because our physio stem reps are working in the area of fracture management. And so they, with physio stem, had to wait for non-union. Now they can go sell every day looking for fresh fractures and then basically apply a cell stem to fresh fractures. And then the physio stem will be on the nonunion, which has really demonstrated excellent clinical results. So we have the best of both worlds. We have technologies that go in both those categories.

Doug it looks like uh inventories are up about four or five million uh since the fourth quarter is that due to you know the supply chain issues are you just having more safety stock on hand or is that finished goods you know in anticipation of higher sales going forward all the above it's a good question Jim thank you yeah we've kept inventory and and fairly flat over the last several quarters and you're right it went up about five million dollars

With all of the supply chain destruction, we proactively decided to deploy our balance sheet and use our cash to invest in inventory and take some of the risks out of our supply chain exposure In our script, we mentioned advanced buying around titanium. You've seen semiconductor chips that we've gotten out ahead of over the last several quarters, and we feel like it's a good way to deploy our balance sheet and ensure that we take some time out of the supply chain risk.

And then on R&D, I think you said 11.5% to 12% of supply revenue for the year. So, you know, it sounds like it's going to take up pretty consider considerably in the second and third quarters, you know, four or five million. You know, what is that for?

That's it, Jim. You heard correctly our prepared remarks. And a lot of that is around EUMDR and the bullets of our spend should end this year. It should start to taper as we get into 23 and the 2024 deadline. But it also includes spending around clinical trials. As COVID impacted Q1, we feel like clinical trial spend will pick up. this summer for Rotator Cup as well as our M6 two-level study. And we've got further investments in innovation that also hits that R&D line. So as we launch new products and support their regulatory pathways, that's where those costs show up.

All right. Thank you. Thank you, Jim.

Thank you. There are no additional questions in the queue at this time, so I will pass the conference over to the management team for closing remarks.

Thank you. On behalf of the ORFIX team, thank you for participating in our Q1 2022 call, earnings release call, and have a great day.

This now concludes the conference call. You may now disconnect your lines.