Orthofix Medical Inc.

Hello, good afternoon, and welcome to the OrthoFix Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. We will be facilitating a question and answer session at the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Louisa Smith from the Gilmartin Group for a few introductory comments.

Louisa Smith Great, and good afternoon, everyone.

Welcome to the OrthoFix Third Quarter 2020 Earnings Call. Joining me on the call today are Board of Directors Chair and Interim Chief Executive Officer, Kathy Burzyk, and Interim Chief Financial Officer, Jeff Gillespie. During this call, we will make 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 under 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, November 8th, 2023. We do not undertake any obligation to revise or update such forward-looking statements. Some factors that could cause actual results to materially differ from the forward-looking statements made by us on the call include risk factors disclosed under the heading Risk Factors, and our Form 10-K for the year ended December 31st, 2022, and Form 10-Q filed this afternoon, November 8th, 2023, as well as additional SEC filings we make in the future. In addition, on today's call, we 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 news release announcing our third quarter 2023 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 Cathy.

Thank you, Louisa. And thank you everyone for joining us this afternoon. On today's call, I will review highlights of the third quarter results, followed by a more detailed look at the performance of our business units, and then finish with some operational comments. Jeff Gillespie will review our financial results, and we will conclude with a question and answer session. Let me begin by saying that we're very pleased that our business has operated smoothly since the management transition announcement in September. am extraordinarily proud of the commitment of our employees and grateful for the support of our distributors and surgeons our company is continuing to build on the momentum we have fostered since the business combinations was finalized in january and simply put we have not taken our foot off the gas throughout the period of transition our leadership team is highly capable and I have the utmost confidence in our ability to capture market share, deliver value, and execute on a long-term vision of the company. The search for a permanent CEO is underway, led by the well-regarded executive search firm, Heidrick & Struggles, and we anticipate announcing our permanent CEO by the end of the year. Let me reiterate that the fundamentals of our business, the merger thesis, and the long-term growth strategy remain intact. Turning now to highlights of the third quarter results. OrthoFix performed well. We saw unprecedented growth in BGP and double-digit growth in U.S. orthopedics. Revenue for the third quarter 2023 was $184 million, representing a growth of 61% on a reported basis and 1.2% on a pro forma basis. Normalizing for a one-time stocking order that occurred in the third quarter of 2022, revenue on a pro forma basis grew 8.4%. We are proud of our strong adjusted EBITDA performance for the quarter, delivering $13.5 million and representing 36% improvement sequentially over the second quarter. We executed on key commercial initiatives and strategic decisions made in prior periods, including cross-selling opportunities and meaningful expansion of our commercial reach with added distributors. Beginning with phone growth therapies, or BGT, revenue for the third quarter of 2023 was a record-breaking $53.4 million, an increase of 15% year over year, marking the third consecutive period of double-digit BGT growth. We are increasingly pleased with the performance of our BGT business, and are encouraged by the effective cross-selling of our sales teams, particularly the legacy seed find sales channel. The quarter's impressive growth in BGT came from success on all product lines across the find and fracture channel, and most significantly, a sell step where we are taking market share from our competitors. In 2022, Orthodox Management made the decision to invest more meaningfully in the fracture channel, which included adding sales representatives and building out their area managers to establish a more focused sales organization. We are now reaping the benefits of that decision. Additionally, we continue to see great traction from a cell stem as demonstrated by further accelerating our sequential growth rate for this product to over 25% relative to the prior quarter an increase from the 23% sequential growth we reported in the second quarter. Moving on to spinal implants, biologics, and enabling technologies. We were pleased with the strong performance in the U.S. during the third quarter. The U.S. reported 6.6% year-over-year growth on a pro forma basis, approximately two times above estimated market rates. The performance was driven in large part by more exclusive distributor partnerships cross-contract access, and an increased focus on adding legacy seed fund products to legacy orthopix distributor offerings and vice versa. Our emphasis on larger and more exclusive partners resulted in year-over-year growth in the high teams from our top 20 distributors. We are pleased we have been able to maintain existing and build new relationships with our key distributor partners. Global revenue for this segment in the third quarter of 2023 totaled $101 million, representing a decrease of 6% on a pro forma basis compared to the third quarter of 2022. It's important, however, to note that the prior year period included a large stocking order of $12 million associated with SeedSpine's planned exit from Europe due to the high cost of MDR compliance. Normalizing for the effect of this stocking order, our global revenue growth was 5.8% year-over-year. From a spinal implant perspective, year-to-date, we have had seven new product launches and line extensions, all of which have been very well received in the market, and we remain committed to innovation across our portfolio. We are particularly proud of new products in Cervical, our fastest-growing franchise, led by Waveform Seeds, our unique cervical intrabody, and Northstar, our posterior cervical system. Within our Thorough Columbar franchise, we continue to see great momentum with our recently launched lattice lateral retractor, which is driving greater than 50% growth across our lateral platform. Surgeons indicate our improved lateral portfolio has optimized each procedural element from access to fusion in order to more effectively treat bearing spinal conditions. We have successfully worked within our supply chain to build additional inventory of spinal implant sets for a significant growth initiative with new channel partners. Many of these sets are coming online this quarter, allowing us to treat even more patients with our new and existing commercial reach. With respect to our M6 motion preservation franchise, we are pleased to share that a detailed manuscript of the five-year results of our FDA investigational device exemption IDE clinical trial of M6C artificial cervical disc has been accepted for publication in the Spine Journal. We have previously shared the very positive results of this IDE study in abstract and other presentations, but this marks the first publication. Results of this trial showed that at the five-year endpoint, the M6C disc demonstrated one of the lowest subsequent surgical interventions SSI rates at 3.1% when compared to other FDA-approved artificial cervical discs. We expect to achieve another major milestone in the M6 franchise. The M6 artificial disc was commercialized outside the United States in 2006 and has an established, robust clinical history. We expect to complete our 100,000th M6 disc implantation during the fourth quarter. Congratulations to this franchise. Within Biologics, in mid-October, we announced 510K clearance and the full commercial launch of OsteoCult, an advanced bioactive synthetic collagen graft. This product, indicated for use in posterior lateral fusions, fills a gap in our bone substitute portfolio. Orthofix has historically been a leader in the DBM and cellular allograft markets. And OsteoCode will strengthen the biologics portfolio with synthetics to offer the entire spectrum of options in a surgeon preference-driven market. Turning now to the enabling technology franchise, we placed 1070 units in the third quarter, with three of those via an earn-out arrangement. This brings the total number of 70 units placed via earn-outs to 11, with an annual revenue commitment of $6.6 million. We are very pleased with the increasing market adoption of our 7D systems and the role our guided navigation technology plays in leveraging growth across all product lines. We believe that 7D, with its unique flash capability that reduced exposure to radiation, is well-positioned to capitalize on the high growth expected in the enabling technology market in both the hospital and ASC environments. In the global orthopedic segment, revenue totaled $29.7 million, which represents approximately 7% year-over-year growth on a reported basis and approximately 1% on a constant currency basis. We are exceptionally pleased with our 14% growth in the U.S. The double-digit growth momentum is driven by investments in U.S. sales and marketing, best-in-class surgeon education programs, and continued product innovation and launches like TrueLock EDO and FitBone. Internationally, we saw a 3% contraction on a constant currency basis, primarily driven by a difficult year-over-year comp as there were significant international stocking orders in the third quarter of 2022. Our commitment to innovation is central to our market share expansion. and we were excited to recently announce the launch of our single-use sterile pack galaxy ankle kit developed specifically for the U.S. market. We continue to expand our already broad offerings of single-use sterile pack kits across all orthopedic product lines. More broadly, beyond our individual businesses, we are fully committed to OrthoFix's mission, and we believe the growth and value opportunities ahead of us are significant. The integration of Orthodox and C-SPY is progressing as originally contemplated without meaningful disruption, and we will continue to drive profitable growth for the company as evidenced by EBITDA margin improvements, as Jeff will explain. We are seeing the benefits of cross-selling initiatives, a strengthening of our commercial channels, and the capturing of market share. We are updating our 2023 revenue range to be between $739 million and $744 million, representing 5.4% to 6.2% pro forma growth over the prior year. This revised guidance is primarily due to changes in the competitive environment resulting in near-term market disruption. While we are not going to give guidance for 2024, I am confident in OrthoFix's ability to leverage our momentum going forward. We are focused on maintaining strong relationships with our distributor and surgeon partners. We have a robust pipeline of new distributors. We believe we have sufficient inventory to meet the expectations of existing and new distributors and surgeons. And we are executing well on commercializing our newly launched products. And we have a strong pipeline of new products under development. that will launch in 2024. Going forward, we are laser focused on driving profitable growth. We will continuously improve EBITDA and expect to be cash flow positive in late 2024. I'm very excited for what's to come at OrthoFix. With that, I'll turn the call over to Jeff for further detail on our third quarter financial results. Jeff?

Thanks, Kathy, and good afternoon, everyone. As Kathy noted earlier, Total revenue for the third quarter of 2023 was $184 million, representing growth of 61% on a reported basis and 1% on a pro forma constant currency basis over the prior year period. Normalizing for a one-time stocking order that occurred in the third quarter of 2022, revenue on a pro forma basis grew 8.4% in the third quarter of 2023 over the prior year period. Revenue growth was led by BGT, which grew 15% year-over-year to $53.4 million. The third quarter marks three consecutive periods of double-digit growth for the BGT franchise, led by the recently launched Excel STEM product, which experienced over 25% sequential growth from Q2 2023. Global Orthopedics reported total revenue of $29.7 million for the third quarter, an increase of 7% over the prior year period, In the U.S., orthopedics revenue continued to show strong growth with a 14% increase over the prior year period and a 4% sequential increase over the second quarter of 2023. Gap gross margins for the third quarter of 2023 was 65% compared to 73% for the third quarter of 2022. Adjusted gross margin was 71% for the third quarter of 2023 compared to 74% for the prior year period for legacy orthopedics. In the third quarter of 2023, merger-related charges continue to temporarily depress GAAP gross margin, primarily driven by the following, $7.9 million in amortization of non-cash purchase accounting adjustments related to acquired C-SPIN inventory. These non-cash charges are standard in business combination, as companies must step up the basis in acquired inventory to ensure that future margins are recognized only on value-added activities subsequent to the merger date. $1.4 million of excess and obsolete inventory charges recorded in connection with product rationalization decisions made as a result of the merger and the dilutive impact of the acquired legacy C-Spine business on legacy OrthoFix's overall gross margin. On a pro forma basis, including financial results of C-Spine for the third quarter of 2022, revised to conform to the OrthoFix presentation, we estimate that adjusted gross margin increased by 350 basis points 71% year over year. The pro forma gross margin improvement is primarily driven by product mix and a large low margin stocking order in Q3 2022 that did not reoccur in the current quarter. We expect adjusted gross margins to increase over time as we recognize efficiencies from spinal implant set utilization and product rationalization, as well as other efficiencies that we expect to generate as a result of the merger. Gap sales and marketing expenses in the third quarter of 2023 were 52% of net sales, up from 49% in the third quarter of 2022. Adjusted sales and marketing expenses were 49% of net sales for the third quarter, up from 48% in the prior year period. The increase in gap sales and marketing expenses primarily driven by integration-related severance, retention costs, stock-based compensation associated with the merger, and higher commissions as a result of the achievement of certain sales objectives. Gap G&A expenses for the third quarter of 2023 were 15% of net sales, down from 17% in the prior year period. Adjusted G&A expenses were 10% of net sales for the third quarter, compared to 11% from the prior year period. The decrease in gap G&A expenses as a percent of revenue was primarily driven by increased leverage on our fixed costs associated with the merger and the capture of merger-related synergies. We anticipate incurring additional severance and retention expenses for the remainder of 2023, but these costs are anticipated to continue to decrease as affected employees reach their respective end dates. GAAP R&D expenses for the third quarter of 2023 were 10% of net sales, down from 11% in the prior year period. Adjusted R&D expenses were 8% of net sales for the third quarter, consistent with the prior year period. The decrease in GAAP R&D expenses primarily driven by lower spend related to EU MDR readiness and compliance and realization of merger-related synergies, which were slightly upset by higher stock-based compensation expense. As we continue to focus on developing and bringing new, innovative, and differentiated products to market, we expect our total research and development investment to be between 9 and 10 percent of net sales for the remainder of 2023. Adjusted EBITDA for the third quarter of 23 was $13.5 million compared to $14.3 million for the third quarter of 2022. On a pro forma basis, including the financial results of C-SPIN for the third quarter of 2022, we estimate that adjusted EBITDA increased by $2 million, representing a 17.1% growth over the prior year period. Finally, we expect adjusted EBITDA to continue to increase in the fourth quarter of 2023 as planned operating expense synergies continue to materialize. Adjusted gross margin and adjusted EBITDA are non-GAAP financial measures that provide valuable information on our operating results, making it easier to compare our core operating performance between periods and against other companies in our industry. A reconciliation of GAAP to adjusted gross margin and adjusted EBITDA is presented in the financial tables of the news release we issued this afternoon. A reconciliation of pro forma adjusted gross margin and pro forma adjusted EBITDA is included in the back of our updated investor presentation that was included in the current report on Form 8K that we filed today. Cash and cash equivalents on September 30th, 2023 total $34 million. And as of September 30th, we had $70 million of outstanding borrowings under our $175 million credit facility. During the fourth quarter of 2023, the company entered into a four-year financing arrangement with Blue Torch Capital. The financing arrangement provides for $100 million senior secured term loan, which was fully funded on the effective date, a $25 million senior secured delayed draw term loan, and a $25 million senior secured revolving credit facility. In connection with entering into the financing agreement, the company repaid in full amounts outstanding and terminated all commitments under the company's prior $175 million senior secured revolving credit facility. Our free cash flow, which includes operating cash flows and capital expenditures, was an outflow of $21.9 million for the third quarter of 2023, which is a sequential increase from $18.3 million reported in the second quarter of 2023. The increase is primarily attributed to continued investments in inventory and capital instruments as we continue to take advantage of channel displacements driven by market disruption. Free cash flow for the first, second, and third quarters of 2023 included an estimated $15.5 million, $5.8 million, and $4.4 million, respectively, of spend on merger-related items. Turning to updated guidance for the full year of 2023. As Kathy mentioned, we are revising our full-year revenue guidance. We now anticipate revenue for the full year of 2023 to be in the range of $739 million to $744 million. representing a 5.4% to a 6.2% year-over-year growth on a pro forma basis. For adjusted gross margin, we are maintaining previously issued estimates to range between 71% and 72% the full year of 2023. We remain focused on overall profitability and positive free cash flow going forward and are reaffirming our full-year adjusted EBITDA guidance to range between $42 to $46 million. We continue to expect that free cash flow will be approximately $100 million outflow for the full year of 23. As we continue to gain operating leverage and realize continued operating expense synergies, we expect to be cash flow positive in late 2024. Finally, in our second quarter earnings call, we raised our estimates of annualized COBS and OpEx expense synergies from $40 million to $50 million by 2025. We are maintaining that guidance and are pleased to be tracking ahead of our estimates and we'll have realized over $30 million of those synergies on the annualized run rate as we exit 2023. The cost to achieve that higher synergy target is expected to be approximately $45 million, with more than $30 million of those dollars being spent in 2023.

At this point, I would like to turn the call over to Kathy to provide closing comments.

I'll close by reiterating that our entire team remains highly encouraged by the stability of our business. the prospect of creating and delivering long-term value, and the incredible momentum we are carrying into 2024. I again want to thank all of our employees for their dedication to the company and their commitment to our mission to collaborate, innovate, and improve the lives of patients. At this point, operators, please open the line for questions. Thank you.

Thank you so much. At this time, if you would like to ask a question, press star, then the number one on your telephone keypad. Again, that is star one. Our first question comes from the line of Matthew Blackman from Stifle. Matthew, please go ahead.

Good afternoon, everybody. Can you hear me okay?

Yeah, we can hear you, Matt.

Oh, great. Thanks, Kathy. I've got a few questions. Maybe just to start, I was hoping you could walk us through the implied 4Q guide. A little bit more detail on what you're seeing that's driving that. Is this sales dislocation you're seeing or you're trying to be prudent with uncertainty or some combination of both. And then the follow-up to that, I think if I do the math on the EBITDA contribution margin for the lower revenues, I would have expected a bigger hit to EBITDA. First of all, is that right? And if so, is that a function of additional cost cutting or are we seeing perhaps a lift from cost synergies mitigating a higher drop-through and then a couple of follow-ups, if I may?

So, let me, let me start Matt and then I'll turn it over to Jeff to talk about the EBITDA question. Thanks. Thanks for the question. And I, you know, your commentary about being prudent, you know, is really the right answer here. As we look at the overall market at this point, you know, others have talked about this too. The competitive environment is complicated right now. And there's a lot of market turbulence that we all are facing. You know, that said, You know, I think we should be very proud. I'm proud of the whole organization here that we have not lost any distributors. We have not lost any ortho-fix employees to competition at all during the course of these past several months. So the company is very stable. What we see happening in the marketplace, however, is a slowdown in decision making, you know, just as a result of the market turbulence. Our pipeline, our distributor pipeline is very strong. We have a very good funnel that we review regularly of opportunities. We have gained a number of distributors already as a result of the activity in the market in the last few months. So, as I said, the adjustment is really just being prudent going forward. You know, I would say that just to give you a little color here, the quarter started out very well in the month of October. So, we'll see how the rest of the quarter turns out. And I'll turn it to Jeff for, yeah, your observation on EBITDA is spot on, and we're pretty proud of our ability to execute on the EBITDA line.

Yeah, I think that's right. You know, as we continue to optimize our company footprint as we go through the integration, that has been top of mind, obviously, and we're starting to see those dollars flow through to the bottom line, and that's really the story here is as we continue to gain synergies and optimization in our business, we're going to continue to see more dollars fall to the bottom line.

Okay, that was both of those answers. Thank you. And, Kat, you gave us, I think, a very encouraging update on the stability of the sales force. I think that was your word as well. I guess the question really is, how much risk is there from here? I guess in particular with some of the larger distributors you've onboarded over the last couple of years, where your conversations are with the the selling footprint? Are we through the worst of it potentially? Obviously, we're still at risk here, but just your thoughts on how far along you're in the process of locking in the selling footprint to the extent that you can, and how much more risk is there from here over the next couple of quarters?

You know, so I say, you know, I meet regularly now with the sales leaders trying to understand the funnel, trying to understand, you know, any distributor relationships that are up for renewal. You know, I think it's fair to say it's, you know, it's an all hands-on process at this point. I think, you know, we have very strong leadership at the top of the sales organization that are dealing with distributors, both new distributors and past distributors. You know, and as I said, right now we're confident you know, in moving forward with the pipeline that we have and the distributors that we have. We obviously have built additional inventory. We've talked about that in past calls. Our final steps, you know, are in the process of rolling out now. So we can definitely get inventory into the hands of, you know, our new distributors as well as updated inventory and sets to our existing distributors as we renew them going forward. So I guess the short answer is, I see things being very stable at this point in time. And, you know, as I mentioned, you know, what we see right now is just a short-term, we think it's a relatively near-term slowdown in decision-making.

Okay. And, Kathy, just to follow up to that last point, this is my last question, I swear. And you, I think, mentioned it to some extent, but obviously you've got more instrument sets available, obviously going to your new distributors. But what's your expectation or hope your ability to use some of those sets to potentially onboard new distributors. Is that a possibility here, even in the midst of this uncertainty?

Yes. We're already onboarding numerous new distributors. I hear about this, you know, weekly, you know, at our meetings. So, yeah, we are onboarding many new distributors. We're providing our sets to the distributors. So, that entire process is rolling forward as planned.

Okay. Thank you so much. You're welcome.

All right. Actually, that looks like our last question. We had somebody on the line, but they dropped off. Okay. I would now like to turn the call back over to Kathy Burzyk for closing comments.

All right. Well, thank you very much. We're really pleased that all of you could join us this afternoon for the conference call, and have a good rest of the day. Thank you very much. Take care. Thank you.

This ends today's call. Have a pleasant day.