Orthofix Medical - Q2 2023

Transcript

Operator (participant)

Ladies and gentlemen, good afternoon. My name is Abby, I will be your conference operator today. At this time, I would like to welcome everyone to the Orthofix Medical second quarter 2023 earnings conference call. Today's conference is being recorded, and all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one a second time. Thank you, I will now turn the conference over to Louisa Smith at Gilmartin. You may begin.

Louisa Smith (VP)

Thank you, operator. Good afternoon, everyone. Welcome to the Orthofix second quarter 2023 earnings call. Joining me on the call today are President and Chief Executive Officer, Keith Valentine, and Chief Financial Officer, John Bostjancic. 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 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, August 8, 2023. 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 risk factors disclosed under the heading Risk Factors in our Form 10-K for the year ended December 31st, 2022, and Form 10-Q, filed this afternoon, August 8th, 2023, as well as additional SEC filings we make in the future. 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 US GAAP. Please refer to today's news release announcing our second quarter 2023 results for reconciliation of these non-GAAP financial measures to our US GAAP financial results. At this point, I will turn the call over to Keith.

Keith Valentine (President and CEO)

Thank you, Louisa, and thank you everyone for joining us this afternoon. Orthofix had a strong quarter marked by solid operational and financial performance following the merger in January. We grew order volumes and leveraged cross-selling opportunities across the complementary portfolios, and perhaps most significantly, continued to effectively manage through the revenue synergy risk associated with the business combination. The Orthofix team is incredibly motivated by these successes, and our teams are working relentlessly to capture market share and deliver value. I'm pleased with the progress of the business, and I'm eager to share with you some high-level achievements from the second quarter. Revenue for the second quarter of 2023 was $187 million, representing reported growth of 58% and pro forma constant currency growth of 7% year-over-year.

The strong quarter reflects our commitment to delivering consistent above-market gains through innovative products and an expanded distribution reach. For this afternoon's call, I'll begin by providing color on each product category, including revenue, innovation initiatives, operational highlights, and commercial channel updates. John will provide a detailed look at financial performance and guidance for full 2023 year before we open the call for your questions. Bone Growth Therapies, or BGT, revenue for the second quarter of 2023 was $52.7 million, an increase of 10% year-over-year. This marks two consecutive quarters of double-digit BGT growth, which was primarily driven by the fracture channel on the strength of the recently launched AccelStim product and investments made in 2022 to create a more focused sales organization.

The spine channel also performed well, growing mid-single digits year-over-year, driven by cross-selling through the legacy SeaSpine distribution channel and from healthy, complex spine surgery volumes. Overall, both commercial channels have also benefited from the more than 6% rate increases that were approved by Medicare this year. Moving on to spinal implants, biologics and enabling technologies. Global revenue totaled $105.3 million, representing 145% growth year-over-year on a reported basis, and 5.4% on a pro forma basis. Growth in the U.S. exceeded 7% on a pro forma basis, while international revenue declined as a result of SeaSpine's exit from the European spinal implants market in the third quarter of last year.

We continue to see strong growth generated by the larger, more exclusive distributor partners and be more aggressive in rationalizing the less exclusive and revenue-inefficient distributors. From a product perspective, our cervical franchise, led by NorthStar and WaveForm C, was the fastest-growing franchise within the quarter. In June, we commercially launched the WaveForm A interbody system to target anterior lumbar interbody fusion, or ALIF procedures, to better address the $200 million market in the U.S. Additionally, we see increasing interest in our foundational Mariner modular pedicle screw system technology as adoption of the Fathom pedicle-based retractor system for use with the Mariner MIS system accelerates as we participate in more complex spine procedures through the Mariner Adult Deformity system, which we launched earlier this year.

With respect to the M6 motion preservation franchise, we were pleased to present in June initial results from a 7-year study of the M6 device at the International Society for the Advancement of Spine Surgery, or ISASS. The abstract is the first public presentation of specific 7-year clinical results associated with the use of the M6-C artificial cervical disc for the treatment of single-level symptomatic cervical radiculopathy. The study highlights that using the M6-C artificial cervical disc leads to decreases in disability as measured by the Neck Disability Index and decreases in the neck and arm pain scores that were observed at prior follow-up periods and were then retained through 7 years post-op. Only 6.9% of secondary surgical interventions were observed among the M6-C disc cohort, which is comparable to 7-year SSI rates reported for other commercially available artificial cervical discs.

Within the biologic franchise, we were looking forward to the expected launch of OsteoCove, an advanced synthetic collagen matrix, in the fourth quarter, which should significantly strengthen our product offering and drive growth in this approximately $250 million market segment, which has not historically been a strong product category for the combined company. The biologics team also has several additional line extensions and new product launches scheduled in 2024. Turning to the enabling technologies franchise, we placed six 7D units in the second quarter, with five being placed in the U.S. and one of those via an earn-out arrangement. This brings the total number of 7D units placed via earn-out to eight, with an annual revenue commitment of $4.8 million in total.

In the global orthopedic segment, revenue totaled $29 million, which represents 6.4% year-over-year growth on a reported basis and 5% on a constant currency basis. We posted mid-single-digit growth in both our US and international markets. Our increased investments in product innovation, our sales channel, and our market-leading surgeon education programs continue to yield positive results. Revenue growth in the quarter was led by our recently launched TrueLok, EVO, Galaxy Gemini, and Fitbone product lines. In June, we announced the launch of TrueLok Phantom and Tornado Hinges, the latest addition to the TrueLok circular frame portfolio, for which we recently celebrated 30 years of clinical use in more than 100,000 patients worldwide. Based on our progress to date and the meaningful market share taking opportunities ahead of us, we are confident in our ability to drive top-line growth across multiple business segments.

Coupled with an improving macro environment as a backdrop, the confidence led us to raise our guidance for full year 2023 revenue to be within a range of $752 million and $758 million, an increase of $2 million to the low and high end of our prior guidance. The integration of the two merged businesses continues to progress nicely. The teams made many critical decisions and executed on many programs that will benefit revenue growth, reduce complexity, and generate future P&L and cash flow leverage for the combined organization.

Some of those key decisions and actions include the implementation of a cross-selling capability to distributors for each of the legacy companies' spinal implant systems, decisions to meaningfully rationalize the many redundant spinal implant systems, final selection of critical ERP and other information systems, and the development of a new mission and vision statement for the company. We are also continuing to refine and identify new operating expense and cost of goods sold synergies, which John will provide more details on later. From a macro perspective, procedure volume trends are improving throughout the med tech sector, especially within the spine market, where Orthofix is an advantaged position to strategically capture additional share. Our broad and innovative products portfolio satisfies demand from patients and surgeons across the continuum of care.

With an increased number of product offerings, increased product utilization, higher revenue per case, and an effective cross-selling strategy, our commercial team is ready to capitalize on those underlying tailwinds. I'm thrilled with our momentum coming out of a successful second quarter as a combined organization, and I'm confident that the best is yet to come. With that, I'll turn the call over to John for further detail with respect to our second quarter financial results and updated financial guidance for the full year.

John Bostjancic (CFO)

Thanks, Keith. Good afternoon, everyone. As Keith noted earlier, total revenue for the second quarter of 2023 was $187 million, a 58% reported increase over the prior year and 7% growth on a pro forma basis. Revenue growth was led by BGT, which grew 10% year-over-year to $52.7 million. This marks the second consecutive quarter of double-digit growth for the BGT franchise and was led by the recently launched AccelStim product, which grew more than 20% sequentially over the first quarter of 2023. While we are very enthusiastic about the 12% year-to-date growth rate, we are setting expectations for mid to high single-digit growth for the remainder of this year.

GAAP gross margin for the second quarter of 2023 was 63.9%, compared to 73.2% for the second quarter of 2022. Adjusted gross margin was 71.6% for the second quarter of 2023, compared to 73.9% for prior year period for legacy Orthofix. The decrease in GAAP gross margin was almost entirely driven by the following merger-related factors: A $9.4 million non-cash purchase accounting fair value step-up charge attributable to SeaSpine acquired inventory that was amortized during the quarter, $3.8 million of excess and obsolete spinal implants inventory charges recorded in connection with merger-related product rationalization decisions, and the dilutive impact of the acquired legacy SeaSpine business on legacy Orthofix's overall gross margin, which we estimate to be more than 200 basis points.

Recall that legacy SeaSpine's financial results for the second quarter of 2022 are not reflected in Orthofix's GAAP results. Likewise, the year-over-year decrease in adjusted gross margin is entirely due to the dilutive impact of acquired legacy SeaSpine business on Orthofix's overall adjusted gross margin. On a pro forma basis, including the financial results of SeaSpine for the second quarter of 2022, revised to conform to the Orthofix presentation, we estimate that adjusted gross margin increased by 120 basis points to 71.6%. 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 economies of scale that we expect to generate from the merger.

GAAP gross margin in the second half of 2023 is likely to be negatively impacted by additional merger-related E&O inventory charges driven by further product rationalization decisions. GAAP sales and marketing expenses in the second quarter of 2023 were 53% of net sales, up from 51% in the second quarter of 2022. Adjusted sales and marketing expenses were 50% of net sales for the second quarter, consistent with the prior year period. The increase in GAAP is primarily driven by integration-related severance and retention costs associated with the merger and higher stock-based compensation. GAAP G&A expenses in the second quarter of 2023 were 18% of net sales, up from 13% in the prior year period.

Adjusted G&A expenses were 11% of net sales for the second quarter, compared to 10% for the prior year period. The increase in GAAP G&A expenses was driven primarily by $6.2 million in higher stock-based compensation, as well as $3 million of merger-related costs, including accrued severance and retention costs and professional fees. We expect to record additional severance and retention expenses throughout the remainder of 2023, albeit at lower dollar amounts per quarter as those affected employees work through their respective end dates. GAAP R&D expenses in the second 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 second quarter, consistent with the prior year period.

The decrease to GAAP R&D was primarily driven by lower spend related to EU MDR readiness and compliance, and the realization of merger-related synergies, which were slightly offset by higher stock-based compensation expense. Our focus continues to be on bringing innovative and differentiated new products to the market, and to that end, we expect to invest between 8% and 9% of revenue on R&D in 2023. Adjusted EBITDA for the second quarter of 2023 was $9.9 million, compared to $11.4 million for the second quarter of 2022.

On a pro forma basis, including the financial results of SeaSpine for the second quarter of 2022, we estimate that Adjusted EBITDA increased by $3.2 million in the second quarter of 2023, compared to $6.7 million in the prior year period. We expect Adjusted EBITDA to continue to increase in subsequent quarters of 2023 as we realize increasing amounts of merger-related operating expense synergies through the remainder of the year. Adjusted gross margin and Adjusted EBITDA are non-GAAP financial measures that we believe provides valuable information on our operating results that facilitates comparability of the core operating performance from period to period 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 8 K that we filed today. Cash and cash equivalents on June 30th, 2023,... totaled $37.6 million, and including the $8 million of additional borrowings we made in July, we now currently have $59 million of outstanding borrowings under our $175 million credit facility. Our free cash flow, which includes operating cash flows and capital expenditures, was an outflow of $18.3 million for the second quarter of 2023, a significant sequential decrease from the $45.9 million reported for the first quarter of 2023.

Free cash flow for the 1st and 2nd quarters of 2023 included an estimated $15.5 million and $5.8 million, respectively, of spend on merger-related items. As Keith indicated, we are increasing our revenue guidance and now expect revenue for the full year 2023 to be between $752 million and $758 million, which represents 7%-8% year-over-year growth on a pro forma basis. While we aren't providing specific quarterly guidance, we expect that 3rd quarter revenue will be fairly consistent with 2nd quarter revenue, and we are anticipating a meaningful increase in the 4th quarter due to typical seasonality patterns and from the additional revenue enabled by the deployment of a significant number of spinal implant sets later in the 3rd quarter.

For adjusted gross margin, we are maintaining previously issued for the full year 2023. For adjusted EBITDA, we are raising the range from $40 million-$45 million to $42 million-$46 million for the full year 2023, which represents a 53%-68% increase on a pro forma basis. We expect to generate a very modest sequential increase in third quarter and fourth quarter as we increase revenue and more fully realize operating expense synergies. We continue to expect that free cash flow will be an approximately $100 million outflow for the full year 2023.

As revenue continues to grow and we continue to gain operating leverage throughout the remainder of the year, we believe that we will have sufficient borrowing capacity under the credit facility. Merger-related expense synergies to include initial estimates for cost of goods sold synergies related to product rationalization and other initiatives. We now anticipate generating more than $50 million in comparison to the previously estimated $40 million. We expect to have realized more than $30 million of those synergies on an annualized run rate basis as we exit 2023. Is now expected to total approximately $45 million, compared to the previous estimate of $40 million, with more than $30 million of those dollars being spent in 2023. Progress that we have achieved so far this year.

We will continue to highlight and update our progress on those initiatives on future earnings calls. We plan to host an investor day in our Lewisville, Texas, headquarters. At this point, I'd like to turn the call back over to Keith to wrap up.

Keith Valentine (President and CEO)

I'm extremely proud of the Orthofix team and all that we've been able to accomplish so far, just seven months after the closing of the merger. We collaborate, innovate, and improve the lives of patients. We make it personal, and we aim to do this through our new rally cry: Be bold, relentlessly innovate, and creatively design.

Operator (participant)

If you would like to ask a question, press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster.

Is there any way, and I appreciate this is probably challenging, but is there any way to quantify the magnitude of, of dyssynergies you saw in the second quarter? Revenue dyssynergies, you know, how far along are you in that? Is there anything baked into the, the now higher guide for potentially lost sales as you rationalize that, the portfolio a bit? I've got a, a follow-up. Thanks.

John Bostjancic (CFO)

We haven't seen a meaning, so there's not much to quantify, which is the good news, right? It's, it's more focused on growing and, and taking market share, and we've made most... The second question was?

Just on rationalizing the portfolio and whether there's.

Right.

you know, potential revenue, you know, lost sales as you guide that you have now for the rest of the year.

Yes. Yeah. The, 1 of the early decisions made in the first quarter was the rationalization of the overlapping spinal implant systems by about 50%, right? That's a meaningful reduction in the systems. The good news is it was a balanced outcome of about half of the go-forward systems will be from legacy Orthofix. The potential for lost revenue, we're being very careful to outline plans for that product rationalization. We've got sort of a runway of, of short-term, you know, kill immediately generating growth activities, and then opportunistically look to cannibalize existing sales for the systems that aren't gonna survive that rationalization over time. You know, that's gonna attack to do that without losing any revenue. We feel confident with the plans we've outlined. The goal is to get all of that done within the next 2 years.

Some systems will be rationalized, redeploy those sets that are going to growth to just accelerate the rationalization where possible.

I really, really appreciate that. Then I'll just ask one, one follow-up. Obviously, nice to hear sort of an you found. Would it be your hope that as you continue to sort of dig in here, that you, you may uncover, you know, incremental opportunities on the cost side above and beyond what you've, you've just laid out? Thanks.

Synergy targets, the, you know, $40 million by year three. That was really just focused on operating expense synergies because we didn't really have a good sense of, you know, what the COGS opportunities would be. Saving of, cost synergies by 2025 is coming from the COGS line, because now that we've made those critical decisions, around product rationalization, we can outline sort of the expectation. There's lots of ancillary cost benefits that come with a supplier rationalization. You know, fewer supplier audits, fewer, sustaining resources needed to maintain those legacy systems and, and, and that supplier base, the margin accretion we've talked about on prior calls.

I apologize, I have one more sort of follow-up question on that. Is there a rule of thumb on, you know, again, let's take this as an example, the higher about reinvesting, just any sort of framework to think about that? Thanks.

Yeah, we're, we're doing that as part of our, our strategic planning process, which we're, you know, deep into, and we'd mentioned that certainly looking at both and some of them will go to the bank and others will be redeployed towards growth or other, you know, efficiency or, or economies of scale type activities. More color to come on that as we provide-

Operator (participant)

Your line is open.

Izzy McMahon (Equity Research Analyst)

Hi, this is Yisi on for Ryan. There's 1 for me. How has the integration of the sales force progressed so far? What areas have been most challenging or most impacted?

Keith Valentine (President and CEO)

There's obviously relationships to, to both existing and, and turning over new relationships. Feel, feel good about the stability of, of the teams. I think we have some great examples all over. Early next year progresses as well. We've always kind of mapped this out. This is, this is not a quick play. This is something that will be done over the course of a few to, you know, five quarters, something like that.

Operator (participant)

Kirk Bowman, your line is open.

Speaker 5

Oh, hi, Keith and John. How are you?

Keith Valentine (President and CEO)

Good. How you doing, Jeff?

Speaker 5

Just a couple from our end. Could you stratify for us where that's being driven from and what's become more complex? Is it the sales of Orthofix products or the cases that you're seeing?

Keith Valentine (President and CEO)

Certainly, a lot of the momentum we're getting on 7D is excitement in and around deformity. We continue to not only advance applications, but make sure that the more we're doing in that voice for, for deformity has created this, this greater awareness and greater opportunity for us in that sector. Then, of course, there is a great opportunity that marries in, if needed for the patient, assist with BGT.

Speaker 5

Okay, got it. One more from me. The, you talked a little at the beginning of the call about AccelStim and its 20%, quarter-over-quarter sequential.

Keith Valentine (President and CEO)

First, that's gonna be, later this year launch, but we're excited about it and certainly getting plans in place and, and getting everything organized. We're most excited just because that has been traditionally an area for both... The first, the first question was in and around?

John Bostjancic (CFO)

On AccelStim. Yeah, I mean, it, it's a, it's a meaningful part of the year-over-year growth dollars, Jeff. It's still not a meaningful part of the over-

Keith Valentine (President and CEO)

Our sales meeting, and obviously, that was a product that was focused on. Love seeing that post-sales meeting, we continue to see more and more momentum with it. We're certainly very excited about the up.

Speaker 6

Hey, good evening.

Keith Valentine (President and CEO)

Hi.

Speaker 6

I think you called out, or actually maybe it was Keith, the cervical being the fastest growing component of. You called out cervical as being the fastest growing component of the spine, franchise. If we look at that sort of $105 million base, I was wondering if you could maybe help us think about.

Keith Valentine (President and CEO)

The, the biggest opportunity or the highest billable is, is posterior cervical. I think the excitement we have, though, specifically on the cervical product line, is it was a newer portfolio. Fits nicely with a strong motion preservation in cervical, and we're excited about it. As I mentioned, the 7-year data, that 7-year data really aligns nicely to, to what we've seen elsewhere in this product range on the market.

Speaker 6

I guess as a quick follow-up, you know, if you look at Bone Growth Therapies obviously growing well, any thoughts about, you know, from Keith, particularly on the spinal side?

Keith Valentine (President and CEO)

Yeah, it's, it's, it's actually something we do, are strategically looking at and trying to continue to refine. I- I'll tell you, it's been great. We just had our, our quarterly visit. There's an incentive for the, the spine, the spine teams that are out there to not only engage with their surgeons, but also engage with local representation. Keep in mind, our, our much co-selling is going on, and so clearly there is an opportunity to continue to expand that. I think that team's got some really nice plans to continue to incentivize and, and drive that forward, because keep in mind-

Operator (participant)

There are no further questions at this time. I will now turn the call back to Mr. Keith Valentine for closing remarks. Ladies and gentlemen, this concludes today's call, and we thank you for your participation. You may now disconnect.