Orthofix Medical Inc. (NASDAQ:OFIX) Q4 2022 Earnings Call Transcript

Orthofix Medical Inc. (NASDAQ:OFIX) Q4 2022 Earnings Call Transcript March 6, 2023

Operator: Good afternoon and welcome to Orthofix Medical’s Q4 and Full-Year 2022 Earnings Call. All participants are in a listen-only mode. As a reminder, this conference call is being recorded. I would now like to turn the call over to Alexa Huerta, Senior Director of Investor Relations. Thank you. Please go ahead.

Alexa Huerta: Thank you, operator, and good afternoon everyone. Welcome to the Orthofix fourth quarter 2022 earnings call. Joining me on the call today are President and Chief Executive Officer, Keith Valentine; and Chief Financial Officer, John Bostjancic; as well as our Executive Chairman of the Board and Orthofix’s Former Chief Executive Officer, Jon Serbousek; and Former Chief Financial Officer, Doug Rice. 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 financial 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, March 6, 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 the risk factors disclosed under the heading Risk Factors in our Form 10-K for the year ended December 31, 2022 filed this afternoon March 6, 2023, as well as additional SEC filings we make in the future. If you need copies of these documents, please contact my office at Orthofix in Lewisville, Texas.

In addition, on today’s call, we will refer to various non-GAAP financial measures. We believe that in order to properly understand our short-term and long-term financial trends, investors may wish to review these matters as a supplement to the financial measures determined in accordance with U.S. GAAP. Please refer to today’s press release announcing our fourth quarter and full-year 2022 results for reconciliations of these non-GAAP financial measures to our U.S. GAAP financial results. We will begin today’s call with commentary from Keith Valentine and John Bostjancic on standalone SeaSpine fourth quarter results followed by Jon Serbousek and Doug Rice, who will speak to the standalone Orthofix fourth quarter results. Keith will conclude the call with information on the newly combined company, including 2023 revenue guidance and some additional future looking commentary from Orthofix.

At this point, I will turn the call over to Keith.

Keith Valentine: Thank you, Alexa, and thank you everyone for joining us this afternoon. Before we get into each company’s standalone results, I’d like to take a moment to highlight the recent closing of the merger of equals between Orthofix and SeaSpine. This merger significantly advances our objective to become a surgeon’s partner of choice in their efforts to increase patient mobility and quality of life. Together, we will continue to develop creative, quality driven procedural solutions through expanded commercial access and commitment to innovation. The new Orthofix has an improved profile of scale, growth, and potential operating leverage. In addition to a highly complementary portfolio, expanded commercial reach, and the capacity to make meaningful investments in organic and inorganic innovation.

We believe our comprehensive product offering puts us in a highly differentiated position in the Spine market by combining bone growth therapies, enabling technologies, spinal fixation, motion preservation, and biologics We see this combined company as a transformative organization in the musculoskeletal space that will address unmet clinical needs to improve the lives of patients worldwide. Turning to the results. SeaSpine had a strong year marked by the consistent execution of our growth strategy capturing a market share and the announcement of the pivotal merger with Orthofix. We are excited by the momentum coming out of our fourth quarter results and the work our teams have done since the business combination on January 5. SeaSpine’s revenue for the fourth quarter was $63.4 million, representing 14% growth over the prior year.

Additionally, we posted full-year revenue of $237.5 million up 24% year-over-year. U.S. Spinal Implants and Orthobiologics revenue grew 23% and 20% respectively in the fourth quarter over the prior year, primarily for new products and expanded distribution as a result of our efforts in recent years to partner with larger, more focused distributors. As for the Enabling Technologies platform, we placed 30 units of the 7D Surgical FLASH Navigation Systems throughout 2022, achieved our 100th unit placement milestone and expanded our installed base into six new countries, a testament to our commitment for increased competitiveness across global markets. In the fourth quarter, placed a record 12 units, 5 in the U.S. and 7 outside the U.S. Of those placed in the U.S., 3 were earnout arrangements, the largest quarterly placement of earnouts since we acquired the technology.

As you may recall, these earnout agreements are a capital efficient way for hospital systems to acquire 7D unit in return for a minimum annual contractual revenue commitment for our spinal implant or biologics products for 3 years to 4 years. Typically at a rate of $600,000 to $800,000 per year. To date, we have executed that represent approximately $4 million in aggregate annual revenue commitments. I’d also like to call out the company’s successful execution of further portfolio expansion through differentiated solutions across a broad spectrum of products and services in the fourth quarter, such as the launch of the first component of our insights suite planning software for , and the full commercialization of our percutaneous procedures to support software enabled through the 7D FLASH Navigation System.

Additionally, we recently announced the full commercial launch and first patient cases of Mariner Deformity System, which was built upon the strength and versatility of SeaSpine’s modular Mariner Pedicle screw system to address the unique clinical requirements of complex adult deformity spine cases, while also reducing the number of surgical trays in the operating room suite. These portfolio advancements are indicative of our commitment to restoring mobility and quality of life to patients. And we are very much looking forward to further integrating the two highly complementary organizations to establish an industry leader in Spine and orthopedic technology. I will now turn the call over to John Bostjancic to review the standalone SeaSpine financial results for the fourth quarter and full-year 2022.

John Bostjancic: Thanks, Keith, and good afternoon everyone. As Keith noted earlier, SeaSpine’s total revenue for the fourth quarter of 2022 was $63.4 million, a 14% increase over the prior year. In the U.S. we posted 16% growth. The U.S. spinal implant and enabling technologies revenue in the fourth quarter increased 12%. Within that category, U.S. spinal implant revenue increased by more than 23%. Products launched or enhanced via line extensions within the past five years continue to grow revenue and accounted for 82% of U.S. spinal implant revenue in the fourth quarter of 2022. International spinal implant sales were down 57% in the fourth quarter, due to our recent exit from the European spinal implant market in the third quarter of 2020.

U.S. Biologics revenue in the fourth quarter and continues to be driven by growth in the OsteoStrand Plus Demineralized Bone Fibers product family. Our U.S. spinal implant surgery volumes increased 23%, compared to the fourth quarter of 2021, while revenue per case increased 4%, compared to the prior year. Utilization of our spinal implant systems and Orthobiologics products increased over 9% to 2.3 per procedure in the fourth quarter of 2022, compared to 2.1 a year ago. We experienced mid-single-digit average price declines in spinal implants and no price declines in biologics. As a reminder, the substantial majority of SeaSpine’s revenue was generated in U.S. dollars, so foreign currency exchange rate changes did not have any meaningful impact on our reported growth rates.

GAAP gross margin for the fourth quarter of 2022 was 62.5%, compared to 53.7% for the fourth quarter of 2021. Adjusted gross margin was 64% for the fourth quarter of 2022 compared to 61.8% for the fourth quarter of 2021. The increase in adjusted gross margin was primarily due to the greater relative growth in higher gross margin domestic spinal implants revenue, the reduction in OUS spinal implants revenue as a result of the recent European market exit, and continued efficiencies realized in the manufacturing of our biologics product lines. Operating expenses for the fourth quarter of 2022 totaled $59.8 million, a $10.9 million increase compared to the fourth quarter of 2021. The increase in operating expenses was driven primarily by $5.3 million in higher selling and marketing expenses attributable to increased commissions and freight and logistics costs associated with the revenue growth, and $5.2 million in higher general and administrative expenses, due primarily to increased headcount related compensation expenses, increased legal and other professional fees incurred in preparation for the merger with Orthofix.

Net loss for the fourth quarter of 2022 was $19 million, compared to a net loss of $18.8 million for the fourth quarter of 2021. Adjusted EBITDA loss for the fourth quarter of 2022 was $5.7 million, an improvement compared to a loss of $6.7 million for the fourth quarter of 2021. Adjusted gross margin and adjusted EBITDA loss are non-GAAP financial measures that we believe provide valuable information on our operating results by facilitating comparability of our core operating performance from period-to-period and against other companies in our industry. The calculation of adjusted gross margin and a reconciliation of GAAP net loss to adjusted EBITDA loss are presented in the financial tables of the press release we issued this afternoon. Cash and cash equivalents on December 31, 2022 totaled $29 million and included $26 million of outstanding borrowings under the SeaSpine credit facility, which we subsequently paid off in full on January 5 in connection with the merger with Orthofix.

Our free cash flow burn, which includes operating cash flows and purchases of property and equipment was $16.7 million for the fourth quarter of 2022 and $75.9 million for the full-year 2022. This spend is consistent with a large amount of inventory and set build capital expenditures necessary to support the recent and upcoming full product launches, as well as our above market U.S. revenue growth. As for additional detail on the full-year revenue results that Keith mentioned earlier, 2022 revenue was $238 million, a 24% increase over 2021. U.S. revenue grew 19%. International revenue increased by 66%, and was driven primarily by the final stocking orders to distributors in connection with SeaSpine’s exit from the European Spinal Implants market in the third quarter 2022, and from significant revenue growth from the Enabling Technologies franchise.

U.S. Orthobiologics revenue grew 17% year-over-year in 2022. U.S. Spinal Implants surgery volumes increased 23%, compared to full-year 2021 as revenue per case increased 4% over the prior year. Utilization of our spinal implant systems and Orthobiologics products increased to 2.2 per procedure in 2022, compared to 2.1 in 2021. I’d now like to turn the call over to Jon Serbousek to provide highlights on Orthofix’s standalone 2022 results.

Jon Serbousek: Thank you, John. As announced early year in January, total revenue in the quarter was 122.2 million, decreasing 2% over 2021 on a reported basis and flat to 2021 on a constant currency basis. Strategic investments in our commercial channel and new products are paying off as Global Orthopedics and Bone Growth Therapies continued their strong performance through the fourth quarter. Specific to innovation, we are encouraged by several new products we introduced in 2022. The Accell stem bone healing therapy for fresh fracture and nonunion fractures, TrueLok EVO, which added radiolucent rings and struts to our market leading ring fixation system and Galaxy Gemini, our next generation pin-to-bar system have all been well received in the marketplace.

We’ve also launched two new biologic solutions in 2022 with our partnership with MTF Biologics. The Virtuos Lyograph, a shelf stable complete autograph substitute and legacy, a demineralized bone matrix. Turning to the performance of each of our product categories, starting with Bone Growth Therapies or BGT, sales for the quarter were $51 million, up 3% on both a reported and constant currency basis, compared to the fourth quarter of 2021. Growth was driven by revenue from a cell stem, our most recent bone growth therapy solution with a new indication for fresh fracture care, which grew almost 50% sequentially over the third quarter of 2022 as we continued our commercial roll-out. Moving to Spinal Implants, which includes both Spinal Fixation and motion preservation, revenue was down approximately 7% on both a reported and constant currency basis, compared to the fourth quarter 2021.

The decline is driven mainly by continued global competitive headwinds in our motion preservation area, as well as a decline in procedural ASPs in the Spine Fixation on flat volumes in the U.S. We did see an encouraging 20% sequential increase in surgeon training for the U.S. M6-C artificial cervical disc in the fourth quarter of 2022. Turning to our Biologics portfolio. Revenue was down 9% on a reported and constant currency basis, compared to 2021. We saw declines coming from some of our trading accounts, driven primarily by sales channel disruption and offset somewhat by sales from our newer biologic solutions. The results from the merger will help growth initiatives in these franchises going forward as we will be able to offer new innovation solutions to our customers, as well as additional options for our surgeon partners.

In our Global Orthopedics business, revenue for the fourth quarter was down 2% on a reported basis and up 6% on a constant currency basis over 2021. Growth at constant currency in both our U.S. and International businesses was driven by strategic investments in our commercial channels and momentum from new product introductions mentioned earlier. Now moving on to a few highlights from our strategic initiatives. Let’s start with product innovation and differentiation. In the fourth quarter, we continue to see Accell stem bone healing therapies gain traction. We are seeing a high rate of physician interest and now have access to new prescribing doctors. We are encouraged by our 2022 commercial roll-out and revenue sales. We have increased the number of sales reps, 4% and added additional sales management to help grow our fracture channel with both fresh and non-unique fracture indications.

Currently our payer coverage for Accell stem includes over 80 million lives and we expect that positive trajectory to continue. Turning to our second initiative, the ongoing development of our commercial channel to expand patient and surgeon at access to our products worldwide. In 2022, we have continued to invest in our development and optimization of our fracture channel, and our orthopedic channel investments have paid off both in the U.S. and international to support continued growth. Now, I’ll turn the call over to Doug to review Orthofix fourth quarter 2022 financial performance. Doug?

Doug Rice: Thanks, Jon, and good afternoon, everyone. As many of the financial measures covered in today’s call are on a non-GAAP basis, please refer to today’s earnings release for further information regarding our non-GAAP reconciliations and disclosures. Starting with revenue, as noted earlier, total net sales in the quarter were $122.2 million, reflecting flat sales at constant currency when compared to the fourth quarter of 2021. In the U.S., total net sales were $95.7 million or 78% of total revenue, down approximately 2% versus the prior year. The primary drivers were declines coming from competitive pressure in biologics and Spinal Implants, as well as decreased procedural ASPs and Spinal Implants offset somewhat by growth coming from the BGT new product introduction of Accell stem and continued momentum in Orthopedics.

International total net sales were $26.6 million, or 22% of total revenue, up 6% in constant currency over the fourth quarter of 2021 as a result of strong growth from strategic investments in the commercial channel and momentum coming from new product introductions. Full-year revenue came in at $460.7 million, up 1% at constant currency and down 1% as reported. The highlight for 2022 was 11% constant currency growth in our Global Orthopedics segment as a result of the strategic investments we made in our commercial channels and new product momentum. GAAP gross margin in the fourth quarter of 2022 was 73%, which was consistent with the prior year period, despite changes in sales mix and volumes. GAAP sales and marketing expenses in the fourth quarter were 49% of net sales, up from 46% in the fourth quarter of 2021.

This increase is primarily driven by an increase in event spending, due to the timing of trade shows, as well as an increase in marketing and sales training spend to bring on new commercial distribution. GAAP G&A expenses in the fourth quarter were 21% of net sales, up from 15% in the prior year period. The increase reflects higher spending on legal and professional fees, primarily related to the recent merger with SeaSpine. GAAP R&D expenses for the fourth quarter stayed flat at 11% of net sales, compared to the prior year period. Our focus in R&D continues to be on bringing innovative and differentiated new products to the market. Adjusted EBITDA margin in the fourth quarter was 13% of net sales, down slightly from 14% of net sales, compared to the same quarter of 2021.

On a dollar basis, adjusted EBITDA in the fourth quarter was $15.8 million, down from $17 million in the fourth quarter of the prior year. Now, turning to tax. We reported GAAP income tax expense of $75,000 or 1% of the loss before income taxes in the quarter as compared to the prior year expense of $23.2 million or 242% loss before income taxes in the same period of 2021. The tax rate in both periods is driven by timing of earnings, as well as GAAP losses without a core responding tax benefit. In particular, we fully reserved our U.S. deferred tax assets in the fourth quarter of 2021, which was a significant component of the disproportionately high reported GAAP tax rate last year. For the fourth quarter, we reported a GAAP loss of $0.35 per share, as compared to a GAAP loss of $1.65 per share in the fourth quarter of 2021.

After adjusting for certain items and when normalizing for tax using our non-GAAP long-term effective tax rate of 28%, adjusted EPS for the fourth quarter of 2022 was $0.19 as compared to an adjusted EPS of $0.27 in the fourth quarter of 2021. Regarding cash, our liquidity position remain strong with $51 million in cash at December 31, 2022 and nearly $100 million of current borrowing capacity under the Orthofix credit facility. Our free cash flow burn was $34.7 million for the full-year 2022 and included strategic investments in inventory and spinal implant set builds, and over $5 million in actual milestone payments related to our partnerships with , CGBio, , and MTF to accelerate new product innovation to support revenue growth, as well as merger and integration costs and $23 million in CapEx for spine implant set builds and leasehold improvements to our Lewisville, Texas headquarters building.

As of December 31, 2022, Orthofix had no borrowings under its $300 million secured revolving credit facility. However, on January 03, 2023, Orthofix borrowed $30 million under this credit facility in-part to fund the full repayment of SeaSpine’s $26.2 million outstanding borrowing against its credit facility, as well as for working capital purposes and for certain merger-related expenses. Furthermore, on March 03, 2023, Orthofix borrowed an additional $15 million under the credit agreement for continued working capital purposes and to help fund merger integration related costs. I’ll now turn the call over to Keith to provide closing comments and 2023 guidance.

Keith Valentine: Thanks, Doug. As you’ve heard today, we are excited about the momentum both standalone companies generated coming out of 2022 and are very much looking forward to building a leading global spine and orthopedics company in the years to come. The combination of these two innovative and ambitious organizations is incredibly energizing. The combined company will ultimately and most importantly provide surgeons with the best resources, technologies, products, and procedures needed to improve patient outcomes. We believe that the combined product portfolios are very complementary. And that we can leverage the best-in-class technologies for each organization to offer the most innovative solutions along the continuum of care, pre and post-operatively.

Orthofix will be hosting an Analyst Teach-In on March 13 at our Lewisville facility where our business unit President will provide additional color on these complementary product portfolios, our planned commercial strategies and expected future growth drivers within each segment and franchise. We invite investors to join us via webcast. In terms of financial guidance, at this point, we are providing a revenue range for the full-year 2023 between $743 million to $753 million, which represents 7% to 9% year-over-year constant currency growth, compared to the approximately $701 million of pro forma combined company revenue for full-year 2022 after giving effect to anticipated reclassifications to conform SeaSpine’s revenue reporting to that of Orthofix.

Because we are still very early in the integration phase, we suggest that investors and analysts set their expectations towards the low-end of that range until we can provide more clarity later this year on how effectively we are managing the approximately $20 million of revenue risk and how quickly we can take advantage of the greater than $25 million of cross-selling opportunities in 20-23. So far, we are very pleased with our ability to manage and mitigate those possible revenue dis-synergies. Additionally, we expect first quarter 2023 revenues in the range of $166 million to $170 million, which represents 7% to 10% year-over-year constant currency growth compared to the approximately $158 million of pro forma combined company revenue for the first quarter 2022.

After giving effect, to anticipated reclassifications to conform SeaSpine’s revenue reporting to that of Orthofix. We do not plan to provide quarterly revenue guidance going forward. However, since the first quarter of 2023 is more than two-thirds completed, and because we are providing a fairly wide initial revenue range for the full-year, we wanted to provide that additional data point on this call. note that any sales generated by SeaSpine for the pre-merger period of January 1, through January 04, 2023 will not be included in the combined company’s first quarter or full-year 2023 revenue results. We are still on-track with initially reported expectations to generate approximately $40 million of operating expense synergies by year three post-merger, with the bulk of those synergies coming from redundant corporate overhead included in G&A, redundant headcount and program spending and spinal implants R&D, sales and marketing, and from a meaningful reduction in IT system-related costs as we integrate a portfolio of very common and in many cases overlapping IT systems.

Cost to achieve those synergies are expected to be around $40 million with the majority of that spend occurring in 2023, 20% incurred in 2024, and the remainder in 2025. And as we get further into the integration process, we will provide additional reporting and guidance metrics. Before closing out my prepared remarks, I would like to highlight an upcoming change to our Board of Directors. Jon Serbousek, our Executive Chairman will not stand for re-election as a Director of Orthofix at the company’s 2023 Annual Stockholders Meeting coming up in June of this year. He will remain an employee of the company through July 05, 2023. We are very appreciative of the years of leadership and the contributions from Jon, and I look forward to maintaining our friendship going forward.

I’m extraordinarily excited about the prospects for Orthofix. And I know our team is already making great strides to create one of the broadest biologics and regenerative technology portfolios in the industry. At this point, operator, please open-up the line for questions.

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Q&A Session

Operator: Our first question comes from Mathew Blackman from Stifel. Please go ahead. Your line is open.

Mathew Blackman: Good afternoon, everybody. Thanks for taking my questions. Hey, Keith. Let me start with the, and I appreciate the top line guidance for 1Q and 2023, but maybe be helpful, for both you, Keith and John, you know we’ve obviously worked with you before. We know your philosophy on guidance from your time at SeaSpine, but how should we think about your views now on guidance sitting in this new in particular, guiding during in integration? Is your philosophy you put out guidance we can hit, guidance we can beat? Is there any cushion in there perhaps for the unknown? And then just a quick follow-up on that. I just want to be clear, it sounds like in the commentary from the press release, at least that there are no revenue or no material revenue synergies baked into the 2023 guide.

Is that full 20 million of dis-synergies baked into that guide? And if so, does that manifest largely in the global spine business of spinal implant business? And then I’ve got one follow-up question.

John Bostjancic: All right. That’s a lot to unpack. First question, on the guidance, the Q1 number obviously were more than two-thirds of the way through the quarter. So, we feel pretty good about how things are shaping up and really pleased to see the growth across just about all portfolios on both companies in those Q1 numbers. So, I think that speaks to the confidence we have in mitigating the dis-synergy risk that seemed to be a lot of concerns when we first talked about the merger. For the full-year number, I think Keith’s comments were spot on that we’d expect everybody to, kind of set expectations towards the low end of that range because it is still early and that’s why we gave a fairly wide range for the full-year as to kind of set a baseline, and yes, you know us Matt and our historical practice of wanting to make sure we set a realistic bar that we’re not going to come under.

And so far the success we’ve had with managing that dis-synergy risk, we feel really good about that. Two months into the merger. The fact that all the portfolios on both sides of the company are growing in the first quarter, I think is a good trend for the full-year. But yes, we do want to be cautious about setting full-year expectations for such a wide timeframe because there is still the potential for dis-synergy risk. We think the timing of when we’ll get spinal implant sets to create some of the upside revenue synergy opportunities is fairly extended lead times, which will probably be most impactful later in the year Q4 to set a realistic timeframe. So, we still need to manage those dis-synergy risks and we don’t see a lot of near-term opportunity on the revenue upside for the synergies.

So, we are being cautious about setting full-year guidance and as Keith said, we’d expect everybody to start on the low-end and hopefully we’ll have opportunities to raise that as the year goes by and get past more of those revenue dis-synergy risks and continue to mitigate those, but also have better clarity as to what the upside can be for the full-year on the revenue synergy possibility as we get delivery of some of those sets that we’ve ordered on the spinal implant side. So, I think that’s .

Mathew Blackman: Yeah, I appreciate that, John. I’ll try to make this follow-up a little bit shorter. Just curious and I think you’ve, sort of touched on as you’re early days still, but maybe dis-synergies tracking as expected. Just any commentary on sales force stability in 4Q after the announced deal and now into 1Q 2023. Just any, sort of early commentary on retaining the folks you want to retain and any discussions going on with distributors moving in to more exclusive or pulling in new distributors entirely? Just any color on that would be helpful. Appreciate it.