Shoulder Innovations, Inc. (SI) Earnings Call Transcript & Summary

Welcome, ladies and gentlemen, to the Third Quarter 2025 Earnings Conference Call for Shoulder Innovations. [Operator Instructions] Please note that this conference is being recorded and will be available on the company's website for replay shortly. I would like to turn the call over to Sam Bentzinger, Investor Relations at Gilmartin Group for a few introductory comments. Please go ahead.

Good afternoon, and thank you for participating in today's call. Joining me from Shoulder Innovations are Rob Ball, Chief Executive Officer; and Jeff Points, Chief Financial Officer. Earlier today, Shoulder Innovations issued a press release announcing financial results for the quarter ended September 30, 2025. A copy of the press release is available on the Investor Relations section of the company's website. Before we begin, I'd like to remind you that this conference call is being recorded and that management will make remarks during this call that constitute forward-looking statements within the meaning of federal securities laws and that these are being made pursuant to the safe harbor provisions from the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. Additionally, during this conference call, the company will discuss certain financial measures that have not been prepared in accordance with GAAP. This non-GAAP information should not be considered in isolation or as a substitute for or superior to results prepared in accordance with GAAP. Please refer to the tables in our earnings release for a reconciliation of these measures to the most directly comparable GAAP financial measure. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 11, 2025. Shoulder Innovations disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. With that, I will now turn the call over to Rob.

Thank you, Sam. Good afternoon, everyone, and thank you for all for joining us for our first earnings call as a public company. We're very excited to share the results, the details of our exceptional third quarter performance today and review our progress against key priorities driving continued commercial momentum. On the top line, revenue in the third quarter was $11.8 million, an increase of 58% year-over-year and over 7% sequentially. We're very pleased with this performance, which was driven by continued market adoption of our implant systems across a growing base of surgeon customers. Q3 gross margin of 76.2% was also strong and reflects our commitment to enhancing profitability. We continue to take intentional actions to drive further improvement in gross margin and believe there is additional opportunity for expansion going forward. From a balance sheet perspective, we significantly strengthened our cash position, ending the third quarter with over $137 million in cash and marketable securities, following our convertible notes financing and our initial public offering in July, which raised a combined $115 million in gross proceeds. Our performance in accelerating business momentum exiting the third quarter, leaving us incrementally confident in our ability to sustain our commercial progress through '25, '26 and beyond. As a result, we are raising our revenue guidance for the full year to a range of $45 million to $46 million, representing growth of 42% to 45% year-over-year. For the remainder of this call, I will provide a brief introduction to Shoulder Innovations for those who may be newer to our story and review our third quarter performance and key growth priorities in greater detail. Jeff will then walk through our full third quarter financial results and discuss our outlook for the remainder of 2025. At the highest level, Shoulder Innovations is exclusively focused on transforming the shoulder surgical care market with an initial focus on shoulder replacement or arthroplasty. We find ourselves in the enviable position of being the only public well-resourced company with this narrow focus in this highly attractive market. We estimate shoulder arthroplasty currently represents a $2.8 billion annual global market with almost 2/3 of that opportunity in the United States. Within the U.S. specifically, we estimate that approximately 250,000 shoulder arthroplasty procedures will be performed in 2025. Today, our product portfolio of advanced implant systems covers approximately 85% of those procedures encompassing both anatomic and reverse shoulder arthroplasty. This comprehensive portfolio includes various specifically designed components capable of different modes of operation, optimized for patient-specific needs. More importantly, all our systems leverage consistent surgical techniques our foundational InSet Glenoid technology and the same efficient two-tray instrumentation system. The remaining 50% of procedures represent adjacent indications in fracture and revision, which we intend to fully enter in the near future with several additional products currently in our pipeline. I'll share an exciting update on this front later in the call. Our product portfolio serves as the foundation for what we refer to as Shoulder Innovations broader ecosystem. In addition to our implant products, this ecosystem also includes best-in-class enabling technology, differentiating efficient instrumentation systems, specialized support and a surgeon-to-surgeon collaboration model. Together, these elements are designed to address the long-standing clinical and operational challenges in the shoulder surgical market by improving outcomes, simplifying procedures and increasing efficiency across all sites of care and our own operations. As mentioned, we are primarily known for our foundational technology to InSet Glenoid, a technology that addresses glenoid loosening, the primary complication with anatomic shoulder arthroplasty. With the InSet Glenoid published data shows an 87% reduction in the mechanism of action leading to failure, namely glenoid loosening. Long-term results published in multiple peer-reviewed publications demonstrate 0 surgical complications, 0 loose implants and 100% implant survivorship at nearly 9 years that follow. These outcomes represent significant improvement over the standard of care designs. We are also focused on enabling technology as a key driver of our approved outcomes in the future. Preoperative planning plays a vital role in improving workflow and patient outcomes, thereby supporting market adoption. To that end, we view our ProVoyance platform, which is integrated with all of our products is a key element of our success. ProVoyance, which we believe to be the first AI-enabled preoperative planning solution in the market allows the surgeon to virtually perform procedures before operating using a CT-based 3D model of each patient's anatomy. I'll note specifically that within our ability to measure virtually all our implants incorporate ProVoyance, making it a routine part of surgeon workforce. Finally, we continue to benefit from the shift of procedures from hospitals to ambulatory surgery centers, or ASCs, following CMS' decision to approve ASC reimbursement for shoulder arthroplasty in early 2024. Our early anticipation of this shift enabled us to offer a distinct advantage in the ASC setting with a two-tray instrumentation system, compared to the 8- to 10-tray typically required by competitors. As a result, our ASC procedures grew from about 10% in December 2023, just prior to the reimbursement decision, to over 30% positioning us well to benefit from the ongoing transition toward ASCs as a preferred site of care in the space. Holistically, we believe our unique ecosystem, combined with being the only company with a singular focus on the shoulder specialist has supported our financial and operational performance to date. To sustain our above-market growth and drive continued commercial momentum, we are focusing on 3 key strategic priorities, which in the near term includes driving adoption among new surgeons, increasing penetration in our existing surgeon customer base, to increase procedural volume and adding products to our portfolio to address the remaining unmet needs of patients and surgeons. This includes both expanding indications and continued enabling technology. We are executing well across each of these priorities with clear progress demonstrated in the third quarter, which I'll touch on now. I'll begin by reviewing our efforts to drive adoption among new surgeons. For context, our commercial model, we sell all our products through a network of independent distributors to that network, we then overlay a dedicated W-2 commercial leadership team with a primary focus of identifying high-volume surgeon targets. To enable this, we leverage a proprietary business intelligence platform allowing us to precisely target our efforts to where we can make a difference and understand our effectiveness in making conversions. In total, there are about 15,000 surgeons in the U.S. performing at least 1 shoulder arthroplasty each year with roughly 1,800 high-volume shoulder specialists accounting for the majority of procedures. These shoulder specialists perform 35 or more procedures annually. Interestingly, while on average, these surgeons perform around 80 arthroplasties annually, shoulder replacement typically represents less than half of the surgical volume for these surgeons. We segment this group of 1,800 high-volume surgeons into 3 categories by the way they interact with Shoulder Innovations, prospects who perform 1 to 2 procedures per quarter, contenders who perform 3 to 8 and core surgeons who perform 9 or more. Combined, our core and contender services generate approximately 95% of our total revenue. This stickiness contributes to our revenue projectability and its validation that positive outcomes is fueling continued uptake among surgeons. We have consistently expanded our base of these core and contender surgeons each quarter through 2025 and have done so at a rapid pace. For instance, last quarter, we announced a nearly 50% year-over-year increase in our core and contender surgeons. These increases have primarily been driven by enhanced awareness of the SI brand, supported by the targeted efforts of our commercial leadership team in identifying and convert high-volume surgeons. While we intend to provide our core and contender surgeon count on an annual basis moving forward, I'll share that we again increased the number of core and contender surgeons at the same pace during the third quarter and expect that trend to be durable moving forward. Once we win new surgeons and they become integrated into our ecosystem, our second priority is to drive increased procedural volume. To achieve this, we seek to transition surgeons over time from prospect to contender and from contender to core by increasing penetration and utilization. In Q3, our core and contender customers skewed more towards core surgeons highlighting our ability to increase utilization into this critical high-volume cohort. A key driver of this is our surgeon-to-surgeon education program facilitated by our customer experience and medical education team, the third component of our broader commercial organization. We are committed to fostering a collaborative community among shoulder surgeons where expertise is shared, new ideas are exchanged and best practices are disseminated to enhance clinical outcomes. By facilitating these peer connections, we strengthen engagement within our ecosystem and reinforce its real-world success. As surgeons share their positive experiences with our ecosystem and the impact of patient outcomes, we believe this organic efficacy further accelerates adoption, positioning us to benefit from the natural network effects within the shoulder surgical care community. As an example, just this past weekend, our team facilitated our second national shoulder symposium this year focused on learning and education around our ecosystem. This event was by far the largest in our history and included wet lab surgical training as well as robust didactic sessions, all designed, written, proctored and driven by surgeons. Of note and unsolicited from the podium, a number of surgeons highlighted the particular value SI provides in creating this community and the positive impact it's having on their practice. This has been a highly intentional effort by our team, and we take great pleasure in hearing the impact it's having. We continue to believe there's a clear differentiator that's helping to drive results. Results in Q3 demonstrate the benefit of our commercial model. Total implant volume increased 53% year-over-year to 1,584 units across our prospect, contender and core surgeon customer base. This performance was driven by a couple of factors. Consistent with prior quarters, implant volume continued to rise as utilization ramped among existing surgeons particularly those added late last year and early in 2025. In addition, newly onboarded surgeons are ramping more quickly and becoming more productive sooner which particularly supported the increase in implant volume on a sequential basis, which grew 5%. As an elective procedure, shoulder arthroplasty typically experiences a summer slowdown. Consistent with prior years, this trend was present in Q3, as average procedure volume among our early cohort core surgeons was down slightly on a sequential basis in Q3 versus Q4 -- Q2. However, we're particularly excited to know that we overcame this normal seasonal downtrend through deeper penetration in later surgeon cohorts as well as new customer additions to drive a meaningful sequential quarter-to-quarter growth. Looking ahead, we believe our commercial model is well optimized to ensure we can continue to add appropriate resources to aggressively grow our customer base. Importantly, we expect to make further significant investments in our sales force as we scale from these early market share positions, driving greater predictability of our business. Leveraging our independent network will create a clear opportunity for operational leverage as we scale a factor we consider critical to our success. To ensure we continue to equip our growing surgeon customer base with a comprehensive, best-in-class suite of shoulder surgical care solutions, our third strategic priority is focused on developing and launching new technologies to address the remaining unmet needs of patients and surgeons. It's part of these efforts in the third quarter, we launched our InSet 70 humeral stem, the latest expansion of our I-Series humeral stem product line. The InSet 70 is indicated for both anatomic and reverse shoulder arthroplasty addressing a broad range of clinical needs. Featuring the same reliable fixation and streamlined workflow as the longer InSet 95, it also provides the added benefit of a bone-sparing nature being the shortest possible stem indicated for reverse arthroplasty. It also maintains the special biomechanics we're known for with customers' feedback strongly suggesting differentiating improvements in the postoperative motion compared to other products and techniques. This bone-sparing approach is gaining traction in the marketplace and the launch of I-70 further strengthens our commitment to innovation, improve patient outcomes and meaningful value for surgeons. We executed a robust limited user release in Q2 and Q3 with a 100% successful customer response. We are pleased with the commercial update we have seen so far in the marketplace with this new product. We're also focused on expanding our product portfolio and capabilities with the goal of providing a comprehensive suite of solutions that cover 100% of shoulder procedures performed. We have several new applications planned in the near term, including fracture, revision and metal sensitivity. These new applications will enable us to capture the remaining 15% of shoulder procedures at our product portfolio currently does not cover. The first of these efforts focuses on an indication expansion. We are pleased to share that we recently received FDA 510(k) clearance that expands our I-Series humeral implant product line to include certain fracture indications. We plan to initiate a limited market release in the coming weeks while we simultaneously seek to advance the full breadth of indications with FDA through the remainder of 2025 and into early 2026. Separately, we also remain on track to launch a new line of humoral and glenoid technologies for the portion of the population who have metal hypersensitivity and may experience adversity associated with allergic reactions for metal implants. We expect to receive FDA clearance and subsequently launch these technologies in the coming weeks, and we look forward to sharing additional updates as we're able to. Importantly, these new products and applications are associated with higher ASPs making them constructive to gross margin and providing a double benefit to our near-term market growth. Finally, in parallel to new implant development and indication expansion, we believe we can further extend our competitive position by introducing complementary enabling technologies to support the full continuum of care in shoulder surgery. As I have shared recently, we've made significant progress in this area and couldn't be more excited about the opportunity. We're looking forward to sharing more on this front in the coming weeks. Looking beyond the near term, we see significant opportunities to further broaden our impact and extend our leadership position, from a longer-term perspective, we plan to evaluate entry into attractive international markets over time, which we currently do not have a presence in and expand into adjacent markets beyond shoulder arthroplasty. With adjacent markets, particularly among the 1,800 high-volume surgeons that were targeting, shoulder arthroplasty typically represents less than half of their case volume. The rest of their surgical volume is commonly comprised of sports medicine and shoulder trauma procedures, both of which are highly relevant markets for us to target moving forward. Sports medicine, driven largely by rotator cuff procedure is a market with a similar size and growth rate to shoulder arthroplasty, this creates a meaningful opportunity to expand our TAM within our existing customer base. I'll continue to update you on our progress on these initiatives as we move forward. With that, I'll now turn the call over to Jeff Points, our CFO, to review our third quarter results in more detail and provide our outlook for the remainder of 2025.

Thanks, Rob, and good afternoon, everyone. As Rob mentioned, total revenue for the third quarter of 2025 was $11.8 million, a 58% increase from $7.5 million in the prior year. Our unique commercial model and proprietary business intelligence capabilities drove continued commercial expansion in the third quarter resulting in increased adoption of our implant systems across new and existing surgeons. Gross margin for the third quarter of 2025 was 76.2% compared to 76.5% in the prior year. Selling, general and administrative expenses in the third quarter of 2025 were $15.1 million compared to $8.5 million in the prior year. The increase was primarily driven by increased headcount on commercial organization, higher legal costs related to litigation, higher variable selling expenses and increased professional service fees related to our transition to a public company. We expect an increasing amount of investment in the fourth quarter, reflecting our accelerating, commercial momentum, the continued impact of ongoing litigation, which is nearing resolution and our first full quarter of public company expenses. Research and development expenses in the third quarter of 2025 were $1.5 million compared to $1.1 million in the prior year. The increase was primarily driven by investment in new product development efforts. Net loss in the third quarter of 2025 was $8.7 million compared to a loss of $4.1 million in the prior year. The adjusted EBITDA loss in the third quarter of 2025 was $7.5 million compared to a loss of $2.9 million in the prior year. The increase in net loss and the adjusted EBITDA loss was primarily related to increasing operating expenses and changes in the fair value of the company's preferred stock warrant liability and convertible loans. Our cash and cash equivalents as of September 30, 2025, were $137 million. This includes gross proceeds of approximately $115 million from our July convertible notes financing and IPO. We continue to believe these funds put us in a strong financial position to continue investing in growth while enabling us to achieve cash flow breakeven with cash on hand. Turning now to our outlook for the remainder of 2025. Reflecting the strong momentum year-to-date, we now expect full year 2025 total revenue to range from $45 million to $46 million up from our prior guidance of $42 million to $44 million, which represents annual growth of 42% to 45% over 2024. With that, I'll turn the call back to Rob for a few closing remarks.

Thanks, Jeff. We are very pleased with our performance in the third quarter and see substantial runway for growth within our $2.8 billion shoulder arthroplasty market. Our disruptive ecosystem backed by strong clinical results and improved outcomes for patients and surgeons is addressing the existing limitations within this market and driving accelerating business momentum. Further, our unique commercial organization and proprietary business intelligence capabilities, AI-enabled preoperative software offering and novel product suite position us well to capture share in this market, particularly as shoulder surgical care continues to grow in the outpatient settings. We appreciate your support and continued interest in Shoulder Innovations as we work towards our mission to redefine shoulder surgical care and enable best-in-class outcomes for shoulder specialists and their patients. We look forward to sharing updates with you on our progress in the quarters and years to come. With that, I'll now turn the call over to the operator for Q&A. Operator?

[Operator Instructions] And your first question comes from the line of Patrick Wood with Morgan Stanley.

Congrats on the first set of results. I'd love just to start -- I love it. I'd love just to start with basically the strength of the business that we saw this quarter, how things landed versus at least your internal expectations? Would it be fair to say the volumes came in a little considerably ahead of where you were hoping, but the surgeon engagement. I'm curious, we can all see versus what our external expectations were. But how did it land relative to how you feel things were going to pan out?

Yes. So we obviously came away very excited, Patrick, with the way we perform. We saw performance as a function of both, kind of existing customers continuing to lean in further, kind of driving those customers from that contender spot to core spot. So obviously, we shared already that as we progress through the quarter, we were able to move a number of those customers towards core and then just continue to add kind of customers before the quarter and through the quarter. So obviously, that business momentum has accelerated relative to where we were early in the year and kind of we're obviously excited about that and are kind of planning on driving that on a go-forward basis. For sure, we came in strong relative to our guidance. And I think that's just a function of, obviously, we remain a relatively immature business as we grow. And we are continuing to reduce, I'll characterize as standard deviation of volatility, if you will, in kind of surgeon-by-surgeon volume. And so obviously, that growth then helps us to kind of continue to prove the predictability of the business.

That's awesome. And then just as a quick follow-up. You obviously mentioned that the newer surgeons are ramping faster with each cohort that's coming on board. How are you guys managing that? Is that a function of getting better at onboarding people, getting them into the ecosystem faster? What's kind of driving that?

Yes. Thanks, Patrick. Great question. So we do manage those groups, indeed by cohorts. And so that's how we're able to analyze and understand that as we've produced those cohorts quarter-by-quarter, we are indeed driving faster ramp through the funnel, so to speak. I'd say it's a function of a number of things. One, as we mature as a business, kind of our brand equity has increased. And so there's a more implied trust related with that brand. So I think that's one element that has been helpful. Obviously, as we have scaled our commercial organization and we've grown in our talent in that commercial organization, that group has become much, much more skilled at leveraging our business intelligence platform for a couple of things. One is to indeed identify who are the right targets to invest our time and energy in. But then also those that we have begun to make progress with how do we cultivate that progress through the funnel for those individuals. And so the way those teams work together and leverage the business intelligence functions has certainly matured very nicely over the past, I'll call it, year to 18 months, and has indeed caused an acceleration of our ability to grow those surgeons towards that core status, which we're after.

The next question comes from the line of David Roman with Goldman Sachs.

I appreciate all the detail and background as you kick off your first earnings call here as a public company. Maybe just to pick up a little bit here on the outlook. As I think about the comments you made about Q3 and seasonal dynamics, then contrast that with how you're presenting the outlook for Q4, it does contemplate fairly marginal sequential growth. So maybe you could just unpack some of the assumptions in the Q4 guidance, and perhaps it's also a good opportunity just to talk to us a little bit about your philosophy in setting guidance as you progress post-IPO?

Yes. So David, I'll start with that. Maybe I'll start with your last question, just on kind of our philosophy. But obviously, we're going to be kind of use a disciplined, thoughtful approach to setting guidance. We're always going to incorporate the latest and best information we have available to us at the time. Keep in mind, we mentioned a couple of times now, our state-of-the-art business intelligence platform. So we've got a significant amount of data that we utilize to help us predict and provide outlooks and forecasts. And so that's kind of how we build it. Obviously, we look at it a lot of different ways. And I think as we look at Q4, we're using all that information to kind of build that up. Really pleased with the momentum that we have kind of coming out of Q3 into Q4. And really, our confidence in that Q4 guidance is grounded in the same drivers, that have propelled us kind of through Q3 so far. We're just really executing well across the entire business, both adding new surgeons to our customer base and then seeing increased procedure volume by existing surgeons as well. So we think that will obviously bode well for the rest of the year and was really how we determine the appropriate guidance for the balance of 2025.

Very helpful. And maybe, Rob, you could talk to us a little bit about. You laid out some of the time line for new product launches and allowing you to access the broader set of the market here, but maybe you can help us further think through just the ramp time lines? Any framework you can help us put around the impact of new product launches like you have the shorter stem approved now. You're obviously continuing to see ProVoyance rollout and have a number of new products coming in -- exiting this year and into '26. So how should we contextualize just product launch timing and when that ultimately translates into an impact to the business?

Yes, sure. Thanks, David. Appreciate the opportunity here. So think about 3 new products. You have I-70, you have the I-135, which is for fracture indications and then what we call N-22 or those devices that are for the hypersensitivity to metallic alloys. So I-70, as I mentioned, is now in market, fully commercial launched, and we're seeing that ramp really nicely. Obviously, it's very early in that launch kind of process. And so we're not necessarily forecasting a massive bolus of growth associated with that in '25 and think that will be more impactful in 2026. We really expect to be able to kind of begin with the I-135 and what we'll characterize as a limited user release phase, really early in 2026, very early in 2026. That's our intention at this point. So we would go through a limited early release phase and then transition into a full launch probably later in the first half of '26. And then with the N-22, we actually have product in the warehouse today. We are completing the regulatory process so as to be able to release that product. That is something I'm hopeful very early in 2026 that we will be able to release into the marketplace. That does not warrant so much of a limited user release, it's quite a bit simpler product, I'll put it that way. And so we're hopeful that, that can expand a little more aggressively in 2026, but that gives you a good feeling.

And maybe I can sneak one more in here. You talked about the summit you hosted over the weekend, which is very prominently featured by a number of your surgeon partners on social media. Can you just maybe give us your takeaways in a little bit more detail from that meeting? What were some of the highlights, especially as it relates to surgeons who are first time being exposed to Shoulder Innovations?

Yes. I mean, as you can imagine, we came away extremely excited about the feedback we received from the meeting. We have done at least 6 of these meetings probably more. I apologize, I don't remember the number off my head. But they -- but we have definitely grown with each meeting and -- but I will characterize this was our largest by far meeting which included a very full cadaveric laboratory session and a very, as I mentioned, robust didactic session. I'd characterize feedback from the meeting was extremely positive, with many elements of direct feedback with surgeons kind of committing like they understand it and want to convert. And so it's been a really fun kind of couple of days coming off that time in Nashville with that group of surgeons. So obviously, we couldn't be much more excited than the impact we expect that can have here on the next couple of quarters.