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spk06: Good morning and welcome to the third quarter 2022 earnings conference call for Conformis, Inc. My name is Shannon and I will be your conference operator today. All lines have been placed on listen-only mode to prevent any background noise. After management's remarks, there will be a question and answer session. I would like to remind you that this call will include forward-looking statements within the meaning of federal securities law. which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward looking. 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. including those discussed in the risk factors sections of conformance public filings with the US Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements. Conformance disclaims any 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. This conference call will include time-sensitive information and is accurate only as of the live broadcast today, November 2nd, 2022. I will now turn the call over to Mark Agusti, President and Chief Executive Officer of Conformis.
spk04: Thank you, operator. With me today is our CFO, Bob Howell. We appreciate you taking the time to hear our business update. I will start by reiterating that we remain confident in our long-term growth strategy. We're gaining traction with Imprint and Platinum Services, which I'll elaborate on in a moment. However, translating our growing surgeon and patient interest in the top line revenue is taking longer than we initially expected. Based on that, we are taking proactive measures with our cost structure to improve our overall cash management. This will result in deliberate expense control efforts that do not impact our long-term opportunity, but do help us in the short term as we execute on our strategy. Bob will share more details on this shortly. We had a good quarter of awareness of our platinum services program for personalized needs. On top of this, we had several positives in the third quarter. One, we initiated the full commercial launch of our imprinting. Two, we formally transitioned to our new platinum services model on September 1st. Three, we received five 10K clearance of the Acterra HIP system and are positioned to launch the limited market release shortly. And four, our international sales grew 5% in constant currency, primarily through our continued progress in Australia. As we execute on our strategic pivot, our near-term performance is driven by two initiatives. Our imprinting system continues to receive great reviews from surgeons that use it. Imprint combines several of the best features of our fully personalized solution with aspects of a traditional off-the-shelf system. So it is truly in a category by itself. Adoption continues to ramp and we now have imprint on contract with approximately 90% of our current customers. We continue to focus on field training and on a focus to the ASCs to increase our overall penetration there. Interest with our new platinum services program continues to gain traction as evidenced by the fact that we added to the number of facilities under contract. We increased the number of healthcare facilities enrolled to 49 at the end of the third quarter, up from 21 through the end of second quarter. We formally transitioned to the new business model on September 1st. So going forward, our fully personalized needs are only available through the Platinum Services program. We've been pleased with the interest we received from surgeons needing conformance for those who have not ordered from us longer than a year. For example, Platinum Services orders were up 4X in September over what they were in the five months leading up to the transition. In terms of our entire product portfolio, we have not seen much change in the overall macro environment. We're still experiencing higher than normal cases that are being rescheduled or canceled due to labor and supply chain challenges. This continues to lead to tight product deliveries and, at times, the need to reschedule surgical cases. In addition, we continue to focus on penetrating the ASC segment as reflected by the growth in revenue for this site of care over Q3 2021. Moving on to an update on our pipeline, We held our own in the quarter. For Actair, we continue to build inventory to support our limited market release and expect the first procedure to be done shortly. We're excited about the product design and feel it will position us well to address the growing position interest in interior hip procedures. The other major project is our porous coated knee. On a positive note, we have submitted our regulatory package to the FDA. However, supply chain challenges remain a headwind. We're exploring options to expedite the timeline, but for now, we continue to expect a limited market release in early Q2 of next year. Lastly, as you saw, on October 26th, our shareholders approved additional ratios on a reverse stock split to help us regain compliance with NASDAQ listing requirements. The company's board of directors has determined to proceed with implementing the reverse stock split using the one for 25 ratio. The company is working with its transfer agent NASDAQ, and other applicable parties to implement the reverse stock split with an expected completion date in November of 2022. We will continue to provide updates via press release and a form A-K as this matter is finalized. I will now turn the call over to Bob for some more details about our financial performance for the quarter and our outlook.
spk02: Thank you, Mark, and good afternoon, everyone. Product revenue was in line with our expectations at $13.6 million. which was down 3% on a reported basis and 2% on a constant currency basis, versus the third quarter of last year. Within product revenue, our worldwide need business was down 1% on a constant currency basis, and our HIP business was down 19%. As Mark mentioned, our international need business was up 5% on a constant currency basis due to strong growth in Australia. Product gross margin for the third quarter was 34.6%. slight sequential decline of 50 basis points as compared to the second quarter. While we continue to face headwinds from increased material and labor costs, and we work through some initial transition inefficiencies related to our new business model, we are focused on making the necessary changes to improve our operations. For the fourth quarter, we expect product gross margin to sequentially improve to the upper 30s. As we head into 2023, this metric should continue to improve as imprint and platinum services becomes a larger portion of our product mix and we make efficiency improvements in our business model transformation. I will now move to OpEx where we continue to manage our costs. Our total operating expenses for the third quarter were $16.8 million, which was $1.4 million lower than the second quarter and down 3% versus the third quarter of last year. As Mark mentioned, we recently implemented a cost reduction plan related to our OpEx structure. This plan is anticipated to stay in place until we regain top line momentum. We're currently targeting to reduce annual variable and employee related expenses by 10 to 12 million, the majority of which will impact 2023. Several initiatives have already been put in place with others to be implemented this quarter and into early 2023. These expense reductions will not impact our porous knee and acterra hip new product development, nor will we significantly reduce our investments in sales and marketing programs focused on driving greater imprint and platinum services adoption. We believe these cash-shaving actions will have limited to no impact on our long-term opportunity, but they will help us maximize our cash near-term. For the full year of 2022, we now expect our OPEX to be between $73 to $75 million, which is lower than the guidance range we provided back in August, where we indicated we would be at the low end of our previous range of 75 to 81 million. Moving to our balance sheet, we have cash and cash equivalents of 59.6 million at the end of the third quarter. Our level of cash use will continue to fluctuate quarter to quarter near term, and as highlighted last quarter, we expect to increase inventory over the next few quarters to support our product launch cadence, which includes the full commercial launch of imprint, and the limited market release of our actuarial hip and porous-coated knee. We expect additional inventory investment to be between $2 million to $4 million over the next few quarters. In terms of outlook, we expect our fourth quarter product revenue to be between $13 million to $14 million. This puts us at the low end of the $57 million to $61 million range for the year we established back in August. We believe our revenue performance has been impacted by transitioning our existing customers to our new product offerings, and by continuing supply chain and operational challenges. At this point, we expect one to two quarters of top line pressure as we complete the transition to our new business model. While this is disappointing, we believe the impact will be relatively short term, and then after we work through these challenges, we'll return to growth. With that, Mark and I are happy to take your questions.
spk06: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster.
spk05: Thank you.
spk06: Our first question comes from Eric Anderson from Cohen. Eric, your line's open.
spk03: Hi, how are you guys doing? Thanks for taking the question. Hi, Eric. I wanted to just start with the Platinum Services program. It sounds like feedback from customers adopting the service model has been positive, but it's not quite translating into revenue growth. Just curious to hear what the company is trying to do to bridge that gap. Is this just a surge in education sort of thing? Is there anything you can do with the sales force to try and accelerate uptake for that program?
spk04: Yeah, that's a great question. There's a couple things we're doing. One is we're taking the feedback from some customers. They agree to the program, but then it takes them a little longer to implement a change in their billing and collections since this is outside their normal sort of course of business. So the actual implementation from them is taking longer than we expected from some of the earlier sites that we're able to implement it quicker. We're putting some things in place and working with consultants to try to package some stuff up to help that implementation go quicker, Eric. So that's one of the things we're doing. The other thing is we've got in the works some additional promotional materials as well as direct-to-consumer advertising and whatnot, which we plan to launch the first quarter of next year. So that should help support that effort. We're pleased, though, with the amount of contracting that got done. I mean, this was a big lift as we moved from, you know, 21 at the end of Q3 to 49. So we added, you know, 28 new contracts. And importantly, some of those contracts involved multiple facilities. So we're pleased with that. But you're right. It's taking longer to translate into actual growth as they now try to operationalize the Platinum Services Program on their end.
spk03: Okay, thanks for that. And then just on the international opportunity, it seems like you're seeing some nice growth, especially in Australia here. Are there any other international markets that we could see the conformance portfolio enter in the near to medium term?
spk04: I don't think there's anything in the near term that is significant as the Australian opportunity. There's some things we're doing to look at improving growth performance in some of our bigger existing markets. But as you know, we're also challenged with some of the NDA requirements and things like that. So that's really, really sort of distracted the ability to focus on those areas. I think longer term, we're looking at some of the Asian markets, as you might expect, Japan and China. But as you know, the regulatory pathway is convoluted there, especially for a custom product. So, I wouldn't factor that in anything in the near term.
spk03: Okay. Understood. Thanks for taking the questions.
spk05: Thank you. Stand by.
spk06: Our next question comes from Caitlin Cronin from Canaccord Genuity. Caitlin, your line is open. Hi, this is Caitlin on for Calrose. Thanks for taking the questions.
spk04: Hi, Caitlin. Thank you.
spk06: Yeah, so just to jump off on Platinum as well, you know, how much time do you guys really need to tell how Platinum Services is taking hold and any metrics from Platinum that you can disclose, such as, you know, conversion rate, mix, percent, et cetera?
spk04: Yeah, the only metric I would say is that I'll answer reversely. When a facility offers the program, it's clearly, clearly successful. And the numbers are bearing out that anywhere from 20% to 30% of the patients upgrade. So the opportunity is real. The challenge is, like anything else, as a smaller market share player, getting that message and reach out We have a challenge with our distribution and field sales force about going after that. I think we've got to continue to educate and, you know, make them feel confident or help them, excuse me, help them feel confident. But when it's offered, it's clearly successful. We've seen that every time a new facility launches the program. As I said earlier with Eric's question, it's been a surprise to us in the sense that for some of the bigger places that are interested, which we're pleased because we've executed these contracts with some pretty big places, but their ability to quickly operationalize it because they have to get IT and revenue cycle management, they have to think through their policies, it's just taking them longer. And so they're actually asking us for help to do some things in the short term. So we're, you know, doing a quick adjustment to that and respond to those things and hopefully that'll, you know, kick in. But it is taking longer from that standpoint. But I'm very pleased with the number of facilities that increased and that we continue to have interesting discussions and we have a lot of, you know, people that are in the queue. So I expect the, I fully expect the number of facilities that are offering Platinum services to grow. And as long as we do that, it should translate into top line growth. It's just got more of a lag from when they execute the agreement to when they operationalize it than we would have anticipated.
spk06: Gotcha. And then just two more questions. With the impact of the business model transition, are you losing customers? And also with the changes to the reductions,
spk04: uh of spending you know what's the updated timing of all the products that you currently have under development thank you um no thanks caitlyn so i think it's a real insightful question the first one which i i think it's you asked it a really good way there's no doubt you know that there is so first off as we said in the prepared remarks the good news is we have about 90 of our existing business contracted with imprint so you know The access to imprint by existing customers is pretty significant. There's no doubt there is some impact on some customers that didn't want their world changed. They wanted to continue to do what they were doing. And as a result, for whatever reason, they may have decided, well, if I can't do a fully custom product, product, then I'll, you know, do something else. It's hard to estimate exactly what that is. We've gone through detail by detail. We think that probably it's like sort of 5% to 10% range, but a lot of it is short-term stuff that we think will come back after, you know, we get some exposure to imprint where we're at. So there's clearly some disruption, and we're seeing that in the top line. Now, I would just like to remind everybody that we also still suffer from a non-optimized portfolio. You know, we don't have a robotic solution. We don't have interoperative guidance. We don't have cement lists. So those are all things we don't have, but we're working on, as we know, forest coated and things like that. So we'll come back. But we do have a very unique program in platinum service that we have to continue to market. And we're also very pleased with our imprint clinical performance. I mean, everybody who has used it now, and we've had more surgeons use it for the first time in the last quarter, clinical performance is good. I would say the other thing, it's implicit in your question, has caused us potentially to see a pullback from a small number of surgeons, some of the operational challenges we've had, which we mentioned in the prepared remarks. And You know, as you've seen from the other companies reporting, while they've had the top line growth, which is great, the reality is there's a lot of pressure throughout the supply chain. And for a company like Conformis that has aggressive, just-in-time delivery model, that has continued to be a headwind for us. And that's a challenge. And so our field has had to deal with rescheduling of cases and moving things around and And I think that's a headwind to top line growth. Okay.
spk06: Awesome. Yeah. Nothing else for me.
spk04: Thank you, Caitlin.
spk05: Thank you. One moment.
spk06: Our next question comes from Steven Lichtman from Oppenheim and Company. Steve, your line is open.
spk07: Hi, everyone. This is Amir on for Steve.
spk02: Hi, Amir. Hey.
spk07: I just had a quick question around supply chain headwinds. Is there any commentary on what you're seeing on the ground as it relates to your previously indicated, like, supply chain headwinds?
spk04: So what we're seeing on the ground? Is that what you said, Amir?
spk07: Yeah. Correct.
spk04: Yeah. Yeah. Well, Bob's very close to it too, but I'll, I get my impression that from my perspective is, um, there's two things going on. One is we're building out a. A new business model, which requires build the stock capabilities, right? Running a warehouse as well as the just in time capabilities. But even in our build stock on imprint, we've got our patient specific instrumentation and we deliver that to a specific patient in about a three week to four week timeframe. And so there's transition involved in our manufacturing facility. At the same time, two things have really challenged us. One is suppliers, as I've said in the past, not meeting their delivery commitments because everything from packaging to femoral components to metals, I mean, it's been raw materials. it's been, frankly, a never-ending game of whack-a-mole. As soon as you think you've got one problem solved, another one rears its head. And then you combine that with the labor market that we have a lot of transition and a lot of turnover, and so the level of institutional knowledge continues to change, and that would be a struggle for any organization. I think smaller organizations get hurt worse than that because we don't have You know, we don't have large purchasing departments or large manufacturing engineering departments. So, you know, when you have departments that consist of just one person or three people and you lose a person, you could lose the bandwidth through that department anywhere from a third to 100%. So other people have to pick up the slack, and that affects us in other areas. So the labor challenges that, you know, that are macroeconomic issues, particularly hit small companies, and in particular have hit us pretty hard. Those are my observations around sort of three things, but I don't know if you would add anything.
spk02: The only thing I would add, I think, Mark, is the big ones from here are, you know, we sporadically deal with some unpredictable shipping, right? So we're shipping, as Mark mentioned, just in time. So when the shipment doesn't show up, when the spotter was going to show up, it causes challenges, certainly in small companies. than the standard off-the-shelf product. So, you know, that ebbed and flowed, but that certainly has added to some of the complexities.
spk07: Great. Thank you. And just another question on my side. Is there anything you can provide on working through the backlog of these prior rescheduled cases? And then just a quick follow-up to that, do you see elevated levels of rescheduled cases being a potential tailwind in 23s? Thank you.
spk02: Yeah, I mean, look at the backlog. I don't think there's necessarily a big backlog. As you know, we have scans, and that's how we do our projections, and those are scheduled, and that's how we plan and forecast. There are times when we have cases that get back on the schedule, and that factors into it, but I don't think, from our standpoint, backlog's a big driver. As far as you're saying the elevated levels of canceled cases in 23 being a headwind, did I hear you right?
spk07: Correct. Yep. Yep.
spk02: You know, look, that's been something, again, that has ebbed and flowed. It hasn't been consistent. Recent quarters, it's elevated. I think part of that is due to some of the dynamics with staffing. Part of that is some of the challenges with us having to reschedule and move because of the stuff we just talked about. I don't think, I don't expect it's going to be worse, but it's tricky to predict. This has been, honestly, the last several quarters have been challenging for us, so I don't expect at this point that it should get worse than what we're seeing.
spk07: Great, great. Thank you. Just one last question on my side. Is there any updates on the vision contract that you guys mentioned in the prior called hasn't, hasn't been, hasn't been helping you guys increase or track more customers for the platinum service program recently. Thank you.
spk04: Yeah, I don't, I don't have a specific number to provide, but it definitely has helped. Um, and it's definitely, um, helped in a couple of situations. Uh, but as I said, when we announced that it's, um, You know, it's more of a, quote, license to hunt. And so, again, it takes our sales force, you know, time to go and qualify and find those. But it's been real helpful, and not only in the visiting customers, but it's also been helpful with some of the other corporate partners that we're talking to about platinum services and that I feel really good about that moving forward. So that part has been good. Okay.
spk07: Thank you so much.
spk04: Thank you, Amir. Appreciate it.
spk06: Thank you. Just as a reminder, if anyone else would like to ask a question, you need to press star 1 1 on your telephone. Just a moment.
spk05: Okay.
spk06: At this time, I would like to now turn it back to Mark for any closing remarks.
spk04: Thank you. Appreciate it, operator. Thank you for everybody who attended the call today. Appreciate you listening in, and thanks to the questions that we had. Appreciate it. We look forward to providing a further update at the start of the new year on fourth quarter. Thank you.
spk01: The conference will begin shortly. To raise your hand during Q&A, you can dial star 1 1. The conference will begin shortly. To raise your hand during Q&A, you can dial star 1 1.
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