Good morning, and welcome to the Second Quarter 2022 Earnings Conference Call for ConforMIS, Inc. My name is Justin, and I will be your conference operator today. All lines have been placed on mute 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 the federal securities laws, which are 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 section of ConforMIS public filings with the U.S. Securities and Exchange Commission. You should not place undue reliance on forward-looking statements. ConforMIS disclaims any obligation, except as required by law to update or revise any financial projections or forward-looking statements, whether of new information, future events, or otherwise. This conference call will include time-sensitive information and is accurate only as of the live broadcast as of today, August ninth, 2022. I will now turn the call over to Mark Augusti, President and Chief Executive Officer of ConforMIS. Thank you, and welcome to our second quarter earnings call. We appreciate you taking the time to hear our business update. With me today is our CFO, Bob Howe. Let's begin with several positives from the quarter. First, our revenue came in at the mid-point of our expectations. Second, our international sales grew 6% in constant currency with our continued progress in several key geographies, including Australia. Third, our Imprint knee continues to receive positive surgeon feedback, and revenue from ASC customers continues to grow. Lastly, we recently executed our first major national agreement for our Platinum Services program. Now, next, I would like to offer additional perspective on our updated outlook. As you will have noted in our release, we adjusted our full-year product revenue outlook to a range of $57 million-$61 million. The main driver for our adjusted outlook is that we did not exit the second quarter with the accelerated business momentum we thought we'd have back in May. There are several reasons for this. First, the environment is still challenging. Despite the general recovery in elective procedures, staffing shortages remain at medical facilities and elevated levels of case rescheduling continue. Second, our portfolio transition to Imprint continues to ramp as we shift our focus to the ASC. However, the commencement of the full commercial release of our Imprint knee system has been impacted due to availability of several key components from our supply chain partners. To address this challenge, we have pivoted our launch approach to a rolling release schedule with the goal to be fully launched by late Q3. Third, supply chain and internal staffing challenges have impacted our just-in-time model. This has led to increased number of cases with tight product deliveries as well as additional cases being rescheduled. Moving to an update on our pipeline, we did have some changes this quarter due mainly to delays from various testing firms we use as well as supply chain partners. For Actera, while I'm pleased to report that we received our 510(k) clearance this week, we nevertheless are now planning for a limited market release early in the fourth quarter, about a 90-day delay due to late shipments of instruments from a supplier. We remain encouraged about the commercial opportunity for Actera given the positive surgeon feedback from our validation labs. Also, due to supplier delays beyond our control, we now anticipate an early April 2023 launch for our porous coated knee. This is particularly frustrating since the segment is one of the faster-growing segments in the ortho space and is commanding more and more interest from our surgeon customers. We are exploring every option possible to expedite the timeline. As I've said on past calls, those two products are critical for us to address gaps within our existing product portfolio. Our long-term growth depends on providing a more robust product offering so we can capture greater procedural share from our existing surgeon users and attract new surgeons. In closing, as I mentioned at the beginning of my comments, we announced last week that we had signed a contract with Vizient, which will allow us to begin contracting at the local level with its members for our Platinum Services program. We believe this is further validation of the benefits that this program can provide for patients and healthcare facilities alike. We continue to add to the number of facilities under contract for Platinum Services program. We've enrolled twenty one healthcare facilities through the end of the second quarter. We anticipate that new facility enrollment in our Platinum Services program will continue to remain choppy, but we are encouraged by the general interest from the marketplace. I will now turn the call over to Bob for some more details about our financial performance for the quarter and our outlook. Thank you, Mark, and good morning, everyone. Product revenue was in line with our expectations at $15.1 million, which was essentially flat compared to last year and showed slight sequential growth from the first quarter. Within product revenue, our worldwide knee products grew 1% on a reported basis. Our hip product revenue was approximately $744,000, which was down 18% compared to last year's second quarter. As I mentioned last quarter, we had a significant amount of rescheduled activity occur in the second quarter last year, which made for a challenging comp this quarter. We expect hip to return to growth in the fourth quarter following the launch of our Actera hip stem. Product gross margin for the second quarter was 35.1%, a sequential improvement of 100 basis points as compared to the first quarter. While we continue to face headwinds from increased material and labor costs as well as inefficiencies as we transition to our new business model, we are focused on making the necessary changes to improve our operations. We expect to sequentially improve this metric again in the third quarter and be back to the low 40% margins in the fourth quarter. As you've heard me say before, longer-term, we believe that as we ramp Imprint and the Platinum Services program, both of which produce higher gross margins than our legacy business, we have a meaningful opportunity to further expand our gross margins. I'll now move to OpEx. Our total operating expenses for the second quarter were $18.2 million, which was $2.3 million lower than the first quarter. Relative to the first quarter, sales and marketing was down slightly. R&D was down $500,000, partly due to adjustments to the timing of our new product launches. G&A was down $1.6 million, primarily due to reductions in legal fees incurred to protect our IP and lower product delivery expenses as we continue to improve our delivery performance. For the year, we now expect to be at the lower end of the $75-$81 million range we previously communicated. Moving to our balance sheet, it remains strong with cash and cash equivalents of $72.6 million at the end of the second quarter. As expected, our use of cash was down in the second quarter as compared to the first quarter. Second quarter cash use was $10.2 million, which was $7.6 million lower than the first quarter. Our 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 releases of our Actera hip and porous coated knee. I will close with some additional details on our outlook. We expect our third quarter product revenue to be between $13 million-$14 million. As Mark mentioned, we did not enter the third quarter with the level of momentum we expected to have back in May. We continue to deal with supply chain issues and the impact from our previous product delivery challenges. In addition, our recent strategy pivot has come as medical facilities are still dealing with staffing issues. This has resulted in more volatility than expected in our near-term order volumes. Based on these factors, we now expect to see the sequential decline in product revenue from the second quarter to the third quarter that we historically experience, since the third quarter is typically the slowest quarter of the year for us. Based on our updated expectations for the third quarter, factoring in our new timelines for the full market release of Imprint and the limited market release of Actera hip and the ongoing portfolio transition, we expect our full year product revenue to be between $57 million and $61 million. With that, Mark and I are happy to take your questions. Thank you. As a reminder, to ask a question, you'll need to press star one one on your telephone. One moment for questions. Our first question comes from Josh Jennings from Cowen. Your line is now open. Hi, this is Eric, on for Josh. Thanks for taking the question. Was hoping to just hear a little bit more on recent procedure volume trends that you've been experiencing. Are you able to share with us the month-over-month trends that you've experienced through 2Q and, now into early 3Q? Yeah. Hi, Eric. This is Mark. Thanks for joining us this morning. Yeah, thanks for that question. It's good too, because I think we experienced what other companies have discussed, and that was early 2Q was strong and, you know, relatively strong. June there was definitely a market slowdown that continued into July, a little bit. We sort of see that continuation in July, but we are expecting a little bit more strength in, you know, later in the quarter, in Q3. Having said that, looking at, you know, taking everything in context, as Bob pointed out, we are gonna see sort of the historic cyclical down for us and I think for the industry for Q3. Not horrible, but you know, just sort of that cyclical kinda summer off vacations and that type of stuff. Again, as we mentioned, the staffing challenges. That's sort of the trends we saw month to month, Eric. Okay. Great. Thank you. Just on the Vizient deal, could you talk a little bit more about how Vizient is gonna be offering ConforMIS products to their hospital customers? Just to double-check, there's no contributions from that deal factored into guidance for this year, correct? Thank you. Yeah. No, not at this point. Yeah, we're very excited about it because they reviewed our program, obviously, you know, and they worked out the contracting with us, which we're excited about. It provides access and it gives us sort of the opportunity to discuss and approach the Vizient customers. There's no sort of obligated purchases or anything like that in there. You understand how these GPOs work. For us, it is pretty exciting because it sort of clears the deck and sort of establishes sort of how the program's rolling out and how it can work. For the facilities that participate in the Vizient network, that'll be a big deal for us to be able to get in there and present the program to them. Great. Thank you for taking the questions. Thanks, Eric. Thank you. One moment for questions. Our next question comes from Steve Lichtman from Oppenheimer. Your line is now open. Thank you. Good morning, guys. Wanted to touch base on this, the supply challenges that you noted, Mark, specifically on Imprint and on Hip. It sounds like the impact, in terms of launches on those two are relatively small. Can you give us, you know, a sense of what you're doing to get better visibility on that supply and what gives you the confidence that for those two products that the impact on launch is not going to be longer than anticipated? Yeah. It's a lot of stuff, Steve, but I'm happy. Appreciate the question. Good morning, by the way, I'm happy to do that. First off, on Imprint, I just wanna point out we are in limited release. We continue to grow volume and roll that out, and we are still planning to transition over our business on September first. In advance of that, when we say full launch, what we're really trying to do is be able to make sure we can deliver the patient specific and intraoperative solution and plan that goes with Imprint within three, four- weeks of the customer ordering versus the six- weeks that it takes us to do a fully custom thing. In limited release, as we build building up inventories, we've kept Imprint at sort of a six-week lead time, which is too long, you know, for that product. We know the customers want it sooner, and that's why we've talked about full market release, getting it down to that 3-4 weeks. We were hoping to do that sooner, Steve, as I said in my prepared comments, but now it's looking like it's gonna be late Q3. What we're doing actually is we're doing a rolling sort of reduction in the lead time. The surgeons and their offices, when they go to order from us, will see each week as the lead time gets pulled in because it's sort of like a reservation, right? They go onto our website and they actually order the product, and they can see the surgery date when it's available. The issue for us there, from a supplier standpoint, some of it, a little bit of it has been our own sort of internal challenges. We're dealing with staffing and some of the changes that happened, you know, towards the end of last year and beginning of this year with the workforce. You're finding that, you know, things for Imprint for us that affect the inventory build is little stuff like packaging, right? I mean, literally packaging suppliers are late in their deliveries. For us, a big thing which you've probably heard about, Steve, is Tyvek and some of the films that we need to make the pouches that stuff gets sterilized in. Those products, the lead times have gone out. Things that were, you know, 2-3, maybe four-week lead times are now six, eight, twelve-week lead times. That's very challenging to deal with this when you know, the product you're expecting to have that goes into your manufacturing process isn't available. Simple one, the reason why I feel comfortable 'cause we're very close on Imprint, so I feel very comfortable on the rolling dates there. High confidence. On the hip, really pleased with the 510(k) approval, really pleased with the surgeon feedback from the validation labs. We have all of the instruments in hand now except for one part from one supplier. We're highly confident based on discussions with that supplier, though it's late, that they'll make the new communicated date. That gives us confidence that we'll be able to get into limited release on this product sort of late Q3 and, you know, from our standpoint, have most of the fourth quarter to have this very exciting new hip product in with limited release with our surgeons that have been involved in designing this. So to that, you know, sort of detail there, but again, you know, the delay there is just in this case, there's a few other instrument suppliers, but they've all been delivered now except for one. So we're only managing one supplier, so high confidence on that target. You didn't ask it, but I'll talk about, I mean, we all know cementless porous coating is important. Again, we've had validation labs been able to continue all the testing and work we need to do for our 510(k) submittal. That's not sort of the concern to us right now. The real issue is just supplier lead times, frankly, on some of the casting components we need for both the femoral and tibia trays, some of the components there to be able to build up inventory stock of the cementless components. That's important 'cause you need to have all the sizes and all the inventory available. Again, it's just one or two suppliers. We've got detailed plans with them. As I mentioned, we're looking at every opportunity. We see some potential to pull things up, but we just wanna be sort of balanced in the approach. Right now it's looking like it's gonna be sort of late Q1, early Q2, which is certainly disappointing, because things that we expected to get in hand, just all of a sudden they're not available for another 60 or 90 days. That's the nature of the supply chain challenges we're dealing with in med tech these days. Okay? That's it. Yeah. That's helpful color. Thanks, Mark. Is the other consideration you mentioned the updated guidance was your, you know, change in the business model. I was just wondering if you could talk a little bit more what, you know, what you're referring to in terms of that having an impact. Obviously, we know what the business model change is, but is it, you know, the shifts from fully custom to Platinum Services? You know, what did that comment mean relative to sort of the impact on, you know, guidance? Well, anytime you make a change, right? You worry just, you know, the rhythm and how customers react. We've done a lot of market research. We've had tons of calls in preparation with our customers. You know, at the end of the day, the ordering site and the webpage and all the other stuff is going to change on September first. You know, and I'm not suggesting it's not gonna be live or active, because all that stuff is, and we're ordering Imprint, as you know, today. The real question is when, you know, we basically flip people over and, you know, they're gonna get Imprint and versus the fully custom product, you know, how will customers behave on balance? I mean, I have every reason to believe it's fine because we still have a lot of value, and actually are giving more flexibility with Imprint. You know, it is a change, Steve. That's really the question. We're managing through that. We feel like all the signs are positive and everything's fine, but you know, it's like anything else, until you take that first step, you're never sure. We're just trying to be balanced in the approach given, you know, given what we're seeing in the market, both from a scans and surgical trend, and you know, I talked a little about that in the first question, with what we saw in the month-to-month. Then also this is all going on while we're doing this business challenge. It. Fundamentally we're doing it 'cause it's gonna be more growth opportunities, and I wanna reiterate that we are seeing really good, you know, competitive uptake in our Imprint. We are seeing really good growth in the ASC segment, which is really the fundamental rationale for the strategy. There's a lot of value there with being able to provide the Imprint system with the business efficient model, with the patient-specific surgical plan, the flexible polys, which we don't have on our intraoperative poly flexibility, which we don't have on our fully custom one, and do all that, as I said, in that three, four- week timeframe. That's what's exciting, you know, our customers and what we're moving towards. We're seeing it in the numbers in what we're seeing in our ASC trends. We feel very bullish about things. You know, we've got the time here to execute this and do this, and we're gonna get it right. It's just a choppy Q3 for us. All right. Just lastly, international. Good to see that is in the positive zone after, you know, obviously having some reimbursement challenges there historically. What's your outlook for international over the next couple of years? What are some specific targets, and what's the opportunity for you? Yeah. Thanks, Steve. It has been a really tough ride over there. You know, I don't wanna get ahead of our skis because Germany's still a challenge for us because of the really just sort of harsh reimbursement environment and whatnot, and then you've got MDR stuff you're dealing with. What we've seen is, you know, the gentleman that's leading our business there has made some really good moves with some of the other countries with our agents, and we've seen growth in some of the other countries. Small growth, but growth that wasn't there before. Obviously, as I mentioned in the remarks, Australia, which is a really good market for our model, it just took longer to get there through a regulatory process than we would've liked. It was worth the pain and toil because now it's delivering, really good for us. I think Australia has a chance to be our second largest market after Germany. Really what you see happening is Germany sort of flattened out. There's still demand for our products because if you really dig into it, we've got great clinical results and a lot of work that's been done in Germany. People really like the product and they want the product. It's just a reimbursement challenge. What's happened is that growth is sort of declining, if you will, right, has bottomed out, Steve. All the other countries have come back into slight growth for the most part, maybe not every single one. That's delivered, you know, finally for us in the quarter, a nice growth. I think you know I think we have a chance to continue sort of on that track here with reasonable expectations internationally. Great. Thanks, Mark. Okay. Thanks, Steve. Thank you. One moment for our next question. Our next question comes from Kyle Rose from Canaccord. Your line is now open. Hi, this is Caitlin on for Kyle Rose. Just on Platinum Services, how is the- Okay. Hi. How's it going? Just on Platinum Services, how is the rollout going? Have you had any challenges similar to the challenges you've noted for your other products? How many more facilities do you expect to add this year on contract? Just on Vizient, how do you expect the Vizient partnership to really drive uptake of Platinum Services as well as Identity and Cordera this year and into next year in the future? Yeah. Thank you. Yeah. Well, they're related. Good question, Caitlin. The discussions on Platinum Services are going really well. I've mentioned that it's sort of like a capital sale, so it's a bit choppy and it's sort of early days, but I would liken it back to, you know, I know we probably can't all remember that far away, but the early days of robotic were sort of very slow initially. Then, you know, obviously there was general acceptance as the market starts to integrate it and bring it online. I think that'll be the case with Platinum Services. Obviously as a smaller market share player, we don't quite have the reach that the big guys have. So our adoption curve is probably gonna be even flatter than robotics. But the business model is just too compelling, and it's. We're sort of very much skating to where the puck's going in the industry as far as patients wanting personalization, as far as premium services being offered to patients willing to pay for cash pay services. All of that's, you know, in line with where the market's going. We added more facilities under contract in Q2. Caitlin, we have a number of discussions. We're very excited about the number of discussions we have, so we're not gonna, you know, give a specific number, but we absolutely expect to add more facilities in the second half. Vizient is gonna be a really nice kind of tailwind in that as well because it really gives us something to go and talk to and market and chat about. I see that tailwind sort of keeping us going into 2023 as we looked at more Platinum Services accounts. This is early days. It's very exciting. Surgeons are interested, very much interested in talking about it. You can see a lot of surgeon peer-to-peer discussion about patient education and the model and how to implement it. As I said, it's just very compelling, and it fits with where the market's going. We're excited about it, but it's gonna be sort of a flat but upward adoption curve, certainly over the next 2- 4 quarters. Okay. Operator, do they have any questions? Thank you. I am showing no further questions. I would now like to turn the call back over to Mark Augusti for closing remarks. Thank you, Justin. Once again, everyone, thanks for joining us this morning. Thank you again for your interest and investment in ConforMIS. The team's working hard to realize the growth opportunity we have. The strategy is strong and remains intact, and we're extremely confident that we have a great implant portfolio that delivers great clinical results and the most unique service program in the industry with our new Platinum Services program that'll gain traction over the coming quarters that I talked about. We look forward to providing further update later in November. With that, we'll end the call and wish you all a great rest of the day. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.