Good day, and thank you for standing by. Welcome to the Dentsply Sirona conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automatic message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your host, Andrea Daley. Please go ahead. Thank you all for joining today's call to discuss Dentsply Sirona's recent Byte business update. With me, we have Simon Campion, Chief Executive Officer, and Rich Rosenzweig, EVP of Corporate Development and General Counsel. During today's call, we may make certain predictive statements that reflect our current views about future performance and financial results. We base these statements and certain assumptions and expectations on future events that are subject to risks and uncertainties. Our most recently filed Form 10-K and any updating information in subsequent SEC filings list some of the most important risk factors that could cause actual results to differ from our predictions. Additionally, on today's call, our remarks about select preliminary financial results will be based on non-GAAP financial results. We believe that non-GAAP financial measures offer investors valuable additional insights into our business's financial performance, enable the comparison of financial results between periods where certain items may vary independently of business performance, and enhance transparency regarding key metrics utilized by management in operating our business. We will provide a reconciliation between GAAP and non-GAAP results in our Q3 earnings press release. Given our Q3 earnings quiet period, we will not be doing additional investor calls following this call until after our Q3 earnings call. With that, I will turn it over to Simon to provide a summary of the announcement, and then we will open it up for some questions. Simon? Thank you, Andrea. Good morning, and thank you for joining us on short notice. Yesterday, we provided an update on our Byte business and released select preliminary third quarter 2024 results. While it's atypical for us to hold an investor call during our quiet period, we felt it was important to uphold our commitment to transparency and communicate directly with you about Byte. To that end, while we have issued some preliminary financials, we will only answer questions related to the Byte announcement today. We look forward to discussing the full details of our third quarter financial and business performance on November 7th. Now, let's turn to the announcement. We disclosed that Dentsply Sirona voluntarily suspended sales and marketing of our Byte aligners and impression kits. We have also suspended shipment and processing of new and recently placed orders for Byte aligners and impression kits. This decision is related to a review we are conducting regarding certain regulatory requirements for these products and was made by working closely with the U.S. FDA. I'd like to take a step back and explain how we got here. Dentsply Sirona holds itself to the highest standards of quality and compliance, with patient safety at the center of everything we do. Consistent with that commitment, we have proactively taken steps to continuously improve our post-market surveillance processes. One way we do this is through the company's operating model, which includes retrospective analysis and reporting. Through this process, and in connection with our ongoing discussions with FDA, we have determined that our patient onboarding workflow may not provide adequate assurance that certain contraindicated patients do not enter treatment with Byte aligners. While we continue to believe the potential risk to patients remains low, we made the decision to voluntarily suspend sales and marketing for these products as we conduct our review. Turning to what this means for Byte. As we work through this review, we will continue to work closely with the FDA and other regulatory authorities. Throughout this process, we will also focus on continuing to communicate with treating dentists and their patients to support their continued care as appropriate. As I said at the beginning of this call, we are committed to transparency and will keep you updated on our progress as we are able. Independent of the product suspension, there had already been work underway within the Byte business. From a macro perspective, the state regulatory environment has adversely impacted our Byte aligner business model. As a result, we've seen declining conversion rates and new documentation records and additional requirements such as evidence of visits to a dentist or patient X-rays. In response to these macro trends, we had begun the process of assessing our resources at Byte and thinking strategically about how to leverage our infrastructure, our talent, and our capabilities elsewhere in the business. For example, we believe there may be opportunities to leverage and/or redeploy these resources to improve other software platforms, which could help accelerate DS Core functionality and support our efforts to enhance the overall patient experience. While our work on both efforts is still underway, I want to underscore that this is an important area of focus for the board and the management team. Our goal is to continue to provide access to quality oral care for patients. I'd now like to discuss our select preliminary third quarter results. The company expects to report third quarter 2024 net sales of approximately $951 million, and Adjusted EPS is expected to be between $0.49 and $0.51. Additionally, we expect to report year-over-year net sales growth in Essential Dental Solutions, partially offset by declines in our Orthodontic and Implant Solutions and Connected Technology Solutions segments. Wellspect Healthcare net sales growth is expected to be approximately flat due to timing with a large U.S. distributor. I'll also note that net sales and Adjusted EPS were favorably impacted by a shift in the timing of distributor orders for Essential Dental Solutions products from the fourth quarter into the third quarter, an impact of approximately $20 million associated with the company's planned fourth quarter ERP implementation in North America. Due to the decline in fair value for the Orthodontic Aligner Solutions and Implant and Prosthetic Solutions business units, the company expects to record non-cash charges for the impairment of goodwill within the range of $450-$550 million net of tax. The decline in fair value for the OAS unit is primarily driven by adverse events from state regulatory trends pertaining to the company's Byte aligner business. For context, the company's OAS business, which includes Byte, Byte+, and SureSmile, had full year 2023 net sales of $339 million. Though we typically do not disclose results for specific product lines, we think it's important to provide some additional context under these circumstances. For Q3 2024, on a preliminary basis, Byte contributed a little more than $40 million in net sales, a decline of approximately 7% compared to the prior year period, a double-digit decline sequentially, and it became dilutive to adjusted earnings per share. The decline in fair value for the Implant and Prosthetic Solutions unit is driven by a weakened demand in conjunction with competitive pricing pressures and adverse impacts of ongoing global conflicts in certain markets, as well as lower long-term expectations for lab material volumes. In all, these factors contributed to reductions in forecasted revenues, lower operating margins, and expectations for lower future cash flows in the near term, resulting in an impairment during the third quarter for the aforementioned reporting units. While that is all I'm able to share on financials today, I look forward to further discussing our third quarter performance and business updates with you on our earnings call on November 7th. Before I open it up for Q&A, I want to reiterate that patient safety and customer care is at the heart of all we do, and we remain focused on our mission of transforming dentistry to improve oral health globally while continuing to be transparent with all stakeholders. We will evaluate and assess the appropriate next steps with regard to Byte in coordination with the FDA, with the goal of continuing to provide innovative, high-quality, and effective solutions to advance patient care. Operator. Thank you. Ladies and gentlemen, if you wish to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, simply press star 11 again. Please stand by while we compile the candidate roster. Our first question, coming from the line of Elizabeth Anderson with Evercore ISI. Your line is open. Hi, guys. Thanks so much for the question this morning. I have two questions. One, is there anything additional you can sort of offer us on the current profitability profile? As you pointed out, it was sort of decaying, so obviously that would sort of limit the impact potentially to 2025 plus. And then secondarily, can you talk to us about how you're thinking about the SureSmile recapture plan? Are there some elements that you can use to boost SureSmile sales because of this? Are the Byte+ people converting over to SureSmile? Anything else on that strategy shift, even if it's early days, would be helpful. Thank you. Yeah, good morning, Elizabeth. Thanks for the questions. Listen, I think the only thing I can say, to be fair about profitability, is what I shared. A decline in performance in Q3, and it turned dilutive in that quarter. I think we've reported before that Byte was moderately profitable for us, but in the past quarter, it had turned dilutive to our business. And then in relation to your comments on SureSmile, I think that's really related to some of the statements I made in the prepared remarks about the infrastructure and capabilities that exist within the Byte area of our business, and a realignment of those resources across some of our businesses, which would include SureSmile. And then the Byte+ capture rate, I think Byte+, I think we shared on the last call that we had just in excess of 100 customers participating in that model, so it was a nominal contributor to the Byte revenue line. Okay, and just sorry, when you're saying turning dilutive to the business in 3Q, does that mean to the corporate operating margins? You're saying it's negative? I just want to make sure I'm 100% understanding that. It's always been dilutive to the corporation. It was actually dilutive in Q3. Got it. Okay, got it. Thank you for clarifying. Thank you, and our next question coming from the line of Alan Woods with Bank of America, Your line is open. Good morning, and thanks for taking the questions. Simon, is there any way to size the non-marketing related OpEx at Byte? You mentioned that you can redeploy some of that spend into DS Core and SureSmile, but just trying to get a sense numerically of how big of a dollar shift that could be. Thanks. I don't think we can share that color at this time, Alan. Probably the best indicator for you is the revenue that I disclosed for Q3 and the fact that it's dilutive to our business. Great. And then is there any way? I know this may be a difficult question to answer here, but the expected duration that Byte could be out of commission, can you talk maybe from a high level about your conversations with the FDA, what you think you need to do? Is there additional cash that may need to be deployed in order to get that product in a position to be put back on the market? Trying to get a sense of timing and maybe the cash that that would require. Thanks. I think with respect to that question, it's best if we postpone answering that question until we get to our earnings call. I can't really discuss nor predict it at this time, Alan, so I apologize for that, but I think it's best we wait until November 7th. Understandable. Thank you. Thank you. And our next question, coming from the line of Michael Cherny with Leerink Partners. Your line is open. Good morning, and thanks for taking the question. I might try another way at Alan's question, but a little bit of a different angle, so to speak. You've invested in Byte+, but obviously have made your SureSmile investments. I know there's tried to be a bifurcation of the market. As you sit here with this clinical hold in place, what are the biggest drivers you're looking for on the potential for go, no go, on whether or not owning Byte for the long term still is the right strategy for the business? I think it's in the general context, Michael, of the profitability profile of this business, the investments that we would need to make to reignite this business, both from a regulatory perspective and reignite the funnel for this business. They're all the angles that we are looking at as we speak, but I'm unable to provide you any clarity on that. The timing of that will depend on many factors, but we hope in short order we'll be able to provide everyone an update on where we stand with Byte with respect to FDA and Byte with respect to the business. And then, is there anything again? I know it's very quick, but is there anything you've seen from the patients where you've paused or canceled orders in terms of activities they're pursuing? I know obviously you have Byte as an option, but is there anything else on the transition side that you're helping them with, given that they made a decision to go down and align their product base and they may look to your other product or they also may look to other participants in the market? How are you supporting those customers more from ones that haven't started the products yet? Yeah. So, Michael, we continue to believe that the potential risk to patients remains low, and we made the decision to voluntarily suspend sales and marketing for the products while we conduct the review. There have been no changes to the quality, safety, and effectiveness of the Byte aligners and impression kits, and we have not established a causal link between the aligners, impression kits, and any reports of serious injuries or adverse results. In relation to your comment about how are we serving our patients and customers right now, we're in the process of establishing that right now. You should expect to see more information on our websites within the next 24 hours with further details about how we plan to serve the customers who are in the process of utilizing the Byte aligner system. Okay. Thanks. Thank you. Our next question, coming from the line of David Saxon with Needham & Company. Your line is open. Great. Good morning, Simon. Thanks for taking my questions. So I guess just on the issues you talked about, I mean, it sounds like it's more of a processes and workflow issue to identify these contraindications. So is the fix just implementing technology or software that flags those patients that are contraindicated, or is it more complicated than that? Any sense of kind of what the actual fix is would be helpful. I would say that we are in the process of assessing what that fix might look like. We'll obviously have to engage with FDA and work closely with them to ensure that meets the requirements and gets us back in line with the indicated patients who are indicated and contraindicated for this product. It's likely to be a combination of a technical and a regulatory solution. Okay. Great. And then I think you had started launching Byte internationally. It sounds like this is more of a US FDA discussion and dynamic. So can you give us a sense for how much of Byte revenue is OUS and kind of how you're thinking about international while you're paused in the US? Thanks so much. The OUS revenue for this product line is minimal in the context of Byte, and we have stopped the sales and marketing efforts for Byte on a global basis. Great. Thanks. Thank you. And our next question, coming from the line of Erin Wright with Morgan Stanley. Your line is open. Great. Thanks. So kind of a bigger picture question. Just at what point does this kind of call into question kind of your commitment to the Byte business from here? And since you're somewhat limited, I guess, on talking about Byte specifically, how do you think about just the overall DTC market, the value proposition, also in light of what's going on from an adverse state regulatory dynamic, just how you're thinking about things? Thanks. Yeah. Thanks, Erin. I think I answered a similar question moments ago. We are looking at the state regulations that have changed the profile of this business. While saying that, we think that aligners and teledentistry are necessary to connect the underserved patient populations that may not be able to access it. But we have a lot of work to do over the next several weeks with respect to the lift to drive our technical and regulatory solution to the challenge that we currently face. I mentioned the profitability of this business, conversion rates, etc., etc. So it's a multifactorial assessment that's underway right now from a technical, regulatory, and commercial perspective, and any further detail would be rather premature on my part to comment any further. But suffice to say, as we have said on many occasions since many of us arrived two years ago, we will, A, be transparent, and, B, be entirely data-driven and objective with respect to this decision. Okay. Thanks. And then in terms of the impairment charge for the implant business, is the weakened demand and pricing pressures incremental to what you have been seeing or a continuation of the same in terms of what we've been seeing recently there? Thanks. I think I will postpone an answer on that until we get to earnings on November 7th, Erin, if you don't mind. That's fair. Thank you. Thank you. And our next question, coming from the line of Jon Block with Stifel. Your line is open. Great. Thanks. Thanks, guys, and good morning. Maybe the first question, Simon, I think you mentioned the issue with Byte is largely around the onboarding process and giving that more scrutiny to ensure proper outcomes. If that's the case, why not leverage and move forward with Byte+? Sort of really lean into that, right? That would seem to run it by the doc, check perio, rectify the onboarding process, and unless I'm mistaken, I think Byte+ is sort of also off the board or suspended during this period of time, so maybe I'll start there, please. Yeah, so Byte+ is off the market as well. As I noted earlier, Jon, that was a very minimal component to the business model that we have. But suffice to say, like in my response to Erin, we are considering that and all the other options that I'm sure you can figure out with respect to the entire Byte model. Do we continue to live with Byte? Do Do we continue to live with a subset of it, or is there another answer entirely? Okay. Got it. And then maybe just to shift gears a little bit, I guess you're calling out how it was dilutive to 3Q Byte, but it had been profitable at one point, as you guys have outlined. And I'm guessing there were thoughts about increasing amounts of profitability when we think out to 2026 and the $3 EPS goal. So is there anything to frame around that and how we have to sort of consider that when we think about numbers and where they go over the next 24 months or so? If I can tack on to that, sorry, Simon, I might be off on this one, but I thought at the time of the Byte acquisition, some of the synergies were on the manufacturing line in SureSmile and Byte and the opportunity there. So is this coming off the same line as SureSmile? If it is, and again, I'm not sure there, but what would that mean from an absorption standpoint or GM as we think about SureSmile? Thank you. There are several great questions, Jon, that I will be glad to try and put some color on November 7th. Thank you. Thank you. Our next question, coming from the line of Brandon Vazquez with William Blair. Your line is open. Hi everyone. Thanks for taking the question. Maybe just one high-level first. As we think about Byte just went a little negative or dilutive in terms of EPS in the quarter. It's always been a little difficult to scale. And as we go forward, it sounds like the regulatory environment from both the federal and the state level is getting more difficult. Maybe can you just talk a little bit about what are the levers that you guys this seems like it's just getting a harder and harder business to scale. So is there a path forward where Byte actually is an attractive business for you guys? Can you just comment on what kind of levers and what that environment would look like once this review is done? Yeah. Hey, Brandon. Listen, I'm afraid I'm probably going to give the same answer I've given to many of the questions. The review is ongoing with respect to the requirements for us to get back into shape. It's a multifaceted solution that we need to go after here to ensure that. But in parallel, on the commercial side, we are in the process of evaluating many alternatives, which may include any of the following: a full restoration of Byte, a subset of Byte such as Byte+, a redeployment of resources, as I commented elsewhere. So everything is on the table. We will make a very objective and data-driven decision about Byte and its future in some manifestation. And as soon as we are in a position to communicate with you all, you have our commitment to do so. Okay. And maybe just to ask, Jon Block was asking this a little bit. I'll ask it slightly different. Can you just comment as of today so that we have an understanding how separated or integrated are the Byte and the SureSmile organizations today from between manufacturing, clinical technicians, sales, and marketing? How siloed are those? And just so we can understand and make our own assumptions on to what degree some of these can just be ported over to SureSmile versus needing a longer kind of strategic review. Thanks. Yeah. Listen, I think probably the only color I can give you at the moment is they were largely separate, but we did communicate previously about manufacturing consolidation. Thank you. And I'm showing no further questions in the queue at this time. I will now turn the call back over to Mr. Simon Campion for any closing remarks. Great. Well, I appreciate all of you joining the call today at very short notice. As I noted at the start of our comments, we will continue to be extremely transparent with you all about our performance across our entire portfolio, but particularly with respect to the recent challenges that we've faced with Byte. And look forward to speaking with many of you on the 7th of November. Thank you. This concludes today's conference. Thank you for your participation, and you may now disconnect.