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spk08: Welcome ladies and gentlemen to the second quarter 2024 earnings conference call for Organogenesis Holdings Inc. At this time, all participants are placed in listen-only mode. Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly. Before we begin, I would like to remind everyone that our remarks today may contain forward-looking statements that are based on the current expectations of management and involve inherent risk and uncertainties that could cause ACWA results to differ materially from those indicated, including the risk and uncertainties described in the company's filings with the Securities and Exchange Commission, including item 1A, risk factors of the company's most recent annual report and its subsequently filed quarterly reports. You are cautioned not to place undue reliance upon any forward-looking statements which speaks only as of the date made. Although it may voluntarily do so from time to time, the company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable security laws. This call will also include reference to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliation of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with the GAAP are available in the earnings press release on the Investor Relations portion of our website. I would now like to turn the call over to Mr. Gary S. Gilhaney, Senior Organogenesis Holdings President, Chief Executive Officer, and Chair of the Board. Please go ahead, sir.
spk05: Thank you, Operator, and welcome everyone to Organogenesis Holdings' second quarter of fiscal year 2024 earnings conference call. I'm joined on the call today by Dave Francisco, our Chief Financial Officer. Let me start with a brief agenda of what we'll cover during our prepared remarks. I will begin with an overview of our second quarter revenue results and an update on our key operating and strategic developments in recent months. Dave will then provide you with an in-depth review of our second quarter financial results, our balance sheet and financial condition at quarter end, as well as our financial guidance for 2024, which we updated in our press release this afternoon. Then I'll share some closing thoughts before we open the call out for your questions. Beginning with the review of our revenue results for Q2, our sales results came in above the high end of the guidance range outlined on our first quarter call, reflecting strong execution and a continuation of the positive momentum and business trends in the first half of 2024. Our team's strong execution resulted in better than expected productivity by enhancing existing customer relationships, regaining lost accounts, and capturing new accounts. And despite disruption in the marketplace fueled by continued aggressive pricing strategies and, in certain circumstances, questionable competitive activities, we believe our second quarter results support our continued confidence that we focused our commercial team on the right strategy to navigate through this challenging operating environment. We are encouraged by the further evidence that our team is driving growth in our customer base by emphasizing our differentiated product and their clinical validation. In addition to the strong commercial momentum in Q2, we were pleased to share updates on the substantial progress we have made on our Renew program in recent months. As announced in a separate press release this afternoon, where we announced additional clinical results from our first phase three trial, a prospective double-blinded, multi-center, saline-controlled, parallel group clinical trial of 515 patients. The Phase III RCT results met the expectations for the study by meeting the primary endpoint of a statistically significant reduction in knee pain and the first secondary endpoint of statistically significant maintenance of function at six months. The statistical power of this study was based on these key efficacy points meeting the predefined requirements supporting a BLA submission. We completed additional subgroup analysis which revealed that the most severe patients known as KL4s treated with Renu responded with similar reduction in pain to those patients with moderate disease, the KL3 group, which is consistent with the top line results. These results are notable given that up to 15% of knee OA patients are classified as severe And the end-stage management of this disease in these patients is typically a total knee replacement when all other treatment options are exhausted. By way of reminder, 30% of the enrolled patients in the first Phase III trial were KL4s. And if successful, Renu would be the only FDA-approved biologic intraarticular injection to improve pain symptoms even in the most severe case of knee OA. Other sensitivity analysis found that subjects in the saline group took substantially more acetaminophen for breakthrough pain during the study, while subjects in the renewed group took less acetaminophen for breakthrough pain. This result further supports the improved outcomes in WOMAC pain seen at six months. During the second quarter, we requested a Type B meeting with the FDA to discuss the clinical data requirements for a biologic license application filing pursuant to the strategy we outlined on our recent earning calls. We completed the Type B meeting with the FDA on July 25th, and the FDA confirmed that a confirmatory trial will be required to support a BLA submission. We received positive feedback and guidance on our Chemistry Manufacturing and Controls, or CMCs, and the agencies affirmed the company's proposed analytical assay strategy and framework for process validations. We were also pleased to announce that we completed enrollment in the second phase three multi-centered randomized control trial, evaluating the safety and efficacy of Renu with 594 patients, significantly outperforming enrollment expectations and well ahead of our original expectations when we started enrolling this study last September. Following the positive type B meeting with the FDA, we now have a clear roadmap and timeline for our renewed BLA submission, and we are on track to deliver the renewed BLA submission by the end of Q4 2025. We continue to believe that if approved, introducing Renu to a large and growing pain management market represents a transformational opportunity for organogenesis. And if approved, introducing Renu as an innovative pain management solution for the millions of patients suffering from EOA represents a significant new addressable market opportunity for organogenesis. Specifically, by 2027, an estimated 34.4 million Americans are expected to be affected by knee osteoarthritis. While there is no known treatment that completely cures knee OA, it is possible to treat the disease symptoms with the goal of avoiding or delaying costly and invasive knee replacement surgery. We believe Renew, if approved, will address an unmet clinical need for all patients suffering from moderate to severe symptomatic knee osteoarthritis. And we are particularly excited by the unique opportunity for Renu to serve the most severe knee OA patients who have limited non-surgical options representing an estimated 5 million Americans. Before turning the call over to Dave, I wanted to share a brief update on our recent progress in the areas of clinical validation and Medicare reimbursement and coverage. Pursuant to the strategy discussed in our last earnings call, we submitted our comment letter to the MACs in advance of the deadline in early June, reiterating our support for the MACs' evidence-based approach reflected in the draft LCDs. As planned, our comment letter included the following existing clinical and real-world data, including RCTs, in support of our case that NuShield, PureApply AM, and PureApply XT should be included on the covered list. For NuShield, a high-quality published data and evidence including a recently published peer-reviewed RCT with 218 patients evaluating NuShield for the treatment of DFUs that was not considered in the draft LCDs, which we believe demonstrates that NuShield meets all the criteria for coverage. The results of this RCT were published on June 6th in the Journal of Wound Care and includes compelling, statistically significant data from this large and rigorously designed prospective Level 1 RCT, evaluating the effectiveness of NuShield for the treatment of complex DFUs in a challenging patient population. For PureApply AM and XT, currently available high-quality published data from a 728-patient study supporting the coverage of PureApply AM and XT for the treatment of DFUs and VLUs. We highlighted that PureFly AM is supported by a large body of data across five peer-reviewed publications showing effectiveness in treating DFUs, BLUs, and pressure injuries in a complex comorbid population. This data included a comparative effectiveness study of 294 patients published in May of 2024, after the literature review for the draft LCDs was completed. which showed a non-inferiority to Theraskin, a product the draft LCD proposed to cover. We are making solid progress towards new RCTs, evaluating the use of PureApply AM for DFUs that we discussed in our last earnings call. We received IRB approval, have identified sites that are targeting first patient enrollment in the coming weeks. We will continue our efforts to build compelling cases to present to the MACs to secure coverage for additional products later this year and into next year. We continue to believe these material changes from CMS and the MACs in the reimbursement of skin substitutes, if ultimately adopted, will be positive for the long-term health of the wound care market. While there will be a period of transition and disruption if these sweeping changes are implemented, we believe that organogenesis is strong brand equity, established commercial infrastructure, and plan to establish additional clinical validation to secure coverage of key commercialized products, which taken together represent a substantial competitive advantage for us that has us well positioned to maximize the enormous opportunity to serve more patients in our highly innovative and efficacious products. With that, let me turn the call over to Dave.
spk07: Thanks, Gary. I'll begin with a review of our second quarter financial results. And unless otherwise specified, all growth rates referenced during my prepared remarks or on a year-over-year basis. Net revenue for the second quarter was $130.2 million, up 11%. As Gary mentioned, these results were ahead of expectations we provided in our Q1 call, which called for total second quarter revenue in the range of $120 million to $125 million, reflecting continued strong momentum in the business during the second quarter. Our advanced wound care net revenue for the second quarter was $123.2 million, up 12%. and net revenue from surgical and sports medicine products for the second quarter was $7 million, down 3%. Gross profit for the second quarter was $101 million, or 77.6% of net revenue, compared to 77.6% last year. Operating expenses for the second quarter were $114.9 million, compared to $81.3 million last year, an increase of $33.7 million, or 41%. Note that second quarter operating expenses included approximately $22.8 million of non-cash impairment of building and unfinished construction improvement work previously capitalized, as well as the write-down of costs related to the development of internal use software. Excluding the aforementioned non-cash charges and approximately $0.8 million of non-cash amortization expense, our second quarter operating expenses increased $11.3 million, or 14%. The year-over-year change in operating expenses included excluding these non-cash items was driven by a $6.6 million or 10% increase in selling general and administrative expenses and a $4.6 million or 43% increase in research and development costs compared to the prior year period. The increase in research and development expenses was primarily due to expenses associated with clinical research and trials primarily related to renew and support of our BLA efforts. Operating loss for the second quarter was $13.9 million compared to operating income of $9.7 million last year, a decrease of $23.6 million. Excluding non-cash impairment charges, write-downs, restructuring, and amortization expenses in both periods, our non-GAAP operating income was $9.7 million, or 7.5% of sales, compared to $10.8 million, or 9.2% of sales last year. Net loss for the second quarter was $17 million compared to net income of $5.3 million last year, a decrease of $22.4 million. Adjusted net income for the second quarter was $0.2 million compared to $6.1 million last year, a decrease in adjusted net loss of $5.9 million. As a reminder, adjusted net income is defined as gap net income, adjusted to exclude the effect of amortization, restructuring charges, write-downs, capitalized software costs, and impairment of building and improvements, and resulting income taxes on these items. Adjusted EBITDA for the second quarter was 15.6 million or 12% of net revenue compared to 15.4 million or 13% of net revenue last year. We've provided a full reconciliation of our adjusted net income and adjusted EBITDA results in our earnings press release. Turning out of the balance sheet, as of June 30th, 2024, the company had 90.5 million in cash, cash flows and restricted cash and 63.5 million in debt obligations, compared to 104.3 million in cash, cash equivalents and restricted cash, and 66.2 million in debt obligations as of December 31st, 2023. We also have up to 125 million of available borrowings on a revolving credit facility as of June 30th, 2024. Turning to a review of our 2024 financial guidance, despite the strong continued momentum that we are experiencing in the business, We are reaffirming our prior revenue guidance that we referenced in our press release this afternoon to account for the potential near-term disruption in the market that we expect from the LCDs. For the 12 months ending December 31, 2024, the company continues to expect net revenue of between $445 million and $470 million, representing a year-over-year increase in the range of 3% to 9% as it compared to net revenue of $433.1 million for the year ended December 31, 2023. The 2024 net revenue guidance assumes net revenue from advanced wound care products of between $415 million and $435 million, representing a year-over-year increase in the range of 2% to 7%, and net revenue from surgical and sports medicine products between $30 million and $35 million, representing a year-over-year increase in the range of 9% to 27%. For modeling purposes, we expect third-quarter revenue to be in the range of approximately $105 million to $113 million. We have updated our GAAP profitability and EBITDA guidance for 2024 to reflect the $22.8 million of non-cash impairment charges and write-down costs and related tax impacts on these items recognized in the second quarter. Specifically, we now expect GAAP net loss in the range of $27 million net loss to a $12 million net loss compared to a range of GAAP net loss of $10.6 million to a GAAP net income of $4.6 million previously We also expect EBITDA in the range of a net loss of $17 million to positive EBITDA of $2 million compared to a range of EBITDA generation of $5.8 million to $25 million previously. Our adjusted net income loss guidance remains unchanged. Specifically, we continue to expect adjusted net income loss in the range of $8 million to adjusted net income of $7 million and adjusted EBITDA in the range of $16 million to $35 million. All other non-GAAP modeling considerations outlined in our fourth quarter 2023 call remain largely unchanged. With that, I'll turn the call back over to Gary for some closing remarks. Thanks, Dave.
spk05: In closing, our second quarter results reflect strong execution from our commercial team amidst the challenging operating environment. We strongly believe the material changes proposed by CMS in the MACs and reimbursement of skin substitutes if ultimately adopted, will be a positive step for the long-term health of the wound care market. We have a strategy to leverage our existing strong clinical and real-world data, including RCTs, and have already initiated a new RCT to secure additional clinical evidence, and we expect to secure coverage for additional products on the covered list later this year and early into next year. While there will be a period of transition and disruption if these sweeping changes are implemented, we believe that organogenesis is strong brand equity, established commercial infrastructure, and a plan to establish additional clinical validation to secure coverage of key commercialized products, which taken together represent a substantial competitive advantage for us that has us well positioned to maximize the enormous opportunity to serve more patients with our highly innovative and efficacious products. And finally, we are excited by the continued progress in our Renew program and have a clear target for submission of our BLA by the end of Q4 of 2025. If approved, introducing Renew as an innovative pain management solution for the millions of patients suffering from NeoA represents a truly transformational opportunity for organogenesis, and importantly, one that is consistent with our mission to provide integrated healing solutions that substantially improve outcomes while lowering the overall cost of care. I would also like to acknowledge the continued hard work and dedication to our mission demonstrated by our employees throughout the organization. Our strong performance and progress towards our key strategic initiative over the first half of 2024 is the result of their efforts. And with that, I'll turn the call back over to you, operator, to open the call off for questions.
spk08: Thank you, sir. If you'd like to ask a question, please signal by pressing star one on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach your equipment. We do ask that you limit your question to one question and one follow-up. If you would like to ask additional questions, we invite you to add yourself to the queue again by pressing star one. And our first question will come from Ryan Zimmerman from BTIG. Please go ahead.
spk02: Hey, guys. Good afternoon. And congrats on the quarter and the progress with Renew. Maybe I want to start with guidance for a second, Gary and Dave, and just talk about, you know, you've had two really strong quarters to start the year. I know there's a lot of balls in the air with the LCDs. Can you talk about, and you kind of referenced it, Gary, a little bit in terms of some of the dynamics in the market, but can you talk about kind of what you've seen thus far through July, maybe what's given you a little pause, particularly as I think about your third quarter guidance relative to our expectations?
spk05: Yeah, so I'll talk a little bit about the environment. So, you know, we're clearly seeing still a positive trend in our business. We've seen it throughout this the second quarter. We've increased the number of accounts that we have sequentially. We've actually ended up with more sales representatives in Q2 than in Q1. And we're continuing to see additional accounts, you know, coming back that we had lost as of last year when some of the LCDs that eventually were removed came into play. So, you know, we see that trend keep Moving forward, we also see a lot of the competitive pricing challenges that I think everyone is seeing. We've been fortunate to continue to grow through that, but that competitive pressure is still there, and at times it seems like it's increasing instead of decreasing. So those pressures are still there, but we're still seeing some positive trends in our base business. As it relates to guidance, I think As it relates to all of the uncertainty with the LCDs coming out and the continuing escalation of some of the competitive practices and pricing, every day seems like there's another product on the market with a high price. We think that that's going to continue until it stops, which would potentially be with the LCDs or some other actions. But that's in our thoughts when we look at our guidance.
spk07: Yeah. So, Ryan, great question. I mean, obviously, we established that guidance early in the year. It was prior to the proposed LCD that came out in late April. We have beat both quarters, and we feel great about that, which, you know, gives us a high level of confidence in delivering that low end of the range. But, you know, to Gary's point, the dynamics are still challenging, and there's a lot of unknowns about, you know, when the customer buying behavior might change. So, you can see, you which was a pretty wide range, and then that implied guidance for Q4, which was also an even wider range. So we still think it's biased towards Q4, but there may be some spillage into Q3 as well, which is what we're just a little bit concerned about. As far as July is concerned, I mean, we're seeing the normal summer seasonality, but we expect to move away from that as long as the customer buying behavior doesn't change dramatically in the back half of this quarter.
spk02: Okay. And just a quick follow-up on that, and then I have some questions on Renew. Any expected timelines for updates to the LCD? I know I've asked you this before, and it's hard to pin the max down specifically, but anything that we should be on the lookout for from a timing perspective on those LCDs?
spk05: I mean, it's our opinion. Obviously, we don't know, as you said, that something will happen that we think those LCDs will do. come effective in the last quarter and really affecting Q1 of next year. We just see the cost still rising substantially out there in the system. I mean, almost doubling from year to year. And the physician fee schedule came out. And at this point, There's really nothing on the payment side that would lead you to believe it's going to control those costs. There's no bundling recommended in that proposal. So the combination of escalated costs, nothing really happening in the physician fee schedule, you know, we just believe something will drop from an LCD perspective sometime in Q4. and be effective on January 1. But those are the factors that we think about, and there does seem to be a lot of activity surrounding these LCDs.
spk02: Yeah, okay. Very helpful, Gary and Dave. Just turning to Renew now, you know, it's good to see we have a clear path for Renew. I'm wondering if, I don't know if Patrick's available, but maybe, Gary, you want to speak to this, but just talk to us about kind of the nuances or the differences between your phase three study and the phase three confirmatory study. Just remind investors if there's anything that you think can differ in those studies. And then the second question to all of this is, what room do you have, when I think about the timelines to submit for BLA, what room do you have to potentially adjust your timeline, if at all, Maybe you're able to get the data and the follow-ups done as quickly as possible, and then we could see something a little maybe earlier than fourth quarter 25. Thank you.
spk05: Sure. So regarding the two studies, I mean, the second study is larger, so it has more power in that study, and we've made some operational adjustments in that study that we think will ultimately lead to better performance in the second study. So we feel pretty comfortable about, obviously, the study is already completed from the perspective of all of the patients have been enrolled. And we expect last patient, last visit next June, June of 25. So that gives us the opportunity to aggressively move forward for a filing. So it is possible, though I think Q4 of 2025 is a reasonable time period. We did ask the FDA in our meeting to consider the six-month data. They have not responded. We'll know when we get the formal minutes of that meeting, which come 30 days after our meeting on the 25th. So, though we have no indication at all that that, you know, would be accepted, that's a potential change that could move it forward a couple of quarters for sure. But as of this point, we're assuming that we will complete the trial and file in Q4 of 2024.
spk02: Thank you, Gary. No, 25. Thank you. Thank you. Thanks for taking the questions. Thanks, Ryan.
spk08: Our next question comes from the line of Brooks O'Neill with Lake Street. Please go ahead.
spk04: Good afternoon, guys. Thanks for taking my questions. I guess I'd like to start by saying that as I talk to various players in the industry, some have expressed the view that the reason for the elevated competitive activity is some suggestion that the Macs might again fail to implement the LCDs. A, what's your opinion on that? And, well, let's leave it at that. How do you respond to that suggestion?
spk05: Well, I think, you know, based on where we see the costs, and those costs are obviously public, that they've really, you know, increased dramatically. And since there's been no change to the position fee schedule unless something happens between now and the end of the year, but not likely if it wasn't included in the proposed rule, it'd be very difficult to implement something that's not in that proposed rule. So there's no payment solution, at least for another year and a half. So that leads me to believe that the LCDs, maybe not in their current form, but in some form will be implemented to try to control the cost right now in the skin substitute market. So it may not be in the form that it is. There's been a number of comments from a number of companies, us as well, that we think they need to make some changes to really improve it where it can be actionable and effective. So it might change. but it's our opinion that something needs to be put in place in the eyes of the MACs and CMS, and ultimately it will.
spk04: Makes sense to me. You presented to us some compelling evidence that several of your products have the clinical evidence that the MACs seem to be suggesting is necessary for reimbursement in the physician office setting, do you have any sense that they hear your case and they understand that you actually do have a lot of well-conceived clinical evidence for those products, or is it a silent response on their end?
spk05: Well, as I mentioned, for NuShield and PureApply AAM, and XT, we have a substantial amount of data, some of which the MACs did not have the opportunity to review before they issued their proposed LCDs. So we've submitted those studies for NuShield and Puriply AM and XT. One is an RCT, and the others are retrospective studies. One for Puriply that actually is a comparative effectiveness study against a product that's already approved on the list of 15 So we think these are large, robust data sets that they are compelling enough that they should be included in the LCD if and when it comes out.
spk04: Makes sense to me. I'll ask one last one. Thanks for taking my questions. I saw after the close, I think you filed a mixed shelf offering, $250 million. I'm curious if you have any comment on whether that's just sort of normal good governance or do you think there's either an appetite on the part of selling shareholders or the company to actually go out to the market and raise some additional capital?
spk07: Yeah, Brooks, thanks, Dave. Yeah, you're absolutely right. I mean, it's just good corporate governance. You know, it provides a tremendous amount of financial flexibility for us, gives the opportunity for certain individuals to, you know, sell their shares in a secondary if that was something that they chose to do. And this is something that we have not had in place since the fall of 2019. So it really just was an opportunity to get this done. And again, to your point, just good corporate governance. And, you know, I might add, too, as you know, you know, from a liquidity standpoint, as of today, we have over 90 million of cash, 125 million on the revolver, and then, you know, a fair amount of working capital available to us as well. So that's, again, to your point, it's just good corporate governance and wanted to get it done.
spk04: Makes sense. Thank you very much.
spk06: Thank you. Thank you.
spk08: Again, if you would like to ask a question, please press star 1 on your telephone keypad and wait for your name to be announced. Our next question comes from the line of... Again, please press star 1 on your telephone keypad and wait for your name to be announced. Our next question comes from the line of Drew Ranieri from Morgan Stanley. Please go ahead.
spk03: Hi, guys. Thanks for taking the questions. Maybe just to start, Gary, I was just flipping through the queue, and you mentioned this briefly to one of the earlier questions. But in terms of the sales force, it looks like you added maybe a handful of reps sequentially. And it's really the first time we've seen you beat net adders than subtractors for a number of quarters. So maybe just talk to us about the rep strategy here. I mean, it sounds and it looks like productivity itself is increasing. But just talk to us more about the Salesforce side, what you're envisioning for 2020, remainder of 2024.
spk05: Sure. So you're correct. We did add representatives during the quarter. As I mentioned earlier, we have been successful in gaining our accounts back. We did have sequential account growth. And our depth in the accounts is getting deeper. So our productivity, even with adding the representatives, which takes a bit of time for them to be completely productive, was up 20%. So that continued growth of accounts and depth in the accounts led us to aggressively add representatives. I think our goal at the end of the year is to have about 306 or so representatives based on the trends that we're seeing. That's our goal. And we'll add them obviously throughout the year. But our goal is to continue as we gain those accounts back and we're gaining new accounts. And when the If the LCD is eventually hit and the market is available, more market is available because fewer products are on the market, we want to be able to cover that additional market share as well.
spk03: You took my follow-up question there, Gary, but I appreciate the answers. Thanks.
spk08: Our next question comes from the line of Ross Osborne with Cantor Fitzgerald. Please go ahead.
spk01: Hi, guys. This is Matthew Park on for Ross. Congrats on the strong quarter, and thanks for taking the questions. If you wanted to start off by getting a better understanding of timelines with the RCTs, do you mind just walking us through the process to get Puriply and NuShield back on the approved list following the completion of these studies?
spk05: Sure. So, Puriply and NuShield studies are complete. They are done now. We are running an additional study, an RCT for Puriply AM. That'll take about a year. So our objective is to have that RCT completed within a year. But we do have studies both for NuShield, which is an RCT that's done, it's published, and the Puriply AM and XT are retrospective studies. Those are done and complete. And we've provided those as well. But a new study for Pure Apply, to answer your question, AM, is about one year from today.
spk01: Got it. That makes sense. Thanks for clarifying. And then I guess just one more from me. I guess turning to the surgical and sports medicine side, I obviously understand it's a much smaller piece of the pie, but can you just walk us through some of the drivers on hitting the low and high end of guidance here? And any plans to introduce new products for this side of the business? Thanks.
spk07: Yeah, sure. That's exactly what we've done is, um, the expectation was it was always assumed that the back half would be stronger than the first. And the reason being is exactly, as you said, we've got some very unique products that are specifically for the OR that are coming out with larger sizes, which are more applicable for the OR in the back half. In addition to that, there's been a strategy to expand, um, you know, channel expansion strategy, you know, with adding incremental agencies and obviously all that stuff is in the works. And so, um, you know, the high and the low is related to, you know, the kind of upside you're going to gain from those two strategies. But always anticipated the back half would be stronger.
spk01: Got it.
spk00: That makes sense. Thanks again for taking the questions and congrats on the quarter. Thank you. Again, it is star one to ask for a question. There are no further questions at this time. That does conclude our conference call for today.
spk08: Thank you for your participation. You may now disconnect.
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