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spk05: Good day, and welcome to the Thera Technologies Q3 2023 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to John Mullaly. Please go ahead.
spk08: Thank you, operator, and good morning, everyone. On the call today will be Thera Technologies President and Chief Executive Officer, Mr. Paul Levesque, and Senior Vice President and Chief Financial Officer, Mr. Philip Dubuc. During the Q&A session, we'll be joined by Dr. Christian Morsalis, Senior Vice President and Chief Medical Officer, and Mr. John Leisure, the company's global commercial officer. Before we begin, I'd like to remind everyone that remarks today contain forward-looking statements regarding the company's current and future plans, expectations, and intentions with respect to future events. Forward-looking statements are based on assumptions, and there are risks that results obtained by Thera Technologies may differ materially from those statements. As such, the company cannot guarantee any forward-looking statements will materialize, and you are cautioned not to place undue reliance on them. The company refers current and potential investors to the forward-looking information section of Thera Technologies Management Discussion and Analysis issued this morning and available on CEDAR, www.cedarplus.ca, and on EDGAR at www.sec.gov. Forward-looking statements represent Thera Technologies' expectations as of this morning, September 26, 2023. Additionally, today the company is using the term adjusted EBITDA, which is not a financial measure under International Financial Reporting Standards, IFRS, or U.S. Generally Accepted Accounting Principles, U.S. GAAP. Adjusted EBITDA excludes the effects of items that primarily reflect the impact of long-term investments and financing decisions rather than the results of day-to-day operations. Thera Technologies believes that this measure can be a useful indicator of its operational performance and financial condition from one period to another. The company uses this non-IFRS measure to make financial, strategic, and operating decisions. Reconciliation of adjusted EBITDA to net loss is found in our MD&A issued this morning, available on CEDAR and on Egger at the web addresses mentioned earlier. Investors can also follow the company on LinkedIn and Twitter and sign up for alerts on Theratechnology's investor website at theratech.com. With that, I would now like to turn the conference over to Theratechnology's President and CEO, Paul Levesque.
spk12: Thank you, John. Hello, everyone, and good morning. I'm pleased to report that we have made fantastic headway across our strategic objectives, as outlined in this morning's press release. Our financial and operational planning for the remainder of the year and into 2024 is well in hand. And in spite of headwinds in the last quarter, we have learned much from both our successes and setbacks. which is exactly why we are pleased to report a positive outlook for the remainder of the year. For example, our quarterly revenue has demonstrated a solid recovery from the most recent period, and we've crossed major milestones in the development of our pipeline and the lifecycle management of our products. With that, today's call will be quick and straight to the point, as our primary goals in the near and medium term are clear and remain set. I want to remind everyone that our sights are zeroed in on advancing the objectives that drive the whole of our business forward, and most importantly, to maintain a strong cash balance and discipline around long-term financial objectives. In this arena, we are laser-focused on revenue strength and improvements to our bottom line. We have and will continue to be stringent with our operating expenses so that the adjusted EBITDA profitability we have just reported is a fixture of our ongoing financial plan. This is core to our success and I cannot emphasize it enough. We also strongly believe that our pipeline progress cannot and should not be underestimated. We are executing on the promise of extending future revenue generation of the commercial business through line extensions of our HIV products, in particular with the FDA submission of the IGRIFTA F8 formulation, which we announced yesterday. We are also committed to capitalizing on the development of our lead anti-cancer agent, Pseudocetaxels and Dusortide. As you know, we are working hard to meet phase one clinical trial milestone timelines and report results as quickly as possible in 2024. I would also like to mention a goal that is very important tied to our operational planning, which is respecting our debt covenants with our lender. I am so pleased to share that we have worked together with Marathon to modify our covenants as our story progresses. These important changes include, among others, removing the increase in the liquidity covenant, which would have stepped up to $30 million should the F-8 not be approved before March 31, 2024, changing the revenue covenant to an adjusted EBITDA base covenant, and changing the liquidity requirements down to $15 million over time as our adjusted EBITDA increases. These adjustments to the loan covenants can be seen as a testament to the rising confidence in our ability to execute on the company's stated goals for the year, Additionally, the new terms will allow their technologies greater flexibility in our quest to deliver better profitability and even stronger financial health. Jumping into our financial progress, in July, we announced measures to realize a $5.5 million in cost reduction for 2024. But through tight expense management, we are already seeing the impact of this measure. We're happy to report that we recorded adjusted EBITDA of $2.2 million in the third quarter. Not only was this critical milestone achieved far before the end of the fiscal year, which was promised in January, but it also marks a significant improvement quarter over quarter. These results put the company in a positive adjusted EBITDA range of 10% of revenues, and we are confident this figure can be improved in the coming quarters. This is the result of a significant reduction in R&D and operational expenses. And now with the completion of a number of key projects, such as studies required for our FDA submissions, significant expenses are behind us. This profitability gives us the agility to seek favorable terms across our strategic endeavors, even accelerating our top line. To elaborate further, our U.S. commercial capabilities are primed to scale up for bolt-on accretive products and new partnerships. Our fixed costs are also optimized and we anticipate ongoing future leverage as we increase the intrinsic value of our technologies. Additionally, we can confidently move forward with the 2024 launch plans of our approved commercial products. Let's take a closer look at our HIV business. For fiscal year 2023, we are tightening our guidance, expecting to finish the year with revenues of $82 million to $85 million. Our top line has recovered, and we report third quarter revenues of $21 million up from a very difficult second quarter that was impacted by buildup of inventory, as previously discussed. In the third quarter, new prescription growth continued on a strong path. and we expect results to follow in Q4 of this year and into next year. Just yesterday, we announced another commercial milestone, having filed the SDLA applications for the new generation of EGRF-Dice-V, the FA formulation with the FDA. In accordance with the agency's filing review period, Ferrate Technologies expects to receive an acknowledgement letter within 30 days, along with the PDUFA goal date. As discussed in the previous quarter, The new formulation has several improvements over prior generations, including frequency of reconstitution, and will immediately replace the current F4 formulation once launched. The F8 formulation is patent protected until 2033 in the U.S. and will support revenue growth in 2024 and beyond. And this is coming at the right time. In our interactions with HIV healthcare providers, we are seeing an increased interest in identifying and treating patients with excess visceral fat. The same momentum holds true for innovations with trigarzo. Following completion of the intramuscular study, we are analyzing the data and are on track for a Q4 filing of an S-BLA seeking approval for trigarzo-IM. In the meantime, we are awaiting FDA approval for IV push administration of the Tregarzo loading dose, a decision which is expected in mid-December. We believe the introduction of the simplified first dose of Tregarzo by IV push, followed by the eventual option for IM administration, will help minimize the daily pill burden for multidrug-resistant patients and serve as a gateway for new trigorzo scripts in combination with other injectable therapies. Wrapping up with oncology and where clinical trial progress is on track, you saw from the press release issued on August 30th that all five of the US-based pseudocytac cell Xenusortide Phase I clinical trial sites have been activated to simultaneously screen, enroll, and dose advanced ovarian cancer patients. A six-site base in Canada is finalizing its startup activity. Full details about the study design, participation criteria, and contact information for the sites can be found on clinicaltrials.gov. I am pleased to share that we already have a number of patients consented and actively being screened, and we look forward to announcing the first patient dose shortly. Additionally, investment in our oncology program remains stage-gated, with funding for the dosing of the 16 Phase I trial patients firmly embedded in our 23 and 24 budgets. Partnering discussions continue for the additional phases of development of Pseudocetaxel's endosortide. Looking ahead, we expect a first interim analysis for preliminary safety and efficacy data from the study by mid-year 2024. Finally, our NASH asset is still in play, and we remain open to research partnerships as the environment for metabolic therapies is opening up. With this, I'd like to turn the call over to Philippe, who will be going over the period's financials in detail. Philippe?
spk02: Thank you, Paul. Good morning, everyone. Consolidated revenue for the three-month period ended August 31, 2023, was $20.9 million. compared to $20.8 million for the same year-ago period. While revenues were flat year-over-year, this performance reflects a nice recovery from the $17.5 million in Q2, which was affected by a number of factors discussed in our Q2 call. For the third quarter of fiscal 2023, net sales of Ingrifta SV reached $13.2 million compared to $12.9 million in Q3 of last year. Higher net sales of Egrifta SV were a result of a higher selling price, but were somewhat hampered by higher rebates to government payers. Throw-in sales of Egrifta SV for the first nine months of the year stands at 2.1%, mostly the result of the negative inventory situation during our second quarter and higher rebates. Tragarso net sales in the third quarter of fiscal 2023 amounted to $7.7 million, compared to $7.9 million for the same quarter of 2022, representing a decrease of 3.3% year over year. Lower sales of Targarzo were a result of our decision to stop commercializing the product in the European territory, where we recorded sales of 517,000 in the third quarter of 2022, as well as slightly lower unit sales in North America, which were offset by our higher selling price. In Q2, cost of goods sold decreased to $5 million from $5.3 million in the same quarter in fiscal 2022. The decrease in cost of goods sold was mainly due to the higher proportion of EGRIFTA SV sales, which carries a higher gross margin than Travarso. I'm happy to report that through rigorous management of spending, R&D, selling, and G&A expense were all lower this year when compared to the third quarter of 2022, helping us achieve our stated objective of becoming adjusted EBITDA positive before year end. R&D expenses decreased by 36% in the third quarter of 2023, compared to the same period last year, mostly due to the lower spending on our oncology program, lower spending in Europe, as well as lower spending following the near completion of our life cycle management projects for both IGRIFTA SV and for Garzo. Selling expenses decreased to $6.7 million for the third quarter of 2023 compared to $8.4 million for the same three-month period last year, or a decrease of $1.7 million. The decrease in selling expenses in the third quarter is mainly related to higher expenses incurred in the same period of 2022 related to the setting up of our internal field force in the United States, as well as severance costs incurred following our decision in 2022 to exit the European market for Garza. Selling expenses should continue to stabilize as our focus on top and bottom line growth remains our main objective for the foreseeable future, and hence we will not be compromising on customer-facing activities. G&A expenses in the third quarter amounted to $3.7 million as compared to $4.2 million for the third quarter of 2022, or a 12% decrease. The decrease in G&A expenses is largely due to our decision to terminate the commercialization activities of Travarso in Europe last year, and G&A expenses are also stable compared to Q2 of this year. As you can see from our reduction in R&D, selling, and G&A expenses, we have right-sized the organization to ensure that we are well on our way in our journey towards becoming adjusted EBITDA positive. As a result of this, we are pleased to report adjusted EBITDA for the third quarter of 2023 of $2.2 million versus negative $3.9 million in the same period last year and negative $6.1 million in the second quarter This significant improvement is due to the number of measures put in place during the year to control spending, as well as lower R&D spending, reflecting the completion of many lifecycle management projects. Net finance costs in the third quarter included interest of $2.2 million, consisting of interest on the convertible senior notes issued in June 2018 of $128,000, and interest of $2.1 million on the loan facility. These were offset by a non-cash gain on the re-evaluation of the warrants issued to Marathon at the beginning of this year. We ended the third quarter of fiscal 2023 with $22.9 million in cash, bonds, and money market funds. During the quarter, we received net proceeds of $19.7 million from the second tranche of the Marathon loan facility, and we redeemed the remaining $27.5 million of convertible debentures, and as of today, no convertible debentures remain outstanding. As Paul briefly described, we agreed to modify certain covenants in the credit agreement. The main change will be that we will no longer be required to hold $30 million in cash equivalents should the F-8 formulation of the GRIFTA not be approved by the end of March 2024. As announced, we have filed the SBLA with the FDA yesterday, and this change in covenant reflects Marathon's full confidence in the timely approval of the formulation by the FDA. With that, Paul will be back for final comments, but first, we will now open the call to take your questions.
spk05: Thank you. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then 2. At this time, we will pause momentarily to assemble our roster.
spk06: Our first question comes from Justin Walsh with Jones Trading.
spk05: Please go ahead.
spk07: Hi. Thanks for taking the questions. Can you provide additional color on feedback you've received from patients and physicians on the potential of a grifta MDV versus a grifta SV? Do you have like a sense of how you anticipate the new formulation driving sales momentum, assuming that it's approved?
spk12: Thank you, Justin, for the question. I'll turn to John, who has hands-on research on this. But obviously, you know, if you take a look at the way this F4 formulation that we have on the market has to be reconstituted, we believe that the once a week reconstitution and a very small volume of injection can be beneficial for creating a better patient experience. So, John, what do we have from a research point of view?
spk09: Yeah, Justin, I think what we mainly expect is an increase in duration of therapy. We don't think it's going to be a major change in a reason to prescribe, but it's certainly much more convenient for the patients. It only has to be reconstituted once a week. It doesn't need to be refrigerated. And I think that's going to be a big help from patients. And that's what we've heard back from feedback from them already.
spk07: Got it. Thanks. One more question for me, if I can. I believe you mentioned that it was budgeted in for this year and next, but I was wondering if you could comment on expectations for R&D spend as enrollment begins to pick up for the phase one Pseudocetaxels and Desortide trial.
spk12: Well, as we previously said, Justin, our spending in oncology is firmly embedded. So it's about $5 or $6 million over the late of 23 and then into 24. But the pressure for reducing expenses will come simply because many of our ongoing programs in clinical development are just completed. So I stress the IM formulation. We're doing the final analysis at the moment. We will continue to have significant medical affairs supporting the business, but we expect that the R&D line as it is today in our P&L will continue to go down simply because some major programs are going away.
spk11: Christian, do you want to further comment? No, that's mainly it, Justin. The IM, the analysis is ongoing. There won't be any activity next year. For the F8, we have some activity this year that will no longer be required next year. That's mainly the reduction at this stage.
spk12: So, Justin, we can name the IM formulation, the F8 formulation that is behind us now, the bacteriostatic water that we had to manufacture earlier At one point, the human factor study for the F8, that was cumbersome and expensive. So there's a slew of activities that will be reduced now, but certainly not to the point that it will compromise our ability to generate new prescriptions. The way that I see the commercial model is, you know, having a very engaged sales team, but also the surround noise all around it with medical affairs and marketing activities so that we can pull the patient in. And this is what we have created. We've got great capabilities in marketing, sales, and medical, and we think that this is going to make the difference again next year as we want to grow the business.
spk10: Great. Thanks for taking the questions. Thank you.
spk05: Our next question comes from Andre Uden with Research Capital. Please go ahead.
spk00: Thank you. Good morning, Paul, Philip, Christian, and John. It's nice to see that your adjusted EBITDA is now positive. If you're assuming FDA approval of the F8 formulation, if we assume that that does occur, would revenue growth primarily be driven by the F8 formulation in 2024?
spk12: Well, I mean, I'll repeat a little bit what I said, and I'll turn to John to see if he has anything else to say. But capturing patients with EF4 is what we're asking our customer-facing people to do. And, in fact, we're growing the number of NRX well over 20% compared to last year's. we are already in a good position. The F8 will certainly facilitate that, but become, I believe, you know, a better formulation for the patient experience, thus having an impact mainly on duration of therapy. John, do you want to further comment?
spk09: I mean, it'll certainly help and be a bit of a driver next year. The full year impact next year will not be as much. It won't be a full year of the launch, but we definitely expect it to be a driver. But as Paul said earlier, We're continuing to see enthusiasm on the front end of enrollments, increased interest in treating excess abdominal fat. And so enrollments are very high. We're encouraged by that. And we think that's probably going to be the biggest driver moving forward.
spk00: Okay, thanks for clarifying that. And just in terms of trigarzo intramuscular formulation, do you happen to know what the volume is that's injected and also – how often do you have to inject that formulation?
spk12: Thank you, André. Christian, do you want to take that on?
spk11: Yeah, André, the drug product is exactly the same. The patient will need to inject twice 2.3 ml. This is at the moment what's mixed in the IV push, if you want, for the injection every two weeks. And this is Every two weeks, there will be two injections of about 2 ml for the patient. You have to understand that this is something which is a water-based monoclonal antibody, then it's very well-treated by the patient. We had some studies during the conduct of this study, and it's very well-perceived and very well-accepted by the patients. And we think that that will also have an impact.
spk12: And we believe it will be administered in pharmacies, which is not the case now for the IV port.
spk11: Well, it could be in pharmacies. It will be much easier in terms of access for patients to get their injection.
spk00: Okay. That's great. Thank you.
spk05: Our next question comes from Andrea Leno with National Bank. Please go ahead.
spk03: Hi, good morning. Thanks for taking my questions and congrats on that positive EBITDA. The first question I wanted to ask is that if you can talk a little bit about the mixture or the combination or the interaction rather of volume and price for the sales of both products into fiscal Q3.
spk10: Yes, thank you, Henry.
spk02: So as I mentioned, both volumes were pretty flat, but we did take some price increases. We gave larger remates because of the patient mix. So all in all, for both products, stable unit numbers and a little bit of price increases. And also for Travarso, remember that we had some sales in Europe last year, which we didn't have this year.
spk03: Thanks, Philip. And just a quick follow-up on that. I mean, was there a pullback in volumes over the summer? I mean, because I think on the last update, I think volumes were growing 27% for a grifta and 8% or 9% for a trocarza or something along those lines.
spk09: Yeah, so what we're seeing is, as I said, it's correct that on the front end, we're seeing increased interest in treatment. We're seeing a lot of new patients coming in, double-digit growth of new enrollments. But we did see early in the year a little bit of a churn in the patient base and refills. And that's since corrected and has been on an upswing since Q2 and now is above where it was. So we are seeing overall growth of the total patient base above where it was last year. But it's not as much as we would expect with the increase in enrollment due to this period early in the year where we had this churn of the patient base.
spk03: Okay, thanks for that, John. And yet, one more question. This is more a little bit looking into Q4, because the implied Q4 revenue, I mean, seems pretty strong sequentially in year over year. I'm assuming that is mostly volume from the interest you're seeing, or do you have any price increase embedded on that one? I mean, in addition to what you've already done.
spk09: Yeah, that'll mainly be volume. We don't have any price increase planned in Q4.
spk12: And traditionally, this is the pattern that we've seen before. Q4 has always been very strong. And obviously, we're counting on this. And following the issue that we had in the second quarter regarding inventory buildup, we are extremely, extremely, you know, focused on inventory at hands at the pharmacy level. So we control what's happening there. And we have all the reasons to believe that the Q4 is going to unfold the way that we've seen it in previous years and that we should actually complete 2023 within the guidance that I've just given today. So we're confident based on the way we're capturing new patients and the way that they were converted into getting the scripts and getting on the medicines that we will get there. And it's going to pave the way for a good 2024 because You know, don't forget that our performance this year, you know, has been set back significantly by the second quarter and the inventory situation that we've described. So if you take that away, our run rate now is significantly over $82 million.
spk03: That's great to hear. Thanks, Paul. And one last one for me. You mentioned in the opening remarks, Paul, of still continuing to look to expand the commercial portfolio. Can you talk a little bit about the quality, the type of assets that you're seeing out there, any multiples, and any color you can share on that regard?
spk12: Yes. We've said before that it could be in HIV. We have, obviously, capabilities, and we're calling on roughly 2,800 HIV providers in the U.S., and they treat the bulk of the HIV patients. We also said that it could be an HIV-adjacent type of business, so something that is not necessarily a specific HIV therapy, but a therapy that HIV patients are using. And looking at the capabilities that we've built in the field and in my management team and in training and all other aspects of our go-to-market model, we could take on small metabolic. Small metabolic is very similar to a rare disease type. And in fact, the business that we have is very much like rare disease because we're calling on very few people healthcare providers, but at the same time, we've got products that are using niche, and they are reimbursed at a high price because they provide high value. So this is very much like a rare disease. So there are some rare disease products that could actually very much fit our model, where we could have to actually build another sales team. But providing that the product is you know, deprioritized by a big pharma or already on the market, it would drive already some accretive, you know, sales and bottom line. And therefore, we would not hesitate for the right agent to build another field force because we do have the infrastructure in sales, marketing, medical, and the back office to take on bolt-on initiatives. And that is why we're so happy now that we were able to renegotiate some of the covenants with Marathon We've got a clean deck moving forward, and we think that we could, providing that we put our hands on the right asset, accelerate our journey towards profitability by looking for bolt-on acquisition type. Have I answered your question?
spk03: Yes, mostly. Just one quick follow-up. Have you seen any changes, let's say over the last year, in terms of the multiple or IRRs or however it is that you value this bolt-on assets?
spk02: Do you want to comment? No, and actually the products we're going after aren't really in auctions or we kind of dig through Big Pharma, their portfolio, and we reach out. So we're not really in competition with anyone else.
spk10: Okay, understood. Okay, thank you.
spk05: Again, if you'd like to ask a question, please press star then one. Our next question comes from Bill Mine with Canaccord. Please go ahead.
spk01: Hi, this is Kathleen on for Bill. Thank you for taking our question. On the oncology phase one trial with the update coming now in mid-2024, what can we expect in terms of patients' numbers there? Another way of asking the question, do you expect the data at that point to address the toxin in the prior study? And how much is that gating partnership interest? Thank you so much.
spk12: So, Christiane, you may want to talk about the expectation I can't address partnerships.
spk11: Yeah, absolutely. As Paul mentioned before, the five sites in the U.S. are recruiting patients at the moment. There are a number of patients in screening that we're expecting to complete the first quarter of patients. What we have in the protocol, there's a court of six patients the first dose, which is 1.75 mg per kg every week for three weeks and a week break. After those Six patients will be initiated on treatment. We wait three months to look at the adverse event profile, and we'll restart after that based on a good safety profile. Six other patients at 2.5 milligram per kilogram every week. And with those 12 patients, I think that we will have a very good sign if there are signs of efficacy by mid-next year. After the six patients at the higher dose, the FDA also wanted us to include another four patients for a total of 10 patients in this cohort, 2.5 mg. Then total, it will be 16 patients. But as we go, based on the data that we have seen so far, based on the disease stabilization that we have seen in a number of patients, we think that we will have clear signs of efficacy by mid-left ear.
spk12: So from a partnership point of view, I said before, and it's still true, We have many companies at the table very interested by our TH1902, but also the platform or the technology we have. However, at this stage of the game, we're only months away from having additional clinical efficacy in humans to report. And a lot of companies will want to actually wait until they see the back-to-back efficacy data that we think we're going to have. Keep in mind that we've already released a lot of information at AACR, but also at ASCO that shows that we actually had clinical benefits in many patients. But now that we have a tighter protocol, we believe that in ovarian cancer, we're going to strike more often and be able to move on to the next phases of development. But what I can say in addition to that is that our platform is being noticed and we see a great deal of interest. for partnership activities at the labs, because people actually see what our receptor does. And by conjugating some technologies to our peptide, they would have access to the cancer cells in a more efficient manner, just like our Th1902 is getting into the cancer cells more effectively. So there's lots developing on oncology. And that's why I think that You know, while we're focusing on turning the organization profitable and first a bit positive, we don't want to abandon this great card that we have in oncology. We just want to stage gate the spending, which is exactly what we're doing at the moment. And we believe that the next phases of development, whether at the labs or whether in the clinic, will come through partnerships. And as I said, we have many oncology companies that have seen what we have reported and And I feel very optimistic for the future.
spk05: This concludes our question and answer session. I would like to turn the conference back over to Paul Levesque for any closing remarks.
spk02: There's a few questions that came in on the webcast. So most of them are related to the 1902 trial and relating to the timing. Are we seeing... You know, patients coming in soon, what's the, you know, has there been more delays than what we expected? And what's our thoughts on enrollment? Christian, do you want to clarify?
spk11: Yeah, this is more or less what we were expecting. But as we had announced, one of the changes, like some of the changes of the protocol were really the selection of patients. Then what we're doing in that study is that we're selecting patients that have less taxane prior exposure. It will be a maximum of one failure on taxane and a lower number of prior treatments. Therefore, the selection of patients is a bit more difficult than what we had in the past, but we do believe that this is the best way to move forward in order to show efficacy with this trial.
spk12: Yes, and do not forget that all the patients can be recruited at the same time. It's not one patient at a time. The the sites are now activated, we could have patients enrolling dosed at the same time. So once the ball gets rolling, it could accelerate very nicely. Absolutely.
spk02: Last question on the status of discussions with our auditors regarding the going concern opinion in view of the marathon changes. Well, it's a little bit early to have discussions, but obviously we had some... They are... aware of the changes, and it was viewed very favorably with auditors and the audit committee yesterday. So we'll see come November what the status will be. And that's it for questions, Paul.
spk12: Thank you, everyone, for attending the call today. As discussed, we have made great progress towards achieving all of our goals for the year. Today's Q3 results demonstrate that we have turned a corner for Q4 and beyond. And there will be no turning back. With the submission of the F8 formulation to the FDA, achieving adjusted EBITDA profitability ahead of schedule, our significant reduction in operating expenses, and the increasing confidence entrusted to us by Marathon, we are enabling long-term value creation for the investors who are with us on this road to growth and ongoing profitability. Ferro Technologies is determined to maintain this upward trajectory. Thank you again and see you soon on the Q4 call and at the upcoming commercial, medical, and investor meetings.
spk10: Have a great day.
spk06: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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