NASDAQ:THTX Theratechnologies Q3 2023 Earnings Report $2.52 -0.05 (-1.95%) Closing price 04/17/2025 04:00 PM EasternExtended Trading$2.52 0.00 (0.00%) As of 04/17/2025 06:21 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Theratechnologies EPS ResultsActual EPS-$0.03Consensus EPS -$0.49Beat/MissBeat by +$0.46One Year Ago EPS-$0.32Theratechnologies Revenue ResultsActual Revenue$20.86 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/ATheratechnologies Announcement DetailsQuarterQ3 2023Date9/26/2023TimeBefore Market OpensConference Call DateTuesday, September 26, 2023Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptReportEarnings HistoryCompany ProfilePowered by Theratechnologies Q3 2023 Earnings Call TranscriptProvided by QuartrSeptember 26, 2023 ShareLink copied to clipboard.There are 10 speakers on the call. Operator00:00:00Good day, and welcome to the Thera Technologies Q3 2023 Earnings Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to John Malloy. Operator00:00:34Please go ahead. Speaker 100:00:37Thank you, operator, and good morning, everyone. On the call today will be Theratechnologies' President and Chief Executive Officer, Mr. Paul Levesque and Senior Vice President and Chief Financial Officer, Mr. Philip Dubuc. During the Q and A session, we'll be joined by Doctor. Speaker 100:00:52Christian Marsalis, 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 Theratechnologies 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. Speaker 100:01:26The company refers current and potential investors to the forward looking information section of Theratechnologies Management Discussion and Analysis issued this morning and available on SEDAR, www.sedarplus. Ca and on EDGAR at www.sec.gov. Forward looking statements represent Theratechnologies' 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. Speaker 100:02:01Generally 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. Theratechnologies believes that this measure can be a useful indicator of its operational performance and financial condition from one period to another. Speaker 100:02:21The 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 and A issued this morning available on SEDAR and on EDGAR at the web addresses mentioned earlier. Investors can also follow the company on LinkedIn and Twitter and sign up for alerts on Theratechnologies' investor website at theratechn.com. With that, I would now like to turn the conference over to Theratechnologies' President and CEO, Paul Levesque. Speaker 200:02:54Thank you, John. Hello, everyone, and good morning. I'm pleased to report that we have made 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. Speaker 200:03:40With 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 key 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. Speaker 200:04:31We also strongly believe that our pipeline progress cannot and should not be underestimated. We are executing on the promise of And we are now extending future revenue generation of the commercial business through line extensions of our HIV products, in particular with the FDA submission of the EGRIFTA M8 formulation, which we announced yesterday. Speaker 300:04:52We Speaker 200:04:52are also committed to cannibalizing on the development of our lead anti cancer agent, Pseudocetaxel and dusortide. As you know, we are working hard to meet Phase 1 clinical trial milestone timelines and report results as quickly as possible in 2024. I would also like to mention a call that 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 $30,000,000 should the FA not be approved before March 31, 2024 changing the revenue covenant to an adjusted EBITDA base covenant and Changing the liquidity requirements down to $15,000,000 over time as our adjusted EBITDA increases. Speaker 200:05:54These 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 Theratechnologies greater flexibility in our quest to deliver better profitability and even stronger financial health. Jumping into our financial progress. In July, we announced We're happy to report that we recorded adjusted EBITDA of $2,200,000 in the 3rd quarter. Not only was this critical milestone achieved far before the end of the fiscal year, which was promised in January, It also marks a significant improvement quarter over quarter. Speaker 200:06:48These 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 and 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 Our time 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. Speaker 200:07:42Additionally, 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 $82,000,000 to 85,000,000 Our top line has recovered and we report 3rd quarter revenues of 21,000,000 up from a very difficult second quarter that was impacted by buildup of inventory as previously discussed. In the Q3, 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 milestones having filed the SPLA applications for the new generation of EGRIFTA SV, the NFATE formulation with the FDA. Speaker 200:08:38In accordance with the agency's filing review period, Theratechnologies expects to receive an acknowledgment letter within 30 days along with 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 FA formulation is patent protected until 2,033 in the U. S. And will support revenue growth in 2024 and beyond. And this is coming at the right time. Speaker 200:09:15In 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 Trogarzo. Following completion of the intramuscular study, we are analyzing the data and are on track for a Q4 filing of Enes BLA seeking approval for Trogarzo I'm In the meantime, we are awaiting the approval for IV push administration of the Trogarzo loading dose, a decision which is expected in mid December. We believe the introduction of the simplified first dose Wrapping up with oncology, our clinical trial progress is on track. You saw from the press release issued on August 30th That all 5 of the U. Speaker 200:10:26S.-based pseudocetaxel zendusortide Phase 1 clinical trial sites have been activated To simultaneously screen, enroll and dose advanced ovarian cancer patients, a 6 site base in Canada is finalizing its start up 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 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 1 trial patients firmly embedded Looking ahead, we expect a 1st interim analysis or preliminary safety and efficacy data from the study by mid year 2020 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 Speaker 300:11:53Thank you, Paul, and good morning, everyone. Consolidated revenue for the 3 month period ended August 31, 2023 was $20,900,000 compared to $20,800,000 for the same year ago period. While revenues were flat year over year, This performance reflects a nice recovery from the $17,500,000 in Q2, which was affected by a number of factors discussed and our Q2 call. For the Q3 of fiscal 2023, net sales of EGRIFTA SV reached $13,200,000 compared to $12,900,000 in Q3 of last year. Higher net sales of EGRIFTA SV were a result of a higher selling price We're somewhat hampered by higher rebates to government payers. Speaker 300:12:42Growth in sales of EGRIFTA ASV for the 1st 9 months of the year Stands at 2.1%, mostly the result of the negative inventory situation during our Q2 and higher rebates. Trogarzo net sales in the Q3 of fiscal 2023 amounted to $7,700,000 compared to $7,900,000 for the same quarter of 2022, representing a decrease of 3.3% year over year. Lower sales of Trogarzo were a result of our decision to stop commercializing the product in the European territory, where we recorded sales of $517,000 in the Q3 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 $5,000,000 from 5 was mainly due to the higher proportion of EGRIFTA SV sales, which carries a higher gross margin than Trogarzo. I'm happy to report that through rigorous management of spending, R and D, selling and G and A expense were all lower this year when compared to the Q3 of 2022, helping us achieve our stated objective of becoming Adjusted EBITDA positive before year end. Speaker 300:14:13R and D expenses decreased by 36% In the Q3 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 lifecycle management projects for both EGRIFTA SV and Trogarzo. Selling expenses decreased to $6,700,000 for the Q3 of 2023 compared to $8,400,000 for the same 3 month period last year or a decrease of $1,700,000 The decrease in selling expenses in the Q3 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 Trogarzo. 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 and A expenses in the 3rd quarter amounted to $3,700,000 as compared $4,200,000 for the Q3 of 2022 or a 12% decrease. The decrease in G and A expenses is largely due to our decision to terminate the commercialization activities of Trogarzo in Europe last year and G and A expenses are also stable compared to Q2 of this year. Speaker 300:15:54As you can see from our reduction in R and D, selling and G and A 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 Q3 of 2023 of $2,200,000 versus negative $3,900,000 in the same period last year and negative $6,100,000 in the Q2 of this year. This significant improvement is due to the number of measures put in place during the year to control spending as well as lower R and D spending, reflecting The completion of many lifecycle management projects. Net finance costs in the 3rd quarter included Interest of $2,200,000 consisting of interest on the convertible senior notes issued in June 2018 of $128,000 and interest of $2,100,000 on the loan facility. These were offset by a non cash gain on the reevaluation of the warrants issued to Marathon at the beginning of this year. Speaker 300:17:05We ended the Q3 of fiscal 2023 with $22,900,000 in cash, bonds and money market funds. During the quarter, we received net proceeds of $19,700,000 From the second tranche of the Marathon loan facility and we redeemed the remaining $27,500,000 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 remains. The main change will be that we will no longer be required $30,000,000 in cash equivalents should the F8 formulation of EGRIFTA not be approved by the end of March 2024. Speaker 300:17:51As 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 FDA. With that, Paul will be back for final comments. But first, We will now open the call to take your questions. Operator00:18:13Thank you. We will now begin the question and answer session. Our first question comes from Justin Walsh with Jones Trading. Please go ahead. Speaker 400:18:54Hi, thanks for taking the questions. Can you provide additional color on feedback you've received from patients and physicians on the potential of EGRIFTA MDV versus EGRIFTA SV. Do you have like a sense of how you anticipate the new formulation driving sales momentum assuming that it's approved? Speaker 200:19:15Thank you, Justin for the question. I'll turn to John, who has hands on research on this. But Obviously, if you take a look at the way this F4 formulation that we have on the market has 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 Speaker 300:19:42a research point of view? Speaker 500:19:43Yes, 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 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 It's going to be a big help from patients and that's what we've heard back from feedback from them already. Speaker 400:20:05Got it. Thanks. One more question for me if I can. I believe you mentioned that it was budgeted in for this year next, but I was wondering if you could comment on expectations for R and D spend as enrollment begins to pick up The Phase 1 sudocetaxel and the sortide trial. Speaker 200:20:24Well, as we previously said, Justin, our Spending in oncology is firmly embedded. So it's about $5,000,000 or $6,000,000 over late of 23 and then into 2024, 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 I'm 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 and D line as it is Today, our P and L will continue to go down simply because some major programs are going away. Christian, do you want to further comment? Speaker 600:21:13No, that's mainly it, Justin. The I'm is 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, then that's mainly the reduction at this stage. Speaker 200:21:29So Justin, we can name the I'm formulation, the F8 formulation that is behind us now, the bacteriostatic water that we had to manufacture 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 having a very engaged sales team, but also the surround noise all around it with medical affairs and marketing activity 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. Speaker 200:22:14And we think that this is going to make the difference again next year as we want to grow the business. Speaker 400:22:21Great. Thanks for taking the questions. Speaker 300:22:24Thank you. Operator00:22:27Our next question comes from Andre Uddin with Research Capital, please go ahead. Speaker 700:22:33Thank you. Good morning, Paul, Philip, Christian and John. It's nice to see that your adjusted EBITDA is now positive. If you're assuming the 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? Speaker 200:23:00Well, I mean, I'll repeat a little bit what I said, but and I'll turn to John to see if he has anything else To say, but capturing patients with the F4 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. So We are already in a good position. The F8 will certainly facilitate that, but become I believe A better formulation for the patient experience thus having an impact mainly on duration of therapy. John, do you want to further comment? Speaker 500:23:38Yes. 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, we're continuing to see enthusiasm on the front end of enrollments, Increased interest in treating excess abdominal fat. Speaker 500:24:00And so enrollments are very high. We're encouraged by that. And we think that's probably going to be the biggest driver moving forward. Speaker 700:24:09Okay. Thanks for clarifying that. And just in terms of Trogarzo Intramuscular formulation, do you happen to know what the volume is that to inject it? And also, How often do you have to inject that formulation? Speaker 200:24:27Thank you, Andre. Christian, do you want to take that on? Speaker 600:24:30Yes. Adi, the drug product is exactly the same that the patient will need to inject twice 2.3 ml, this is at the moment what's mix for the in the IV push if you want for the injection every 2 weeks and this is every 2 weeks there will be 2 injections about 2 ml for the patient. You have to understand that this is something which is Water based monoclonal antibody then it's very well tolerated by the patient. We had some studies during The conduct of this study and it's very well perceived and well accepted by the patients. Speaker 300:25:13And we think that that will also have an impact. Speaker 200:25:16And we believe it will be administered in pharmacies, which is not the case now for the IV port. Speaker 300:25:23Well, it Could be Speaker 600:25:24in pharmacies, certainly like it will be much easier in terms of access for patient to get their injection. Speaker 700:25:31Okay, that's great. Thank you. Operator00:25:37Our next question comes from Andrea Leno with National Bank. Please go ahead. Speaker 800:25:43Hi, 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 Little bit about the mixture or the combination or the interaction rather of volume and price for the sales of both products into fiscal Speaker 300:26:06Yes. Thank you, Endri. So as I mentioned, both Volumes were pretty flat, but we did take some price increases. We gave larger rebates because of the patient mix. So all in all, for both products, stable unit numbers and a little bit of price Increases. Speaker 300:26:29And also for Trogarzo, remember that we had some sales in Europe last year, which we didn't have this year. Speaker 800:26:38Thanks, 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 20 Speaker 500:26:54Yes. So what we're seeing is, as I said, it's correct that the on the front end, we're seeing increased interest in treatment. Seeing a lot of new patients coming in, double digit growth of new enrollments. But we did see early in the year Speaker 300:27:08a little bit of a churn in Speaker 500:27:09the patient base and refills. And that 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 With the enrollment increased enrollment due to this period early in the year, where we had this churn of Speaker 300:27:34the patient base. Speaker 800:27:37Okay. Thanks for that, John. And yet one more question. Just this is more a little bit looking into Q4 because the implied Q4 revenue, I mean, seems pretty strong Sequentially and 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 Speaker 500:27:58Yes, that will mainly be volume. We don't have any price increase planned in Q4. Speaker 200:28:02Yes. 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 Q2 regarding inventory buildup, we are extremely, extremely Focused on inventory at hand at the pharmacy level, so we control what's happening 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. Speaker 200:28:45So we're confident based on the way we're capturing new patients and the way that they were converted into getting scripts and getting on the medicines that we will get there. And it's going to pave the way for a good 2024 because don't forget that our performance this year has been set back Significantly by the Q2 and the inventory situation that we've described. So if you take that away, our run rate now It's significantly over $82,000,000 Speaker 800:29:18That's great to hear. Thanks, Paul. And one last one for me. You mentioned in the opening remarks, Paul, you're 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? Speaker 200:29:38Yes. So we 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. Speaker 200:29:53We also said that it could be an HIV adjacent type of business. So something that is not necessarily a specific HIV therapies, What 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 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. Speaker 200:30:46So 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 deprioritized by Pharma or already on the market, it would drive already some accretive sales and bottom line. And therefore, we would not hesitate for the 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 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? Speaker 800:31:49Yes, mostly. Just one quick follow-up is that in terms have you seen any changes, let's Over the last year in terms of the multiple or IRRs or however it is that you value this bolt on assets? Speaker 200:32:05David, do you want to comment? Speaker 300:32:07No. And actually the products we're going after aren't really In auctions or we kind of dig through big pharma, their portfolio when we reach out. So We're not really in competition with anyone else. Speaker 800:32:25Okay. Okay, understood. Okay, thank you. Operator00:32:34Our next question comes from Bill Miehm with Canaccord. Please go ahead. Speaker 900:32:41Hi. This is Kathleen on for Bill. Thank you for taking our question. On the oncology Phase 1 trial with the update coming now in mid-twenty 24. What can we expect in terms of patients' numbers there? Speaker 900:32:55Another way of asking the question, do you expect the data at that point to address the tox seen in the prior study? And how much is that gating partnership interest? Thank you so much. Speaker 200:33:08So Christian, you may want to talk about the expectation. I can address partnership. Speaker 600:33:12Yes, absolutely. The 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 1st quarter patients. Speaker 600:33:24What we have in the protocol, There's a cohort of 6 patients. The first dose, which is 1.75 megagram Per kg every week for 3 weeks and a week break. After those 6 Patient will be initiated on treatment. We wait 3 months to look at the adverse event profile and we'll restart after that based on a good safety profile. 6 other patients at 2.5 milligram per kilogram every week. Speaker 600:33:56And with those 12 patients, I think that we will have a In total, it will be 16 patients. But as we go, based on the data that we have seen so far, based on Speaker 200:34:32So 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 TH-nineteen oh two, but also the platform or the technology we have. However, at this stage of the game, we're only months away from having No 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 And be able to move on to the next phases of development. But what I can say in addition to that is that our The 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 TH-nineteen oh two is getting into the cancer cells more effectively. Speaker 200:35:50So there's lots developing on oncology and that's why I think that while we're focusing on turning the organization profitable and First EBITDA positive, we don't want to abandon this credit 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 I feel very optimistic for the future. Operator00:36:35This concludes our question and answer session. I would like to turn the conference back over to Paul Leveque for any closing remarks. Speaker 300:36:45There'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 Patients coming in soon, what's the has there been more delays than what we expected? And what's our thoughts on enrollment? Speaker 200:37:07Christian, do you want to clarify? Speaker 600:37:09Yes. This is more or less what we were expecting. But as we had announced, one of the change like some of the changes of the protocol were really the selection of base. Then what we're doing in that study is that we're selecting patient that have less taxane prior exposure. It will be a maximum of 1 failure on taxane and a lower number of prior treatments. Speaker 600:37:33Therefore, the selection of patient 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. Speaker 200:37:44Yes. And do not forget that all the patients can be recruited at the same time. It's not one patient at a time. 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. Speaker 300:38:05Absolutely. 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 Speaker 600:38:33what the status would be. Speaker 300:38:35And that's it for questions, Paul. Speaker 200:38:38Thank 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 FDA formulations 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. Theratechnologies is determined to maintain this upward trajectory. Speaker 200:39:22Thank you again and see you soonRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallTheratechnologies Q3 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsReport Theratechnologies Earnings HeadlinesFY2026 Earnings Estimate for THTX Issued By Leede FinancialApril 17 at 3:51 AM | americanbankingnews.comLeede Financial Issues Pessimistic Outlook for THTX EarningsApril 17 at 2:21 AM | americanbankingnews.comThe Trump Dump is starting; Get out of stocks now?The first 365 days of the Trump presidency… Will be the best time to get rich in American history.April 18, 2025 | Paradigm Press (Ad)Theratechnologies to further evaluate potential sale of the companyApril 16 at 3:47 AM | markets.businessinsider.comTheratechnologies Provides Update on Sale ProcessApril 15 at 6:18 PM | financialpost.comTheratechnologies Provides Update on Sale ProcessApril 15 at 6:00 PM | globenewswire.comSee More Theratechnologies Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Theratechnologies? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Theratechnologies and other key companies, straight to your email. Email Address About TheratechnologiesTheratechnologies (NASDAQ:THTX), a biopharmaceutical company, focuses on the development and commercialization of various therapies to address the unmet medical needs in the United States, Canada, and Europe. The company offers EGRIFTA SV for the reduction of excess abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy; and Trogarzo for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen. Its pipeline products include F8 Formulation that is in Phase 2b/3 clinical trials for studying tesamorelin for the treatment of nonalcoholic steatohepatitis; multi -dose pen injector for the administration of tesamorelin; SORT1+ Technology Platform for the development of proprietary peptides for cancer drug development targeting SORT1 receptors; Sudocetaxel Zendusortide, which is in Phase 1 Clinical Trial for various solid tumor types, including HR+ breast, triple negative breast, ovarian, endometrial, melanoma, thyroid, small cell lung, and prostate cancers. The company was incorporated in 1993 and is headquartered in Montreal, Canada.View Theratechnologies ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Archer Aviation Unveils NYC Network Ahead of Key Earnings Report3 Reasons to Like the Look of Amazon Ahead of EarningsTesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? 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There are 10 speakers on the call. Operator00:00:00Good day, and welcome to the Thera Technologies Q3 2023 Earnings Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to John Malloy. Operator00:00:34Please go ahead. Speaker 100:00:37Thank you, operator, and good morning, everyone. On the call today will be Theratechnologies' President and Chief Executive Officer, Mr. Paul Levesque and Senior Vice President and Chief Financial Officer, Mr. Philip Dubuc. During the Q and A session, we'll be joined by Doctor. Speaker 100:00:52Christian Marsalis, 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 Theratechnologies 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. Speaker 100:01:26The company refers current and potential investors to the forward looking information section of Theratechnologies Management Discussion and Analysis issued this morning and available on SEDAR, www.sedarplus. Ca and on EDGAR at www.sec.gov. Forward looking statements represent Theratechnologies' 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. Speaker 100:02:01Generally 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. Theratechnologies believes that this measure can be a useful indicator of its operational performance and financial condition from one period to another. Speaker 100:02:21The 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 and A issued this morning available on SEDAR and on EDGAR at the web addresses mentioned earlier. Investors can also follow the company on LinkedIn and Twitter and sign up for alerts on Theratechnologies' investor website at theratechn.com. With that, I would now like to turn the conference over to Theratechnologies' President and CEO, Paul Levesque. Speaker 200:02:54Thank you, John. Hello, everyone, and good morning. I'm pleased to report that we have made 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. Speaker 200:03:40With 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 key 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. Speaker 200:04:31We also strongly believe that our pipeline progress cannot and should not be underestimated. We are executing on the promise of And we are now extending future revenue generation of the commercial business through line extensions of our HIV products, in particular with the FDA submission of the EGRIFTA M8 formulation, which we announced yesterday. Speaker 300:04:52We Speaker 200:04:52are also committed to cannibalizing on the development of our lead anti cancer agent, Pseudocetaxel and dusortide. As you know, we are working hard to meet Phase 1 clinical trial milestone timelines and report results as quickly as possible in 2024. I would also like to mention a call that 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 $30,000,000 should the FA not be approved before March 31, 2024 changing the revenue covenant to an adjusted EBITDA base covenant and Changing the liquidity requirements down to $15,000,000 over time as our adjusted EBITDA increases. Speaker 200:05:54These 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 Theratechnologies greater flexibility in our quest to deliver better profitability and even stronger financial health. Jumping into our financial progress. In July, we announced We're happy to report that we recorded adjusted EBITDA of $2,200,000 in the 3rd quarter. Not only was this critical milestone achieved far before the end of the fiscal year, which was promised in January, It also marks a significant improvement quarter over quarter. Speaker 200:06:48These 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 and 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 Our time 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. Speaker 200:07:42Additionally, 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 $82,000,000 to 85,000,000 Our top line has recovered and we report 3rd quarter revenues of 21,000,000 up from a very difficult second quarter that was impacted by buildup of inventory as previously discussed. In the Q3, 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 milestones having filed the SPLA applications for the new generation of EGRIFTA SV, the NFATE formulation with the FDA. Speaker 200:08:38In accordance with the agency's filing review period, Theratechnologies expects to receive an acknowledgment letter within 30 days along with 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 FA formulation is patent protected until 2,033 in the U. S. And will support revenue growth in 2024 and beyond. And this is coming at the right time. Speaker 200:09:15In 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 Trogarzo. Following completion of the intramuscular study, we are analyzing the data and are on track for a Q4 filing of Enes BLA seeking approval for Trogarzo I'm In the meantime, we are awaiting the approval for IV push administration of the Trogarzo loading dose, a decision which is expected in mid December. We believe the introduction of the simplified first dose Wrapping up with oncology, our clinical trial progress is on track. You saw from the press release issued on August 30th That all 5 of the U. Speaker 200:10:26S.-based pseudocetaxel zendusortide Phase 1 clinical trial sites have been activated To simultaneously screen, enroll and dose advanced ovarian cancer patients, a 6 site base in Canada is finalizing its start up 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 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 1 trial patients firmly embedded Looking ahead, we expect a 1st interim analysis or preliminary safety and efficacy data from the study by mid year 2020 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 Speaker 300:11:53Thank you, Paul, and good morning, everyone. Consolidated revenue for the 3 month period ended August 31, 2023 was $20,900,000 compared to $20,800,000 for the same year ago period. While revenues were flat year over year, This performance reflects a nice recovery from the $17,500,000 in Q2, which was affected by a number of factors discussed and our Q2 call. For the Q3 of fiscal 2023, net sales of EGRIFTA SV reached $13,200,000 compared to $12,900,000 in Q3 of last year. Higher net sales of EGRIFTA SV were a result of a higher selling price We're somewhat hampered by higher rebates to government payers. Speaker 300:12:42Growth in sales of EGRIFTA ASV for the 1st 9 months of the year Stands at 2.1%, mostly the result of the negative inventory situation during our Q2 and higher rebates. Trogarzo net sales in the Q3 of fiscal 2023 amounted to $7,700,000 compared to $7,900,000 for the same quarter of 2022, representing a decrease of 3.3% year over year. Lower sales of Trogarzo were a result of our decision to stop commercializing the product in the European territory, where we recorded sales of $517,000 in the Q3 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 $5,000,000 from 5 was mainly due to the higher proportion of EGRIFTA SV sales, which carries a higher gross margin than Trogarzo. I'm happy to report that through rigorous management of spending, R and D, selling and G and A expense were all lower this year when compared to the Q3 of 2022, helping us achieve our stated objective of becoming Adjusted EBITDA positive before year end. Speaker 300:14:13R and D expenses decreased by 36% In the Q3 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 lifecycle management projects for both EGRIFTA SV and Trogarzo. Selling expenses decreased to $6,700,000 for the Q3 of 2023 compared to $8,400,000 for the same 3 month period last year or a decrease of $1,700,000 The decrease in selling expenses in the Q3 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 Trogarzo. 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 and A expenses in the 3rd quarter amounted to $3,700,000 as compared $4,200,000 for the Q3 of 2022 or a 12% decrease. The decrease in G and A expenses is largely due to our decision to terminate the commercialization activities of Trogarzo in Europe last year and G and A expenses are also stable compared to Q2 of this year. Speaker 300:15:54As you can see from our reduction in R and D, selling and G and A 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 Q3 of 2023 of $2,200,000 versus negative $3,900,000 in the same period last year and negative $6,100,000 in the Q2 of this year. This significant improvement is due to the number of measures put in place during the year to control spending as well as lower R and D spending, reflecting The completion of many lifecycle management projects. Net finance costs in the 3rd quarter included Interest of $2,200,000 consisting of interest on the convertible senior notes issued in June 2018 of $128,000 and interest of $2,100,000 on the loan facility. These were offset by a non cash gain on the reevaluation of the warrants issued to Marathon at the beginning of this year. Speaker 300:17:05We ended the Q3 of fiscal 2023 with $22,900,000 in cash, bonds and money market funds. During the quarter, we received net proceeds of $19,700,000 From the second tranche of the Marathon loan facility and we redeemed the remaining $27,500,000 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 remains. The main change will be that we will no longer be required $30,000,000 in cash equivalents should the F8 formulation of EGRIFTA not be approved by the end of March 2024. Speaker 300:17:51As 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 FDA. With that, Paul will be back for final comments. But first, We will now open the call to take your questions. Operator00:18:13Thank you. We will now begin the question and answer session. Our first question comes from Justin Walsh with Jones Trading. Please go ahead. Speaker 400:18:54Hi, thanks for taking the questions. Can you provide additional color on feedback you've received from patients and physicians on the potential of EGRIFTA MDV versus EGRIFTA SV. Do you have like a sense of how you anticipate the new formulation driving sales momentum assuming that it's approved? Speaker 200:19:15Thank you, Justin for the question. I'll turn to John, who has hands on research on this. But Obviously, if you take a look at the way this F4 formulation that we have on the market has 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 Speaker 300:19:42a research point of view? Speaker 500:19:43Yes, 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 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 It's going to be a big help from patients and that's what we've heard back from feedback from them already. Speaker 400:20:05Got it. Thanks. One more question for me if I can. I believe you mentioned that it was budgeted in for this year next, but I was wondering if you could comment on expectations for R and D spend as enrollment begins to pick up The Phase 1 sudocetaxel and the sortide trial. Speaker 200:20:24Well, as we previously said, Justin, our Spending in oncology is firmly embedded. So it's about $5,000,000 or $6,000,000 over late of 23 and then into 2024, 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 I'm 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 and D line as it is Today, our P and L will continue to go down simply because some major programs are going away. Christian, do you want to further comment? Speaker 600:21:13No, that's mainly it, Justin. The I'm is 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, then that's mainly the reduction at this stage. Speaker 200:21:29So Justin, we can name the I'm formulation, the F8 formulation that is behind us now, the bacteriostatic water that we had to manufacture 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 having a very engaged sales team, but also the surround noise all around it with medical affairs and marketing activity 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. Speaker 200:22:14And we think that this is going to make the difference again next year as we want to grow the business. Speaker 400:22:21Great. Thanks for taking the questions. Speaker 300:22:24Thank you. Operator00:22:27Our next question comes from Andre Uddin with Research Capital, please go ahead. Speaker 700:22:33Thank you. Good morning, Paul, Philip, Christian and John. It's nice to see that your adjusted EBITDA is now positive. If you're assuming the 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? Speaker 200:23:00Well, I mean, I'll repeat a little bit what I said, but and I'll turn to John to see if he has anything else To say, but capturing patients with the F4 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. So We are already in a good position. The F8 will certainly facilitate that, but become I believe A better formulation for the patient experience thus having an impact mainly on duration of therapy. John, do you want to further comment? Speaker 500:23:38Yes. 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, we're continuing to see enthusiasm on the front end of enrollments, Increased interest in treating excess abdominal fat. Speaker 500:24:00And so enrollments are very high. We're encouraged by that. And we think that's probably going to be the biggest driver moving forward. Speaker 700:24:09Okay. Thanks for clarifying that. And just in terms of Trogarzo Intramuscular formulation, do you happen to know what the volume is that to inject it? And also, How often do you have to inject that formulation? Speaker 200:24:27Thank you, Andre. Christian, do you want to take that on? Speaker 600:24:30Yes. Adi, the drug product is exactly the same that the patient will need to inject twice 2.3 ml, this is at the moment what's mix for the in the IV push if you want for the injection every 2 weeks and this is every 2 weeks there will be 2 injections about 2 ml for the patient. You have to understand that this is something which is Water based monoclonal antibody then it's very well tolerated by the patient. We had some studies during The conduct of this study and it's very well perceived and well accepted by the patients. Speaker 300:25:13And we think that that will also have an impact. Speaker 200:25:16And we believe it will be administered in pharmacies, which is not the case now for the IV port. Speaker 300:25:23Well, it Could be Speaker 600:25:24in pharmacies, certainly like it will be much easier in terms of access for patient to get their injection. Speaker 700:25:31Okay, that's great. Thank you. Operator00:25:37Our next question comes from Andrea Leno with National Bank. Please go ahead. Speaker 800:25:43Hi, 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 Little bit about the mixture or the combination or the interaction rather of volume and price for the sales of both products into fiscal Speaker 300:26:06Yes. Thank you, Endri. So as I mentioned, both Volumes were pretty flat, but we did take some price increases. We gave larger rebates because of the patient mix. So all in all, for both products, stable unit numbers and a little bit of price Increases. Speaker 300:26:29And also for Trogarzo, remember that we had some sales in Europe last year, which we didn't have this year. Speaker 800:26:38Thanks, 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 20 Speaker 500:26:54Yes. So what we're seeing is, as I said, it's correct that the on the front end, we're seeing increased interest in treatment. Seeing a lot of new patients coming in, double digit growth of new enrollments. But we did see early in the year Speaker 300:27:08a little bit of a churn in Speaker 500:27:09the patient base and refills. And that 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 With the enrollment increased enrollment due to this period early in the year, where we had this churn of Speaker 300:27:34the patient base. Speaker 800:27:37Okay. Thanks for that, John. And yet one more question. Just this is more a little bit looking into Q4 because the implied Q4 revenue, I mean, seems pretty strong Sequentially and 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 Speaker 500:27:58Yes, that will mainly be volume. We don't have any price increase planned in Q4. Speaker 200:28:02Yes. 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 Q2 regarding inventory buildup, we are extremely, extremely Focused on inventory at hand at the pharmacy level, so we control what's happening 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. Speaker 200:28:45So we're confident based on the way we're capturing new patients and the way that they were converted into getting scripts and getting on the medicines that we will get there. And it's going to pave the way for a good 2024 because don't forget that our performance this year has been set back Significantly by the Q2 and the inventory situation that we've described. So if you take that away, our run rate now It's significantly over $82,000,000 Speaker 800:29:18That's great to hear. Thanks, Paul. And one last one for me. You mentioned in the opening remarks, Paul, you're 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? Speaker 200:29:38Yes. So we 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. Speaker 200:29:53We also said that it could be an HIV adjacent type of business. So something that is not necessarily a specific HIV therapies, What 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 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. Speaker 200:30:46So 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 deprioritized by Pharma or already on the market, it would drive already some accretive sales and bottom line. And therefore, we would not hesitate for the 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 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? Speaker 800:31:49Yes, mostly. Just one quick follow-up is that in terms have you seen any changes, let's Over the last year in terms of the multiple or IRRs or however it is that you value this bolt on assets? Speaker 200:32:05David, do you want to comment? Speaker 300:32:07No. And actually the products we're going after aren't really In auctions or we kind of dig through big pharma, their portfolio when we reach out. So We're not really in competition with anyone else. Speaker 800:32:25Okay. Okay, understood. Okay, thank you. Operator00:32:34Our next question comes from Bill Miehm with Canaccord. Please go ahead. Speaker 900:32:41Hi. This is Kathleen on for Bill. Thank you for taking our question. On the oncology Phase 1 trial with the update coming now in mid-twenty 24. What can we expect in terms of patients' numbers there? Speaker 900:32:55Another way of asking the question, do you expect the data at that point to address the tox seen in the prior study? And how much is that gating partnership interest? Thank you so much. Speaker 200:33:08So Christian, you may want to talk about the expectation. I can address partnership. Speaker 600:33:12Yes, absolutely. The 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 1st quarter patients. Speaker 600:33:24What we have in the protocol, There's a cohort of 6 patients. The first dose, which is 1.75 megagram Per kg every week for 3 weeks and a week break. After those 6 Patient will be initiated on treatment. We wait 3 months to look at the adverse event profile and we'll restart after that based on a good safety profile. 6 other patients at 2.5 milligram per kilogram every week. Speaker 600:33:56And with those 12 patients, I think that we will have a In total, it will be 16 patients. But as we go, based on the data that we have seen so far, based on Speaker 200:34:32So 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 TH-nineteen oh two, but also the platform or the technology we have. However, at this stage of the game, we're only months away from having No 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 And be able to move on to the next phases of development. But what I can say in addition to that is that our The 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 TH-nineteen oh two is getting into the cancer cells more effectively. Speaker 200:35:50So there's lots developing on oncology and that's why I think that while we're focusing on turning the organization profitable and First EBITDA positive, we don't want to abandon this credit 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 I feel very optimistic for the future. Operator00:36:35This concludes our question and answer session. I would like to turn the conference back over to Paul Leveque for any closing remarks. Speaker 300:36:45There'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 Patients coming in soon, what's the has there been more delays than what we expected? And what's our thoughts on enrollment? Speaker 200:37:07Christian, do you want to clarify? Speaker 600:37:09Yes. This is more or less what we were expecting. But as we had announced, one of the change like some of the changes of the protocol were really the selection of base. Then what we're doing in that study is that we're selecting patient that have less taxane prior exposure. It will be a maximum of 1 failure on taxane and a lower number of prior treatments. Speaker 600:37:33Therefore, the selection of patient 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. Speaker 200:37:44Yes. And do not forget that all the patients can be recruited at the same time. It's not one patient at a time. 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. Speaker 300:38:05Absolutely. 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 Speaker 600:38:33what the status would be. Speaker 300:38:35And that's it for questions, Paul. Speaker 200:38:38Thank 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 FDA formulations 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. Theratechnologies is determined to maintain this upward trajectory. Speaker 200:39:22Thank you again and see you soonRead morePowered by