Theratechnologies Inc

TSX:TH

Earnings Call Analysis

Earnings Call Transcript 2023-Q3

[Operator]

Good day, and welcome to the Theratechnologies Q3 2023 Earnings Conference Call. [Operator Instructions] This event is being recorded.

I would now like to turn the conference over to John Mullaly. Please go ahead.

[John Mullaly]

Thank you, operator, and good morning, everyone. On the call today will be Theratechnologies's President and Chief Executive Officer; Mr. Paul Lévesque; and Senior Vice President and Chief Financial Officer, Mr. Philippe Dubuc. During the Q&A session will be joined by Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer; and Mr. John Leasure, 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.

The 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.sedar.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. 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 result of day-to-day operations.

Theratechnologies believes that this measure can be a useful indicator of its operational performance and financial condition from one 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 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 theratec.com.

With that, I would now like to turn the conference over to Theratechnologies President and CEO, Paul Lévesque.

[Paul Lévesque, executive]

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 life cycle 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 sites 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. 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 EGRIFTA and F8 formulation which we announced yesterday.

We are also committed to cannibalizing on the development of our lead anticancer agent, Sudocetaxel Zendusortide. As you know, we are working hard to meet Phase I clinical trial milestone timelines and report results as quickly as possible in 2024.

I would also like to mention a call 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 DFA 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 Theratechnologies greater flexibility in our quest to deliver better profitability and even stronger financial accounts.

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 for 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 submission, 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 prime 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 Theratechnologies. 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 affected 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 milestones having filed the sBLA applications for the new generation of EGRIFTA SV, the F8 formulation with the FDA. In accordance with the agency's filing review period, Theratechnologies expects to receive an acknowledgment 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 launch.

The F8 formulation is patent protected until 2033 in the U.S. and will support revenue growth in '24 and beyond. And this is coming at the right time. In our interactions with HIV health care providers, we are seeing an increased interest in identifying and treating patients with excess visceral fat. The same momentum holds true for innovation with Trogarzo. Following completion of the intramuscular study, we are analyzing the data and are on track for a Q4 filing of an sBLA seeking approval for Trogarzo IM.

In the meantime, we are awaiting the FDA approval for IV push instauration of the Trogarzo loading dose, a decision, which is expected in mid-December. We believe the introduction of the simplified first dose of Trogarzo by IV push followed by the eventual option for IM administration will help minimize the daily field burden for multidrug resistant patients and serve as a gateway for [ nutrogarzal 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 30, that all 5 of the U.S.-based Sudocetaxel Zendusortide Phase I 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 consented in actively being screened, and we look forward to announcing the first-patient dose shortly. Additionally, investments 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 Sudocetaxel Zendusortide. Looking ahead, we expect a first interim analysis or preliminary safety and efficacy data from the study by midyear 2024. Finally, our NASH asset is still in play, and we remain open to research partnerships as the environment for metabolic therapies it's 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?

[Philippe Dubuc, executive]

Thank you, Paul, and good morning, everyone. Consolidated revenue for the 3-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 EGRIFTA 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 that were somewhat hampered by higher rebates to government payers. [ Growing ] sales of EGRIFTA SV for the first 9 months of the year stands at 2.1%, mostly the result of the negative inventory situation during our second quarter and higher rebates. Trogarzo 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 and 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 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 Trogarzo. 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 EGRIFTA SV and Trogarzo.

Selling expenses decreased to $6.7 million for the third quarter of 2023 compared to $8.4 million for the same 3-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 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&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 Trogarzo 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 rightsized 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 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&D spending, reflecting the completion of many life cycle 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 noncash gain on the reevaluation 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 remains. The main change will mean that we will no longer be required to hold $30 million in cash and equivalents should the F8 formulation of EGRIFTA 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.

[Operator]

[Operator Instructions] Our first question comes from Justin Walsh with JonesTrading.

[Justin Walsh, analyst]

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?

[Paul Lévesque, executive]

Thank you, Justin, for the question. I'll turn it 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 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.

[John Leasure, executive]

Yes. Justin, I think what we mainly expect is the increase in duration of therapy. We don't think it's going to be a major change and 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.

[Justin Walsh, analyst]

Got it. 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 I Sudocetaxel Zendusortide trial?

[Paul Lévesque, executive]

Well, as we previously said, Justin, our spending in oncology is firmly embedded. So it's about $5 million or $6 million over 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. Christian, do you want to further comment?

[Christian Marsolais, executive]

No, that's mainly it, Justin. The IM is -- the analysis is ongoing. There won't be any activity next year. For the F8, we had some activity this year that will no longer be required next year, then that's mainly reduction at this stage.

[Paul Lévesque, executive]

So Justin, we can name the IM 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. And we think that this is going to make the difference again next year as we want to grow the business.

[Operator]

Our next question comes from Andre Uddin with Research Capital.

[Andre Uddin, analyst]

It's nice to see that your adjusted EBITDA is now positive. If we're assuming the FDA approval of the F8 formulation, if we see that, that does occur, would revenue growth primarily be driven by the F8 formulation in 2024?

[Paul Lévesque, executive]

Well, I mean, I'll repeat a little bit what I said, but -- and I'll turn it to John to see if he has anything else to say, but capturing patients with the F4 is when 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?

[John Leasure, executive]

Yes. I mean it will certainly help and be a bit of a driver next year. The full year impact next year will not be as much as 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. 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.

[Andre Uddin, analyst]

Okay. And just in terms of Trogarzo 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?

[Paul Lévesque, executive]

Thank you, Andre. Christian, do you want to take that one?

[Christian Marsolais, executive]

Yes. Andre, 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 of about 2 ml for the patient. .

You have to understand that this is something which is a water-based on a clonal antibody, then it's very well tolerated by the patient. We had some two studies during the conduct of this study. and it's very well perceived and well accepted by the patients. And we think that, that will also have an impact.

[Paul Lévesque, executive]

And we believe it will be administered in pharmacies, which is not the case now for the IV push.

[Christian Marsolais, executive]

Well, it will -- it could be in pharmacies, certain like -- and it will be much easier in terms of access for patients to get their injection.

[Operator]

Our next question comes from Endri Leno with National Bank.

[Endri Leno, analyst]

Congrats on the positive EBITDA. The first question I wanted to ask is that if you can talk a little bit about the mixture of the combination or the interaction rather, of volume and price for the sales of both products into fiscal Q3.

[Philippe Dubuc, executive]

Yes. 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. And also for Trogarzo, remember that we had some sales in Europe last year, which we didn't have this year.

[Endri Leno, analyst]

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 EGRIFTA and 8% or 9% for Trogarzo or something along those lines.

[John Leasure, executive]

Yes. So what we're seeing is, as I said, is correct that the -- 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 in 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 enrollment -- increase in enrollment due to this period early in the year where we had this churn of the patient base.

[Endri Leno, analyst]

Okay. And yes, 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 already done.

[John Leasure, executive]

Yes, that will mainly be volume. We don't have any pricing increase planned in Q4.

[Paul Lévesque, executive]

Yes. 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 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 we've seen it in the 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 are 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 don't forget that our performance this year 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.

[Endri Leno, analyst]

That's great to hear. 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 and your multiples? And any color you can share on that regard.

[Paul Lévesque, executive]

Yes. 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. We also said that it could be an HIV adjacent type of business. So something that is not necessarily a specific HIV therapies 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 health care 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 deprioritized by big pharma or already on the market, it would drive already some accretive 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?

[Endri Leno, analyst]

Yes, mostly. Just one quick follow-up. Is that, in terms -- 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.

[Paul Lévesque, executive]

Philippe, do you want to comment?

[Philippe Dubuc, executive]

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.

[Operator]

[Operator Instructions] Our next question comes from Will Maughan with Canaccord.

[Unknown Analyst]

This is [ Kathleen ] on for Will. On the oncology Phase I trial with the update coming now in mid-2024, what can we expect in terms of patient numbers there? Another way of asking the question, do you expect the data at that point to address the taxane in the prior study? And how much is that gating partnership interest.

[Paul Lévesque, executive]

So Christian, you may want to talk about the expectation, and I can address a partnership.

[Christian Marsolais, executive]

Yes, absolutely. The -- as Paul mentioned before, the 5 sites in the U.S. are recruiting patients at the moment. There are a number of patients in screening, then we're expecting to complete the first quarter of patients. What we have in the protocol, there is a court of 6 patients, the first dose, which is 1.75 milligram per kg every week for 3 weeks and a week break. After those 6 patients 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.

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 6 patients at the higher dose, the FDA also wanted us to include another 4 patients for a total of 10 patients in this cohort 2.5 milligram. 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 middle of the year.

[Paul Lévesque, executive]

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 ACR, 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 contributing 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 while we're focusing on turning the organization profitable and first EBITDA positive, we don't want to abandon the screen 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.

[Operator]

This concludes our question-and-answer session. I would like to turn the conference back over to Paul Lévesque for any closing remarks.

[Philippe Dubuc, executive]

Well, 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 patients coming in soon. What's the -- has there been more delays than what we expected? And what's our thoughts on enrollment.

[Paul Lévesque, executive]

Christian, do you want to clarify?

[Christian Marsolais, executive]

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 basin. 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.

[Paul Lévesque, executive]

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 sites are now activated we could have patients enroll in dosed at the same time. So once the ball gets rolling, it could accelerate very nicely.

[Philippe Dubuc, executive]

Absolutely, yes. And 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's the status will be. And that's it for questions, Paul.

[Paul Lévesque, executive]

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. Theratechnologies 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. Have a great day.

[Operator]

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.