Q3 2024 Theratechnologies Inc Earnings Call
Unknown Executive: Good morning, ladies and gentlemen, and thank you for standing by.
Good morning, ladies and gentlemen, and thank you for standing by.
Unknown Executive: Welcome to Theratechnology Third Quarter 2024 earnings call. We would like to remind everyone that all figures on this call are quoted in US dollars. At this time, all participants aren't in a listen-only mode.
Welcome to <unk> technologies third quarter 2024 earnings call.
We would like to remind everyone that all figures on this call are quoted in U S dollars.
At this time all participants are in a listen only mode.
Unknown Executive: Following the presentation, we will conduct a question-and-answer session with analysts. Instructions will be provided at the time for you to queue up for questions. Following the analyst Q&A session, investors wishing to submit a question may do so by clicking the "Ask a Question" link on the webcast platform. If anyone has any difficulties hearing the conference, please press the star key followed by zero for operator assistance at any time.
Following the presentation, we will conduct a question and answer session with analysts.
Instructions will be provided at that time for you to queue up for questions.
Following the analyst Q&A session investors wishing to submit a question may do so by clicking the ask a question link on the webcast platform.
Speaker Change: If anyone has any difficulties hearing the conference. Please press star followed by zero for operator assistance at any time.
Unknown Executive: I would like to remind everyone that this conference call is being recorded today, Thursday, October 10, 2024, at 8:30 AM Eastern Time.
I would like to remind everyone that this conference call is being recorded today Thursday October 10th 2024 at 830, a M eastern time.
Julie Schneiderman: I will now turn the call over to Julia Schneiderman, Senior Director of Communications and Corporate Affairs at Barrett Technology. Julie, please go ahead.
Speaker Change: I will now turn the call over to Julian Schneiderman Senior director of Communications and corporate affairs at their technology.
Speaker Change: Julie Please go ahead.
Julie Schneiderman: Thank you, operator, and good morning, everyone. On the call today, we'll be terror technologies president and chief executive officer, Mr. Paula Beck, and senior vice president and chief financial officer, Mr. Philippe Dubuc. During the Q&A session, they will be joined by Dr. Christian Masale, Senior Vice President and Chief Medical Officer, and John Leisure, the company's Global Commercial Officer.
Thank you operator, and good morning, everyone on the call today will be Terry technologies, President and Chief Executive Officer, Mr. Paolo <unk>, and senior Vice President and Chief Financial Officer, Mr. Felipe.
Speaker Change: During the Q&A session. They will be joined by Dr. Christian <unk> Senior Vice President and Chief Medical Officer, and 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.
Julie Schneiderman: 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 terror technologies may differ materially from those statements. As such, the company cannot guarantee that any forward-looking statement 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 their technologies, management, discussion, and analysis issue this morning and available on CedarPlus at CedarPlus.ca and on EDGAR at www.cc.gov.
Speaker Change: Her plans expectations and intentions with respect to future events forward looking statements are based on assumptions and there are risks that results obtained by <unk> technologies may differ materially from those statements as such the company cannot guarantee that any forward looking statement will materialize.
Speaker Change: And you are cautioned not to place undue reliance on them.
Speaker Change: <unk> refers current and potential investors to the forward looking information section are bearing technologies management's discussion and analysis issued this morning and available on SEDAR at SEDAR Plas dossier and on Edgar at Www Dot S E drive got.
Julie Schneiderman: Forward-looking statements represent their technologies, expectations as of this morning of October 10, 2024.
Speaker Change: Forward looking statements represent their technologies expectations as of this morning October 10th 2024.
Julie Schneiderman: Additionally, today, the company is using the term adjusted EBITDA, which is not a financial measure under International Financial Reporting Standards, or U.S. generally accepted accounting principles. Adjusted EBITDA excludes the effects of items that primarily reflect the impact of long-term investment and financing decisions rather than the results of day-to-day operations. Their technologies believe that this measure can be a useful indicator of its operational performance and financial conditions from one period to another. The company uses this non-IFRS measure to make financial, strategic, and operating decisions. Reconciliation of adjusted EBITDA to net loss is found in our MD&A issued this morning, available on CedarPlus and on EDGAR at the web address mentioned earlier.
Speaker Change: Additionally, today the company is using the term adjusted EBITDA, which is not a financial measure under international financial reporting standards or U S. Generally accepted accounting principles adjusted EBITDA excludes the effects of the items that primarily reflect the impact of long term investment and financing decision.
<unk> rather than the result of day to day operations. There are technologies believes that this measure can be a useful indicator of its operational performance and financial condition from one period to another the company uses this non I F. R. S measure to make financial strategic and operating decisions.
Speaker Change: Filiation of adjusted EBITDA to net loss is found in our MD&A issued this morning available on SEDAR Plas and on Edgar at the web address as mentioned earlier.
Julie Schneiderman: Investors can also follow the company on LinkedIn and X, formally Twitter, and sign up for alerts on their technologies investor website at theiratech.com.
Speaker Change: Baxter's can also follow the company on Linkedin, and ex formerly Twitter and sign up for alerts on Tara technologies Investor website at Aerotech Dot com with that I would now like to turn the conference over to our President and CEO Paula back.
Paul Lvesque: With that, I would now like to turn the conference over to our President and CEO's polivex. Thank you, Judy. Hello, everyone. Good morning. I'm pleased to be reporting on Theratechnologies, financial results, for the 3rd quarter, ended August 31, 2020, 4th.
Paula Back: Thank you Judy Hello, everyone and good morning.
Paula Back: Pleased to be reporting on <unk> Technologies' financial results for the third quarter ended August 31, 'twenty 'twenty four.
Paul Lvesque: As I explained during our 2nd quarter call, we have embarked on a new chapter at Theratechnologies, focused on commercializing innovative treatments. This strategic pivot, coupled with a cluster structure that is hit for purpose, has enabled the company to achieve profitability and deliver in our commitment to show all there is to be adjusted in the positive quarter after quarter. In fact, in a short period of time, the turnaround is nothing short of spectacular. As you have seen today, our third quarter did not disappoint, and we have continued to demonstrate strength on the bottom line with an adjusted EBITDA figure of $7.2 million, and a net profit of $3 million.
Paula Back: As I explained during our second quarter call, we have embarked on a new chapter at their technologies focused on commercializing innovative treatments.
Paula Back: This strategic pivot coupled with a cost structure that is fit for purpose has enabled the company to achieve profitability and deliver on our commitment to shareholders to be adjusted EBITDA positive quarter after quarter.
Paula Back: In fact in a short period of time, the turnaround is nothing short of spectacular.
Paula Back: As you have seen today or third quarter did not disappoint and we have continued to demonstrate strength on the bottom line with adjusted EBITDA figure of $7.2 million and a net profit of $3 million.
Paul Lvesque: Red and use for the quarter are also trending positively, up 8% from the same period last year, and driven by our engine of growth, a grip that is V. Aromas, unique patients, and unit souls of the grip that is V reached double digit growth year-to-date compared to the same period last year. In fact, in the last 6 months of the grip that is V has recorded, the drug has recorded its best performance in recent history, capturing patients and new prescribers at the non-presidents rate. By highlighting grip, the SV's unique value proposition, we have been able to differentiate the therapy from weight loss drugs, or the focus is on BMI.
Paula Back: Revenues for the quarter are also trending positively up 8% from the same period last year and driven by our engine of growth at Griffith Davy.
Paula Back: Enrollments unique patients in units sold so the grip stage V reached double digit growth year to date compared to the same period last year.
In the last six months or it drifts days V has recorded the drug has recorded its best performance in recent history, capturing patients and new prescribers at the non percent incident rate.
Paula Back: By highlighting <unk> unique value proposition, we have been able to differentiate the therapy from weight loss drugs or the focus is on BMI, a grifter ASB reduces visceral abdominal fat.
Paul Lvesque: In grip, the SV reduces visual abdominal fat, which, if left untreated, can lead to serious medical conditions, and is easily identifiable by measurement of waist of circumstances. Tragarzo remains one of the few options for the management of HIV-multidrug resistance, while it has been facing strong competition over the past year. New prescriptions and repeals of Tragarzo have stabilized, and we do not expect further declines next year.
Paula Back: If left untreated can lead to serious medical conditions and is easily identifiable by measurement of waist circumference.
Paula Back: With regards to what remains one of the few options for the management of HIV multi drug resistance, while it has been facing strong competition over the past year, new prescriptions and refills of <unk> have stabilized.
Paula Back: We do not expect further declines next year.
Paul Lvesque: Now, as previously announced in September, our CDM will be responsible for the manufacturing of a grip that is being implemented and an unexpected voluntary shutdown following an FDA inspection in order to implement corrective measures to their plant. As a result, the production of two batches of the grip days V was cancelled, thus creating pressure on current inventory. It is important to note that the corrective measures have nothing to do with the manufacturing process of our medicine, but rather with the environment in which the product is manufactured. I want to be clear that this situation will have no impact at the patient leveling 2020-4.
Paula Back: Now as previously announced in September our C. D M more responsible for the manufacturing of our Big Rooster is implemented and none expected voluntary shut down following an FDA inspection in order to implement corrective measures to their plant.
Paula Back: As a result the <unk>.
Paula Back: Production of two batches of the grip days be where cancel thus creating pressure on current inventory it.
It is important to note that the corrective measures have nothing to do with the manufacturing process of our medicine, but rather with the environment in which the product is manufactured.
Paula Back: I want to be clear that this situation will have no impact at the patient level in 'twenty 'twenty. Four however, we believe it will have an impact on ex factory sales in the fourth quarter and in turn total revenue for full year 2024.
Paul Lvesque: However, we believe it will have an impact on extractory sales in the fourth quarter, and in turn, total revenue for full year 2020-4. Given this, and considering current transfer to Varsal, we are changing the top line revenue guidance to be between $83.85 million. This change does not reflect the man for a grip day V, which in recent history has never been sold strong across all metrics. The new guidance reflects a constrained supply situation.
Paula Back: Given this and considering current trends with regards though we are changing a topline revenue guidance to be between 80 $385 million. This change does not reflect demand for retrofit grift days V, which in recent history has never been so strong across all metrics new patients don't unit.
Paula Back: Patients in units sold the new guidance reflects a constrained supply situation.
Despite the circumstances affecting our top line, we're happy to firm up guidance for adjusted EBITDA, increasing it to 17.
Paula Back: $19 million from $13 million to $15 million. This is a result of adapting our cost structure to our new strategic direction of refocusing efforts on commercial activities.
Paula Back: With a cash position of close to $39 million in such a robust trajectory for adjusted EBITDA. We are in a strong position to take things to the next level.
Paula Back: Looking to 2025 I want to share the latest information we have on the supply of a grip stays weak.
Paula Back: Our C D M O S. Reconfirm it will resume activities mid October and a manufacturing slots for Arista as we scheduled for the week of October 20th first.
There are technologies will file a prior authorization supplement or P. Yes, with the review Division.
Paula Back: The P. S will include the remediation plan implemented by our C. D. M O one and we expect to summit in early November.
Paula Back: Well, we expect to have very limited supply of a grifter. It's V. In the latter part of November in terms of ex factory sales.
Paula Back: There will be still a six week inventory held at the wholesaler and specialty pharmacy level.
Paula Back: This will be enough drug to meet patient demand until mid January.
Paula Back: D M D and up to 120 days to approve the P. A S. N enabled the batch to be released as such we took the precautionary step to modify or to notify rather E. F D. A.
Paula Back: Drug shortage staff of the situation and also advise the market.
We are working closely with all stakeholders and remain confident that any impact on patients in 2025 will be avoided. Moreover, we believe.
In the first part of 'twenty, one if I, we will fully make up for sale was not recorded in the fourth quarter of 2024.
Paula Back: We will continue to update the market as.
Paula Back: Things becomes available.
Paula Back: Turning to DSA formulation of some warranty and I wanted to provide an update on our timelines for a resubmission to the FDA.
Paula Back: Yeah.
Following our type a meeting with the FDA. We believe we have addressed all of the agency's questions, including the ones related to Immunogenicity and microbiology and I am confident these pieces are behind us.
Paula Back: We expect to have the final completed shortly and intend to submit.
Paula Back: By the end of November.
Paula Back: D M D S confirm a four month review.
Paula Back: It is also important to note that our C. D. M O for DSA is not the same as our manufacturer for the S. Four.
Paula Back: Our team believes strongly in the benefits of disarm warning is the only FDA approved treatment of its kind for people with HIV lipodystrophy and we are all hands on deck to bring this new formulation to market and to continue sharing our value proposition and new data.
Paula Back: Next week Threes are technologies poster will be presented at I'd week in Los Angeles I D week is one of the foremost scientific conferences in this field.
Paula Back: One poster presents data linking excess visceral abdominal fat or Ive S. Two increased cardiovascular risk in people with HIV. One a second poster documents how use up to some more linked to reduce excess visceral abdominal fat.
Paula Back: Lower cardiovascular disease risk in people with HIV.
Paula Back: Another posters of.
Paula Back: We will report on the study design and baseline characteristics of the promise you is trialing observational real World study of the believes a mab in heavily treatment experienced patients with multi drug resistance. We've also had the recent publications on your Malaysian a map data in the journal of AIDS.
Paula Back: As people live longer with HIV and with greater exposure to anti retroviral medicines. They may experience higher amounts of excess visceral abdominal fat and risk multi drug resistance. We look forward to sharing our findings with HIV clinicians and researchers into contributing to the scientific.
And treatment discourse on HIV.
Speaker Change: In keeping with our commitment to weddings values through medical activities I would like to provide an update on our ongoing phase one clinical trial of pseudo sit themselves into sort tied our lead investigational P. D C candidate.
Speaker Change: At this time recruitment for both cohorts in advanced ovarian cancer has been completed.
Speaker Change: We've had no reports of dlt's, including neuropathy and I to assist city.
Speaker Change: One patient remains in the trial at the higher dose of two five milligram per kilogram and we plan to share results. Once the last patient has completed treatment and the overall data analysis is finalized.
Our strengthened financial positioning in particular, our bottom line performance and cash position as change many things for us opening the door to new possibilities and collaborations we have doubled down on our efforts to find new products to market.
Speaker Change: And to enter into partnerships.
Speaker Change: And we've made significant progress in our search for new products, both in the U S and in Canada.
Speaker Change: Based on our experience with the Griffith Central Garden as well as the commercial capabilities, we have built.
Speaker Change: We are uniquely positioned to in license and bring to market innovative therapies that challenge the standard of care in rare or niche markets.
Speaker Change: This requires a specialized set of skills and experience managing regulatory and market access requirements and specialized patient support initiatives.
Speaker Change: We are confident that there are technologies has a compelling value proposition to offer.
Speaker Change: Our North American focused strategy is very clear and we're confident we can achieve our long term objective of delivering sustained top and bottom line growth and value for shareholders.
With this I'd like to turn the call over to Filip, who will go over the periods financials in details.
Filip: Philipp Thank you Paul and good morning, everyone.
Filip: I'm pleased to report that we recorded another strong quarter, both on the top and bottom lines with net sales of $22 6 million or eight 4% growth versus the same quarter last year. Furthermore, I want to highlight that the efforts to reorganize the cost structure of the company are continuing to pay.
Filip: With $7 2 million of adjusted EBITDA or close to 30% of revenues and we recorded a net profit of about $3 million for the quarter or <unk> <unk> per share.
Filip: I can now say that we've built a high performing organization that can take on additional challenges as just mentioned by Paul.
Speaker Change: For the third quarter of fiscal 2024, net sales of a grifter SV reached $16 7 million compared to $13 2 million in Q3 of last year, which represents a 27% increase year over year as mentioned previously inventory levels have.
Reverted to normal levels, and we should continue to see that going forward.
For the nine month period ended August 31, two gripped our revenues have grown 16%, which is supported by our key performance indicators, such as new enrollments and total unique patients.
Speaker Change: <unk> net sales in the third quarter amounted to $5 9 million compared to $7 7 million for the same quarter last year.
Speaker Change: The decrease was mainly due to lower unit sales in the quarter as compared to last year, mostly as a result of competitive pressures in the multi drug resistant segment of the HIV one market.
Speaker Change: This impact is stabilizing as sales of <unk> units to pharmacies have grown slightly in Q3 compared to Q2 of this year.
Speaker Change: In the third quarter of 2020 for cost of sales came in at $4 $5 million down from $5 million in the same quarter of last year, a drift of gross margins for a bristow where 91%.
Speaker Change: Which is in line with historical values and <unk> margins were at 48% consistent with the terms of the time that agreement.
Speaker Change: Again in the third quarter of 2020 for the rigorous management of spending in R&D, selling and G&A expense helped us achieve our fifth straight quarter of strong adjusted EBITDA.
Speaker Change: As as established as an objective early in 2023.
Speaker Change: Adjusted EBITDA for the past four quarters was $17 4 million, which is why we increased our guidance this morning to $17 million to $19 million for 2024.
Speaker Change: We expect adjusted EBITDA to be flat to slightly positive in the fourth quarter compared to Q4 of last year, mainly because of the shortfall anticipated to the supply constraints discussed earlier.
Speaker Change: Although this shortfall will affect our revenue revenues in Q4 patients patient supply will not be affected until mid January if at all as there is inventory both at Mckesson, our distributor and specialty pharmacy level.
Speaker Change: R&D expenses again decreased substantially in the third quarter of 2024 compared to the same period last year, mostly due to lower spending on our oncology program as long as well as lower expenses. Following the near completion of our lifecycle management projects for both <unk> and <unk>.
Speaker Change: R&D expenses came in at $2 6 million versus $5 $4 million.
Speaker Change: Last year for a 52% decrease.
Speaker Change: Selling expenses came in at $6 3 million for Q3 compared to $6 7 million for the same period last year.
Speaker Change: Selling expenses have stabilized in the past few quarters and should continue at roughly the same level in the next few quarters as the focus on top in line.
Speaker Change: And bottom line growth remains our main objective.
G&A expenses in the third quarter of 2024 amounted to $3 million as compared to $3 7 million for the third quarter of 2023 or a 19% decrease.
Speaker Change: The decrease in G&A expenses is largely due to our decision to focus on our U S commercial operations.
Speaker Change: And on controlling expenses.
Again these expenses are expected to stabilize going forward as evidenced by the similar level of expenses in Q2 of this year.
Speaker Change: As you can see from our reduction of expenses in R&D and G&A in the past six quarters. We have now right sized the organization to ensure that we're well on our way in our journey towards showing strong growth in adjusted EBITDA.
Speaker Change: As a result of this we are pleased to report adjusted EBITDA in the third quarter of $7 2 million versus $2 2 million in the same period last year, a significant improvement of $5 million a.
Speaker Change: A combination of topline growth and realignment of spending.
Speaker Change: Net finance costs in the third quarter amounted to $2 4 million and include interest of $2 3 million on the marathon loan facility.
Speaker Change: As per the credit agreement, we have initiated the reimbursement of the principal in August 2024, and the loan will be amortized over a 36 month period.
Speaker Change: Our strong operations generate solid cash flow, enabling us to repay the facility and the contracted amounts of $5 million per quarter.
Speaker Change: When considering our first monthly repayment of the credit facility. We ended the third quarter on solid financial footing with cash bonds and money market funds at the end of the quarter amounting to $39 million, an increase of close to $3 million over Q2 of 2024, and we ended the quarter with 58.
Speaker Change: $9 million drawn on the marathon facility for a net debt position of $20 million.
Speaker Change: I'm also happy to report that we recorded a net profit of $3 million or.
Speaker Change: Core <unk> per share in the third quarter of 2024.
Speaker Change: As Paul briefly alluded to in his remarks, we are revising our guidance this morning.
Speaker Change: Revenues of $83 million to $85 million for fiscal 2024, and increasing our guidance for adjusted EBITDA to.
Speaker Change: To between 17 and $19 million, even as we include the spending on our oncology program. This year pointing to the continued strong performance of our commercial operations for the remainder of the year.
Speaker Change: As previously previously mentioned any additional spending on oncology after the completion of the phase one trial will be carried out through partnerships. So this program will no longer affect our adjusted EBITDA in 2025 and beyond.
Speaker Change: With that Paul will be back for final comments, but first we will now open the call to take your questions. We will start by taking questions from analysts operator.
Speaker Change: Yeah.
Speaker Change: We will now begin the question and answer session.
Speaker Change: To ask a question you May Press Star then one on your Touchtone phone.
Speaker Change: If you are using a speakerphone please pick up your handset before pressing the pool.
Speaker Change: If at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.
Speaker Change: At this time, we will pause momentarily to assemble our roster.
Speaker Change: The first question today comes from Jeff Jim Walsh with Jones trading. Please go ahead.
Speaker Change: Alright, Thanks for taking my questions I was wondering if you can provide any color on the remediation efforts being undertaken by the manufacturer and maybe outline.
Speaker Change: <unk> contingency plans, if gripped to SB manufacturing does not resume in mid October.
Speaker Change: Thank you Justin for the question so it.
Speaker Change: It is a complex situation, but we are in discussion almost every day with the manufacturers. So that we can confirm the sequence of events that I have highlighted in my speech.
Speaker Change: And it comes down to making a submission of the phs filing that will be comprehensive which will come from the full appreciation.
Speaker Change: The collective measures and as soon as we hear back from our CMO and their interaction with their compliance division that will give us all and munition needed to go back to the review division and the work with the drug shortage of staff to engage with.
Speaker Change: Our review division, so that the expedited the review and quite frankly, they don't need to do it in 15 days you don't need to do with EBIT 30 days, we have enough supply at the patient level up the way until mid January. So we're confident that that period of time is long enough for the.
Speaker Change: Agency to approve the releasing of the batch that will be produce the week of October 'twenty, one so John when it comes down to handling of the.
Speaker Change: The stock that we currently have what what do you what do you have lining up well that's what we're managing inventory more closely in the fourth quarter just to ensure that we have equal distribution amongst all our specialty pharmacy partners partners.
Speaker Change: And we're working with our patient support program than to ensure we get product to the right. The right location for the right patient So I think.
Speaker Change: That's how we're managing that Justin.
Speaker Change: And then just maybe to add.
Speaker Change: We do have another slot that is reserved after the one in the first week of October 20, <unk>. So we actually had multiple slots coming up so if that one doesn't happen. There is there is more in the past in the back of it.
Got it. Thank you just follow up yes.
Speaker Change: Yes.
Speaker Change: I was wondering if there's any comment you can have on color for the timing expectations for the BD activity and potentially accretive assets, there and thats. It for me. Thanks.
Speaker Change: Yeah, well I mean, we've been active for a certain period of time.
Speaker Change: I cannot tell you when I cannot tell you. However, I just want to tell you again that this new situation that we're in when it comes down to being stronger on the bottom line of the firm with a strong cash position.
Speaker Change: And you see the rhythm of the.
Speaker Change: The numbers now when it comes down to generating EBITDA. So we are in a much much.
In much better position than we used to be.
Speaker Change: We've been even to capabilities that John and his team have built in the U S.
Speaker Change: You've seen.
Speaker Change: How robust the performance of a grifter is turning to be in an environment that was unsure a year ago. So we're going to build on all of this and quite frankly, it hasn't gone unnoticed by some of the biotechs in the U S that might need a partner to advance their science and I just want to stress again that this organization.
Speaker Change: <unk> has a track record for establishing.
Speaker Change: The science, so we do have medical activities on the ground, we're capable of conducting medical to medical Doc.
Speaker Change: Session. So that we can establish new medicines and there are many firms of our size in the U S that actually specialize in 505, BS we sell innovation and we're proud of that and that's the type of.
Speaker Change: Product that we're after so stay tuned for the next phases of announcement okay.
Speaker Change: The next question comes from Andre Uddin with research capital. Please go ahead.
Okay. Thank you Hi, Paul Felipe Krishna and Tom just in terms of looking at innovative products.
Andre Uddin: Your portfolio are you only looking at commercially available assets and with those drugs be in license are required and we do also built with Canadian sales force.
Andre Uddin: So.
Speaker Change: We are looking a couple of things we're looking at the territories will master. The most so obviously the U S and Canada, we have capabilities in Canada as you can imagine being located here.
Speaker Change: If we need to actually set up a field force either in the U S, where our Canada, we will obviously the value proposition coming from and in license or acquisition has to be compelling. So we will look at this very closely and we want it to be accretive as fast as possible.
Speaker Change: So that doesn't mean that there's not going to be any period of time to ramp up to get access and reimbursement.
But to answer your question again, what is most important to US is the value proposition, we want to challenge standard of care.
Speaker Change: And if there are some drugs in the U S that are prioritized by big pharma or small pharma companies. We are interested in making acquisition of that too. So it could be a mix of what you just mentioned.
Speaker Change: Okay. That's great. Thanks, Paul and just in terms of <unk>.
Speaker Change: <unk> do you plan on setting up a backup facility going forward.
Speaker Change: Do you want to take that question no I don't think we'll need to first of all we're hoping to launch the FAA next year, we have another manufacturer and what we'll do is as a buildup of <unk>.
Speaker Change: Solid inventory, so that we have one or two years of.
<unk>.
Speaker Change: So.
Speaker Change: It's so expensive to set up these manufacturers that it's much cheaper to keep more inventory than less.
Speaker Change: Okay, and just to clarify if you follow your P F.
Speaker Change: In early November.
Speaker Change: With a review actually take up to four months or is based on the FDA shortage.
Speaker Change: Do you think it's going to be shorter than that.
Speaker Change: Well, we absolutely believe that we have and we will have the information needed to accelerate the review.
Speaker Change: Unfortunately, they have not confirmed that to us and it's not a surprise quite frankly, because they have to hear back from the compliance divisions first in the compliance division is working with our CMO and they need to see the Finalization. The final report of their corrective measures. So this is a step wise.
Speaker Change: Approach what makes me believe that we're not going to phase drug shortage at the patient level is that they have sufficient time to review.
Speaker Change: Our <unk> submission.
Speaker Change: Until we actually run out of Medicine mid January I would not understand why they would in that case, knowing that we could face drug shortage.
Speaker Change: I would not understanding understand why they would actually take up their 120 days that specifically why the drug shortage staff exist and all divisions have to work together. So I'm absolutely confident that we will find all the information.
Speaker Change: <unk> needed to convince them to review.
Speaker Change: Our PFS finally in a period of time that will not actually lead to a drug shortage.
Speaker Change: Okay, that's good and just in terms of ph.
Speaker Change: Page 19 O. Two can we get an approximate timeline and when the final data would be in fact going to be in 2024 calendar year or 2025 do you think.
Speaker Change: Discount do you want to.
Speaker Change: Provide an update you're absolutely absolutely out of your first of all laundry we.
Speaker Change: It's progressing well as you know we have some.
Speaker Change: Fees when we're administering the drug every three weeks now that it is the new regimen on a weekly basis with when we break three weeks of treatment followed by one week break.
Speaker Change: At the highest dose which is the two five milligram per kg, which was similar you remember the 300 milligram per meter square every three weeks.
Speaker Change: We don't see any VLT, which is a very good sign it shows that eventually we can probably give more drug and in terms of the overall analysis.
Speaker Change: It will probably come towards the later part of this year.
Speaker Change: Okay, that's great. Thanks.
That's it for me.
Speaker Change: Yeah.
Speaker Change: As a reminder, if he would like to ask a question. Please press star one to enter the question queue.
Speaker Change: The next question comes from Louise Chen with Cantor. Please go ahead.
Speaker Change: Good morning, everyone. This is carvey onto Louise from Cantor. Thank you for taking our questions first can you discuss the strategy to ensure the sustainability of your EBITDA.
Speaker Change: Bottom line performance that you've been able to generate the last few quarters secondly, given the current status of the Griffith supply from a growth perspective, how my gripped our sales growth looked like in 2025 versus this year. Thank you.
Speaker Change: So second question I'm going to ask John in the moment that are fit for the first part do you want to go and please sure. So.
Speaker Change: As I said in my speech car BD the structure the operating structure that we have right now is really.
Speaker Change: Ideal for both regards though and a grifter. So it's not that we've been cutting costs and to the detriment of generating new scripts in topline.
Speaker Change: We're really.
Speaker Change: Ideally positioned so we see any growth in topline and.
Speaker Change: In the next year or two.
Speaker Change: We will flow straight to the bottom line, we're not going to have to spend a lot more.
Speaker Change: The cuts that we took.
Speaker Change: <unk> did not affect any of our operating performance. So we're in a really good position.
Speaker Change: Got it.
Speaker Change: Yes, so in terms of the performance for next year.
Speaker Change: We do anticipate that.
Speaker Change: Sales would be a little bit lighter early in Q1, but we think that will just completely reverse so.
Speaker Change: Later in the quarter. So we have.
Speaker Change: Two five weeks at our wholesaler, we have 30 days roughly in the specialty pharmacy level. So that's six five weeks of inventory when does that when that gets depleted down to very low levels. We will just see very large orders later in the quarter. So.
Assuming things go as Paul laid out then.
Speaker Change: Q1 should be basically a wash.
Speaker Change: So this is important to stress again ex factory sales will be affected in the fourth quarter, which is not related to demand and as soon as we actually have the released of that batch we will make up for sales and we have enough into distribution pipes.
Speaker Change: For six weeks. So we have until mid January to be able to serve our patients.
Speaker Change: Got it that's helpful. Thanks, so much.
Speaker Change: This concludes our question and answer session I would like to turn the conference back over to Paul.
Speaker Change: Yeah.
Speaker Change: Before we turn it over to Paul Theres, a few questions on the on the.
Speaker Change: Cap on via on the webcast. So one is on the Entre <unk> John.
Speaker Change: Please give us more color on why you expect regardless, we'll still sales to stabilize in 2005.
Speaker Change: Well as we look at unique patients and where they are.
Speaker Change: Trending it has sort of stabilized in the last four to five.
Speaker Change: Bob models.
Plus you see.
Speaker Change: Sort of.
Speaker Change: As we have more patients earlier on as more patients drop off and we're getting more patients dropping off and we are coming in you see a more rapid decline, but does that begin to stabilize moving forward and we see things leveling off so.
Speaker Change: Or what we anticipated in terms of enrollments.
Speaker Change: We are right. There. So we're not seeing any further decline in enrollments and so we anticipate going forward that things have sort of leveled out where they are.
Speaker Change: And there was a question also how would you characterize your ability to meet the loan covenants with marathon.
So right now.
Speaker Change: There's two main covenants the liquidity covenant, which is at $17 5 million and we have $40 million in the bank. So we're fine there. We're also building quite a cushion on the adjusted EBITDA.
Speaker Change: <unk> covenant because.
Speaker Change: This is a rolling 12 month covenant.
Speaker Change: And as we continuously beat our own expectations, we're building more of a cushion.
Speaker Change: And there was a second part to this question have you had discussions on waivers, we havent because we don't need them, obviously the Griffith.
Speaker Change: <unk> goes into 2025 deeper in the year.
We will definitely have to talk to them, but thats really not the plan right now so we're in very good position with.
The marathon credit facility.
And thats at the pole for questions. So.
Speaker Change: You can be.
Speaker Change: Well. Thank you everyone for attending the call today, our Bottomline is strong as demonstrated by nearly $12 million of adjusted EBITDA year to date and the increase of our guidance no doubt, we will continue to maximize our profitability through the sustained growth of a grifter SV and the planned.
Speaker Change: Expansion of our product portfolio.
Speaker Change: We are seizing every opportunity to leverage our commercial experience and expertise across North America and I look forward to updating you on key developments again. Thank you for your support and have a great day.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now.
Now disconnect.
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Unknown Executive: Thank you for watching, and I'll see you in the next video.
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