Good morning, ladies and gentlemen, and welcome to the Valeo Pharma Inc. third quarter results conference call. Bonjour et bienvenue à la conférence sur les résultats du troisième trimestre de Valeo Pharma Inc. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, September 14, 2023. I will now extend the conference over to Frédéric Dumais, Director of Communications and Investor Relations. Please go ahead.
Thank you, operator. Good morning, everyone. Present with me today for our third quarter 2023 financial results conference call are Mr. Steve Saviuk, our CEO, and Mr. Luc Mainville, our Senior VP and Chief Financial Officer. Before we begin our call, I would like to remind everyone that this conference call may contain certain forward-looking statements regarding the company's expectations or future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this conference call. The company disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required by security laws. I would now like to pass the call over to our CEO, Mr. Steve Saviuk.
Please go ahead, Steve.
Hey, good morning, Fred, and thank you for the introduction. Thanks, everyone, for joining us on Valeo Pharma's third quarter 2023 financial results and highlights conference call. I will start by reviewing our latest quarterly results, followed by a commercial and operational progress update before passing the call over to our Senior VP and CFO, Luc Mainville, who will provide more details and explanations of our third quarter results. For our third quarter ended July 31st, we are pleased to report revenues reached CAD 14.1 million, a new record for us at Valeo and the seventh consecutive quarter of revenue growth. This represents a 132% increase over the same quarter last year. We also reported a seventh consecutive quarter of increased adjusted gross profit at CAD 5.1 million, up 106% over Q3 2022.
We are now about midway through our fourth quarter and are tracking ahead of Q3, giving us confidence that we'll reach a new high in revenues for the current quarter. During Q3 2023, operating expenses and corresponding EBITDA were impacted by several factors, including product samples purchased in the quarter. As you may be aware, current accounting standards require samples to be expensed in month of purchase rather than in the period or spread out during the period where they are distributed. Our Adjusted EBITDA loss has increased this quarter, and Luc will provide more color on this shortly. In brief, we expect our Adjusted EBITDA loss to resume its downward trend, that is to say, to continue being reduced in the current quarter and beyond. Entering the final quarter of 2023, we reported...
We expect to report full-year revenues that will be more than double the CAD 27.7 million reported in 2022. I would now like to provide an overview of the quarterly performance of our three business units, touching on key takeaways from the quarter and outlook. Our respiratory business unit consists of three products: Enerzair Breezhaler, Atectura Breezhaler, two advanced asthma therapies, as well as Allerject, an epinephrine auto-injector used to treat severe allergic reactions. Both Enerzair and Atectura continue to demonstrate significant month-over-month prescriber and prescription growth. At the end of the third quarter, prescribing physicians exceeded 2,500, a 23% growth from the prior quarter and a 221% increase over the prior year. Total prescriptions for the last 12 months were up 310% year-over-year. I...
As I mentioned in last quarter's call, changing established physician prescribing practices requires both reach and frequency by our field team to deliver the key messages of the therapeutic benefits of our asthma therapies. We face the additional challenge of having a first-in-class drug, Enerzair, which contains a fixed dose of three different chemical components, necessitating an even higher level of physical, physician interaction and education. In the face of these challenges, we are very pleased with the launch success and rapid prescriber and prescription growth that is taking place, and which we have described in the numbers that I've just mentioned. We expect that this growth will accelerate as physicians and patients experience the benefits through symptom control that our products provide.
While widely supported through public and private benefits, benefits plans, Enerzair is still faced with a reimbursement obstacle in Quebec, which has slowed adoption of the product in our home province. We estimate that this has reduced Enerzair revenues by over CAD 1 million this year, as physicians are required to submit supporting documentation and patients must wait for approval before their therapy is publicly paid for. That approval could take three to four months. We are working diligently to resolve this issue and ensure patients have prompt access to Enerzair when prescribed and feel very confident that we'll be able to do so shortly. The Canadian asthma market is now valued at well over CAD 800 million annually. We are challenging the established asthma brands and gaining increased physician adoption through our dedicated 60-person commercial field team.
Expected to engage in over 45,000 physician interactions this year. Despite advances in electronic technology, in-person interactions continue to be the most favored and effective means of demonstrating product benefits. Our field representative call efficiency, that is the number of physician interactions on a daily basis, is back to expected levels. While the progress of our two brands have made over the last quarter, we continue to forecast that our two asthma therapies have peak expected revenue potential in excess of CAD 100 million. And what we are seeing anecdotally is that the products that we compare ourselves to and that we compete against, Symbicort, Advair, Breo, are all growing also.
Our epinephrine auto-injector, Allerject, for the treatment of severe allergic reactions, has many feature benefits, which we believe will cause it to challenge EpiPen for leadership in the CAD 85+ million severe allergy market. Although we didn't see significant revenue improvement in the third quarter, recently in launch initiatives with several allergy agencies, coupled with the important back-to-school season, show promise, increasing both awareness and sales. When given the opportunity to decide between Allerject and its only competitor device, patients prefer Allerject 70% of the time. With less than a year under Valeo stewardship, building awareness is key, and we continue to believe that our product feature benefits will help us gain important market share in the coming quarters. We continue to believe strongly in the future of our ophthalmology business unit, despite some uncertainty which has arisen in the third quarter.
Our Ophtha commercial team has been fully engaged since the end of calendar 2022, and their efforts have yielded positive trends that support Valeo's belief that product detailing and support can improve revenue outcomes. Our glaucoma drug, Simbrinza, has seen calendar year sales grow by 10%, and we expect and we continue to expect sales will continue to increase in the quarters to come. The Xiidra brand drops for dry eye, or the treatment of dry eye, have also been positively impacted by our commercial efforts as we overcome unforeseen changes in market conditions, which has started to negatively impact sales at the time of its license by Valeo last summer. During the quarter, Novartis Canada, Novartis Global announced its intention to sell dry eyes, Xiidra, as well as several other ophthalmology products to Bausch + Lomb Corporation.
This sale is expected to close in the fall of 2023 and does not include Simbrinza. Under the terms of our commercialization and supply agreement with Novartis that was signed in July 2022, Novartis is obliged to reimburse a portion of a significant portion of the $10 million upfront license fee paid by Valeo, should it opt to terminate the agreement within the first 3 years. Valeo expects that following the sale of Xiidra to Bausch + Lomb Corporation, it will continue to generate revenues from the sale of Xiidra during that transition period. The duration of this transition period is still undetermined, but we expect that it will continue through the end of fiscal 2023 and into the beginning of fiscal 2024.
The termination rights provided in the agreement by Valeo, and the resulting termination fee would be expected to be redeployed by Valeo towards other revenue-generating ophthalmic assets. As mentioned previously, our corporate product licensing, acquisition, and in-licensing activities are strongly focused on building our ophthalmology franchise, and we are engaged in the review and negotiation of a number of target products, which would move Valeo closer to our stated goal of being one of the leading prescription ophthalmic companies in Canada with a strong healthcare professional and patient focus. Our specialty business unit is centered around Redesca, a hospital-based anticoagulant, which is the number one biosimilar in Canada. While sales during the quarter remained largely flat, we continue to believe the market opportunity for Redesca remains strong.
Canadian enoxaparin market has undergone dramatic change during the last 24 months, as provinces have moved quickly to favorably open their markets to biosimilars, which provides significant cost savings as well as securing product availability. Ontario, which represents 45% of the enoxaparin market, was the last province to announce its biosimilar policy and has only recently started to implement this policy. Valeo had expected that sales of Redesca would have been positively impacted by this opening of the market. However, it now appears that this is more likely to occur in the first half of fiscal 2024. We are also very encouraged by some recent events, and recent successes we have had in expanding Redesca's usage.
Our medical team has been engaging with hospitals across the country to educate these health centers on the benefits of adopting Redesca over other anticoagulant biologics, dalteparin and tinzaparin, which would more than double the addressable market for Redesca. These efforts are starting to bear fruit as a number of hospitals have contractually committed to convert their dalteparin use to Redesca. While we had forecast earlier implementation, we now expect these transitions to start occurring in the fourth quarter. While we showed increased revenues for the seventh consecutive quarter, these operating results fell short of our expectations. Our outlook for our product portfolio remains as positive as ever, and the headwinds that have impacted revenue growth have or will be overcome. We can do better, and we will do better. We have implemented measures to rationalize and contain operating costs....
and have seen a positive impact as we reach midway through Q4. We expect this trend to continue as we move closer to our goal of positive EBITDA and positive cash flow. Valeo has a diverse and innovative drug portfolio. We have an all-star commercial team and an experienced and committed management team. Organic revenue growth and improved financial performance is forecast to continue for quarters to come, and future product acquisitions will only accelerate this trend. With a multi-product portfolio, we can expect that there will be some variability in results from quarter to quarter. However, our overall trend continues upward. Concluding, I would like to wind up my portion of this call by paying tribute to the over 125 entrepreneurial men and women whose daily efforts continue to make Valeo one of the fastest-growing healthcare companies in Canada.
Valeo brings innovation to Canadians, and innovation means better healthcare for all. With that, I'd like to turn the call over to Luc.
Thank you, Steve. Our Q3 2023 and year-to-date 2023 results show the full impact of the addition of Xiidra, Simbrinza and Allerject to our commercial portfolio in the last quarter of fiscal year 2022, as well as the strong continued organic growth from Enerzair, Atectura, and Redesca. In the third quarter, we have been able to continue growing our revenue and margins while continued control over OpEx. In Q3 2023 showed a slight increase in our Adjusted EBITDA loss compared to the prior quarter after six consecutive quarters of EBITDA improvement. We believe Q3 2023 is not indicative of our progress and expect significant EBITDA improvement over the coming quarters. We are still aiming to reach breakeven EBITDA over the coming quarters due to the continued growth of our core commercial assets and tighter control over operating costs.
Our financial results for the third quarter 2023 also show the full impact of two financing transactions completed during fiscal year 2022. Valeo completed a CAD 25 million convertible debenture financing in December 2021, as well as a $30 million term loan in July 2022. Now commenting on our results. In the third quarter of 2023, the corporation saw its revenue increase for the seventh consecutive quarter, while we achieved record revenue for the fifth consecutive quarter at CAD 14.1 million, compared to CAD 6.1 million in the third quarter of 2022, representing a 132% increase. The increase resulted mainly from the addition of Xiidra, Simbrinza, and Allerject, as well as 20% organic growth of our other products, including Redesca, Enerzair, and Atectura.
Revenues in the third in year-to-date 2023 increased 171% over year-to-date 2022, including 38% organic growth before new products. Our gross profit contribution in the third quarter of 2023 was up 92% over the third quarter 2022, at CAD 4.3 million. Gross profit for the year-to-date period was up 135% over the prior year. Our gross profit in the third quarter and year-to-date 2023 has been impacted by the increase in amortization and of product rights for the Novartis and Kaléo product license in the third quarter 2022, as well as increased accruals for GPO and PLA provisions. After eliminating the amortization charges, as well as other non-recurrent adjustments, our adjusted gross profit for the third quarter increased 106% over the third quarter of the prior year.
Adjusted gross profit for the year-to-date period was up 148% over the prior year. Gross profit margins and adjusted gross profit margin percentages decreased slightly between the third quarter 2023 and year-to-date 2023, compared to the prior year periods, due to our new product mix. Our total OpEx for the third quarter stood at CAD 7.7 million, up 22% compared to CAD 6.3 million in the prior year. Total OpEx for the third quarter have been impacted by CAD 0.5 million of sample costs compared to nil during the prior quarter 2023. Total OpEx for the year-to-date period increased 23% over 2022. Our total OpEx increased in the later part of fiscal year 2022 to reflect the addition of the Ophthalmology business unit.
OpEx in fiscal year 2023 includes CAD 0.4 million severance paid in Q1, while OpEx in fiscal year 2022 includes a CAD 0.4 million positive recovery from the bank fraud. After adjusting for these two non-recurrent items, our OpEx increased only 9% in the current fiscal year compared to last year, as compared to a significant increase of 171% in net revenue and 148% in adjusted net earnings. Total OpEx to revenues have declined significantly in year-to-date 2023 compared to the prior year, at 55% compared to 121%. The increase in operating margins and control over OpEx led to a reduction of our operating loss in both Q3 2023 and year-to-date 2023 compared to the prior year periods.
Our financial expenses in the third quarter and year-to-date period were CAD 2.4 million and CAD 8.8 million, compared to CAD 1.3 million and CAD 3.4 million last year. In fiscal year 2023, our financial expenses include the full impact of the two financing transactions completed last year.... The increase between the reported periods also include the effective interest costs on the long-term debt. Financial expenses in the third quarter benefited from a CAD 1 million unrealized net foreign exchange gain, resulting from the conversion of our U.S. dollar-denominated term loan compared to the prior quarter. The net foreign exchange impact for the year-to-date period was CAD 1.1 million gain.
Our net loss for the third quarter and year-to-date was CAD 5.8 million and CAD 18.6 million, compared to CAD 5.4 million and CAD 16.4 million for the prior year periods, representing increases of 8% and 13%. These slight increases in net loss were mainly due to the increase in financial expenses, which was partly offset by the reduction of our operating loss. EBITDA loss and Adjusted EBITDA loss in the third quarter decreased by 53% and 28% compared to Q3 2022. EBITDA loss and Adjusted EBITDA loss for the year-to-date 2023 period decreased 43% and 45% compared to last year. Cash at the end of the third quarter stood at CAD 9.8 million, representing a CAD 0.3 million or 3% decrease compared to the last quarter.
Our working capital surplus at the end of the third quarter stood at CAD 12.5 million. Recognizing the need to fund operation and inventory requirements to support our growth, Valeo recently proceeded with a series of transactions aimed at improving further its working capital. A private placement and subordinated loan transaction were completed in August 2023, and contributed net proceeds of CAD 4.4 million. CAD 1.3 million was secured in the third quarter and was presented as advances from shareholder in our Q3 2023 financial statements. In addition to its cash resources, Valeo has the ability to implement an operating line of credit to leverage its growing high-quality short-term assets. Management is currently implementing a $5 million line of credit to provide increased working capital flexibility. The facility is expected to be implemented before the end of the current fiscal year.
These transactions will provide close to CAD 10 million of working capital flexibility to Valeo. This concludes the financial part of our call. I will now turn the call back to Steve.
Great. Thank you, Luc. We are now ready to open the call up for questions. Although this portion of the call is reserved for questions from financial analysts, we invite any of our shareholders or any other interested parties to contact us directly with any questions they may have, and we will try to get back to you as quickly as possible. Operator, you may now proceed with the questions part of this call.
Thank you. Ladies and gentlemen, we will now take questions from our analysts. Should you have a question, please press the star followed by the one on your touchtone phone. If you'd like to withdraw your question, please press the star followed by the two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Scott McAuley, from Paradigm Capital. Please go ahead.
Morning, gentlemen. Thanks for taking the questions. Just to start off, I guess, on the top line. You know, from the asthma portfolio, you know, seems like really good organic kind of month-over-month growth on prescription numbers, number of prescribers. But looking at kind of the sales by business unit and, you know, squinting a little bit at the charts, it doesn't seem like that's really translating too much into sequential growth on kind of the revenue side. So just wanting to kind of dig into a little bit on, you know, if you're kind of achieving your targets for that kind of revenue growth and how you look to convert kind of that prescription and prescriber growth to the dollars and cents line on the top line.
Well, look, Luc will answer, but I'll maybe thanks a lot for being on the call and for your questions. Maybe I'll just make an overall kind of market or cyclical kind of comment, is that traditionally the summer months, and July obviously being one, and part of June, are slow months for in the asthma market across Canada. It's not unexpected to see revenues drop by 30%+ for all the brands. There's just that, whether it's patients that are away, doctors are away, or the fact that being outdoors as you typically are in a good summer, not like this summer, but in a good summer, your asthma symptoms seem to be less intense.
So there is a summer cyclicality in asthma, and what we saw in July and what we saw in August is, whereas last year our revenues dropped by well over 30% during those two months, this year they were flat, which I think is a very positive. So Luc, maybe you want to add some comments to that.
Yes, thanks, Steve, and thanks, Scott, for your questions. Well, a couple of items. Of course, we're tracking growth and we're presenting net revenue. So, the thing that we're focused on is growing the gross revenue, because that's what we control. We did have to adjust our accruals for PLAs and GPO. GPO, mainly for Redesca, PLAs, mainly for Enerzair, Atectura, because now we're starting to see the true trend on public reimbursement versus private reimbursement on these drugs. So the increase in the accrual has negatively impacted the respiratory unit. Another item that we try to not really focus on too much is the quarter end adjustment.
There was significant sales achieved in the last two days, prior to the end of the quarter. Those days were not captured in Q3 and will be captured in Q4. For Enerzair Atectura, that represents, you know, at least CAD 250,000 of sales that we were not able to recognize. So, this, this, this typical Q over Q adjustment, is in the, in the CAD 300,000-CAD 400,000 range. This, this quarter, it was more than twice, that, that level. So it's timing issue, but in, in this case, it's gonna be a favorable impact on our Q, Q4. Finally, don't forget that, that, division now, includes the, Allerject, product. So the, you know, the graph, the graph doesn't, fully, present the the impact of Enerzair Atectura.
But Steve is right, the summer months were not spectacular in terms of growth. We did achieve some growth, while typical industry standards would lead to a drop in the level of prescription. And early days in Q4, we're on track to have a significant bump in respiratory revenue and the addition of Allerject with the back to school will show, you know, we're back on track. And maybe not meeting expectations, but clearly showing growth and that is sustainable growth, by the way, because these are chronic indications, and we're happy just about the results.
Yep.
Yeah, just, Scott, one little thing here. We don't talk, and we haven't spoken about this, but it, in terms of, moving annual total NBRX, and, you know, these are numbers that are not, there's a lot of adjustment to them. We understand their sampling. It takes time for IQVIA to get this right, but when you look at our moving annual total, we're around 10% of NBRX right now. So we've and that, if you look, if you turn back the page, to a year or turn back the calendar a year, we were around 3%. So we've in terms of new prescriptions, we feel we're touching this low, very low double digits of new prescriptions, but still a significant increase over last year.
When you look at some of our, our competitors, although they are growing, as I've mentioned, you know, Symbicort is almost CAD 300 million of revenues now and continues to grow, but their, their share of NBRX is dropping, and, and certainly some of that is coming our way. So maybe that, that gives you a sense that it may be the numbers aren't showing it, but some of the underlying trends and, and metrics that we are following on it, they are, are definitely moving in the direction we, we like to see.
Yeah, that's great. That makes sense. I guess on the Xiidra side of things, so that's, you know, a bit of clarity in terms of when the deal is expected to close and, you know, the potential for some continuing revenue through a transition period. I guess on your side at the moment, you know, are you continuing to promote the product? Are you continuing to kind of dedicate internal resources to it, or is it just, you know, maintaining kind of the status quo and just waiting until that, you know, that transition, that deal closes and going through the transition process?
We continue to support the product commercially until we hear differently. Publicly, what's been announced is that the deal is expected to close by the end of the year. I saw that there's probably... Well, our feeling is that that might be; it might happen earlier, but there more than likely will be a transition period, and my comment was certainly through the end of our fiscal year and to the end of the calendar year is, I think, a very reasonable expectation, perhaps even beyond, in terms of this transition period that we would enter into. But again, we haven't, you know, we haven't received our termination notice.
We haven't, you know, there's so little, sort of, guesswork as to a transition, but nothing in these type of things. You know, when I say these, the transition of products and pharma, nothing happens quickly. There is a lot of regulatory back end of things, and I would expect that, as I mentioned, at least till the end of the calendar year, we'll continue to be as actively involved as we are today.
Yeah, that's great. And then, you know, obviously a lot of focus in the disclosures and in comments around the samples and kind of understanding that as kind of a one-time or, you know, kind of bulky cost versus the reality of it, you know, being sampled out through the course of time. But, you know, in the next few quarters, kind of, are you expecting, you know, similar or other bulk ups in terms of samples, other kind of big working capital additions in terms of inventory or other things that could affect kind of the cash balance sheet?
Luc, take that one.
Yeah. So with regards to the inventory, after a couple of years of, you know, supporting new products like Enerzair Atectura, and even Redesca and the ophthalmology assets, you know, now we're really managing the inventory to provide, I don't wanna say just in time, but the carrying inventory has kind of normalized, so we're not investing as much as we used to, to build the inventory in anticipation of a growth that we had a hard time projecting. Now that we know our growth pattern, now that we know the growth initiative, we're basically buying inventory to be depleted within the next six months, and that helps on the working cap.
With regards to samples, yeah, we did provide some information in the MD&A, to get the reader to appreciate that expensing samples on purchase versus use has a big impact on our number. But as we grow our number, I mean, top line and margin, that impact will get smaller and smaller and should no longer, you know, be material enough to influence our results. I would say that the initial, the last few quarters, we've had to basically buy initial levels of samples with the minimum order quantities that we were given by the manufacturer. Clearly, that has an impact, but over the coming years, we'll probably see a diminishing impact of that.
We wish we could be able to time this to use, but it will never happen. We're doing our best. I don't think we'll have as big an impact going forward as we've had in Q3.
That's great. I think it's last for me. You know, good to see with the financing, you know, Investissement Québec coming in as a partner, and again, kind of the ongoing participation from insiders. So both, you know, very positive. In terms of kind of the balance sheet overall, you know, are you kind of confident that between the current cash, that financing, the potential line of credit, that that kind of gets you to the, you know, cash flow breakeven point, sometime next year?
Well, clearly, the Xiidra situation has created some uncertainty. However, when you're looking, you're dissecting, the transaction, there will be a payment, that will have to be made, that will provide cash, and we will lose margins going forward, but there will be cash coming in. We will until During the transition period, we will no longer have to carry the inventory, or that's our expectation, that we will not have to carry the inventory for the transition because it will no longer be our product. So those two, plus the 4.5 PIPE and the CAD 5 million line of credit, on top of the CAD 10 million cash we had at the end of Q3, provides us, you know, significant, I would say, operating flexibility.
On top of that, you know, we're clearly focused on dropping our loss, and of course, our cash burn is going down sequentially, and that accelerating as we speak. But for sure, if we could add a couple of additional business development assets, that would accelerate our growth and provide additional margins without impacting our G&A, that would be great. So what we believe right now is we've got a war chest that is capable of supporting the addition of a couple of products and accelerate our profitability. So long answer to a short question, Scott, we're fixed on achieving break-even profitability, not only the EBITDA, but P&L profitability as quickly as possible. And right now, the two transactions that we're working on right now will provide us that needed flexibility.
It will have to be seen if we're able to implement BD initiative and how long we'll carry Xiidra. But for now, we feel we're good until the second half of next year, for sure.
Thanks a lot, guys. I'll hop in the queue.
Thanks, Scott.
Thanks.
Ladies and gentlemen, as a reminder, should you have a question, please press the star followed by the one. Your next question comes from Stefan Quenneville from Echelon Capital Markets. Please go ahead.
Yeah. Hi, guys. Thanks for taking my questions. Just a kind of follow-up on the Xiidra situation. Maybe just help me understand a little more detail mechanistically, you know, what might occur or is likely to occur. Your initial deal was for two products, right? But it sounds likely that you're gonna continue on with Simbrinza, but not Xiidra. You know, how is that gonna work mechanistically? And then, you know, if the Xiidra rights go back or go to Bausch, what would a transition look like mechanistically, where you're still, you know, you'd be, you know, detailing the product for a period when it then belongs to Bausch? Help me understand that, please. Thanks.
Well, let me start, Luc, and then you can come in, because a lot of it is unknown. But one, one thing that you did say, Stefan, is about regarding Simbrinza, and as you saw in our results, we've grown Simbrinza in a market which is, you know, not growing at 10% a year, it's growing significantly lower, and yet we were able to take Simbrinza without samples, by the way. We want to sample it, but the sampling is still not available to us and still grow that product 10%.
So yeah, we want to continue with Simbrinza, and our margins are increasing with Simbrinza by virtue of the deal that we have with Novartis, where there was a, as you may recall, a sort of a lower margin up front, but over time, the margin actually increased due to a number of factors. So that's positive. In terms of how the structure will look like going forward, very difficult to tell. I presume it's gonna be something very similar to what we have, whether we book the sale and then get the margin, or whether we just collect a kind of a fee for the mar-- that would be equivalent to the margin, is yet to be determined. But you know, it's just a, it's a very...
You know, until the transaction closes, it's hard to know exactly, but our sense is, and as I mentioned earlier, this is a, you know, highly regulated industry, as you well know, and things don't happen overnight. Transfers don't happen overnight. Product relabeling, product DIN transfers, all these things take time. Then being the drug identification number with Health Canada and what have you. And during that time, it's not uncustomary, if we look at other transactions we've done, for this to take six-plus months. Whether it will be six-plus months in this case or not, we don't know. When will that six months start? We don't know.
But, you know, these are—it's a very promotionally sensitive product as Xiidra is, as are many other pharmaceutical products in a very competitive environment. You have obviously Restasis from Allergan, you have Cequa from Sun, which are the two main competitors right now. And, you know, any reduction of commercial activities leads to, not decreases in market share over time, leads to, like, immediate decreases in market share. So that's why this transition is important and why we feel it's something where you can't say, well, you know, three, four months, there's nothing done on this product. There's no issue, it'll continue selling. That's not the case for a product like Xiidra. So I don't know if that... That's about as much as I can say.
Luc, can you say, and not just what I can say, what I know right now. So Luc, maybe you have-
Yeah. Well, thank you, Stefan, for your question. And if I can add a couple of comments to Steve. Maybe two things regarding the money that has to be paid back. I mean, we said what we could say in the MD&A, so a significant part of the initial license fee has to be paid back to cancel the license. We knew this could happen when we were negotiating the agreement, and we protected ourselves for that possibility that could happen the first couple of years. So what is said is like, it's a significant portion, so it's not the full amount. However, it's not half of it. It's gonna be material. What clearly is there, we know, is that there will need to be an allocation for Simbrinza.
Both parties want Valeo to continue promoting. We've done very, very well. We're 10% up over last year, last year, for the year-to-date number. So clearly, Simbrinza should be part of our commercial portfolio going forward. So there will need to be an allocation, how much still to be negotiated. However, one comment, both when we did the deal and we agreed on the CAD 10 million, both the sales and the growth prospect of Xiidra were greater than Simbrinza. So that's the, I guess, the prevailing assumption that should guide us towards the split of what comes back. First thing. Second thing, with regards to going forward, all parties recognize that Xiidra is a promotion-sensitive product, requires detailing, and there should not be a period where that product is left without support.
Takes time to build a unit to promote products. It took us six months after the deal, so we believe there will be a similar period until Bausch + Lomb will be ready to take over that asset. During that time, we'll, you know, look forward to benefit from the margin. As Steve mentioned, it could be in many ways, but we'll have the economic impact of keeping that asset as during the transition.
Okay. And also just mechanistically, it's likely if the termination occurs, it will occur before the closing of the transaction between Novartis and Bausch, or will it be subsequent to that?
You presume it happens at the same time, right? I think it's hard for them-
Okay.
to terminate our agreement before they sign,
Yeah.
Because they have... It's not sold, but I imagine, to me, it should happen, in our view, it probably happens simultaneously.
Oh, okay. Just back to your business development actions. A couple of things. Maybe run me through your war chest of capital you have to put to work there. You know, because you didn't mention the Sagard licensing line of credit, which had a sort of time limit on it as well, which I think runs to the end of this calendar year. So walk me through that and maybe just, you know, obviously, you guys are active, but if you could give me any, you know, additional color on, you know, how you could maybe fill the larger gap or even, you know, go beyond that in terms of the things you're looking at.
Well, maybe, Luc, you can start on the funding side, and maybe I'll talk about the what's in the horizon.
Yeah. Well, with regards to Sagard, we do have, we have a $40 million facility. We took, the first $30 million, the last $10 million. Of course, it's subject to, their consent, so it's not like, you know, a blank check. So we have to, put forward, you know, the rationale and the thesis for the assets that we wanna go after and get their support to do that. You know, we're having ongoing discussion with, with Sagard with regards to the assets that we are currently discussing, i.e., chasing, and, time will tell if we need Sagard's $10 million or part of, to, to clinch any of the business development deals.
Having said that, historically, the company has been very, very creative at structuring deals for new assets that are either commercial or to be launched or under regulatory development. We didn't pay anything for Redesca. We paid CAD 1.8 million for Atectura. We paid almost nothing for Yondelis and Ametop and assets like that. So, of course, our priority would be to pay less upfront and have a, you know, the economics of the transfer price, you know, meet the objective of the licensor. And that would, of course, reduce the need for an upfront payment.
And of course, we know that adding products right now at the top line has very little impact on the SG&A, and that provides us significant flexibility to structure deals without material upfront to still benefit from material EBITDA impact. So maybe, Steve, you wanna add to this?
Well, and just, you know, in terms of just finishing up on Luc, in terms of availability, discussions with about five different players, strategic and not strategic in terms of, you know, if there was a big, if there was a big milestone payment, how do we fund it? Things of that nature. So there is these discussions going underway. In terms of business development, I like to kind of just take a matrix a little bit to me. The one part of the matrix is like, what therapeutic area? Clearly, ophthalmology is the one that we feel has the biggest opportunities, probably followed by the hospital group and much less so the respiratory group, which their hands really full with Enerzair and Atectura.
They, they're 100% dedicated to that. Then you look at and you say short term, long term. So short term would be immediately accretive revenues, and clearly that's our priority. Number one, to fill the Xiidra gap, so to speak, but number two, to get to breakeven as quick as possible. And we do have a number of opportunities there, that number being, you know, greater than two, that we are looking at, and not just looking at, but in sort of letter of intent, due diligence, the, you know, discussions. We'd like to see those closed before the end of the calendar year. And then there are a couple of really interesting development projects, which would necessitate less money upfront, probably more money centered around Health Canada approval.
So these are not approved drugs in Canada. So in the first instance, I'm talking about drugs that are approved in Canada, in many cases, already selling or ready to sell. In the second instance, you're looking at innovative drugs that have... You know, we're, we're looking at two right now, two separate opportunities, net revenue potential, over CAD 100 million combined. So that gives you a sense that, that these are real needle movers or, or however you call it, gauge movers, in terms of move the needle, I guess is the term.
Money makers, I would call them.
Those would be less money upfront, more money on terms of back-end approvals or sales milestones, things of that nature. So, but again, very confident that certainly we've shown a history of in-licensing deals, so we kinda know when something looks like it's gonna happen and when it's not gonna happen. And we feel very confident that we're gonna land several before the end of the calendar year. As you know, timing is everything on these things. It's not, you know, sometimes it takes time because of issues that are outside of our control, but our discussions are moving forward fairly rapidly.
Okay. So, just, just to be clear, so this, whatever happens with Novartis is not a gating, like it's not stopping you from doing anything. You know, it's not like that's gonna happen, and then you'll follow up with some BD. The BD could occur prior, you know?
Yeah, yeah, absolutely.
Okay.
Absolutely. Yeah, yeah. It's,
Okay.
It's, you know, it's. Again, you know, we believe, and we've looked at this Canadian Ophtha marketplace in terms of the Rx drug side of it, I mean, not the macular degeneration side, so more front of the eye, not the prescription lens or contact lens part of the optometry market. And we feel there's a gap there of companies in terms of that have this Pan-Canadian commercial team. Then you look at what's coming down the pipe from companies in Europe and the U.S. in terms of innovative, and that means patented, new, improved medication for various front of eye ailments.
It's quite an interesting sort of intersection of this need for a Canadian player and availability of some really interesting drugs, that's got us very excited about building within Valeo a really strong ophtho franchise, which we can, we believe will rival our respiratory franchise in top line revenue.
Great. And just one last quick one for Luc. In your MD&A, sort of, you got some language about EBITDA for the coming quarter being an improvement on your EBITDA level last quarter, you know, with this quarter being a bit of an aberration. Are you sticking to that in your comments here? Or did I read that properly, I guess is my question.
Yeah. Prior comments were that we were aiming for breakeven EBITDA in fiscal-
Yeah
... 2023, exiting the year.
Yeah.
you know, what we're seeing in Q4, we've took some initiatives in Q3 that are paying off in Q4 to lower our operating costs significantly. So, we believe top line is, is happening and will continue to happen because of this, you know, as I mean, the, the trend that we see on respiratory is sustainable, meaning the growth trend. And, and that will bring us to the levels, that, that will more than cover, you know, add significant margins. However, we can do better on OpEx, and we're working hard on that. So the combination of those two will bring us, to breakeven profitability on EBITDA in the next couple of quarters. so we'll not exiting 2023, but that clearly in 2024 will see us, EBITDA positive.
You know, then the next step will be P&L positive, and that will follow with the trend on the top line and control of OpEx.
All right. Thanks, guys. That's all for me.
Thanks, Stefan.
Thanks, Stefan.
There are no further questions at this time. I will turn the call over to the CEO, Steve, for closing remarks.
Thank you, operator. Well, thank you all for attending our quarterly results conference call. We appreciate your time and the opportunity to provide you with more details and color on our progress as we continue building Valeo into a leading Canadian pharmaceutical company. With that, I'd like to pass it back to the operator. Again, we'll see you next quarter, and in the interim, we have our ongoing dialogues with the analysts. But certainly, as we mentioned at the outset, for any shareholders that are out there, reach out to Fred Dumais or myself.
Be happy to answer your questions and give you as much insight as we're able to give you in terms of any of what we've covered today or any questions you may have. Thanks again.
Ladies and gentlemen, this concludes your conference call for today. We thank you for joining, and you may now disconnect your lines. Thank you.