Good morning, ladies and gentlemen, and welcome to the Valeo Pharma Inc third quarter results conference call. At this time, all participant 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. Also note that the call is being recorded on Wednesday, September 14, 2022. I would like to turn the conference over to Monsieur Frederic Dumais. Please go ahead. Thank you, operator. Good morning, everyone. Present with me today on the call are Mr. Steve Saviuk, our CEO, Mr. Frederic Fasano, our President and Chief Operating Officer, 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. 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 securities laws. I'd like to pass the call now over to our CEO, Steve Saviuk. Please go ahead, Steve. Thank you, Fred, and good morning, all. Thank you for joining us on our third quarter 2022 results conference call. I will start by quickly providing an overview of the quarterly results and other highlights and then pass the microphone over to Frederic Fasano, our President and Chief Operating Officer, who will provide more details on our commercial progress. Finally, by our Senior VP and CFO, Luc Mainville, who will provide more details on the third quarter and year-to-date financial results. Our third quarter was a record revenue quarter. As we announced last night, CAD 6.1 billion, 27% increase over Q2 organic growth. Third consecutive quarter of double-digit revenue growth. We expect that's a trend that'll continue. Our gross margins were up 34% over Q2. Our Adjusted EBITDA loss, and it's an important indicator of how we're doing and where we're going in terms of reaching our profitability. The EBITDA loss was CAD 2.9 million, down almost CAD 1 million from the previous quarter. Year to date, CAD 15.1 million of revenue, 48% jump from the prior year. Our quarter also saw us expand our product portfolio and add ophthalmology as an area of focus. The end of July, just before quarter end, we entered into an agreement with Novartis Canada for the licensing rights to Xiidra for dry eye and Simbrinza for glaucoma. These two products generated CAD 23 million of revenue in the prior 12 months. We also announced on the same day an agreement with kaléo Inc out of the United States for the licensing rights to ALLERJECT. ALLERJECT is used for severe allergic reactions. ALLERJECT had current run rate is approximately CAD 4 million and is a natural fit for our respiratory business unit. We now have over a dozen products in our portfolio, six of which we consider core and are all considered revenue drivers and significant revenue growth in the years to come. We should not forget to mention Enerzair, one of the six that remains the most promising with a peak sales target of over CAD 100 million, a rarity in the Canadian healthcare scene. Very nice group of core products, diversified group of core products, all with revenue growth potential, various timings. We should have a number of good quarters and actually good years ahead of us from a revenue growth perspective. To fund these new product acquisitions, we completed a $40 million financing with Sagard Healthcare Partners, proceeds of which will be used or were used for the acquisition of the aforementioned licenses, working capital, but also to provide funds for future acquisitions. Guidance for Q4. We have for the first time we're providing guidance for quarters ahead as we start to be able to have more visibility on our revenue run rates, based on organic growth and the new acquisitions which are accretive as of August first. The revenues from Xiidra, Simbrinza and ALLERJECT are, we're recognizing by Valeo as of August first, the first day of our fourth quarter. We expect revenues in the fourth quarter to exceed CAD 11 million. Just this morning we came out with some very interesting news by announcing a licensing agreement with Veru Inc out of the United States, Nasdaq listed. The product is sabizabulin. It is a product that Veru has applied for emergency use authorization with the FDA and in many countries around the world. They will be doing so with Health Canada shortly. What we have seen is that in the phase three clinical study, the interim analysis showed that sabizabulin reduced deaths compared to placebo in hospitalized adult patients with moderately severe COVID-19 by 55%, which is truly remarkable. Sabizabulin also showed significant reduction of days in intensive care, mechanical ventilation and days in the hospital. Again, a new product to our portfolio. Where I mentioned six, we now with sabizabulin, assuming we had approval from Health Canada, that would be our seventh product and a nice fit with our specialty hospital unit and our key account managers that cover over 200 hospitals across Canada. With that, I'll now pass the microphone over to Frederic Fasano, who will provide more details and color on our latest additions of our product portfolio and our results for the quarter. Fred? Yeah, thank you, Steve, and good morning to all people online this morning. It's my pleasure today to report on the third quarter results of 2022 and on milestones that we have reached during this quarter, both in terms of sales, business development and financing. Indeed, there's been an intense quarter from the operation standpoint, and that is on all fronts. First and foremost, promoting our asthma franchise as the new standard of care for moderate to severe asthma patients, supporting the race for Redesca hospital listings and conquer the retail markets across the country. As Steve mentioned, closing two additional transactions which are bringing three new assets to Valeo's portfolio while closing a financing round with our new partner, Sagard Healthcare Partners. Let's start, of course, with the comment on the sales and the Q3 results. Actually, it's a record quarter establishing itself at CAD 6.1 million net revenue, growth of 7% versus Q3 last year and 27% versus Q2 this year. You will remember that Q3 last year did exceptionally well on Redesca thanks to the pipeline fill in BC. Q2, Q3 this year has seen a nice growth in volume, 10,000 units more than Q3 last year, which means a 22% growth in volume, but which is not reflected in the dollar value due to GPO and PLA discounts agreements. In other words, the price effect is negative, and that is why we see only a limited growth of Redesca revenue compared to Q3 last year. However, Redesca growth over the third quarter has been sustained thanks to a very good performance in Quebec and on the retail channel. At the end of July, biosimilars together owned 46% of the total enoxaparin market and Redesca is the number one biosimilar in Canada with 53% market share on this biosimilar market. The same market share, if you look more with more granularity into Quebec, is rising up to 76%. Redesca owns 76% market share of the biosimilar market in Quebec and 69% in the retail channel across the country. The KAM team has been working tirelessly with hospitals in Quebec to support the conversion from Lovenox to Redesca and with outpatient thrombosis clinics and pharmacies across the country to detail on Redesca value proposition and gain such a momentum in the retail channel. As you know, Redesca is fully covered on the public and private payer side. Contrary to our competitor, we support a full team of KAM across Canada dedicated to Redesca and covering approximately 220 hospitals. We are also proud to report that Redesca is the only enoxaparin product which has been continuously supplied to the Canadian market over the past months with no shortage at all recorded on S Canada website. For that, Valeo has been recognized recently as a trustable and reliable partner by Mohawk Medbuy belonging to the top 10 best manufacturer in Canada in terms of hospital supply. To conclude on Redesca, yes, good market position overall, but still a lot to accomplish on this market. In terms of next step, Redesca is very well positioned in the Atlantic provinces to become soon the biosimilar of choice. Redesca is also well positioned in Ontario to leverage this major growth opportunity. However, Ontario as a province is lagging behind in terms of biosimilar penetration, which represent today less than 5% compared to more than 80% biosimilar penetration in British Columbia or Quebec. This is a call to action for Ontario policy makers in Ontario to de-list Lovenox to incentivize hospital listings and retail substitution to biosimilars, including Redesca. Finally, the secondary market, which includes other low molecular weight heparin product like enoxaparin and dalteparin, is another midterm growth opportunity for Redesca since they represent 63% of the total market in volume. Overall, in this competitive environment, Q3 Redesca results came out with a sustained growth in volume, less so in dollar value due to a negative price effect, a strong competitive position across Canada, and an important potential of growth on the remaining provinces against enoxaparin, that is about Ontario, and against also other low molecular weight heparin, that is the secondary market potential. Q4 results is expected to confirm the trend and the momentum behind this product. On the respiratory side, we closed the quarter with a record month in July. Over 6,000 units of Enerzair and Atectura are sold. Overall, the contribution to the quarter results of our asthma franchise is growing fast. With CAD 1 million net revenue contribution, the franchise account now for 16% of our total quarter revenues. Market penetration continues to grow for both products in terms of sales, prescribers, and prescriptions. As of June 2022, 683 doctors did prescribe in the last twelve months Enerzair and Atectura, and they all together generated more than 15,000 prescriptions. In terms of new script, if you consider Enerzair + Atectura combined, both of them are capturing more than any of the competing dual therapy except one, the leader of the market, Symbicort. Our team is doing a good job at positioning our product as a preferred choice for clinicians and patients as compared to the old brands. Even taken individually, our two product did capture more than Advair, which has been the standard of care for many years, and almost as many new script as Zenhale or Breo as of June 2022. This means that we are closing the gap with these old brands in terms of capture of new script, and we are now focusing and gaining momentum against the leading product, which is Symbicort. If we go a little bit deeper, if we focus on the triple therapy market in asthma, which is worth today CAD 5 million, but is supposed to take up to 30% of the total maintenance asthma market, which is worth more than CAD 200 million. On this triple therapy market, Enerzair is owning 80% of the total new script against Trelegy, which owns only 20% of them. On the dual therapy market, Atectura is the fastest-growing dual therapy, reaching 8.5% of the total new script at the end of June. These key performance indicators are very healthy sign of early adoption for both products. We confirm definitely the potential that we see ahead of us for both products, and we are now looking at ways to accelerate the momentum. As we already mentioned earlier in the year, the impact of COVID-19 on the management of asthma has been significant. Doctors seeing less asthma patients in person during the pandemic were less inclined to change their therapy when poorly controlled. As a result of that, the number of treatment adaptation decreased significantly up to the end of 2021. The good news is that we see this number slightly growing again since early 2022. This comes as a result of more assessments and change in therapy done by physicians to improve the level of control of their asthma patients. We expect this trend to continue to grow over the coming months, and this is a great opportunity for Enerzair and Atectura to be positioned at best treatment alternatives when others are not effective anymore. Also worth to be mentioned, market trend in asthma are showing a seasonality with a low peak during summer and a high peak during the fall from September to November. We have recently put in place a program called the Asthma Peak to leverage the seasonality in support of more assessments of asthma control being done by healthcare providers. These asthma patients are at greater risk of either loss of control or asthma exacerbation and also admission to an emergency room during this period of time. We expect this seasonal peak to be supportive of an acceleration of our sales in the second half of the year. As a summary for our respiratory product, they are definitely our priority number one based on their respective potential, with Enerzair still exhibiting a potential over CAD 100 million. They are competing well on their respective dual and triple markets. Those products are starting to deliver a material contribution to our quarter results, and acceleration is definitely needed here. Seasonality and the other marketing programs will help boost our sales in the short term. That was about the product that I want to comment shortly on our business development activities. Two major deals signed late July, bringing three new products in our portfolio, and all three aiming at accelerating our top-line growth and our time to breaking even. Most of our exec team, nothing less than two BD deals and a financing round closing the same day on the 29th of July. Importantly, all three products are aligned with our BD strategy to be immediately accretive to our top line. Valeo is now entering two new therapeutic areas with Simbrinza and Xiidra for glaucoma and dry eye disease. As Steve mentioned, both products have generated CAD 23 million net revenues in 2021. Valeo is also entering allergy with ALLERJECT, which is an epinephrine auto-injector indicated in severe allergic reaction. The product has generated in the U.S. by Kaléo $150 million revenue line. In Canada, the same product generated in 2021 CAD 4 million. That is to serve all the potential of this product. We are now reorganized in three different business units, respiratory allergy business unit, ophthalmology business unit, and specialty product business unit. As you have seen, the leadership team has been reinforced with the addition of Jean-François Fournier as Ophthalmology Business Unit Head and Kyle Steiger as Senior Vice-President and Chief Commercial Officer, both bringing years of pharma commercial and leadership experience. Q3 results in a nutshell are robust and promising despite the complex environment out there. Q4 will be another record quarter as we are adding top-line revenues with our new product while consolidating the growth on our current business. Valeo has now six leading products exhibiting a large potential of growth and competitive market position as of now. We have to build on the current momentum behind our lead product to accelerate our company performance and to become cash flow positive and to become a leading Canadian pharma company. I want to thank all our employees at Valeo for their commitment and hard work, but also for their leadership and winning spirit. This concludes the product review section of our call. I'll pass now it over to Luc for a complete review on our quarter three financial results. Thank you, Fred. Our Q3 2022 and our year-to-date 2022 results reflect the added revenue and margin contributions of Redesca and Ozurdex, Teveten, which contributed for the full nine month period in fiscal year 2022 versus only a few months last year. The contribution of Xiidra, Simbrinza and ALLERJECT licensed during the last week of Q3 2022 have commenced during the first quarter, the first week of August and consequently will only impact our Q4 2022 performance. The addition of these products, which generated combined revenues in excess of CAD 24 million in calendar 2021, will be strong contributors to Valeo's growth over the coming year. Our Q3 2022 financial statements show the full impact of two significant financing transactions completed during the fiscal year 2022. Following the CAD 25 million convertible debenture financing completed in December 2021, we have secured a $30 million term loan from Sagard Healthcare Partners in Q3 2022. Full details of these transactions of this transaction were discussed during our August 4, 2022 conference call and can be found in note 15 of our Q3 2022 financial statements. The Sagard loan has provided Valeo with the required non-dilutive capital to meet its in-licensing requirements for acquiring the Canadian commercial rights to Xiidra, Simbrinza and Allerject, and to significantly strengthen our balance sheet by providing the required capital to support our operations and working capital requirements for the coming years. The Corporation achieved record quarterly revenue in Q3 2022 at CAD 6.1 million compared to revenues of CAD 5.7 million in Q3 2021. Net revenues increased 7% in Q3 2022 over Q3 2021, but 27% over the prior Q2 2022 quarter. For the first nine months of fiscal year 2022, the corporation achieved record year-to-date revenues of CAD 15.1 million compared to CAD 10.2 million for the same period last year, representing a 48% increase. While our Q3 2021 revenues had benefited from a significant non-recurrent pipeline fill effect following the launch of Redesca, the quarter-over-quarter and year-to-date 2022 increases result mainly from recurrent contract and market share gains for Redesca, which contributed for the full 9 months in year-to-date 2022 versus four months last year. Revenues in last quarter, Q3 quarter and year-to-date 2022 also benefited from the continued growth of Ozurdex, Teveten, which experienced a significant quarter-over-quarter market share gains since they were formally launched in the later part of fiscal year 2021. We generated record quarterly margins in Q3 2022. Our gross margin contribution was up 3% over the same period last year at CAD 2.2 million, while our gross margin contribution for year-to-date increased significantly over year-to-date 2021 at CAD 5.3 million compared to CAD 3.3 million, representing a CAD 2 million increase. We experienced a slightly less favorable revenue mix in Q3 2022 compared to Q3 2021. However, our year-to-date 2022 gross margin benefited from the 48% growth in revenue as well as a more favorable revenue mix for the year-to-date, leading to a 63% increase. We continued to control our operating expenses during the quarter. Our total operating expenses stood at CAD 5.8 million and CAD 17.7 million in Q3 2022 and for the year-to-date 2022 period, compared to CAD 4.8 million for Q3 2021 and CAD 9.1 million for year-to-date 2021 period. Our total OpEx have increased in the second half of fiscal year 2021 to support the growth of our commercial platform and head office infrastructure. Since then, our ratio of total OpEx to revenue is declining fast as we take full advantage of this operating leverage. For Q3 2022, the ratio of total OpEx to revenue was down to 95% compared to 110%-117% in Q2 2022 and 149% for Q1 2022. We expect the ratio of total OpEx to revenue to decline sequentially over the coming quarters. Starting Q4 2022, the addition of Xiidra, Simbrinza and ALLERJECT will also contribute to accelerate this trend. Our financial expenses were CAD 1.3 million in Q3 2022 compared to CAD 0.4 million in Q3 2021. Financial expense for year-to-date were CAD 3.5 million as compared to CAD 0.8 million in fiscal year 2021. Financial expenses for the quarter and year-to-date periods included the impact of interest and effective interest on the debenture issued in Q1 2022. The increase between the two reported quarters also included incremental lease interest charge, which resulted from the expansion and extension of our head office lease last year. The addition of the Sagard new loan facility did not materially impact our financial expenses for the third quarter. In Q3 2022, despite strong commercial gains, our net loss was CAD 4.7 million compared to CAD 3 million in Q3 2021. Our net loss in Q3 2022 decreased 7% compared to the prior Q2 2022 period performance. Our net loss in year-to-date 2022 was CAD 15.7 million compared to CAD 6.6 million for year-to-date 2021. Our net loss for Q3 2022 and the year-to-date 2022 period reflect the incremental costs involved in the expansion of our commercial medical head office teams in the second part of last year. EBITDA loss in Q3 2022 was CAD 3.3 million compared to CAD 2.3 million in Q3 2021. Our EBITDA loss for year-to-date 2022 was CAD 11.5 million compared to CAD 5.3 million last year. Same for our net loss analysis. Our EBITDA loss for each of the quarter and the year to date period reflected the net impact of the creation of our commercial and corporate structure last year. Our EBITDA loss was down 10% compared to our prior quarter Q2 2022 period. Adjusted EBITDA loss in Q3 2022 was CAD 2.9 million, compared to CAD 0.8 million in Q3 2021, representing a CAD 1.9 million increase, but was down CAD 0.9 million or 23% compared to the prior Q2 2022 quarter. Adjusted EBITDA loss for year to date 2022 was CAD 11.1 million, compared to CAD 3.1 million in year to date 2021. On the cash flow statement, the Sagard financing as well as the two licensing transaction completed in July 2022 have materially impacted our financial statements. Cash used in operations for Q3 2022 was CAD 2.1 million, compared to CAD 5.5 million in Q3 2021. The CAD 3.3 million improvement came from a CAD 4.5 million improvement in non-cash working capital, offset by a CAD 1.8 million increase in net loss. The CAD 1.4 million positive change in non-cash working cap included CAD 5.5 million of payables due to Novartis and Kaléo, representing deferred license repayments on the July 2022 licensing transaction. Those payments are expected to be made in the Q4 2022 period. Cash used by investing activity during the Q3 2022 was CAD 11.6 million, compared to CAD 0.1 million in the same quarter last year. Cash used by investing activities was CAD 11.8 million for year to date, compared to CAD 2.3 million last year. During the third quarter, the corporation acquired the commercial rights to Xiidra and Simbrinza for CAD 10 million paid to be payable to Novartis, and acquired rights to ALLERJECT for CAD 1.5 million. Both transactions included a deferred license fee payment. Financing activity generated CAD 36.4 million in Q3 2022, compared to CAD 10.9 million in Q3 2021. During Q3 2022, the corporation secured a $30 million US term loan from Sagard to fund the acquisition of the commercial rights to Xiidra and Simbrinza and ALLERJECT. Last year in the third quarter, the corporation implemented a CAD 11.5 million bought deal transaction to fund its operation. For the year to date 2022 period, financing activities provided cash of CAD 55 million compared to CAD 18.3 million for year to date 2021. In addition to the Sagard financing completed in the third quarter, our year to date 2022 financing activities included CAD 19 million of net proceeds from the convertible debenture financing closed in December 2021. Our cash and liquidities at the end of Q3 stood at CAD 27.8 million as compared to CAD 2 million at the start of the year, representing a CAD 26 million improvement. Our working capital as at the end of Q3 stood at CAD 30.9 million as compared to CAD 3 million deficit as at year-end, representing a CAD 33.4 million improvement. Since April 2021, Valeo has secured CAD 75 million to acquire new product rights, strengthen its balance sheet to fund its growth. We now have the resources and the proper organizational structure to capture the significant market opportunities for our existing and growing commercial portfolio. This concludes the financial review of our call, and I will now turn back the call over to Steve. Thank you, Luc and Fred. We are now ready to open up the call 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, and we will endeavor to get back to you as quickly as possible. Operator, you may now proceed with the questions part of this call. Thank you, sir. Ladies and gentlemen, if you would like to ask a question, please slowly press star followed by one on your touchtone phone. You will then hear a three-tone prompt acknowledging your request. If you would like to withdraw from the question queue, please press star followed by two. If you're using a speakerphone, you will need to first lift the handset before pressing any keys. Please go ahead and press star one now if you do have a question. Your first question will be from Scott McAuley at Paradigm Capital. Please go ahead. Morning, gentlemen. Thanks for taking the questions and congrats on the record quarter. First just wanted, you know, a lot to talk about, but first I wanted to just touch on the guidance. You know, greater than CAD 11 million for Q4, you know, strong growth quarter-over-quarter. I don't know if you have any additional comments on how much of this contribution would be from kind of the three new products that were just acquired in Q3 versus the kind of prior portfolio that kind of preceded it. Scott, it's Steve here. Our sense is probably 60/40 organic growth being 60, so that means the old portfolio and 40 with the new products. You know, onboarding new products, there's always glitches and what have you. I think for the first few weeks and potentially first few months, you'll see some, you know, inventory back and forth. We had a situation with ALLERJECT where we basically sold out our inventory very quickly, and we're in a shortage of supply, which should be rectified by the end of this month. These are the normal teething pains, inventory transfers and what have you, that certainly impact the new products. 11, I would say, is a safe, low number. We certainly are aiming to beat that number. Again, six core products are gonna be driving that. You know, our expectations on all those six is that for the quarters to come, those revenue numbers will continue to increase. Maybe to add, Steve, to your comment, also those products are currently not promoted. That's the case for instance. I'm thinking about ophthalmology for several months now. This is what is putting a bit of uncertainty in terms of how they're gonna deliver in Q4. It's also bringing. There's a point that we will be ready to fully operate on those products in terms of promotional support, certainly by first of November. That's an additional comment. Thanks for that. No, that's, appreciate that. I guess kind of leading into that, in terms of recruitment into the new ophthalmology business and, you know, saw that you had those hires straight from Novartis, which again is always good to see, people who are experienced in the field and with the products joining the team. You know, any commentary on building out the kind of sales team underneath them, how that's going, and kind of expectations on the overall kind of operating expenses in the next few quarters? Maybe if I can- Maybe I can. Yeah. Yeah. Yeah. Again, what Jean-François Fournier, the new Business Unit Head, will be leading is, of course, putting the sales force in place. Again, the promotional model that we have behind those products are definitely a specialty model where we think that a field force composed of 12-14 reps on the field will be enough to basically cover ophthalmologists and optometrists for those products. That's a limited extra number of accounts, and we try of course to keep that under control. In terms of potential impact on the yearly basis, it should go on a quarter basis. I mean, it should be below CAD 500,000, CAD 500,0000, sorry, CAD 500,000 for supporting the sales force. That's what we have in mind. Allergy and allergic will be allocated respiratory and allergy business unit. Again, that's leveraging our current structure. That's great. Kinda you'd mentioned the expectation to have kind of the promotion up and running in kind of early November. Is that, you know, in terms of hiring these new sales reps and getting them up to speed, that's kind of the timeline you're looking at? Yeah, actually, Scott, I should say that we already started with one, or at least with one of them recently. No, we may have earlier hires because actually we find a substantial number of specialized representatives in ophthalmology. Of course, we're gonna make all the effort to bring on board the most talented people. In terms of starting really to detail and visiting those doctors, probably it will be around, let's say, in the first half of November. Got it. That's great. For Redesca, you know, you had touched on the transition to biosimilar market, and good to hear Redesca is still taking the lion's share of that. Kind of commenting on Ontario as a laggard. Do you have any comments on movement there? I know you've been kind of lobbying them. You know, are we seeing signs of them starting to go down the path of delisting? Or is that still something that we're kinda waiting for? No, that's as you know, Scott, I mean, we have been talking about this delisting for a while. Uncertainty certainly part of the game still. What has to be said is, okay, this situation is not only related to enoxaparin biosimilars, it's a general situation that we have seen for other biosimilars. Now what we are hearing is that we are very close to having a potential decision from ODB to delist. Putting your head a day ahead today would be really kind of having a crystal ball, but we are hearing that it should come soon. That's not official, but by contact with our customers. We have made representation, as you know, no later than July. I talked to the representative of the ODB office, making very clear the comparison with the other provinces, and they did acknowledge the situation. Again, BC biosimilar penetration has gone up to more than 80%. Even Quebec today, the last data we got is over 90%. It's kind of making the case for them really to push forward adopting this biosimilar framework or pushing a certain condition that would be supportive of developing a biosimilar market. Definitely lagging behind. Quite difficult, honestly, Scott, to put any date ahead of us, doing what we can to push for that. Yeah. No, I appreciate that. Just lastly on the new product, you know, certainly kind of unexpected this morning. I don't know if you have any kind of additional comments on the economics of the deal in terms of kind of payments, expected margins, for kind of the structure? Just a couple of comments on that. Number one, the FDA, there will be an FDA review on October 6 with Veru, so that's a very important date for everyone to see how the FDA is gonna assess their application for emergency use. The deal is currently structured as a commercial arrangement with double-digit revenue or margins. We expect also that deal will expand further as they require further services from us, both from a logistics, operational, regulatory and medical. It's a I don't wanna call it a phase one agreement, but it's an important agreement which can generate material revenues to us. As you know, COVID drugs in Canada are currently controlled or at least acquired by the federal government. We've already been in contact with the federal agencies to make them aware that there will be an application coming. It's a very exciting opportunity. It's hard to necessarily put a dollar amount on it yet. We believe if emergency or expedited review is given in Canada, in addition to going down the formal pathway of full-fledged approval of the drug under a NOC DIN sort of application, that it would be material to our margins and to our revenues. Right. Got it. I know you said that they're planning on doing the Health Canada submission kind of in the near term. Is that, you know, this month? Is that by the end of the year? It's actually in the process. They're going through a process. I remember it's indicated in our press release. They are going through a process which they've started in Australia, which encompasses a grouping of several countries that have sort of a common pathway. They've decided that they'll go through Australia, which would then lead them through Health Canada. That process started several weeks ago. My expectation is a couple of things. Number one, the FDA is the gateway for many countries. Should FDA give EUA access, then I think a lot of other countries will follow suit quickly. A lot will revolve around that October sixth date. Yeah. Lastly, you touched on it, that the kind of procurement for this is done through the federal government, and you have been kind of in touch with them. How long would you expect, you know, that process to take? You know, have the initial kind of comments been positive in your discussions? Well, Fred, maybe you can answer that interactions. Maybe just as a complement to Steve's comments before, actually all drugs in Canada related to any aspect associated with COVID-19 is going through a specific path for the regulatory approval. That's all starting with this regulatory approval, which is a combination of Health Canada deciding for that and the Public Health Agency Canada, PHAC, that is also pushing some product to be part of this accelerated process. As a result of that, then the purchase process is taking place under still the Public Health Agency with the Public Services and Procurement Canada. That's a centralized process of purchase as well, which is then dealing in the interesting way that then you're negotiating contract. It's depending on the regulatory path, but it could be coming very soon because the scope is making those treatment alternative available for COVID patients as soon as possible. At the end of the day, they are also dealing with provinces in order to supply all hospitals and to make the necessary transfer of knowledge on this product. That could be very fast, but again, very much depending on the status or on the regulatory status. Yeah. No, appreciate that. Well, thank you for taking the questions. Been hogging the airtime, so I'll jump off for the moment being. Thanks, gentlemen. Thank you. Once again, as a reminder, ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad. Your next question will be from Paul Svendsen at iA Capital Markets. Please go ahead. Good morning, guys. Just a couple questions from me on behalf of Chelsea. Congrats on the new deal. In terms of the, you know, market size, obviously this is something that's in flux, depending on the shape of the curve and so forth. Do you have some precedents in terms of, you know, remdesivir or some of the others in Canada for what kind of market size you could potentially be going after, if there is approval of sabizabulin? Well, maybe one thing, Fred, you'll. You know, remdesivir, based on the latest IQVIA data's revenues, is about CAD 30 million, and it's probably, it's pretty well its sole application right now is use in COVID. There are a number of other products, both existing that have been approved for COVID and a couple of new ones that have come out from Pfizer and what have you. Fred, maybe you wanna add some more to that. Yeah. Yeah, I see, Steve. I mean, you mentioned that the only benchmark we have today, which is the closest to what sabizabulin could be as a marketed product, is definitely remdesivir in the sense that we are dealing here with a population of patients which is hospitalized patients and at risk of acute respiratory distress syndrome. It's a very narrow population of patients, but with such a great kind of a impact on mortality rate. And despite the use of standard of care, this is also important to mention. It's a narrow population of patients, very much looking like what remdesivir is doing today. Not prevention, not prophylactic, meaning, you know, patients vaccinated at risk of hospitalization, that would be earlier on in the pathological process. Size again is, it could be, of course, depending on the price assumptions, which is still, of course, very early to talk about that, but the size of the population of patients again is close to what would have won over. What I would suggest is looking over the last three or four Veru Inc press releases, where they give a lot more detail about the study results and the outcomes. You know, the moniker is against placebo, but as Fred mentioned, it was against standard of care. Remdesivir, dexamethasone, and others were used in both sets of patients. It was double blind. The internal monitoring committee actually halted the study prior to completion because the results were so compelling in favor of the reduction of deaths for the sabizabulin group. The other thing was kind of interesting is they actually followed the patients for 60 days, which is a bit longer than some of the other studies have done. They've actually were able to capture patients who ultimately might have had more complications further away from the initiated trial. As Fred said, pricing is still very much up in the air. Obviously, I think the price negotiated in the U.S. will be a bit of an indicator of the prices that they will have around the world. We have some indication internally about that, but we can't disclose for the time being. Again, looking at those releases or if you have access to that New England Journal of Medicine publication, which came out, I believe, about two weeks ago or so, I think it'll give you a lot more insight into the drug. That's great. Thank you. I guess a similar follow-up, just in terms of the access consortium regulatory pathway. Is that something you have any precedence that you can look at in terms of the timeline that that process takes? I know it would be obviously different under the COVID, you know, NDS CV submission type, but is there any way to sort of ballpark what other, you know, similar applications have taken to go through that process? The thing I could say on that, and obviously none of the three of us are regulatory experts in our group. We have those people at the office. Veru is handling the regulatory process worldwide. They are consulting with us on it, but they want to drive that with a common platform, which is understandable. They've made the decision to go through Australia as the lead jurisdiction in this application. It's very difficult for us to say what the timeline would be. Obviously, the essence is it's emergency use, it's accelerated use. You would expect that to be talked about once. I think again, the big timeline and the next gating date is October sixth, when there's the formal review with the FDA, which have, by the way, inspected their various clinical sites. They had three sites around the world. Obviously, the results being what they were, there was a fair amount of interest in the types of patients. We understand the FDA has not only visited the sites but vetted all the data. October sixth will be, I think we'll have more to say about the timing of approval in Canada. Okay. That's helpful. I guess just one last question on this new product. In terms of the deal structure, you mentioned it's sort of early stage. Would there be any upfront or milestone components, or is this a revenue share, profit share basis? The latter. Okay, great. Then just in terms of for the quarter, trying to look at. I mean, last year, Q3 was obviously a bit idiosyncratic with the way the hospital sales were happening with Redesca. Is there any seasonality here that's a part of that, or was that a one-off thing that you know. Will we see a little bit of pull back in Q4 for Redesca, just for any sort of seasonality effects? I think what typically happens when you launch a product, and we did so several years back when we launched Onstryv, is there's a sort of a introduction to the wholesale channel, which generates across Canada, which typically generates sort of a one-time bubble at the beginning or bolus kind of at the beginning just to make sure that there is product in the pipeline. That's what was really the impetus for that strong quarter last year, which. Now we're more on a consistent run rate. What we're seeing is with Redesca, sales are consistently higher month-over-month, so we shouldn't have that bolus effect. Now, if Ontario does open up or when Ontario does open up, I think you're gonna see an acceleration of revenues, but I think it'll be much more smoother than having, you know, going straight from zero to high. I think we shipped over CAD 3 million of product in the month of July last year. Then subsequently, there's very little demand, so the product sits in the warehouse, and you have to start building demand. I think now we're much more on a sort of a conveyor belt kind of thing, where product is going out every day. It's being used across hospitals in Canada on a daily basis. The use of the product is fairly consistent month-over-month. I mean, it's used mostly in pre and post-surgical situations where patients are bedridden. You know, with COVID now, with more normalization of operating rooms, we see the revenues are fairly consistent month-over-month. Perfect. Thanks so much for taking our questions. I'll drop back into queue. Thank you. At this time, gentlemen, we have no further questions. Please proceed with your closing remarks. Thank you, operator. Again, thank you all for being on this call. It's an exciting time at Valeo. As I mentioned, our third sequential quarterly revenue growth double digit. We expect that to continue, certainly in the fourth quarter with the guidance that we're giving and four quarters going forward. We have six core products, all our revenue drivers all have growth, varying degrees of growth, but certainly growth potential that we are seeing and believing will occur. I mean, I think that's a nice diversified within our three business units. Q4, again, we talked about CAD 11 million, exceeding CAD 11 million of revenue. Revenues in 2023 are expected to double over revenues in 2022. This financing that we concluded with Sagard not only brings to us a very experienced stakeholder that we have a very good relationship with, and we have a lot of expectations going forward in terms of how we will work together. It provides stability for us. It provides flexibility. For all our shareholders and stakeholders, we want to reiterate that you know, cash management, driving towards cash flow break-even in 2023 are at the top of our list of objectives, and we're unwavering in that. I think that we now have the product base, we have the revenue growth, we have the margin growth. Our margin growth is in the mid, you know, mid- to high-30s%, and we expect that to continue to edge upwards. All bodes well for us reaching those objectives in 2023. Again, thanks to everyone for being on the call. We look forward to talking to you again shortly. Thank you, sir. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending, and at this time, we ask that you please disconnect your lines. Have a good day.